After 5 years, the combination of lenalidomide and rituximab as first-line therapy for mantle cell lymphoma (MCL) continues to show durable responses with manageable toxicities, long-term results from a phase 2 clinical trial show.

After a median follow-up of 64 months, 21 of 33 patients with initial responses remained in durable, minimal residual disease (MRD)-negative remission following induction with lenalidomide and rituximab and maintenance with those same two agents for at least 3 years.

The patients with durable responses included five who opted to discontinue maintenance after 3 years, reported Jia Ruan, MD, PhD, of Cornell University, New York, and her colleagues.

“Our long-term data provide proof of concept that an outpatient-based induction and maintenance strategy free of conventional chemotherapy is effective, safe, and feasible as first-line therapy for MCL,” they wrote. Their report was published in Blood.

In the multicenter, phase 2 single-arm study, 38 patients with untreated MCL were enrolled and treated with lenalidomide 20 mg daily on days 1-21 of each 28-day cycle for 12 cycles during induction, followed by dose reduction to 15 mg during the maintenance phase. Patients also received standard dose rituximab 375 mg/m² weekly for 4 weeks during cycle 1, then once every other cycle.

Patients remained on treatment until disease progression, unacceptable toxicities, or study withdrawal. Patients who remained in remission after 3 years, based on routine surveillance CT scans, had the option to discontinue maintenance.

Of the original 38 patients enrolled, 36 were evaluable for response, including 23 with a complete response (CR) and 10 with a partial response.

At the 64-month median follow-up, neither the median progression-free survival (PFS) nor duration of response had been reached.

Overall, 21 of the 33 patients with responses (64%) had ongoing responses, including six patients with responses beyond 6 years.

Estimated 3-year and 5-year PFS rates were 80.3% and 63.9%, respectively. Respective estimated 3- and 5-year overall survival rates were 89.5% and 77.4%.

Mantle cell lymphoma international prognostic index (MIPI) scores were not associated with either response or PFS rates, but patients with high-risk MIPI scores were significantly more likely to have worse overall survival (P = .04).

Grade 3 or greater hematologic toxicities included neutropenia in 42% of patients in both induction and maintenance, anemia in 8% and 3%, thrombocytopenia in 11% and 5%, and febrile neutropenia in 3% and 5%.

Secondary primary malignancies occurred in six patients. These included five noninvasive skin cancers requiring only local therapy without the need for study interruption. Two patients, including one with a skin cancer, died from the secondary malignancies, including one from Merkel cell carcinoma and one from pancreatic cancer.

“The efficacy and survival outcome observed in our study compared favorably to those reported with lenalidomide either as single agent, or in combination with rituximab in relapsed and refractory setting, lending support for prioritizing novel agents such as lenalidomide early in the treatment sequence, to compare to conventional chemotherapy-based approach,” the investigators wrote.

The study was supported in part by Celgene Corporation, a Clinical Translational Science Center grant, and the Lymphoma Foundation. Dr. Ruan has received research support and been a consultant for Celgene, and other coauthors reported research support and consultant relationships with the company.

SOURCE: Ruan J et al. Blood. 2018 Sep 4. doi: 10.1182/blood-2018-07-859769.

After 5 years, the combination of lenalidomide and rituximab as first-line therapy for mantle cell lymphoma (MCL) continues to show durable responses with manageable toxicities, long-term results from a phase 2 clinical trial show.

After a median follow-up of 64 months, 21 of 33 patients with initial responses remained in durable, minimal residual disease (MRD)-negative remission following induction with lenalidomide and rituximab and maintenance with those same two agents for at least 3 years.

The patients with durable responses included five who opted to discontinue maintenance after 3 years, reported Jia Ruan, MD, PhD, of Cornell University, New York, and her colleagues.

“Our long-term data provide proof of concept that an outpatient-based induction and maintenance strategy free of conventional chemotherapy is effective, safe, and feasible as first-line therapy for MCL,” they wrote. Their report was published in Blood.

In the multicenter, phase 2 single-arm study, 38 patients with untreated MCL were enrolled and treated with lenalidomide 20 mg daily on days 1-21 of each 28-day cycle for 12 cycles during induction, followed by dose reduction to 15 mg during the maintenance phase. Patients also received standard dose rituximab 375 mg/m² weekly for 4 weeks during cycle 1, then once every other cycle.

Patients remained on treatment until disease progression, unacceptable toxicities, or study withdrawal. Patients who remained in remission after 3 years, based on routine surveillance CT scans, had the option to discontinue maintenance.

Of the original 38 patients enrolled, 36 were evaluable for response, including 23 with a complete response (CR) and 10 with a partial response.

At the 64-month median follow-up, neither the median progression-free survival (PFS) nor duration of response had been reached.

Overall, 21 of the 33 patients with responses (64%) had ongoing responses, including six patients with responses beyond 6 years.

Estimated 3-year and 5-year PFS rates were 80.3% and 63.9%, respectively. Respective estimated 3- and 5-year overall survival rates were 89.5% and 77.4%.

Mantle cell lymphoma international prognostic index (MIPI) scores were not associated with either response or PFS rates, but patients with high-risk MIPI scores were significantly more likely to have worse overall survival (P = .04).

Grade 3 or greater hematologic toxicities included neutropenia in 42% of patients in both induction and maintenance, anemia in 8% and 3%, thrombocytopenia in 11% and 5%, and febrile neutropenia in 3% and 5%.

Secondary primary malignancies occurred in six patients. These included five noninvasive skin cancers requiring only local therapy without the need for study interruption. Two patients, including one with a skin cancer, died from the secondary malignancies, including one from Merkel cell carcinoma and one from pancreatic cancer.

“The efficacy and survival outcome observed in our study compared favorably to those reported with lenalidomide either as single agent, or in combination with rituximab in relapsed and refractory setting, lending support for prioritizing novel agents such as lenalidomide early in the treatment sequence, to compare to conventional chemotherapy-based approach,” the investigators wrote.

The study was supported in part by Celgene Corporation, a Clinical Translational Science Center grant, and the Lymphoma Foundation. Dr. Ruan has received research support and been a consultant for Celgene, and other coauthors reported research support and consultant relationships with the company.

SOURCE: Ruan J et al. Blood. 2018 Sep 4. doi: 10.1182/blood-2018-07-859769.

After 5 years, the combination of lenalidomide and rituximab as first-line therapy for mantle cell lymphoma (MCL) continues to show durable responses with manageable toxicities, long-term results from a phase 2 clinical trial show.

After a median follow-up of 64 months, 21 of 33 patients with initial responses remained in durable, minimal residual disease (MRD)-negative remission following induction with lenalidomide and rituximab and maintenance with those same two agents for at least 3 years.

The patients with durable responses included five who opted to discontinue maintenance after 3 years, reported Jia Ruan, MD, PhD, of Cornell University, New York, and her colleagues.

“Our long-term data provide proof of concept that an outpatient-based induction and maintenance strategy free of conventional chemotherapy is effective, safe, and feasible as first-line therapy for MCL,” they wrote. Their report was published in Blood.

In the multicenter, phase 2 single-arm study, 38 patients with untreated MCL were enrolled and treated with lenalidomide 20 mg daily on days 1-21 of each 28-day cycle for 12 cycles during induction, followed by dose reduction to 15 mg during the maintenance phase. Patients also received standard dose rituximab 375 mg/m² weekly for 4 weeks during cycle 1, then once every other cycle.

Patients remained on treatment until disease progression, unacceptable toxicities, or study withdrawal. Patients who remained in remission after 3 years, based on routine surveillance CT scans, had the option to discontinue maintenance.

Of the original 38 patients enrolled, 36 were evaluable for response, including 23 with a complete response (CR) and 10 with a partial response.

At the 64-month median follow-up, neither the median progression-free survival (PFS) nor duration of response had been reached.

Overall, 21 of the 33 patients with responses (64%) had ongoing responses, including six patients with responses beyond 6 years.

Estimated 3-year and 5-year PFS rates were 80.3% and 63.9%, respectively. Respective estimated 3- and 5-year overall survival rates were 89.5% and 77.4%.

Mantle cell lymphoma international prognostic index (MIPI) scores were not associated with either response or PFS rates, but patients with high-risk MIPI scores were significantly more likely to have worse overall survival (P = .04).

Grade 3 or greater hematologic toxicities included neutropenia in 42% of patients in both induction and maintenance, anemia in 8% and 3%, thrombocytopenia in 11% and 5%, and febrile neutropenia in 3% and 5%.

Secondary primary malignancies occurred in six patients. These included five noninvasive skin cancers requiring only local therapy without the need for study interruption. Two patients, including one with a skin cancer, died from the secondary malignancies, including one from Merkel cell carcinoma and one from pancreatic cancer.

“The efficacy and survival outcome observed in our study compared favorably to those reported with lenalidomide either as single agent, or in combination with rituximab in relapsed and refractory setting, lending support for prioritizing novel agents such as lenalidomide early in the treatment sequence, to compare to conventional chemotherapy-based approach,” the investigators wrote.

The study was supported in part by Celgene Corporation, a Clinical Translational Science Center grant, and the Lymphoma Foundation. Dr. Ruan has received research support and been a consultant for Celgene, and other coauthors reported research support and consultant relationships with the company.

SOURCE: Ruan J et al. Blood. 2018 Sep 4. doi: 10.1182/blood-2018-07-859769.

The Food and Drug Administration has approved duvelisib (Copiktra), a dual PI3K delta/gamma inhibitor, for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma.

Duvelisib has full FDA approval to treat adults with relapsed or refractory CLL/SLL who have received at least two prior therapies. Duvelisib also has accelerated approval to treat adults with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

Accelerated approval is based on a surrogate or intermediate endpoint – in this case, overall response rate – that is reasonably likely to predict clinical benefit. Continued approval of duvelisib in FL may be contingent upon results of confirmatory trials verifying that the drug provides a clinical benefit.

Duvelisib will be available in the U.S. immediately, according to Verastem, the company marketing the drug. The prescribing information for duvelisib includes a boxed warning detailing four fatal and/or serious toxicities associated with the drug – infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem said it is implementing an informational risk evaluation and mitigation strategy to provide appropriate dosing and safety information for duvelisib.

The recommended dose of duvelisib is 25 mg orally twice daily, taken continuously in 28-day treatment cycles.

The FDA’s approval of duvelisib is supported by data from the phase 3 DUO trial and the phase 2 DYNAMO trial. The DUO trial included 319 patients with CLL (n=312) or SLL (n=7) who had received at least one prior therapy. They were randomized to receive either duvelisib (25 mg orally twice daily) or ofatumumab (initial infusion of 300 mg followed by 7 weekly infusions and 4 monthly infusions of 2,000 mg).

Efficacy results are based on patients who had received at least two prior therapies, including 95 patients in the duvelisib arm and 101 in the ofatumumab arm. The overall response rate was 78% in the duvelisib arm and 39% in the ofatumumab arm. All responses in both arms were partial responses.

The median progression-free survival was 16.4 months with duvelisib and 9.1 months with ofatumumab.

The safety results include all patients treated with duvelisib or ofatumumab in this trial. In the duvelisib arm, 12% of patients had fatal adverse events (AEs) within 30 days of the last dose. The same was true of 4% of patients treated with ofatumumab. Serious AEs occurred in 73% of patients treated with duvelisib. The most common were infection and diarrhea/colitis. The DYNAMO trial enrolled patients with indolent non-Hodgkin lymphoma whose disease was refractory to both rituximab and chemotherapy or radioimmunotherapy. There were 83 patients with FL.

Patients received duvelisib at 25 mg orally twice daily until disease progression or unacceptable toxicity.

The overall response rate was 42%. One patient achieved a complete response, and 34 had a partial response.

Forty-three percent of responders maintained their response at 6 months, and 17% maintained their response at 12 months.

Serious AEs occurred in 58% of FL patients. The most common were diarrhea/colitis, pneumonia, renal insufficiency, rash, and sepsis.

[email protected]

The Food and Drug Administration has approved duvelisib (Copiktra), a dual PI3K delta/gamma inhibitor, for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma.

Duvelisib has full FDA approval to treat adults with relapsed or refractory CLL/SLL who have received at least two prior therapies. Duvelisib also has accelerated approval to treat adults with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

Accelerated approval is based on a surrogate or intermediate endpoint – in this case, overall response rate – that is reasonably likely to predict clinical benefit. Continued approval of duvelisib in FL may be contingent upon results of confirmatory trials verifying that the drug provides a clinical benefit.

Duvelisib will be available in the U.S. immediately, according to Verastem, the company marketing the drug. The prescribing information for duvelisib includes a boxed warning detailing four fatal and/or serious toxicities associated with the drug – infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem said it is implementing an informational risk evaluation and mitigation strategy to provide appropriate dosing and safety information for duvelisib.

The recommended dose of duvelisib is 25 mg orally twice daily, taken continuously in 28-day treatment cycles.

The FDA’s approval of duvelisib is supported by data from the phase 3 DUO trial and the phase 2 DYNAMO trial. The DUO trial included 319 patients with CLL (n=312) or SLL (n=7) who had received at least one prior therapy. They were randomized to receive either duvelisib (25 mg orally twice daily) or ofatumumab (initial infusion of 300 mg followed by 7 weekly infusions and 4 monthly infusions of 2,000 mg).

Efficacy results are based on patients who had received at least two prior therapies, including 95 patients in the duvelisib arm and 101 in the ofatumumab arm. The overall response rate was 78% in the duvelisib arm and 39% in the ofatumumab arm. All responses in both arms were partial responses.

The median progression-free survival was 16.4 months with duvelisib and 9.1 months with ofatumumab.

The safety results include all patients treated with duvelisib or ofatumumab in this trial. In the duvelisib arm, 12% of patients had fatal adverse events (AEs) within 30 days of the last dose. The same was true of 4% of patients treated with ofatumumab. Serious AEs occurred in 73% of patients treated with duvelisib. The most common were infection and diarrhea/colitis. The DYNAMO trial enrolled patients with indolent non-Hodgkin lymphoma whose disease was refractory to both rituximab and chemotherapy or radioimmunotherapy. There were 83 patients with FL.

Patients received duvelisib at 25 mg orally twice daily until disease progression or unacceptable toxicity.

The overall response rate was 42%. One patient achieved a complete response, and 34 had a partial response.

Forty-three percent of responders maintained their response at 6 months, and 17% maintained their response at 12 months.

Serious AEs occurred in 58% of FL patients. The most common were diarrhea/colitis, pneumonia, renal insufficiency, rash, and sepsis.

[email protected]

The Food and Drug Administration has approved duvelisib (Copiktra), a dual PI3K delta/gamma inhibitor, for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma.

Duvelisib has full FDA approval to treat adults with relapsed or refractory CLL/SLL who have received at least two prior therapies. Duvelisib also has accelerated approval to treat adults with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

Accelerated approval is based on a surrogate or intermediate endpoint – in this case, overall response rate – that is reasonably likely to predict clinical benefit. Continued approval of duvelisib in FL may be contingent upon results of confirmatory trials verifying that the drug provides a clinical benefit.

Duvelisib will be available in the U.S. immediately, according to Verastem, the company marketing the drug. The prescribing information for duvelisib includes a boxed warning detailing four fatal and/or serious toxicities associated with the drug – infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem said it is implementing an informational risk evaluation and mitigation strategy to provide appropriate dosing and safety information for duvelisib.

The recommended dose of duvelisib is 25 mg orally twice daily, taken continuously in 28-day treatment cycles.

The FDA’s approval of duvelisib is supported by data from the phase 3 DUO trial and the phase 2 DYNAMO trial. The DUO trial included 319 patients with CLL (n=312) or SLL (n=7) who had received at least one prior therapy. They were randomized to receive either duvelisib (25 mg orally twice daily) or ofatumumab (initial infusion of 300 mg followed by 7 weekly infusions and 4 monthly infusions of 2,000 mg).

Efficacy results are based on patients who had received at least two prior therapies, including 95 patients in the duvelisib arm and 101 in the ofatumumab arm. The overall response rate was 78% in the duvelisib arm and 39% in the ofatumumab arm. All responses in both arms were partial responses.

The median progression-free survival was 16.4 months with duvelisib and 9.1 months with ofatumumab.

The safety results include all patients treated with duvelisib or ofatumumab in this trial. In the duvelisib arm, 12% of patients had fatal adverse events (AEs) within 30 days of the last dose. The same was true of 4% of patients treated with ofatumumab. Serious AEs occurred in 73% of patients treated with duvelisib. The most common were infection and diarrhea/colitis. The DYNAMO trial enrolled patients with indolent non-Hodgkin lymphoma whose disease was refractory to both rituximab and chemotherapy or radioimmunotherapy. There were 83 patients with FL.

Patients received duvelisib at 25 mg orally twice daily until disease progression or unacceptable toxicity.

The overall response rate was 42%. One patient achieved a complete response, and 34 had a partial response.

Forty-three percent of responders maintained their response at 6 months, and 17% maintained their response at 12 months.

Serious AEs occurred in 58% of FL patients. The most common were diarrhea/colitis, pneumonia, renal insufficiency, rash, and sepsis.

[email protected]

SAN DIEGO – An all-comers trial conducted in China confirms that intravascular ultrasound (IVUS)–guided implantation of drug-eluting stents (DES) resulted in better clinical outcomes than did angiography-guided procedures, Jun-Jie Zhang, MD, said in reporting results of the ULTIMATE trial at the Transcatheter Cardiovascular Therapeutics annual meeting.

Jim Kling/MDedge News

The ULTIMATE trial is the latest in a line of evidence showing the utility of IVUS guidance, though uptake of the procedure is not high in the United States or Europe. Its broader focus also rounds out the findings of earlier studies, which focused on patients with more complex lesions.

“How can people continue to ignore the importance of imaging-guided stent optimization? Even with second-generation DES, the results are consistent across the studies. This is just another piece of irrefutable evidence,” said discussant Gary Mintz, MD.

That sentiment was generally echoed by the rest of the panel. John McB Hodgson, MD, a professor of medicine at MetroHealth Medical Center in Cleveland, also pointed out the consistency of the body of evidence supporting the use of imaging. The study also represented a variety of cases, and the angiography arm of the study showed that the procedure was performed to a high standard. “It shows that even with a good angiographic approach, IVUS still wins. I’m amazed that there’s still some resistance to image guidance,” said Dr. Hodgson.

In ULTIMATE, 1,448 all-comer patients were randomized to either IVUS-guided or angiography-guided DES implantation. Patients with a life-expectancy shorter than 12 months, who were intolerant of dual-antiplatelet therapy, or who had severe calcification needing rotational atherectomy were excluded.

The procedural time was longer in the IVUS group, at 61 min, compared with 45 min in the angiography group, and the contrast volume was higher, at 178 mL and 162 mL, respectively (P less than .001 for both). At 30 days, the incidence of target vessel failure (TVF) was 0.8% in the IVUS group and 1.9% in the angiographic group, though this difference did not reach statistical significance (P = .08). The trend did reach significance at 1 year, with failure occurring in 2.9% of IVUS patients and 5.4% of angiography patients (P = .019). The hazard ratio for TVF in the IVUS group was 0.53 (95% confidence interval, 0.312-0.901), for a relative risk reduction of 47%, reported Dr. Zhang of Nanjing (China) Medical University.

Patients also underwent a postprocedure IVUS assessment to determine whether the stent was deployed optimally or suboptimally. The criteria for optimal deployment included minimal lumen area in the stented segment at least 5.0 mm², or 90% of the minimal lumen area at distal reference segment meeting that criteria; a less than 50% plaque burden at the 5 mm of vessel proximal or distal to the stent edge; and no edge dissection involving media greater than 3 mm in length.

More than half (53%) of patients in the IVUS group had optimal placement, and 47% did not. Significantly fewer (1.6%) of patients with optimal IVUS experienced TVF at 12 months, compared with 4.4% of the suboptimal group (HR, 0.35; 95% CI, 0.135-0.898). The results were published online simultaneously with the presentation in the Journal of the American College of Cardiology.

“I’m particularly impressed by the analysis of the optimal versus nonoptimal group. If you don’t use IVUS correctly, you don’t get a benefit. The ones who did not get optimal stenting were very similar to the angiographic group,” said Dr. Mintz, chief medical officer at the Cardiovascular Research Foundation, which sponsored the meeting.

ULTIMATE was funded by the National Science Foundation of China and several other research organizations. Dr. Zhang had no relevant disclosures. Dr. Mintz has received research support and/or consulting fees from Abbott Vascular, Boston Scientific, Volcano, and Infraredx. Dr. Hodgson has received research support and consulted for Volcano.

SAN DIEGO – An all-comers trial conducted in China confirms that intravascular ultrasound (IVUS)–guided implantation of drug-eluting stents (DES) resulted in better clinical outcomes than did angiography-guided procedures, Jun-Jie Zhang, MD, said in reporting results of the ULTIMATE trial at the Transcatheter Cardiovascular Therapeutics annual meeting.

Jim Kling/MDedge News

The ULTIMATE trial is the latest in a line of evidence showing the utility of IVUS guidance, though uptake of the procedure is not high in the United States or Europe. Its broader focus also rounds out the findings of earlier studies, which focused on patients with more complex lesions.

“How can people continue to ignore the importance of imaging-guided stent optimization? Even with second-generation DES, the results are consistent across the studies. This is just another piece of irrefutable evidence,” said discussant Gary Mintz, MD.

That sentiment was generally echoed by the rest of the panel. John McB Hodgson, MD, a professor of medicine at MetroHealth Medical Center in Cleveland, also pointed out the consistency of the body of evidence supporting the use of imaging. The study also represented a variety of cases, and the angiography arm of the study showed that the procedure was performed to a high standard. “It shows that even with a good angiographic approach, IVUS still wins. I’m amazed that there’s still some resistance to image guidance,” said Dr. Hodgson.

In ULTIMATE, 1,448 all-comer patients were randomized to either IVUS-guided or angiography-guided DES implantation. Patients with a life-expectancy shorter than 12 months, who were intolerant of dual-antiplatelet therapy, or who had severe calcification needing rotational atherectomy were excluded.

The procedural time was longer in the IVUS group, at 61 min, compared with 45 min in the angiography group, and the contrast volume was higher, at 178 mL and 162 mL, respectively (P less than .001 for both). At 30 days, the incidence of target vessel failure (TVF) was 0.8% in the IVUS group and 1.9% in the angiographic group, though this difference did not reach statistical significance (P = .08). The trend did reach significance at 1 year, with failure occurring in 2.9% of IVUS patients and 5.4% of angiography patients (P = .019). The hazard ratio for TVF in the IVUS group was 0.53 (95% confidence interval, 0.312-0.901), for a relative risk reduction of 47%, reported Dr. Zhang of Nanjing (China) Medical University.

Patients also underwent a postprocedure IVUS assessment to determine whether the stent was deployed optimally or suboptimally. The criteria for optimal deployment included minimal lumen area in the stented segment at least 5.0 mm², or 90% of the minimal lumen area at distal reference segment meeting that criteria; a less than 50% plaque burden at the 5 mm of vessel proximal or distal to the stent edge; and no edge dissection involving media greater than 3 mm in length.

More than half (53%) of patients in the IVUS group had optimal placement, and 47% did not. Significantly fewer (1.6%) of patients with optimal IVUS experienced TVF at 12 months, compared with 4.4% of the suboptimal group (HR, 0.35; 95% CI, 0.135-0.898). The results were published online simultaneously with the presentation in the Journal of the American College of Cardiology.

“I’m particularly impressed by the analysis of the optimal versus nonoptimal group. If you don’t use IVUS correctly, you don’t get a benefit. The ones who did not get optimal stenting were very similar to the angiographic group,” said Dr. Mintz, chief medical officer at the Cardiovascular Research Foundation, which sponsored the meeting.

ULTIMATE was funded by the National Science Foundation of China and several other research organizations. Dr. Zhang had no relevant disclosures. Dr. Mintz has received research support and/or consulting fees from Abbott Vascular, Boston Scientific, Volcano, and Infraredx. Dr. Hodgson has received research support and consulted for Volcano.

SAN DIEGO – An all-comers trial conducted in China confirms that intravascular ultrasound (IVUS)–guided implantation of drug-eluting stents (DES) resulted in better clinical outcomes than did angiography-guided procedures, Jun-Jie Zhang, MD, said in reporting results of the ULTIMATE trial at the Transcatheter Cardiovascular Therapeutics annual meeting.

Jim Kling/MDedge News

The ULTIMATE trial is the latest in a line of evidence showing the utility of IVUS guidance, though uptake of the procedure is not high in the United States or Europe. Its broader focus also rounds out the findings of earlier studies, which focused on patients with more complex lesions.

“How can people continue to ignore the importance of imaging-guided stent optimization? Even with second-generation DES, the results are consistent across the studies. This is just another piece of irrefutable evidence,” said discussant Gary Mintz, MD.

That sentiment was generally echoed by the rest of the panel. John McB Hodgson, MD, a professor of medicine at MetroHealth Medical Center in Cleveland, also pointed out the consistency of the body of evidence supporting the use of imaging. The study also represented a variety of cases, and the angiography arm of the study showed that the procedure was performed to a high standard. “It shows that even with a good angiographic approach, IVUS still wins. I’m amazed that there’s still some resistance to image guidance,” said Dr. Hodgson.

In ULTIMATE, 1,448 all-comer patients were randomized to either IVUS-guided or angiography-guided DES implantation. Patients with a life-expectancy shorter than 12 months, who were intolerant of dual-antiplatelet therapy, or who had severe calcification needing rotational atherectomy were excluded.

The procedural time was longer in the IVUS group, at 61 min, compared with 45 min in the angiography group, and the contrast volume was higher, at 178 mL and 162 mL, respectively (P less than .001 for both). At 30 days, the incidence of target vessel failure (TVF) was 0.8% in the IVUS group and 1.9% in the angiographic group, though this difference did not reach statistical significance (P = .08). The trend did reach significance at 1 year, with failure occurring in 2.9% of IVUS patients and 5.4% of angiography patients (P = .019). The hazard ratio for TVF in the IVUS group was 0.53 (95% confidence interval, 0.312-0.901), for a relative risk reduction of 47%, reported Dr. Zhang of Nanjing (China) Medical University.

Patients also underwent a postprocedure IVUS assessment to determine whether the stent was deployed optimally or suboptimally. The criteria for optimal deployment included minimal lumen area in the stented segment at least 5.0 mm², or 90% of the minimal lumen area at distal reference segment meeting that criteria; a less than 50% plaque burden at the 5 mm of vessel proximal or distal to the stent edge; and no edge dissection involving media greater than 3 mm in length.

More than half (53%) of patients in the IVUS group had optimal placement, and 47% did not. Significantly fewer (1.6%) of patients with optimal IVUS experienced TVF at 12 months, compared with 4.4% of the suboptimal group (HR, 0.35; 95% CI, 0.135-0.898). The results were published online simultaneously with the presentation in the Journal of the American College of Cardiology.

“I’m particularly impressed by the analysis of the optimal versus nonoptimal group. If you don’t use IVUS correctly, you don’t get a benefit. The ones who did not get optimal stenting were very similar to the angiographic group,” said Dr. Mintz, chief medical officer at the Cardiovascular Research Foundation, which sponsored the meeting.

ULTIMATE was funded by the National Science Foundation of China and several other research organizations. Dr. Zhang had no relevant disclosures. Dr. Mintz has received research support and/or consulting fees from Abbott Vascular, Boston Scientific, Volcano, and Infraredx. Dr. Hodgson has received research support and consulted for Volcano.

SAN DIEGO – When it comes to preparing highly calcified coronary lesions for drug-eluting stents, rotational atherectomy has an early procedural advantage over modified balloons that cut or score the lesion, but yields similar clinical outcomes over time, according to results of the randomized PREPARE-CALC trial.

Susan London/MDedge News

“Because severe calcification is mostly excluded from randomized PCI [percutaneous coronary intervention] trials, there is poor evidence for best PCI practice,” commented presenter Gert Richardt, MD, PhD, chief of cardiology and angiology at the Heart Center Segeberger Kliniken, Bad Segeberg, Germany. “Most interventional cardiologists will agree it is essential to facilitate stent delivery and adequate stent expansion in severely calcified lesions.”

Compared with standard balloon preparation, rotational atherectomy (rotablation) achieves a higher stenting success rate and better acute luminal gain, but its stimulatory effect leads to neointima formation that translates to late lumen loss, he noted. New balloons and drug-eluting stents may alter that calculus, however.

The 200 patients in PREPARE-CALC were randomized evenly to undergo preparation of their severely calcified coronary lesions with rotational atherectomy or a modified cutting/scoring balloon, each followed by placement of drug-eluting stents.

Compared with modified balloons, rotational atherectomy yielded a higher rate of successful stent delivery and expansion, according to data reported at the Transcatheter Cardiovascular Therapeutics annual meeting and simultaneously published online (Circ Cardiovasc Interv. 2018;11:e007415). The two methods did not differ significantly with respect to the 9-month magnitude of restenosis or rate of target vessel failure, at 6% with rotational atherectomy and 8% with modified balloons.

Importantly, about one in six patients in the modified balloon group had to cross over to rotational atherectomy because the balloon could not pass or sufficiently dilate the lesion.

“In patients with severely calcified coronary lesions, elective rotablation is feasible in nearly all patients, and the acute success rate is superior to modified balloons. Both approaches, elective rotational atherectomy and balloon plus bailout rotational atherectomy, are equally safe and effective,” Dr. Richardt summarized at the meeting sponsored by the Cardiovascular Research Foundation. “Use of rotablation is no longer associated with excessive late lumen loss in the era of modern drug-eluting stents.”
 

An underused tool

“This is a little bit ‘back to the future’ for me,” commented press conference panelist Mark Reisman, MD, director of the Center for Emerging Cardiovascular Therapies and head of UW Cardiology, Seattle. The PREPARE-CALC results are not surprising, but low uptake of rotablation in Europe, at just 1%-2%, is surprising and unexplained.

Susan London/MDedge News

Importantly, the trial allows a sound comparison of rotational atherectomy with the best available alternatives, he said. “This may significantly impact the behavior and maybe some of the reimbursement in Europe. ... I’m sure that drives a lot of the decisions: cost as well as technique.”

Many of the original rotational atherectomy studies used larger burrs and multiple burrs, whereas the trial investigators applied less aggressive, more refined parameters. It will be interesting to look at their technique as it may have contributed to the favorable findings, according to Dr. Reisman.

“Based on what we just heard, there are very complex lesions that were maybe not being approached historically, which now people will feel a lot more confident in approaching, looking at the durable outcome with the Rotablator [Boston Scientific],” he summarized.

“From the practice of a clinician, it’s very frustrating to hit a calcified lesion and attempt to work on it up front and find you can’t cross it,” commented press conference panelist Morton J. Kern, MD, professor of medicine at the school of medicine and chief of medicine, VA Long Beach Health Care System, University of California, Irvine Medical Center. The high rate of crossover to rotablation in PREPARE-CALC speaks to this problem. Having to resort to this tool after failure of other lesional interventions often translates to a rockier overall procedure and clinical course.

Susan London/MDedge News

“Lesion preparation is underestimated. I know from my own experience that [in] those calcified long lesions where I didn’t use the Rotablator, I regretted it in a fair number of cases,” Dr. Kern said. “So my view is that we probably don’t use it enough. This trial suggests that you can get away [without it], but I think ultimately, we are going to need this tool, even though it’s not used in a huge number of patients.”
 

Trial details

Patients enrolled in PREPARE-CALC had severely calcified coronary lesions according to angiographic criteria. For lesion preparation, half underwent high-speed rotational atherectomy (Rotablator), and half underwent treatment with either a cutting balloon (Flextome, Boston Scientific) or a scoring balloon (AngioSculpt, AngioScore, or Scoreflex, OrbusNeich Medical). Thereafter, all received sirolimus-eluting stents (Orsiro, Biotronik).

Results reported at the meeting, which is sponsored by the Cardiovascular Research Foundation, showed that, compared with the modified balloons, rotational atherectomy yielded a higher rate of strategy success, defined as successful stent delivery and expansion with less than 20% in-stent residual stenosis and TIMI 3 flow, without crossover to the other arm or stent failure. The rotational atherectomy patients had a success rate of 98%, compared with 81% for the balloon patients (P = .0001).

“This difference was mainly driven by a high rate of crossovers from balloon to rotablation,” Dr. Richardt, noted, with 16% of patients assigned to the former modality ultimately receiving the latter. “These crossovers were due to noncrossable or nondilated lesions.”

Analyses suggested three subgroups did not benefit from rotational atherectomy when it came to strategy success: women, patients in whom the left anterior descending artery was the target, and patients not having type C lesions.

Quantitative coronary analysis showed that the acute lumen gain, whether in-stent or in-segment, did not differ significantly between the two preparation methods. “This is different from what we know from historical studies where the Rotablator was always achieving more acute gain than standard balloons,” Dr. Richardt commented.

Rotational atherectomy and modified balloons were similar with respect to the magnitude of in-stent late lumen loss (0.22 vs. 0.16 mm, P = .021 for superiority; P = .01 for noninferiority) and the rate of target-vessel failure (6% vs. 8%) at 9 months. Those failure rates were lower than the 10% expected from previous trials, he pointed out. “This might increase over time, but it’s not so far away from what we see in contemporary drug-eluting stent trials.”

Fluoroscopy time was about 4 minutes longer with rotational atherectomy than with modified balloons. “You may say that’s a lot. I would say in these 75-year-old patients, it is acceptable,” Dr. Richardt commented. “But to be honest, we had some cases where we had to place a pacemaker, and this increases the duration of the fluoroscopy time.”

The PREPARE-CALC findings should improve the rate of rotational atherectomy use in Europe, he said. “If you believe my data, then the rate should go up to 10% or 12%.”

Dr. Richardt disclosed that he receives speaker’s honoraria from Boston Scientific and Biotronik. The trial was sponsored by the Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH.

SAN DIEGO – When it comes to preparing highly calcified coronary lesions for drug-eluting stents, rotational atherectomy has an early procedural advantage over modified balloons that cut or score the lesion, but yields similar clinical outcomes over time, according to results of the randomized PREPARE-CALC trial.

Susan London/MDedge News

“Because severe calcification is mostly excluded from randomized PCI [percutaneous coronary intervention] trials, there is poor evidence for best PCI practice,” commented presenter Gert Richardt, MD, PhD, chief of cardiology and angiology at the Heart Center Segeberger Kliniken, Bad Segeberg, Germany. “Most interventional cardiologists will agree it is essential to facilitate stent delivery and adequate stent expansion in severely calcified lesions.”

Compared with standard balloon preparation, rotational atherectomy (rotablation) achieves a higher stenting success rate and better acute luminal gain, but its stimulatory effect leads to neointima formation that translates to late lumen loss, he noted. New balloons and drug-eluting stents may alter that calculus, however.

The 200 patients in PREPARE-CALC were randomized evenly to undergo preparation of their severely calcified coronary lesions with rotational atherectomy or a modified cutting/scoring balloon, each followed by placement of drug-eluting stents.

Compared with modified balloons, rotational atherectomy yielded a higher rate of successful stent delivery and expansion, according to data reported at the Transcatheter Cardiovascular Therapeutics annual meeting and simultaneously published online (Circ Cardiovasc Interv. 2018;11:e007415). The two methods did not differ significantly with respect to the 9-month magnitude of restenosis or rate of target vessel failure, at 6% with rotational atherectomy and 8% with modified balloons.

Importantly, about one in six patients in the modified balloon group had to cross over to rotational atherectomy because the balloon could not pass or sufficiently dilate the lesion.

“In patients with severely calcified coronary lesions, elective rotablation is feasible in nearly all patients, and the acute success rate is superior to modified balloons. Both approaches, elective rotational atherectomy and balloon plus bailout rotational atherectomy, are equally safe and effective,” Dr. Richardt summarized at the meeting sponsored by the Cardiovascular Research Foundation. “Use of rotablation is no longer associated with excessive late lumen loss in the era of modern drug-eluting stents.”
 

An underused tool

“This is a little bit ‘back to the future’ for me,” commented press conference panelist Mark Reisman, MD, director of the Center for Emerging Cardiovascular Therapies and head of UW Cardiology, Seattle. The PREPARE-CALC results are not surprising, but low uptake of rotablation in Europe, at just 1%-2%, is surprising and unexplained.

Susan London/MDedge News

Importantly, the trial allows a sound comparison of rotational atherectomy with the best available alternatives, he said. “This may significantly impact the behavior and maybe some of the reimbursement in Europe. ... I’m sure that drives a lot of the decisions: cost as well as technique.”

Many of the original rotational atherectomy studies used larger burrs and multiple burrs, whereas the trial investigators applied less aggressive, more refined parameters. It will be interesting to look at their technique as it may have contributed to the favorable findings, according to Dr. Reisman.

“Based on what we just heard, there are very complex lesions that were maybe not being approached historically, which now people will feel a lot more confident in approaching, looking at the durable outcome with the Rotablator [Boston Scientific],” he summarized.

“From the practice of a clinician, it’s very frustrating to hit a calcified lesion and attempt to work on it up front and find you can’t cross it,” commented press conference panelist Morton J. Kern, MD, professor of medicine at the school of medicine and chief of medicine, VA Long Beach Health Care System, University of California, Irvine Medical Center. The high rate of crossover to rotablation in PREPARE-CALC speaks to this problem. Having to resort to this tool after failure of other lesional interventions often translates to a rockier overall procedure and clinical course.

Susan London/MDedge News

“Lesion preparation is underestimated. I know from my own experience that [in] those calcified long lesions where I didn’t use the Rotablator, I regretted it in a fair number of cases,” Dr. Kern said. “So my view is that we probably don’t use it enough. This trial suggests that you can get away [without it], but I think ultimately, we are going to need this tool, even though it’s not used in a huge number of patients.”
 

Trial details

Patients enrolled in PREPARE-CALC had severely calcified coronary lesions according to angiographic criteria. For lesion preparation, half underwent high-speed rotational atherectomy (Rotablator), and half underwent treatment with either a cutting balloon (Flextome, Boston Scientific) or a scoring balloon (AngioSculpt, AngioScore, or Scoreflex, OrbusNeich Medical). Thereafter, all received sirolimus-eluting stents (Orsiro, Biotronik).

Results reported at the meeting, which is sponsored by the Cardiovascular Research Foundation, showed that, compared with the modified balloons, rotational atherectomy yielded a higher rate of strategy success, defined as successful stent delivery and expansion with less than 20% in-stent residual stenosis and TIMI 3 flow, without crossover to the other arm or stent failure. The rotational atherectomy patients had a success rate of 98%, compared with 81% for the balloon patients (P = .0001).

“This difference was mainly driven by a high rate of crossovers from balloon to rotablation,” Dr. Richardt, noted, with 16% of patients assigned to the former modality ultimately receiving the latter. “These crossovers were due to noncrossable or nondilated lesions.”

Analyses suggested three subgroups did not benefit from rotational atherectomy when it came to strategy success: women, patients in whom the left anterior descending artery was the target, and patients not having type C lesions.

Quantitative coronary analysis showed that the acute lumen gain, whether in-stent or in-segment, did not differ significantly between the two preparation methods. “This is different from what we know from historical studies where the Rotablator was always achieving more acute gain than standard balloons,” Dr. Richardt commented.

Rotational atherectomy and modified balloons were similar with respect to the magnitude of in-stent late lumen loss (0.22 vs. 0.16 mm, P = .021 for superiority; P = .01 for noninferiority) and the rate of target-vessel failure (6% vs. 8%) at 9 months. Those failure rates were lower than the 10% expected from previous trials, he pointed out. “This might increase over time, but it’s not so far away from what we see in contemporary drug-eluting stent trials.”

Fluoroscopy time was about 4 minutes longer with rotational atherectomy than with modified balloons. “You may say that’s a lot. I would say in these 75-year-old patients, it is acceptable,” Dr. Richardt commented. “But to be honest, we had some cases where we had to place a pacemaker, and this increases the duration of the fluoroscopy time.”

The PREPARE-CALC findings should improve the rate of rotational atherectomy use in Europe, he said. “If you believe my data, then the rate should go up to 10% or 12%.”

Dr. Richardt disclosed that he receives speaker’s honoraria from Boston Scientific and Biotronik. The trial was sponsored by the Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH.

SAN DIEGO – When it comes to preparing highly calcified coronary lesions for drug-eluting stents, rotational atherectomy has an early procedural advantage over modified balloons that cut or score the lesion, but yields similar clinical outcomes over time, according to results of the randomized PREPARE-CALC trial.

Susan London/MDedge News

“Because severe calcification is mostly excluded from randomized PCI [percutaneous coronary intervention] trials, there is poor evidence for best PCI practice,” commented presenter Gert Richardt, MD, PhD, chief of cardiology and angiology at the Heart Center Segeberger Kliniken, Bad Segeberg, Germany. “Most interventional cardiologists will agree it is essential to facilitate stent delivery and adequate stent expansion in severely calcified lesions.”

Compared with standard balloon preparation, rotational atherectomy (rotablation) achieves a higher stenting success rate and better acute luminal gain, but its stimulatory effect leads to neointima formation that translates to late lumen loss, he noted. New balloons and drug-eluting stents may alter that calculus, however.

The 200 patients in PREPARE-CALC were randomized evenly to undergo preparation of their severely calcified coronary lesions with rotational atherectomy or a modified cutting/scoring balloon, each followed by placement of drug-eluting stents.

Compared with modified balloons, rotational atherectomy yielded a higher rate of successful stent delivery and expansion, according to data reported at the Transcatheter Cardiovascular Therapeutics annual meeting and simultaneously published online (Circ Cardiovasc Interv. 2018;11:e007415). The two methods did not differ significantly with respect to the 9-month magnitude of restenosis or rate of target vessel failure, at 6% with rotational atherectomy and 8% with modified balloons.

Importantly, about one in six patients in the modified balloon group had to cross over to rotational atherectomy because the balloon could not pass or sufficiently dilate the lesion.

“In patients with severely calcified coronary lesions, elective rotablation is feasible in nearly all patients, and the acute success rate is superior to modified balloons. Both approaches, elective rotational atherectomy and balloon plus bailout rotational atherectomy, are equally safe and effective,” Dr. Richardt summarized at the meeting sponsored by the Cardiovascular Research Foundation. “Use of rotablation is no longer associated with excessive late lumen loss in the era of modern drug-eluting stents.”
 

An underused tool

“This is a little bit ‘back to the future’ for me,” commented press conference panelist Mark Reisman, MD, director of the Center for Emerging Cardiovascular Therapies and head of UW Cardiology, Seattle. The PREPARE-CALC results are not surprising, but low uptake of rotablation in Europe, at just 1%-2%, is surprising and unexplained.

Susan London/MDedge News

Importantly, the trial allows a sound comparison of rotational atherectomy with the best available alternatives, he said. “This may significantly impact the behavior and maybe some of the reimbursement in Europe. ... I’m sure that drives a lot of the decisions: cost as well as technique.”

Many of the original rotational atherectomy studies used larger burrs and multiple burrs, whereas the trial investigators applied less aggressive, more refined parameters. It will be interesting to look at their technique as it may have contributed to the favorable findings, according to Dr. Reisman.

“Based on what we just heard, there are very complex lesions that were maybe not being approached historically, which now people will feel a lot more confident in approaching, looking at the durable outcome with the Rotablator [Boston Scientific],” he summarized.

“From the practice of a clinician, it’s very frustrating to hit a calcified lesion and attempt to work on it up front and find you can’t cross it,” commented press conference panelist Morton J. Kern, MD, professor of medicine at the school of medicine and chief of medicine, VA Long Beach Health Care System, University of California, Irvine Medical Center. The high rate of crossover to rotablation in PREPARE-CALC speaks to this problem. Having to resort to this tool after failure of other lesional interventions often translates to a rockier overall procedure and clinical course.

Susan London/MDedge News

“Lesion preparation is underestimated. I know from my own experience that [in] those calcified long lesions where I didn’t use the Rotablator, I regretted it in a fair number of cases,” Dr. Kern said. “So my view is that we probably don’t use it enough. This trial suggests that you can get away [without it], but I think ultimately, we are going to need this tool, even though it’s not used in a huge number of patients.”
 

Trial details

Patients enrolled in PREPARE-CALC had severely calcified coronary lesions according to angiographic criteria. For lesion preparation, half underwent high-speed rotational atherectomy (Rotablator), and half underwent treatment with either a cutting balloon (Flextome, Boston Scientific) or a scoring balloon (AngioSculpt, AngioScore, or Scoreflex, OrbusNeich Medical). Thereafter, all received sirolimus-eluting stents (Orsiro, Biotronik).

Results reported at the meeting, which is sponsored by the Cardiovascular Research Foundation, showed that, compared with the modified balloons, rotational atherectomy yielded a higher rate of strategy success, defined as successful stent delivery and expansion with less than 20% in-stent residual stenosis and TIMI 3 flow, without crossover to the other arm or stent failure. The rotational atherectomy patients had a success rate of 98%, compared with 81% for the balloon patients (P = .0001).

“This difference was mainly driven by a high rate of crossovers from balloon to rotablation,” Dr. Richardt, noted, with 16% of patients assigned to the former modality ultimately receiving the latter. “These crossovers were due to noncrossable or nondilated lesions.”

Analyses suggested three subgroups did not benefit from rotational atherectomy when it came to strategy success: women, patients in whom the left anterior descending artery was the target, and patients not having type C lesions.

Quantitative coronary analysis showed that the acute lumen gain, whether in-stent or in-segment, did not differ significantly between the two preparation methods. “This is different from what we know from historical studies where the Rotablator was always achieving more acute gain than standard balloons,” Dr. Richardt commented.

Rotational atherectomy and modified balloons were similar with respect to the magnitude of in-stent late lumen loss (0.22 vs. 0.16 mm, P = .021 for superiority; P = .01 for noninferiority) and the rate of target-vessel failure (6% vs. 8%) at 9 months. Those failure rates were lower than the 10% expected from previous trials, he pointed out. “This might increase over time, but it’s not so far away from what we see in contemporary drug-eluting stent trials.”

Fluoroscopy time was about 4 minutes longer with rotational atherectomy than with modified balloons. “You may say that’s a lot. I would say in these 75-year-old patients, it is acceptable,” Dr. Richardt commented. “But to be honest, we had some cases where we had to place a pacemaker, and this increases the duration of the fluoroscopy time.”

The PREPARE-CALC findings should improve the rate of rotational atherectomy use in Europe, he said. “If you believe my data, then the rate should go up to 10% or 12%.”

Dr. Richardt disclosed that he receives speaker’s honoraria from Boston Scientific and Biotronik. The trial was sponsored by the Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH.

Boston Scientific announced the approval of its polymer-coated, paclitaxel-eluting Eluvia vascular stent just 2 days after the results of its pivotal trial, IMPERIAL, was presented at the Transcatheter Cardiovascular Therapeutics annual meeting in San Diego.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The Eluvia Drug-Eluting Vascular Stent System is designed to restore blood flow in the peripheral arteries above the knee – specifically, the superficial femoral artery and proximal popliteal artery, according to the company.

Lead investigator William A. Gray, MD, a cardiologist at the Lankenau Heart Institute, Wynnewood, Pa., presented the results of IMPERIAL at TCT 2018. The randomized, head-to-head trial compared the performance of Eluvia with the paclitaxel-eluting Zilver PTX, which at the time was the only drug-releasing stent approved in the United States for the indication. Patients had occlusive lesions of the superficial femoral and/or proximal popliteal arteries.

At 12 months, primary patency was 86.8% in the Eluvia group versus 81.5% among those randomized to Zilver PTX, meeting the threshold for noninferiority.

For the endpoint of target lesion revascularization, Eluvia was superior to Zilver PTX, with 4.5% and 9% of patients, respectively, requiring it (Lancet. 2018 Sep 22. doi: 10.1016/S0140-6736[18]32262-1).

According to Boston Scientific’s announcement of the approval, the drug-polymer combination used in the Eluvia stent offers sustained release of paclitaxel over 1 year to prevent tissue regrowth.

Eluvia was approved in Europe in early 2016.

[email protected]

Boston Scientific announced the approval of its polymer-coated, paclitaxel-eluting Eluvia vascular stent just 2 days after the results of its pivotal trial, IMPERIAL, was presented at the Transcatheter Cardiovascular Therapeutics annual meeting in San Diego.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The Eluvia Drug-Eluting Vascular Stent System is designed to restore blood flow in the peripheral arteries above the knee – specifically, the superficial femoral artery and proximal popliteal artery, according to the company.

Lead investigator William A. Gray, MD, a cardiologist at the Lankenau Heart Institute, Wynnewood, Pa., presented the results of IMPERIAL at TCT 2018. The randomized, head-to-head trial compared the performance of Eluvia with the paclitaxel-eluting Zilver PTX, which at the time was the only drug-releasing stent approved in the United States for the indication. Patients had occlusive lesions of the superficial femoral and/or proximal popliteal arteries.

At 12 months, primary patency was 86.8% in the Eluvia group versus 81.5% among those randomized to Zilver PTX, meeting the threshold for noninferiority.

For the endpoint of target lesion revascularization, Eluvia was superior to Zilver PTX, with 4.5% and 9% of patients, respectively, requiring it (Lancet. 2018 Sep 22. doi: 10.1016/S0140-6736[18]32262-1).

According to Boston Scientific’s announcement of the approval, the drug-polymer combination used in the Eluvia stent offers sustained release of paclitaxel over 1 year to prevent tissue regrowth.

Eluvia was approved in Europe in early 2016.

[email protected]

Boston Scientific announced the approval of its polymer-coated, paclitaxel-eluting Eluvia vascular stent just 2 days after the results of its pivotal trial, IMPERIAL, was presented at the Transcatheter Cardiovascular Therapeutics annual meeting in San Diego.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The Eluvia Drug-Eluting Vascular Stent System is designed to restore blood flow in the peripheral arteries above the knee – specifically, the superficial femoral artery and proximal popliteal artery, according to the company.

Lead investigator William A. Gray, MD, a cardiologist at the Lankenau Heart Institute, Wynnewood, Pa., presented the results of IMPERIAL at TCT 2018. The randomized, head-to-head trial compared the performance of Eluvia with the paclitaxel-eluting Zilver PTX, which at the time was the only drug-releasing stent approved in the United States for the indication. Patients had occlusive lesions of the superficial femoral and/or proximal popliteal arteries.

At 12 months, primary patency was 86.8% in the Eluvia group versus 81.5% among those randomized to Zilver PTX, meeting the threshold for noninferiority.

For the endpoint of target lesion revascularization, Eluvia was superior to Zilver PTX, with 4.5% and 9% of patients, respectively, requiring it (Lancet. 2018 Sep 22. doi: 10.1016/S0140-6736[18]32262-1).

According to Boston Scientific’s announcement of the approval, the drug-polymer combination used in the Eluvia stent offers sustained release of paclitaxel over 1 year to prevent tissue regrowth.

Eluvia was approved in Europe in early 2016.

[email protected]

PARIS – Two compelling reasons exist to take excessive sweating in children and adolescents more seriously, Lawrence J. Green, MD, asserted at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

One is that this is a surprisingly common and embarrassing medical condition that can have a profound adverse developmental impact in young people at a time when they are engaged in forming their self-image.

The other reason to get serious about addressing primary axillary hyperhidrosis in pediatric patients is the recent approval of glycopyrronium tosylate as a topical therapy, Dr. Green, a dermatologist at George Washington University, Washington. The treatment, glycopyrronium pads (Qbrexza), was approved by the Food and Drug Administration for the topical treatment of primary axillary hyperhidrosis in patients aged 9 years and older in June 2018, and will be available in October 2018.

He presented new data from a 44-week, open-label extension of two pivotal 4-week, phase 3, randomized, double-blind, placebo-controlled trials known as ATMOS-1 and ATMOS-2. The new post hoc analysis from the extension study, known as the ARIDO study, provides reassurance that the product remains both safe and durably effective with longterm use.

Dr. Green’s analysis focused on the 44 pediatric participants aged 9-16 years. That’s because even though primary axillary hyperhidrosis affects people of all ages, with an estimated 4.8% prevalence in the U.S. population – 5.3 million people – it is more common in children and adolescents than adults. And it hits them particularly hard.

“Hyperhidrosis is largely underdiagnosed and undertreated, particularly among pediatric patients,” he said. “The impact on quality of life is comparable to or greater than acne, psoriasis, or eczema.”

The glycopyrronium pad is self-applied as a once-daily wipe. Glycopyrronium is an anticholinergic agent, which blocks sweat production by inhibiting the receptors that activate sweat glands.

Dr. Green noted several key findings from the 44-week ARIDO analysis, presented for the first time at the EADV congress.

The median absolute decrease in sweat production in pediatric patients at 44 weeks as measured gravimetrically was 50.3 mg per 5 minutes from a baseline of 150 mg per 5 minutes, comparable with the mean 75 mg reduction from a baseline of 175 mg in the 507-patient older cohort. However, Dr. Green advised not to make too much of this endpoint, as sweat production is notoriously difficult to measure accurately. In addition, an individual’s sweat rate can vary widely depending upon a multitude of factors, including ambient temperature and even what a patient is thinking about. The FDA recognizes this and therefore elevated several validated patient-reported outcomes to the status of coprimary endpoints in the clinical trials.

A positive result on one such patient-reported outcome, the Hyperhidrosis Severity Scale, was achieved in 57% of pediatric patients and 64% of adults at week 44 of open-label therapy. This required at least a 2-grade improvement from baseline, when roughly 60% of youths had a score of 3 and the remainder scored 4 on the 1-4 point scale.

From a mean baseline score of 9.2 on the Children’s Dermatology Life Quality Index, the pediatric group averaged a mean 6.2-point improvement at week 44, while adults experienced a mean 8.7-point improvement on the Dermatology Life Quality Index from a baseline of 11.25.

There was no diminution in treatment efficacy through 44 weeks, Dr. Green noted. Treatment-emergent adverse events consisted largely of transient mild to moderate anticholinergic effects, which seldom led to study discontinuation.

Dilated pupils and blurred vision were more common in children than adults (7.9% and 10.5% vs. 5.1% and 6.4%, respectively). “Why that is I can only speculate. Kids do tend to touch their eyes more often than adults. Pretty much everything else was the same. The adverse events can be worked around by educating people to use the pads appropriately. We saw the anticholinergic side effects more often in the first 4 weeks of the double-blind trials than in the longterm extension because once patients learned how to use the pad and not touch themselves afterwards, the adverse events came down,” he said.

The studies were sponsored by Dermira. Dr. Green has received research funding from and been a consultant to the company.

[email protected]

PARIS – Two compelling reasons exist to take excessive sweating in children and adolescents more seriously, Lawrence J. Green, MD, asserted at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

One is that this is a surprisingly common and embarrassing medical condition that can have a profound adverse developmental impact in young people at a time when they are engaged in forming their self-image.

The other reason to get serious about addressing primary axillary hyperhidrosis in pediatric patients is the recent approval of glycopyrronium tosylate as a topical therapy, Dr. Green, a dermatologist at George Washington University, Washington. The treatment, glycopyrronium pads (Qbrexza), was approved by the Food and Drug Administration for the topical treatment of primary axillary hyperhidrosis in patients aged 9 years and older in June 2018, and will be available in October 2018.

He presented new data from a 44-week, open-label extension of two pivotal 4-week, phase 3, randomized, double-blind, placebo-controlled trials known as ATMOS-1 and ATMOS-2. The new post hoc analysis from the extension study, known as the ARIDO study, provides reassurance that the product remains both safe and durably effective with longterm use.

Dr. Green’s analysis focused on the 44 pediatric participants aged 9-16 years. That’s because even though primary axillary hyperhidrosis affects people of all ages, with an estimated 4.8% prevalence in the U.S. population – 5.3 million people – it is more common in children and adolescents than adults. And it hits them particularly hard.

“Hyperhidrosis is largely underdiagnosed and undertreated, particularly among pediatric patients,” he said. “The impact on quality of life is comparable to or greater than acne, psoriasis, or eczema.”

The glycopyrronium pad is self-applied as a once-daily wipe. Glycopyrronium is an anticholinergic agent, which blocks sweat production by inhibiting the receptors that activate sweat glands.

Dr. Green noted several key findings from the 44-week ARIDO analysis, presented for the first time at the EADV congress.

The median absolute decrease in sweat production in pediatric patients at 44 weeks as measured gravimetrically was 50.3 mg per 5 minutes from a baseline of 150 mg per 5 minutes, comparable with the mean 75 mg reduction from a baseline of 175 mg in the 507-patient older cohort. However, Dr. Green advised not to make too much of this endpoint, as sweat production is notoriously difficult to measure accurately. In addition, an individual’s sweat rate can vary widely depending upon a multitude of factors, including ambient temperature and even what a patient is thinking about. The FDA recognizes this and therefore elevated several validated patient-reported outcomes to the status of coprimary endpoints in the clinical trials.

A positive result on one such patient-reported outcome, the Hyperhidrosis Severity Scale, was achieved in 57% of pediatric patients and 64% of adults at week 44 of open-label therapy. This required at least a 2-grade improvement from baseline, when roughly 60% of youths had a score of 3 and the remainder scored 4 on the 1-4 point scale.

From a mean baseline score of 9.2 on the Children’s Dermatology Life Quality Index, the pediatric group averaged a mean 6.2-point improvement at week 44, while adults experienced a mean 8.7-point improvement on the Dermatology Life Quality Index from a baseline of 11.25.

There was no diminution in treatment efficacy through 44 weeks, Dr. Green noted. Treatment-emergent adverse events consisted largely of transient mild to moderate anticholinergic effects, which seldom led to study discontinuation.

Dilated pupils and blurred vision were more common in children than adults (7.9% and 10.5% vs. 5.1% and 6.4%, respectively). “Why that is I can only speculate. Kids do tend to touch their eyes more often than adults. Pretty much everything else was the same. The adverse events can be worked around by educating people to use the pads appropriately. We saw the anticholinergic side effects more often in the first 4 weeks of the double-blind trials than in the longterm extension because once patients learned how to use the pad and not touch themselves afterwards, the adverse events came down,” he said.

The studies were sponsored by Dermira. Dr. Green has received research funding from and been a consultant to the company.

[email protected]

PARIS – Two compelling reasons exist to take excessive sweating in children and adolescents more seriously, Lawrence J. Green, MD, asserted at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

One is that this is a surprisingly common and embarrassing medical condition that can have a profound adverse developmental impact in young people at a time when they are engaged in forming their self-image.

The other reason to get serious about addressing primary axillary hyperhidrosis in pediatric patients is the recent approval of glycopyrronium tosylate as a topical therapy, Dr. Green, a dermatologist at George Washington University, Washington. The treatment, glycopyrronium pads (Qbrexza), was approved by the Food and Drug Administration for the topical treatment of primary axillary hyperhidrosis in patients aged 9 years and older in June 2018, and will be available in October 2018.

He presented new data from a 44-week, open-label extension of two pivotal 4-week, phase 3, randomized, double-blind, placebo-controlled trials known as ATMOS-1 and ATMOS-2. The new post hoc analysis from the extension study, known as the ARIDO study, provides reassurance that the product remains both safe and durably effective with longterm use.

Dr. Green’s analysis focused on the 44 pediatric participants aged 9-16 years. That’s because even though primary axillary hyperhidrosis affects people of all ages, with an estimated 4.8% prevalence in the U.S. population – 5.3 million people – it is more common in children and adolescents than adults. And it hits them particularly hard.

“Hyperhidrosis is largely underdiagnosed and undertreated, particularly among pediatric patients,” he said. “The impact on quality of life is comparable to or greater than acne, psoriasis, or eczema.”

The glycopyrronium pad is self-applied as a once-daily wipe. Glycopyrronium is an anticholinergic agent, which blocks sweat production by inhibiting the receptors that activate sweat glands.

Dr. Green noted several key findings from the 44-week ARIDO analysis, presented for the first time at the EADV congress.

The median absolute decrease in sweat production in pediatric patients at 44 weeks as measured gravimetrically was 50.3 mg per 5 minutes from a baseline of 150 mg per 5 minutes, comparable with the mean 75 mg reduction from a baseline of 175 mg in the 507-patient older cohort. However, Dr. Green advised not to make too much of this endpoint, as sweat production is notoriously difficult to measure accurately. In addition, an individual’s sweat rate can vary widely depending upon a multitude of factors, including ambient temperature and even what a patient is thinking about. The FDA recognizes this and therefore elevated several validated patient-reported outcomes to the status of coprimary endpoints in the clinical trials.

A positive result on one such patient-reported outcome, the Hyperhidrosis Severity Scale, was achieved in 57% of pediatric patients and 64% of adults at week 44 of open-label therapy. This required at least a 2-grade improvement from baseline, when roughly 60% of youths had a score of 3 and the remainder scored 4 on the 1-4 point scale.

From a mean baseline score of 9.2 on the Children’s Dermatology Life Quality Index, the pediatric group averaged a mean 6.2-point improvement at week 44, while adults experienced a mean 8.7-point improvement on the Dermatology Life Quality Index from a baseline of 11.25.

There was no diminution in treatment efficacy through 44 weeks, Dr. Green noted. Treatment-emergent adverse events consisted largely of transient mild to moderate anticholinergic effects, which seldom led to study discontinuation.

Dilated pupils and blurred vision were more common in children than adults (7.9% and 10.5% vs. 5.1% and 6.4%, respectively). “Why that is I can only speculate. Kids do tend to touch their eyes more often than adults. Pretty much everything else was the same. The adverse events can be worked around by educating people to use the pads appropriately. We saw the anticholinergic side effects more often in the first 4 weeks of the double-blind trials than in the longterm extension because once patients learned how to use the pad and not touch themselves afterwards, the adverse events came down,” he said.

The studies were sponsored by Dermira. Dr. Green has received research funding from and been a consultant to the company.

[email protected]

Rapidly increasing cases of newborn syphilis have reached their highest prevalence in 2 decades, according to a new report by the Centers for Disease Control and Prevention on sexually transmitted disease surveillance in 2017.

U.S. Centers for Disease Control and Prevention

Newborn syphilis incidence has more than doubled, from 362 cases in 2013 to 918 cases in 2017, resulting in 64 syphilitic stillbirths and 13 infant deaths that year, according to data published in Sexually Transmitted Disease Surveillance 2017.

At least one case was reported in 37 states last year, and the greatest burden of cases occurred in California, Arizona, Texas, Louisiana, and Florida, together accounting for 70% of all 2017 cases.

“The resurgence of syphilis, and particularly congenital syphilis, is not an arbitrary event, but rather a symptom of a deteriorating public health infrastructure and lack of access to health care,” wrote Gail Bolan, MD, director of the Division of STD Prevention at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. “It is exposing hidden, fragile populations in need that are not getting the health care and preventive services they deserve.”

Dr. Bolan recommends modernizing surveillance to capture more of the cases in populations without ready access to diagnosis and treatment and in those choosing not to access care.

“It is imperative that federal, state, and local programs employ strategies that maximize long-term population impact by reducing STD incidence and promoting sexual, reproductive, maternal, and infant health,” she wrote. “Further, it will be important for us to measure and monitor the adverse health consequences of STDs, such as ocular and neurosyphilis, pelvic inflammatory disease, ectopic pregnancy, infertility, HIV, congenital syphilis, and neonatal herpes.”

Multiple sources contributed data to the report: state and local STD programs’ notifiable disease reporting, private and federal national surveys, and specific projects that collect STD prevalence data, including the National Job Training Program, the STD Surveillance Network and the Gonococcal Isolate Surveillance Project.

The four nationally notifiable STDs are chlamydia, gonorrhea, syphilis, and chancroid.

The rise in newborn syphilis cases, currently at 23.3 cases per 100,000 live births, mirrors the increased U.S. prevalence of both primary and secondary syphilis in 2017, with 9.5 cases per 100,000 people. Syphilis has increased every year since 2000-2001, when prevalence was at a record low.
 

Chlamydia and gonorrhea rates climb too

The report also noted increases in the prevalence of other STDs. Chlamydia, the most common STD, increased 6.9% as compared to 2016, with 528.8 cases per 100,000 people. This increase occurred in all U.S. regions and independently of sex, race, or ethnicity, though rates were highest in teens and young adults. Nearly two-thirds of chlamydia cases in 2017 occurred in people ages 15-24 years old.

Reported rates were higher in women than in men, likely due to women’s increased likelihood of undergoing screening, the report suggested. Better surveillance may also partly explain the climb in men’s cases.

“Increases in rates among men may reflect an increased number of men, including gay, bisexual and other men who have sex with men (collectively referred to as MSM) being tested and diagnosed with a chlamydial infection due to increased availability of urine testing and extragenital screening,” according to the report.

The CDC received reports of more than a half million gonorrhea infections in 2017 (555,608 cases), an increase of 18.6% since the previous year, including a 19.3% increase among men and a 17.8% increase among women.

“The magnitude of the increase among men suggests either increased transmission, increased case ascertainment (e.g., through increased extra-genital screening among MSM), or both,” the authors wrote. “The concurrent increase in cases reported among women suggests parallel increases in heterosexual transmission, increased screening among women, or both.”

Overall, gonorrhea cases have skyrocketed 75.2% since their historic low in 2009, compounding the problem of antibiotic resistance that has limited CDC-recommended treatment to just ceftriaxone and azithromycin.

The report was supported by the Centers for Disease Control and Prevention. The authors did not report having any disclosures.

SOURCE: Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2017; https://www.cdc.gov/std/stats
 

Rapidly increasing cases of newborn syphilis have reached their highest prevalence in 2 decades, according to a new report by the Centers for Disease Control and Prevention on sexually transmitted disease surveillance in 2017.

U.S. Centers for Disease Control and Prevention

Newborn syphilis incidence has more than doubled, from 362 cases in 2013 to 918 cases in 2017, resulting in 64 syphilitic stillbirths and 13 infant deaths that year, according to data published in Sexually Transmitted Disease Surveillance 2017.

At least one case was reported in 37 states last year, and the greatest burden of cases occurred in California, Arizona, Texas, Louisiana, and Florida, together accounting for 70% of all 2017 cases.

“The resurgence of syphilis, and particularly congenital syphilis, is not an arbitrary event, but rather a symptom of a deteriorating public health infrastructure and lack of access to health care,” wrote Gail Bolan, MD, director of the Division of STD Prevention at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. “It is exposing hidden, fragile populations in need that are not getting the health care and preventive services they deserve.”

Dr. Bolan recommends modernizing surveillance to capture more of the cases in populations without ready access to diagnosis and treatment and in those choosing not to access care.

“It is imperative that federal, state, and local programs employ strategies that maximize long-term population impact by reducing STD incidence and promoting sexual, reproductive, maternal, and infant health,” she wrote. “Further, it will be important for us to measure and monitor the adverse health consequences of STDs, such as ocular and neurosyphilis, pelvic inflammatory disease, ectopic pregnancy, infertility, HIV, congenital syphilis, and neonatal herpes.”

Multiple sources contributed data to the report: state and local STD programs’ notifiable disease reporting, private and federal national surveys, and specific projects that collect STD prevalence data, including the National Job Training Program, the STD Surveillance Network and the Gonococcal Isolate Surveillance Project.

The four nationally notifiable STDs are chlamydia, gonorrhea, syphilis, and chancroid.

The rise in newborn syphilis cases, currently at 23.3 cases per 100,000 live births, mirrors the increased U.S. prevalence of both primary and secondary syphilis in 2017, with 9.5 cases per 100,000 people. Syphilis has increased every year since 2000-2001, when prevalence was at a record low.
 

Chlamydia and gonorrhea rates climb too

The report also noted increases in the prevalence of other STDs. Chlamydia, the most common STD, increased 6.9% as compared to 2016, with 528.8 cases per 100,000 people. This increase occurred in all U.S. regions and independently of sex, race, or ethnicity, though rates were highest in teens and young adults. Nearly two-thirds of chlamydia cases in 2017 occurred in people ages 15-24 years old.

Reported rates were higher in women than in men, likely due to women’s increased likelihood of undergoing screening, the report suggested. Better surveillance may also partly explain the climb in men’s cases.

“Increases in rates among men may reflect an increased number of men, including gay, bisexual and other men who have sex with men (collectively referred to as MSM) being tested and diagnosed with a chlamydial infection due to increased availability of urine testing and extragenital screening,” according to the report.

The CDC received reports of more than a half million gonorrhea infections in 2017 (555,608 cases), an increase of 18.6% since the previous year, including a 19.3% increase among men and a 17.8% increase among women.

“The magnitude of the increase among men suggests either increased transmission, increased case ascertainment (e.g., through increased extra-genital screening among MSM), or both,” the authors wrote. “The concurrent increase in cases reported among women suggests parallel increases in heterosexual transmission, increased screening among women, or both.”

Overall, gonorrhea cases have skyrocketed 75.2% since their historic low in 2009, compounding the problem of antibiotic resistance that has limited CDC-recommended treatment to just ceftriaxone and azithromycin.

The report was supported by the Centers for Disease Control and Prevention. The authors did not report having any disclosures.

SOURCE: Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2017; https://www.cdc.gov/std/stats
 

Rapidly increasing cases of newborn syphilis have reached their highest prevalence in 2 decades, according to a new report by the Centers for Disease Control and Prevention on sexually transmitted disease surveillance in 2017.

U.S. Centers for Disease Control and Prevention

Newborn syphilis incidence has more than doubled, from 362 cases in 2013 to 918 cases in 2017, resulting in 64 syphilitic stillbirths and 13 infant deaths that year, according to data published in Sexually Transmitted Disease Surveillance 2017.

At least one case was reported in 37 states last year, and the greatest burden of cases occurred in California, Arizona, Texas, Louisiana, and Florida, together accounting for 70% of all 2017 cases.

“The resurgence of syphilis, and particularly congenital syphilis, is not an arbitrary event, but rather a symptom of a deteriorating public health infrastructure and lack of access to health care,” wrote Gail Bolan, MD, director of the Division of STD Prevention at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. “It is exposing hidden, fragile populations in need that are not getting the health care and preventive services they deserve.”

Dr. Bolan recommends modernizing surveillance to capture more of the cases in populations without ready access to diagnosis and treatment and in those choosing not to access care.

“It is imperative that federal, state, and local programs employ strategies that maximize long-term population impact by reducing STD incidence and promoting sexual, reproductive, maternal, and infant health,” she wrote. “Further, it will be important for us to measure and monitor the adverse health consequences of STDs, such as ocular and neurosyphilis, pelvic inflammatory disease, ectopic pregnancy, infertility, HIV, congenital syphilis, and neonatal herpes.”

Multiple sources contributed data to the report: state and local STD programs’ notifiable disease reporting, private and federal national surveys, and specific projects that collect STD prevalence data, including the National Job Training Program, the STD Surveillance Network and the Gonococcal Isolate Surveillance Project.

The four nationally notifiable STDs are chlamydia, gonorrhea, syphilis, and chancroid.

The rise in newborn syphilis cases, currently at 23.3 cases per 100,000 live births, mirrors the increased U.S. prevalence of both primary and secondary syphilis in 2017, with 9.5 cases per 100,000 people. Syphilis has increased every year since 2000-2001, when prevalence was at a record low.
 

Chlamydia and gonorrhea rates climb too

The report also noted increases in the prevalence of other STDs. Chlamydia, the most common STD, increased 6.9% as compared to 2016, with 528.8 cases per 100,000 people. This increase occurred in all U.S. regions and independently of sex, race, or ethnicity, though rates were highest in teens and young adults. Nearly two-thirds of chlamydia cases in 2017 occurred in people ages 15-24 years old.

Reported rates were higher in women than in men, likely due to women’s increased likelihood of undergoing screening, the report suggested. Better surveillance may also partly explain the climb in men’s cases.

“Increases in rates among men may reflect an increased number of men, including gay, bisexual and other men who have sex with men (collectively referred to as MSM) being tested and diagnosed with a chlamydial infection due to increased availability of urine testing and extragenital screening,” according to the report.

The CDC received reports of more than a half million gonorrhea infections in 2017 (555,608 cases), an increase of 18.6% since the previous year, including a 19.3% increase among men and a 17.8% increase among women.

“The magnitude of the increase among men suggests either increased transmission, increased case ascertainment (e.g., through increased extra-genital screening among MSM), or both,” the authors wrote. “The concurrent increase in cases reported among women suggests parallel increases in heterosexual transmission, increased screening among women, or both.”

Overall, gonorrhea cases have skyrocketed 75.2% since their historic low in 2009, compounding the problem of antibiotic resistance that has limited CDC-recommended treatment to just ceftriaxone and azithromycin.

The report was supported by the Centers for Disease Control and Prevention. The authors did not report having any disclosures.

SOURCE: Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2017; https://www.cdc.gov/std/stats
 

The start of the school year brings excitement and some expected anxiety, around seeing friends and undertaking new challenges. While setbacks, small failures, and disappointments are an essential part of a child’s mastery of new challenges, academic and otherwise, occasionally a child will experience school failure in many areas. When this happens, the school usually will engage parents to help understand and address what might be interfering with the child’s performance at school. Parents may turn to their trusted pediatricians for guidance in sorting out school failure, as the list of possible causes is very long. By asking the right questions and knowing your patient, you can efficiently investigate this problem so that your patient may quickly get back on track, both academically and in overall development.

dtiberio/iStock/Getty Images

Are their academic problems a striking change from prior years? If your patients previously had managed coursework with ease, then there is a new problem interfering with their performance, unless they are young enough that earlier years were not as challenging. Possibly a previous school was not as demanding or new academic expectations such as writing an essay or a dramatic increase in reading expectations have exposed a learning disability or attentional issue that is interfering with performance. This can be sorted out by asking more specific questions about their function. Do they struggle more with reading, essay writing, or math? Do they struggle with sustained attention on assignments or handing in completed work? Your patients can help answer these questions, as can as parents and teachers. Neuropsychological testing can elucidate specific learning disabilities or indicate marked problems with attention, working memory, or processing speed that may be improved with cognitive coaching, in-class strategies, and even medications. With older patients, a new problem is less likely to be the first presentation of an underlying learning or attentional issue and will need further investigation.

Do your patients still enjoy school or are they resisting attending? Students who are avoiding school may be struggling with anxiety. This may be a consequence of their academic struggles, as they try to avoid the shame, embarrassment, or discomfort of their failure to understand material, keep up, or perform. Alternately, the anxiety may have come first, leading to an inability to manage the challenges of school and then failure academically. Similarly, a mood disorder such as depression can create problems with attention, energy, interest, and motivation that make it difficult to attend and participate in school.

Ask about any family history of school problems and psychiatric disorders as these issues often run in families. Ask if there is anxiety around academic or social performance or more generalized anxiety. Are they experiencing trouble with sleep, energy, appetite? Have they withdrawn from other interests? Are they more tearful or irritable in all settings? When these symptoms are universal (i.e., occurring across settings and affecting school), there is likely an underlying psychiatric disorder driving them, and they require a full psychiatric assessment. It is worth noting that often children or adolescents with mood or anxiety disorders will experience somatic symptoms such as stomach aches or headaches alongside the loss of energy and motivation. They may come to the pediatrician first, and it is important to investigate the likely psychiatric illnesses (anxiety in prepubertal children and anxiety or depression in adolescents) as well as the more esoteric medical problems that could be causing such universal impairment in a child or teenager. Stigma still exists around psychiatric illness and it is powerful when a pediatrician can tell a family that these illnesses are common in young people (affecting nearly 20% of children by the age of 18) and very treatable.

Drug and alcohol abuse may be associated with another psychiatric illness or can be independent problems that interfere with the healthy development and school performance of young people, including middle school students. Find out if your patients are drinking alcohol, using marijuana, vaping, utilizing prescription medications that are not their own, or using other illegal drugs. Substance use that has led to problems at school is by definition a problem (in addition to being illegal) and will not improve without treatment. These young people need a full psychiatric evaluation, and they and their parents require specialized treatment and support to address the substance abuse problem.

Of course, school failure may represent other sources of stress. It is critical to find out from your patients if they feel safe at school. Are they being bullied or threatened? Do they have a safe way to get to and from school? Has something else occurred at the school that has left them feeling vigilant and unable to concentrate on classwork? While bullying or living in a neighborhood plagued by violence may not be easy problems to fix, it is critical to find out about them so the adults – parents, teachers, and others – can provide the students with support while directly addressing the safety issue. Do not fail to find out if the fear is at home. Children who are managing physical or sexual abuse may be too stressed to complete homework or even attend school. A caring, curious pediatrician will be a lifeline to a safer future for these children.

Similarly, it is important to find out if your patient is managing less dramatic stresses at home. Perhaps a parent has been seriously ill, working two jobs, or managing a problem with drugs or alcohol, and your patient is caring for that person, or for siblings, instead of keeping up with schoolwork. Perhaps there has been a stressful loss or transition, such as the death of a grandparent or pet, the loss of a job, or a big move, or family discord/violence that has made it difficult for your patient to focus on homework or interfered with parental supervision or homework help. Perhaps your patient has gotten a job to help the family financially and has no time for homework. Bringing such a challenge out into the open and rallying support for your patient and the family in these circumstances is often enough to foster adaptation to these stresses and a return to healthy function in school.

Finally, it is possible that school failure is a function of milder imbalances in a young person’s life. Some children may respond to the expanded independence of adolescence by making poor choices. When do they go to bed at night? Are they staying up late playing video games or surfing the web? Not all insomnia represents illness. Find out how much independence your patients have and how they are managing their time and responsibilities. Help them to think about how to protect time for both responsibilities and relaxation. You also may help the parents of these young people think about how to set expectations and basic rules while stepping back appropriately to allow for expanding independence in ways that will help their children to flourish.

Once defined, school failure should be comprehensively treated because the educational consequences and potentially lifelong damage to self-esteem can be severe. Setting reasonable expectations, curriculum adjustments, any needed psychiatric treatment, building on a child’s strengths, and paying attention to self-esteem are the hallmarks of effective interventions.
 

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

The start of the school year brings excitement and some expected anxiety, around seeing friends and undertaking new challenges. While setbacks, small failures, and disappointments are an essential part of a child’s mastery of new challenges, academic and otherwise, occasionally a child will experience school failure in many areas. When this happens, the school usually will engage parents to help understand and address what might be interfering with the child’s performance at school. Parents may turn to their trusted pediatricians for guidance in sorting out school failure, as the list of possible causes is very long. By asking the right questions and knowing your patient, you can efficiently investigate this problem so that your patient may quickly get back on track, both academically and in overall development.

dtiberio/iStock/Getty Images

Are their academic problems a striking change from prior years? If your patients previously had managed coursework with ease, then there is a new problem interfering with their performance, unless they are young enough that earlier years were not as challenging. Possibly a previous school was not as demanding or new academic expectations such as writing an essay or a dramatic increase in reading expectations have exposed a learning disability or attentional issue that is interfering with performance. This can be sorted out by asking more specific questions about their function. Do they struggle more with reading, essay writing, or math? Do they struggle with sustained attention on assignments or handing in completed work? Your patients can help answer these questions, as can as parents and teachers. Neuropsychological testing can elucidate specific learning disabilities or indicate marked problems with attention, working memory, or processing speed that may be improved with cognitive coaching, in-class strategies, and even medications. With older patients, a new problem is less likely to be the first presentation of an underlying learning or attentional issue and will need further investigation.

Do your patients still enjoy school or are they resisting attending? Students who are avoiding school may be struggling with anxiety. This may be a consequence of their academic struggles, as they try to avoid the shame, embarrassment, or discomfort of their failure to understand material, keep up, or perform. Alternately, the anxiety may have come first, leading to an inability to manage the challenges of school and then failure academically. Similarly, a mood disorder such as depression can create problems with attention, energy, interest, and motivation that make it difficult to attend and participate in school.

Ask about any family history of school problems and psychiatric disorders as these issues often run in families. Ask if there is anxiety around academic or social performance or more generalized anxiety. Are they experiencing trouble with sleep, energy, appetite? Have they withdrawn from other interests? Are they more tearful or irritable in all settings? When these symptoms are universal (i.e., occurring across settings and affecting school), there is likely an underlying psychiatric disorder driving them, and they require a full psychiatric assessment. It is worth noting that often children or adolescents with mood or anxiety disorders will experience somatic symptoms such as stomach aches or headaches alongside the loss of energy and motivation. They may come to the pediatrician first, and it is important to investigate the likely psychiatric illnesses (anxiety in prepubertal children and anxiety or depression in adolescents) as well as the more esoteric medical problems that could be causing such universal impairment in a child or teenager. Stigma still exists around psychiatric illness and it is powerful when a pediatrician can tell a family that these illnesses are common in young people (affecting nearly 20% of children by the age of 18) and very treatable.

Drug and alcohol abuse may be associated with another psychiatric illness or can be independent problems that interfere with the healthy development and school performance of young people, including middle school students. Find out if your patients are drinking alcohol, using marijuana, vaping, utilizing prescription medications that are not their own, or using other illegal drugs. Substance use that has led to problems at school is by definition a problem (in addition to being illegal) and will not improve without treatment. These young people need a full psychiatric evaluation, and they and their parents require specialized treatment and support to address the substance abuse problem.

Of course, school failure may represent other sources of stress. It is critical to find out from your patients if they feel safe at school. Are they being bullied or threatened? Do they have a safe way to get to and from school? Has something else occurred at the school that has left them feeling vigilant and unable to concentrate on classwork? While bullying or living in a neighborhood plagued by violence may not be easy problems to fix, it is critical to find out about them so the adults – parents, teachers, and others – can provide the students with support while directly addressing the safety issue. Do not fail to find out if the fear is at home. Children who are managing physical or sexual abuse may be too stressed to complete homework or even attend school. A caring, curious pediatrician will be a lifeline to a safer future for these children.

Similarly, it is important to find out if your patient is managing less dramatic stresses at home. Perhaps a parent has been seriously ill, working two jobs, or managing a problem with drugs or alcohol, and your patient is caring for that person, or for siblings, instead of keeping up with schoolwork. Perhaps there has been a stressful loss or transition, such as the death of a grandparent or pet, the loss of a job, or a big move, or family discord/violence that has made it difficult for your patient to focus on homework or interfered with parental supervision or homework help. Perhaps your patient has gotten a job to help the family financially and has no time for homework. Bringing such a challenge out into the open and rallying support for your patient and the family in these circumstances is often enough to foster adaptation to these stresses and a return to healthy function in school.

Finally, it is possible that school failure is a function of milder imbalances in a young person’s life. Some children may respond to the expanded independence of adolescence by making poor choices. When do they go to bed at night? Are they staying up late playing video games or surfing the web? Not all insomnia represents illness. Find out how much independence your patients have and how they are managing their time and responsibilities. Help them to think about how to protect time for both responsibilities and relaxation. You also may help the parents of these young people think about how to set expectations and basic rules while stepping back appropriately to allow for expanding independence in ways that will help their children to flourish.

Once defined, school failure should be comprehensively treated because the educational consequences and potentially lifelong damage to self-esteem can be severe. Setting reasonable expectations, curriculum adjustments, any needed psychiatric treatment, building on a child’s strengths, and paying attention to self-esteem are the hallmarks of effective interventions.
 

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

The start of the school year brings excitement and some expected anxiety, around seeing friends and undertaking new challenges. While setbacks, small failures, and disappointments are an essential part of a child’s mastery of new challenges, academic and otherwise, occasionally a child will experience school failure in many areas. When this happens, the school usually will engage parents to help understand and address what might be interfering with the child’s performance at school. Parents may turn to their trusted pediatricians for guidance in sorting out school failure, as the list of possible causes is very long. By asking the right questions and knowing your patient, you can efficiently investigate this problem so that your patient may quickly get back on track, both academically and in overall development.

dtiberio/iStock/Getty Images

Are their academic problems a striking change from prior years? If your patients previously had managed coursework with ease, then there is a new problem interfering with their performance, unless they are young enough that earlier years were not as challenging. Possibly a previous school was not as demanding or new academic expectations such as writing an essay or a dramatic increase in reading expectations have exposed a learning disability or attentional issue that is interfering with performance. This can be sorted out by asking more specific questions about their function. Do they struggle more with reading, essay writing, or math? Do they struggle with sustained attention on assignments or handing in completed work? Your patients can help answer these questions, as can as parents and teachers. Neuropsychological testing can elucidate specific learning disabilities or indicate marked problems with attention, working memory, or processing speed that may be improved with cognitive coaching, in-class strategies, and even medications. With older patients, a new problem is less likely to be the first presentation of an underlying learning or attentional issue and will need further investigation.

Do your patients still enjoy school or are they resisting attending? Students who are avoiding school may be struggling with anxiety. This may be a consequence of their academic struggles, as they try to avoid the shame, embarrassment, or discomfort of their failure to understand material, keep up, or perform. Alternately, the anxiety may have come first, leading to an inability to manage the challenges of school and then failure academically. Similarly, a mood disorder such as depression can create problems with attention, energy, interest, and motivation that make it difficult to attend and participate in school.

Ask about any family history of school problems and psychiatric disorders as these issues often run in families. Ask if there is anxiety around academic or social performance or more generalized anxiety. Are they experiencing trouble with sleep, energy, appetite? Have they withdrawn from other interests? Are they more tearful or irritable in all settings? When these symptoms are universal (i.e., occurring across settings and affecting school), there is likely an underlying psychiatric disorder driving them, and they require a full psychiatric assessment. It is worth noting that often children or adolescents with mood or anxiety disorders will experience somatic symptoms such as stomach aches or headaches alongside the loss of energy and motivation. They may come to the pediatrician first, and it is important to investigate the likely psychiatric illnesses (anxiety in prepubertal children and anxiety or depression in adolescents) as well as the more esoteric medical problems that could be causing such universal impairment in a child or teenager. Stigma still exists around psychiatric illness and it is powerful when a pediatrician can tell a family that these illnesses are common in young people (affecting nearly 20% of children by the age of 18) and very treatable.

Drug and alcohol abuse may be associated with another psychiatric illness or can be independent problems that interfere with the healthy development and school performance of young people, including middle school students. Find out if your patients are drinking alcohol, using marijuana, vaping, utilizing prescription medications that are not their own, or using other illegal drugs. Substance use that has led to problems at school is by definition a problem (in addition to being illegal) and will not improve without treatment. These young people need a full psychiatric evaluation, and they and their parents require specialized treatment and support to address the substance abuse problem.

Of course, school failure may represent other sources of stress. It is critical to find out from your patients if they feel safe at school. Are they being bullied or threatened? Do they have a safe way to get to and from school? Has something else occurred at the school that has left them feeling vigilant and unable to concentrate on classwork? While bullying or living in a neighborhood plagued by violence may not be easy problems to fix, it is critical to find out about them so the adults – parents, teachers, and others – can provide the students with support while directly addressing the safety issue. Do not fail to find out if the fear is at home. Children who are managing physical or sexual abuse may be too stressed to complete homework or even attend school. A caring, curious pediatrician will be a lifeline to a safer future for these children.

Similarly, it is important to find out if your patient is managing less dramatic stresses at home. Perhaps a parent has been seriously ill, working two jobs, or managing a problem with drugs or alcohol, and your patient is caring for that person, or for siblings, instead of keeping up with schoolwork. Perhaps there has been a stressful loss or transition, such as the death of a grandparent or pet, the loss of a job, or a big move, or family discord/violence that has made it difficult for your patient to focus on homework or interfered with parental supervision or homework help. Perhaps your patient has gotten a job to help the family financially and has no time for homework. Bringing such a challenge out into the open and rallying support for your patient and the family in these circumstances is often enough to foster adaptation to these stresses and a return to healthy function in school.

Finally, it is possible that school failure is a function of milder imbalances in a young person’s life. Some children may respond to the expanded independence of adolescence by making poor choices. When do they go to bed at night? Are they staying up late playing video games or surfing the web? Not all insomnia represents illness. Find out how much independence your patients have and how they are managing their time and responsibilities. Help them to think about how to protect time for both responsibilities and relaxation. You also may help the parents of these young people think about how to set expectations and basic rules while stepping back appropriately to allow for expanding independence in ways that will help their children to flourish.

Once defined, school failure should be comprehensively treated because the educational consequences and potentially lifelong damage to self-esteem can be severe. Setting reasonable expectations, curriculum adjustments, any needed psychiatric treatment, building on a child’s strengths, and paying attention to self-esteem are the hallmarks of effective interventions.
 

Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

For the last 8 years I have worked as a locum tenens hospitalist. I began on this path when it was the least popular option upon graduation from residency.

I did countless hours of research trying to find accurate information about locum tenens companies, but never found anything written by physicians, only by the companies themselves. So, I stepped into this field blindfolded and learned the hard way. Since than, I have worked with over 16 locum tenens companies, 14 hospitals, and eight electronic medical record systems.

Through these experiences I’ve realized that, unfortunately, some locum tenens companies do not act with the professionalism and efficiency that both physicians and hospital systems would expect. This can lead to more stress than an actual employed position for physicians, and poor coverage with enormous costs for hospitals.

I decided to take matters into my own hands because I wanted to make the locum tenens system easier to navigate. I believe that the system can play a role in decreasing physician burnout, and I deeply understand the need that hospitals have to serve their patients with a shortage of doctors. As locum tenens physicians, we serve a need and shouldn’t have to deal with inefficient placement systems.

Here are five mistakes to avoid for physicians that are first entering into the locum tenens world:

1. Beware choosing a “factory mill” locum tenens company. Bigger companies have higher overhead, which usually means that they take more of a margin from physicians. Generally speaking, larger locum tenens companies pay their recruiters a lower percentage commission, so each recruiter has more physicians. This can lead to mistakes which can cause stress for both physicians and hospitals.

2. Beware long travel. Hourly rates that are $5-$10 dollars more per hour in remote locations are attractive. However, the amount of travel needed to get to these locations may not be worth it. When negotiating a rate, make sure not to lose sight of the amount of time it will take to travel to the hospital or outpatient location.

3. Beware short-term placements. There are a lot of hospitals that just need one or two weeks covered. Even if it’s at a much higher rate, the amount of paper work and credentialing hassle may not be worth the amount of time you work there. The greater number of cumulative hospitals worked, the longer credentialing will take in future locum tenens placements.

4. Beware using multiple travel services. Stick to one airline, one rental car company, and one hotel chain. This way when you are not working, you may be able to use the points earned during your work days for future vacations.

5. Beware companies that are not organized. If you find that a locum tenens company is asking you to do all of the paperwork to get credentialed, move on. This can be a red flag and may mean they lack credentialing staff. You should never have to fill out your own paperwork; rather you should be the one that simply reviews and corrects it.

Dr. Arora works as a liaison between hospitals, physicians, and locum tenens companies and is a member of The Hospitalist’s editorial advisory board. She negotiates rates and expectations with multiple locum tenens companies on behalf of physicians in all fields of practice and does not own or endorse a locum tenens company. You can contact her at www.doctorsliaison.com.

For the last 8 years I have worked as a locum tenens hospitalist. I began on this path when it was the least popular option upon graduation from residency.

I did countless hours of research trying to find accurate information about locum tenens companies, but never found anything written by physicians, only by the companies themselves. So, I stepped into this field blindfolded and learned the hard way. Since than, I have worked with over 16 locum tenens companies, 14 hospitals, and eight electronic medical record systems.

Through these experiences I’ve realized that, unfortunately, some locum tenens companies do not act with the professionalism and efficiency that both physicians and hospital systems would expect. This can lead to more stress than an actual employed position for physicians, and poor coverage with enormous costs for hospitals.

I decided to take matters into my own hands because I wanted to make the locum tenens system easier to navigate. I believe that the system can play a role in decreasing physician burnout, and I deeply understand the need that hospitals have to serve their patients with a shortage of doctors. As locum tenens physicians, we serve a need and shouldn’t have to deal with inefficient placement systems.

Here are five mistakes to avoid for physicians that are first entering into the locum tenens world:

1. Beware choosing a “factory mill” locum tenens company. Bigger companies have higher overhead, which usually means that they take more of a margin from physicians. Generally speaking, larger locum tenens companies pay their recruiters a lower percentage commission, so each recruiter has more physicians. This can lead to mistakes which can cause stress for both physicians and hospitals.

2. Beware long travel. Hourly rates that are $5-$10 dollars more per hour in remote locations are attractive. However, the amount of travel needed to get to these locations may not be worth it. When negotiating a rate, make sure not to lose sight of the amount of time it will take to travel to the hospital or outpatient location.

3. Beware short-term placements. There are a lot of hospitals that just need one or two weeks covered. Even if it’s at a much higher rate, the amount of paper work and credentialing hassle may not be worth the amount of time you work there. The greater number of cumulative hospitals worked, the longer credentialing will take in future locum tenens placements.

4. Beware using multiple travel services. Stick to one airline, one rental car company, and one hotel chain. This way when you are not working, you may be able to use the points earned during your work days for future vacations.

5. Beware companies that are not organized. If you find that a locum tenens company is asking you to do all of the paperwork to get credentialed, move on. This can be a red flag and may mean they lack credentialing staff. You should never have to fill out your own paperwork; rather you should be the one that simply reviews and corrects it.

Dr. Arora works as a liaison between hospitals, physicians, and locum tenens companies and is a member of The Hospitalist’s editorial advisory board. She negotiates rates and expectations with multiple locum tenens companies on behalf of physicians in all fields of practice and does not own or endorse a locum tenens company. You can contact her at www.doctorsliaison.com.

For the last 8 years I have worked as a locum tenens hospitalist. I began on this path when it was the least popular option upon graduation from residency.

I did countless hours of research trying to find accurate information about locum tenens companies, but never found anything written by physicians, only by the companies themselves. So, I stepped into this field blindfolded and learned the hard way. Since than, I have worked with over 16 locum tenens companies, 14 hospitals, and eight electronic medical record systems.

Through these experiences I’ve realized that, unfortunately, some locum tenens companies do not act with the professionalism and efficiency that both physicians and hospital systems would expect. This can lead to more stress than an actual employed position for physicians, and poor coverage with enormous costs for hospitals.

I decided to take matters into my own hands because I wanted to make the locum tenens system easier to navigate. I believe that the system can play a role in decreasing physician burnout, and I deeply understand the need that hospitals have to serve their patients with a shortage of doctors. As locum tenens physicians, we serve a need and shouldn’t have to deal with inefficient placement systems.

Here are five mistakes to avoid for physicians that are first entering into the locum tenens world:

1. Beware choosing a “factory mill” locum tenens company. Bigger companies have higher overhead, which usually means that they take more of a margin from physicians. Generally speaking, larger locum tenens companies pay their recruiters a lower percentage commission, so each recruiter has more physicians. This can lead to mistakes which can cause stress for both physicians and hospitals.

2. Beware long travel. Hourly rates that are $5-$10 dollars more per hour in remote locations are attractive. However, the amount of travel needed to get to these locations may not be worth it. When negotiating a rate, make sure not to lose sight of the amount of time it will take to travel to the hospital or outpatient location.

3. Beware short-term placements. There are a lot of hospitals that just need one or two weeks covered. Even if it’s at a much higher rate, the amount of paper work and credentialing hassle may not be worth the amount of time you work there. The greater number of cumulative hospitals worked, the longer credentialing will take in future locum tenens placements.

4. Beware using multiple travel services. Stick to one airline, one rental car company, and one hotel chain. This way when you are not working, you may be able to use the points earned during your work days for future vacations.

5. Beware companies that are not organized. If you find that a locum tenens company is asking you to do all of the paperwork to get credentialed, move on. This can be a red flag and may mean they lack credentialing staff. You should never have to fill out your own paperwork; rather you should be the one that simply reviews and corrects it.

Dr. Arora works as a liaison between hospitals, physicians, and locum tenens companies and is a member of The Hospitalist’s editorial advisory board. She negotiates rates and expectations with multiple locum tenens companies on behalf of physicians in all fields of practice and does not own or endorse a locum tenens company. You can contact her at www.doctorsliaison.com.

ABSTRACT

Surgical reconstruction of the ankle and hindfoot in patients with diabetes, Charcot neuroarthropathy, osteomyelitis, deformity, and/or bone loss can be challenging and often results in amputation. In these patients, conventional internal fixation with plates, screws, and intramedullary nails is often not feasible because of ongoing infection or poor bone stock and soft tissue quality. The Ilizarov method of ankle and hindfoot arthrodesis is a well-established technique for limb reconstruction that uses circular external fixation to achieve solid bony fusion, optimal leg length, and eradication of infection in cases of complex pathology. This article discusses indications, contraindications, pearls, and pitfalls of performing ankle and hindfoot arthrodesis using the Ilizarov technique.

Continue to: Patients with complex ankle and hindfoot deformity...

Patients with complex ankle and hindfoot deformity present a unique challenge to both nonoperative management and surgical reconstruction. Nonoperative management focuses on wound care, bracing, and immobilization using ankle-foot orthoses, total contact casts, and Charcot restraint orthotic walker boots for external stabilization. Fusion using the Ilizarov technique with circular fixation is a salvage limb-preservation procedure that has shown good results in select patient populations.^1-5 Indications include post-traumatic, degenerative, and rheumatoid arthritis, osteomyelitis, tumors, neuromuscular conditions, and salvage of failed ankle and hindfoot procedures.^6-9 Relative contraindications include wet gangrene, severe limb ischemia, and soft tissue compromise requiring urgent amputation. In addition, circular frames are not recommended in patients who are unable to comply with postoperative restrictions, and pin and wire care for the duration of frame placement because of personal, psychological, or socioeconomic reasons.

The Ilizarov technique of ring fixation provides dynamic, modular, and rigid fixation in multiple planes to control shear, bending, and rotational forces, and allows for early weight-bearing and postoperative adjustments as needed.^10,11 Percutaneously placed half-pins and wires allow for solid fixation in the setting of both poor bone and soft tissue quality, and fusion can be achieved in the presence of active infection in a 1-stage procedure. The goal of ankle and hindfoot fusion using the Ilizarov technique is to achieve an infection-free, stable, plantigrade foot with neutral ankle alignment to allow for patient ambulation and return to activities of daily living.

Nonunion rates with circular fixation are reported to be as high as 16% to 54%, due to medical comorbidities, such as smoking, peripheral vascular disease, and Charcot neuroarthropathy.¹Charcot, in particular, is a risk factor for nonunion as patients lack protective sensation, and have a higher rate of wound dehiscence, noncompliance with weight-bearing precautions, pin site infections, and frame breakage. In these patients, tibiotalocalcaneal (TTC) arthrodesis is preferred over the isolated ankle, or subtalar fusion to both provide a stable platform for ambulation and reduce the incidence of adjacent joint breakdown. Common complications of the Ilizarov technique include pin site infections, wire breakage, talar necrosis, and tibial stress fractures after frame removal.^1,2,6,11-13 Circular frames are typically maintained for 3 to 8 months, until solid fusion is achieved radiographically. Frames are removed in the operating room with the concurrent examination of the fusion sites under anesthesia followed by a period of protected weight-bearing in a cast or tall controlled ankle motion (CAM) boot.

This article reviews several technical details, tips, and tricks that can help improve the intraoperative and postoperative outcomes of combined ankle and hindfoot arthrodesis using the Ilizarov technique with circular external fixation.

Continue to: SURGICAL TECHNIQUE...

SURGICAL TECHNIQUE

SETUP AND APPROACH

Patients are positioned supine with padding under the operative extremity to achieve neutral leg rotation (Figures 1A-1D). A thigh tourniquet is placed with the foot positioned at the end of the bed and on top of the radiolucent padding to avoid interference of the contralateral leg during lateral X-rays. After sterile prepping and draping, the extremity is exsanguinated above the level of an active infection, and the tourniquet inflated.

For isolated ankle arthrodesis, an anterior or lateral approach can be used, while for TTC arthrodesis, a lateral approach is required to access both the ankle and subtalar joints. A 10-cm longitudinal incision is made along the distal fibula, curving slightly and anteriorly along the distal extent of the incision. Dissection is continued down to bone using full thickness flaps, and the distal fibula is removed 2 to 3 cm above the ankle joint using a saw and osteotome (Figures 2A-2G). The distal fibula can be used subsequently as bone grafts depending on the quality of bone. The peroneal tendons are retracted posteriorly, and dissection is then continued to the posterior facet of the subtalar joint.

JOINT PREPARATION AND ALIGNMENT

Both the anterior and posterior neurovascular bundles are protected along the distal tibia with Hohmann retractors while a saw is used to create flat cuts across the tibial plafond and talus to allow apposition of flat, broad cancellous bony surfaces. Flat cuts followed by later joint compression will often shorten the limb by 2 to 3 cm. This leg length discrepancy can later be accommodated using a shoe lift, as needed. All retained hardware and/or infected and necrotic tissues in the ankle and hindfoot are removed using a rongeur and a pituitary rongeur.

The medial malleolus is osteotomized vertically using a direct medial incision and approach with full thickness flaps, and in line with the previous tibial plafond, is both cut and removed. The medial malleolus can also be used for bone grafts in fusion sites. A smooth-tip lamina spreader is placed in the subtalar joint for distraction and a curved osteotome, curettes, and a small rongeur are used to remove all remaining cartilage from the subtalar joint. Flat cuts in the subtalar joint can remove excessive bone, particularly from the inferior aspect of the talus. The subchondral bone is perforated using a 2.5- to 3.0-mm drill bit and a curved osteotome.

A bone graft from the distal fibula and medial malleolus, with or without the addition of allograft adjuvants, is placed evenly across the ankle and subtalar joints (Figures 3A-3E). At this point, the ankle and subtalar joints can be manipulated in multiple planes to achieve neutral coronal, sagittal, and axial alignment. With both the ankle and hindfoot held in a neutral position, multiple Steinman pins and K-wires in different orientations are inserted through the plantar aspect of the heel to hold the ankle and subtalar joints in place temporarily. Wires are cut short to prevent interference with subsequent foot olive wire placement through the frame.

Continue to: X-rays should be carefully checked...

X-rays should be carefully checked to ensure proper alignment. Wounds are gently irrigated, and vancomycin powder (2 g) can be placed within wounds for local antibiotic delivery. Lateral tissues are sharply debulked to allow for decreased tension on the incision, and small ulcers can be excised in their entirety. Wounds are closed in a layered fashion using 0-polydioxanone (PDS, Ethicon) suture for deep tissue, 2-0 PDS for subcutaneous tissue, and 2-0 nylon for skin closure. The tourniquet is deflated for the remainder of the case to reduce limb ischemia during frame placement. 

CIRCULAR FRAME CONCEPTS AND PLACEMENT

The majority of circular frames for both ankle and hindfoot fusion have multiple ring sizes available in aluminum and radiolucent carbon fiber reinforced polymer (Hoffmann LRF, Stryker). Rings are available in full, open, segment, and both short- and long-foot options. Frames can be sterilized in a prebuilt 3 to 4 ring construct with 4 static or dynamic (telescopic) struts (100-277 mm). The most commonly used tibia and foot ring sizes are 155 cm, 180 cm, and 210 cm. Ring size should be able to accommodate posterior soft tissue swelling and avoid circumferential soft tissue abrasion against the rings. Anterior foot arches are used for increased construct stability and can be locked to the distal tibia ring for weight-bearing support. Wire and half-pin bolts, adaptors, and nuts are used to join each ring of the frame to the patient’s bone.

For TTC arthrodesis, 2 rings are typically used in the tibia, and 1 ring is used in the foot. For isolated ankle arthrodesis, an additional ring can be added with olive wires in the talus to permit compression only across the ankle joint. Multiple points of fixation are used in each ring in different planes to achieve both maximal stability and rotational control. If a single wire or half-pin becomes infected and requires removal, there are still multiple other points of fixation in the ring to maintain stability. Fixation within each ring should be off axis compared with the adjacent ring to both avoid stress risers and increase construct rigidity.

The prebuilt frame is checked on the back table to ensure proper orientation and component alignment. The frame is then placed over both the foot and ankle, and multiple stacks of towels are placed behind the heel, ankle, and calf to center the foot and ankle in the frame (Figures 4A-4F). At least 4 to 6 cm of space is needed in between the posterior soft tissues and each ring to accommodate postoperative swelling. On the lateral view, the foot ring should be in the mid-portion of the calcaneus. If there is a concern, particularly in Charcot patients, regarding early weight-bearing noncompliance, the foot ring can be placed flush with the plantar aspect of the foot, and olive wires can be inserted using longer adaptors. The frame should be checked from multiple viewpoints to ensure that both the foot and ankle are centered and in neutral rotation.

Continue to: TIBIA RING FIXATION...

TIBIA RING FIXATION

Tibia rings can be fixed using 2 to 3 half-pins (4-6 mm) alone or 2 half-pins in combination with a smooth wire. A small incision is made over the area of planned half-pin insertion, and the periosteum is cleared away using a hemostat. An adaptor sleeve is used, and the bone is drilled bicortically, followed by insertion of the half-pin. Hydroxyapatite-coated pins are used to improve the strength of the bone-pin interface and reduce the incidence of pin tract infections. Pins are inserted along both the anterior and medial aspects of the tibia, avoiding the thick lateral musculature. Care is taken to protect the medial neurovascular structures during pin placement following established Ilizarov safe zones.

After each pin is placed in the bone, the pin is secured to the adaptor that is then tightened to the ring. This process is repeated for both the proximal and distal tibia rings. Pins should be placed above and below each ring to avoid creating stress risers. During smooth wire placement, each wire is pushed by hand through the soft tissues and then drilled into the bone while the exposed segment is held with a damp sponge to reduce the incidence of thermal bone necrosis. Once the wire is drilled bicortically, a mallet is used to tap the wire through the remaining soft tissues to avoid wrapping them up in the wire. Each wire should be parallel to the ring to get an even line of compression.

Each wire is secured on 1 end and then tensioned to 130 kg using a hand tensioner. An additional tool can be placed in the wire adaptor to prevent the wire from bending during tensioning. If the wire is passing above or below the ring, longer wire adaptors should be used to build to the wire. The wire should never be bent toward the ring as this can increase the likelihood of improper pin tensioning and breakage. Wire placement should be avoided posteriorly as this can make it difficult to secure and/or tension wires, and also increases the risk of damage to posterior structures.

Ring fixation in the distal tibia near the plafond may require 1 half-pin and 2 wires to avoid damage to the tibialis anterior and posterior tibial tendons. In this case, smooth wires should be placed in a crossing pattern and tensioned simultaneously to avoid pulling the ankle away from the center of the frame. Wires should be bent and curved over each ring and then cut to facilitate subsequent removal.

FOOT RING FIXATION

In the foot, olive wires are used to increase fixation against bone. For each olive wire, a small incision is made to accommodate the diameter of the olive through the soft tissue. Similar to the distal tibia, 2 olive wires should be placed above and below the foot ring in a crossing pattern through the calcaneus (Figures 5A-5F). The axial view of the frame should be checked to ensure proper wire orientation. When using olive wires, it is essential to tension both at the same time to 90 kg, as the foot can be pulled medially or laterally in the frame if 1 wire is tensioned before the other.

Forefoot olive wires should also be placed in a crossing pattern, with 1 wire fixed through the first, second, and third metatarsals, and 1 wire through the fourth and fifth metatarsals. Additional forefoot olive wires can be placed if compression is needed across the midfoot or Chopart joints for fusion. Multiple X-rays should be checked to ensure that the calcaneus and forefoot olive wires are firmly fixed both in and against bone.

Continue to: JOINT COMPRESSION AND FINAL FRAME ADJUSTMENTS...

JOINT COMPRESSION AND FINAL FRAME ADJUSTMENTS

Once all rings are secured to the bone with half-pins and wires, the previously placed Steinman pins, and K-wires through the heel are removed. Both ankle and subtalar joint alignments are rechecked, and then axial compression is placed through the foot ring with the knee extended and the struts unlocked. Static or telescopic struts are used to achieve 8 to 10 mm of bony compression. X-rays are taken before and after to analyze final joint compression and alignment. Struts should be sequentially tightened (1/2 turn of a static strut) 1 at a time as final tightening of 1 strut alone can bind and interfere with both the compression and tightening of the remaining struts.

Once final compression is achieved, the struts are locked, and the front foot arch is closed anteriorly and connected to the distal tibia ring for increased stability (Figures 6A-6D). Each pin and wire is covered in a sterile dressing followed by gauze to allow for soft tissue padding. The entire frame is then overwrapped in bias stockinette rolls or ace wraps.

Walking attachments can be added immediately to the frame that allows for early weight-bearing. Rocker shoe attachments with a 15° anterior and posterior slope and rubber soles can help offload the ankle and subtalar joints, decrease pressure on heel strike, and reduce ankle motion during ambulation (Hoffmann LRF, Stryker).

POSTOPERATIVE PROTOCOL

Depending on individual characteristics, patients can be immediately weight-bearing in the circular frame. Patients with Charcot neuroarthropathy are recommended to remain non-weight-bearing for the first 2 months to reduce the likelihood of pin, wire, and frame breakage along with nonunion. Pin and wire site care and maintenance are initiated the day after surgery and continue on a daily basis for the duration of frame placement. Sutures are removed 4 to 5 weeks after surgery to ensure adequate wound healing. Serial X-rays are taken monthly to analyze fusion sites.

If pins or wires become infected, patients are placed on oral antibiotics, and both pins and wires can be removed or exchanged in the operating room. Once fusion is achieved in 3 to 8 months (Figures 7A-7C), the frame is removed in the operating room, and fusion sites are examined under dynamic fluoroscopy. If fusion is confirmed, patients are made weight-bearing as tolerated in a short-leg cast or tall CAM boot for 6 to 8 weeks, and then transitioned to an ankle brace in an accommodative shoe.

Continue to: DISCUSSION...

DISCUSSION

A key aspect of recovery after ankle and hindfoot fusion using the Ilizarov technique is balancing pin care, soft tissue swelling, and weight-bearing status. The average time patients will spend in the frame is approximately 25 to 28 weeks, but can range from 12 to 84 weeks.^1,2Given the considerable variability in both soft tissue healing and bony union, patients should be extensively counseled before surgery to set expectations correctly and ensure that they have the necessary help and support to care for the frame during the treatment period. Patients should be followed closely during the first 6 weeks to ensure that pins and wires do not become infected or break, as both of these issues require immediate intervention.

In a review of 11 patients who underwent tibiocalcaneal arthrodesis using an Ilizarov external fixator for infected talar nonunions or extrusions, Rochman and colleagues⁸ reported an 81% rate of successful fusion with a final mean American Orthopaedic Foot and Ankle Society score of 65 (out of a maximum 86). Similar results were reported by Saltzman⁹ in a series of 8 patients with diffuse ankle osteomyelitis treated with resection of all infected tissue and hybrid-frame compression arthrodesis. All patients received 6 weeks of intravenous antibiotics, and frames were removed at 3 months, and walking casts were applied for 1 to 2 additional months. Ankle sepsis was eradicated in all patients, and 7/8 (87.5%) ankles successfully fused at an average of 13.5 weeks (range, 10-16 weeks). One limb required below-knee amputation at 5 weeks due to non-reconstructible vascular insufficiency. At an average of 3.4-year follow-up, none of the 7 fused ankles required further surgery.

Fragomen and colleagues¹ retrospectively reviewed 101 patients who underwent complex ankle fusion using the Ilizarov technique and found that 76/91 (83.5%) patients achieved fusion at an average of 25 weeks (range, 10-65 weeks). Smoking was associated with a 54% rate of nonunion and 15/19 (79%) patients with Charcot neuroarthropathy achieved ankle fusion, but had a subsequent subtalar joint failure, thus highlighting the need for TTC arthrodesis in Charcot patients. Salem and colleagues² reviewed 21 Ilizarov ankle fusions and reported that all patients achieved fusion at an average of 28 weeks (range, 12-84 weeks). Complications occurred in 11 patients, including 2 nonunions that healed after revision frame application and 4 pin tract infections.

CONCLUSION

Overall, the Ilizarov technique using circular external fixation is a powerful tool that can be used to treat a variety of disorders including complex foot and ankle deformity and infection. While case series generally show favorable outcomes, patients must be informed that this technique is a salvage procedure for limb preservation that requires meticulous operative technique, diligent postoperative care, and tight control of medical comorbidities, such as blood sugar levels in individuals with diabetes to achieve a successful outcome.

ABSTRACT

Surgical reconstruction of the ankle and hindfoot in patients with diabetes, Charcot neuroarthropathy, osteomyelitis, deformity, and/or bone loss can be challenging and often results in amputation. In these patients, conventional internal fixation with plates, screws, and intramedullary nails is often not feasible because of ongoing infection or poor bone stock and soft tissue quality. The Ilizarov method of ankle and hindfoot arthrodesis is a well-established technique for limb reconstruction that uses circular external fixation to achieve solid bony fusion, optimal leg length, and eradication of infection in cases of complex pathology. This article discusses indications, contraindications, pearls, and pitfalls of performing ankle and hindfoot arthrodesis using the Ilizarov technique.

Continue to: Patients with complex ankle and hindfoot deformity...

Patients with complex ankle and hindfoot deformity present a unique challenge to both nonoperative management and surgical reconstruction. Nonoperative management focuses on wound care, bracing, and immobilization using ankle-foot orthoses, total contact casts, and Charcot restraint orthotic walker boots for external stabilization. Fusion using the Ilizarov technique with circular fixation is a salvage limb-preservation procedure that has shown good results in select patient populations.^1-5 Indications include post-traumatic, degenerative, and rheumatoid arthritis, osteomyelitis, tumors, neuromuscular conditions, and salvage of failed ankle and hindfoot procedures.^6-9 Relative contraindications include wet gangrene, severe limb ischemia, and soft tissue compromise requiring urgent amputation. In addition, circular frames are not recommended in patients who are unable to comply with postoperative restrictions, and pin and wire care for the duration of frame placement because of personal, psychological, or socioeconomic reasons.

The Ilizarov technique of ring fixation provides dynamic, modular, and rigid fixation in multiple planes to control shear, bending, and rotational forces, and allows for early weight-bearing and postoperative adjustments as needed.^10,11 Percutaneously placed half-pins and wires allow for solid fixation in the setting of both poor bone and soft tissue quality, and fusion can be achieved in the presence of active infection in a 1-stage procedure. The goal of ankle and hindfoot fusion using the Ilizarov technique is to achieve an infection-free, stable, plantigrade foot with neutral ankle alignment to allow for patient ambulation and return to activities of daily living.

Nonunion rates with circular fixation are reported to be as high as 16% to 54%, due to medical comorbidities, such as smoking, peripheral vascular disease, and Charcot neuroarthropathy.¹Charcot, in particular, is a risk factor for nonunion as patients lack protective sensation, and have a higher rate of wound dehiscence, noncompliance with weight-bearing precautions, pin site infections, and frame breakage. In these patients, tibiotalocalcaneal (TTC) arthrodesis is preferred over the isolated ankle, or subtalar fusion to both provide a stable platform for ambulation and reduce the incidence of adjacent joint breakdown. Common complications of the Ilizarov technique include pin site infections, wire breakage, talar necrosis, and tibial stress fractures after frame removal.^1,2,6,11-13 Circular frames are typically maintained for 3 to 8 months, until solid fusion is achieved radiographically. Frames are removed in the operating room with the concurrent examination of the fusion sites under anesthesia followed by a period of protected weight-bearing in a cast or tall controlled ankle motion (CAM) boot.

This article reviews several technical details, tips, and tricks that can help improve the intraoperative and postoperative outcomes of combined ankle and hindfoot arthrodesis using the Ilizarov technique with circular external fixation.

Continue to: SURGICAL TECHNIQUE...

SURGICAL TECHNIQUE

SETUP AND APPROACH

Patients are positioned supine with padding under the operative extremity to achieve neutral leg rotation (Figures 1A-1D). A thigh tourniquet is placed with the foot positioned at the end of the bed and on top of the radiolucent padding to avoid interference of the contralateral leg during lateral X-rays. After sterile prepping and draping, the extremity is exsanguinated above the level of an active infection, and the tourniquet inflated.

For isolated ankle arthrodesis, an anterior or lateral approach can be used, while for TTC arthrodesis, a lateral approach is required to access both the ankle and subtalar joints. A 10-cm longitudinal incision is made along the distal fibula, curving slightly and anteriorly along the distal extent of the incision. Dissection is continued down to bone using full thickness flaps, and the distal fibula is removed 2 to 3 cm above the ankle joint using a saw and osteotome (Figures 2A-2G). The distal fibula can be used subsequently as bone grafts depending on the quality of bone. The peroneal tendons are retracted posteriorly, and dissection is then continued to the posterior facet of the subtalar joint.

JOINT PREPARATION AND ALIGNMENT

Both the anterior and posterior neurovascular bundles are protected along the distal tibia with Hohmann retractors while a saw is used to create flat cuts across the tibial plafond and talus to allow apposition of flat, broad cancellous bony surfaces. Flat cuts followed by later joint compression will often shorten the limb by 2 to 3 cm. This leg length discrepancy can later be accommodated using a shoe lift, as needed. All retained hardware and/or infected and necrotic tissues in the ankle and hindfoot are removed using a rongeur and a pituitary rongeur.

The medial malleolus is osteotomized vertically using a direct medial incision and approach with full thickness flaps, and in line with the previous tibial plafond, is both cut and removed. The medial malleolus can also be used for bone grafts in fusion sites. A smooth-tip lamina spreader is placed in the subtalar joint for distraction and a curved osteotome, curettes, and a small rongeur are used to remove all remaining cartilage from the subtalar joint. Flat cuts in the subtalar joint can remove excessive bone, particularly from the inferior aspect of the talus. The subchondral bone is perforated using a 2.5- to 3.0-mm drill bit and a curved osteotome.

A bone graft from the distal fibula and medial malleolus, with or without the addition of allograft adjuvants, is placed evenly across the ankle and subtalar joints (Figures 3A-3E). At this point, the ankle and subtalar joints can be manipulated in multiple planes to achieve neutral coronal, sagittal, and axial alignment. With both the ankle and hindfoot held in a neutral position, multiple Steinman pins and K-wires in different orientations are inserted through the plantar aspect of the heel to hold the ankle and subtalar joints in place temporarily. Wires are cut short to prevent interference with subsequent foot olive wire placement through the frame.

Continue to: X-rays should be carefully checked...

X-rays should be carefully checked to ensure proper alignment. Wounds are gently irrigated, and vancomycin powder (2 g) can be placed within wounds for local antibiotic delivery. Lateral tissues are sharply debulked to allow for decreased tension on the incision, and small ulcers can be excised in their entirety. Wounds are closed in a layered fashion using 0-polydioxanone (PDS, Ethicon) suture for deep tissue, 2-0 PDS for subcutaneous tissue, and 2-0 nylon for skin closure. The tourniquet is deflated for the remainder of the case to reduce limb ischemia during frame placement. 

CIRCULAR FRAME CONCEPTS AND PLACEMENT

The majority of circular frames for both ankle and hindfoot fusion have multiple ring sizes available in aluminum and radiolucent carbon fiber reinforced polymer (Hoffmann LRF, Stryker). Rings are available in full, open, segment, and both short- and long-foot options. Frames can be sterilized in a prebuilt 3 to 4 ring construct with 4 static or dynamic (telescopic) struts (100-277 mm). The most commonly used tibia and foot ring sizes are 155 cm, 180 cm, and 210 cm. Ring size should be able to accommodate posterior soft tissue swelling and avoid circumferential soft tissue abrasion against the rings. Anterior foot arches are used for increased construct stability and can be locked to the distal tibia ring for weight-bearing support. Wire and half-pin bolts, adaptors, and nuts are used to join each ring of the frame to the patient’s bone.

For TTC arthrodesis, 2 rings are typically used in the tibia, and 1 ring is used in the foot. For isolated ankle arthrodesis, an additional ring can be added with olive wires in the talus to permit compression only across the ankle joint. Multiple points of fixation are used in each ring in different planes to achieve both maximal stability and rotational control. If a single wire or half-pin becomes infected and requires removal, there are still multiple other points of fixation in the ring to maintain stability. Fixation within each ring should be off axis compared with the adjacent ring to both avoid stress risers and increase construct rigidity.

The prebuilt frame is checked on the back table to ensure proper orientation and component alignment. The frame is then placed over both the foot and ankle, and multiple stacks of towels are placed behind the heel, ankle, and calf to center the foot and ankle in the frame (Figures 4A-4F). At least 4 to 6 cm of space is needed in between the posterior soft tissues and each ring to accommodate postoperative swelling. On the lateral view, the foot ring should be in the mid-portion of the calcaneus. If there is a concern, particularly in Charcot patients, regarding early weight-bearing noncompliance, the foot ring can be placed flush with the plantar aspect of the foot, and olive wires can be inserted using longer adaptors. The frame should be checked from multiple viewpoints to ensure that both the foot and ankle are centered and in neutral rotation.

Continue to: TIBIA RING FIXATION...

TIBIA RING FIXATION

Tibia rings can be fixed using 2 to 3 half-pins (4-6 mm) alone or 2 half-pins in combination with a smooth wire. A small incision is made over the area of planned half-pin insertion, and the periosteum is cleared away using a hemostat. An adaptor sleeve is used, and the bone is drilled bicortically, followed by insertion of the half-pin. Hydroxyapatite-coated pins are used to improve the strength of the bone-pin interface and reduce the incidence of pin tract infections. Pins are inserted along both the anterior and medial aspects of the tibia, avoiding the thick lateral musculature. Care is taken to protect the medial neurovascular structures during pin placement following established Ilizarov safe zones.

After each pin is placed in the bone, the pin is secured to the adaptor that is then tightened to the ring. This process is repeated for both the proximal and distal tibia rings. Pins should be placed above and below each ring to avoid creating stress risers. During smooth wire placement, each wire is pushed by hand through the soft tissues and then drilled into the bone while the exposed segment is held with a damp sponge to reduce the incidence of thermal bone necrosis. Once the wire is drilled bicortically, a mallet is used to tap the wire through the remaining soft tissues to avoid wrapping them up in the wire. Each wire should be parallel to the ring to get an even line of compression.

Each wire is secured on 1 end and then tensioned to 130 kg using a hand tensioner. An additional tool can be placed in the wire adaptor to prevent the wire from bending during tensioning. If the wire is passing above or below the ring, longer wire adaptors should be used to build to the wire. The wire should never be bent toward the ring as this can increase the likelihood of improper pin tensioning and breakage. Wire placement should be avoided posteriorly as this can make it difficult to secure and/or tension wires, and also increases the risk of damage to posterior structures.

Ring fixation in the distal tibia near the plafond may require 1 half-pin and 2 wires to avoid damage to the tibialis anterior and posterior tibial tendons. In this case, smooth wires should be placed in a crossing pattern and tensioned simultaneously to avoid pulling the ankle away from the center of the frame. Wires should be bent and curved over each ring and then cut to facilitate subsequent removal.

FOOT RING FIXATION

In the foot, olive wires are used to increase fixation against bone. For each olive wire, a small incision is made to accommodate the diameter of the olive through the soft tissue. Similar to the distal tibia, 2 olive wires should be placed above and below the foot ring in a crossing pattern through the calcaneus (Figures 5A-5F). The axial view of the frame should be checked to ensure proper wire orientation. When using olive wires, it is essential to tension both at the same time to 90 kg, as the foot can be pulled medially or laterally in the frame if 1 wire is tensioned before the other.

Forefoot olive wires should also be placed in a crossing pattern, with 1 wire fixed through the first, second, and third metatarsals, and 1 wire through the fourth and fifth metatarsals. Additional forefoot olive wires can be placed if compression is needed across the midfoot or Chopart joints for fusion. Multiple X-rays should be checked to ensure that the calcaneus and forefoot olive wires are firmly fixed both in and against bone.

Continue to: JOINT COMPRESSION AND FINAL FRAME ADJUSTMENTS...

JOINT COMPRESSION AND FINAL FRAME ADJUSTMENTS

Once all rings are secured to the bone with half-pins and wires, the previously placed Steinman pins, and K-wires through the heel are removed. Both ankle and subtalar joint alignments are rechecked, and then axial compression is placed through the foot ring with the knee extended and the struts unlocked. Static or telescopic struts are used to achieve 8 to 10 mm of bony compression. X-rays are taken before and after to analyze final joint compression and alignment. Struts should be sequentially tightened (1/2 turn of a static strut) 1 at a time as final tightening of 1 strut alone can bind and interfere with both the compression and tightening of the remaining struts.

Once final compression is achieved, the struts are locked, and the front foot arch is closed anteriorly and connected to the distal tibia ring for increased stability (Figures 6A-6D). Each pin and wire is covered in a sterile dressing followed by gauze to allow for soft tissue padding. The entire frame is then overwrapped in bias stockinette rolls or ace wraps.

Walking attachments can be added immediately to the frame that allows for early weight-bearing. Rocker shoe attachments with a 15° anterior and posterior slope and rubber soles can help offload the ankle and subtalar joints, decrease pressure on heel strike, and reduce ankle motion during ambulation (Hoffmann LRF, Stryker).

POSTOPERATIVE PROTOCOL

Depending on individual characteristics, patients can be immediately weight-bearing in the circular frame. Patients with Charcot neuroarthropathy are recommended to remain non-weight-bearing for the first 2 months to reduce the likelihood of pin, wire, and frame breakage along with nonunion. Pin and wire site care and maintenance are initiated the day after surgery and continue on a daily basis for the duration of frame placement. Sutures are removed 4 to 5 weeks after surgery to ensure adequate wound healing. Serial X-rays are taken monthly to analyze fusion sites.

If pins or wires become infected, patients are placed on oral antibiotics, and both pins and wires can be removed or exchanged in the operating room. Once fusion is achieved in 3 to 8 months (Figures 7A-7C), the frame is removed in the operating room, and fusion sites are examined under dynamic fluoroscopy. If fusion is confirmed, patients are made weight-bearing as tolerated in a short-leg cast or tall CAM boot for 6 to 8 weeks, and then transitioned to an ankle brace in an accommodative shoe.

Continue to: DISCUSSION...

DISCUSSION

A key aspect of recovery after ankle and hindfoot fusion using the Ilizarov technique is balancing pin care, soft tissue swelling, and weight-bearing status. The average time patients will spend in the frame is approximately 25 to 28 weeks, but can range from 12 to 84 weeks.^1,2Given the considerable variability in both soft tissue healing and bony union, patients should be extensively counseled before surgery to set expectations correctly and ensure that they have the necessary help and support to care for the frame during the treatment period. Patients should be followed closely during the first 6 weeks to ensure that pins and wires do not become infected or break, as both of these issues require immediate intervention.

In a review of 11 patients who underwent tibiocalcaneal arthrodesis using an Ilizarov external fixator for infected talar nonunions or extrusions, Rochman and colleagues⁸ reported an 81% rate of successful fusion with a final mean American Orthopaedic Foot and Ankle Society score of 65 (out of a maximum 86). Similar results were reported by Saltzman⁹ in a series of 8 patients with diffuse ankle osteomyelitis treated with resection of all infected tissue and hybrid-frame compression arthrodesis. All patients received 6 weeks of intravenous antibiotics, and frames were removed at 3 months, and walking casts were applied for 1 to 2 additional months. Ankle sepsis was eradicated in all patients, and 7/8 (87.5%) ankles successfully fused at an average of 13.5 weeks (range, 10-16 weeks). One limb required below-knee amputation at 5 weeks due to non-reconstructible vascular insufficiency. At an average of 3.4-year follow-up, none of the 7 fused ankles required further surgery.

Fragomen and colleagues¹ retrospectively reviewed 101 patients who underwent complex ankle fusion using the Ilizarov technique and found that 76/91 (83.5%) patients achieved fusion at an average of 25 weeks (range, 10-65 weeks). Smoking was associated with a 54% rate of nonunion and 15/19 (79%) patients with Charcot neuroarthropathy achieved ankle fusion, but had a subsequent subtalar joint failure, thus highlighting the need for TTC arthrodesis in Charcot patients. Salem and colleagues² reviewed 21 Ilizarov ankle fusions and reported that all patients achieved fusion at an average of 28 weeks (range, 12-84 weeks). Complications occurred in 11 patients, including 2 nonunions that healed after revision frame application and 4 pin tract infections.

CONCLUSION

Overall, the Ilizarov technique using circular external fixation is a powerful tool that can be used to treat a variety of disorders including complex foot and ankle deformity and infection. While case series generally show favorable outcomes, patients must be informed that this technique is a salvage procedure for limb preservation that requires meticulous operative technique, diligent postoperative care, and tight control of medical comorbidities, such as blood sugar levels in individuals with diabetes to achieve a successful outcome.

ABSTRACT

Surgical reconstruction of the ankle and hindfoot in patients with diabetes, Charcot neuroarthropathy, osteomyelitis, deformity, and/or bone loss can be challenging and often results in amputation. In these patients, conventional internal fixation with plates, screws, and intramedullary nails is often not feasible because of ongoing infection or poor bone stock and soft tissue quality. The Ilizarov method of ankle and hindfoot arthrodesis is a well-established technique for limb reconstruction that uses circular external fixation to achieve solid bony fusion, optimal leg length, and eradication of infection in cases of complex pathology. This article discusses indications, contraindications, pearls, and pitfalls of performing ankle and hindfoot arthrodesis using the Ilizarov technique.

Continue to: Patients with complex ankle and hindfoot deformity...

Patients with complex ankle and hindfoot deformity present a unique challenge to both nonoperative management and surgical reconstruction. Nonoperative management focuses on wound care, bracing, and immobilization using ankle-foot orthoses, total contact casts, and Charcot restraint orthotic walker boots for external stabilization. Fusion using the Ilizarov technique with circular fixation is a salvage limb-preservation procedure that has shown good results in select patient populations.^1-5 Indications include post-traumatic, degenerative, and rheumatoid arthritis, osteomyelitis, tumors, neuromuscular conditions, and salvage of failed ankle and hindfoot procedures.^6-9 Relative contraindications include wet gangrene, severe limb ischemia, and soft tissue compromise requiring urgent amputation. In addition, circular frames are not recommended in patients who are unable to comply with postoperative restrictions, and pin and wire care for the duration of frame placement because of personal, psychological, or socioeconomic reasons.

The Ilizarov technique of ring fixation provides dynamic, modular, and rigid fixation in multiple planes to control shear, bending, and rotational forces, and allows for early weight-bearing and postoperative adjustments as needed.^10,11 Percutaneously placed half-pins and wires allow for solid fixation in the setting of both poor bone and soft tissue quality, and fusion can be achieved in the presence of active infection in a 1-stage procedure. The goal of ankle and hindfoot fusion using the Ilizarov technique is to achieve an infection-free, stable, plantigrade foot with neutral ankle alignment to allow for patient ambulation and return to activities of daily living.

Nonunion rates with circular fixation are reported to be as high as 16% to 54%, due to medical comorbidities, such as smoking, peripheral vascular disease, and Charcot neuroarthropathy.¹Charcot, in particular, is a risk factor for nonunion as patients lack protective sensation, and have a higher rate of wound dehiscence, noncompliance with weight-bearing precautions, pin site infections, and frame breakage. In these patients, tibiotalocalcaneal (TTC) arthrodesis is preferred over the isolated ankle, or subtalar fusion to both provide a stable platform for ambulation and reduce the incidence of adjacent joint breakdown. Common complications of the Ilizarov technique include pin site infections, wire breakage, talar necrosis, and tibial stress fractures after frame removal.^1,2,6,11-13 Circular frames are typically maintained for 3 to 8 months, until solid fusion is achieved radiographically. Frames are removed in the operating room with the concurrent examination of the fusion sites under anesthesia followed by a period of protected weight-bearing in a cast or tall controlled ankle motion (CAM) boot.

This article reviews several technical details, tips, and tricks that can help improve the intraoperative and postoperative outcomes of combined ankle and hindfoot arthrodesis using the Ilizarov technique with circular external fixation.

Continue to: SURGICAL TECHNIQUE...

SURGICAL TECHNIQUE

SETUP AND APPROACH

Patients are positioned supine with padding under the operative extremity to achieve neutral leg rotation (Figures 1A-1D). A thigh tourniquet is placed with the foot positioned at the end of the bed and on top of the radiolucent padding to avoid interference of the contralateral leg during lateral X-rays. After sterile prepping and draping, the extremity is exsanguinated above the level of an active infection, and the tourniquet inflated.

For isolated ankle arthrodesis, an anterior or lateral approach can be used, while for TTC arthrodesis, a lateral approach is required to access both the ankle and subtalar joints. A 10-cm longitudinal incision is made along the distal fibula, curving slightly and anteriorly along the distal extent of the incision. Dissection is continued down to bone using full thickness flaps, and the distal fibula is removed 2 to 3 cm above the ankle joint using a saw and osteotome (Figures 2A-2G). The distal fibula can be used subsequently as bone grafts depending on the quality of bone. The peroneal tendons are retracted posteriorly, and dissection is then continued to the posterior facet of the subtalar joint.

JOINT PREPARATION AND ALIGNMENT

Both the anterior and posterior neurovascular bundles are protected along the distal tibia with Hohmann retractors while a saw is used to create flat cuts across the tibial plafond and talus to allow apposition of flat, broad cancellous bony surfaces. Flat cuts followed by later joint compression will often shorten the limb by 2 to 3 cm. This leg length discrepancy can later be accommodated using a shoe lift, as needed. All retained hardware and/or infected and necrotic tissues in the ankle and hindfoot are removed using a rongeur and a pituitary rongeur.

The medial malleolus is osteotomized vertically using a direct medial incision and approach with full thickness flaps, and in line with the previous tibial plafond, is both cut and removed. The medial malleolus can also be used for bone grafts in fusion sites. A smooth-tip lamina spreader is placed in the subtalar joint for distraction and a curved osteotome, curettes, and a small rongeur are used to remove all remaining cartilage from the subtalar joint. Flat cuts in the subtalar joint can remove excessive bone, particularly from the inferior aspect of the talus. The subchondral bone is perforated using a 2.5- to 3.0-mm drill bit and a curved osteotome.

A bone graft from the distal fibula and medial malleolus, with or without the addition of allograft adjuvants, is placed evenly across the ankle and subtalar joints (Figures 3A-3E). At this point, the ankle and subtalar joints can be manipulated in multiple planes to achieve neutral coronal, sagittal, and axial alignment. With both the ankle and hindfoot held in a neutral position, multiple Steinman pins and K-wires in different orientations are inserted through the plantar aspect of the heel to hold the ankle and subtalar joints in place temporarily. Wires are cut short to prevent interference with subsequent foot olive wire placement through the frame.

Continue to: X-rays should be carefully checked...

X-rays should be carefully checked to ensure proper alignment. Wounds are gently irrigated, and vancomycin powder (2 g) can be placed within wounds for local antibiotic delivery. Lateral tissues are sharply debulked to allow for decreased tension on the incision, and small ulcers can be excised in their entirety. Wounds are closed in a layered fashion using 0-polydioxanone (PDS, Ethicon) suture for deep tissue, 2-0 PDS for subcutaneous tissue, and 2-0 nylon for skin closure. The tourniquet is deflated for the remainder of the case to reduce limb ischemia during frame placement. 

CIRCULAR FRAME CONCEPTS AND PLACEMENT

The majority of circular frames for both ankle and hindfoot fusion have multiple ring sizes available in aluminum and radiolucent carbon fiber reinforced polymer (Hoffmann LRF, Stryker). Rings are available in full, open, segment, and both short- and long-foot options. Frames can be sterilized in a prebuilt 3 to 4 ring construct with 4 static or dynamic (telescopic) struts (100-277 mm). The most commonly used tibia and foot ring sizes are 155 cm, 180 cm, and 210 cm. Ring size should be able to accommodate posterior soft tissue swelling and avoid circumferential soft tissue abrasion against the rings. Anterior foot arches are used for increased construct stability and can be locked to the distal tibia ring for weight-bearing support. Wire and half-pin bolts, adaptors, and nuts are used to join each ring of the frame to the patient’s bone.

For TTC arthrodesis, 2 rings are typically used in the tibia, and 1 ring is used in the foot. For isolated ankle arthrodesis, an additional ring can be added with olive wires in the talus to permit compression only across the ankle joint. Multiple points of fixation are used in each ring in different planes to achieve both maximal stability and rotational control. If a single wire or half-pin becomes infected and requires removal, there are still multiple other points of fixation in the ring to maintain stability. Fixation within each ring should be off axis compared with the adjacent ring to both avoid stress risers and increase construct rigidity.

The prebuilt frame is checked on the back table to ensure proper orientation and component alignment. The frame is then placed over both the foot and ankle, and multiple stacks of towels are placed behind the heel, ankle, and calf to center the foot and ankle in the frame (Figures 4A-4F). At least 4 to 6 cm of space is needed in between the posterior soft tissues and each ring to accommodate postoperative swelling. On the lateral view, the foot ring should be in the mid-portion of the calcaneus. If there is a concern, particularly in Charcot patients, regarding early weight-bearing noncompliance, the foot ring can be placed flush with the plantar aspect of the foot, and olive wires can be inserted using longer adaptors. The frame should be checked from multiple viewpoints to ensure that both the foot and ankle are centered and in neutral rotation.

Continue to: TIBIA RING FIXATION...

TIBIA RING FIXATION

Tibia rings can be fixed using 2 to 3 half-pins (4-6 mm) alone or 2 half-pins in combination with a smooth wire. A small incision is made over the area of planned half-pin insertion, and the periosteum is cleared away using a hemostat. An adaptor sleeve is used, and the bone is drilled bicortically, followed by insertion of the half-pin. Hydroxyapatite-coated pins are used to improve the strength of the bone-pin interface and reduce the incidence of pin tract infections. Pins are inserted along both the anterior and medial aspects of the tibia, avoiding the thick lateral musculature. Care is taken to protect the medial neurovascular structures during pin placement following established Ilizarov safe zones.

After each pin is placed in the bone, the pin is secured to the adaptor that is then tightened to the ring. This process is repeated for both the proximal and distal tibia rings. Pins should be placed above and below each ring to avoid creating stress risers. During smooth wire placement, each wire is pushed by hand through the soft tissues and then drilled into the bone while the exposed segment is held with a damp sponge to reduce the incidence of thermal bone necrosis. Once the wire is drilled bicortically, a mallet is used to tap the wire through the remaining soft tissues to avoid wrapping them up in the wire. Each wire should be parallel to the ring to get an even line of compression.

Each wire is secured on 1 end and then tensioned to 130 kg using a hand tensioner. An additional tool can be placed in the wire adaptor to prevent the wire from bending during tensioning. If the wire is passing above or below the ring, longer wire adaptors should be used to build to the wire. The wire should never be bent toward the ring as this can increase the likelihood of improper pin tensioning and breakage. Wire placement should be avoided posteriorly as this can make it difficult to secure and/or tension wires, and also increases the risk of damage to posterior structures.

Ring fixation in the distal tibia near the plafond may require 1 half-pin and 2 wires to avoid damage to the tibialis anterior and posterior tibial tendons. In this case, smooth wires should be placed in a crossing pattern and tensioned simultaneously to avoid pulling the ankle away from the center of the frame. Wires should be bent and curved over each ring and then cut to facilitate subsequent removal.

FOOT RING FIXATION

In the foot, olive wires are used to increase fixation against bone. For each olive wire, a small incision is made to accommodate the diameter of the olive through the soft tissue. Similar to the distal tibia, 2 olive wires should be placed above and below the foot ring in a crossing pattern through the calcaneus (Figures 5A-5F). The axial view of the frame should be checked to ensure proper wire orientation. When using olive wires, it is essential to tension both at the same time to 90 kg, as the foot can be pulled medially or laterally in the frame if 1 wire is tensioned before the other.

Forefoot olive wires should also be placed in a crossing pattern, with 1 wire fixed through the first, second, and third metatarsals, and 1 wire through the fourth and fifth metatarsals. Additional forefoot olive wires can be placed if compression is needed across the midfoot or Chopart joints for fusion. Multiple X-rays should be checked to ensure that the calcaneus and forefoot olive wires are firmly fixed both in and against bone.

Continue to: JOINT COMPRESSION AND FINAL FRAME ADJUSTMENTS...

JOINT COMPRESSION AND FINAL FRAME ADJUSTMENTS

Once all rings are secured to the bone with half-pins and wires, the previously placed Steinman pins, and K-wires through the heel are removed. Both ankle and subtalar joint alignments are rechecked, and then axial compression is placed through the foot ring with the knee extended and the struts unlocked. Static or telescopic struts are used to achieve 8 to 10 mm of bony compression. X-rays are taken before and after to analyze final joint compression and alignment. Struts should be sequentially tightened (1/2 turn of a static strut) 1 at a time as final tightening of 1 strut alone can bind and interfere with both the compression and tightening of the remaining struts.

Once final compression is achieved, the struts are locked, and the front foot arch is closed anteriorly and connected to the distal tibia ring for increased stability (Figures 6A-6D). Each pin and wire is covered in a sterile dressing followed by gauze to allow for soft tissue padding. The entire frame is then overwrapped in bias stockinette rolls or ace wraps.

Walking attachments can be added immediately to the frame that allows for early weight-bearing. Rocker shoe attachments with a 15° anterior and posterior slope and rubber soles can help offload the ankle and subtalar joints, decrease pressure on heel strike, and reduce ankle motion during ambulation (Hoffmann LRF, Stryker).

POSTOPERATIVE PROTOCOL

Depending on individual characteristics, patients can be immediately weight-bearing in the circular frame. Patients with Charcot neuroarthropathy are recommended to remain non-weight-bearing for the first 2 months to reduce the likelihood of pin, wire, and frame breakage along with nonunion. Pin and wire site care and maintenance are initiated the day after surgery and continue on a daily basis for the duration of frame placement. Sutures are removed 4 to 5 weeks after surgery to ensure adequate wound healing. Serial X-rays are taken monthly to analyze fusion sites.

If pins or wires become infected, patients are placed on oral antibiotics, and both pins and wires can be removed or exchanged in the operating room. Once fusion is achieved in 3 to 8 months (Figures 7A-7C), the frame is removed in the operating room, and fusion sites are examined under dynamic fluoroscopy. If fusion is confirmed, patients are made weight-bearing as tolerated in a short-leg cast or tall CAM boot for 6 to 8 weeks, and then transitioned to an ankle brace in an accommodative shoe.

Continue to: DISCUSSION...

DISCUSSION

A key aspect of recovery after ankle and hindfoot fusion using the Ilizarov technique is balancing pin care, soft tissue swelling, and weight-bearing status. The average time patients will spend in the frame is approximately 25 to 28 weeks, but can range from 12 to 84 weeks.^1,2Given the considerable variability in both soft tissue healing and bony union, patients should be extensively counseled before surgery to set expectations correctly and ensure that they have the necessary help and support to care for the frame during the treatment period. Patients should be followed closely during the first 6 weeks to ensure that pins and wires do not become infected or break, as both of these issues require immediate intervention.

In a review of 11 patients who underwent tibiocalcaneal arthrodesis using an Ilizarov external fixator for infected talar nonunions or extrusions, Rochman and colleagues⁸ reported an 81% rate of successful fusion with a final mean American Orthopaedic Foot and Ankle Society score of 65 (out of a maximum 86). Similar results were reported by Saltzman⁹ in a series of 8 patients with diffuse ankle osteomyelitis treated with resection of all infected tissue and hybrid-frame compression arthrodesis. All patients received 6 weeks of intravenous antibiotics, and frames were removed at 3 months, and walking casts were applied for 1 to 2 additional months. Ankle sepsis was eradicated in all patients, and 7/8 (87.5%) ankles successfully fused at an average of 13.5 weeks (range, 10-16 weeks). One limb required below-knee amputation at 5 weeks due to non-reconstructible vascular insufficiency. At an average of 3.4-year follow-up, none of the 7 fused ankles required further surgery.

Fragomen and colleagues¹ retrospectively reviewed 101 patients who underwent complex ankle fusion using the Ilizarov technique and found that 76/91 (83.5%) patients achieved fusion at an average of 25 weeks (range, 10-65 weeks). Smoking was associated with a 54% rate of nonunion and 15/19 (79%) patients with Charcot neuroarthropathy achieved ankle fusion, but had a subsequent subtalar joint failure, thus highlighting the need for TTC arthrodesis in Charcot patients. Salem and colleagues² reviewed 21 Ilizarov ankle fusions and reported that all patients achieved fusion at an average of 28 weeks (range, 12-84 weeks). Complications occurred in 11 patients, including 2 nonunions that healed after revision frame application and 4 pin tract infections.

CONCLUSION

Overall, the Ilizarov technique using circular external fixation is a powerful tool that can be used to treat a variety of disorders including complex foot and ankle deformity and infection. While case series generally show favorable outcomes, patients must be informed that this technique is a salvage procedure for limb preservation that requires meticulous operative technique, diligent postoperative care, and tight control of medical comorbidities, such as blood sugar levels in individuals with diabetes to achieve a successful outcome.