Cardiothoracic

NASHVILLE, TENN. – Device closure of a patent foramen ovale didn’t reduce the composite risk of death, stroke, or transient ischemic attack when compared against medical therapy alone in a pooled analysis of three trials.

Device intervention, did, however, reduce the individual risk of recurrent stroke, although the absolute reduction seemed modest, Dr. David M. Kent said at the International Stroke Conference, sponsored by the American Heart Association.

Overall device closure conferred about a 30% annual risk reduction of recurrent stroke upon those with patent foramen ovale (PFO) who had experienced a prior cryptogenic stroke. About 30 patients would have to be treated to prevent one stroke over 5 years, said Dr. Kent of Tufts University, Boston.

“It’s not a huge benefit – it’s not like thrombectomy. But it’s comparable to the benefit of high-dose statins seen in the SPARCL [Stroke Prevention by Aggressive Reduction in Cholesterol Levels] trial.”

Dr. Kent and his colleagues’ analysis used three trials: the CLOSURE trial, which used the STARflex device, and two trials that tested the Amplatzer device, the PC TRIAL and RESPECT.

Altogether, the pooled analysis comprised about 2,300 patients. Of these, 440 were lost to 5-year follow-up; their outcomes were imputed into an intent-to-treat analysis based on last-known clinical status.

Dr. Kent and his colleagues also conducted a subanalysis of only the two Amplatzer device trials, which comprised 1,400 patients.

The primary outcome for each analysis was a composite of recurrent stroke, transient ischemic attack (TIA), and early death. The secondary outcome was recurrent stroke alone.

The patients were a mean of 45 years old. About a third had dyslipidemia, and a third had hypertension. The PFO was considered large in 60%.

During the 5-year follow-up period, there were 58 strokes and 54 TIAs. Four patients died during the trial – two in the device arms and two in the medical therapy arms.

When all three trials were analyzed together, PFO closure was not significantly better than medical therapy in the composite endpoint (1.5% vs. 2.3%). The difference in recurrent stroke rate alone was significant (0.7% vs. 1.3%), although Dr. Kent did note that the event rate was very low in both groups.

In the two Amplatzer trials, the device also did not significantly reduce the risk of the composite endpoint. It did confer significant benefit on the stroke-only outcome (hazard ratio, 0.41; 0.4% vs. 1.1%). Again, Dr. Kent said, the event rate was very low for both intervention groups.

There was no significantly increased risk of bleeding with PFO closure in the analysis of all three trials or in the two Amplatzer device trials alone, although both did find a significantly increased risk of atrial fibrillation. In the three-trial analysis, rates of atrial fibrillation were 1.5% vs. 0.48%; in the Amplatzer-only analysis, rates were 0.87% vs. 0.47%. The investigators weren’t able to identify any factors that might predispose to a safety event.

The analyses were sponsored by the National Institutes of Health. Dr. Kent had no financial disclosures, although several coauthors had ties with multiple pharmaceutical companies, or were investigators on the original trials, which were sponsored by the device manufacturers.

[email protected]

On Twitter @alz_gal

NASHVILLE, TENN. – Device closure of a patent foramen ovale didn’t reduce the composite risk of death, stroke, or transient ischemic attack when compared against medical therapy alone in a pooled analysis of three trials.

Device intervention, did, however, reduce the individual risk of recurrent stroke, although the absolute reduction seemed modest, Dr. David M. Kent said at the International Stroke Conference, sponsored by the American Heart Association.

Overall device closure conferred about a 30% annual risk reduction of recurrent stroke upon those with patent foramen ovale (PFO) who had experienced a prior cryptogenic stroke. About 30 patients would have to be treated to prevent one stroke over 5 years, said Dr. Kent of Tufts University, Boston.

“It’s not a huge benefit – it’s not like thrombectomy. But it’s comparable to the benefit of high-dose statins seen in the SPARCL [Stroke Prevention by Aggressive Reduction in Cholesterol Levels] trial.”

Dr. Kent and his colleagues’ analysis used three trials: the CLOSURE trial, which used the STARflex device, and two trials that tested the Amplatzer device, the PC TRIAL and RESPECT.

Altogether, the pooled analysis comprised about 2,300 patients. Of these, 440 were lost to 5-year follow-up; their outcomes were imputed into an intent-to-treat analysis based on last-known clinical status.

Dr. Kent and his colleagues also conducted a subanalysis of only the two Amplatzer device trials, which comprised 1,400 patients.

The primary outcome for each analysis was a composite of recurrent stroke, transient ischemic attack (TIA), and early death. The secondary outcome was recurrent stroke alone.

The patients were a mean of 45 years old. About a third had dyslipidemia, and a third had hypertension. The PFO was considered large in 60%.

During the 5-year follow-up period, there were 58 strokes and 54 TIAs. Four patients died during the trial – two in the device arms and two in the medical therapy arms.

When all three trials were analyzed together, PFO closure was not significantly better than medical therapy in the composite endpoint (1.5% vs. 2.3%). The difference in recurrent stroke rate alone was significant (0.7% vs. 1.3%), although Dr. Kent did note that the event rate was very low in both groups.

In the two Amplatzer trials, the device also did not significantly reduce the risk of the composite endpoint. It did confer significant benefit on the stroke-only outcome (hazard ratio, 0.41; 0.4% vs. 1.1%). Again, Dr. Kent said, the event rate was very low for both intervention groups.

There was no significantly increased risk of bleeding with PFO closure in the analysis of all three trials or in the two Amplatzer device trials alone, although both did find a significantly increased risk of atrial fibrillation. In the three-trial analysis, rates of atrial fibrillation were 1.5% vs. 0.48%; in the Amplatzer-only analysis, rates were 0.87% vs. 0.47%. The investigators weren’t able to identify any factors that might predispose to a safety event.

The analyses were sponsored by the National Institutes of Health. Dr. Kent had no financial disclosures, although several coauthors had ties with multiple pharmaceutical companies, or were investigators on the original trials, which were sponsored by the device manufacturers.

[email protected]

On Twitter @alz_gal

NASHVILLE, TENN. – Device closure of a patent foramen ovale didn’t reduce the composite risk of death, stroke, or transient ischemic attack when compared against medical therapy alone in a pooled analysis of three trials.

Device intervention, did, however, reduce the individual risk of recurrent stroke, although the absolute reduction seemed modest, Dr. David M. Kent said at the International Stroke Conference, sponsored by the American Heart Association.

Overall device closure conferred about a 30% annual risk reduction of recurrent stroke upon those with patent foramen ovale (PFO) who had experienced a prior cryptogenic stroke. About 30 patients would have to be treated to prevent one stroke over 5 years, said Dr. Kent of Tufts University, Boston.

“It’s not a huge benefit – it’s not like thrombectomy. But it’s comparable to the benefit of high-dose statins seen in the SPARCL [Stroke Prevention by Aggressive Reduction in Cholesterol Levels] trial.”

Dr. Kent and his colleagues’ analysis used three trials: the CLOSURE trial, which used the STARflex device, and two trials that tested the Amplatzer device, the PC TRIAL and RESPECT.

Altogether, the pooled analysis comprised about 2,300 patients. Of these, 440 were lost to 5-year follow-up; their outcomes were imputed into an intent-to-treat analysis based on last-known clinical status.

Dr. Kent and his colleagues also conducted a subanalysis of only the two Amplatzer device trials, which comprised 1,400 patients.

The primary outcome for each analysis was a composite of recurrent stroke, transient ischemic attack (TIA), and early death. The secondary outcome was recurrent stroke alone.

The patients were a mean of 45 years old. About a third had dyslipidemia, and a third had hypertension. The PFO was considered large in 60%.

During the 5-year follow-up period, there were 58 strokes and 54 TIAs. Four patients died during the trial – two in the device arms and two in the medical therapy arms.

When all three trials were analyzed together, PFO closure was not significantly better than medical therapy in the composite endpoint (1.5% vs. 2.3%). The difference in recurrent stroke rate alone was significant (0.7% vs. 1.3%), although Dr. Kent did note that the event rate was very low in both groups.

In the two Amplatzer trials, the device also did not significantly reduce the risk of the composite endpoint. It did confer significant benefit on the stroke-only outcome (hazard ratio, 0.41; 0.4% vs. 1.1%). Again, Dr. Kent said, the event rate was very low for both intervention groups.

There was no significantly increased risk of bleeding with PFO closure in the analysis of all three trials or in the two Amplatzer device trials alone, although both did find a significantly increased risk of atrial fibrillation. In the three-trial analysis, rates of atrial fibrillation were 1.5% vs. 0.48%; in the Amplatzer-only analysis, rates were 0.87% vs. 0.47%. The investigators weren’t able to identify any factors that might predispose to a safety event.

The analyses were sponsored by the National Institutes of Health. Dr. Kent had no financial disclosures, although several coauthors had ties with multiple pharmaceutical companies, or were investigators on the original trials, which were sponsored by the device manufacturers.

[email protected]

On Twitter @alz_gal

SAN DIEGO – Predictive factors such as Zubrod score, previous cardiothoracic surgery, history of smoking, and hypertension can give health care providers a powerful tool for predicting the likelihood of patient morbidity resulting from esophagectomy, thus allowing accurate stratification of such patients and thereby mitigating morbidity rates, a study showed.

Patients who had previously undergone cardiothoracic surgery, had Zubrod scores of at least 2, had diabetes mellitus requiring insulin therapy, were currently smoking, had hypertension, were female, and had a forced expiratory volume in 1 second (FEV_{1) score} of less than 60% were the most highly predisposed to mortality after undergoing esophagectomy, said Dr. J. Matthew Reinersman of the Mayo Clinic in Rochester, Minn., who presented the findings at the annual meeting of the Society of Thoracic Surgeons.

Dr. Reinersman led a team of investigators in a retrospective analysis of 343 consecutive patients in the STS General Thoracic Surgery Database who underwent esophagectomies for malignancies between August 2009 and December 2012. “Our primary outcome variables were operative mortality, both in-hospital and 30-day mortality, as well as major morbidity, which we defined as anastomotic leak, myocardial infarction, pulmonary embolism, pneumonia, reintubation for respiratory failure, empyema, chylothorax, and any reoperation,” he explained.

Univariate and multivariate analyses, using a chi-square test or Fisher’s exact analyses, were performed to look for predictors within the data set, and were subsequently used to craft the risk-based model that assigned each patient a score for how likely he or she would be to experience morbidity or mortality after undergoing an esophagectomy. Each patient was then assigned to one of four groups based on this score – group A (86 subjects), group B (138 subjects), group C (81 subjects), or group D (38 subjects) – in ascending order of score.

Dr. Reinersman and his coauthors found that 17 subjects (19.8%) in group A had either morbidity or mortality, as did 45 subjects (32.6%) in group B, 61 subjects (75.3%) in group C, and 36 (94.7%) in group D, indicating that the model and scoring system developed by the investigators was successful in predicting likely morbidity and mortality outcomes based on patients’ medical histories.

The mean patient age was 63.2 years, and the majority of subjects were male. Smokers were prevalent in the study population: Roughly 56% were former smokers, and 12% were current smokers. Endocarcinoma was the predominant tissue type observed by the authors, and the most common tumor location was the gastroesophageal junction or lower third of the esophagus. Approximately, 75% of patients received neoadjuvant therapy as well.

“This risk-assessment tool, which uses only seven factors and an easy-to-remember scoring system dividing patients into four risk categories, can be easily integrated into everyday clinical practice,” said Dr. Reinersman. “It can help inform patient selection and education, [and] also identifies smoking as an important but modifiable preoperative risk factor.”

Dr. Reinersman reported no relevant financial conflicts.

[email protected]

SAN DIEGO – Predictive factors such as Zubrod score, previous cardiothoracic surgery, history of smoking, and hypertension can give health care providers a powerful tool for predicting the likelihood of patient morbidity resulting from esophagectomy, thus allowing accurate stratification of such patients and thereby mitigating morbidity rates, a study showed.

Patients who had previously undergone cardiothoracic surgery, had Zubrod scores of at least 2, had diabetes mellitus requiring insulin therapy, were currently smoking, had hypertension, were female, and had a forced expiratory volume in 1 second (FEV_{1) score} of less than 60% were the most highly predisposed to mortality after undergoing esophagectomy, said Dr. J. Matthew Reinersman of the Mayo Clinic in Rochester, Minn., who presented the findings at the annual meeting of the Society of Thoracic Surgeons.

Dr. Reinersman led a team of investigators in a retrospective analysis of 343 consecutive patients in the STS General Thoracic Surgery Database who underwent esophagectomies for malignancies between August 2009 and December 2012. “Our primary outcome variables were operative mortality, both in-hospital and 30-day mortality, as well as major morbidity, which we defined as anastomotic leak, myocardial infarction, pulmonary embolism, pneumonia, reintubation for respiratory failure, empyema, chylothorax, and any reoperation,” he explained.

Univariate and multivariate analyses, using a chi-square test or Fisher’s exact analyses, were performed to look for predictors within the data set, and were subsequently used to craft the risk-based model that assigned each patient a score for how likely he or she would be to experience morbidity or mortality after undergoing an esophagectomy. Each patient was then assigned to one of four groups based on this score – group A (86 subjects), group B (138 subjects), group C (81 subjects), or group D (38 subjects) – in ascending order of score.

Dr. Reinersman and his coauthors found that 17 subjects (19.8%) in group A had either morbidity or mortality, as did 45 subjects (32.6%) in group B, 61 subjects (75.3%) in group C, and 36 (94.7%) in group D, indicating that the model and scoring system developed by the investigators was successful in predicting likely morbidity and mortality outcomes based on patients’ medical histories.

The mean patient age was 63.2 years, and the majority of subjects were male. Smokers were prevalent in the study population: Roughly 56% were former smokers, and 12% were current smokers. Endocarcinoma was the predominant tissue type observed by the authors, and the most common tumor location was the gastroesophageal junction or lower third of the esophagus. Approximately, 75% of patients received neoadjuvant therapy as well.

“This risk-assessment tool, which uses only seven factors and an easy-to-remember scoring system dividing patients into four risk categories, can be easily integrated into everyday clinical practice,” said Dr. Reinersman. “It can help inform patient selection and education, [and] also identifies smoking as an important but modifiable preoperative risk factor.”

Dr. Reinersman reported no relevant financial conflicts.

[email protected]

SAN DIEGO – Predictive factors such as Zubrod score, previous cardiothoracic surgery, history of smoking, and hypertension can give health care providers a powerful tool for predicting the likelihood of patient morbidity resulting from esophagectomy, thus allowing accurate stratification of such patients and thereby mitigating morbidity rates, a study showed.

Patients who had previously undergone cardiothoracic surgery, had Zubrod scores of at least 2, had diabetes mellitus requiring insulin therapy, were currently smoking, had hypertension, were female, and had a forced expiratory volume in 1 second (FEV_{1) score} of less than 60% were the most highly predisposed to mortality after undergoing esophagectomy, said Dr. J. Matthew Reinersman of the Mayo Clinic in Rochester, Minn., who presented the findings at the annual meeting of the Society of Thoracic Surgeons.

Dr. Reinersman led a team of investigators in a retrospective analysis of 343 consecutive patients in the STS General Thoracic Surgery Database who underwent esophagectomies for malignancies between August 2009 and December 2012. “Our primary outcome variables were operative mortality, both in-hospital and 30-day mortality, as well as major morbidity, which we defined as anastomotic leak, myocardial infarction, pulmonary embolism, pneumonia, reintubation for respiratory failure, empyema, chylothorax, and any reoperation,” he explained.

Univariate and multivariate analyses, using a chi-square test or Fisher’s exact analyses, were performed to look for predictors within the data set, and were subsequently used to craft the risk-based model that assigned each patient a score for how likely he or she would be to experience morbidity or mortality after undergoing an esophagectomy. Each patient was then assigned to one of four groups based on this score – group A (86 subjects), group B (138 subjects), group C (81 subjects), or group D (38 subjects) – in ascending order of score.

Dr. Reinersman and his coauthors found that 17 subjects (19.8%) in group A had either morbidity or mortality, as did 45 subjects (32.6%) in group B, 61 subjects (75.3%) in group C, and 36 (94.7%) in group D, indicating that the model and scoring system developed by the investigators was successful in predicting likely morbidity and mortality outcomes based on patients’ medical histories.

The mean patient age was 63.2 years, and the majority of subjects were male. Smokers were prevalent in the study population: Roughly 56% were former smokers, and 12% were current smokers. Endocarcinoma was the predominant tissue type observed by the authors, and the most common tumor location was the gastroesophageal junction or lower third of the esophagus. Approximately, 75% of patients received neoadjuvant therapy as well.

“This risk-assessment tool, which uses only seven factors and an easy-to-remember scoring system dividing patients into four risk categories, can be easily integrated into everyday clinical practice,” said Dr. Reinersman. “It can help inform patient selection and education, [and] also identifies smoking as an important but modifiable preoperative risk factor.”

Dr. Reinersman reported no relevant financial conflicts.

[email protected]

SNOWMASS, COLO. – For all the talk of embracing the heart team approach to coronary revascularization as the new standard, emphasizing interdisciplinary collaboration between cardiologists and surgeons, hybrid coronary revascularization remains a rarely employed strategy.

Hybrid coronary revascularization (HCR) is performed at one-third of U.S. centers providing coronary artery bypass graft (CABG) surgery, but that’s a misleading statistic. A mere handful of the centers have extensive experience with this strategy, according to the first nationwide assessment of HCR in patients with multivessel coronary artery disease.

“Only a very few centers – maybe 5 or 10 – do hybrid procedures as 8%-10% of their volume,” Dr. Vinod H. Thourani* said at the Annual Cardiovascular Conference at Snowmass.

He was a coinvestigator in the analysis of nearly 200,000 CABG procedures in the Society of Thoracic Surgeons (STS) national database for 2011-2013. Hybrid coronary revascularization – a combination of surgical and percutaneous techniques coupling minimally invasive bypass of the left anterior descending (LAD) coronary artery using an internal mammary artery graft along with drug-eluting stents for non-LAD lesions – accounted for just 0.48% of total CABG volume. And no trend for growth in the HCR approach was evident during the study period.

Moreover, even in the one-third of U.S. CABG centers that performed hybrid coronary revascularization, the strategy was used on average in less than 1% of all CABG procedures (Circulation 2014;130:872-9), noted Dr. Thourani, professor of cardiothoracic surgery and codirector of the Structural Heart and Valve Center at Emory University, Atlanta.

In contrast, he and his Emory colleagues have fully embraced HCR. At Emory, even as the annual number of primary isolated CABG procedures with sternotomy fell by 44% from 2005 to 2012, there was a compensatory increase in the number of HCRs.

“We’ve actually maintained our coronary bypass volume based on introducing HCR, unlike a lot of programs,” according to the surgeon.

The appeal of HCR is that it combines the durability of the internal mammary artery-to-LAD graft – long recognized as the main source of the survival advantage CABG holds over percutaneous interventions – with drug-eluting stents as a less invasive alternative to often-unreliable vein grafts in non-LAD target vessels.

The current American College of Cardiology/American Heart Association guidelines on coronary revascularization give HCR a favorable class IIa recommendation. However, since there are few data on clinical outcomes with HCR versus conventional CABG, Dr. Thourani and his coinvestigators compared in-hospital outcomes in the STS database. They found that after adjustment for the higher cardiovascular risk profiles present in patients undergoing HCR, the rates of in-hospital mortality and major morbidity in the two groups were similar, suggesting HCR may offer an equally safe alternative to CABG in selected patients.

Patients want less invasive alternatives to CABG with sternotomy. The three most common minimally invasive, sternal-sparing approaches are minimally invasive direct coronary artery bypass, or MIDCAB; robotic-assisted totally endoscopic coronary artery bypass, or TECAB; and robotic-assisted coronary artery bypass, a favored approach at Emory. In robotic-assisted coronary artery bypass, the harvest of the left internal mammary artery, pericardiotomy, and targeting of the LAD are accomplished with robotic assistance, but the anastomosis is hand sewn under direct vision, off pump, via a non–rib-spreading 3- to 4-cm minithoracotomy.

In a report on 307 consecutive patients who underwent robotic-assisted CABG at the university, including 159 who had HCR for multivessel disease, short-term clinical and angiographic outcomes were excellent (J. Thorac. Cardiovasc. Surg. 2014;147:179-85). Particularly striking, in Dr. Thourani’s view, was that only one postoperative stroke occurred, for a 0.3% incidence. That’s a far lower rate than typical with CABG with vein grafts.

In a more recent, as-yet-unpublished update including 477 consecutive HCR patients at Emory, the stroke rate remained extraordinarily low at 0.2%, he said.

“You can almost eliminate stroke with this procedure,” according to Dr. Thourani.

Thirty-day mortality was 0.8%, with an MI rate of 1.0%, a 3.8% incidence of conversion to sternotomy, and a 1.9% repeat revascularization rate. The rate of Fitzgibbon A patency was 96.2%, he noted.

“Return to work is really at the patient’s discretion. We tell them, ‘when you don’t hurt, you can go back.’ Some people go back 4-5 days after surgery. And there are really zero limitations for the patient – none whatsoever,” the surgeon said.

The HCR approach to multivessel revascularization appears to be particularly advantageous in diabetic patients and in older individuals. In a retrospective, nonrandomized single-center comparison of 143 HCR recipients who were propensity score matched to 572 patients who underwent multivessel CABG (Am. J. Cardiol. 2014;114:224-9), the HCR recipients had significantly fewer procedural complications, faster recovery, and similar 3-year mortality (see graphic).

Dr. Thourani said that because of the dirth of randomized trials data, it must be conceded that there is equipoise at present regarding the most effective treatment strategy in patients with multivessel coronary disease. The options are CABG with left internal mammary artery and vein grafts, HCR, medical management, multivessel percutaneous coronary intervention (PCI), and multiarterial CABG. But he added that the available evidence, while not definitive, does point the way forward.

“As we move into 2015 and the future, I think we should be doing less of the left intermal mammary artery with vein grafts, potentially less of the medical therapy, and I think we need to do a lot more multiarterial grafts if we think patients need to be opened up with a sternotomy. And if we don’t think they need to be opened up, we need to think very strongly about hybrid revascularization instead of multivessel PCI, especially in patients who are diabetic or old,” according to the surgeon.

Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.

[email protected]

*Clarification, 4/20/2015: Dr. Vinod H. Thourani wishes to clarify that,  as he stated in his presentation, the current work he reported on from Emory University was performed by Dr. Michael Halkos, who is the leader of hybrid revascularization at Emory, and that Dr. Halkos was lead author and researcher in several of the other studies reported upon.

SNOWMASS, COLO. – For all the talk of embracing the heart team approach to coronary revascularization as the new standard, emphasizing interdisciplinary collaboration between cardiologists and surgeons, hybrid coronary revascularization remains a rarely employed strategy.

Hybrid coronary revascularization (HCR) is performed at one-third of U.S. centers providing coronary artery bypass graft (CABG) surgery, but that’s a misleading statistic. A mere handful of the centers have extensive experience with this strategy, according to the first nationwide assessment of HCR in patients with multivessel coronary artery disease.

“Only a very few centers – maybe 5 or 10 – do hybrid procedures as 8%-10% of their volume,” Dr. Vinod H. Thourani* said at the Annual Cardiovascular Conference at Snowmass.

He was a coinvestigator in the analysis of nearly 200,000 CABG procedures in the Society of Thoracic Surgeons (STS) national database for 2011-2013. Hybrid coronary revascularization – a combination of surgical and percutaneous techniques coupling minimally invasive bypass of the left anterior descending (LAD) coronary artery using an internal mammary artery graft along with drug-eluting stents for non-LAD lesions – accounted for just 0.48% of total CABG volume. And no trend for growth in the HCR approach was evident during the study period.

Moreover, even in the one-third of U.S. CABG centers that performed hybrid coronary revascularization, the strategy was used on average in less than 1% of all CABG procedures (Circulation 2014;130:872-9), noted Dr. Thourani, professor of cardiothoracic surgery and codirector of the Structural Heart and Valve Center at Emory University, Atlanta.

In contrast, he and his Emory colleagues have fully embraced HCR. At Emory, even as the annual number of primary isolated CABG procedures with sternotomy fell by 44% from 2005 to 2012, there was a compensatory increase in the number of HCRs.

“We’ve actually maintained our coronary bypass volume based on introducing HCR, unlike a lot of programs,” according to the surgeon.

The appeal of HCR is that it combines the durability of the internal mammary artery-to-LAD graft – long recognized as the main source of the survival advantage CABG holds over percutaneous interventions – with drug-eluting stents as a less invasive alternative to often-unreliable vein grafts in non-LAD target vessels.

The current American College of Cardiology/American Heart Association guidelines on coronary revascularization give HCR a favorable class IIa recommendation. However, since there are few data on clinical outcomes with HCR versus conventional CABG, Dr. Thourani and his coinvestigators compared in-hospital outcomes in the STS database. They found that after adjustment for the higher cardiovascular risk profiles present in patients undergoing HCR, the rates of in-hospital mortality and major morbidity in the two groups were similar, suggesting HCR may offer an equally safe alternative to CABG in selected patients.

Patients want less invasive alternatives to CABG with sternotomy. The three most common minimally invasive, sternal-sparing approaches are minimally invasive direct coronary artery bypass, or MIDCAB; robotic-assisted totally endoscopic coronary artery bypass, or TECAB; and robotic-assisted coronary artery bypass, a favored approach at Emory. In robotic-assisted coronary artery bypass, the harvest of the left internal mammary artery, pericardiotomy, and targeting of the LAD are accomplished with robotic assistance, but the anastomosis is hand sewn under direct vision, off pump, via a non–rib-spreading 3- to 4-cm minithoracotomy.

In a report on 307 consecutive patients who underwent robotic-assisted CABG at the university, including 159 who had HCR for multivessel disease, short-term clinical and angiographic outcomes were excellent (J. Thorac. Cardiovasc. Surg. 2014;147:179-85). Particularly striking, in Dr. Thourani’s view, was that only one postoperative stroke occurred, for a 0.3% incidence. That’s a far lower rate than typical with CABG with vein grafts.

In a more recent, as-yet-unpublished update including 477 consecutive HCR patients at Emory, the stroke rate remained extraordinarily low at 0.2%, he said.

“You can almost eliminate stroke with this procedure,” according to Dr. Thourani.

Thirty-day mortality was 0.8%, with an MI rate of 1.0%, a 3.8% incidence of conversion to sternotomy, and a 1.9% repeat revascularization rate. The rate of Fitzgibbon A patency was 96.2%, he noted.

“Return to work is really at the patient’s discretion. We tell them, ‘when you don’t hurt, you can go back.’ Some people go back 4-5 days after surgery. And there are really zero limitations for the patient – none whatsoever,” the surgeon said.

The HCR approach to multivessel revascularization appears to be particularly advantageous in diabetic patients and in older individuals. In a retrospective, nonrandomized single-center comparison of 143 HCR recipients who were propensity score matched to 572 patients who underwent multivessel CABG (Am. J. Cardiol. 2014;114:224-9), the HCR recipients had significantly fewer procedural complications, faster recovery, and similar 3-year mortality (see graphic).

Dr. Thourani said that because of the dirth of randomized trials data, it must be conceded that there is equipoise at present regarding the most effective treatment strategy in patients with multivessel coronary disease. The options are CABG with left internal mammary artery and vein grafts, HCR, medical management, multivessel percutaneous coronary intervention (PCI), and multiarterial CABG. But he added that the available evidence, while not definitive, does point the way forward.

“As we move into 2015 and the future, I think we should be doing less of the left intermal mammary artery with vein grafts, potentially less of the medical therapy, and I think we need to do a lot more multiarterial grafts if we think patients need to be opened up with a sternotomy. And if we don’t think they need to be opened up, we need to think very strongly about hybrid revascularization instead of multivessel PCI, especially in patients who are diabetic or old,” according to the surgeon.

Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.

[email protected]

*Clarification, 4/20/2015: Dr. Vinod H. Thourani wishes to clarify that,  as he stated in his presentation, the current work he reported on from Emory University was performed by Dr. Michael Halkos, who is the leader of hybrid revascularization at Emory, and that Dr. Halkos was lead author and researcher in several of the other studies reported upon.

SNOWMASS, COLO. – For all the talk of embracing the heart team approach to coronary revascularization as the new standard, emphasizing interdisciplinary collaboration between cardiologists and surgeons, hybrid coronary revascularization remains a rarely employed strategy.

Hybrid coronary revascularization (HCR) is performed at one-third of U.S. centers providing coronary artery bypass graft (CABG) surgery, but that’s a misleading statistic. A mere handful of the centers have extensive experience with this strategy, according to the first nationwide assessment of HCR in patients with multivessel coronary artery disease.

“Only a very few centers – maybe 5 or 10 – do hybrid procedures as 8%-10% of their volume,” Dr. Vinod H. Thourani* said at the Annual Cardiovascular Conference at Snowmass.

He was a coinvestigator in the analysis of nearly 200,000 CABG procedures in the Society of Thoracic Surgeons (STS) national database for 2011-2013. Hybrid coronary revascularization – a combination of surgical and percutaneous techniques coupling minimally invasive bypass of the left anterior descending (LAD) coronary artery using an internal mammary artery graft along with drug-eluting stents for non-LAD lesions – accounted for just 0.48% of total CABG volume. And no trend for growth in the HCR approach was evident during the study period.

Moreover, even in the one-third of U.S. CABG centers that performed hybrid coronary revascularization, the strategy was used on average in less than 1% of all CABG procedures (Circulation 2014;130:872-9), noted Dr. Thourani, professor of cardiothoracic surgery and codirector of the Structural Heart and Valve Center at Emory University, Atlanta.

In contrast, he and his Emory colleagues have fully embraced HCR. At Emory, even as the annual number of primary isolated CABG procedures with sternotomy fell by 44% from 2005 to 2012, there was a compensatory increase in the number of HCRs.

“We’ve actually maintained our coronary bypass volume based on introducing HCR, unlike a lot of programs,” according to the surgeon.

The appeal of HCR is that it combines the durability of the internal mammary artery-to-LAD graft – long recognized as the main source of the survival advantage CABG holds over percutaneous interventions – with drug-eluting stents as a less invasive alternative to often-unreliable vein grafts in non-LAD target vessels.

The current American College of Cardiology/American Heart Association guidelines on coronary revascularization give HCR a favorable class IIa recommendation. However, since there are few data on clinical outcomes with HCR versus conventional CABG, Dr. Thourani and his coinvestigators compared in-hospital outcomes in the STS database. They found that after adjustment for the higher cardiovascular risk profiles present in patients undergoing HCR, the rates of in-hospital mortality and major morbidity in the two groups were similar, suggesting HCR may offer an equally safe alternative to CABG in selected patients.

Patients want less invasive alternatives to CABG with sternotomy. The three most common minimally invasive, sternal-sparing approaches are minimally invasive direct coronary artery bypass, or MIDCAB; robotic-assisted totally endoscopic coronary artery bypass, or TECAB; and robotic-assisted coronary artery bypass, a favored approach at Emory. In robotic-assisted coronary artery bypass, the harvest of the left internal mammary artery, pericardiotomy, and targeting of the LAD are accomplished with robotic assistance, but the anastomosis is hand sewn under direct vision, off pump, via a non–rib-spreading 3- to 4-cm minithoracotomy.

In a report on 307 consecutive patients who underwent robotic-assisted CABG at the university, including 159 who had HCR for multivessel disease, short-term clinical and angiographic outcomes were excellent (J. Thorac. Cardiovasc. Surg. 2014;147:179-85). Particularly striking, in Dr. Thourani’s view, was that only one postoperative stroke occurred, for a 0.3% incidence. That’s a far lower rate than typical with CABG with vein grafts.

In a more recent, as-yet-unpublished update including 477 consecutive HCR patients at Emory, the stroke rate remained extraordinarily low at 0.2%, he said.

“You can almost eliminate stroke with this procedure,” according to Dr. Thourani.

Thirty-day mortality was 0.8%, with an MI rate of 1.0%, a 3.8% incidence of conversion to sternotomy, and a 1.9% repeat revascularization rate. The rate of Fitzgibbon A patency was 96.2%, he noted.

“Return to work is really at the patient’s discretion. We tell them, ‘when you don’t hurt, you can go back.’ Some people go back 4-5 days after surgery. And there are really zero limitations for the patient – none whatsoever,” the surgeon said.

The HCR approach to multivessel revascularization appears to be particularly advantageous in diabetic patients and in older individuals. In a retrospective, nonrandomized single-center comparison of 143 HCR recipients who were propensity score matched to 572 patients who underwent multivessel CABG (Am. J. Cardiol. 2014;114:224-9), the HCR recipients had significantly fewer procedural complications, faster recovery, and similar 3-year mortality (see graphic).

Dr. Thourani said that because of the dirth of randomized trials data, it must be conceded that there is equipoise at present regarding the most effective treatment strategy in patients with multivessel coronary disease. The options are CABG with left internal mammary artery and vein grafts, HCR, medical management, multivessel percutaneous coronary intervention (PCI), and multiarterial CABG. But he added that the available evidence, while not definitive, does point the way forward.

“As we move into 2015 and the future, I think we should be doing less of the left intermal mammary artery with vein grafts, potentially less of the medical therapy, and I think we need to do a lot more multiarterial grafts if we think patients need to be opened up with a sternotomy. And if we don’t think they need to be opened up, we need to think very strongly about hybrid revascularization instead of multivessel PCI, especially in patients who are diabetic or old,” according to the surgeon.

Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.

[email protected]

*Clarification, 4/20/2015: Dr. Vinod H. Thourani wishes to clarify that,  as he stated in his presentation, the current work he reported on from Emory University was performed by Dr. Michael Halkos, who is the leader of hybrid revascularization at Emory, and that Dr. Halkos was lead author and researcher in several of the other studies reported upon.

CHICAGO – The next generation of hybrid carotid stents is slowly breathing life into the stagnant field of carotid artery stenting.

The new hybrid stents combine the flexibility of a traditional open-cell, nitinol stent with the stabilization typically offered by a closed-cell stent design. The initial clinical experience is limited, but shows promising results against embolization, Dr. Claudio Schönholz said at a symposium on vascular surgery sponsored by Northwestern University.

Last year, Dr. Schönholz and his colleagues at the Medical University of South Carolina in Charleston reported the first-in-man use of the investigational Gore Carotid Stent (W.L. Gore & Associates) (J. Endovasc. Thera. 2014 Aug;21:601-4).

As part of the Gore Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events from Carotid Endarterectomy (SCAFFOLD) study, the team has successfully treated another four patients with no evidence of peri- or postprocedural neurological events. This included a case with such severe high-grade stenosis and slow flow that the external carotid artery was not even visible on imaging before the stent was placed, Dr. Schönholz said.

The Food and Drug Administration recently reviewed unreleased data for the first 100 patients enrolled in SCAFFOLD and given the green light for the multicenter, 312-patient study to resume with the start of the new year, he said.

Medtronic’s Cristallo Ideale hybrid stent is already approved outside the United States and was associated with no major neurological events and two cases of transient ischemic attack in 124 patients treated at four expert centers in Italy and Germany in the Cristallo study (J. Endovasc. Ther. 2008;15:186-92).

A more recent retrospective study revealed only one minor stroke in the perioperative period and during the first 30 days in 68 patients with symptomatic carotid stenosis treated by Turkish surgeons with the Cristallo Ideale stent and a proximal protection device (MO.MA, Invatec s.r.l., Medtronic, Italy) (Int. Angiol. 2014 Nov. 14. [Epub ahead of print]).

Better patient selection, increased operator experience, and use of embolic protection devices has reduced neurological events associated with carotid artery stenting, but embolization still occurs after protection devices are removed due to plaque protrusion through the stent struts, Dr. Schönholz said.

The unique design of the hybrid stents “may prevent plaque protrusion, eliminating peri- and postprocedural events,” he said.

The Cristallo Ideale hybrid stent is a nitinol-based stent that has a closed-cell portion at its center and an open-cell configuration on the distal and proximal sections.

In contrast, the Gore Carotid Stent has a closed-cell component throughout the entire device length that is created by placing an expanded polytetrafluoroethylene lattice with 500-micron pores over an open-cell frame. Once combined, both the stent frame and lattice are coated on all surfaces with Carmeda Bioactive Surface (CBAS) heparin. It’s action is limited only to the device surface and has no systemic anticoagulation effects, said Dr. Schönholz, who disclosed serving on Gore’s scientific advisory board.

The open-cell frame allows a high degree of flexibility and conformity to the native anatomy, while the stent lattice provides a high degree of plaque scaffolding that can reduce plaque prolapse, he said. The lattice also reduces the amount of emboli released during and after stent deployment and stabilizes the stent frame by resisting elongation as well as “fish-scaling,” or the misalignment of stent struts that protrude into the vessel wall, particularly when stents are deployed in tortuous anatomy.

When asked during a discussion whether the same results couldn’t be achieved by simply putting in another covered stent like a Viabahn, Dr. Schönholz replied that the Gore Stent isn’t a true covered stent because the 500-micron pores allow perfusion to be maintained to the external carotid artery. “It was intended to prevent plaque profusion, but at the same time allowing perfusion of the external carotid,” he said.

So far, the investigators have not incorporated intravascular ultrasound during stent placement, as it was not part of the SCAFFOLD protocol, but this will likely be used once the device is approved, he added.

Course director Dr. Mark K. Eskandari, chief of vascular surgery at Northwestern University in Chicago, said the results show that “carotid stenting isn’t dead yet and we can persevere. Advances in technology, both in regards to mechanical embolic protection devices and stent design systems, continue to improve the already great results of carotid artery stenting.”

[email protected]

CHICAGO – The next generation of hybrid carotid stents is slowly breathing life into the stagnant field of carotid artery stenting.

The new hybrid stents combine the flexibility of a traditional open-cell, nitinol stent with the stabilization typically offered by a closed-cell stent design. The initial clinical experience is limited, but shows promising results against embolization, Dr. Claudio Schönholz said at a symposium on vascular surgery sponsored by Northwestern University.

Last year, Dr. Schönholz and his colleagues at the Medical University of South Carolina in Charleston reported the first-in-man use of the investigational Gore Carotid Stent (W.L. Gore & Associates) (J. Endovasc. Thera. 2014 Aug;21:601-4).

As part of the Gore Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events from Carotid Endarterectomy (SCAFFOLD) study, the team has successfully treated another four patients with no evidence of peri- or postprocedural neurological events. This included a case with such severe high-grade stenosis and slow flow that the external carotid artery was not even visible on imaging before the stent was placed, Dr. Schönholz said.

The Food and Drug Administration recently reviewed unreleased data for the first 100 patients enrolled in SCAFFOLD and given the green light for the multicenter, 312-patient study to resume with the start of the new year, he said.

Medtronic’s Cristallo Ideale hybrid stent is already approved outside the United States and was associated with no major neurological events and two cases of transient ischemic attack in 124 patients treated at four expert centers in Italy and Germany in the Cristallo study (J. Endovasc. Ther. 2008;15:186-92).

A more recent retrospective study revealed only one minor stroke in the perioperative period and during the first 30 days in 68 patients with symptomatic carotid stenosis treated by Turkish surgeons with the Cristallo Ideale stent and a proximal protection device (MO.MA, Invatec s.r.l., Medtronic, Italy) (Int. Angiol. 2014 Nov. 14. [Epub ahead of print]).

Better patient selection, increased operator experience, and use of embolic protection devices has reduced neurological events associated with carotid artery stenting, but embolization still occurs after protection devices are removed due to plaque protrusion through the stent struts, Dr. Schönholz said.

The unique design of the hybrid stents “may prevent plaque protrusion, eliminating peri- and postprocedural events,” he said.

The Cristallo Ideale hybrid stent is a nitinol-based stent that has a closed-cell portion at its center and an open-cell configuration on the distal and proximal sections.

In contrast, the Gore Carotid Stent has a closed-cell component throughout the entire device length that is created by placing an expanded polytetrafluoroethylene lattice with 500-micron pores over an open-cell frame. Once combined, both the stent frame and lattice are coated on all surfaces with Carmeda Bioactive Surface (CBAS) heparin. It’s action is limited only to the device surface and has no systemic anticoagulation effects, said Dr. Schönholz, who disclosed serving on Gore’s scientific advisory board.

The open-cell frame allows a high degree of flexibility and conformity to the native anatomy, while the stent lattice provides a high degree of plaque scaffolding that can reduce plaque prolapse, he said. The lattice also reduces the amount of emboli released during and after stent deployment and stabilizes the stent frame by resisting elongation as well as “fish-scaling,” or the misalignment of stent struts that protrude into the vessel wall, particularly when stents are deployed in tortuous anatomy.

When asked during a discussion whether the same results couldn’t be achieved by simply putting in another covered stent like a Viabahn, Dr. Schönholz replied that the Gore Stent isn’t a true covered stent because the 500-micron pores allow perfusion to be maintained to the external carotid artery. “It was intended to prevent plaque profusion, but at the same time allowing perfusion of the external carotid,” he said.

So far, the investigators have not incorporated intravascular ultrasound during stent placement, as it was not part of the SCAFFOLD protocol, but this will likely be used once the device is approved, he added.

Course director Dr. Mark K. Eskandari, chief of vascular surgery at Northwestern University in Chicago, said the results show that “carotid stenting isn’t dead yet and we can persevere. Advances in technology, both in regards to mechanical embolic protection devices and stent design systems, continue to improve the already great results of carotid artery stenting.”

[email protected]

CHICAGO – The next generation of hybrid carotid stents is slowly breathing life into the stagnant field of carotid artery stenting.

The new hybrid stents combine the flexibility of a traditional open-cell, nitinol stent with the stabilization typically offered by a closed-cell stent design. The initial clinical experience is limited, but shows promising results against embolization, Dr. Claudio Schönholz said at a symposium on vascular surgery sponsored by Northwestern University.

Last year, Dr. Schönholz and his colleagues at the Medical University of South Carolina in Charleston reported the first-in-man use of the investigational Gore Carotid Stent (W.L. Gore & Associates) (J. Endovasc. Thera. 2014 Aug;21:601-4).

As part of the Gore Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events from Carotid Endarterectomy (SCAFFOLD) study, the team has successfully treated another four patients with no evidence of peri- or postprocedural neurological events. This included a case with such severe high-grade stenosis and slow flow that the external carotid artery was not even visible on imaging before the stent was placed, Dr. Schönholz said.

The Food and Drug Administration recently reviewed unreleased data for the first 100 patients enrolled in SCAFFOLD and given the green light for the multicenter, 312-patient study to resume with the start of the new year, he said.

Medtronic’s Cristallo Ideale hybrid stent is already approved outside the United States and was associated with no major neurological events and two cases of transient ischemic attack in 124 patients treated at four expert centers in Italy and Germany in the Cristallo study (J. Endovasc. Ther. 2008;15:186-92).

A more recent retrospective study revealed only one minor stroke in the perioperative period and during the first 30 days in 68 patients with symptomatic carotid stenosis treated by Turkish surgeons with the Cristallo Ideale stent and a proximal protection device (MO.MA, Invatec s.r.l., Medtronic, Italy) (Int. Angiol. 2014 Nov. 14. [Epub ahead of print]).

Better patient selection, increased operator experience, and use of embolic protection devices has reduced neurological events associated with carotid artery stenting, but embolization still occurs after protection devices are removed due to plaque protrusion through the stent struts, Dr. Schönholz said.

The unique design of the hybrid stents “may prevent plaque protrusion, eliminating peri- and postprocedural events,” he said.

The Cristallo Ideale hybrid stent is a nitinol-based stent that has a closed-cell portion at its center and an open-cell configuration on the distal and proximal sections.

In contrast, the Gore Carotid Stent has a closed-cell component throughout the entire device length that is created by placing an expanded polytetrafluoroethylene lattice with 500-micron pores over an open-cell frame. Once combined, both the stent frame and lattice are coated on all surfaces with Carmeda Bioactive Surface (CBAS) heparin. It’s action is limited only to the device surface and has no systemic anticoagulation effects, said Dr. Schönholz, who disclosed serving on Gore’s scientific advisory board.

The open-cell frame allows a high degree of flexibility and conformity to the native anatomy, while the stent lattice provides a high degree of plaque scaffolding that can reduce plaque prolapse, he said. The lattice also reduces the amount of emboli released during and after stent deployment and stabilizes the stent frame by resisting elongation as well as “fish-scaling,” or the misalignment of stent struts that protrude into the vessel wall, particularly when stents are deployed in tortuous anatomy.

When asked during a discussion whether the same results couldn’t be achieved by simply putting in another covered stent like a Viabahn, Dr. Schönholz replied that the Gore Stent isn’t a true covered stent because the 500-micron pores allow perfusion to be maintained to the external carotid artery. “It was intended to prevent plaque profusion, but at the same time allowing perfusion of the external carotid,” he said.

So far, the investigators have not incorporated intravascular ultrasound during stent placement, as it was not part of the SCAFFOLD protocol, but this will likely be used once the device is approved, he added.

Course director Dr. Mark K. Eskandari, chief of vascular surgery at Northwestern University in Chicago, said the results show that “carotid stenting isn’t dead yet and we can persevere. Advances in technology, both in regards to mechanical embolic protection devices and stent design systems, continue to improve the already great results of carotid artery stenting.”

[email protected]

The use of a modified percutaneous placement technique for right ventricular assist device (RVAD) implantation showed the potential to lessen complications and improve outcomes, according to the results of a retrospective review of 21 patients with right ventricular failure (RVF) implanted with RVADs using this technique.

“This study shows the feasibility and safety of the proposed RVAD implantation technique for various forms of perioperative RVF. A satisfactory outcome can be achieved with a minimal rate of complications,” according to Dr. Diyar Saeed and colleagues at the Clinic for Cardiovascular Surgery, Heinrich-Heine University of Dusseldorf (Germany). Their report appears in the March issue of The Journal of Thoracic and Cardiovascular Surgery [doi:10.1016/j/jtcvs.2014.10.104].

Although this technique has been previously described anecdotally in a few case reports, this study is the largest series reported to date, according to the authors.

A total of 63 left ventricular assist devices (LVADs) were placed during the study period (January 2010 to February 2014); 17 (27%) of these patients subsequently received RVADs. An additional four patients were included who received RVADs after developing postcardiotomy RVF. The mean patient age of the RVAD patients 58 years, and 71% were men, The primary diagnosis was ischemic cardiomyopathy in 57% of the patients, dilative cardiomyopathy in 24%, and acute myocardial infarction in 19% .

The initial operation for RVAD implantation required a median sternotomy and was performed via cardiopulmonary bypass in 14 patients, LVAD support in 3 patients, ECMO support in 3 patients, and off-pump in 1 patient. A dacron graft was attached to the pulmonary artery and passed through a subxiphoid exit, where the RVAD outflow cannula was inserted. The inflow cannula was percutaneously cannulated in the femoral vein, and the sternum was primarily closed.

The median duration of RVAD support was 9 days (range 2-88 days). Explantation of the RVAD was performed by pulling and ligating the outflow graft followed by closure of the insertion site. The RVAD inflow cannula was removed and direct pressure applied.

The overall outcomes were that 52% of patients were successfully weaned from the RVAD; 38% of patients died; and 10% of patients received cardiac transplants, giving a survival rate to discharge or heart transplantation of 62%. The overall 1-year survival rate was 52%, but this comprised an improved survival rate of the 4 postcardiotomy patients (75%) compared with the 17 LVAD patients who received an RVAD (47%). Because of the small population size, these latter differences were not significant.

The main drawback of the technique is the limited mobility of the patients owing to the presence of the inflow cannula in the groin, according to the authors, with the majority of the patients remaining bed or chair bound.

“Early extubation, extended support duration, and reduction of resternotomy risks may be the main advantage of this technique. The RVAD removal can be reproducibly performed under minimal anesthesia and without the need for resternotomy. [However], the survival rate remains limited in patients requiring RVAD support after LVAD implantation,” the researchers concluded.

The authors reported having no financial disclosures.

[email protected]

The use of a modified percutaneous placement technique for right ventricular assist device (RVAD) implantation showed the potential to lessen complications and improve outcomes, according to the results of a retrospective review of 21 patients with right ventricular failure (RVF) implanted with RVADs using this technique.

“This study shows the feasibility and safety of the proposed RVAD implantation technique for various forms of perioperative RVF. A satisfactory outcome can be achieved with a minimal rate of complications,” according to Dr. Diyar Saeed and colleagues at the Clinic for Cardiovascular Surgery, Heinrich-Heine University of Dusseldorf (Germany). Their report appears in the March issue of The Journal of Thoracic and Cardiovascular Surgery [doi:10.1016/j/jtcvs.2014.10.104].

Although this technique has been previously described anecdotally in a few case reports, this study is the largest series reported to date, according to the authors.

A total of 63 left ventricular assist devices (LVADs) were placed during the study period (January 2010 to February 2014); 17 (27%) of these patients subsequently received RVADs. An additional four patients were included who received RVADs after developing postcardiotomy RVF. The mean patient age of the RVAD patients 58 years, and 71% were men, The primary diagnosis was ischemic cardiomyopathy in 57% of the patients, dilative cardiomyopathy in 24%, and acute myocardial infarction in 19% .

The initial operation for RVAD implantation required a median sternotomy and was performed via cardiopulmonary bypass in 14 patients, LVAD support in 3 patients, ECMO support in 3 patients, and off-pump in 1 patient. A dacron graft was attached to the pulmonary artery and passed through a subxiphoid exit, where the RVAD outflow cannula was inserted. The inflow cannula was percutaneously cannulated in the femoral vein, and the sternum was primarily closed.

The median duration of RVAD support was 9 days (range 2-88 days). Explantation of the RVAD was performed by pulling and ligating the outflow graft followed by closure of the insertion site. The RVAD inflow cannula was removed and direct pressure applied.

The overall outcomes were that 52% of patients were successfully weaned from the RVAD; 38% of patients died; and 10% of patients received cardiac transplants, giving a survival rate to discharge or heart transplantation of 62%. The overall 1-year survival rate was 52%, but this comprised an improved survival rate of the 4 postcardiotomy patients (75%) compared with the 17 LVAD patients who received an RVAD (47%). Because of the small population size, these latter differences were not significant.

The main drawback of the technique is the limited mobility of the patients owing to the presence of the inflow cannula in the groin, according to the authors, with the majority of the patients remaining bed or chair bound.

“Early extubation, extended support duration, and reduction of resternotomy risks may be the main advantage of this technique. The RVAD removal can be reproducibly performed under minimal anesthesia and without the need for resternotomy. [However], the survival rate remains limited in patients requiring RVAD support after LVAD implantation,” the researchers concluded.

The authors reported having no financial disclosures.

[email protected]

The use of a modified percutaneous placement technique for right ventricular assist device (RVAD) implantation showed the potential to lessen complications and improve outcomes, according to the results of a retrospective review of 21 patients with right ventricular failure (RVF) implanted with RVADs using this technique.

“This study shows the feasibility and safety of the proposed RVAD implantation technique for various forms of perioperative RVF. A satisfactory outcome can be achieved with a minimal rate of complications,” according to Dr. Diyar Saeed and colleagues at the Clinic for Cardiovascular Surgery, Heinrich-Heine University of Dusseldorf (Germany). Their report appears in the March issue of The Journal of Thoracic and Cardiovascular Surgery [doi:10.1016/j/jtcvs.2014.10.104].

Although this technique has been previously described anecdotally in a few case reports, this study is the largest series reported to date, according to the authors.

A total of 63 left ventricular assist devices (LVADs) were placed during the study period (January 2010 to February 2014); 17 (27%) of these patients subsequently received RVADs. An additional four patients were included who received RVADs after developing postcardiotomy RVF. The mean patient age of the RVAD patients 58 years, and 71% were men, The primary diagnosis was ischemic cardiomyopathy in 57% of the patients, dilative cardiomyopathy in 24%, and acute myocardial infarction in 19% .

The initial operation for RVAD implantation required a median sternotomy and was performed via cardiopulmonary bypass in 14 patients, LVAD support in 3 patients, ECMO support in 3 patients, and off-pump in 1 patient. A dacron graft was attached to the pulmonary artery and passed through a subxiphoid exit, where the RVAD outflow cannula was inserted. The inflow cannula was percutaneously cannulated in the femoral vein, and the sternum was primarily closed.

The median duration of RVAD support was 9 days (range 2-88 days). Explantation of the RVAD was performed by pulling and ligating the outflow graft followed by closure of the insertion site. The RVAD inflow cannula was removed and direct pressure applied.

The overall outcomes were that 52% of patients were successfully weaned from the RVAD; 38% of patients died; and 10% of patients received cardiac transplants, giving a survival rate to discharge or heart transplantation of 62%. The overall 1-year survival rate was 52%, but this comprised an improved survival rate of the 4 postcardiotomy patients (75%) compared with the 17 LVAD patients who received an RVAD (47%). Because of the small population size, these latter differences were not significant.

The main drawback of the technique is the limited mobility of the patients owing to the presence of the inflow cannula in the groin, according to the authors, with the majority of the patients remaining bed or chair bound.

“Early extubation, extended support duration, and reduction of resternotomy risks may be the main advantage of this technique. The RVAD removal can be reproducibly performed under minimal anesthesia and without the need for resternotomy. [However], the survival rate remains limited in patients requiring RVAD support after LVAD implantation,” the researchers concluded.

The authors reported having no financial disclosures.

[email protected]