Cardiothoracic

A new hemodynamic measurement can provide prognostic information that goes beyond just the degree of aortic regurgitation after percutaneous aortic implantation, according to a single-center, retrospective, European study.

The study validates the team’s earlier findings in a slightly larger group of patients. Called aortic regurgitation index (AR index), the parameter is measured by subtracting the left ventricular end-diastolic pressure from the diastolic blood pressure and dividing the result by systolic blood pressure, and then multiplying it by 100.

The measurement can provide additional information beyond echocardiography when it comes to assessing the severity and outcome of periprosthetic aortic regurgitation (periAR), wrote Dr. Mariuca Vasa-Nicotera and colleagues. Even patients with nonexistent or mild periAR after transcatheter aortic valve implantation (TAVI) can be stratified based on their AR index score. It can also help predict 1-year mortality after TAVI.

The findings "are not going to change practice," commented Dr. William Zoghbi, chief of cardiovascular imaging at Methodist DeBakey Heart and Vascular Center in Houston, who was not involved in the study. Rather, the AR index "would help with predicting prognosis for those individuals who have valve implantation."

AR index is also more than just an index of valve regurgitation, said Dr. Zoghbi, who is also the current president of the American College of Cardiology. The measurement shows whether the heart has a significant abnormality in diastolic function and how it is handing the hemodynamic load of valvular regurgitation, he said.

Paravalvular leakage is a common observation following TAVI, and growing evidence has shown an association between the leakage and dramatic increase in morbidity and mortality.

The researchers analyzed data from 122 high-risk or inoperable patients who underwent TAVI during January 2007–March 2011 at Glenfield University Hospital in Leicester, United Kingdom.

The procedure was performed using third^-generation 18-F Medtronic CoreValves or Edwards SAPIEN valves. Afterward, severity of periAR was assessed angiographically, echocardiographically by transesophageal echocardiography, and hemodynamically.

Patients were then divided into two groups on the basis of periAR: 102 had no or mild periAR (26 and 76 patients, respectively), and 20 had moderate or severe periAR (18 and 2 patients).

There were significant differences between the two patient groups.

Patients with moderate to severe periAR after TAVI had a significantly higher EuroSCORE (28.5, compared with 21.2 in those with no to mild periAR) and Society of Thoracic Surgeons mortality score (9.5 and 6.8, respectively). They also had a higher rate of myocardial infarction (40% v. 10%), and a lower left ventricular ejection fraction (45 v. 51).

Thirty-two patients (26%) died during the 1-year follow-up.

Among those remaining, 1-year mortality was 60% in patients with moderate to severe periAR, compared with 20% in patients with no or mild periAR.

The AR index declined in step with periAR severity, from 29.4 in patients with no periAR to 28.0 in those with mild periAR, to19.6 in patients with moderate periAR, and to 7.6 with severe periAR.

One-year mortality by AR index also paralleled that by periAR. That outcome was tripled in patients with an AR index of less than 25, compared with patients who had an AR index of at least 25 (42.3% vs. 14.3%), the authors reported.

AR index was also useful in patients with no or mild periAR, and provided complementary prognostic information, according to the authors.

The patients in that group who had an AR index of at least 25 had a 1-year mortality rate of 14.3%. But that rate was more than doubled those with an AR index of less than 25, at 31.3%. (All patients with moderate to severe periAR after TAVI had an AR index of less than 25.)

Dr. Vasa-Nicotera, who led the study, also published a similar study earlier this year, involving 146 patients with the CoreValve prosthesis.

In that study, the group concluded, "The assessment of the AR index allows a precise judgment of periAR, independently predicts 1-year mortality after TAVI, and provides prognostic information that is complementary to the degree of periAR."

In their current paper, the authors wrote that since "The validity of the AR index could be confirmed in this independent cohort of another high-volume TAVI center," the finding can be generalized.

They added that a prospective multicenter trial might be needed to verify the results. It is also not clear if valves other than Medtronic CoreValve and Edwards SAPIEN will yield the same results.

Dr. Zoghbi added that AR index can also be measure noninvasively with Doppler echocardiography, something that can be considered in the future.

Dr. Vasa-Nicotera had no relevent disclosures. Other investigators disclosed ties to CoreValve/Medtronic and Edwards-Sapien, the makers of the valves used in the study. Dr. Zoghbi had no relevant disclosures.

A new hemodynamic measurement can provide prognostic information that goes beyond just the degree of aortic regurgitation after percutaneous aortic implantation, according to a single-center, retrospective, European study.

The study validates the team’s earlier findings in a slightly larger group of patients. Called aortic regurgitation index (AR index), the parameter is measured by subtracting the left ventricular end-diastolic pressure from the diastolic blood pressure and dividing the result by systolic blood pressure, and then multiplying it by 100.

The measurement can provide additional information beyond echocardiography when it comes to assessing the severity and outcome of periprosthetic aortic regurgitation (periAR), wrote Dr. Mariuca Vasa-Nicotera and colleagues. Even patients with nonexistent or mild periAR after transcatheter aortic valve implantation (TAVI) can be stratified based on their AR index score. It can also help predict 1-year mortality after TAVI.

The findings "are not going to change practice," commented Dr. William Zoghbi, chief of cardiovascular imaging at Methodist DeBakey Heart and Vascular Center in Houston, who was not involved in the study. Rather, the AR index "would help with predicting prognosis for those individuals who have valve implantation."

AR index is also more than just an index of valve regurgitation, said Dr. Zoghbi, who is also the current president of the American College of Cardiology. The measurement shows whether the heart has a significant abnormality in diastolic function and how it is handing the hemodynamic load of valvular regurgitation, he said.

Paravalvular leakage is a common observation following TAVI, and growing evidence has shown an association between the leakage and dramatic increase in morbidity and mortality.

The researchers analyzed data from 122 high-risk or inoperable patients who underwent TAVI during January 2007–March 2011 at Glenfield University Hospital in Leicester, United Kingdom.

The procedure was performed using third^-generation 18-F Medtronic CoreValves or Edwards SAPIEN valves. Afterward, severity of periAR was assessed angiographically, echocardiographically by transesophageal echocardiography, and hemodynamically.

Patients were then divided into two groups on the basis of periAR: 102 had no or mild periAR (26 and 76 patients, respectively), and 20 had moderate or severe periAR (18 and 2 patients).

There were significant differences between the two patient groups.

Patients with moderate to severe periAR after TAVI had a significantly higher EuroSCORE (28.5, compared with 21.2 in those with no to mild periAR) and Society of Thoracic Surgeons mortality score (9.5 and 6.8, respectively). They also had a higher rate of myocardial infarction (40% v. 10%), and a lower left ventricular ejection fraction (45 v. 51).

Thirty-two patients (26%) died during the 1-year follow-up.

Among those remaining, 1-year mortality was 60% in patients with moderate to severe periAR, compared with 20% in patients with no or mild periAR.

The AR index declined in step with periAR severity, from 29.4 in patients with no periAR to 28.0 in those with mild periAR, to19.6 in patients with moderate periAR, and to 7.6 with severe periAR.

One-year mortality by AR index also paralleled that by periAR. That outcome was tripled in patients with an AR index of less than 25, compared with patients who had an AR index of at least 25 (42.3% vs. 14.3%), the authors reported.

AR index was also useful in patients with no or mild periAR, and provided complementary prognostic information, according to the authors.

The patients in that group who had an AR index of at least 25 had a 1-year mortality rate of 14.3%. But that rate was more than doubled those with an AR index of less than 25, at 31.3%. (All patients with moderate to severe periAR after TAVI had an AR index of less than 25.)

Dr. Vasa-Nicotera, who led the study, also published a similar study earlier this year, involving 146 patients with the CoreValve prosthesis.

In that study, the group concluded, "The assessment of the AR index allows a precise judgment of periAR, independently predicts 1-year mortality after TAVI, and provides prognostic information that is complementary to the degree of periAR."

In their current paper, the authors wrote that since "The validity of the AR index could be confirmed in this independent cohort of another high-volume TAVI center," the finding can be generalized.

They added that a prospective multicenter trial might be needed to verify the results. It is also not clear if valves other than Medtronic CoreValve and Edwards SAPIEN will yield the same results.

Dr. Zoghbi added that AR index can also be measure noninvasively with Doppler echocardiography, something that can be considered in the future.

Dr. Vasa-Nicotera had no relevent disclosures. Other investigators disclosed ties to CoreValve/Medtronic and Edwards-Sapien, the makers of the valves used in the study. Dr. Zoghbi had no relevant disclosures.

A new hemodynamic measurement can provide prognostic information that goes beyond just the degree of aortic regurgitation after percutaneous aortic implantation, according to a single-center, retrospective, European study.

The study validates the team’s earlier findings in a slightly larger group of patients. Called aortic regurgitation index (AR index), the parameter is measured by subtracting the left ventricular end-diastolic pressure from the diastolic blood pressure and dividing the result by systolic blood pressure, and then multiplying it by 100.

The measurement can provide additional information beyond echocardiography when it comes to assessing the severity and outcome of periprosthetic aortic regurgitation (periAR), wrote Dr. Mariuca Vasa-Nicotera and colleagues. Even patients with nonexistent or mild periAR after transcatheter aortic valve implantation (TAVI) can be stratified based on their AR index score. It can also help predict 1-year mortality after TAVI.

The findings "are not going to change practice," commented Dr. William Zoghbi, chief of cardiovascular imaging at Methodist DeBakey Heart and Vascular Center in Houston, who was not involved in the study. Rather, the AR index "would help with predicting prognosis for those individuals who have valve implantation."

AR index is also more than just an index of valve regurgitation, said Dr. Zoghbi, who is also the current president of the American College of Cardiology. The measurement shows whether the heart has a significant abnormality in diastolic function and how it is handing the hemodynamic load of valvular regurgitation, he said.

Paravalvular leakage is a common observation following TAVI, and growing evidence has shown an association between the leakage and dramatic increase in morbidity and mortality.

The researchers analyzed data from 122 high-risk or inoperable patients who underwent TAVI during January 2007–March 2011 at Glenfield University Hospital in Leicester, United Kingdom.

The procedure was performed using third^-generation 18-F Medtronic CoreValves or Edwards SAPIEN valves. Afterward, severity of periAR was assessed angiographically, echocardiographically by transesophageal echocardiography, and hemodynamically.

Patients were then divided into two groups on the basis of periAR: 102 had no or mild periAR (26 and 76 patients, respectively), and 20 had moderate or severe periAR (18 and 2 patients).

There were significant differences between the two patient groups.

Patients with moderate to severe periAR after TAVI had a significantly higher EuroSCORE (28.5, compared with 21.2 in those with no to mild periAR) and Society of Thoracic Surgeons mortality score (9.5 and 6.8, respectively). They also had a higher rate of myocardial infarction (40% v. 10%), and a lower left ventricular ejection fraction (45 v. 51).

Thirty-two patients (26%) died during the 1-year follow-up.

Among those remaining, 1-year mortality was 60% in patients with moderate to severe periAR, compared with 20% in patients with no or mild periAR.

The AR index declined in step with periAR severity, from 29.4 in patients with no periAR to 28.0 in those with mild periAR, to19.6 in patients with moderate periAR, and to 7.6 with severe periAR.

One-year mortality by AR index also paralleled that by periAR. That outcome was tripled in patients with an AR index of less than 25, compared with patients who had an AR index of at least 25 (42.3% vs. 14.3%), the authors reported.

AR index was also useful in patients with no or mild periAR, and provided complementary prognostic information, according to the authors.

The patients in that group who had an AR index of at least 25 had a 1-year mortality rate of 14.3%. But that rate was more than doubled those with an AR index of less than 25, at 31.3%. (All patients with moderate to severe periAR after TAVI had an AR index of less than 25.)

Dr. Vasa-Nicotera, who led the study, also published a similar study earlier this year, involving 146 patients with the CoreValve prosthesis.

In that study, the group concluded, "The assessment of the AR index allows a precise judgment of periAR, independently predicts 1-year mortality after TAVI, and provides prognostic information that is complementary to the degree of periAR."

In their current paper, the authors wrote that since "The validity of the AR index could be confirmed in this independent cohort of another high-volume TAVI center," the finding can be generalized.

They added that a prospective multicenter trial might be needed to verify the results. It is also not clear if valves other than Medtronic CoreValve and Edwards SAPIEN will yield the same results.

Dr. Zoghbi added that AR index can also be measure noninvasively with Doppler echocardiography, something that can be considered in the future.

Dr. Vasa-Nicotera had no relevent disclosures. Other investigators disclosed ties to CoreValve/Medtronic and Edwards-Sapien, the makers of the valves used in the study. Dr. Zoghbi had no relevant disclosures.

NATIONAL HARBOR, MD. – Transesophageal echocardiography during percutaneous valve replacement plays an important role in monitoring patients and has the potential to prevent intraprocedural complications, according to a single-center retrospective study.

"There has not been a study that has looked at intraprocedural complications," said Dr. Aditya Saini, lead author and assistant researcher at Clinical Echocardiography Laboratory at MedStar Washington Hospital Center, in the District of Columbia. "We wanted to find out what exactly were the rates and incidence of these complications," Dr. Saini said at the annual meeting of the American Society of Echocardiography.

Several studies from Europe and Canada have already established the importance of TEE during transcatheter aortic valve implantation (TAVI) (JACC Cardiovasc. Imaging 2008;1:15-24).

Dr. Saini and colleagues reviewed intraprocedural 3D-TEE images of 216 consecutive TAVI (commonly referred to as transcatheter aortic valve replacement or TAVR) procedures at MedStar Washington Hospital Center between May 2007 and November 2011. Edwards SAPIEN prosthetic valve was used in the procedure, and implanted through the transapical (27.3% of the patients) or transfemoral (72.7%) approach. All valves were seated appropriately.

Researchers also recorded the occurrence of mobile thrombi immediately after the valves’ implantation.

Results showed that perivalvular leak was the most common observation during the procedure and occurred in roughly 80% of the cases, usually mild and of moderate severity in only 8.7% of the cases. Other complications, which occurred in one or two patients each, included severe central aortic incompetence, ruptured chord off anterior mitral leaflet, new wall motion abnormalities, ascending aortic dissection, and new pericardial effusion.

The most common location for mobile thrombi was the aortic arch (15% of the cases). The thrombi were also observed in the left atrium, left atrial appendage, attached to the catheter in LVOT, attached to native aortic valve after valve implantation, between the prosthesis and aortic annulus, in one or two patients each.

The study’s findings are "nothing earth shattering or new," said Dr. Steven A. Goldstein of MedStar Washington Hospital Center. Dr. Goldstein oversaw the study. "It’s a nice study because it’s a collection of data."

The study "lays down a baseline with a substantial number of patients," said Dr. Saini, chief resident in internal medicine at MedStar Harbor Hospital in Baltimore. "We can’t draw any conclusions from an observational study, but it always starts from the basics."

TEE is routinely used during TAVI to help with balloon positioning, assessing paravalvular aortic regurgitation, and detecting the device’s function and immediate complications, according to the authors.

Dr. Saini and Dr. Goldstein had no relevant disclosures.

NATIONAL HARBOR, MD. – Transesophageal echocardiography during percutaneous valve replacement plays an important role in monitoring patients and has the potential to prevent intraprocedural complications, according to a single-center retrospective study.

"There has not been a study that has looked at intraprocedural complications," said Dr. Aditya Saini, lead author and assistant researcher at Clinical Echocardiography Laboratory at MedStar Washington Hospital Center, in the District of Columbia. "We wanted to find out what exactly were the rates and incidence of these complications," Dr. Saini said at the annual meeting of the American Society of Echocardiography.

Several studies from Europe and Canada have already established the importance of TEE during transcatheter aortic valve implantation (TAVI) (JACC Cardiovasc. Imaging 2008;1:15-24).

Dr. Saini and colleagues reviewed intraprocedural 3D-TEE images of 216 consecutive TAVI (commonly referred to as transcatheter aortic valve replacement or TAVR) procedures at MedStar Washington Hospital Center between May 2007 and November 2011. Edwards SAPIEN prosthetic valve was used in the procedure, and implanted through the transapical (27.3% of the patients) or transfemoral (72.7%) approach. All valves were seated appropriately.

Researchers also recorded the occurrence of mobile thrombi immediately after the valves’ implantation.

Results showed that perivalvular leak was the most common observation during the procedure and occurred in roughly 80% of the cases, usually mild and of moderate severity in only 8.7% of the cases. Other complications, which occurred in one or two patients each, included severe central aortic incompetence, ruptured chord off anterior mitral leaflet, new wall motion abnormalities, ascending aortic dissection, and new pericardial effusion.

The most common location for mobile thrombi was the aortic arch (15% of the cases). The thrombi were also observed in the left atrium, left atrial appendage, attached to the catheter in LVOT, attached to native aortic valve after valve implantation, between the prosthesis and aortic annulus, in one or two patients each.

The study’s findings are "nothing earth shattering or new," said Dr. Steven A. Goldstein of MedStar Washington Hospital Center. Dr. Goldstein oversaw the study. "It’s a nice study because it’s a collection of data."

The study "lays down a baseline with a substantial number of patients," said Dr. Saini, chief resident in internal medicine at MedStar Harbor Hospital in Baltimore. "We can’t draw any conclusions from an observational study, but it always starts from the basics."

TEE is routinely used during TAVI to help with balloon positioning, assessing paravalvular aortic regurgitation, and detecting the device’s function and immediate complications, according to the authors.

Dr. Saini and Dr. Goldstein had no relevant disclosures.

NATIONAL HARBOR, MD. – Transesophageal echocardiography during percutaneous valve replacement plays an important role in monitoring patients and has the potential to prevent intraprocedural complications, according to a single-center retrospective study.

"There has not been a study that has looked at intraprocedural complications," said Dr. Aditya Saini, lead author and assistant researcher at Clinical Echocardiography Laboratory at MedStar Washington Hospital Center, in the District of Columbia. "We wanted to find out what exactly were the rates and incidence of these complications," Dr. Saini said at the annual meeting of the American Society of Echocardiography.

Several studies from Europe and Canada have already established the importance of TEE during transcatheter aortic valve implantation (TAVI) (JACC Cardiovasc. Imaging 2008;1:15-24).

Dr. Saini and colleagues reviewed intraprocedural 3D-TEE images of 216 consecutive TAVI (commonly referred to as transcatheter aortic valve replacement or TAVR) procedures at MedStar Washington Hospital Center between May 2007 and November 2011. Edwards SAPIEN prosthetic valve was used in the procedure, and implanted through the transapical (27.3% of the patients) or transfemoral (72.7%) approach. All valves were seated appropriately.

Researchers also recorded the occurrence of mobile thrombi immediately after the valves’ implantation.

Results showed that perivalvular leak was the most common observation during the procedure and occurred in roughly 80% of the cases, usually mild and of moderate severity in only 8.7% of the cases. Other complications, which occurred in one or two patients each, included severe central aortic incompetence, ruptured chord off anterior mitral leaflet, new wall motion abnormalities, ascending aortic dissection, and new pericardial effusion.

The most common location for mobile thrombi was the aortic arch (15% of the cases). The thrombi were also observed in the left atrium, left atrial appendage, attached to the catheter in LVOT, attached to native aortic valve after valve implantation, between the prosthesis and aortic annulus, in one or two patients each.

The study’s findings are "nothing earth shattering or new," said Dr. Steven A. Goldstein of MedStar Washington Hospital Center. Dr. Goldstein oversaw the study. "It’s a nice study because it’s a collection of data."

The study "lays down a baseline with a substantial number of patients," said Dr. Saini, chief resident in internal medicine at MedStar Harbor Hospital in Baltimore. "We can’t draw any conclusions from an observational study, but it always starts from the basics."

TEE is routinely used during TAVI to help with balloon positioning, assessing paravalvular aortic regurgitation, and detecting the device’s function and immediate complications, according to the authors.

Dr. Saini and Dr. Goldstein had no relevant disclosures.

Use of biolimus-eluting stents with a biodegradable polymer resulted in a significantly lower major adverse cardiac event rate at 1 year than did use of bare-metal stents in patients with acute myocardial infarction who were undergoing primary percutaneous coronary intervention.

The finding comes from Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction (COMFORTABLE AMI), a multicenter, randomized, assessor-blinded, superiority trial in patients presenting with STEMI who were undergoing primary PCI. The trial of more than 1,100 patients found that compared with the use of bare-metal stents, the use of biolimus-eluting stents with a biodegradable polymer was associated with a significant 4.4% absolute reduction and 51% relative reduction in the risk of major adverse cardiac events at 1 year. Use of the biolimus-eluting stents prevented 42 events per 1,000 patients at 1 year compared with bare-metal stents, said Dr. Lorenz Raber of Bern (Switzerland) University Hospital and his associates (JAMA 2012;308:777-87).

The final analysis included 575 patients with 629 infarct vessel lesions randomly assigned to biolimus-eluting stents (Bio-Matrix, Biosensors Europe SA) and 582 patients with 648 infarct-vessel lesions randomly assigned to otherwise identically designed bare-metal stents (Gazelle, Biosensors Europe SA). The patients had a mean age of 61 years, and 79% were men. The median time from symptom onset to balloon inflation was 234 minutes, and from hospital admission to balloon inflation, 44 minutes. There were no apparent differences in lesion complexity between the two groups.

At discharge, 43% of patients received prasugrel and 57% of patients received clopidogrel. In contrast with most previous trials of patients with STEMI, the use of dual antiplatelet therapy remained balanced in both treatment groups throughout the entire follow-up period up to 1 year, the investigators noted.

At 1 year, the primary end point of major adverse cardiac events (cardiac death, target vessel–related reinfarction, and ischemia-driven target-lesion revascularization) occurred in 4.3% of patients who received biolimus-eluting stents and 8.7% of patients given bare-metal stents, producing a hazard ratio of 0.49 (P = .004). For cardiac death alone, the percentages were 2.9% with biolimus-eluting stents and 3.5% for bare-metal stents (HR 0.81, P = .53).

The treatment effect in favor of patients receiving biolimus-eluting stents was attributable to significantly lower risks of target vessel–related reinfarction (0.5% vs 2.7% HR, 0.20, P =.01) and ischemia-driven target-lesion revascularization (1.6% vs 5.7%, HR 0.28). Differences between stent types with respect to the primary outcome emerged early and continued throughout the study period, Dr. Raber and his associates said.

The rates of definite stent thrombosis at 1 year did not differ significantly, at 0.9% in patients receiving biolimus-eluting stents and 2.1% in those receiving bare-metal stents. Furthermore, no differences were seen in all-cause and cardiac mortality between the groups at 1 year.

The biolimus-eluting stent used in this study is not approved by the Food and Drug Administration, but data showing that it was noninferior to the sirolimus-eluting Cypher stent (Lancet 2011;378:1940-8) provided the basis for a recommendation for its use in European guidelines on myocardial revascularization (Eur. Heart J. 2010;31:2501-5), they noted.

The COMFORTABLE AMI trial was investigator-initiated, managed by the Clinical Trials Unit, University of Bern (Switzerland), and supported by the Swiss National Science Foundation and an unrestricted research grant from Biosensors Europe SA, Morges, Switzerland. Dr. Raber is the recipient of a research fellowship funded by the Swiss National Science Foundation.

Use of biolimus-eluting stents with a biodegradable polymer resulted in a significantly lower major adverse cardiac event rate at 1 year than did use of bare-metal stents in patients with acute myocardial infarction who were undergoing primary percutaneous coronary intervention.

The finding comes from Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction (COMFORTABLE AMI), a multicenter, randomized, assessor-blinded, superiority trial in patients presenting with STEMI who were undergoing primary PCI. The trial of more than 1,100 patients found that compared with the use of bare-metal stents, the use of biolimus-eluting stents with a biodegradable polymer was associated with a significant 4.4% absolute reduction and 51% relative reduction in the risk of major adverse cardiac events at 1 year. Use of the biolimus-eluting stents prevented 42 events per 1,000 patients at 1 year compared with bare-metal stents, said Dr. Lorenz Raber of Bern (Switzerland) University Hospital and his associates (JAMA 2012;308:777-87).

The final analysis included 575 patients with 629 infarct vessel lesions randomly assigned to biolimus-eluting stents (Bio-Matrix, Biosensors Europe SA) and 582 patients with 648 infarct-vessel lesions randomly assigned to otherwise identically designed bare-metal stents (Gazelle, Biosensors Europe SA). The patients had a mean age of 61 years, and 79% were men. The median time from symptom onset to balloon inflation was 234 minutes, and from hospital admission to balloon inflation, 44 minutes. There were no apparent differences in lesion complexity between the two groups.

At discharge, 43% of patients received prasugrel and 57% of patients received clopidogrel. In contrast with most previous trials of patients with STEMI, the use of dual antiplatelet therapy remained balanced in both treatment groups throughout the entire follow-up period up to 1 year, the investigators noted.

At 1 year, the primary end point of major adverse cardiac events (cardiac death, target vessel–related reinfarction, and ischemia-driven target-lesion revascularization) occurred in 4.3% of patients who received biolimus-eluting stents and 8.7% of patients given bare-metal stents, producing a hazard ratio of 0.49 (P = .004). For cardiac death alone, the percentages were 2.9% with biolimus-eluting stents and 3.5% for bare-metal stents (HR 0.81, P = .53).

The treatment effect in favor of patients receiving biolimus-eluting stents was attributable to significantly lower risks of target vessel–related reinfarction (0.5% vs 2.7% HR, 0.20, P =.01) and ischemia-driven target-lesion revascularization (1.6% vs 5.7%, HR 0.28). Differences between stent types with respect to the primary outcome emerged early and continued throughout the study period, Dr. Raber and his associates said.

The rates of definite stent thrombosis at 1 year did not differ significantly, at 0.9% in patients receiving biolimus-eluting stents and 2.1% in those receiving bare-metal stents. Furthermore, no differences were seen in all-cause and cardiac mortality between the groups at 1 year.

The biolimus-eluting stent used in this study is not approved by the Food and Drug Administration, but data showing that it was noninferior to the sirolimus-eluting Cypher stent (Lancet 2011;378:1940-8) provided the basis for a recommendation for its use in European guidelines on myocardial revascularization (Eur. Heart J. 2010;31:2501-5), they noted.

The COMFORTABLE AMI trial was investigator-initiated, managed by the Clinical Trials Unit, University of Bern (Switzerland), and supported by the Swiss National Science Foundation and an unrestricted research grant from Biosensors Europe SA, Morges, Switzerland. Dr. Raber is the recipient of a research fellowship funded by the Swiss National Science Foundation.

Use of biolimus-eluting stents with a biodegradable polymer resulted in a significantly lower major adverse cardiac event rate at 1 year than did use of bare-metal stents in patients with acute myocardial infarction who were undergoing primary percutaneous coronary intervention.

The finding comes from Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction (COMFORTABLE AMI), a multicenter, randomized, assessor-blinded, superiority trial in patients presenting with STEMI who were undergoing primary PCI. The trial of more than 1,100 patients found that compared with the use of bare-metal stents, the use of biolimus-eluting stents with a biodegradable polymer was associated with a significant 4.4% absolute reduction and 51% relative reduction in the risk of major adverse cardiac events at 1 year. Use of the biolimus-eluting stents prevented 42 events per 1,000 patients at 1 year compared with bare-metal stents, said Dr. Lorenz Raber of Bern (Switzerland) University Hospital and his associates (JAMA 2012;308:777-87).

The final analysis included 575 patients with 629 infarct vessel lesions randomly assigned to biolimus-eluting stents (Bio-Matrix, Biosensors Europe SA) and 582 patients with 648 infarct-vessel lesions randomly assigned to otherwise identically designed bare-metal stents (Gazelle, Biosensors Europe SA). The patients had a mean age of 61 years, and 79% were men. The median time from symptom onset to balloon inflation was 234 minutes, and from hospital admission to balloon inflation, 44 minutes. There were no apparent differences in lesion complexity between the two groups.

At discharge, 43% of patients received prasugrel and 57% of patients received clopidogrel. In contrast with most previous trials of patients with STEMI, the use of dual antiplatelet therapy remained balanced in both treatment groups throughout the entire follow-up period up to 1 year, the investigators noted.

At 1 year, the primary end point of major adverse cardiac events (cardiac death, target vessel–related reinfarction, and ischemia-driven target-lesion revascularization) occurred in 4.3% of patients who received biolimus-eluting stents and 8.7% of patients given bare-metal stents, producing a hazard ratio of 0.49 (P = .004). For cardiac death alone, the percentages were 2.9% with biolimus-eluting stents and 3.5% for bare-metal stents (HR 0.81, P = .53).

The treatment effect in favor of patients receiving biolimus-eluting stents was attributable to significantly lower risks of target vessel–related reinfarction (0.5% vs 2.7% HR, 0.20, P =.01) and ischemia-driven target-lesion revascularization (1.6% vs 5.7%, HR 0.28). Differences between stent types with respect to the primary outcome emerged early and continued throughout the study period, Dr. Raber and his associates said.

The rates of definite stent thrombosis at 1 year did not differ significantly, at 0.9% in patients receiving biolimus-eluting stents and 2.1% in those receiving bare-metal stents. Furthermore, no differences were seen in all-cause and cardiac mortality between the groups at 1 year.

The biolimus-eluting stent used in this study is not approved by the Food and Drug Administration, but data showing that it was noninferior to the sirolimus-eluting Cypher stent (Lancet 2011;378:1940-8) provided the basis for a recommendation for its use in European guidelines on myocardial revascularization (Eur. Heart J. 2010;31:2501-5), they noted.

The COMFORTABLE AMI trial was investigator-initiated, managed by the Clinical Trials Unit, University of Bern (Switzerland), and supported by the Swiss National Science Foundation and an unrestricted research grant from Biosensors Europe SA, Morges, Switzerland. Dr. Raber is the recipient of a research fellowship funded by the Swiss National Science Foundation.

Major vascular complications following transfemoral percutaneous aortic valve replacement using first-generation devices were associated with a nearly fivefold increase in 30-day mortality, according to a post hoc analysis of the PARTNER trial.

The complications also were associated with higher 1-year all-cause and cardiac mortality, Dr. Philippe Généreux and his colleagues reported in the Journal of the American College of Cardiology (2012 August [doi: 10.1016/j.jacc.2012.07.003]).

"This is a wonderful technique, but you have to be very careful with patient selection, especially if you’re starting a new program," Dr. Généreux, an interventional cardiologist at Columbia University Medical Center/New York Presbyterian Hospital, said in an interview.

The findings also highlight the importance of having a heart team and appropriate training, said Dr. Généreux, who also practices at the University of Montreal.

He and his colleagues pooled data from the PARTNER (Placement of Aortic Transcatheter Valve) trial’s cohort A (J. Am. Coll. Cardiol. 2012;60:548-58) and cohort B (N. Engl. J. Med. 2010;363:1597-607) for only those patients who had undergone transcatheter aortic valve replacement via the transfemoral approach (242 from cohort A and 177 from cohort B.)

First-generation Edwards Sapien valves were used, via a 22-F or 24-F sheath.

Dr. Généreux said he expected the complication rates to drop in the near future as new-generation devices and smaller delivery systems arrive in the U.S. market and as cardiologists gain more experience performing transcatheter aortic valve replacement (TAVR).

A recent study showed that from 2009 to 2010, major vascular complications decreased from 8% to 1%, and minor vascular complications decreased from 24% to 8% (J. Am. Coll. Cardiol. 2012;59:113-8). The authors noted that "[s]maller sheaths, rigorous angiographic and computed tomographic screening and patient selection, and percutaneous vascular repair techniques were increasingly used over this period."

Results of the current study showed that roughly 15% (64) of the patients had a major vascular complication, and 12% (50) patients had minor complications within 30 days following the procedure.

The most common major vascular complications after TAVR included vascular dissection (63%), vascular perforation (31%), access site hematoma (23%), and retroperitoneal bleeding (10%).

Patients who had a major vascular complication following transfemoral TAVR, compared with those who did not, had a significantly higher rate of 30-day mortality (14% vs. 3%, respectively) and 1-year mortality (39% vs. 23%). The occurrence of a major vascular complication also was associated with significantly higher 30-day rates of transfusions (41% vs. 5%), major bleeding (61% vs. 7%), and renal failure requiring dialysis (8% vs. 2%).

However, "the incidence and impact of major [vascular complications] seem to decrease in a lower-risk population," the authors wrote.

Moreover, patients in cohort B had a higher rate of major and minor vascular complications (32.8%) than did patients in cohort A (23.2%). The difference is partly explained by the fact that patients in cohort B were sicker and, unlike cohort A, had no alternative routes available to them, said Dr. Généreux, who also is the director of the Angiographic Core Laboratory at the Cardiovascular Research Foundation in New York.

The analysis showed that patients with major vascular complications had a lower body surface area, a smaller vessel diameter, and higher sheath-to-femoral-artery and sheath-to-external-iliac-artery ratios. They also were more likely to have insulin-treated diabetes at baseline and to be female.

Female sex was in fact the only independent predictor of major vascular complications after TAVR, according to the analysis, even after adjustment for the sheath-to-femoral-artery ratio. However, female sex was also associated with a reduction in all-cause mortality at 1 year after TAVR, the authors noted. "Thus, the impact of sex on short- and long-term outcomes is complex, and a more detailed analysis is needed," they wrote.

Dr. Généreux said that if this analysis were to be repeated in a few years, he expected the vascular complication rates to fall to a range of 1%-5%, and that fewer dramatic complications would be reported.

Dr. Généreux is a speaker and consultant for Edwards Lifesciences. Several coauthors have received consulting fees, travel reimbursement, and/or grant support from Edwards and other device companies.

Major vascular complications following transfemoral percutaneous aortic valve replacement using first-generation devices were associated with a nearly fivefold increase in 30-day mortality, according to a post hoc analysis of the PARTNER trial.

The complications also were associated with higher 1-year all-cause and cardiac mortality, Dr. Philippe Généreux and his colleagues reported in the Journal of the American College of Cardiology (2012 August [doi: 10.1016/j.jacc.2012.07.003]).

"This is a wonderful technique, but you have to be very careful with patient selection, especially if you’re starting a new program," Dr. Généreux, an interventional cardiologist at Columbia University Medical Center/New York Presbyterian Hospital, said in an interview.

The findings also highlight the importance of having a heart team and appropriate training, said Dr. Généreux, who also practices at the University of Montreal.

He and his colleagues pooled data from the PARTNER (Placement of Aortic Transcatheter Valve) trial’s cohort A (J. Am. Coll. Cardiol. 2012;60:548-58) and cohort B (N. Engl. J. Med. 2010;363:1597-607) for only those patients who had undergone transcatheter aortic valve replacement via the transfemoral approach (242 from cohort A and 177 from cohort B.)

First-generation Edwards Sapien valves were used, via a 22-F or 24-F sheath.

Dr. Généreux said he expected the complication rates to drop in the near future as new-generation devices and smaller delivery systems arrive in the U.S. market and as cardiologists gain more experience performing transcatheter aortic valve replacement (TAVR).

A recent study showed that from 2009 to 2010, major vascular complications decreased from 8% to 1%, and minor vascular complications decreased from 24% to 8% (J. Am. Coll. Cardiol. 2012;59:113-8). The authors noted that "[s]maller sheaths, rigorous angiographic and computed tomographic screening and patient selection, and percutaneous vascular repair techniques were increasingly used over this period."

Results of the current study showed that roughly 15% (64) of the patients had a major vascular complication, and 12% (50) patients had minor complications within 30 days following the procedure.

The most common major vascular complications after TAVR included vascular dissection (63%), vascular perforation (31%), access site hematoma (23%), and retroperitoneal bleeding (10%).

Patients who had a major vascular complication following transfemoral TAVR, compared with those who did not, had a significantly higher rate of 30-day mortality (14% vs. 3%, respectively) and 1-year mortality (39% vs. 23%). The occurrence of a major vascular complication also was associated with significantly higher 30-day rates of transfusions (41% vs. 5%), major bleeding (61% vs. 7%), and renal failure requiring dialysis (8% vs. 2%).

However, "the incidence and impact of major [vascular complications] seem to decrease in a lower-risk population," the authors wrote.

Moreover, patients in cohort B had a higher rate of major and minor vascular complications (32.8%) than did patients in cohort A (23.2%). The difference is partly explained by the fact that patients in cohort B were sicker and, unlike cohort A, had no alternative routes available to them, said Dr. Généreux, who also is the director of the Angiographic Core Laboratory at the Cardiovascular Research Foundation in New York.

The analysis showed that patients with major vascular complications had a lower body surface area, a smaller vessel diameter, and higher sheath-to-femoral-artery and sheath-to-external-iliac-artery ratios. They also were more likely to have insulin-treated diabetes at baseline and to be female.

Female sex was in fact the only independent predictor of major vascular complications after TAVR, according to the analysis, even after adjustment for the sheath-to-femoral-artery ratio. However, female sex was also associated with a reduction in all-cause mortality at 1 year after TAVR, the authors noted. "Thus, the impact of sex on short- and long-term outcomes is complex, and a more detailed analysis is needed," they wrote.

Dr. Généreux said that if this analysis were to be repeated in a few years, he expected the vascular complication rates to fall to a range of 1%-5%, and that fewer dramatic complications would be reported.

Dr. Généreux is a speaker and consultant for Edwards Lifesciences. Several coauthors have received consulting fees, travel reimbursement, and/or grant support from Edwards and other device companies.

Major vascular complications following transfemoral percutaneous aortic valve replacement using first-generation devices were associated with a nearly fivefold increase in 30-day mortality, according to a post hoc analysis of the PARTNER trial.

The complications also were associated with higher 1-year all-cause and cardiac mortality, Dr. Philippe Généreux and his colleagues reported in the Journal of the American College of Cardiology (2012 August [doi: 10.1016/j.jacc.2012.07.003]).

"This is a wonderful technique, but you have to be very careful with patient selection, especially if you’re starting a new program," Dr. Généreux, an interventional cardiologist at Columbia University Medical Center/New York Presbyterian Hospital, said in an interview.

The findings also highlight the importance of having a heart team and appropriate training, said Dr. Généreux, who also practices at the University of Montreal.

He and his colleagues pooled data from the PARTNER (Placement of Aortic Transcatheter Valve) trial’s cohort A (J. Am. Coll. Cardiol. 2012;60:548-58) and cohort B (N. Engl. J. Med. 2010;363:1597-607) for only those patients who had undergone transcatheter aortic valve replacement via the transfemoral approach (242 from cohort A and 177 from cohort B.)

First-generation Edwards Sapien valves were used, via a 22-F or 24-F sheath.

Dr. Généreux said he expected the complication rates to drop in the near future as new-generation devices and smaller delivery systems arrive in the U.S. market and as cardiologists gain more experience performing transcatheter aortic valve replacement (TAVR).

A recent study showed that from 2009 to 2010, major vascular complications decreased from 8% to 1%, and minor vascular complications decreased from 24% to 8% (J. Am. Coll. Cardiol. 2012;59:113-8). The authors noted that "[s]maller sheaths, rigorous angiographic and computed tomographic screening and patient selection, and percutaneous vascular repair techniques were increasingly used over this period."

Results of the current study showed that roughly 15% (64) of the patients had a major vascular complication, and 12% (50) patients had minor complications within 30 days following the procedure.

The most common major vascular complications after TAVR included vascular dissection (63%), vascular perforation (31%), access site hematoma (23%), and retroperitoneal bleeding (10%).

Patients who had a major vascular complication following transfemoral TAVR, compared with those who did not, had a significantly higher rate of 30-day mortality (14% vs. 3%, respectively) and 1-year mortality (39% vs. 23%). The occurrence of a major vascular complication also was associated with significantly higher 30-day rates of transfusions (41% vs. 5%), major bleeding (61% vs. 7%), and renal failure requiring dialysis (8% vs. 2%).

However, "the incidence and impact of major [vascular complications] seem to decrease in a lower-risk population," the authors wrote.

Moreover, patients in cohort B had a higher rate of major and minor vascular complications (32.8%) than did patients in cohort A (23.2%). The difference is partly explained by the fact that patients in cohort B were sicker and, unlike cohort A, had no alternative routes available to them, said Dr. Généreux, who also is the director of the Angiographic Core Laboratory at the Cardiovascular Research Foundation in New York.

The analysis showed that patients with major vascular complications had a lower body surface area, a smaller vessel diameter, and higher sheath-to-femoral-artery and sheath-to-external-iliac-artery ratios. They also were more likely to have insulin-treated diabetes at baseline and to be female.

Female sex was in fact the only independent predictor of major vascular complications after TAVR, according to the analysis, even after adjustment for the sheath-to-femoral-artery ratio. However, female sex was also associated with a reduction in all-cause mortality at 1 year after TAVR, the authors noted. "Thus, the impact of sex on short- and long-term outcomes is complex, and a more detailed analysis is needed," they wrote.

Dr. Généreux said that if this analysis were to be repeated in a few years, he expected the vascular complication rates to fall to a range of 1%-5%, and that fewer dramatic complications would be reported.

Dr. Généreux is a speaker and consultant for Edwards Lifesciences. Several coauthors have received consulting fees, travel reimbursement, and/or grant support from Edwards and other device companies.

SAN FRANCISCO – Considerable variation by institution suggests that additional training is needed to standardize radiofrequency ablation of persistent atrial fibrillation in patients undergoing concomitant cardiac surgery, according to a prospective, multicenter study.

"As surgeons we need to take the ‘a fib’ part of the procedure more seriously. There can be a high cure rate," Dr. Ralph J. Damiano Jr. said at the annual meeting of the American Association for Thoracic Surgery.

He and his associates studied 150 consecutive patients with persistent or permanent atrial fibrillation (AF) undergoing irrigated unipolar or bipolar radiofrequency treatment at 15 centers between May 2007 and July 2011. The study protocol included use of the Cox Maze IV lesion set.

Freedom from AF at 6-9 months’ follow-up was a primary efficacy end point of the CURE AF (Concomitant Utilization of Radiofrequency Energy for Atrial Fibrillation) trial; this outcome was achieved by 66% of patients. Just more than half of patients, 53%, were not taking antiarrhythmia medications at this follow-up time, another measure of efficacy.

"The Cox Maze IV procedure performed with irrigated radiofrequency ablation in patients with persistent atrial fibrillation restored the majority of patients to sinus rhythm with a low complication rate," Dr. Damiano said.

There was no statistical difference in efficacy outcomes by AF type. Most of the participants, 75%, had long-standing persistent atrial fibrillation, 22% had persistent AF, and 3% had paroxysmal AF.

The mean patient age was 71 years, 56% were men, and the majority had New York Heart Association (NYHA) class II or III heart failure. The mean duration of AF was 64 months.

The primary safety measure in the study was the major cardiac composite adverse event rate within 30 days. A total 6.6% of participants experienced such an event, although none were device related, Dr. Damiano said. There were no cases of pulmonary vein stenosis, he added. Operative mortality was 4%.

Significant predictors of success, defined as freedom from AF, included shorter duration of the persistent or permanent atrial fibrillation, smaller left atrial diameter, and fewer concomitant cardiac procedures, said Dr. Damiano, a cardiothoracic surgeon at Barnes Jewish Hospital in St. Louis.

As an example, the success rate was 50% when total radiofrequency ablation time was less than 6 minutes. By comparison, success grew to 80% with ablation times of 12 minutes or longer.

Left atrial diameter was the only significant predictor of success that remained on a multivariate analysis. Dr. Damiano and his colleagues found that 69% of patients with a left atrial diameter of 3.0-4.5 cm were free from AF, compared with 36% who had a diameter larger than 6 cm. The overall mean left atrial diameter was 5.2 cm.

There were significant differences in achievement of success among different study centers, including a 33% success rate at one site versus 100% at three other sites, Dr. Damiano said.

"The variability between centers is probably one of the most important findings in this study," study discussant Dr. Niv Add said. He asked: "How would you see moving forward with training and credentialing of surgeons?" Dr. Add is chief of cardiac surgery at Inova Fairfax Hospital, Falls Church, Va.

"We were supposed to perform the exact same procedure in the same way," Dr. Damiano replied. "The surgeons all agreed on the lesion set [but] it’s hard to quantify experience. You can see a huge variation in ablation time, so clearly we were not all performing the same procedure. This variability suggests a need for more effective procedural and device training."

A total 80% of patients had concomitant mitral disease; 58% had heart failure; and 52% had tricuspid disease.

The most common surgical procedure was single valve with or without coronary artery bypass grafting (CABG) in 53%. Double-valve surgery with or without CABG was performed in 30% of patients; CABG in 15%; triple-valve with or without CABG in 1%; and other surgery in 1%.

Intraoperative pulmonary vein isolation was measured using exit block and was achieved for 81% of patients. Radiofrequency ablation was performed using Medtronic’s Cardioblate unipolar or bipolar device. As the device is not yet cleared by the Food and Drug Administration for this indication, such use is considered off label.

Dr. Damiano is a consultant for Medtronic. Medtronic sponsored the trial.

SAN FRANCISCO – Considerable variation by institution suggests that additional training is needed to standardize radiofrequency ablation of persistent atrial fibrillation in patients undergoing concomitant cardiac surgery, according to a prospective, multicenter study.

"As surgeons we need to take the ‘a fib’ part of the procedure more seriously. There can be a high cure rate," Dr. Ralph J. Damiano Jr. said at the annual meeting of the American Association for Thoracic Surgery.

He and his associates studied 150 consecutive patients with persistent or permanent atrial fibrillation (AF) undergoing irrigated unipolar or bipolar radiofrequency treatment at 15 centers between May 2007 and July 2011. The study protocol included use of the Cox Maze IV lesion set.

Freedom from AF at 6-9 months’ follow-up was a primary efficacy end point of the CURE AF (Concomitant Utilization of Radiofrequency Energy for Atrial Fibrillation) trial; this outcome was achieved by 66% of patients. Just more than half of patients, 53%, were not taking antiarrhythmia medications at this follow-up time, another measure of efficacy.

"The Cox Maze IV procedure performed with irrigated radiofrequency ablation in patients with persistent atrial fibrillation restored the majority of patients to sinus rhythm with a low complication rate," Dr. Damiano said.

There was no statistical difference in efficacy outcomes by AF type. Most of the participants, 75%, had long-standing persistent atrial fibrillation, 22% had persistent AF, and 3% had paroxysmal AF.

The mean patient age was 71 years, 56% were men, and the majority had New York Heart Association (NYHA) class II or III heart failure. The mean duration of AF was 64 months.

The primary safety measure in the study was the major cardiac composite adverse event rate within 30 days. A total 6.6% of participants experienced such an event, although none were device related, Dr. Damiano said. There were no cases of pulmonary vein stenosis, he added. Operative mortality was 4%.

Significant predictors of success, defined as freedom from AF, included shorter duration of the persistent or permanent atrial fibrillation, smaller left atrial diameter, and fewer concomitant cardiac procedures, said Dr. Damiano, a cardiothoracic surgeon at Barnes Jewish Hospital in St. Louis.

As an example, the success rate was 50% when total radiofrequency ablation time was less than 6 minutes. By comparison, success grew to 80% with ablation times of 12 minutes or longer.

Left atrial diameter was the only significant predictor of success that remained on a multivariate analysis. Dr. Damiano and his colleagues found that 69% of patients with a left atrial diameter of 3.0-4.5 cm were free from AF, compared with 36% who had a diameter larger than 6 cm. The overall mean left atrial diameter was 5.2 cm.

There were significant differences in achievement of success among different study centers, including a 33% success rate at one site versus 100% at three other sites, Dr. Damiano said.

"The variability between centers is probably one of the most important findings in this study," study discussant Dr. Niv Add said. He asked: "How would you see moving forward with training and credentialing of surgeons?" Dr. Add is chief of cardiac surgery at Inova Fairfax Hospital, Falls Church, Va.

"We were supposed to perform the exact same procedure in the same way," Dr. Damiano replied. "The surgeons all agreed on the lesion set [but] it’s hard to quantify experience. You can see a huge variation in ablation time, so clearly we were not all performing the same procedure. This variability suggests a need for more effective procedural and device training."

A total 80% of patients had concomitant mitral disease; 58% had heart failure; and 52% had tricuspid disease.

The most common surgical procedure was single valve with or without coronary artery bypass grafting (CABG) in 53%. Double-valve surgery with or without CABG was performed in 30% of patients; CABG in 15%; triple-valve with or without CABG in 1%; and other surgery in 1%.

Intraoperative pulmonary vein isolation was measured using exit block and was achieved for 81% of patients. Radiofrequency ablation was performed using Medtronic’s Cardioblate unipolar or bipolar device. As the device is not yet cleared by the Food and Drug Administration for this indication, such use is considered off label.

Dr. Damiano is a consultant for Medtronic. Medtronic sponsored the trial.

SAN FRANCISCO – Considerable variation by institution suggests that additional training is needed to standardize radiofrequency ablation of persistent atrial fibrillation in patients undergoing concomitant cardiac surgery, according to a prospective, multicenter study.

"As surgeons we need to take the ‘a fib’ part of the procedure more seriously. There can be a high cure rate," Dr. Ralph J. Damiano Jr. said at the annual meeting of the American Association for Thoracic Surgery.

He and his associates studied 150 consecutive patients with persistent or permanent atrial fibrillation (AF) undergoing irrigated unipolar or bipolar radiofrequency treatment at 15 centers between May 2007 and July 2011. The study protocol included use of the Cox Maze IV lesion set.

Freedom from AF at 6-9 months’ follow-up was a primary efficacy end point of the CURE AF (Concomitant Utilization of Radiofrequency Energy for Atrial Fibrillation) trial; this outcome was achieved by 66% of patients. Just more than half of patients, 53%, were not taking antiarrhythmia medications at this follow-up time, another measure of efficacy.

"The Cox Maze IV procedure performed with irrigated radiofrequency ablation in patients with persistent atrial fibrillation restored the majority of patients to sinus rhythm with a low complication rate," Dr. Damiano said.

There was no statistical difference in efficacy outcomes by AF type. Most of the participants, 75%, had long-standing persistent atrial fibrillation, 22% had persistent AF, and 3% had paroxysmal AF.

The mean patient age was 71 years, 56% were men, and the majority had New York Heart Association (NYHA) class II or III heart failure. The mean duration of AF was 64 months.

The primary safety measure in the study was the major cardiac composite adverse event rate within 30 days. A total 6.6% of participants experienced such an event, although none were device related, Dr. Damiano said. There were no cases of pulmonary vein stenosis, he added. Operative mortality was 4%.

Significant predictors of success, defined as freedom from AF, included shorter duration of the persistent or permanent atrial fibrillation, smaller left atrial diameter, and fewer concomitant cardiac procedures, said Dr. Damiano, a cardiothoracic surgeon at Barnes Jewish Hospital in St. Louis.

As an example, the success rate was 50% when total radiofrequency ablation time was less than 6 minutes. By comparison, success grew to 80% with ablation times of 12 minutes or longer.

Left atrial diameter was the only significant predictor of success that remained on a multivariate analysis. Dr. Damiano and his colleagues found that 69% of patients with a left atrial diameter of 3.0-4.5 cm were free from AF, compared with 36% who had a diameter larger than 6 cm. The overall mean left atrial diameter was 5.2 cm.

There were significant differences in achievement of success among different study centers, including a 33% success rate at one site versus 100% at three other sites, Dr. Damiano said.

"The variability between centers is probably one of the most important findings in this study," study discussant Dr. Niv Add said. He asked: "How would you see moving forward with training and credentialing of surgeons?" Dr. Add is chief of cardiac surgery at Inova Fairfax Hospital, Falls Church, Va.

"We were supposed to perform the exact same procedure in the same way," Dr. Damiano replied. "The surgeons all agreed on the lesion set [but] it’s hard to quantify experience. You can see a huge variation in ablation time, so clearly we were not all performing the same procedure. This variability suggests a need for more effective procedural and device training."

A total 80% of patients had concomitant mitral disease; 58% had heart failure; and 52% had tricuspid disease.

The most common surgical procedure was single valve with or without coronary artery bypass grafting (CABG) in 53%. Double-valve surgery with or without CABG was performed in 30% of patients; CABG in 15%; triple-valve with or without CABG in 1%; and other surgery in 1%.

Intraoperative pulmonary vein isolation was measured using exit block and was achieved for 81% of patients. Radiofrequency ablation was performed using Medtronic’s Cardioblate unipolar or bipolar device. As the device is not yet cleared by the Food and Drug Administration for this indication, such use is considered off label.

Dr. Damiano is a consultant for Medtronic. Medtronic sponsored the trial.

In cases of blunt thoracoabdominal trauma, the abdomen should be the initial cavity of exploration in patients requiring emergent surgery without direct radiologic data, based on the results of a trauma registry and medical record review of 1,661 patients.

Abdominal exploration first is justified because rarely are nonresuscitative thoracotomy or combined thoracoabdominal operations needed, researchers stated in the June issue of Archives of Surgery.

"To our knowledge, the current study is the most complete examination of injury patterns and outcomes in the largest series of blunt thoracoabdominal trauma patients to date," wrote study investigators Dr. Regan J. Berg and colleagues in the division of trauma surgery and surgical critical care, Los Angeles County + University of Southern California Medical Center in Los Angeles.

The researchers retrospectively studied all patients with blunt thoracoabdominal trauma (defined as an Abbreviated Injury Score of 2 or more in both the chest and abdomen) who were admitted to the LAC+USC Medical Center between January 1996 and December 2010. They examined a trauma registry and obtained additional data from the review of individual medical records.

A total of 1,667 patients fulfilled the inclusion criteria, but 6 were excluded for incomplete medical data. The most frequent causes of injury in the remaining 1,661 patients were motor vehicle collision (68.1%), falls (15.6%), and motorcycle collisions (10.4%), with assault accounting for only 1.8% of patients (Arch. Surg. 2012;147:498-504).

Most patients with isolated thoracoabdominal trauma arriving alive and without severe head trauma (821/1,135 patients, or 72.3%) were managed conservatively, without thoracotomy or laparotomy. Only 9/1,135 patients (0.8%) required a thoracotomy alone. Of those, three had the thoracotomy in the operating room, and six patients had resuscitative therapy (RT) performed outside the operating room for postadmission cardiac arrest or hemodynamic deterioration, according to the researchers.

Laparotomy alone was required in 281 (24.8%), while only 24 patients (2.1%) had both a laparotomy and a thoracotomy; 7 patients (0.6%) had a laparotomy following RT.

Independent risk factors of mortality included an Injury Severity Score of 25 or more, a Glasgow Coma Scale score of 8 or less, the need for massive transfusions, age of 55 years or older, and the need for dual-cavity intervention. Among injury patterns, liver, abdominal vascular, and cardiac injury were independently associated with mortality, they added.

"Most thoracic procedures were performed for resuscitative purposes with low survival rates, in keeping with previous literature. Furthermore, concomitant thoracic injury did not preclude nonoperative management of abdominal solid organ injury, with a degree of success comparable with previous reports," the researchers concluded.

The authors reported that they had no relevant financial disclosures.

In cases of blunt thoracoabdominal trauma, the abdomen should be the initial cavity of exploration in patients requiring emergent surgery without direct radiologic data, based on the results of a trauma registry and medical record review of 1,661 patients.

Abdominal exploration first is justified because rarely are nonresuscitative thoracotomy or combined thoracoabdominal operations needed, researchers stated in the June issue of Archives of Surgery.

"To our knowledge, the current study is the most complete examination of injury patterns and outcomes in the largest series of blunt thoracoabdominal trauma patients to date," wrote study investigators Dr. Regan J. Berg and colleagues in the division of trauma surgery and surgical critical care, Los Angeles County + University of Southern California Medical Center in Los Angeles.

The researchers retrospectively studied all patients with blunt thoracoabdominal trauma (defined as an Abbreviated Injury Score of 2 or more in both the chest and abdomen) who were admitted to the LAC+USC Medical Center between January 1996 and December 2010. They examined a trauma registry and obtained additional data from the review of individual medical records.

A total of 1,667 patients fulfilled the inclusion criteria, but 6 were excluded for incomplete medical data. The most frequent causes of injury in the remaining 1,661 patients were motor vehicle collision (68.1%), falls (15.6%), and motorcycle collisions (10.4%), with assault accounting for only 1.8% of patients (Arch. Surg. 2012;147:498-504).

Most patients with isolated thoracoabdominal trauma arriving alive and without severe head trauma (821/1,135 patients, or 72.3%) were managed conservatively, without thoracotomy or laparotomy. Only 9/1,135 patients (0.8%) required a thoracotomy alone. Of those, three had the thoracotomy in the operating room, and six patients had resuscitative therapy (RT) performed outside the operating room for postadmission cardiac arrest or hemodynamic deterioration, according to the researchers.

Laparotomy alone was required in 281 (24.8%), while only 24 patients (2.1%) had both a laparotomy and a thoracotomy; 7 patients (0.6%) had a laparotomy following RT.

Independent risk factors of mortality included an Injury Severity Score of 25 or more, a Glasgow Coma Scale score of 8 or less, the need for massive transfusions, age of 55 years or older, and the need for dual-cavity intervention. Among injury patterns, liver, abdominal vascular, and cardiac injury were independently associated with mortality, they added.

"Most thoracic procedures were performed for resuscitative purposes with low survival rates, in keeping with previous literature. Furthermore, concomitant thoracic injury did not preclude nonoperative management of abdominal solid organ injury, with a degree of success comparable with previous reports," the researchers concluded.

The authors reported that they had no relevant financial disclosures.

In cases of blunt thoracoabdominal trauma, the abdomen should be the initial cavity of exploration in patients requiring emergent surgery without direct radiologic data, based on the results of a trauma registry and medical record review of 1,661 patients.

Abdominal exploration first is justified because rarely are nonresuscitative thoracotomy or combined thoracoabdominal operations needed, researchers stated in the June issue of Archives of Surgery.

"To our knowledge, the current study is the most complete examination of injury patterns and outcomes in the largest series of blunt thoracoabdominal trauma patients to date," wrote study investigators Dr. Regan J. Berg and colleagues in the division of trauma surgery and surgical critical care, Los Angeles County + University of Southern California Medical Center in Los Angeles.

The researchers retrospectively studied all patients with blunt thoracoabdominal trauma (defined as an Abbreviated Injury Score of 2 or more in both the chest and abdomen) who were admitted to the LAC+USC Medical Center between January 1996 and December 2010. They examined a trauma registry and obtained additional data from the review of individual medical records.

A total of 1,667 patients fulfilled the inclusion criteria, but 6 were excluded for incomplete medical data. The most frequent causes of injury in the remaining 1,661 patients were motor vehicle collision (68.1%), falls (15.6%), and motorcycle collisions (10.4%), with assault accounting for only 1.8% of patients (Arch. Surg. 2012;147:498-504).

Most patients with isolated thoracoabdominal trauma arriving alive and without severe head trauma (821/1,135 patients, or 72.3%) were managed conservatively, without thoracotomy or laparotomy. Only 9/1,135 patients (0.8%) required a thoracotomy alone. Of those, three had the thoracotomy in the operating room, and six patients had resuscitative therapy (RT) performed outside the operating room for postadmission cardiac arrest or hemodynamic deterioration, according to the researchers.

Laparotomy alone was required in 281 (24.8%), while only 24 patients (2.1%) had both a laparotomy and a thoracotomy; 7 patients (0.6%) had a laparotomy following RT.

Independent risk factors of mortality included an Injury Severity Score of 25 or more, a Glasgow Coma Scale score of 8 or less, the need for massive transfusions, age of 55 years or older, and the need for dual-cavity intervention. Among injury patterns, liver, abdominal vascular, and cardiac injury were independently associated with mortality, they added.

"Most thoracic procedures were performed for resuscitative purposes with low survival rates, in keeping with previous literature. Furthermore, concomitant thoracic injury did not preclude nonoperative management of abdominal solid organ injury, with a degree of success comparable with previous reports," the researchers concluded.

The authors reported that they had no relevant financial disclosures.

Transcatheter aortic valve replacement, or TAVR, is a little over 10 years old, and although it was approved in the United States only last year, there have been more than 50,000 implants in 40 countries, according to a recent review published in the Journal of American College of Cardiology (J Am Coll Cardiol, doi:10.1016/j.jacc.2012.01.071).

The Canadian authors, Dr. John G. Webb and Dr. David A. Wood, provide a meticulous and comprehensive review of the procedure, covering the current and up-and-coming valves, patient selection and evaluation, routes of implantation, and the risks of the procedure.

Throughout the article, the authors point out that increased level of experience, use of lower profile delivery systems, and thorough screening and imaging can reduce the risk of complications.

The SAPIEN transcatheter heart valve, made by Edwards Lifesciences, is the only valve currently approved in the United States for inoperable, high-risk patients.

More recently, an advisory panel to the Food and Drug Administration recommended the approval of the valve for high-risk patients who are operable, but it’s yet to be seen whether the agency will approve the valve for that indication.

Meanwhile, some reports show that TAVR will be the main driving force behind the U.S. heart valve market, projected to reach $1.5 billion by 2016.

"It is possible that, with time, TAVR will become a preferred option for a much broader group of patients," the authors conclude. However, a major concern remains: "When are patients too ill, frail, or old to gain significant benefit in terms of duration or quality of life?"

See the Storify below of the arrival and approval of the SAPIEN valve in the United States:

Transcatheter aortic valve replacement, or TAVR, is a little over 10 years old, and although it was approved in the United States only last year, there have been more than 50,000 implants in 40 countries, according to a recent review published in the Journal of American College of Cardiology (J Am Coll Cardiol, doi:10.1016/j.jacc.2012.01.071).

The Canadian authors, Dr. John G. Webb and Dr. David A. Wood, provide a meticulous and comprehensive review of the procedure, covering the current and up-and-coming valves, patient selection and evaluation, routes of implantation, and the risks of the procedure.

Throughout the article, the authors point out that increased level of experience, use of lower profile delivery systems, and thorough screening and imaging can reduce the risk of complications.

The SAPIEN transcatheter heart valve, made by Edwards Lifesciences, is the only valve currently approved in the United States for inoperable, high-risk patients.

More recently, an advisory panel to the Food and Drug Administration recommended the approval of the valve for high-risk patients who are operable, but it’s yet to be seen whether the agency will approve the valve for that indication.

Meanwhile, some reports show that TAVR will be the main driving force behind the U.S. heart valve market, projected to reach $1.5 billion by 2016.

"It is possible that, with time, TAVR will become a preferred option for a much broader group of patients," the authors conclude. However, a major concern remains: "When are patients too ill, frail, or old to gain significant benefit in terms of duration or quality of life?"

See the Storify below of the arrival and approval of the SAPIEN valve in the United States:

Transcatheter aortic valve replacement, or TAVR, is a little over 10 years old, and although it was approved in the United States only last year, there have been more than 50,000 implants in 40 countries, according to a recent review published in the Journal of American College of Cardiology (J Am Coll Cardiol, doi:10.1016/j.jacc.2012.01.071).

The Canadian authors, Dr. John G. Webb and Dr. David A. Wood, provide a meticulous and comprehensive review of the procedure, covering the current and up-and-coming valves, patient selection and evaluation, routes of implantation, and the risks of the procedure.

Throughout the article, the authors point out that increased level of experience, use of lower profile delivery systems, and thorough screening and imaging can reduce the risk of complications.

The SAPIEN transcatheter heart valve, made by Edwards Lifesciences, is the only valve currently approved in the United States for inoperable, high-risk patients.

More recently, an advisory panel to the Food and Drug Administration recommended the approval of the valve for high-risk patients who are operable, but it’s yet to be seen whether the agency will approve the valve for that indication.

Meanwhile, some reports show that TAVR will be the main driving force behind the U.S. heart valve market, projected to reach $1.5 billion by 2016.

"It is possible that, with time, TAVR will become a preferred option for a much broader group of patients," the authors conclude. However, a major concern remains: "When are patients too ill, frail, or old to gain significant benefit in terms of duration or quality of life?"

See the Storify below of the arrival and approval of the SAPIEN valve in the United States:

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the annual meeting of the American Association for Thoracic Surgery is any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A. Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of the congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided the following overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a multicenter comparison of 549 infants who were randomized to a modified BT or PA-RV shunt; the study revealed a 10% survival advantage for the PV-RA patients at 1 year (N. Engl. J. Med. 2010:362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BTshunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, attending cardiothoracic surgeon at the Children’s Hospital of Philadelphia (CHOP).

"Most of the benefit of the RV-PA is in the early interstage period," Dr. Gaynor said. He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points," it may be time for a new trial."

Dr. Gaynor suggested that he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV PA may have some advantages for high-risk subgroups, but more data are needed, he said.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "It requires significant resource utilization, even in the modern era."

Ultimately, "it’s really not about which of these procedures is better as all or nothing. It’s which is better for which subcategory of patient," said Dr. Galantowicz.

According to Dr. Bacha, "I think we can all agree there is equipoise between the BT shunt and the RV-PA conduit, and the hybrid procedures are being increasingly employed for high-risk patients."

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the annual meeting of the American Association for Thoracic Surgery is any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A. Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of the congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided the following overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a multicenter comparison of 549 infants who were randomized to a modified BT or PA-RV shunt; the study revealed a 10% survival advantage for the PV-RA patients at 1 year (N. Engl. J. Med. 2010:362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BTshunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, attending cardiothoracic surgeon at the Children’s Hospital of Philadelphia (CHOP).

"Most of the benefit of the RV-PA is in the early interstage period," Dr. Gaynor said. He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points," it may be time for a new trial."

Dr. Gaynor suggested that he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV PA may have some advantages for high-risk subgroups, but more data are needed, he said.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "It requires significant resource utilization, even in the modern era."

Ultimately, "it’s really not about which of these procedures is better as all or nothing. It’s which is better for which subcategory of patient," said Dr. Galantowicz.

According to Dr. Bacha, "I think we can all agree there is equipoise between the BT shunt and the RV-PA conduit, and the hybrid procedures are being increasingly employed for high-risk patients."

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

SAN FRANCISCO – There is no consensus among experts on the optimal surgical approach to repair neonatal hypoplastic left heart syndrome, if a series of consecutive talks at the annual meeting of the American Association for Thoracic Surgery is any indication.

Dr. David J. Barron is a proponent of the placement of a stage 1 right ventricle–pulmonary artery (RV-PA) conduit (Circulation 2003;108[suppl. 1]:II155-60); Dr. J. William Gaynor prefers a stage 1 Blalock-Taussig (BT) shunt; and Dr. Mark E. Galantowicz advocates a hybrid stage 1 procedure.

Dr. Emile A. Bacha tied all these strategies together in a differential approach to management of neonates with hypoplastic left heart syndrome. There may be no one answer; local factors such as surgeon experience or medical center volume can impart significant difference on outcomes, Dr. Bacha said. His bias, in general, is to use the BT shunt for aortic stenosis and the RV-PA conduit for aortic atresia, and to reserve the hybrid approach for high-risk patients. Dr. Bacha is director of the congenital and pediatric cardiac surgery at the Morgan Stanley Children’s Hospital of New York–Presbyterian in New York City.

The surgeons provided the following overview:

• Stage 1 RV-PA conduits. "If you have any condition where there are three different ways to do the same operation, [it indicates that] we are still looking for the right way of doing it. What is important is trying to find the right operation for the right patient," said Dr. Barron, a consultant cardiac surgeon at Birmingham (England) Children’s Hospital.

"It’s all about diastole" with the RV-PA conduit, Dr. Barron said. The maintenance of diastolic pressure is a benefit with RV-PA, compared with the classic Norwood shunt, he added. "When you turn off the shunt in the OR, you get dramatic drop with Norwood where both systolic and diastolic drop. With the RV-PA, the systolic pressure drops but the diastolic pressure is maintained. This facilitates "more of cardiac output to systemic circulation, where you want it to be."

"We’re in an era of evidence-based medicine, and it’s not always easy to find class I evidence in congenital heart disease. The strategy sounds good, but can we actually prove it is better?" Dr. Barron asked. He pointed to a multicenter comparison of 549 infants who were randomized to a modified BT or PA-RV shunt; the study revealed a 10% survival advantage for the PV-RA patients at 1 year (N. Engl. J. Med. 2010:362:1980-92).

A disadvantage of the PV-RA shunt was more catheterization lab interventions (41%, vs. 26% for the modified BT shunt). In addition, the transplantation-free survival advantage was no longer significant after 12 months, he said.

• Stage 1 BTshunts. "We really need to focus on how well these children do over the long run," said Dr. Gaynor, attending cardiothoracic surgeon at the Children’s Hospital of Philadelphia (CHOP).

"Most of the benefit of the RV-PA is in the early interstage period," Dr. Gaynor said. He pointed out that transplant-free survival was not statistically different in the New England Journal of Medicine study at a mean of 32 months’ follow-up.

Dr. Bacha noted that with both speakers using the same study to argue their points," it may be time for a new trial."

Dr. Gaynor suggested that he will remain a proponent of the modified BT shunt until sufficient, long-term evidence supports survival and other advantages with the use of the RV-PA. The RV PA may have some advantages for high-risk subgroups, but more data are needed, he said.

Likewise, an examination of stage 1 reconstruction at CHOP with either the RV-PA or a modified BT shunt showed no significant difference on overall survival, Dr. Gaynor said. (Ann. Thorac. Surg. 2005:80:1582-90). Interestingly, timing made a difference: Patients with the modified BT shunt had significantly higher morbidity during the interstage period, but those with an RV-PA conduit demonstrated a trend toward increased death or transplant for heart failure after stage 2 reconstruction.

• Hybrid stage 1 surgery. "I am in favor of hybrid stage 1 for initial palliation for hypoplastic left heart syndrome. Hybrid stage 1 has at least equivalent results to traditional approaches in standard-risk patients," said Dr. Galantowicz, chief of cardiothoracic surgery at Nationwide Children’s Hospital in Columbus, Ohio.

A hybrid stage 1 can effectively bridge a child to recovery and can salvage a child who was not diagnosed at birth, Dr. Galantowicz said.

There is some evidence that a hybrid approach is less costly overall, compared with placement of a modified BT shunt (Ann. Thorac. Surg. 2009;87:1885-92).

"The standard approach is one of the most costly and resource intensive for any of the congenital children we have," Dr. Galantowicz said. "It requires significant resource utilization, even in the modern era."

Ultimately, "it’s really not about which of these procedures is better as all or nothing. It’s which is better for which subcategory of patient," said Dr. Galantowicz.

According to Dr. Bacha, "I think we can all agree there is equipoise between the BT shunt and the RV-PA conduit, and the hybrid procedures are being increasingly employed for high-risk patients."

Dr. Barron, Dr. Gaynor, Dr. Galantowicz, and Dr. Bacha each said they had no relevant financial disclosures.

Surgeons are more reluctant to withdraw life support if they made an error during surgery. This is especially true after an elective procedure, according to an extended analysis of a recent scenario-based survey of 2,100 surgeons who were involved in high-risk operations.

The survey included a series of questions regarding specialty-specific scenarios for 700 vascular surgeons (elective and emergent thoracoabdominal aortic aneurysm repair), 700 cardiothoracic surgeons (elective and emergent ascending aortic aneurysm repair), and 700 neurosurgeons (elective and emergent calcified right middle cerebral artery aneurysm clipping), according to Dr. Margaret L. Schwarze of the University of Wisconsin, Madison, and colleagues.

In the case of the vascular and the cardiac surgeons, the complication was the same: The "patient has weakness in left arm and leg when she awakes from anesthesia." The surgical error for the vascular surgeons was inadvertent placement of the proximal clamp so that it occluded the left carotid artery; for the cardiac surgeons, it was inadvertent dislodging of the arterial cannula. For both vascular and cardiac procedures, the non–error-caused complication resulted from unexplained intraoperative stroke.

The three specialties were chosen based on the presumption of routine high-risk operations, according to a report published online ahead of print in the Annals of Surgery (2012;256:10-15).

This analysis follows an earlier report in the Annals of Surgery by these same authors, who used these same survey data to determine that the majority of these surgeons performing high-risk operations did not discuss advanced directives with their patients, and 54% were unlikely to operate on these patients if they were aware of such directives prior to surgery (Ann. Surg. 2012;255:418-23).

Of the original 2,100 surveys that were sent out, 912 were completed and returned, with roughly equal percentages (54%-56%) for each specialty.

Multivariate analysis showed that surgeons who faced complications after emergency surgery that were not clearly the result of surgeon error were nearly twice as likely to agree to withdraw life-sustaining support, compared with surgeons evaluating elective procedures that had a complication resulting from surgeon error (odds ratio, 1.95). In addition, the odds of withdrawing life support were significantly greater among surgeons who were not optimistic about the patient’s future quality of life (OR, 1.75) and among those who were not concerned that the patients did not accurately value their future health state (OR, 1.59), compared with their counterparts, according to the authors.

"Iatrogenic complications that clearly derive from technical errors during elective procedures may pose considerable guilt and emotional burden upon surgeons," the authors speculated. "It is understandable that such factors should weigh on the surgeon. However, our findings call into question the degree to which these factors may unduly interfere with a patient’s ability to control his or her health care decisions."

In addition, "our data suggest that the commission of an error in surgical technique and prognostic optimism may present a challenge to patient autonomy. ... [This] suggests the importance of efforts to alleviate surgeons’ emotional strain while simultaneously respecting the fierce ethic of responsibility that surgeons possess for patients’ outcomes."

When a patient experiences a life-threatening complication and requests withdrawal of life-supporting therapy postoperatively, surgeons may be unlikely to do so without delay, according to the authors. "These decisions may be influenced by both the timing of surgery and whether the complication was the result of explicit technical error. In addition, these nonclinical factors may be associated with surgeons’ optimism about the patient’s postoperative quality of life," they concluded.

The authors reported that they had no financial disclosures.

Surgeons are more reluctant to withdraw life support if they made an error during surgery. This is especially true after an elective procedure, according to an extended analysis of a recent scenario-based survey of 2,100 surgeons who were involved in high-risk operations.

The survey included a series of questions regarding specialty-specific scenarios for 700 vascular surgeons (elective and emergent thoracoabdominal aortic aneurysm repair), 700 cardiothoracic surgeons (elective and emergent ascending aortic aneurysm repair), and 700 neurosurgeons (elective and emergent calcified right middle cerebral artery aneurysm clipping), according to Dr. Margaret L. Schwarze of the University of Wisconsin, Madison, and colleagues.

In the case of the vascular and the cardiac surgeons, the complication was the same: The "patient has weakness in left arm and leg when she awakes from anesthesia." The surgical error for the vascular surgeons was inadvertent placement of the proximal clamp so that it occluded the left carotid artery; for the cardiac surgeons, it was inadvertent dislodging of the arterial cannula. For both vascular and cardiac procedures, the non–error-caused complication resulted from unexplained intraoperative stroke.

The three specialties were chosen based on the presumption of routine high-risk operations, according to a report published online ahead of print in the Annals of Surgery (2012;256:10-15).

This analysis follows an earlier report in the Annals of Surgery by these same authors, who used these same survey data to determine that the majority of these surgeons performing high-risk operations did not discuss advanced directives with their patients, and 54% were unlikely to operate on these patients if they were aware of such directives prior to surgery (Ann. Surg. 2012;255:418-23).

Of the original 2,100 surveys that were sent out, 912 were completed and returned, with roughly equal percentages (54%-56%) for each specialty.

Multivariate analysis showed that surgeons who faced complications after emergency surgery that were not clearly the result of surgeon error were nearly twice as likely to agree to withdraw life-sustaining support, compared with surgeons evaluating elective procedures that had a complication resulting from surgeon error (odds ratio, 1.95). In addition, the odds of withdrawing life support were significantly greater among surgeons who were not optimistic about the patient’s future quality of life (OR, 1.75) and among those who were not concerned that the patients did not accurately value their future health state (OR, 1.59), compared with their counterparts, according to the authors.

"Iatrogenic complications that clearly derive from technical errors during elective procedures may pose considerable guilt and emotional burden upon surgeons," the authors speculated. "It is understandable that such factors should weigh on the surgeon. However, our findings call into question the degree to which these factors may unduly interfere with a patient’s ability to control his or her health care decisions."

In addition, "our data suggest that the commission of an error in surgical technique and prognostic optimism may present a challenge to patient autonomy. ... [This] suggests the importance of efforts to alleviate surgeons’ emotional strain while simultaneously respecting the fierce ethic of responsibility that surgeons possess for patients’ outcomes."

When a patient experiences a life-threatening complication and requests withdrawal of life-supporting therapy postoperatively, surgeons may be unlikely to do so without delay, according to the authors. "These decisions may be influenced by both the timing of surgery and whether the complication was the result of explicit technical error. In addition, these nonclinical factors may be associated with surgeons’ optimism about the patient’s postoperative quality of life," they concluded.

The authors reported that they had no financial disclosures.

Surgeons are more reluctant to withdraw life support if they made an error during surgery. This is especially true after an elective procedure, according to an extended analysis of a recent scenario-based survey of 2,100 surgeons who were involved in high-risk operations.

The survey included a series of questions regarding specialty-specific scenarios for 700 vascular surgeons (elective and emergent thoracoabdominal aortic aneurysm repair), 700 cardiothoracic surgeons (elective and emergent ascending aortic aneurysm repair), and 700 neurosurgeons (elective and emergent calcified right middle cerebral artery aneurysm clipping), according to Dr. Margaret L. Schwarze of the University of Wisconsin, Madison, and colleagues.

In the case of the vascular and the cardiac surgeons, the complication was the same: The "patient has weakness in left arm and leg when she awakes from anesthesia." The surgical error for the vascular surgeons was inadvertent placement of the proximal clamp so that it occluded the left carotid artery; for the cardiac surgeons, it was inadvertent dislodging of the arterial cannula. For both vascular and cardiac procedures, the non–error-caused complication resulted from unexplained intraoperative stroke.

The three specialties were chosen based on the presumption of routine high-risk operations, according to a report published online ahead of print in the Annals of Surgery (2012;256:10-15).

This analysis follows an earlier report in the Annals of Surgery by these same authors, who used these same survey data to determine that the majority of these surgeons performing high-risk operations did not discuss advanced directives with their patients, and 54% were unlikely to operate on these patients if they were aware of such directives prior to surgery (Ann. Surg. 2012;255:418-23).

Of the original 2,100 surveys that were sent out, 912 were completed and returned, with roughly equal percentages (54%-56%) for each specialty.

Multivariate analysis showed that surgeons who faced complications after emergency surgery that were not clearly the result of surgeon error were nearly twice as likely to agree to withdraw life-sustaining support, compared with surgeons evaluating elective procedures that had a complication resulting from surgeon error (odds ratio, 1.95). In addition, the odds of withdrawing life support were significantly greater among surgeons who were not optimistic about the patient’s future quality of life (OR, 1.75) and among those who were not concerned that the patients did not accurately value their future health state (OR, 1.59), compared with their counterparts, according to the authors.

"Iatrogenic complications that clearly derive from technical errors during elective procedures may pose considerable guilt and emotional burden upon surgeons," the authors speculated. "It is understandable that such factors should weigh on the surgeon. However, our findings call into question the degree to which these factors may unduly interfere with a patient’s ability to control his or her health care decisions."

In addition, "our data suggest that the commission of an error in surgical technique and prognostic optimism may present a challenge to patient autonomy. ... [This] suggests the importance of efforts to alleviate surgeons’ emotional strain while simultaneously respecting the fierce ethic of responsibility that surgeons possess for patients’ outcomes."

When a patient experiences a life-threatening complication and requests withdrawal of life-supporting therapy postoperatively, surgeons may be unlikely to do so without delay, according to the authors. "These decisions may be influenced by both the timing of surgery and whether the complication was the result of explicit technical error. In addition, these nonclinical factors may be associated with surgeons’ optimism about the patient’s postoperative quality of life," they concluded.

The authors reported that they had no financial disclosures.

Patients who develop postoperative delirium after cardiac surgery are at risk for an overall decline in cognitive function and a prolonged period of impairment during the following year, according to a study published online July 4 in the New England Journal of Medicine.

Compared with cardiac surgery patients who do not develop postoperative delirium, those who do are significantly less likely to return to their preoperative level of cognitive performance within 6 months, said Jane S. Saczynski, Ph.D., of the division of geriatric medicine and Meyers Primary Care Institute at the University of Massachusetts, Worcester, and her associates.

"Our findings suggest that the development of postoperative delirium should be added to the list of risk factors for prolonged impairment after cardiac surgery, which includes the development of atrial fibrillation, a history of depression, a lower level of education, and preexisting cerebrovascular disease," they said.

Delirium is the only one of these factors that is potentially preventable, the investigators noted.

Delirium is common following cardiac surgery, affecting up to 75% of patients by some estimates. Dr. Saczynski and her colleagues followed 225 patients aged 60 years or older for 1 year after they underwent CABG (coronary artery bypass graft) or valve replacement, to assess the effect of postoperative delirium on later cognitive performance.

The study subjects were treated at two academic medial centers and a Veterans Affairs hospital. They were interviewed daily while they were hospitalized to assess delirium, and their records were reviewed for evidence of the clinical features of the condition. After discharge, the subjects were again interviewed in their residences at 1, 6, and 12 months to assess their cognitive function.

Delirium was rated as present or absent based on results of the CAM (Confusion Assessment Method), which evaluates four key features: acute change with a fluctuating course, inattention, disorganized thinking, and altered level of consciousness. This assessment was supported with results on the MMSE (Mini-Mental State Examination), the digit-span test, and the Delirium Symptom Interview.

The patients also were evaluated using the Charlson comorbidity index, which estimates the burden of illness based on the presence and severity of 17 medical conditions.

The mean age of the study subjects was 73 years; approximately 25% were women, and almost all were white and non-Hispanic.

Postoperative delirium developed in 46% of the study subjects. It lasted 1-2 days in 65% of these patients and for 3 or more days in the remaining 35%.

Subjects who developed delirium were significantly older and less educated than were those who did not; were more likely to have a history of stroke or TIA (transient ischemic attack); to have higher scores on the comorbidity index; and to have a lower level of cognitive function before the cardiac surgery.

Surgery type (whether CABG only, valve replacement only, or valve replacement with CABG) was not significantly associated with postoperative delirium.

In the study population as a whole, cognitive function declined significantly (by 4.6 points on the MMSE) between baseline and postoperative day 2. This initial drop was followed by significant increases in cognitive function, by 1 point per day, on days 3-5. The rate of improvement then slowed considerably and stabilized at approximately 6 months, showing no significant change thereafter.

However, this pattern changed when patients were stratified by the presence of delirium. Those who developed delirium showed a much greater decline in cognitive function in the immediate postoperative period, with a drop of 7.7 points vs. 2.1 points on the MMSE. They then showed more rapid recovery on days 3-5, and slightly greater recovery over the next 6 months.

"Patients without delirium returned to their preoperative level of cognitive function by approximately 1 month after surgery, whereas patients with delirium had not returned to their preoperative level of function by 1 year postoperatively," Dr. Saczynski and her associates said (N. Engl. J. Med. 2012 July 4 [doi:10.1056/NEJMoa1112923]).

"In addition, the proportion of patients who did not return to their preoperative level of function was significantly higher in the group with delirium than in the group without delirium through 6 months postoperatively (40% vs. 24%), but this proportion was not significantly different at 12 months (31% and 20%, respectively)," they noted.

This suggests that delirium, "which was once thought of as a short-term transient cognitive disorder, may have longer-term observed effects on cognitive function in patients who have undergone cardiac surgery," the investigators said.

The researchers did point out some potential caveats in their conclusions. The study did not have a nonsurgical group as a comparative control. In addition, the lower level of cognitive function at baseline in the group with postoperative delirium, as compared with those patients without postoperative delirium, could be caused by a trajectory of decline from a greater burden of preexisting disease that was not fully addressed in the multivariate models.

However, they added that in a sensitivity analysis, the baseline differences between the two study groups in cognitive function was controlled for by matching subjects’ preoperative MMSE scores and the results did not change.

The study results highlight the importance of proactive interventions such as the Hospital Elder Life Program to prevent delirium and to ameliorate its effects if it does develop. In addition, "cognitive screening at hospital discharge may identify high-risk patients who require close monitoring after discharge or tailored transitional care in order to enhance functional and clinical outcomes," they said.

The findings also have implications for postoperative and rehabilitative care after cardiac surgery. "Since patients with postoperative delirium continue to have improvements in cognitive function up to 6 months after surgery, rehabilitation services, such as physical and occupational therapy, may need to be extended for these patients," Dr. Saczynski and her colleagues said

This study was supported by the Harvard Older Americans Independence Center; the National Institute on Aging; the National Heart, Lung, and Blood Institute; and the National Institutes of Health. The authors reported no financial conflicts of interest relevant to the study.

Patients who develop postoperative delirium after cardiac surgery are at risk for an overall decline in cognitive function and a prolonged period of impairment during the following year, according to a study published online July 4 in the New England Journal of Medicine.

Compared with cardiac surgery patients who do not develop postoperative delirium, those who do are significantly less likely to return to their preoperative level of cognitive performance within 6 months, said Jane S. Saczynski, Ph.D., of the division of geriatric medicine and Meyers Primary Care Institute at the University of Massachusetts, Worcester, and her associates.

"Our findings suggest that the development of postoperative delirium should be added to the list of risk factors for prolonged impairment after cardiac surgery, which includes the development of atrial fibrillation, a history of depression, a lower level of education, and preexisting cerebrovascular disease," they said.

Delirium is the only one of these factors that is potentially preventable, the investigators noted.

Delirium is common following cardiac surgery, affecting up to 75% of patients by some estimates. Dr. Saczynski and her colleagues followed 225 patients aged 60 years or older for 1 year after they underwent CABG (coronary artery bypass graft) or valve replacement, to assess the effect of postoperative delirium on later cognitive performance.

The study subjects were treated at two academic medial centers and a Veterans Affairs hospital. They were interviewed daily while they were hospitalized to assess delirium, and their records were reviewed for evidence of the clinical features of the condition. After discharge, the subjects were again interviewed in their residences at 1, 6, and 12 months to assess their cognitive function.

Delirium was rated as present or absent based on results of the CAM (Confusion Assessment Method), which evaluates four key features: acute change with a fluctuating course, inattention, disorganized thinking, and altered level of consciousness. This assessment was supported with results on the MMSE (Mini-Mental State Examination), the digit-span test, and the Delirium Symptom Interview.

The patients also were evaluated using the Charlson comorbidity index, which estimates the burden of illness based on the presence and severity of 17 medical conditions.

The mean age of the study subjects was 73 years; approximately 25% were women, and almost all were white and non-Hispanic.

Postoperative delirium developed in 46% of the study subjects. It lasted 1-2 days in 65% of these patients and for 3 or more days in the remaining 35%.

Subjects who developed delirium were significantly older and less educated than were those who did not; were more likely to have a history of stroke or TIA (transient ischemic attack); to have higher scores on the comorbidity index; and to have a lower level of cognitive function before the cardiac surgery.

Surgery type (whether CABG only, valve replacement only, or valve replacement with CABG) was not significantly associated with postoperative delirium.

In the study population as a whole, cognitive function declined significantly (by 4.6 points on the MMSE) between baseline and postoperative day 2. This initial drop was followed by significant increases in cognitive function, by 1 point per day, on days 3-5. The rate of improvement then slowed considerably and stabilized at approximately 6 months, showing no significant change thereafter.

However, this pattern changed when patients were stratified by the presence of delirium. Those who developed delirium showed a much greater decline in cognitive function in the immediate postoperative period, with a drop of 7.7 points vs. 2.1 points on the MMSE. They then showed more rapid recovery on days 3-5, and slightly greater recovery over the next 6 months.

"Patients without delirium returned to their preoperative level of cognitive function by approximately 1 month after surgery, whereas patients with delirium had not returned to their preoperative level of function by 1 year postoperatively," Dr. Saczynski and her associates said (N. Engl. J. Med. 2012 July 4 [doi:10.1056/NEJMoa1112923]).

"In addition, the proportion of patients who did not return to their preoperative level of function was significantly higher in the group with delirium than in the group without delirium through 6 months postoperatively (40% vs. 24%), but this proportion was not significantly different at 12 months (31% and 20%, respectively)," they noted.

This suggests that delirium, "which was once thought of as a short-term transient cognitive disorder, may have longer-term observed effects on cognitive function in patients who have undergone cardiac surgery," the investigators said.

The researchers did point out some potential caveats in their conclusions. The study did not have a nonsurgical group as a comparative control. In addition, the lower level of cognitive function at baseline in the group with postoperative delirium, as compared with those patients without postoperative delirium, could be caused by a trajectory of decline from a greater burden of preexisting disease that was not fully addressed in the multivariate models.

However, they added that in a sensitivity analysis, the baseline differences between the two study groups in cognitive function was controlled for by matching subjects’ preoperative MMSE scores and the results did not change.

The study results highlight the importance of proactive interventions such as the Hospital Elder Life Program to prevent delirium and to ameliorate its effects if it does develop. In addition, "cognitive screening at hospital discharge may identify high-risk patients who require close monitoring after discharge or tailored transitional care in order to enhance functional and clinical outcomes," they said.

The findings also have implications for postoperative and rehabilitative care after cardiac surgery. "Since patients with postoperative delirium continue to have improvements in cognitive function up to 6 months after surgery, rehabilitation services, such as physical and occupational therapy, may need to be extended for these patients," Dr. Saczynski and her colleagues said

This study was supported by the Harvard Older Americans Independence Center; the National Institute on Aging; the National Heart, Lung, and Blood Institute; and the National Institutes of Health. The authors reported no financial conflicts of interest relevant to the study.

Patients who develop postoperative delirium after cardiac surgery are at risk for an overall decline in cognitive function and a prolonged period of impairment during the following year, according to a study published online July 4 in the New England Journal of Medicine.

Compared with cardiac surgery patients who do not develop postoperative delirium, those who do are significantly less likely to return to their preoperative level of cognitive performance within 6 months, said Jane S. Saczynski, Ph.D., of the division of geriatric medicine and Meyers Primary Care Institute at the University of Massachusetts, Worcester, and her associates.

"Our findings suggest that the development of postoperative delirium should be added to the list of risk factors for prolonged impairment after cardiac surgery, which includes the development of atrial fibrillation, a history of depression, a lower level of education, and preexisting cerebrovascular disease," they said.

Delirium is the only one of these factors that is potentially preventable, the investigators noted.

Delirium is common following cardiac surgery, affecting up to 75% of patients by some estimates. Dr. Saczynski and her colleagues followed 225 patients aged 60 years or older for 1 year after they underwent CABG (coronary artery bypass graft) or valve replacement, to assess the effect of postoperative delirium on later cognitive performance.

The study subjects were treated at two academic medial centers and a Veterans Affairs hospital. They were interviewed daily while they were hospitalized to assess delirium, and their records were reviewed for evidence of the clinical features of the condition. After discharge, the subjects were again interviewed in their residences at 1, 6, and 12 months to assess their cognitive function.

Delirium was rated as present or absent based on results of the CAM (Confusion Assessment Method), which evaluates four key features: acute change with a fluctuating course, inattention, disorganized thinking, and altered level of consciousness. This assessment was supported with results on the MMSE (Mini-Mental State Examination), the digit-span test, and the Delirium Symptom Interview.

The patients also were evaluated using the Charlson comorbidity index, which estimates the burden of illness based on the presence and severity of 17 medical conditions.

The mean age of the study subjects was 73 years; approximately 25% were women, and almost all were white and non-Hispanic.

Postoperative delirium developed in 46% of the study subjects. It lasted 1-2 days in 65% of these patients and for 3 or more days in the remaining 35%.

Subjects who developed delirium were significantly older and less educated than were those who did not; were more likely to have a history of stroke or TIA (transient ischemic attack); to have higher scores on the comorbidity index; and to have a lower level of cognitive function before the cardiac surgery.

Surgery type (whether CABG only, valve replacement only, or valve replacement with CABG) was not significantly associated with postoperative delirium.

In the study population as a whole, cognitive function declined significantly (by 4.6 points on the MMSE) between baseline and postoperative day 2. This initial drop was followed by significant increases in cognitive function, by 1 point per day, on days 3-5. The rate of improvement then slowed considerably and stabilized at approximately 6 months, showing no significant change thereafter.

However, this pattern changed when patients were stratified by the presence of delirium. Those who developed delirium showed a much greater decline in cognitive function in the immediate postoperative period, with a drop of 7.7 points vs. 2.1 points on the MMSE. They then showed more rapid recovery on days 3-5, and slightly greater recovery over the next 6 months.

"Patients without delirium returned to their preoperative level of cognitive function by approximately 1 month after surgery, whereas patients with delirium had not returned to their preoperative level of function by 1 year postoperatively," Dr. Saczynski and her associates said (N. Engl. J. Med. 2012 July 4 [doi:10.1056/NEJMoa1112923]).

"In addition, the proportion of patients who did not return to their preoperative level of function was significantly higher in the group with delirium than in the group without delirium through 6 months postoperatively (40% vs. 24%), but this proportion was not significantly different at 12 months (31% and 20%, respectively)," they noted.

This suggests that delirium, "which was once thought of as a short-term transient cognitive disorder, may have longer-term observed effects on cognitive function in patients who have undergone cardiac surgery," the investigators said.

The researchers did point out some potential caveats in their conclusions. The study did not have a nonsurgical group as a comparative control. In addition, the lower level of cognitive function at baseline in the group with postoperative delirium, as compared with those patients without postoperative delirium, could be caused by a trajectory of decline from a greater burden of preexisting disease that was not fully addressed in the multivariate models.

However, they added that in a sensitivity analysis, the baseline differences between the two study groups in cognitive function was controlled for by matching subjects’ preoperative MMSE scores and the results did not change.

The study results highlight the importance of proactive interventions such as the Hospital Elder Life Program to prevent delirium and to ameliorate its effects if it does develop. In addition, "cognitive screening at hospital discharge may identify high-risk patients who require close monitoring after discharge or tailored transitional care in order to enhance functional and clinical outcomes," they said.

The findings also have implications for postoperative and rehabilitative care after cardiac surgery. "Since patients with postoperative delirium continue to have improvements in cognitive function up to 6 months after surgery, rehabilitation services, such as physical and occupational therapy, may need to be extended for these patients," Dr. Saczynski and her colleagues said

This study was supported by the Harvard Older Americans Independence Center; the National Institute on Aging; the National Heart, Lung, and Blood Institute; and the National Institutes of Health. The authors reported no financial conflicts of interest relevant to the study.