Mortality Soared With Post-TAVR Vascular Complications

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.