More Than One in Seven TAVR Patients Have Complications
More Than One in Seven TAVR Patients Have Complications
August 10, 2012 (New York, New York)— A new analysis of the PARTNER study suggests that major complications occur frequently in patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral route. Combining cohort B, which included patients unable to undergo aortic valve replacement surgery, and cohort A, which included patients at high-risk for surgery, major vascular complications occurred in 15.3% of treated patients within 30 days of the procedure.
These included vascular dissection, perforation, and access-site hematoma, which were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, as well as significantly higher rates of 30-day and one-year mortality.
"The study is really a reflection of first-generation devices, with large diameter sheaths, 22- and 24-French sheath sizes, and early experiences, with physicians often doing their first cases," lead investigator Dr Philippe Généreux (Columbia University, New York, NY) told heartwire. "So everybody is concerned that the incidence of complications is high and that there is an impact on mortality, which is true, but these are patients who were very sick, the catheters were very big, and the operators were early on in the learning curve. Right now, the rate of major vascular complications is probably in the single digits. With the new devices, the new catheters and sheath sizes, we're probably down to around 1% to 5%. This study is more of a landmark study to assess the rate and impact of vascular complications that we can use to compare with newer-generation devices."
Early Experiences in PARTNER A and B
The analysis, which is published online August 10, 2012 in the Journal of the American College of Cardiology, included 419 patients who were randomly assigned to TAVR via the transfemoral route. Of these patients, 177 were from cohort B and 242 were from cohort A, and all received the first-generation Edwards Lifescience’s Sapien valves and delivery systems.
In total, 64 patients (15.3%) had a major vascular complication and 50 patients (11.9%) had a minor vascular complication within 30 days of receiving the valve. Vascular dissection and perforation were common types of major vascular complications that occurred in 62.8% and 31.3% of patients, respectively. Access-site hematoma also occurred in 22.9% of those with a major vascular complication. There were also three cases of aortic dissection and two cases of left ventricle perforation.
Major vascular complications, along with renal disease at baseline, was an independent predictor of death at one year, while female gender was the lone independent predictor of major vascular complications (hazard ratio 2.31; 95% CI 1.08–4.98).
PARTNER: 30-Day and One-Year Events According to the Occurrence of Major Vascular Complications up to 30 Days
"There is a notion that women might be more fragile and prone to vascular complications," said Généreux. "Women are also likely to have smaller vessels than men, but beyond that, when we control for the vessel size, women remain at increased risk for vascular complications. Still, at one year, women tend to have better outcomes than men, so it's a bit of gender paradox. During the procedure they are more prone to vascular complications, but in the long run they do better."
There were fewer vascular complications in the high-risk, but operable, patients compared with those unable to undergo aortic-valve replacement surgery, and the vascular complications appeared to have less impact on the short- and long-term mortality in the former group. "Vascular complications tend to have a bigger impact on sicker patients," said Généreux. "When you look at the impact of vascular complications in cohort B compared with cohort A, the sicker patients in cohort B are less able to tolerate the complications and less likely to survive."
In addition, differences in outcomes between cohort A and B might also be explained by the fact that the transapical approach was available for operators involved in cohort A, making it less likely that "borderline" vessel diameter or vascular anatomy would be attempted with the transfemoral approach. Cohort B patients were also treated by operators and at enrolling sites in the early stages of their experience with TAVR.
Criticisms of TAVR
Earlier this week, Drs Chintan Desai and Robert Bonow (Northwestern University, Chicago, IL) wrote an editorial in the Journal of the American Medical Association urging doctors and patients to curb their enthusiasm for TAVR and to take a complete look at the risks and benefits of the procedure [2]. The editorialists were particularly concerned with the expansion of TAVR to patients better suited for surgery and those not meeting existing criteria. For Desai and Bonow, the complication rates observed outside the clinical trials are likely to be higher, thereby altering the risk–benefit ratio in PARTNER.
To heartwire, Généreux said he is aware of the criticisms but that the PARTNER study was a well-conducted clinical trial that showed TAVR was noninferior to surgery in patients at high risk for aortic valve replacement and was better than not treating patients ineligible for surgical valve replacement. As for indication creep, the PARTNER II study will address the use of TAVR in lower-risk patients. Based on the Canadian and European experiences, which is where the 1% to 5% complication rate cited by Généreux comes from, he said complication rates are already down below their published rate of 15.3% and are likely to fall further as technology improves and operator experience increases. Although some might want to knock TAVR now, the procedure is here to stay, he added.
August 10, 2012 (New York, New York)— A new analysis of the PARTNER study suggests that major complications occur frequently in patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral route. Combining cohort B, which included patients unable to undergo aortic valve replacement surgery, and cohort A, which included patients at high-risk for surgery, major vascular complications occurred in 15.3% of treated patients within 30 days of the procedure.
These included vascular dissection, perforation, and access-site hematoma, which were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, as well as significantly higher rates of 30-day and one-year mortality.
"The study is really a reflection of first-generation devices, with large diameter sheaths, 22- and 24-French sheath sizes, and early experiences, with physicians often doing their first cases," lead investigator Dr Philippe Généreux (Columbia University, New York, NY) told heartwire. "So everybody is concerned that the incidence of complications is high and that there is an impact on mortality, which is true, but these are patients who were very sick, the catheters were very big, and the operators were early on in the learning curve. Right now, the rate of major vascular complications is probably in the single digits. With the new devices, the new catheters and sheath sizes, we're probably down to around 1% to 5%. This study is more of a landmark study to assess the rate and impact of vascular complications that we can use to compare with newer-generation devices."
Early Experiences in PARTNER A and B
The analysis, which is published online August 10, 2012 in the Journal of the American College of Cardiology, included 419 patients who were randomly assigned to TAVR via the transfemoral route. Of these patients, 177 were from cohort B and 242 were from cohort A, and all received the first-generation Edwards Lifescience’s Sapien valves and delivery systems.
In total, 64 patients (15.3%) had a major vascular complication and 50 patients (11.9%) had a minor vascular complication within 30 days of receiving the valve. Vascular dissection and perforation were common types of major vascular complications that occurred in 62.8% and 31.3% of patients, respectively. Access-site hematoma also occurred in 22.9% of those with a major vascular complication. There were also three cases of aortic dissection and two cases of left ventricle perforation.
Major vascular complications, along with renal disease at baseline, was an independent predictor of death at one year, while female gender was the lone independent predictor of major vascular complications (hazard ratio 2.31; 95% CI 1.08–4.98).
PARTNER: 30-Day and One-Year Events According to the Occurrence of Major Vascular Complications up to 30 Days
| Event | Major vascular complications (n=64) | No major vascular complications (n=355) | Hazard ratio (95% CI) |
| 30 days | |||
| Death from any cause, % | 14.1 | 3.1 | 4.87 (2.02–11.75) |
| Death from cardiovascular causes, % | 12.6 | 2.8 | 4.75 (1.87–12.04) |
| Major bleeding, % | 60.9 | 6.8 | 12.73 (7.57–21.42) |
| Renal failure requiring dialysis, % | 8.1 | 1.7 | 4.96 (1.51–16.27) |
| One year | |||
| Death from any cause, % | 39.4 | 22.8 | 2.04 (1.30–3.19) |
| Death from cardiovascular causes, % | 27.4 | 8.7 | 3.75 (2.06–6.83) |
"There is a notion that women might be more fragile and prone to vascular complications," said Généreux. "Women are also likely to have smaller vessels than men, but beyond that, when we control for the vessel size, women remain at increased risk for vascular complications. Still, at one year, women tend to have better outcomes than men, so it's a bit of gender paradox. During the procedure they are more prone to vascular complications, but in the long run they do better."
There were fewer vascular complications in the high-risk, but operable, patients compared with those unable to undergo aortic-valve replacement surgery, and the vascular complications appeared to have less impact on the short- and long-term mortality in the former group. "Vascular complications tend to have a bigger impact on sicker patients," said Généreux. "When you look at the impact of vascular complications in cohort B compared with cohort A, the sicker patients in cohort B are less able to tolerate the complications and less likely to survive."
In addition, differences in outcomes between cohort A and B might also be explained by the fact that the transapical approach was available for operators involved in cohort A, making it less likely that "borderline" vessel diameter or vascular anatomy would be attempted with the transfemoral approach. Cohort B patients were also treated by operators and at enrolling sites in the early stages of their experience with TAVR.
Criticisms of TAVR
Earlier this week, Drs Chintan Desai and Robert Bonow (Northwestern University, Chicago, IL) wrote an editorial in the Journal of the American Medical Association urging doctors and patients to curb their enthusiasm for TAVR and to take a complete look at the risks and benefits of the procedure [2]. The editorialists were particularly concerned with the expansion of TAVR to patients better suited for surgery and those not meeting existing criteria. For Desai and Bonow, the complication rates observed outside the clinical trials are likely to be higher, thereby altering the risk–benefit ratio in PARTNER.
To heartwire, Généreux said he is aware of the criticisms but that the PARTNER study was a well-conducted clinical trial that showed TAVR was noninferior to surgery in patients at high risk for aortic valve replacement and was better than not treating patients ineligible for surgical valve replacement. As for indication creep, the PARTNER II study will address the use of TAVR in lower-risk patients. Based on the Canadian and European experiences, which is where the 1% to 5% complication rate cited by Généreux comes from, he said complication rates are already down below their published rate of 15.3% and are likely to fall further as technology improves and operator experience increases. Although some might want to knock TAVR now, the procedure is here to stay, he added.
