PARTNER A: Transfemoral TAVR Improves Early QOL vs. Surgery
Transcatheter aortic valve replacement (TAVR) via the transfemoral route improves quality of life (QOL) for high-risk patients sooner than conventional surgical replacement, according to an analysis of Cohort A from the PARTNER trial published online July 18, 2012, ahead of print in the Journal of the American College of Cardiology. However, over time both TAVR and surgery provide similarly strong gains in health status.
The data were first presented in November 2011 at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, CA.
The main results of PARTNER Cohort A, published in the New England Journal of Medicine in June 2011, showed that TAVR and surgical valve replacement yield similar 12-month survival.
For the current analysis, investigators led by David J. Cohen, MD, of Saint Luke’s Mid America Heart Institute (Kansas City, MO), prospectively evaluated the health status of 628 PARTNER A patients at baseline and 1, 6, and 12 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and generic quality-of-life instruments.
Early Results Better With Transfemoral TAVR
Patients deemed suitable for transfemoral access (n = 446) were randomized to transfemoral TAVR or surgery, while those with unsuitable anatomy (n = 182) were randomized to transapical TAVR or surgery.
Both TAVR and surgical patients showed substantial improvement (> 20 points) in KCCQ summary scores at 6 and 12 months. Overall, TAVR resulted in more rapid improvement in KCCQ summary scale (primary endpoint), than surgery, with an advantage at 1 month (mean adjusted difference 5.5; 95% CI 1.2-9.8; P = 0.01) but no difference at 6 or 12 months.
However, because there was an interaction between treatment assignment and access site, QOL was analyzed independently for the transfemoral and transapical cohorts.
For transfemorally treated patients, TAVR resulted in higher KCCQ summary scores than surgery at 1 month, with no difference at 6 and 12 months. By contrast, in the transapical cohort, KCCQ summary scores tended to favor surgery at 1 month and clearly did so at 6 months, but were similar between the treatment groups at 12 months (table 1).
Table 1. KCCQ Summary Score Difference for TAVR vs. Surgery
Adjusted Mean Difference
Results for the KCCQ subscales such as physical and social limitations, total symptoms, and QOL largely paralleled those observed for the summary scale. Also, evaluation of the SF-12 and EQ-5D utility scales showed patterns similar to those for the disease-specific scales.
A ‘Sobering’ Finding
“It’s unsurprising but gratifying that the less invasive approach [to valve replacement] was associated with more rapid recovery and early quality-of-life benefit,” Dr. Cohen told TCTMD in a telephone interview. On the other hand, he added, it was “surprising and sobering” that the same results were not seen with the transapical approach.
One possible explanation for the recovery disadvantage with transapical access lies in the nature of the incision, Dr. Cohen suggested. It is well established in the surgical literature that the median sternotomy used in surgery is one of the least painful chest incisions, whereas a thoracotomy, which spreads the ribs and is used in transapical TAVR, leaves a wound that moves with each breath, he said. “So it takes longer to heal and the healing process is more painful.”
Several strategies are being explored to mitigate the trauma of the transapical approach, Dr. Cohen reported, such as minimizing the thoracotomy incision and rib spreading and using nerve blocks or epidural anesthesia to dampen post-procedure pain. Efforts are also under way to transform transapical TAVR into a fully percutaneous procedure.
Meanwhile, patients who do not qualify for transfemoral TAVR may consider alternative routes with the CoreValve (Medtronic, Minneapolis, MN) device, such as subclavian access or the direct approach via a suture in the ascending aorta, which may have better recovery patterns, Dr. Cohen said.
Overall, however, Dr. Cohen cautioned against overplaying the differences between transfemoral and transapical approaches, noting that the study data may represent an early stage in the development of TAVR in the United States that operators have already moved beyond. “Many surgeons who have done a large number of [TAVR] procedures have the strong impression that patients are making a more rapid recovery than if they had had conventional surgery,” he said.
“We know that in the later stages of PARTNER the mortality and stroke rates with the transapical approach came down dramatically from what was seen in the first 100 or so patients,” Dr. Cohen continued. “The question is whether that also affects the quality of life. We haven’t had the opportunity to analyze those data yet.”
Focusing on the ‘Big Picture’
In a telephone interview with TCTMD, John Rumsfeld, MD, PhD, of the University of Colorado School of Medicine (Denver, CO), preferred to focus on what he called “the big picture”: the fact that the QOL outcomes for TAVR and surgery are ultimately equivalent—and substantial.
“A change in KCCQ score of 25 points is almost unheard of,” he commented. By comparison, the modest difference in the pace of recovery between the transfemoral and transapical approaches is “not a big deal,” he added.
According to Dr. Rumsfeld, the take-home message from the study is that either TAVR or surgery “can be considered in elderly patients at elevated surgical risk, and this suggests a strong role for shared decision making.” In presenting the options, a clinician could point out to eligible patients that transfemoral TAVR is typically associated with a quicker recovery, he said. Nonetheless, there are still trade-offs to consider, such as the different complications associated with the procedures or the fact that surgery is ‘tried and true’ while TAVR is new. Ultimately, doctors should not overstate the small early QOL benefit of transfemoral TAVR, he advised.
On the other hand, patients who prefer TAVR but do not qualify for the transfemoral approach can be reassured that they will reap the same QOL benefit within a few years, Dr. Rumsfeld added.
Patients’ mean age was 83 years, and all had a high burden of both cardiac and noncardiac comorbidities. Those randomized to the transapical approach were more likely to have cerebrovascular disease, PAD, and previous CABG. Within both the transfemoral and transapical subgroups, the baseline characteristics of patients randomized to TAVR and surgery were well balanced.
Note: Coauthor Martin B. Leon, MD, is a faculty member of the Cardiovascular Research Foundation, which owns and operates TCTMD.
Reynolds MR, Magnuson EA, Wang K, et al. Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: Results from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial (Cohort A). J Am Coll Cardiol. 2012;Epub ahead of print.
- PARTNER A: Transfemoral TAVR Improved QOL, Costs vs. Surgery
- TAVR Improves Quality of Life in Clinical Practice
- PARTNER: Quality of Life Greatly Improved by Transcatheter Valve Procedure
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- The study was supported by Edwards Lifesciences.
- Dr. Cohen reports receiving research grants from Abbott Vascular, AstraZeneca, Boston Scientific, Edwards Lifesciences, Eli Lilly, and Medtronic; serving as a consultant for Abbott Vascular and Medtronic; and receiving speaking honoraria from Eli Lilly.
- Dr. Rumsfeld reports serving as chief science officer for the American College of Cardiology’s National Cardiovascular Data Registry.