CoreValve US Subanalysis: Only Femoral TAVR Offers Early QoL Advantage Over Surgery
In elderly high-risk patients, transfemoral TAVR with a self-expanding device improves quality of life (QoL) more than does surgery within the first month, according to an analysis of the CoreValve US Pivotal Trial published in the August 17, 2015, issue of JACC: Cardiovascular Interventions. However, by 1 year there is no difference in health status between the 2 treatments, and no advantage was seen for nontransfemoral TAVR.
“All of the previous randomized trials that have examined health status after TAVR or [surgical aortic valve replacement (SAVR)] have been performed with the balloon-expandable Sapien valve,” David J. Cohen, MD, MSc, of Saint Luke’s Mid America Heart Institute (Kansas City, MO), told TCTMD in an email. “Since the CoreValve differs from the Sapien valve in many respects…, it is important to examine health status after this device as well.”
In the CoreValve US Pivotal Trial, 795 patients with severe aortic stenosis at high surgical risk were randomized to TAVR with the self-expanding CoreValve (Medtronic) or SAVR at 45 US centers from 2011 to 2012. Most patients (84%) were eligible for femoral access, whereas 16% required nonfemoral access (subclavian or direct aortic approach).
Generic health status was assessed via the Medical Outcomes Study Short-Form 12 (SF-12) questionnaire and the EuroQoL 5-dimension questionnaire (EQ-5D), while disease-specific health status was evaluated with the Kansas City Cardiomyopathy Questionnaire (KCCQ). Furthermore, mortality and QoL were combined into a single outcome to examine outcomes after TAVR.
The treatment groups were well matched. Compared with patients who were eligible for femoral access, those who were not had more cardiac comorbidities and peripheral vascular disease and lower body weight.
Early Gains, But Improvement Ultimately Similar
Health status, both disease-specific and generic, improved in both TAVR and SAVR patients by 1-year follow-up. Interaction between treatment assignment and access site was seen at 1 month favoring femoral—but not nonfemoral—TAVR over surgery across all metrics (table 1).
The rate of patients with acceptable outcome (survival and QoL combined) favored TAVR over SAVR at 6 months (73% vs 64%; P = .02). By 1 year, however, there were no differences in rates of acceptable outcome or any health assessment measures between the overall TAVR and surgery arms.
The Importance of Access
According to the study authors, the results are “particularly interesting” in comparison to those of PARTNER Cohort A. In that group, there was a similarly strong interaction between access site and early health status favoring transfemoral TAVR patients but, unlike in the current study, TAVR patients ineligible for femoral access received a transapical procedure.
Dr. Cohen and colleagues say that transapical access is thought to lead to longer recovery time and greater pain due to the requirement for lateral thoracotomy. In contrast, they say, the subclavian artery or direct aortic approach used for nonfemoral patients in the CoreValve trial “might be expected to produce less postoperative pain”—and yet these procedures were still associated with similar QoL to surgery at 1 month.
“One of the main reasons why patients choose TAVR over SAVR relates to the perception that TAVR, as a ‘less invasive’ procedure, will allow an earlier functional recovery,” Dr. Cohen said.
“This study (along with similar findings from the PARTNER trial) suggests that ‘less invasive’ may not always mean ‘less painful’ or ‘quicker recovery,’” he explained. “For this reason, patients who are primarily choosing TAVR as a means toward a quicker recovery should be informed that this may not be the case if nonfemoral access is required. Fortunately, with the current generation of TAVR devices, transfemoral access can be performed safely in the vast majority of patients.”
Asked whether a randomized trial comparing alternative access sites would be a good idea, Dr. Cohen said that while the idea is “fascinating,” it would be difficult to execute.
“In many cases, the specific alternative access approach is dictated by the patient’s anatomy or comorbidities,” he noted. “In addition, different surgeons may be more skilled at different approaches such that controlling for these differences would be exceedingly difficult.”
In an email to TCTMD, John S. Rumsfeld, MD, PhD, of the University of Colorado (Denver, CO), agreed, adding that as TAVR technologies rapidly evolve, there will be less need to use alternative access as more patients potentially qualify for transfemoral access. These newer TAVR devices are likely to improve the procedural outcomes for alternative access patients as well, he said.
Individualized Risk Prediction
Dr. Rumsfeld observed that it has taken a long time for “the science of health status measurement to become embedded in the science of medicine. In addition to survival, health status is the most important outcome from the patient perspective.”
He added that the study “is reassuring for patients and clinicians that TAVR using CoreValve achieves the same quality-of-life benefits as surgical AVR.”
That being said, the critical next phase in this type of research lies in understanding which patients do not stand to see better health status after TAVR, Dr. Rumsfeld commented. “[C]an we get to a point where patient health status outcomes can be predicted with enough accuracy to help inform patients, their families, and their doctors before undergoing TAVR or AVR, so they can better weigh the risks and benefits of the procedure?”
Ultimately, incorporating QoL, as a clinical metric will allow for shared decision making.
“For an individual patient with severe aortic stenosis and poor health status, they either will or will not have a femoral access option,” Dr. Rumsfeld said. “If not, that should be included in the discussions of their risk, but the alternative… may be medical therapy.”
Arnold SV, Reynolds MR, Wang K, et al. Health status after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis at increased surgical risk: results from the CoreValve US Pivotal Trial. J Am Coll Cardiol Intv. 2015;8:1207-1217.
- Dr. Cohen reports having received research support and consulting income from multiple device and pharmaceutical companies and speaking honoraria from AstraZeneca.
- Dr. Rumsfeld reports no relevant conflicts of interest.
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