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A single-center experience out of the United Kingdom confirms results of the PARTNER trial, finding that transcatheter aortic valve replacement (TAVR) quickly improves quality of life (QOL), with both patient sex and operator experience key in obtaining good results, according to a paper published in the May 8, 2012, issue of the Journal of the American College of Cardiology.

The PARTNER (Placement of AoRTic TraNscathetER valve) trial employed the Sapien device (Edwards Lifesciences, Irvine, CA), whereas the current study used the CoreValve device (Medtronic, Minneapolis, MN).

For the study, John P. Greenwood, PhD, of the University of Leeds (Leeds, United Kingdom), and colleagues looked at 102 patients who were undergoing TAVR at the Leeds General Infirmary. The researchers administered 2 health-related QOL questionnaires—the social functioning (SF)-12v2 with physical and mental components and the European QOL (EQ)-5D—at baseline and then again 30 days, 6 months, and 1 year after the procedure.

The greatest improvements in QOL measures occurred between baseline and 30 days (P < 0.001), with further benefits observed out to 6 months (P < 0.01). Scores actually diminished slightly from 6 months out to 1 year, but this reduction was not statistically significant, and a linear pattern of change remained for most measures (table 1).

Table 1. Mean Improvements in QOL Following TAVR

^a Significant vs. baseline.

By 6 months postprocedure, all QOL scores reached age-adjusted US population norms for healthy individuals, with some exceeding normal measures.

Based on multivariate analyses, independent predictors of QOL improvements were male sex (P = 0.01) and increased operator experience (P < 0.05).

Backing PARTNER

Dr. Greenwood told TCTMD in an e-mail communication that the findings mirrored those of PARTNER’s cohort A, which included patients eligible for surgery, recently presented at the annual Transcatheter Cardiovascular Therapeutics scientific symposium in November 2011 in San Francisco, CA. “We have [additionally] shown that patient factors, procedural complications, and operator experience are predictors of health benefit at 1 year,” he said.

Thus, to maximize patient QOL following TAVR, Dr. Greenwood recommends “appropriate patient selection and having the procedure performed in a high-volume centre by experienced operators.”

PARTNER researcher David J. Cohen, MD, MSc, of Saint Luke’s Mid America Heart and Vascular Institute (Kansas City, MO) agrees. “The results of this study are virtually identical to those that we have previously reported from the PARTNER trial. . . . Thus, I would view these findings as confirmatory for the most part,” he wrote in an e-mail communication with TCTMD. In addition to the cohort A analysis, a paper outlining QOL outcomes in the trial’s cohort B was published in the March 6, 2012, issue of Circulation.

Operator Experience Factor in QOL?

“The most unique factor of this study is the authors’ attempt to identify key predictors of improvement and benchmarking the outcomes to the age-adjusted US population (although it would have been more appropriate to use the UK population for this study). The finding that operator experience seemed to predict greater improvement is novel and worthy of further investigation,” Dr. Cohen commented.

In a telephone interview with TCTMD, Philippe Généreux, MD, of Columbia University Medical Center (New York, NY), noted that this study does differ somewhat from PARTNER. In particular, the population was lower risk, suggesting that TAVR improves QOL in both high- and low-risk patients.

Dr. Généreux was also intrigued by the multivariate analysis aimed at identifying predictors of improvement. “Now the challenge is to identify who is going to be a good responder, both for survival and quality of life. The problem is that there were not enough patients [in this study] for this type of analysis,” he said, noting that previous studies had suggested similar results irrespective of patient sex or better survival in women. “I don’t know how to interpret that [inconsistency]. This is what happens when we have a small number of patients.”

The new study also highlights the importance of a learning curve, Dr. Généreux added. “Maybe the skill and experience of the operator is important for quality of life,” he said. “This is new, but it is also intuitive. If you have more experience, you have fewer complications, so you have a better quality of life. Also, the more experienced operator probably selects patients better.”

2. Hayashida K, Morice MC, Chevalier BJ et al. Sex-related differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis. J Am Coll Cardiol. 2012:59:566-71.

Related Stories:

• PARTNER: Quality of Life Greatly Improved by Transcatheter Valve Procedure
• PARTNER Analysis: TAVI Substantially Improves QOL vs. Standard Therapy
• PARTNER: All-Cause, CV Mortality Lower in Patients Treated with TAVI vs. Standard Therapy at 1 Year
  

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