Author + information
- Published online June 18, 2018.
- aDepartment of Cardiovascular Surgery, German Heart Center Munich, Technische Universität, Munich, Germany
- bInsure (Institute for Translational Cardiac Surgery), Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany
- ↵∗Address for correspondence:
Prof. Dr. Sabine Bleiziffer, Department of Cardiovascular Surgery, German Heart Center Munich, Lazarettstrasse 36, 80636 Munich, Germany.
Improvement of health-related quality of life (HrQoL) after aortic valve replacement is a proven outcome for both surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) (1). The TAVR technique used to be reserved for inoperable and high-risk patients whose primary goal is not longevity, but rather the restoration of comfort in daily life and maintenance of their independent status. Thus, demonstration of a benefit for these multimorbid patients in terms of HrQoL through randomized trials has been paramount. More recently, HrQoL was also assessed in intermediate-risk patients by randomized trials comparing TAVR and SAVR (2,3). The major findings were that HrQoL improvements were similar for both treatment options, but TAVR patients improved more rapidly, in particular transfemorally treated patients. However, with extension of the TAVR indication to intermediate- or low-risk patients, outcomes of the latest-generation TAVR prostheses are of increasing interest.
In this issue of JACC: Cardiovascular Interventions, Baron et al. (4) address this gap in knowledge by comparing 1,049 patients who received a latest-generation balloon-expandable Sapien 3 valve (Edwards Lifesciences, Irvine, California) for aortic stenosis with PARTNER II (Placement of AoRTic TraNscathetER Valves) study patients (926 patients with Sapien XT TAVR and 854 patients of the surgical arm). All patients had undergone questionnaire analyses using the Kansas City Cardiomyopathy Questionnaire (KCCQ) for HrQoL assessment, the Medical Outcomes Study Short-Form 36 (SF-36) for generic health status assessment, and the EuroQOL-5D at baseline, at 1 month, and at 1 year after the procedure (4). The Sapien 3 TAVR patients exhibited a significantly greater improvement in KCCQ and SF-36 scales at 1 month compared with both Sapien XT TAVR and SAVR patients. At 1 year, the differences were smaller but remained significant for the KCCQ scales. Categorical analysis demonstrated that there was a larger proportion of patients among the Sapien 3 group who had a “substantial improvement” and an “excellent outcome” according to the KCCQ. When procedural complications were added to the statistical models, the observed differences at 1 year were attenuated and no longer significant.
Comparing 2 different study populations, the study has inherent limitations that were well addressed in the paper. It still remains unclear how unmeasured confounders influenced the results. While the TAVR XT and SAVR patients were randomized to the method of treatment, the Sapien 3 patients were recruited in a registry and were treated later, in more experienced centers, and had a lower mean STS (Society of Thoracic Surgeons) score than PARTNER II study patients. Generic health status or HrQoL improvement after a surgical or interventional procedure is certainly multifactorial and hardly attributed solely to a specific valve type: baseline comorbidities and procedural factors may have various effects. Lange et al. (5) have identified multiple factors being predictive for a less pronounced or absent improvement in HrQoL after TAVR using the EQ-5D in a large national registry, for example, female sex, low body mass index, or neurodysfunction. Notably, different factors were found to be predictive for transfemoral and transapical TAVR patients. Baron et al. (4) did not differentiate between access routes, although it was already known from the PARTNER II study population that transfemoral patients improved more rapidly (6).
Due to the particular study design, risk factors for a favorable outcome, defined as survival plus KCCQ Overall Summary score >60 and absence of decrease in KCCQ Overall Summary score <10 from baseline, were assessed only within the Sapien 3 study group. To see such data from another perspective, it would be of interest to assess whether a specific valve type is an independent predictor of HrQoL outcomes. Baron et al. (4) found increasing age, prior stroke, diabetes, oxygen-dependent chronic obstructive pulmonary disease, and a slow walking speed to be significantly predictive for a less favorable outcome. These factors are in accordance to other studies, but do not explain the surprising finding that TAVR with the latest-generation Sapien 3 leads to superior HrQoL outcomes compared with SAVR or TAVR with the Sapien XT over 1 year. Superiority of the Sapien 3 over SAVR at 1 month reflects faster recovery with a less invasive procedure. This phenomenon has been likewise observed in the randomized trials comparing TAVR versus SAVR (2,3). Superiority of the Sapien 3 over XT at 1 month is explained by the authors with the smaller sheath size of the Sapien 3 along with a higher proportion of transfemoral access. The question is why the transfemoral groups were not investigated separately. This finding could also have been affected by the differences in the patient populations that could not be controlled by statistical methods. And superiority of the Sapien 3 at 1 year? Mediation analyses were performed to investigate this finding in more detail, suggesting that at least part of the health status benefit of the Sapien 3 relates to differing post-procedural complications. But do post-procedural complications still affect health status at 1 year, or is this again an effect of the differences in baseline characteristics?
In my eyes, the essential finding of the study by Baron et al. (4) is that significant and clinically meaningful HrQoL and health status improvements are seen after TAVR with either valve type, which are sustained over time. Some factors may predict even better outcomes, such as a high rate of transfemoral access, or absence of procedural complications, both of which are facilitated by latest-generation TAVR systems. For better patient selection, it is, however, key to identify those patients in future studies who will not improve with either treatment or valve type.
↵∗ Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC: Cardiovascular Interventions or the American College of Cardiology.
Prof. Bleiziffer has reported that she has no relationships relevant to the contents of this paper to disclose.
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