Health Status Benefits of Transcatheter vs Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: Results From the PARTNER 2 Randomized Clinical Trial

Abstract

Importance: In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar 2-year survival. The effect of TAVR vs SAVR on health status in patients at intermediate surgical risk is unknown.

Objective: To compare health-related quality of life among intermediate-risk patients with severe AS treated with either TAVR or SAVR.

Design, setting, and participants: Between December 2011 and November 2013, 2032 intermediate-risk patients with severe AS were randomized to TAVR with the Sapien XT valve or SAVR in the Placement of Aortic Transcatheter Valve 2 Trial and were followed up for 2 years. Data analysis was conducted between March 1, 2016, to April 30, 2017.

Main outcomes and measures: Health status was assessed at baseline, 1 month, 1 year, and 2 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ) (23 items covering physical function, social function, symptoms, self-efficacy and knowledge, and quality of life on a 0- to 100-point scale; higher scores indicate better quality of life), Medical Outcomes Study Short Form-36 (36 items covering 8 dimensions of health status as well as physical and mental summary scores; higher scores represent better health status), and EuroQOL-5D (assesses 5 dimensions of general health on a 3-level scale, with utility scores ranging from 0 [death] to 1 [ideal health]). Analysis of covariance was used to examine changes in health status over time, adjusting for baseline status.

Results: Of the 2032 randomized patients, baseline health status was available for 1833 individuals (950 TAVR, 883 SAVR) who formed the primary analytic cohort. A total of 1006 (54.9%) of the population were men; mean (SD) age was 81.4 (6.8) years. Over 2 years, both TAVR and SAVR were associated with significant improvements in both disease specific (16-22 points on the KCCQ-OS scale) and generic health status (3.9-5.1 points on the SF-36 physical summary scale). At 1 month, TAVR was associated with better health status than SAVR, but this difference was restricted to patients treated via transfemoral access (mean difference in the KCCQ overall summary [KCCQ-OS] score, 14.1 points; 95% CI, 11.7 to 16.4; P < .01) and was not seen in patients treated via transthoracic access (mean difference in KCCQ-OS, 3.5 points; 95% CI, -1.4 to 8.4; P < .01 for interaction). There were no significant differences between TAVR and SAVR in any health status measures at 1 or 2 years.

Conclusions and relevance: Among intermediate-risk patients with severe AS, health status improved significantly with both TAVR and SAVR through 2 years of follow up. Early health status improvement was greater with TAVR, but only among patients treated via transfemoral access. Longer term follow-up is needed to assess the durability of quality-of-life improvement with TAVR vs SAVR in this population.

Trial registration: clinicaltrials.gov Identifier: NCT01314313.

Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Baron has received consulting fees from Edwards Lifesciences Inc and from St Jude Inc. Dr Makkir has received grants from Edwards Lifesciences and St Jude Medical Center and personal fees from Abbott Vascular, Cordis, and Medtronic. Dr Herrmann has received grants from Abbott Vascular, Edwards Lifesciences Inc, Boston Scientific, Medtronic, and St Jude Medical, and personal fees from Edwards Lifesciences Inc. Dr Kodali is a paid member of the scientific advisory boards of Dura Biotec, Thubrikar Aortic Valve, Inc, and BioTrace Medical, and is an unpaid consultant for Medtronic, Edwards Lifesciences Inc, Claret Medical, and Boston Scientific. Dr Thourani has received grants and personal fees from Edwards Lifesciences Inc. Dr Mack has received compensation from Edwards Lifesciences Inc. Dr Cohen has received grants and personal fees from Edwards Lifesciences Inc and Medtronic and grants from Abbott Vascular. No other conflicts were reported.

Figures

Figure 1.. Adjusted Between-Group Differences Between the Transcatheter Aortic Valve Replacement (TAVR) and Surgical Aortic Valve Replacement (SAVR) Cohorts Stratified by Access Sites

A, Differences between TAVR and SAVR on the disease-specific Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score as well as the Physical Limitations, Total Symptoms, Quality of Life, and Social Limitations Subscales. B, Differences in generic health status between TAVR and SAVR as assessed by the Medical Outcomes Study Short-Form-36 (SF-36) physical and mental component summary scores as well as EuroQOL-5D (EQ-5D) utilities. Scales described in the Measurement of Health Status subsection. Error bars denote 95% CIs. P values represent the interaction between treatment group and access site at each time point.

Figure 2.. The Proportions of Transcatheter Aortic Valve Replacement (TAVR) and Surgical Aortic Valve Replacement (SAVR) Patients Achieving Specific Levels of Change in the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) Scores

Changes from baseline to 1 month, 1 year, and 2 years, as defined in the Measurement of Health Status subsection. Proportions are presented separately for patients in the transfemoral (A) and transthoracic (B) access cohorts. The P values were based on ordinal logistic regression.