MedicalResearch.com Interview with:
Suzanne J. Baron, MD, MSc
Saint Luke’s Mid America Heart Institute
School of Medicine
University of Missouri, Kansas City
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Transcatheter Aortic Valve Replacement (TAVR) has emerged as a viable treatment option for patients with severe aortic stenosis in patients at high and intermediate surgical risk. Prior studies have demonstrated that both TAVR and surgical AVR (SAVR) results in substantial quality of life benefit in patients at high surgical risk.
Whether these results applied to an intermediate risk population was unknown and so we performed a prospective study alongside the PARTNER 2A trial to compare both short- and long-term health status outcomes in intermediate-risk patients with AS treated with either TAVR or SAVR. The analysis included 1833 patients (950 TAVR, 833 SAVR), who were evaluated at 1 month, 1 year and 2 years post procedure. By 1 month, quality of life had improved in both the TAVR and SAVR groups, although the gain was significantly greater in patients treated with TAVR via the transfemoral approach as opposed to patients treated with SAVR or with TAVR via the transthoracic approach (i.e. direct aortic access or transapical access). At 1 and 2 years, both TAVR (via either approach) and SAVR were associated with similarly large, clinically meaningful improvements from baseline in both disease-specific and generic health status scales at 2 years.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: Not only did TAVR resulted in substantial improvements in quality of life measures at 2 years as compared to baseline, the degree of improvement with TAVR was similar to that seen with SAVR, despite the higher rates of paravalvular aortic regurgitation and pacemaker implantation associated with TAVR. Additionally, it is important to note that transfemoral TAVR may provide an extra component of benefit beyond that associated with SAVR. Firstly, health status was significantly improved at 1 month with transfemoral TAVR – this benefit was not seen with either SAVR or transthoracic TAVR. Secondly, when quality of life was analyzed in combination with survival, transfemoral TAVR was found to be superior to both SAVR and transthoracic TAVR at all time points out to 2 years, although the differences in the later time points (i.e. at 1 year and 2 years) were small and driven mainly by a trend towards a lower mortality in the TAVR arm.
Hence, these results add to the growing literature that transthoracic TAVR may not offer significant benefit over SAVR from a quality of life perspective and they also raise the possibility that there may be a sustained overall benefit of transfemoral TAVR over SAVR in this population.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Longer term follow up will be needed to assess the durability of health status improvement of TAVR beyond 2 years. In particular, it will be interesting to see whether the benefit of transfemoral TAVR over SAVR when mortality and quality of life are analyzed as a single outcome is sustained past 2 years. Further research is also needed to see if these findings extend to a low risk population as well as how these findings are affected by the use of a future generation TAVR devices
Disclosures: I have received modest consulting fees from St. Jude Medical Inc and Edwards LifeSciences.
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Baron SJ, Arnold SV, Wang K, Magnuson EA, Chinnakondepali K, Makkar R, Herrmann HC, Kodali S, Thourani VH, Kapadia S, Svensson L, Brown DL, Mack MJ, Smith CR, Leon MB, Cohen DJ, for the PARTNER 2 Investigators.
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. JAMA Cardiol. Published online June 28, 2017. doi:10.1001/jamacardio.2017.2039
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