Study results show that transcatheter aortic valve replacement (TAVR) with the SAPIEN transcatheter heart valve (THV; Edwards Lifesciences) has excellent long-term durability and improves quality of life.1,2

Pamela Douglas, MD, of Duke Clinical Research Institute; David Cohen, MD, MSc, of Saint Luke’s Mid America Heart Institute; and colleagues presented the findings of PARTNER I and PARTNER II at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, DC.

TAVR has been shown to improve hemodynamics post-procedure, but limited data exist regarding the long-term durability of THVs.3 “As we use more and more THVs and use them in lower risk patients, the durability of the prosthesis becomes extremely important,” Dr Douglas told Cardiology Advisor.


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In PARTNER I, Dr Douglas and colleagues evaluated the long-term durability of the SAPIEN THV in 2404 patients using data from 10,560 echocardiograms that were performed at 7 days, 30 days, 6 months, and annually for up to 5 years after TAVR.2

Mean aortic gradient decreased within 3 months after TAVR (12.1 mm Hg pre-procedure to 9.2 mm Hg post-procedure), and a non-significant increase to 10.3 mm Hg was observed at 5 years.2 According to Dr Douglas, the 5-year event-free survival was 39%. However, adverse hemodynamics likely did not contribute to low survival rates since severe abnormal hemodynamics were uncommon.2

“With no adverse changes out to 5 years, THVs appear to have similar durability as open surgical valves,” Dr Douglas concluded. “The question is at what point, if ever, do they develop a problem? Open surgical valves seem to develop problems around 8 to 12 years. Longer-term studies evaluating the durability of THVs beyond 5 years are needed,” she added.

Among patients at intermediate surgical risk, TAVR has been shown to be non-inferior to surgical aortic valve replacement (SAVR) for the outcomes of 2-year death and disabling stroke.4 “Patients undergoing TAVR are elderly, and while this population values longevity, quality of life tends to be even more important,” Dr Cohen said in an interview with Cardiology Advisor. Health-related quality of life (QOL) outcomes with these interventions have not been reported in the intermediate-risk population.4

In PARTNER II, Dr Cohen and colleagues measured QOL, using the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, in 1833 patients who were randomized to SAVR or TAVR with SAPIEN THV. QOL was assessed at 1 month, 12 months, and 24 months. Data from patients treated via the transfemoral (TF) and transthoracic (TT) approach were analyzed separately.4

Compared with SAVR, TAVR improved QOL at 1 month in the TF and TT subgroups, but the improvement was significant only in the TF subgroup (P <.001). QOL scores were similar among TAVR and SAVR patients at 12 and 24 months.4

“The patients treated via TT access didn’t seem to derive any QOL benefit compared with surgery, which raises the question of whether TAVR really has advantages for that group,” Dr Cohen noted. “Perhaps similar results as the TF approach could be obtained by using other forms of alternative access, such as subclavian or carotid, which would require further study.”

“The most important take away point is that TAVR and SAVR both provide substantial QOL benefits over the long-term,” Dr Cohen said. “QOL with TAVR and SAVR was very similar, which is reassuring because certain complications are more common with TAVR, such as paravalvular leaks and the need for permanent pacing, and they did not seem to impact long-term QOL.”

Disclosures: PARTNER I and PARTNER II were funded by Edwards Lifesciences, Inc. Dr Cohen is a consultant to Edwards Lifesciences.

References

  1. Edwards SAPIEN valves demonstrate excellent durability in 5-year ECHO Study [news release]. PR Newswire.http://www.prnewswire.com/news-releases/edwards-sapien-valves-demonstrate-excellent-durability-in-5-year-echo-study-300354518.html. Published November 1, 2016. Accessed November 2, 2016.
  2. PARTNER I FIVE-YEAR ECHO: hemodynamic trends after TAVR in severe AS [news release]: Washington, DC. American College of Cardiology Newsroom. http://www.acc.org/latest-in-cardiology/articles/2016/10/27/11/06/tues-920am-partner-ii-quality-of-life-tct-2016. November 2, 2016. Accessed November 2, 2016.
  3. Rodés-Cabau J, Webb JG, Cheung A, et al. Long-term outcomes after transcatheter aortic valve implantation: insights on prognostic factors and valve durability from the Canadian Multicenter Experience. J Am Coll Cardiol. 2012;60(19):1864-1875. doi:10.1016/j.jacc.2012.08.960.
  4. Cohen DJ; on behalf of 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 trial. Presented at Transcatheter Cardiovascular Therapeutics 2016 scientific symposium. October 30-November 2, 2016; Washington, DC.