Registry Data Show Promise of Valve-in-Valve TAVR in High-Risk Patients

 

Transcatheter aortic valve replacement (TAVR) appears to be a viable therapeutic alternative to repeat surgery in high-risk patients with a failed surgical heart valve, according to 1-year results of the PARTNER II Valve-in-Valve Registry. 

sun.suri.headData showing early procedural success, acceptable mortality, and low risk of coronary obstruction or new pacemaker implantation were reported at the American College of Cardiology Scientific Session in 2014, said Rakesh M. Suri, MD, DPhil, of the Mayo Clinic, Rochester, Minn.

For the current analysis, Suri and colleagues sought to assess the 1-year safety and efficacy of the Sapien XT valve (Edwards Lifesciences) in a cohort of 97 patients enrolled across 24 sites between June 2012 and April 2013. Patients had symptomatic, severe stenosis or regurgitation of a surgical aortic tissue valve and faced a surgical mortality or major morbidity of 50% or more. All were suitable for a 23-mm or 26-mm TAVR device.

During his presentation at TCT 2014, Suri reported 1-year rates of both all-cause and cardiac mortality (see Figure). All-cause mortality was 18.8% for transfemoral and 21.6% for transapical TAVR. All-cause death stratified by mode of surgical heart valve failure was 19.5% for patients with predominate aortic stenosis, 18.4% for those with predominate aortic regurgitation and 25.0% for those with both. Other clinical outcomes included stroke/transient ischemic attack (4.5%), rehospitalization (17.2%) and permanent pacemaker implantation (1.1%).

sun.suri.figureLeft ventricular mass index regressed from 141.17 g/m² at baseline to 119.16 g/m² at 1 year (P<.0001). Among surviving patients, 84% were NYHA functional class I and II by 1 year (P<.0001 vs. baseline). KCCQ quality of life (QoL) assessment improved from an overall summary score of 39.97 at baseline to 74.74 at 1 year (P<.0001). In addition, 33.3% of patients had moderate-to-severe mitral regurgitation at baseline compared with 16% at 1 year (P=.04), and the prevalence of moderate-to-severe tricuspid regurgitation decreased from 48% at baseline to 27.5% at 1 year (P=.0004).

“Retrospective registries to date have shown valve-in-valve TAVR [to be] an alternative to reoperation for patients with failing surgical heart valves,” Suri said. “Patients gained significant benefit from this therapy with improvements in functional class and QoL. However, the current analysis is small, and further study is needed to determine whether these midterm benefits improve long-term outcomes.”

Mean age was 80.1 years, and 55.7% of patients were men. Most patients (95.9%) were classified with NYHA class III or IV, and 37.1% were deemed frail.

  

 Disclosures:

  • Suri reports no relevant conflict of interests.
  • The study was funded by Edwards Lifesciences, the Sorin Group and St. Jude Medical.

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