Valve-in-Valve Registry Data Demonstrate Positive 1-Year Results for Transcatheter Aortic Valve Replacement

SAN FRANCISCO – In high-risk patients with failed surgical bioprostheses, transcatheter aortic valve replacement (TAVR) resulted in low rates of all-cause mortality at 30 days and 1 year, according to results from the PARTNER II Valve-in-Valve (VIV) Registry.

The findings were presented at the Transcatheter Cardiovascular Therapeutics 2015 meeting in San Francisco and simultaneously published in JACC: Cardiology Interventions.

“Valve-in-valve TAVR has emerged as a viable alternative for patients with failing surgical aortic bioprostheses,” Danny Dvir, MD, study investigator from St. Paul’s Hospital in Vancouver, Canada, said during a TCT press conference. “We sought..to assess the safety and efficacy of [VIV TAVR] in patients with failed surgical bioprostheses considered at high risk for reoperation.”

Dr. Dvir and fellow researchers enrolled patients who had severe stenosis or regurgitation of a surgical aortic tissue valve; were at high risk for reoperation (estimated surgical mortality or major morbidity ≥50%); and were suitable for a 23 mm or 26 mm Sapien XT transcatheter heart valve (Edwards Lifesciences, Irvine, CA). Patients with a surgical valve size of <21 mm or a prosthetic valve in another position were excluded.

The final analysis included 197 patients—97 from the PARTNER II VIV Registry and 100 from the PARTNER II VIV Extended Registry. Baseline characteristics between the 2 cohorts were similar except for a trend for younger age in the Extended Registry (77 years vs. 80.1 years; P=.05).

One-year all-cause mortality served as the primary endpoint.

At 30 days, all-cause mortality for all VIV patients was 4.1% (VIV Registry, 9.3% vs. VIV Extended Registry, 0%), and at 1 year, it was 13.4% (VIV Registry, 19.7% vs. VIV Extended Registry, 7.2%).

Overall rates of stroke were 2.5% at 30 days and 3.7% at 1 year, and rehospitalization was 7.3% at 1 month and 11.8% at 1 year.

Compared with baseline, significantly less patients were categorized as New York Heart Association class 3 or 4 at 30 days (11.6% vs. 95.5%; P<.0001), a rate that remained stable at 1 year (12%).

Dr. Dvir also reported significant improvements in 6-minute walk test distance, Kansas City Cardiomyopathy Questionnaire overall summary score, and left ventricular ejection fraction, as well as a significant decrease in left ventricular mass index.

“[VIV] TAVR using Sapien XT is a beneficial therapeutic alternative to reoperation in patients with failed aortic bioprostheses,” Dvir said.

Following his presentation of the data, Dr. Dvir noted that the Sapien XT valve has received FDA approval for aortic VIV procedures in patients who are at high risk for repeat surgical bioprosthetic valve replacement. 

Disclosures: This study was funded by Edward Lifesciences (Irvine, CA).

References

1. Dvir D et al. Late-Breaking Trials and First Report Investigations IV. Presented at: 27^th Annual Transcatheter Cardiovascular Therapeutics scientific symposium; October 10-15, 2015; San Francisco.

2. Ye J et al. Transcatheter Aortic and Mitral Valve-in-Valve Implantation for Failed Surgical Bioprosthetic Valves: an 8-year Single Centre Experience. J Am Coll Cardiol Interv. 2015; doi:10.1016/j.jcin.2015.08.012