The use of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) for bioprosthetic aortic valve failure in high surgical risk patients was associated with sustained improvements in clinical and echocardiographic outcomes, as well as acceptable mortality, at 5 years. These findings were published in the journal JACC: Cardiovascular Interventions.
The multicenter, prospective Placement of Aortic Transcatheter Valves (PARTNER) 2 trial included a registry of patients with degenerated surgical aortic bioprostheses who were considered at high surgical risk, which was defined as “a predicted risk of mortality or major morbidity of 50% or higher.” The investigators sought to explore 5-year outcomes of TAVR for degenerated surgical bioprostheses in individuals at high risk for reoperative surgery.
A total of 96 patients were enrolled in the initial registry (nested) and an additional 269 individuals were enrolled in a continued access registry. All participants needed to have symptomatic, severe dysfunction of a bioprosthesis that was appropriate for ViV treatment with a 23-mm or a 26-mm transcatheter heart valve. To be diagnosed with severe dysfunction, patients needed to have severe stenosis, severe regurgitation, or a combination of at least moderate stenosis and moderate regurgitation via standard echocardiographic criteria.
The primary endpoint was all-cause mortality at 5-year follow-up. Secondary endpoints included cardiac mortality, stroke, aortic valve reintervention, major vascular complications, acute kidney injury, new permanent pacemaker, myocardial infarction, hemodynamic valve deterioration (HVD) and clinical report of symptoms based on New York Heart Association (NYHA) functional status, and quality of life.
The mean age of the 365 participants was 78.9±10.2 years. Mean Society of Thoracic Surgeons predicted risk for surgical mortality score was 9.1±4.7%. NYHA functional class was III or IV in 90.1% of the participants.
Kaplan-Meier rates of all-cause mortality and any stroke at 5 years were 50.6% and 10.5%, respectively. HVD due to structural valve deterioration (SVD) at 5 years was observed in 5.9% of patients, yielding a rate of 1.2% per 100 patient-years. Bioprosthetic aortic valve failure secondary to SVD was reported in 2.3% of participants, representing a rate of 0.43% per 100 patient-years.
Overall, 4.7% of patients met criteria for bioprosthetic aortic valve failure due to SVD, reintervention, or death related to valve dysfunction, yielding a rate of 0.88% per 100 patient-years. HVD or bioprosthetic valve failure was observed in 6.6% of individuals. At 5 years, 14 aortic valve reinterventions for aortic valve dysfunction were reported, most often for stenosis (8 participants). Further, 7 patients underwent redo surgical aortic valve replacement and 5 had a repeat ViV TAVR.
A key limitation of the study is the fact that since it was a prospective registry, there was no randomized comparator arm; thus, it was difficult to place the outcomes in any context.
The researchers concluded that additional studies are warranted, in order to define the clinical and echocardiographic characteristics of those individuals with degenerated surgical bioprostheses who are most likely to derive sustained benefit from TAVR. “At the 5-year follow-up, TAVR for bioprosthetic aortic valve failure in high surgical risk patients was associated with acceptable mortality and sustained improvement in clinical and echocardiographic outcomes,” the study authors wrote.
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Hahn RT, Webb J, Pibarot P, et al. 5-Year follow-up from the PARTNER 2 Aortic Valve-in-Valve Registry for degenerated aortic surgical bioprostheses. JACC Cardiovasc Interv. Published online April 4, 2022. doi:10.1016/j.jcin.2022.02.014