The size of an original failed aortic bioprosthesis and the type of transcatheter valve used to replace it can influence clinical outcomes years after a valve-in-valve (ViV) procedure, researchers say.
Among more than 1000 patients in the Valve-in-Valve International Data (VIVID) registry, estimated survival at 8 years was worse with a small failed bioprosthesis (true internal diameter ≤20 mm) compared with larger bioprostheses (33.2% vs 40.5%; P = .01).
Reintervention was more common with balloon-expandable than with self-expanding transcatheter aortic valves (6.0% vs 2.0%; P = .02), and in those with pre-existing severe patient-prosthesis mismatch (PPM) than in those with no or moderate mismatch (12.5% vs 3.0%; P = .02).
"The size of the original failed valve may influence long-term mortality and the type of transcatheter valve may influence the need for reintervention after aortic valve-in-valve," senior author Danny Dvir, MD, University of Washington Medical Center, Seattle, said.
"Operator decisions during the original tissue valve implantation and/or during the valve-in-valve procedure itself may influence meaningful clinical outcomes," he said.
The results were presented during PCR e-Course 2020, the virtual congress of the European Association of Percutaneous Cardiovascular Interventions, and published simultaneously in the European Heart Journal.
A recent Society of Thoracic Surgeons database analysis and a national propensity-matched analysis also showed worse early outcomes with redo surgery for failed bioprostheses. However, long-term data after ViV procedures are limited, Dvir noted.
Using the multicenter VIVID registry, the investigators identified 1006 ViV procedures performed before December 2014, with a median follow-up of 3.9 years. Most patients were male (58.8%), transfemoral access was used in 69.5%, and 6.2% had pre-existing severe PPM.
About one-half (52%) were treated with Medtronic self-expandable CoreValve/Evolut valves; 43.2% with Edwards Lifesciences balloon-expandable Sapien, Sapien XT, Sapien 3 valves; and 4.8% with other devices. The mean internal valve diameter was 19.9 mm and median label size of the transcatheter valve was 23 mm.
The 8-year survival rate was 38%. Smaller bioprosthetic valves, older age, lower baseline ejection fraction, chronic kidney disease, nontransfemoral access, and diabetes were independent predictors of all-cause mortality.
In all, 40 patients required reintervention during follow-up, 60% for severe transvalvular stenosis and two patients for valve thrombosis.
Independent predictors of reintervention were older age, balloon-expandable valves, malposition, and pre-existing severe PPM.
"Taken together with prior findings, our study adds further evidence and insight into the fact that small bioprostheses, which frequently exhibit severe PPM, bear a high risk for worse outcomes after ViV procedures," Dvir and colleagues write.
"When evaluating a patient with a failing small bioprosthetic valve, patients should understand the additional surgical risk of redo open heart surgery, especially when root enlargement is performed, and also the limitations of a ViV procedure with regard to residual stenosis," they suggest.
Dvir and colleagues suggest surgeons avoid implanting small bioprostheses "whenever possible (i.e., label size <23 mm, or with predicted severe PPM)."
To reduce the risk for residual stenosis, operators should aim to position devices precisely and fracture the surgical bioprosthetic valve — a technique that facilitates ViV but was not used in this cohort.
Other study limitations are the lack of a control group of conventional surgery, variation in the mode and method of follow-up among centers, and low representation of currently used valves, such as Sapien 3 and Evolut R.
Invited discussant Nicolas Dumonteil, MD, Clinique Pasteur, Toulouse, France, said the data confirm worse long-term prognosis associated with small bioprosthetic valves treated by ViV and provide a "strong suggestion" for self-expandable valve use in small surgical failed bioprosthesis.
Pending issues are a description of long-term structural valve deterioration, thrombosis, and bioprosthetic valve failure in accordance with 2017 European consensus definitions, Dumonteil said.
The study was supported by the nonprofit Institute of Valvular Research. Dvir reported consulting for Medtronic, Edwards Lifesciences, Abbott, and Jena. Dumonteil has received proctor fees and is a consultant for Edwards LifeSciences, Medtronic, and Boston Scientific.
Eur Heart J. Published online June 27, 2020. Full text
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