Five-Year Follow-Up from the CoreValve Expanded Use Transcatheter Aortic Valve-in-Surgical Aortic Valve Study.

Transcatheter aortic valve replacement (TAVR) provides an option for extreme-risk patients who underwent reoperation for a failed surgical aortic bioprosthesis. Long-term data on patients who underwent TAVR within a failed surgical aortic valve (TAV-in-SAV) are limited. The CoreValve Expanded Use Study evaluated patients at extreme surgical risk who underwent TAV-in-SAV. Outcomes at 5 years were analyzed by SAV failure mode (stenosis, regurgitation, or combined). Echocardiographic outcomes are site-reported. TAV-in-SAV was attempted in 226 patients with a mean age of 76.7 ± 10.8 years; 63.3% were male, the Society of Thoracic Surgeons predicted risk of mortality score was 9.0 ± 6.7%, and 87.5% had a New York Heart Association classification III or IV symptoms. Most of the failed surgical bioprostheses were stented (81.9%), with an average implant duration of 10.2 ± 4.3 years. The 5-year all-cause mortality or major stroke rate was 47.2% in all patients; 54.4% in the stenosis, 37.6% in the regurgitation, and 38.0% in the combined groups (p = 0.046). At 5 years, all-cause mortality was higher in patients with versus without 30-day severe prosthesis-patient mismatch (51.7% vs 38.3%, p = 0.026). The overall aortic valve reintervention rate was 5.9%; highest in the regurgitation group (12.6%). The mean aortic valve gradient was 14.1 ± 9.8 mm Hg and effective orifice area was 1.57 ± 0.70 at 5 years. Few patients had >mild paravalvular regurgitation at 5 years (5.5% moderate, 0.0% severe). TAV-in-SAV with supra-annular, self-expanding TAVR continues to represent a safe and lasting intermediate option for extreme-risk patients who have appropriate sizing of the preexisting failed surgical valve. Clinical and hemodynamic outcomes were stable through 5 years.
Competing Interests: Declaration of competing interest Dr. Bajwa reports fees for consulting and proctoring from Medtronic; Dr. Laham has received research grants from Boston Scientific, Medtronic, Edwards Lifesciences, and Abbott Vascular; Dr. Dauerman is a consultant to Medtronic and Boston Scientific; Data Safety and Monitoring Board member for health care research institute, Recor Medical and Cardiovascular Research Foundation (multiple trials), research grants from Medtronic and Boston Scientific; Dr. Waksman is a member of the advisory board for Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc, Medtronic (Abbot), Philips Volcano, Pi-Cardia Ltd; as a Consultant for Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc, Medtronic, Philips Volcano, Pi-Cardia Ltd; receives grant support from Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Chiesi; serves on the Speakers Bureau for AstraZeneca and Chiesi; and is an investor in Med Alliance; Dr. Allaqaband is a proctor and consultant for Medtronic; Dr. Caskey reports proctor fees from Medtronic; Dr. Byrne reports proctor fees and honoraria from Medtronic and proctor fees and honoraria from Abbott; Dr. Li is an employee and shareholder of Medtronic; Dr. Kleiman is a consultant for Medtronic and Boston Scientific and receives grant support from Medtronic; Dr. Reardon is a consultant for Medtronic, W.L. Gore and Associates and Boston Scientific; Dr. Chetcuti has received grant support and fees for proctoring from Medtronic and is a consultant for Jena valve; Dr. Deeb serves as on an advisory board and as a proctor for Medtronic; as a consultant and research investigator for Edwards Lifesciences; as a consultant and proctor for Terumo; and as a research investigator for Gore Medical with all fees paid to his institution. The remaining authors have no competing interests to declare.
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