TY - JOUR
T1 - Five-Year Follow-Up from the CoreValve Expanded Use Transcatheter Aortic Valve-in-Surgical Aortic Valve Study
AU - Bajwa, Tanvir K.
AU - Laham, Roger J.
AU - Khabbaz, Kamal
AU - Dauerman, Harold L.
AU - Waksman, Ron
AU - Weiss, Eric
AU - Allaqaband, Suhail
AU - Badr, Salem
AU - Caskey, Michael
AU - Byrne, Timothy
AU - Applegate, Robert J.
AU - Kon, Neal D.
AU - Li, Shuzhen
AU - Kleiman, Neal
AU - Reardon, Michael J.
AU - Chetcuti, Stanley J.
AU - Deeb, G. Michael
N1 - Funding Information:
Michelle Bierig, PhD, CMPP, an employee and shareholder of Medtronic, plc, drafted the methods, created tables and figures, revised the manuscript for journal style, and provided copyediting assistance, all under the direction of the lead author. Jane Moore, MS, ELS, MSRM LLC, funded by Medtronic, provided editing assistance under the direction of Dr. Bajwa and Dr. Deeb.
Publisher Copyright:
© 2023 Elsevier Inc.
PY - 2024/3/1
Y1 - 2024/3/1
N2 - 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.
AB - 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.
KW - outcomes
KW - surgical aortic valve failure
KW - transcatheter aortic valve replacement
KW - Constriction, Pathologic/etiology
KW - Follow-Up Studies
KW - Humans
KW - Heart Valve Prosthesis
KW - Risk Factors
KW - Aortic Valve Stenosis/diagnosis
KW - Male
KW - Treatment Outcome
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Bioprosthesis
KW - Surgical Instruments
KW - Prosthesis Design
KW - Aged, 80 and over
KW - Female
KW - Aged
KW - Aortic Valve/diagnostic imaging
UR - http://www.scopus.com/inward/record.url?scp=85182632039&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85182632039&partnerID=8YFLogxK
U2 - 10.1016/j.amjcard.2023.11.071
DO - 10.1016/j.amjcard.2023.11.071
M3 - Article
C2 - 38110018
AN - SCOPUS:85182632039
SN - 0002-9149
VL - 214
SP - 1
EP - 7
JO - American Journal of Cardiology
JF - American Journal of Cardiology
ER -