Thomas G. Gleason, MD, David H. Adams, MD, et al.
The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients.
The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability.
Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned.
A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years.
This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
Serratus Anterior Plane Block for Transapical Off-Pump Mitral Valve Repair With NeoChord Implantation.Himani V. Bhatt, DO, Morgan L. Montgomery, MD, Alexander J.C. Mittnacht, MD, Ali Shariat, MD, Ahmed El-Eshmawi, MD, David H. Adams, MD, Menachem M. Weiner, MD
Mitral valve repair for severe mitral valve regurgitation during left ventricular assist device implantation.Amit Pawale, MD, Shinobu Itagaki, MD, Aditya Parikh, MD, Sean P. Pinney, MD, David H.Adams, MD, Anelechi C. Anyanwu, MD
Reply: Off-Pump Surgeons' Experience Is Paramount to Delivering High-Quality CABG Outcomes: But What Constitutes Experience?Joanna Chikwe, MD, Timothy Lee, MD, Shinobu Itagaki, MD, David H. Adams, MD, Natalia N. Egorova, PhD
Correlation of 2-Dimensional and 3-Dimensional Echocardiographic Analysis to Surgical Measurements of the Tricuspid Valve Annular Diameter.Himani V. Bhatt, DO, MPA, FASE, FASA, John Spivack, PhD, Pritul R. Patel, MD, Ahmed El-Eshmawi, MD, Yasmin Amir, BS, David H. Adams, MD, Gregory W. Fischer, MD, FASA