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Technique and Patient Selection Criteria of Right Anterior Mini-Thoracotomy for Minimal Access Aortic Valve Replacement
Published on: March 26, 2018
Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients
Michael J Reardon1, Nicolas M Van Mieghem1, Jeffrey J Popma1
1From Methodist DeBakey Heart and Vascular Center, Houston (M.J.R., N.S.K.); Erasmus University Medical Center, Rotterdam, the Netherlands (N.M.V.M., P.W.J.C.S., A.P.K.); Beth Israel Deaconess Medical Center, Boston (J.J.P.); the Heart Center, Rigshospitalet, Copenhagen (L.S., P.S.O.); PinnacleHealth Hospitals, Harrisburg (M.M., H.G.), and University of Pittsburgh Medical Center, Pittsburgh (T.G., J.S.L.) - both in Pennsylvania; Mount Sinai Health System (D.H.A.) and New York University Langone Medical Center (M.W.) - both in New York; University of Michigan, Ann Arbor (G.M.D., S.C.), and Spectrum Health Hospitals, Grand Rapids (J.H., W.M.) - both in Michigan; Tenet Healthcare, Delray Beach, FL (B.M.); German Heart Center Munich, Munich (R.L.), and Siegburg Heart Center, Siegburg (E.G.) - both in Germany; Mayo Clinic, Rochester (J.K.O.), Medtronic, Minneapolis (E.V., H.N., Y.C.), and Paradigm Biostatistics, Anoka (A.S.M.) - all in Minnesota; McGill University Medical Centre, Montreal (N.P.); University Hospital Bern, Bern, Switzerland (S.W.); Riverside Methodist Hospital, Columbus, OH (S.J.Y.); Cedars-Sinai Medical Center, Los Angeles (R.M.); and Johns Hopkins University, Baltimore (J.C.).
Background:
Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk.
Methods:
We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement.
Results:
A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group.
Conclusions:
TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).
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