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TRANSAPICAL AORTIC VALVE IMPLANTATION AT 5 YEARS
Martin Haensig, MD1, Ardawan J. Rastan, MD, PhD1, David Holzhey, MD1, Thomas Walther, MD, PhD2, Jens Garbade, MD, PhD1, Michael A. Borger, MD, PhD1, Axel Linke, MD, PhD1, Jörg Ender, MD1, Gerhard Schuler, PhD, MD1, Jörg Kempfert, MD2, Friedrich W. Mohr, MD, PhD1.
1Heart Center Leipzig, Leipzig, Germany, 2Kerkhoff-Clinic, Bad Nauheim, Germany.
OBJECTIVE:
The aim was to study the results of transapical aortic valve implantation in high-risk patients with aortic stenosis at up to 5 years after the procedure based on the newly established Valve Academic Research Consortium criterions.
METHODS:
A total of 439 patients underwent transapical aortic valve implantation from February 2006 until August 2011 using the Edwards SAPIENTM prosthesis. Mean patient age was 81 ± 6 years and 64% were female. Logistic EuroSCORE and Society of Thoracic Surgeons score predicted risks for mortality were 30% ± 16% and 11% ± 8%, respectively. All patients were treated in a hybrid suite with advanced imaging modalities by a specialized TAVI team.
RESULTS:
Intraprocedural device success was 90.2% and the combined safety endpoint at 30 days occurred in 20.3%. Major vascular complications (3.4%), life-threatening or disabling bleeding (6.2%), and acute kidney injury using a modified RIFLE classification (stage 1: 8.3%, stage 2: 3.3% and stage 3: 16.3%) were further major adverse events. Periprocedural stroke/TIA was observed in 2.1% and further 2.1% of patients had a spontaneous stroke during their hospital stay (minor: 1.6% and major: 2.5%). Transapical aortic valve implantation was uneventful in 384 patients, whereas 55 patients (12.5%) required additional interventions. Such interventions included cardiopulmonary bypass support in 6.2%, implantation of a second SAPIEN valve in 5.5%, coronary intervention in 3.0%, conversion to conventional surgery in 2.5%, and annulus perforation in 0.7% patients (not mutually exclusive). Overall survival was 90% at 30 days, 73% at 1 year, 68% at 2 years, 58% at 3 years, 53% at 4 years and 44% at 5 years.
CONCLUSIONS:
Transapical aortic valve implantation can be performed with good outcomes in high-risk patients with severe aortic stenosis. Perioperative complications occur in approximately 12.5% of patients. Standardized VARC definitions appear to facilitate outcome reporting beyond regulatory and clinical trials.
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