Background-To evaluate initial multicenter results with minimally invasive transapical aortic valve implantation (TAP-AVI) for high risk patients with aortic stenosis. Methods and Results-TAP-AVI was performed via a small anterolateral minithoracotomy with or without femorofemoral extracorporeal circulation (ECC) on the beating heart. A pericardial xenograft fixed within a stainless steel, balloon expandable stent (Edwards SAPIEN THV, Edwards Lifesciences) was used. Fifty-nine consecutive patients (81Ϯ6 years, 44 female) were operated on from 02/06 until 10/06 at 4 centers using fluoroscopic and echocardiographic visualization. Average EuroSCORE predicted risk for mortality was 27Ϯ14%. TAP valve positioning was performed successfully in 53 patients, 4 required early conversion to sternotomy. Implantation (23-mm valves in 19 and 26-mm valves in 40 patients) was performed on the beating heart during brief periods of rapid ventricular pacing. Thirty-one patients were operated on without cardiopulmonary bypass. Neither coronary artery obstruction nor migration of the prosthesis was observed, and all valves had good hemodynamic function. Echocardiography revealed minor paravalvular leakage in 26 patients (trace in 11, mild in 12, and severe in 3). Eight patients died in-hospital (13.6%) without any valve dysfunction. Actuarial survival was 75.7Ϯ5.9% at a follow-up interval of 110Ϯ77 days (range 1 to 255 days). Conclusions-TAP-AVI can be performed safely with good early results in high risk patients. Long-term valve performance as well as broader based applications of this promising approach will need to be studied.
BackgroundTranscatheter aortic valve implantation (TAVI) has emerged as a new therapeutic option in high-risk patients with severe aortic stenosis.AimsPARTNER EU is the first study to evaluate prospectively the procedural and mid-term outcomes of transfemoral (TF) or transapical (TA) implantation of the Edwards SAPIEN® valve involving a multi-disciplinary approach.Methods and resultsPrimary safety endpoints were 30 days and 6 months mortality. Primary efficacy endpoints were haemodynamic and functional improvement at 12 months. One hundred and thirty patients (61 TF, 69 TA), aged 82.1 ± 5.5 years were included. TA patients had higher logistic EuroSCORE (33.8 vs. 25.7%, P = 0.0005) and more peripheral disease (49.3 vs. 16.4%, P< 0.0001). Procedures were aborted in four TA (5.8%) and six TF cases (9.8%). Valve implantation was successful in the remaining patients in 95.4 and 96.4%, respectively. Thirty days and 6 months survival were 81.2 and 58.0% (TA) and 91.8 and 90.2% (TF). In both groups, mean aortic gradient decreased from 46.9 ± 18.1 to 10.9 ± 5.4 mmHg 6 months post-TAVI. In total, 78.1 and 84.8% of patients experienced significant improvement in New York Heart Association (NYHA) class, whereas 73.9 and 72.7% had improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores in TA and TF cohorts, respectively.ConclusionThis first team-based multi-centre European TAVI registry shows promising results in high-risk patients treated by TF or TA delivery. Survival rates differ significantly between TF and TA groups and probably reflect the higher risk profile of the TA cohort. Optimal patient screening, approach selection, and device refinement may improve outcomes.
Minimally invasive beating heart TAP-AVI is feasible. Initial results are encouraging in view of the high-risk profile of the patients. Long-term studies as well as randomized protocols are required.
The present data show the feasibility of closed chest single- and double-vessel revascularization, with good clinical results. However, procedural time is prolonged and the complex endoscopic and endoaortic occlusion techniques, as well as the extensive anesthesiologic monitoring, are demanding. The need for conversion to an open procedure diminished after a relatively short learning curve. All postulated benefits of totally endoscopic surgery other than excellent cosmesis must be evaluated in larger cohorts.
Both on- and off-pump totally endoscopic coronary artery bypass grafting are feasible, with a conversion rate that diminishes with increasing experience. Conversion does not adversely affect outcome and thus constitutes a safe alternative. Although target vessel reintervention may be slightly higher than that reported for open coronary artery bypass grafting, graft patency and major adverse cardiac events for both approaches are comparable to those reported in the Society of Thoracic Surgeons database, demonstrating the safety and efficacy of the totally endoscopic coronary artery bypass grafting procedure.
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