The SOURCE Registry: what is the learning curve in trans-apical aortic valve implantation?

Abstract

Although the incidence of technical intra procedural complications has trended downward, reflecting the learning curve for TA-AVI, 30-day mortality was unchanged, likely due to patient co-morbidities not captured by preoperative risk variables.

Transapikaler Aortenklappenersatz – Indikationen, Risiken und Grenzen

“…Ein Unterschied zwischen den beiden Zugangswegen scheint hinsichtlich der 30TageMortalität nicht zu bestehen, wie Bleiziffer [17] an 203 Hochrisikopatienten mit einer Mortalitätsrate von 10,8 % (transfemoral) und 8,3 % (transapikal) zeigen konnte. Die intraoperative Komplikationsrate konnte mit zunehmender Erfahrung der implantierenden Zentren reduziert werden, so dass die Frühmortalität gegenwärtig maßgeblich von der Komorbidität der Patienten bestimmt wird, wie Wendler [18] in einer kürzlich veröffentlichten Studie berichtet. Die 1Jah-resÜberlebenswahrscheinlichkeit nach transapikaler TAVI wird in der Literatur mit 70-85 % [18,19] angegeben.…”

Transcatheter Aortic Valve Replacement Indications Should be Expanded to Lower-Risk and Younger Patients

“…18 Because of the improved knowledge of patient screening, assessment of the access vessels and annulus, prosthesis selection, procedural planning, and safety networks (eg, crossover wires) to avoid the deleterious outcome after vascular insults, complications are prevented or treated at an early stage of occurrence, which has made TAVR much safer in 2014 compared with 2006. 37,48,51 all-cause mortality was 0% and 3.5%, the rate of cerebrovascular events was 0% versus 4.5%, and the rate of major strokes was 0% versus 3.5% in the low-and intermediate-risk group, respectively. There were no differences between the 2 groups with regard to major or life-threatening bleeding, the occurrence of acute renal failure, and major or minor access site complications.…”

“…Hence, data from Edwards transcatheter valve registries, [34][35][36][37][38] Medtronic Core valve registries, [39][40][41][42][43] and mixed multicenter and national registries [44][45][46][47][48][49][50][51] containing a broad range of patients treated transfemorally, transapically, or with a direct aortic, subclavian, and carotid approach are the only resources potentially supporting an expansion of indications. The predominant valves evaluated in these registries were the balloon-expandable Edwards SAPIEn, the Edwards SAPIEn XT, and the self-expandable Medtronic CoreValve prosthesis.…”

“…Stroke rates at 30 days varied between 1 and 10%, whereas a new pacemaker was implanted in up to 40% of the patients. [34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52] In general, patients treated through the transfemoral approach had fewer comorbidities and hence better short-and long-term survival. Interestingly, 30-day mortality rates after TAVR dropped by >50% from 9.5% in 2009 to 4.2% in 2013, with stroke rates also halved (Table).…”

Another New Era for Cardiac Surgeons? Induction of TAVI Procedure to Japan

“…2,3) The most recent clinical studies showed that the rate of death from any cause at 1 year among patients treated with TAVI was 25%-30%. Wendler et al 4) described the early results from the multicenter SOURCE registry of European countries for Sapien valve implantation. He reported a 92.7% success rate with 2.1% reoperation, 7.3% pacemaker implantation, 7.1% dialysis, and 2.6% major vascular complications.…”