Thirty-Day Results of the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry

Abstract

Background-Transcatheter aortic valve implantation was developed to mitigate the mortality and morbidity associated with high-risk traditional aortic valve replacement. PϽ0.001). Therefore, these groups are considered different, and outcomes cannot be compared. Overall short-term procedural success was observed in 93.8%. The incidence of valve embolization was 0.3% (nϭ3), and coronary obstruction was reported for 0.6% (nϭ6 cases). Incidence of stroke was 2.5% and similar for both procedural approaches. Thirty-day mortality was 6.3% in transfemoral patients and 10.3% in transapical patients. The occurrence of vascular complications was not a predictor of Ͻ30-day mortality in the transfemoral population. Conclusion-Technical proficiency can be learned and adapted readily as demonstrated by the short-term procedural success rate and low 30-day mortality rates reported in the SOURCE Registry. Specific complication management and refinement of patient selection are needed to further improve outcomes. (Circulation. 2010;122:62-69.)

Two-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement

“…[2][3][4][5] Transcatheter aorticvalve replacement (TAVR) has emerged as an alternative therapy in high-risk patients with aortic stenosis. [6][7][8][9][10] Observational registries from various countries have reported 1-month and 1-year outcomes after TAVR, [11][12][13][14] but there are limited long-term follow-up data. 15 The Placement of Aortic Transcatheter Valves (PARTNER) trial was a randomized trial comparing TAVR with standard-of-care therapies in highrisk patients with aortic stenosis.…”

“…Early (30-day) mortality after TAVR has decreased to approximately 5% in several recent studies, probably because of a combination of improvements in patient selection, procedural techniques, and device technologies. 12,14,[16][17][18] However, 1-and 2-year mortality rates have remained above 20% and 30%, respectively, 11,15,19,20 raising a concern that TAVR may be associated with important late complications. The results from the PARTNER trial reveal similarly high mortality at 2 years with TAVR and with surgical replacement, indicating that coexisting conditions play a role in late mortality.…”

Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

“…Although early TAVI reports varied considerably in terms of frequency and type of complications owing to the lack of standardized endpoint definitions,9, 10, 11 this was successfully addressed by the Valve Academic Research Consortium (VARC) in 2011 12. The first VARC consensus document aimed to harmonize endpoint definitions in TAVI trials and registries and provide guidance for uniform and standardized reporting of clinical outcomes.…”

Almanac 2013: novel non-coronary cardiac interventions

“…Rezultati iz registra SOURCE donose rezultate primjene Edwards Sapien valvule kod uzastopnih bolesnika iz Europe, s uËestalosti uspjeha ovog zahvata od 93,8% i niskom pojavnoπÊu komplikacija povezanih s zahvatom. 40 Pojavnost MU je bila sliËna (2,5%) kod transfemoralnog i transapikalnog pristupa. Smrtnost nakon 30 dana je bila niaea (6,3% u odnosu na 10,3%) i jednogodiπnje preaeivljavanje je bilo viπe (81,1% naspram 72,1%) u bolesnika s transfemoralnim pristupom.…”