Prospective analysis of 30-day safety and performance of transfemoral transcatheter aortic valve implantation with Edwards SAPIEN XT versus SAPIEN prostheses

Department of Cardiology, Hospital Charles-Nicolle, University Hospital of Rouen, Rouen cedex, France.
Archives of cardiovascular diseases (Impact Factor: 1.84). 03/2012; 105(3):132-40. DOI: 10.1016/j.acvd.2012.02.002
Source: PubMed


A new generation of balloon-expandable valves (e.g. Edwards SAPIEN XT) enables the use of a decreased sheath size using the NovaFlex™ delivery system for transfemoral transcatheter aortic valve implantation (TAVI). However, there are few data analysing the efficacy and safety of this new prosthesis.
To evaluate periprocedural and 30-day clinical outcomes using the Edwards SAPIEN XT compared with the first-generation Edwards SAPIEN prosthesis.
Between May 2006 and October 2011, consecutive high-risk or non-operable patients with severe aortic stenosis had TAVI using an Edwards SAPIEN or SAPIEN XT prosthesis. Valve Academic Research Consortium endpoints were used.
Of 250 patients who underwent TAVI, 190 were performed transfemorally (78 SAPIEN and 112 SAPIEN XT). Transfemoral access was possible more often using SAPIEN XT (112/123 [91.1%] vs 78/127 [61.4%]; P<0.001). Mean logistic EuroSCORE was significantly lower in the SAPIEN XT group (18.1±11.0% vs 27.3±11.1%; P<0.0001), and the iliofemoral artery minimal lumen diameter was smaller (6.7±1.2 vs 8.5±1.3mm; P<0.0001). Device success was similar in both groups (95.5% for SAPIEN XT and 93.6% for SAPIEN), as was the 30-day combined safety endpoint (15.2% and 17.9%, respectively). At 30days, prosthesis performance was similar in both groups.
Short-term safety and performance analysis of the latest generation of balloon-expandable valve, the SAPIEN XT, seem similar to the previous generation. However, transfemoral implantation is more often possible, related to sheath size reduction.

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    • "The majority of researchers assumed that, a high percentage of VCs are directly associated with technical aspects and complexity of the procedure [5–9]. On the other hand, a few reports suggest that despite down-sizing the sheath diameters and device sizes, with increasing operators’ experience, the prevalence of VCs still remains at a relatively high level [5, 6]. Although TAVI population is a special group of elderly with many comorbidities, which may be crucial for constantly high proportion of VCs, the impact of patients’ characteristics on early VCs has not been sufficiently assessed so far. "
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    ABSTRACT: Unlabelled: Vascular complications are the main safety limitations of transcatheter aortic valve implantation (TAVI). The aim of the study was to assess the incidents, predictors, and the impact of early vascular complications on prognosis after TAVI. This was a single-center analysis of vascular complications related to TAVI. Early vascular complications were defined as incidents within 30 days after TAVI and comprised complications related to transvascular: transfemoral/transsubclavian ,and transapical bioprosthesis implantation. Evaluated risk factors were: (1) clinical characteristics, (2) TAVI route, and (3) center experience. In patients with transvascular TAVI the impact of: (1) diameters of access arteries, vascular sheathes and difference between them, (2) arterial wall calcification, and (3) ProStar devices used for access site closure were assessed. Arterial wall calcification and arteries diameters were measured by 64-slice computer tomography. Arterial wall calcification was graded according to 5° scale. Results: between 2009-2011; follow-up 1-23 months (12 ± 15.55), 83 consecutive patients, and 62-91 (81.10 ± 7.20) years, underwent TAVI: 67 (80.72%) patients had transvascular, and 16 (19.27%) patients had transapical bioprosthesis implantation. We noted 44 (53.01%) early vascular complications: 17 (20.48%) were major and 27 (32.53%) were minor incidents. Independent predictors of early vascular complications were: history of anaemia (OR 3.497: 95% CI [1.276-9.581]; p = 0.014), diabetes (OR 0.323: 95% CI [0.108-0.962]; p = 0.042), percutaneous coronary intervention performed as preparation for TAVI (OR 4.809: 95 % CI [1.172-19.736]; p = 0.029), and arterial wall calcification (OR 1.945: 95% CI [1.063-3.558]; p = 0.03). Of 6 (7.22%) in-hospital and 10 (12.98%) late deaths: 5 (83.33%) patients and 8 (80%) patients respectively had post-procedural vascular complications. Vascular complications, which occurred in 30-days after TAVI, predict late mortality (p = 0.036). Conclusions derived were: (1) TAVI patients with history of anaemia and diabetes required careful monitoring for early vascular complications. (2) If coronary intervention before TAVI is required, it should be performed in the time allowing vascular injuries to heal. (3) Calcification of access arteries is an independent predictor of post-procedural vascular complications; therefore, its estimation should be a regular element of preceding computer tomography. (4) Vascular complications seem to be predictors of late mortality after TAVI.
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    • "After a median followup of 10.9 months, imaging studies showed no evidence of hemodynamically significant stenosis in repaired femoral vessels [57]. Bleeding after TAVI is mostly related to vascular complications [53, 58]. Blood transfusion following TAVI is associated with increased mortality at 1 year and increased risk of major stroke and acute kidney injury [59]. "
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    ABSTRACT: Transcatheter aortic valve implantation (TAVI) has emerged for treating aortic stenosis in patients who are poor candidates for surgical aortic valve replacement. Currently, the balloon-expandable Edwards Sapien valve-which is usually implanted via a transfemoral or transapical approach-and the self-expanding CoreValve ReValving system-which is designed for retrograde application-are the most widely implanted valves worldwide. Although a promising approach for high-risk patients, the indication may be expanded to intermediate- and eventually low-risk patients in the future; however, doing so will require a better understanding of potential complications, risk factors for these complications, and strategies to individualize each patient to a different access route and a specific valve. This paper reviews the most relevant complications that may occur in patients who undergo catheter-based aortic valve implantation.
    Full-text · Article · May 2013
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    • "Valve performance was also comparable at 30 days. In addition, transfemoral success was 91.1% using the SAPIEN XT vs. 61.4% using the SAPIEN.11 "
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    ABSTRACT: Transcatheter aortic valve replacement (TAVR) was approved in the United States in late 2011, providing a critically needed alternative therapy for patients with severe aortic stenosis previously refused surgical aortic valve replacement (SAVR). Over 20,000 TAVR have been performed in patients worldwide since 2002 when Alain Cribier performed the first-in-man TAVR. This paper reviews the data from balloon expandable and self-expanding aortic stent valves as well as data comparing them with traditional surgical aortic valve replacement (SAVR). Complications using criteria established by the Valve Academic Research Consortium (VARC) are reviewed. Future challenges and possibilities are discussed and will make optimizing TAVR an important goal in the years to come.
    Preview · Article · Aug 2012 · Clinical Medicine Insights: Cardiology
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