First Experience With the New Generation Edwards Sapien 3 Aortic Bioprosthesis: Procedural Results and Short Term Outcome

Murray, Marie‐Isabel; Geis, Nicolas; Pleger, Sven T.; Kallenbach, Klaus; Katus, Hugo A.; Bekeredjian, Raffi; Chorianopoulos, Emmanuel

doi:10.1111/joic.12182

Cited by 49 publications

(24 citation statements)

References 18 publications

(33 reference statements)

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“…The S3 may be delivered via a lower profile delivery system and incorporates a sealing cuff intended to reduce PAR. Despite positive results during the first-in-human S3 experience 14 and subsequent small 15,16 series, it is not established whether the new features of the S3 will translate into improved procedural and clinical outcomes compared with the XT. We therefore analyzed and compared all patients who underwent transfemoral TAVI with the S3 or the XT in the prospective, nationwide Swiss TAVI registry in Switzerland (ClinicalTrials.gov NCT01368250).…”

mentioning

confidence: 99%

Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland

Binder¹,

Stortecky²,

Heg³

et al. 2015

Circ: Cardiovascular Interventions

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mentioning

confidence: 99%

Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland

Binder¹,

Stortecky²,

Heg³

et al. 2015

Circ: Cardiovascular Interventions

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“…17 Finally, novel second-generation TAVI devices have been specially designed to reduce PVL after TAVI; the Edwards SAPIEN 3 valve device possess an outer skirt to improve valve sealing and apposition. 18 The Corevalve Evolut R and the Lotus Valve System have repositionable features, which contribute to optimize valve positioning and, therefore, to reduce paravalvular AR. 19,20 Acute kidney injury is a known predictor of poor prognosis after TAVI, and the results of our analysis are in accordance with previous reported experiences.…”

Section: Discussionmentioning

confidence: 99%

Long-Term Outcomes for Patients With Severe Symptomatic Aortic Stenosis Treated With Transcatheter Aortic Valve Implantation

Codner

Orvin

Assali

et al. 2015

The American Journal of Cardiology

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Transcatheter aortic valve implantation (TAVI) is an established technique for the treatment of severe symptomatic aortic stenosis. Data on long-term TAVI outcomes, both hemodynamic and clinical, in real-world practice settings are limited. We aim to explore the long-term clinical results in patients with severe symptomatic aortic stenosis using multiple catheter-based options: 360 TAVI-treated patients were followed up for ≤5 years. The Medtronic CoreValve was used in 71% and the Edwards SAPIEN in 26%. The primary end point was all-cause mortality during follow-up. Outcomes were assessed based on the Valve Academic Research Consortium 2 criteria. The mean ± SD patient age was 82.1 ± 6.9 years (56.4% women). The Society of Thoracic Surgeons score was 7.5 ± 4.7. The clinical efficacy end point and time-related valve safety at 3 years was 50% and 81.7%, respectively. The calculated 3- and 5-year survival rates were 71.6% and 56.4%, respectively. Five-year follow-up data were obtained for 54 patients alive; 96.2% of alive patients were in the New York Heart Association class I and II, 4 years after TAVI. No gender differences in all-cause mortality rates were observed (p = 0.58). In multivariate analysis, hospitalization 6 months previous to TAVI (hazard ratio [HR] 1.92, 95% confidence interval [CI] 1.17 to 3.15, p = 0.01), frailty (HR 1.89, 95% CI 1.11 to 3.2, p = 0.02), acute kidney injury (HR 1.93, 95% CI 1.03 to 3.61, p = 0.04), and moderate or more paravalvular aortic regurgitation after TAVI (HR 4.26, 95% CI 2.54 to 7.15, p <0.001) were independent predictors for all-cause mortality. In conclusion, long-term outcomes of TAVI are encouraging. Prevention and early identification of paravalvular leak and acute renal failure after the procedure would improve short- and long-term outcomes.

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“…This algorithm defaults In the case of the latest SAPIEN valve (SAPIEN 3; Edwards), a retrospective study (n=125) showed an impressive reduction in significant paravalvular regurgitation, but observed a PPM rate of 25.5 %, a similar rate to CoreValve. 32 However, a study comparing the outcomes of TAVR with the Lotus valve versus the SAPIEN 3 valve showed a significantly higher need for pacemaker implantation in the former (27 % vs 4 %; p<0.003). 33 The JenaValve device and Acurate valve also demonstrated relatively low pacemaker implantation rates (9.1 % and 10.0 %), though in a small prospective trial and in a short-term registry study.…”

Section: Pacing Modesmentioning

confidence: 99%

Mechanisms of Heart Block after Transcatheter Aortic Valve Replacement – Cardiac Anatomy, Clinical Predictors and Mechanical Factors that Contribute to Permanent Pacemaker Implantation

Lee¹,

Yeshwant²,

Chava³

et al. 2015

Arrhythmia &Amp; Electrophysiology Review

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Aortic stenosis (AS) is the most common valvular heart disease in industrialised countries with a prevalence of about 5 % in the general population aged greater than 75 years. During the past decade, transcatheter aortic valve replacement (TAVR) has emerged as a valuable, minimally invasive treatment option for patients presenting with symptomatic severe AS, who due to their advanced age and relevant comorbidities are at prohibitive risk for conventional surgery, 1 whereas surgical aortic valve replacement (SAVR) remains the gold standard for the treatment of symptomatic AS in patients with low to moderate surgical risk.2 However, many patients begin to experience AS-related symptoms late in their lives when multiple comorbidities preclude surgery as an option. As a result, before the advent of TAVR, patients considered high-or extreme-risk surgical candidates were once limited to conventional medical therapy. Ever since the first device was deployed in 2002, TAVR has enabled inoperable patients the opportunity to experience survival rates equivalent to their surgical counterparts with considerably less procedural risk.1 Therefore, the number of patients undergoing TAVR has increased steadily, and the complications related to valve implantation have been well defined.The development of atrioventricular (AV) conduction disturbances is one of the most commonly encountered complications associated with TAVR. Between 3 and 6 % of patients undergoing surgical replacement of their aortic valve will develop complete heart block (CHB), 3 while considerably higher rates have been reported in the setting of TAVR in individual studies. 4 In this review, we aim to explore the significance of conduction disturbances preceding and resulting from TAVR. We have focused on data that raise concerns around creating chronic left ventricular (LV) dyssynchrony in this patient population, either as a consequence of creating left bundle branch block (LBBB), or from chronic right ventricular (RV) pacing. Additionally, we reviewed a number of factors that predispose TAVR patients to develop conduction disturbances, and clinical factors that can be used to identify those patients likely to require permanent pacing and alternatively those in whom it may be worth waiting longer prior to committing to permanent pacemaker (PPM) implantation. Shy of unique valve designs, it has become clear there are only modest improvements an operator can make to avoid the complication of heart block and this complication is simply part of the procedure. It is critical to anticipate it and think prospectively about the ideal pacing mode for the individual patient to prevent chronic LV dyssynchrony in those patients at highest risk. Mechanisms of Heart Block Anatomical Relationship of the Cardiac Conduction System and the Aortic RootSince the 16th century when Leonardo da Vinci conducted the first known cadaveric studies of the heart, the aortic root complex has been studied extensively. With the advent of percutaneous valves, there has been renewed interest ...

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First Experience With the New Generation Edwards Sapien 3 Aortic Bioprosthesis: Procedural Results and Short Term Outcome

Cited by 49 publications

References 18 publications

Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland

Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland

Long-Term Outcomes for Patients With Severe Symptomatic Aortic Stenosis Treated With Transcatheter Aortic Valve Implantation

Mechanisms of Heart Block after Transcatheter Aortic Valve Replacement – Cardiac Anatomy, Clinical Predictors and Mechanical Factors that Contribute to Permanent Pacemaker Implantation

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