Transfemoral aortic valve implantation with the repositionable Lotus valve compared with the balloon-expandable Edwards Sapien 3 valve

Wöhrle, Jochen; Gonska, Birgid; Rodewald, Christoph; Trepte, Ulrike; Koch, Sabrina; Scharnbeck, Dominik; Seeger, Julia; Markovic, Sinisa; Rottbauer, Wolfgang

doi:10.1016/j.ijcard.2015.05.139

Cited by 47 publications

(27 citation statements)

References 21 publications

(34 reference statements)

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“…The need for a PPM was detected less in SAPIEN 3 than in LOTUS valves in the study of Wöhrle et al In our study, a first-generation SAPIEN XT and second-generation LOTUS valve were compared. It can be said that the SAPIEN 3 is more advantageous in terms of the need for post-procedure PPM according to our results and those of Wöhrle et al 16 Accumulating data have linked device failure and more-than-mild PVL after TAVI with significantly increased late mortality after TAVI. 1 This complication was more frequent with the first-generation valves, as the new-generation systems are less likely to be associated with moderate-tosevere PVL.…”

Section: One-year Cumulative Clinical Outcomessupporting

confidence: 81%

“…The rate of mild PVL was insignificant in both groups (23% vs 15%, p = 0.40, respectively). 16 Although the present study used the SAPIEN XT rather than the SAPIEN 3, our findings were very similar. Moreover, except for the need for a TAV-in-TAV procedure due to valve malposition resulting in severe PVL, no patient in our series had post-procedural severe PVL.…”

Section: One-year Cumulative Clinical Outcomessupporting

confidence: 66%

“…Authors reported no significant difference in terms of clinical and procedural outcomes except for the need for PPM. 16 PPM was more frequently required with the LOTUS compared with the SAPIEN 3 (26.9% vs. 3.8%, p<0.003, respectively). In another study conducted by Gooley et al, the LOTUS valve and CoreValve were compared.…”

Section: One-year Cumulative Clinical Outcomesmentioning

confidence: 96%

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Comparison of the Clinical Outcomes in High-Risk Patients with Severe Aortic Stenosis Undergoing Transfemoral Aortic Valve Implantation Using SAPIEN XT and LOTUS Valve

Aslan¹,

Gül²,

Çakmak³

et al. 2017

Turkiye Klinikleri J Cardiovasc Sci

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A AB BS ST TR RA AC CT T O Ob bj je ec ct ti iv ve e: : The aim of this study was to compare the procedural, 30-day, and one-year follow-up Valve Academic Research Consortium-2 (VARC-2) defined outcomes using either the LOTUS valve or the conventional the SAPIEN XT valve. M Ma at te er ri ia al l a an nd d M Me et th ho od ds s: : 50 patients (25 with LOTUS and 25 with SAPIEN XT) with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) were included in this study. We evaluated the procedural outcomes, early safety, and clinical efficacy endpoints of patients who were treated with the LOTUS or the SAPIEN XT valve delivered via the transfemoral route. R Re es su ul lt ts s: : Accordingly, the Valve Academic Research Consortium-2-defined safety endpoints within 30 days and combined efficacy endpoints at one-year follow-up were the same in both groups (p=0.569, p=0.529, respectively). The need for permanent pacemaker implantation in the LOTUS group was higher than in the SAPIEN XT group at 30 days (20% vs. 8%, p=0.221, respectively) and at one-year (24.0% vs. 16%, p=0.480, respectively). Echocardiography upon discharge demonstrated that trivial or mild paravalvular leakage in SAPIEN XT patients was significantly higher than in LOTUS patients (52% vs. 24%, p=0.041, respectively). Moderate or severe paravalvular leakage was observed in only one patient in a SAPIEN group. C Co on nc cl lu us si io on n: : 30 days and one-year follow-up results according to Valve Academic Research Consortium-2 were similar in both groups. The permanent pacemaker rate was higher in LOTUS group despite an insignificant difference between the groups. LOTUS was associated significantly lower rate of trivial or mild paravalvular leakage compared with the SAPIEN XT. TAVI with LOTUS valve was associated with no moderate or severe paravalvular leakage and a low rate of mild paravalvular leakage. K Ke ey yw wo or rd ds s: : Aortic valve stenosis; heart valve prosthesis implantation; pacemaker, artificial Ö ÖZ ZE ET T A Am ma aç ç: : Bu çalışmanın amacı LOTUS kapak ve SAPIEN XT kapak sistemlerinin 'Valve Academic Research Consortium-2' (VARC-2) kriterlerine göre prosedürel, 30. gün ve 1 yıllık klinik sonuçlarını karşılaştırmaktır. G Ge er re eç ç v ve e Y Yö ön nt te em ml le er r: : Transkateter aort kapak implantasyonu (TAVİ) uygulanan şiddetli semptomatik aort darlıklı 50 hasta (25 LOTUS ve 25 SAPIEN) bu çalışmaya dahil edildi. LOTUS veya SAPIEN XT kapak ile transfemoral TAVİ uygulanan hastalarda prosedürel, erken güvenlik ve klinik etkinlik sonlanım sonuçları değerlendirildi. B Bu ul lg gu ul la ar r: : "Valve Academic Research Consortium-2" kriterlerine göre, 30 günde güvenlik ve 1 yıllık klinik etkinlik sonlanım noktalarında iki grup arasında fark saptanmadı (p=0,569, p=0,529, sırasıyla). Kalıcı pil gereksinimi LOTUS kapakta, SAPIEN XT kapağa göre 30 gün (%20 vs. %8, p=0,221, sırasıyla) ve 1 yıllık (%24,0 vs. %16, p=0,480, sırasıyla) takiplerde daha fazla gözlendi. Ekokardiyografik incelemede eser ve...

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Section: One-year Cumulative Clinical Outcomessupporting

confidence: 81%

Section: One-year Cumulative Clinical Outcomessupporting

confidence: 66%

Section: One-year Cumulative Clinical Outcomesmentioning

confidence: 96%

See 1 more Smart Citation

Comparison of the Clinical Outcomes in High-Risk Patients with Severe Aortic Stenosis Undergoing Transfemoral Aortic Valve Implantation Using SAPIEN XT and LOTUS Valve

Aslan¹,

Gül²,

Çakmak³

et al. 2017

Turkiye Klinikleri J Cardiovasc Sci

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“…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. 34,35 While the reduced profile and improved features of novel valve designs strive to minimise post-procedural conductional abnormalities, further study with larger datasets will be needed to determine if this is in fact the case.…”

Section: Pacing Modesmentioning

confidence: 94%

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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“…82,83 Newer devices-some are repositionable and totally retrievable-are provided with effective paravalvular sealing mechanisms, and their use is associated with a very low rate of moderate-tosevere AR. [84][85][86][87] Although the deleterious effect of greater than mild AR after TAVI is well taken, the reported malignant effect of mild AR 88 is more challenging to explain. Although some authors consider this association with worse outcome justified by the sudden conversion of the left ventricle from pressure to volume overload, 89 some refer to misclassification of moderateto-severe into mild as the explanation of this association.…”

Section: Aortic Regurgitationmentioning

confidence: 99%

Transcatheter Aortic Valve Implantation in Lower-Risk Patients With Aortic Stenosis

Abdelghani

Serruys

2016

Circ: Cardiovascular Interventions

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Abstract-Transcatheter aortic valve implantation underwent progressive improvements until it became the default therapy for inoperable patients, and a recommended therapy in high-risk operable patients with symptomatic severe aortic stenosis. In the lower-risk patient strata, a currently costly therapy that still has important complications with questionable durability is competing with the established effective and still-improving surgical replacement. This report tries to weigh the clinical evidence, the recent technical improvements, the durability, and the cost-effectiveness claims supporting the adoption of transcatheter aortic valve implantation in intermediate-low risk patients. The importance of appropriate patients' risk stratification and a more comprehensive approach to estimate that risk are also emphasized in the present report. (Circ Cardiovasc Interv. 2016;9:e002944.

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Transfemoral aortic valve implantation with the repositionable Lotus valve compared with the balloon-expandable Edwards Sapien 3 valve

Cited by 47 publications

References 21 publications

Comparison of the Clinical Outcomes in High-Risk Patients with Severe Aortic Stenosis Undergoing Transfemoral Aortic Valve Implantation Using SAPIEN XT and LOTUS Valve

Comparison of the Clinical Outcomes in High-Risk Patients with Severe Aortic Stenosis Undergoing Transfemoral Aortic Valve Implantation Using SAPIEN XT and LOTUS Valve

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

Transcatheter Aortic Valve Implantation in Lower-Risk Patients With Aortic Stenosis

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