Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: the REPRISE I study

Meredith, Ian T.; Worthley, Stephen G.; Whitbourn, Robert; Antonis, P.; Montarello, Joseph; Newcomb, Andrew; Lockwood, S.; Haratani, Nicole; Allocco, Dominic J.; Dawkins, Keith D.

doi:10.4244/eijv9i11a216

Cited by 118 publications

(87 citation statements)

References 45 publications

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“…8 LOTUS implantation is frequently associated with atrioventricular block requiring PPM. 7,8 This is possibly because of greater expansion into the left ventricular outflow tract with compression of the septal conduction pathways, extensive metal burden, and the fact that this valve is longer than the SAPIEN XT valve, leading to deeper settlement.…”

Section: One-year Cumulative Clinical Outcomesmentioning

confidence: 99%

“…In addition, the presence of an adaptive seal around the outer aspect of the lower valve frame appears to reduce PVL by occupying residual interstices between the frame and native annulus. 7,8 Gooley et al reported that in comparison of LOTUS versus CoreValve groups, there was significant difference in terms of post-procedural PVL. 17 Furthermore, Wöhrle et al reported that in a comparison of LOTUS and SAPIEN 3 groups, there was no post-procedural moderate or severe PVL.…”

Section: One-year Cumulative Clinical Outcomesmentioning

confidence: 99%

“…15 In the REPRISE I study, which included 11 patients treated with the 23-mm LOTUS device, the need for PPM implantation arose in 36% of cases (N=4/11). 7 Meanwhile, in the REPRISE II study, which included 120 patients treated with the 23-or 27-mm valve, the need for PPM was evident in 29% of cases. 8 LOTUS implantation is frequently associated with atrioventricular block requiring PPM.…”

Section: One-year Cumulative Clinical Outcomesmentioning

confidence: 99%

“…[6][7][8] However, the clinical data regarding second-generation TAVI valves are very limited. There has been an adoption of new devices such as the LOTUS at some centers, to date, there have been no systematic head-to-head comparisons for LOTUS and SAPIEN XT.…”

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confidence: 99%

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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 Outcomesmentioning

confidence: 99%

Section: One-year Cumulative Clinical Outcomesmentioning

confidence: 99%

Section: One-year Cumulative Clinical Outcomesmentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

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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“…The REPRISE I Trial (Repositionable Percutaneous Replacement of Stenotic Aortic valve Through Implantation of Lotus-Valve System) was a proof-of-concept study with the Lotus valve for TAVR with a procedural success rate of 100% (n = 11) [9]. The REPRISE II study showed that the valve was successfully implanted in all patients, with no cases of valve embolization, ectopic valve deployment, or additional valve implantation.…”

Section: Introductionmentioning

confidence: 99%

Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol

et al. 2017

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Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR

et al. 2022

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ImportanceLong-term follow-up after transcatheter aortic valve replacement (TAVR) is of interest given that longitudinal data on mortality and durability of transcatheter heart valves are limited. The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System—Randomized Clinical Evaluation) randomized clinical trial compared the mechanically expanded Lotus valve with the self-expanding CoreValve/EvolutR TAVR platforms.ObjectiveTo describe the final 5-year outcomes of the REPRISE III trial.Design, Setting, and ParticipantsThis prespecified secondary analysis assessed the final 5-year clinical, functional, and echocardiographic outcomes of 912 patients from the REPRISE III trial, which was conducted at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015. Patients had high risk for aortic stenosis or severe or symptomatic aortic stenosis. Data were analyzed from September 22, 2014, to May 21, 2021.InterventionLotus valve or CoreValve/EvolutR TAVR platforms.Main Outcomes and MeasuresValve Academic Research Consortium-2 end points, hemodynamic measures, functional status, and health status were examined through the 5-year follow-up.ResultsA total of 912 patients (mean [SD] age, 82.8 [7.3] years; 463 women [50.8%]) were randomized to either the Lotus valve group (n = 607) or CoreValve/EvolutR group (n = 305), with a baseline Society of Thoracic Surgeons risk score of 6.8%. Clinical follow-up data from the REPRISE III trial were available for 581 patients (95.7%) in the Lotus valve group and 285 patients (93.4%) in the CoreValve/EvolutR group. At 5 years, the cumulative event rate for all-cause mortality was 50.9% in the Lotus valve group vs 52.8% in the CoreValve/EvolutR group (P = .59). Disabling stroke was less frequent with the Lotus valve vs CoreValve/EvolutR (cumulative event rates, 8.3% vs 12.2%; P = .04), whereas the cumulative event rates for overall stroke were similar in both groups (14.1% vs 15.3%; P = .38). Insertion of a new permanent pacemaker (38.9% vs 27.3%; P &lt; .001) and detection of prosthetic aortic valve thrombosis (5.8% vs 1.8%; P = .007) were more common in the Lotus valve group than in the CoreValve/EvolutR group. A smaller proportion of patients who received the Lotus valve experienced valve malpositioning (0% vs 2.6%; P &lt; .001) and required the use of a second valve (1.0% vs 3.8%; P &lt; .001) during the procedure compared with those who received the CoreValve/EvolutR. Compared with the Lotus valve group, the CoreValve/EvolutR group had a significantly lower mean (SD) aortic gradient (7.8 [4.2] mm Hg vs 12.6 [6.7] mm Hg; P &lt; .001) and larger valve areas (1.57 [0.56] cm2 vs 1.42 [0.42] cm2; P = .10). After 5 years, the proportion of patients with moderate or greater paravalvular leak was not significantly higher with the CoreValve/EvolutR than with the Lotus valve (1.9% vs 0%; P = .31); however, the proportion of patients with mild paravalvular leak was higher in the CoreValve/EvolutR group compared with the Lotus valve group (23.1% vs 7.8%; P = .006). Long-term, similar improvements in New York Heart Association class and Kansas City Cardiomyopathy Questionnaire score were observed in both groups.Conclusions and RelevanceThe REPRISE III trial found that, at 5 years, the clinical outcomes of the Lotus valve were comparable to those of the CoreValve/EvolutR and that the Lotus valve was safe and effective.Trial RegistrationClinicalTrials.gov Identifier: NCT02202434

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Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: the REPRISE I study

Abstract: Initial results support proof-of-concept with the Lotus Valve for TAVR.

Cited by 118 publications

References 45 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

Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol

Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR

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