One-Year Outcomes of Cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry

Thomas, Martyn; Schymik, Gerhard; Walther, Thomas; Himbert, Dominique; Lefèvre, Thierry; Treede, Hendrik; Eggebrecht, Holger; Rubino, Paolo; Colombo, Antonio; Lange, Rüdiger; Schwarz, Rebecca R.; Wendler, Olaf

doi:10.1161/circulationaha.110.001545

Cited by 478 publications

(99 citation statements)

References 26 publications

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“…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. The Lotus is totally repositionable, even when fully expanded in the final position by virtue of its deployment and coupling mechanism.…”

Section: One-year Cumulative Clinical Outcomesmentioning

confidence: 97%

“…[1][2][3][4] Although TAVI appeared to be associated with favorable clinical results and a lower risk of periprocedural complications, there is an increased risk of moderate-to-severe paravalvular aortic leakage (PVL) with first generation devices. In addition, atrioventricular conduction disturbances, and access-related complications could be identified as important factors regarding the postprocedural outcomes.…”

mentioning

confidence: 99%

“…In addition, atrioventricular conduction disturbances, and access-related complications could be identified as important factors regarding the postprocedural outcomes. 1,5 Driven by these concerns, rapid innovation of novel TAVI devices and implantation techniques would help to prevent device-specific intra-and post-procedural complications.…”

mentioning

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: 97%

mentioning

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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“…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. 40,41 No, uËestalost vaskularnih komplikacija s transfemoralnim TAVR je bila znatno viπa (22,9% u odnosu na 4,7%), vjerojatno zbog velikog promjera femoralne uvodnice. VeÊina timova koji primjenjuje TAVR preferira transfemoralni pristup jer se time izbjegava kirurπki zahvat na prsiπtu i smanjuje se postoperativna bol.…”

Section: Aortic Valve Interventionsunclassified

“…The 30-day mortality was lower (6.3% vs 10.3%) and 1-year survival was higher (81.1% vs 72.1%) in patients with the transfemoral approach. 40,41 However, there was a much higher rate of vascular complications with transfemoral TAVR (22.9% vs 4.7%), probably because of the larger diameter of the delivery sheath.…”

Section: Aortic Valve Interventionsmentioning

confidence: 99%

Almanac 2013: novel non-coronary cardiac interventions

Meier

Franzen²,

Lansky³

2013

Cardiol Croat.

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SAAEETAK:Aktualne inovacije u intervencijskoj kardiologiji dramatiËno su proπirile terapijske moguÊnosti za srËa-ne bolesnike. Intervencijska kardiologija viπe nije ograniËena na lijeËenje koronarne bolesti srca veÊ je moguÊe lijeËiti bolesti zalistaka, raditi na prevenciji moaedanog udara, lijeËenju arterijske hipertenzije, itd. Jedna od najvaaenijih novih moguÊnosti lijeËenja je perkutano lijeËenje aortne stenoze (transkateterska implantacija aortne valvule), buduÊi da je bolest aortne valvule vrlo Ëest problem u bolesnika starije aeivotne dobi, a mnogi od njih imaju visok rizik od operacije. Isto tako, mitralna regurgitacija je Ëesto povezana s pojavom komorbiditeta koji Ëine operaciju visokoriziËnom. MitraClip je obeÊavajuÊe perkutano alternativno rjeπenje za kirurπki popravak ili zamjenu srËanog zaliska. Ostali postupci koji se spominju u ovom preglednom Ëlanku su perkutano zatvaranje aurikule lijevog atrija kao nefarmakoloπka terapija za prevenciju moaedanog udara, renalna denervacija za rezistentnu arterijsku hipertenziju. U ovom se Ëlanku pojaπnjavaju osnovni principi ovih postupaka, najvaaenije kliniËke studije uz dodatne kliniËke podatke o svakom od njih. KLJU»NE RIJE»I: intervencijska kardiologija, intervencijski zahvati na zaliscima. SUMMARY:Recent innovations in interventional cardiology have dramatically expanded the therapeutic options for patients with cardiac conditions. Interventional cardiology is no longer limited to the treatment of coronary artery disease but allows also treatment of valvular disease, stroke prevention, hypertension, etc. One of the most important new treatment options is the percutaneous treatment for aortic valve stenosis (transcatheter aortic valve implantation), since aortic valve disease is a rather common problem in elderly patients, with many of them at high risk for surgery. Similarly, mitral regurgitation is often associated with comorbidities which make surgery high risk. The MitraClip is a promising percutaneous alternative to surgical valve repair or replacement. Other procedures discussed in this review are the percutaneous left atrial appendage closure as a non-pharmacologic therapy to prevent strokes, and renal denervation for resistant hypertension. This review explains the basic principles of these procedures, the most important clinical evidence, and also provides additional recent clinical data on each of these them.

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Transfemoral transcatheter aortic valve replacement

Mylotte

Martucci

Lange

et al. 2013

Endovascular and Hybrid Therapies for Structural Heart and Aortic Disease

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One-Year Outcomes of Cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry

Abstract: Background-Transcatheter aortic valve implantation was developed to provide a therapeutic option for patients considered to be ineligible for, and to mitigate mortality and morbidity associated with, high-risk surgical aortic valve replacement. Methods and Results-The

Cited by 478 publications

References 26 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

Almanac 2013: novel non-coronary cardiac interventions

Transfemoral transcatheter aortic valve replacement

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