Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis

Yoon, Sung Han; Lefèvre, Thierry; Ahn, Jung Ming; Perlman, Gidon; Dvir, Danny; Latib, Azeem; Barbanti, Marco; Deuschl, Florian; Backer, Ole De; Blanke, Philipp; Modine, Thomas; Pache, Gregor; Neumann, Franz Josef; Ruile, Philipp; Arai, T.; Ohno, Yohei; Kaneko, Hidehiro; Tay, Edgar; Schofer, Niklas; Holy, Erik W.; Luk, Ngai Hong Vincent; Yong, Gerald; Lu, Qingsheng; Kong, William; Hon, Jimmy Kim Fatt; Kao, Hsien‐Li; Lee, Michael; Yin, Wei Hsian; Park, Duk‐Woo; Kang, Soo Jin; Lee, Seung Whan; Kim, Young Hak; Lee, Cheol Whan; Park, Seong Wook; Kim, Hyo Soo; Butter, Christian; Khalique, Omar; Schäefer, Ulrich; Nietlispach, Fabiàn; Kodali, Susheel; Leon, Martin B.; Ye, Jian; Chevalier, Bernard; Leipsic, Jonathon; Delgado, Victoria; Bax, Jeroen J.; Tamburino, Corrado; Colombo, Antonio; Søndergaard, Lars; Webb, John G.; Park, Seung Jung

doi:10.1016/j.jacc.2016.06.041

Cited by 189 publications

(130 citation statements)

References 42 publications

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“…Implantations of new generation devices were less likely to result in residual moderate to severe paravalvular leak, annulus rupture or second valve-in-valve implantation. 44 Furthermore, when compared to TAVR in patients with tricuspid aortic valves, there were no differences in procedural complications with these new generation devices when implanted in BAV patients. Cumulative event rates for all-cause mortality were similar between bicuspid and tricuspid aortic valves.…”

Section: Transcatheter Aortic Valve Replacementmentioning

confidence: 91%

“…[43][44][45] The Bicuspid Transcatheter Aortic Valve Replacement Registry is the largest international, multicenter, observational registry that enrolls all consecutive patients with bicuspid AS from Europe, North America, and Asia-Pacific regions. 44,45 In the published studies, TAVR devices were divided into early generation (Sapien XT, Edwards Lifesciences, Irvine, California; CoreValve, Medtronic, Minneapolis, Minnesota) versus new generation devices (Sapien 3, Edwards Lifesciences, Irvine, California; Lotus, Boston Scientific, Marlborough, Massachusetts; Evolut R, Medtronic, Minneapolis, Minnesota). Implantations of new generation devices were less likely to result in residual moderate to severe paravalvular leak, annulus rupture or second valve-in-valve implantation.…”

Section: Transcatheter Aortic Valve Replacementmentioning

confidence: 99%

“…45 Despite the foregoing data, selection bias nearly always exists whereby TAVR was generally performed in highrisk or inoperable bicuspid AS patients. In addition, bicuspid AS patients are more likely to be younger, [43][44][45] and the long-term implications of age-related progressive aortic dilatation and its complications need to be included in the decision-making process. Therefore, expanding TAVR indications to include bicuspid AS patients, especially those who are young and at lower operative risk, should proceed with caution until further evidence accumulates supporting and confirming its long-term success and durability.…”

Section: Transcatheter Aortic Valve Replacementmentioning

confidence: 99%

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Bicuspid Aortic Valve Disease: New Insights

Wang

Delgado

et al. 2017

Structural Heart

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Bicuspid aortic valve (BAV) is the most common cardiac congenital abnormality and can be associated with significant valvulopathy or aortopathy. Current active areas of BAV research include prediction of development of valve dysfunction and aortopathy, and the various surgical valvular strategies with or without ascending aortic replacement. There is also increasing interest in the emerging role of transcatheter aortic valve replacement (TAVR) even though it is listed as a relative contraindication in current TAVR recommendations. Although there are clearly established guidelines in the clinical management and surgical techniques for the management of BAV with or without aortopathy, many of these newer surgical techniques have shown excellent post-surgical results but need to be directly compared against "standard" guidelines recommended treatment. As such, this creates new controversies regarding the clinical and surgical management of BAV. In this review, we have summarized the current understanding of the pathophysiology of BAV valvulopathy and aortopathy, various newer surgical therapies, and gaps in our scientific knowledge that require further research.

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Section: Transcatheter Aortic Valve Replacementmentioning

confidence: 91%

Section: Transcatheter Aortic Valve Replacementmentioning

confidence: 99%

Section: Transcatheter Aortic Valve Replacementmentioning

confidence: 99%

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Bicuspid Aortic Valve Disease: New Insights

Wang

Delgado

et al. 2017

Structural Heart

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“…However, a recent study has shown that TAVR in bicuspid valves may just be a matter of operator experience. The Bicuspid TAVR Registry, initiated in December 2013, is a multicenter, multinational (20 centers across North America, Europe and Asia-Pacific) observational study which is investigating all patients with bicuspid aortic valves undergoing TAVR at enrolled institutions (15). The outcomes in these patients were compared between early generation (Sapien XT and CoreValve) and late generation TAVR valves (Sapien 3 and Lotus).…”

mentioning

confidence: 99%

Transcatheter aortic valve replacement in intermediate and low risk patients-clinical evidence

Arora

Vavalle

2017

Ann. Cardiothorac. Surg.

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has now shifted to clinical trials comparing TAVR to surgery in low-surgical-risk populations with a goal to expand TAVR to all-risk patients. However, low-surgical-risk patients continue to be acceptable candidates for surgical aortic valve replacement, with proven outcomes over many decades. Although new data has emerged showing feasibility of TAVR in young patients with bicuspid valves, with newer generation TAVR valves there will be minimal tolerance for adverse outcomes in the low risk category. To expand the reach of TAVR into low-surgical-risk patients, important questions about valve durability, leaflet thrombosis, higher rates of paravalvular leak and permanent pacemakers (PPM) will need to be addressed. However, as TAVR technology continues to evolve, it seems to be just a matter of time before TAVR establishes itself as a modality for aortic valve replacement regardless of surgical risk.

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“…It is now a more common procedure in Germany that surgical aortic valve replacement (SAVR), has a role for the treatment of intermediate-risk patients, and has been used for stenotic BAV with good short-and intermediate-term results (10)(11)(12)(13). The role of TAVR in low-risk populations is currently being investigated, and while early results have been promising, the approach remains controversial (14).…”

mentioning

confidence: 99%