Transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation - initial German experience

Seiffert, Moritz; Bader, Ralf; Kappert, Utz; Krapf, Stephan; Rastan, A; Bleiziffer, Sabine; Hofmann, Steffen; Arnold, Martin; Kallenbach, Klaus; Conradi, Lenard; Schlingloff, Friederike; Wilbring, Manuel; Schäfer, Ulrich; Treede, Hendrik

doi:10.1055/s-0034-1367114

Cited by 38 publications

(74 citation statements)

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“…This is due to the non-calcified aortic annulus in this population leading to the presumed risk of device failure from inadequate anchoring of the transcatheter valve prosthesis (7). Despite the relative contra-indication of TAVR in NAVR, there have been a few published reports (8)(9)(10)(11)) that continue to show that TAVR in carefully selected patients with NAVR is feasible with good outcomes especially in the high surgical risk population. This study is a systematic review analyzing current data on short and midterm outcomes of TAVR in patients with NAVR.…”

Section: Introductionmentioning

confidence: 99%

Outcomes following transcatheter aortic valve replacement in patients with native aortic valve regurgitation

et al. 2018

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Due to the absence of annular calcification for device anchoring, it is presumed that transcatheter aortic valve replacement (TAVR) is not suitable for the treatment of native aortic valve regurgitation (NAVR) resulting in very limited data and experience concerning its safety and efficacy. We sought to review published data on the safety and efficacy of TAVR in high-risk patients with NAVR. Studies including case reports, case series and original articles published between 2002 and 2016 on TAVR in patients with NAVR were identified with a systematic electronic search using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Only studies reporting data on demographic and procedural characteristics, management and follow up outcomes were analyzed. A total of 30 publications describing 182 patients were identified. Most patients (54%) were men, with a mean age of 70.1±2.6 years, mean logistic European System for Cardiac Operative Risk Evaluation score (EuroSCORE) of 21.8%±4.5% and mean Society of Thoracic Surgeons (STS) score of 8%±1.8% for mortality. The majority (87%) of patients had severe NAVR with no valvular calcification. TAVR was mostly performed through the femoral (58.8%) and apical (33.1%) approach. Device success, defined by VARC-2, was achieved in 86.3% of our study population.A second valve was required in 17 patients (9.3%) during the index procedure for residual aortic regurgitation or malposition. Post-procedure aortic regurgitation of grade 1 or less was present in 80 patients (81%).Pacemaker implantation was required post procedure in 17 patients (9.3%). The 30-day and 1-year mortality was 11.9% and 16.2%, respectively. TAVR is associated with favorable pacemaker implantation and 1-year mortality rates with a high 30-day mortality among selected patients with NAVR.

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Section: Introductionmentioning

confidence: 99%

Outcomes following transcatheter aortic valve replacement in patients with native aortic valve regurgitation

et al. 2018

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“…The JenaValve TM system is a second-generation transcatheter heart valves that provides a successful deployment not only in calcified, stenotic aortic valves but also in non-calcified, severely regurgitant aortic valves by its feeler guided positioning and secure clip fixation mechanism to the native aortic valve cusps. Calcium spots occurring on regurgitant aortic valve may complicate the procedure by causing an incomplete stent expansion because the JenaValve TM system carries less radial force than a balloonexpandable transcatheter heart valves [3].…”

Section: Discussionmentioning

confidence: 99%

“…The procedure can be performed while heart is beating and this makes the procedure safer than the others especially in patients with low cardiac output as our patient [3].…”

Section: Discussionmentioning

confidence: 99%

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Transapical transcatheter aortic valve implantation in a high-risk patient with aortic and mitral regurgitation: usage of the JenaValve™ system

Surer¹,

İnce²,

Duvan³

et al. 2016

Eur Res J

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JenaValveTM system is a second-generation transcatheter heart valve that provides a successful deployment not only in calcified stenotic aortic valves but also in non-calcified, severe regurgitant aortic valves. We performed a transapical transcatheter aortic valve implantation procedure using this system without any procedure-related complications in a 75-year-old woman with multiple co-morbidity factors, who had both mitral and aortic regurgitation, and low ejection fraction.Eur Res J 2016;2(3):219-221

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“…The first successful cases were reported as 'off-label' procedures by using the CoreValve™ (Medtronic, Minneapolis, Minnesota, USA) as well as the Edwards Sapien THV system (Edwards Lifesciences LLC, Irvine, CA, USA) (4-6). Since then, the only approved valve system to be used in pure aortic regurgitation is the JenaValve™ prosthesis (JenaValve Technology GmbH, Munich, Germany) (7,8). The J-valve™ system (JC Medical, Inc. Burlingame, CA, USA and Suzhou, China), a recently introduced new, also selfexpandable TAVI-system has also been used in pure aortic regurgitation (9) and just recently, the Lotus™ valve system (Boston Scientific, Marlborough, MA, USA) was reported to be used successfully for treatment of patients with pure aortic regurgitation.…”

Section: Introductionmentioning

confidence: 99%

Transcatheter aortic valve implantation (TAVI) in patients with aortic regurgitation

Thielmann¹,

Tsagakis²,

Gabry³

et al. 2017

ASVIDE

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Transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation - initial German experience

Cited by 38 publications

References 0 publications

Outcomes following transcatheter aortic valve replacement in patients with native aortic valve regurgitation

Outcomes following transcatheter aortic valve replacement in patients with native aortic valve regurgitation

Transapical transcatheter aortic valve implantation in a high-risk patient with aortic and mitral regurgitation: usage of the JenaValve™ system

Transcatheter aortic valve implantation (TAVI) in patients with aortic regurgitation

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