Transcatheter aortic valve replacement for pure aortic valve regurgitation: “on-label” versus “off-label” use of TAVR devices

Wernly, Bernhard; Eder, Sarah; Navarese, Eliano Pio; Kretzschmar, Daniel; Franz, Marcus; Alushi, Brunilda; Beckhoff, Frederik; Jung, Christian; Lichtenauer, Michael; Datz, Christian; Schulze, P. Christian; Landmesser, Ulf; Hoppe, Uta C.; Falk, Volkmar; Lauten, Alexander

doi:10.1007/s00392-019-01422-0

Cited by 54 publications

(39 citation statements)

References 48 publications

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“…In comparison to standard newer generation transcatheter heart valves, dedicated devices lead to a higher procedural success. However, there seems to be no difference in mortality, stroke or residual AR (41).…”

Section: Treatment Decision and Current Limitationsmentioning

confidence: 82%

Transcatheter Aortic Valve Implantation Current Indications and Future Directions

Winkel

Stortecky

Wenaweser

2019

Front. Cardiovasc. Med.

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Degenerative heart valve disease is associated with significant morbidity and mortality and healthcare expenditures. Transcatheter heart valve repair and replacement has introduced a fundamental change in the therapeutic management and transcatheter aortic valve replacement (TAVR) has gained substantial popularity. Favorable results from randomized trials and large real world registries lead to TAVR being considered a standard procedure with high rates of procedural success and low rates of peri-procedural complications. This article aims to review the past evolution, summarize the available evidence, discuss current indications and limitations and venture a glimpse into the future of percutaneous interventions for aortic valve disease.

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Section: Treatment Decision and Current Limitationsmentioning

confidence: 82%

Transcatheter Aortic Valve Implantation Current Indications and Future Directions

Winkel

Stortecky

Wenaweser

2019

Front. Cardiovasc. Med.

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“…12) J-Valve and Jenavalve 17) have been certified for PAR and had a significantly higher procedural success rate compared to other "offlabel" second-generation devices. 12) In addition, the feasibility of TAVI for patients with PAR was proven in several second-generation THV, including Evolut-R, 18) SAPIEN 3, 8) ACURATE neo, 9) Direct Flow Medical, 10) Lotus 11) et al The 1-year outcome of TAVI using a second-generation THV (J-Valve and Jenavalve) for PAR has been reported, and it presented a satisfactory outcome. 4,5,7) However, the long-term durability and efficiency of these devices were not demonstrated.…”

Section: Discussionmentioning

confidence: 99%

“…In second-generation devices, the advantage is more pronounced on the "on-label" THVs (J-Valve and JenaValve) than "off-label" THVs. 12) The J-Valve (Jie Cheng Medical Technologies, Suzhou, China) is a self-expandable TAVI device featuring three U-shaped anatomically oriented "graspers" for the accurate positioning to the Valsalva sinus. 6) In previous studies, we have described J-Valve performed satisfactory early outcomes in highrisk surgical patients with AS or PAR.…”

Section: Introductionmentioning

confidence: 99%

Structural Valve Deterioration after Transcatheter Aortic Valve Implantation Using J-Valve: A Long-Term Follow-Up

Wang

et al. 2020

ATCS

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Purpose: Our study aimed to investigate the structural valve deterioration (SVD) after transcatheter aortic valve implantation (TAVI) using J-Valve. Methods: In all, 14 patients with aortic stenosis (AS) and 4 patients with pure aortic regurgitation (PAR) were available in the study. Four-year follow-up was performed in all patients, and the clinical data and echocardiographic findings were recorded and analyzed. Results: All patients survived at the 4-year follow-up. There was no evidence of morphological SVD or prosthetic valve thrombosis in enrolled patients. None of the hemodynamic SVD occurred in patients with PAR. Mean gradients decreased from 61.93 ± 15.42 mm Hg (pre-TAVI) to 19.64 ± 9.16 mm Hg (discharge) in patients with AS (p <0.001); subsequently, a slight increase was observed in the mean trans-aortic gradient throughout follow-up (p = 0.967). Overall, in patients with AS, six individuals suffered moderate (3/14, 21.4%) or severe (3/14, 21.4%) hemodynamic SVD at 4-year follow-up. Conclusions: The limited number of cases provides a preliminary indication of the longterm efficacy of TAVI using J-Valve in patients with PAR. In patients with AS, although the higher rate of SVD was observed, the overall transcatheter heart valve (THV) hemodynamics remained stable over time after prosthetic valve implantation and the longterm durability of J-Valve was convincing.

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“…17,18 Further refinement of the TAVR valves designed specifically for pure aortic valve regurgitation will likely expand the indications for TAVR in this setting. 19 Points of consideration during the evolution of TAVR for aortic regurgitation include lack of annular calcification, reliance on echocardiographic imaging for positioning, the need for oversizing of the valve, and the risks of valve complications such malposition, migration, and aortic annular rupture. 16,19 Further trials will likely evaluate these considerations in the era of expanding indications for TAVR for aortic regurgitation and beyond.…”

Section: Anesthetic Technique In Tavrmentioning

confidence: 99%

The Year in Cardiothoracic and Vascular Anesthesia: Selected Highlights from 2019

Evans¹,

Weiner

Shaefi

et al. 2020

Journal of Cardiothoracic and Vascular Anesthesia

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This highlights in our specialty for 2019 begin with the ongoing major developments in transcatheter valve interventions. Thereafter, the advances in left ventricular assist devices are reviewed. The recent focus on conduit selection and robotic options in coronary artery bypass surgery are then explored. Finally, this special articles closes with a discussion of pulmonary hypertension in noncardiac surgery, anesthetic technique in cardiac surgery, as well as postoperative pneumonia and its outcome consequences.

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Transcatheter aortic valve replacement for pure aortic valve regurgitation: “on-label” versus “off-label” use of TAVR devices

Cited by 54 publications

References 48 publications

Transcatheter Aortic Valve Implantation Current Indications and Future Directions

Transcatheter Aortic Valve Implantation Current Indications and Future Directions

Structural Valve Deterioration after Transcatheter Aortic Valve Implantation Using J-Valve: A Long-Term Follow-Up

The Year in Cardiothoracic and Vascular Anesthesia: Selected Highlights from 2019

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