Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation

Fam, Neil; Braun, Daniel; Bardeleben, Ralph Stephan von; Näbauer, Michael; Ruf, T.; Connelly, Kim A.; Ho, Edwin; Thiele, Holger; Lurz, Philipp; Weber, Marcel; Nickenig, Georg; Narang, Akhil; Davidson, Charles J.; Hausleiter, Jörg

doi:10.1016/j.jcin.2019.09.046

Cited by 123 publications

(92 citation statements)

References 35 publications

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“…The Transcatheter Clip Repair System in Patients With Moderate or Greater TR (TRILUMINATE) trial demonstrated the feasibility of the TriClip in a selected cohort of patients with stable results at 6 months follow-up ( 15 ). The PASCAL (Edwards Lifescience, Irvine, CA) clip is an alternative device, which has been used in the tricuspid position with good feasibility, safety and procedural outcomes ( 22 ). Other devices still remain under clinical development ( 14 ).…”

Section: Which Device For Which Patient? Moving Toward a Tailored Appmentioning

confidence: 99%

“…Certain technologies have indeed failed because of dramatic rates of device detachment and second generation devices are being developed to overcome this issue ( 26 ). Retrospective registries report a detachment rate of 12.9 and 7.1% with the Mitraclip XTR and PASCAL devices, respectively, whilst in the TRILUMINATE trial (Mitraclip NTR) the rate of single leaflet device attachment was 7% ( 22 , 24 , 27 ). Further evaluation of the causes, mechanisms and subsequent treatment of this condition are required.…”

Section: Which Device For Which Patient? Moving Toward a Tailored Appmentioning

confidence: 99%

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Future Perspectives in Percutaneous Treatment of Tricuspid Regurgitation

Mangieri

Pagnesi

Regazzoli

et al. 2020

Front. Cardiovasc. Med.

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Tricuspid regurgitation (TR) has a not negligible prevalence and its severity is correlated with poorer outcomes. However, surgical options are rarely offered to these patients because of their high surgical risk. Given that medical therapy plays a limited role in the management of these patients, there is an increasing clinical need for transcatheter treatment options. Although, transcatheter tricuspid valve interventions (TTVIs) are still at an early stage, emerging data suggests their clinical effectiveness and safety, with preliminary results highlighting the potential benefits of transcatheter treatments over medical therapy. In this review, we highlight the challenges and future directions of current and emerging technologies dedicated to the treatment of TR along with an analysis of the next steps required in future clinical trials and studies dedicated to the treatment of the forgotten valve.

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Section: Which Device For Which Patient? Moving Toward a Tailored Appmentioning

confidence: 99%

Section: Which Device For Which Patient? Moving Toward a Tailored Appmentioning

confidence: 99%

Future Perspectives in Percutaneous Treatment of Tricuspid Regurgitation

Mangieri

Pagnesi

Regazzoli

et al. 2020

Front. Cardiovasc. Med.

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“…Among them, coaptation devices attempt to increase valve coaptation by leaflet plication or occupying the regurgitant orifice with a spacer. To date, the Mitraclip and Triclip devices (Abbott, Santa Clara, CA, USA), the PASCAL system (Edwards Lifesciencies, Irvine, CA, USA) and the FORMA device (Edwards Lifesciencies, Irvine, CA, USA) have been used as coaptation devices in the TTVI field ( Figure 1 ) ( 1 , 6 ). The present review document focuses on coaptation devices, describing its design characteristics, main procedural steps and the reported early and mid-term outcomes.…”

Section: Introductionmentioning

confidence: 99%

“…RA, Right atrium; RV, Right ventricle. Reproduced with permission from Asmarats et al ( 1 ) and Fam et al ( 6 ) and modified for the authors.…”

Section: Introductionmentioning

confidence: 99%

“…First, large-bore conventional percutaneous venous access is obtained in the right femoral vein to introduce the 22 French guide sheath. To date, all reported cases using the Pascal system in the context of TTVI have been performed through the femoral approach ( 6 , 31 ). Once the guide sheath is advanced in the RA and proper orientation is achieved, the implant is advanced into the right ventricle in an open configuration.…”

Section: Introductionmentioning

confidence: 99%

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Transcatheter Tricuspid Valve Intervention: Coaptation Devices

Muntané‐Carol

Alperi

Faroux

et al. 2020

Front. Cardiovasc. Med.

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Transcatheter tricuspid valve intervention (TTVI) has recently emerged as an alternative for the treatment of severe tricuspid regurgitation (TR). Multiple percutaneous devices have been developed in the last decade with promising early results. Among them, the coaptation devices are designed to reduce TR severity by valve leaflet plication or occupying the regurgitant orifice with a spacer. To date, the MitraClip/TriClip devices (Abbott, Santa Clara, CA, USA), the PASCAL system (Edwards Lifesciencies, Irvine, CA, USA), and the FORMA device (Edwards Lifesciencies, Irvine, CA, USA) have been used as coaptation devices for treating severe TR. The present document aimed to review the clinical evidence on coaptation devices in the field of TTVI, describing its design characteristics, main procedural steps, and early and mid-term outcomes.

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