Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial - CLASP IID

Sep 17, 2022
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, FACC
Trial Sponsor:
Edwards Lifesciences
Date Presented:
09/17/2022
Date Published:
09/17/2022
Original Posted Date:
09/17/2022
References

Contribution To Literature:

The CLASP IID trial showed that transcatheter mitral edge-to-edge repair with the PASCAL system is noninferior to MitraClip for major adverse events among patients with degenerative MR and prohibitive surgical risk.

Description:

The goal of the trial was to assess the safety and efficacy of the PASCAL system compared with the MitraClip among patients with degenerative mitral regurgitation (MR) who were at prohibitive surgical risk.

Study Design

Eligible patients were randomized in a 2:1 fashion to either PASCAL (n = 117) or MitraClip (n = 63). Patients had to be anatomically suitable for both devices. PASCAL was available in two sizes (original and narrow Ace). In the MitraClip arm, about 39% received third-generation devices (NT, NTR, XTR) and the rest received fourth-generation devices (NT, NTW, XT, XTW).

  • Total number of enrollees: 180
  • Duration of follow-up: 6 months
  • Mean patient age: 81 years
  • Percentage female: 33%

Inclusion criteria:

  • Age ≥18 years
  • 3+ or 4+ degenerative MR by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) as assessed by the echocardiographic core laboratory
  • Mitral valve transcatheter edge-to-edge repair (M-TEER) candidate suitable for both the PASCAL system and the MitraClip system
  • Deemed prohibitive surgical risk by the local heart team including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease     

Exclusion criteria:

  • Contraindication for TEE or unsuccessful screening TEE
  • Mitral valve anatomy which may preclude proper access, use, and/or deployment of either device

Other salient features/characteristics:

  • Median Society of Thoracic Surgeons–Predicted Risk of Mortality (STS PROM) for replacement: 5.4%
  • Atrial fibrillation: 58%
  • Heart failure hospitalization within 1 year: 37%
  • MR 4+: 77%
  • Effective regurgitant orifice area: 0.5 cm2, left ventricular (LV) end-systolic dimension: 39 mm, LV end-diastolic dimension: 57 mm, tricuspid regurgitation ≥3+: 3.5%; LV ejection fraction: 59%
  • Mean number of implanted devices: 1.5

Principal Findings:

The primary safety endpoint, major adverse events (cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, and nonelective mitral valve re-intervention [either percutaneous or surgical]) for 30 days, for PASCAL vs. MitraClip, was: 3.4% vs. 4.8% (p for noninferiority < 0.05). Cardiovascular mortality was: 0.9% vs. 1.6%.

Secondary outcomes for PASCAL vs. MitraClip:

  • Major adverse events at 6 months: 6.1% vs. 11.1%
  • All-cause mortality or heart failure hospitalization at 12 months: 6.9% vs. 7.9% (p = 0.78)
  • MR ≤2+ at 6 months: 97.7% vs. 98.1%; MR ≤1 at 6 months: 83.7% vs. 71.2%
  • Mean mitral gradient: 3.7 mm Hg vs. 3.4 mm Hg (p > 0.05)
  • New York Heart Association (NYHA) class I/II at 6 months: 86.1% vs. 94.6%
  • Kansas City Cardiomyopathy Questionnaire (KCCQ-OS) at 6 months: 74 vs. 79 (p = 0.16)

Interpretation:

The results of this trial indicate that transcatheter mitral edge-to-edge repair with the PASCAL system is noninferior to MitraClip for major adverse events among patients with degenerative MR and prohibitive surgical risk. Echocardiographic results at 6 months seemed similar as well. These are important results and led to Food and Drug Administration approval for use of the PASCAL device in the United States for this indication. Long-term results and cost differences, if any, are awaited. Data among functional MR patients are also awaited.

References:

Lim DS, Smith RL, Gillam LD, et al., on behalf of the CLASP IID Pivotal Trial Investigators. Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC Cardiovasc Interv 2022;Sep 17:[Epub ahead of print].

Presented by Dr. Konstantinos P. Koulogiannis at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2022), Boston, MA, September 17, 2022.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound, Mitral Regurgitation

Keywords: Atrial Fibrillation, Cardiac Surgical Procedures, Echocardiography, Transesophageal, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Mitral Valve Insufficiency, Myocardial Infarction, Percutaneous Coronary Intervention, Renal Replacement Therapy, Risk, Stroke, TCT22, Transcatheter Aortic Valve Replacement, Transcatheter Cardiovascular Therapeutics, Tricuspid Valve Insufficiency


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