Is the PASCAL Device Effective against MitraClip?

Mitral regurgitation (MR) is the most common valvulopathy and full medical treatment at maximal tolerated doses has been shown quite effective to treat it. However, its limited in a group of patients that require valve intervention. 

¿Es efectivo el dispositivo PASCAL comparado con MitraClip?

At present, the ideal treatment is surgical valve replacement, which is in many cases is not viable because of its high surgical risk. It is in this scenario where Edge-to-edge with MitraClip has been shown beneficial. 

Currently, there is another device available, the PASCAL, but its safety and efficacy has not been yet analyzed against the MitraClip. 

The CLASP IID is a randomized, multicenter, multinational, prospective study assessing the safety and efficacy of the PASCAL against MitraClip in patients with degenerative mitral regurgitation with prohibitive risk of surgery. 

Safety end point was the composite of MAE at 30 days (cardiovascular death, MI, stroke, need for dialysis, major bleeding and surgical or percutaneous non-elective reintervention of the mitral valve) and effective end point was the presence of MI ≤2 + at 6 months.

It included 180 patients, 117 receiving PASCAL and 63 MitraClip.

Read also: Combined Calcified Lesion Preparation Strategy.

Mean age was 81, 66% were men, 85% had hypertension, 18% diabetes, and 58% atrial fibrillation.

75% of mitral regurgitation was grade 4+, effective orifice area was 0.50 cm2, ejection fraction 58%, diastolic volume 145, pulmonary artery systolic pressure 43 mmHg, TAPSE 20, atrial volume 120 ml and severe tricuspid failure 3%.

Primary safety end point at 30 days was similar (3.4% for PASCAL vs. 4.8% for MitraClip), showing non-inferiority between devices. There was no difference in mortality, stroke, MI, need for dialysis, major bleeding and non-elective mitral valve intervention. 

Read also: Is Clopidogrel Monotherapy Safe After a Month of Dual Antiplatelet Therapy in Diabetic Patients?

Efficacy end point at 6 months also resulted similar, meeting non-inferiority criteria (96.5% for PASCAL vs. 96.8% for MitraClip).

Conclusion

the CLASP IID showed PASCAL system met non-inferiority primary end points expanding percutaneous treatment as a valid option for patients with symptomatic degenerative mitral valve regurgitation at prohibitive surgical risk.

Dr. Carlos Fava - Consejo Editorial SOLACI

Dr. Carlos Fava.
Member of the Editorial Board SOLACI.org.

Original Title: Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

Reference: D. Scott Lim, M. J Am Coll Cardiol Intv 2022;15:2523–2536.


Subscribe to our weekly newsletter

Get the latest scientific articles on interventional cardiology

More articles by this author

Prospective Analysis of the Feasibility of the PASCAL System for Transcatheter Mitral Repair: OneForAll Registry

Courtesy of Dr. Juan Manuel Pérez. Mitral transcatheter edge-to-edge repair (M-TEER) is an effective option for patients with severe mitral regurgitation who are at high...

Left Bundle Branch Block after TAVR: What Is Its Impact?

Courtesy of Dr. Juan Manuel Pérez. Left bundle branch block (LBBB) is a common complication following transcatheter aortic valve replacement (TAVR), which can be either...

Multicenter Experience with 3D Intracardiac Echocardiography for Guiding Interventional Cardiac Procedures

Courtesy of Dr. Juan Manuel Pérez. Imaging techniques play a fundamental role in interventional cardiac procedures. Intracardiac echocardiography (ICE) appears as an alternative to transesophageal...

Pathology of Self-Expanding Transcatheter Aortic Bioprostheses and Hypoattenuated Leaflet Thickening

Courtesy of Dr. Juan Manuel Pérez. Despite the available long term followup data on of transcatheter aortic valve replacement (TAVR), bioprosthesis durability continues under debate....

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Related Articles

SOLACI Sessionsspot_img

Recent Articles

ACC 2025 | FAME 3: FFR Guided PCI vs CABG 5 Year Outcomes.

Earlier studies comparing percutaneous coronary intervention (PCI) vs coronary artery bypass graft (CABG) have shown fewer events at long term for the surgical strategy.  However,...

ACC 2025 | API-CAT: Reduced vs. Full Dose Extended Anticoagulation in Patients with Cancer Related VTE

The risk of cancer related recurrent venous thromboembolism (VTE) will drop over time, while bleeding risk will persist. At present, it is recommended we...

STRIDE: Semaglutide in Patients with Peripheral Arterial Disease and Type II Diabetes

Peripheral arterial disease (PAD) is a severe complication in patients with type II diabetes, primarily affecting peripheral vessels, especially below-the-knee (BTK) arteries. This condition...