Severe symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging.
The CLASP IID (Edwards PASCAL Transcatheter ...Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents the primary safety and effectiveness endpoints for the trial.
Patients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months.
A prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and MR ≤2+ (96.5% vs 96.8%), respectively. Functional and quality-of-life outcomes significantly improved in both groups (P < 0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months (PASCAL, 87.2% and 83.7% P = 0.317 vs discharge; MitraClip, 88.5% and 71.2% P = 0.003 vs discharge).
The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.
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Severe mitral regurgitation is associated with impaired prognosis if left untreated. Using the devices currently available, transcatheter mitral valve repair (TMVr) remains challenging in complex ...anatomical situations. We report the procedural and 30-day results of the first-in-man study of the Edwards PASCAL TMVr system.
In this multicentre, prospective, observational, first-in-man study, we collected data from seven tertiary care hospitals in five countries that had a compassionate use programme in which patients underwent transcatheter mitral valve repair using the Edwards PASCAL TMVr system. Eligible patients were those with symptomatic, severe functional, degenerative, or mixed mitral regurgitation deemed at high risk or inoperable. Safety and efficacy of the procedure were prospectively assessed at device implantation, discharge, and 30 days after device implantation. The key study endpoints were technical success assessed at the end of the procedure and device success 30 days after implantation using the Mitral Valve Academic Research Consortium definitions.
Between Sept 1, 2016, and March 31, 2017, 23 patients (median age 75 years IQR 61–82) had treatment for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the Edwards PASCAL TMVr system. At baseline, the median EuroScore II score was 7·1% (IQR 3·6–12·8) and the median Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair was 4·8% (2·1–9·0) and 6·8% (2·9–10·1) for mitral valve replacement. 22 (96%) of 23 patients were New York Heart Association (NYHA) class III or IV at baseline. The implantation of at least one device was successful in all patients, resulting in procedural residual mitral regurgitation of grade 2+ or less in 22 (96%) patients. Six (26%) of 23 patients had two implants. Periprocedural complications occurred in two (9%) of 23 patients (one minor bleeding event and one transient ischaemic attack). Despite the anatomical complexity of mitral regurgitation in the patients in this compassionate use cohort, technical success was achieved in 22 (96%) of 23 patients, and device success at 30 days was achieved in 18 (78%) patients. Three patients (13%) died during the 30 day follow-up. 19 (95%) of 20 patients alive 30 days after implantation were NYHA class I or II.
This study establishes feasibility of the Edwards PASCAL TMVr system with a high rate of technical success and reduction of mitral regurgitation severity. Further research is needed on procedural and long-term clinical outcomes.
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The combination of mitral regurgitation and tricuspid regurgitation is common in patients with multiple valvular disease and patient management can be challenging. Surgical combined mitral and ...tricuspid valve surgery is a treatment option for patients meeting criteria but has demonstrated inconsistent long-term benefits.
Transcatheter mitral and tricuspid edge-to-edge repair has demonstrated early promising results in patients with a prohibitive surgical risk, making it an interesting treatment option. The present review will discuss the physiopathology of this complex disease and contemporary data regarding treatment options for the treatment of combined mitral and tricuspid regurgitation.
Combined transcatheter mitral and tricuspid edge-to-edge repair is a novel treatment option for patients with multiple valvular disease. Further studies are needed to determine optimal patient selection and timing of intervention and demonstrate survival benefit and improvement in clinical outcomes. Advances in technology, with dedicated devices and enhanced imaging techniques may also improve patient outcomes.
Tricuspid transcatheter edge-to-edge repair (T-TEER) has emerged as a well tolerated and effective therapeutic option for many patients with symptomatic severe tricuspid regurgitation at prohibitive ...surgical risk. However, there remain several important limitations to clip-based technology in the context of other rapidly emerging percutaneous treatment options for tricuspid regurgitation.
Tricuspid lesions pose unique challenges to treatment with the current toolbox of transcatheter clip-based technologies. This review will explore key issues related to patient factors, anatomical factors, and imaging factors that may render lesions to be unsuitable for treatment with T-TEER.
Selection for T-TEER must include a detailed clinical evaluation in the context of a 'heart team' approach involving multiple subspecialists, with screening for patient/lesion characteristics that make T-TEER suboptimal with current clip-based technologies. Future directions for research include patient-specific 3D modeling techniques, leaflet grasping techniques, clip deployment strategies, and personalized device sizing to increase the spectrum of lesions that may be treated with T-TEER within the context of other emerging transcatheter treatment options.
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