Transcatheter Mitral Valve Repair System Research Articles

First-in-human Results of the Novel Transcatheter Mitral Valve Repair System for Severe Mitral Regurgitation

Objective: To evaluate the feasibility, safety, and effectiveness of a novel edge-to-edge mitral valve repair system (the NovoClasp system) in patients with severe mitral regurgitation. Methods: In this prospective, single-arm, first-in-human study conducted at Beijing Anzhen Hospital, data were collected from patients undergoing transcatheter edge-to-edge repair using the NovoClasp system. The study candidates were patients exhibiting a mitral regurgitation severity of 3+ or more and were at high-risk or contraindicated for surgical intervention. Technical success and device success according to the Mitral Valve Academic Research Consortium definitions were used as primary outcomes. Other safety and efficacy outcomes were prospectively assessed at device implantation, discharge, and 30 d, 6 months, and 12 months post-procedure. Results: Between October 1, 2021, and January 31, 2022, 11 patients were treated for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the NovoClasp system. All patients had a baseline New York Heart Association functional class of III–IV, with 7/11 exhibiting complex mitral valve disease. All patients achieved the primary endpoints of technical and device success, with a post-operative 30-d mitral regurgitation grade reduction to 2+ or lower, which was maintained at 12 months. One patient had minor bleeding and hematoma at the access site before discharge, and 2 patients were readmitted due to fast atrial fibrillation within 12 months post-discharge. No additional cases of death, adverse cerebral or cardiovascular events, or device-related complications was observed during the follow-up. Conclusion: This study suggested the potential feasibility and safety of the NovoClasp system, showing a promising technical and device success rate, along with a decrease in mitral regurgitation severity. A further pivotal study is needed to assess the procedural and long-term outcomes.

Thirty-day Outcomes of First-in-man Implantation of a Novel Transcatheter Edge-to-edge Mitral Repair System in Patients With Severe Mitral Regurgitation

Objectives: The aim of this multicenter, prospective, single-arm pilot study (ClinicalTrials.gov number: NCT05040074) was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system, SQ-Kyrin®-M Clip (Shenqi Medical, Shanghai, China), in patients with severe mitral regurgitation (MR). Methods: The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation ≥3+ despite optimal medical therapy or degenerative mitral regurgitation ≥3+ with high surgical risk as candidates for transcatheter repair. All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia. The primary outcome was technical success, which included all of the following measured at the exit from the catheterization laboratory: (1) absence of procedural mortality; (2) successful access, delivery, and retrieval of the device delivery system; (3) successful deployment and correct positioning of the first intended device; and (4) no emergency surgery or reintervention related to the device or access procedure. The secondary outcomes included all-cause mortality, serious adverse events, device success, and procedural success 30 d after the intervention. Results: From June 2021 to December 2021, 18 patients were enrolled in this study with age (75.7 ± 7.4) years. Fifteen patients had MR 4+, while 3 had MR 3+. Technical success was achieved in all patients, including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients. There was no all-cause mortality at 30 d. One patient had single leaflet device attachment within 30 d, which was regarded as a serious adverse event, and the patient was successfully treated with reintervention by implanting another clip. Another patient’s transmitral gradient was 6 mmHg (>5 mmHg), with an effective orifice area of 2.57 cm2 after the procedure. Sixteen patients had device success and procedural success at 30 d postoperation. Fourteen patients had MR 1+, 3 had MR 2+, and only 1 patient had MR 3 + 30 d after the procedure. Conclusions: The results of this feasibility study showed the efficacy and safety of the SQ-Kyrin®-M device in the Chinese population with severe MR, laying a solid foundation for a subsequent large-scale confirmatory study.

MitraClip: a review of its current status and future perspectives.

Mitral regurgitation (MR), among the most common valvular heart diseases, is closely associated with heart failure and worse clinical outcomes. Surgical repair or replacement as an intervention for MR is deemed too high risk in patients who are elderly or have multiple comorbidities; thus, nearly half of all patients with severe symptomatic MR are not referred for surgical therapy. MitraClip, a transcatheter mitral valve repair system for MR that mimics the Alfieri surgical edge-to-edge technique for mitral valve repair, was developed in the late 1990s. After clinical trials demonstrated its safety and efficacy, it received approval for clinical use, particularly for aging and inoperable or high-risk patients for heart surgery in Europe, the US, and Japan. Since the start of its clinical use, randomized clinical trials (RCTs) have optimized patient selection, and the latest generation MitraClip can increase procedural success, even in patients with challenging mitral valve anatomy. Therefore, here, we review evidence from clinical trials and RCTs and discuss optical patient selection and future perspectives for the MitraClip.

First-in-Human Study of the Novel Transcatheter Mitral Valve Repair Systemfor Mitral Regurgitation.

Transcatheter mitral valve intervention treatment is a promising alternative therapy for patients with severe mitral regurgitation (MR). This is a multicenter, prospective, first-in-human study of transcatheter edge-to-edge repair (TEER) using a novel device for severe MR. Safety and efficacy were assessed immediately after the procedure and at 30-day follow-up. Twenty-three patients (age 70.0 ± 5.2 years) who were at high/prohibitive surgical risk underwent successful procedures without major periprocedural complications. All patients achieved residual MR≤2+ at discharge, with 73.9% with 1+ residual MR. The left ventricular end-systolic diameter improved from 4.1cm at baseline to 3.4cm at 30-day follow-up. New York Heart Association functional class I/II after TEER was achieved in 87% of patients. This study demonstrated that TEER with the device was feasible and safe for the treatment of patients with severe MR. (Dragonfly-M Transcatheter Mitral Valve Repair System Early Feasibility Study; NCT04528576).

German Multicenter Experience With a New Leaflet-Based Transcatheter Mitral Valve Repair System for Mitral Regurgitation.

The aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system. The PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture. Procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE). Among the 309 patients (mean age 77 ± 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 ± 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was≤2+ in 93.5%. At 30days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class≤II (p<0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%). Mitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status.

1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.

The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR). The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported. Eligible patients had symptomatic MR≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30days. Follow-up was continued to 1 year. One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30days, there was 1 cardiovascular death (0.9%), MR≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p<0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was≤1+ in 82% of patients (79% FMR, 86% DMR) and≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p<0.001 for all). The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349).

First Report on the Surgical Removal of the PASCAL Device After Failed Transcatheter Mitral Valve Repair

The PASCAL transcatheter mitral valve repair system (PASCAL-TMVR) (Edwards Lifesciences, Irvine, California) is a novel device for edge-to-edge TMVR. Distinctive features include a central spacer and broad paddles made of pliable nitinol ([1][1],[2][2]). So far, we are lacking experience regarding

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study

ObjectivesThe authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study. BackgroundSevere MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated. MethodsEligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days. ResultsBetween June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively. ConclusionsThe PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349)

Transcatheter Mitral Valve Repair in Patients with Functional Mitral Regurgitation—One-Year Outcomes From the Multicenter CE Trial

The aim of this multicenter study was to evaluate the feasibility, safety and outcomes up to 12 months of the Edwards Cardioband transcatheter mitral valve repair system in the treatment of patients with secondary mitral regurgitation (MR). Between February 2013 and June 2016, 61 patients at high

TCT-56 Transcatheter Mitral Valve Repair in Patients with Functional Mitral Regurgitation – One-Year Outcomes from the Multicenter CE Trial

The aim of this multicenter study was to evaluate the feasibility, safety and outcomes up to 12 months of the Edwards Cardioband transcatheter mitral valve repair system in the treatment of patients with secondary mitral regurgitation (MR). Between February 2013 and June 2016, 61 patients at high

TCT-54 First-in-Human Compassionate Use Results of the Novel PASCAL Transcatheter Mitral Valve Repair System for the Treatment of Severe Mitral Regurgitation

Severe mitral regurgitation (MR) is associated with impaired prognosis if left untreated. Using current systems, transcatheter mitral valve repair (TMVr) remains challenging in many complex anatomical situations. We report the procedural and 30-day results of the first-in-human multicenter

Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study

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. None.

Percutaneous Repair of Mitral Regurgitation.

Mitral regurgitation (MR) affects more than 2 million people in the United States annually and is the second leading cause of heart valve disease after aortic stenosis. Surgical intervention is the currently accepted treatment of choice in patients with either symptomatic degenerative MR or asymptomatic MR with pulmonary hypertension, atrial fibrillation, or left ventricular dysfunction. Based on robust evidence from clinical trials, the MitraClip Transcatheter Mitral Valve Repair system (Abbott Vascular) was approved in the United States for commercial use in 2013. To date, more than 4,000 patients have been treated with the MitraClip in the United States and more than 35,000 patients worldwide. The device is approved in the United States for symptomatic degenerative mitral regurgitation in patients who are at high risk for surgery, as registry data has shown the device to be safe and effective in high-risk patients. In fact, when evaluated in the real-world setting in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, the device appears to be more safe and effective than in the original clinical trials. This review summarizes the clinical trials and registry data, reviews ongoing trials evaluating the device's utility in expanding populations, and introduces novel mitral valve repair devices in various stages of development.

The MitraClip transcatheter mitral valve repair system.

The MitraClip transcatheter mitral valve repair system.

The Arto transcatheter mitral valve repair system.

The Arto transcatheter mitral valve repair system.

ICoapsys mitral valve repair system: Percutaneous implantation in an animal model

Determine if the iCoapsys device could be accurately and safely implanted using a novel transcatheter system. Functional mitral regurgitation is a ventricular disease characterized by mitral insufficiency in the absence of structural valve abnormalities. It occurs in the presence of ischemic or non-ischemic cardiomyopathy. The Coapsys (surgical) transventricular device, currently undergoing randomized evaluation, offers a more integrated treatment strategy. The iCoapsys transcatheter mitral valve repair system was developed for percutaneous delivery of an implant designed to emulate the surgical (i.e. Coapsys) device. Nine operators tested the ability of this novel catheter system to successfully deliver and position the iCoapsys implant in 12 adult sheep. Post mortem evaluation in this acute model demonstrated precise percutaneous delivery and implantation in all 12 animals using fluoroscopic, coronary angiographic, and epicardial echo guidance. There was no excessive bleeding, hemodynamic compromise or sustained arrhythmias. A novel transcatheter methodology was developed to consistently deliver and accurately position the iCoapsys implant. The percutaneous iCoapsys system was successfully implanted without complication in this acute animal model series.