Mitral Valve Transcatheter Edge-to-Edge Repair Using MitraClip or PASCAL

BackgroundThere is a paucity of data regarding the comparative efficacy and safety of Mitral valve transcatheter edge‐to‐edge repair (MTEER) using the PASCAL or MitraClip systems for patients with mitral regurgitation (MR).MethodsAn electronic search was conducted for MEDLINE, COCHRANE, and EMBASE, through February 2023, for studies comparing the clinical outcomes of MTEER using PASCAL versus MitraClip systems among patients with severe MR. The primary study outcome was residual MR ≤ 2 at discharge. Data were pooled using a random‐effects model.ResultsThe final analysis included six studies with a total of 1581 patients, with a weighted follow‐up period of 3.5 months. Two studies only included patients with degenerative MR, while the remaining studies included both degenerative and functional MR. There was no significant difference in procedure duration between MTEER with the PASCAL or MitraClip systems. There was no difference in residual MR ≤ 2 at discharge (94.7% vs. 91.9%; odds ratio [OR]: 1.44; 95% confidence interval [CI]: 0.92–2.27) or residual MR ≤ 2 at the mid‐term follow‐up (94.6% vs. 91.0%, p = 0.05) among the PASCAL versus MitraClip systems. There was no difference between both groups in residual MR ≤ 1 at discharge (73.1% vs. 63.8%, p = 0.12), while there was greater incidence of residual MR ≤ 1 at midterm follow‐up with the PASCAL system (71.3% vs. 56.2%, p < 0.001). There was no difference between the PASCAL and MitraClip MTEER systems in technical success (97.0% vs. 97.9%, p = 0.15), procedural success (89.1% vs. 87.1%, p = 0.78), single leaflet detachment (1.8% vs. 1.4%, p = 0.55), or all‐cause mortality (3.6% vs. 4.6%, p = 0.71).ConclusionIn this meta‐analysis, we demonstrated comparable efficacy and safety between the PASCAL and MitraClip MTEER systems at short‐ and mid‐term assessments. Randomized trials are warranted to evaluate the comparative long‐term outcomes between both MTEER systems.

Section: Resultsmentioning

confidence: 99%

Transcatheter edge‐to‐edge repair for mitral regurgitation using PASCAL or MitraClip

Elbadawi

Dang

Hamed

et al. 2023

“…TEER is most frequently used in patients with symptomatic severe MR and high surgical risk. In several clinical trials, the complication rate associated with TEER is low, thus this procedure is both safe and effective 1–4 . According to follow‐up data in some major registries, the incidence of IE following TEER generally ranges between 1.0% and 2.6% during the 5‐year follow‐up 30,31 .…”

Section: Discussionmentioning

confidence: 99%

“…In several clinical trials, the complication rate associated with TEER is low, thus this procedure is both safe and effective. [1][2][3][4] According to follow-up data in some major registries, the incidence of IE following TEER generally ranges between 1.0% and 2.6% during the 5-year follow-up. 30,31 Moreover, a data analysis by the Society of Thoracic Surgery demonstrated endocarditis to be responsible for cardiac surgery in 4.5% of all cases after TEER.…”

Section: Discussionmentioning

confidence: 99%

“…Transcatheter edge‐to‐edge repair (TEER) is an alternative treatment for patients with symptomatic severe mitral regurgitation (MR) and high surgical risk. The use of the MitraClip (Abbott Vascular) or PASCAL systems (Edwards Lifesciences) has been associated with an improvement in heart failure (HF) symptoms as well as a reduction in all‐cause death and hospitalization rates for HF patients 1–4 …”

Section: Introductionmentioning

confidence: 99%

“…The use of the MitraClip (Abbott Vascular) or PASCAL systems (Edwards Lifesciences) has been associated with an improvement in heart failure (HF) symptoms as well as a reduction in all-cause death and hospitalization rates for HF patients. [1][2][3][4] Prosthetic valve endocarditis (PVE) is a serious complication with a high mortality rate and accounts for up to 30% of all cases of infective endocarditis (IE). 5 However, PVE is a rare occurrence with an overall incidence rate of 3%-4% during 5-year follow-up.…”

mentioning

confidence: 99%

See 2 more Smart Citations

Infective endocarditis after transcatheter edge‐to‐edge repair for severe mitral regurgitation; a case report and a systematic review

Yokoyama

Ochiai

Saito

2023

Transcatheter edge‐to‐edge repair (TEER) is used extensively in patients with symptomatic severe mitral regurgitation and high surgical risk. While prosthetic valve endocarditis is well documented, infective endocarditis (IE) after TEER is a rare occurrence. To date, no study has been conducted on this complication. We report the case of an 85‐year‐old man who developed IE 3 months after undergoing TEER, and we systematically review 26 previously published cases of this complication. Our review findings indicate that discussion within the heart team is essential for the decision‐making process and treatment strategy determination.

Contemporary experience of mitral transcatheter edge‐to‐edge repair technology in patients with mitral annular calcification

Mustafa,

Basman,

Cinelli

et al. 2024

BackgroundMitral annular calcification (MAC) has been an exclusion for many of the earlier pivotal trials that were instrumental in gaining device approval and indications for mitral transcatheter edge‐to‐edge repair (M‐TEER).AimsTo evaluate the impact of MAC on the procedural durability and success of newer generation MitraClip® systems (G3 and G4 systems).MethodsData were collected from Northwell TEER registry. Patients that underwent M‐TEER with third or fourth generation MitraClip device were included. Patients were divided into −MAC (none‐mild) and +MAC (moderate‐severe) groups. Procedural success was defined as ≤ grade 2 + mitral regurgitation (MR) postprocedure, and durability was defined as ≤ grade 2 + MR retention at 1 month and 1 year. Univariate analysis compared outcomes between groups.ResultsOf 260 M‐TEER patients, 160 were −MAC and 100 were +MAC. Procedural success was comparable; however, there were three patients who required conversion to cardiac surgery during the index hospitalization in the +MAC group versus none in the −MAC group (though this was not statistically significant). At 1‐month follow‐up, there were no significant differences in MR severity. At 1‐year follow‐up, +MAC had higher moderate‐severe MR (22.1% vs. 7.5%; p = 0.002) and higher mean transmitral gradients (5.3 vs. 4.0 mmHg; p = 0.001) with no differences in mortality, New York Heart Association functional class or ejection fraction.ConclusionIn selective patients with high burden of MAC, contemporary M‐TEER is safe, and procedural success is similar to patients with none‐mild MAC. However, a loss of procedural durability was seen in +MAC group at 1‐year follow‐up. Further studies with longer follow‐ups are required to assess newer mTEER devices and their potential clinical implications in patients with a high burden of MAC.