Complications Following Percutaneous Mitral Valve Edge-to-Edge Repair Using MitraClip.
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ABSTRACT:
SUBMITTER: Shah MA
PROVIDER: S-EPMC8311053 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC7925964 | biostudies-literature
Project description:BackgroundTranscatheter mitral valve repair (TMVR) has shown to improve symptoms and functional capacity in patients with severe mitral valve regurgitation (MR). Novel device developments provide the technology to treat patients with complex anatomies and large coaptation gaps. Nevertheless, the question of superiority of one device remains unanswered. We aimed to compare the MitraClip XTR and MitraClip NTR system in a real world setting.HypothesisTMVR with the MitraClip XTR system is equally effective, but associated with a higher risk of leaflet injury.MethodsWe retrospectively analyzed peri-procedural and mid-term clinical and echocardiographic outcomes of 113 patients treated for severe MR between March 2018 and August 2019 at the University Hospital of Munich.ResultsPostprocedural MR reduction to ≤2+ was comparable in both groups (XTR: 96.1% vs. NTR: 97.6%, p = .38). There was a significant difference in a composite safety endpoint of periprocedural Major adverse cardiac and cerebrovascular events (MACCE) including leaflet injury between groups (XTR 14.6% vs. NTR 1.7%, 95% CI [2.7, 24.6], p = .012). After a median follow-up of 8.5 (4.4, 14.0) months, durable reduction of MR was confirmed (XTR: in 91.9% vs. NTR: 96.8%, p = .31) and clinical and symptomatic improvement was comparable in both groups accordingly.ConclusionWhile efficacy was comparable in both treatment groups, patients treated with the MitraClip XTR systems showed more events of acute leaflet tear and single leaflet device attachment (SLDA). A detailed echocardiographic assessment should be done to identify risk candidates for acute leaflet injury.
| S-EPMC8119798 | biostudies-literature
Project description:ObjectiveIn the current study, we present our mid-term experience with modified edge-to-edge repair technique through a transventricular and transaortic route in patients requiring left ventricular remodeling or aortic root/valve surgery.MethodsFrom December 2006 through April 2015, 49 high-risk patients (median age: 69 years; median European System for Cardiac Operative Risk Evaluation II: 11.4 [6.54-14.9]) underwent transventricular (N = 7; 14%) or transaortic (N = 42; 86%) edge-to-edge mitral valve repair. The Alfieri stitch technique was modified by MitraClip type overcorrection and solid buttressing behind the posterior leaflet. Indication was grade 2+ functional mitral valve incompetence and dilated or impaired left ventricle (N = 25; 52%), or grade 3+ (N = 22; 45%) and grade 4+ functional mitral valve regurgitation (N = 2; 4%). Surgical procedure included aortic root surgery in 65%, aortic valve replacement with surgical revascularization in 18%, and Dor-plasty with surgical revascularization in 14%.ResultsIntraoperative mortality and early neurologic complications were absent in our series. Ninety-day mortality was 12.2% (N = 6). Median clinical and echocardiographic follow-up-time was 50.7 (21.5-44.1) and 39.2 (33.7-44.1) months, respectively. Median postoperative transvalvular gradient was low (2.72 [1.91-4.22] mm Hg) and did not increase during follow-up (P = .268), although peak gradient rose slightly from 7.41 to 8.12 mm Hg (P = .071). The actuarial reoperation free rate at the index valve was 96.8%.ConclusionsTransventricular or transaortic Alfieri mitral repair mimicking mitral clip overcorrection represents a quick and safe technique in the setting of high-risk patients undergoing left ventricular remodeling or aortic root/valve surgery and can be performed with low risk of creating mitral stenosis at midterm. The technique is straightforward, with reliable identification of the center of the valve leaflets being the limitation.
| S-EPMC8987813 | biostudies-literature
Project description:BackgroundTranscatheter edge-to-edge repair (TEER) of the mitral valve (MV) can be performed using the PASCAL or MitraClip devices. Few studies offer a head-to-head outcome comparison of these two devices.Material and methodsPubMed, EMBASE, Cochrane Library, Clinicaltrials.gov and WHO's International Clinical Trials Registry Platform, from 1 January 2000 until 1 March 2023, were searched. Study protocol details were registered in the International Prospective Register of Systematic Reviews (PROSPERO ID: CRD42023405400). Randomized Controlled Trials and observational studies reporting head-to-head clinical comparison of PASCAL and MitraClip devices were eligible for selection. Patients with severe functional or degenerative mitral regurgitation (MR) who had undergone TEER of the MV with either PASCAL or MitraClip devices were included in the meta-analysis. Data from six studies (five observational and one randomized clinical trial) were extracted and analyzed. The main outcomes were a reduction in MR to 2+ or less, improvement of New York Heart Association (NYHA) and 30-day all-cause mortality. Peri-procedural mortality, success rate and adverse events were also compared.ResultsData from 785 and 796 patients that underwent TEER using PASCAL and MitraClip, respectively, were analyzed. Thirty-day all-cause mortality (Risk ratio [RR] = 1.51, 95% CI 0.79-2.89), MR reduction to maximum 2+ (RR = 1.00, 95% CI 0.98-1.02) and NYHA improvement (RR = 0.98, 95% CI 0.84-1.15) were similar in both device groups. Both devices had high and similar success rates (96.9% and 96.7% for the PASCAL and MitraClip group, respectively, p value = 0.91). MR reduction to 1+ or less at discharge was similar in both device groups (RR = 1.06, 95% CI 0.95-1.19). Composite peri-procedural and in-hospital mortality was 0.64% and 1.66% in the PASCAL and MitraClip groups, respectively (p value = 0.094). Rates of peri-procedural cerebrovascular accidents were 0.26% in PASCAL and 1.01% in MitraClip (p value = 0.108).ConclusionsBoth PASCAL and MitraClip devices have high success and low complication rates for TEER of the MV. PASCAL was not inferior to MitraClip in reducing the MR level at discharge.
| S-EPMC10219028 | biostudies-literature
Project description:BackgroundMitral regurgitation (MR) is one of the most prevalent valvular diseases in our society. Transcatheter mitral valve repair (TMVR) with the MitraClip® system is increasingly used for treating this condition. The aim of our study is to analyse morphological mitral valve changes related to the procedure and its correlation with the degree of regurgitation at mid-term follow-up and with the combined endpoint of heart failure and all-cause mortality.MethodsA single-centre, prospective and observational study including consecutive patients admitted between October 2015 and October 2019 for TMVR was designed. The mitral valve annulus (MVA) was analyzed using the three-dimensional MVQ QLAB mitral valve quantification software (Philips; Amsterdam, The Netherlands). Clinical data was collected retrospectively.ResultsEighty-two MitraClip® were implanted. Control echocardiograms showed a significant decrease in the three measures: annular diameters, perimeter and area. Patients with functional MR had greater left ventricular and mitral annular dimensions and experienced greater reductions in anteroposterior diameter and mitral valve area compared with organic MR patients. The anteroposterior diameter reduction (OR 0.90; 95% CI: 0.82-0.99), as well as posterior leaflet grasping (OR 0.94; 95% CI: 0.89-0.99) were associated with the probability of significant MR recurrence. Posterior leaflet grasping and left ventricle ejection fraction were associated with the combined endpoint of heart failure and any cause death.ConclusionsMitraClip® implantation results in secondary changes in the mitral annular morphology. The magnitude of these morphological changes varies depending on the etiology of the mitral valve regurgitation. Posterior leaflet grasping and anteroposterior diameter reduction after clip are factors associated with relevant clinical and echocardiographic endpoints.
| S-EPMC7475407 | biostudies-literature
Project description:BackgroundLate post-operative systolic anterior motion (SAM) is a rare but challenging issue. The feasibility of percutaneous mitral valve edge-to-edge repair (PMVR) using the MitraClip to treat late refractory SAM after surgical mitral valve repair has rarely been reported in the literature.Case summaryAn 88-year-old woman with a history of mitral valve repair for a P2 prolapse 14 years before, presented with signs of congestive heart failure. Transoesophageal echocardiogram (TOE) demonstrated significant SAM of the anterior mitral leaflet, resulting in the detachment from the posterior mitral leaflet in mid-to-late systole and severe mitral regurgitation (MR). The heart team decided to perform PMVR using the MitraClip to simultaneously address the issues of SAM and MR, considering the patient's high surgical risk. TOE after the clip deployment at the medial edge of the mitral valve, where the most severe SAM was detected, confirmed resolution of SAM with marked reduction of MR. The patient was discharged home with good haemodynamic compensation.DiscussionPost-operative SAM typically occurs immediately after the reparative surgery and resolves with conservative treatment; however, persistent SAM requiring repeat surgery remains a serious concern. As an alternative strategy, the MitraClip has some advantages, including low procedural risk, immediately observable results, and the ability to relocate the clip. Meanwhile, the greater risk of post-procedural mitral stenosis, particularly in patients undergoing mitral repair, should be taken into account. In our case, the clip deployment at the medial edge of the valve could minimize the progression of mitral stenosis with a satisfactory reduction of MR.
| S-EPMC8564687 | biostudies-literature
Project description:Highlights•First in human experience: percutaneous mitral valve repair (PMVR) procedure guided by three-dimensional volume intracardiac echocardiography (ICE).•Volume ICE adds valuable information to two-dimensional ICE•Further improvements such as wider opening angle of the volume ICE probe are needed for routine use in PMVR.
| S-EPMC6034481 | biostudies-other
Project description:Percutaneous edge-to-edge mitral valve (MV) repair is a relatively new treatment option for mitral regurgitation (MR). After the feasibility and safety having been proved in low-surgical-risk patients, the use of this procedure has shifted more to the treatment of high-risk patients. With the absence of randomized controlled trials (RCT) for this particular subgroup, observational studies try to add evidence to the safety aspect of this procedure. These also provide short- and mid-term mortality figures. Several mortality predictors have been identified, which may help the optimal selection of patients who will benefit most from this technique. In this article we provide an overview of the literature about mortality and its predictors in patients treated with the percutaneous edge-to-edge device.
| S-EPMC4805767 | biostudies-literature
Project description:BackgroundThe PASCAL system is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of this study was to compare the safety and efficacy of the PASCAL to the MitraClip system in a highly selected group of patients with complex primary mitral regurgitation (PMR) defined as effective regurgitant orifice area (MR-EROA) ≥ 0.40 cm2, large flail gap (≥ 5 mm) or width (≥ 7 mm) or Barlow's disease.Methods38 patients with complex PMR undergoing mitral intervention using PASCAL (n = 22) or MitraClip (n = 16) were enrolled. Primary efficacy endpoints were procedural success and degree of residual MR at discharge. The rate of major adverse events (MAE) according to the Mitral Valve Academic Consortium (MVARC) criteria was chosen as the primary safety endpoint.ResultsPatient collectives did not differ relevantly regarding pertinent baseline parameters. Patients` median age was 83.0 [77.5-85.3] years (PASCAL) and 82.5 [76.5-86.5] years (MitraClip). MR-EROA at baseline was 0.70 [0.68-0.83] cm2 (PASCAL) and 0.70 [0.50-0.90] cm2 (MitraClip), respectively. 3D-echocardiographic morphometry of the mitral valve apparatus revealed no relevant differences between groups. Procedural success was achieved in 95.5% (PASCAL) and 87.5% (MitraClip), respectively. In 86.4% of the patients a residual MR grade ≤ 1 + was achieved with PASCAL whereas reduction to MR grade ≤ 1 + with MitraClip was achieved in 62.5%. Neither procedure time number of implanted devices, nor transmitral gradient differed significantly. No periprocedural MAE according to MVARC occured.ConclusionIn this highly selected patient group with complex PMR both systems exhibited equal procedural safety. MitraClip and PASCAL reduced qualitative and semi-quantitative parameters of MR to an at least comparable extent.
| S-EPMC8639575 | biostudies-literature
Project description:Papillary muscle rupture is an infrequent and highly morbid mechanical complication of acute myocardial infarction. Surgical repair or replacement is traditionally considered first-line therapy. However, many of these patients present in extremis with prohibitively high surgical risk. Repair of mitral regurgitation with the MitraClip device (Abbot Vascular, Menlo Park, CA, USA) is an established therapy to treat degenerative and functional mitral regurgitation. We present a case of successful repair of severe mitral regurgitation due to papillary muscle rupture in the setting of acute myocardial infarction. A two-clip strategy resulted in mild residual mitral regurgitation with resolution of cardiogenic shock and refractory hypoxemia requiring veno-venous extracorporeal membrane oxygenation. Six-month follow-up echocardiogram identified durable results with mild mitral regurgitation and left ventricular ejection fraction of 63 %. Our case demonstrates that percutaneous mitral valve repair with MitraClip is a well-tolerated procedure that can provide acute and long-term benefit for patients with acute mitral regurgitation due to papillary muscle rupture who are at prohibitively high surgical risk. <Learning Objective: Our case illustrates the role of MitraClip in acute mitral regurgitation due to papillary muscle rupture in cardiogenic shock as an alternative to surgical intervention in extremely high-risk patients.>.
| S-EPMC7588477 | biostudies-literature