Mitral Transcatheter Edge-to-Edge Repair With the PASCAL Precision System: Device Knobology and Review of Advanced Steering Maneuvers
Ontology highlight
ABSTRACT:
SUBMITTER: Garcia S
PROVIDER: S-EPMC10818146 | biostudies-literature | 2023 Nov
REPOSITORIES: biostudies-literature
Similar Datasets
Project description: Not available
| S-EPMC11697868 | biostudies-literature
Project description:BackgroundVersaCross is a novel radiofrequency transseptal solution that may improve the efficiency and workflow of transseptal puncture (TSP). The aim of this study was to compare the VersaCross transseptal system with mechanical needle systems during mitral transcatheter edge-to-edge repair (M-TEER) with the PASCAL device.MethodsThis is a single-center retrospective study of consecutive patients who underwent M-TEER with the PASCAL. Transseptal puncture was undertaken with either a mechanical needle or the VersaCross wire. The primary endpoints were success of TSP and successful delivery of the Edwards sheath on the chosen delivery wire. Secondary endpoints included number of wires used, tamponade rate, interval from femoral venous access to TSP and first PASCAL device deployment, procedural death, and stroke.ResultsThirty-three consecutive patients (10 with mechanical needle, 23 with VersaCross) who underwent M-TEER with the Edwards PASCAL device were identified. All patients had successful TSP. In the mechanical needle group, the Edwards sheath was successfully delivered on the Superstiff Amplatz wire in all cases. In the VersaCross arm, the radiofrequency wire was used successfully for delivery of the sheath in all cases. There were no cases of pericardial effusion/tamponade in either arm. Interval from femoral venous access to TSP and to deployment of the first PASCAL device was shorter with the VersaCross system. Significantly fewer wires were used with VersaCross. There were no procedural deaths or strokes in either group.ConclusionsVersaCross appears a safe and effective method of TSP and for delivery of the 22Fr sheath for M-TEER with PASCAL.
| S-EPMC10692349 | biostudies-literature
Project description:In severely symptomatic patients with primary severe mitral regurgitation at high or prohibitive surgical risk, mitral transcatheter edge-to-edge repair is a reasonable strategy. We present a successful case of right internal jugular vein access using PASCAL mitral valve repair (Edwards Lifesciences) in a patient with prohibitive risk for surgical mitral repair.
| S-EPMC11522722 | 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: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:An 80-year-old woman with mitral valve repair failure was admitted with hemolytic anemia secondary to the impact of a regurgitant jet on the annuloplasty ring. Transcatheter repair to treat both mitral regurgitation and hemolysis was favored because of surgical risk. Transcatheter edge-to-edge repair represents an alternative for treating hemolysis associated with mitral regurgitation. (Level of Difficulty: Advanced.).
| S-EPMC9207944 | biostudies-literature
Project description:We describe an unusual presentation of transcatheter mitral valve edge-to-edge repair device embolization into the left common femoral vein in a patient with primary degenerative mitral regurgitation. We hypothesize a possible mechanism for this phenomenon, factors that may increase the risk of this complication, and outline the patient's clinical course. (Level of Difficulty: Intermediate.).
| S-EPMC9745655 | biostudies-literature
Project description:Mitral regurgitation (MR) is the most prevalent valvular heart disease and, when left untreated, results in reduced quality of life, heart failure, and increased mortality. Mitral valve transcatheter edge-to-edge repair (M-TEER) has matured considerably as a non-surgical treatment option since its commercial introduction in Europe in 2008. As a result of major device and interventional improvements, as well as the accumulation of experience by the interventional cardiologists, M-TEER has emerged as an important therapeutic strategy for patients with severe and symptomatic MR in the current European and American guidelines. Herein, we provide a comprehensive up-do-date overview of M-TEER. We define preprocedural patient evaluation and highlight key aspects for decision-making. We describe the currently available M-TEER systems and summarise the evidence for M-TEER in both primary mitral regurgitation (PMR) and secondary mitral regurgitation (SMR). In addition, we provide recommendations for device selection, intraprocedural imaging and guiding, M-TEER optimisation and management of recurrent MR. Finally, we provide information on major unsolved questions and "grey areas" in M-TEER.
| S-EPMC9869401 | biostudies-literature
Project description:A patient with severe mitral regurgitation and chronic systolic heart failure taking inotropic support at home presents for transcatheter edge-to-edge mitral valve repair, complicated by torrential mitral regurgitation from damaged mitral leaflets requiring escalating mechanical circulatory support and ultimately expedited orthotopic heart transplantation. (Level of Difficulty: Intermediate.).
| S-EPMC8305671 | biostudies-literature
Project description:BackgroundWe previously reported procedural and 30-day outcomes of a German early multicenter experience with the PASCAL system for severe mitral regurgitation (MR). This study reports 1-year outcomes of mitral valve transcatheter edge-to-edge repair with the PASCAL system according to MR etiology in a large all-comer cohort.Methods and resultsClinical and echocardiographic outcomes up to 1-year were investigated according to MR etiology (degenerative [DMR], functional [FMR], or mixed [MMR]) in the first 282 patients with symptomatic MR 3+/4+ treated with the PASCAL implant at 9 centers in 2019. A total of 282 patients were included (33% DMR, 50% FMR, 17% MMR). At discharge, MR reduction to ≤1+/2+ was achieved in 58%/87% of DMR, in 75%/97% of FMR, and in 78%/98% of patients with MMR (P=0.004). MR reduction to ≤1+/2+ was sustained at 30 days (50%/83% DMR, 67%/97% FMR, 74%/100% MMR) and at 1 year (53%/78% DMR, 75%/97% FMR, 67%/91% MMR) with significant differences between etiologies. DMR patients with residual MR 3+/4+ at 1-year had at least complex valve morphology in 91.7%. Valve-related reintervention was performed in 7.4% DMR, 0.7% FMR, and 0.0% MMR (P=0.010). At 1-year, New York Heart Association Functional Class was significantly improved irrespective of MR etiology (P<0.001).ConclusionsIn this large all-comer cohort, mitral valve transcatheter edge-to-edge repair with the PASCAL system was associated with an acute and sustained MR reduction at 1-year in all causes. However, in patients with DMR, MR reduction was less pronounced, reflecting the high incidence of complex or very complex anatomies being referred for mitral valve transcatheter edge-to-edge repair.
| S-EPMC10863793 | biostudies-literature