Pulmonary Regurgitation - Results from the Harmony™ Transcatheter Pulmonary Valve Trial.
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ABSTRACT:
SUBMITTER: Cheatham J
PROVIDER: S-EPMC9524622 | biostudies-literature | 2020
REPOSITORIES: biostudies-literature
Publications
Pulmonary Regurgitation - Results from the Harmony™ Transcatheter Pulmonary Valve Trial.
Heart international 20201020 2
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Project description: Not available
| S-EPMC11307746 | biostudies-literature
Project description:BackgroundVarying rates of nonsustained ventricular tachycardia (NSVT) have been reported early after transcatheter pulmonary valve replacement (TPVR) with the Harmony valve, but data regarding rhythm outcomes beyond hospital discharge are limited. This study aims to characterize ventricular arrhythmias after Harmony TPVR from implant through mid-term follow-up.MethodsVentricular arrhythmia data from postimplant telemetry and follow-up extended rhythm monitoring (ERM) were analyzed after Harmony TPVR.ResultsFifty-four patients with tetralogy of Fallot (n=39), valvar pulmonary stenosis (n=10), or pulmonary atresia with intact ventricular septum (n=5) were studied; 22% had prior NSVT and 24% were on prior rhythm medication. On postimplant telemetry, 27 patients (50%) had NSVT, including 1 who had torsade de pointes, but most had <5 episodes. Pre-TPVR NSVT or rhythm medications, diagnosis other than tetralogy, and substantial device contact with the myocardium were associated with more frequent NSVT on telemetry. Ten patients (19%) were started on a new antiarrhythmic medication. On discharge ERM, 37% of patients had NSVT, most with <5 episodes and only 13% with NSVT beyond 5 days post-discharge. On follow-up ERM, 14% of patients had a single episode of NSVT and 1 had 5 episodes. During follow-up, antiarrhythmic medications were discontinued in 8 of 10 patients and no patients died or had sustained ventricular tachycardia.ConclusionsNSVT and ventricular ectopy were common early after TPVR but were infrequent in most cases and diminished rapidly after discharge. The incidence of NSVT on follow-up ERM was similar to preimplant incidence. Few patients had antiarrhythmic medications initiated, and most were discontinued on follow-up. There were no major arrhythmic events after discharge.
| S-EPMC11748900 | biostudies-literature
Project description:This review outlines the first trial experience with transcatheter therapy for mitral regurgitation (MR), developed from the EVEREST II MitraClip trial in a trial population comprised predominantly of patients with degenerative mitral regurgitation (DMR). Subsequent experience with MitraClip and several other devices has been mostly in functional MR patients. At the same time, there has been ongoing experience with MitraClip in DMR, and a variety of other devices have been developed for catheter-based treatment of MR. Annuloplasty devices have been indicated for DMR, and the potential for transcatheter annuloplasty to be used, in conjunction with other catheter techniques, such as chordal replacement, as it is in standard mitral repair, is developing. Transcatheter mitral valve replacement will clearly have some role for MR of both functional and degenerative etiologies, when repair is not feasible or fails. This review will discuss the evidence base and future development of these mitral repair and replacement approaches for DMR.
| S-EPMC6288224 | biostudies-other
Project description:To analyse the impact of postprocedural mitral regurgitation (MR), in an interaction with aortic regurgitation (AR), on mortality following transcatheter aortic valve implantation (TAVI).To assess the interaction between MR and AR, we compared the survival rate of patients (i) without both significant MR and AR versus (ii) those with either significant MR or significant AR versus (iii) with significant MR and AR, all postprocedure. 381 participants of the Polish Transcatheter Aortic Valve Implantation Registry (166 males (43.6%) and 215 females (56.4%), age 78.8±7.4 years) were analysed. Follow-up was 94.1±96.5 days.In-hospital and midterm mortality were 6.6% and 10.2%, respectively. Significant MR and AR were present in 16% and 8.1% patients, including 3.1% patients with both significant MR and AR. Patients with significant versus insignificant AR differed with respect to mortality (log rank p=0.009). This difference was not apparent in a subgroup of patients without significant MR (log rank p=0.80). In a subgroup of patients without significant AR, there were no significant differences in mortality between individuals with versus without significant MR (log rank p=0.44). Significant MR and AR had a significant impact on mortality only when associated with each other (log rank p<0.0001). At multivariate Cox regression modelling concomitant significant MR and AR were independently associated with mortality (OR 3.2, 95% CI 1.54 to 5.71, p=0.002).Significant MR or AR postprocedure, when isolated, had no impact on survival. Combined MR and AR had a significant impact on a patient's prognosis.
| S-EPMC4862065 | biostudies-other
Project description:Patients undergoing transcatheter aortic valve replacement (TAVR) might have an associated significant MR that can potentially lead to left ventricular (LV) failure after procedure. Considering the specific alterations in the mitral valve in TAVR scenario and the widespread use of TAVR in recent years, it appears important to know and understand the anatomical, functional and clinical implications to develop adequate strategies for the future. Patients with severe mitral regurgitation (MR) have been generally excluded from randomized clinical trials, making poor the impact that associated MR can have on clinical outcomes after TAVR. Several factors must be considered whose presence influences the severity of MR. For example, the elevated prevalence of coronary disease with consequent ischemic MR may account for LV dilation observed at the end stage of aortic stenosis. Evidence randomized studies and registries suggests that the rate of concomitant moderate-to-severe MR in patients undergoing TAVR oscillates between 2% and 33%, and patients with moderate to severe MR may have hemodynamic frailty with clinical deterioration during mechanical intervention. Short- and long-term outcomes, including cardiac mortality, appear to be influenced by the existence of preoperative moderate-to-severe MR or by the postprocedural worsening of mild MR, generally due to adverse LV remodeling. The incidence and the prognostic effect of concomitant MR in patients undergoing TAVR requires specific attention as might trigger adjunctive strategy treatment which should be carefully evaluated in clinical trials.KeywordsMitral regurgitation (MR); mitral valve; transcatheter aortic valve; transcatheter aortic valve replacement (TAVR).
| S-EPMC7330403 | biostudies-literature
Project description:ImportanceThere are limited data on the outcomes of transcatheter edge-to-edge mitral valve repair for degenerative mitral regurgitation (MR) in a real-world setting.ObjectiveTo evaluate the outcomes of transcatheter mitral valve repair for degenerative MR.Design, setting, and participantsCohort study of consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent nonemergent transcatheter mitral valve repair for degenerative MR in the US from 2014 through 2022.ExposureTranscatheter edge-to-edge mitral valve repair with the MitraClip device (Abbott).Main outcomes and measuresThe primary end point was MR success, defined as moderate or less residual MR and a mean mitral gradient of less than 10 mm Hg. Clinical outcomes were evaluated based on the degree of residual MR (mild or less MR or moderate MR) and mitral valve gradients (≤5 mm Hg or >5 to <10 mm Hg).ResultsA total of 19 088 patients with isolated moderate to severe or severe degenerative MR who underwent transcatheter mitral valve repair were analyzed (median age, 82 years; 48% women; median Society of Thoracic Surgeons predicted risk of mortality with surgical mitral valve repair, 4.6%). MR success was achieved in 88.9% of patients. At 30 days, the incidence of death was 2.7%; stroke, 1.2%; and mitral valve reintervention, 0.97%. MR success compared with an unsuccessful procedure was associated with significantly lower mortality (14.0% vs 26.7%; adjusted hazard ratio, 0.49; 95% CI, 0.42-0.56; P < .001) and heart failure readmission (8.4% vs 16.9%; adjusted hazard ratio, 0.47; 95% CI, 0.41-0.54; P < .001) at 1 year. Among patients with MR success, the lowest mortality was observed in patients who had both mild or less residual MR and mean mitral gradients of 5 mm Hg or less compared with those with an unsuccessful procedure (11.4% vs 26.7%; adjusted hazard ratio, 0.40; 95% CI, 0.34-0.47; P < .001).Conclusions and relevanceIn this registry-based study of patients with degenerative MR undergoing transcatheter mitral valve repair, the procedure was safe and resulted in successful repair in 88.9% of patients. The lowest mortality was observed in patients with mild or less residual MR and low mitral gradients.
| S-EPMC10208157 | biostudies-literature
Project description:Transcatheter pulmonary valve replacement (tPVR) has evolved into a viable alternative to surgical conduit or bioprosthetic valve replacement. This procedure has paved the way for a more advanced approach to congenital and structural interventional cardiology. Although many successes have been noted, there are still a number of challenges with this procedure, including large delivery systems, the need for a conduit or a bioprosthetic valve as a landing zone for the valve, optimal timing of the procedure to prevent right ventricular failure, arrhythmias, and possible death. Research is ongoing to broaden the use of this technology when treating patients with dilated right ventricular outflow tracts, and early experience with a self-expanding valve model has been reported. Affordability is an important factor that must be considered especially in developing nations. The aim of this review is to emphasize the advancement of tPVR, the benefits and challenges of valve implantation, the current state, and the future innovations associated with this approach.
| S-EPMC4107445 | biostudies-literature
Project description:ObjectivesWe developed and tested a novel transcatheter circumferential annuloplasty technique to reduce mitral regurgitation in porcine ischemic cardiomyopathy.BackgroundCatheter-based annuloplasty for secondary mitral regurgitation exploits the proximity of the coronary sinus to the mitral annulus, but is limited by anatomic variants and coronary artery entrapment.MethodsThe procedure, "cerclage annuloplasty," is guided by magnetic resonance imaging (MRI) roadmaps fused with live X-ray. A coronary sinus guidewire traverses a short segment of the basal septal myocardium to re-enter the right heart where it is exchanged for a suture. Tension is applied interactively during imaging and secured with a locking device.ResultsWe found 2 feasible suture pathways from the great cardiac vein across the interventricular septum to create cerclage. Right ventricular septal re-entry required shorter fluoroscopy times than right atrial re-entry, which entailed a longer intramyocardial traversal but did not cross the tricuspid valve. Graded tension progressively reduced septal-lateral annular diameter, but not end-systolic elastance or regional myocardial function. A simple arch-like device protected entrapped coronary arteries from compression even during supratherapeutic tension. Cerclage reduced mitral regurgitation fraction (from 22.8 +/- 12.7% to 7.2 +/- 4.4%, p = 0.04) by slice tracking velocity-encoded MRI. Flexible cerclage reduced annular size but preserved annular motion. Cerclage also displaced the posterior annulus toward the papillary muscles. Cerclage introduced reciprocal constraint to the left ventricular outflow tract and mitral annulus that enhanced leaflet coaptation. A sample of human coronary venograms and computed tomography angiograms suggested that most have suitable venous anatomy for cerclage.ConclusionsTranscatheter mitral cerclage annuloplasty acutely reduces mitral regurgitation in porcine ischemic cardiomyopathy. Entrapped coronary arteries can be protected. MRI provided insight into the mechanism of cerclage action.
| S-EPMC3034128 | biostudies-literature
Project description:Introduction: Clinically significant severe tricuspid regurgitation (TR) is a common untreated pathology associated with increased mortality. Even though surgical valve replacement has been the mainstay option, transcatheter intervention is a novel and potentially effective tool. To the best of our knowledge, this is the first systematic review that assessed and compared clinical and echocardiographic outcomes of coaptation and annuloplasty devices in patients with clinically significant TR. Methods: PubMed, the Cochrane Central Register of Controlled Trials, and EMBASE were searched for articles published from August 2016 until February 2023. Primary endpoints were technical and procedural successes. Secondary endpoints were TR grade, NYHA, change in 6 min walk distance (6MWD), and echocardiographic parameters at 30-day follow-up. Results: We included thirty-eight studies consisting of 2273 patients with severe symptomatic TR (NYHA III-IV 77% and severe/massive/torrential TR 83.3%) and high surgical risk (mean EUROSCORE of 7.54). The technical success for the annuloplasty devices was 96.7% and for the coaptation device was 94.8%. The procedural success for the annuloplasty devices was 64.6% and for the coaptation device was 81.4%. The 6MWD increased by 17 m for the coaptation devices and increased by 44 m after 30 days for the annuloplasty devices. A reduction in TR grade to <2 was seen in 70% of patients with coaptation and 59% of patients with annuloplasty devices. Conclusions: Transcatheter tricuspid valve intervention appears to be feasible and is associated with favorable outcomes.
| S-EPMC11546873 | biostudies-literature
Project description:BackgroundAortic regurgitation (AR) is a condition associated with significant morbidity and mortality, particularly in severe cases. The J-Valve system, next-generation transcatheter heart valve, may overcome the procedural challenges associated with treating pure AR. This study reported the outcome of use of the J-Valve for treatment of AR.MethodsThis study observed 47 patients undergoing transcatheter aortic valve implantation (TAVI) with the J-Valve system. Diagnostic evaluation included transthoracic echocardiography and multislice computed tomography to assess AR severity and anatomic characteristics essential for TAVI. Follow-up evaluations were conducted at various intervals postoperation to evaluate outcomes.ResultsThe patients had a mean age of 73.0 ± 9.0 years and a median ejection fraction of 58.0% (interquartile range, 45.0%-64.0%). The median European System for Cardiac Operative Risk Evaluation (EuroSCORE II) was 3.0% (interquartile range, 2.0%-6.7%). The procedural success rate was 100%, with no need for a second valve implantation or conversion to sternotomy. Short-term outcomes showed significant improvements in the New York Heart Association functional classification (P < 0.001), the left ventricular ejection fraction (P = 0.009), and the left ventricular end-diastolic diameter (P < 0.001). A singular case of valve migration and severe perivalvular leakage due to Behçet's disease prompted a revised approach incorporating immunomodulation therapy.ConclusionsTAVI with the J-Valve system presents a viable alternative for managing severe AR, demonstrating high procedural success and substantial clinical improvement. However, the case of valve migration due to Behçet's disease highlights the need for careful preoperative screening and consideration of autoimmune disorders in differential diagnoses.
| S-EPMC11886369 | biostudies-literature