First-in-Human Percutaneous Circumferential Annuloplasty for Secondary Tricuspid Regurgitation.
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ABSTRACT:
SUBMITTER: Reddy VY
PROVIDER: S-EPMC8299844 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundTo identify the association between tricuspid annular circumference and secondary tricuspid regurgitation and analyze the risk factors of recurrent tricuspid regurgitation after concomitant tricuspid annuloplasty during left heart surgery.MethodsFrom October 2018 to June 2019, a total of 117 patients receiving concomitant tricuspid annuloplasty within left heart surgery were enrolled. Severity of tricuspid regurgitation was classified as 4 subtypes: normal, mild, moderate and severe. Perioperative data and mid-term outcome were collected. Tricuspid annular circumference (TAC) was measured under cardiac arrest during surgery procedure by cardioplegia. Optimal TAC and TAC index (TAC/body surface area, BSA) cutoffs of significant tricuspid annulus dilatation (moderate and severe) were obtained. Univariable and multivariable logistic regression analyses were performed to identify the risk factors of postoperative recurrent tricuspid regurgitation. The follow up period is 13-19 months (mean 15.5?±?3.2 months).ResultsThere was 1 patient was excluded who died after surgery. A total of 116 patients receiving tricuspid annuloplasty were included. Optimal cutoffs of significant tricuspid annulus dilatation were recommended (TAC 11.45 cm, Sensitivity 82.89%, Specificity 73.68%, AUC 0.915; TAC index 7.09 cm/m2, Sensitivity 73.68%, Specificity 85%, AUC 0.825, respectively). Based on findings of multivariable logistic regression, it has been showed that TAC index and postoperative atrial fibrillation were the independent risk factors of recurrent regurgitation after surgery. Optimal TAC index cutoff to predict recurrent tricuspid regurgitation was 7.86 cm/m2 CONCLUSIONS: The severity of secondary tricuspid regurgitation is associated with the tricuspid annular circumference. The cut-offs of significant tricuspid regurgitation (more than moderate) were TAC 11.45 cm and TAC index 7.09 cm/m2, respectively. Clinically, concomitant tricuspid annuloplasty is relative safe and effective. TAC index???7.86 cm/m2 and postoperative atrial fibrillation are the risk factors of recurrent significant tricuspid regurgitation after concomitant tricuspid annuloplasty during left heart surgery.
| S-EPMC7836580 | biostudies-literature
Project description:ObjectivesWe report the first pledget-assisted suture tricuspid annuloplasty (PASTA) in a patient with torrential tricuspid regurgitation (TR).BackgroundTricuspid valve regurgitation is a common malignant disease with no commercially available transcatheter therapy. PASTA is a "percutaneous surgical" procedure using pledgeted sutures to create a double-orifice tricuspid valve.MethodsAn 83-year-old man had end-stage TR caused by a defibrillator lead. He consented to undergo PASTA on a compassionate basis. A double-orifice valve was created with pledgeted sutures from percutaneous right ventricular apical access.ResultsTR was reduced from torrential to trace. The vena contracta reduced to from 23 to 1 mm and annular area reduced from 1817 to 782 mm2 . However, the annulus dehisced and required closure with a percutaneous nitinol plug. The patient was discharged home and was alive 6 months later but with persistent symptoms.ConclusionsThe anatomy of a double-orifice valve can eliminate TR but a better solution is required to avoid excessive suture tension on annular tissue.
| S-EPMC7648719 | biostudies-literature
Project description:ObjectiveSurgical annuloplasty for functional tricuspid regurgitation (FTR) is on the rise and can be performed in several ways with varied outcomes. In this study, we sought to compare the hemodynamic outcomes of tricuspid annuloplasty performed with a commercially available annuloplasty ring (tricuspid valve annuloplasty [TVA]) compared with focal suture annuloplasty (Hetzer) in an experimental FTR model.MethodsAn ex vivo FTR model was developed by inducing right ventricular dilatation by acute afterload elevation, causing severe tricuspid valve tethering and annular dilatation, leading to regurgitation. Ten porcine hearts in which FTR was induced underwent TVA with a 26-mm Edwards MC3 ring and Hetzer annuloplasty with a pledgeted suture cinching the anteroposterior and septal annulus. FTR was measured before after each repair, and tenting geometry, valve kinematics, and subvalvular geometry were measured with echocardiography.ResultsAt baseline, none of the hearts had FTR, but upon afterload elevation an FTR volume of 17.7 ± 9.2 mL (26.38 ± 17.47% regurgitant fraction) was measured (P < .0001). TVA reduced regurgitation by 50% and Hetzer annuloplasty by 56% , respectively, but both left persistent FTR. Anteroseptal tenting area was 279.0 ± 158.9 mm2 before repair and decreased significantly to 147.2 ± 134.8 mm2 (P = .0195) with Hetzer but not with TVA. Posteroseptal tenting area was 425.1 ± 169.2 mm2 before repair and was significantly reduced by both techniques (TVA: 200.3 ± 102.9 mm2 [P = .0012]; Hetzer: 237.6 ± 127.6 mm2 [P = .0270]).ConclusionsTricuspid annuloplasty with a ring or a focal suture can reduce FTR but not eliminate it. Annular approaches did not relieve tricuspid valve tethering and reduced leaflet mobility persisted. Either subannular repairs or judicious use of valve replacement may be necessary.
| S-EPMC7921216 | biostudies-literature
Project description:Tricuspid regurgitation (TR) has a not negligible prevalence and its severity is correlated with poorer outcomes. However, surgical options are rarely offered to these patients because of their high surgical risk. Given that medical therapy plays a limited role in the management of these patients, there is an increasing clinical need for transcatheter treatment options. Although, transcatheter tricuspid valve interventions (TTVIs) are still at an early stage, emerging data suggests their clinical effectiveness and safety, with preliminary results highlighting the potential benefits of transcatheter treatments over medical therapy. In this review, we highlight the challenges and future directions of current and emerging technologies dedicated to the treatment of TR along with an analysis of the next steps required in future clinical trials and studies dedicated to the treatment of the forgotten valve.
| S-EPMC7591745 | biostudies-literature
Project description:A 27-year-old man admitted with tricuspid valve endocarditis with a large vegetation, persistent bacteremia, and pulmonary and systemic septic embolization was deemed not a suitable surgical candidate. He underwent percutaneous vegetation debulking using the AngioVac system. The patient defervesced post-operatively with clinical improvement but with abruptly worsened tricuspid regurgitation. (Level of Difficulty: Beginner.).
| S-EPMC8311153 | biostudies-literature
Project description:Functional tricuspid regurgitation (FTR) is frequent in patients with mitral valve disease. Untreated tricuspid regurgitation (TR) may cause poor clinical outcomes. The surgical factors involved in annuloplasty for FTR remain controversial. Our objective was to compare effectiveness of different tricuspid annuloplasty (TVP), and reveal the risk factors of recurrence.We analyzed the clinical details of 399 consecutive patients who underwent mitral surgery with concomitant TVP, from 2006 to 2011, in two Chinese single-centers. Three methods were used for TVP: De Vega surgery was completed in 242 patients; annuloplasty using a flexible band was completed in 98 patients; and surgery with a rigid ring was performed in 59 patients.The operative mortality rate was 2.3%. After surgery, the TR grade of all patients decreased significantly. At three years postoperatively, 13.7% of patients were diagnosed with recurrent FTR. At the three year time point, severe TR in the De Vega group was 18%, which was higher than those in the flexible (8.4%) and rigid planner ring groups (5.2%). During follow-up, the recurrent rates in the rigid group were significantly lower than in the flexible group. Multivariate analysis revealed that pre-operative atrial fibrillation, severe TR, large left atrial, ejection fraction (EF) < 40%, De Vega annuloplasty, and postoperative permanent pacemaker installation were independent risk factors for severe recurrent TR.Rigid ring annuloplasty efficaciously improved post-operative tricuspid valve function in patients with FTR. Atrial fibrillation, a large left atrium, low EF and postoperative permanent pacemaker installation were independent risk factors for severe recurrent TR.
| S-EPMC5497159 | biostudies-other
Project description:OBJECTIVES:This study sought to demonstrate transcatheter deployment of a circumferential device within the pericardial space to modify tricuspid annular dimensions interactively and to reduce functional tricuspid regurgitation (TR) in swine. BACKGROUND:Functional TR is common and is associated with increased morbidity and mortality. There are no reported transcatheter tricuspid valve repairs. We describe a transcatheter extracardiac tricuspid annuloplasty device positioned in the pericardial space and delivered by puncture through the right atrial appendage. We demonstrate acute and chronic feasibility in swine. METHODS:Transatrial intrapericardial tricuspid annuloplasty (TRAIPTA) was performed in 16 Yorkshire swine, including 4 with functional TR. Invasive hemodynamics and cardiac magnetic resonance imaging (MRI) were performed at baseline, immediately after annuloplasty and at follow-up. RESULTS:Pericardial access via a right atrial appendage puncture was uncomplicated. In 9 naïve animals, tricuspid septal-lateral and anteroposterior dimensions, the annular area and perimeter, were reduced by 49%, 31%, 59%, and 24% (p < 0.001), respectively. Tricuspid leaflet coaptation length was increased by 53% (p < 0.001). Tricuspid geometric changes were maintained after 9.7 days (range, 7 to 14 days). Small effusions (mean, 46 ml) were observed immediately post-procedure but resolved completely at follow-up. In 4 animals with functional TR, severity of regurgitation by intracardiac echocardiography was reduced. CONCLUSIONS:Transatrial intrapericardial tricuspid annuloplasty is a transcatheter extracardiac tricuspid valve repair performed by exiting the heart from within via a transatrial puncture. The geometry of the tricuspid annulus can interactively be modified to reduce severity of functional TR in an animal model.
| S-EPMC4524739 | biostudies-literature
Project description:Mitral regurgitation is frequently associated with ventricular dysfunction and carries a high mortality. Guideline-directed medical therapy, surgical mitral valve repair or replacement, and, in the setting of advanced heart failure, heart transplant and left ventricular assist devices have been the mainstay of treatment. However, rapid advancement in the field has resulted in approval of edge-to-edge mitral valve repair with the MitraClip, and there are several novel catheter-based percutaneous options in clinical trials. Percutaneous options, while promising, must be deployed in patients who are most likely to benefit, and thus, understanding the pathophysiology of specific subgroups of patients with functional mitral regurgitation (eg, disproportionate versus proportionate mitral regurgitation) is key to the success of new devices. We review the pathophysiology, percutaneous therapeutic treatment options, and ongoing clinical trials for functional mitral regurgitation.
| S-EPMC8207332 | biostudies-literature
Project description:Mitral regurgitation (MR) is a frequent valvular disease among patients deemed too high risk for surgery. Echocardiography along with CT is the primary diagnostic tool for MR and offers a comprehensive 3D assessment in patient selection and screening for the optimal treatment method. The direct percutaneous mitral annuloplasty addresses the underlying mechanisms of functional MR with a less invasive, catheter-based approach. The here-described techniques proved a sufficient safety profile, delivered significant MR reduction in most of the cases, and were associated with a notable improvement of symptoms. Although long-term outcome assessment is needed to support these early reports, the percutaneous mitral annuloplasty is likely to set a new standard of treatment in the forthcoming future.
| S-EPMC6855240 | biostudies-literature
Project description:AimsThe study sought to investigate the long-term outcome after transcatheter mitral valve annuloplasty for secondary mitral regurgitation (MR).Methods and resultsConsecutive patients with symptomatic secondary MR undergoing transcatheter mitral valve annuloplasty with the Carillon device at Leipzig University Hospital between 2012 and 2018 were studied prospectively. Left ventricular (LV) function and MR severity were quantified by standardized echocardiography. 33 patients were included. Mean age was 75 ± 10 years, and 20 patients were women. A Society of Thoracic Surgeons score of 8.1 ± 7.2% indicated high-risk status. In 24 patients, MR resulted from LV remodelling and dysfunction, eight suffered from left atrial dilatation, and one patient had MR due to combined primary and secondary aetiology. LV ejection fraction at baseline was (median) 38% [inter-quartile range (IQR) 30-49%]. During the mean follow-up time of 45 ± 20 months, 17 patients died, two patients withdraw consent, and four patients were lost. Of the remaining patients, four were hospitalized for decompensated heart failure. Two of these patients underwent additional transcatheter edge-to-edge mitral valve repair. At follow-up, New York Heart Association (NYHA) functional class improved from 95% in Class III/IV at baseline to 70% in Class I/II with no patients in NYHA Class IV (P < 0.0001). Mitral regurgitant volume was reduced from 27 mL (IQR 25-42 mL) to 8 mL (IQR 3-17 mL) (P = 0.018) and regurgitant fraction from 42% (IQR 34-54%) to 11% (IQR 8-24%) (P = 0.014). LV end-diastolic volume index [92 mL/m2 (IQR 74-107 mL/m2 ) vs. 67 mL/m2 (IQR 46-101 mL/m2 ), P = 0.065] and end-systolic volume index [50 mL/m2 (IQR 44-69 mL/m2 ) vs. 32 mL/m2 (IQR 20-53 mL/m2 ), P = 0.037] decreased. Total stroke volume remained unchanged [38 mL/m2 (IQR 33-43 mL/m2 ) vs. 33 mL/m2 (IQR 26-44 mL/m2 ), P = 0.695], while LV ejection fraction increased [43% (IQR 35-49%) vs. 54% (IQR 46-57%), P = 0.014]. Forward stroke volume, heart rate, and forward cardiac output were not significantly altered.ConclusionsAmong high-risk patients undergoing transcatheter mitral valve annuloplasty for symptomatic secondary MR, mortality was ~50% at 4 years. In the surviving patients, reduced MR severity was associated with reduced NYHA functional class, reverse LV remodelling, and improved LV function.
| S-EPMC8318490 | biostudies-literature