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2.
Article in English | MEDLINE | ID: mdl-38693866

ABSTRACT

AIMS: Evaluation of left and right ventricular longitudinal systolic function may enhance risk stratification following aortic valve replacement (AVR). The study objective was to evaluate the changes in left and right ventricular longitudinal systolic function and RV-pulmonary artery (RV-PA) coupling from baseline to 30-days and 1-year after aortic valve replacement (AVR). METHODS AND RESULTS: LV longitudinal strain (LS), tricuspid annulus plane systolic excursion (TAPSE), and RV-PA coupling were evaluated in patients from the PARTNER-2A surgical AVR (SAVR) arm (n=985) and from the PARTNER-2 SAPIEN-3 registry (n=719). TAPSE and RV-PA coupling decreased significantly following SAVR, but remained stable following TAVR. Lower LV LS, TAPSE, or RV-PA coupling at baseline were associated with increased risk of the composite of death, hospitalization, and stroke at 5-years (Adjusted-HRs for LV LS<15%: 1.24 95%CI 1.05-1.45, p=0.001; TAPSE<14mm: 1.44 95%CI 1.21-1.73, p<0.001; RV/PA coupling<0.55mm/mmHg: 1.32 95% CI 1.07-1.63, p=0.011). Reduced TAPSE at baseline was the most powerful predictor of the composite endpoint at 5-years. Patients with LV ejection fraction <50% at baseline had increased risk of the primary endpoint with SAVR (HR: 1.34, 95%CI 1.08-1.68, p=0.009) but not with TAVR (HR: 1.12, 95%CI 0.88-1.42). Lower RV-PA coupling at 30-days showed the strongest association with cardiac mortality. CONCLUSION: SAVR but not TAVR was associated with a marked deterioration in RV longitudinal systolic function and RV-PA coupling. Lower TAPSE and RV-PA coupling at 30-days were associated with inferior clinical outcomes at 5-years. In patients with LVEF<50%, TAVR was associated with superior 5-year outcomes.

3.
J Am Coll Cardiol ; 83(20): 2002-2014, 2024 May 21.
Article in English | MEDLINE | ID: mdl-38749619

ABSTRACT

Orthotopic transcatheter tricuspid valve replacement (TTVR) devices have been shown to be highly effective in reducing tricuspid regurgitation (TR), and interest in this therapy is growing with the recent commercial approval of the first orthotopic TTVR. Recent TTVR studies report preexisting cardiac implantable electronic device (CIED) transvalvular leads in ∼35% of patients, with entrapment during valve implantation. Concerns have been raised regarding the safety of entrapping leads and counterbalanced against the risks of transvenous lead extraction (TLE) when indicated. This Heart Valve Collaboratory consensus document attempts to define the patient population with CIED lead-associated or lead-induced TR, describe the risks of lead entrapment during TTVR, delineate the risks and benefits of TLE in this setting, and develop a management algorithm for patients considered for TTVR. An electrophysiologist experienced in CIED management should be part of the multidisciplinary heart team and involved in shared decision making.


Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Tricuspid Valve Insufficiency , Humans , Tricuspid Valve Insufficiency/surgery , Defibrillators, Implantable/adverse effects , Pacemaker, Artificial/adverse effects , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/adverse effects , Severity of Illness Index
4.
JACC Cardiovasc Interv ; 17(7): 837-858, 2024 Apr 08.
Article in English | MEDLINE | ID: mdl-38599687

ABSTRACT

Severe tricuspid regurgitation (TR) is a progressive condition associated with substantial morbidity, poor quality of life, and increased mortality. Patients with TR commonly have coexisting conditions including congestive heart failure, pulmonary hypertension, chronic lung disease, atrial fibrillation, and cardiovascular implantable electronic devices, which can increase the complexity of medical and surgical TR management. As such, the optimal timing of referral for isolated tricuspid valve (TV) intervention is undefined, and TV surgery has been associated with elevated risk of morbidity and mortality. More recently, an unprecedented growth in TR treatment options, namely the development of a wide range of transcatheter TV interventions (TTVI) is stimulating increased interest and referral for TV intervention across the entire medical community. However, there are no stepwise algorithms for the optimal management of symptomatic severe TR before TTVI. This article reviews the contemporary assessment and management of TR with addition of a medical framework to optimize TR before referral for TTVI.


Subject(s)
Heart Valve Prosthesis Implantation , Tricuspid Valve Insufficiency , Humans , Tricuspid Valve Insufficiency/diagnostic imaging , Tricuspid Valve Insufficiency/surgery , Quality of Life , Treatment Outcome , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/surgery
5.
JACC Cardiovasc Interv ; 17(7): 859-870, 2024 Apr 08.
Article in English | MEDLINE | ID: mdl-38599688

ABSTRACT

BACKGROUND: Data on the prognostic role of the TRI-SCORE in patients undergoing transcatheter tricuspid valve intervention (TTVI) are limited. OBJECTIVES: The aim of this study was to evaluate the performance of the TRI-SCORE in predicting outcomes of patients undergoing TTVI. METHODS: TriValve (Transcatheter Tricuspid Valve Therapies) is a large multicenter multinational registry including patients undergoing TTVI. The TRI-SCORE is a risk model recently proposed to predict in-hospital mortality after tricuspid valve surgery. The TriValve population was stratified based on the TRI-SCORE tertiles. The outcomes of interest were all-cause death and all-cause death or heart failure hospitalization. Procedural complications and changes in NYHA functional class were also reported. RESULTS: Among the 634 patients included, 223 patients (35.2%) had a TRI-SCORE between 0 and 5, 221 (34.8%) had 6 or 7, and 190 (30%) had ≥8 points. Postprocedural blood transfusion, acute kidney injury, new atrial fibrillation, and in-hospital mortality were more frequent in the highest TRI-SCORE tertile. Postprocedure length of stay increased with a TRI-SCORE increase. A TRI-SCORE ≥8 was associated with an increased risk of 30-day all-cause mortality and all-cause mortality and the composite endpoint assessed at a median follow-up of 186 days (OR: 3.00; 95% CI: 1.38-6.55; HR: 2.17; 95% CI: 1.78-4.13; HR: 2.08, 95% CI: 1.57-2.74, respectively) even after adjustment for procedural success and EuroSCORE II or Society of Thoracic Surgeons Predicted Risk of Mortality. The NYHA functional class improved across all TRI-SCORE values. CONCLUSIONS: In the TriValve registry, the TRI-SCORE has a suboptimal performance in predicting clinical outcomes. However, a TRISCORE ≥8 is associated with an increased risk of clinical events and a lack of prognostic benefit after successful TTVI.


Subject(s)
Heart Failure , Heart Valve Prosthesis Implantation , Tricuspid Valve Insufficiency , Humans , Cardiac Catheterization/methods , Heart Failure/diagnosis , Heart Failure/therapy , Heart Failure/etiology , Treatment Outcome , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/surgery , Tricuspid Valve Insufficiency/diagnostic imaging , Tricuspid Valve Insufficiency/surgery , Multicenter Studies as Topic , Registries
7.
Eur Heart J ; 45(11): 895-911, 2024 Mar 14.
Article in English | MEDLINE | ID: mdl-38441886

ABSTRACT

Atrial secondary tricuspid regurgitation (A-STR) is a distinct phenotype of secondary tricuspid regurgitation with predominant dilation of the right atrium and normal right and left ventricular function. Atrial secondary tricuspid regurgitation occurs most commonly in elderly women with atrial fibrillation and in heart failure with preserved ejection fraction in sinus rhythm. In A-STR, the main mechanism of leaflet malcoaptation is related to the presence of a significant dilation of the tricuspid annulus secondary to right atrial enlargement. In addition, there is an insufficient adaptive growth of tricuspid valve leaflets that become unable to cover the enlarged annular area. As opposed to the ventricular phenotype, in A-STR, the tricuspid valve leaflet tethering is typically trivial. The A-STR phenotype accounts for 10%-15% of clinically relevant tricuspid regurgitation and has better outcomes compared with the more prevalent ventricular phenotype. Recent data suggest that patients with A-STR may benefit from more aggressive rhythm control and timely valve interventions. However, little is mentioned in current guidelines on how to identify, evaluate, and manage these patients due to the lack of consistent evidence and variable definitions of this entity in recent investigations. This interdisciplinary expert opinion document focusing on A-STR is intended to help physicians understand this complex and rapidly evolving topic by reviewing its distinct pathophysiology, diagnosis, and multi-modality imaging characteristics. It first defines A-STR by proposing specific quantitative criteria for defining the atrial phenotype and for discriminating it from the ventricular phenotype, in order to facilitate standardization and consistency in research.


Subject(s)
Atrial Fibrillation , Heart Failure , Tricuspid Valve Insufficiency , Humans , Female , Aged , Tricuspid Valve Insufficiency/etiology , Tricuspid Valve Insufficiency/complications , Heart Atria/diagnostic imaging , Tricuspid Valve/diagnostic imaging , Atrial Fibrillation/diagnosis , Atrial Fibrillation/etiology , Atrial Fibrillation/therapy
8.
Int J Cardiol ; 405: 131934, 2024 Jun 15.
Article in English | MEDLINE | ID: mdl-38437953

ABSTRACT

AIMS: T-TEER is an effective therapy for the treatment of tricuspid regurgitation (TR). However, the effects of leaflets clipping on tricuspid valve annulus (TA) have not been investigated in detail. The aim of this study is to investigate the effects of tricuspid transcatheter edge-to-edge repair (T-TEER) on TA diameter. METHODS AND RESULTS: The TriValve registry (Transcatheter Tricuspid Valve Therapies, NCT03416166) collected 556 patients from 22 European and North American centres undergoing transcatheter tricuspid valve interventions from 2016 to 2022. Patients undergoing T-TEER with available pre- and post-procedural data on TA diameter measured in the apical 4-chamber view on transthoracic echocardiography were selected for this study. Primary end-point was the reduction of TA diameter after T-TEER. A total of 186 patients were included in the study. In 115 patients (62%) TA diameter was reduced by at least 1 mm as compared to baseline. A significant reduction of TA dimension was observed following T-TEER (mean 2.3 mm [from pre-procedural diameter 46.7 mm to post-procedural diameter 44.4 mm], p < 0.001). In particular, the greatest reduction was observed in those with T-TEER in antero-septal commissure (mean 2.7 mm [from 47.1 mm to 44.4 mm], p < 0.001) as compared to those combining both antero-septal and postero-septal commissures (mean 1.4, from 46.0 mm to 44.6 mm, P = 0.06). A significant reduction of TA dimension was recorded in patients with 1 or 2 clips implanted but not in those patients with ≥3 clips implanted. CONCLUSIONS: In almost two third of patients T-TEER reduces TA diameter in addition to leaflet approximation. CONDENSED ABSTRACT: The effects of tricuspid transcatheter edge-to-edge repair (T-TEER) on tricuspid valve annulus (TA) have not been studied in details. This study investigates TA diameter as measured in apical 4-chamber view on transthoracic echocardiography before and after T-TEER. A total of 186 patients from the TriValve registry were included in the study. The study results show that 62% of patients have a TA reduction after T-TEER, especially in those receiving 1 or 2 clips in the antero-septal commissure. These suggest that T-TEER reduces tricuspid regurgitation not only by approximation of leaflets, but also by TA diameter reduction.


Subject(s)
Cardiac Catheterization , Registries , Tricuspid Valve Insufficiency , Tricuspid Valve , Humans , Male , Female , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/surgery , Aged , Tricuspid Valve Insufficiency/surgery , Tricuspid Valve Insufficiency/diagnostic imaging , Cardiac Catheterization/methods , Aged, 80 and over , Treatment Outcome , Heart Valve Prosthesis Implantation/methods , Middle Aged , Echocardiography/methods
11.
J Cardiovasc Comput Tomogr ; 18(3): 259-266, 2024.
Article in English | MEDLINE | ID: mdl-38383226

ABSTRACT

AIM: To identify anatomical computed tomography (CT) predictors of procedural and clinical outcomes in patients undergoing tricuspid transcatheter edge-to-edge repair (T-TEER). METHODS AND RESULTS: Consecutive patients undergoing T-TEER between March 2018 to December 2022 who had cardiac CT prior to the procedure were included. CT scans were automatically analyzed using a dedicated software that employs deep learning techniques to provide precise anatomical measurements and volumetric calculations. Technical success was defined as successful placement of at least one implant in the planned anatomic location without single leaflet device attachment. Procedural success was defined as tricuspid regurgitation reduction to moderate or less. Procedural complexity was assessed by measuring the fluoroscopy time. The clinical endpoint was a composite of death, heart failure hospitalization, or tricuspid re-intervention throughout two years. A total of 33 patients (63.6% male) were included. Procedural success was achieved in 22 patients (66.7%). Shorter end-systolic (ES) height between the inferior vena cava (IVC) and tricuspid annulus (TA) (r â€‹= â€‹- 0.398, p â€‹= â€‹0.044) and longer ES RV length (r â€‹= â€‹0.551, p â€‹= â€‹0.006) correlated with higher procedural complexity. ES RV length was independently associated with lower technical(adjusted Odds ratio [OR] 0.812 [95% CI 0.665-0.991], p â€‹= â€‹0.040) and procedural success (adjusted OR 0.766, CI [0.591-0.992], p â€‹= â€‹0.043). Patients with ES right ventricular (RV) length of >77.4 â€‹mm had a four-fold increased risk of experiencing the composite clinical endpoint compared to patients with ES RV length ≤77.4 â€‹mm (HR â€‹= â€‹3.964 [95% CI, 1.018-15.434]; p â€‹= â€‹0,034]). CONCLUSION: CT-derived RV length and IVC-to-TA height may be helpful to identify patients at increased risk for procedural complexity and adverse outcomes when undergoing T-TEER. CT provides valuable information for preprocedural decision-making and device selection.


Subject(s)
Cardiac Catheterization , Predictive Value of Tests , Tricuspid Valve Insufficiency , Tricuspid Valve , Humans , Male , Female , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/physiopathology , Tricuspid Valve/surgery , Aged , Tricuspid Valve Insufficiency/diagnostic imaging , Tricuspid Valve Insufficiency/surgery , Tricuspid Valve Insufficiency/physiopathology , Treatment Outcome , Risk Factors , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Retrospective Studies , Aged, 80 and over , Time Factors , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/adverse effects , Recovery of Function , Tomography, X-Ray Computed , Risk Assessment , Middle Aged
12.
Ann Thorac Surg ; 2024 Feb 03.
Article in English | MEDLINE | ID: mdl-38316377

ABSTRACT

BACKGROUND: Our objective was to compare the impact of patient-prosthesis mismatch (PPM) for 2 years after surgical aortic valve replacement within the prospective, randomized Placement of Aortic Transcatheter Valves (PARTNER) trials. METHODS: Surgical aortic valve replacement patients from the PARTNER 1, 2, and 3 trials were included. PPM was classified as moderate (indexed effective orifice area ≤0.85 cm2/m2) or severe (indexed effective orifice area ≤0.65 cm2/m2). The primary endpoint was the composite of all-cause death and heart failure rehospitalization at 2 years. RESULTS: By the predicted PPM method (PPMP), 59.1% had no PPM, 38.8% moderate PPM, and 2.1% severe PPM; whereas by the measured PPM method (PPMM), 42.4% had no PPM, 36.0% moderate, and 21.6% severe. Patients with no PPMP (23.6%) had a lower rate of the primary endpoint compared with patients with moderate (28.2%, P = .03) or severe PPMP (38.8%, P = .02). Using the PPMM method, there was no difference between the no (17.7%) and moderate PPMM groups (21.1%) in the primary outcome (P = .16). However, those with no PPMM or moderate PPMM were improved compared with severe PPMM (27.4%, P < .001 and P = .02, respectively). CONCLUSIONS: Severe PPM analyzed by PPMP was only 2.1% for surgical aortic valve replacement patients. The PPMM method overestimated the incidence of severe PPM relative to PPMP, but was also associated with worse outcome. There was higher all-cause mortality in patients with severe PPM, thus surgical techniques to minimize PPM remain critical.

13.
Circ Cardiovasc Imaging ; 17(2): e016409, 2024 02.
Article in English | MEDLINE | ID: mdl-38377238

ABSTRACT

Innovations in cardiac imaging have fundamentally advanced the understanding and treatment of cardiovascular disease. These advances in noninvasive cardiac imaging have also expanded the role of the cardiac imager and dramatically increased the demand for imagers who are cross-trained in multiple modalities. However, we hypothesize that there is significant variation in the availability of cardiac imaging expertise and a disparity in the adoption of advanced imaging technologies across the United States. To evaluate this, we have brought together the leaders of cardiovascular imaging societies, imaging trainees, as well as collaborated with national imaging accreditation commissions and imaging certification boards to assess the state of cardiac imaging and the diversity of the imaging workforce in the United States. Aggregate data confirm the presence of critical gaps, such as limited access to imaging and imaging expertise in rural communities, as well as disparities in the imaging workforce, notably among women and underrepresented minorities. Based on these results, we have proposed solutions to promote and maintain a robust and diverse community of cardiac imagers and improve equity and accessibility for cardiac imaging technologies.


Subject(s)
Cardiovascular Diseases , Minority Groups , Humans , Female , United States , Workforce , Multimodal Imaging , Cardiac Imaging Techniques
14.
J Thorac Dis ; 16(1): 26-39, 2024 Jan 30.
Article in English | MEDLINE | ID: mdl-38410607

ABSTRACT

Background: Systolic anterior motion (SAM) of the mitral valve can result in mitral regurgitation (MR) and adverse outcomes in patients with obstructive hypertrophic cardiomyopathy (HCM). However, the mechanism and characteristics of MR severity mediated by SAM are unresolved. This study aimed to elucidate the anatomic and hemodynamic associations of MR and the impact of septal myectomy on changes in MR severity in patients with HCM. Methods: We retrospectively reviewed patients who underwent septal myectomy with SAM and interpretable imaging between 2017-2022. Significant MR was defined as moderate or more MR. The mitral valve, papillary muscle, and left ventricular geometry were quantitatively evaluated via echocardiography and cardiac computed tomography. Results: Out of 34 patients, two groups were identified: those with preoperative significant MR (n=16) and those without significant MR (n=18). Patients with significant preoperative MR exhibited worse heart failure symptoms at baseline than those without. Following myectomy, these patients showed higher residual left ventricular outflow tract (LVOT) gradients at rest and with provocative measures than those without preoperative MR. Multivariate regression analysis revealed a significant association between the tenting area and MR severity. Additionally, the chordal cutting procedure alleviated the tenting area [2.1 (1.8-2.6) vs. 1.4 (1.2-1.6) cm2] compared to those without it. Conclusions: Our preliminary data suggested that chordal cutting with septal myectomy was associated with an improvement in the tenting area, contributing to MR severity. This procedure may serve as an effective therapy for patients with SAM and significant MR.

15.
Struct Heart ; 8(1): 100225, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38283566

ABSTRACT

Background: Baseline left ventricular diastolic dysfunction (LVDD) is associated with poor health status in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), but health status improvement after TAVR appears similar across all grades of LVDD. Here, we aim to examine the relationship between changes in LVDD severity and health status outcomes following TAVR. Methods: Patients who underwent TAVR and had evaluable LVDD at both baseline and 1 year in the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registries and PARTNER 3 trial were analyzed. LVDD grade was evaluated using echocardiography core lab data and an adapted definition of American Society of Echocardiography guidelines. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score. The association between ΔLVDD severity and ΔKCCQ-OS was examined using linear regression models adjusted for baseline KCCQ-OS. Results: Of 1100 patients, 724 (65.8%), 283 (25.7%), and 93 (8.5%) had grade 0/1, 2, and 3 LVDD at baseline, respectively. At 1 year, LVDD severity was unchanged in 790 (71.8%) patients, improved in 189 (17.2%), and worsened in 121 (11.0%). Among 376 patients with baseline grade 2 or 3 LVDD, 50.3% had improvement in LVDD. In the overall cohort, KCCQ-OS score improved by 21.9 points at 1 year. There was a statistically significant association between change in LVDD severity (improved, unchanged, and worsened) and ΔKCCQ-OS at 1 year (p = 0.007). Conclusions: Change in LVDD grade was associated with change in health status 1 year following TAVR.

16.
J Am Soc Echocardiogr ; 37(1): 2-63, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38182282

ABSTRACT

In patients with significant cardiac valvular disease, intervention with either valve repair or valve replacement may be inevitable. Although valve repair is frequently performed, especially for mitral and tricuspid regurgitation, valve replacement remains common, particularly in adults. Diagnostic methods are often needed to assess the function of the prosthesis. Echocardiography is the first-line method for noninvasive evaluation of prosthetic valve function. The transthoracic approach is complemented with two-dimensional and three-dimensional transesophageal echocardiography for further refinement of valve morphology and function when needed. More recently, advances in computed tomography and cardiac magnetic resonance have enhanced their roles in evaluating valvular heart disease. This document offers a review of the echocardiographic techniques used and provides recommendations and general guidelines for evaluation of prosthetic valve function on the basis of the scientific literature and consensus of a panel of experts. This guideline discusses the role of advanced imaging with transesophageal echocardiography, cardiac computed tomography, and cardiac magnetic resonance in evaluating prosthetic valve structure, function, and regurgitation. It replaces the 2009 American Society of Echocardiography guideline on prosthetic valves and complements the 2019 guideline on the evaluation of valvular regurgitation after percutaneous valve repair or replacement.


Subject(s)
Heart Valve Diseases , Heart , Adult , Humans , Magnetic Resonance Imaging , Echocardiography , Prostheses and Implants , Heart Valve Diseases/diagnosis , Heart Valve Diseases/surgery , Magnetic Resonance Spectroscopy
17.
Eur Heart J ; 45(5): 346-365, 2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38096587

ABSTRACT

The role of cardiac implantable electronic device (CIED)-related tricuspid regurgitation (TR) is increasingly recognized as an independent clinical entity. Hence, interventional TR treatment options continuously evolve, surgical risk assessment and peri-operative care improve the management of CIED-related TR, and the role of lead extraction is of high interest. Furthermore, novel surgical and interventional tricuspid valve treatment options are increasingly applied to patients suffering from TR associated with or related to CIEDs. This multidisciplinary review article developed with electrophysiologists, interventional cardiologists, imaging specialists, and cardiac surgeons aims to give an overview of the mechanisms of disease, diagnostics, and proposes treatment algorithms of patients suffering from TR associated with CIED lead(s) or leadless pacemakers.


Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Rheumatic Heart Disease , Tricuspid Valve Insufficiency , Humans , Pacemaker, Artificial/adverse effects , Defibrillators, Implantable/adverse effects , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/surgery , Tricuspid Valve Insufficiency/surgery , Tricuspid Valve Insufficiency/complications , Rheumatic Heart Disease/complications , Retrospective Studies
18.
JACC Cardiovasc Imaging ; 17(1): 79-95, 2024 01.
Article in English | MEDLINE | ID: mdl-37731368

ABSTRACT

Tricuspid regurgitation (TR) is a highly prevalent and heterogeneous valvular disease, independently associated with excess mortality and high morbidity in all clinical contexts. TR is profoundly undertreated by surgery and is often discovered late in patients presenting with right-sided heart failure. To address the issue of undertreatment and poor clinical outcomes without intervention, numerous structural tricuspid interventional devices have been and are in development, a challenging process due to the unique anatomic and physiological characteristics of the tricuspid valve, and warranting well-designed clinical trials. The path from routine practice TR detection to appropriate TR evaluation, to conduction of clinical trials, to enriched therapeutic possibilities for improving TR access to treatment and outcomes in routine practice is complex. Therefore, this paper summarizes the key points and methods crucial to TR detection, quantitation, categorization, risk-scoring, intervention-monitoring, and outcomes evaluation, particularly of right-sided function, and to clinical trial development and conduct, for both interventional and surgical groups.


Subject(s)
Heart Valve Prosthesis Implantation , Tricuspid Valve Insufficiency , Humans , Diagnostic Imaging , Predictive Value of Tests , Treatment Outcome , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/surgery , Tricuspid Valve Insufficiency/diagnostic imaging , Tricuspid Valve Insufficiency/surgery , Clinical Trials as Topic
20.
JACC Cardiovasc Imaging ; 17(5): 471-485, 2024 May.
Article in English | MEDLINE | ID: mdl-38099912

ABSTRACT

BACKGROUND: The CLASP IID randomized trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial) demonstrated the safety and effectiveness of the PASCAL system for mitral transcatheter edge-to-edge repair (M-TEER) in patients at prohibitive surgical risk with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: This study describes the echocardiographic methods and outcomes from the CLASP IID trial and analyzes baseline variables associated with residual mitral regurgitation (MR) ≤1+. METHODS: An independent echocardiographic core laboratory assessed echocardiographic parameters based on American Society of Echocardiography guidelines focusing on MR mechanism, severity, and feasibility of M-TEER. Factors associated with residual MR ≤1+ were identified using logistic regression. RESULTS: In 180 randomized patients, baseline echocardiographic parameters were well matched between the PASCAL (n = 117) and MitraClip (n = 63) groups, with flail leaflets present in 79.2% of patients. Baseline MR was 4+ in 76.4% and 3+ in 23.6% of patients. All patients achieved MR ≤2+ at discharge. The proportion of patients with MR ≤1+ was similar in both groups at discharge but diverged at 6 months, favoring PASCAL (83.7% vs 71.2%). Overall, patients with a smaller flail gap were significantly more likely to achieve MR ≤1+ at discharge (adjusted OR: 0.70; 95% CI: 0.50-0.99). Patients treated with PASCAL and those with a smaller flail gap were significantly more likely to sustain MR ≤1+ to 6 months (adjusted OR: 2.72 and 0.76; 95% CI: 1.08-6.89 and 0.60-0.98, respectively). CONCLUSIONS: The study used DMR-specific echocardiographic methodology for M-TEER reflecting current guidelines and advances in 3-dimensional echocardiography. Treatment with PASCAL and a smaller flail gap were significant factors in sustaining MR ≤1+ to 6 months. Results demonstrate that MR ≤1+ is an achievable benchmark for successful M-TEER. (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID]; NCT03706833).


Subject(s)
Cardiac Catheterization , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Mitral Valve , Predictive Value of Tests , Recovery of Function , Severity of Illness Index , Humans , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/physiopathology , Male , Female , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve/physiopathology , Treatment Outcome , Cardiac Catheterization/instrumentation , Cardiac Catheterization/adverse effects , Aged , Risk Factors , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/adverse effects , Time Factors , Aged, 80 and over , Heart Valve Prosthesis , Feasibility Studies , Risk Assessment , Prosthesis Design , Echocardiography, Three-Dimensional
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