Severe tricuspid regurgitation is a debilitating condition that is associated with substantial morbidity and often with poor quality of life. Decreasing tricuspid regurgitation may reduce symptoms ...and improve clinical outcomes in patients with this disease.
We conducted a prospective randomized trial of percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation. Patients with symptomatic severe tricuspid regurgitation were enrolled at 65 centers in the United States, Canada, and Europe and were randomly assigned in a 1:1 ratio to receive either TEER or medical therapy (control). The primary end point was a hierarchical composite that included death from any cause or tricuspid-valve surgery; hospitalization for heart failure; and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an improvement defined as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of tricuspid regurgitation and safety were also assessed.
A total of 350 patients were enrolled; 175 were assigned to each group. The mean age of the patients was 78 years, and 54.9% were women. The results for the primary end point favored the TEER group (win ratio, 1.48; 95% confidence interval, 1.06 to 2.13; P = 0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The KCCQ quality-of-life score changed by a mean (±SD) of 12.3±1.8 points in the TEER group, as compared with 0.6±1.8 points in the control group (P<0.001). At 30 days, 87.0% of the patients in the TEER group and 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (P<0.001). TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days.
Tricuspid TEER was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life. (Funded by Abbott; TRILUMINATE Pivotal ClinicalTrials.gov number, NCT03904147.).
Severe mitral regurgitation is associated with impaired prognosis if left untreated. Using the devices currently available, transcatheter mitral valve repair (TMVr) remains challenging in complex ...anatomical situations. We report the procedural and 30-day results of the first-in-man study of the Edwards PASCAL TMVr system.
In this multicentre, prospective, observational, first-in-man study, we collected data from seven tertiary care hospitals in five countries that had a compassionate use programme in which patients underwent transcatheter mitral valve repair using the Edwards PASCAL TMVr system. Eligible patients were those with symptomatic, severe functional, degenerative, or mixed mitral regurgitation deemed at high risk or inoperable. Safety and efficacy of the procedure were prospectively assessed at device implantation, discharge, and 30 days after device implantation. The key study endpoints were technical success assessed at the end of the procedure and device success 30 days after implantation using the Mitral Valve Academic Research Consortium definitions.
Between Sept 1, 2016, and March 31, 2017, 23 patients (median age 75 years IQR 61–82) had treatment for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the Edwards PASCAL TMVr system. At baseline, the median EuroScore II score was 7·1% (IQR 3·6–12·8) and the median Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair was 4·8% (2·1–9·0) and 6·8% (2·9–10·1) for mitral valve replacement. 22 (96%) of 23 patients were New York Heart Association (NYHA) class III or IV at baseline. The implantation of at least one device was successful in all patients, resulting in procedural residual mitral regurgitation of grade 2+ or less in 22 (96%) patients. Six (26%) of 23 patients had two implants. Periprocedural complications occurred in two (9%) of 23 patients (one minor bleeding event and one transient ischaemic attack). Despite the anatomical complexity of mitral regurgitation in the patients in this compassionate use cohort, technical success was achieved in 22 (96%) of 23 patients, and device success at 30 days was achieved in 18 (78%) patients. Three patients (13%) died during the 30 day follow-up. 19 (95%) of 20 patients alive 30 days after implantation were NYHA class I or II.
This study establishes feasibility of the Edwards PASCAL TMVr system with a high rate of technical success and reduction of mitral regurgitation severity. Further research is needed on procedural and long-term clinical outcomes.
None.
Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR).
This study sought to compare the outcomes of TAVR ...with early- and new-generation devices in symptomatic patients with pure native AR.
From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices.
A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001).
Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.
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Background:The aim of this study was to clarify the clinical outcomes of patients with atrial functional mitral regurgitation (FMR) who underwent the MitraClip procedure compared with those with ...conventional FMR and sinus rhythm (SR).Methods and Results:Of 303 patients with FMR who underwent the MitraClip procedure, 40 with “atrial-FMR” defined as FMR with permanent atrial fibrillation and normal left ventricular (LV) function/size and 115 with “sinus-FMR” defined as FMR with SR and LV dysfunction were reviewed. Transthoracic and 3D transesophageal echocardiography, and the cardiac complication rate (composite of all-cause death, heart failure admission, mitral valve (MV) surgery, and redo MitraClip procedure) during the 12-month follow-up were compared between the groups. After the MitraClip procedure, reductions in the mitral annular area and its anteroposterior dimension and in the leaflet closure area were observed in both groups. MV orifice area was smaller with greater transmitral pressure gradient (P<0.05) after the procedure in atrial-FMR patients than in those with sinus-FMR. The prevalence of residual MR was similar, but significant tricuspid regurgitation (TR) was more prevalent in the atrial-FMR group at follow-up. Cardiac complication rate was comparable between groups (20% vs. 25%, P=0.63).Conclusions:Reduction of MR occurred in atrial-FMR probably because of the increase in leaflet coaptation area. Significant TR was more common after the MitraClip procedure in patients with atrial-FMR than with sinus-FMR. However, mid-term outcomes were comparable between patients with atrial-FMR and sinus-FMR.
Objectives This study compared cross-sectional three-dimensional (3D) transesophageal echocardiography (TEE) to two-dimensional (2D) TEE as methods for predicting aortic regurgitation after ...transcatheter aortic valve replacement (TAVR). Background Data have shown that TAVR sizing using cross-sectional contrast computed tomography (CT) parameters is superior to 2D-TEE for the prediction of paravalvular aortic regurgitation (AR). Three-dimensional TEE can offer cross-sectional assessment of the aortic annulus but its role for TAVR sizing has been poorly elucidated. Methods All patients had severe symptomatic aortic stenosis and were treated with balloon-expandable TAVR in a single center. Patients studied had both 2D-TEE and 3D imaging (contrast CT and/or 3D-TEE) of the aortic annulus at baseline. Receiver-operating characteristic curves were generated for each measurement parameter using post-TAVR paravalvular AR moderate or greater as the state variable. Results For the 256 patients studied, paravalvular AR moderate or greater occurred in 26 of 256 (10.2%) of patients. Prospectively recorded 2D-TEE measurements had a low discriminatory value (area under the curve = 0.52, 95% confidence interval: 0.40 to 0.63, p = 0.75). Average cross-sectional diameter by CT offered a high degree of discrimination (area under the curve = 0.82, 95% confidence interval: 0.73 to 0.90, p < 0.0001) and mean cross-sectional diameter by 3D-TEE was of intermediate value (area under the curve = 0.68, 95% confidence interval: 0.54 to 0.81, p = 0.036). Conclusions Cross-sectional 3D echocardiographic sizing of the aortic annulus dimension offers discrimination of post-TAVR paravalvular AR that is significantly superior to that of 2D-TEE. Cross-sectional data should be sought from 3D-TEE if good CT data are unavailable for TAVR sizing.
There is scarce data on transcatheter edge-to-edge repair (TEER) for chronic functional mitral regurgitation (FMR) in the setting of very severe left ventricular dysfunction (LVD), defined by a left ...ventricular ejection fraction (LVEF) of <20%.
We retrospectively explored periprocedural characteristics and one-year clinical and echocardiographic outcomes of consecutive patients with chronic FMR and very severe LVD who underwent an isolated, first-time TEER. The composite of all-cause mortality or heart failure hospitalizations constituted the primary outcome.
Ninety-six patients (median age 69 IQR, 55-76 years, 64 (66.7%) males, median LVEF 15 IQR, 12-17 %) were included. In 47 (49.0%), TEER was performed urgently or in the setting of hemodynamic instability. Almost all procedures (98.0%) were technically successful, leading to ≤moderate MR in 94.7% and 90.7% of cases by 1-month and 1-year, respectively. New York Heart Association class ≤II was maintained in 60.0% of patients. One-year survival and freedom from the primary outcome were 74.0% and 50.0%, respectively. Functional and echocardiographic improvement compared to baseline was independent of procedural urgency, hemodynamic stability, and downstream left ventricular assist device implantation / heart transplantation (n = 12). Mortality was not predicted by COAPT exclusion criteria, nor was the primary outcome discriminated by published risk models.
TEER for chronic FMR is feasible, safe, and efficacious in selected patients with very severe LVD. Preprocedural risk stratification in this population may be optimized.
Abstract Percutaneous edge-to-edge repair using the MitraClip system causes reduction of mitral valve area (MVA). However, its clinical impact is not fully elucidated. This study assessed the impact ...of postprocedural MVA reduction on pulmonary hypertension and outcomes. A total of 92 patients with grades 3 to 4+ mitral regurgitation (MR) who underwent MitraClip therapy were retrospectively reviewed. Using intraprocedural 3-dimensional transesophageal echocardiography (3DTEE), postprocedural MVA was obtained by 2 optimized planes through the medial and lateral orifices of the repaired valve. MVA was reduced by 60.1% immediately after MitraClip procedure (p <0.001). Postprocedural MVA correlated moderately with mean transmitral pressure gradient (TMPG) in the majority of patients (r = −0.56, p < 0.001), but discordance of MVA and TMPG was observed in 40% of patients. In multivariable linear regression analysis, postprocedural MVA ≤1.94 cm2 was independently associated with a blunted decrease of systolic pulmonary artery pressure at 1-month follow-up (β-estimate -4.63, 95% confidence interval -9.71 to -0.15, p = 0.042). Postprocedural MVA ≤1.94 cm2 was an independent predictor of all-cause mortality and heart failure hospitalization after MitraClip (hazard ratio 4.28, 95% confidence interval 1.56 to 11.7, p = 0.005) even after adjustment for age, gender, atrial fibrillation, etiology of MR, left ventricular systolic function, preexisting pulmonary hypertension, and residual MR. After further adjustment for TMPG ≥5 mm Hg, postprocedural MVA ≤1.94 cm2 remained predictive for adverse outcomes (p = 0.048). In conclusion, the intraprocedural assessment of MVA by 3DTEE can predict hemodynamic response and postprocedural prognosis after MitraClip therapy.
There are limited data on the outcomes of transcatheter edge-to-edge mitral valve repair for degenerative mitral regurgitation (MR) in a real-world setting.
To evaluate the outcomes of transcatheter ...mitral valve repair for degenerative MR.
Cohort 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.
Transcatheter edge-to-edge mitral valve repair with the MitraClip device (Abbott).
The 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).
A 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).
In 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.
Achieving minimal residual mitral regurgitation (MR) after percutaneous MitraClip repair is limited by iatrogenic mitral stenosis. It is unknown whether allowing moderately elevated postprocedural ...mean mitral gradients (MMGs) to achieve < moderate residual MR is preferable to moderate residual regurgitation. Patients with less-than-moderate residual MR but a MMG of ≥5 mm Hg (Group 1) were compared with patients with moderate residual MR (Group 2). The primary end point was heart failure hospitalization. Secondary end points included mortality, subsequent mitral valve surgery, and MR at 1 year. Seventy-eight patients were included in the study. Group 1 included 48 patients (median MMG 6, interquartile range 5–6 mm Hg). Group 2 included 30 patients (median MMG 3.5, interquartile range 2–5 mm Hg). Age, baseline MR severity, and type of MR were not different between groups. Freedom from heart failure hospitalization at 1 year was 91.2 ± 4.2% in Group 1 versus 70.8 ± 8.7% in Group 2 (p = 0.021). Achieved differences in MR reduction between groups persisted at 1 year (p = 0.007). Survival was not different (p = 0.402), and subsequent mitral valve surgery occurred in 4 of 48 (8%) and in 4 of 30 patients (13%) in Group 1 and Group 2, respectively (p = 0.476). By multivariate Cox regression analysis, less-than-moderate residual MR, despite moderately elevated mitral gradients, was associated with a hazard ratio of 0.21 (95% confidence interval 0.04 to 0.96) for subsequent heart failure hospitalization (p = 0.044). In conclusion, patients with less-than-moderate residual MR despite a MMG of ≥5 had a 79% reduction in hazard for subsequent heart failure hospitalization compared with patients with moderate residual MR.
Multidetector computed tomography (MDCT) can provide valuable information for mitral assessment, but its role in transcatheter mitral edge-to-edge repair (TEER) planning has been poorly elucidated. ...We aimed to compare MDCT with 3-dimensional transesophageal echocardiography (3D-TEE) for TEER preprocedural evaluation. We analyzed the preprocedural MDCT and 3D-TEE of 108 consecutive patients with mitral regurgitation (MR) who underwent MitraClip implantation. The levels of agreement for the etiology and mechanism of MR, mitral calcification, mitral annulus, and mitral valve orifice area (MVOA) measurements were compared between MDCT and 3D-TEE data. Receiver-operating-characteristic curves were generated for mitral annulus area and MVOA using a low mean transmitral pressure gradient at discharge (<5 mm Hg) as the state variable, and the primary outcome of all-cause mortality or rehospitalization for heart failure at 1 year was compared between MDCT's and 3D-TEE's MVOA <4-cm2 cutoff. Good levels of agreement between MDCT and 3D-TEE were observed for determining the etiology (κ = 0.81) and mechanism (κ = 0.62) of MR but not for grading mitral calcification (κ = 0.31 to 0.35). The correlations between MDCT and 3D-TEE measurements were strong for mitral annulus area (r = 0.90) and good for MVOA (r = 0.73). Furthermore, no significant differences in the area under the receiver-operating-characteristic curve to predict low transmitral pressure gradient at discharge or the primary outcome at 1 year were detected between MDCT- and 3D-TEE-derived parameters (all p >0.05). In conclusion, in patients who underwent TEER with MitraClip, a high degree of agreement for comprehensive evaluation of MR and prediction of clinical outcomes between MDCT and 3D-TEE was observed.
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