Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

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).

A novel method of prosthetic leaflet modification to enable transcatheter mitral valve-in-valve replacement.

Left ventricular outflow tract (LVOT) obstruction from the displaced prosthetic anterior mitral leaflet is a life-threatening complication that can occur during valve-in-valve (ViV) transcatheter mitral valve replacement (TMVR). Laceration of the anterior mitral leaflet to prevent outflow obstruction is a well-established transcatheter technique to mitigate the risk of LVOT obstruction in high-risk anatomies. In this report, we present a novel transseptal technique of prosthetic leaflet modification to prevent LVOT obstruction during ViV TMVR.

The Added Value of Preprocedural Cardiac Computed Tomography in Planning Left Atrial Appendage Closure With the Watchman FLX Device.

•Cardiac computed tomography (CCT) can be used as a useful complementary tool in preprocedural planning of left atrial appendage closure.•CCT planning includes assessing exclusion criteria, device sizing, sheath selection, anticipating challenging anatomies, and transseptal puncture planning.•Procedural 3D intracardiac echocardiography (3D-ICE) is increasingly being used instead of transesophageal echocardiography. In this setting, preprocedural CCT is useful to compensate for 3D ICE's reduced resolution.

1-Year Outcomes of Transcatheter Tricuspid Valve Repair.

BACKGROUND: Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution. OBJECTIVES: The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR. METHODS: Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates. RESULTS: Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001). CONCLUSIONS: The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year. (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study [CLASP TR EFS]; NCT03745313).

Patient Selection for Mitral Transcatheter Edge-to-Edge Repair.

Mitral regurgitation (MR) is one of the most common valvular heart diseases, with many patients remaining non-suitable for surgical interventions. Transcatheter edge-to-edge repair (TEER) is a rapidly evolving procedure that allows safe and effective reduction of MR in high-risk patients. However, adequate patient selection through clinical assessment and imaging modalities remains a key factor for procedural success. In the following review, we highlight recent developments in TEER technologies that are expanding the target population and currently available imaging modalities that allow detailed evaluation of the mitral valve and surrounding structures for optimal patient selection.

Ross procedure after prosthetic valve thrombosis in a patient with antiphospholipid syndrome and recurrent bleeding.

The Ross procedure allows replacement of a diseased aortic valve with pulmonary root autograft, possibly avoiding the highly thrombotic mechanical valves and immunologic deterioration of tissue valves in antiphospholipid syndrome (APS). Here, we present the use of the Ross procedure in a 42-year-old woman with mild intellectual disability, APS, and a complex anticoagulation history after she presented with thrombosis of her mechanical On-X aortic valve previously implanted for non-bacterial thrombotic endocarditis.

Role of Cardiac Computed Tomography in Planning Transcatheter Mitral Valve Replacement (TMVR).

PURPOSE OF REVIEW: Transcatheter mitral valve replacement (TMVR) is an evolving and rapidly expanding field within structural interventions, offering renewed treatment options for patients with high-risk mitral valve disease. We aim to highlight and illustrate the importance of cardiac CT in the planning of TMVR. RECENT FINDINGS: As TMVR has evolved, so has the specific nuances of cardiac CT planning, we now understand the importance of accurate annular sizing and valve simulation to predict complications such as neo-LVOT obstruction and paravalvular leak (PVL). More so than any other modality, cardiac CT remains instrumental in accurately planning TVMR from feasibility, device sizing, access, and fluoroscopic angles. Cardiac CT remains the key modality in TMVR evaluation, often the first step in determining patient eligibility through comprehensive procedural planning as well as informing potential outcomes and prognosis. In this review, we discuss the critical role of cardiac computed tomography (CT) and the specific considerations involved in TMVR.

Postdischarge-to-30-Day Mortality Among Patients Receiving MitraClip: A Systematic Review and Meta-Analysis.

Background: MitraClip (MC) implantation is the recommended treatment for severe symptomatic mitral regurgitation in patients not responding to medical therapy and at prohibitive surgical risk. It is important to quantify immediate mortality during postdischarge-to-30-day period so as to improve the procedural outcomes. Hence, we aim to identify the incidence of postdischarge-to-30-day mortality and its associated predictors using the technique of meta-analysis. Methods: We searched Medline, Embase, and Cochrane CENTRAL databases from inception until July 3, 2019 for studies reporting mortality prior to discharge, at 30 days and 1 year after MC implantation. The primary outcome was postdischarge-to-30-day all-cause mortality. Results: Of 2394 references, 15 studies enrolling 7498 patients were included. Random effects analysis showed that all-cause cumulative inpatient, 30-day, and 1-year mortality was 2.40% (2.08, 2.77; I2 = 0%), 4.31% (3.64, 5.09, I2 = 41.9%), and 20.71% (18.32; 23.33, I2 = 81.5%), respectively. The postdischarge-to-30-day mortality was 1.70% (95% confidence interval: 1.0, 2.70; I2 = 84%). A total of 71.50% of deaths (95% confidence interval: 36.80-91.50, I2 = 63%) in the postdischarge-to-30-day period were due to cardiac etiology. On meta-regression, pre-MC left ventricular ejection fraction (p = 0.003), Log.Euroscore (p = 0.047), Society of Thoracic Surgeons Predicted Risk of Mortality (p < 0.001), and prolonged ventilation >48 ​hours (p < 0.001) were found to be its significant predictors. Conclusions: Our meta-analysis reports an additional mortality of ∼2% immediately after MC implantation during the postdischarge-to-30-day period. Majority of deaths occurred due to cardiac causes. Pre-MC left ventricular ejection fraction, Log.Euroscore, Society of Thoracic Surgeons Predicted Risk of Mortality score, and prolonged ventilation were found to be its significant predictors. Further studies are needed to better understand the causes of this early mortality to maximize benefits of this important therapy.

Periprocedural Echocardiographic Guidance of Transcatheter Mitral Valve Edge-to-Edge Repair Using the MitraClip.

Transcatheter edge-to-edge mitral valve repair is a minimally invasive treatment option for selected patients with moderate to severe or severe mitral regurgitation. Although transcatheter edge-to-edge mitral valve repair offers a significant step forward in the management of mitral regurgitation, the rate of procedural-related complications is not trivial. High-quality periprocedural imaging is important for optimal patient selection and procedural success. In this review, we present a step-by-step approach of the recommended echocardiographic views for transcatheter edge-to-edge mitral valve repair.

Severe Atrial Functional Mitral Regurgitation: Clinical and Echocardiographic Characteristics, Management and Outcomes.

OBJECTIVES: This study was designed to compare the clinical and echocardiographic characteristics, management, and outcomes of severe atrial functional mitral regurgitation (AFMR) to primary mitral regurgitation (PMR). BACKGROUND: AFMR remains poorly defined clinically. METHODS: Consecutive patients who underwent transesophageal echocardiography at our institution between 2011 and 2018 for severe mitral regurgitation with preserved left ventricular function were screened. We excluded patients with endocarditis, any form of cardiomyopathy, or prior mitral intervention. The absence of leaflet pathology defined AFMR. Outcomes included death and heart failure hospitalizations. RESULTS: A total of 283 patients were included (AFMR = 14%, PMR = 86%). Compared to PMR, patients with AFMR had more comorbidities, including hypertension (94.9% vs. 76.2%; p = 0.015), diabetes mellitus (46.2% vs. 18.4%; p < 0.001), long-standing atrial fibrillation (28.2% vs. 13.1%; p = 0.015), prior nonmitral cardiac surgery (25.6% vs. 9.8%; p = 0.004), and pacemaker placement (33.3% vs. 13.5%; p = 0.002). They also had higher average E/e' (median [interquartile range]:16.04 [13.1 to 22.46] vs. 14.1 [10.89 to 19]; p = 0.036) and worse longitudinal left atrial strain peak positive value (16.86 ± 12.15% vs. 23.67 ± 14.09%; p = 0.002) compared to PMR. During follow-up (median: 22 months), patients with AFMR had worse survival (log-rank p = 0.009) and more heart failure hospitalizations (log-rank p = 0.002). They were also less likely to undergo mitral valve intervention (59.0% vs. 83.6%; p = 0.001), although surgery was associated with improved survival (log-rank p = 0.021). On multivariable regression analysis, AFMR was independently associated with mortality [adjusted odds ratio: 2.61, 95% confidence interval: 1.17 to 5.83; p = 0.02]. CONCLUSIONS: AFMR constitutes an under-recognized high-risk group, with significant comorbidities, limited therapeutic options, and poor outcomes.