Mortality Associated With Proportionality of Secondary Mitral Regurgitation After Transcatheter Mitral Valve Repair: North American Mitraclip for Functional Mitral Regurgitation Registry.

The association, if any, between the effective regurgitant orifice area (EROA) to left ventricular end-diastolic volume (LVEDV) ratio and 1-year mortality is controversial in patients who undergo mitral transcatheter edge-to-edge repair (m-TEER) with the MitraClip system (Abbott Vascular, Santa Clara, CA). This study's objective was to determine the association between EROA/LVEDV and 1-year mortality in patients who undergo m-TEER with MitraClip. In patients with severe secondary (functional) mitral regurgitation (MR), we analyzed registry data from 11 centers using generalized linear models with the generalized estimating equations approach. We studied 525 patients with secondary MR who underwent m-TEER. Most patients were male (63%) and were New York Heart Association class III (61%) or IV (21%). Mitral regurgitation was caused by ischemic cardiomyopathy in 51% of patients. EROA/LVEDV values varied widely, with median = 0.19 mm2/ml, interquartile range [0.12,0.28] mm2/ml, and 187 patients (36%) had values <0.15 mm2/ml. Postprocedural mitral regurgitation severity was substantially alleviated, being 1+ or less in 74%, 2+ in 20%, 3+ in 4%, and 4+ in 2%; 1-year mortality was 22%. After adjustment for confounders, the logarithmic transformation (Ln) of EROA/LVEDV was associated with 1-year mortality (odds ratio 0.600, 95% confidence interval 0.386 to 0.933, p = 0.023). A higher Society of Thoracic Surgeons risk score was also associated with increased mortality. In conclusion, lower values of Ln(EROA/LVEDV) were associated with increased 1-year mortality in this multicenter registry. The slope of the association is steep at low values but gradually flattens as Ln(EROA/LVEDV) increases.

Mitral Valve Transcatheter Edge-to-Edge Repair Volumes and Trends.

Background: Despite an association between operator volumes and procedural success, there remains an incomplete understanding of the contemporary utilization and procedural volumes for mitral valve transcatheter edge-to-edge repair (MTEER). We aimed to identify annual operator procedural volumes, temporal trends, and geographic variability for MTEER among Medicare patients in the United States (US). Methods: We queried the National Medicare Provider Utilization and Payment Database for a CPT code (33418) specific for MitraClip device from 2015 through 2019. We analyzed annual operator procedural volumes and incidence and identified longitudinal and geographic trends in MTEER utilization. Results: From 2015 through 2019, a total of 27,034 MTEER procedures were performed among Medicare patients in the US. The nationwide incidence increased from 6.2 per 100,000 patients in 2015 to 23.8 per 100,000 patients in 2019, a 283% increase over the study period (Ptrend < 0.001). The incidence of MTEER by state varied by nearly 900% (range 5.5 to 54.9 per 100,000 person-years). In 2019, the mean annual MTEER operator annual volume was 9.1 MTEER procedures and had grown from 6.2 per year in 2015. Conclusions: In this nationwide study of Medicare beneficiaries in the United States, we identified a significant and sustained increase in the utilization of MTEER devices and operators and growth in annual procedural volumes from 2015 through 2019 with considerable variability in utilization by state. Further studies are needed to understand the clinical impact of variability in utilization and the optimal procedural volumes to ensure high efficacy outcomes and maintain critical access to MTEER therapies.

Intermediate-Term Outcomes Following Transcatheter Aortic Valve Implantation in Patients with a History of Chest Radiation Therapy: A Propensity Score Matched Analysis.

Chest radiation therapy (XRT) has been associated with a higher rate of mortality following surgical aortic valve replacement. We performed a single-center retrospective analysis of patients with severe AS who underwent TAVI from January 1 2012 to July 31 2020 comparing patients with and without XRT. A total of 915 patients met inclusion criteria, with a total of 50 patients found to have a history of XRT. At a mean follow-up of 2.4 years, unadjusted and propensity score matching analysis demonstrated no differences in mortality, heart failure or bleeding-related hospitalization, overall stroke, and 30-day pacemaker implantation in patients with and without XRT.

Clinical Predictors of Mortality and Heart Failure Hospitalization in Patients With Severe Tricuspid Regurgitation.

Background: There is an incomplete understanding of the predictors of morbidity and mortality in patients with severe tricuspid regurgitation (TR). This study sought to identify key risk factors for all-cause mortality and heart failure (HF) hospitalization among patients with severe TR. Methods: Patients with severe TR were identified from 2 centers, Oregon Health & Science University and Abrazo Health, from January 01, 2016 to December 31, 2018. Patients with any concomitant severe valvular diseases or prior valvular intervention were excluded. Multivariable regression was utilized to identify demographic, clinical, and echocardiographic variables independently associated with all-cause mortality or HF hospitalization. Results: 435 patients with severe TR were followed for a median of 2.8 years. The mean age of the population was 66.9 ± 18.5 years and 58% were female. All-cause mortality was identified in 20.5% of the population. Of the cohort, 35.4% of patients were hospitalized for HF. Isolated tricuspid valve intervention was performed in 2.5% of patients. Independent predictors of all-cause mortality included history of solid tumor (odds ratio [OR] 6.6, 95% confidence interval [CI] 2.1-19.1, p = 0.001), history of peripheral artery disease (OR 3.5, 95% CI 1.2-9.4, p = 0.013), and elevated international normalized ratio in the absence of anticoagulation (OR 1.9, 95% CI 1.2-3.2, p = 0.008). Predictors of HF hospitalization included history of diabetes mellitus (OR 2.2, 95% CI 1.1-4.0, p = 0.014) and history of reduced left ventricular ejection fraction (OR 5.7, 95% CI 2.9-11.7, p < 0.0001). Conclusions: Severe untreated TR is associated with high mortality and frequent HF hospitalizations. Understanding predictors of these outcomes is important to identify patients who may benefit from early tricuspid valve intervention to help improve outcomes in this patient population.

Clinical Outcomes of Revascularization with Percutaneous Coronary Intervention Prior to Transcatheter Aortic Valve Replacement: A Comprehensive Meta-Analysis.

BACKGROUND: Prior studies on revascularization prior to transcatheter aortic valve replacement (TAVR), in patients with significant coronary artery disease (CAD), have reported mixed results. AIM: We sought to perform a meta-analysis combining current evidence by investigating outcomes of revascularization in patients who undergo TAVR with coexisting CAD. METHODS: We searched literature for studies reporting on outcomes following TAVR performed with versus without pre-TAVR PCI, for coexisting CAD. Random-effect model was used to pool estimates of odds ratios (ORs). RESULTS: Twenty-four reports with 12,182 TAVR patients were included: 22 observational and 2 clinical trials. 4,110 (33.7%) were in the pre-TAVR PCI group, 51.4% were females, and mean age was 81.9 years. The 30-day mortality was 5.2% versus 5.0% in patients with versus without pre-TAVR PCI, respectively [OR= 1.19 (95% CI: 0.91-1.55, P= 0.20)]. Pooled 1-year mortality was 18.1% versus 19.1% in patients with versus without pre-TAVR PCI (OR= 1.12, 95% CI: 0.95-1.31, P= 0.61). There was no significant difference between the groups for myocardial infarction, stroke, acute kidney injury, pacemaker implantation, or re-hospitalization. Pre-TAVR PCI was associated with an increased risk of life-threatening bleeding at 30 days. CONCLUSION: Pre-TAVR revascularization with PCI was not associated with improved 30-day or 1-year mortality; however, it was associated with an increased risk of life-threatening bleeding at 30-day post-TAVR. Our results do not support routine revascularization with PCI prior to TAVR with coexisting CAD. Future trials addressing anatomical complexity and symptom burden may help better risk stratify patients who may benefit from pre-TAVR revascularization.

Three-Dimensional Intracardiac Echocardiography for Tricuspid Transcatheter Edge-to-Edge Repair.

Patients with severe symptomatic tricuspid regurgitation face a significant dilemma in treatment options, as the yearly mortality with medical therapy and the surgical mortality for tricuspid repair or replacement are high. Transcatheter edge-to-edge repair (TEER) for the tricuspid valve is becoming a viable option in patients, although procedural success is dependent on high-quality imaging. While transesophageal echocardiography remains the standard for tricuspid TEER procedures, intracardiac echocardiography (ICE) with three-dimensional (3D) multiplanar reconstruction (MPR) has many theoretical and practical advantages. The aim of this article was to describe the in vitro wet lab-based imaging work done to facilitate the best approach to 3D MPR ICE imaging and the procedural experience gained with 3D MPR ICE in tricuspid TEER procedures with the PASCAL device.

Clinical and Echocardiographic Predictors of Outcomes in Patients With Moderate (Mean Transvalvular Gradient 20 to 40 mm Hg) Aortic Stenosis.

Risk factors for adverse clinical outcomes in patients with moderate aortic stenosis are not well defined. Previous studies have suggested that certain patients with moderate AS may be at an increased risk of heart failure (HF) or death. All patients with moderate AS seen in our institution during the study period (6/1/2014 to 6/30/2017) with a minimum 1-year follow-up were included. Clinical and echocardiographic data were collected retrospectively. End points were defined as HF hospitalization, aortic valve replacement (AVR), or death. Kaplan-Meier and multivariable Cox proportional hazard models analyses were conducted using composite outcomes of (1) HF hospitalization or AVR and (2) HF hospitalization, AVR, or all-cause death. A total of 151 subjects met the inclusion criteria. The most significant risk factors associated with the composite outcomes were an ejection fraction (EF) <50% ((1) hazard ratio [HR]: 4.1; 95% confidence interval [CI]: 2.34, 7.12; (2) HR: 3.8; 95% CI: 2.2, 6.6), atrial fibrillation ((1) HR: 2.0; 95% CI: 1.2, 3.2; (2) HR: 2.1; 95% CI: 1.43, 3.2), left ventricular hypertrophy ((1) HR: 5.85; 95% CI: 2.0, 15.8; (2) HR: 3.2; 95% CI: 1.4, 7.4), aortic valve area ((1) HR: 0.3; 95% CI: 0.1, 0.6; (2) HR: 0.32; 95% CI: 0.1, 0.65), and abnormal right ventricular function ((1) HR: 4.3; 95% CI: 2.5, 7.5; (2) HR: 5.5; 95% CI: 3.0, 9.8). In conclusion, presence of reduced ejection fraction, atrial fibrillation, left ventricular hypertrophy, and abnormal right ventricular function are associated with an increased risk of HF hospitalization, AVR, and death in patients with moderate aortic stenosis.

Bioprosthetic aortic valve leaflet disruption with high energy electrocautery to prevent coronary artery obstruction during valve-in-valve transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) is well-established for the treatment of bioprosthetic aortic valve stenosis (AS) in high surgical risk patients. Coronary artery obstruction from displacement of the bioprosthetic valve leaflets during valve-in-valve (VIV) TAVR is a rare, but potentially fatal, complication. Recently, the bioprosthetic aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) procedure was developed as a method for disrupting bioprosthetic leaflets in patients undergoing VIV TAVR at high risk for coronary obstruction. This case describes a successful VIV TAVR utilizing a simplified concept of the BASILICA technique in a patient where the full procedure could not be completed.