Impact of coronary artery disease and revascularization on outcomes of transcatheter aortic valve replacement for severe aortic stenosis.

BACKGROUND/PURPOSE: To evaluate the impact of coronary artery disease (CAD), percutaneous coronary intervention (PCI), and coronary lesion complexity on outcomes of transcatheter aortic valve replacement (TAVR) for aortic stenosis. METHODS/MATERIALS: This retrospective study included 1042 patients divided into two groups by the presence or absence of CAD (SYNTAX score 0, no history of revascularization). Propensity score matching was used to compare the two groups. The effect of PCI, SYNTAX score, and residual SYNTAX score was also analyzed. RESULTS: The median age of the cohort was 82 years, and 641 patients had CAD. After propensity score matching, 346 pairs were analyzed. During 5 years of follow-up (median: 25, range 0-72 months), the rate of coronary intervention was significantly higher in CAD patients (p = 0.018). However, all-cause mortality, composite of all-cause mortality, stroke, and coronary intervention, and overt bleeding defined by VARC-3 were comparable. After stratification, in patients with creatinine ≥1.5 mg/dl, CAD was associated with a worse composite outcome (p = 0.016). Neither PCI nor SYNTAX score was associated with all-cause mortality in CAD patients. Similarly, residual SYNTAX score showed no association with mortality in patients undergoing PCI (all p values >0.7). PCI did not reach a significant difference in overt bleeding in CAD patients (adjusted p = 0.06). CONCLUSIONS: Despite a higher incidence of coronary interventions, major clinical outcomes were similar between patients with and without CAD after TAVR. In patients with chronic kidney disease, CAD may be associated with an adverse composite outcome. Neither PCI nor SYNTAX/residual SYNTAX score influenced all-cause mortality.

Impact of prior coronary artery bypass grafting and coronary lesion complexity on outcomes of transcatheter aortic valve replacement for severe aortic stenosis.

OBJECTIVE: To investigate the impact of prior coronary artery bypass grafting (CABG) and coronary lesion complexity on transcatheter aortic valve replacement (TAVR) outcomes for aortic stenosis. METHODS: Clinical outcomes of TAVR were retrospectively compared between patients with and without prior CABG, and between patients with prior CABG and without coronary artery disease (CAD). The impact of the CABG SYNTAX score was also evaluated in patients with prior CABG. RESULTS: The study included 1042 patients with a median age and follow-up of 82 years and 25 (range: 0-72) months, respectively. Of these, 175 patients had a history of CABG, while 401 were free of CAD. Patients with prior CABG were more likely to be male and had higher rates of diabetes, peripheral artery disease and atrial fibrillation compared with patients without prior CABG. After 2 : 1 propensity score matching, all-cause mortality (P = 0.17) and the composite of all-cause mortality, stroke and coronary intervention (P = 0.16) were similar between patients with (n = 166) and without (n = 304) prior CABG. A 1 : 1 propensity score-matched analysis, however, showed lower rates of all-cause mortality (P = 0.04) and the composite outcome (P = 0.04) in patients with prior CABG (n = 134) compared with patients without CAD (n = 134). The median CABG SYNTAX score was 16 (interquartile range: 9.0-23), which was not associated with better/worse clinical outcomes in patients with prior CABG. CONCLUSION: Prior CABG may positively affect mid-term TAVR outcomes for aortic stenosis compared with no CAD when adjusted for other comorbidities. The CABG SYNTAX score did not influence the prognosis after TAVR.

Impact of mitral stenosis on early and late outcomes of transcatheter aortic valve replacement for aortic stenosis: a single-center analysis.

OBJECTIVES: To assess the impact of concomitant mitral stenosis (MS) on early and late outcomes of transcatheter aortic valve replacement (TAVR) for aortic stenosis. METHODS: This study involved 952 patients undergoing TAVR for severe tricuspid aortic stenosis. The patients were classified into 3 groups: without MS, with progressive MS, and severe MS (mitral valve area ≤ 1.5 cm2). Clinical outcomes between these groups were compared. RESULTS: The median age of the overall cohort was 82 years, and patients in the progressive (n = 49) and severe (n = 24) MS groups were more likely to be female than those in the no-MS group (n = 879). Periprocedural mortality rate was lowest in the no-MS group (1.8%) compared with the progressive (4.1%) and severe (4.2%) MS groups, which were not significantly different (P = .20). During 5 years of follow-up (median: 27, range: 0-72 months), there was no significant difference in all-cause mortality (log-rank P = .99), a composite of all-cause mortality or rehospitalization for heart failure (log-rank P = .84), or cardiovascular death (log-rank P = .57) between groups. Although crude analysis showed a significant difference in rehospitalization for heart failure in the severe MS group compared with the no-MS group (P = .049), the difference was not significant in the multivariate analysis (adjusted hazard ratio: 1.36 [95% CI, 0.66-2.80], P = .41). CONCLUSIONS: TAVR can be safely performed in patients with severe tricuspid aortic stenosis and concomitant MS, with early and mid-term outcomes comparable to those in patients without MS.

Clinical and Echocardiographic Outcomes of Patients Undergoing Transcatheter Edge-to-Edge Repair for Functional vs Degenerative Mitral Valve Regurgitation.

To analyze clinical and echocardiographic outcomes after transcatheter edge-to-edge repair (TEER) with mitral valve clip device (MitraClip-TM) for functional vs degenerative mitral valve regurgitation (MR). All consecutive 185 patients undergoing TEER between January 2019 and March 2023 were included in the study. A propensity-adjusted analysis investigated differences among functional vs degenerative MR mechanism groups. Preoperatively, functional vs degenerative MR included 43 vs 142 patients, respectively. Mean ejection fraction (EF) values were 37% vs 57.8%, mean STS-PROM risk score was 7% vs 4% while patients with severe MR included 29 (67.4%) vs 129 (90.9%) patients, respectively. Postoperatively, functional MR patients experienced a higher incidence of prolonged postoperative length of stay (LOS), reduced creatinine clearance, and EF<50% compared to the degenerative MR group. Mean EF was 35.9% vs 56.2% (P < 0.0001) and 1 (2.3%) vs 16 (11.3%) patients had residual severe MR (P = 0.01) in functional vs degenerative MR groups, respectively. At 30-days follow-up, all-cause death incidence was 1 (2.3%) vs 3 (2.1%) patients in functional vs degenerative MR, respectively (P = 0.9). At a mean of 1.6-years follow-up, all-cause death (P = 0.01), major adverse cardiovascular and cerebrovascular events (MACCE) (P = 0.02), cardiac death (P = 0.01) and hazard ratio for all-cause death higher in functional vs degenerative MR group. Mean EF was 39.7% vs 56% (P < 0.001) while residual severe MR was 4 (9.3%) vs 34 (24.5%) (P = 0.1) in functional vs degenerative MR groups, respectively. TEER with MitraClip device showed a higher incidence of all-cause death, cardiac death, and MACCE at follow-up for functional compared to degenerative MR after TEER.

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).

Computed tomography-derived membranous septum length as predictor of conduction abnormalities and permanent pacemaker implantation after TAVI: A meta-analysis of observational studies.

BACKGROUND: Permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) is associated with higher risk of mortality and rehospitalization for heart failure. Efforts to prevent conduction abnormalities (CA) requiring PPI after TAVI should be made. The membranous septum (MS) length and its interaction with implantation depth (ID-ΔMSID) could provide useful information about the risk of CA/PPI following TAVI. OBJECTIVES: To identify MS length and ΔMSID as predictors of CA/PPI following TAVI. METHODS: Study-level meta-analysis of studies published by September 30, 2022. RESULTS: Eighteen studies met our eligibility including 5740 patients. Shorter MS length was associated with a significantly higher risk of CA/PPI (per 1 mm decrease: odds ratio [OR] 1.60, 95% confidence interval [CI] 1.28-1.99, p < 0.001). Similarly, lower ΔMSID was associated with a significantly higher risk of CA/PPI (per 1 mm decrease: OR 1.75, 95% CI 1.32-2.31, p < 0.001). Meta-regression analyses revealed a statistically significant modulation of the effect of shorter MS length and lower ΔMSID on the outcome (CA/PPI) by balloon postdilatation (positive regression coefficients with p < 0.001); with increasing use of balloon postdilatation, the effect of shorter MS length and lower ΔMSID on the outcome increased. MS length and ΔMSID demonstrated excellent discriminative abilities, with diagnostic ORs equaling 9.49 (95% CI 4.73-19.06), and 7.19 (95% CI 3.31-15.60), respectively. CONCLUSION: Considering that short MS length and low ΔMSID are associated with higher risk of CA and PPI, we should include measurement of MS length in the pre-TAVI planning with MDCT and try to establish optimal ID values before the procedure to avoid CA/PPI.

1-Year Outcomes of Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study.

BACKGROUND: Tricuspid regurgitation (TR) is prevalent and undertreated, with mortality and morbidity increasing with TR severity. Given poor outcomes with medical therapy and high in-hospital mortality for isolated tricuspid valve surgery, emerging transcatheter repair devices offer a promising alternative. OBJECTIVES: The Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility study (NCT03382457) evaluates the treatment of functional TR via annular reduction with the Cardioband Tricuspid Valve Reconstruction System (Edwards Lifesciences). METHODS: Patients with ≥ moderate functional TR were eligible for this prospective, single-arm multicenter study. At 1 year, patients were evaluated for echocardiographic parameters, clinical and quality-of-life measures, and major adverse events. RESULTS: The 37 patients enrolled had a mean age of 78 years; 76% were female; and they had ≥ severe functional (97.3%) or mixed (2.7%) TR, atrial flutter/fibrillation (97%), and New York Heart Association functional class III/IV (65%). At 1 year, 73.0% achieved ≤ moderate TR (P < 0.0001), and 73.1% had ≥2 grade reductions. Echocardiography showed significant reductions in the tricuspid annulus diameter (P < 0.0001), mean vena contracta (P < 0.0001), proximal isovelocity surface area effective regurgitant orifice area (P < 0.0001), right ventricular end-diastolic diameter (P < 0.0001), and inferior vena contracta (P = 0.0006). New York Heart Association functional class improved significantly (P < 0.0001), with 92.3% achieving class I/II, and Kansas City Cardiomyopathy Questionnaire scores improved by 19.0 points (P < 0.0001). One-year cardiovascular mortality was 8.1%, reinterventions were necessary in 5.4%, major access site complications occurred in 8.1%, and severe bleeding was noted in 35.1% of patients. Kaplan-Meier estimates of survival and freedom from heart failure rehospitalization were 85.9% and 88.7%, respectively. CONCLUSIONS: One-year experience using the Cardioband system for tricuspid valve repair shows high survival and low rehospitalization rates with durable outcomes in TR reduction and echocardiographic, clinical, and quality-of-life outcomes.

Pulmonary Embolus Imaging Assessment With Emphasis on Echocardiography.

BACKGROUND: This case discusses the importance of echocardiography, or transthoracic echocardiography (TTE), in detecting and diagnosing pulmonary embolisms (PE). The patient described in this case study, who underwent an echocardiography examination a few years before, had little reason to suspect the result of his PE would be a metastatic tumor showering masses of cancerous material and blood clots to his lungs. DISCUSSION: Although computed tomography angiography is the gold standard for diagnosing PE, echocardiography is the preferred modality for identifying heart masses or tumors and provides vital PE information. Four testing components provide essential information for PE detection (ie, right ventricle dysfunction, McConnell sign, elevated pulmonary artery pressures, and visualization of the mass or thrombus). Through these components, TTE has a vital role in patient care, which other imaging modalities lack. The patient in this case study is an example of why protocols should be standardized for preventive hepatocellular carcinoma screenings and sonography implemented as a routine PE detection tool. CONCLUSION: Echocardiography is noninvasive, causes no known adverse effects to the patient, presents instantaneous results, and is cost effective and time efficient. Although PE is treatable, it is a common cause of death; the use of echocardiography to diagnose PE might change that outcome.

Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes.

OBJECTIVES: The study reports for the first time the 30-day outcomes of the first U.S. study with the Cardioband tricuspid valve reconstruction system for the treatment of functional tricuspid regurgitation (TR). BACKGROUND: Increasing severity of TR is associated with progressively higher morbidity and mortality; however, treatment options for isolated significant disease are limited. METHODS: In this single-arm, multicenter, prospective Food and Drug Administration-approved early feasibility study (EFS), 30 patients with severe or greater symptomatic functional TR were enrolled who were deemed candidates for transcatheter tricuspid repair with the Cardioband tricuspid system by the local heart team and multidisciplinary screening committee. RESULTS: The mean patient age was 77 years, 80% were women, 97% had atrial fibrillation, 70% were in New York Heart Association functional class III to IV with mean left ventricular ejection fraction of 58%, and 27% had severe, 20% massive, and 53% torrential TR. Device success was 93% and all patients were alive at 30 days. Between baseline and 30 days, septolateral tricuspid annular diameter was reduced by 13% (p < 0.001), 85% of patients had ≥1 grade TR reduction and 44% had ≤moderate TR, 75% were in New York Heart Association functional class I to II (p < 0.001), and overall Kansas City Cardiomyopathy Questionnaire score improved by 16 points (p < 0.001). CONCLUSIONS: In patients with severe symptomatic functional TR, this is the first study in the United States with the Cardioband tricuspid system for direct transcatheter annular reduction. This early feasibility study demonstrates high procedural feasibility with no 30-day mortality. There is significant reduction of functional TR with clinically significant improvements in functional status and quality of life. (Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study; NCT03382457).

Large obstructive cardiac myxofibrosarcoma is nearly invisible on transthoracic echocardiogram.

Malignant primary cardiac tumors are exceptionally rare, and the most common of these are sarcomas. We present a case of a patient who was found to have a large mass in the left atrium causing obstruction of mitral inflow. Only selected views on a transthoracic echocardiogram reveal the mass and its hemodynamic effect. Although the mass was sizeable, it could be easily overlooked on cursory review of the echocardiogram. After surgical resection, the mass was proven to be a myxofibrosarcoma. We review the etiologies and possible solutions for the imperfect sensitivity of transthoracic echocardiography for cardiac masses.