Abstract Tricuspid valve (TV) disease has been relatively neglected, despite the known association between severe tricuspid regurgitation (TR) and mortality. Few patients undergo isolated tricuspid ...surgery, which remains associated with high in-hospital mortality rates, particularly in patients with prior left-sided valve surgery. Patients with severe TR are often managed medically for years before TV repair or replacement. Current guidelines recommend TV repair in the presence of a dilated tricuspid annulus at the time of a left-sided valve surgical intervention, even if regurgitation is mild. This proposed algorithm aims to prevent the inevitable progression to severe TR and the need for a second surgical intervention. Recently, novel transcatheter treatment options were developed for treating patients with severe TR and right heart failure with prohibitive surgical risk. Here we describe currently available transcatheter treatment options for severe TR implanted at different levels: the junction between vena cavae and right atrium; the tricuspid annulus; or between TV leaflets, improving coaptation.
Abstract Background Identifying transcatheter aortic valve replacement (TAVR) patients at high risk for cerebrovascular events (CVE) is of major clinical relevance. However, predictors have varied ...across studies. Objectives The purpose of this study was to analyze the predictors of 30-day CVE post-TAVR. Methods A systematic review of studies that reported the incidence of CVE post-TAVR while providing raw data for predictors of interest was performed. Data on study, patient, and procedural characteristics were extracted. Crude risk ratios (RRs) and 95% confidence intervals for each predictor were calculated. Results Sixty-four studies involving 72,318 patients (2,385 patients with a CVE within 30 days post-TAVR) were analyzed. Incidence of CVE ranged from 1% to 11% (median 4%) without significant differences between single and multicenter studies, or according to CVE adjudication availability. The summary RRs indicated lower risk for men (RR: 0.82; p = 0.02) and higher risk for patients with chronic kidney disease (RR: 1.29; p = 0.03) and with new-onset atrial fibrillation post-TAVR (RR: 1.85; p = 0.005), and for procedures performed within the first half of center experience (RR: 1.55; p = 0.003). The use of balloon post-dilation tended to be associated with a higher risk of CVE (RR: 1.43; p = 0.07). Valve type (balloon-expandable vs. self-expandable, p = 0.26) and approach (transfemoral vs. nontransfemoral, p = 0.81) did not predict CVE. Conclusions Female sex, chronic kidney disease, enrollment date, and new-onset atrial fibrillation were predictors of CVE post-TAVR. This study provides effect estimates to identify high-risk TAVR patients for early CVE, providing possible guidance for tailored preventive strategies.
Body composition (fat mass FM and skeletal muscle mass SMM) predicts clinical outcomes. In particular, loss of SMM (sarcopenia) is associated with frailty and mortality. There are no data on the ...prevalence and impact of FM and SMM in patients undergoing transcatheter aortic valve implantation (TAVI). The objective of this study is to determine body composition from pre-TAVI computed tomography (CT) and evaluate its association with clinical outcomes in patients who underwent TAVI. A total of 460 patients (mean age 81 ± 8 years, men: 51%) were included. Pre-TAVI CTs of the aorto-ilio-femoral axis were analyzed for FM and SMM cross-sectional area at the level of the third lumbar vertebrae (L3). Regression equations correlating cross-sectional area at L3 to total body FM and SMM were used to determine prevalence of sarcopenia, obesity, and sarcopenic obesity in patients (64%, 65%, and 46%, respectively). Most TAVI procedures were performed through a transfemoral approach (59%) using a balloon-expandable valve (94%). The 30-day and mid-term (median 12 months interquartile range 6 to 27) mortality rates were 6.1% and 29.6%, respectively. FM had no association with clinical outcomes, but sarcopenia predicted cumulative mortality (hazard ratio 1.55, 95% confidence interval 1.02 to 2.36, p = 0.04). In conclusion, body composition analysis from pre-TAVI CT is feasible. Sarcopenia, obesity, and sarcopenic obesity are prevalent in the TAVI population, with sarcopenia predictive of cumulative mortality.
Abstract Background Data regarding the mid- to long-term cognitive trajectory of transcatheter aortic valve (TAVR) recipients are scarce. Objectives Changes in global cognition and specific cognitive ...domains up to 1 year post-TAVR were evaluated. Methods Fifty-one patients (median age 80.0 interquartile range: 72.0 to 85.0 years; 37% women) underwent TAVR and prospective assessment of cognitive function using the Montreal Cognitive Assessment (MoCA) at baseline, short-term (30 days), and 1 year post-TAVR. Processing speed and executive cognitive functions were further evaluated with the digit-symbol substitution test (DSST), Trail Making Tests (TMT), and verbal fluency tests at the same time points. Cognitive decline (CD) was determined by changes in mean scores and as a rate using practice-corrected reliable change index (RCI). Results The baseline mean total MoCA score was 22.71 ± 3.84. Twenty patients (39.2%) were considered cognitively impaired using a cutoff of <23 of 30 points. Mean total MoCA score improved at short-term post-TAVR and remained stable at 1 year (p = 0.022). On the basis of the RCI of total MoCA score, 4 patients (7.8%) presented with short-term CD, which persisted at 1 year in 1 patient (2.0%). Four patients (7.8%) exhibited cognitive improvement at 1 year, increasing to 15% among those with baseline cognitive impairment. No significant changes were observed over time in the mean DSST, TMT, and verbal fluency test scores. On the basis of the RCI, 10 of 40 patients (25%) presented with a reduction in performance of at least 1 test at 30 days that persisted at 1 year in 4 patients (10%). Conclusions TAVR was associated with global improvement in cognitive status, more pronounced among those with cognitive impairment pre-TAVR. However, early decline in some complex cognitive functions was observed in one-quarter of TAVR recipients, persisting at 1 year in 10% of patients.
Abstract Background Isolated tricuspid valve surgery is associated with high morbidity and mortality, especially in patients with prior cardiac surgery. The transcatheter Forma Repair System (Edwards ...Lifesciences, Irvine, California) is designed to provide a surface for native leaflet coaptation to reduce tricuspid regurgitation (TR) by occupying the regurgitant orifice area. Objectives This study sought to evaluate the feasibility and exploratory efficacy with this transcatheter repair system for the treatment of severe TR. Methods Seven high-risk patients with severe TR and clinical signs of heart failure were declined for surgery and offered transcatheter treatment with this device. All procedures were performed within a cardiac catheterization laboratory or hybrid operating room under general anesthesia with transesophageal echocardiographic guidance. Vascular access was via the left axillary vein. Baseline characteristics, procedural and in-hospital outcomes, as well as 30-day follow-up were prospectively collected. Results All patients had severe TR and New York Heart Association (NYHA) functional class II to IV (mean age 76 ± 13 years; mean logistic EuroSCORE 25.7 ± 17.4%), and underwent device implantation to improve tricuspid leaflet coaptation, thereby reducing TR. Device implantation was successful without procedural complications in all patients, with significant reductions in TR severity (moderate in 3 patients and mild in 4 patients). Median hospital length of stay was 4 days. At 30-day follow-up, all patients but 1 demonstrated improvements in NYHA functional status (to class II) with pronounced reductions in the presence and severity of peripheral edema. TR severity was assessed as being moderate at 30-day transthoracic echocardiography follow-up in all patients. No complications related to the device or vascular access were observed during follow-up. Conclusions A transcatheter-based treatment option for severe TR appears safe and feasible with this repair system. Improvements in TR severity were documented in all patients, which were accompanied by improvements in peripheral edema and functional status.
Abstract Objectives The study sought to examine the risk of ischemic events and bleeding episodes associated with differing antithrombotic strategies in patients undergoing transcatheter aortic valve ...replacement (TAVR) with concomitant atrial fibrillation (AF). Background Guidelines recommend antiplatelet therapy (APT) post-TAVR to reduce the risk of stroke. However, data on the efficacy and safety of this recommendation in the setting of a concomitant indication for oral anticoagulation (due to atrial fibrillation AF) with a vitamin K antagonist (VKA) are scarce. Methods A multicenter evaluation comprising 621 patients with AF undergoing TAVR was undertaken. Post-TAVR prescriptions were used to determine the antithrombotic regimen used according to the following 2 groups: monotherapy (MT) with VKA (n = 101) or multiple antithrombotic therapy (MAT) with VKA plus 1 or 2 antiplatelet agents (aspirin or clopidogrel; n = 520). Endpoint definitions were in accordance with Valve Academic Research Consortium-2 criteria. The rate of stroke, major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death), major or life-threatening bleeding events, and death were assessed by a Cox multivariate model regression survival analysis according to the antithrombotic regime used. Results During a median follow-up of 13 months (interquartile range: 3 to 31 months) there were no differences between groups in the rate of stroke (MT: 5%, MAT: 5.2%; adjusted hazard ratio HR: 1.25; 95% confidence interval CI: 0.45 to 3.48; p = 0.67), major adverse cardiovascular events (MT: 13.9%, MAT: 16.3%; adjusted HR: 1.33; 95% CI: 0.75 to 2.36; p = 0.33), and death (MT 22.8%, MAT: 19.2%; adjusted HR: 0.93; 95% CI: 0.58 to 1.50; p = 0.76). A higher risk of major or life-threatening bleeding was found in the MAT group (MT: 14.9%, MAT: 24.4%; adjusted HR: 1.85; 95% CI: 1.05 to 3.28; p = 0.04). These results remained similar when patients receiving VKA plus only 1 antiplatelet agent (n = 463) were evaluated. Conclusions In TAVR recipients prescribed VKA therapy for AF, concomitant antiplatelet therapy use appears not to reduce the incidence of stroke, major adverse cardiovascular events, or death, while increasing the risk of major or life-threatening bleeding.
Summary Background In patients with heart failure, interventions to reduce elevated left atrial pressure improve symptoms and reduce the risk of hospital admission. We aimed to assess the safety and ...potential efficacy of therapeutic left-to-right interatrial shunting in patients with heart failure with reduced ejection fraction. Methods We did this proof-of-principle cohort study at one centre in Canada. Patients (aged ≥18 years) with New York Heart Association (NYHA) class III chronic heart failure with reduced ejection fraction were enrolled under the Canadian special access programme. Shunt implants were done after transseptal catheterisation with transoesophageal echocardiographic guidance under general anaesthesia. Patients had clinical and echocardiography evaluations at baseline and months 1 and 3 after shunt implantation. Findings Between Oct 10, 2013, and March 27, 2015, we enrolled ten patients. The device was successfully implanted in all patients; no device-related or procedural adverse events occurred during follow-up. Transoesophageal echocardiography at 1 month showed that all shunts were patent, with no thrombosis or migration. From baseline to 3 month follow-up, we recorded improvements in NYHA classification (from class III to class II in seven 78% of nine patients, from class III to class I in one 11% patient, and no change in one 11% patient; p=0·0004); quality of life, as assessed by the Duke Activity Status Index (from a mean score of 13 SD 6·2 to 24·8 12·9; p=0·016) and the Kansas City Cardiomyopathy Questionnaire (from a mean score of 44·3 SD 9·8 to 79·1 13·0; p=0·0001); and 6 min walk test distance (from a mean of 244 m SD 112 to 318 m 134; p=0·016). Pulmonary capillary wedge pressure was reduced from a mean of 23 mm Hg (SD 5) at baseline to 17 mm Hg (8) at 3 months (p=0·035), with no changes in right atrial pressure, pulmonary arterial pressure, or pulmonary resistance. No patient was admitted to hospital for worsening heart failure. One (10%) patient was admitted to hospital with gastrointestinal bleeding at month 1; one (10%) patient died after incessant ventricular tachycardia storm, which led to terminal heart failure 2 months post-procedure. Interpretation This first-in-man experience with an implanted left-to-right interatrial shunt demonstrates initial safety and early beneficial clinical and haemodynamic outcomes in patients with heart failure with reduced ejection fraction. Further large-scale randomised studies are warranted. Funding V-Wave.
Abstract Background Residual aortic regurgitation (AR) following transcatheter aortic valve replacement (TAVR) is associated with greater mortality; yet, determining AR severity post-TAVR using ...Doppler echocardiography remains challenging. Cardiovascular magnetic resonance (CMR) is purported as a more accurate means of quantifying AR; however, no data exist regarding the prognostic value of AR as assessed by CMR post-TAVR. Objectives This study sought to evaluate the effect of AR assessed with CMR on clinical outcomes post-TAVR. Methods We included 135 patients from 3 centers. AR was quantified using regurgitant fraction (RF) measured by phase-contrast velocity mapping CMR at a median of 40 days post-TAVR, and using Doppler echocardiography at a median of 6 days post-TAVR. Median follow-up was 26 months. Clinical outcomes included mortality and rehospitalization for heart failure. Results Moderate-severe AR occurred in 17.1% and 12.8% of patients as measured by echocardiography and CMR, respectively. Higher RF post-TAVR was associated with increased mortality (hazard ratio: 1.18 for each 5% increase in RF 95% confidence interval: 1.08 to 1.30; p < 0.001) and the combined endpoint of mortality and rehospitalization for heart failure (hazard ratio: 1.19 for each 5% increase in RF; 95% confidence interval: 1.15 to 1.23; p < 0.001). Prediction models yielded significant incremental predictive value; CMR performed a median of 40 days post-TAVR had a greater association with post-TAVR clinical events compared with early echocardiography (p < 0.01). RF ≥30% best predicted poorer clinical outcomes (p < 0.001 for either mortality or the combined endpoint of mortality and heart failure rehospitalization). Conclusions Worse CMR-quantified AR was associated with increased mortality and poorer clinical outcomes following TAVR. Quantifying AR with CMR may identify patients with AR who could benefit from additional treatment measures.
Abstract Background Elderly patients represent a large proportion of patients admitted for Acute Coronary Syndrome (ACS). Whether frailty, defined as a biological syndrome that reflects a state of ...decreased physiological reserve and vulnerability to stressors, may impact the clinical outcomes in this population remains unclear. We aimed to determine the prevalence of frailty and its impact on mortality in patients aged ≥ 80 years admitted for ACS. Methods This prospective observational study was conducted among patients aged 80 or older admitted in a tertiary hospital for ACS. Frailty was assessed using the Edmonton Frail Scale (EFS) which provides a score ranging from 0 (not frail) to 17 (very frail). Population was divided into 3 classes: 0-3 EFS-score, 4-6 EFS-score, and >7 EFS-score. Results 236 patients were included with a mean follow-up duration of 470 days. The mean age was 85.9 years. 75 patients died during follow-up period.119 subjects (50.4%) had a 0-3 EFS-score, 68 patients (28.8%) had a 4-6 EFS-score and 49 patients (20.8%) had a ≥ 7 EFS-score. All-cause mortality rate was 17.7% in the 0-3 EFS-score group, 35.3% in the 4-6 EFS-score group and 61.2% in the ≥ 7 EFS-score group, (p<0.001). After multivariate analysis, frailty status remained associated with all-cause mortality: HR was 1.53 (95% CI 0.74 - 3.16) within the 4-6 EFS-score group, and HR was 3.60 (95% CI 1.70 - 7.63) within the ≥ 7 EFS-score group. Conclusion Frailty is a strong and independent prognosis factor of midterm all-cause mortality in elderly patients presenting with ACS.
Background The release of cardiac biomarkers of myocardial injury after transcatheter aortic valve replacement (TAVR) is common, but no data exist on patients undergoing TAVR through a transaortic ...approach. We aimed to evaluate the incidence and prognostic significance of the increase in cardiac biomarkers in nontransfemoral TAVR candidates, comparing transaortic and transapical approaches. Methods After excluding patients deemed suitable for transfemoral TAVR, 251 consecutive patients (transaortic, 45; transapical, 206) were prospectively evaluated. Creatine kinase–myocardial band and cardiac troponin T levels were measured at baseline and at 6, 12, 24, 48, and 72 hours after TAVR. Baseline and 6- to 12-month echocardiographic and clinical follow-up were performed. Results After TAVR, cardiac troponin T increased above the upper normal values in all patients (peak value 0.64 μg/L IQR, 0.39 to 1.03 μg/L), whereas creatine kinase–myocardial band levels increased in 88% of patients (transaortic 51%, transapical 96%, p < 0.001; peak value 20.1 μg/L interquartile range, 14.3 to 31.6 μg/L). Compared with the transaortic approach, the transapical approach was associated with a greater rise in both cardiac biomarkers ( p < 0.001 for both), and a lesser improvement in left ventricular ejection fraction ( p = 0.058) and global longitudinal strain ( p = 0.039) at 6- to 12-month follow-up. Greater increases of cardiac troponin T levels were independently associated with 30-day and 1-year overall and cardiovascular mortality ( p < 0.001 for all). A 15-fold rise in cardiac troponin T levels was the optimal threshold for determining poorer outcomes ( p < 0.001). Conclusions Periprocedural TAVR-related myocardial injury in nontransfemoral candidates was demonstrated in all patients, but the transapical approach was associated with significantly greater myocardial injury compared with the transaortic approach. A higher degree of myocardial injury translated into reduced left ventricular function improvement and lower early and midterm survival rates.
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