Dhoble, Abhijeet

Abstract Background and Aims The TRISCEND II trial demonstrated superior clinical benefits for patients with ≥severe tricuspid regurgitation (TR) treated with the EVOQUE transcatheter tricuspid valve replacement (TTVR) system plus medical therapy vs medical therapy alone. This work reports 1-year and 18-month outcomes in patients stratified by baseline TR severity. Methods The multicentre, prospective TRISCEND II trial enrolled 400 patients with symptomatic, ≥severe TR, and randomized 2:1 to TTVR (n = 267) or control (n = 133). In a post hoc analysis, patients were stratified into severe TR (n = 172) and massive/torrential TR (n = 220) cohorts. Clinical and quality-of-life outcomes were reported at 1 year, with Kaplan–Meier estimates for all-cause mortality and heart failure (HF) hospitalization assessed at 18 months. Study oversight included an independent echocardiographic core laboratory, clinical events committee, and data safety monitoring board. Results One year after TTVR, TR was ≤mild in 95.2% of severe TR and 95.3% of massive/torrential TR patients. The primary safety and effectiveness endpoint (win ratio) favoured TTVR over control regardless of baseline TR severity: severe {1.64 [95% confidence interval (CI): 1.11, 2.43]} and massive/torrential [2.20 (1.55, 3.14)]. At 18 months, TTVR patients had similar mortality to controls [rate difference: severe 0.2% (−11.6, 11.9), massive/torrential −5.8% (−17.6, 6.0)], whereas HF hospitalization rates favoured TTVR in the massive/torrential cohort [vs control, severe 9.8% (−3.0, 22.7), massive/torrential -15.2% (−28.9, −1.5)]. Conclusions Patients with ≥severe TR benefit from TTVR, experiencing improvements in TR severity, functional capacity, and quality of life regardless of baseline TR severity, with a signal for greater benefit in patients with more advanced disease.

BACKGROUND: Previous transcatheter valve therapy registry analyses of transcatheter mitral valve in valve (MViV) replacement of degenerated bioprosthesis reported early experience in the United States. Given recent increases in transseptal MViV volumes and introduction of the SAPIEN 3 Ultra valve, it is important to determine contemporary outcomes for patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV replacement. METHODS: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry was used to extract data for all patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV from 2015 to September 2022. Primary efficacy outcome was 1-year all-cause mortality. Secondary end points included 30-day mortality, functional class, quality of life, and mitral valve performance. Primary safety outcomes were device success and in-hospital complications. RESULTS: A total of 4243 patients with a mean±SD STS score of 9.2±7.7 underwent transseptal MViV at 455 sites. The rate of Mitral Valve Academic Research Consortium technical (96.6%) success was high, and procedural complications were low. All-cause in-hospital, 30-day, and 1-year mortality rates were 3.2%, 4.3%, and 13.4%, respectively. Significant improvements in New York Heart Association class (New York Heart Association I/II, 18% to 87%) and quality of life (Kansas City Cardiomyopathy Questionnaire score, 38 to 78) were noted at 1 year ( P <0.0001 for both) after MViV. Upon stratifying by STS scores, it was observed that the low-risk group (STS<4) had a significantly lower in-hospital mortality rate of 0.4%, whereas the intermediate-risk group (STS, 4–8) had an in-hospital mortality rate of 1.9%. From 2015 to 2022, the number of transseptal MViV cases/year increased significantly, whereas procedure times, length of stay, and intensive care unit hours shortened significantly. At the same time, there was a significant trend toward reduced in-hospital ( P =0.0005), 30-day ( P =0.004), and 1-year mortality rates ( P =0.01). CONCLUSIONS: This multicenter, prospective study reports excellent procedural outcomes, acceptable 1-year mortality rates, and a significant improvement in quality of life for patients undergoing transseptal MViV in the contemporary era. Patients in the low-risk and intermediate-risk STS score categories had significantly better outcomes compared with those in the high-risk category. MViV is a reasonable therapy for the majority of patients with degenerated bioprosthetic mitral valves, who are anatomical candidates.

Background The rapid evolution of artificial intelligence (AI) in conjunction with recent updates in dual antiplatelet therapy (DAPT) management guidelines emphasizes the necessity for innovative models to predict ischemic or bleeding events after drug‐eluting stent implantation. Leveraging AI for dynamic prediction has the potential to revolutionize risk stratification and provide personalized decision support for DAPT management. Methods and Results We developed and validated a new AI‐based pipeline using retrospective data of drug‐eluting stent‐treated patients, sourced from the Cerner Health Facts data set (n=98 236) and Optum's de‐identified Clinformatics Data Mart Database (n=9978). The 36 months following drug‐eluting stent implantation were designated as our primary forecasting interval, further segmented into 6 sequential prediction windows. We evaluated 5 distinct AI algorithms for their precision in predicting ischemic and bleeding risks. Model discriminative accuracy was assessed using the area under the receiver operating characteristic curve, among other metrics. The weighted light gradient boosting machine stood out as the preeminent model, thus earning its place as our AI‐DAPT model. The AI‐DAPT demonstrated peak accuracy in the 30 to 36 months window, charting an area under the receiver operating characteristic curve of 90% [95% CI, 88%–92%] for ischemia and 84% [95% CI, 82%–87%] for bleeding predictions. Conclusions Our AI‐DAPT excels in formulating iterative, refined dynamic predictions by assimilating ongoing updates from patients' clinical profiles, holding value as a novel smart clinical tool to facilitate optimal DAPT duration management with high accuracy and adaptability.

Background: We conducted this study to assess the safety of symptom-limited cardiopulmonary exercise testing (CPX) in patients with varying severity of aortic stenosis (AS). We hypothesized that exercise testing would be safe, as defined by a rates for all-cause death of <0.01% and rate of nonfatal major cardiovascular (CV) events <0.1% within 24 hours of CPX. Secondary purpose of this study was to determine the frequency of complications during CPX. Methods: This cohort study was carried out with 308 consecutive patients with varying degree of AS (as determined by standard echocardiographic criteria) with no or equivocal symptoms who were referred for clinically indicated cardiopulmonary testing between 1994 and 2009. We did not include patients with pending or completed heart transplant, or ventricular assist device implantation. These patients underwent standard symptom limited CPX, and continuous monitoring of heart rate, blood pressure, and electrocardiogram was performed. Complications recorded included death, non-fatal major CV events (cardiac arrest, symptomatic and sustained ventricular or atrial tachycardia, and syncope), and minor events such as hypotension, non-sustained atrial and ventricular arrhythmias, positive exercise ECG and anginal pain. Results: The mean age of patients was 66 ± 14 years, and 252 (82%) were males. The number of patients with mild, moderate and severe AS were 44 (14%), 138 (49%), and 126 (41%) respectively. No death or major CV event occurred during or within 24 hours of CPX. Eleven patients developed supraventricular arrhythmias without compromising hemodynamic status, and one had asymptomatic non-sustained ventricular tachycardia. Detailed description of complications is presented in the Table 1 . Conclusion: Our results show that symptom-limited CPX is safe among AS patients with no or equivocal symptoms based on no deaths or major CV events in our cohort. Minor complications occurred in 110 patients (36%). Table 1 Mild AS (n=44) Moderate AS (n=138) Severe AS (n=126) Age 61.7 ± 15.3 66.5 ± 13.86 67.89 ± 12.74 Males 36 (81%) 128 (83%) 96 (85%) Test protocol O2 protocol 39 (86%) 123 (89%) 104 (82%) Other 5 15 22 Reason for termination Symptom-limited 41 (93%) 114 (82%) 96 (76%) Other 3 24 30 Chest pain None 41 (93%) 122 (88%) 117 (93%) Non-cardiac 0 2 0 Non-anginal 0 2 0 Anginal 2 14 9 Treadmill ECG interpretation Negative 27 (61%) 67 (49%) 45 (37%) Non-diagnostic 14 48 58 Positive 3 23 23 Ventricular arrhythmia None 42 (95%) 134 (97%) 122 (97%) 3-5 beats VT 2 3 4 NSVT 0 1 0 Supraventricular arrhythmia None 42 (95%) 135 (97%) 120 (95%) SVT ≤ 30 sec 2 3 4 SVT > 30 sec 0 0 1 Afib 0 0 1 BP response Normal 41 (93%) 117 (85%) 93 (74%) Hypotensive 3 21 33 AS = Aortic Stenosis, ECG = Electrocardiogram, VT = Ventricular tachycardia, NSVT = Non-sustained ventricular tachycardia, SVT = Supraventricular tachycardia, Afib = Atrial fibrillation, BP = Blood pressure

BackgroundObesity can lead to increased oxidative stress which is one of the proposed mechanisms in the etiopathogenesis of takotsubo cardiomyopathy (TCM).HypothesisThe presence of obesity adversely impacts clinical outcomes in TCM patients.MethodsWe queried the Nationwide Inpatient Sample database (2010‐2014) to identify adult patients admitted with a principal diagnosis of TCM with and without obesity. We compared the categorical and continuous variables by Pearson χ2 and Student t test, respectively, in propensity‐score matched cohorts.ResultsThe study cohort comprised 612 obese TCM (weighted n = 3034) and 5696 nonobese TCM (weighted n = 28 186) patients. Obese TCM patients were more often younger and private‐insurance enrollees. Cardiac complications including acute myocardial infarction (9.0% vs 7.4%; P = 0.04), cardiac arrest (2.3% vs. 0.4%; P < 0.001), cardiogenic shock (4.3% vs. 3.2%; P = 0.03), congestive heart failure (5.0% vs. 3.8%; P = 0.02), respiratory failure (12.9% vs. 11.0%; P = 0.021) and use of mechanical hemodynamic support (Impella; 0.2% vs. 0.0%, P = 0.02) were significantly higher among obese TCM patients. There were no significant differences between the 2 groups in all‐cause mortality (1.0% vs. 0.8%; P = 0.35), arrhythmia (24.5% vs. 22.7%, P = 0.123), length of stay (3.7 ±3.5 vs. 3.7 ±3.6 days; P = 0.68), and total hospital charges ($40 780.16 vs. $42 575.14; P = 0.08).ConclusionsObese TCM patients were more susceptible to developing TCM‐related cardiac complications than were nonobese TCM patients, without any impact on all‐cause in‐hospital mortality, LOS, and hospital charges.

Background Exercise testing provides valuable information in addition to ST ‐segment changes. The present study evaluated the associations among exercise test parameters and all‐cause mortality in a referral population. Methods and Results We examined conventional cardiovascular risk factors and exercise test parameters in 6546 individuals (mean age 49 years, 58% men) with no known cardiovascular disease who were referred to our clinic for exercise stress testing between 1993 and 2003. The association of exercise parameters with mortality was assessed during a follow‐up of 8.1±3.7 years. A total of 285 patients died during the follow‐up period. Adjusting for age and sex, the variables associated with mortality were: smoking, diabetes, functional aerobic capacity ( FAC ), heart rate recovery ( HRR ), chronotropic incompetence, and angina during the exercise. Adjusting for cardiovascular risk factors (diabetes, smoking, body mass index, blood pressure, serum total, HDL , LDL cholesterol, and triglycerides) and other exercise variables in a multivariable model, the only exercise parameters independently associated with mortality were lower FAC (adjusted hazard ratio [ HR ] per 10% decrease in FAC , 1.21; 95% confidence interval [ CI ], 1.13 to 1.29; P <0.001), and abnormal HRR , defined as failure to decrease heart rate by 12 beats at 1 minute recovery (adjusted HR per 1‐beat decrease, 1.05; 95% CI , 1.03 to 1.07; P <0.001). The additive effects of FAC and HRR on mortality were also highly significant when considered as categorical variables. Conclusion In this cohort of patients with no known cardiovascular disease who were referred for exercise electrocardiography, FAC and HRR were independently associated with all‐cause mortality.

Purrpose: To evaluate myocardial microvascular disease in patients with type 2 diabetes mellitus (DM) using myocardial contrast echocardiography (MCE) and to report on its diagnostic accuracy using single photon emission tomography (SPECT) as reference test. Methods: We prospectively enrolled 79 patients (25 DM; 66±11 years) who underwent simultaneous SPECT and MCE with contrast agent during adenosine stress. MCE and SPECT were visually analyzed using 17 segments. Quantitative MCE parameters were derived from replenishment curves. Microbubble velocity (β min −1 ), absolute myocardial blood flow (MBF ml/min/g), and reserve values were calculated. Diagnostic accuracy and area under curve (AUC) was reported. Results: Patients with DM had higher BMI vs non DM (33±7 vs 28±5kg/m 2 P=0 .007), with more prior myocardial infarction (40 vs 15% P=.01). Visual MCE was abnormal in 40 (51%) patients (60% in DM vs 46% in non DM P=0.04). SPECT was abnormal in 38 (48%) patients [60% in DM vs 42% non DM, P=0.01]. Reserve parameters were lower in DM vs. non DM patients: (β 1.77±1.12 vs 2.20±1.4, P<0.001 and MBF 2.86± 2.62 vs. 3.67±2.84, P<0.001). DM patients without CAD on SPECT had significantly lower β, and MBF reserve compared to non DM patients without CAD. Compared to SPECT, β reserve cutoff 1.6 had AUC 0.817, sensitivity 81%, and specificity 66% while MBF reserve cutoff 1.9 had AUC 0.760, sensitivity 79%, and specificity 63% in DM patients. Conclusion: Diabetes is associated with myocardial microvascular abnormalities as evidenced by abnormal myocardial perfusion on visual and quantitative MCE.

Background— Microbubble safety concerns led to changes in product recommendations for patients with pulmonary hypertension. Noninvasive estimation of right ventricular systolic pressure (RVSP) is equivalent to pulmonary artery systolic pressure in the absence of pulmonary outflow obstruction. We analyzed the short- and long-term outcomes of patients who received microbubble contrast and those who did not during stress echocardiography (SE) according to resting RVSP. Methods and Results— From November 2003 to December 2007, 26 774 patients underwent SE. RVSP (mean, 32.6�9.6 mm Hg) was measured in 16 434 patients. Of these, 6164 (37.5%) received contrast for left ventricular opacification and 10 270 (62.5%) did not. Short-term (≤72 hours and ≤30 days) and long-term (4.3 years) end points were death and myocardial infarction. Analysis was done for rest RVSP cut-points ≥35, ≥50, and ≥60 mm Hg and tricuspid regurgitant velocities ≥2.7 ms −1 and ≥3.5 ms −1 . Adjusted Cox regression models were used. The contrast cohort comprised older patients (age, 67�12 versus 64�14 years; P <0.001), who were more likely to have positive SE results (35% versus 30%, P <0.001) compared with the noncontrast cohort. Using RVSP ≥50 mm Hg, there was no significant difference in short-term events between the contrast and noncontrast cohorts. For long-term events, there was no significant difference between both cohorts (adjusted hazard ratios [95% confidence intervals] for death, 1.10 [0.80 to 1.50], P =0.56; and myocardial infarction, 0.34 [0.11 to 1.03], P =0.06). Similar results were obtained at different RVSP and tricuspid regurgitant cut-points. Contrast agent–related adverse effects occurred in <1% of patients. Conclusion— RVSP had no impact on predisposition to adverse outcomes in patients undergoing contrast SE in the population studied.