Citations

AbstractBackgroundSex‐based differences in transcatheter aortic valve replacement (TAVR) outcomes have been previously documented. However, whether these differences persist with contemporary third generation transcatheter heart valves (THVs) is unknown.MethodsWe utilized Vizient's clinical database/resource manager (CDB/RM™) to identify patients who underwent TAVR between January 1, 2018 and March 31, 2020 to compare in‐hospital outcomes between males and females. The primary endpoint was in‐hospital mortality. Secondary endpoints included key in‐hospital complications, length of stay, discharge disposition, and cost. Unadjusted, propensity‐score matched and risk‐adjusted analyses of outcomes were performed.ResultsDuring the study period, 44,280 patients (24,842 males, 19,438 females) underwent TAVR. The primary endpoint of in‐hospital mortality was higher in females than in males (1.6 vs. 1.1% p < .001) in unadjusted analysis and persisted following propensity matching (1.6 vs. 0.9%, p < .001) and multivariable logistic regression with various risk‐adjustment models. In the most comprehensive model adjusting for age, race, and clinical comorbidities, female sex was associated with 34% greater odds of in‐hospital death (95% CI 20–50%, p < .001). Unadjusted and risk‐adjusted rates of post‐TAVR stroke, vascular complication, and blood transfusion were higher in females. Moreover, females demonstrated longer hospitalizations, higher costs and reduced rates of independent discharge home.ConclusionSex‐based differences in TAVR in‐hospital outcomes persist in contemporary practice with third generation transcatheter heart valves. Further research is needed to assess the reasons for these observed disparities and to identify effective mitigation strategies.

AbstractBackgroundRepresentation trends of women, older adults, and ethnic/racial minorities in randomized controlled trials (RCTs) of atrial fibrillation (AF) are uncertain.MethodsWe systematically reviewed 134 AF related RCTs (phase II and III) encompassing 149,162 participants using Medline and ClinicalTrials.gov through April 2019 to determine representation trends of women, older patients (≥75 years), and ethnic/racial minorities. Weighted data on the prevalence of AF from epidemiological studies were used to compare the representation of the studied groups of interest in AF RCTs to their expected burden of the disease.ResultsOnly 18.7% of the RCTs reported proportion of older patients, and 12.7% RCTs reported ethnic/racial minorities. The proportions of women in RCTs versus general population were 35.2% and 35.1%, of Hispanics were 11.9% and 5.2%, of Blacks were 1.2% and 5.7%, of American Indian/Alaskans were 0.2% and 0.2%, of Asians were 14.2% and 2.4%, of native Hawaiian/Pacific Islanders were 0.05% and 0.1% and of non‐Whites were 19.5% and 22.5%, respectively. The weighted mean age (SD) across the trials was 65.3 (3.2) years which was less than the corresponding weighted mean age of 71.1 (4.5) years in the comparative epidemiological data.ConclusionThe reporting of older patients and ethnic/racial minorities was poor in RCTs of AF. The representation of women and American Indian/Alaskan natives matched their expected population share of disease burden. Hispanics and Asians were over‐represented and Blacks, native Hawaiian/Pacific Islanders and non‐Whites were under‐represented in RCTs of AF.

Abstract Aims Anticoagulants are the mainstay treatment for stroke prevention in patients with non-valvular atrial fibrillation (NVAF), and the CHA2DS2-VASc score is widely used to guide anticoagulation therapy in this cohort. However, utility of CHA2DS2-VASc in NVAF patients is debated, primarily because it is a vascular scoring system, which does not incorporate atrial fibrillation related parameters. Therefore, we conducted a meta-analysis to estimate the discrimination ability of CHA2DS2-VASc in predicting ischaemic stroke overall, and in subgroups of patients with or without NVAF. Methods and results PubMed and Embase databases were searched till June 2020 for published articles that assessed the discrimination ability of CHA2DS2-VASc, as measured by C-statistics, during mid-term (2–5 years) and long-term (&gt;5 years) follow-up. Summary estimates were reported as random effects C-statistics with 95% confidence intervals (CIs). Seventeen articles were included in the analysis. Nine studies (n = 453 747 patients) reported the discrimination ability of CHA2DS2-VASc in NVAF patients, and 10 studies (n = 138 262 patients) in patients without NVAF. During mid-term follow-up, CHA2DS2-VASc predicted stroke with modest discrimination in the overall cohort [0.67 (0.65–0.69)], with similar discrimination ability in patients with NVAF [0.65 (0.63–0.68)] and in those without NVAF [0.69 (0.68–0.71)] (P-interaction = 0.08). Similarly, at long-term follow-up, CHA2DS2-VASc had modest discrimination [0.66 (0.63–0.69)], which was consistent among patients with NVAF [0.63 (0.54–0.71)] and those without NVAF [0.67 (0.64–0.70)] (P-interaction = 0.39). Conclusion This meta-analysis suggests that the discrimination power of the CHA2DS2-VASc score in predicting ischaemic stroke is modest, and is similar in the presence or absence of NVAF. More accurate stroke prediction models are thus needed for the NVAF population.

AbstractBackgroundChange in left atrial pressure (LAP) has been shown to be associated with symptom improvement post‐MitraClip; however, the association between acute procedural changes in transmitral diastolic mean gradient (MG) compared to LAP and symptom improvement is not well established.Methods164 consecutive patients undergoing MitraClip at Mayo Clinic between June 2014 and May 2018 were included. Preclip and postclip MG and LAP were recorded. Baseline demographics, clinical, and echocardiographic outcomes, including 30‐day New York Heart Association (NYHA) functional status were obtained from patient charts.ResultsMedian age was 81.5 years (IQR: 76.3, 87), 34% were female and 94.5% had NYHA class III and IV functional status at baseline. At baseline, median MG was 4 mmHg (IQR: 3, 5) and LAP was 19 mmHg (IQR: 16, 23.5). Following MitraClip deployment, the median MG was 4 mmHg (IQR: 3, 6) and the median LAP was 17 mmHg (IQR: 14, 21), 69.5% of patients had less than moderate MR. There was no statistically significant association between change in MG and NYHA functional class at 30 days (OR = 0.95, 95% CI: 0.76–1.20). However, a reduction in LAP following MitraClip deployment was significantly associated with improvement in NYHA functional status at 30 days following adjustments for age and sex (aOR 3.36, 95% CI: 1.34–8.65). There was no significant correlation between change in mean LAP and change in MG (p = .98).ConclusionUnlike change in left atrial pressure, change in MG post‐MitraClip was not associated with patient reported outcomes at 30 days and did not correlate with change in left atrial pressure. Long‐term follow up is needed to evaluate the impact of LA pressure on symptoms.

Background Whether the poor outcomes of isolated tricuspid valve surgery are related to the operation itself or to certain patient characteristics including late referral is unknown. Methods and Results Adult patients who underwent isolated tricuspid valve surgery were identified in the Nationwide Readmissions Database (2016–2017). Patients who had redo tricuspid valve surgery, endocarditis, or congenital heart disease were excluded. Multivariable logistic regression was performed to identify contributors to postoperative mortality. A total of 1513 patients were included (mean age 55.7±16.6 years, 49.6% women). Surrogates of late referral were frequent: 41% of patients were admitted with decompensated heart failure, 44.3% had a nonelective surgery status, 16.8% had advanced liver disease, and 31% had an unplanned hospitalization in the prior 90 days. The operation was performed on day 0 to 1 of the hospitalization in only 50% of patients, and beyond day 10 in 22% of patients. In‐hospital mortality occurred in 8.7% of patients. Median length of stay was 14 days (7–35 days), and median cost was $87 223 ($43 122–$200 872). In multivariable logistic regression analysis, surrogates for late referrals (acute heart failure decompensation, nonelective surgery status, or advanced liver disease) were the strongest predictors of in‐hospital mortality (odds ratio [OR], 4.75; 95% CI, 2.74–8.25 [ P <0.001]). This was also consistent in a second model incorporating unplanned hospitalizations in the 90 days before surgery as a surrogate for late referral (OR, 5.50; 95% CI, 2.28–10.71 [ P <0.001]). Conclusions The poor outcomes of isolated tricuspid valve surgery may be largely explained by the late referral for intervention. Studies are needed to determine the role of early intervention for severe isolated tricuspid regurgitation.

Abstract Aim The 2018 American Heart Association/American College of Cardiology/Multi-Society Cholesterol Guidelines recommended the addition of non-statins to statin therapy for high-risk secondary prevention patients above a low-density lipoprotein cholesterol (LDL-C) threshold of ≥70 mg/dL (1.8 mmol/L). We compared effectiveness and safety of treatment to achieve lower (&lt;70) vs. higher (≥70 mg/dL) LDL-C among patients receiving intensive lipid-lowering therapy (statins alone or plus ezetimibe or proprotein convertase subtilisin/kexin type 9 inhibitors). Methods and results Eleven randomized controlled trials (130 070 patients), comparing intensive vs. less-intensive lipid-lowering therapy, with follow-up ≥6 months and sample size ≥1000 patients were selected. Meta-analysis was reported as random effects risk ratios (RRs) [95% confidence intervals] and absolute risk differences (ARDs) as incident cases per 1000 person-years. The median LDL-C levels achieved in lower LDL-C vs. higher LDL-C groups were 62 and 103 mg/dL, respectively. At median follow-up of 2 years, the lower LDL-C vs. higher LDL-C group was associated with significant reduction in all-cause mortality [ARD −1.56; RR 0.94 (0.89–1.00)], cardiovascular mortality [ARD −1.49; RR 0.90 (0.81–1.00)], and reduced risk of myocardial infarction, cerebrovascular events, revascularization, and major adverse cardiovascular events (MACE). These benefits were achieved without increasing the risk of incident cancer, diabetes mellitus, or haemorrhagic stroke. All-cause mortality benefit in lower LDL-C group was limited to statin therapy and those with higher baseline LDL-C (≥100 mg/dL). However, the RR reduction in ischaemic and safety endpoints was independent of baseline LDL-C or drug therapy. Conclusion This meta-analysis showed that treatment to achieve LDL-C levels below 70 mg/dL using intensive lipid-lowering therapy can safely reduce the risk of mortality and MACE.

Abstract Aims Primary percutaneous coronary intervention (pPCI) is the gold standard, guideline-recommended revascularization strategy in patients presenting with ST-elevation myocardial infarction (STEMI). However, there are limited data on its use and effectiveness among patients with active cancer presenting with STEMI. Methods and results All STEMI hospitalizations between 2004 and 2015 from the National Inpatient Sample were retrospectively analysed, stratified by cancer type. Propensity score matching was performed to estimate the average treatment effect of pPCI in each cancer on in-hospital adverse events, including major adverse cardiovascular and cerebrovascular events (MACCE) and its individual components, and compare treatment effect between cancer and non-cancer patients. Out of 1 870 815 patients with STEMI, 38 932 (2.1%) had a current cancer diagnosis [haematological: 11 251 (28.9% of all cancers); breast: 4675 (12.0%); lung: 9538 (24.5%); colon: 3749 (9.6%); prostate: 9719 (25.0%)]. Patients with cancer received pPCI less commonly than those without cancer (from 54.2% for lung cancer to 70.6% for haematological vs. 82.3% in no cancer). Performance of pPCI was strongly associated with lower adjusted probabilities of MACCE and all-cause mortality in the cancer groups compared with the no cancer group. There was no significant difference in estimated average pPCI treatment effect between the cancer groups and non-cancer group. Conclusion Primary percutaneous coronary intervention is underutilized in STEMI patients with current cancer despite its significantly lower associated rates of in-hospital all-cause mortality and MACCE that is comparable to patients without cancer. Further work is required to assess the long-term benefit and safety of pPCI in this high-risk group.

Abstract Background The management of patients with severe but asymptomatic aortic stenosis (AS) is a challenge of daily practice. Evidence on early aortic valve replacement (AVR) versus symptom-driven approach is controversial. Methods Electronic databases were searched and articles comparing early-AVR with conservative management for severe asymptomatic AS were identified. The pooled unadjusted odds ratio (OR) was computed using a random-effects model. Results A total of 10 studies (observational=9, and randomized clinical trials=1) consisting of 5,291 patients were included. On a mean follow up duration of 4 years, the odds of early-AVR vs conservative management were in favour for early intervention in terms of cardiovascular mortality (OR 0.26, 95% CI 0.13–0.53, p=0.0002, figure-1) and all-cause mortality (OR 0.27, 95% CI: 0.17–0.41, p≤00001). The number needed to treat (NNT) by performing early AVR (either SAVR or TAVR) to prevent one death secondary to either cardiovascular or all-cause was 8 (95% CI: 6–10), and 5 (95% CI, 4.2–5.4) respectively. The odds of all-cause mortality in a selected patient population undergoing surgical AVR (SAVR) (OR 0.17, 95% CI 0.10–0.29, p≤0.00001) or transcatheter AVR (TAVR) (OR 0.45, 95% CI 0.31–0.64, p≤0.0001) were significantly lower compared to patients who were managed conservatively. A subgroup sensitivity analysis based on severe vs. very severe AS and early vs. symptom based AVR also mirrored the findings of overall results. Conclusions Patients with asymptomatic aortic valve stenosis have lower odds of all-cause and cardiovascular mortality when managed with early-AVR compared to conservative management. Figure 1 Funding Acknowledgement Type of funding source: None

AbstractBackgroundWe sought to evaluate the nationwide trends in the characteristics and outcomes of for endovascular stroke therapy in contemporary practice.MethodsWe selected patients with acute ischemic stroke who underwent endovascular stroke therapy between 01 October 2015 and 30 September 2019 in a large academic consortium database. The end points of this study were (a) in‐hospital mortality and functional outcomes and, (b) predictors of poor functional outcome, defined as death or discharge to hospice, or to a long‐term nursing facility.ResultsAmong the 22,193 included patients; 50.3% were females, and 66.5% were white. Mean age was 68±15 years. Poor functional outcomes occurred in 8,274 patients (37.4%), of whom 2,741 (12.4%) died in the hospital, 1,345 (6.1%) were discharged to hospice, and 4,188 (18.9%) were discharged to other long‐term facilities. Most common in‐hospital complications were mechanical ventilation (32.3%), intracranial hemorrhage (18.9%), and acute kidney injury (15.6%). Median total and intensive‐care length‐of‐stay were 7 days (IQR = 4–9), and 2 days (IQR = 1–4), respectively. Median cost was $36,609 (IQR = $26,034–$54,313). In a multi‐logistic regression analysis; age, hypertension, diabetes, anemia, heart failure, vascular disease, chronic pulmonary disease, renal insufficiency, Medicare/medicaid insurance, transfer from nonendovascular capable hospital, and low procedural volume independently predicted poor functional outcomes. Tissue plasminogen activator use was associated with better functional outcomes.ConclusionThere is a substantial growth in the performance of endovascular stroke interventions in the United States in recent years, and those were associated with favorable short‐term outcomes.