New-onset atrial fibrillation detected by ambulatory ECG monitoring after transcatheter aortic valve implantation.

BACKGROUND: Little is known about the occurrence of subclinical new-onset atrial fibrillation (NOAF) after transcatheter aortic valve implantation (TAVI). AIMS: We aimed to evaluate the incidence, predictors, and clinical impact of subclinical NOAF after TAVI. METHODS: This was a multicentre study, including patients with aortic stenosis (AS) and no previous atrial fibrillation undergoing TAVI, with continuous ambulatory electrocardiogram (AECG) monitoring after TAVI. RESULTS: A total of 700 patients (79±8 years, 49% female, Society of Thoracic Surgeons score 2.9% [1.9-4.0]) undergoing transarterial TAVI were included (85% balloon-expandable valves). AECG was started 1 (0-1) day after TAVI (monitoring time: 14121314 days). NOAF was detected in 49 patients (7%), with a median duration of 185 (43-421) minutes (atrial fibrillation burden of 0.7% [0.3-2.8]). Anticoagulation was started in 25 NOAF patients (51%). No differences were found in baseline or procedural characteristics, except for a higher AS severity in the NOAF group (peak gradient: no NOAF: 71.9±23.5 mmHg vs NOAF: 85.2±23.8 mmHg; p=0.024; mean gradient: no NOAF: 44.4±14.7 mmHg vs NOAF: 53.8±16.8 mmHg; p=0.004). In the multivariable analysis, the baseline mean transaortic gradient was associated with a higher risk of NOAF after TAVI (odds ratio 1.04, 95% confidence interval: 1.01-1.06 for each mmHg; p=0.006). There were no differences between groups in all-cause mortality (no NOAF: 4.7% vs NOAF: 0%; p=0.122), stroke (no NOAF: 1.4% vs NOAF: 2.0%; p=0.723), or bleeding (no NOAF: 1.9% vs NOAF: 4.1%; p=0.288) from the 30-day to 1-year follow-up. CONCLUSIONS: NOAF detected with AECG occurred in 7% of TAVI recipients and was associated with a higher AS severity. NOAF detection determined the start of anticoagulation therapy in about half of the patients, and it was not associated with an increased risk of clinical events at 1-year follow-up.

Association of Psychosocial Risk Factors With Quality of Life and Readmissions 1 Year After LVAD Implantation.

BACKGROUND: Among patients with advanced heart failure (HF), treatment with a left ventricular assist device (LVAD) improves health-related quality of life (HRQOL). We investigated the association between psychosocial risk factors, HRQOL and outcomes after LVAD implantation. METHODS: A retrospective cohort (n = 9832) of adults aged ≥ 19 years who received durable LVADs between 2008 and 2017 was identified by using the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Patients were considered to have psychosocial risk factors if ≥ 1 of the following were present: (1) substance abuse; (2) limited social support; (3) limited cognitive understanding; (4) repeated nonadherence; and (5) major psychiatric disease. Multivariable logistic and linear regression models were used to evaluate the association between psychosocial risk factors and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 scores from baseline to 1 year, persistently poor HRQOL (KCCQ-12 score < 45 at baseline and 1 year), and 1-year rehospitalization. RESULTS: Among the final analytic cohort, 2024 (20.6%) patients had ≥ 1 psychosocial risk factors. Psychosocial risk factors were associated with a smaller improvement in KCCQ-12 scores from baseline to 1 year (mean ± SD, 29.1 ± 25.9 vs 32.6 ± 26.1; P = 0.015) for a difference of -3.51 (95% confidence interval [CI]: -5.88 to -1.13). Psychosocial risk factors were associated with persistently poor HRQOL (adjusted odds ratio [aOR] 1.35, 95% confidence interval [CI] 1.04-1.74), and 1-year all-cause readmission (adjusted hazard ratio [aHR] 1.11, 95% CI 1.05-1.18). Limited social support, major psychiatric disorder and repeated nonadherence were associated with persistently poor HRQOL, while major psychiatric disorder was associated with 1-year rehospitalization. CONCLUSION: The presence of psychosocial risk factors is associated with lower KCCQ-12 scores and higher risk for readmission at 1 year after LVAD implantation. These associations are statistically significant, but further research is needed to determine whether these differences are clinically meaningful.

Prevalence of Cardiovascular Disease and Risk Factors Among Former National Football League Players.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death worldwide, but prevalence estimates in former professional athletes are limited. OBJECTIVES: HUDDLE (Heart Health: Understanding and Diagnosing Disease by Leveraging Echocardiograms) aimed to raise awareness and estimate the prevalence of CVD and associated risk factors among members of the National Football League (NFL) Alumni Association and their families through education and screening events. METHODS: HUDDLE was a multicity, cross-sectional study of NFL alumni and family members aged 50 years and older. Subjects reported their health history and participated in CVD education and screening (blood pressure, electrocardiogram, and transthoracic echocardiogram [TTE] assessments). Phone follow-up by investigators occurred 30 days postscreening to review results and recommendations. This analysis focuses on former NFL athletes. RESULTS: Of 498 participants screened, 57.2% (N = 285) were former NFL players, the majority of whom were African American (67.6%). The prevalence of hypertension among NFL alumni was estimated to be 89.8%, though only 37.5% reported a history of hypertension. Of 285 evaluable participants, 61.8% had structural cardiac abnormalities by TTE. Multivariable analysis showed that hypertension was a significant predictor of clinically relevant structural abnormalities on TTE. CONCLUSIONS: HUDDLE identified a large discrepancy between participant self-awareness and actual prevalence of CVD and risk factors, highlighting a significant opportunity for population health interventions. Structural cardiac abnormalities were observed in most participants and were independently predicted by hypertension, affirming the role of TTE for CVD screening in this population aged older than 50 years. (Heart Health: Understanding and Diagnosing Disease by Leveraging Echocardiograms [HUDDLE]; NCT05009589).

Impact of chronic thrombocytopenia on healthcare resource utilization, in-hospital outcomes, and costs following percutaneous coronary intervention of chronic total occlusion: a nationwide propensity weighted analysis.

BACKGROUND: Data on the impact of chronic thrombocytopenia (CT) on outcomes following chronic total occlusion (CTO) percutaneous coronary interventions (PCI) is limited. Most studies are case reports and focused on postprocedural thrombocytopenia. The purpose of this present study is to assess the impact of CT (> one year) on health resource utilization (HRU), in-hospital outcomes, and cost following CTO PCI. METHODS: We used discharge data from the 2016-2018 National Inpatient Sample and propensity score-weighted approach to examine the association between CT and HRU among patients undergoing CTO PCI. HRU was measured as a binary indicator defined as a length of stay greater than seven days and/or discharge to a non-home setting. The cost was measured as total charges standardized to 2018 dollars. Both outcomes were assessed using generalized linear models adjusted for survey year, and baseline characteristics. RESULTS: Relative to its absence, the presence of CT following CTO PCI was associated with a 4.8% increased probability of high HRU (Population Average Treatment Effect (PATE) estimate = 0.048; 95% Confidence Interval (CI) = 0.041-0.055; P<0.001) and approximately $18,000 more in total hospital charges (PATE estimate = +$18,297.98; 95% CI = $15,101.33-$21,494.63, P<0.001). CONCLUSION: Among chronic total occlusion patients undergoing percutaneous coronary intervention, those with chronic thrombocytopenia had higher resource use, including total hospital charges, and worse in-hospital outcomes when compared with those without chronic thrombocytopenia.

Racial and Ethnic Disparities in Perioperative Health Care Among Patients Undergoing Cardiac Surgery: JACC State-of-the-Art Review.

There has been little progress in reducing health care disparities since the 2003 landmark Institute of Medicine's report Unequal Treatment. Despite the higher burden of cardiovascular disease in underrepresented racial and ethnic groups, they have less access to cardiologists and cardiothoracic surgeons, and have higher rates of morbidity and mortality with cardiac surgical interventions. This review summarizes existing literature and highlights disparities in cardiovascular perioperative health care. We propose actionable solutions utilizing multidisciplinary perspectives from cardiology, cardiac surgery, cardiothoracic anesthesiology, critical care, medical ethics, and health disparity experts. Applying a health equity lens to multipronged interventions is necessary to eliminate the disparities in perioperative health care among patients undergoing cardiac surgery.

Minimally invasive, surgical, and transcatheter aortic valve replacement: A network meta-analysis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has evolved as an alternative to surgical aortic valve replacement (SAVR). In addition to full-sternotomy (FS), recent reports have shown successful minimally-invasive SAVR approaches, including mini-sternotomy (MS) and mini-thoracotomy (MT). This network-meta-analysis (NMA) seeks to provide an outcomes comparison based on these different modalities (MS, MT, TAVR) compared with FS as a reference arm for the management of aortic valve disease. METHODS: A comprehensive literature search was performed to identify studies that compared minimally-invasive SAVR (MS/MT) to conventional FS-SAVR, and/or TAVR. Bayesian NMA was performed using the random effects model. Outcomes were pooled as risk ratios (RR) with their 95 % confidence intervals (CIs). Our primary outcomes included 30-day mortality, stroke, acute kidney injury (AKI), major bleeding, new permanent pacemaker (PPM), and paravalvular leak (PVL). We also assessed long-term mortality at the latest follow-up. RESULTS: A total of 27,117 patients (56 studies) were included; 10,397 patients had FS SAVR, 9523 had MS, 5487 had MT, and 1710 had TAVR. Compared to FS, MS was associated with statistically-significantly lower rates of 30-day mortality (RR, 0.76, 95%CI 0.59-0.98), stroke (RR, 0.84, 95%CI 0.72-0.97), AKI (RR, 0.76, 95%CI 0.61-0.94), and long-term mortality (RR 0.84, 95%CI 0.72-0.97) at a weighted mean follow-up duration of 10.4 years, while MT showed statistically-significantly higher rates of 30-day PVL (RR, 3.76, 95%CI 1.31-10.85) and major bleeding (RR 1.45; 95%CI 1.08-1.94). TAVR had statistically significant lower rates of 30-day AKI (RR 0.49, 95%CI 0.31-0.77), but showed statistically-significantly higher PPM (RR 2.50; 95%CI 1.60-3.91) and 30-day PVL (RR 12.85, 95%CI 5.05-32.68) compared to FS. CONCLUSIONS: MS was protective against 30-day mortality, stroke, AKI, and long-term mortality compared to FS; TAVR showed higher rates of 30-day PVL and PPM but was protective against AKI. Conversely, MT showed higher rates of 30-day PVL and major bleeding. With the emergence of TAVR, the appropriate benchmarks for SAVR comparison in future trials should be the minimally-invasive SAVR approaches to provide clinical equipoise.

A Pilot Study of Neurobiological Mechanisms of Stress and Cardiovascular Risk.

Objective: Coronary heart disease is a leading cause of death and disability. Although psychological stress has been identified as an important potential contributor, mechanisms by which stress increases risk of heart disease and mortality are not fully understood. The purpose of this study was to assess mechanisms by which stress acts through the brain and heart to confer increased CHD risk. Methods: Coronary Heart Disease patients (N=10) underwent cardiac imaging with [Tc-99m] sestamibi single photon emission tomography at rest and during a public speaking mental stress task. Patients returned for a second day and underwent positron emission tomography imaging of the brain, heart, bone marrow, aorta (indicating inflammation) and subcutaneous adipose tissue, after injection of [18F]2-fluoro-2-deoxyglucose for assessment of glucose uptake followed mental stress. Patients with (N=4) and without (N=6) mental stress-induced myocardial ischemia were compared for glucose uptake in brain, heart, adipose tissue and aorta with mental stress. Results: Patients with mental stress-induced ischemia showed a pattern of increased uptake in the heart, medial prefrontal cortex, and adipose tissue with stress. In the heart disease group as a whole, activity increase with stress in the medial prefrontal brain and amygdala correlated with stress-induced increases in spleen (r=0.69, p=0.038; and r=0.69, p=0.04 respectfully). Stress-induced frontal lobe increased uptake correlated with stress-induced aorta uptake (r=0.71, p=0.016). Activity in insula and medial prefrontal cortex was correlated with post-stress activity in bone marrow and adipose tissue. Activity in other brain areas not implicated in stress did not show similar correlations. Increases in medial prefrontal activity with stress correlated with increased cardiac glucose uptake with stress, suggestive of myocardial ischemia (r=0.85, p=0.004). Conclusions: These findings suggest a link between brain response to stress in key areas mediating emotion and peripheral organs involved in inflammation and hematopoietic activity, as well as myocardial ischemia, in Coronary Heart Disease patients.

Racial Differences in Mental Stress-Induced Transient Endothelial Dysfunction and Its Association With Cardiovascular Outcomes.

OBJECTIVE: This study aimed to investigate differences in transient endothelial dysfunction (TED) with mental stress in Black and non-Black individuals with coronary heart disease (CHD), and their potential impact on cardiovascular outcomes. METHODS: We examined 812 patients with stable CHD between June 2011 and March 2016 and followed through February 2020 at a university-affiliated hospital network. Flow-mediated vasodilation (FMD) was assessed before and 30 minutes after mental stress. TED was defined as a lower poststress FMD than prestress FMD. We compared prestress FMD, post-stress FMD, and TED between Black and non-Black participants. In both groups, we examined the association of TED with an adjudicated composite end point of cardiovascular death or nonfatal myocardial infarction (first and recurring events) after adjusting for demographic, clinical, and socioeconomic factors. RESULTS: Prestress FMD was lower in Black than non-Black participants (3.7 [2.8] versus 4.9 [3.8], p < .001) and significantly declined with mental stress in both groups. TED occurred more often in Black (76%) than non-Black patients (67%; multivariable-adjusted odds ratio = 1.6, 95% confidence interval = 1.5-1.7). Over a median (interquartile range) follow-up period of 75 (65-82) months, 142 (18%) patients experienced either cardiovascular death or nonfatal myocardial infarction. Black participants had a 41.9% higher risk of the study outcome than non-Black participants (95% confidence interval = 1.01-1.95). TED with mental stress explained 69% of this excess risk. CONCLUSIONS: Among CHD patients, Black individuals are more likely than non-Black individuals to develop endothelial dysfunction with mental stress, which in turn explains a substantial portion of their excess risk of adverse events.

Impact of frailty on outcomes in acute ST-elevated myocardial infarctions undergoing percutaneous coronary intervention.

AIMS: We analyzed the impact of frailty on readmission rates for ST-elevated myocardial infarctions (STEMIs) and the utilization of percutaneous coronary intervention (PCI) in STEMI admissions. METHODS AND RESULTS: The 2016-2019 Nationwide Readmission Database was analyzed for patients admitted with an acute STEMI. Patients were categorized by frailty risk and analyzed for 30-day readmission risk after acute STEMIs, PCI utilization and outcomes, and healthcare resource utilization. Qualifying index admissions were found in 584,918 visits. Low risk frailty was noted in 78.20%, intermediate risk in 20.67%, and high risk in 1.14% of admissions. Thirty-day readmissions occurred in 7.74% of index admissions, increasing with frailty (p < 0.001). Readmission risk increased with frailty, 1.37 times with intermediate and 1.21 times with high-risk frailty. PCI was performed in 86.40% of low-risk, 66.03% of intermediate-risk, and 58.90% of high-risk patients (p < 0.001). Intermediate patients were 55.02% less likely and high-risk patients were 61.26% less likely to undergo PCI (p < 0.001). Length of stay means for index admissions were 2.96, 7.83, and 16.32 days for low, intermediate, and high-risk groups. Intermediate and high-risk frailty had longer length of stay, higher total cost, and were more likely to be discharged to a skilled facility (p < 0.001). CONCLUSION: Among adult, all-payer inpatient visits, frailty discerned by the hospital frailty risk score was associated with increased readmissions, increased healthcare resource utilization, and lower PCI administration.

Disparities in Health and Healthcare: Impact of Race on Resource Utilization and Costs Following Transcatheter Edge-to-Edge Repair.

BACKGROUND: This study sought to investigate health and healthcare disparities in the management of severe mitral regurgitation with transcatheter edge-to-edge repair using MitraClip and how racial differences impact resource utilization and costs. METHODS: We retrospectively analyzed the National Inpatient Sample (NIS) for patients who underwent Transcatheter Edge-to-Edge Repair (TEER) using MitraClip between 2016 and 2018. The patients were stratified into four racial cohorts and study outcomes included high resource utilization (HRU), periprocedural complications, and total procedural costs. High resource utilization (HRU) was defined as length of stay (LOS) ≥7 days or a nonhome disposition at discharge. Multivariate logistic regression models were utilized to determine independent predictors of HRU. RESULTS: 17,100 weighted TEER patients were segregated by race: Caucasian (n = 13,270), others (n = 1510), African Americans, AA (n = 1245) and Hispanics (n = 1075). More African Americans and Hispanics had TEER at Urban facilities (P < 0.001), which were teaching hospitals as well (P < 0.001) but were less likely to be covered by public insurance options -Medicare or Medicaid (P < 0.001). More AA (52.2 %) and Hispanics (27.6 %) were likely to be in the lowest median annual income quartile versus Caucasians (19.2 %) (P = 0.003). AA and Hispanics had higher resource utilization (HRU), prolonged length of stay, nonhome disposition at discharge, higher procedural costs and periprocedural complications versus Caucasians. The logistic regression model revealed acute kidney injury (AKI) and actual procedural costs as independent predictors of HRU in both African American and Hispanic groups. CONCLUSION: Significant Health and healthcare disparities do exist among underrepresented, racial minority patients undergoing transcatheter edge-to-edge repair in the US. These disparities were associated with higher resource utilization and actual costs in patients with mitral regurgitation treated with TEER.

Gender and Race Differences in HeartMate3 Left Ventricular Assist Device as a Bridge to Transplantation.

BACKGROUND: Gender and racial disparities exist after left ventricular assist device (LVAD) implantation. Compared with older devices, the HeartMate 3 (HM3) (Abbott Cardiovascular) has demonstrated improved survival. Whether HM3 differentially improves outcomes by gender or race and ethnic groups is unknown. OBJECTIVES: The purpose of this study is to examine differences by gender and race in the use of HM3 among patients listed for heart transplantation (HT) and associated waitlist and post-transplant outcomes. METHODS: The authors examined all patients (20% women, 33% Black) who received LVADs as bridge to transplantation (BTT) between January 2018 and June 2020, in the OPTN (Organ Procurement and Transplantation Network) database. Trends in use of HM3 were evaluated by gender and race. Competing events of death/delisting and transplantation were evaluated using subdistribution hazard models. Post-transplant outcomes were evaluated using multivariate logistic regression adjusted for demographic, clinical, and donor characteristics. RESULTS: Of 11,524 patients listed for HT during the study period, 955 (8.3%) had HM3 implanted as BTT. Use of HM3 increased for all patients, with no difference in use by gender (P = 0.4) or by race (P = 0.2). Competing risk analysis did not demonstrate differences in transplantation or death/delisting in men compared with women (HT: adjusted HR [aHR]: 0.92 [95% CI: 0.70-1.21]; death/delisting: aHR: 0.91 [95% CI: 0.59-1.42]), although Black patients were transplanted fewer times than White patients (HT: aHR: 0.72 [95% CI: 0.57-0.91], death/delisting: aHR: 1.36 [95% CI: 0.98-1.89]). One-year post-transplant survival was comparable by gender (aHR: 0.52 [95% CI: 0.21-1.70]) and race (aHR: 0.76 [95% CI: 0.34-1.70]), with no differences in rates of stroke, acute rejection, or graft failure. CONCLUSIONS: Use of HM3 among patients listed for HT has increased over time and by gender and race. Black patients with HM3 were less likely to be transplanted compared with White patients, but there were no differences in post-transplant outcomes between these groups or between men and women.

Disparity in hospital admissions and length of stay based on income status for emergency department hypertensive crisis visits.

OBJECTIVE: Racial, gender, and socioeconomic status have been shown to impact the delivery of care. How this impacts the management of hypertensive crisis remains unclear. We aim to identify disparities on admission frequency and length of stay (LOS) among those presenting with hypertensive crisis, as a function of household income. METHODS: This is a cross-sectional analysis of 2016 emergency department visits and supplemental inpatient data from the Nationwide Emergency Department Sample. Median household income quartiles were established. A multivariable logistic regression model was used to estimate odds of admission in each income quartile. A multivariable linear regression model was used to predict LOS. RESULTS: After applying sample weighting, the total number of emergency department visits was 33 727 with 6906, 25 443, and 1378 visits for hypertensive emergency, hypertensive urgency, and unspecified crisis, respectively. There were 13 191, 8889, 6400, 5247 visits in the (first) lowest, second, third , and fourth (highest) income quartiles, respectively. The median age for the study population was 60. The most common comorbidity was chronic kidney disease. Individuals with the highest income, had a lower likelihood of admission, compared with the lowest quartile (adjusted odds ratio: 0.41, 95% CI 0.22-0.74). There was a significant association between income quartile and LOS among hypertensive emergency patients (beta coefficient: 0.407, P value = 0.019). CONCLUSION: In this study, patients with lower income were more likely to be admitted, whereas those with higher income exhibited a longer LOS. Clinicians must be made aware these disparities to ensure equitable delivery of care.

Does the "July effect" of new trainees at teaching hospitals impact outcomes for patients hospitalized with heart failure? Real-world analyses of more than half a million US admissions.

Introduction: The "July effect" refers to the potential of adverse clinical outcomes related to the annual turnover of trainees. We investigated whether this impacts inpatient heart failure (HF) outcomes. Methods: Data from all adults (≥18 years) admitted with a primary diagnosis of HF at US teaching hospitals from the 2012-2014 National Inpatient Sample were analyzed. Non-teaching hospital admissions were excluded. The primary outcome was in-hospital mortality. Secondary metrics included hospital length of stay (LOS) and total cost adjusted for inflation. Logistic and linear regression models were used to adjust for confounders. Admissions were classified into 4 quarters (Q1-Q4), based on the academic calendar. Q1 and Q4 were designated to assess the effect of novice (July effect) versus experienced trainees, respectively. Results: There were 699,675 HF admissions during Q1 and Q4 in the study period. Mean age was 71 ± 15 years and 48% were females. There were 20,270 in-hospital deaths, with no difference between Q1 and Q4; crude odds ratio (OR) 1.00, 95% confidence interval (CI) 0.94-1.07, p = 0.95. After risk adjustment, there was no in-hospital mortality difference between Q1 and Q4 admissions; adjusted OR 0.96, 95% CI 0.89-1.03, p = 0.23. There was no difference in hospital LOS or total cost; 5.8 versus 5.8 days, p = 0.66 and $13,755 versus $13,586, p = 0.46, in Q1 and Q4, respectively. Conclusions: In this nationally representative sample, there was no evidence of a "July effect" on inpatient HF outcomes in the US. This suggests that HF patients should not delay seeking care during trainee transitions at teaching hospitals.

Derivation and validation of the bridge to transplantation with left ventricular assist device score for 1 year mortality after heart transplantation. The BTT-LVAD score.

BACKGROUND: To derive and validate a risk score that accurately predicts 1-year mortality after heart transplantation (HT) in patients bridged to transplant (BTT) with a left ventricular assist device (LVAD). METHODS: The UNOS database was queried to identify patients BTT with an LVAD between 2008 and 2018. Patients with ⩾1-year follow up were randomly divided into derivation (70%) and validation (30%) cohorts. The primary endpoint was 1-year mortality. A simple additive risk score was developed based on the odds of 1-year mortality after HT. Risk groups were created, and survival was estimated and compared. RESULTS: A total of 7759 patients were randomly assigned to derivation (n = 5431) and validation (n = 2328) cohorts. One-year post-transplant mortality was 9.8% (n = 760). A 33-point scoring was created from six recipient variables and two donor variables. Risk groups were classified as low (0-5), intermediate (6-10), and high (>10). In the validation cohort, the predicted 1-year mortality was significantly higher in the high-risk group than the intermediate and low-risk groups, 14.7% versus 9% versus 6.1% respectively (log-rank test: p < 0.0001). CONCLUSION: The BTT-LVAD Score can serve as a clinical decision tool to guide therapeutic decisions in advanced heart failure patients.

Adverse Events Following Transcatheter Edge-to-Edge Repair (TEER) Using MitraClip: Lessons Learned From the Manufacturer and User Facility Device Experience (MAUDE) Registry.

OBJECTIVE: The MitraClip from Abbott is FDA approved intracardiac implantable device for transcatheter edge-to-edge repair (TEER). Despite a few previously published studies, there is limited safety data for its use in clinical practice, hence, we designed this study using data obtained from a safety nationwide database to demonstrate the safety profile of MitraClip. METHODS: The first two of the five authors independently queried all reported adverse events from the United State Food and Drug Administration [FDA] Manufacturer and User Facility Device Experience [MAUDE] registry from January 2014 to December 2020. The primary end point was trend in reported fatal events obtained from this database. The secondary end points included the causes of reported nonfatal reports from the MAUDE registry. The trend of reported fatal events was assessed using the Cochran Armitage trend test over the period of the study. RESULTS: During the study period, subjects included 3370 patients whose MitraClip-associated adverse events were reported and captured by MAUDE registry. Of these, 211 were fatal and 3159 nonfatal events. Fatal event reports resulted deaths and reported nonfatal events were from injuries and device system malfunction. This study demonstrated an initial upward trend from 2014 to 2015 then a subsequent statistically significant downward trend in reported fatal events from 2015 to 2020 (Cochran-Armitage test P = 0.039). The peak proportion of reported fatal events occurred in 2015, (n = 44; representing 1.25% of reported adverse events) and lowest proportion of reported fatal events took place in 2020 (n = 19; representing 0.56% of reported adverse events). The most reported nonfatal events were from malfunctioning of MitraClip system (n = 1170; representing 37% of reported nonfatal events), new unremarkable repolarization abnormalities on periprocedural EKG (n = 864; representing 27% of reported nonfatal events), leaflet rupture (n = 651; representing 21% of reported nonfatal events), and cardiogenic shock (n = 170; representing 5% of reported nonfatal events). CONCLUSIONS: This analysis of the MAUDE Registry indicated, especially within the confines of this study's limitations and poor data quality of information, an apparent downward trend of reported fatal events over the study period. Even though conclusive attributions cannot be made regarding this important finding, perhaps, this points to early evidence of a potential institutional or operator learning curve with this device. However, in view of the inferior quality of the data accrued from the MAUDE Registry, more high-precision studies are needed to better understand these changes, as the utility of MitraClip, becomes more established in clinical practice.

Early Discharge After Minimally Invasive Aortic and Mitral Valve Surgery.

BACKGROUND: We investigated patient outcomes in relation to their postoperative length of stay after minimally invasive valve surgery. METHODS: All adults who survived elective, uncomplicated minimally invasive aortic or mitral valve surgery at a single center between 2012 and 2019 were classified by postoperative length of stay: early discharge (≤3 days) or late discharge (>3 days). The trend in early discharge was investigated over the study period, predictors of early discharge were identified using multivariate logistic regression modeling, and 1:1 propensity score matching was used to determine which patients in the late-discharge cohort had similar health to patients discharged early. Adjusted outcomes of 30-day mortality, readmission, and direct costs were analyzed. RESULTS: Among 1262 consecutive patients undergoing minimally invasive valve surgery, 618 were elective and uncomplicated, 25% (n = 162) of whom were discharged early. The proportion of early-discharge patients increased over time (P for trend < .05). A history of congestive heart failure, stroke, or smoking and higher Society of Thoracic Surgeons predictive risk of mortality score negatively predicted early discharge (P < .05). Propensity score matching identified 101 (22%) late-discharge patients comparable with early-discharge patients. Adjusted 30-day mortality and readmission rates were comparable between cohorts. The median direct costs per patient ($20,046 vs $22,124, P < .05) were significantly lower in the early-discharge cohort. CONCLUSIONS: In well-selected patients early discharge after minimally invasive valve surgery was associated with lower costs but comparable postoperative outcomes. About one-fifth of patients who remain in the hospital beyond postoperative day 3 may be candidates for earlier discharge.

Safety and Efficacy of the Amplatzer Septal Occluder: A Systematic Review and Meta-Analysis.

OBJECTIVES: To assess the safety and efficacy of the Amplatzer Septal Occluder in the closure of secundum type atrial septal defects. BACKGROUND: The Amplatzer Septal Occluder (ASO; Abbott, St. Paul, MN) is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). Previous small cohort trials have shown a favorable safety and technical efficacy profile. METHODS: We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. The primary endpoint was the technical success rate of implantations. Secondary outcomes included proportions of arrhythmias and embolism specific-adverse events. RESULTS: We included a total of 12 studies with 2972 patients. The ratio of device implantation was 2:1 by sex [female: male]. Pooled technical success rate of implantation was 98% (95% CI: 0.968-0.990, P < 0.01). The cumulative adverse event rate was 5.1% (95% CI: 0.035-0.068, P < 0.01), which included arrhythmia and embolism specific adverse event rates of 1.8% (95% CI: 0.007-0.032, P < 0.01) and 0.7% (95% CI: 0.002-0.013, P < 0.01), respectively. Sensitivity analysis did not significantly affect pooled outcomes for success rate and adverse events; both forest plot and Begg's and Egger's regression tests supported symmetricity. CONCLUSION: A high likelihood of technical success can be expected when implanting the ASO in secundum type ASDs. Adverse event rates are expected for one in twenty patients, and thus, our results support the safe use of ASO in secundum type ASDs closure. CONDENSED ABSTRACT: The AMPLATZER Septal Occluder is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. We included a total of 12 studies with 2972 patients. Pooled technical success rate of implantation was 98% (P < 0.01). The cumulative adverse event rate was 5.1% (P < 0.01), 1.8% (P < 0.01) rate of arrhythmias, and 0.7% (P < 0.01) rate of embolisms. A high likelihood of technical success can be expected with a low rate of adverse events.

Utilizing ambulatory electrocardiogram monitoring to reduce conduction related death after transcatheter aortic valve replacement.

OBJECTIVE: The purpose of this study is to assess the utility of ambulatory cardiac monitoring (ACM) in detecting delayed advanced conduction abnormalities (DACA) and associated 30-day mortality. BACKGROUND: DACA are well-known complications of TAVR and may be associated with post-discharge mortality within 30-days. METHODS: Between October 2019 and October 2020, TAVR patients who were discharged home without a permanent pacemaker (PPM) were monitored with an ACM device for 14-days. The incidence of DACA at follow up, mortality and readmission within 30-days were investigated. The risk of DACA was assessed in three patient categories based on a composite of their 12-lead electrocardiogram (ECG) data. Group I: Normal pre-TAVR, periprocedural, and discharge ECGs. Group II: Normal pre-TAVR and abnormal subsequent ECGs. Group III. Abnormal baseline and abnormal subsequent ECGs. RESULTS: Among 340 TAVR patients, 248 were discharged home with an ACM device. The overall incidence of DACA was 7% (n = 17), of whom 4% (n = 10) required a PPM. Mortality and readmission between discharge and 30 days was 0% and 8.3%, respectively. Stratification of patients identified 96 (38.7%) patients in Group I: 50 (20%) in Group II, and 102 (41%) in Group III. The incidence of DACA requiring a PPM was 0% in Group I, 4% (n = 2) in Group II, and 8.5% (n = 8) in Group III (p < 0.004). CONCLUSIONS: In TAVR patients who were discharged home with ACM, none died between discharge and 30-days. For those with normal baseline, perioperative and discharge ECG, there were no events of DACA at 14-days.

Contemporary Nationwide Heart Transplantation and Left Ventricular Assist Device Outcomes in Patients with Histories of Bariatric Surgery.

Bariatric surgery may play a role in the management of morbidly obese patients with end-stage heart failure through increasing eligibility and improving the outcomes of destination therapies. We conducted a nationally representative, retrospective cohort study of patients with previous bariatric surgery undergoing either heart transplantation or left ventricular assist device implantation. Of 200 patients, < 6% experienced in-hospital mortality after destination therapy, comparable to that reported in the general population of heart recipients. Risk-adjusted outcomes differed minimally from those of obese patients undergoing destination therapy without previous bariatric surgery. This study provides important safety benchmarking data and demonstrates the feasibility of bariatric surgery as a potential bridge to left ventricular assist device implantation or heart transplantation in obese patients with end-stage heart failure.