Prognostic value of initial electrocardiography in predicting long-term all-cause mortality in COVID-19.

BACKGROUND: The electrocardiography (ECG) has short-term prognostic value in coronavirus disease 2019 (COVID-19), yet its ability to predict long-term mortality is unknown. This study aimed to elucidate the predictive role of initial ECG on long-term all-cause mortality in patients diagnosed with COVID-19. METHODS: In this prospective cohort study, adults with COVID-19 who underwent ECG testing within a 17-hospital health system in Northeast Ohio and Florida between 03/2020-06/2020 were identified. An expert ECG reader analyzed all studies blinded to patient status. The associations of ECG characteristics with long-term all-cause mortality and intensive care unit (ICU) admission were assessed using Cox proportional hazards regression model and multivariable logistic regression models, respectively. Status of long-term mortality was adjudicated on 01/07/2022. RESULTS: Of 837 patients (median age 65 years, 51% female, 44% Black), 683 (81.6%) were hospitalized, 281 (33.6%) required ICU admission, 67 (8.0%) died in-hospital, and 206 (24.6%) died at final follow-up after a median (IQR) of 21 (9-103) days after ECG. Overall, 179 (20.7%) patients presented with sinus tachycardia, 12 (1.4%) with atrial flutter, and 45 (5.4%) with atrial fibrillation (AF). After multivariable adjustment, sinus tachycardia (E-value for HR=3.09, lower CI=2.2) and AF (E-value for HR=3.13, lower CI=2.03) each independently predicted all-cause mortality. At final follow-up, patients with AF had 64.5% probability of death compared with 20.5% for those with normal sinus rhythm (P<.0001). CONCLUSIONS: Sinus tachycardia and AF on initial ECG strongly predict long-term all-cause mortality in COVID-19. The ECG can serve as a powerful long-term prognostic tool in COVID-19.

Pregnancy-Associated Myocardial Infarction: A Review of Current Practices and Guidelines.

PURPOSE OF REVIEW: Pregnancy-associated myocardial infarction is a principal cause of cardiovascular disease with a steadily rising incidence of 4.98 AMI events/100,000 deliveries over the last four decades in the USA. It is also linked with significant maternal and fetal morbidity and mortality, with maternal case fatality rate ranging from 5.1 to 37%. The management of acute myocardial infarction can be challenging in pregnant patients since treatment modalities and medication use are limited by their safety during pregnancy. RECENT FINDINGS: Limited guidelines exist regarding the management of pregnancy-associated myocardial infarction. Routinely used medications in myocardial infarction including angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), and statin therapy are contraindicated during pregnancy. Aspirin use is considered safe in pregnant women, but dual antiplatelet therapy and therapeutic anticoagulation can be associated with increased risk of maternal and fetal complications, and should only be used after a comprehensive benefit-to-risk assessment. The standard approach to revascularization requires additional caution in pregnant women. Percutaneous coronary intervention is generally considered safe but can be associated with high failure rates and poor outcomes depending on the etiology. Fibrinolytic therapy may have significant sequelae in pregnant patients, and hemodynamic management during surgery is complex and adds risk during pregnancy. Understanding the risks and benefits of the different treatment modalities available and their utility depending on the underlying etiology, encompassed with a multidisciplinary team approach, is vital to improve outcomes and minimize maternal and fetal complications.

Validating and implementing cardiac telemetry for continuous QTc monitoring: A novel approach to increase healthcare personnel safety during the COVID-19 pandemic.

BACKGROUND: Minimizing direct patient contact among healthcare personnel is crucial for mitigating infectious risk during the coronavirus disease 2019 (COVID-19) pandemic. The use of remote cardiac telemetry as an alternative to 12­lead electrocardiography (ECG) for continuous QTc monitoring may facilitate this strategy, but its application has not yet been validated or implemented. METHODS: In the validation component of this two-part prospective cohort study, a total of 65 hospitalized patients with simultaneous ECG and telemetry were identified. QTc obtained via remote telemetry as measured by 3 independent, blinded operators were compared with ECG as assessed by 2 board-certified electrophysiologists as the gold-standard. Pearson correlation coefficients were calculated to measure the strength of linear correlation between the two methods. In a separate cohort comprised of 68 COVID-19 patients treated with combined hydroxychloroquine and azithromycin, telemetry-based QTc values were compared at serial time points after medication administration using Friedman rank-sum test of repeated measures. RESULTS: Telemetry-based QTc measurements highly correlated with QTc values derived from ECG, with correlation coefficients of 0.74, 0.79, 0.85 (individual operators), and 0.84 (mean of all operators). Among the COVID-19 cohort, treatment led to a median QTc increase of 15 milliseconds between baseline and following the 9th dose (p = 0.002), with 8 (12%) patients exhibiting an increase in QTc ≥ 60 milliseconds and 4 (6%) developing QTc ≥ 500 milliseconds. CONCLUSIONS: Cardiac telemetry is a validated clinical tool for QTc monitoring that may serve an expanding role during the COVID-19 pandemic strengthened by its remote and continuous monitoring capability and ubiquitous presence throughout hospitals.

Association of adoption of transradial access for percutaneous coronary intervention in ST elevation myocardial infarction with door-to-balloon time.

OBJECTIVES: We aimed to study adoption of transradial primary percutaneous coronary intervention (TR-PPCI) for ST elevation myocardial infarction (STEMI) ("radial first" approach) and its association with door-to-balloon time (D2BT). BACKGROUND: TR-PPCI for STEMI is underutilized in the United States due to concerns about prolonging D2BT. Whether operators and hospitals adopting a radial first approach in STEMI incur prolonged D2BT is unknown. METHODS: In 1,272 consecutive cases of STEMI with PPCI at our hospital from January 1, 2011, to December 31, 2016, we studied TR-PPCI adoption and its association with D2BT including a propensity matched analysis of similar risk TR-PPCI and trans-femoral primary PCI (TF-PPCI) patients. RESULTS: With major increases in hospital-level TR-PPCI (hospital TR-PPCI rate: 2.6% in 2011 to 79.4% in 2016, p-trend<.001) and operator-level TR-PPCI (mean operator TR-PPCI rate: 2.9% in 2011 to 81.1% in 2016, p-trend = .005), median hospital level D2BT decreased from 102 min [81, 142] in 2011 to 84 min [60, 105] in 2016 (p-trend<.001). TF crossover (10.3%; n = 57) was not associated with unadjusted D2BT (TR-PPCI success 91 min [72, 112] vs. TF crossover 99 min [70, 115], p = .432) or D2BT adjusted for study year and presenting location (7.2% longer D2BT with TF crossover, 95% CI: -4.0% to +18.5%, p = .208). Among 273 propensity-matched pairs, unadjusted D2BT (TR-PPCI 98 [78, 117] min vs. TF-PPCI 101 [76, 132] min, p = .304), and D2BT adjusted for study year and presenting location (5.0% shorter D2BT with TR-PPCI, 95% CI: -12.4% to +2.4%, p = .188) were similar. CONCLUSIONS: TR-PPCI can be successfully implemented without compromising D2BT performance.

A hospital-wide system to ensure rapid treatment time across the entire spectrum of emergency percutaneous intervention.

OBJECTIVES: This study's aim was to describe a hospital-wide system to deliver rapid door-to-balloon time across the entire spectrum of emergency percutaneous intervention. BACKGROUND: Many patients needing emergency PCI are excluded from door-to-balloon public reporting metric; these groups do not achieve door-to-balloon times ≤90 min and have increased mortality rates. METHODS: We prospectively implemented a protocol for patients with STEMI or other emergency indication for catheterization mandating (1) emergency department physician or cardiologist activation of the catheterization lab and (2) immediate patient transfer to an immediately available catheterization lab by an in-house nursing transfer team. RESULTS: From September 1, 2005 to December 31, 2008, 526 consecutive patients underwent emergency PCI. Median door-to-balloon time was 68 min with 85.7% ≤90 min overall. Important subgroups included primary emergency department (62.5 min), cardiorespiratory arrest (71 min), cardiogenic shock (68 min), need for temporary pacemaker or balloon pump (67 min), initial ECG without ST-elevation (66.5 min), transfer from another ED (84 min), in-hospital (70 min), and activation indications other than STEMI (68 min). Patients presenting to primary ED and in transfer were compared to historical controls. Treatment ≤90 min increased (28%-85%, P < 0.0001). Mean infarct size decreased, as did hospital length-of-stay and admission total hospital costs. Acute myocardial infarction all-cause 30-day unadjusted mortality and risk-standardized mortality ratios were substantially lower than national averages. CONCLUSION: A hospital-wide systems approach applied across the entire spectrum of emergency PCI leads to rapid door-to-balloon time, reduced infarct size and hospitals costs, and low myocardial infarction 30-day all-cause mortality. © 2015 Wiley Periodicals, Inc.

Association Between Off-site Central Monitoring Using Standardized Cardiac Telemetry and Clinical Outcomes Among Non-Critically Ill Patients.

IMPORTANCE: Telemetry alarms involving traditional on-site monitoring rarely alter management and often miss serious events, sometimes resulting in death. Poor patient selection contributes to a high alarm volume with low clinical yield. OBJECTIVE: To evaluate outcomes associated with an off-site central monitoring unit (CMU) applying standardized cardiac telemetry indications using electronic order entry. DESIGN, SETTING, AND PARTICIPANTS: All non-intensive care unit (ICU) patients at Cleveland Clinic and 3 regional hospitals over 13 months between March 4, 2014, and April 4, 2015. EXPOSURES: An off-site CMU applied standardized cardiac telemetry when ordered for standard indications, such as for known or suspected tachyarrhythmias or bradyarrhythmias. MAIN OUTCOMES AND MEASURES: CMU detection and notification of rhythm/rate alarms occurring 1 hour or less prior to emergency response team (ERT) activation, direct CMU-to-ERT notification outcomes, total telemetry census, and cardiopulmonary arrests in comparison with the previous 13 months. RESULTS: The CMU received electronic telemetry orders for 99,048 patients (main campus, 72,199 [73%]) and provided 410,534 notifications (48% arrhythmia/hemodynamic) among 61 nursing units. ERT activation occurred among 3243 patients, including 979 patients (30%) with rhythm/rate changes occurring 1 hour or less prior to the ERT activation. The CMU detected and provided accurate notification for 772 (79%) of those events. In addition, the CMU provided discretionary direct ERT notification for 105 patients (ventricular tachycardia, n = 44; pause/asystole, n = 36; polymorphic ventricular tachycardia/ventricular fibrillation, n = 14; other, n = 11), including advance warning of 27 cardiopulmonary arrest events (26%) for which return of circulation was achieved in 25 patients (93%). Telemetry standardization was associated with a mean 15.5% weekly census reduction in the number of non-ICU monitored patients per week when compared with the prior 13-month period (580 vs 670 patients; mean difference, -90 patients [95% CI, -82 to -99]; P < .001). The number of cardiopulmonary arrests was 126 in the 13 months preintervention and 122 postintervention. CONCLUSIONS AND RELEVANCE: Among non-critically ill patients, use of standardized cardiac telemetry with an off-site central monitoring unit was associated with detection and notification of cardiac rhythm and rate changes within 1 hour prior to the majority of ERT activations, and also with a reduction in the census of monitored patients, without an increase in cardiopulmonary arrest events.

Clinicopathological characteristics of colorectal cancer presenting under the age of 50.

OBJECTIVE: Previous studies suggest that colorectal cancer (CRC) presenting at a young age tends to be advanced, proximally located and associated with a poor outcome. The aim of this study was to analyse characteristics of CRC in a cohort under the age of 50. METHOD: A single centre retrospective cohort study of consecutive patients under the age of 50 receiving potentially curative resection was performed. Clinical and pathological data was collected from a prospectively maintained cancer registry database. Of 2799 patients having CRC resections between 2002 and 2013, 103 patients (3.6%) were under 50, with full survival data available on 98 (3.5%). An additional 7 patients under 50 had inoperable disease. The proportion of patients under 50 was constant throughout the study period. A group of 98 consecutive patients over the age of 50 undergoing surgery for colorectal cancer in the same centre was used for comparison. Just 7 patients (7%) had pathologically verified FAP or Lynch syndrome, although there was a high suspicion of Lynch syndrome in further 3 patients. CONCLUSION: There was a higher proportion of rectal cancer in the under 50s (p < 0.0001), although there was no significant difference in the staging of the disease or lymph node positivity. There was a greater incidence of poor differentiation in the younger patients, but there was no effect on 5-year overall survival (71.4%) which is much higher than in the reported literature. The majority of colorectal cancers presenting under the age of 50 were sporadic, and a higher proportion of rectal cancer was observed compared with the older patients, and as compared to the published literature on younger CRC patients. This paper adds to the literature by demonstrating that despite advanced stage at presentation of colorectal cancer requiring extended surgery and multimodal treatment, this young age group experienced good overall survival.

Single center TAVR experience with a focus on the prevention and management of catastrophic complications.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an important treatment option for patients with severe symptomatic aortic stenosis (AS) who are inoperable or at high risk for complications with surgical aortic valve replacement. We report here our single-center data on consecutive patients undergoing transfemoral (TF) TAVR since the inception of our program, with a special focus on minimizing and managing complications. METHODS: The patient population consists of all consecutive patients who underwent an attempted TF-TAVR at our institution, beginning with the first proctored case in May 2006, through December 2012. Clinical, procedural, and echocardiographic data were collected by chart review and echo database query. All events are reported according to Valve Academic Research Consortium-2. RESULTS: During the study period, 255 patients with AS had attempted TF-TAVR. The procedure was successful in 244 (95.7%) patients. Serious complications including aortic annular rupture (n = 2), coronary occlusion (n = 2), iliac artery rupture (n = 1), and ventricular embolization (n = 1) were successfully managed. Death and stroke rate at 30 days was 0.4% and 1.6%, respectively. One-year follow-up was complete in 171 (76%) patients. One-year mortality was 17.5% with a 3.5% stroke rate. Descending aortic rupture, while advancing the valve, was the only fatal procedural event. There were 24.4% patients with ≥2+ aortic regurgitation. CONCLUSIONS: TAVR can be accomplished with excellent safety in a tertiary center with a well-developed infrastructure for the management of serious complications. The data presented here provide support for TAVR as an important treatment option, and results from randomized trials of patients with lower surgical risk are eagerly awaited.

Impact of Age, Gender, and Body Mass Index on Short-Term Outcomes of Patients With Cardiogenic Shock on Mechanical Circulatory Support.

This single-center, observational study assessed the impact of age, gender, and body mass index (BMI) in patients with cardiogenic shock (CS) on temporary mechanical circulatory support. All adult patients admitted to the Cleveland Clinic main campus Cardiac Intensive Care Unit (CICU) between December 1, 2015, to December 31, 2019, CICU with CS necessitating mechanical circulatory support (MCS) with intra-aortic balloon pump, Impella, or venous arterial-extra corporeal membrane oxygenation were retrospectively analyzed for this study. Baseline characteristics and 30-day outcomes were collected through physician-directed chart review. The impact of age, gender, and BMI on 30-day mortality was assessed using multivariable logistic regression. Kaplan-Meier survival curves were used to analyze the survival difference in specific subsets. A total of 393 patients with CS on temporary MCS were admitted to our CICU during the study period. The median age of our cohort was 63 years (interquartile range 54 to 70 years), median BMI was 28.50 kg/m2 (interquartile range 24.62 to 29.72) and 70% (n = 276) were men. In total, 22 patients >80 years had received MCS compared with 372 patients <80 years. Patients >80 years on MCS had significantly higher 30-day mortality compared with those <80 years (81.8% vs 49.3%, p = 0.006). Upon stratifying patients by BMI, 161 (41%) patients were found to have BMI ≥30 kg/m2 whereas 232 (59%) patients had BMI <30 kg/m2. Comparison of 30-day mortality revealed that patients with BMI ≥30 did significantly worse than patients with BMI <30 (59.6% vs 45.3%, p = 0.007). There was no difference in 30-day mortality between men and women. On multivariable logistic regression, both age and BMI had a positive linear relation with adjusted 30-day mortality whereas gender did not have a major effect. Advanced age and higher BMI are independently associated with worse outcomes in patients with CS on MCS. Utilizing a strict selection criterion for patients in CS is pertinent to derive the maximum benefit from advanced mechanical support.

Aetiology and predictors of major bleeding events in patients with heart failure with reduced ejection fraction undergoing percutaneous coronary intervention.

OBJECTIVES: We sought to determine the relationship between the degree of left ventricular ejection fraction (LVEF) impairment and the frequency and type of bleeding events after percutaneous coronary intervention (PCI). DESIGN: This was an observational retrospective cohort analysis. Patients who underwent PCI from 2009 to 2017 were identified from our institutional National Cardiovascular Disease Registry (NCDR) CathPCI database. Patients were stratified by pre-PCI LVEF: preserved (≥50%), mildly reduced (41%-49%) and reduced (≤40%) LVEF. PRIMARY OUTCOME MEASURES: The outcome was major bleeding, defined by NCDR criteria. Events were classified based on bleeding aetiology and analysed by multivariable logistic regression. RESULTS: Among 13 537 PCIs, there were 817 bleeding events (6%). The rate of bleeding due to any cause, blood transfusion, gastrointestinal bleeding and coronary artery perforation or tamponade each increased in a stepwise fashion comparing preserved, mildly reduced and reduced LVEF reduction (p<0.05 for all comparisons). However, there were no differences in bleeding due to asymptomatic drops in haemoglobin, access site haematoma or retroperitoneal bleeding. After multivariable adjustment, mildly reduced and reduced LVEF remained independent predictors of bleeding events (OR 1.36, 95% CI 1.06 to 1.74, p<0.05 and OR 1.73, 95% CI 1.45 to 2.06, p<0.0001). CONCLUSIONS: The degree of LV dysfunction is an independent predictor of post-PCI major bleeding events. Patients with mildly reduced or reduced LVEF are at greatest risk of post-PCI bleeding, driven by an increased need for blood transfusion, major GI bleeding events and coronary artery perforation or tamponade. Pre-PCI LV dysfunction does not predict asymptomatic declines in haemoglobin, access site haematoma or retroperitoneal bleeding.

Implementing a comprehensive STEMI protocol to improve care metrics and outcomes in patients with in-hospital STEMI: an observational cohort study.

BACKGROUND: Patients who experience in-hospital ST-segment elevation myocardial infarction (iSTEMI) represent a uniquely high-risk cohort owing to delays in diagnosis, prolonged time to reperfusion and increased mortality. Quality initiatives aimed at improving the care of this vulnerable, yet understudied population are needed. METHODS: This study included consecutive patients with iSTEMI treated with percutaneous coronary intervention (PCI) between 1 January 2011 and 15 July 2019 at a single, tertiary referral centre. A comprehensive iSTEMI protocol (CSP) was implemented on 15 July 2014, incorporating: (1) cardiology fellow activation of the catheterisation lab using standardised criteria, (2) nursing chest pain protocol, (3) improved electronic access to electrocardiographic studies, (4) checklist for initial triage and management, (5) 24/7/365 catheterisation lab readiness and (6) radial-first PCI approach. Key metrics and clinical outcomes were compared before and after CSP implementation. RESULTS: Among 125 total subjects, the post-CSP cohort (n=81) was younger, had more males and were more likely to be hospitalised for cardiac-related reasons relative to the pre-CSP cohort (n=44) who were more likely hospitalised for operative-related aetiologies. After CSP adoption, median ECG-to-first-device-activation time decreased from 113 min to 64 min (p<0.001), goal ECG-to-first-device-activation time increased from 36% to 76% of patients (p<0.001), administration of guideline-directed medical therapy prior to PCI increased from 27.3% to 65.4% (p<0.001), trans-radial access increased from 16% to 70% (p<0.001) and rates of discharge home increased from 56.8% to 76.5% (p=0.04). Statistically insignificant numerical reductions were observed post-CSP in in-hospital mortality (18.2% vs 9.9%, p=0.30), 30-day mortality (15.9% vs 12.3%, p=0.78) and 1-year mortality (27.3% vs 21.0%, p=0.57). CONCLUSIONS: The implementation of a CSP was associated with marked enhancements in key care metrics among patients with iSTEMI. Among a larger cohort, the use of a CSP yielded a significant reduction in ECG-to-first-device-activation time in a particularly vulnerable population at high risk of death.

Patient, Operator, and Procedural Characteristics of Guidewire Retention as a Complication of Vascular Catheter Insertion.

Guidewire retention after intravascular catheter insertion is considered a "never event." Prior reports attribute this complication to various characteristics including uncooperative patients, operator inexperience, off-hour or emergent insertion, and underutilization of ultrasound guidance. In this descriptive analysis of consecutive events, we assessed the frequency of patient, operator, and procedural factors in guidewire retention. DESIGN: Pre-specified observational analysis as part of a quality improvement study of consecutive guidewire retention events across a multihospital health system from August 2007 to October 2015. SETTING: Ten hospitals within the Cleveland Clinic Health System in Ohio, United States. PATIENTS: Consecutive all-comers who experienced guidewire retention after vascular catheter insertion. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Data were manually obtained from the electronic medical records and reviewed for potential contributing factors for guidewire retention, stratified into patient, operator, and procedural characteristics. A total of 24 events were identified. Overall, the median age was 74 years, 58% were males, and the median body mass index was 26.5 kg/m2. A total of 12 (50%) individuals were sedated during the procedure. Most incidents (10 [42%]) occurred in internal jugular venous access sites. The majority of cases (13 [54%]) were performed or supervised by an attending. Among all cases, three (12%) were performed by first-year trainees, seven (29%) by residents, three (12%) by fellows, and four (17%) by certified nurse practitioners. Overall, 16 (67%) events occurred during regular working hours (8 amto 5 pm). In total, 22 (92%) guidewires were inserted nonemergently, with two (8%) during a cardiac arrest. Ultrasound guidance was used in all but one case. CONCLUSIONS: Guidewire retention can occur even in the presence of optimal patient, operator, and procedural circumstances, highlighting the need for constant awareness of this risk. Efforts to eliminate this important complication will require attention to issues surrounding the technical performance of the procedure.

Assessment of freely available online videos of cardiac electrophysiological procedures from a shared decision-making perspective.

Background: Physicians recommend electrophysiological (EP) procedures to patients with arrhythmic risk. This involves shared decision-making (SDM). Patients increasingly search for additional information online. Freely available online videos are an attractive source. Objective: We assessed freely available online videos for EP procedures from the perspective of SDM to determine if such videos can be shared with patients for SDM. Methods: We searched for freely available online videos related to 6 common EP procedures limited to English language and duration between 1 and 10 minutes using Google and Bing. Data collected included date and source of upload, number of hits, and duration. Videos were assessed systematically for understandability, actionability (PEMAT tool), relatability, teamwork, and mention of risk. Results: A total of 78 videos met our inclusion criteria, out of 960 video links. Overall inter-rater agreement was moderate to good. Video upload dates spanned 12 years and number of hits ranged from 87 to 594,000. The majority of videos (63%) were produced by health care systems or academic institutions. For all 78 videos the mean total PEMAT tool score was 48.6%. Thirty-five percent of videos showed a patient engaged in a conversation with the physician or a team member; 41% of videos showed other team members. The potential for complications was mentioned in 10%. Conclusion: The majority of online, freely available videos for common EP procedures lack features useful for SDM and may not be helpful for sharing with patients from that perspective. It is possible to create high-quality videos that can facilitate SDM.

Pelvic Exenteration for the Treatment of Locally Advanced Vulvar Cancer in South West Wales.

The treatment of locally advanced vulvar carcinoma (LAVC) represents a major challenge. We investigated the role of pelvic exenteration as a treatment of LAVC. Women who underwent pelvic exenteration for primary and recurrent LAVC in our centre between 2001 and 2019 were included. Among the 19 women included during the study period, 14 women (73.7%) had primary LAVC while 5 women (26.3%) had recurrent disease. Surgical resection margins were microscopically clear (R0) in 94.7% of patients-14/14 undergoing primary treatment and 4/5 undergoing treatment for recurrent disease. Complete closure of the wound was achieved in 100% of women, with no wound left to heal by secondary intention. Tumour size was a predictor of requiring myocutaneous flap reconstruction, with all tumours less than 40 mm undergoing primary closure, while almost all tumours 40 mm diameter or greater (14/15 women) required flap reconstruction (p = 0.001). The 30-day major morbidity rate was 42% and there was no perioperative death. The mean overall survival was 144.8 months (2-206 months), with 1-, 2- and 5-year survival rates of 89.5%, 75.1% and 66.7%, respectively. In our centre, a primary surgical approach to the management of LAVC has resulted in good survival outcomes with acceptable morbidity rates.

Revascularization or Optimal Medical Therapy for Stable Ischemic Heart Disease: A Bayesian Meta-Analysis of Contemporary Trials.

BACKGROUND: The role of revascularization in patients with stable ischemic heart disease (SIHD) has been controversial, more so in the present era of drug-eluting stents. AIMS: To examine the absolute risk difference (ARD) between revascularization plus optimal medical therapy (OMT) versus OMT alone among patients with SIHD using Bayesian approach. METHODS: PubMed/MEDLINE and Cochrane citation indices were utilized to identify randomized controlled trials (RCTs) through March 31, 2020. Among trials comparing initial revascularization plus OMT with initial OMT alone, revascularization arm must have comprised >50% of patients receiving either percutaneous or surgical revascularization, and >50% of patients must have received aspirin and statin as OMT in both arms. RESULTS: Seven RCTs (12,494) were included in the final analysis. The ARD of all-cause mortality for revascularization with respect to OMT was centred at -0.002 (95% CrI: -0.01; 0.01, Tau: 0.01, 67% probability of ARD of revascularization vs. OMT < 0). The ARD for cardiac mortality was centred at -0.0025 (95%CrI: -0.01; 0.01, Tau: 0.01, 77% probability of ARD of revascularization vs. OMT < 0). The ARD for MI was -0.02 (95% CrI: -0.06; 0.00, Tau: 0.02, 97% probability of ARD for revascularization vs. OMT < 0). There was 96% probability of ARD for unstable angina with revascularization vs. OMT < 0, 4.5% probability of ARD for freedom from angina with revascularization vs. OMT < 0, and 6% probability of ARD for stroke with revascularization vs. OMT < 0. CONCLUSIONS: Bayesian analysis demonstrated minimal probability of difference in all-cause mortality and cardiac mortality in patients with SIHD who underwent revascularization compared with OMT alone. However, revascularization was associated with lower probability of MI, unstable angina, and increased freedom from angina, but a higher risk of stroke compared with OMT alone. PROSPERO: The protocol of this systematic review and meta-analysis was registered in PROSPERO [CRD42020160540].

Interaction Between Race and Income on Cardiac Outcomes After Percutaneous Coronary Intervention.

Background Compared with White Americans, Black Americans have a greater prevalence of cardiac events following percutaneous coronary intervention. We evaluated the association between race and neighborhood income on post-percutaneous coronary intervention cardiac events and assessed whether income modifies the effect of race on this relationship. Methods and Results Consecutive patients (n=23 822) treated with percutaneous coronary intervention from January 1, 2000, to December 31, 2016, were included. All-cause mortality and major adverse cardiac event were assessed at 3 years. Extended 10-year follow-up was performed for those residing locally (n=1285). Neighborhood income was derived using median adjusted annual gross household income reported within the patient's zip code. We compared differences in treatment and outcomes, adjusting for race, income, and their interaction. In total, 3173 (13.3%) patients self-identified as Black Americans, and 20 649 (86.7%) self-identified as White Americans. Black Americans had a worse baseline cardiac risk profile and lower neighborhood income compared with White Americans. Although risk profile improved with increasing income in White Americans, no difference was observed across incomes among Black Americans. Despite similar long-term outpatient cardiology follow-up and medication prescription, risk profiles among Black Americans remained worse. At 3 years, unadjusted all-cause mortality (18.0% versus 15.2%; P<0.001) and major adverse cardiac event (37.3% versus 34.6%; P<0.001) were greater among Black Americans and with lower income (both P<0.001); race, income, and their interaction were not significant predictors in multivariable models. At 10-year follow-up, increasing income was associated with improved outcomes only in White Americans but not Black Americans. In multivariable models for major adverse cardiac event, income (hazard ratio [HR], 0.97 [95% CI, 0.96-0.98]; P=0.005), Black race (HR, 1.77 [95% CI, 1.58-1.96]; P=0.006), and their interaction (HR, 0.98 [95% CI, 0.97-0.99]; P=0.003) were significant predictors. Similar findings were observed for cardiac death. Conclusions Early 3-year post-percutaneous coronary intervention outcomes were driven by worse risk factor profiles in both Black Americans and those with lower neighborhood income. However, late 10-year outcomes showed an independent effect of race and income, with improving outcomes with greater income limited to White Americans. These findings illustrate the importance of developing novel care strategies that address both risk factor modification and social determinants of health to mitigate disparities in cardiac outcomes.