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.

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.

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.

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.

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.

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].

Relationship of Neighborhood Deprivation and Outcomes of a Comprehensive ST-Segment-Elevation Myocardial Infarction Protocol.

Background We evaluated whether a comprehensive ST-segment-elevation myocardial infarction protocol (CSP) focusing on guideline-directed medical therapy, transradial percutaneous coronary intervention, and rapid door-to-balloon time improves process and outcome metrics in patients with moderate or high socioeconomic deprivation. Methods and Results A total of 1761 patients with ST-segment-elevation myocardial infarction treated with percutaneous coronary intervention at a single hospital before (January 1, 2011-July 14, 2014) and after (July 15, 2014- July 15, 2019) CSP implementation were included in an observational cohort study. Neighborhood deprivation was assessed by the Area Deprivation Index and was categorized as low (≤50th percentile; 29.0%), moderate (51st -90th percentile; 40.8%), and high (>90th percentile; 30.2%). The primary process outcome was door-to-balloon time. Achievement of guideline-recommend door-to-balloon time goals improved in all deprivation groups after CSP implementation (low, 67.8% before CSP versus 88.5% after CSP; moderate, 50.7% before CSP versus 77.6% after CSP; high, 65.5% before CSP versus 85.6% after CSP; all P<0.001). Median door-to-balloon time among emergency department/in-hospital patients was significantly noninferior in higher versus lower deprivation groups after CSP (noninferiority limit=5 minutes; Pnoninferiority high versus moderate = 0.002, high versus low <0.001, moderate versus low = 0.02). In-hospital mortality, the primary clinical outcome, was significantly lower after CSP in patients with moderate/high deprivation in unadjusted (before CSP 7.0% versus after CSP 3.1%; odds ratio [OR], 0.42 [95% CI, 0.25-0.72]; P=0.002) and risk-adjusted (OR, 0.42 [95% CI, 0.23-0.77]; P=0.005) models. Conclusions A CSP was associated with improved ST-segment-elevation myocardial infarction care across all deprivation groups and reduced mortality in those from moderate or high deprivation neighborhoods. Standardized initiatives to reduce care variability may mitigate social determinants of health in time-sensitive conditions such as ST-segment-elevation myocardial infarction.

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.

Prognostic implications and outcomes of cardiac arrest among contemporary patients with STEMI treated with PCI.

BACKGROUND: Cardiac arrest (CA) complicating ST-elevation myocardial infarction (STEMI) is associated with a disproportionately higher risk of mortality. We described the contemporary presentation, management, and outcomes of CA patients in the era of primary percutaneous coronary intervention (PCI). METHODS: We reviewed 1,272 consecutive STEMI patients who underwent PCI between 1/1/2011-12/31/2016 and compared characteristics and outcomes between non-CA (N = 1,124) and CA patients (N = 148), defined per NCDR definitions as pulseless arrest requiring cardiopulmonary resuscitation and/or defibrillation within 24-hr of PCI. RESULTS: Male gender, cerebrovascular disease, chronic kidney disease, in-hospital STEMI, left main or left anterior descending culprit vessel, and initial TIMI 0 or 1 flow were independent predictors for CA. CA patients had longer door-to-balloon-time (106 [83,139] vs. 97 [74,121] minutes, p = 0.003) and greater incidence of cardiogenic shock (48.0% vs. 5.9%, p < 0.001), major bleeding (25.0% vs. 9.4%, p < 0.001), and 30-day mortality (16.2% vs. 4.1%, p < 0.001). Risk score for 30-day mortality based on presenting characteristics provided excellent prognostic accuracy (area under the curve = 0.902). However, over long-term follow-up of 4.5 ± 2.4 years among hospital survivors, CA did not portend any additional mortality risk (HR: 1.01, 95% CI: 0.56-1.82, p = 0.97). CONCLUSIONS: In a contemporary cohort of STEMI patients undergoing primary PCI, CA occurs in >10% of patients and is an important mechanism of mortality in patients with in-hospital STEMI. While CA is associated with adverse outcomes, it carries no additional risk of long-term mortality among survivors highlighting the need for strategies to improve the in-hospital care of STEMI patients with CA.

Characteristics and Outcomes of Early Recurrent Myocardial Infarction After Acute Myocardial Infarction.

Background We aimed to understand the characteristics and outcomes of patients readmitted with a recurrent myocardial infarction (RMI) within 90 days of discharge after an acute myocardial infarction (early RMI). Methods and Results We analyzed the timing of reinfarction, etiology, and outcome for all patients admitted with an early RMI within 90 days of discharge after an acute myocardial infarction between January 1, 2010 and January 1, 2017. We identified 6626 admissions for acute myocardial infarction (index myocardial infarction) which led to 168 cases of RMI within 90 days of discharge. The mean patient age was 65.1±13.1 years, and 37% were women. The 90-day probability of readmission with an early RMI was 2.5%. Black race, medical management, higher troponin T, and shorter length of stay were independent predictors of early RMI. Medically managed group had a higher risk for early RMI compared with percutaneous coronary intervention (P=0.04) or coronary artery bypass grafting (P=0.2). Predominant mechanisms for reinfarction were stent thrombosis (17%), disease progression (12%), and unchanged coronary artery disease (11%). At 5 years, the all-cause mortality rate for patients with an early RMI was 49% (95% CI, 40%-57%) compared with 22% (95% CI, 21%-23%) for patients without an early RMI (P<0.0001). Conclusions Early RMI is a life-threatening condition with nearly 50% mortality within 5 years. Stent-related events and progression in coronary artery disease account for most early RMI. Medication compliance, aggressive risk factor management, and care transitions should be the cornerstone in preventing early RMI.

Dual antiplatelet therapy after percutaneous coronary intervention: Personalize the duration.

The recommended duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with a drug-eluting stent has changed from 1 year for all to a more personalized approach based on the patient's risks of ischemia and bleeding. The trend is toward shorter treatment in view of lower rates of late and very late stent thrombosis with newer drug-eluting stents and the risk of bleeding with DAPT. But some patients at high risk of ischemic events and low risk of bleeding may benefit from longer treatment.