Hospital-wide strategies improve outcomes in STEMI, yet their impact on patients with nonsystem delays (NSD) to primary PCI remains unknown. This study evaluated the effect of a 4-step comprehensive STEMI protocol (CSP) on outcomes in this high-risk population. This observational cohort analysis included STEMI patients with NSD as defined by the ACC National Cardiovascular Data Registry CathPCI Registry v5.0 criteria, which included difficult vascular access, difficulty crossing the culprit lesion, cardiac arrest and/or need for intubation before PCI, patient delays in providing consent for PCI, emergent placement of left-ventricular support device before PCI, and other reasons. Process and outcome metrics were compared before (January, 2011-July, 2014; n = 163) and after (July, 2014-July, 2019; n = 196) CSP implementation. The CSP comprised: (1) emergency department catheterization-laboratory activation; (2) STEMI Safe Handoff Checklist; (3) immediate transfer to an available laboratory; and (4) radial-first PCI. Among 359 patients with NSD, CSP implementation increased pre-PCI guideline-directed medical therapy (57.1%-79.6%, p <0.001) and radial access (16.6%-55.6%, p <0.001), and reduced median door-to-balloon time (132-101 minutes, p = 0.001). Post-CSP patients experienced lower rates of bleeding (22.7%-10.2%, p = 0.002), cardiac arrest (36.2%-23.5%, p = 0.01), circulatory shock (39.9%-24.5%, p = 0.003), and acute kidney injury (30.7%-19.9%, p = 0.03), with more frequent discharge to home (65.0%-78.6%, p = 0.006). In-hospital mortality was similar (14.1% vs 9.2%, p = 0.20). In conclusion, a 4-step CSP improved process metrics and clinical outcomes among STEMI patients with NSD, challenging the notion that outcomes of NSD cohort are unmodifiable and underscoring the importance of system-based interventions in this high-risk cohort.

BACKGROUND:Patients with heart failure with reduced ejection fraction (HFrEF) were excluded from major trials of left atrial appendage occlusion (LAAO). AIM:The objective of this study was to describe this population and evaluate outcomes after LAAO in patients with and without HFrEF. METHODS:Patients with and without HFrEF undergoing LAAO were identified in the Nationwide Readmissions Database from 2016 to 2020. Outcomes of interest were major in-hospital adverse events (death, stroke, pericardial effusion, tamponade, pericardial window, transfusion) and 6-month readmissions (any readmission, heart failure readmission, death/stroke readmission). To account for differences between patients with and without HFrEF, outcomes were evaluated using risk-adjusted logistic regression models and risk-adjusted Cox proportional hazards models. RESULTS:Of 50,526 encounters for LAAO, 5895 (11.7%) patients had HFrEF. The HFrEF group had a lower proportion of women and a higher proportion of major cardiovascular comorbidities. CHA2DS2-VASC score was 3.8 ± 1.3 in the HFrEF group and 3.7 ± 1.4 in those without HFrEF. HFrEF was associated with a higher risk of composite in-hospital major adverse events (6.0% vs. 5.0%, adjusted OR 1.23 [95% CI 1.09-1.40], p = 0.001) and a higher risk of 6-month all-cause readmission (adjusted HR 1.18 [95% CI 1.08-1.28], p < 0.001), heart failure readmission (adjusted HR 1.59 [95% CI 1.46-1.72], p < 0.001), and readmission with death or stroke (adjusted HR 1.27 [95% CI 1.03-1.57], p = 0.001). CONCLUSION:One out of nine patients treated with LAAO in the United States has HFrEF, which is associated with a higher risk of major in-hospital complications and hospital readmission.

BACKGROUND:In ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), an invasive strategy demonstrated better health status outcomes than a conservative strategy in patients with chronic coronary disease (CCD). Some previous studies have shown greater health status benefits with coronary artery bypass grafting (CABG) than percutaneous coronary intervention (PCI). Whether the health status benefits of invasive management in ISCHEMIA were driven primarily by participants treated with CABG is unknown. METHODS:The aim of this analysis was to describe the health status outcomes of participants treated with a conservative strategy (n=2232) compared with invasively managed participants treated with PCI (n=1198) or CABG (n=340) in ISCHEMIA. The Seattle Angina Questionnaire-7 summary score (SAQ-SS) and angina frequency score (SAQ-AF) were the primary outcomes, with higher scores indicating better health status. Proportional odds models comparing 1- and 3-year outcomes were fit, adjusting for demographic, clinical, and angiographic characteristics. RESULTS:SAQ-SS in the conservative, PCI, and CABG groups increased by 9.9±18.1, 15.7±19.3, and 16.1±19.1 points at 1 year and 11.5±20.2, 16.5±21.8, and 15.0±19.4 points at 3 years, respectively. Freedom from angina in the conservative, PCI, and CABG groups was noted in 61.4%, 73.3%, and 82.4% at 1 year and 70.4%, 76.1%, 81.4% at 3 years, respectively. In risk-adjusted analyses, PCI and CABG were each associated with a higher SAQ-SS and SAQ-AF at 1 and 3 years compared with conservative management. SAQ-AF was higher with CABG than PCI at 1 year (odds ratio, 1.54 [95% CI, 1.03, 2.31]), but no differences between CABG and PCI were observed in SAQ-SS (odds ratio, 1.11 [95% CI, 0.78, 1.57]) or SAQ-AF (odds ratio, 0.94 [95% CI, 0.58, 1.54]) at 3 years. CONCLUSIONS:In ISCHEMIA, both PCI and CABG were associated with better 3-year health status than conservative management. Better angina relief with CABG than PCI was seen at 1, but not 3, years. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.

Background Most US patients with ST‐segment–elevation myocardial infarction (STEMI) transferred for percutaneous coronary intervention (PCI) do not achieve the goal door‐to‐balloon time (D2BT) of ≤120 minutes. We evaluated the impact of a comprehensive STEMI protocol (CSP) implemented in our health care system on STEMI process metrics in patients transferred for PCI. Methods AND RESULTS The CSP is a 4‐step protocol including (1) emergency department (ED) cardiac catheterization laboratory activation; (2) a STEMI Safe Handoff Checklist; (3) immediate transfer to an available cardiac catheterization laboratory; and (4) radial‐first approach to PCI. We compared the use of guideline‐directed medical therapy before angiography, radial‐first access, and D2BT in 1274 consecutive patients with STEMI transferred to our hospital for PCI before (pre‐CSP group; January 1, 2011, to July 14, 2014) and after (CSP group; July 15, 2014, to July 15, 2019) CSP implementation. The study population included 499 patients in the pre‐CSP group and 775 patients in the CSP group. After CSP implementation, guideline‐directed medical therapy before angiography (84.6% versus 93.9%, P<0.001) and radial access (19.0% versus 77.7%, P<0.001) both increased significantly. Median D2BT decreased from 114 (interquartile range, 94–146 minutes) to 97 minutes (interquartile range, 82–115 minutes; P<0.001) after CSP implementation, with substantially more patients treated with D2BT of ≤120 minutes (55.7% versus 80.1%, P<0.001). Achievement of D2BT <120 minutes in the CSP group was associated with a 50% relative risk reduction in the 30‐day mortality rate (odds ratio, 0.50; P=0.04) and an absolute risk reduction of 0.7%. Conclusions In patients with STEMI transferred for PCI, a standardized protocol for STEMI care was associated in improvements in key process metrics (guideline‐directed medical therapy, radial access, and D2BT) with associated reduction in the 30‐day mortality rate.

•A new mitral annuloplasty ring was purpose-built for transcatheter valve-in-ring.•Bench testing confirmed anchoring of transcatheter valves inside the ring.•Balloon filling volumes are provided for several sizes of valve-ring pairs.•Surgeons should consider future intervention when selecting an annuloplasty device.•Heart team collaboration can optimize lifetime management of mitral valve disease.

BACKGROUND: While initial data for transcatheter aortic valve replacement (TAVR) in aortic stenosis patients with mitral stenosis (MS) suggested a poor short-term prognosis, outcomes for contemporary balloon-expandable valves remain unknown. The aim of this retrospective multicenter registry study was to compare the potential impact of MS on TAVR outcomes with balloon-expandable valves. METHODS: Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry and Centers for Medicare & Medicaid Services claims data were used to obtain a cohort of 327 925 patients who underwent TAVR with current balloon-expandable valves (SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra Resilia) between June 2015 and December 2022 across 791 sites. Severe MS (defined as >10 mm Hg mean gradient or <1.5 cm 2 area) was compared with mild or less MS (defined as <5 mm Hg mean gradient and >2 cm 2 area) using propensity matching to minimize confounding variables. RESULTS: Patients with severe MS (n=8500; 2.6%) had a higher number of comorbid conditions, Society of Thoracic Surgeons risk scores, and were more often women than patients with mild or less MS at the time of index TAVR. While patients with severe MS had worse outcomes at 30 days, when propensity-matched, patients exhibited similar 30-day rates of death (3.2% versus 3.0%), stroke (2.4% versus 2.2%), major vascular complications (1.6% versus 1.6%), device implant success (98.9% versus 99.2%), and new dialysis (0.7% versus 0.5%), with higher rates of pacemaker implantation (11.3% versus 9.4%; P <0.001). By 1 year, there was no difference in the change in the KCCQ (Kansas City Cardiomyopathy Questionnaire) overall score from baseline to 1 year (30.7±27.0 versus 31.9±27.0; P =0.07). By 3 years, an increase in the mortality rate (45.1% versus 40.9%; P <0.001) of patients with severe MS was observed. CONCLUSIONS: MS in isolation is not associated with worsened short-term outcomes among patients undergoing contemporary TAVR with balloon-expandable valves.

Patients with normal-flow low-gradient (NFLG) severe aortic stenosis present both diagnostic and management challenges, with debate about the whether this represents true severe stenosis and the need for valve replacement. Studies exploring the natural history without intervention have shown similar outcomes of patients with NFLG severe aortic stenosis to those with moderate aortic stenosis and better outcomes after valve replacement than those with low-flow low-gradient severe aortic stenosis. Most studies (all observational) have shown that aortic valve replacement was associated with a survival benefit vs surveillance. Based on available data, the European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines and European Association of Cardiovascular Imaging/American Society of Echocardiography suggest that these patients are more likely to have moderate aortic stenosis. This clinical entity is not mentioned in the American Heart Association/American College of Cardiology guidelines. Here we review the definition of NFLG severe aortic stenosis, potential diagnostic algorithms and points of error, the data supporting different management strategies, and the differing guidelines and outline the unanswered questions in the diagnosis and management of these challenging patients.

Patients with normal-flow low-gradient (NFLG) severe aortic stenosis present both diagnostic and management challenges, with debate about the whether this represents true severe stenosis and the need for valve replacement. Studies exploring the natural history without intervention have shown similar outcomes of patients with NFLG severe aortic stenosis to those with moderate aortic stenosis and better outcomes after valve replacement than those with low-flow low-gradient severe aortic stenosis. Most studies (all observational) have shown that aortic valve replacement was associated with a survival benefit vs surveillance. Based on available data, the European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines and European Association of Cardiovascular Imaging/American Society of Echocardiography suggest that these patients are more likely to have moderate aortic stenosis. This clinical entity is not mentioned in the American Heart Association/American College of Cardiology guidelines. Here we review the definition of NFLG severe aortic stenosis, potential diagnostic algorithms and points of error, the data supporting different management strategies, and the differing guidelines and outline the unanswered questions in the diagnosis and management of these challenging patients.

BACKGROUND:Outcomes of mitral transcatheter edge-to-edge repair (MTEER) in patients with secondary mitral regurgitation (sMR) and preserved left ventricular ejection fraction (LVEF) are uncertain. OBJECTIVES:This study sought to describe outcomes of MTEER for sMR with preserved LVEF. METHODS:Using the STS/ACC TVT (Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy) Registry, we evaluated the risk-adjusted outcomes of MTEER for sMR with LVEF >50% by the severity of residual mitral regurgitation (MR), and we compared these outcomes to patients undergoing MTEER for sMR with LVEF of 20% to 50%. RESULTS:Among 12,083 patients, LVEF was >50% in 3,011 (24.9%) and 20% to 50% in 9,072 (75.1%). Technical success, in-hospital complications, the 1-year death rate, and the 1-year Kansas City Cardiomyopathy Questionnaire score were similar in patients with LVEF >50% vs LVEF of 20% to 50%. The 1-year adjusted risk of heart failure hospitalization was lower in patients with LVEF >50% vs LVEF of 20% to 50% (adjusted HR: 0.81; 95% CI: 0.68-0.97; P = 0.02). Among patients with LVEF >50%, residual MR was ≤ mild in 76.0% and moderate in 19.0%. Compared with ≤ mild MR, moderate residual MR was associated with increased 1-year risks of death (adjusted HR: 1.46; 95% CI: 1.01-2.10; P = 0.04) and heart failure hospitalization (adjusted HR: 1.82; 95% CI: 1.32-2.52; P < 0.001). At 1 year, the KCCQ score improved in patients with LVEF >50% treated with MTEER (residual MR grade ≤ mild, 28.7 ± 26.8; moderate MR, 25.7 ± 27.2; > moderate MR, 21.6 ± 12.0; all P < 0.05). CONCLUSIONS:In patients with sMR and preserved LVEF, MTEER was associated with a high rate of technical success, a low rate of complications, and large improvements in health status.

Transcatheter closure of atrial septal defects (ASD) and patent foramen ovale (PFO) can be performed with transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) guidance, but data comparing both modalities in contemporary practice is lacking. Using ICD-10 codes, patients who underwent transcatheter ASD/PFO closure between 2016 and 2020 using ICE or TEE in the Nationwide Readmissions Database (NRD) were identified. Propensity-score matching was performed to compare in-hospital adverse events, length of stay (LOS), cost, and 30-day non-elective readmissions. A total of 964 patients underwent ASD/PFO closure with ICE (38.3 %, n = 369) or TEE (61.7 %, n = 595) between 2016 and 2020. Propensity score matching yielded 327 patients in each group, which were well balanced. Median (IQR) age was 59.0 (46.0, 72.0) years and 54.7 % were female. No difference was observed in the rate of in-hospital major adverse events between groups. ICE guidance was associated with a lower median cost (ICE $20,140.1 (14,622.3, 25,027.0) vs TEE $20,740.4 (14,137.5, 33,045.3), p < 0.04). In conclusion, ICE guided ASD/PFO closure was associated with lower hospitalization cost without increasing in-hospital adverse events when compared with TEE guidance.

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.

BACKGROUND Mitral valve transcatheter edge-to-edge repair (MTEER) was approved in the United States for treatment of functional mitral regurgitation (FMR) based on results from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial. OBJECTIVES The authors sought to analyze outcomes of MTEER in FMR patients who would have been excluded from COAPT. METHODS MTEER procedures performed for FMR in the TVT (Transcatheter Valve Therapy) Registry between January 1, 2013, and April 30, 2020, were categorized as "trial-ineligible" if any of the following were present: cardiogenic shock, inotropic support, left ventricular ejection fraction <20%, left ventricular end-systolic dimension >7 cm, home oxygen use, or severe tricuspid regurgitation. Trial-ineligible and trial-eligible groups were compared through 1 year using multivariable models. The primary endpoint was 1-year death or heart failure hospitalization (HFH). RESULTS Of 6,675 patients who underwent MTEER for FMR, 3,721 (55.7%) were trial-eligible and 2,954 (44.3%) were trial-ineligible. Trial-ineligible patients had lower rates of technical procedural success (86.9% vs 92.6%; P < 0.001) and more frequent in -hospital complications (11.8% vs 5.7%; P < 0.001) compared with trial-eligible patients. A clinically meaningful improvement in health status at 30 days was observed in 78.9% and 77.0% of patients in the trial-ineligible and trial-eligible groups, respectively. There was a higher risk of 1-year death or HFH (HR: 1.73; 95% CI: 1.57-1.91; P < 0.001) in trial-ineligible patients. CONCLUSIONS Among patients who underwent MTEER for FMR in the TVT Registry, nearly one-half would have been ineligible for the COAPT trial. Health status improvement at 30 days was similar in COAPT-ineligible and COAPT-eligible patients, but trial-ineligible patients had higher 1-year rates of death or HFH. (J Am Coll Cardiol 2024;83:488-499) (c) 2024 by the American College of Cardiology Foundation.

Severe aortic stenosis (AS) carries a poor prognosis with the onset of heart failure (HF) symptoms, and surgical or transcatheter aortic valve replacement (AVR) is its only definitive treatment. The management of AS has seen a paradigm shift with the adoption of transcatheter aortic valve replacement (TAVR), allowing for the treatment of AS in patients who would not otherwise be candidates for surgical AVR. Despite improving long-term survival after TAVR in recent years, residual HF symptoms and HF hospitalization are common and are associated with an increased mortality and a poor health status. This review article summarizes the incidence and risk factors for HF after AVR. Strategies for preventing and better managing HF after AVR are necessary to improve outcomes in this patient population. Extensive research is underway to assess whether earlier timing for AVR, prior to the development of severe symptomatic AS and associated extra-valvular cardiac damage, can improve post-AVR patient outcomes.

HomeJournal of the American Heart AssociationAhead of PrintImpact of a Comprehensive ST‐Segment–Elevation Myocardial Infarction Protocol on Key Process Metrics in Black Americans Open AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citations ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toOpen AccessLetterPDF/EPUBImpact of a Comprehensive ST‐Segment–Elevation Myocardial Infarction Protocol on Key Process Metrics in Black Americans Raunak M. Nair, Anirudh Kumar, Chetan P. Huded, Kathleen Kravitz, Grant W. Reed, Amar Krishnaswamy, Venu Menon, A. Michael Lincoff, Samir R. Kapadia and Umesh N. Khot Raunak M. NairRaunak M. Nair https://orcid.org/0000-0002-8939-141X , Cleveland Clinic Heart, , Vascular and Thoracic Institute, , Cleveland, , OH, , USA, , Cleveland Clinic Heart, , Vascular and Thoracic Institute Center for Healthcare Delivery Innovation, , Cleveland, , OH, , USA, , Anirudh KumarAnirudh Kumar https://orcid.org/0000-0002-4413-5439 , Cleveland Clinic Heart, , Vascular and Thoracic Institute, , Cleveland, , OH, , USA, , Cleveland Clinic Heart, , Vascular and Thoracic Institute Center for Healthcare Delivery Innovation, , Cleveland, , OH, , USA, , Chetan P. HudedChetan P. Huded , Saint Luke's Mid America Heart Institute, , Kansas City, , MO, , USA, , Kathleen KravitzKathleen Kravitz , Cleveland Clinic Heart, , Vascular and Thoracic Institute, , Cleveland, , OH, , USA, , Grant W. ReedGrant W. Reed , Cleveland Clinic Heart, , Vascular and Thoracic Institute, , Cleveland, , OH, , USA, , Cleveland Clinic Heart, , Vascular and Thoracic Institute Center for Healthcare Delivery Innovation, , Cleveland, , OH, , USA, , Amar KrishnaswamyAmar Krishnaswamy , Cleveland Clinic Heart, , Vascular and Thoracic Institute, , Cleveland, , OH, , USA, , Venu MenonVenu Menon , Cleveland Clinic Heart, , Vascular and Thoracic Institute, , Cleveland, , OH, , USA, , A. Michael LincoffA. Michael Lincoff , Cleveland Clinic Heart, , Vascular and Thoracic Institute, , Cleveland, , OH, , USA, , Samir R. KapadiaSamir R. Kapadia , Cleveland Clinic Heart, , Vascular and Thoracic Institute, , Cleveland, , OH, , USA, and Umesh N. KhotUmesh N. Khot *Correspondence to: Umesh N. Khot, MD, Heart, Vascular and Thoracic Institute Center for Healthcare Delivery Innovation, Cleveland Clinic, 9500 Euclid Ave/J2‐4, Cleveland, OH 44195. Email: E-mail Address: [email protected] https://orcid.org/0000-0001-6121-1280 , Cleveland Clinic Heart, , Vascular and Thoracic Institute, , Cleveland, , OH, , USA, , Cleveland Clinic Heart, , Vascular and Thoracic Institute Center for Healthcare Delivery Innovation, , Cleveland, , OH, , USA, Originally published17 Apr 2023https://doi.org/10.1161/JAHA.122.028519Journal of the American Heart Association. 2023;0:e028519Black Americans continue to receive suboptimal care following an ST‐segment–elevation myocardial infarction (STEMI) compared with other racial groups.1 In addition to delays in transfer, lower rates of revascularization, and longer door‐to‐balloon times, such differences in care delivery contribute to the poor outcomes noted in this population.2, 3 However, despite well‐recognized disparities in the care received by Black Americans with STEMI, there have been no prior quality improvement efforts that have been successful at addressing this issue. Our study aimed to assess whether a comprehensive STEMI protocol (CSP) could improve key process metrics in Black Americans with STEMI and if these improvements were equitable to White Americans.Because of the patient‐specific nature of our data, we will not be able to share it with individuals outside of this research project. We performed a retrospective, registry‐based study of consecutive patients with STEMI treated with percutaneous coronary intervention (PCI) at the Cleveland Clinic main campus from January 1, 2011 to July 15, 2019. On July 15,2014, we implemented a CSP intending to minimize STEMI care variability by (1) emergency department catheterization laboratory activation; (2) use of an STEMI Safe Handoff Checklist, (3) immediate transfer to an immediately available catheterization laboratory; and (4) radial first approach to PCI.4 Patients treated from January 1, 2011 to July 14, 2014 were defined as the pre‐CSP group and those treated from July 15, 2014 to July 15, 2019 as the post‐CSP group. Race was collected from electronic medical records and reflects self‐identification. Differences in key process metrics (guideline‐directed medical therapy administration, radial access use, door‐to‐balloon time, contrast dose, and fluoroscopy dose) were assessed for all Black Americans admitted to our hospital with STEMI during the pre‐ and post‐CSP periods. Pre‐ and post‐CSP process metrics were also compared between Black Americans and White Americans to assess for differences in improvements. Other racial groups contributed to <1% of the total cohort and were excluded. Multivariable logistic and linear regression models were created to understand the impact of the interactive effect between race and CSP on each of the key process metrics. The study protocol was approved by the Cleveland Clinic Foundation Institutional Review Board; the need for informed consent was waived.There were 208 Black Americans in the pre‐CSP group and 271 in the post‐CSP group. Comorbidities were generally well balanced between the 2 groups except for a lower rate of prior myocardial infarction in the post‐CSP group (Table). After implementation of the CSP, guideline‐directed medical therapy increased (71.6% pre‐CSP to 81.9% post‐CSP, P=0.01), radial PCI use increased (14.4%–73.8%, P<0.001), median door‐to‐balloon time decreased (90 [Q1 64, Q3 120] minutes to 70 [45, 95] minutes, P<0.001), median fluoroscopy dose decreased (1610 [980, 2592] mGy to 1147 [742, 1844] mGy, P<0.001), and median contrast dose decreased (180 [140, 240] mL to 145 [110, 180] mL, P<0.001). Multivariable regression models created for each key process metric showed no significant interaction between race and CSP for any of the key process metric (P>0.05 for all) indicating that race did not significantly impact the benefits gained with CSP.Table . Comparison of Baseline Characteristics and Key Process Metrics Among Black American and White American Patients During the Pre‐ and Post‐CSP Time PeriodsComparison of baseline characteristics among BA and WA patients before and after CSP time periodsVariableBlack AmericansWhite AmericansPre‐CSP (n=208)Post‐CSP (n=271)P valuePre‐CSP (n=479)Post‐CSP (n=793)P valueAge, y, mean (SD)58.7 (12.27)60.4 (13.12)0.1662.77 (12.49)62.67 (12.18)0.89BMI, kg/m2 mean (SD)30.0 (7.39)30.5 (7.70)0.4928.83 (5.42)30.56 (9.93)<0.001Men, n (%)128 (61.5)168 (62)0.99338 (70.6)543 (68.5)0.47Hypertension, n (%)173 (83.2)222 (81.9)0.81334 (70.0)583 (73.5)0.20Dyslipidemia, n (%)151 (73.3)193 (74.2)0.90360 (75.5)561 (73.0)0.36Diabetes, n (%)79 (38)108 (39.9)0.75126 (26.3)229 (28.9)0.35COPD, n (%)22 (10.6)39 (14.4)0.2658 (12.1)102 (12.9)0.76Smoker, n (%)114 (54.8)165 (60.9)0.21207 (43.2)379 (47.9)0.12Chronic kidney disease, n (%)44 (23)48 (21.7)0.84108 (25.2)188 (25.9)0.85Prior myocardial infarction, n (%)93 (44.7)81 (29.9)0.001153 (31.9)153 (19.3)<0.001Prior PCI, n (%)50 (24)72 (26.6)0.6086 (18.0)182 (23.0)0.04Prior CABG, n (%)5 (2.4)11 (4.1)0.4631 (6.5)39 (4.9)0.29Presentation*0.050.66ED, n (%)94 (44.5)144 (53.1)74 (15.4)108 (13.6)Transfer, n (%)106 (51)109 (40.2)369 (77)625 (78.8)In‐hospital, n (%)9 (4.3)18 (6.6)36 (7.5)60 (7.6)Comparison of key process metrics among BA and WA patients before and after CSP time periodsVariableBlack AmericansWhite AmericansAdjusted P values for interaction†Pre‐CSP (n=208)Post‐CSP (n=271)P valuePre‐CSP (n=479)Post‐CSP (n=793)P valueGDMT, n (%)149 (71.6)221 (81.9)0.01368 (76.8)705 (88.9)<0.0010.34Radial use, n (%)30 (14.4)200 (73.8)<0.00197 (20.3)604 (76)<0.0010.25Door‐to‐balloon time, min, median (IQR)90 (64–120)70 (45–95)<0.001111.00 (86–146)91.00 (72–111)<0.0010.35Fluoroscopy dose, mGy, median (IQR)1610 (980.25–2592.25)1147 (742–1844)<0.0011517.00 (1001–2394)1212.00 (721–1933)<0.0010.35Contrast, mL, median (SD)180.00 (140, 240)145.00 (110, 180)<0.001170.00 (140, 225)140.00 (101, 180)<0.0010.66BA indicates Black American; BMI, body mass index; CABG, coronary artery bypass grafting; COPD, chronic obstructive pulmonary disease; CSP, comprehensive ST‐segment–elevation myocardial infarction protocol; ED, emergency department; GDMT, guideline‐directed medical therapy; IQR, interquartile range; and WA, White American.*Door‐to‐balloon time notably lower in Black American group at baseline as our hospital is located closer to several Black American communities, and so they present directly to the emergency department (49.5% Black Americans presented to emergency department vs 14.9% for White Americans, P<0.01).†Regression models assessing each of the key process metrics were adjusted for age, sex, body mass index, prior myocardial infarction, prior percutaneous coronary intervention, race, comprehensive ST‐segment–elevation myocardial infarction protocol, and the interaction between race and comprehensive ST‐segment–elevation myocardial infarction protocol.To our knowledge, our study is the first to show that a comprehensive STEMI protocol can successfully and equitably improve the care of Black American patients. We show that implementing a CSP can be pivotal in cultivating an "ideal PCI environment" in the Black American population, which ensures timely guideline‐directed medical therapy use, radial access PCI, and reduces the cumulative effect of fluoroscopy and contrast in Black American patients with STEMI. Furthermore, upon comparing the process metrics between Black Americans and White Americans during the post‐CSP time period, we saw that the there was no significant difference in the key process metrics between the 2 races suggesting that the benefits gained were equitable. Our findings imply that developing a CSP can be effective in reducing care variability in the management of Black American patients with STEMI. This is in contrast to the study by Hsia et al in which regionalization of STEMI care led to further worsening of care disparities between races.5 Since Black Americans are often subjected to implicit bias in health care, adopting a CSP would help in eliminating structural racism. Hospital systems that cater to a large proportion of Black Americans should be at the forefront of establishing such standards of care as this could be pivotal in improving the outcomes of this high‐risk group.The results of our study should be interpreted with the following limitations. Our findings were obtained from observations at a single STEMI referral center and thus require further validation at other health care institutions. Secondly, because of the observational nature of our study, the effect of unmeasured covariates cannot be excluded.Implementing a CSP improved key process metrics in STEMI care for Black American patients and lead to equitable improvements. Rapid identification of STEMI, development of standardized care protocols, and procedural optimization are important components of the CSP that served to reduce care variability. Widespread adoption of the CSP by health care systems serving Black Americans can optimize the immediate care of this life‐threatening disease.Sources of FundingNone.DisclosuresNone.Footnotes*Correspondence to: Umesh N. Khot, MD, Heart, Vascular and Thoracic Institute Center for Healthcare Delivery Innovation, Cleveland Clinic, 9500 Euclid Ave/J2‐4, Cleveland, OH 44195. Email: [email protected]orgThis manuscript was sent to Sula Mazimba, MD, MPH, associate editor, for review by expert referees, editorial decision, and final disposition.For Sources of Funding and Disclosures, see page 3.References1 Raparelli V, Benea D, Nunez Smith M, Behlouli H, Murphy TE, D' Onofrio G, Pilote L, Dreyer RP. Impact of race on the in‐hospital quality of care among young adults with acute myocardial infarction. J Am Heart Assoc. 2021; 10:e021408. doi: 10.1161/JAHA.121.021408LinkGoogle Scholar2 Cooke CR, Nallamothu B, Kahn JM, Birkmeyer JD, Iwashyna TJ. Race and timeliness of transfer for revascularization in patients with acute myocardial infarction. Med Care. 2011; 49:662–667. doi: 10.1097/MLR.0b013e31821d98b2CrossrefMedlineGoogle Scholar3 Graham G. Racial and ethnic differences in acute coronary syndrome and myocardial infarction within the United States: from demographics to outcomes: racial/ethnic differences in ACS and MI. Clin Cardiol. 2016; 39:299–306. doi: 10.1002/clc.22524CrossrefMedlineGoogle Scholar4 Huded CP, Johnson M, Kravitz K, Menon V, Mouin A, Gullett T, Hantz S, Ellis SG, Podolsky SR, Meldon SW, et al. 4‐step protocol for disparities in STEMI care and outcomes in women. J Am Coll Cardiol. 2018; 71:2122–2132. doi: 10.1016/j.jacc.2018.02.039CrossrefMedlineGoogle Scholar5 Hsia RY, Krumholz H, Shen YC. Evaluation of STEMI regionalization on access, treatment, and outcomes among adults living in nonminority and minority communities. JAMA Netw Open. 2020; 3:e2025874. doi: 10.1001/jamanetworkopen.2020.25874CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails Article InformationMetrics Copyright © 2023 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley BlackwellThis is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.https://doi.org/10.1161/JAHA.122.028519PMID: 37066811 Manuscript receivedOctober 17, 2022Manuscript acceptedMarch 21, 2023Originally publishedApril 17, 2023 Keywordscomprehensive protocolST‐segment–elevation myocardial infarctionPDF download SubjectsDisparitiesQuality and Outcomes