Mortality in ST-Segment Elevation Myocardial Infarction With Nonobstructive Coronary Arteries and Mimickers.

Importance: The clinical characteristics and prognosis of patients with ST-segment elevation myocardial infarction (STEMI) with nonobstructive coronaries (MINOCA) are largely unknown. Objective: To assess differences in 5-year mortality in patients presenting with STEMI due to MINOCA and MINOCA mimickers as compared with obstructive disease. Design, Setting, and Participants: A retrospective analysis of a prospective registry-based cohort study of consecutive STEMI activations at 3 regional Midwest STEMI programs. STEMI without a culprit artery and elevated troponin levels were categorized as MINOCA (absence of coronary artery stenosis >50% and confirmed or suspected coronary artery plaque disruption, epicardial coronary spasm, or coronary embolism/thrombosis) or MINOCA mimickers (takotsubo cardiomyopathy, myocarditis, or nonischemic cardiomyopathy). Data were analyzed from March 2003 to December 2020. Main Outcomes and Measures: Adjusted Cox regression analysis was used to assess 5-year mortality risk in STEMI presenting with MINOCA and MINOCA mimickers in comparison with obstructive disease. Results: Among 8560 consecutive patients with STEMI, mean (SD) age was 62 (14) years, 30% were female (2609 participants), and 94% were non-Hispanic White (4358 participants). The cohort included 8151 patients with STEMI due to obstructive disease (95.2%), 120 patients with MINOCA (1.4%), and 289 patients with MINOCA mimickers (3.8%). Patients were followed up for a median (IQR) of 7.1 (3.6-10.7) years. Patients with MINOCA and MINOCA mimickers were less likely to be discharged with cardiac medications compared with obstructive disease. At 5-year follow-up, mortality in STEMI presenting with obstructive disease (1228 participants [16%]) was similar to MINOCA (20 participants [18%]; χ21 = 1.1; log-rank P = .29) and MINOCA mimickers (52 participants [18%]; χ21 = 2.3; log-rank P = .13). In adjusted Cox regression analysis compared with obstructive disease, the 5-year mortality hazard risk was 1.93 times higher in MINOCA (95% CI, 1.06-3.53) and similar in MINOCA mimickers (HR, 1.08; 95% CI, 0.79-1.49). Conclusions and Relevance: In this large multicenter cohort study of consecutive clinical patients with STEMI, presenting with MINOCA was associated with a higher risk of mortality than obstructive disease; the risk of mortality was similar in patients with MINOCA mimickers and obstructive disease. Further investigation is necessary to understand the pathophysiologic mechanisms involved in this high-risk STEMI population.

Characteristics and Long-term Mortality in Patients with ST-Segment Elevation Myocardial Infarction with Non-Obstructive Coronary Arteries (STE-MINOCA): A High Risk Cohort.

Background: The prognosis of ST-segment elevation myocardial infarction with non-obstructive coronaries (STE-MINOCA) is largely unknown. Methods: The objective of this study is to evaluate the prevalence, characteristics, and 5-year mortality of patients with STE-MINOCA compared to STEMI with coronary artery obstruction (STEMI-Obstruction) using a multicenter cohort of consecutive STEMI patients at 3 regional Midwest STEMI programs from 2003 to 2020. STE-MINOCA was defined based on (1) coronary stenosis < 60% by visual estimation, (2) ischemia with elevated troponin, and (3) no alternative diagnosis. STE-MINOCA was further classified based on American Heart Association (AHA) definition as AHA STE-MINOCA and AHA STE-MINOCA Mimicker. Results: 8,566 STEMI patients, including 420 (4.9%) STE-MINOCA (26.9% AHA STE-MINOCA and 73.1% AHA STE-MINOCA Mimicker) were followed for a median of 7.1 years. Compared to STEMI-Obstruction, STE-MINOCA were younger, more often female, had fewer cardiovascular risk factors, and were less likely to be discharged on cardiac medications. At five years, mortality was higher in STE-MINOCA compared with STEMI-Obstruction (18% vs. 15%, p=0.033). In propensity score-matched analysis, STE-MINOCA had a 1.4-fold (95% CI: 1.04-1.89, p=0.028) higher risk of 5-year all-cause mortality compared with STEMI-Obstruction. Furthermore, 5-year mortality risk was significantly higher in AHA STE-MINOCA Mimicker (19% vs. 15%, p=0.043) but similar in AHA STE-MINOCA (17% vs. 15%, p=0.42) compared with STEMI-Obstruction. Conclusions: In this large multicenter STEMI cohort, nearly 5% of patients presented with STE-MINOCA. At five years, mortality approached 20% among patients with STE-MINOCA. Despite the lower risk profile, STE-MINOCA patients were at 40% higher risk of 5-year all-cause mortality compared with STEMI-Obstruction. Additionally, 5-year all-cause mortality risk was higher in AHA STE-MINOCA Mimicker but similar in AHA STE-MINOCA compared to STEMI-Obstruction.

Variability in reporting of key outcome predictors in acute myocardial infarction cardiogenic shock trials.

BACKGROUND: Among acute myocardial infarction patients with cardiogenic shock (AMICS), a number of key variables predict mortality, including cardiac arrest (CA) and shock classification as proposed by Society for Cardiovascular Angiography and Intervention (SCAI). Given this prognostic importance, we examined the frequency of reporting of high risk variables in published randomized controlled trials (RCTs) of AMICS patients. METHODS: We identified 15 RCTs enrolling 2,500 AMICS patients and then reviewed rates of CA, baseline neurologic status, right heart catheterization data, lactate levels, inotrope and vasopressor requirement, hypothermia, mechanical ventilation, left ventricular ejection fraction (LVEF), mechanical circulatory support, and specific cause of death based on the primary manuscript and Data in S1. RESULTS: A total of 2,500 AMICS patients have been enrolled in 15 clinical trials over 21 years with only four trials enrolling >80 patients. The reporting frequency and range for key prognostic factors was: neurologic status (0% reported), hypothermia (28% reported, prevalence 33-75%), specific cause of death (33% reported), cardiac index and wedge pressure (47% reported, range 1.6-2.3 L min-1  m-2 and 15-24 mmHg), lactate (60% reported, range 4-7.7 mmol/L), LVEF (73% reported, range 25-45%), CA (80% reported, prevalence 0-92%), MCS (80% reported, prevalence 13-100%), and mechanical ventilation (93% reported, prevalence 35-100%). This variability was reflected in the 30-day mortality which ranged from 20-73%. CONCLUSIONS: In a comprehensive review of seminal RCTs in AMICS, important predictors of outcome were frequently not reported. Future efforts to standardize CS trial data collection and reporting may allow for better assessment of novel therapies for AMICS.

Is Compliance With Guideline Recommended Follow-Up After Aortic Dissection Associated With Survival?

BACKGROUND: Patients with acute aortic dissection (AD) remain at risk for long-term complications and thus are recommended to adhere closely to American College of Cardiology and American Heart Association aorta guideline-based follow-up imaging and clinic visits. The long-term outcomes of compliance with such a model are not well understood. METHODS: This was a retrospective cohort study of patients at a regional AD center who survived hospital discharge for AD and who were analyzed by compliance with initial follow-up at 3 months and long term after AD. The primary end point was death. RESULTS: A total of 172 (66% type A; 33% type B) patients survived hospitalization and were followed up over 48 months (interquartile range [IQR], 21, 88 months). Of these patients, 122 (71%) attended the first follow-up appointment, and 90 (52%) attended more than two-thirds of recommended appointments. Patients who attended the first follow-up visit had improved long-term follow-up compliance (75% [IQR, 50%, 91%]) compared with patients who did not attend the first visit (18% [IQR, 0%, 57%]). Noncompliance with the scheduled long-term follow-up was associated with a 50% increase in the risk of death (hazard ratio, 1.6; 95% confidence interval, 1.2, 2.1; P < .001). Furthermore, in patients with low compliance (consistently attending less than one-third of follow-up appointments), the lifetime risk of death after AD was more than double that of patients with high compliance (consistently attending more than two-thirds of appointments) (hazard ratio, 2.2; 95% confidence interval, 1.5, 3.1; P < .001). CONCLUSIONS: Nearly one-third of patients with AD do not attend the first recommended follow-up visit, and such failure was associated with later noncompliance with subsequent follow-up. Low-compliant patients have double the lifetime risk of death after AD than do high-compliant patients.

Frequency, Etiology, and Impact of Unplanned Repeat Coronary Angiography After ST-Elevation Myocardial Infarction.

Unplanned repeat coronary angiography (CAG) after balloon angioplasty for ST-elevation myocardial infarction (STEMI) was common before the advent of coronary stenting. Limited data are available regarding the role of unplanned repeat CAG in contemporary percutaneous coronary intervention (PCI) for STEMI. Therefore, we analyzed a large, 2-center prospective STEMI registry (January 2011 to June 2020) stratified by the presence or absence of unplanned repeat CAG during index hospitalization. Patients with planned CAG for staged PCI or experimental drug administration were excluded. Among 3,637 patients with STEMI, 130 underwent unplanned repeat CAG (3.6%) during index hospitalization. These patients were more likely to have cardiogenic shock (16% vs 9.8%, p = 0.021), left anterior descending culprit (44% vs 31%, p <0.001), lower left ventricular ejection fraction (45% vs 52%, p <0.001), and higher peak troponin levels (22 vs 8 ng/ml, p <0.001) than those without repeat CAG. At repeat CAG, 80 patients had a patent stent (62%) including 65 requiring no further intervention (50%) and 15 who underwent intervention on a nonculprit lesion (12%). Only 32 patients had stent thrombosis (25%). Repeat CAG was associated with a higher incidence of recurrent MI (19% vs 0%, p <0.001) and major bleeding (12% vs 4.5%, p <0.001), yet similar in-hospital mortality (7% vs 6.4%, p = 0.93) than those without repeat CAG. In conclusion, in the era of contemporary PCI for STEMI, unplanned repeat CAG during index hospitalization was infrequent and more commonly observed in patients with left anterior descending culprit in the presence of significant left ventricular dysfunction or shock and was associated with higher in-hospital recurrent myocardial infarction and major bleeding complications.

The impact of regional STEMI systems on protocol use and quality improvement initiatives in community hospitals without cardiac catheterization laboratories.

Study objective: Since the 1990s, national guidelines have recommended hospitals develop STEMI treatment protocols and monitor quality. A 2003 survey of Minnesota hospitals without cardiac catheterization laboratories (CCL) found <2/3 had STEMI protocols, <50% had a quality assessment (QA) process, and protocols in existence were incomplete. We evaluated temporal changes in STEMI processes in relationship to changes in mortality. Design setting and participants: Follow-up surveys were mailed to emergency departments at 108 Minnesota hospitals without CCL. Results: Among 87% of responding hospitals, 89% had formal protocols or guidelines for STEMI management compared to 63% in 2003 (p < 0.001). In 2010, 67% of hospitals had triage/transfer criteria and 15% of hospitals used protocols for transfer decisions, compared to only 8% (p < 0.001) and 1% (p = 0.098), respectively, in 2003. The percentage of hospitals transferring patients with STEMI from the emergency department increased from 23% in 2003 to 56% in 2010 (p < 0.001). During this time, age-adjusted acute MI mortality rate in Minnesota decreased 33% and was more pronounced in areas with regional STEMI systems. Conclusions: Since 2003, utilization of STEMI guidelines, protocols, and standing orders in Minnesota hospitals without CCL has markedly improved with <10% of hospitals lacking specific STEMI management protocols. The majority of hospitals routinely transfer patients with STEMI for primary PCI and have comprehensive QA processes. This improvement was stimulated by regional STEMI systems, further supporting the current class I recommendation for STEMI systems of care in current guidelines. The decline in Minnesota STEMI mortality paralleled the growth of regional STEMI systems.

Serotonergic antidepressants and hospitalization for bleeding in patients supported with a continuous flow left ventricular assist device.

BACKGROUND: Continuous flow left ventricular assist devices (CF -LVAD) improve survival in patients with advanced heart failure, but confer risk of bleeding complications. Serotonergic antidepressants (SA) are commonly used in heart failure patients receiving LVADs, but their inhibitory effect on platelet function may contribute to bleeding risk. METHODS: We performed a retrospective analysis of LVAD patients at our institution from 2016 -2019 comparing patients treated with SA after LVAD to those without SA. Demographic and clinical variables related to bleeding were collected on discharge from index hospitalization for CF-LVAD implantation and on admission for any bleeding event. The primary endpoint was incidence of bleeding requiring hospitalization after discharge. Secondary endpoints included overall number of admissions for bleeding, time to first hospitalization for a bleeding event, and incidence rate of hospitalizations for bleeding per patient year. RESULTS: 100 patients met inclusion criteria for the study. A total of 5 patients without a history of SA use and 31 patients who were prescribed SA after CF -LVAD implant were readmitted for a bleeding event after initial implant hospitalization (15% vs 46%, p = 0.004). Bleeding rate per person year (0.3 vs 0.61, p = 0.01) were significantly less in patients without SA use. Age-adjusted multivariable analysis found SA use to be associated with a hospitalization for bleeding (HR 2.3, 95% CI 0.99 -5.4). The higher incidence of hospitalization for bleeding was driven by non-gastrointestinal anatomical sites (6% vs 28%, p = 0.02) with a HR 7.7 (95% CI 0.96 -62). CONCLUSIONS: SA treatment after CF-LVAD implantation was associated with an increased risk for bleeding complications requiring hospitalization, particularly non-gastrointestinal bleeding.

Rate of Incomplete Revascularization Following Coronary Artery Bypass Grafting at a Single Institution Between 2007 and 2017.

Incomplete revascularization following coronary artery bypass grafting (CABG) is associated with increased repeat revascularization, myocardial infarction and death. Whether the rate of incomplete revascularization is increasing over time has not been previously described. All patients with multivessel coronary artery disease who underwent isolated and elective CABG at our Institution in 2007 (n = 291) were compared to patients who underwent CABG in 2017 (n = 290). A Revascularization Index Score was created to compare rates of incomplete revascularization between the 2 years based on the coronary anatomy and degree of stenosis. Comparison of the 2 years disclose that the rate of incomplete revascularization increased from 17.9% in 2007 to 28.3% in 2017 (p = 0.003) and was accompanied by a decline in the Revascularization Index Score from 0.73 to 0.67 (p = 0.005). Left ventricular function improved in both groups following CABG. Two-year cardiovascular mortality was significantly higher in the 2017 cohort compared to the 2007 cohort. These differences may be attributable to patient factors including more severe coronary artery disease associated with older age, greater incidence of smoking and previous percutaneous coronary intervention. In conclusion, the rate of incomplete revascularization following CABG significantly increased in 2017 compared to 2007 and was associated with higher cardiovascular mortality.

Impact of Intravascular Ultrasound Utilization for Stent Optimization on 1-Year Outcomes After Chronic Total Occlusion Percutaneous Coronary Intervention.

BACKGROUND: The impact of intravascular ultrasound (IVUS) utilization for stent optimization on the long-term outcomes in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We examined the outcomes of CTO-PCI with and without IVUS use for stent optimization in 922 CTO-PCIs performed between 2012 and 2019 at 12 United States centers. Major adverse cardiac event (MACE) was defined as the composite of cardiac death, acute coronary syndrome, and target-vessel revascularization. RESULTS: IVUS was used in 344 procedures (37%) for stent optimization. Mean patient age was 65 ± 10 years and 83% were men. Patients in the IVUS group were less likely to have a prior myocardial infarction (39% vs 50%; P<.01), more likely to undergo right coronary artery CTO-PCI (49% vs 55%; P=.01), and had higher mean J-CTO score (2.6 ± 1.1 vs 2.4 ± 1.2; P=.04). The final crossing strategy in patients in the IVUS group was less likely to be antegrade wire escalation (54% vs 57%) and more likely to be retrograde (29% vs 21%; P<.01). Median follow-up was 141 days (interquartile range, 30-365 days). The incidence of 12-month MACE was similar in the IVUS and no-IVUS groups (20.3% vs 18.3%; log-rank P=.67). CONCLUSION: IVUS was used for stent optimization in approximately one-third of CTO-PCIs. Despite higher lesion complexity in the IVUS group, the incidence of MACE was similar during follow-up.

CD34+ cell therapy significantly reduces adverse cardiac events, health care expenditures, and mortality in patients with refractory angina.

Patients with refractory angina who are suboptimal candidates for further revascularization have improved exercise time, decreased angina frequency, and reduced major adverse cardiac events with intramyocardial delivery of CD34+ cells. However, the effect of CD34+ cell therapy on health care expenditures before and after treatment is unknown. We determined the effect of CD34+ cell therapy on cardiac-related hospital visits and costs during the 12 months following stem cell injection compared with the 12 months prior to injection. Cardiac-related hospital admissions and procedures were retrospectively tabulated for patients enrolled at one site in one of three double-blinded, placebo-controlled CD34+ trials in the 12 months before and after intramyocardial injections of CD34+ cells vs placebo. Fifty-six patients were randomized to CD34+ cell therapy (n = 37) vs placebo (n = 19). Patients randomized to cell therapy experienced 1.57 ± 1.39 cardiac-related hospital visits 12 months before injection, compared with 0.78 ± 1.90 hospital visits 12 months after injection, which was associated with a 62% cost reduction translating to an average savings of $5500 per cell therapy patient. Patients in the placebo group also demonstrated a reduction in cardiac-related hospital events and costs, although to a lesser degree than the CD34+ group. Through 1 January 2019, 24% of CD34+ subjects died at an average of 6.5 ± 2.4 years after enrollment, whereas 47% of placebo patients died at an average of 3.7 ± 1.9 years after enrollment. In conclusion, CD34+ cell therapy for subjects with refractory angina is associated with improved mortality and a reduction in hospital visits and expenditures for cardiac procedures in the year following treatment.

Long-Term (3 Years) Outcomes of Ranolazine Therapy for Refractory Angina Pectoris (from the Ranolazine Refractory Registry).

Ranolazine is approved for patients with chronic stable angina but has not been formally studied in patients with refractory angina pectoris (RAP). Patients with RAP have limited therapeutic options and significant limitations in their quality of life. The Ranolazine Refractory Angina Registry was designed to evaluate the safety, tolerability, and effectiveness of ranolazine in RAP patients in order to expand treatment options for this challenging patient population. Using an extensive prospective database, we enrolled 158 consecutive patients evaluated in a dedicated RAP clinic. Angina class, medications, major adverse cardiac events including death, myocardial infarction, and revascularization were obtained at 12, 24, and 36 months. At 3 years, 95 (60%) patients remained on ranolazine. A ≥2 class improvement in angina was seen in 48% (38 of 80 patients with known Canadian Cardiovascular Society class) of those who remained on ranolazine. Discontinuation due to side effects, ineffectiveness, cost, and progression of disease were the principle reasons for discontinuation, but primarily occurred within the first year. In conclusion, ranolazine is an effective antianginal therapy at 3-year follow-up in patients with RAP and may reduce cardiac readmission.

Coexistence of acute takotsubo syndrome and acute coronary syndrome.

BACKGROUND: Takotsubo syndrome (TS) is an acute cardiac condition with presentation indistinguishable from acute coronary syndrome (ACS), and mechanism independent of epicardial coronary obstruction. Acute coronary artery plaque rupture/occlusion is not expected in TS. Nonetheless, the physiologic stress of ACS might itself trigger TS, leading to coexistence of both conditions, and diagnostic uncertainty. METHODS: From 2011 to 2014, we encountered 137 consecutive patients with typical TS (without acute coronary plaque rupture/occlusion). During this time, among a population of 3,506 consecutive ACS patients, nine (0.3%) presented with features of both ACS and TS, that is, acute onset, troponin elevation, acute plaque rupture/occlusion, and reversible LV ballooning not corresponding to culprit coronary distribution. RESULTS: The nine patients (seven female) with TS-ACS coexistence, average age 70 ± 13 years, presented with chest pain (n = 6), nausea/vomiting (n = 2), or cardiac arrest (n = 1), ST-elevation (n = 5), all with troponin elevation (peak 1.3 ± 1.2 ng/ml). Each had single vessel coronary disease; right coronary (n = 3), circumflex (n = 3), mid-LAD (n = 2), ramus intermedius (n = 1), with percutaneous coronary intervention in seven patients (78%). Initial ejection fraction was 26 ± 7%, with apical ballooning in eight patients and mid-LV ballooning in one patient. Each patient had LV ballooning resolution and ejection fraction normalization to 57 ± 3%, hospital survival was 89%. CONCLUSIONS: Among patients with ACS, a subset have evidence of coexisting TS, findings which further expand the clinical profile of both conditions, raising the possibility that ACS itself may trigger TS.

Revascularization in Patients With Spontaneous Coronary Artery Dissection and ST-Segment Elevation Myocardial Infarction.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) is an increasingly recognized cause of myocardial infarction (MI) in younger women, often treated conservatively due to revascularization risks. Revascularization outcomes are largely unknown in SCAD presenting with ST-segment elevation myocardial infarction (STEMI). OBJECTIVES: The purpose of this study was to compare revascularization strategies and outcomes of STEMI-SCAD with STEMI atherosclerosis (STEMI-ATH). METHODS: Consecutive STEMI patients were retrospectively analyzed (2003 to 2017) at 2 regional STEMI programs (Minneapolis Heart Institute and Cedars-Sinai Smidt Heart Institute) with 3-year outcomes. RESULTS: Among 5,208 STEMI patients, SCAD was present in 53 (1%; 93% female). SCAD prevalence was 19% in female STEMI patients age ≤50 years. Compared with STEMI-ATH, STEMI-SCAD patients were younger (age 49 ± 10 years vs. 63 ± 13 years), were more often female (93% vs. 27%), and had more frequent cardiogenic shock (19% vs. 9%); all p ≤ 0.03. In STEMI-SCAD, the culprit artery was more commonly left main (13% vs. 1%) or left anterior descending (47% vs. 38%); both p = 0.003. Acute revascularization was lower in STEMI-SCAD (70% vs. 97%); p < 0.001. In STEMI-SCAD, acute revascularization included percutaneous coronary intervention (PCI), n = 33 (62%), or bypass grafting, n = 4 (8%); PCI success was 91%. Those with revascularization were more likely to have shock, left main culprit, proximal dissection, and initial TIMI (Thrombolysis In Myocardial Infarction) flow grade 0 to 1. The 3-year survival was 98% for STEMI-SCAD versus 84% for STEMI-ATH; p < 0.001. CONCLUSIONS: STEMI-SCAD represents an important STEMI subset, particularly among younger women, characterized by significantly greater frequency of left main or left anterior descending culprit and cardiogenic shock than STEMI-ATH. Primary PCI is successful in most STEMI-SCAD patients, with low 3-year mortality.

Computed Tomographic Angiography-Derived Risk Factors for Vascular Complications in Percutaneous Transfemoral Transcatheter Aortic Valve Implantation.

Transfemoral aortic valve implantation (TAVI) has become a viable alternative to surgical valve implantation, particularly for higher risk patients; however, vascular complications (VCs) remain a concern in transfemoral TAVI. We aimed to determine clinical and computed tomographic angiography-derived risk factors associated with Valve Academic Research Consortium (VARC)-2 criteria VCs in patients who underwent TAVI. From 2011 to 2017, 481 patients underwent percutaneous transfemoral TAVI at the Minneapolis Heart Institute and were screened for procedural and postprocedural access-related VC according to VARC-2 criteria. Clinical and clinical and computed tomographic angiography-derived data were collected to establish risk factors for VC. A total of 99 (21%) patients had VARC-2 VCs. Closure device failure (CDF) occurred in 56 of 99 (57%), minor VCs in 37 of 99 (37%), and major VCs occurred in 6 of 99 (6%). Access site-related VCs were preceded by CDF in 18 of 43 (42%) patients and the risk of major/minor VCs was 14 times greater in patients who experienced closure complications. The incidence of CDF was higher in common femoral artery (CFA) access sites with circumferential vessel wall calcification of more than 90° (p = 0.02) and when skin-surface to CFA access-site distance at an optimal access angle of 45° exceeded 80 mm (p = 0.03). In conclusion, both the degree of circumferential CFA access site calcification and distance to skin surface at an optimal access angle may improve risk stratification of access planning in patients who underwent percutaneous transfemoral TAVI.

A systematic approach for successful PCSK9 inhibitor prescribing in clinical practice.

BACKGROUND: Despite patient and provider interest, the use of PCSK9i therapy remains limited in clinical practice. High annual listed prices have created intense payer scrutiny and frequent health plan denials, with national approval rates in the range of 30% to 40%. OBJECTIVE: Our goal was to validate the strategies for increasing PCSK9i approval rates and to present a framework for successful PCSK9i prescribing in clinical practice. METHODS: In Sept 2015, a systematic team-based approach was developed and implemented at our institution. The approach centered on a preventive team of 3 senior staff cardiologists, 1 nurse practitioner, 1 physician assistant, 1 care coordinator, 1 pharmacist, and 1 pharmacy technician. The team was responsible for gathering and compiling the required documents to support an approval, as well as collaborating with the in-house pharmacy to complete PA and appeals processes. RESULTS: In the total study population, 141 (71.9%) were approved for PCSK9i therapy at first submission and 55 (28.1%) were rejected. Of those initially rejected, 48 (85.7%) appealed and all 48 who appealed (100.0%) were ultimately approved. The final coverage decision was 189 (96.4%) approved and 7 (3.6%) rejected. CONCLUSION: Our study highlights the presence of modifiable barriers in the PCSK9i approval process. Given the crucial role of health care teams in overcoming these modifiable barriers, we developed a simple stepwise algorithm for navigating the PCSK9i approval process. Our algorithm can help relieve busy providers of heavy administrative burdens and facilitate greater accuracy, standardization, and efficiency in documentation.

NHLBI-Sponsored Randomized Trial of Postconditioning During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction.

RATIONALE: Postconditioning at the time of primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction may reduce infarct size and improve myocardial salvage. However, clinical trials have shown inconsistent benefit. OBJECTIVE: We performed the first National Heart, Lung, and Blood Institute-sponsored trial of postconditioning in the United States using strict enrollment criteria to optimize the early benefits of postconditioning and assess its long-term effects on left ventricular (LV) function. METHODS AND RESULTS: We randomized 122 ST-segment-elevation myocardial infarction patients to postconditioning (4, 30 seconds PTCA [percutaneous transluminal coronary angioplasty] inflations/deflations)+PCI (n=65) versus routine PCI (n=57). All subjects had an occluded major epicardial artery (thrombolysis in myocardial infarction=0) with ischemic times between 1 and 6 hours with no evidence of preinfarction angina or collateral blood flow. Cardiac magnetic resonance imaging measured at 2 days post-PCI showed no difference between the postconditioning group and control in regards to infarct size (22.5±14.5 versus 24.0±18.5 g), myocardial salvage index (30.3±15.6% versus 31.5±23.6%), or mean LV ejection fraction. Magnetic resonance imaging at 12 months showed a significant recovery of LV ejection fraction in both groups (61.0±11.4% and 61.4±9.1%; P<0.01). Subjects randomized to postconditioning experienced more favorable remodeling over 1 year (LV end-diastolic volume =157±34 to 150±38 mL) compared with the control group (157±40 to 165±45 mL; P<0.03) and reduced microvascular obstruction ( P=0.05) on baseline magnetic resonance imaging and significantly less adverse LV remodeling compared with control subjects with microvascular obstruction ( P<0.05). No significant adverse events were associated with the postconditioning protocol and all patients but one (hemorrhagic stroke) survived through 1 year of follow-up. CONCLUSIONS: We found no early benefit of postconditioning on infarct size, myocardial salvage index, and LV function compared with routine PCI. However, postconditioning was associated with improved LV remodeling at 1 year of follow-up, especially in subjects with microvascular obstruction. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01324453.

Clinical and pathologic findings of aortic dissection at autopsy: Review of 336 cases over nearly 6 decades.

BACKGROUND: We aimed to characterize the clinical and pathologic findings of aortic dissection (AD) over a nearly 60-year period. METHODS: The Jesse E. Edwards Registry of Cardiovascular Disease database was queried for cardiac specimens from autopsies with AD as a diagnosis and compared 2 cohorts: early (1956-1992) and current (1993-2015). RESULTS: From 1956 to 2015, 338 cases (166 early, 170 current) with AD were included (mean age: 60; 62% male). The AD was 86% type A and 14% type B. Sixty-two percent of cases were under medical care at time of death (61% early, 62% current, P = not significant). Of those under medical care, 63% were not diagnosed prior to death (64% early, 62% current, P = not significant). Risks for dissection did not differ between time intervals and include left ventricular hypertrophy, suggestive of hypertension (84%), prior cardiovascular surgery (38%), bicuspid valve (14%), and connective tissue disease (9%). An intimal tear was identified in the ascending aorta in the majority (68%), followed by descending (14%), root (9.5%), and arch (7%). Aortic rupture occurred in 58%, most frequently in the ascending aorta (41%). CONCLUSIONS: In a large cardiovascular registry, >60% of cases of AD were not detected clinically and first identified at autopsy. Although diagnostic techniques have significantly improved over the time interval, the percentage of AD discovered at autopsy did not differ from the early to the current era. The most prevalent risk factors for dissection including hypertension and prior cardiovascular surgery remain similar in both time periods. AD death is related to rupture of the aorta in the majority of cases.

Revascularization in "no option" patients with refractory angina: Frequency, etiology and outcomes.

BACKGROUND: A significant proportion of patients with complex, advanced coronary artery disease have refractory angina (RA) despite maximal pharmacological therapy and are deemed suboptimal candidates for revascularization. These patients are frequently termed "no-option" patients. However, despite this designation, many subsequently undergo coronary revascularization. We sought to determine the incidence, etiology and outcome of revascularization in "no-option" patients. METHODS AND RESULTS: We examined a comprehensive, prospective RA database to identify 342 of 1363 (25.1%) patients who subsequently underwent revascularization after a median interval of 2.2 years from the "no-option" diagnosis. Coronary revascularization was achieved by percutaneous coronary intervention (PCI) (n = 274, 20.1%), coronary bypass graft surgery (n = 44, 3.2%) or both (n = 24, 1.8%). During a median follow-up of 5.1 years, patients who underwent revascularization had lower annual mortality (2% vs. 4.4%, P < .001). Detailed paired angiographic records were available for 181 PCI patients with a combined 302 lesions. Of these interventions, 48% were for a new lesion, 31% for an existing lesion and 21% for restenosis. The location was a native vessel in 77% and a bypass graft in 23%. CONCLUSIONS: The "no-option" or non-revascularizable designation is frequently based on angiography at a single time-point. However, coronary artery disease is a progressive and dynamic process and new lesions often develop in such patients. Given the association between revascularization and better survival, careful consideration should be given to repeat revascularization in patients with refractory angina previously classified as "no-option".

Resource utilization and outcome among patients with selective versus nonselective troponin testing.

OBJECTIVE: In patients with suspected acute coronary syndrome (ACS), troponin testing is effective for diagnosis and prognosis. Troponin testing has now expanded to include patients without suspected ACS. This nonselective troponin testing has unknown consequences for resource utilization and outcome. Therefore, we examined selective versus nonselective troponin testing with respect to patient characteristics, resource utilization, and outcome. METHODS: This retrospective 1-year study included all patients with troponin testing at a U.S. emergency department. Testing was classified as selective (ACS) or nonselective (non-ACS) based on admission ICD-9 codes. Troponin upper reference limit (URL) was ≥99th percentile. RESULTS: Among 47,053 patients, troponin was measured in 9109 (19%) of whom 5764 were hospitalized. Admission diagnosis was non-ACS in 4427 (77%) and ACS in 1337 (23%). Non-ACS patients were older, 71±17 versus 65±16 years, with longer hospital stay, 77 versus 32 h, and greater 1-year mortality 22% versus 6.7%; P<.001. In patients with troponin ≥URL, revascularization was performed in 64 (4.7%) of non-ACS versus 213 (48%) of ACS; P<.001. In patients with troponin 80% of the non-ACS population CONCLUSIONS: Contemporary troponin testing is frequently nonselective. The non-ACS and ACS populations differ significantly regarding clinical characteristics, revascularization rates, and outcomes. Troponin elevation is a powerful predictor of 1-year mortality in non-ACS, this association reveals an opportunity for risk stratification and targeted therapy. KEY QUESTIONS: In patients with suspected acute coronary syndrome (ACS), troponin testing is effective for diagnosis and prognosis. However, troponin testing has now expanded to include patients without suspected ACS. This nonselective troponin testing has unknown consequences for hospital resource utilization and patient outcome. Our findings demonstrate contemporary troponin testing is largely nonselective (77% of testing was performed in patients without acute coronary syndrome). In comparison to patients with acute coronary syndrome, those with non-acute coronary syndrome are older, with longer hospital stay, lower revascularization rates, and greater 1-year mortality. Troponin elevation identifies a high-risk population in both acute coronary syndrome and non-acute coronary syndrome populations, yet effective treatment for the latter is lacking.