Sex Differences in Health Status and Clinical Outcomes After Nonprimary Percutaneous Coronary Intervention.

BACKGROUND: Greater insight into sex-based differences in health status can lay the foundation for more equitable health care. This study compares differences in health status of women and men in the CPORT-E trial (Cardiovascular Patient Outcomes Research Team Non-Primary Percutaneous Coronary Intervention) undergoing nonprimary percutaneous coronary intervention. METHODS: We compared Seattle Angina Questionnaire scores at baseline, 6 weeks, and 9 months for 6851 women and 12 016 men undergoing nonprimary percutaneous coronary intervention. RESULTS: Proportions of angina-free patients increased from 26.2% and 29.8% at baseline to 71.6% and 78.7% at 6 weeks to 78.1% and 83.0% at 9 months in women and men, respectively (P<0.001 for all). After adjusting for clinical and procedural characteristics as well as baseline angina, freedom from angina in women was 34% less likely at 6 weeks (odds ratio, 0.66 [95% CI, 0.61-0.71]; P<0.001) and 32% less likely at 9 months (odds ratio, 0.68 [95% CI, 0.62-0.74]; P<0.001) compared with men. CONCLUSIONS: Although health status increased significantly after percutaneous coronary intervention in both women and men, women had poorer health status outcomes than men before and after percutaneous coronary intervention. Additional investigation into therapies that address the causes of poorer health status in women with coronary artery disease is needed. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00549796.

Novel FHL1 Mutation Associated With Hypertrophic Cardiomyopathy, Sudden Cardiac Death, and Myopathy.

A 24-year-old man with muscle cramps and a family history of sudden death presented with palpitations. Electrocardiography showed signs of left ventricular hypertrophy and nonsustained ventricular tachycardia, and imaging studies confirmed hypertrophic cardiomyopathy. Genetic testing revealed a novel FHL1 mutation associated with Emery-Dreifuss muscular dystrophy. An implantable cardioverter-defibrillator was placed. (Level of Difficulty: Advanced.).

Nonprimary PCI at hospitals without cardiac surgery on-site: Consistent outcomes for all?

BACKGROUND: The CPORT-E trial showed the noninferiority of nonprimary percutaneous coronary intervention (PCI) at hospitals without cardiac surgery on-site (SoS) compared with hospitals with SoS for 6-week mortality and 9-month major adverse cardiac events (MACE). However, target vessel revascularization (TVR) was increased at non-SoS hospitals. Therefore, we aimed to determine the consistency of the CPORT-E trial findings across the spectrum of enrolled patients. METHODS: Post hoc subgroup analyses of 6-week mortality and 9-month MACE, defined as the composite of death, Q-wave myocardial infarction, or TVR, were performed. Patients with and without 9-month TVR and rates of related outcomes were compared. RESULTS: There was no interaction between SoS status and clinically relevant subgroups for 6-week mortality or 9-month MACE (P for any interaction=.421 and .062, respectively). In addition to increased 9-month rates of TVR and diagnostic catheterization at hospitals without SoS, non-TVR was also increased (2.7% vs 1.9%, P=.002); there was no difference in myocardial infarction-driven TVR, non-TVR, or diagnostic catheterization. Predictors of 9-month TVR included intra-aortic balloon pump use, any index PCI complication, and 3-vessel PCI, whereas predictors of freedom from TVR included SoS, discharge on a P2Y12 inhibitor, and stent implantation. CONCLUSIONS: The noninferiority of nonprimary PCI at non-SoS hospitals was consistent across clinically relevant subgroups. Elective PCI at an SoS hospital conferred a TVR benefit which may be related to a lower rate of referral for diagnostic catheterization for reasons other than myocardial infarction.

Heparin versus bivalirudin for non-primary percutaneous coronary intervention: A post-Hoc analysis of the CPORT-E trial.

OBJECTIVES: To compare bivalirudin to heparin during non-primary percutaneous coronary intervention (PCI). BACKGROUND: The optimal anticoagulant to support PCI remains uncertain. METHODS: We performed a propensity score-based analysis comparing clinical outcomes of patients receiving heparin to those receiving bivalirudin during non-primary PCI. RESULTS: Of 18,867 patients in the Cardiovascular Patient Outcomes Research Team Non-Primary PCI (CPORT-E) trial, we selected 7,913 patients undergoing non-staged PCI of whom 57.3% received heparin and 42.7% received bivalirudin. In-hospital myocardial infarction occurred in 4.4% of patients receiving bivalirudin and 3.0% of patients receiving heparin (relative risk [RR] 1.5, 95% confidence interval [CI] 1.1-2.1, P = 0.022); this difference persisted at 6 weeks (5.0% vs. 3.6%, RR 1.4, 95% CI 1.0-1.8, P = 0.041). There was no difference in all-cause mortality either in-hospital (0.2% vs. 0.1% for heparin vs. bivalirudin, P = 0.887) or at 6 weeks (0.5% vs. 0.7%, P = 0.567). In-hospital bleeding requiring transfusion occurred in 0.9% of patients receiving bivalirudin and 1.9% of patients receiving heparin (RR 0.4, 95% CI 0.3-0.7, P <0.001), but there was no difference at 6 weeks (2.7% for heparin vs. 1.9% for bivalirudin, RR 0.7, 95% CI 0.5-1.0, P = 0.062). CONCLUSIONS: In patients undergoing non-primary PCI at hospitals without on-site cardiac surgery, bivalirudin was associated with a decreased risk of in-hospital bleeding requiring transfusion and an increased risk of in-hospital MI compared to heparin. © 2017 Wiley Periodicals, Inc.

Outcomes of PCI at hospitals with or without on-site cardiac surgery.

BACKGROUND: Performance of percutaneous coronary intervention (PCI) is usually restricted to hospitals with cardiac surgery on site. We conducted a noninferiority trial to compare the outcomes of PCI performed at hospitals without and those with on-site cardiac surgery. METHODS: We randomly assigned participants to undergo PCI at a hospital with or without on-site cardiac surgery. Patients requiring primary PCI were excluded. The trial had two primary end points: 6-week mortality and 9-month incidence of major adverse cardiac events (the composite of death, Q-wave myocardial infarction, or target-vessel revascularization). Noninferiority margins for the risk difference were 0.4 percentage points for mortality at 6 weeks and 1.8 percentage points for major adverse cardiac events at 9 months. RESULTS: A total of 18,867 patients were randomly assigned in a 3:1 ratio to undergo PCI at a hospital without on-site cardiac surgery (14,149 patients) or with on-site cardiac surgery (4718 patients). The 6-week mortality rate was 0.9% at hospitals without on-site surgery versus 1.0% at those with on-site surgery (difference, -0.04 percentage points; 95% confidence interval [CI], -0.31 to 0.23; P=0.004 for noninferiority). The 9-month rates of major adverse cardiac events were 12.1% and 11.2% at hospitals without and those with on-site surgery, respectively (difference, 0.92 percentage points; 95% CI, 0.04 to 1.80; P=0.05 for noninferiority). The rate of target-vessel revascularization was higher in hospitals without on-site surgery (6.5% vs. 5.4%, P=0.01). CONCLUSIONS: We found that PCI performed at hospitals without on-site cardiac surgery was noninferior to PCI performed at hospitals with on-site cardiac surgery with respect to mortality at 6 weeks and major adverse cardiac events at 9 months. (Funded by the Cardiovascular Patient Outcomes Research Team [C-PORT] participating sites; ClinicalTrials.gov number, NCT00549796.).

Finger photoplethysmography during the Valsalva maneuver reflects left ventricular filling pressure.

It is often challenging to assess cardiac filling pressure clinically. An improved system for detecting or ruling out elevated cardiac filling pressure may help reduce hospitalizations for heart failure. The blood pressure response to the Valsalva maneuver reflects left heart filling pressure, but its underuse clinically may be due in part to lack of continuous blood pressure recording along with lack of standardization of expiratory effort. In this study, we tested whether Valsalva-induced changes in the pulse amplitude of finger photoplethysmography (PPG), a technology already widely available in medical settings, correlate with invasively measured left ventricular end-diastolic pressure (LVEDP). We tested 33 subjects before clinically scheduled cardiac catheterizations. A finger photoplethysmography waveform was recorded during a Valsalva effort of 20 mmHg expiratory pressure sustained for 10 s, an effort most patients can achieve. Pulse amplitude ratio (PAR) was calculated as the PPG waveform amplitude just before release of expiratory effort divided by the waveform amplitude at baseline. PAR was well correlated with LVEDP (r = 0.68; P < 0.0001). For identifying LVEDP > 15 mmHG, PAR > 0.4 was 85% sensitive [95% confidence interval (95CI): 54-97%] and 80% specific (95CI: 56-93%). In conclusion, finger PPG, a technology already ubiquitous in medical centers, may be useful for assessing clinically meaningful categories of left heart filling pressure, using simple analysis of the waveform after a Valsalva maneuver effort that most patients can achieve.

Percutaneous coronary intervention at centers with and without on-site surgery: a meta-analysis.

CONTEXT: Percutaneous coronary interventions are performed at centers without onsite surgery, despite current guidelines discouraging this. OBJECTIVE: To assess literature comparing rates of in-hospital mortality and emergency coronary artery bypass grafting surgery at centers with and without on-site surgery. DATA SOURCES: A systematic search of studies published between January 1990 and May 2010 was conducted using MEDLINE, EMBASE, and Cochrane Review databases. STUDY SELECTION: English-language studies of percutaneous coronary intervention performed at centers with and without on-site surgery providing data on in-hospital mortality and emergency bypass were identified. Two study authors independently reviewed the 1029 articles originally identified and selected 40 for analysis. DATA EXTRACTION: Study title, time period, indication for angioplasty, and outcomes were extracted manually from all selected studies, and quality of each study was assessed using the strengthening the reporting of observational studies in epidemiology (STROBE) checklist. DATA SYNTHESIS: High-quality studies of percutaneous coronary interventions performed at centers with and without on-site surgery were included. Pooled-effect estimates were calculated with random-effects models. Analyses of primary percutaneous coronary intervention for ST-segment elevation myocardial infarction of 124,074 patients demonstrated no increase in in-hospital mortality (no on-site surgery vs on-site surgery: observed risk, 4.6% vs 7.2%; odds ratio [OR], 0.96; 95% CI, 0.88-1.05; I(2) = 0%) or emergency bypass (observed risk, 0.22% vs 1.03%; OR, 0.53; 95% CI, 0.35-0.79; I(2) = 20%) at centers without on-site surgery. For nonprimary percutaneous coronary interventions (elective and urgent, n = 914,288), the rates of in-hospital mortality (observed risk, 1.4% vs 2.1%; OR, 1.15; 95% CI, 0.93-1.41; I(2) = 46%) and emergency bypass (observed risk, 0.17% vs 0.29%; OR, 1.21; 95% CI, 0.52-2.85; I(2) = 5%) were not significantly different at centers without or with on-site surgery. CONCLUSION: Percutaneous coronary interventions performed at centers without on-site surgery, compared with centers with on-site surgery, were not associated with a higher incidence of in-hospital mortality or emergency bypass surgery.

Comparative effectiveness of ST-segment-elevation myocardial infarction regionalization strategies.

BACKGROUND: Primary percutaneous coronary intervention (PCI) is more effective on average than fibrinolytic therapy in the treatment of ST-segment-elevation myocardial infarction. Yet, most US hospitals are not equipped for PCI, and fibrinolytic therapy is still widely used. This study evaluated the comparative effectiveness of ST-segment-elevation myocardial infarction regionalization strategies to increase the use of PCI against standard emergency transport and care. METHODS AND RESULTS: We estimated incremental treatment costs and quality-adjusted life expectancies of 2000 patients with ST-segment-elevation myocardial infarction who received PCI or fibrinolytic therapy in simulations of emergency care in a regional hospital system. To increase access to PCI across the system, we compared a base case strategy with 12 hospital-based strategies of building new PCI laboratories or extending the hours of existing laboratories and 1 emergency medical services-based strategy of transporting all patients with ST-segment-elevation myocardial infarction to existing PCI-capable hospitals. The base case resulted in 609 (95% CI, 569-647) patients getting PCI. Hospital-based strategies increased the number of patients receiving PCI, the costs of care, and quality-adjusted life years saved and were cost-effective under a variety of conditions. An emergency medical services-based strategy of transporting every patient to an existing PCI facility was less costly and more effective than all hospital expansion options. CONCLUSION: Our results suggest that new construction and staffing of PCI laboratories may not be warranted if an emergency medical services strategy is both available and feasible.

A percutaneous coronary intervention-thrombolytic predictive instrument to assist choosing between immediate thrombolytic therapy versus delayed primary percutaneous coronary intervention for acute myocardial infarction.

Based on the thrombolytic predictive instrument (TPI), we sought to create electrocardiographically based, real-time decision support to immediate identification of patients with ST-segment elevation myocardial infarction (STEMI) likely to benefit from primary percutaneous coronary intervention (PCI) compared with thrombolysis. Using data from the Atlantic Cardiovascular Patient Outcomes Research Team (C-PORT) Trial, we tested a mathematical model predicting mortality in patients with STEMI if treated with PCI and if treated with thrombolytic therapy. We adapted the model for incorporation into computerized electrocardiograms as a PCI-TPI. For patients with STEMI in the C-PORT Trial, the model yielded unbiased mortality predictions: for those receiving thrombolysis, it predicted 6.3% mortality and actual mortality was 6.0% (95% confidence interval 3.0 to 10.6); for those receiving PCI, it predicted 4.5% mortality and actual mortality was 3.9% (95% confidence interval 1.4 to 8.2). Excellent discrimination was reflected by its receiver operating characteristic curve area of 0.86. According to the model, and validated by actual trial outcomes, 1/3 of subjects accounted for all the mortality benefit from PCI. In conclusion, for STEMI, the PCI-TPI accurately predicts mortality for treatment with PCI and with thrombolytic therapy. Incorporated into electrocardiogram, it may assist targeting PCI to those who benefit most and identifying patients before hospitalization for whom a receiving hospital should prepare for PCI.

A geospatial analysis of emergency transport and inter-hospital transfer in ST-segment elevation myocardial infarction.

Primary percutaneous coronary intervention (PCI) yields better outcomes than thrombolytic therapy in the treatment of patients with ST-segment elevation myocardial infarctions (STEMIs). Emergency medical service systems are potentially important partners in efforts to expand the use of PCI. This study was conducted to explore the probable impact on patient mortality and hospital volumes of competing strategies for the emergency transport of patients with STEMIs. Emergency transport was simulated for 2,000 patients with STEMIs from the Atlantic Cardiovascular Patient Outcomes Research Team (C-PORT) trial in a geospatial model of Dallas County, Texas. Patient mortality estimates were obtained from a recently developed predictive model comparing PCI and thrombolytic therapy. A strategy of transporting patients to the closest hospital and treating with PCI if available and thrombolytic therapy if not yielded a 5.2% 30-day mortality rate (95% confidence interval [CI] 4.2% to 6.3%). A strategy of universal PCI, in which patients were transported only to PCI-capable hospitals, yielded 4.4% (95% CI 3.6% to 5.4%) mortality and an increase in patient volume at 2 full-time PCI hospitals of >1,000%. A strategy of targeted PCI, in which high-benefit patients were transported or transferred to PCI-capable hospitals, yielded 4.5% (95% CI 3.8% to 5.5%) mortality if transfers were decided in the emergency department and 4.2% (95% CI 3.4% to 5.1%) if transport was decided in the emergency vehicle. Targeted PCI strategies increased patient volumes at full-time PCI hospitals by about 700%. In conclusion, the selection of high-benefit patients for transport or transfer to PCI-capable hospitals can reduce mortality while minimizing major shifts in hospital patient volumes.

Comparison of mortality benefit of immediate thrombolytic therapy versus delayed primary angioplasty for acute myocardial infarction.

Primary percutaneous coronary intervention (PPCI) yields superior mortality outcomes compared with thrombolysis in ST-elevation acute myocardial infarction (STEMI) but takes longer to administer. Previous meta-regressions have estimated that a procedure-related delay of 60 minutes would nullify the benefits of PPCI on mortality. Using a combined database from randomized clinical trials and registries (n = 2,781) and an independently developed model of mortality risk in STEMI, we developed logistic regression models predicting 30-day mortality for PPCI and thrombolysis by examining the influence of baseline risk on the treatment effect of PPCI and on the hazard of treatment delay. We used these models to solve mathematically for "time interval to mortality equivalence," defined as the PPCI-related delay that would nullify its expected mortality benefit over thrombolysis, and to explore the influence of baseline risk on this value. As baseline risk increases, the relative benefit of PPCI compared with thrombolytic therapy significantly increases (p = 0.002); patients with STEMI at relatively low risk of mortality accrue little or no incremental mortality benefit from PPCI, but high-risk patients benefit greatly. However, as baseline risk increases, the hazard associated with longer treatment-related delay also increases (p = 0.007). These 2 effects are compensatory and yield a roughly uniform time interval to mortality equivalence of approximately 100 minutes in patients who have at least a moderate degree of mortality risk (> approximately 4%). In conclusion, the mortality benefits of PPCI and the hazard of PPCI-related delay depend on baseline risk. Previous meta-regressions appear to have underestimated the PPCI-related delay that would nullify the incremental benefits of PPCI.

Improving systems of care in primary angioplasty.

AMI is a life-threatening condition. Poor performance on the part of caregivers can result in the death of a patient. It is critical that a PPCI capability be developed in such a way that error is minimized. It is not enough that the system works well or very well. Aviation is often used as the example that medical systems should emulate. In developing the many interrelated systems required to function properly to ensure safe, effective,prompt, and appropriate application of PPCI,an aviation parallel should be kept in mind. If you were walking on the jetway toward a plane and were greeted by the pilot who said to you, "You know, I can land this thing 99% of the time," you would never get on that plane. It is important to develop a PPCI system that is absolutely never the cause of harm to any patient. Doing so requires exquisite attention to detail, algorithms of care when possible, redundancy, and clear orders for all drugs and procedures.

Detecting occult coronary disease in a high-risk asymptomatic population.

BACKGROUND: Exercise stress testing alone or with perfusion imaging is the standard screening method to determine the presence of obstructive coronary artery disease (CAD) in people with chest pain. In asymptomatic individuals with a family history of premature CAD, it is unclear whether abnormalities on these functional exercise tests represent significant coronary disease. METHODS AND RESULTS: An abnormal exercise test, thallium scan, or both occurred in 153 (21%) of 734 asymptomatic siblings of persons with documented CAD, of whom 105 underwent coronary angiography with quantitative analysis of stenosis severity. Overall, 95% had coronary atherosclerosis, but only 39% had 1 or more stenoses with >or=50% narrowing. Of 30 siblings in whom the exercise test and perfusion scan were both abnormal, 70% had >or=50% stenoses. The mean stenosis in arteries that fed perfusion defects was only 43+/-31%, and 68% of such stenoses were <50%. However, in 71% of all defects, the location matched arteries with the most severe stenoses. CONCLUSIONS: In asymptomatic persons with a family history of CAD, abnormal exercise scintigraphy identifies predominantly mild coronary atherosclerosis. Perfusion defects may be caused by coronary vasomotor dysfunction in addition to atherosclerotic plaque.

Thrombolytic therapy vs primary percutaneous coronary intervention for myocardial infarction in patients presenting to hospitals without on-site cardiac surgery: a randomized controlled trial.

CONTEXT: Trials comparing primary percutaneous coronary intervention (PCI) and thrombolytic therapy for treatment of acute myocardial infarction (MI) suggest primary PCI is the superior therapy, although they differ with respect to the durability of benefit. Because PCI is often limited to hospitals that have on-site cardiac surgery programs, most acute MI patients do not have access to this therapy. OBJECTIVE: To determine whether treatment of acute MI with primary PCI is superior to thrombolytic therapy at hospitals without on-site cardiac surgery and, if so, whether superiority is durable. DESIGN: The Atlantic Cardiovascular Patient Outcomes Research Team (C-PORT) trial, a prospective, randomized trial conducted from July 1996 through December 1999. SETTING: Eleven community hospitals in Massachusetts and Maryland without on-site cardiac surgery or extant PCI programs. PATIENTS: Four hundred fifty-one thrombolytic-eligible patients with acute MI of less than 12 hours' duration associated with ST-segment elevation on electrocardiogram. INTERVENTIONS: After a formal primary PCI development program was completed at all sites, patients were randomly assigned to receive primary PCI (n = 225) or accelerated tissue plasminogen activator (bolus dose of 15 mg and an infusion of 0.75 mg/kg for 30 minutes followed by 0.5 mg/kg for 60 minutes; n = 226). After initiation of assigned treatment, all care was determined by treating physicians. MAIN OUTCOME MEASURES: Six-month composite incidence of death, recurrent MI, and stroke; median hospital length of stay. RESULTS: The incidence of the composite end point was reduced in the primary PCI group at 6 weeks (10.7% vs 17.7%; P =.03) and 6 months (12.4% vs 19.9%; P =.03) after index MI. Six-month rates for individual outcomes were 6.2% vs 7.1% for death (P =.72), 5.3% vs 10.6% for recurrent MI (P =.04), and 2.2% vs 4.0% for stroke (P =.28) for primary PCI vs thrombolytic therapy, respectively. Median length of stay was also reduced in the primary PCI group (4.5 vs 6.0 days; P =.02). CONCLUSIONS: Compared with thrombolytic therapy, treatment of patients with primary PCI at hospitals without on-site cardiac surgery is associated with better clinical outcomes for 6 months after index MI and a shorter hospital stay.

Regional intracoronary analgesia during percutaneous transluminal coronary angioplasty.

The ischemic pain associated with balloon inflation during coronary angioplasty remains a significant source of procedural discomfort and sets a limit on the duration of percutaneous transluminal intravascular interventions. The present study examined whether intracoronary lidocaine reduced the pain of coronary angioplasty. Sixteen patients undergoing elective coronary angioplasty underwent three 90 sec balloon inflations: the first with administration of no intracoronary agent, and the second and third with administration of one or the other of placebo or an equal volume of lidocaine (10-16 mg). Placebo or lidocaine were randomized in administration sequence and were given just before balloon inflation. During the occlusions, pain was scored on an ordinal scale (0 = no pain; 10 = most severe pain). Lidocaine delayed the onset of pain (23 +/- 4 vs. 48 +/- 7 sec, P < 0.005) and reduced its magnitude (at end-inflation: 7.8 +/- 1.3 vs. 3.2 +/- 1.3, P < 0.01). There were no significant hemodynamic or electrophysiologic effects in this group of patients, although atrioventricular conduction was delayed when lidocaine was administered into the epicardial coronary which had the atrioventricular node artery as a branch. Intracoronary analgesia with lidocaine is safe and effective in a select group of patients with normal ventricular function undergoing elective coronary angioplasty.