Temporal changes in patient characteristics and outcomes in ST-segment elevation myocardial infarction 2003-2018.

BACKGROUND: We sought to describe changes in demographic variables, process of care measures, and outcomes of patients treated in a regional ST-segment elevation myocardial infarction (STEMI) program over the last 15 years. METHODS: We describe demographic variables, process of care measures, and outcomes of patients treated in the program in various 5-year time periods: 2003-2007 (n = 1,821), 2008-2012 (n = 1,968), and 2013-2018 (n = 2,223). The primary outcome measures were in-hospital and 30-day mortality. RESULTS: Among 6,012 STEMI patients treated from 2003 to 2018 we observed a significant increase in mean age at presentation (62 ± 14 to 64 ± 13 years) and diabetes (14-22%, p < .01). The proportion of patients with cardiogenic shock (CS) and cardiac arrest (CA) pre-PCI increased significantly from 9.5% to 11.1% and 8.5% to 12.7% (p < .05), respectively. The median door-to-balloon (D2B) times decreased from 98 to 93 min and total ischemic time decreased from 202 to 185 min (all p < .05). Despite increased patient complexity, the proportion of nontransfer and transfer patients achieving D2B times consistent with guideline recommendations remained unchanged (for nontransfer patients 79-82%, p = .45 and for transfer patients 65-64%, p = .34). Among all STEMI patients, in-hospital mortality increased during the study period from 4.9 to 6.9% (p = .007) but remained stable (<2%) when CA and CS patients were excluded. CONCLUSIONS: Over the last 15 years, short-term STEMI mortality has increased despite improvements in care delivery metrics. Patients with CA and/or CS now represent 10% of STEMI patients and are responsible for 80% of deaths. Therefore, efforts to improve STEMI mortality, and metrics for assessing STEMI programs, should focus on these patients.

ST-elevation myocardial infarction diagnosed after hospital admission.

BACKGROUND: Treatment times for ST-elevation myocardial infarction (STEMI) patients presenting to percutaneous coronary intervention hospitals have improved dramatically over the past 10 years, particularly for patients using emergency medical services. Limited data exist regarding treatment times and outcomes for patients who develop STEMI after hospital admission. METHODS AND RESULTS: With the use of a comprehensive prospective regional STEMI program database, we evaluated the characteristics and outcomes for patients who develop STEMI after hospital admission. Of the 3795 consecutive STEMI patients treated by the use of the Minneapolis Heart Institute regional STEMI program from March 2003 to January 2013, 990 (26.1%) presented initially to the percutaneous coronary intervention facility, including 640 arriving via emergency medical services, 267 self/family driven, and 83 already admitted to the hospital. Patients with in-hospital presentation were older with higher body mass indexes, were more likely to have hypertension, and to present with pre-percutaneous coronary intervention cardiac arrest and cardiogenic shock. Door-to-balloon times (diagnostic ECG-to-balloon for in-hospital patients) were longer than for patients using emergency medical services (76 versus 51 minutes; P<0.001), but similar to self/family-driven patients (76 versus 66 minutes; P=0.13). In-hospital patients had longer lengths of stay (5 versus 3 versus 3 days; P<0.001) and higher 1-year mortality (16.9% versus 10.3% versus 7.1%; P=0.032). These patients frequently had high-risk and complex reasons for admission, including 30.1% with acute coronary syndrome, 22.9% postsurgery, 13.3% respiratory failure, and 8.4% ventricular fibrillation. CONCLUSIONS: Patients who develop STEMI while in-hospital represent a unique, high-risk subset of patients. They have increased treatment time and lengths of stay and higher mortality rates than the patients presenting via emergency medical services or who are self/family driven.

Long-term survival in patients with refractory angina.

AIMS: An increasing number of patients with severe coronary artery disease (CAD) are not candidates for traditional revascularization and experience angina in spite of excellent medical therapy. Despite limited data regarding the natural history and predictors of adverse outcome, these patients have been considered at high risk for early mortality. METHODS AND RESULTS: The OPtions In Myocardial Ischemic Syndrome Therapy (OPTIMIST) program at the Minneapolis Heart Institute offers traditional and investigational therapies for patients with refractory angina. A prospective clinical database includes detailed baseline and yearly follow-up information. Death status and cause were determined using the Social Security Death Index, clinical data, and death certificates. Time to death was analysed using survival analysis methods. For 1200 patients, the mean age was 63.5 years (77.5% male) with 72.4% having prior coronary artery bypass grafting, 74.4% prior percutaneous coronary intervention, 72.6% prior myocardial infarction, 78.3% 3-vessel CAD, 23.0% moderate-to-severe left-ventricular (LV) dysfunction, and 32.6% congestive heart failure (CHF). Overall, 241 patients died (20.1%: 71.8% cardiovascular) during a median follow-up 5.1 years (range 0-16, 14.7% over 9). By Kaplan-Meier analysis, mortality was 3.9% (95% CI 2.8-5.0) at 1 year and 28.4% (95% CI 24.9-32.0) at 9 years. Multivariate predictors of all-cause mortality were baseline age, diabetes, angina class, chronic kidney disease, LV dysfunction, and CHF. CONCLUSION: Long-term mortality in patients with refractory angina is lower than previously reported. Therapeutic options for this distinct and growing group of patients should focus on angina relief and improved quality of life.

Patients with coronary artery disease not amenable to traditional revascularization: prevalence and 3-year mortality.

OBJECTIVES: To determine the contemporary prevalence of and mortality in patients with coronary artery disease (CAD) not amenable to revascularization. BACKGROUND: A growing number of patients have severe CAD with ongoing angina despite optimal medical therapy which is not amenable to traditional revascularization. Limited data exist on contemporary prevalence and outcome for these patients. METHODS: Clinical and angiographic data were reviewed for 493 consecutive patients undergoing coronary angiography and revascularization if indicated. Patients were categorized into six groups: (1) normal coronary arteries, (2) CAD <70%, (3) CAD >70% with complete revascularization by percutaneous intervention or coronary artery bypass grafting, (4) CAD >70% with partial revascularization, (5) CAD >70% treated medically, and (6) CAD >70% on optimal medical therapy with no revascularization option. All-cause mortality at 3 years was determined. RESULTS: Prevalence for groups 1-6 was 14.8, 19.5, 36.9, 12.8, 9.3, and 6.7%, respectively. Three-year mortality increased with angiographic severity of CAD: 2.7, 6.3, 8.2, 12.7, 17.4, and 15.2%, respectively. Patients with incomplete revascularization (groups 4-6, n = 142) had higher mortality than completely revascularized patients (groups 1-3, n = 351): 14.8 vs. 6.6% (P = 0.004). CONCLUSIONS: In a contemporary series of patients undergoing coronary angiography, 28.8% (142/493) of patients had significant CAD and did not undergo complete revascularization, including 12.8% partially revascularized, 9.3% managed medically, and 6.7% with "no-option." These patients had higher mortality at 3 years (14.8 vs. 6.6%, P = 0.004) when compared with completely revascularized patients.

A regional system to provide timely access to percutaneous coronary intervention for ST-elevation myocardial infarction.

BACKGROUND: Percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) is superior to fibrinolysis when performed in a timely manner in high-volume centers. Recent European trials suggest that transfer for PCI also may be superior to fibrinolysis and increase access to PCI. In the United States, transfer times are consistently long; therefore, many believe a transfer for PCI strategy for STEMI is not practical. METHODS AND RESULTS: We developed a standardized PCI-based treatment system for STEMI patients from 30 hospitals up to 210 miles from a PCI center. From March 2003 to November 2006, 1345 consecutive STEMI patients were treated, including 1048 patients transferred from non-PCI hospitals. The median first door-to-balloon time for patients <60 miles (zone 1) and 60 to 210 miles (zone 2) from the PCI center was 95 minutes (25th and 75th percentiles, 82 and 116 minutes) and 120 minutes (25th and 75th percentiles, 100 and 145 minutes), respectively. Despite the high-risk unselected patient population (cardiogenic shock, 12.3%; cardiac arrest, 10.8%; and elderly [> or =80 years of age], 14.6%), in-hospital mortality was 4.2%, and median length of stay was 3 days. CONCLUSIONS: Rapid transfer of STEMI patients from community hospitals up to 210 miles from a PCI center is safe and feasible using a standardized protocol with an integrated transfer system.

Enhanced external counterpulsation improves systolic blood pressure in patients with refractory angina.

BACKGROUND: Enhanced external counterpulsation (EECP) is a noninvasive treatment of patients with refractory angina. The immediate hemodynamic effects of EECP are similar to intra-aortic balloon pump counterpulsation, but EECP's effects on standard blood pressure measurements during and after treatment are unknown. METHODS: We evaluated systolic blood pressure (SBP) and diastolic blood pressure (DBP) for 108 consecutive patients undergoing EECP. Baseline SBP, DBP, and heart rate were compared for each patient before and after each EECP session, at the end of the course of EECP, and 6 weeks after the final EECP session. RESULTS: One hundred eight patients (mean age 66.4 +/- 11.2 years, 81% male) completed 36.5 +/- 5.1 EECP sessions per patient. Overall, based on 3,586 individual readings, EECP resulted in a decrease in mean SBP of 1.1 +/- 15.3 mm Hg at the end of each EECP session (P < .001), 6.4 +/- 18.2 mm Hg at the end the course of EECP (P < .001), and 3.7 +/- 17.8 mm Hg 6 weeks after the final EECP session (P = .07), with no significant change in DBP or heart rate. Stratifying by baseline SBP, a differential response was demonstrated: SBP increased in the 2 lowest strata (<100 mm Hg and 101-110 mm Hg) and decreased in the remaining strata (P < .001). Stratified differences were sustained after individual EECP sessions, at the end of the course of EECP, and 6 weeks after the final EECP session and were independent of changes in cardiovascular medications. CONCLUSIONS: Enhanced external counterpulsation improved SBP in patients with refractory angina. On average, EECP decreased SBP during treatment and follow-up; but for patients with low baseline SBP (<110 mm Hg), EECP increased SBP. The improvements in SBP may contribute to the clinical benefit of EECP.

Comparison of outcomes in high-risk patients>70 years of age with aortic valvuloplasty and percutaneous coronary intervention versus aortic valvuloplasty alone.

The goal of this study was to compare outcomes of combined balloon aortic valvuloplasty (BAV) plus percutaneous coronary intervention (PCI) with BAV alone in a surgically high risk, older (>70 years) population with both aortic stenosis (AS) and coronary artery disease (CAD). The medical records, coronary angiograms, and procedural reports of 100 consecutive patients who underwent BAV and coronary angiography at our institution from July 2003 to November 2006 were reviewed. Seventeen patients (mean age 86.2+/-6.4 years) underwent combined (nonstaged) BAV and PCI with a calculated Society of Thoracic Surgery risk score of 13.5%+/-6.7; 13 of these underwent coronary stenting before BAV and 4 after BAV. All 17 patients were successfully treated with this combined strategy. The incidence of periprocedural mortality, myocardial infarction, and stroke was zero. An additional 25 patients (mean age 85.9+/-6.9) with CAD were identified who underwent BAV alone with a Society of Thoracic Surgery risk score of 12.6+/-5.7%. PCI in these patients was avoided primarily because of greater lesion complexity or a perceived low probability of symptomatic benefit. There was 1 procedural death, no myocardial infarction, and 1 postprocedural stroke in these 25 patients. The procedural duration and hospital length of stay for the combined BAV and PCI group was 98.8+/-17.6 minutes and 4.1+/-2.8 days, respectively, and for the BAV only group was 86.2+/-27.3 minutes and 3.3+/-2.1 days, respectively. In conclusion, with appropriate selection, BAV plus PCI was safely performed in this retrospective series of elderly, high-risk patients with severe AS and CAD.

Emerging therapies for refractory angina.

In recent years, improvements in both pharmacologic and revascularization therapies have greatly increased life expectancy for patients with coronary artery disease (CAD). As patients with more extensive CAD live longer, many develop myocardial ischemia and clinical angina that is not amenable to traditional revascularization therapy. Patients with severe, symptomatic, chronic CAD have been described as having refractory angina; they have also been termed "no-option" patients. This article discusses clinical management of this unique and growing group of patients and emerging therapeutic options including pharmacologic agents, enhanced external counterpulsation therapy, therapeutic angiogenesis, neurostimulation, and transmyocardial revascularization.

New or presumed new left bundle branch block in patients with suspected ST-elevation myocardial infarction.

AIMS: Using a comprehensive large prospective regional ST-elevation myocardial infarction (STEMI) system database, we evaluated the prevalence, clinical and angiographic characteristics, and outcomes in patients with ischemic symptoms and new or presumed new left bundle branch block (LBBB). We then tested a new hierarchical diagnosis and triage algorithm to identify more accurately new LBBB patients with an acute culprit lesion. METHODS AND RESULTS: From March 2003 to June 2013, 3903 consecutive STEMI patients were treated using the Minneapolis Heart Institute regional STEMI protocol including 131 patients (3.3%) with new LBBB. These patients had fewer culprit arteries (54.2% vs. 86.4%; P<0.001), were older, more commonly women, with a lower ejection fraction, and more frequently presented with cardiac arrest or heart failure than those without new LBBB. At 1 year follow-up, all-cause mortality accounting for baseline differences was higher in patients with new LBBB (hazard ratio 1.73, 95% confidence interval 1.17-2.58; P=0.007). The new algorithm yielded high sensitivity (97%) and negative predictive value (94%) for identification of a culprit lesion. Using the definition of new LBBB with either hemodynamically unstable features or Sgarbossa concordance criteria on electrocardiogram (ECG), 45% of new LBBB patients would have been treated as 'STEMI equivalent'. CONCLUSION: Patients with acute ischemic symptoms and new LBBB represent a high-risk population with unique clinical challenges. If validated in an independent dataset, the new algorithm may improve the diagnostic accuracy regarding reperfusion therapy for new LBBB patients.

Value-Based ST-Segment-Elevation Myocardial Infarction Care Using Risk-Guided Triage and Early Discharge.

BACKGROUND: Prior studies suggest that low-risk ST-segment-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention can be considered for early discharge. We describe the implementation of an STEMI risk score to decrease cost while maintaining optimal patient outcomes. METHODS AND RESULTS: We determined the impact of risk-guided STEMI care on healthcare value through the retrospective application of the Zwolle Risk Score to 967 patients receiving primary percutaneous coronary intervention between 2009 and 2011. Of these patients, 540 (56%) were categorized as low risk, indicating they may be safely triaged directly to a telemetry unit rather than the intensive care unit and targeted for early discharge. We subsequently developed and implemented a modified Zwolle Risk Calculator into the electronic medical record to support application of the fast-track protocol for low-risk STEMI patients. Among 549 prospective patients with STEMI, 62% were low risk, and the fast-track protocol was followed in 75% of cases. Prospective results confirmed lower rates of complications (low risk 8.3% versus high risk 38.7%; P<0.001) and in-hospital mortality (low risk 0.4% versus High risk 12.5%; P<0.001) in the low-risk cohort. Low-risk patients had a shorter median length of stay (median and [25th, 75th percentiles]: low risk 2 [2, 3] versus high risk: 3 [2, 6]; P<0.001) and lower overall costs (low risk $6720 [$5280-$9030] versus high risk $11 783 [$7953-$25 359]; P<0.001). Low-risk patients treated on-protocol had shorter median length of stay (on-protocol 2 [1, 2] versus off-protocol 2 [2, 3]; P<0.001) and hospital costs (on-protocol $6090 [$4730, $7356] versus off-protocol $11 783 [$7953, $25 359]; P<0.001) than those treated off-protocol. On-protocol low-risk patients in the prospective cohort also had lower costs and shorter length of stay than low-risk patients in the retrospective cohort (P<0.001 for both). CONCLUSIONS: In our study, risk-guided triage and discharge after primary percutaneous coronary intervention for STEMI improved healthcare value by reducing costs of care without compromising quality of care or patient outcomes.

Transient Aortic Intramural Hematoma Complicating Transaortic Valve Replacement.

Acute aortic intramural hematoma, which is a variant of acute aortic syndromes, most frequently occurs spontaneously and typically is treated similar to classic aortic dissection. Here, we describe a case in which an iatrogenic aortic intramural hematoma occurs shortly after transaortic valve replacement. The patient was managed conservatively, and the hematoma quickly resolved as demonstrated by serial imaging.

Ranolazine refractory angina registry: 1-year results.

Patients with refractory angina (RA) have limited therapeutic options and significant limitations in their quality of life. Ranolazine is approved for patients with chronic stable angina but has not been studied in patients with RA. The Ranolazine Refractory Angina Registry was designed to evaluate the safety, tolerability, and effectiveness in RA patients. In a dedicated RA clinic using an extensive prospective database, 100 patients were enrolled. Angina class, medications, major adverse cardiac events including death, myocardial infarction, and revascularization were obtained at 1, 6, and 12 months. Overall 43% of patients had a ≥2 class improvement in angina. At 1 year, 57% patients remained on ranolazine (91.2%; 500 mg BID), including 58% with a ≥2 class improvement in angina. Reasons for discontinuation included: side effects (n = 16), major adverse cardiac events (n = 10), cost (n = 5), ineffective (n = 6), cost and ineffective (n = 3), and unknown (n = 3). In conclusion, ranolazine is an effective antianginal therapy in patients with RA; still at 1 year only 57% of patients remained on ranolazine because of side effects, suboptimal effectiveness, cost, or progression of disease.

Are the results of a regional ST-elevation myocardial infarction system reproducible?

Primary percutaneous coronary intervention (PCI) is the preferred reperfusion method in patients with ST-elevation myocardial infarction (STEMI) if it can be performed in a timely manner in high-volume centers. Regional STEMI networks improve timely access to PCI but are frequently criticized for being single center. To determine if results of regional STEMI systems could be replicated and achieve similar outcomes in 2 separate geographic regions, we examined the prospective databases of 2 large regional STEMI networks that use identical standardized protocols and integrated transfer systems. The Minneapolis Heart Institute (MHI) database included 2,266 patients with STEMI from 31 hospitals (498 at the PCI hospital, 1,033 transferred from 11 hospitals <60 miles away, and 735 transferred from 19 hospitals 60 to 210 miles away). The Iowa Heart Center (IHC) database included 1,206 patients with STEMI from 24 hospitals (710 at the PCI hospital, 266 transferred from 10 hospitals <60 miles away, and 230 transferred from 13 hospitals 60 to 120 miles away). Median total door-to-balloon times for the PCI hospital, zone 1, and zone 2 patients were 64, 95, and 123 minutes for the MHI and 59, 102, and 136 for the IHC (p <0.05 for each comparison between MHI and IHC). Overall in-hospital, 30-day, and 1-year mortalities was 4.8%, 5.4%, and 8.0% respectively (p = NS for each comparison between MHI and IHC). In conclusion, the use of identical protocols in 2 large regional STEMI systems in geographically separate locations produced nearly identical outcomes, adding to evidence that regional STEMI centers expand timely access to PCI.

Radiation following percutaneous balloon aortic valvuloplasty to prevent restenosis (RADAR pilot trial).

OBJECTIVES: We wished to determine the feasibility and early safety of external beam radiation therapy (EBRT) used following balloon aortic valvuloplasty (BAV) to prevent restenosis. BACKGROUND: BAV for calcific aortic stenosis (AS) has been largely abandoned because of high restenosis rates, i.e., > 80% at 1 year. Radiation therapy is useful in preventing restenosis following vascular interventions and treating other benign noncardiovascular disorders. METHODS: We conducted a 20-patient, pilot study evaluating EBRT to prevent restenosis following BAV in elderly patients with calcific AS. Total doses ranging from 12-18 Gy were delivered in fractions over a 3-5 day post-op period to the aortic valve. Echocardiography was performed pre and 2 days post-op, 1, 6, and 12 months following BAV. RESULTS: One-year follow-up is completed (age 89 +/- 4). There were no complications related to EBRT. Eight patients died prior to 1 year; 5 of 10 (50%) in the low-dose (12 Gy) group and 3 of 10 (30%) in the high-dose (15-18 Gy) group. None of these 8 patients had restenosis, i.e., > 50% loss of the initial AVA gain, and only three deaths were cardiac in origin. One patient underwent aortic valve replacement and none repeated BAV. By 1 year, 3 of the initial 10 (30%) in the low-dose group and 1 of 9 (11%) in the high-dose group demonstrated restenosis (21% overall). CONCLUSIONS: EBRT following BAV in elderly patients with AS is feasible, free of early complications, and holds promise in reducing the 1 year restenosis rate in a dose-dependent fashion.