Anil Poulose

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 [≥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.

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.

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.

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.

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.

Transseptal technique of percutaneous PFO closure results in persistent interatrial shunting

Our goal was to review the effectiveness of the transseptal and tunnel techniques of patent foramen ovale (PFO) closure. Percutaneous PFO closure is an increasingly common treatment for prevention of paradoxical embolism and is typically performed by passing the device through the defect tunnel itself. The transseptal technique, in which the septum primum is punctured to create a hole through which the device is passed, has been proposed for patients with long‐tunnel PFO. From May 2001 to December 2003, 120 patients underwent PFO closure at our institution and were included in this analysis. Defect closure was assessed by transesophageal echocardiography (TEE) with bubble study. Clinical follow‐up data were obtained by clinic visits or standardized telephone interviews. Device closure was successfully completed in all patients, with 12 (10%) undergoing transseptal closure and 108 (90%) undergoing tunnel closure. Immediately following the procedure, complete closure occurred in 6 of 12 (50%) of the transseptal group and 88 of 108 (81.5%) of the tunnel group (P = 0.0120). Of the 89 patients (74.2%) who returned for 6‐month TEE, complete closure was demonstrated in 4 out of 10 (40%) of the transseptal group and 58 out of 79 (73.4%) of the tunnel group (P = 0.0303). There have been four transient ischemic attacks during a mean follow‐up of 11 months. The transseptal technique of PFO closure results in a higher proportion of patients with persistent interatrial shunting when compared with the tunnel technique. Whether this is due to a difference in technique, device, or patient anatomy is unclear.

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 EECPs 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.

Real-Time Decision Support to Guide Percutaneous Coronary Intervention Bleeding Avoidance Strategies Effectively Changes Practice Patterns

Approximately 600 000 percutaneous coronary interventions (PCIs) are performed annually in the United States.1 Periprocedural bleeding is a common complication of PCI,2–6 occurring in 2% to 6% of cases.6–12 Bleeding is associated with major adverse events, including short- and long-term mortality,4,8–11,13 as well as prolonged hospital length of stay (LOS)7–10,14 and higher hospital costs.6,7,15,16 Periprocedural bleeding seems to be predictable and modifiable.4 A validated risk prediction algorithm may help clinicians estimate bleeding risk in patients undergoing PCI, and established bleeding avoidance strategies (BAS), such as bivalirudin, radial artery access, and vascular closure devices, have been demonstrated to reduce bleeding.2,16–24 However, recent studies have reported that patients at highest risk for bleeding are least likely to receive treatment with BAS.2,5 Accurate preprocedure bleeding risk assessment scoring may provide a significant opportunity for physicians to selectively use effective preventative tactics in patients most likely to benefit and improve PCI safety, care quality, and subsequently hospitalization costs. Bleeding events after cardiovascular procedures have been identified by the Centers for Medicare and Medicaid Services to be quality indicators among centers participating in its Acute Care Episode demonstration.2 However, data on the impact of pre-PCI bleeding risk assessment on physician practice patterns, BAS use, and quality outcomes are sparse. We developed a quality improvement program for PCI patients using a preprocedure bleeding risk score to stimulate the use of consensus BAS in high-risk, high-cost patients. The specific aims of the program were to improve patient safety and care quality and to decrease LOS and hospital costs by reducing bleeding events and associated complications in PCI patients. An interdisciplinary team …

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.

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.