M. Nicholas Burke

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.

Therapeutic Hypothermia After Out-of-Hospital Cardiac Arrest Evaluation of a Regional System to Increase Access to Cooling

Background— Therapeutic hypothermia (TH) improves survival and confers neuroprotection in out-of-hospital cardiac arrest (OHCA), but TH is underutilized, and regional systems of care for OHCA that include TH are needed. Methods and Results— The Cool It protocol has established TH as the standard of care for OHCA across a regional network of hospitals transferring patients to a central TH-capable hospital. Between February 2006 and August 2009, 140 OHCA patients who remained unresponsive after return of spontaneous circulation were cooled and rewarmed with the use of an automated, noninvasive cooling device. Three quarters of the patients (n=107) were transferred to the TH-capable hospital from referring network hospitals. Positive neurological outcome was defined as Cerebral Performance Category 1 or 2 at discharge. Patients with non–ventricular fibrillation arrest or cardiogenic shock were included, and patients with concurrent ST-segment elevation myocardial infarction (n=68) received cardiac intervention and cooling simultaneously. Overall survival to hospital discharge was 56%, and 92% of survivors were discharged with a positive neurological outcome. Survival was similar in transferred and nontransferred patients. Non–ventricular fibrillation arrest and presence of cardiogenic shock were associated strongly with mortality, but survivors with these event characteristics had high rates of positive neurological recovery (100% and 89%, respectively). A 20% increase in the risk of death (95% confidence interval, 4% to 39%) was observed for every hour of delay to initiation of cooling. Conclusions— A comprehensive TH protocol can be integrated into a regional ST-segment elevation myocardial infarction network and achieves broad dispersion of this essential therapy for OHCA.Background— Therapeutic hypothermia (TH) improves survival and confers neuroprotection in out-of-hospital cardiac arrest (OHCA), but TH is underutilized, and regional systems of care for OHCA that include TH are needed. Methods and Results— The Cool It protocol has established TH as the standard of care for OHCA across a regional network of hospitals transferring patients to a central TH-capable hospital. Between February 2006 and August 2009, 140 OHCA patients who remained unresponsive after return of spontaneous circulation were cooled and rewarmed with the use of an automated, noninvasive cooling device. Three quarters of the patients (n=107) were transferred to the TH-capable hospital from referring network hospitals. Positive neurological outcome was defined as Cerebral Performance Category 1 or 2 at discharge. Patients with non–ventricular fibrillation arrest or cardiogenic shock were included, and patients with concurrent ST-segment elevation myocardial infarction (n=68) received cardiac intervention and cooling simultaneously. Overall survival to hospital discharge was 56%, and 92% of survivors were discharged with a positive neurological outcome. Survival was similar in transferred and nontransferred patients. Non–ventricular fibrillation arrest and presence of cardiogenic shock were associated strongly with mortality, but survivors with these event characteristics had high rates of positive neurological recovery (100% and 89%, respectively). A 20% increase in the risk of death (95% confidence interval, 4% to 39%) was observed for every hour of delay to initiation of cooling. Conclusions— A comprehensive TH protocol can be integrated into a regional ST-segment elevation myocardial infarction network and achieves broad dispersion of this essential therapy for OHCA. # Clinical Perspective {#article-title-40}

Use of a novel crossing and re-entry system in coronary chronic total occlusions that have failed standard crossing techniques: Results of the FAST-CTOs (facilitated antegrade steering technique in chronic total occlusions) trial

OBJECTIVES This study sought to examine the efficacy and safety of 3 novel devices to recanalize coronary chronic total occlusions (CTOs). BACKGROUND Successful percutaneous coronary intervention (PCI) of CTOs improves clinical outcome in appropriately selected patients. CTO PCI success, however, remains suboptimal. METHODS A new crossing catheter and re-entry system was evaluated in a prospective, multicenter, single-arm trial of CTO lesions refractory to standard PCI techniques. The primary efficacy endpoint was the frequency of true lumen guidewire placement distal to the CTO (technical success). RESULTS Enrollment included 147 patients with 150 CTOs. The mean lesion length was 41 ± 17 mm. A crossing catheter crossed 56 lesions into the distal true lumen, and a re-entry catheter facilitated tapered-wire cannulation of the distal lumen in 59 CTOs initially crossed subintimally (77% technical success). Success in the first 75 CTOs was 67%, rising to 87% in the last 75 CTOs. Mean fluoroscopy and procedure times were 45 ± 16 min and 90 ± 12 min, respectively, each significantly shorter than in historical controls (p < 0.0001 for both). Coronary perforation occurred in 14 cases (9.3%), requiring treatment in 3 cases (prolonged balloon inflation, with additional coil embolization in 1 case). No tamponade or hemodynamic instability occurred. Six patients had periprocedural non-ST-segment elevation myocardial infarction. No emergency surgery, ST-segment elevation myocardial infarction, or cardiac reintervention occurred. Two deaths occurred within 30 days, neither as a direct result of the procedure. The 30-day major adverse cardiac event rate was 4.8%. CONCLUSIONS In CTOs failing standard techniques, use of a new crossing and re-entry system results in a high success rate without increasing complications.

Clopidogrel pretreatment in ST-elevation myocardial infarction patients transferred for percutaneous coronary Intervention

BACKGROUND Pretreatment with clopidogrel reduces ischemic complications before percutaneous coronary intervention (PCI). Limited data exist regarding the effect of pretreatment for ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI. METHODS Prospective data were analyzed from a regional STEMI system using rapid transfer for primary PCI in 30 community hospitals. Zone 1 community hospitals are <60 miles and Zone 2 hospitals are 60 to 210 miles away from the PCI hospital. Compared with 63 minutes in the PCI hospital, median door-to-balloon times were 94 minutes in Zone 1 and 123 minutes in Zone 2 hospitals. All patients received aspirin, unfractionated heparin, and clopidogrel 600 mg in the emergency department of the presenting hospital within 15 minutes of diagnosis. RESULTS From April 2003 through December 2008, 2,014 consecutive STEMI patients were pretreated with clopidogrel before PCI, with a median (25th-75th percentile) duration from pretreatment to PCI of 75 (58-93) minutes. Patients with longer pretreatment duration had significantly reduced reinfarction/reischemia at 30 days (Zone 1: 0.85%, Zone 2: 0.9%) compared with nontransferred patients (3.2%, P = .001) as well as reduced stent thrombosis (Zone 1: 0.6%, Zone 2: 0.6% vs Abbott Northwestern: 2.0%; P = .04). Similarly, pretreatment duration of >60 minutes before PCI had reduced 30-day reinfarction/reischemia (1.0% vs 2.9%, P = .003). There were no significant differences in mortality or major bleeding. CONCLUSION ST-segment elevation myocardial infarction patients undergoing primary PCI in a regional STEMI network who received earlier pretreatment with a 600-mg loading dose of clopidogrel had less ischemic complications without increased bleeding or mortality.

Has the Time Come for a National Cardiovascular Emergency Care System

In 2007, there were ≈4 million visits to emergency departments in the United States with a primary diagnosis of cardiovascular disease.1 Current forecasts estimate that the direct medical costs for cardiovascular disease in the United States will triple by 2030 to

StarClose® vascular closure system (VCS) is safe and effective in patients who ambulate early following successful femoral artery access closure—results from the RISE clinical trial†

800 billion dollars.2 Acute cardiovascular emergencies, including ST-segment–elevation myocardial infarction (STEMI), non-STEMI/unstable angina, out-of-hospital cardiac arrest (OHCA), acute aortic dissection (AAD), abdominal aortic aneurysm (AAA), stroke, and acute decompensated heart failure/cardiogenic shock, require rapid, complex, and resource-intensive care and confer a high risk of mortality. Regionalized systems of care enable patients with complex and urgent medical needs to be systematically directed to hospitals that can provide the highest level of clinical expertise and resources (ie, designated centers). Historically, trauma systems have used this paradigm with improved outcomes. There is a growing focus on regionalized medical care as a strategy to leverage limited resources, to manage cost, and to improve outcomes for other medical emergencies. National cardiovascular organizations have already published recommendations for the establishment of centers and regional systems of care for STEMI,3–6 cardiac arrest,7–9 and stroke.10,11 The purpose of this article is to propose the concept of a cardiovascular emergency system, ie, a comprehensive regional system of care for cardiovascular emergencies led by a designated cardiovascular emergency receiving center. Over the past decade, the Minneapolis Heart Institute at Abbott Northwestern Hospital (MHI-ANW) has implemented regional systems of care for STEMI,12 OHCA,13 AAD,14 non-STEMI, and AAA. These initiatives provide a demonstration of the clinical programs and supportive network that reflect the burgeoning framework of a cardiovascular emergency system. Informed by this work, we discuss the historical perspective of, rationale for, and proposed principal elements of a cardiovascular emergency system. Trauma systems are the prototype for …

ST-Segment Elevation Myocardial Infarction Resulting From Stent Thrombosis: An Enlarging Subgroup of High-Risk Patients

Objective: The RISE study was a prospective, multicenter, single‐arm study evaluating the safety and efficacy of the StarClose® Vascular Closure System (VCS) in the femoral artery in subjects who were ambulated early following percutaneous diagnostic coronary or peripheral catheterization procedures. Background: Previous studies have demonstrated that several vascular closure devices are able to safely decrease the amount of bedrest needed following angiography. To date, no device has been shown to be safe for immediate ambulation. Methods: Between April 2006 and November 2006, 315 patients undergoing a catheterization via the femoral artery were enrolled (intent‐to‐treat population, ITT). Of these, 171 subjects were not excluded by angiographic or clinical criteria and had a StarClose device placed to attain hemostasis. If hemostasis was immediately achieved, patients were ambulated within 20 min for 20 feet without assistance (per‐protocol population, PP). Patients were followed for 30 days after the index procedure. The primary endpoint of the study was time to ambulation (TTA). Results: Immediate hemostasis was achieved in 156 patients (91.2%). The mean TTA in the PP was 8.29 min, median 5.92. There were no deaths or major vascular complications, and the rate of minor vascular complications was 1.9% (3/156). Conclusion: The StarClose® VCS device is both safe and effective allowing immediate ambulation of patients who have undergone catheterization via the femoral artery.

The Hybrid Approach to Chronic Total Occlusion Percutaneous Coronary Intervention: Update From the PROGRESS CTO Registry

To the Editor: Stent thrombosis (ST) is an infrequent but major complication after percutaneous coronary intervention (PCI) and frequently is associated with ST-segment elevation myocardial infarction (STEMI). As the population of stented patients has grown, the number of patients at risk for STEMI

Incidence, Treatment, and Outcomes of Coronary Perforation During Chronic Total Occlusion Percutaneous Coronary Intervention

OBJECTIVES The aim of this study was to determine the techniques and outcomes of hybrid chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a diverse group of patients and operators on 2 continents. BACKGROUND CTO PCI has been evolving with constant improvement of equipment and techniques. METHODS Contemporary outcomes of CTO PCI were examined by analyzing the clinical, angiographic, and procedural characteristics of 3,122 CTO interventions performed in 3,055 patients at 20 centers in the United States, Europe, and Russia. RESULTS The mean age was 65 ± 10 years, and 85% of the patients were men, with high prevalence of diabetes (43%), prior myocardial infarction (46%), prior coronary artery bypass graft surgery (33%), and prior PCI (65%). The CTO target vessels were the right coronary artery (55%), left anterior descending coronary artery (24%), and left circumflex coronary artery (20%). The mean J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores were 2.4 ± 1.3 and 1.3 ± 1.0, respectively. The overall technical and procedural success rate was 87% and 85%, respectively, and the rate of in-hospital major complications was 3.0%. The final successful crossing strategy was antegrade wire escalation in 52.0%, retrograde in 27.1%, and antegrade dissection re-entry in 20.9%; >1 crossing strategy was required in 40.9%. Median contrast volume, air kerma radiation dose, and procedure and fluoroscopy time were 270 ml (interquartile range: 200 to 360 ml), 2.9 Gy (interquartile range: 1.7 to 4.7 Gy), 123 min (interquartile range: 81 to 188 min) and 47 min (interquartile range: 29 to 77 min), respectively. CONCLUSIONS CTO PCI is currently being performed with high success and acceptable complication rates among various experienced centers in the United States, Europe, and Russia. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436).

Chronic Total Occlusion Percutaneous Coronary Intervention Bridging the Gap

Coronary perforation is a potential complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We analyzed 2,097 CTO PCIs performed in 2,049 patients from 2012 to 2017. Patient age was 65 ± 10 years, 85% were men, and 36% had prior coronary artery bypass graft surgery. Technical and procedural success were 88% and 87%, respectively. A major periprocedural adverse cardiovascular event occurred in 2.6%. Coronary perforation occurred in 85 patients (4.1%); The frequency of Ellis class 1, 2, and 3 perforations was 21%, 26%, and 52%, respectively. Perforation occurred more frequently in older patients and those with previous coronary artery bypass graft surgery (61% vs 35%, p < 0.001). Cases with perforation were angiographically more complex (Multicenter CTO Registry in Japan score 3.0 ± 1.2 vs 2.5 ± 1.3, p < 0.001). Twelve patients (14%) with perforation experienced tamponade requiring pericardiocentesis. Patient age, previous PCI, right coronary artery target CTO, blunt or no stump, use of antegrade dissection re-entry, and the retrograde approach were associated with perforation. Adjusted odds ratio for periprocedural major periprocedural adverse cardiovascular events among patients with perforation was 15.04 (95% confidence interval 7.35 to 30.18). In conclusion, perforation occurs relatively infrequently in contemporary CTO PCI performed by experienced operators and is associated with baseline patient characteristics and angiographic complexity necessitating use of advanced crossing techniques. In most cases, perforations do not result in tamponade requiring pericardiocentesis, but they are associated with reduced technical and procedural success, higher periprocedural major adverse events, and reduced procedural efficiency.