Long term effects of epoetin alfa in patients with ST- elevation myocardial infarction.

PURPOSE: The HEBE III trial showed that epoetin alfa administration in patients with a first ST-elevation myocardial infarction (STEMI) did not improve left ventricular function at 6 weeks after primary percutaneous coronary intervention (PCI). The long term effects of erythropoiesis- stimulating agents on cardiovascular morbidity and mortality are unknown, therefore we evaluated clinical events at 1 year after PCI. METHODS: A total of 529 patients with a first STEMI and successful primary PCI were randomized to standard optimal medical treatment (N = 266) or an additional bolus of 60,000 IU epoetin alfa administered intravenously (N = 263) within 3 h after PCI. Analyses were performed by intention to treat. RESULTS: At 1 year after STEMI, 485 patients had complete follow-up. The rate of the composite end point of all-cause mortality, re-infarction, target vessel revascularization, stroke and/or heart failure was 6.4 % (N = 15) in the epoetin alfa group and 9.6 % (N = 24) in the control group (p = 0.18). Thromboembolic events were present in 1.3 % (N = 3) of patients in the epoetin alfa group and 2.4 % (N = 6) in the control group. There was no evidence of benefit from epoetin alfa administration in subgroups of patients. CONCLUSIONS: Administration of a single bolus of epoetin alfa in patients with STEMI does not result in a reduction of cardiovascular events at 1 year after primary PCI. There was a comparable incidence of thromboembolic complications in both treatment groups, suggesting that epoetin alfa administration is safe at long term.

Infarct size in primary angioplasty without on-site cardiac surgical backup versus transferal to a tertiary center: a single photon emission computed tomography study.

BACKGROUND: Primary percutaneous coronary intervention (PCI) performed in large community hospitals without cardiac surgery back-up facilities (off-site) reduces door-to-balloon time compared with emergency transferal to tertiary interventional centers (on-site). The present study was performed to explore whether off-site PCI for acute myocardial infarction results in reduced infarct size. METHODS AND RESULTS: One hundred twenty-eight patients with acute ST-segment elevation myocardial infarction were randomly assigned to undergo primary PCI at the off-site center (n = 68) or to transferal to an on-site center (n = 60). Three days after PCI, (99m)Tc-sestamibi SPECT was performed to estimate infarct size. Off-site PCI significantly reduced door-to-balloon time compared with on-site PCI (94 +/- 54 versus 125 +/- 59 min, respectively, p < 0.01), although symptoms-to-treatment time was only insignificantly reduced (257 +/- 211 versus 286 +/- 146 min, respectively, p = 0.39). Infarct size was comparable between treatment centers (16 +/- 15 versus 14 +/- 12%, respectively p = 0.35). Multivariate analysis revealed that TIMI 0/1 flow grade at initial coronary angiography (OR 3.125, 95% CI 1.17-8.33, p = 0.023), anterior wall localization of the myocardial infarction (OR 3.44, 95% CI 1.38-8.55, p < 0.01), and development of pathological Q-waves (OR 5.07, 95% CI 2.10-12.25, p < 0.01) were independent predictors of an infarct size > 12%. CONCLUSIONS: Off-site PCI reduces door-to-balloon time compared with transferal to a remote on-site interventional center but does not reduce infarct size. Instead, pre-PCI TIMI 0/1 flow, anterior wall infarct localization, and development of Q-waves are more important predictors of infarct size.

Outcome in transferred and nontransferred patients after primary percutaneous coronary intervention for ischaemic out-of-hospital cardiac arrest.

OBJECTIVE: To evaluate the impact of transfer from a referral hospital to a center with primary percutaneous coronary intervention (PCI) facilities of ST-segment elevation myocardial infarction (STEMI) patients after successful cardiopulmonary resuscitation (CPR). METHODS: We studied all STEMI patients with successful CPR admitted to two centers after out-of-hospital cardiac arrest and CPR from January 2004 to December 2005. Subjects were divided in a transferred (PCI performed after referral from center without PCI facility) and nontransferred (PCI performed in hospital of admission, i.e. center with PCI facility) group. RESULTS: A total of 44 patients were included. Mean age was 61 +/- 13 year and 35 (80%) patients were male. Of all patients 16 (36%) were transferred for treatment. After treatment, the left ventricular function was preserved in 4 (25%) patients of the transferred group are compared with 17 (61%) of the nontransferred group (P = 0.024). In-hospital mortality after follow-up did not differ with 7 (44%) survivors in the transferred group versus 15 (54%) survivors in the nontransferred group (P = 0.76). Patients who did not survive were more often treated with endotracheal intubation (100% versus 71%, P= 0.019), had more often an occlusion of the proximal right coronary artery (37% versus 10%, P= 0.02), and higher glucose levels at admission (15.2 mmol/l +/- 4.4 versus 11.5 mmol/l +/- 4.2, P= 0.009). CONCLUSION: In conclusion, no difference in outcome was observed between nontransferred and transferred patients. Therefore, we suggest that transfer for primary PCI for STEMI patients after successful CPR should be considered.

Percutaneous coronary intervention with off-site cardiac surgery backup for acute myocardial infarction as a strategy to reduce door-to-balloon time.

We investigated whether primary percutaneous coronary intervention (PCI) for patients admitted with an acute ST-segment elevation myocardial infarction could be performed more rapidly and with comparable outcomes in a community hospital versus a tertiary center with cardiac surgery. We started the first PCI with an off-site surgery program in The Netherlands in 2002 and report the results of 439 consecutive patients. In the safety phase, 199 patients presenting with ST-segment elevation myocardial infarction were randomly assigned to treatment at our off-site center versus a more distant cardiac surgery center. In the confirmation phase, 240 consecutive patients were treated in the off-site hospital. Safety and efficacy end points were the rate of an angiographically successful PCI procedure (diameter stenosis <50% and Thrombolysis In Myocardial Infarction grade 3 flow) in the absence of major adverse cardiac and cerebrovascular events at 30 days. The randomization phase showed a 37-minute decrease in door-to-balloon time (p <0.001) with comparable procedural and clinical successes (91% Thrombolysis In Myocardial Infarction grade 3 flow in the 2 groups). In the confirmation phase, the 30-day rate without major adverse cardiac and cerebrovascular events was 95%. None of the 439 patients in the study required emergency surgery for failed primary PCI. In conclusion, time to treatment with primary PCI can be significantly shortened when treating patients in a community hospital setting with off-site cardiac surgery backup compared with transport for PCI to a referral center with on-site surgery. PCI at hospitals with off-site cardiac surgery backup can be considered a needed strategy to improve access to primary PCI for a larger segment of the population and can be delivered with a very favorable safety profile.

Mechanical intervention after thrombolysis.

Revascularisation strategies for acute myocardial infarction have evolved from early admission to coronary care units, bed rest and cardiac rhythm monitoring, to thrombolytic therapy and primary angioplasty. Although mechanical intervention for a failed prior revascularisation attempt is common widespread clinical practice, the outcome of this two-step modality may yet be an issue of debate. The available evidence is selected and reviewed within a clinical reference framework. This enables the presentation of a practical model for all stakeholders participating in cardiovascular care.

Clinical performance indicators for percutaneous coronary intervention.

Quality indicators in cardiology can be used to guide performance at a patient level, or at an organizational level. To positively influence adherence to performance guidelines, policymakers have to ensure that employees are involved in the development of guidelines and indicators. The first phase for selecting performance measures is creating a set of performance indicators. The aim of this study was to identify performance indicators with a high degree of consensus among professionals in daily practice for interventional cardiology. Each of the 50 predefined performance indicators was rated by 17 cardiologists and 17 head nurses (one from each participating center) on a 5-point scale. The cluster of indicators with the highest scores was resubmitted to the participants of the first phase for verification. After the second phase, performance indicators with >90% positive score for inclusion were qualified as key performance indicator (KPI). In the first phase, 24 of 34 response forms were returned (71%). Performance indicators with the highest overall mean scores were complications (4.71), in-hospital delay for patients with acute myocardial infarction (4.67), mortality (4.63), technical result (4.42), and patient satisfaction (4.38). The scores of cardiologists and nurses showed similar patterns. Nineteen indicators were selected for verification. After the second phase, 8 indicators qualified as KPI: complications, data flow, in-hospital delay, frequency of heart team meetings, number of procedures per center, mortality, restenosis rate, and use of protocols. The 8 KPI are both quantifiable and aimed at the catheterization laboratory as a unit.