Efficacy and Safety of Pharmacoinvasive Strategy Compared to Primary Percutaneous Coronary Intervention in the Management of ST-Segment Elevation Myocardial Infarction: A Prospective Country-Wide Registry.

Background: A pharmacoinvasive reperfusion strategy is recommended for ST-elevation myocardial infarction (STEMI) patients when primary percutaneous coronary intervention (PCI) cannot be achieved in a timely fashion. This is based on a limited number of trials. The effectiveness of this strategy in the real-world is unclear. Objectives: To compare the effectiveness of pharmacoinvasive strategy versus primary PCI using a nationwide prospective registry of STEMI patients. Methods: We examined 936 STEMI patients from the reperfusion in ST-elevation myocardial infarction in Kuwait (REPERFUSE Kuwait) registry who underwent either primary PCI or pharmacoinvasive reperfusion. A composite outcome was measured based on death, congestive heart failure, reinfarction or stroke prospectively ascertained during hospital stay and up to one-year follow-up. The association between reperfusion strategy and the composite outcome was assessed using multivariate regression and Poisson proportional hazard model. Results: Compared to the pharmacoinvasive group, those undergoing primary PCI had higher Killip class on presentation and required more blood transfusions during hospitalization. There was no significant difference between primary PCI and pharmacoinvasive strategy with regards to the incidence of the composite outcome during the in-hospital period (RR = 1.0; 95% CI 0.98-1.02; p = 0.96) after adjustment for possible confounders. Over one-year follow-up, the survival of the two groups was not different (p = 0.66). The incidence of major bleeding was similar in both groups. Conclusion: STEMI patients treated with a pharmacoinvasive strategy have comparable outcomes to those treated with primary PCI with no increased risk of major bleeding. These real-world data support the use of a pharmacoinvasive strategy when primary PCI cannot be achieved in a timely fashion.

Association of Statewide Certificate of Need Regulations With Percutaneous Coronary Intervention Appropriateness and Outcomes.

Background Certificate of need ( CON ) regulations are intended to coordinate new healthcare services, limit expansion of unnecessary new infrastructure, and limit healthcare costs. However, there is limited information about the association of CON regulations with the appropriateness and outcomes of percutaneous coronary interventions ( PCI ). The study sought to characterize the association between state CON regulations and PCI appropriateness. Methods and Results We used data from the American College of Cardiology's Cath PCI Registry to analyze 1 268 554 PCI s performed at 1297 hospitals between January 2010 and December 2011. We used the Appropriate Use Criteria to classify PCI procedures as appropriate, maybe appropriate, or rarely appropriate and used Chi-square analyses to assess whether the proportions of PCI s in each Appropriate Use Criteria category varied depending on whether the procedure had been performed in a state with or without CON regulations. Analyses were repeated stratified by whether or not the procedure had been performed in the setting of an acute coronary syndrome ( ACS ). Among 1 268 554 PCI procedures, 674 384 (53.2%) were performed within 26 CON states. The proportion of PCI s classified as rarely appropriate in CON states was slightly lower compared with non- CON states (3.7% versus 4.0%, P<0.01). Absolute differences were larger among non- ACS PCI (23.1% versus 25.0% [ P<0.01]) and were not statistically significantly different in ACS (0.62% versus 0.63% [ P>0.05]). Conclusions States with CON had lower proportions of rarely appropriate PCI s, but the absolute differences were small. These findings suggest that CON regulations alone may not limit rarely appropriate PCI among patients with and without ACS .

A personal perspective: can legislated state regional STEMI centers provide timely STEMI treatment while overlooking early fibrinolysis?

Because a patient's odds of surviving a ST-Elevation Myocardial Infarction (STEMI) depend on how much myocardium is salvaged by treatment, this article presents information about whether the Missouri Regional STEMI Center Program, created by state law, can provide STEMI treatment in time to preserve the ischemic heart muscle. The law states that "Patients who suffer a STEMI, as defined in Section 190.100, shall be transported to a STEMI Center." Administration is by the Missouri Department of Health and Senior Services (DHSS) which states that the preferred treatment for STEMI is percutaneous coronary intervention (PCI) and does not mention fibrinolysis when eligible. Level I and II receiving centers are hospitals with catheterization laboratories that perform a high volume of PCI procedures. Level I centers have heart surgery facilities. Level II centers may have such services or may have prompt access to nearby facilities. The law states that the smaller level III and IV hospitals are to stabilize patients for transport to a level I or II center. Although the law lists no patients to be excluded from transport, DHSS is limiting the program to patients picked up at the scene by ambulance. The majority of STEMI patients going to community hospitals by car are not included. Data are presented, showing that when blood flow is restored to the ischemic muscle during infarction before the end of the second hour of symptoms most can be saved. Data also show that only a small fraction of patients with PCI receives it before the end of the second hour of symptoms, whereas many more fibrinolysis patients were treated within 2 hours. Clinical practice data are given, showing mortality rates to increase with longer times to treatment. This information clearly defines timely treatment of STEMI to be that carried out before the end of the second hour of symptoms. Setting forth details of how long after symptom onset will be required to get to the catheterization laboratory shows that not many Missouri Program STEMI patients will get there before the end of the second hour of symptoms when salvageable heart muscle remains. The second thrust of this article is to draw attention to the seriousness of the Missouri Program overlooking the extremely important early fibrinolysis option for achieving treatment during the first 2 hours of symptoms.

Medico-legal issues in cardiology.

The aim of this article is to educate physicians about the current litigation climate in cardiology and cardiac surgery, with a focus on the most frequently litigated areas of practice, including failure to diagnose and treat myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, and the use of tissue plasminogen activator. Empirical research on cardiology malpractice is presented, along with a sampling of up-to-date cases designed to illustrate common issues and important themes. The principles for reducing legal liability are also discussed, including the informed consent process, spoliation of records, and the role of documentation. Finally, practical recommendations are provided for cardiologists and cardiac surgeons to limit their legal liability.