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To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2004.05.062 Byline: Jeffrey S. Berger, Timothy A. Sanborn, Warren Sherman, David L. Brown Abstract: Early studies suggested that morbidity and mortality after percutaneous coronary intervention (PCI) were greater for women than men. However, in recent reports, sex-related differences in short-term outcome have decreased as outcomes among women have improved. Author Affiliation: Department of Medicine (Cardiovascular Medicine), SUNY Stony Brook School of Medicine, Stony Brook, NY Article History: Received 23 December 2003; Accepted 18 May 2004

The field of myocardial regeneration (angiogenesis and myogenesis) might prove to play an important role in the future management of cardiovascular disease. Stem cells are currently undergoing testing in Phase I and Phase II clinical trials. Methods of delivery will affect the outcome of such therapies, perhaps significantly. This document provides suggested guidance in 4 methods of delivery: endocardial, intracoronary, coronary sinus, and epicardial. [Copyright &y& Elsevier]

Background: Cognitive decline after open-heart surgery has been the subject of a number of conflicting reports in recent years. Determination of possible cognitive impairment due to surgery or use of cardiopulmonary bypass is complicated by numerous factors, including use of appropriate comparison groups and consideration of practice effects in cognitive testing. Methods: Neuropsychological data were gathered from 46 healthy controls, 42 cardiac patients referred for percutaneous coronary intervention (PCI), and 43 cardiac patients referred for coronary artery bypass grafting (CABG). Fourteen cognitive function tests were utilized at baseline and at three time points after surgery (3 weeks, 4 months, 1 year). Measures showing acceptable test-retest reliability based on intraclass correlations were compared using regression-based reliable change indices. Results: No clear pattern of group differences or change at follow-up emerged. A greater percentage of CABG patients than controls worsened in seven tests (three at 1 year), but a greater percentage of PCI patients than controls also worsened in seven tests (three at 1 year). Generalized estimating equations showed only two tests (Wechsler Adult Intelligence Scale, Third Edition, Digit Symbol, and Hopkins Verbal Learning Test, Revised, Total Recall) to be significantly different between groups from baseline to 1 year. Interestingly, compared with healthy controls, more PCI patients than CABG patients worsened in the former of those two tests, whereas more PCI and CABG patients improved on the latter. Conclusions: Using healthy controls and a relevant nonsurgical comparison group to contend with important methodological considerations, current CABG procedure does not appear to create cognitive decline. [Copyright &y& Elsevier]

Background: Cognitive decline has been associated with coronary artery bypass grafting (CABG), but the extent to which these findings are related to the natural history of cognitive deficits in elderly patients with cardiac disease or have been influenced by the research methods used to determine abnormalities warrants further study. Methods: After excluding individuals with conditions known to cause brain dysfunction, individuals referred for percutaneous coronary intervention (n = 42) or CABG (n = 35) were compared with an age-matched and education-matched control group without clinical evidence of coronary artery disease (n = 44). These subjects underwent a battery of 14 neurocognitive tests at baseline (preoperatively) and at 3 weeks and 4 months postoperatively. Results: The majority of test scores for all three cohorts were within nonimpaired ranges at baseline and 3 weeks later. Change in impairment status from baseline to 3-week assessment was not associated statistically with type of treatment as referenced to clinical norms, and was associated with type of treatment on only one measure as referenced to control group performances. A further overall improvement in impairment status from 3 weeks’ to 4 months’ follow-up was seen in both CABG and percutaneous coronary intervention patients. Mean test scores were significantly worse in CABG patients versus percutaneous coronary intervention patients in 4 of 13 measures at 3 weeks’ follow-up, but significant de novo impairment at 3 weeks’ follow-up in the CABG group compared with the percutaneous coronary intervention and control groups was present in only one test. As assessed by reliable change methodology, impairment was statistically associated with type of treatment for only 1 of 13 measures. Conclusions: As compared with changes seen in repeat testing of healthy control subjects and individuals who underwent percutaneous coronary intervention, clinically meaningful cognitive deterioration was not observed after CABG. [Copyright &y& Elsevier]

Background: Cognitive deficits have been reported to occur in a significant proportion of patients undergoing coronary artery bypass grafting (CABG), but the extent to which these deficits were preexistent or related to the natural history of cognitive decline in this patient population remains poorly defined. Methods: After excluding patients with conditions known to cause brain dysfunction (eg, hepatic dysfunction, stroke), a group of patients referred for percutaneous coronary intervention (PCI) or CABG (n = 82) was compared with an age- and education-matched control group that did not have clinical evidence of coronary artery disease (n = 41). These subjects underwent a battery of neurocognitive and emotional testing. Results: Test score means for 5 of 14 different measures were significantly greater (impaired) in cardiac compared with control group subjects. Of cardiac subjects, 20% demonstrated clinical impairment (test result ≥ 1 SD worse than mean for normative standards) in 6 of 14 tests, compared with 10% of the controls. By clinical standards, 46% of cardiac subjects would be considered to be impaired (score 1 SD or more below the control group mean) on 3 or more neuropsychologic measures, compared with 29% of the controls. By this (control group mean) standard, cardiac subjects demonstrated impaired scores on 3.06 ± 2.6 tests compared with impairment in 2.0 ± 2.35 tests for the control group (p = 0.01). Conclusions: Even excluding patients at high risk for brain dysfunction, cognitive impairment is found in patients with coronary artery disease before interventional therapy. Baseline impairment must be considered when evaluating outcomes after intervention. [Copyright &y& Elsevier]

Background: In the SHOCK trial, the group of patients aged ≥75 years did not appear to derive the mortality benefit from early revascularization (ERV) versus initial medical stabilization (IMS) that was seen in patients aged <75 years. We sought to determine the reason for this finding by examining the baseline characteristics and outcomes of the 2 treatment groups by age. Methods: Patients with cardiogenic shock (CS) secondary to left ventricular (LV) failure were randomized to ERV within 6 hours or to a period of IMS. We compared the characteristics by treatment group of patients aged ≥75 years and of their younger counterparts. Results: Of the 56 enrolled patients aged ≥75 years, those assigned to ERV had lower LV ejection fraction at baseline than IMS-assigned patients (27.5% ± 12.7% vs 35.6% ± 11.6%, P = .051). In the elderly ERV and IMS groups, 54.2% and 31.3%, respectively, were women (P = .105) and 62.5% and 40.6%, respectively, had an anterior infarction (P = .177). The 30-day mortality rate in the ERV group was 75.0% in patients aged ≥75 years and 41.4% in those aged <75 years. In the IMS group, 30-day mortality was 53.1% for those aged ≥75 years, similar to the 56.8% for patients aged <75 years. Conclusions: Overall, the elderly randomized to ERV did not have better survival than elderly IMS patients. Despite the strong association of age and death post-CS, elderly patients assigned to IMS had a 30-day mortality rate similar to that of IMS patients aged <75 years, suggesting that this was a lower-risk group with more favorable baseline characteristics. The lack of apparent benefit from ERV in elderly patients in the SHOCK trial may thus be due to differences in important baseline characteristics, specifically LV function, and play of chance arising from the small sample size. Therefore, the SHOCK trial overall finding of a 12-month survival benefit for ERV should be viewed as applicable to all patients, including those ≥75 years of age, with acute myocardial infarction complicated by CS. [Copyright &y& Elsevier]

Initial reports have suggested that primary percutaneous coronary intervention (PCI) can be performed safely in selected hospitals without on-site cardiac surgery; however, quality-of-care indicators for primary PCI in these institutions is unknown. Therefore, symptom onset-to-door intervals, door-to-balloon times, compliance with American College of Cardiology/American Heart Association (ACC/AHA) management guidelines, and in-hospital mortality were evaluated in 108,132 patients in 3 hospital settings in the National Registry of Myocardial Infarction: (1) diagnostic laboratories only (n = 47), (2) elective PCI only (n = 50), and (3) elective PCI and cardiac surgery (n = 562). Mean symptom onset-to-door intervals (127 minutes, 95% confidence interval 118 to135; 134 minutes, 95% confidence interval 125 to 142; and 140 minutes, 95% confidence intervals 138 to 141; p = 0.01) and door-to-balloon intervals (104 minutes, 95% confidence interval 101 to 108; 116 minutes, 95% confidence interval 112 to 119; and 119 minutes, 95% confidence interval 118 to 120; p <0.0001) were shorter in hospitals without cardiac surgery. Adherence to ACC/AHA guidelines for medications within the first 24 hours (aspirin, β blockers, angiotensin-converting enzyme inhibitors) was greater in hospitals without cardiac surgery. There were comparable in-hospital mortality rates (3.2%, 4.2%, and 4.8%, respectively; p = 0.07) for patients with similar Thrombolysis In Myocardial Infarction risk scores; however, 4.7% of patients treated with primary PCI in hospitals without cardiac surgery were transferred to another institution. Thus, hospitals performing primary PCI without on-site cardiac surgery that participated in this registry have quality-of-care indicators and adherence to ACC/AHA management guidelines that are comparable to hospitals with on-site cardiac surgery. The lack of on-site cardiac surgery does not appear to adversely affect quality-of-care indicators in primary PCI. [Copyright &y& Elsevier]

: ObjectivesThe goal of this study was to describe the core laboratory angiographic findings of “SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK” (SHOCK) trial participants and to determine the relationship of angiographic parameters to one-year survival.: BackgroundIn the SHOCK trial, emergency revascularization improved one-year survival of patients with cardiogenic shock compared with initial medical stabilization including thrombolysis and intraaortic balloon counterpulsation.: MethodsCoronary angiography was performed by protocol in 147 of 152 (97%) patients in the emergency revascularization (ERV) group and by clinical selection in 100 of 150 (67%) patients in the initial medical stabilization (IMS) group. Of the other 50 IMS patients, 45 of 50 (90%) died rapidly and did not undergo angiography.: ResultsLeft ventricular ejection fraction was correlated with one-year survival in both treatment groups (p < 0.001). In the IMS group, the hazard ratio for death was 2.59 (95% confidence interval 1.47 to 4.58, p = 0.001) per diseased vessel (0/1 vs. 2 vs. 3). In the ERV group, the hazard ratio for death per diseased vessel was 1.11 (95% confidence interval 0.79 to 1.56, p = 0.559). Multivariate analysis of the angiography cohort (without regard for left ventriculogram measurements) identified initial Thrombolysis in Myocardial Infarction flow grade (p = 0.032), number of diseased vessels (for IMS patients only, p = 0.024), and culprit vessel (p = 0.004) as independent correlates of one-year survival, even after adjustment for key clinical factors. In the smaller cohort with left ventricular ejection fraction measured (n = 97), ejection fraction and culprit vessel remained independently correlated with survival.: ConclusionsFor patients in cardiogenic shock, left ventricular function and culprit vessel were independent correlates of one-year survival. [Copyright &y& Elsevier]

There are limited data regarding the effect of chronic obstructive pulmonary disease (COPD) on the survival of patients with coronary artery disease. Prospectively developed and collected data elements on 4,284 consecutive patients who underwent percutaneous coronary intervention in 3 hospitals in 1998 and 1999 were pooled and analyzed. In-hospital major adverse cardiac outcomes were not different between groups. At 3-year follow-up, mortality for patients with COPD was 21% versus 9% for patients without COPD (log-rank p <0.001). COPD was independently associated with a 2-fold increase in the hazard of long-term mortality (hazard ratio 2.146, 95% confidence interval 1.525 to 3.021, p <0.001). [Copyright &y& Elsevier]

There are limited data regarding the effect of race on survival after percutaneous coronary intervention (PCI) in the modern era. The investigators analyzed the impact of race on 3-year survival in 3,783 consecutive patients who underwent PCI in 1998 and 1999. [Copyright &y& Elsevier]

: ObjectivesWe examined the clinical, angiographic, and procedural characteristics determining survival after percutaneous coronary intervention (PCI) for cardiogenic shock.: BackgroundThe SHOCK (SHould we emergently revascularize Occluded coronaries for Cardiogenic shocK?) trial prospectively enrolled patients with shock complicating acute myocardial infarction (MI). Patients were randomized to a strategy of early revascularization or initial medical stabilization.: MethodsPatients randomized to early revascularization underwent PCI or bypass surgery on the basis of predefined clinical criteria. Patients randomized to early revascularization who underwent PCI and had angiographic films available for analysis are the subject of this report (n = 82).: ResultsThe median time from MI to PCI was 11 h. The majority of patients had occluded culprit arteries (Thrombolysis In Myocardial Infarction [TIMI] grade 0 or 1 flow in 62%) and multivessel disease (81%). One-year mortality in PCI patients was 50%. Mortality was 39% if PCI was successful but 85% if unsuccessful (p < 0.001). Mortality was 38% if TIMI flow grade 3 was achieved, 55% with TIMI grade 2 flow, and 100% with TIMI grade 0 or 1 flow (p < 0.001). Mortality was 67% if severe mitral regurgitation was documented. Independent correlates of mortality were as follows: increasing age (p < 0.001), lower systolic blood pressure (p = 0.009), increasing time from randomization to PCI (p = 0.019), lower post-PCI TIMI flow (0/1 vs. 2/3) (p < 0.001), and multivessel PCI (p = 0.040).: ConclusionsRestoration of coronary blood flow is a major predictor of survival in cardiogenic shock. Benefit appears to extend beyond the generally accepted 12-h post-infarction window. Surgery should be considered in shock patients with severe mitral insufficiency or multivessel disease not amenable to relatively complete percutaneous revascularization. [Copyright &y& Elsevier]

In patients with cardiogenic shock (CS) complicating acute myocardial infarction, echocardiographic and angiographic findings are used to aid diagnosis, determine prognosis, and guide management. The purpose of this analysis from the Should we emergently revascularize Occluded Coronary arteries for Cardiogenic ShocK (SHOCK) trial is to identify relations between the angiographic and echocardiographic features of patients with CS. Such an analysis of the correlations between echocardiographic and angiographic findings in patients with CS may provide insights into the etiology and treatment of CS. In 302 randomized patients, an echocardiogram and an angiogram before revascularization were available in 127 patients. Although the median ejection fraction derived by echocardiography and left ventricular angiography was identical (30%), the positive correlation was weak (R2 = 0.209, p = 0.019). Patients with a larger number of diseased vessels had worse mitral regurgitation (MR) by echocardiography (p = 0.005). There was a significant but weak association between left ventricular angiographic MR grade and echocardiographic MR severity (R2 = 0.162, p = 0.015), but there was no association between culprit vessel and degree of MR. In conclusion, worse coronary artery disease is associated with more severe MR. Echocardiography and angiography are valuable and result in similar estimated ejection fractions in a large cohort, but there is wide variation between the techniques in patients. [Copyright &y& Elsevier]

Objectives: This study sought to evaluate the clinical results of a percutaneous approach to mitral valve repair for mitral regurgitation (MR). Background: A surgical technique approximating the middle scallops of the mitral leaflets to create a double orifice with improved leaflet coaptation was introduced in the early 1990s. Recently, a percutaneous method to create the same type of repair was developed. A trans-septal approach was used to deliver a clip device that grasps the mitral leaflet edges to create the double orifice. Methods: General anesthesia, fluoroscopy, and echocardiographic guidance are used. A 24-F guide is positioned in the left atrium. The clip is centered over the mitral orifice, passed into the left ventricle, and pulled back to grasp the mitral leaflets. After verification that MR is reduced, the clip is released. Results: Twenty-seven patients had six-month follow-up. Clips were implanted in 24 patients. There were no procedural complications and four 30-day major adverse events: partial clip detachment in three patients, who underwent elective valve surgery, and one patient with post-procedure stroke that resolved at one month. Three additional patients had surgery for unresolved MR, leaving 18 patients free from surgery. In 13 of 14 patients with reduction of MR to ≤2+ after one month, the reduction was maintained at six months. Conclusions: Percutaneous edge-to-edge mitral valve repair can be performed safely and a reduction in MR can be achieved in a significant proportion of patients to six months. Patients who required subsequent surgery had elective mitral valve repair or intended replacement. [Copyright &y& Elsevier]

It is unknown whether the benefits of parenteral platelet glycoprotein (GP) IIb/IIIa inhibitors as an adjunct to percutaneous coronary intervention (PCI) demonstrated in randomized clinical trials extend to patients treated outside the setting of clinical trials. A contemporary registry of 10,847 consecutive PCI procedures was analyzed to determine the effect of GP IIb/IIIa inhibitor treatment on in-hospital major adverse coronary events ([MACEs] composite of death, urgent coronary artery bypass surgery, periprocedural myocardial infarction, abrupt closure, and stent thrombosis). In this registry, GP IIb/IIIa inhibitors were administered to 20.1% of patients. These patients were younger, more often men, and less often hypertensive than untreated patients. GP IIb/IIIa inhibitor-treated patients were more likely to present with acute myocardial infarction or unstable angina. Stents were placed in 79% of patients treated with GP IIb/IIIa inhibitors. MACEs occurred in 7.8% of GP IIb/IIIa inhibitor-treated patients compared with 3.8% of untreated patients (p <0.001). After multivariable adjustment for the propensity of GP IIb/IIIa inhibitor treatment as well as other possible confounders and interactions known to influence MACEs, GP IIb/IIIa inhibitor treatment was associated with a 57% increase in the risk of a MACE (odds ratio 1.57, 95% confidence interval 1.22 to 2.03; p = 0.0004). In a data set consisting of patients with a high degree of acuity predominantly treated with stent placement, GP IIb/IIIa inhibitor treatment is associated with an increase in thrombotic complications of PCI. [ABSTRACT FROM AUTHOR]