Sameer Mehta

Bleeding in Patients Undergoing Percutaneous Coronary Intervention: The Development of a Clinical Risk Algorithm from the National Cardiovascular Data Registry

Background—Bleeding in patients undergoing percutaneous coronary intervention (PCI) is associated with increased morbidity, mortality, length of hospitalization, and cost. We identified baseline clinical characteristics associated with bleeding complications after PCI and developed a simplified, clinically useful algorithm to predict patient risk. Methods and Results—Data were analyzed from 302 152 PCI procedures performed at 440 US centers participating in the National Cardiovascular Data Registry. As defined by the National Cardiovascular Data Registry, bleeding required transfusion, prolonged hospital stay, and/or a drop in hemoglobin >3.0 g/dL from any location, including percutaneous entry site, retroperitoneal, gastrointestinal, genitourinary, and other/unknown location. Bleeding complications occurred in 2.4% of patients. From the best-fitting model consisting of 15 clinical elements associated with post-PCI bleeding in a random 80% training cohort, we developed a parsimonious risk algorithm. Predictors of bleeding included age, gender, previous heart failure, glomerular filtration rate, peripheral vascular disease, no previous PCI, New York Heart Association/Canadian Cardiovascular Society Functional Classification class IV heart failure, ST-elevation myocardial infarction, non–ST-elevation myocardial infarction, and cardiogenic shock. The parsimonious model was validated in the remaining 20% of the population (c-statistic, 0.72) and in clinically relevant subgroups of patients. This simplified model was used to derive a clinical risk algorithm, with larger numbers corresponding with greater risk. In 3 categories, bleeding rates were greater in patients with higher estimates (≤7, 0.7%; 8 to 17, 1.8%; ≥18, 5.1%). Conclusions—This report identifies baseline clinical factors associated with bleeding and proposes a clinically useful algorithm to estimate bleeding risk. This model is potentially actionable in altering therapeutic decision making and improving outcomes in patients undergoing PCI.Background— Bleeding in patients undergoing percutaneous coronary intervention (PCI) is associated with increased morbidity, mortality, length of hospitalization, and cost. We identified baseline clinical characteristics associated with bleeding complications after PCI and developed a simplified, clinically useful algorithm to predict patient risk. Methods and Results— Data were analyzed from 302 152 PCI procedures performed at 440 US centers participating in the National Cardiovascular Data Registry. As defined by the National Cardiovascular Data Registry, bleeding required transfusion, prolonged hospital stay, and/or a drop in hemoglobin >3.0 g/dL from any location, including percutaneous entry site, retroperitoneal, gastrointestinal, genitourinary, and other/unknown location. Bleeding complications occurred in 2.4% of patients. From the best-fitting model consisting of 15 clinical elements associated with post-PCI bleeding in a random 80% training cohort, we developed a parsimonious risk algorithm. Predictors of bleeding included age, gender, previous heart failure, glomerular filtration rate, peripheral vascular disease, no previous PCI, New York Heart Association/Canadian Cardiovascular Society Functional Classification class IV heart failure, ST-elevation myocardial infarction, non–ST-elevation myocardial infarction, and cardiogenic shock. The parsimonious model was validated in the remaining 20% of the population (c-statistic, 0.72) and in clinically relevant subgroups of patients. This simplified model was used to derive a clinical risk algorithm, with larger numbers corresponding with greater risk. In 3 categories, bleeding rates were greater in patients with higher estimates (≤7, 0.7%; 8 to 17, 1.8%; ≥18, 5.1%). Conclusions— This report identifies baseline clinical factors associated with bleeding and proposes a clinically useful algorithm to estimate bleeding risk. This model is potentially actionable in altering therapeutic decision making and improving outcomes in patients undergoing PCI. Received December 22, 2008; accepted April 20, 2009. # CLINICAL PERSPECTIVE {#article-title-2}

Influence of gender on in-hospital clinical and angiographic outcomes and on one-year follow-up in the New Approaches to Coronary Intervention (NACI) registry.

Higher complication rates and lower success rates for treatment of women compared with men have been reported in prior studies of coronary angioplasty and in most early reports of outcome with new coronary interventional devices. In multivariate analysis this has been attributed largely to older age and other unfavorable clinical characteristics. These results are reflected in the current guidelines for coronary angioplasty. Women in prior studies have also had different distributions of vessel and lesion characteristics, but the influence of these differences on the outcome of new-device interventions have not been adequately evaluated. This article evaluates the influence of gender on clinical and angiographic characteristics, interventional procedure and complications, angiographic success, and clinical outcomes at hospital discharge and 1-year follow-up, as observed in the New Approaches to Coronary Intervention (NACI) registry. The NACI registry methodology has been reported in detail elsewhere in this supplement. This study focuses on the 90% of patients-975 women and 1,880 men-who had planned procedures with a single new device and also had angiographic core laboratory readings. Women compared with men were older, had more recent onset of coronary ischemic pain that was more severe and unstable, and had more frequent histories of other adverse clinical conditions. The distributions of several but not all angiographic characteristics before intervention were considered more favorable to angioplasty outcome in women. Differences were observed in device use and procedure staging. Angiographically determined average gain in lumen diameter after new-device intervention, with or without balloon angioplasty, was significantly less in women (1.38 mm) than in men (1.53 mm; p < 0.001); this 0.15 mm difference is consistent with the 0.16-mm smaller reference vessel lumen diameter of women. However, final percent diameter stenoses and TIMI flow and lesion compliance characteristics were similar. Among procedural complications, only treatment for hypotension, blood transfusion, and vascular repair occurred more often in women. More women than men were clinically unstable (2.1% vs 1.1%) or went directly to emergent coronary artery bypass graft surgery (CABG; 1.2% vs 0.6%) on leaving the interventional laboratory. However, in-hospital death (1.4% vs 1.1%), Q-wave myocardial infarction (MI) (0.9% vs 1.1%), and emergent CABG (1.5% vs 1.0%, for women and men, respectively) were not significantly different. Nonemergent CABG was more frequent in women (1.8% vs 0.9%; p < 0.05) and length of hospital stay after device intervention was longer (4.4 days vs 3.8 days in men; p < 0.01). In both univariate and multivariate analyses gender did not emerge as a significant variable in relation to the combined endpoint, death, Q-wave MI, or emergent CABG at hospital discharge. At 1-year follow-up more women than men reported improvement in angina (70% vs 62%) and fewer women than men had had repeat revascularization (32% vs 36%). Similar proportions were alive and free of angina, Q-wave MI and repeat revascularization (46% of women vs 45% of men). Although several procedure-related complications were more frequent in women than men after coronary interventions with new devices, no important disadvantages were observed for women in the rates of major clinical events at hospital discharge and at 1-year clinical follow-up. Additional studies are needed to evaluate the complex interplay of clinical, vessel, and lesion characteristics on success and complications of specific interventional techniques and to determine whether gender, per se, is a risk factor and whether gender specific interventional strategies may be beneficial.

Left Ventricular Hypertrophy, Subclinical Atherosclerosis, and Inflammation

To elucidate mechanisms by which left ventricular (LV) hypertrophy (LVH) increases the risk of atherosclerotic heart disease, we sought to determine whether LVH is independently associated with coronary artery calcium (CAC) and serum C-reactive protein (CRP) levels in the general population. The Dallas Heart Study is a population-based sample in which 2633 individuals underwent cardiac MRI to measure LV structure, electron beam CT to measure CAC, and measurement of plasma CRP. We used univariate and multivariable analyses to determine whether LV mass and markers of concentric LV hypertrophy or dilation were associated with CAC and CRP. Increasing quartiles of LV mass indexed to fat-free mass, LV wall thickness, and concentricity, but not LV volume, were associated with CAC in both men and women (P<0.001). After adjustment for traditional cardiovascular risk factors and statin use, LV wall thickness and concentricity remained associated with CAC in linear regression (P<0.001 for each). These associations were particularly robust in blacks. LV wall thickness and concentricity were also associated with elevated CRP levels (P=0.001 for both) in gender-stratified univariate analyses, although these associations did not persist in multivariable analysis. In conclusion, concentric LVH is an independent risk factor for subclinical atherosclerosis. LVH is also associated with an inflammatory state as reflected in elevated CRP levels, although this relationship appears to be mediated by comorbid conditions. These data likely explain in part why individuals with LVH are at increased risk for myocardial infarction.

Excimer laser coronary angioplasty

BackgroundPercutaneous transluminal coronary angioplasty (PICA) of aorto-ostial stenosis has been associated with a lower rate of acute success, a high risk of vessel closure, and late restenosis. The purpose of this report is to document a prospective multicenter trial of excimer laser coronary angioplasty (ELCA) of aorto-ostial stenosis involving the coronary arteries and saphenous vein grafts. Methods and ResultsBetween December 1989 and May 1992, 206 aorto-ostial ELCA procedures were performed on 209 stenoses in 200 patients. Canadian Cardiovascular Society class III or IV angina was present in 76%. The distribution of stenosis locations was left main coronary (LM) in 26 (12%), right coronary (RCA) in 124 (59%/o), and vein grafts (VG) in 59 (28%). Adjunctive PTCA was performed in 72%. Procedure success defined as .50%, diameter stenosis without major complications was achieved in 90% (LM, 92%; RCA, 89%; VG, 90%o). Quantitative angiographic analysis documented an improvement in stenosis diameter from 0.8±0.5 mm or 76±14% at baseline to 2.1±0.6 mm or 36±15% at completion (P<.01). The majority of the acute gain in diameter (1.0±0.6 mm) resulted from ELCA. A major complication during hospitalization occurred in 3.9% (death, 0%; Q-wave myocardial infarction, 0.5%; bypass surgery, 3.4%). The only logistic regression univariate and multivariate predictor of procedure failure was female gender. Six-month angiographic follow-up, available in 51% of eligible patients, documented an average lumen diameter of 1.7±1.0 mm and mean diameter stenosis of 46±26%. Restenosis (>50%o diameter stenosis) occurred in 39%o (LM, 64%; RCA, 35%; VG, 35%). Restenosis was less likely when residual stenosis was <35% (28% versus 53%, P<.05). Clinical events at follow-up were death, 2.7%; bypass surgery, 6.5%; myocardial infarction, 2.2%; and repeat angioplasty, 16.2%. Of the remainder, 78% were asymptomatic, class I or II for anginal symptoms. An adverse event during follow-up was more than twice as likely in the group with LM (50.0% versus 21.1%, P<.02). ConclusionsELCA is acutely effective and safe therapy in patients with aorto-ostial stenosis. Six-month restenosis, adverse-event rates were higher and functional status was poorer in the group with LM stenosis. ELCA may be considered as an alternative to bypass surgery in carefully selected patients with isolated aorto-ostial stenosis of the RCA and saphenous vein grafts.

Drug-Eluting Stents and the Use of Percutaneous Coronary Intervention Among Patients With Class I Indications for Coronary Artery Bypass Surgery Undergoing Index Revascularization: Analysis From the NCDR (National Cardiovascular Data Registry)

OBJECTIVES Our purpose was to evaluate percutaneous coronary intervention (PCI) attempt rates in patients with class I indications for coronary artery bypass graft (CABG) surgery after the introduction of drug-eluting stents (DES). BACKGROUND In patients with severe, multivessel coronary disease, CABG has historically been recommended over PCI. Practice guidelines for CABG were last updated before the emergence of data on DES efficacy. METHODS We analyzed 265,028 procedures from the NCDR (National Cardiovascular Data Registry) meeting American College of Cardiology/American Heart Association class I indications for surgical revascularization. Temporal trends in PCI attempt rates were analyzed during 3 consecutive time periods: pre-DES (before April 1, 2003), DES diffusion (April 1, 2003 to December 31, 2004), and DES (January 1, 2005 to September 30, 2006). RESULTS The attempted rate of PCI in patients with class I indications for CABG increased over the 3 time periods (pre-DES: 29.4%, DES diffusion: 33.4%, and DES era: 34.7%, p < 0.001). In a hierarchical multivariable logistic model adjusting for patient and PCI site characteristics, PCI attempts were more likely in the DES compared with pre-DES era (odds ratio: 1.44, 95% confidence interval: 1.40 to 1.48) and the DES diffusion era (odds ratio: 1.20, 95% confidence interval: 1.17 to 1.23). PCI attempt rates increased in all 3 time periods, although the average rate of increase during the DES era was 0.6% per quarter compared with 0.3% per quarter for both the DES diffusion and the pre-DES eras (p = 0.03). CONCLUSIONS DES use in clinical practice was associated with a significant overall increase in PCI to treat patients with class I indications for CABG. Long-term follow-up of this cohort of patients is warranted.

Intravascular ultrasound measures of coronary atherosclerosis are associated with the Framingham risk score: an analysis from a global IVUS registry

AIMS In addition to an adjunctive imaging platform during coronary angiography, intravascular ultrasound (IVUS) with Virtual Histology (VH) is increasingly being used to quantify coronary atherosclerosis. The relationship between VH-IVUS measures of coronary atherosclerosis and traditional cardiovascular risk factors has not been completely described. The objective of this study was to determine if an association exists between VH-IVUS measures of coronary atherosclerosis and the Framingham risk score in a prospective, multinational registry. METHODS AND RESULTS Patients enrolled from 2004-2006 at 37 multinational centres in the prospective VHIVUS Global Registry were analysed. All subjects underwent diagnostic coronary angiography followed by IVUS. A Framingham risk score (FRS) was calculated for each subject, then stratified into three exclusive estimates (<10%, 10-19%, or >or= 20%) for future coronary heart disease (CHD) event risk over 10 years. Among 531 patients, plaque volume of the most diseased 10 mm segment increased with increasing FRS (P=0.006, adjusted for multiple comparisons). Patients with higher FRS estimates of CHD risk had a higher proportion of plaque classified as thin cap fibroatheroma compared with patients in the middle and lower risk score categories (21.4% vs 15.2% and 11.3%, respectively, P=0.008, adjusted for multiple comparisons). CONCLUSIONS Using data from a large, multinational VH-IVUS registry we describe an association between the Framingham risk score and VH-IVUS measures of atherosclerosis within the most diseased 10 mm segment, namely plaque volume and the proportion of thin cap fibroatheroma.

Excimer Laser Coronary Angioplasty: The New Approaches to Coronary Intervention (NACI) Experience

In the New Approaches to Coronary Intervention (NACI) registry, 887 patients were electively treated with excimer laser coronary angioplasty (ELCA) for coronary artery disease. The Advanced Interventional System (AIS) system was used in 487 cases; the Spectranetics system, in 400. The mean age was 63.4 years. Most patients had unstable angina (60.3%); 43.7% had a prior myocardial infarction; and 18.6% were high risk or inoperable patients. Mean ejection fraction was 55.4%. A total of 1,000 lesions were treated in the 887 patients. Of the 1,000 lesions treated with ELCA in the 887 patients, 36% were in the right coronary artery; 33%, left anterior descending; 13%, circumflex; 3%, left main; and 16.6%, vein graft. By angiographic core laboratory analysis available for 752 (85%) patients with 839 lesions, lesions were 12.76 mm long. The minimum lumen diameter increased to 1.29 mm after the laser and finally to 1.95 mm after adjunctive percutaneous transluminal coronary angioplasty (PTCA) (which was performed in 93% of all lesions), with a final residual stenosis of 32.1% and Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow in 95%. Dissections of grades B, C, or D were seen after 22.0% of initial laser attempts, and postlaser perforations were noted in 2.6%. Additional such dissections accumulated after adjunctive PTCA but the perforation rate remained low. Procedural success was achieved in 84% of patients, but 1.2% died, 0.7% experienced Q-wave myocardial infarction (MI), and 2.7% required emergency bypass surgery. Multiple logistic regression analysis could not identify any independent predictors of these in-hospital complications. One-year mortality was 5.7% and the cumulative incidence of Q-wave MI was 1.5%. Coronary artery bypass graft (CABG) surgery was performed in 15.0% of patients whereas 25.5% required repeat percutaneous intervention with a target lesion revascularization rate of 31%. Independent predictors of death, Q-wave MI, or target lesion revascularization (which, combined, occurred in 35.6% of patients) were the absence of prior MI, ELCA in the circumflex, perforation after the procedure, and small (<2 mm) final minimal lumen diameter. Considering the large number of patients with high-risk lesions, laser angioplasty was performed with excellent procedural success rates and a reasonable incidence of major complications.

Differentiating true versus pseudo left ventricular aneurysm: a case report and review of diagnostic strategies.

The differentiation of left ventricular pseudoaneurysm from true aneurysm is sometimes difficult. Given the propensity for pseudoaneurysms to rupture leading to cardiac tamponade, shock, and death, compared with a more benign natural history for true aneurysms, accurate diagnosis of these conditions is clinically important. Clinical symptoms, physical examination findings, electrocardiograms, and routine x-rays are not sensitive or specific for diagnosing left ventricular aneurysms nor for distinguishing true from pseudoaneurysm once detected. Our aim is to present a case report demonstrating these difficulties and to review the use of various cardiac imaging modalities in differentiating between these 2 entities.

The impact of bivalirudin on percutaneous coronary intervention-related bleeding

Aims: We studied the clinical and economic impact of bivalirudin in clinical practice. Methods and results: Consecutive patients undergoing PCI via the common femoral artery for stable, unstable, or atypical angina, silent ischaemia, or non-ST-elevation myocardial infarction indications during 2007-2008 were prospectively studied. In-hospital bleeding events were systematically assessed and classified as either major or minor. Use of bivalirudin, vascular closure devices, heparin and/or glycoprotein (GP) IIb/IIIa inhibitor was at the operator’s discretion. Among 1,364 patients, 503 received bivalirudin and 861 received usual care consisting of either heparin monotherapy (n=687) or heparin+GP IIb/IIIa (n=174). Any post-PCI bleeding occurred in 356 (26.1%) patients, including 32 (2.3%) major and 324 (23.8%) minor events. Compared with usual care, bivalirudin was associated with reduced bleeding before adjustment (any: 17.3% vs. 31.2%, P<0.001; major: 1.2% vs. 3.0%, P=0.03; minor: 16.1% vs. 28.2%, P<0.01) and after propensity-matching (OR 0.46, 95% CI 0.34-0.63, P<0.001). Use of vascular closure devices was associated with an increase in any bleeding (32.2% vs. 17.7%, P<0.001), primarily due to an increase in minor bleeding (30.8% vs. 14.1%, P<0.001) while there was a significant decrease in major bleeding (1.4% vs. 3.7%, P=0.007). Bivalirudin was associated with total hospitalisation costs that were lower than usual care (mean cost savings,

Hemolysis induced pancreatitis after orbital atherectomy in a heavily calcified superficial femoral artery

463/patient; 95% CI 1,594 less to 621 more). Conclusions: In this prospective PCI cohort, bivalirudin was associated with reduced major and minor bleeding without a significant increase in hospital costs compared with other anticoagulation regimens. Closure device use was associated with decreased major but increased minor bleeding.