In-hospital Bleeding Complications Research Articles

The obesity paradox in patients undergoing transcatheter aortic valve implantation: is there any effect of body mass index on survival?

Conflicting results have been presented regarding the influence of body mass index (BMI) on outcomes among patients undergoing transcatheter aortic valve implantation (TAVI). To investigate the impact of BMI on clinical outcomes after TAVI. A total of 148 consecutive patients were categorised using baseline BMI according to the World Health Organization criteria. Baseline patient characteristics, frailty, and procedural and clinical outcomes including 30-day and 12-month all-cause mortality were compared between the BMI categories. Patients were followed up for a median of 460.0 (182.0-1042.0) days. Obesity was diagnosed in 37 (25.2%) patients, 73 (49.7%) patients were overweight, and 37 (25.2%) had normal weight. Prevalence of lower frailty as assessed by five-metre walk test was confirmed in obese patients as compared to other groups. A trend towards a lower rate of in-hospital bleeding complications (18 [48.6%] vs. 21 [28.8%] vs. 9 [24.3%] in normal-weight, overweight, and obese patients, respectively; p = 0.06) and less frequent blood transfusions (18 [48.6%] vs. 17 [23.3%) vs. 8 [21.6%]; p = 0.016) was observed in overweight and obese groups. The rate of grade 3 acute kidney injury was lowest in the overweight group (4 [10.8%] vs. 1 [1.4%] vs. 3 [8.1%]; p = 0.05). There was no difference between the groups in terms of 30-day all-cause mortality (p = 0.15). However, 12-month all-cause mortality was lowest in obese pa-tients (12 [32.4%] vs. 10 [13.7%] vs. 2 [5.4%]; p = 0.004). Increase in BMI was independently associated with lower all-cause mortality (hazard ratio [95% confidence interval] per 1 kg/m2 increase: 0.91 [0.845-0.98]; p = 0.018). Increased BMI was independently associated with survival benefit after TAVI.

An overview of percutaneous coronary intervention in dialysis patients: Insights from a Japanese nationwide registry

This study sought to provide an overview of percutaneous coronary intervention (PCI) in dialysis patients from a Japanese nationwide registry. Little is known about dialysis patients undergoing PCI because few are enrolled in clinical trials. We analyzed 624,900 PCI cases including 41,384 dialysis patients (6.6%) from 1,017 Japanese hospitals between 2014 and 2016. We investigated differences in characteristics and in-hospital outcomes between dialysis and nondialysis patients, and assessed factors associated with an increased risk of adverse outcomes. Dialysis patients had more comorbidities than nondialysis patients and higher rates of complications including in-hospital mortality (3.3% vs. 1.5%, respectively, in the acute coronary syndrome [ACS] cohort, 0.2% vs. 0.1% in the non-ACS cohort) and bleeding complications requiring blood transfusion (1.1% vs. 0.4% in ACS, 0.5% vs. 0.2% in non-ACS). Dialysis was significantly associated with an increased risk of in-hospital mortality (odds ratio [OR]: 1.42, 95% confidence interval [CI]: 1.24-1.62 in ACS, OR: 2.25, 95% CI: 1.66-3.05 in non-ACS) and bleeding (OR: 1.60, 95% CI: 1.30-1.96 in ACS, OR: 1.55, 95% CI: 1.27-1.88 in non-ACS). For dialysis patients, age, acute heart failure, and cardiogenic shock were associated with an increased risk of in-hospital mortality in the ACS cohort, whereas age, female gender, and history of heart failure were associated with higher in-hospital mortality in the non-ACS cohort. PCI was widely performed for dialysis patients with either ACS or non-ACS in Japan. Dialysis patients had a greater risk of adverse outcomes than nondialysis patients after PCI.

Patterns of in-hospital mortality and bleeding complications following PCI for very elderly patients: insights from the Dartmouth Dynamic Registry.

BackgroundVery elderly patients (age ≥ 85 years) are a rapidly increasing segment of the population. As a group, they experience high rates of in-hospital mortality and bleeding complications following percutaneous coronary intervention (PCI). However, the relationship between bleeding and mortality in the very elderly is unknown.MethodsRetrospective review was performed on 17,378 consecutive PCI procedures from 2000 to 2015 at Dartmouth-Hitchcock Medical Center. Incidence of bleeding during the index PCI admission (bleeding requiring transfusion, access site hematoma > 5 cm, pseudoaneurysm, and retroperitoneal bleed) and in-hospital mortality were reported for four age groups (< 65 years, 65–74 years, 75–84 years, and ≥ 85 years). The mortality of patients who suffered bleeding complications and those who did not was calculated and multivariate analysis was performed for in-hospital mortality. Lastly, known predictors of bleeding were compared between patients age < 85 years and age ≥ 85 years.ResultsOf 17,378 patients studied, 1019 (5.9%) experienced bleeding and 369 (2.1%) died in-hospital following PCI. Incidence of bleeding and in-hospital mortality increased monotonically with increasing age (mortality: 0.94%, 2.27%, 4.24% and 4.58%; bleeding: 3.96%, 6.62%, 10.68% and 13.99% for ages < 65, 65–74, 75–84 and ≥ 85 years, respectively). On multivariate analysis, bleeding was associated with increased mortality for all age groups except patients age ≥ 85 years [odds ratio (95% CI): age < 65 years, 3.65 (1.99–6.74); age 65–74 years, 2.83 (1.62–4.94); age 75–84 years, 3.86 (2.56–5.82), age ≥ 85 years: 1.39 (0.49–3.95)].ConclusionsBleeding and mortality following PCI increase with increasing age. For the very elderly, despite high rates of bleeding, bleeding is no longer predictive of in-hospital mortality following PCI.

Comparison of In-Hospital Outcomes and Readmission Rates in Acute Pulmonary Embolism Between Systemic and Catheter-Directed Thrombolysis (from the National Readmission Database): Arora S, Panaich SS, Ainani N, et al. Am J Cardiol. 2017;120(9):1653-1661

Current guidelines recommend treatment with systemic thrombolysis for patients with pulmonary embolism (PE) that are hemodynamically unstable, with weaker recommendations for those with submassive PE resulting in right ventricular dysfunction or myocardial injury. Systemic thrombolysis comes with the risk of major bleeding including gastrointestinal and intracranial hemorrhage. Catheter-Directed Thrombolysis (CDT) may provide a solution to this problem by targeting the therapy directly at the thrombus as opposed to delivering the therapy systemically, resulting in lower total delivered dosages and potentially lesser bleeding risk. The goal of this study was to compare the in-hospital mortality, bleeding complications and 30-day readmission rates between patients treated for PE with systemic thrombolysis and CDT. Data was gathered from 2013-2014 using the National Readmission Database (NRD), a multicenter database that comprises 49.3% of all hospitalizations in the United States. The subjects included were at least 18 years old and were identified through an electronic search of the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes for PE, thrombolysis and CDT. Propensity score matching was used to compare subjects with similar demographics and co-morbidities who received either systemic thrombolytics (n=2,256) or CDT (n=1,128). The co-primary outcomes were in-hospital mortality and 30-day readmission rates and the secondary outcome was combined in-hospital mortality + gastrointestinal (GI) bleed + intracranial hemorrhage. In-hospital mortality was lower in the CDT cohort (6.12%) than the systemic thrombolytics cohort (14.94%) (Odds Ratio [OR] 0.37, 95% Confidence Interval [CI] 0.28-0.49). Patients who received CDT also had a lower composite secondary outcome (in-hospital mortality + GI bleed +intracranial hemorrhage) of 8.42% versus 18.13% in those who received systemic thrombolysis (OR 0.41, 95% CI 0.33-0.53). The CDT cohort also had a lower 30-day readmission rate compared to those who received systemic thrombolysis (7.65% versus 10.58%, OR 0.70, 95% CI 0.54-0.92). The authors concluded that treatment for PE with CDT resulted in improved mortality, fewer bleeding complications, and lower readmission rates than systemic thrombolysis. They theorize that CDT was more effective at clot removal due to direct administration of thrombolytics at the intended target, while the better safety profile was attributed to lower doses of thrombolytics administered during CDT with reduced systemic reabsorption. Comment: This retrospective trial is the largest study to date comparing outcomes between CDT and systemic thrombolytics in the treatment of PE. The mortality and readmission rates favoring CDT are compelling, as well as the decrease bleeding rates. The authors attempted to control for bias by using propensity score matching, however, they lacked data regarding the details of the individual cases, the thrombolytic agents that were administered and their doses. Additionally, they were not able to control for illness severity which may bias the results as more unstable patients may have been more likely to receive systemic thrombolysis as opposed to procedural CDT.

Minimally Invasive Access Aortic Arch Surgery.

Median sternotomy is still the standard approach for aortic arch surgery. Minimally invasive techniques promise faster recovery with shorter hospital stay due to thoracic stability, reduced pain, and superior cosmetic results. However, safety is a concern in complex aortic surgery. The aim of our study was to demonstrate that aortic arch surgery via partial upper sternotomy is viable, safe, and equivalent to standard procedure both in terms of its safety and the risk of major adverse cardiac and cerebrovascular events. We interrogated our prospectively collected database and identified a total of 21 nonemergent patients operated on at our center between October 2008 and February 2015. Indication for operation was aneurysmatic disease in 18 and aortic dissection in 3 patients. Data were analyzed for in-hospital mortality, stroke, bleeding complications, and acute kidney injury. Mean ± standard deviation age of patients was 69.3 ± 14.4 years, 57.1% were female, and mean ± standard deviation logistic EuroSCORE was 17.0 ± 7.2%. Surgery on the aortic arch comprised proximal arch in 9, hemiarch in 9, and total arch replacement plus frozen elephant trunk in 3 patients. Concomitant procedures included aortic root repair in 10, aortic root replacement in 2, and aortic valve replacement in 3 patients. We lost one patient because of septic shock, no stroke occurred, but a transient neurologic deficit in three and a postoperative delirium in four patients. Re-exploration for bleeding was necessary in two patients, and one patient had acute kidney injury. Minimally invasive aortic arch surgery via partial upper sternotomy does not increase the risk of morbidity or mortality. Thus, in experienced hands, it is viable, safe, and therefore favorable and as a result should be offered to more patients.

A retrospective analysis of Impella use in all-comers: 1-year outcomes.

There are non-randomized data about the benefits of Impella use in the setting of cardiogenic shock. However, limited data exist to help guide clinicians about whether in the context of the intervention the device should be implanted early or late; how long the device should stay in; and how the mode of explant should be. This is a retrospective, single center registry over 5 years comparing in-hospital outcomes and 1-year mortality in all-comers who had the Impella device placed early versus those who had the device placed late as a bailout. The primary endpoint was a composite of in-hospital all-cause mortality, major vascular, bleeding complications, and stroke. A secondary endpoint was 1-year mortality. Of 262 total patients, 181 (69.1%) had early and 81 (30.9%) had late Impella placement. Patients in the early group had a lower combined MACCE (17.1% vs 59.3%, P < 0.001) and in-hospital mortality (8.8% vs 48.1%, P < 0.001) compared to the late group. Major vascular (3.3% vs 2.5%, P = 1.0), bleeding complications (5.0% vs 7.4%, P = 0.57), and stroke (3.3% vs 7.4%, P = 0.20) were not significant between groups. Early Impella placement had lower 6 month (17.7% vs 53.1%, P < 0.001) and 1-year mortality rates (21.5% vs 53.1%, P < 0.001) compared to those in the late group. For patients with need for an Impella device, regardless of the indication, early implantation is associated with better in-hospital and 1-year outcomes as compared to when the device is implanted late as a bailout.

Comparison of prasugrel versus clopidogrel in Korean patients with acute myocardial infarction undergoing successful revascularization

BackgroundAlthough there have been several reports that prasugrel can improve clinical outcomes, the efficacy and safety of prasugrel is unknown in Korean patients with acute myocardial infarction (AMI) undergoing successful revascularization. MethodsA total of 4421 patients [637 patients were prescribed prasugrel (60/10 or 5mg, loading/maintenance dose) and 3784 patients clopidogrel (600 or 300/75mg)] with AMI undergoing successful revascularization were enrolled from the core clinical cohort of Korea Acute Myocardial Infarction Registry-National Institute of Health. ResultsAfter propensity score matching (637 pairs), there were no significant differences in baseline clinical and procedural characteristics and in-hospital medications between the two groups. The primary efficacy endpoint, defined as the composite of cardiac death, MI, stroke, or target vessel revascularization at 6 months showed no significant difference between prasugrel and clopidogrel (2.4% vs. 2.9%, p=0.593). Also, no difference was observed in the composite of cardiac death, MI, or stroke during hospitalization between two groups (0.8% vs. 0.9%, p=0.762). However, the incidence of in-hospital Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding was significantly higher in prasugrel compared with clopidogrel (5.3% vs. 2.7%, p=0.015). In multivariate linear regression analysis, trans-femoral intervention, use of glycoprotein IIb/IIIa inhibitors, use of calcium channel blocker, and use of prasugrel were independent predictors of in-hospital TIMI major or minor bleeding [odds ratio (OR)=6.918; 95% confidence interval (CI)=2.453–19.510, OR=2.577; 95% CI=1.406–4.724, OR=4.016; 95% CI=1.382–11.668, OR=2.022; 95% CI=1.101–3.714]. ConclusionsOur study shows that the recommended dose of prasugrel had significantly higher in-hospital bleeding complications without reducing ischemic events compared with clopidogrel. However, further large-scale, long-term, randomized clinical trials are required to accurately assess the efficacy and safety of prasgurel and to find out the optimal dose for Korean AMI patients.

Significance of the age of transfused blood for prognosis after transcatheter aortic valve implantation.

INTRODUCTION Blood transfusion after transcatheter aortic valve implantation (TAVI) is frequently required owing to the high vulnerability of this patient group and procedure-related bleeding. OBJECTIVES We assessed the impact of postprocedural blood transfusion and the age of transfused red blood cell (RBC) units on prognosis after TAVI. PATIENTS AND METHODS This was a single-center, observational analysis conducted between the years 2009 and 2014. The adopted endpoints were early and long-term mortality after TAVI. The risk factors for mortality included in-hospital bleeding and vascular complications, the number of transfused RBC units, transfusion of at least 2 RBC units, the age of transfused RBCs, and standard deviation of the age of RBCs. RESULTS The study included 178 patients (mean [SD] age, 80.07 [7.47] years; range, 55-91 years). The follow-up ranged between 1 month and 5.8 years (mean [SD], 20.1 [15.2] months) after discharge; 14 early deaths (7.8%) and 27 late deaths (16.5%) were noted. In-hospital bleeding and vascular complications increased the risk of early deaths (hazard ratio [HR], 2.113; 95% CI, 1.011-4.418; P = 0.046 and HR, 2.265; 95% CI, 1.270-4.039; P = 0.005). Transfusion of younger RBCs (HR, 1.044; 95% CI, 1.004-1.085; P = 0.028) and a greater discrepancy in the age of transfused RBCs (HR, 1.153; 95% CI, 1.042-1.275; P = 0.006) were positively correlated with the risk of late deaths only in a univariate analysis. A higher number of transfused RBC units was the only independent predictor of long-term mortality (HR, 1.149; 95% CI, 1.024-1.291; P = 0.018). CONCLUSIONS The higher number of RBC units transfused early after TAVI worsens long-term prognosis. Shorter-storage RBCs and a greater discrepancy in RBC age in multitransfused elderly patients after TAVI might have a deleterious effect on life expectancy.

Second-generation drug-eluting stents in the elderly patients with acute coronary syndrome: the in-hospital and 12-month follow-up of the all-comer registry

BackgroundKatowice–Zabrze registry provides data that can be used to evaluate clinical outcomes of percutaneous coronary interventions in elderly patients (≥70 y/o) treated with either first- (DES-I) or second-generation (DES-II) drug-eluting stents (DES).MethodsThe registry consisted of data from 1916 patients treated with coronary interventions using either DES-I or DES-II stents. For our study, we defined patients ≥70 years of age as elderly. We evaluated any major adverse cardiac and cerebral events (MACCE) at 12-month follow-up.ResultsCoronary angiography revealed a higher incidence of multivessel coronary artery disease in this elderly patient population. There were no differences in acute and subacute stent thrombosis (0.4 vs. 0.6%, p = 0.760; 0.4 vs. 0.4%; p = 0.712). Elderly patients experienced more in-hospital bleeding complications requiring blood transfusion (2.0 vs. 0.9%; p = 0.003). Resuscitated cardiac arrests (2.0 vs. 0.9%; p = 0.084) were observed more often in this elderly patients during hospitalization. The composite in-hospital MACCE rates did not differ statistically between both groups (1.4 vs. 1.1%; p = 0.567). Data from a twelve-month follow-up disclosed that mortality was higher (7.1 vs. 1.8%; p < 0.001) in the elderly, with no difference in TVR (7.2 vs. 9.9%, p = 0.075), MI (6.0 vs. 4.8%, p = 0.300), stroke (0.8 vs. 0.6%, p = 0.600) and composite MACCE (15.0 vs. 13.4%, p = 0.324). The age of 70 years or over was an independent predictor of death [HR = 2.55 (95% CI 1.49–4.37); p < 0.001]. The use of DES-II reduced the risk of MI [HR = 0.40 (95% CI 0.19–0.82); p = 0.012] in the elderly.ConclusionThis elderly patient population had an increased risk of in-hospital bleeding complications requiring blood transfusion and a higher risk of death at 12-month follow-up. The use of new-generation DES reduced the risk of MI in the elderly population.

Gender differences and bleeding complications after PCI on first and second generation DES

Background. The aim of this study was to evaluate gender differences in the long-term clinical outcomes and safety of patients treated with first- and second generation DES. Methods. The Katowice–Zabrze Registry included 1916 consecutive patients treated with either first or second generation DES. We evaluated major adverse cardiac and cerebrovascular events (MACCE) [composite of death, myocardial infarction (MI), stroke and target vessel revascularization (TVR)] at 12-month follow-up. Safety end point was bleeding complications and stent thrombosis. Results. Registry included [unstable angina (UA) 1500(78%), non-ST-segment elevation myocardial infarction (NSTEMI) 285 (15%), ST-segment elevation myocardial infarction/left bundle branch block (STEMI/LBBB) 131 (7%)]. There were 35.5% females and 64.5% males. Women were older and had higher prevalence of comorbidities. Males more often had multivessel disease and higher Syntax score when comparable to females. We did not observed difference in acute and subacute stent thrombosis in our data, however, females had more in-hospital bleeding complications. Univariable Cox regression analysis revealed that women had similar outcomes when compared to men in terms of a risk of death, MI, TVR, stroke and MACCE at 1-year follow-up. There were no differences between males and females in MACCE when first- and second generation DES were analyzed separately. Conclusion. Despite higher risk profile, women treated with DES have similar outcomes as males in 1-year follow-up. However there is, an increased risk of in-hospital bleedings in women.

TCTAP A-067 Does a Simple Clinical Bleeding Risk Scoring System Predict In-Hospital Bleeding Complications in Patients Undergoing Elective Percutaneous Coronary Intervention?

TCTAP A-067 Does a Simple Clinical Bleeding Risk Scoring System Predict In-Hospital Bleeding Complications in Patients Undergoing Elective Percutaneous Coronary Intervention?

Clinical outcomes of percutaneous coronary intervention for acute coronary syndrome between hospitals with and without onsite cardiac surgery backup

BackgroundBased on the 2011 American College of Cardiology/American Heart Association percutaneous coronary intervention (PCI) guideline, it is recommended that PCI should be performed at hospital with onsite cardiac surgery. But, data suggest that there is no significant difference in clinical outcomes following primary or elective PCI between the two groups. We examined the impact of with or without onsite cardiac surgery on clinical outcomes following PCI for acute coronary syndrome (ACS). Methods and resultsFrom August 2008 to March 2011, subjects (n=3241) were enrolled from the Kumamoto Intervention Conference Study (KICS). Patients were assigned to two groups treated in hospitals with (n=2764) or without (n=477) onsite cardiac surgery. Clinical events were followed up for 12 months. Primary endpoint was in-hospital death, cardiovascular death, myocardial infarction, and stroke. And we monitored in-hospital events, non-cardiovascular deaths, bleeding complications, revascularizations, and emergent coronary artery bypass grafting (CABG). There was no overall significant difference in primary endpoint between hospitals with and without onsite cardiac surgery [ACS, 7.6% vs. 8.0%, p=0.737; ST-segment elevation myocardial infarction (STEMI), 10.4% vs. 7.5%, p=0.200]. There was also no significant difference when events in primary endpoint were considered separately. In other events, revascularization was more frequently seen in hospitals with onsite surgery (ACS, 20.0% vs. 13.0%, p<0.001; STEMI, 21.9% vs. 14.5%, p=0.009). We performed propensity score matching analysis to correct for the disparate patient numbers between the two groups, and there was also no significant difference for primary endpoint (ACS, 8.6% vs. 7.5%, p=0.547; STEMI, 11.2% vs. 7.5%, p=0.210). ConclusionsThere is no significant difference in clinical outcomes following PCI for ACS between hospitals with and without onsite cardiac surgery backup in Japan.

Trends in use of anti-thrombotic agents and outcomes in patients with non-ST-segment elevation myocardial infarction (NSTEMI) managed with an invasive strategy

ObjectiveTo analyze trends in utilization of anti-thrombotic agents (ATA) and in-hospital clinical outcomes in non-ST-elevation myocardial infarction (NSTEMI) patients managed with an invasive strategy from 2007 to 2010. Methods & resultsUsing ACTION Registry®-GWTG™ data, we analyzed trends in use of ATA and in-hospital clinical outcomes among 64,199 NSTEMI patients managed invasively between 2007 and 2010. ATA included unfractionated heparin (UFH), low molecular weight heparin (LMWH), glycoprotein IIb/IIIa inhibitors (GPI) and bivalirudin. Although the proportion of NSTEMI patients treated with PCI within 48h of hospital arrival was similar in 2007 and 2010, percentage use of bivalirudin (13.4–27.3%; p<0.01) and UFH increased (60.0–67.5%, p<0.01), and that of GPI (62.3–41.0%; p<0.01) and LMWH (41.5–36.8%; p<0.01) declined. Excess dosing of UFH (75.9–59.3%, p<0.01), LMWH (9.6–5.2%; p<0.01) and GPI (8.9–5.9%, p<0.01) was also significantly lower in 2010 compared with 2007. Though in-hospital mortality rates were similar in 2007 and 2010 (2.3–1.9%, p=0.08), the rates of in-hospital major bleeding (8.7–6.6%, p<0.01) and non-CABG related RBC transfusion (6.3–4.6%, p<0.01) were significantly lower in 2010 compared with 2007. ConclusionCompared with 2007, patients with NSTEMI, who were managed invasively in 2010 received GPI and LMWH less often and bivalirudin and UFH more frequently. There were sizeable reductions in the rates of excess dosing of UFH (though still occurred in 67% of patients), GPI and LMWH. In-hospital major bleeding complications and post-procedural RBC transfusion were lower in 2010 compared with 2007.

Comparison of the Global Registry of Acute Coronary Events Risk Score Versus the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse outcomes With Early Implementation of the ACC/AHA Guidelines Risk Score to Predict In-Hospital Mortality and Major Bleeding in Acute Coronary Syndromes

Risk assessment plays a major role in the management of acute coronary syndrome. The aim was to compare the performance of the Global Registry of Acute Coronary Events (GRACE) and the Can Rapid risk stratification of Unstable angina patients Suppress Adverse outcomes with Early implementation of the American College of Cardiology/American Heart Asociation guidelines (CRUSADE) risk scores to predict in-hospital mortality and major bleeding (MB) in 1,587 consecutive patients with acute coronary syndrome. In-hospital deaths and bleeding complications were prospectively collected. Bleeding complications were defined according to CRUSADE and Bleeding Academic Research Consortium (BARC) criteria. During the hospitalization, 71 patients (4.5%) died, 37 patients (2.3%) had BARC MB and 34 patients (2.1%) had CRUSADE MB. Receiver operating characteristic curves analyses showed GRACE risk score has better discrimination capacity than CRUSADE risk score for both, mortality (0.86 vs 0.79; p = 0.018) and BARC MB (0.80 vs 0.73; p = 0.028), but similar for CRUSADE MB (0.79 vs 0.79; p = 0.921). Both scores had low discrimination for predicting MB in the elderly (>75 years) and patients with atrial fibrillation, whereas CRUSADE risk score was especially poor for predicting MB in patients with <60 ml/min/1.73 m(2) or those treated with new antiplatelets. Reclassification analyses showed GRACE risk score was associated with a significant improvement in the predictive accuracy of CRUSADE risk score for predicting mortality (net reclassification improvement: 22.5%; p <0.001) and MB (net reclassification improvement: 17.6%; p = 0.033) but not for CRUSADE MB. In conclusion, GRACE risk score has a better predictive performance for predicting both in-hospital mortality and BARC MB. In light of these findings, we propose the GRACE score as a single score to predict these in-hospital complications.

Circulation : Clinical Summaries

<i>Circulation</i> : Clinical Summaries

Association of Physician Certification in Interventional Cardiology With In-Hospital Outcomes of Percutaneous Coronary Intervention.

The value of American Board of Internal Medicine certification has been questioned. We evaluated the Association of Interventional Cardiology certification with in-hospital outcomes of patients undergoing percutaneous coronary intervention (PCI) in 2010. We identified physicians who performed ≥10 PCIs in 2010 in the CathPCI Registry and determined interventional cardiology (ICARD) certification status using American Board of Internal Medicine data. We compared in-hospital outcomes of patients treated by certified and noncertified physicians using hierarchical multivariable models adjusted for differences in patient characteristics and PCI volume. Primary end points were all-cause in-hospital mortality and bleeding complications. Secondary end points included emergency coronary artery bypass grafting, vascular complications, and a composite of any adverse outcome. With 510,708 PCI procedures performed by 5175 physicians, case mix and unadjusted outcomes were similar among certified and noncertified physicians. The adjusted risks of in-hospital mortality (odds ratio, 1.10; 95% confidence interval, 1.02-1.19) and emergency coronary artery bypass grafting (odds ratio, 1.32; 95% confidence interval, 1.12-1.56) were higher in the non-ICARD-certified group, but the risks of bleeding and vascular complications and the composite end point were not statistically significantly different between groups. We did not observe a consistent association between ICARD certification and the outcomes of PCI procedures. Although there was a significantly higher risk of mortality and emergency coronary artery bypass grafting in patients treated by non-ICARD-certified physicians, the risks of vascular complications and bleeding were similar. Our findings suggest that ICARD certification status alone is not a strong predictor of patient outcomes and indicate a need to enhance the value of subspecialty certification.

Effect of access site, gender, and indication on clinical outcomes after percutaneous coronary intervention: Insights from the British Cardiovascular Intervention Society (BCIS)

Gender is a strong predictor of periprocedural major bleeding complications after percutaneous coronary intervention (PCI). The access site represents an important site of such bleeding complications, which has driven adoption of the transradial access (TRA) use during PCI, although female gender is an independent predictor of transradial PCI failure. This study sought to define gender differences in access site practice and study associations between access site choice and clinical outcomes for PCI over a 6-year period, through the analysis of the British Cardiovascular Intervention Society observational database. In-hospital major adverse cardiovascular events (a composite of in-hospital mortality and in-hospital myocardial reinfarction and target vessel revascularization), in-hospital bleeding complications, and 30-day mortality were studied based on gender and access site choice (transfemoral access, TRA) in 412,122 patients who underwent PCI between 2007 and 2012 in the United Kingdom. Use of TRA increased in both genders over time, although this lagged behind in women (21% in 2007 to 58% in 2012) compared with men (24% in 2007 to 64% in 2012). In both men and women, TRA was independently associated with a lower in-hospital major adverse cardiovascular event (odds ratio [OR] 0.82, 95% CI 0.76-0.90; OR 0.75, 95% CI 0.66-0.84), in-hospital major bleeding (OR 0.54, 95% CI 0.44-0.66; OR 0.26, 95% CI 0.20-0.33), and 30-day mortality (OR 0.80, 95% CI 0.73-0.89; OR 0.82, 95% CI 0.71-0.94), respectively. Where possible, TRA should be considered as the preferred access site choice for PCI, particularly in women in whom the greatest reductions bleeding end points were observed across all indications.

0062: Clinical effectiveness of the systematic use of the GRACE scoring system for ischaemic outcomes and bleeding complications in the management of NSTEMI

We assessed the interest of systematically using the GRACE scoring system (in addition to clinical assessment) for in-hospital outcomes and bleeding complications in the management of NSTEMI compared with clinical assessments alone. Multicentre, randomized study that included 572 consecutive NSTEMI patients, randomized 1:1, into group A: clinical stratification alone and group B: clinical+ GRACE score stratification. In-hospital outcomes and bleeding complications. There was no significant difference between the two groups for baseline data or for in-hospital MACE. In multivariate analysis, only a GRACE >140 (OR: 3.5, 95% CI: 1.8-6.6, p<0.001) and PCI (OR: 0.55, 95% CI: 0.3-1.0; p=0.05) were independent predictors of in-hospital MACE. The sub-analysis of group B showed that 56 patients (20%) were given a compliance score of 0, showing that diagnostic angiography was performed later than as recommended by the guidelines. Interestingly, 91% had a Grace score>140, and these patients were significantly older, and were more likely to have a history of diabetes, stroke and renal failure, together with symptoms of heart failure. After multivariate analysis, the independent predictors of a lack of compliance with guideline delays were a GRACE score >140 (OR: 9.2; CI: 4.2-20.3, p<0.001) and secondary referral from a non-PCI cardiology department (OR: 2.7; CI: 1.4-5.2, p=0.003). In a real-world setting of patients admitted with NSTEMI, the systematic use of the GRACE scoring system at admission in the PCI centre does not improve in-hospital outcomes and bleeding complications.

The learning curve for transradial percutaneous coronary intervention among operators in the United States: a study from the National Cardiovascular Data Registry.

Adoption of transradial percutaneous coronary intervention (TRI) in the United States is low and may be related to challenges learning the technique. We examined the relationships between operator TRI volume and procedural metrics and outcomes. We used CathPCI Registry data from July 2009 to December 2012 to identify new radial operators, defined by an exclusively femoral percutaneous coronary intervention approach for 6 months after their first percutaneous coronary intervention in the database and ≥15 total TRIs thereafter. Primary outcomes of fluoroscopy time, contrast volume, and procedure success were chosen as markers of technical proficiency. Secondary outcomes included in-hospital mortality, bleeding, and vascular complications. Adjusted outcomes were analyzed by using operator TRI experience as a continuous variable with generalized linear mixed models. Among 54 561 TRI procedures performed at 704 sites, 942 operators performed 1 to 10 procedures, 942 operators performed 11 to 50 procedures, 375 operators performed 51 to 100 procedures, and 148 operators performed 101 to 200 procedures. As radial caseload increased, more TRIs were performed in women, in patients presenting with ST-segment elevation myocardial infarction, and for emergency indications. Decreased fluoroscopy time and contrast use were nonlinearly associated with greater operator TRI experience, with faster reductions observed for newer (<30-50 cases) compared with more experienced (>30-50 cases) operators. Procedure success was high, whereas mortality, bleeding, and vascular complications remained low across TRI volumes. As operator TRI volume increases, higher-risk patients are chosen for TRI. Despite this, operator proficiency improves with greater TRI experience, and safety is maintained. The threshold to overcome the learning curve appears to be approximately 30 to 50 cases.

Abstract 9869: Collagen-plug based Vascular Closure Devices can they Decrease Vascular and Bleeding Complications occurring After Balloon Aortic Valvuloplasty ?

Introduction: Whereas they are controversial after coronary angioplasty, we assessed the hypothesis that the use of vascular closure devices (VCDs) after balloon aortic valvuloplasty (BAV), may decrease vascular and bleeding complications of the procedure. Methods: We conducted a prospective analysis of consecutive patients who underwent BAV in our center between 2009 and 2012. BAV was performed by femoral retrograde technique using 8 to 10 French sheaths. Group 1 consists of patients from which femoral puncture hemostasis was obtained with use of a 8 French collagen-plug based VCD (Angio-seal, St Jude Medical), group 2 consists of patients who have manual or mechanical compression (FemoStop, RADI Medical systems) of the femoral puncture site. We collected all major in-hospital adverse events, major bleeding (≥ BARC 3) and serious vascular access complications (pseudoanerysm, arterio venous fistula or acute limb ischemia). Results: Overall, 180 patients were included in that study. Indications for performing BAV included bridge to surgery (n=27), bridge to TAVI (n=71), therapy before extra cardiac surgery (n=35) or palliative (n=47). The two groups had similar median age (84 years) and previous lower extremity artery disease (overall n= 47, 26%, p=0.79). Vascular and bleeding complications occurred overall among 11.7% of the patients (n=21) and were more frequent in group 1 (p=0;02; table 1). Five of the 6 patients who suffered acute limb ischemia belonged to this group (p= 0.15). The rate of complications was the same whatever was the size if the sheath used. In conclusion, this study shows that collagen-plug based vascular closure devices increase vascular and bleeding complications occurring after balloon aortic valvuloplasty. Except in high risk bleeding patients, in whom femoral hemostasis can be difficult to obtain, the systematic use of these devices in a population of elderly patients with often advanced limb atherosclerosis, is questionable.