Coronary perforation complicating percutaneous coronary intervention in patients presenting with an acute coronary syndrome: An analysis of 1013 perforation cases from the British Cardiovascular Intervention Society database.

BACKGROUND: The evidence base for coronary perforation occurring during percutaneous coronary intervention in patients presenting with an acute coronary syndrome (ACS-PCI) is limited and the specific role of acute pharmacology in its clinical presentation unclear. METHODS AND RESULTS: Using the BCIS PCI database, data were analysed on all ACS-PCI procedures performed in England and Wales between 2007 and 2014. Multiple regressions were used to identify predictors of coronary perforation and its association with outcomes. Propensity score matching was used to evaluate the association between differing P2Y12 inhibitors or glycoprotein inhibitors (GPI) and CP. During 270,329 ACS-PCI procedures, 1013 coronary perforations were recorded (0.37%) with a stable annual incidence. In multiple regression analysis, covariates associated with increased frequency of coronary perforation included age, female gender, CTO intervention, number and length of stents used, and rotational atherectomy use, whilst differing P2Y12 inhibitors were not predictive. Using propensity score matching, use of a GPI was independently associated with tamponade (OR 1.50, [1.08-2.06], p = 0.014). The adjusted odds ratios for all clinical outcomes were adversely affected by coronary perforation. CONCLUSIONS: Coronary perforation is an infrequent event during ACS-PCI but is closely associated with adverse clinical outcomes. GPI use was associated with higher rates of tamponade.

Association between time of hospitalization with acute myocardial infarction and in-hospital mortality.

AIMS: To study the association between time of hospitalization and in-hospital mortality for acute myocardial infarction (AMI). METHODS AND RESULTS: Patients admitted with ST-elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) across 243 hospitals in England and Wales between 1 January 2004 and 31 March 2013 were included. The outcome measure was in-hospital mortality. Adjusted odds ratios (ORs) for in-hospital mortality were estimated across six 4-hourly time periods over the 24-h clock using multilevel logistic regression, inverse-probability weighting propensity score, and instrumental variable analysis. Among 615 035 patients [median age 70.0 years, interquartile range 59.0-80.0 years; 406 519 (66.0%) men], there were 52 777 (8.8%) in-hospital deaths. At night, patients with NSTEMI were more frequently comorbid, and for STEMI had longer symptom-onset-to-reperfusion times. For STEMI, unadjusted in-hospital mortality was highest between 20:00 and 23:59 [4-h period range 8.4-9.9%; OR compared with 00:00-03:59 reference 1.13, 95% confidence interval (CI) 1.07-1.20], and for NSTEMI highest between 12:00 and 15:59 (8.0-8.8%; OR compared with 00:00-03:59 reference 1.07, 95% CI 1.03-1.12). However, these differences were only apparent in the earlier years of the study, and were attenuated by adjustment for demographics, comorbidities, and clinical presentation. Differences were not statistically significant after adjustment for acute clinical treatment provided. CONCLUSION: There is little evidence to support an association between time of hospitalization and in-hospital mortality for AMI; variation in in-hospital mortality may be explained by case mix and the use of treatments.

Do frailty measures improve prediction of mortality and morbidity following transcatheter aortic valve implantation? An analysis of the UK TAVI registry.

OBJECTIVES: Previous studies indicate frailty to be associated with poor outcomes following transcatheter aortic valve implantation (TAVI), but there is limited evidence from multicentre registries. The aim was to investigate the independent association of frailty with TAVI outcomes, and the prognostic utility of adding frailty into existing clinical prediction models (CPMs). DESIGN: The UK TAVI registry incorporated three frailty measures since 2013: Canadian Study of Health and Ageing, KATZ and poor mobility. We investigated the associations between these frailty measures with short-term and long-term outcomes, using logistic regression to estimate multivariable adjusted ORs, and Cox proportional hazards models to explore long-term survival. We compared the predictive performance of existing TAVI CPMs before and after updating them to include each frailty measure. SETTING: All patients who underwent a TAVI procedure in England or Wales between 2013 and 2014. PARTICIPANTS: 2624 TAVI procedures were analysed in this study. PRIMARY AND SECONDARY OUTCOMES: The primary endpoints in this study were 30-day mortality and long-term survival. The Valve Academic Research Consortium (VARC)-2 composite early safety endpoint was considered as a secondary outcome. RESULTS: KATZ <6 (OR 2.10, 95% CI 1.39 to 3.15) and poor mobility (OR 2.15, 95% CI 1.41 to 3.28) predicted 30-day mortality after multivariable adjustment. All frailty measures were associated with increased odds of the VARC-2 composite early safety endpoint. We observed a significant increase in the area under the receiver operating characteristic curves by approximately 5% after adding KATZ <6 or poor mobility into the TAVI CPMs. Risk stratification agreement was significantly improved by the addition of each frailty measure, with an increase in intraclass correlation coefficient of between 0.15 and 0.31. CONCLUSION: Frailty was associated with worse outcomes following TAVI, and incorporating frailty metrics significantly improved the predictive performance of existing CPMs. Physician-estimated frailty measures could aid TAVI risk stratification, until more objective scales are routinely collected.

Legacy Effect of Coronary Perforation Complicating Percutaneous Coronary Intervention for Chronic Total Occlusive Disease: An Analysis of 26 807 Cases From the British Cardiovascular Intervention Society Database.

BACKGROUND: Coronary perforation (CP) during chronic total occlusion percutaneous coronary intervention for stable angina (CTO-PCI) is a rare but serious event. The evidence base is limited, and the long-term effects are unclear. Using a national PCI database, the incidence, predictors, and outcomes of CP during CTO-PCI were defined. METHODS AND RESULTS: Data analyzed from the British Cardiovascular Intervention Society data set on all CTO-PCI procedures performed in England and Wales between 2006 and 2013. Multivariate logistic regressions and propensity scores were used to identify predictors of CP and its association with outcomes. A total of 376 CP were recorded from 26 807 CTO-PCI interventions (incidence of 1.40%) with an increase in frequency during the study period (P=0.012). Patient-related factors associated with an increased risk of CP were age and female sex. Procedural factors indicative of complex CTO intervention strongly related to an increased risk of CP with a close relationship between the number of complex strategies used and CP evident (P=0.008 for trend). Tamponade occurred in 16.6% and emergency surgery in 3.4% of cases. Adverse outcomes were frequent in those patients with perforation including bleeding, transfusion, myocardial infarction, and death. A legacy effect of perforation on mortality was evident, with an odds ratio for 12-month mortality of 1.60 for perforation survivors compared with matched nonperforation survivors without a CP (P<0.0001). CONCLUSIONS: Many of the factors associated with an increased risk of CP were related to CTO complexity. Perforation was associated with adverse outcomes, with a legacy effect on later mortality after CP also observed.

Incidence, Determinants, and Outcomes of Coronary Perforation During Percutaneous Coronary Intervention in the United Kingdom Between 2006 and 2013: An Analysis of 527 121 Cases From the British Cardiovascular Intervention Society Database.

BACKGROUND: As coronary perforation (CP) is a rare but serious complication of percutaneous coronary intervention (PCI) the current evidence base is limited to small series. Using a national PCI database, the incidence, predictors, and outcomes of CP as a complication of PCI were defined. METHODS AND RESULTS: Data were prospectively collected and retrospectively analyzed from the British Cardiovascular Intervention Society data set on all PCI procedures performed in England and Wales between 2006 and 2013. Multivariate logistic regressions and propensity scores were used to identify predictors of CP and its association with outcomes. In total, 1762 CPs were recorded from 527 121 PCI procedures (incidence of 0.33%). Patients with CP were more often women or older, with a greater burden of comorbidity and underwent more complex PCI procedures. Factors predictive of CP included age per year (odds ratio [OR], 1.03; 95% confidence intervals, 1.02-1.03; P<0.001), previous coronary artery bypass graft (OR, 1.44; 95% confidence intervals, 1.17-1.77; P<0.001), left main (OR, 1.54; 95% confidence intervals, 1.21-1.96; P<0.001), use of rotational atherectomy (OR, 2.37; 95% confidence intervals, 1.80-3.11; P<0.001), and chronic total occlusions intervention (OR, 3.96; 95% confidence intervals, 3.28-4.78; P<0.001). Adjusted odds of adverse outcomes were higher in patients with CP for all major adverse coronary events, including stroke, bleeding, and mortality. Emergency surgery was required in 3% of cases. Predictors of mortality in patients with CP included age, diabetes mellitus, previous myocardial infarction, renal disease, ventilatory support, use of circulatory support, glycoprotein inhibitor use, and stent type. CONCLUSIONS: Using a national PCI database for the first time, the incidence, predictors, and outcomes of CP were defined. Although CP as a complication of PCI occurred rarely, it was strongly associated with poor outcomes.

The Effectiveness and Cost-Effectiveness of Spinal Cord Stimulation for Refractory Angina (RASCAL Study): A Pilot Randomized Controlled Trial.

BACKGROUND: Patients with "refractory angina" (RA) unsuitable for coronary revascularization experience high levels of hospitalization and poor health-related quality of life. Randomized trials have shown spinal cord stimulation (SCS) to be a promising treatment for chronic stable angina and RA; however, none has compared SCS with usual care (UC). The aim of this pilot study was to address the key uncertainties of conducting a definitive multicenter trial to assess the clinical and cost-effectiveness of SCS in RA patients, i.e., recruitment and retention of patients, burden of outcome measures, our ability to standardize UC in a UK NHS setting. METHODS: RA patients deemed suitable were randomized in a 1:1 ratio to SCS plus UC (SCS group) or UC alone (UC group). We sought to assess: recruitment, uptake, and retention of patients; feasibility and acceptability of SCS treatment; the feasibility and acceptability of standardizing UC; and the feasibility and acceptability of the proposed trial outcome measures. Patient outcomes were assessed at baseline (prerandomization) and three and six months postrandomization. RESULTS: We failed to meet our planned recruitment target (45 patients) and randomized 29 patients (15 SCS group, 14 UC group) over a 42-month period across four sites. None of the study participants chose to withdraw following consent and randomization. With exception of two deaths, all completed evaluation at baseline and follow-up. Although the study was not formally powered to compare outcomes between groups, we saw a trend toward larger improvements in both primary and secondary outcomes in the SCS group. CONCLUSIONS: While patient recruitment was found to be challenging, levels of participant retention, outcome completion, and acceptability of SCS therapy were high. A number of lessons are presented in order to take forward a future definitive pragmatic randomized trial.

Management of concomitant coronary artery disease in patients undergoing transcatheter aortic valve implantation: the United Kingdom TAVI Registry.

BACKGROUND: The management and impact of concomitant coronary artery disease in patients referred for TAVI remains contentious. We describe the prevalence, clinical impact and management of coronary artery disease (CAD) in patients in the United Kingdom TAVI Registry. METHODS: All-inclusive study of patients undergoing TAVI in the United Kingdom (excluding Northern Ireland) from January 2007 to December 2011. Coronary artery disease at the time of TAVI was demonstrated on invasive angiography. RESULTS: 2588 consecutive patients were entered in the U.K. TAVI Registry. CAD was reported in 1171 pts with left main stem involvement in 12.4% of this cohort (n=145). Most patients were free of chest pain, but limited by dyspnoea (NYHA Class III & IV 81.9%). Angina was however more prevalent in those patients with CAD (p<0.0001). Hybrid PCI was uncommon, performed in only 14.7% of the CAD cohort (n=172). Survival at 30days, 1year, and 4years was 93.7%, 81.4% and 72.0% respectively. Adjusting for confounders in a multivariate model the presence and extent of CAD was not associated with early (30-days, p=0.36) or late (4years, p=0.10) survival. CONCLUSIONS: This contemporary study of coronary artery disease management in an "all-comers" patient population undergoing TAVI demonstrates that whilst often an indicator of significant underlying comorbidity coronary artery disease is not associated with decreased short or long-term survival. The majority of patients with aortic stenosis and concomitant CAD can be managed effectively by TAVI alone. However, the importance of the Heart Team in making decisions on individual patients must not be underestimated.

Device-dependent association between paravalvar aortic regurgitation and outcome after TAVI.

OBJECTIVE: The aim of the current study was to identify predictors of paraprosthetic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) and examine its influence on short/medium-term mortality using the UK TAVI Registry. TAVI is an effective treatment for high-risk patients with severe symptomatic aortic stenosis (AS), but paraprosthetic AR has been associated with increased in-hospital and mid-term mortality. METHODS: Between January 2007 and December 2011, 2584 TAVI procedures were performed in the UK. Patients undergoing 'valve-in-valve' procedures, patients with aortic regurgitation as the primary pathology and with no recorded severity of AR were excluded from this analysis (n=144). In total, therefore, 2440 patients were included. Balloon-expandable and self-expanding devices were implanted in 52.7 and 47.2%, respectively, using either transfemoral (67.7%) or non-transfemoral, surgical access (32.3%). RESULTS: Postprocedural AR was observed in 68%, mild AR in 57% and moderate-severe in 10%. A large aortic annulus, high preprocedural transaortic gradient, and use of self-expanding valve were independent predictors of moderate-severe AR. Moderate-severe (but not mild) AR was associated with increased mortality, and this relationship appeared significant for the balloon-expandable but not the self-expanding device. CONCLUSIONS: Our data suggest that a large aortic annulus, high preprocedural transaortic gradient, and use of the self-expanding valve predict moderate-severe AR after TAVI. Such a degree of AR is associated with a significantly worse outcome with the balloon-expandable, but not with the self-expanding valve. Further studies are needed to verify this and explore potential mechanisms.