Abstract Background In the Complete Revascularization with Multivessel PCI for Myocardial Infarction (COMPLETE) trial, patients with ST-segment-elevation myocardial infarction (MI) who underwent staged revascularization of non-culprit coronary stenoses experienced fewer major adverse cardiovascular events than those who underwent a culprit-only approach (1). Inclusion was, however, based on angiographic and not physiological criteria. Purpose To analyse, using computational modelling, the physiological significance of non-culprit lesions included in the COMPLETE trial, to compare these against angiographic measures of severity, and investigate interactions between physiology and the benefits of complete revascularization. Methods Angiograms with appropriate digital imaging and communications in medicine (DICOM) data from the COMPLETE trial (n=1327) underwent software-based 3-dimensional (3D) arterial reconstruction and analysis of 3D-quantitative coronary angiography (QCA) and virtual fractional flow reserve (vFFR) using computational fluid dynamics software. Physiological lesion significance was defined as vFFR ≤0.80 and was compared with operators’ visual angiographic analysis, core-laboratory 2D-QCA and 3D-QCA. Results vFFR was computed successfully in 635 patients (710 lesions). The median vFFR was 0.82 (interquartile range 0.73–0.91). 302 patients (48%) had at least one physiologically significant lesion and 333 (52%) had none. 321 (45%) lesions were physiologically significant and 389 (55%) were not. Physiologically significant lesions were angiographically more severe than non-significant lesions according to the operator’s visual angiographic assessment (mean stenosis 80% vs. 75%, P<0.0001), 2D-QCA (69% vs. 59%, p<0.0001), and 3D-QCA (56% vs. 43, P<0.0001). Percentage lesion stenosis was significantly different when measured visually, with 2D-QCA and with 3D-QCA (80% vs 62% vs 49%, P<0.0001). vFFR was weakly correlated with operators’ visual angiographic severity (Figure 1) and 2D-QCA, but more strongly with 3D-QCA (r=-0.21, -0.21, and -0.60, respectively; all p<0.0001). 3D-QCA predicted vFFR significance more accurately than visual and 2D-QCA (concordance 73% vs 49% vs 59%, respectively). There was no statistically significant interaction between physiological lesion significance and any of the trial coprimary or key secondary clinical outcomes, or on an exploratory outcome of ischaemia-driven revascularization without preceding MI (all interactions P>0.30) (Figure 2). Conclusions In this virtual physiological substudy of the COMPLETE trial, 52% of patients lacked any physiologically-significant lesions, 3D-QCA was a better predictor of physiological significance than either 2D-QCA or operator visual analysis, and the benefits of complete revascularization appeared to be independent of physiological lesion significance. Further research is warranted to compare angiography-guided and physiology-guided complete revascularization strategies.Figure 1.Figure 2.

Introduction: The impact of frailty on outcomes in a contemporary ST-segment-elevation myocardial infarction (STEMI) population is unclear. This study hypothesized that frail STEMI patients undergoing primary percutaneous coronary intervention (pPCI) have worse in-hospital and 1-year outcomes compared to non-frail STEMI patients. Methods: We retrospectively identified 600 STEMI patients who had received pPCI (2013 - 2016). A frailty index (FI) was determined using the health deficit accumulation model (Table 1). Frail patients were defined as those with a FI > 0.25. The composite outcome comprised in-hospital heart failure, cardiogenic shock, re-infarction, major bleeding, stroke and all-cause mortality. A multivariable model adjusting for age and sex was performed. Results: Among 600 STEMI patients receiving pPCI, 67 (11.2%) were classified as frail. Compared to non-frail patients, frail patients were older (mean 80.3 vs. 75.8 years, p < 0.001) and had a higher comorbidity burden. After adjustment, baseline frailty was independently associated with delayed reperfusion time, in-hospital all-cause mortality, and higher incidence of the composite outcome (Figure 1). Frailty was also associated with increased 1-year all-cause mortality and cardiovascular rehospitalization. Conclusions: Among STEMI patients receiving pPCI, 1 in 10 were frail. Frailty was associated with increased rate of the primary in-hospital composite adverse outcome, delayed reperfusion time and worse long-term outcomes. Efforts to routinely identify frail STEMI patients and to implement best practices to reduce the risk of adverse events in this vulnerable population are warranted.

BACKGROUND:In ST-segment elevation myocardial infarction (STEMI), complete revascularization with percutaneous coronary intervention (PCI) reduces major cardiovascular events compared with culprit-lesion-only PCI. Whether age influences these results remains unknown. METHODS:COMPLETE was a multinational, randomized trial evaluating a strategy of staged complete revascularization, consisting of angiography-guided PCI of all suitable nonculprit lesions, versus a strategy of culprit-lesion-only PCI. In this prespecified subgroup analysis, treatment effect according to age (≥65 years vs <65 years) was determined for the first coprimary outcome of cardiovascular (CV) death or new myocardial infarction (MI) and the second coprimary outcome of CV death, new MI, or ischemia-driven revascularization (IDR). Median follow-up was 35.8 months (interquartile range [IQR]: 27.6-44.3 months). RESULTS:Of 4,041 patients randomized in COMPLETE, 1,613 were aged ≥ 65 years (39.9%). Higher event rates were observed for both coprimary outcomes in patients aged ≥ 65 years comparted with those aged < 65 years (11.2% vs 7.9%, HR 1.49, 95% CI 1.22-1.83; 14.4% vs 11.8%, HR 1.28, 95% CI 1.07-1.52, respectively). Complete revascularization reduced the first coprimary outcome in patients ≥ 65 years (9.7% vs 12.5%, HR 0.77; 95% CI, 0.58-1.04) and < 65 years (6.7% vs 9.1%, HR 0.72; 95% CI, 0.54-0.96)(interaction P = .74). The second coprimary outcome was reduced in those ≥ 65 years (HR 0.56, 95% CI, 0.43-0.74) and < 65 years (HR 0.48, 95% CI, 0.37-0.61 (interaction P = .37). A sensitivity analysis was performed with consistent results demonstrated using a 75-year threshold (albeit attenuated). CONCLUSIONS:In patients with STEMI and multivessel CAD, complete revascularization compared with culprit-lesion-only PCI reduced major cardiovascular events regardless of patient age and could be considered as a revascularization strategy in older adults.

Abstract Background/Introduction Previously validated risk scores for identifying low-risk patients after ST-segment elevation myocardial infarction (STEMI) have led to acceptance of the safety and feasibility of discharge after 48–72 hours of hospitalization, reducing hospital length of stay and costs. With ongoing improvements in outcomes, it may be possible to select patients who are safe to discharge very early (24–48 hours) but this has never been evaluated. Purpose We sought to develop and validate a novel risk score for identifying low-risk patients suitable for very early discharge (≤48 hours of hospitalization) post-STEMI. Methods We derived a novel risk score using data from patients enrolled in the Trial of Routine Aspiration Thrombectomy with PCI versus PCI alone in Patients with STEMI (TOTAL). The TOTAL database was randomly divided into a derivation cohort with 2/3 of the composite events and non-events and remaining 1/3 as the internal validation cohort. Using the derivation cohort, we identified risk factors for cardiovascular death (CV) or non-fatal cardiac arrest by performing a univariate and multivariable stepwise regression analysis of baseline clinical and angiographic characteristics. Each co-variate was assigned an integer score based on regression coefficients and the novel TOTAL risk score was developed by adding points from each risk factor profile. We externally validated the TOTAL score using data from the Radial versus Femoral Access for Coronary Intervention (RIVAL) trial. Results The TOTAL derivation cohort included 6331 participants with 287 events (CV death/cardiac arrest). Twelve independent risk-factors associated with risk of CV death and non-fatal cardiac arrest at 1 year were selected and weighted for the TOTAL risk score (Table 1). In the TOTAL validation cohort (n=3166), patients with a TOTAL score of 0–4 points (n=779 (24.6%)) were categorized as very low risk with only a 0.1% risk of CV death/cardiac arrest observed within 24 hours of hospitalization, and no further events observed between 24 hours and 30 days post-STEMI. In the RIVAL validation dataset (n=1451), patients with a TOTAL score of 0–4 points (n=737 (50.7%)) had a 0.3% risk of CV death/cardiac arrest within 24 hours, with no further events observed between 24 hours and 72 hours of hospitalization. Conclusion The TOTAL risk score identified a very low risk subset of patients for whom early discharge, 24–48 hours post-STEMI, is likely safe. These findings have the potential to change practice and support early discharge after STEMI. Funding Acknowledgement Type of funding sources: None.

LV dysfunction is common after STEMI, and is associated with worse outcomes. The EPHESUS trial demonstrated that use of a mineralocorticoid receptor antagonist (MRA) compared with placebo reduced mortality when started within 3-14 days (particularly when started within 7 days) after hospitalization for acute MI with LV dysfunction and either clinical HF or diabetes. Current guidelines therefore recommend their use in this setting. Among patients included in the Vancouver Coastal Health Authority (VCHA) STEMI database, we previously showed that only 22% of STEMI patients with LV dysfunction eligible for an MRA were prescribed one at discharge. Clinicians caring for these patients during the index admission may favour delaying MRA initiation until after titration of other LV-enhancing therapies, such as ACE inhibitors and beta-blockers. The primary objective of this follow-up study was to determine the proportion of MRA-eligible STEMI patients prescribed an MRA in the subsequent 3 months after discharge. The secondary objective was to identify patient characteristics associated with post-discharge MRA prescription among MRA-eligible patients.

Major bleeding is an independent predictor of mortality, reinfarction, and stroke among ST-elevation myocardial infarction (STEMI) patients receiving primary percutaneous coronary intervention (pPCI). Limited data exists on the association of major bleeding post-PCI and other significant in-hospital outcomes. Furthermore, bleeding avoidance strategies (BAS) such as radial access and bivalirudin are associated with reductions in major bleeding but the impact on the reduction of other in-hospital adverse events has not been reported. We identified 1494 STEMI patients who underwent primary pPCI within the Vancouver Coastal Health Authority (2012-2018) of whom 121 (8.1%) had major bleeding. Access site bleeding occurred in 2.0% whereas non-access site bleeding occurred in 6.1%. Between-group differences in (unadjusted) in-hospital clinical outcomes including cardiac arrest, reinfarction, stroke, cardiogenic shock, heart failure, and mortality were assessed. Spearman correlation and multivariate logistic regression were used to evaluate the relationship of major bleeding with in-hospital outcomes. Compared with no major bleeding, patients experiencing major bleeding were more likely to be female, older, have atrial fibrillation, chronic kidney disease, anemia, heart failure, prehospital cardiac arrest or cardiogenic shock at baseline. Major bleeding was associated with higher rates of in-hospital death (20.7% vs. 4.4%; P < 0.001), stroke or intracranial hemorrhage (10.8% vs 1.1%; P < 0.001), cardiogenic shock (38.3 vs 6.3%; P < 0.001), heart failure (40.8% vs. 12.0%; P < 0.001), or cardiac arrest post-PCI (20.0 vs 3.5%; P < 0.001). Major bleeding was also associated with a significantly longer hospital stay (median 7.8. vs 3.0 days; P < 0.001). Major bleeding was independently associated with death (OR 3.15; 95% CI 1.59-6.25), cardiogenic shock (OR 8.10; 95% CI 4.46-14.72), heart failure (OR 3.43; 95% CI 2.09-5.63), and in-hospital cardiac arrest post-PCI (OR 4.19; 95% CI 2.21-7.94). The use of any BAS (radial access, bivalirudin, vascular closure device) was associated with a reduction in major bleeding (OR 0.49; 95% CI 0.32-0.74) and mortality (OR 0.20; 95% CI 0.13 to 0.32) but after adjustment did not reduce major bleeding (OR 0.68; 95% CI 0.43-1.07) or mortality (OR 0.63; 95% CI 0.33-1.20). In a contemporary STEMI cohort receiving pPCI, major bleeding was predominately caused by non-access site bleeding and was independently associated with in-hospital mortality, cardiogenic shock, heart failure, and cardiac arrest post-PCI. After adjustment, BAS were not associated with a reduction in major bleeding nor in-hospital mortality, likely due to low rates of access-site bleeding. Additional study of strategies to reduce the incidence or impact of non-access site bleeding appears warranted.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

In patients undergoing transcatheter aortic valve replacement (TAVR), a “minimalist” approach has been advocated with a focus on simplification of both procedural steps and patient care [(1,2)][1]. A strategy of minimal procedural sedation with avoidance of general anesthesia is usually

Abstract Background In patients with severe calcific aortic stenosis, transcatheter aortic valve replacement (TAVR) has been shown to significantly improve quality of life (QOL). However, changes in QOL at early follow-up (<1 month), and following next-day discharge are poorly understood. Methods A total of 411 patients at 13 centers were enrolled in the Multimodality, Multidisciplinary but Minimalist TAVR (3M TAVR) study in 2015–2017. QOL was evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) in participants with a baseline score and at least one score at 2 weeks, 30 days and 1 year. Study endpoints were change in (1) KCCQ-Overall Summary Score (KCCQ-OS) and (2) minimal clinically important differences (MCID). Mixed effects models were used to explore patterns of change from baseline, with fixed terms for time, status at 1-year and their interaction terms, and a random intercept for subject to account for within subject correlation. Descriptive statistics were used to report MCID. Results Data were available for 358 (87.1%) participants. 216 (60.3%) were men with a median age 84.0 and STS 5.0 There was significant increase in QOL 2 weeks after TAVR (p≤0.01), and further significant improvement at the 1-month timepoint (p<0.01) for participants who were alive at 1 year. Sex, age category, and STS score category did not have a significant effect on the change in QOL (p>0.05). In the first 2 weeks, moderate (10–20 points) and large (>20 points) improvements were observed in 19.9% and 49.0% of the surviving patients, respectively; at 1-year, similar MCID were seen in 14.6% and 64.0% respectively. Figure 1 Conclusion This is the first study to report significant increase in QOL 2 weeks after TAVR, with sustained improvement during the first year in patients treated with the Vancouver TAVR Clinical Pathway with a goal of next-day discharge. Further studies are necessary to determine whether alternative TAVR clinical pathways yield similar findings. Acknowledgement/Funding Investigator-initiated unrestricted research grant, Edwards

LV dysfunction (defined as LVEF ≤40%) is present in approximately 25% of patients post-MI and is associated with increased mortality. The EPHESUS trial demonstrated that, compared to placebo, mineralocorticoid receptor antagonist (MRA) therapy reduced mortality when started within 3-14 days (particularly when started within 7 days) after hospital admission for acute MI in patients with LV dysfunction and either clinical HF or diabetes, leading guidelines to recommend their use in these patients. However, there is substantial practice variability and under-use of MRA therapy, with data from the United States suggesting that only 14% of MRA-eligible MI patients are prescribed these agents at discharge. We analyzed a large, population-based Canadian STEMI database to evaluate rates of MRA prescription at discharge among MRA-eligible STEMI patients, and to identify clinical predictors of MRA prescription. Using data from the prospective, population-based Vancouver Coastal Health Authority (VCHA) STEMI database, we identified adults admitted for STEMI and discharged from hospital alive between June 26, 2007 and March 31, 2018 who were revascularized using primary PCI or fibrinolysis. We excluded patients with out-of-hospital cardiac arrest or missing data on LVEF, diabetes or discharge prescriptions. The primary outcome was the proportion of MRA-eligible STEMI patients (LVEF ≤40% plus: clinical HF on presentation or in hospital, or diabetes) who were prescribed an MRA at discharge. A pre-specified list of candidate predictors of MRA prescription at discharge was evaluated in multivariable logistic regression: Age, sex, anterior MI, hospital length-of-stay, LVEF, presentation to a PCI-capable hospital, ACE inhibitor/ARB within 24 hours of presentation. P-values < 0.05 were considered statistically significant. Of 2691 STEMI patients, 318 (11.8%) had LVEF ≤40% and were MRA-eligible. Among MRA-eligible STEMI patients, median age was 67.4 years, 21.4% were female, and 21.7% presented with an anterior MI. Further, mean LVEF was 32.6% (standard deviation ±6.6%), 47.8% had diabetes, and 68.9% had clinical HF (18.6% on presentation, 65.1% in hospital). Of MRA-eligible patients, 70 (22%) were prescribed an MRA at discharge. In the pre-specified multivariable analysis, only LVEF was significantly associated with MRA prescription at discharge (Table). In contemporary practice, MRAs are not prescribed at discharge in most eligible STEMI patients, despite high-quality evidence demonstrating that early use reduces mortality. Furthermore, aside from lower LVEF, MRA prescription was not associated with any clinical predictors, suggesting unexplained variability in clinical practice. Quality and process improvement strategies should be implemented to target this gap in STEMI care.

BACKGROUND:In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion reduces the risk of cardiovascular death or myocardial infarction. Whether PCI of nonculprit lesions further reduces the risk of such events is unclear. METHODS:We randomly assigned patients with STEMI and multivessel coronary artery disease who had undergone successful culprit-lesion PCI to a strategy of either complete revascularization with PCI of angiographically significant nonculprit lesions or no further revascularization. Randomization was stratified according to the intended timing of nonculprit-lesion PCI (either during or after the index hospitalization). The first coprimary outcome was the composite of cardiovascular death or myocardial infarction; the second coprimary outcome was the composite of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. RESULTS:At a median follow-up of 3 years, the first coprimary outcome had occurred in 158 of the 2016 patients (7.8%) in the complete-revascularization group as compared with 213 of the 2025 patients (10.5%) in the culprit-lesion-only PCI group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60 to 0.91; P = 0.004). The second coprimary outcome had occurred in 179 patients (8.9%) in the complete-revascularization group as compared with 339 patients (16.7%) in the culprit-lesion-only PCI group (hazard ratio, 0.51; 95% CI, 0.43 to 0.61; P<0.001). For both coprimary outcomes, the benefit of complete revascularization was consistently observed regardless of the intended timing of nonculprit-lesion PCI (P = 0.62 and P = 0.27 for interaction for the first and second coprimary outcomes, respectively). CONCLUSIONS:Among patients with STEMI and multivessel coronary artery disease, complete revascularization was superior to culprit-lesion-only PCI in reducing the risk of cardiovascular death or myocardial infarction, as well as the risk of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. (Funded by the Canadian Institutes of Health Research and others; COMPLETE ClinicalTrials.gov number, NCT01740479.).

The importance of grade of ischemia (GI) classification in the risk assessment of patients with ST-elevation myocardial infarction has been shown previously. Grade 3 ischemia (G3I) is defined by the Sclarovsky-Birnbaum grading system as ECG with ST-elevation and distortion of the terminal portion of the QRS complex in two or more adjacent leads, while grade 2 ischemia (G2I) is defined as ECG with ST-elevation without QRS distortion. In a substudy of the international, multicenter, prospective, randomized Trial of Routine Aspiration Thrombectomy with PCI versus PCI Alone in Patients with STEMI (TOTAL), we studied the prognostic impact of the grade of ischemia classification on the outcome in patients with STEMI (n=7,211). The primary outcome was a composite of death from cardiovascular causes, recurrent MI, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within one year. The primary outcome occurred in 153 of 1,563 patients (9.8%) in the G3I group vs. 364 of 5,648 patients (6.4%) in the G2I group (hazard ratio [HR], 1.55; 95% confidence interval [CI], 1.29 to 1.88; p<0.001). The rates of cardiovascular death (4.8% with G3I vs. 2.5% with G2I; HR, 1.92; 95% CI, 1.45 to 2.54; p<0.001) and all-cause mortality (5.2% with G3I vs. 3.3% with G2I; HR, 1.62; 95% CI, 1.25 to 2.10; p<0.001) were also higher in patients with G3I. The rate of stroke or TIA were similar within the two groups (1.1% with G3I vs. 1.0% with G2I; HR, 1.13; 95% CI, 0.66 to 1.95; p=0.650). The grade of ischemia (G3I vs G2I) was shown to be an independent predictor of primary outcome in adjusted multivariable analysis (adjusted HR, 1.43; 95% CI, 1.18 to 1.74; p<0.001). STEMI patients with G3I in the presenting ECG proved to have an increased rate of cardiovascular death, recurrent MI, cardiogenic shock, or NYHA class IV heart failure within one year compared to patients with G2I. Competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital, The unit of Heart Center Co. [Z60064]

The Vancouver Coastal Health Authority (VCHA) STEMI Program was created to integrate all aspects of STEMI care in a large geographically complex urban centre, including optimization of in-field diagnosis, interhospital patient transportation and delivery of reperfusion therapy. The program evolved over 3 implementation phases: (Phase 1 [P1]: 2007 - regionalization of STEMI orders; Phase 2 [P2]: 2008 - implementation of prehospital ECGs; Phase 3 [P3]: 2011 – optimization of interfacility transfers from urban community hospitals to increase primary PCI (PPCI) availability. We report on the impact of our program on reperfusion times and clinical outcomes for all STEMI patients treated over 11 years. We analyzed 3794 STEMI patients treated with either PPCI, fibrinolysis or no reperfusion (NR) between June 2007 and March 2018. 63% of patients were treated in PCI-capable centres (PCI-C). Implementation of interfacility transfer (T-PPCI) in P3 resulted in an increased proportion of PPCI-treated patients compared to P1/2, with a corresponding decrease in the proportion of patients treated with either fibrinolysis or NR (Figure 1a). Regional median first medical contact to device time (FMC-DT) for PPCI treated patients was 103min (95min and 126min for patients presenting to PCI-Cs and non-PCI-Cs, respectively). A greater proportion of patients met guideline-recommended reperfusion times for PPCI in P3 compared to P1/2 (45.9% vs 40.5%, p=0.009) (Figure 1b). Overall 11-year regional mortality was 9.2%; overall reperfusion-specific mortality was 5.7%, 3.6% and 31.3% amongst patients treated with PPCI, fibrinolysis and NR respectively. After implementation of T-PPCI in P3 there was no change in mortality amongst patients treated with PPCI (P3 5.7% vs P1/2, 5.8%, p=0.91) nor fibrinolysis (P3 3.0% vs P1/2 4.2%, p=0.63), possibly because of increasing co-morbidities in STEMI patients over time. There was a significant mortality increase amongst patients receiving NR (41.7% vs 22.2%, p=0.0003). A greater proportion of patients receiving NR were treated at PCI-Cs in P3 compared to P21/2 (67% vs 45.6%, p=0.0002). A regional approach to STEMI care resulted in a greater proportion of patients treated with PPCI, with a higher proportion meeting guideline recommended FMC-DT following the implementation of T-PPCI. T-PPCI did not result in a reduction in overall regional mortality nor mortality amongst PPCI-treated patients. Although the proportion of patients receiving NR decreased over time, they had a significant increase in mortality, with a higher proportion of them being treated at PCI-Cs. STEMI patients receiving NR remain an important subgroup of patients impacting regional STEMI clinical outcomes.

Clinical trainees—are you looking to incorporate and balance research into your practice? Undecided which path is recommended for early career researchers who strive to become successful investigators? Should we stay away from industry-sponsored research? We, the editors of the Trainee Section of the Canadian Journal of Cardiology, have asked for advice from Dr John Cairns, a late career cardiologist. We hope you will find it useful! Dr John A. Cairns is an experienced clinical cardiologist with a focus on invasive cardiology and broad, well funded research interests (in infarct size measurement and modification in dogs and humans, clinical trials of antithrombotic therapies for acute coronary syndromes and atrial fibrillation, and clinical trials of antiarrhythmic therapies). Dr Cairns has held a number of leadership roles, including coordinator of the Regional Cardiovascular Program and then Chair of Medicine at McMaster University, Dean of Medicine at the University of British Columbia, and President of the Canadian Academy of Health Sciences. Dr John A. Cairns is an experienced clinical cardiologist with a focus on invasive cardiology and broad, well funded research interests (in infarct size measurement and modification in dogs and humans, clinical trials of antithrombotic therapies for acute coronary syndromes and atrial fibrillation, and clinical trials of antiarrhythmic therapies). Dr Cairns has held a number of leadership roles, including coordinator of the Regional Cardiovascular Program and then Chair of Medicine at McMaster University, Dean of Medicine at the University of British Columbia, and President of the Canadian Academy of Health Sciences.

Abstract Background High rates of ICD lead mechanical failures (insulation abrasion and conductor fracture) resulted in FDA recalls and substantial design modifications. Most subsequent reports of lead failures of newer generation leads are based upon modest-sized, retrospective cohorts with relatively brief follow-up and may be unreliable. Following lead modifications (including silicone-polyurethane copolymer insulation coating), in 2007, one manufacturer established 3 prospective registries, and engaged a university-based methods center to independently review the registries, to adjudicate all reports of lead failures and to independently analyze lead survival. Up to 11 years of follow-up is now available. Purpose To adjudicate all reports of leads inactivated because of possible mechanical failure and to independently calculate rates of mechanical failure overall and by specific type. Methods Manufacturer expert staff confirm each lead inactivation by site interrogation. Following formal algorithms which incorporate lead testing and remote monitoring, they designate all-cause mechanical failure (fracture; insulation abrasion; failure at crimp, bond or weld; or uncertain) based upon the finding of electrical noise, very low or very high or rapidly rising impedance or alternatively they designate non-mechanical dysfunction (e.g. no impedance criteria but elevated thresholds, over or under sensing). The results of returned product analyses are incorporated when available (31%). The methods center receives electronic data transfers twice yearly, reviews all documentation, adjudicates all instances of possible lead failure, assigns probable cause (by 2 electrophysiologists) and conducts independent analyses of lead survival. Results 10,866 patients (73% male, mean age 65.9 yr., LVEF 29.3%, NYHA class II or III 89%) with 11,132 leads had follow-up of 4.6 yr. (median) and 11 yr. (maximum) (Aug 31, 2018). Lead follow-up was censored at the time of lead inactivation, death/transplant or administrative withdrawal. Of leads enrolled, there were 26.6% still in follow-up and of those not the status was 7.4% inactivated, 29.5% death or transplant, 33.8% administrative withdrawal and 3.7% reason missing. Following adjudication, there were 156 all-cause mechanical failures (1.40% total, 0.29%/yr.). Rates of cause-specific mechanical failures were: fracture 1.02% total, 0.22%/yr.; insulation abrasion 0.28% total, 0.06%/yr.; miscellaneous/uncertain 0.12% total, 0.02%/yr.; and externalized conductors 0%. Life-table rates of freedom from lead failure by 11 years were: all-cause mechanical failure 95.9%, conductor fracture 97.0%, insulation abrasion 99.1%, mechanical failure other/uncertain type 99.9%, and externalized conductors 100%. Conclusions Up to 11 yr prospective follow-up of silicone-polyurethane-coated ICD leads with independent adjudication and analyses of events shows low rates of all-cause mechanical failure and no externalized conductors. Acknowledgement/Funding Abbott

From 2007 to 2016, the Vancouver Coastal Health Authority implemented several care processes resulting in reduced reperfusion times for patients with ST-elevation myocardial infarction (STEMI). However, these reductions were not accompanied by a parallel improvement in clinical outcomes, including mortality, similar to what has been described in other North American case series. We hypothesized that this may at least be partially attributable to an increased co-morbidity burden in the population. To describe the burden of patient co-morbidities in the VCH STEMI database from 2007-2016, and determine their association with adverse in-hospital outcomes. We conducted a retrospective review of 1931 patients receiving primary percutaneous coronary intervention (pPCI) for acute STEMI between June 2007 and March 2016 across three phases (June 2007-May 2008: regionalization with standardized protocols; May 2008-May 2011: addition of pre-hospital ECGs and in-field re-direction to PCI-capable centres; May 2011-March 2016: addition of a single-call transfer protocol for non-PCI capable centres). We analyzed the specific co-morbidity frequency over the three phases of refinement of the regional model, as well as the association of individual co-morbidities with adverse in-hospital outcomes. Compared to Phase 1 (n=114), patients in Phase 3 (n=1203) were more likely to be hypertensive: (phase 1 [43.0%], phase 3 [55.1%], p=0.02), diabetic: (phase 1 [9.3%], phase 3 [21.5%], p=0.029), with a trend towards an increase in cerebrovascular disease (Figure). There was a trend towards an increased number of co-morbidities between Phases 1 (mean 2.2) and 3 (mean 2.4, p=0.2). In-hospital mortality was significantly increased with age over 65 (9.8 vs 2.9%, p<0.001), female sex (8.3 vs. 7.3%, p=0.047), hypertension (7.9 vs. 3.9%, p<0.001), diabetes (8.8 vs. 5.3%, p=0.011), previous heart failure (25.5 vs. 5.4%, p<0.001), and prior TIA/CVA (14.7 vs. 5.3%, p<0.001). In general, the greater the baseline co-morbidity burden, the more likely patients were to develop CHF, cardiogenic shock, a rise in creatinine, a reduction in ejection fraction, and to have increased in-hospital mortality. Among patients in our regional STEMI network who received pPCI, there was a trend toward increased co-morbidity burden over time, which was associated with worse in-hospital outcomes. The increased rate of co-morbidity burden among STEMI patients over time may partially explain the lack of improvement in clinical outcomes despite improved reperfusion times in regional models of STEMI care.