Complete revascularization in stable multivessel coronary artery disease: A real world analysis from the British Columbia Cardiac Registry.

BACKGROUND: More than half of patients undergoing percutaneous coronary intervention (PCI) have multivessel disease (MVD). The prognostic significance of PCI in stable patients has recently been debated, but little data exists about the potential benefit of complete revascularization (CR) in stable MVD. We investigated the prognostic benefit of CR in patients undergoing PCI for stable disease. METHODS: We compared CR versus incomplete revascularization (IR) in 8,436 patients with MVD. The primary outcome was all-cause mortality at 5 years. RESULTS: A total of 1,399 patients (17%) underwent CR during the index PCI procedure for stable disease. CR was associated with lower mortality (6.2 vs. 10.7%, p < .001) and lower repeat revascularization at 5 years (12.7 vs. 18.4%, p < .001). Multivariable-adjusted analyses indicated that CR was associated with lower mortality (HR = 0.73, 95% CI: 0.58-0.91, p = .005) and repeat revascularization at 5 years (HR = 0.78, 95% CI: 0.66-0.93, p = .005). These findings were also confirmed in propensity-matched cohorts. Subgroup analyses indicated that CR conferred survival in older patients, male patients, absence of renal disease, greater angina (CCS Class III-IV) and heart failure (NYHA Class III-IV) symptoms, and greater burden of coronary disease. In sensitivity analyses where patients with subsequent repeat revascularization events were excluded, CR remained a strong predictor for lower mortality (HR = 0.69, 95% CI: 0.54-0.89, p = .004). CONCLUSIONS: In this study of stable patients with MVD, CR was an independent predictor of long-term survival. This benefit was specifically seen in higher risk patient groups and indicates that CR may benefit selected stable patients with MVD.

The Impact of Pre-Procedural Renal Impairment on Outcomes Following Percutaneous Coronary Intervention: An Analysis of 45,287 Patients From the British Columbia Cardiac Registry.

BACKGROUND: Renal disease confers a strong independent risk for morbidity and mortality after percutaneous coronary intervention (PCI). We evaluated the relationship between baseline pre-procedural renal function and outcomes following PCI. METHODS: We examined 45,287 patients who underwent PCI in British Columbia. We evaluated all-cause mortality and target vessel revascularisation (TVR) at 2 years. Pre-procedural renal impairment was categorised by creatinine clearance (CrCl, mL/min): CrCl≥90 (n=14,876), 90>CrCl≥60 (n=10,219), 60>CrCl≥30 (n=14,876), 30>CrCl≥0 (n=2,594) and dialysis (n=579). RESULTS: Declining CrCl values less than 60 mL/min were progressively associated with greater mortality: 60>eGFR≥30 (HR=2.01, 95% CI 1.71-2.37, p<0.001); 30>eGFR≥0 (HR=4.10, 95% CI 3.39-4.95, p<0.001); and dialysis (HR=6.22, 95% CI 5.07-7.63, p<0.001). A reduction in eGFR was not associated with TVR in non-dialysis patients. However, dialysis was a strong independent predictor for TVR (HR=1.69, 95% CI 1.37-2.08, p<0.001). This was confirmed in propensity-matched analyses where, dialysis was strongly associated with TVR (HR=1.53, 95% CI 1.24-1.89, p<0.001). This association was consistently seen in stratified analyses for diabetic versus non-diabetic patients; stent length >30 mm versus <30 mm; stent diameter >3 mm versus <3 mm; and receipt of bare metal stents versus drug-eluting stents. CONCLUSIONS: This study indicates the association with declining renal function and mortality in patients undergoing PCI. Whilst renal disease was not associated with increased TVR in non-dialysis patients, dialysis-dependence was a strong independent predictor for increased TVR.

Upstream anticoagulation for patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: Insights from the TOTAL trial.

OBJECTIVES: To assess the relationship between preprocedural anticoagulation use and clinical and angiographic outcomes. BACKGROUND: For patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the optimal timing of anticoagulant administration remains uncertain. METHODS: Patients enrolled in the TOTAL trial were stratified based on whether or not they had received any parenteral anticoagulant prior to randomization and PCI. Baseline and procedural characteristics were compared. For one-year clinical outcomes, Cox proportional modeling adjusted on a propensity score was used to analyze differences between groups. Angiographic endpoints were analyzed by logistic regression models adjusted for propensity scores. RESULTS: In the trial, 10,064 patients were enrolled and underwent PCI. Preprocedural anticoagulation was used in 6,381 patients (63%).The most common anticoagulant was intravenous unfractionated heparin (5,188, 81%). Patients who received preprocedural anticoagulation had higher rates of TIMI-2-3 or TIMI-3 flow and lower grades of thrombus prior to PCI. Pretreatment with anticoagulation was associated with lower use of bailout thrombectomy, GP IIb/IIIa inhibitors, and intra-aortic balloon pump. After adjustment, preprocedural anticoagulation was associated with lower rates of CABG and minor bleeding at 1 year but there were no significant differences in death, stroke, recurrent MI, cardiogenic shock, or congestive heart failure. CONCLUSIONS: Preprocedural anticoagulation is associated with improved flow and reduced thrombus in the IRA prior to PCI, less bailout thrombectomy during PCI but no difference in death, recurrent infarction, or heart failure at 1 year.

The prognostic impact of revascularization strategy in acute myocardial infarction and cardiogenic shock: Insights from the British Columbia Cardiac Registry.

BACKGROUND: In patients with acute myocardial infarction (AMI) and cardiogenic shock (CS), percutaneous coronary intervention (PCI) of the culprit vessel is associated with improved outcomes. A large majority of these patients have multivessel disease (MVD). Whether or not PCI of non-culprit disease in the acute setting improves outcomes continues to be debated. We evaluated the prognostic impact of revascularization strategy for patients presenting with AMI and CS. METHODS: We compared culprit vessel intervention (CVI) versus multivessel intervention in 649 patients with AMI, CS, and MVD enrolled in the British Columbia Cardiac Registry. We evaluated mortality at 30 days and 1 year. RESULTS: CVI was associated with lower mortality at 30 days (23.7% vs. 34.5%, P = 0.004) and 1 year (32.6% vs. 44.3%, P = 0.003). CVI was an independent predictor for survival at 30 days (HR = 0.63, 95% CI: 0.45-0.88, P = 0.009) and 1 year (HR = 0.72, 95% CI: 0.54-0.96, P = 0.027). These findings were confirmed in propensity-matched cohorts. Subgroup analyses indicated that CVI was associated with lower mortality in patients aged <80 years; non-diabetics; and those presenting with ST-elevation MI. When analyzing non-culprit anatomy, PCI of non-culprit LAD disease was associated with higher 1-year mortality (HR = 1.51, 95% CI: 1.13-2.01, P = 0.006), primarily with non-culprit proximal LAD disease (HR = 1.82, 95% CI: 1.20-2.76, P = 0.005). However, PCI of non-culprit non-proximal LAD, LCx, and RCA disease was not associated with mortality. CONCLUSIONS: In patients with AMI and CS, a strategy of CVI appears to be associated with lower mortality. These findings are consistent with recently published randomized-controlled trial data.

Variation in practice and concordance with guideline criteria for length of stay after elective percutaneous coronary intervention.

BACKGROUND: Considerable variability remains as regards the appropriate and safe length of stay after elective PCI. We performed a survey of interventional cardiologists to identify current views on appropriate and safe length of stay after PCI. METHODS: We created an online survey using the commercially available SurveyMonkey application. This was sent to interventional cardiologists in the US, Canada and the UK with the assistance of the national interventional cardiology societies (SCAI, CAIC/CCS, BCIS/BCS) as well as being made available on the theheart.org website. RESULTS: 505 interventional cardiologists responded, of which 237 were practicing in the US. Of those from the US, 52% were not aware of any guidelines for length of stay and 48% reported that their unit did not have a standard practice for length of stay. Same-day discharge after PCI was practiced as routine by 14% of cardiologists in the US versus 32% of cardiologists from Canada (P = 0.003) and 57% (P < 0.0001) from the UK. Amongst respondents, there was significant variation between respondents and divergence from published SCAI guidelines regarding appropriate length of stay for patient specific and procedural related clinical factors. CONCLUSIONS: There is considerable variation in practice patterns regarding length of stay after PCI. Whilst most cardiologists practice overnight observation, a significant minority utilize same-day discharge. There is also lack of familiarity with published guidelines. This variation and knowledge gap confirms an urgent need for updated guidelines and a concerted effort to educate cardiologists on appropriate post-PCI length of stay. © 2017 Wiley Periodicals, Inc.

Embolic protection device use and its association with procedural safety and long-term outcomes following saphenous vein graft intervention: An analysis from the British Columbia Cardiac registry.

BACKGROUND: Embolic protection devices (EPDs) have been designed and introduced to reduce distal embolization and peri-procedural myocardial infarction during saphenous vein graft (SVG) intervention. Current guidelines give a class I recommendation to EPD use during SVG intervention when technically feasible. However, the routine use of these devices has recently been debated. METHODS: We analyzed 1,359 patients undergoing isolated SVG intervention between 2008 and 2013 in the British Columbia Cardiac Registry. We analyzed (a) post-procedural TIMI flow; and (b) target vessel revascularization (TVR) and mortality at 1 and 2 years. RESULTS: EPD use was an independent predictor of post-procedural TIMI 2/3 flow (OR = 2.38, 95% CI: 1.51-3.74, P < 0.001). At 1 year, EPD use was an independent predictor for lower TVR (HR = 0.35, 95% CI: 0.14-0.85, P = 0.021) and a trend towards lower mortality (HR = 0.45, 95% CI: 0.18-1.10, P = 0.082). These associations were lost at 2 years where EPD use was not predictive of mortality (HR = 0.62, 95% CI: 0.33-1.17, P = 0.144) or TVR (HR = 0.70, 95% CI: 0.41-1.17, P = 0.176). These findings were confirmed in propensity-matched and inverse probability treatment weighted analyses. CONCLUSIONS: In this analysis of patients undergoing SVG intervention, EPD use was a strong predictor for improved post-procedural TIMI flow. Whilst EPD use was associated with lower TVR and a trend for lower mortality at 1 year, these associations were lost at 2 years. These findings would appear to support the use of EPD for SVG intervention. © 2015 Wiley Periodicals, Inc.

Radial artery pseudoaneurysms after transradial cardiac catheterisation.

BACKGROUND: Although uncommon, radial artery access site complications are likely to become more frequent with the increased adoption of transradial cardiac catheterisation. There is a lack of data regarding the incidence and clinical features of radial artery pseudoaneuryms. We aimed to describe the incidence, clinical features and management of radial artery pseudoaneurysms in a high-volume transradial cardiac catheterisation centre. PATIENTS AND METHODS: We performed a search of the Vancouver Island Health Authority medical imaging database from 1st Jan 2008 to April 2012 looking for all radial and femoral artery pseudoaneuryms occurring after cardiac catheterisation. Hospital charts were reviewed to determine patient and procedural characteristics as well as management and outcome. RESULTS: There were a total of 14,968 coronary procedures performed over the four year search period, of which 13,216 (88%) were trans-radial. The incidence of radial artery pseudoaneurysm after cardiac catheterisation was 0.08%, and did not differ between transradial diagnostic angiography and PCI (0.07% vs 0.08%; P = 0.90). In contrast, the incidence of femoral artery pseudoaneurysm was higher, at 1.4% (P < 0.0001). Patients with radial pseudoaneurysms were generally elderly, with a median age of 77 years, and there were no gender differences. Only one patient had received a glycoprotein IIb/IIIa inhibitor, whilst two received warfarin post-procedure. The majority of cases (80%) were treated with surgical repair. CONCLUSIONS: We have demonstrated that radial artery pseudoaneuryms are a rare but important complication of transradial cardiac catheterisation, with patients generally requiring surgical repair. Most patients were elderly, but surprisingly only a minority were anti-coagulated with warfarin.

VEGF gene therapy fails to improve perfusion of ischemic myocardium in patients with advanced coronary disease: results of the NORTHERN trial.

Despite the promise of proangiogenic gene therapy most clinical trials have failed to show benefit for the primary end point analysis. The NOGA angiogenesis Revascularization Therapy: assessment by RadioNuclide imaging (NORTHERN) trial was a double-blind, placebo-controlled study of intramyocardial vascular endothelial growth factor (VEGF165) gene therapy versus placebo, involving seven sites across Canada, designed to overcome major limitations of previous proangiogenic gene therapy trials. A total of 93 patients with refractory Canadian Cardiovascular Society (CCS) class 3 or 4 anginal symptoms were randomized to receive 2,000 microg of VEGF plasmid DNA or placebo (buffered saline) delivered via the endocardial route using an electroanatomical NOGA guidance catheter. There was no difference between the VEGF-treated and the placebo groups in the primary end point of change in myocardial perfusion from baseline to 3 or 6 months, assessed by single photon emission tomography (SPECT) imaging, although a significant reduction in the ischemic area was seen in both groups. Also, similar improvements in exercise treadmill time and anginal symptoms were seen in the VEGF and the placebo groups at 3 and 6 months, although again there were no differences between these groups. Despite the intramyocardial administration of a high "dose" of plasmid DNA using a percutaneous guidance catheter system, there was no benefit of VEGF gene therapy at 3 or 6 months for any of the end points studied.

Timing of Staged Nonculprit Artery Revascularization in Patients With ST-Segment Elevation Myocardial Infarction: COMPLETE Trial.

BACKGROUND: The COMPLETE (Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI) trial demonstrated that staged nonculprit lesion percutaneous coronary intervention (PCI) reduced major cardiovascular (CV) events in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD). OBJECTIVES: The purpose of this study was to determine the effect of nonculprit-lesion PCI timing on major CV outcomes and also the time course of the benefit of complete revascularization. METHODS: Following culprit-lesion PCI, 4,041 patients with STEMI and multivessel CAD were randomized to staged nonculprit-lesion PCI or culprit-lesion only PCI. Randomization was stratified according to investigator-planned timing of nonculprit-lesion PCI: during or after the index hospitalization. The first coprimary outcome was the composite of CV death or myocardial infarction (MI). In pre-specified analyses, hazard ratios (HRs) were calculated for each time stratum. Landmark analyses of the entire population were performed within 45 days and after 45 days. RESULTS: For nonculprit-lesion PCI planned during the index hospitalization (actual time: median 1 day), CV death or MI was reduced with complete revascularization compared with culprit-lesion only PCI (HR: 0.77; 95% confidence interval [CI]: 0.59 to 1.00). For nonculprit lesion PCI planned to occur after hospital discharge (actual time: median 23 days), CV death or MI was also reduced with complete revascularization (HR: 0.69; 95% CI: 0.49 to 0.97; interaction p = 0.62). Landmark analyses demonstrated an HR of 0.86 (95% CI: 0.59 to 1.24) during the first 45 days and 0.69 (95% CI: 0.54 to 0.89) from 45 days to the end of follow-up for intended nonculprit lesion PCI versus culprit lesion only PCI. CONCLUSIONS: Among STEMI patients with multivessel disease, the benefit of complete revascularization over culprit-lesion only PCI was consistent irrespective of the investigator-determined timing of nonculprit-lesion intervention. The benefit of complete revascularization on hard clinical outcomes emerged mainly over the long term.

Coronary Angiography and Revascularization Following Coronary Artery Bypass Grafting in British Columbia: Incidence, Predictors and Longer-term Outcomes.

BACKGROUND: Coronary artery bypass grafting (CABG) is established treatment for subsets of coronary artery disease (CAD). Observational data have characterised significant progression of native coronary as well as graft vessel disease during longer-term follow-up, potentially reducing the benefit of CABG. We sought to assess longer-term outcomes following CABG by determining rates of repeat coronary angiography, revascularization procedures, and survival. METHODS: Data for all patients undergoing isolated CABG in British Columbia between 2001 and 2009 inclusive, and with follow-up until the end of 2013, were retrieved from the British Columbia Cardiac Registry. Cox proportional hazard regression and competing risk regression were performed for survival and subsequent cardiac procedures (coronary angiography, percutaneous coronary intervention [PCI] or repeat CABG). RESULTS: Data were available from 17,316 patients with a mean age at index CABG of 65.7 ± 9.8 years. At a median follow-up of 8.5 (range 4.0 to 12.9) years, 3185 patients (18.4%) had died, 3135 (18.1%) underwent repeat coronary angiography with or without PCI or repeat CABG, and 11,557 (66.7%) had survived without additional procedures. Of those who underwent angiography, 1459 patients (46.5%) underwent further revascularization. In multivariate analysis, the strongest predictors of long-term mortality were dialysis dependency and age >75, whereas left internal mammary artery utilization and aspirin therapy were protective. Repeat revascularization predicted survival (adjusted hazard ratio 0.76; 95% confidence interval, 0.63-0.92; P = 0.004), whereas angiography alone did not. CONCLUSIONS: Following CABG, patients frequently undergo repeat coronary angiography. Although only a minority of patients receive further revascularization, this appears to be associated with longer-term survival.

Implications of Transcatheter Heart Valve Selection on Early and Late Pacemaker Rate and on Length of Stay.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) can cause injury to the atrioventricular conduction system. We evaluated the effect of transcatheter heart valve (THV) type on the rate of new pacemaker implantation and length of hospital stay. METHODS: Patients across all hospitals performing transfemoral TAVR in the province of British Columbia between 2012 and 2016 participated in a mandated registry with linkages to provincial health databases. We evaluated 1141 patients undergoing successful transfemoral TAVR for native aortic valve stenosis with 5 commonly used valves. RESULTS: Valves implanted were balloon-expandable (BEV) (n = 728), self-expandable (SEV) (n = 341), and mechanically-expandable (MEV) (n = 72). Baseline clinical characteristics were similar between groups: mean age 82.5 years with multiple comorbidities. The mean Society of Thoracic Surgeons predicted risk of mortality was 6.0%. Indwelling temporary pacemakers after TAVR varied by THV type: (BEV) 4.0%, (SEV) 69.3%, and (MEV) 63.0% (P < 0.002). The need for a new permanent pacemaker varied by THV type: (BEV) 6.6%, (SEV) 24.0%, and (MEV) 32.8% at 30 days (P < 0.001). At 1 year, permanent pacemaker rates continued to rise, and remained divergent: (BEV) 8.9%, (SEV) 26.9%, and (MEV) 35.9% (P < 0.001). Median length of stay varied according to THV type: (BEV) 1, (SEV) 3, and (MEV) 4 days (P < 0.001 across groups). Crude mortality rates were not statistically different by THV type, either at 30 days (BEV 3.0%, SEV 2.9%, and MEV 0.0%; P = 0.33), or at 1 year (BEV 10.3%, SEV 15.0%, and MEV 8.3%; P = 0.11). CONCLUSIONS: The choice of a THV device was associated with significant differences in the need for post-TAVR temporary pacemakers, hospital length of stay, and both early and late pacemaker implantation rates. These differences may have an impact on patient morbidity and resource utilization.

Culprit Vessel Versus Multivessel Versus In-Hospital Staged Intervention for Patients With ST-Segment Elevation Myocardial Infarction and Multivessel Disease: Stratified Analyses in High-Risk Patient Groups and Anatomic Subsets of Nonculprit Disease.

OBJECTIVES: This study evaluated revascularization strategies for patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. BACKGROUND: In patients with STEMI and multivessel disease, it is unclear whether multivessel intervention (MVI), culprit vessel intervention (CVI) only (CVI-O) or CVI with staged revascularization (CVI-S) is associated with improved outcomes. Whether MVI at primary percutaneous coronary intervention may benefit specific patient groups is unclear. METHODS: We compared revascularization strategies (MVI, CVI-O, and CVI-S) in 6,503 patients with STEMI and multivessel disease enrolled in the British Columbia Cardiac Registry (2008 to 2014). We evaluated all-cause mortality and repeat revascularization at 2 years. RESULTS: Compared with MVI, CVI-O (hazard ratio [HR]: 0.78; 95% confidence interval [CI]: 0.64 to 0.97; p = 0.023) and CVI-S (HR: 0.55; 95% CI: 0.36 to 0.82; p = 0.004) were associated with lower mortality. Comparing CVI-O with CVI-S, CVI-S was associated with lower mortality (HR: 0.65; 95% CI: 0.47 to 0.91; p = 0.013). Compared with MVI, CVI-O was associated with increased repeat revascularization (HR: 1.25; 95% CI: 1.02 to 1.54; p = 0.036). Comparing CVI-O versus CVI-S, CVI-S was associated with lower repeat revascularization (HR: 0.64; 95% CI: 0.46 to 0.90; p = 0.012). CVI was associated with lower mortality in the presence of nonculprit left circumflex artery disease (HR: 0.63; 95% CI: 0.45 to 0.89; p = 0.011) and right coronary artery disease (HR: 0.66; 95% CI: 0.44 to 0.99; p = 0.050), but not nonculprit left anterior descending artery disease (HR: 0.83; 95% CI: 0.54 to 1.28; p = 0.399). CONCLUSIONS: In patients with STEMI undergoing primary percutaneous coronary intervention, a strategy of CVI-S seems to be associated with lower mortality and repeat revascularization rates. However, MVI may be considered in selected patients and in the setting of nonculprit left anterior descending artery disease. These findings warrant prospective evaluation in large adequately powered randomized controlled trials.

Structural Heart Disease Intervention: The Canadian Landscape.

Cardiovascular disease encompasses coronary artery disease and valvular heart disease, and the prevalence of both increases with age. Over the past decade, the landscape of interventional cardiology has evolved to encompass a new set of percutaneous procedures outside the coronary tree, including transcatheter aortic valve implantation, transcatheter mitral valve repair, and left atrial appendage occlusion. These interventions have sparked a new discipline within interventional cardiology referred to as structural heart disease (SHD) intervention. The access to and numbers of such procedures performed in Canada is currently unknown. This "first of its kind" survey of structural interventions provides insight into the landscape of SHD intervention in Canada and the challenges faced by cardiologists to deliver this important care.

Intra-Aortic Balloon Pump Counterpulsation during Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction and Cardiogenic Shock: Insights from the British Columbia Cardiac Registry.

BACKGROUND: Cardiogenic shock complicating ST-elevation myocardial infarction (STEMI) is associated with significant morbidity and mortality. In the primary percutaneous coronary intervention (PPCI) era, randomized trials have not shown a survival benefit with intra-aortic balloon pump (IABP) therapy. This differs to observational data which show a detrimental effect, potentially reflecting bias and confounding. Without robust and valid risk adjustment, findings from non-randomized studies may remain biased. METHODS: We compared long-term mortality following IABP therapy in patients with cardiogenic shock undergoing PPCI during 2008-2013 from the British Columbia Cardiac Registry. We addressed measured and unmeasured confounding using propensity score and instrumental variable methods. RESULTS: A total of 12,105 patients with STEMI were treated with PPCI during the study period. Of these, 700 patients (5.8%) had cardiogenic shock. Of the patients with cardiogenic shock, 255 patients (36%) received IABP therapy. Multivariable analyses identified IABP therapy to be associated with increased mortality up to 3 years (HR = 1.67, 95% CI:1.20-2.67, p<0.001). This association was lost in propensity-matched analyses (HR = 1.23, 95% CI: 0.84-1.80, p = 0.288). When addressing measured and unmeasured confounders, instrumental variable analyses demonstrated that IABP therapy was not associated with mortality at 3 years (Δ = 16.7%, 95% CI: -12.7%, 46.1%, p = 0.281). Subgroup analyses demonstrated IABP was associated with increased mortality in non-diabetics; patients not undergoing multivessel intervention; patients without renal disease and patients not having received prior thrombolysis. CONCLUSIONS: In this observational analysis of patients with STEMI and cardiogenic shock, when adjusting for confounding, IABP therapy had a neutral effect with no association with long-term mortality. These findings differ to previously reported observational studies, but are in keeping with randomized trial data.

Prognostic Significance of Polymer Coatings in Zotarolimus-Eluting Stents.

Polymer coatings on drug-eluting stents (DES) serve as a vehicle for delivery of antirestenotic drugs. Whether they influence outcomes for contemporary DES is unknown. The evolution of polymer coatings for zotarolimus-eluting stents (ZES) provides a natural experiment that facilitates such analysis. The Resolute ZES (R-ZES) uses the same antirestenotic drug as the Endeavor ZES (E-ZES) but has a more biocompatible polymer with enhanced drug release kinetics. However, there are limited data on the real-world comparative efficacy of R-ZES and the preceding E-ZES. Thus, we analyzed 17,643 patients who received either E-ZES or R-ZES from 2008 to 2014 from the British Columbia Cardiac Registry. A total of 9,869 patients (56%) received E-ZES and 7,774 patients (44%) received R-ZES. Compared with E-ZES, R-ZES was associated with lower 2-year mortality (4.1% vs 6.4%, p <0.001) and 2-year target vessel revascularization (TVR; 6.8% vs 10.7%, p <0.001). R-ZES use was an independent predictor of lower mortality rate and TVR. This was confirmed in propensity-matched analyses for 2-year mortality (hazard ratio [HR] 0.59, 95% CI 0.49 to 0.71, p <0.001) and 2-year TVR (HR 0.86, 95% CI 0.75 to 0.98, p = 0.032). Instrumental variable analyses demonstrated R-ZES to be associated with lower 2-year mortality (Δ = -2.2%, 95% CI -4.3% to -0.2%, p = 0.032) and 2-year TVR (Δ = -3.3% to 95% CI -6.1% to -0.7%, p = 0.015). Acknowledging the limitations of observational analyses, this study has shown that R-ZES was associated with lower long-term TVR and mortality. These data are reassuring for the newer R-ZES and demonstrate how polymer coatings may influence the clinical performance of DES with wider implications for future DES development and design.

Regional Systems of Care to Optimize Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to describe the development of a multicenter, transcatheter aortic valve replacement program and regional systems of care intended to optimize coordinated, efficient, and appropriate delivery of this new therapy. BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an accepted treatment option for patients with severe aortic stenosis who are at high surgical risk. Regional systems of care have led to improvements in outcomes for patients undergoing intervention for myocardial infarction, cardiac arrest, and stroke. We implemented a regional system of care for patients undergoing TAVR in British Columbia, Canada. METHODS: We describe a prospective observational cohort of 583 patients who underwent TAVR in British Columbia between 2012 and 2014. Regionalization of TAVR care in British Columbia refers to a centrally coordinated, funded, and evaluated program led by a medical director and a multidisciplinary advisory group that oversees planning, access to care, and quality of outcomes at the 4 provincial sites. Risk-stratified case selection for transfemoral TAVR is performed by heart teams at each site on the basis of consensus provincial indications. Referrals for lower volume and more complicated TAVR, including nontransfemoral access and valve-in-valve procedures, are concentrated at a single site. In-hospital and 30-day outcomes are reported. RESULTS: The median age was 83 years (interquartile range [IQR]: 78 to 87 years) and median STS score was 6% (IQR: 4% to 8%). Transfemoral access was performed in 499 (85.6%) cases and nontransfemoral in 84 (14.4%). Transcatheter valve-in-valve procedures in for failed bioprosthetic valves were performed in 43 patients (7.4%). A balloon-expandable valve was inserted in 386 (66.2%) and a self-expanding valve in 189 (32.4%). All-cause 30-day mortality was 3.5%. All-cause in-hospital mortality and disabling stroke occurred in 3.1% and 1.9%, respectively. Median length of stay was 3 days (IQR: 3 to 6 days), with 92.8% of patients discharged directly home. CONCLUSIONS: This experience demonstrates the potential benefits of a regional system of care for TAVR. Excellent outcomes were demonstrated: most patients had short in-hospital stays and were discharged directly home.