Acute kidney injury after radial or femoral artery access in ST-segment elevation myocardial infarction: AKI-SAFARI.

BACKGROUND: Acute kidney injury (AKI) complicating primary percutaneous coronary intervention (PCI) is an independent predictor of short- and long-term outcomes in patients presenting with ST-elevation myocardial infarction (STEMI). Prior studies suggest a lower incidence of AKI in patients undergoing PCI through radial artery compared to femoral artery access; however, no randomized clinical trials have specifically investigated this question in patients presenting with STEMI. METHODS: To determine whether radial access (RA) is associated with a reduced frequency of AKI following primary PCI, we performed a substudy of the SAFARI-STEMI trial. The SAFARI-STEMI trial was an open-label, multicenter trial, which randomized patients presenting with STEMI to RA or femoral access (FA), between July 2011 and December 2018. The primary outcome of this post hoc analysis was the incidence of AKI, defined as an absolute (>0.5 mg/dL) or relative (>25%) increase in serum creatinine from baseline. RESULTS: In total 2,285 (99.3%) of the patients enrolled in SAFARI-STEMI were included in the analysis-1,132 RA and 1,153 FA. AKI occurred in 243 (21.5%) RA patients and 226 (19.6%) FA patients (RR: 0.91, 95% CI: 0.78-1.07, P = .27). An absolute increase in serum creatinine >0.5 mg/dL was seen in 49 (4.3%) radial and 52 (4.5%) femoral patients (RR: 1.04, 95% CI: 0.71-1.53, P = .83). AKI was lower in both groups when the KDIGO definition was applied (RA 11.9% vs FA 10.8%; RR: 0.90, 95% CI: 0.72-1.13, P = .38). CONCLUSIONS: Among STEMI patients enrolled in the SAFARI-STEMI trial, there was no association between catheterization access site and AKI, irrespective of the definition applied. These results challenge the independent association between catheterization access site and AKI noted in prior investigations.

Inequity in Access to Transcatheter Aortic Valve Replacement: A Pan-Canadian Evaluation of Wait-Times.

BACKGROUND: There has been an exponential increase in the demand for transcatheter aortic valve replacement (TAVR). Our goal was to examine trends in TAVR capacity and wait-times across Canada. METHODS: All TAVR cases were identified from April 1, 2014, to March 31, 2017. Wait-time was defined as the duration in days from the initial referral to the TAVR procedure. TAVR capacity was defined as the number of TAVR procedures per million population/province/fiscal year. We performed multivariable multilevel Cox proportional hazards modelling of the time to TAVR as the dependant variable and the effect of provinces as random effects. We quantified the variation in wait-times among provinces using the median hazard ratio. RESULTS: We identified a total of 4906 TAVR procedures across 9 provinces. Despite a year over year increase in overall capacity, there was a greater than 3-fold difference in capacity between provinces. Crude median wait-times increased over time in all provinces, with marked variation from 71.5 days in Newfoundland to 190.5 and 203 days in Manitoba and Alberta, respectively. This suggests increasing demand outpaced the growth in capacity. We found a median hazard ratio of 1.62, indicating that in half of the possible pairwise comparisons, the time to TAVR for identical patients was at least 62% longer between different provinces. CONCLUSION: We found substantial geographic inequity in TAVR access. This calls for policy makers, clinicians, and administrators across Canada to address this inequity through revaluation of provincial funding mechanisms, as well as implementation of efficient care pathways.

Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial.

Importance: Among patients with ST-segment elevation myocardial infarction (STEMI) referred for primary percutaneous coronary intervention (PCI), a survival benefit associated with radial access compared with femoral access remains controversial. Objective: To assess whether there is a survival benefit when radial access is used instead of femoral access among patients with STEMI referred for primary PCI. Design, Setting, and Participants: This multicenter, open-label, randomized clinical trial was conducted at 5 PCI centers in Canada. In total, 2292 patients with STEMI referred for primary PCI were enrolled between July 2011 and December 2018, with a 30-day follow-up. The primary analyses were conducted based on the intention-to-treat population. Interventions: Patients were randomized to radial access (n = 1136) or to femoral access (n = 1156) for PCI. Main Outcomes and Measures: Initially, the primary outcome was bleeding, but this outcome was modified to 30-day all-cause mortality following the recommendation of the granting agency. Secondary outcomes included recurrent myocardial infarction, stroke, and Thrombolysis in Myocardial Infarction-defined major or minor bleeding. Results: Among the 2292 patients enrolled, the mean (SD) age of the patients randomized to radial access was 61.6 (12.3) years and to femoral access was 62.0 (12.1) years, with 883 male patients in the radial access and 901 male patients in the femoral access group. The trial was stopped early following a futility analysis. Primary PCI was performed in 1082 of 1136 patients (95.2%) in the radial access group and 1109 of 1156 patients (95.9%) in the femoral access group. Bivalirudin was administered to 1001 patients (88.1%) in the radial access group and to 1068 patients (92.4%) in the femoral access group, whereas glycoprotein IIb/IIIa inhibitors were administered in only 69 patients (6.1%) in the radial access group and 68 patients (5.9%) in the femoral access group. A vascular closure device was used in 789 patients (68.3%) in the femoral group. The primary outcome, 30-day all-cause mortality, occurred in 17 patients (1.5%) assigned to radial access and in 15 patients (1.3%) assigned to femoral access (relative risk [RR], 1.15; 95% CI, 0.58-2.30; P = .69). There were no significant differences between patients assigned to radial and femoral access in the rates of reinfarction (1.8% vs 1.6%; RR, 1.07; 95% CI, 0.57-2.00; P = .83), stroke (1.0% vs 0.4%; RR, 2.24; 95% CI, 0.78-6.42; P = .12), and bleeding (1.4% vs 2.0%; RR, 0.71; 95% CI, 0.38-1.33; P = .28). Conclusions and Relevance: No significant differences were found for survival or other clinical end points at 30 days after the use of radial access vs femoral access in patients with STEMI referred for primary PCI. However, small absolute differences in end points cannot be definitively refuted given the premature termination of the trial. Trial Registration: ClinicalTrials.gov identifier: NCT01398254.

Regional differences in aortic valve replacements: Atlantic Canadian experience.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is evolving rapidly and is increasingly being adopted in the treatment of aortic valve disease. The goal of this study was to examine regional differences in surgical aortic valve replacement (SAVR) and TAVI across Atlantic Canada. METHODS: We identified all patients who underwent SAVR or TAVI between Jan. 1, 2010, and Dec. 31, 2014, in New Brunswick, Nova Scotia and Newfoundland and Labrador. Data obtained included patient demographic characteristics and surgical procedure details. We performed univariate descriptive analyses and calculated crude and age- and sex-adjusted incidence rates. RESULTS: A total of 3042 patients underwent SAVR or TAVI during the study period, 1491 in Nova Scotia, 1042 in New Brunswick and 509 in Newfoundland and Labrador. Patient demographic characteristics were similar across regions. A much higher proportion of patients in Newfoundland and Labrador (43.6%) than in Nova Scotia (4.2%) or New Brunswick (13.6%) received a mechanical versus a bioprosthetic valve. Rates of TAVI increased over the study period, with New Brunswick adopting their program before Nova Scotia (144 v. 74 procedures). Adjusted rates of all AVR procedures remained stable in Nova Scotia (40-50 per 100 000 people). Adjusted rates were lower in New Brunswick and Newfoundland and Labrador than in Nova Scotia; they increased slowly in New Brunswick over the study period. CONCLUSION: Despite geographical proximity and similar patient demographic characteristics, there existed regional differences in the management of aortic valve disease within Atlantic Canada. Further study is required to determine whether the observed differences in age- and sex-adjusted rates of AVR may be explained by geographical disease-related differences, varying practice patterns or barriers in access to care.

CONTEXTE: Le remplacement valvulaire aortique par cathéter, une méthode en pleine évolution, est de plus en plus utilisé pour le traitement des valvulopathies aortiques. Cette étude visait à examiner les différences régionales quant au remplacement valvulaire aortique par cathéter ou par chirurgie dans les provinces de l'Atlantique. MÉTHODES: Nous avons recensé tous les patients ayant subi un remplacement valvulaire aortique entre le 1er janvier 2010 et le 31 décembre 2014 au Nouveau-Brunswick, en Nouvelle-Écosse et à Terre-Neuve-et-Labrador. Nous avons recueilli des données sur les caractéristiques démographiques des patients et les interventions chirurgicales, puis nous avons réalisé une analyse descriptive univariée et avons calculé les taux d'incidence bruts et corrigés selon l'âge et le sexe. RÉSULTATS: En tout, 3042 patients ont subi un remplacement valvulaire aortique par cathéter ou par chirurgie pendant la période à l'étude : 1491 en Nouvelle-Écosse, 1042 au Nouveau-Brunswick et 509 à Terre-Neuve-et-Labrador. Les caractéristiques démographiques des patients étaient semblables d'une région à l'autre. La proportion des patients recevant une prothèse mécanique plutôt qu'une bioprothèse était beaucoup plus élevée à Terre-Neuve-et-Labrador (43,6 %) qu'en Nouvelle-Écosse (4,2 %) ou au Nouveau-Brunswick (13,6 %). Les taux de remplacement par cathéter ont augmenté au cours de la période à l'étude; le Nouveau-Brunswick a adopté un programme à ce sujet avant la Nouvelle-Écosse (144 c. 74 interventions). Les taux corrigés pour tous les remplacements étaient stables en Nouvelle-Écosse (40-50 par 100 000 habitants); ils étaient plus faibles au Nouveau-Brunswick et à Terre-Neuve-et-Labrador, mais ont augmenté lentement au Nouveau-Brunswick pendant la période à l'étude. CONCLUSION: Malgré la proximité géographique des provinces de l'Atlantique et les caractéristiques démographiques semblables des patients, il existait des différences dans la prise en charge des valvulopathies aortiques. D'autres études seront nécessaires pour déterminer si les variations dans les taux de remplacement corrigés selon l'âge et le sexe pourraient s'expliquer par des différences géographiques dans le nombre de cas, des différences dans les pratiques ou des obstacles à l'accès aux soins.

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.