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Background Transcatheter aortic valve replacement (TAVR) computed tomography (CTA) images can be used to evaluate coronary artery disease (CAD). Methods We conducted a prospective cohort study of consecutive TAVR patients from November 2019 to February 2021 to evaluate TAVR CTA assessment of CAD on the rate of pre-TAVR invasive angiography. Patients had CTA first or invasive angiography first at the discretion of their treating physician. TAVR CTA scans were categorized as normal/mild CAD, single vessel disease, high risk (multi-vessel or left main disease), or non-diagnostic in patients without prior coronary artery bypass grafting (CABG) and as low risk or high risk in patients with prior CABG. Invasive angiography was recommended pre-TAVR for high risk or non-diagnostic CTA findings. Results TAVR was performed on 354 patients and CTA first was performed in 273 patients and invasive angiography first in 81 patients. Among 231 patients without prior CABG who had CTA first, 22.1% (51/231) had pre-TAVR invasive angiography and 1.3% (3/231) had pre-TAVR revascularization. Normal/mild CAD or single vessel disease was found on CTA in 174 patients of whom, 0.5% (1/174) had high risk disease on invasive angiography. Among 42 patients with prior CABG who had CTA first, 14.3% (6/42) had pre-TAVR invasive angiography and 2.4% (1/42) had pre-TAVR revascularization. Conclusion TAVR CTA CAD evaluation can avoid pre-TAVR invasive angiography in over 70 % of patients while rarely missing high-risk findings. A CTA first strategy to assess CAD should be considered, especially among patients where conservative management of CAD is preferred.

In patients with ST-segment elevation myocardial infarction (STEMI), early initiation of high-intensity statin therapy, regardless of low-density lipoprotein (LDL) cholesterol levels, is the standard of practice worldwide. Aims: We sought to determine the effect of a similar early initiation strategy, using a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor added to the high-intensity statin, on LDL cholesterol in acute STEMI.In a randomised, double-blind trial we assigned 68 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) to early treatment with alirocumab 150 mg subcutaneously or to a matching sham control. The first injection was given before primary PCI regardless of the baseline LDL level, then at 2 and 4 weeks. The primary outcome was the percent reduction in direct LDL cholesterol up to 6 weeks, analysed using a linear mixed model. Results: High-intensity statin use was 97% and 100% in the alirocumab and sham-control groups, respectively. At a median of 45 days, the primary outcome of LDL cholesterol decreased by 72.9% with alirocumab (2.97 mmol/L to 0.75 mmol/L) versus 48.1% with the sham control (2.87 mmol/L to 1.30 mmol/L), for a mean between-group difference of -22.3% (p0.001). More patients achieved the European Society of Cardiology/European Atherosclerosis Society dyslipidaemia guideline target of LDL ≤1.4 mmol/L in the alirocumab group (92.1% vs 56.7%; p0.001). Within the first 24 hours, LDL declined slightly more rapidly in the alirocumab group than in the sham-control group (-0.01 mmol/L/hour; p=0.03) with similar between-group mean values. Conclusions: In this randomised trial of routine early initiation of PCSK9 inhibitors in patients undergoing primary PCI for STEMI, alirocumab reduced LDL cholesterol by 22% compared with sham control on a background of high-intensity statin therapy. A large trial is needed to determine if this simplified approach followed by long-term therapy improves cardiovascular outcomes in patients with acute STEMI. (ClinicalTrials.gov: NCT03718286).

Background: The 3M-TAVR trial (3M-Transcatheter Aortic Valve Replacement) demonstrated the feasibility and safety of next-day hospital discharge after transfemoral TAVR with implementation of a minimalist pathway. However, the economic impact of this approach is unknown. Therefore, we evaluated costs for patients undergoing minimalist TAVR compared with conventional TAVR. Methods: We used propensity matching to compare resource utilization and costs (from a US health care system perspective) for patients in the 3M-TAVR trial with those for transfemoral TAVR patients enrolled in the contemporaneous S3i trial (PARTNER SAPIEN-3 Intermediate Risk). Procedural costs were estimated using measured resource utilization for both groups. For the S3i group, all other costs through 30-day follow-up were assessed by linkage with Medicare claims; for 3M, these costs were assessed using regression models derived from S3i cost and resource utilization data. Results: After 1:1 propensity matching, 351 pairs were included in our study (mean age 82, mean Society of Thoracic Surgery risk score 5.3%). There were no differences in death, stroke, or rehospitalization between the 3M-TAVR and S3i groups through 30-day follow-up. Index hospitalization costs were $10 843/patient lower in the 3M-TAVR cohort, driven by reductions in procedure duration, anesthesia costs, and length of stay. Between discharge and 30 days, costs were similar for the 2 groups such that cumulative 30-day costs were $11 305/patient lower in the 3M-TAVR cohort compared with the S3i cohort ($49 425 versus $60 729, 95% CI for difference $9378 to $13 138; P Conclusions: Compared with conventional transfemoral TAVR, use of a minimalist pathway in intermediate-risk patients was associated with similar clinical outcomes and substantial in-hospital cost savings, which were sustained through 30 days. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02287662.

In the COMPLETE (Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI) trial, angiography-guided percutaneous coronary intervention (PCI) of nonculprit lesions with the aim of complete revascularization reduced major cardiovascular (CV) events in patients with ST-segment elevation myocardial infarction (MI) and multivessel coronary artery disease.The purpose of this study was to determine the effect of nonculprit-lesion stenosis severity measured by quantitative coronary angiography (QCA) on the benefit of complete revascularization.Among 4,041 patients randomized in the COMPLETE trial, nonculprit lesion stenosis severity was measured using QCA in the angiographic core laboratory in 3,851 patients with 5,355 nonculprit lesions. In pre-specified analyses, the treatment effect in patients with QCA stenosis ≥60% versus 60% on the first coprimary outcome of CV death or new MI and the second co-primary outcome of CV death, new MI, or ischemia-driven revascularization was determined.The first coprimary outcome was reduced with complete revascularization in the 2,479 patients with QCA stenosis ≥60% (2.5%/year vs. 4.2%/year; hazard ratio [HR]: 0.61; 95% confidence interval [CI]: 0.47 to 0.79), but not in the 1,372 patients with QCA stenosis 60% (3.0%/year vs. 2.9%/year; HR: 1.04; 95% CI: 0.72 to 1.50; interaction p = 0.02). The second coprimary outcome was reduced in patients with QCA stenosis ≥60% (2.9%/year vs. 6.9%/year; HR: 0.43; 95% CI: 0.34 to 0.54) to a greater extent than patients with QCA stenosis 60% (3.3%/year vs. 5.2%/year; HR: 0.65; 95% CI: 0.47 to 0.89; interaction p = 0.04).Among patients with ST-segment elevation MI and multivessel coronary artery disease, complete revascularization reduced major CV outcomes to a greater extent in patients with stenosis severity of ≥60% compared with 60%, as determined by quantitative coronary angiography.

ImportanceA significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared with radial access. Strategies to make femoral access safer are needed.ObjectiveTo determine whether routinely using ultrasonography guidance for femoral arterial access for coronary angiography/intervention reduces bleeding or vascular complications.Design, Setting, and ParticipantsThe Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures (UNIVERSAL) randomized clinical trial is a multicenter, prospective, open-label trial of ultrasonography-guided femoral access vs no ultrasonography for coronary angiography or intervention with planned femoral access. Patients were randomized from June 26, 2018, to April 26, 2022. Patients with ST-elevation myocardial infarction were not eligible.InterventionsUltrasonography guidance vs no ultrasonography guidance for femoral arterial access on a background of fluoroscopic landmarking.Main Outcomes and MeasuresThe primary composite outcome is the composite of major bleeding based on the Bleeding Academic Research Consortium 2, 3, or 5 criteria or major vascular complications within 30 days.ResultsA total of 621 patients were randomized at 2 centers in Canada (mean [SD] age, 71 [10.24] years; 158 [25.4%] female). The primary outcome occurred in 40 of 311 patients (12.9%) in the ultrasonography group vs 50 of 310 patients (16.1%) without ultrasonography (odds ratio, 0.77 [95% CI, 0.49-1.20]; P = .25). The rates of Bleeding Academic Research Consortium 2, 3, or 5 bleeding were 10.0% (31 of 311) vs 10.7% (33 of 310) (odds ratio, 0.93 [95% CI, 0.55-1.56]; P = .78). The rates of major vascular complications were 6.4% (20 of 311) vs 9.4% (29 of 310) (odds ratio, 0.67 [95% CI, 0.37-1.20]; P = .18). Ultrasonography improved first-pass success (277 of 311 [86.6%] vs 222 of 310 [70.0%]; odds ratio, 2.76 [95% CI, 1.85-4.12]; P P P P = .34). All prerandomization prespecified subgroups were consistent with the overall finding.Conclusions and RelevanceIn this randomized clinical trial, use of ultrasonography for femoral access did not reduce bleeding or vascular complications. However, ultrasonography did reduce the risk of venipuncture and number of attempts. Larger trials may be required to demonstrate additional potential benefits of ultrasonography-guided access.Trial RegistrationClinicalTrials.gov Identifier: NCT03537118

Background: The COMPLETE trial (Complete Versus Culprit-Only Revascularization to Treat Multi-Vessel Disease After Early PCI for STEMI) demonstrated that staged nonculprit lesion percutaneous coronary intervention (PCI) reduced major cardiovascular events in patients with ST-segment–elevation myocardial infarction and multivessel coronary artery disease. It is unclear whether consistent benefit is observed in patients undergoing a pharmacoinvasive strategy compared with primary PCI. Methods: Following culprit lesion PCI, 4041 patients with ST-segment–elevation myocardial infarction and multivessel coronary artery disease were randomized to either routine nonculprit lesion PCI or culprit lesion only PCI. In a prespecified analysis, we determined the treatment effect in 303 patients undergoing a pharmacoinvasive strategy versus 3738 patients undergoing primary PCI on the first coprimary outcome of cardiovascular death or new myocardial infarction and the second coprimary outcome of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. Results: The first coprimary was reduced with complete revascularization both in the patients undergoing a pharmacoinvasive strategy (2.1%/y versus 4.7%/y, hazard ratio, 0.45 [95% CI, 0.21–0.97]) and in patients undergoing primary PCI (2.7%/y versus 3.6%/y, hazard ratio, 0.77 [95% CI, 0.62–0.95]; interaction P =0.18). The second coprimary outcome was reduced with complete revascularization in patients undergoing a pharmacoinvasive strategy (2.3%/y versus 8.5%/y, hazard ratio, 0.28 [95% CI, 0.14–0.56]), and in patients undergoing primary PCI (3.2%/y versus 6.0%/y, hazard ratio, 0.53 [95% CI, 0.44–0.64], interaction P =0.07). Conclusions: Among patients with ST-segment–elevation myocardial infarction and multivessel disease, complete revascularization with multivessel PCI consistently reduces major cardiovascular events in patients undergoing an initial pharmacoinvasive strategy as well as in those undergoing primary PCI. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01740479.

Objectives The authors sought to prospectively determine the safety and efficacy of next-day discharge using the Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway. Background Transfemoral transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high- and intermediate-risk patients; however, hospital stays average at least 6 days in most trials. The Vancouver 3M Clinical Pathway is focused on next-day discharge, made possible by the use of objective screening criteria as well as streamlined peri- and post-procedural management guidelines. Methods Patients were enrolled from 6 low-volume ( 200 TAVR/year) centers in Canada and the United States. The primary outcomes were a composite of all-cause death or stroke by 30 days and the proportion of patients successfully discharged home the day following TAVR. Results Of 1,400 screened patients, 411 were enrolled at 13 centers and received a SAPIEN XT (58.2%) or SAPIEN 3 (41.8%) valve (Edwards Lifesciences, Irvine, California). In centers enrolling exclusively in the study, 55% of screened patients were enrolled. The median age was 84 years (interquartile range: 78 to 87 years) with a median STS score of 4.9% (interquartile range: 3.3% to 6.8%). Next-day discharge home was achieved in 80.1% of patients, and within 48 h in 89.5%. The composite of all-cause mortality or stroke by 30 days occurred in 2.9% (95% confidence interval: 1.7% to 5.1%), with neither component of the primary outcome affected by hospital TAVR volume (p = 0.51). Secondary outcomes at 30 days included major vascular complication 2.4% (n = 10), readmission 9.2% (n = 36), cardiac readmission 5.7% (n = 22), new permanent pacemaker 5.7% (n = 23), and >mild paravalvular regurgitation 3.8% (n = 15). Conclusions Adherence to the Vancouver 3M Clinical Pathway at low-, medium-, and high-volume TAVR centers allows next-day discharge home with excellent safety and efficacy outcomes.

Background Patients with severe, symptomatic aortic stenosis derive substantial 30-day quality of life (QOL) benefit from transcatheter aortic valve replacement (TAVR). Whether the QOL benefit of TAVR emerges earlier is unknown. We used data from the Multimodality, Multidisciplinary but Minimalist (3M) TAVR study to assess early changes in QOL after transfemoral (TF) TAVR. Methods Health status was assessed at baseline, 2-weeks, 30-days, and 1-year after TAVR using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Medical Outcomes Study Short-Form 12 (SF-12). The KCCQ overall summary (KCCQ-OS) score (range 0–100; higher scores = better health) was the primary health status outcome. Linear mixed effects models were used to describe trajectories of QOL scores over time. A good outcome was defined as being “alive and well”, with a KCCQ-OS score ≥ 60 points with no decrease from baseline ≥10 points. Results A total of 358 patients (87.1%) completed the baseline and at least one follow-up survey. Between baseline and 2-weeks, the KCCQ-OS increased by 21.3 points (95% confidence interval [CI]: 19.3–23.2). This improvement was sustained over time with only slight further improvement between 2-weeks and 1-month (3.4 points; 95% CI: 1.4 to 5.5) and no significant change between 1-month and 1-year (1.9 points; 95% CI: −0.2 to 4.1). Scores for the KCCQ subscales and SF-12 physical and mental component summary scales showed a similar pattern. Most patients (74.4%) were “alive and well” at 2 weeks with similar rates at 1-month and 1-year (79.5% and 77.3%, respectively). Conclusions Among patients undergoing TF-TAVR, both disease-specific and generic health status improved substantially within the first 2 weeks, with only minimal further improvement thereafter.

Key Points Question Do treatments recommended by a heart team differ from those recommended by an original treating interventional cardiologist for patients with multivessel coronary artery disease? Findings In this cross-sectional study of 245 patients with multivessel coronary artery disease, heart team treatment recommendations indicated moderate agreement (with discordance in 30% of cases) with the original treating interventional cardiologist. Unanimous decisions within the heart team and agreement between the heart team interventional cardiologist and the original treating interventional cardiologist were less frequent in this subset of cases, while interventional cardiologist recommendations for angioplasty and medication therapy were more frequent. Meaning The study’s findings indicated that heart team recommendations differed from those of the original treating interventional cardiologist in approximately one-third of cases; this subset of cases was associated with a greater number of divergent opinions between interventional cardiologists and within the heart team., Importance Although the heart team approach is recommended in revascularization guidelines, the frequency with which heart team decisions differ from those of the original treating interventional cardiologist is unknown. Objective To examine the difference in decisions between the heart team and the original treating interventional cardiologist for the treatment of patients with multivessel coronary artery disease. Design, Setting, and Participants In this cross-sectional study, 245 consecutive patients with multivessel coronary artery disease were recruited from 1 high-volume tertiary care referral center (185 patients were enrolled through a screening process, and 60 patients were retrospectively enrolled from the center’s database). A total of 237 patients were included in the final virtual heart team analysis. Treatment decisions (which comprised coronary artery bypass grafting, percutaneous coronary intervention, and medication therapy) were made by the original treating interventional cardiologists between March 15, 2012, and October 20, 2014. These decisions were then compared with pooled-majority treatment decisions made by 8 blinded heart teams using structured online case presentations between October 1, 2017, and October 15, 2018. The randomized members of the heart teams comprised experts from 3 domains, with each team containing 1 noninvasive cardiologist, 1 interventional cardiologist, and 1 cardiovascular surgeon. Cases in which all 3 of the heart team members disagreed and cases in which procedural discordance occurred (eg, 2 members chose coronary artery bypass grafting and 1 member chose percutaneous coronary intervention) were discussed in a face-to-face heart team review in October 2018 to obtain pooled-majority decisions. Data were analyzed from May 6, 2019, to April 22, 2020. Main Outcomes and Measures The Cohen κ coefficient between the treatment recommendation from the heart team and the treatment recommendation from the original treating interventional cardiologist. Results Among 234 of 237 patients (98.7%) in the analysis for whom complete data were available, the mean (SD) age was 67.8 (10.9) years; 176 patients (75.2%) were male, and 191 patients (81.4%) had stenosis in 3 epicardial coronary vessels. A total of 71 differences (30.3%; 95% CI, 24.5%-36.7%) in treatment decisions between the heart team and the original treating interventional cardiologist occurred, with a Cohen κ of 0.478 (95% CI, 0.336-0.540; P = .006). The heart team decision was more frequently unanimous when it was concordant with the decision of the original treating interventional cardiologist (109 of 163 cases [66.9%]) compared with when it was discordant (28 of 71 cases [39.4%]; P, This cross-sectional study examines the differences in treatment decisions between a heart team and an original treating interventional cardiologist for patients with multivessel coronary artery disease.

Remote ambulatory cardiac monitoring (rACM) could identify high-grade atrioventricular block (AVB) before and after transcatheter aortic valve replacement (TAVR). Retrospective analysis of patients undergoing TAVR, with 14-day rACM before and after TAVR, was performed. Of 62 patients undergoing TAVR, 41 patients had rACM before TAVR. Three patients had asymptomatic AVB leading to planned pacemaker (PM) implant. After TAVR, 23 patients had rACM, with 1 patient requiring a PM implant for asymptomatic AVB. Five patients underwent unplanned PM after TAVR. Using rACM, almost half of PM implants in TAVR recipients were identified electively. High-grade AVB requiring PM was identified in nearly 10% of patients before TAVR. Résumé: La surveillance ambulatoire par télémétrie cardiaque pourrait permettre de détecter un bloc auriculoventriculaire (BAV) de haut grade avant et après le remplacement valvulaire aortique par cathéter (RVAC). Les données concernant des patients ayant subi un RVAC précédé ou suivi d’une période de surveillance ambulatoire de 14 jours ont été l’objet d’une analyse rétrospective. La surveillance ambulatoire a précédé le RVAC chez 41 patients sur 62 ayant subi l’intervention. Chez trois patients, un BAV asymptomatique a donné lieu à l’implantation planifiée d’un stimulateur cardiaque (SC). Le RVAC a été suivi d’une surveillance ambulatoire par télémétrie cardiaque chez 23 patients. La présence d’un BAV asymptomatique a nécessité l’implantation d’un SC chez un patient. L’implantation non planifiée d’un SC a été effectuée chez cinq patients après le RVAC. Grâce à la surveillance ambulatoire par télémétrie cardiaque, près de la moitié des cas nécessitant l’implantation d’un SC ont été dépistés accessoirement parmi les patients ayant subi un RVAC. Un BAV de haut grade nécessitant l’implantation d’un SC a été détecté chez près de 10 % des patients avant le RVAC.

The globe is currently in the midst of a COVID-19 pandemic, resulting in significant morbidity and mortality. This pandemic has placed considerable stress on health care resources and providers. This document from the Canadian Association of Interventional Cardiology- Association Canadienne de Cardiologie d'intervention, specifically addresses the implications for the care of patients in the cardiac catheterization laboratory (CCL) in Canada during the COVID-19 pandemic. The key principles of this document are to maintain essential interventional cardiovascular care while minimizing risks of COVID-19 to patients and staff and maintaining the overall health care resources. As the COVID-19 pandemic evolves, procedures will be increased or reduced based on the current level of restriction to health care services. Although some consistency across the country is desirable, provincial and regional considerations will influence how these recommendations are implemented. We believe the framework and recommendations in this document will provide crucial guidance for clinicians and policy makers on the management of coronary and structural procedures in the CCL as the COVID-19 pandemic escalates and eventually abates.

Background Routine thrombus aspiration in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) does not improve clinical outcomes. However, there is remaining uncertainty about the potential benefit in those patients with high thrombus burden, where there is a biological rationale for greater benefit. Objectives The purpose of this study was to evaluate the benefit of thrombus aspiration among STEMI patients with high thrombus burden. Methods TOTAL (ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI) was a randomized trial of routine manual thrombectomy versus PCI alone in patients with STEMI (n = 10,732). High thrombus burden (Thrombolysis In Myocardial Infarction thrombus grade ≥3) was a pre-specified subgroup. Results The primary outcome of cardiovascular (CV) death, MI, cardiogenic shock, or heart failure was not different at 1 year with thrombus aspiration in patients with high thrombus burden (8.1% vs. 8.3% thrombus aspiration; hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.84 to 1.13) or low thrombus burden (6.0% vs. 5.0% thrombus aspiration; HR: 1.22; 95% CI: 0.73 to 2.05; interaction p = 0.41). However, among patients with high thrombus burden, stroke at 30 days was more frequent with thrombus aspiration (31 [0.7%] thrombus aspiration vs. 16 [0.4%] PCI alone, HR: 1.90; 95% CI: 1.04 to 3.48). In the high thrombus burden group, thrombus aspiration did not significantly improve CV mortality at 30 days (HR: 0.78; 95% CI: 0.61 to 1.01; p = 0.06) and at 1 year (HR: 0.88; 95% CI: 0.72 to 1.09; p = 0.25). Irrespective of treatment assignment, high thrombus burden was an independent predictor of death (HR: 1.78; 95% CI: 1.05 to 3.01). Conclusions In patients with high thrombus burden, routine thrombus aspiration did not improve outcomes at 1 year and was associated with an increased rate of stroke. High thrombus burden is still an important predictor of outcome in STEMI. (A Trial of routine aspiration ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI [TOTAL]; NCT01149044)

In patients with a ST-segment elevation myocardial infarction (STEMI), the prevalence of chronic total occlusion (CTO) in a non–infarct-related artery (non-IRA) is 8% to 15% [(1)][1] with 2-fold greater morbidity and mortality than in those with single-vessel disease (SVD) [(2)][2]. The TOTAL (

The authors sought to prospectively determine the safety and efficacy of next-day discharge using the Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway.Transfemoral transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high- and intermediate-risk patients; however, hospital stays average at least 6 days in most trials. The Vancouver 3M Clinical Pathway is focused on next-day discharge, made possible by the use of objective screening criteria as well as streamlined peri- and post-procedural management guidelines.Patients were enrolled from 6 low-volume (100 TAVR/year), 4 medium-volume, and 3 high-volume (200 TAVR/year) centers in Canada and the United States. The primary outcomes were a composite of all-cause death or stroke by 30 days and the proportion of patients successfully discharged home the day following TAVR.Of 1,400 screened patients, 411 were enrolled at 13 centers and received a SAPIEN XT (58.2%) or SAPIEN 3 (41.8%) valve (Edwards Lifesciences, Irvine, California). In centers enrolling exclusively in the study, 55% of screened patients were enrolled. The median age was 84 years (interquartile range: 78 to 87 years) with a median STS score of 4.9% (interquartile range: 3.3% to 6.8%). Next-day discharge home was achieved in 80.1% of patients, and within 48 h in 89.5%. The composite of all-cause mortality or stroke by 30 days occurred in 2.9% (95% confidence interval: 1.7% to 5.1%), with neither component of the primary outcome affected by hospital TAVR volume (p = 0.51). Secondary outcomes at 30 days included major vascular complication 2.4% (n = 10), readmission 9.2% (n = 36), cardiac readmission 5.7% (n = 22), new permanent pacemaker 5.7% (n = 23), andmild paravalvular regurgitation 3.8% (n = 15).Adherence to the Vancouver 3M Clinical Pathway at low-, medium-, and high-volume TAVR centers allows next-day discharge home with excellent safety and efficacy outcomes.

Background Despite evidence of high heritability, monogenic disorders are identified in a minor fraction of individuals with early-onset coronary artery disease (EOCAD). We hypothesized that some individuals with EOCAD carry a high number of common genetic risk variants, with a combined effect similar to Mendelian forms of coronary artery disease, such as familial hypercholesterolemia. Methods and Results To confirm the polygenic contribution to EOCAD (age of ≤40 years for men and ≤45 years for women), we calculated in 111 418 British participants from the UK Biobank cohort a genetic risk score (GRS) based on the presence of 182 independent variants associated with coronary artery disease (GRS182). Participants with a diagnosis of EOCAD who underwent a revascularization procedure (n=96) had a significantly higher GRS182 ( P =3.21×10 −9 ) than those without EOCAD. An increase of 1 SD in GRS182 corresponded to an odds ratio of 1.84 (1.52–2.24) for EOCAD. The prevalence of a polygenic contribution that increased EOCAD risk similar to what is observed in heterozygous familial hypercholesterolemia was estimated at 1 in 53. In a local cohort of individuals with EOCAD (n=30), GRS182 was significantly increased compared with UK Biobank controls ( P =0.001). Seven participants (23%) had a GRS182 corresponding to an estimated 2-fold increase in EOCAD risk; none had a rare mutation involved in monogenic dyslipidemia or EOCAD. Conclusions These results suggest a significant polygenic contribution in individuals presenting with EOCAD, which could be more prevalent than familial hypercholesterolemia. Determination of the polygenic risk component could be included in the diagnostic workup of patients with EOCAD.

Patients with annular areas just above nominal S3 valve areas are at increased risk of over-sizing if a larger valve is implanted. We therefore evaluated the rate of permanent pacemaker (PPM) implantation associated with avoiding over-sizing by selective deployment balloon over-filling during transcatheter aortic valve replacement (TAVR) with the Sapien 3 (S3) valve.We included consecutive patients treated with the S3 valve from January 2016 to May 2017. We identified computed tomography annular areas where the nominally deployed valve would be over-sized by12%-15% (areas 340-360 mm² for 23 mm valve, 420-450 mm² for 26 mm valve, 530-580 mm² for 29 mm valve) as those at highest risk for valve over-sizing. In these situations, we used the smaller valve and over-filled the deployment balloon to achieve a predicted valve area/annular area ratio of approximately 1. For annular areas650 mm², we over-filled the 29 mm valve to achieve a similar ratio.We evaluated 102 patients (59 males; mean age, 83.7 ± 6.5 years; mean STS score, 10.2). Over-filling of the deployment balloon was used in 35 cases (34%). We observed a post-TAVR PPM rate of 6.9% overall and 2.7% among the 75 patients without pre-TAVR right bundle-branch block (RBBB). Cases with valve over-filling vs nominal deployment had infrequent need for postdilation (14.3% vs 6.0%, respectively; P=.17) and similar postprocedure gradients (9.9 mm Hg vs 10.3 mm Hg, respectively; P=.59).A strategy to avoid S3 valve over-sizing by selective deployment balloon over-filling was associated with a low rate of PPM, especially in patients without pre-existing RBBB.

Objectives The purpose of this study was to determine the efficacy and safety of radial versus femoral access in women undergoing coronary angiography/intervention. Background The risk of bleeding and vascular access site complications are higher in women than in men. Methods In a pre-specified RIVAL (RadIal Vs femorAL access for coronary intervention) subgroup analysis, we compared outcomes in women (n = 1,861) and men (n = 5,160) randomized to radial versus femoral access. Results Overall, women were at higher risk of major vascular complications compared with men (4.7% vs. 1.7%; p Conclusions Women undergoing coronary angiography and PCI have a higher risk of vascular access site complications compared with men, and radial access is an effective method to reduce these complications.

Background: Although considered the evidence-based best therapy for ST-segment elevation myocardial infarction (STEMI), many patients do not receive primary percutaneous coronary intervention (PCI) because of health care resource distribution and constraints. This study describes the clinical management and outcomes of all patients identified with STEMI within a region, including those who did not receive primary PCI. Methods: This study used a prospective cohort design. Patients presenting with STEMI to PCI- and non−PCI-capable hospitals in one integrated health region in Ontario were included in the study. The primary objective was to examine use of reperfusion strategies and timeliness of care. Secondary objectives included determining (through regression models) which variables were associated with mortality within 90 days, and describing patient uptake of risk-reducing therapies and activities post-STEMI. Results: Between Apr. 1, 2010, and Mar. 31, 2013, data were collected on 2247 consecutive patients presenting with STEMI. Patients presenting to the PCI-capable hospital were more likely to receive primary PCI (82.5% v. 65.2%, p < 0.001) and be treated within optimal treatment times. However, there was no appreciable difference in mortality at 90 days post-STEMI between patients presenting to PCI- and non−PCI-capable hospitals (7.8% v. 7.5%, p = 0.82), even after adjustment for acuity on presentation. Despite recognized risk factors, many patients were not taking evide–≠≠nce-based medications for risk factor modification before STEMI. Interpretation: A systematic approach to regional STEMI care focusing on timely access to the best available therapies, rather than the type of reperfusion provided alone, can yield favourable outcomes.

An 85-year-old man presented to the emergency department with a 3-week history of progressive dyspnea, orthopnea, and mild ankle edema without chest discomfort. His past medical history was significant for coronary artery disease with a non–ST-segment–elevation myocardial infarction 8 years prior with percutaneous coronary intervention to the distal right coronary artery, with mild residual nonobstructive disease in the left anterior descending artery and circumflex artery. Cardiovascular risk factors included hypertension, dyslipidemia, and chronic kidney disease stage 3. His remaining medical history was significant for cecal adenocarcinoma with a right hemicolectomy 20 years prior, and pulmonary sarcoidoisis that was quiescent without any history of steroid use or immunosuppression. The most recent pulmonary function tests revealed normal spirometry and diffusion capacity. He was a nonsmoker, and before the onset of symptoms he was functionally independent only using a cane for mobility. Initial vital signs revealed a regular heart rate of 81 bpm, and blood pressure of 121/78 mm Hg. He was afebrile, and his oxygen saturation was 95% on 2-L nasal prongs. Jugular venous pressure was elevated at 7 cm above the sternal angle with a normal waveform; the hepatojugular reflex was positive. The carotid pulse was of decreased volume but normal contour, without audible bruits. Auscultation revealed a normal S1 and S2, a holosystolic murmur at the apex, and a grade 2 midpeaking systolic ejection murmur at the base, with radiation to the carotids. Respiratory examination revealed clear and equal breath sounds bilaterally with the presence of bibasilar crackles at the lung bases. Peripheral pulses were present, with bilateral pitting edema at the ankles. Abdominal examination was unremarkable. Initial investigations revealed hemoglobin of 103 g/dL, and electrolytes within the normal range with a creatinine of 121 mmol/L (estimated glomerular filtration rate 50 mL/min). Troponin I (high sensitivity) was elevated with peak of …

Aim The aim of this study was to determine the effects of advanced chronic kidney disease (CKD) on early and late outcomes after transcatheter aortic valve implantation (TAVI), and to evaluate the predictive factors of poorer outcomes in such patients. Methods and results This was a multicentre study including a total of 2075 consecutive patients who had undergone TAVI. Patients were grouped according the estimated glomerular filtration rate as follows: CKD stage 1-2 (≥60 mL/min/1.73 m2; n = 950), stage 3 (30–59 mL/min/1.73 m2; n = 924), stage 4 (15–29 mL/min/1.73 m2; n = 134) and stage 5 (

Once considered a childhood disease, the number of adults living with congenital heart disease (CHD) has now exceeded the number of pediatric patients. The landscape of percutaneous intervention for adult congenital heart disease (ACHD) has evolved over the past decade and has yet to be characterized in Canada. The aim of this study was to begin to understand the current infrastructure underlying ACHD interventions in Canada and to characterize the type and number of interventions being carried out across the country. A cross-sectional national survey was distributed by e-mail to all cardiac catheterization laboratory directors in 2015. All Canadian laboratories involved in ACHD interventions responded, encompassing 19 institutions spanning 69 cardiac catheterization laboratories. A total of 1451 percutaneous interventions were recorded. Nationwide, the most common simple ACHD interventions were for atrial septal defect and patent foramen ovale closures. The most common ACHD interventions of increased complexity were for coarctation stenting and transcatheter pulmonary valve implantation. There was a marked clustering of procedures in Ontario, Quebec, British Columbia, and Alberta in keeping with Canada's population-density distribution. A total of 23 ACHD operators were identified, half of whom had ACHD-specific fellowship training. These data can be used as a starting point to inform the present state of affairs in the area and lay the groundwork for further work to assess resource allocation and human resource planning for the care of patients with ACHD in Canada.

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.

Objectives This study sought to evaluate the main baseline and procedural characteristics, management, and clinical outcomes of patients from a large cohort of patients undergoing transcatheter aortic valve implantation (TAVI) who suffered coronary obstruction (CO). Background Very little data exist on CO following TAVI. Methods This multicenter registry included 44 patients who suffered symptomatic CO following TAVI of 6,688 patients (0.66%). Pre-TAVI computed tomography data was available in 28 CO patients and in a control group of 345 patients (comparisons were performed including all patients and a cohort matched 1:1 by age, sex, previous coronary artery bypass graft, transcatheter valve type, and size). Results Baseline and procedural variables associated with CO were older age (p Conclusions Symptomatic CO following TAVI was a rare but life-threatening complication that occurred more frequently in women, in patients receiving a balloon-expandable valve, and in those with a previous surgical bioprosthesis. Lower-lying coronary ostium and shallow sinus of Valsalva were associated anatomic factors, and despite successful treatment, acute and late mortality remained very high, highlighting the importance of anticipating and preventing the occurrence of this complication.

Objectives This study sought to evaluate the long-term outcomes after transcatheter aortic valve implantation (TAVI) in the Multicenter Canadian Experience study, with special focus on the causes and predictors of late mortality and valve durability. Background Very few data exist on the long-term outcomes associated with TAVI. Methods This was a multicenter study including 339 patients considered to be nonoperable or at very high surgical risk (mean age: 81 ± 8 years; Society of Thoracic Surgeons score: 9.8 ± 6.4%) who underwent TAVI with a balloon-expandable Edwards valve (transfemoral: 48%, transapical: 52%). Follow-up was available in 99% of the patients, and serial echocardiographic exams were evaluated in a central echocardiography core laboratory. Results At a mean follow-up of 42 ± 15 months 188 patients (55.5%) had died. The causes of late death (152 patients) were noncardiac (59.2%), cardiac (23.0%), and unknown (17.8%). The predictors of late mortality were chronic obstructive pulmonary disease (hazard ratio [HR]: 2.18, 95% confidence interval [CI]: 1.53 to 3.11), chronic kidney disease (HR: 1.08 for each decrease of 10 ml/min in estimated glomerular filtration rate, 95% CI: 1.01 to 1.19), chronic atrial fibrillation (HR: 1.44, 95% CI: 1.02 to 2.03), and frailty (HR: 1.52, 95% CI: 1.07 to 2.17). A mild nonclinically significant decrease in valve area occurred at 2-year follow-up (p Conclusions Approximately one-half of the patients who underwent TAVI because of a high or prohibitive surgical risk profile had died at a mean follow-up of 3.5 years. Late mortality was due to noncardiac comorbidities in more than one-half of patients. No clinically significant deterioration in valve function was observed throughout the follow-up period.

Summary Background Two large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice. Methods The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included patients who underwent index PCI. This trial is registered with ClinicalTrials.gov, number NCT01149044. Findings Between Aug 5, 2010, and July 25, 2014, 10 732 eligible patients were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of patients who did not undergo PCI in each group (337 in the PCI and thrombectomy group and 331 in the PCI alone group), the final study population comprised 10 064 patients (5035 thrombectomy and 5029 PCI alone). The primary outcome at 1 year occurred in 395 (8%) of 5035 patients in the thrombectomy group compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio [HR] 1·00 [95% CI 0·87–1·15], p=0·99). Cardiovascular death within 1 year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 0·93 [95% CI 0·76–1·14], p=0·48). The key safety outcome, stroke within 1 year, occurred in 60 patients (1·2%) in the thrombectomy group compared with 36 (0·7%) in the PCI alone group (HR 1·66 [95% CI 1·10–2·51], p=0·015). Interpretation Routine thrombus aspiration during PCI for STEMI did not reduce longer-term clinical outcomes and might be associated with an increase in stroke. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI. Funding Canadian Institutes of Health Research, Canadian Network and Centre for Trials Internationally, and Medtronic Inc.

ObjectivesThe aim of this study was to compare the incidence and predictive factors of complete atrioventricular block (AVB) and permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR).BackgroundNo data exist on the need for PPI after TAVI versus SAVR in patients with similar baseline electrocardiographic (ECG) findings.MethodsA total of 411 patients with severe aortic stenosis (AS) and no prior pacemaker who underwent TAVI with the balloon-expandable Edwards valve (Edwards Lifesciences, Irvine, California) were matched (1:1) with 411 elderly patients with severe AS who underwent isolated SAVR on the basis of baseline ECG findings. The incidence, reasons, and predictive factors for PPI within 30 days after the procedure were compared between groups.ResultsMean age was similar in both groups (p = 0.11), and the TAVI group had a higher Society of Thoracic Surgeons score (p < 0.001). The rate of new PPI was higher after TAVI (7.3%) compared with SAVR (3.4%), p = 0.014. Complete AVB and severe symptomatic bradycardia, respectively, were the reasons for PPI in the TAVI (5.6% and 1.7%, respectively) and SAVR (2.7% and 0.7%, respectively) groups (p = 0.039 for complete AVB, p = NS for symptomatic bradycardia). The presence of baseline right bundle branch block was the only variable associated with PPI in the TAVI group (odds ratio: 8.61, 95% confidence interval: 3.14 to 23.67, p < 0.0001), whereas no variable was found in the SAVR group.ConclusionsTranscatheter aortic valve implantation was associated with a higher rate of complete AVB and PPI compared with SAVR in elderly patients with severe AS and similar baseline ECG findings. The presence of baseline right bundle branch block correlated with the need for PPI in the TAVI group.

ObjectivesWe sought to determine whether radial artery access is associated with increased radiation exposure during cardiac catheterization and whether this relationship differs between operators, after adjustment for clinical and patient characteristics associated with greater radiation exposure.BackgroundAlthough previous studies have demonstrated a relationship between radial access and increased radiation exposure to the patient during fluoroscopy-guided cardiac procedures, such studies did not account for differences in operator technique or clustering of patients, procedure complexity, or patient size. Those studies included data from few operators.MethodsData were collected prospectively on 5,954 diagnostic cardiac catheterizations performed at a tertiary cardiac center. A multilevel regression analysis was used to determine the relationship between radial artery access and radiation exposure.ResultsAfter adjustment for multiple factors, radial access was associated with increased exposure (beta = 0.22, p < 0.0001) when compared with the use of femoral access, as measured using the logarithmically transformed air kerma (LogAK). On average, radial access accounted for a 23% increase in measured AK. This was consistent between operators. There were observed differences in the mean LogAK between operators (p = 0.0158), as well as substantial variation in measured LogAK between patients within each operator's practice (p < 0.001).ConclusionsRadial artery access cardiac catheterization was associated with increased radiation exposure to the patient when compared with femoral access. The measured AK was still far below the threshold for deterministic effects in most patients studied. Observed variations in AK between and within operators may point to better opportunities to reduce exposure.

Objectives We evaluated transcatheter aortic valve implantation (TAVI) in high-risk patients with bicuspid aortic valve (BAV) stenosis. Background TAVI shows promise in the treatment of severe stenosis of triscupid aortic valves, especially in high-risk patients. However, BAV stenosis has been considered a contraindication to TAVI. Methods Eleven patients (age 52 to 90 years) with symptomatic severe BAV stenosis underwent TAVI at 3 Canadian tertiary hospitals between May 2006 and April 2010. All patients were considered high risk for surgical aortic valve replacement. Edwards-SAPIEN transcatheter heart valves (Edwards Lifesciences, Inc., Irvine, California) were used. Transfemoral or transapical access was selected, depending on the adequacy of femoral access. Results Access was transfemoral in 7 patients and transapical in 4 patients. There were no intraprocedural complications. Significant symptomatic and hemodynamic improvement was observed in 10 of 11 patients. Baseline aortic valve area of 0.65 ± 0.17 cm 2 and mean transaortic pressure gradient of 41 ± 22.4 mm Hg were improved to 1.45 ± 0.3 cm 2 and 13.4 ± 5.7 mm Hg, respectively. Two patients had moderate perivalvular leaks. At the 30-day follow-up there were 2 deaths due to multisystem failure in 2 transapical patients. In 1 patient an undersized, suboptimally positioned, unstable valve required late conversion to open surgery. Conclusions TAVI in selected high-risk patients with severe BAV stenosis can be successfully performed with acceptable clinical outcomes but will require further evaluation.

A ‘minimalist’ approach to transcatheter aortic valve replacement (TAVR) usually advocates avoidance of general anaesthesia; however, there is currently no consensus on the optimal degree of procedural sedation. We assessed the impact of the level of anaesthesia on procedural variables and early

A minimalist approach for transcatheter aortic valve replacement (TAVR) may be advantageous in frail patients undergoing TAVR. We assessed the impact of frailty, as measured with a 5-meter walk test, on early discharge and clinical outcomes using the Vancouver Clinical Pathway in the 3M (

Background— Drug-eluting stents are more effective in reducing restenosis than bare-metal stents. Less certain is the relative performance of 2 widely used drug-eluting stents—sirolimus- and paclitaxel-eluting stents—in diabetic and nondiabetic patients undergoing percutaneous coronary intervention in routine clinical practice. We therefore studied the long-term effectiveness and safety of sirolimus versus paclitaxel stents overall and stratified by the absence or presence of diabetes. Methods and Results— We compared sirolimus and paclitaxel stents in a propensity-score matched cohort of 2054 pairs of patients (835 matched pairs of diabetic patients and 1219 matched pairs of nondiabetic patients) undergoing percutaneous coronary intervention in Ontario between December 1, 2003 and March 31, 2006. The cohort was derived from the Cardiac Care Network of Ontario percutaneous coronary intervention registry and linked to population-based administrative health databases. In the overall cohort, there was no difference in rates of target-vessel revascularization ( P =0.47), myocardial infarction ( P =0.71), or death ( P =0.49). As compared with paclitaxel stents, the use of sirolimus stents was associated with a significantly lower 3-year rate of target-vessel revascularization in nondiabetic patients (8.3% versus 10.0%, P =0.01), but not in diabetic patients (12.7% versus 10.3%, P =0.07). Rates of all-cause mortality were similar in patients receiving sirolimus stents versus paclitaxel stents in both the diabetic (8.4% versus 9.2%, P =0.91) and nondiabetic (4.6% versus 3.0%, P =0.22) groups. Conclusions— In this large observational study, patients receiving paclitaxel and sirolimus stents had similar mortality rates, but nondiabetic patients receiving sirolimus stents were significantly less likely to require repeat revascularization.

Purpose: Nasal septoplasty is a surgical procedure offered to patients with chronic snoring secondary to nasal obstruction. We describe a case of cardiogenic shock following the administration of metoprolol to treat hypertension, (likely) induced by systemic absorption of topical epinephrine used during a routine nasal septoplasty. Clinical features: A 29-yr-old male, with no significant medical history, was scheduled for nasal septoplasty for mild nasal obstruction. Following routine anesthetic induction, cotton balls, soaked with epinephrine (1:1000), were applied to the nasal mucosa. The patient became hypertensive with a blood pressure of 207/123 mmHg. Intravenous metoprolol was administered. Severe pulmonary edema ensued, with resulting hypoxic respiratory failure and cardiogenic shock. The patient was transferred to a tertiary care facility for percutaneous cardiopulmonary bypass. After five days of cardiopulmonary bypass support and six weeks of intensive care monitoring, the patient’s cardiac status returned to normal limits. Conclusion: A hypertensive response, following systemically absorbed topical vasoconstrictors, including both phenylephrine and epinephrine, can be associated with dire consequences when treated with a beta-adrenergic blocking drug and, possibly, calcium channel blockers. To prevent severe complications including; pulmonary edema, cardiogenic shock, cardiac arrest, and, possibly, death, these drug interactions need to be appreciated.

Background— Interventional cardiologists receive one of the highest levels of annual occupational radiation exposure. Further measures to protect healthcare workers are needed. Methods and Results— We evaluated the efficacy of a pelvic lead shield and a novel surgical cap in reducing operators’ radiation exposure. Patients undergoing coronary angiography or percutaneous coronary intervention (n=230) were randomized to have their procedure with or without a lead shield (Ultraray Medical, Oakville, Canada) placed over the patient. During all procedures, operators wore the No Brainer surgical cap (Worldwide Innovations and Technology, Kansas City, KS) designed to protect the head from radiation exposure. The coprimary outcomes for the lead shield comparison were (1) operator dose (µSv) and (2) operator dose indexed for air kerma (µSv/mGy). For the cap comparison, the primary outcome was the difference between total radiation dose (µSv; internal and external to cap). The lead shield use resulted in a 76% reduction in operator dose (mean dose, 3.07; 95% confidence interval [CI], 2.00–4.71 µSv lead shield group versus 12.57; 95% CI, 8.14–19.40 µSv control group; P P P Conclusions— The use of a pelvic lead shield and the cap reduced significantly the operator radiation exposure and can be easily incorporated into clinical practice. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT02128035.

Objective We sought to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BiAV). Background BiAV remains a relative contraindication to TAVI resulting in exclusion from TAVI trials and thus limiting data on the clinical performance of transcatheter valves in these patients. Methodology We conducted an international patient level multicenter analysis on outcomes in patients with BiAV undergoing TAVI. The primary outcome of the study was the combined early safety endpoint — a composite of 30day mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication and valve related dysfunction. Secondary endpoints included the individual components of the primary endpoint as well as post-TAVI paravalvular leak (PVL), rehospitalization, new pacemaker insertion and device success rates at 30days and 1year. Results A total of 108 patients with BiAV were identified in 21 centers in Canada, Spain, Italy, Poland and Singapore who underwent TAVI between January 2005 and March 2014. The composite primary outcome occurred in one quarter of patients (26.9%) — mainly driven by re-intervention for valve malposition (9.3%). The 30-day and 1year mortality rates were 8.3% and 16.9% respectively with AR≥3+ occurring in 9.6% of patients. Device success was achieved in 85.2% of cases with pacemaker insertion in 19.4%. While PVL was not associated with an increased risk of 30day or 1year mortality — Type I BiAV anatomy with left and right cusp fusion had significantly better outcomes than other valve variants. Conclusion In selected patients with BiAV and severe aortic stenosis, TAVI appears both safe and feasible with acceptable clinical outcomes. Clinical studies of TAVI in this patient population are warranted.

Most patients with symptomatic acute myocardial infarction (AMI), the leading cause of death in western industrialized nations, use the emergency department (ED) as their point of entry. Yet, one identified barrier to early recognition of patients with AMI is ED overcrowding. In this paper, the author presents a quality improvement model that applies Lean Six Sigma guidelines to the clinical setting.

Background Post–transcatheter aortic valve implantation (TAVI) dual-antiplatelet therapy (DAPT) with acetylsalicylic acid and clopidogrel is common practice to reduce ischemic complications despite the lack of clinical trial evidence demonstrating superiority over mono-antiplatelet therapy (MAPT). Methods A systematic search was conducted to retrieve studies that investigated DAPT vs MAPT in patients who have undergone TAVI. Outcomes of interest included both ischemic and bleeding events at 30 days and 6 months. Results Four studies met inclusion criteria–2 randomized control trials and 2 observational studies, with 286 patients in the DAPT group and 354 patients in the MAPT group. For the primary outcome of a combined end point of 30-day major stroke, spontaneous myocardial infarction (MI), all-cause mortality, and combined lethal and major bleeding, there was a trend toward increased harm in the DAPT group (29%) compared with the MAPT group (16%), with an odds ratio (OR) of 1.88 ( P = 0.05). Secondary outcome analysis revealed that there was no significant difference between groups regarding 30-day stroke, 30-day spontaneous MI, and 30-day all-cause mortality. Patients who received DAPT had a significant increase in combined 30-day lethal and major bleeding (OR, 2.62; P = 0.008). Further analysis revealed that increased adverse events were driven by observational studies, with no difference in outcomes between groups in randomized controlled trials. Conclusions DAPT in patients who have undergone TAVI demonstrated no benefit over MAPT in reduction of ischemic events, with a trend toward increased harm because of bleeding. Future considerations should be given to MAPT with clopidogrel alone, as well as the omission of clopidogrel loading before the procedure.

Objective: The purpose of the study was to determine the safety and efficacy of TAVI in patients with stenotic bicuspid aortic valve (BAV). Background: To date, patients with BAV have been excluded from major TAVI studies due to a theoretical increased risk of paravalvular leak (PVL). Data on the clinical performance of TAVI in these patients is limited. Methodology: We conducted a retrospective international multicenter cohort study of patients with BAV undergoing TAVI. The primary outcome of the study was the combined early safety endpoint - a composite of 30 day mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication and valve related dysfunction. Secondary endpoints included the individual components of the primary endpoint as well as post TAVI paravalvular leak (PVL), rehospitalization, new pacemaker insertion and device success rates at 30 days and 1 year. Results: A total of 107 patients with BAV were identified in 21 centers in Canada, Spain, Italy, Poland and Singapore who underwent TAVI between January 2005 and March 2014. The composite primary outcome occurred in one third of patients (28.6%) - mainly driven by re-intervention for valve malposition (12.3%). The 30-day and 1 year mortality rate was 9.7% and 17.2% respectively with AR ≥ 3+ occurring in 8.8% of patients. Device success was achieved in 85% of cases with pacemaker insertion in 17.9%. While PVL was not associated with an increased risk of 30 day or 1 year mortality - Type I BAV anatomy with left and right cusp fusion had significantly better outcomes than other variants. Conclusion: In selected patients with BAV and severe aortic stenosis TAVI appears both safe and feasible with acceptable clinical outcomes. A randomized comparison of TAVI versus surgical aortic valve replacement in this patient population is warranted.

Background— Factor Xa plays a central role in the generation of thrombin, making it a novel target for treatment of arterial thrombosis. Fondaparinux is a synthetic factor Xa inhibitor that has been shown to be superior to standard therapies for the prevention of venous thrombosis. We performed a randomized trial to determine the safety and feasibility of fondaparinux in the percutaneous coronary intervention (PCI) setting. Methods and Results— A total of 350 patients undergoing elective or urgent PCI were randomized in a blinded manner to receive unfractionated heparin (UFH), 2.5 mg fondaparinux IV, or 5.0 mg fondaparinux IV. Randomization was stratified for planned or no planned use of glycoprotein (GP) IIb/IIIa antagonists. The primary safety outcome was total bleeding, which was a combination of major and minor bleeding events. The incidence of total bleeding was 7.7% in the UFH group and 6.4% in the combined fondaparinux groups (hazard ratio, 0.81; 95% confidence interval, 0.35 to 1.84; P =0.61). Bleeding was less common in the 2.5-mg fondaparinux group compared with the 5-mg fondaparinux group (3.4% versus 9.6%, P =0.06). The composite efficacy outcome of all-cause mortality, myocardial infarction, urgent revascularization, or need for a bailout GPIIb/IIIa antagonist was 6.0% in the UFH group and 6.0% in the fondaparinux group, with no significant difference in efficacy among the fondaparinux doses compared with UFH. Coagulation marker analysis at 6 and 12 hours after PCI demonstrated that fondaparinux was superior to UFH in inducing a sustained reduction in markers of thrombin generation, as measured by prothrombin fragment F1.2 ( P =0.02). Conclusions— In this pilot study of patients undergoing contemporary PCI, factor Xa inhibition with the synthetic anticoagulant fondaparinux in doses of 2.5 and 5.0 mg was comparable to UFH for clinical safety and efficacy outcomes. These data form the basis for further evaluation of fondaparinux in arterial thrombosis.

The objectives of this study were to investigate the incidence, predictors, and clinical significance of isolated postprocedural troponin-I elevations in a consecutive series of patients who underwent percutaneous coronary intervention. We observed, in a series of 1,128 patients, that isolated troponin-I elevations without concomitant creatine kinase elevations occurred in 17% of patients after percutaneous coronary intervention, and that even troponin-I elevations 5 times above the upper limit of normal did not predict events after hospital discharge.

Background It is unclear if holding angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) prior to coronary angiography reduces contrast-induced acute kidney injury (AKI). We undertook a randomized trial to investigate the effect of holding ACEI/ARB therapy prior to coronary angiography on the incidence of AKI. Methods We randomly assigned 208 patients with moderate renal insufficiency (creatinine ≥ 1.7mg/dL within 3months and/or documented creatinine ≥ 1.5mg/dL within 1week before cardiac catheterization) to hold ACEI/ARB ≥24hours preprocedure or continue ACEI/ARB. The primary outcome was the incidence of AKI defined as an absolute rise in serum creatinine of ≥0.5mg/dL from baseline and/or a relative rise in serum creatinine of ≥25% compared with baseline measured at 48 to 96 hours postcardiac catheterization. Results All patients were taking an ACEI (72.1%) or ARB (27.9%) prior to randomization. At 48 to 96 hours, the primary outcome occurred in 18.4% of patients who continued ACEI/ARB compared with 10.9% of the patients who held ACEI/ARB (hazard ratio 0.59, 95% CI 0.30-1.19, P = .16). In a prespecified secondary outcome, there was a lower rise in mean serum creatinine after the procedure in patients who held ACEI/ARB (0.3 ± 0.5 vs 0.1 ± 0.3mg/dL, P = .03). The clinical composite of death, myocardial infarction, ischemic stroke, congestive heart failure, rehospitalization for cardiovascular cause, or need for dialysis preprocedure occurred in 3.9% who continued ACEI/ARB compared with 0% who held the ACEI/ARB (hazard ratio 0.11, 95% CI 0.01-2.96, P = .06). Conclusion In this pilot study of patients with moderate renal insufficiency undergoing cardiac catheterization, with-holding ACEI/ARB resulted in a non-significant reduction in contrast-induced AKI and a significant reduction in post-procedural rise of creatinine. This low cost intervention could be considered when referring a patient for cardiac catheterization.

The purpose of this study was to determine the efficacy and safety of radial versus femoral access in women undergoing coronary angiography/intervention.The risk of bleeding and vascular access site complications are higher in women than in men.In a pre-specified RIVAL (RadIal Vs femorAL access for coronary intervention) subgroup analysis, we compared outcomes in women (n=1,861) and men (n=5,160) randomized to radial versus femoral access.Overall, women were at higher risk of major vascular complications compared with men (4.7% vs. 1.7%; p0.0001). Major vascular complications were significantly reduced with radial access in women (3.1% vs. 6.1%; hazard ratio [HR]: 0.5; 95% confidence interval [CI]: 0.32 to 0.78; p=0.002) and in men (0.7% vs. 2.8%; HR: 0.27; 95% CI: 0.17 to 0.45; p0.0001; interaction p=0.092). Crossover rates were higher with radial compared with femoral access in women (11.1% vs. 1.9%; HR: 5.88; p0.0001) and men (6.3% vs. 1.9%; HR: 3.32; p0.0001; interaction p=0.054). Percutaneous coronary intervention (PCI) success rates were similar irrespective of access site (women: HR: 1.05; p=0.471; men: HR: 1.00; p=0.888; interaction p=0.674), with no differences in PCI complications. In multivariable analyses, female sex was an independent predictor of major vascular complications (HR: 2.39; 95% CI: 1.76 to 3.25; p0.0001). There were consistent findings for women and men, with no difference for the primary composite endpoint of death, myocardial infarction, stroke, and non-coronary artery bypass grafting bleeding (women: 3.9% vs. 5.0%; HR: 0.77; 95% CI: 0.50 to 1.19; men: 3.54% vs. 3.5%; HR: 1.00; 95% CI: 0.75 to -1.34; interaction p=0.325).Women undergoing coronary angiography and PCI have a higher risk of vascular access site complications compared with men, and radial access is an effective method to reduce these complications.