Ultrasound-guided femoral access in patients with vascular closure devices: a prespecified analysis of the randomised UNIVERSAL trial.

BACKGROUND: Whether ultrasound (US)-guided femoral access compared to femoral access without US guidance decreases access site complications in patients receiving a vascular closure device (VCD) is unclear. AIMS: We aimed to compare the safety of VCD in patients undergoing US-guided versus non-US-guided femoral arterial access for coronary procedures. METHODS: We performed a prespecified subgroup analysis of the UNIVERSAL trial, a multicentre randomised controlled trial of 1:1 US-guided femoral access versus non-US-guided femoral access, stratified for planned VCD use, for coronary procedures on a background of fluoroscopic landmarking. The primary endpoint was a composite of major Bleeding Academic Research Consortium 2, 3 or 5 bleeding and vascular complications at 30 days. RESULTS: Of 621 patients, 328 (52.8%) received a VCD (86% ANGIO-SEAL, 14% ProGlide). In patients who received a VCD, those randomised to US-guided femoral access compared to non-US-guided femoral access experienced a reduction in major bleeding or vascular complications (20/170 [11.8%] vs 37/158 [23.4%], odds ratio [OR] 0.44, 95% confidence interval [CI]: 0.23-0.82). In patients who did not receive a VCD, there was no difference between the US- and non-US-guided femoral access groups, respectively (20/141 [14.2%] vs 13/152 [8.6%], OR 1.76, 95% CI: 0.80-4.03; interaction p=0.004). CONCLUSIONS: In patients receiving a VCD after coronary procedures, US-guided femoral access was associated with fewer bleeding and vascular complications compared to femoral access without US guidance. US guidance for femoral access may be particularly beneficial when VCD are used.

No-reflow after primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction: an angiographic core laboratory analysis of the TOTAL Trial.

BACKGROUND: The optimal strategy to prevent no-reflow in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) is unknown. AIMS: We aimed to examine the effect of thrombectomy on the outcome of no-reflow in key subgroups and the adverse clinical outcomes associated with no-reflow. METHODS: We performed a post hoc analysis of the TOTAL Trial, a randomised trial of 10,732 patients comparing thrombectomy versus PCI alone. This analysis utilised the angiographic data of 1,800 randomly selected patients. RESULTS: No-reflow was diagnosed in 196 of 1,800 eligible patients (10.9%). No-reflow occurred in 95/891 (10.7%) patients randomised to thrombectomy compared with 101/909 (11.1%) in the PCI-alone arm (odds ratio [OR] 0.95, 95% confidence interval [CI]: 0.71-1.28; p-value=0.76). In the subgroup of patients who underwent direct stenting, those randomised to thrombectomy compared with PCI alone experienced less no-reflow (19/371 [5.1%] vs 21/216 [9.7%], OR 0.50, 95% CI: 0.26-0.96). In patients who did not undergo direct stenting, there was no difference between the groups (64/504 [12.7%] vs 75/686 [10.9%)], OR 1.18, 95% CI: 0.82-1.69; interaction p-value=0.02). No-reflow patients had a significantly increased risk of experiencing the primary composite outcome (cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA Class IV heart failure) at 1 year (adjusted hazard ratio 1.70, 95% CI: 1.13-2.56; p-value=0.01). CONCLUSIONS: In patients with STEMI treated by PCI, thrombectomy did not reduce no-reflow in all patients but may be synergistic with direct stenting. No-reflow is associated with increased adverse clinical outcomes.

Effects of routine early treatment with PCSK9 inhibitors in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a randomised, double-blind, sham-controlled trial.

BACKGROUND: 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. METHODS: 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% (p<0.001). 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%; p<0.001). 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).

Coronary lithotripsy for the treatment of underexpanded stents: the international & multicentre CRUNCH registry.

BACKGROUND: Stent underexpansion increases the risk of cardiac adverse events. At present, there are limited options to treat refractory stent underexpansion. In this context, the intravascular lithotripsy (IVL) system might be a safe and effective strategy. AIMS: We aimed to evaluate the safety and efficacy of IVL in addressing resistant stent underexpansion due to heavy underlying calcification. METHODS: This was an international multicentre registry including patients receiving IVL therapy to treat stent underexpansion from December 2017 to August 2020. Angiographic and intracoronary imaging data were collected. The efficacy endpoint was device success (technical success with a final percentage diameter stenosis <50%). The safety endpoint was in-hospital major adverse cardiac events (MACE). RESULTS: Seventy patients were included, the mean age was 73±9.2 years and 76% were male. The median time from stent implantation to IVL therapy was 49 days (0-2,537). Adjuvant treatment with non-compliant balloon dilatations pre- and post-IVL was performed in 72.3% and 76.8% of patients, respectively, and additional stenting was performed in 22.4%. Device success was 92.3%. Minimum lumen diameter increased from 1.49±0.73 mm to 2.41±0.67 mm (p<0.001) and stent expansion increased by 124.93±138.19% (p=0.016). No IVL-related procedural complications or MACE were observed. The use of bailout IVL therapy directly after stenting and the presence of ostial underexpanded lesions negatively predicted lumen diameter gain. CONCLUSIONS: Coronary lithotripsy is safe and effective in increasing lumen and stent dimensions in underexpanded stents secondary to heavily calcified lesions.

Remote Ambulatory Cardiac Monitoring Before and After Transcatheter Aortic Valve Replacement.

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.

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.

Increasing Wait-Time Mortality for Severe Aortic Stenosis: A Population-Level Study of the Transition in Practice From Surgical Aortic Valve Replacement to Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has emerged as a reasonable alternative to surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis (AS). There is limited data on temporal trends in wait-times and access to care for patients with AS, irrespective of treatment modality. We sought to investigate the trends in wait-times for the treatment (either SAVR or TAVR) of AS in Ontario, Canada, and to understand the drivers of wait-list mortality and hospitalization due to heart failure. METHODS: In this population-level retrospective cohort study, we identified patients from April 1, 2012, to March 31, 2018, who were referred for treatment of symptomatic severe AS awaiting either SAVR or TAVR. The primary outcome was the median total wait-time from referral date to either SAVR or TAVR procedure. Primary clinical outcomes were all-cause mortality and heart failure-related hospitalizations while on the wait-list. RESULTS: The referral cohort consisted of a total of 22 876 referrals for aortic valve replacement, with (N=8098) TAVR and (N=14 778) SAVR referrals. The mean and median wait times for the overall AVR cohort were 87 and 59 days, respectively. The TAVR subcohort had longer wait-times (median 84 days) compared with the SAVR subcohort (median 50 days). Year over year, there was a statistically significant an increase in wait-times (P<0.001) for the overall AS cohort as well as each of the TAVR (P<0.0001) and SAVR (P<0.0001) subgroups. Wait-time mortality was 2.5% (TAVR 5.2% and SAVR 1.05%), while the cumulative probability of heart failure hospitalization was 3.6% (TAVR 7.7% and SAVR 1.3%). CONCLUSIONS: In patients with severe symptomatic AS awaiting aortic valve replacement, there has been a trend of increasing wait times for both SAVR and TAVR. This was associated with increasing mortality and hospitalizations related to heart failure while on the wait-list.

Analytic approaches to establish the diagnostic accuracy of coronary computed tomography angiography as a tool for clinical decision making.

Although 64-slice multidetector coronary computed tomography angiography (CTA) has been reported to have excellent test characteristics for the detection of significant coronary artery disease, current analytic approaches may not appropriately reflect the process of clinical decision making. Thirty-seven patients (29 men; mean age 63 +/- 11 years) who underwent coronary CTA for clinical indications followed by invasive coronary angiography within 4 weeks were studied. Computed tomography angiograms were analyzed independently for the presence of significant coronary artery stenosis (>or=50% luminal narrowing) by 2 observers blinded to invasive coronary angiographic results. The diagnostic test performance of coronary CTA was determined with and without inclusion of unassessable segments. Because stenosis could not be excluded in unassessable segments, these segments were counted as positive for stenosis. Sensitivity, specificity, and positive (PPV) and negative predictive values of CTA for detecting significant stenoses on assessable segments were 85% (51 of 60, 95% confidence interval [CI] 76% to 94%), 99% (414 of 416, 95% CI 99 to 100), 96% (95% CI 51 of 53), and 98% (95% CI 414 of 423), respectively. Overall, 13% of coronary segments (70 of 546) were not assessable using CTA (heavy calcium in 48 segments). By including these segments, PPV decreased from 96% to 60% (74 of 123), whereas sensitivity improved from 85% to 89% (95% CI 74 of 83). In conclusion, the clinical utility of coronary CTA may be limited by a low PPV in patients with a high prevalence of coronary artery disease.

Usefulness of coronary computed tomographic angiography to assess suitability for revascularization in patients with significant coronary artery disease and angina pectoris.

Coronary computed tomographic angiography (CTA) accurately excludes the presence of coronary stenoses in selected patient populations. However, it remains unclear whether coronary CTA has the potential to replace invasive coronary angiography as a tool to assess a patient's suitability for revascularization as determined by the characterization of lesion morphology in patients with significant coronary artery disease. Coronary CTA (64-slice computed tomography) was performed before invasive coronary angiography in 29 patients. We evaluated the accuracy of CTA for the detection of complex lesion morphology, including the presence of severe calcium, total occlusions, and ostial or bifurcation location, and compared the results with those of invasive angiography. On CTA, 10 of 69 lesions (15%) were not evaluable for any feature of complex lesion morphology. Of the evaluable lesions, CTA detected >or=1 feature of complexity in 58% of lesions, corresponding to a sensitivity of 88% (23 of 26) and a specificity of 83% (24 of 29). For those single features, the sensitivity of CTA was 100% for the presence of severe calcium, 93% for total occlusions, and 60% and 80% for the detection of ostial and bifurcation lesions, respectively. The specificity was high for total occlusions (97%), ostial lesions (97%), and bifurcations (100%). It was moderate (85%) for severe calcium. Severe calcium precluded the evaluation of other features of complex lesion morphology in 6 lesions (11%). In conclusion, invasive selective coronary angiography remains the cornerstone to assess a patient's suitability for revascularization given the high proportion of unevaluable segments and segments with severe calcium that precluded adequate revascularization planning on CTA.

Optical Coherence Tomography-Guided Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Prospective Propensity-Matched Cohort of the Thrombectomy Versus Percutaneous Coronary Intervention Alone Trial.

BACKGROUND: Patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction are at increased risk for adverse events. It is unclear if image guidance by optical coherence tomography (OCT) can improve outcomes in these patients. We compared OCT-guided versus angiography-guided primary PCI for ST-segment-elevation myocardial infarction among patients in the Thrombectomy Versus PCI Alone (TOTAL) trial. METHODS AND RESULTS: Among 10 732 patients enrolled in the TOTAL trial, OCT was used for PCI guidance as a part of a prospective substudy in 214 patients. Using 2:1 propensity matching, we identified 428 patients in the trial who had PCI performed with angiography guidance alone. The primary outcome was a composite of cardiovascular death, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. Secondary outcomes included final in-stent angiographic minimum lumen diameter, procedure time, and contrast dose. The final in-stent angiographic minimum lumen diameter was 2.99±0.48 mm in the OCT-guided group versus 2.79±0.47 mm in the angiography-guided group (P<0.0001). OCT- and angiography-guided PCI had a median (interquartile range) procedure time of 58 (47, 71) minute versus 38 (28, 52) minute (P<0.0001) and total contrast dose of 239.7±81.1 mL versus 193.3±78.6 mL (P<0.0001). The primary outcome was observed in 7.5% of the OCT-guided group versus 9.8% of the angiography-guided group (hazard ratio, 0.76; 95% confidence interval, 0.43-1.34; P=0.34). CONCLUSIONS: OCT-guided primary PCI for ST-segment-elevation myocardial infarction was associated with a larger final in-stent minimum lumen diameter. There was no significant difference in clinical outcomes at 1 year; however, the study was underpowered to detect a treatment effect. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01149044.

Canadian Cardiovascular Society position statement on radiation exposure from cardiac imaging and interventional procedures.

Exposure to ionizing radiation is a consequence of many diagnostic and interventional cardiac procedures. Radiation exposure can result in detrimental health effects because of deterministic (eg, skin reaction) and stochastic effects (eg, cancer). However, with the levels experienced during cardiac procedures these risks can be difficult to quantify. Healthcare providers and patients might not fully appreciate radiation-related risks. Though in many cases radiation exposure cannot be avoided, a practice of minimizing exposures to levels "as low as reasonably achievable" (ALARA principle) without compromising the utility of the procedure is encouraged. The purpose of this document is to inform health care providers on the key concepts related to radiation risk from common cardiac procedures and provide specific recommendations on ensuring quality of care.

Randomized trial of insulin versus usual care in reducing restenosis after coronary intervention in patients with diabetes. the STent Restenosis And Metabolism (STREAM) study.

BACKGROUND: Diabetes status is an independent marker of restenosis after percutaneous coronary intervention (PCI). Previous studies suggest that metabolic abnormalities associated with diabetes increase stent restenosis by promoting intimal hyperplasia. Preclinical studies have indicated that insulin therapy reduces intimal hyperplasia. The objective of this study was to determine whether insulin-mediated glucose lowering reduces in-stent restenosis in patients with diabetes undergoing PCIs. METHODS: We conducted a prospective, randomized, multicenter, open-labeled study with blinded outcomes. Patients were randomized 1:1 to daily bedtime subcutaneous NPH insulin (Novo Nordisk) versus usual therapy with oral hypoglycemic agents. The main outcomes were change in volume of intimal hyperplasia within the stent measured by intravascular ultrasound and late lumen loss by quantitative coronary angiography at 6 months post-PCI. RESULTS: Seventy-eight patients (36 insulin, 42 usual care) were randomized. Eight patients in each group received drug-eluting stents. The insulin group achieved greater reductions in both glycosylated hemoglobin A1c (mean±S.D.) (insulin: 8.0%±1.2% to 6.7%±0.7% vs. control: 7.5%±1.2% to 7.1%±1.0 %, P=.0038) and fasting glucose (insulin: 9.3±3.8 to 5.8±1.7 vs. usual care: 8.4±2.4 to 7.7±2.0 mmol/l, P<.0001). There were no hypoglycemic events. At 6 months, there were no significant differences in either intravascular-ultrasound-determined neointimal volume (insulin: 41.2±38.9 vs. usual care: 48.4±40.2 mm(3), P=.33) or late lumen loss by angiography (insulin: 1.29±0.74 mm vs. usual care: 1.02±0.71 mm, P=.17). CONCLUSIONS: Addition of a single bedtime dose of insulin in patients with diabetes does not influence in-stent restenosis.

Assessment of the presence and extent of coronary collateralization by coronary computed tomographic angiography in patients with total occlusions.

Coronary computed tomography angiography (CTA) may be helpful to manage patients with chronic coronary occlusions. The aim of this study was to determine the sensitivity and specificity of CTA to detect the presence and extent of coronary collaterals as compared to invasive coronary angiography (ICA). We retrospectively evaluated 26 patients who underwent both coronary CTA and ICA within 3 weeks and demonstrated a total coronary occlusion (TIMI grade 0) in one of the major coronary arteries. CTA was performed using a 64-slice multidetector CT. The presence, and extent of collateralization was assessed by two blinded observers using the Rentrop classification for ICA. CTA accurately identified the presence and location of all 26 total occlusions. The presence of any collaterals was accurately detected in 21/23 patients [sensitivity 91% (CI: 71-98%)] and the absence in three patients [specificity 100% (CI: 29%-100%)]. The sensitivity of coronary CTA to identify patients with collateralization increased from 91 to 94% (CI: 71-99%) and 100% (CI: 59-100%) for collaterals Rentrop grade 2 and 3 in ICA, respectively. Coronary CTA accurately detects the presence of any coronary collateralization in patients with total occlusions. Although CT technology is currently limited in the assessment of individual collaterals and smaller vessels, it may be helpful in the management of patients with total occlusions.