Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL).

Background: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared to radial access. Ultrasound (US)-guided femoral access may reduce major vascular complications and bleeding. We aim to determine whether routinely using US guidance for femoral arterial access for coronary angiography or intervention will reduce Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding or major vascular complications. Methods: The Ultrasound Guidance for Vascular Access for Cardiac Procedures: A Randomized Trial (UNIVERSAL) is a multicentre, prospective, open-label, randomized trial with blinded outcomes assessment. Patients undergoing coronary angiography with or without intervention via a femoral approach with fluoroscopic guidance will be randomized 1:1 to US-guided femoral access, compared to no US. The primary outcome is the composite of major bleeding based on the BARC 2, 3, or 5 criteria or major vascular complications within 30 days. The trial is designed to have 80% power and a 2-sided alpha level of 5% to detect a 50% relative risk reduction for the primary outcome based on a control event rate of 14%. Results: We completed enrollment on April 29, 2022, with 621 randomized patients. The patients had a mean age of 71 years (25.4% female), with a high rate of comorbidities, as follows: 45% had a prior percutaneous coronary intervention; 57% had previous coronary artery bypass surgery; and 18% had peripheral vascular disease. Conclusions: The UNIVERSAL trial will be one of the largest randomized trials of US-guided femoral access and has the potential to change guidelines and increase US uptake for coronary procedures worldwide.

Introduction: Par rapport à l'abord radial, la limitation importante de l'abord artériel fémoral lors des interventions au cœur pose un risque accru de complications vasculaires et de saignements. L'abord fémoral guidé par ultrasons (US) peut contribuer à réduire les complications vasculaires majeures et les saignements. Nous avons pour objectif de déterminer si l'utilisation systématique du guidage par US pour l'abord artériel fémoral lors des angiographies ou des interventions coronariennes contribuera à réduire les saignements de type 2, 3 ou 5 selon le B leeding A cademic R esearch C onsortium (BARC) ou les complications vasculaires majeures. Méthodes: L' U ltrasou n d Gu i dance for V ascular Acc e ss fo r Cardiac Procedure s : A Randomized Tria l (UNIVERSAL) est un essai multicentrique, prospectif, ouvert, à répartition aléatoire, réalisé par une évaluation à l'insu des résultats. Les patients subissant une angiographie coronarienne avec ou sans intervention par voie fémorale sous guidage fluoroscopique seront répartis de façon aléatoire 1:1 à l'abord fémoral guidé par US ou sans US. Le principal critère d'évaluation est le critère composite de saignements majeurs de type 2, 3 ou 5 selon les critères du BARC ou de complications vasculaires majeures dans les 30 jours. L'essai est conçu de façon à avoir une puissance de 80 % et un seuil alpha bilatéral de 5 % pour déterminer la réduction du risque relatif de 50 % du critère d'évaluation principal selon un taux d'événements dans le groupe témoin de 14 %. Résultats: Le 29 avril 2022, nous avons terminé le recrutement de 621 patients choisis aléatoirement. Les patients avaient un âge moyen de 71 ans (25,4 % de femmes) et un taux élevé de comorbidités : 45 % avaient déjà subi une intervention coronarienne percutanée, 57 % avaient déjà subi un pontage aorto-coronarien et 18 % avaient une maladie vasculaire périphérique. Conclusions: L'essai UNIVERSAL qui sera l'un des plus vastes essais à répartition aléatoire sur l'abord fémoral guidé par US a le potentiel de faire changer les lignes directrices et de faire augmenter le recours aux US lors des interventions coronariennes dans le monde entier.

Comparison of Heart Team vs Interventional Cardiologist Recommendations for the Treatment of Patients With Multivessel Coronary Artery Disease.

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 < .001). When the heart team agreed with the original treatment decision, there was more agreement between the heart team interventional cardiologist and the original treating interventional cardiologist (138 of 163 cases [84.7%]) compared with when the heart team disagreed with the original treatment decision (14 of 71 cases [19.7%]); P < .001). Those with an original treatment of coronary artery bypass grafting, percutaneous coronary intervention, and medication therapy, 32 of 148 patients [22.3%], 32 of 71 patients [45.1%], and 6 of 15 patients [40.0%], respectively, received a different treatment recommendation from the heart team than the original treating interventional cardiologist; the difference across the 3 groups was statistically significant (P = .002). Conclusions and Relevance: The heart team's recommended treatment for patients with multivessel coronary artery disease differed from that of the original treating interventional cardiologist in up to 30% of cases. This subset of cases was associated with a lower frequency of unanimous decisions within the heart team and less concordance between the interventional cardiologists; discordance was more frequent when percutaneous coronary intervention or medication therapy were considered. Further research is needed to evaluate whether heart team decisions are associated with improvements in outcomes and, if so, how to identify patients for whom the heart team approach would be beneficial.

Cardiac Complications Associated With Checkpoint Inhibition: A Systematic Review of the Literature in an Important Emerging Area.

BACKGROUND: Immune checkpoint inhibitors, including programmed cell death-1, programmed cell death ligand-1 and cytotoxic lymphocyte antigen-4 inhibitors, have emerged as important therapeutic alternatives for advanced malignancies. This drug class upregulates T-cell activity, leading to an immune response against cancer cells. However, the increased activity of T cells can lead to autoimmune reactions. METHODS: We conducted a systematic review of all published articles and grey literature in PubMed, Medline, and Embase on cardiac complications associated with checkpoint inhibitor use from September 1, 1996 to November 10, 2017. RESULTS: The search strategy yielded 908 unique articles. Of these, 835 were excluded on the basis of abstract and full-text review. A total of 73 studies met eligibility criteria and were included. We found a total of 99 cases of cardiotoxicity with the use of checkpoint inhibitors. Myocarditis (45%) was the most common cardiotoxicity. The overall case fatality rate was 35%. This was notably higher in patients with myocarditis, complete heart block, or conduction abnormalities, and ventricular arrhythmias. There was no difference in outcomes for patients treated with or without steroids. Immunosuppressive therapies such as infliximab, mycophenolate, intravenous immunoglobulin, antithymocyte globulin, and/or plasmapheresis were used in 12 patients leading to survival in 9 of these patients (75%). CONCLUSIONS: Immune checkpoint inhibitors are associated with cardiotoxicity. Because of the high case fatality rate, close surveillance and prompt empiric therapy for cardiovascular complications of checkpoint inhibitors should be considered. Aggressive treatment with immunosuppressive agents and/or plasmapheresis might lead to clinical improvement and increased survival.

Randomized Controlled Trial of Radiation Protection With a Patient Lead Shield and a Novel, Nonlead Surgical Cap for Operators Performing Coronary Angiography or Intervention.

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<0.001). The mean dose indexed for air kerma was reduced by 72% (0.004; 95% CI, 0.003-0.005 µSv/mGy lead shield group versus 0.015; 95% CI, 0.012-0.019 µSv/mGy control group; P<0.001). The cap use resulted in a significant reduction in operator head radiation exposure (mean left temporal difference [external-internal] radiation dose was 4.79 [95% CI, 3.30-6.68] µSv; P<0.001). 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.

Radial artery access as a predictor of increased radiation exposure during a diagnostic cardiac catheterization procedure.

OBJECTIVES: We 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. BACKGROUND: Although 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. METHODS: Data 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. RESULTS: After 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). CONCLUSIONS: Radial 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.

Predictors of increased radiation dose during percutaneous coronary intervention.

Radiation-induced injury is a potential unintended outcome of fluoroscopy-supported cardiology procedures (e.g., percutaneous coronary intervention [PCI]). The injury might be deterministic in nature. Air kerma (AK) is considered an indicator of skin dose, and thus, an indicator for deterministic effects. Few studies have investigated the factors that contribute to an increased radiation dose, and none have used AK as a dependent variable. We studied the registry data of 967 consecutive patients (derivation model) undergoing ad hoc PCI. Linear and multiple regression analyses were performed to investigate which clinical, technical, and anatomic factors were associated with an increased AK. Multiple regression analyses were performed on an additional sample of 1,082 consecutive patients (validation model) to confirm the results. The variables found significant (multiple regression analyses) were radial access (mean increase in AK 253 mGy, 95% confidence interval [CI] 104 to 418, p = 0.0006), number of lesions treated (547 mGy, 95% CI 332 to 789, p < 0.0001), Type C lesions (132 mGy, 95% CI, 26 to 246, p = 0.014), bifurcation lesions (280 mGy, 95% CI 104 to 477, p = 0.0013), and chronic total occlusions (453 mGy, 95% CI 76 to 923, p = 0.016). The validation model (n = 1,082) confirmed all but type C lesions (p = 0.065). In conclusion, the present study has described factors that might contribute to an increased AK during PCI. In revealing a priori known factors associated with an increased radiation dose during PCI, physicians and patients might be more able to evaluate the risks and benefits of such a procedure.

Off-pump coronary artery bypass grafting attenuates postoperative bleeding associated with preoperative clopidogrel administration.

BACKGROUND: Clopidogrel is being increasingly administered as primary therapy for acute coronary syndromes and prior to planned percutaneous coronary intervention (PCI). In these settings, surgical revascularization results in signifi- cantly increased postoperative bleeding, transfusion, and reexploration. Off-pump coronary artery bypass grafting (OPCAB) may decrease the extent of postoperative bleeding in patients exposed to clopidogrel. METHODS: The cases of 78 consecutive patients undergoing OPCAB by a single surgeon were retrospectively analyzed, and the patients were divided into 2 groups, those with immediately preoperative clopidogrel exposure (clopidogrel OPCAB, n = 15) and those without (control OPCAB, n = 63). Multiple perioperative parameters were statistically compared. The clopidogrel OPCAB group also was compared with a group of previously described on-pump coronary bypass patients who made up a historical control group (n = 59). RESULTS: Postoperative bleeding, transfusion requirements, reexploration rates, duration of mechanical ventilation, and length of stay were markedly less for clopidogrel OPCAB patients than for historical controls and were statistically equivalent to those of control OPCAB patients. CONCLUSION: Among these 15 OPCAB patients with immediately preoperative administration of clopidogrel and aspirin, outcome was improved compared with published results for on-pump coronary bypass patients and was equivalent to results among OPCAB patients not exposed to clopidogrel. Published, recommended approaches to clopidogrel administration, such as avoidance of pre-PCI clopidogrel, delay of surgery, and platelet transfusion do not appear to be necessary with OPCAB.