Interventional cardiologist perceptions about PCI without surgical backup-Results of an international survey.

BACKGROUND: Percutaneous coronary intervention (PCI) without surgical backup is becoming increasingly common in the United States. Additionally, a recent SCAI expert consensus document has liberalized recommendations for performing PCI without cardiac surgery on site (SOS). AIMS: The current study sought to understand practice patterns and operator preferences with regard to performing PCI without SOS. METHODS: Two internet-based surveys were distributed to interventional cardiologists worldwide. Survey items asked about operator demographics, procedural preferences when performing PCI without SOS, self-judged personality traits, and history of malpractice. RESULTS: Between March 2021 and May 2021, 517 interventional cardiologists completed the survey; 341 of whom perform elective PCI without SOS (no-SOS operators), and 176 who perform elective PCI with surgical backup (SOS operators). Most operators were male 473 (91.5%). There was a greater proportion of SOS operators in academic practice (86 vs. 75, p < 0.001) and greater proportion of no-SOS operators in hospital-owned practices (158 vs. 56, p < 0.001). Lesion characteristics (left main, chronic total occlusions, and need for atherectomy) were the most important procedural attributes for no-SOS operators, and international operators reported higher comfort levels with PCI on high-risk lesions. Cumulative personality profile scores were similar between SOS and no-SOS operators. SOS operators expressed more concern with legal ramifications of performing PCI without SOS (2.57 vs. 2.34, p = 0.049). CONCLUSIONS: In the absence of surgical backup, lesion characteristics were the most important consideration for PCI patient selection for operators worldwide. Compared to the United States, international operators were more confident in performing high-risk PCI without surgical backup.

Team-Based Coaching Intervention to Improve Contrast-Associated Acute Kidney Injury: A Cluster-Randomized Trial.

BACKGROUND: Up to 14% of patients in the United States undergoing cardiac catheterization each year experience AKI. Consistent use of risk minimization preventive strategies may improve outcomes. We hypothesized that team-based coaching in a Virtual Learning Collaborative (Collaborative) would reduce postprocedural AKI compared with Technical Assistance (Assistance), both with and without Automated Surveillance Reporting (Surveillance). METHODS: The IMPROVE AKI trial was a 2×2 factorial cluster-randomized trial across 20 Veterans Affairs medical centers (VAMCs). Participating VAMCs received Assistance, Assistance with Surveillance, Collaborative, or Collaborative with Surveillance for 18 months to implement AKI prevention strategies. The Assistance and Collaborative approaches promoted hydration and limited NPO and contrast dye dosing. We fit logistic regression models for AKI with site-level random effects accounting for the clustering of patients within medical centers with a prespecified interest in exploring differences across the four intervention arms. RESULTS: Among VAMCs' 4517 patients, 510 experienced AKI (235 AKI events among 1314 patients with preexisting CKD). AKI events in each intervention cluster were 110 (13%) in Assistance, 122 (11%) in Assistance with Surveillance, 190 (13%) in Collaborative, and 88 (8%) in Collaborative with Surveillance. Compared with sites receiving Assistance alone, case-mix-adjusted differences in AKI event proportions were -3% (95% confidence interval [CI], -4 to -3) for Assistance with Surveillance, -3% (95% CI, -3 to -2) for Collaborative, and -5% (95% CI, -6 to -5) for Collaborative with Surveillance. The Collaborative with Surveillance intervention cluster had a substantial 46% reduction in AKI compared with Assistance alone (adjusted odds ratio=0.54; 0.40-0.74). CONCLUSIONS: This implementation trial estimates that the combination of Collaborative with Surveillance reduced the odds of AKI by 46% at VAMCs and is suggestive of a reduction among patients with CKD. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: IMPROVE AKI Cluster-Randomized Trial (IMPROVE-AKI), NCT03556293.

A Heart Team Approach to Assessing Frailty in the Cardiac Catheterization Laboratory.

INTRODUCTION: Frailty is a well-documented risk factor for increased morbidity and mortality among patients undergoing percutaneous coronary intervention (PCI). There remains a lack of knowledge regarding the impact of patient frailty in cardiac patient management and outcomes. Thus, this study examined whether the Heart Team, without using frailty assessments, made decisions regarding coronary interventions [medical management (MM) vs. PCI vs. coronary artery bypass grafting (CABG)] that aligned with formally quantified frailty status. MATERIAL AND METHODS: This cross-sectional quality-improvement (QI) study was performed at a single, large, urban Veterans Affairs Hospital. From September 2019 to November 2020, heart team nurses approached patients prior to coronary angiograms and assessed for frailty using the Risk Analysis Index Questionnaire (RAIC). Interventional cardiologists were blinded to the results. This study's independent variable was RAI-C score. The outcome variables were "intervention performed" (MM, PCI, or CABG) and presence of a "reduced invasiveness intervention" (RI). RESULTS: Ninety-five of the 182 participants had obstructive coronary artery disease. Among them, there were 69 PCIs, 10 CABGs, and 16 MMs. 26 received RIs. The primary outcomes demonstrated that frailty score was positively associated with receiving RI [adjusted OR = 1.13, 95% CI = 1.02-1.24, p = 0.02] and MM [adjusted OR = 1.13, CI = 1.02-1.25, p = 0.02], and negatively associated with receiving PCI [adjusted OR = 0.94, CI = 0.88-0.998, p = 0.04]. There was no significant association between frailty and the likelihood of undergoing CABG [AOR = 0.95, CI = 0.81-1.10, p = 0.47]. CONCLUSION: This study demonstrated that the Heart Team and patients at baseline reduced high-risk interventions in frailer patients. A Heart Team, shared-decision-making model utilizing the RAI-C was found to be efficient and effective at measuring frailty in coronary angiogram patients and should be considered for use in the clinical setting.

Coronary Artery Radial Deformation and Velocity in Native and Stented Arteries.

Introduction: Coronary arteries are exposed to a variety of complex biomechanical forces during a normal cardiac cycle. These forces have the potential to contribute to coronary stent failure. Recent advances in stent design allow for the transmission of native pulsatile biomechanical forces in the stented vessel. However, there is a significant lack of evidence in a human model to measure vessel motion in native coronary arteries and stent conformability. Thus, we aimed to characterize and define coronary artery radial deformation and the effect of stent implantation on arterial deformation. Materials and Methods: Intravascular ultrasound (IVUS) pullback DICOM images were obtained from human coronary arteries using a coronary ultrasound catheter. Using two-dimensional speckle tracking, coronary artery radial deformation was defined as the inward and outward displacement (mm) and velocity (cm/s) of the arterial wall during the cardiac cycle. These deformation values were obtained in native and third-generation drug-eluting stented artery segments. Results: A total of 20 coronary artery segments were independently analyzed pre and poststent implantation for a total of 40 IVUS runs. Stent implantation impacted the degree of radial deformation and velocity. Mean radial deformation in native coronary arteries was 0.1230 mm ± 0.0522 mm compared to 0.0775 mm ± 0.0376 mm in stented vessels (p=0.0031). Mean radial velocity in native coronary arteries was 0.1194 cm/s ± 0.0535 cm/s compared to 0.0840 cm/s ± 0.0399 cm/s in stented vessels (p=0.0228). Conclusion: In this in vivo analysis of third-generation stents, stent implantation attenuates normal human coronary deformation during the cardiac cycle. The implications of these findings on stent failure and improved clinical outcomes require further investigation.

Adaptive Coronary Artery Rotational Motion Through Uncaging of a Drug-Eluting Bioadaptor Aiming to Reduce Stress on the Coronary Artery.

BACKGROUND: Caged drug-eluting stents impede natural coronary rotational motion and increase vessel stress, which can contribute towards adverse events. The DynamX™ Drug-Eluting Bioadaptor is a cobalt­chromium platform with a novel mechanism that uncages the vessel after the bioresorbable coating resorbs over six months. This study aimed to analyze the effects of the rotational uncaging in a finite element analysis (FEA) model, validating its effect on coronary artery rotational motion through in-vivo stationary intravascular ultrasound (IVUS). METHODS: Maximum Von Mises stresses were measured in an FEA model and compared for caged and uncaged bioadaptors. Stationary IVUS images from 20 patients enrolled in a single center were acquired post implantation and at 9-12-month follow-up to evaluate coronary artery rotational motion. RESULTS: The FEA model showed that rotational uncaging of the bioadaptor reduces peak stress by 70%. In-vivo, the in-bioadaptor segment was significantly distorted post-implant compared to the native distal and proximal vessel, measured by IVUS: The sum of clockwise and counterclockwise rotational motion (net-effect rotational motion) was -2.7 ± 4.3° versus 0.5 ± 5.0° (proximal vessel), p = 0.036, and versus 0.2 ± 3.8° (distal vessel), p = 0.042. At follow up, when the bioadaptor had uncaged, the vessel returned towards its equilibrium (net-effect rotational motion -0.2 ± 5.6°), with no significant difference between the vessel segments. CONCLUSIONS: In concurrence with the FEA observation, the in-vivo IVUS-analysis demonstrates that uncaging of the bioadaptor affects coronary artery rotational motion. The effect of these findings on reducing clinical events warrants further investigation.

Radial versus femoral access for left main percutaneous coronary intervention: An analysis from the Veterans Affairs Clinical, Reporting, and Tracking Program.

OBJECTIVES: We aimed to compare clinical characteristics and procedural outcomes of left main percutaneous interventions (LM-PCI) by transradial (TRA) versus transfemoral (TFA) approach in the VA healthcare system. BACKGROUND: TRA for percutaneous coronary intervention (PCI) is steadily increasing. However, the frequency and efficacy of TRA for LM-PCI remain less studied. METHODS: All LM-PCIs performed in the VA healthcare system were identified for fiscal year 2008 through 2018. Patients' baseline characteristics and procedure-related variables were compared by access site. Both short- and long-term clinical outcomes were analyzed using propensity score matching. RESULTS: A total of 4004 LM-PCI were performed in the VA via either radial or femoral access from 2008 to 2018. Among these, 596 (14.9%) LM PCIs were performed via TRA. Use of TRA for LM-PCI increased from 2.2% to 31.5% over the study period. Propensity matched outcome analysis, comparing TRA versus TFA, showed a similar procedural success (98.4% for TRA vs. 97.8% for TFA; RR: 1.01 [0.98, 1.03]) and 1-year major adverse cardiovascular events (MACE) (25.9% for TRA vs. 26.8% TFA; RR: 0.96 [0.74, 1.25]). There were no statistically significant differences among secondary outcomes analyses including major bleeding. CONCLUSION: Use of TRA for LM-PCI has been steadily increasing in the VA healthcare system. These findings demonstrate similar procedural success and 1-year MACE across access strategies, suggesting an opportunity to continue increasing TRA use for LM-PCI.

Transradial Interventions at the Forefront of Innovation.

Interventional cardiology has witnessed tremendous changes over the years from a mainly diagnostic approach in an elective population to therapeutic strategies in critically ill patients. Currently, we can treat a broad spectrum of coronary artery, peripheral artery, and structural heart diseases with less invasive, percutaneous approaches that we did not anticipate to be possible just a decade ago. It is certain that the interventional techniques will see further development and we will be able to treat by percutaneous methods more conditions previously thought beyond our reach. Regardless of the advances in catheter-based diagnostic and therapeutic techniques, one thing remains constant. They all require vascular access. And, vascular access is the first technical part of any percutaneous cardiovascular procedure that can determine its overall success. High-quality data together with the availability of training courses for interventional cardiologists and fellows-in-training ensure systematic use of the transradial approach (TRA) which has demonstrated a considerable benefit compared to transfemoral approach both in chronic and acute coronary syndromes. Constant improvement of TRA techniques will further facilitate transradial endovascular and structural interventions, and the growing use for high-risk and complex percutaneous coronary interventions. A continuously growing body of evidence is focused on surpassing current TRA limitations (specifically radial artery occlusion) and expanding alternative vascular accesses such as transulnar approach or distal TRA ("snuff-box" technique). Should this downsizing trend continue, we could see a further paradigm shift toward using the snuff-box technique.

This Can Be as Easy as 1-2-3.

The S1S2S3 pattern, in conjunction with right-dominant forces on a 12-lead electrocardiogram including a tall R-wave in lead V1 (R:S >1), deep S waves in the left precordial leads V5 and V6 (R:S <1), QRS interval <120 ms, and right atrial enlargement (P-wave in lead II >2.5 mm), is highly specific for right ventricular dysfunction with pulmonary hypertension. (Level of Difficulty: Intermediate.).

Comparison of distal radial access versus standard transradial access in patients with smaller diameter radial Arteries(The distal radial versus transradial access in small transradial ArteriesStudy: D.A.T.A - S.T.A.R study).

AIMS: To evaluate safety and efficacy of distal right radial access (DRRA) compared to right radial access (RRA), for coronary procedures, in patients with smaller diameter radial arteries (SDRA) (radial artery diameter (RAD) < 2.1 mm). METHODS AND RESULTS: This is a retrospective analysis of safety and efficacy of DRRA Vs. RRA in patients undergoing coronary procedures at our cardiac catheterization laboratories over a 10- month period between September 2017 and June, 2018 (first 5 calendar months with RRA-first; next 5 calendar months with DRRA-first). All patients underwent pre-procedure ultrasound of arm arteries. All patients had RAD<2.1 mm (mean RAD 1.63 ± 0.27 mm; RAD≤1.6 mm in 73.5%). Baseline characteristics were similar between groups. Primary end-point of puncture success was significantly lower in DRRA vs RRA group [79.5% vs 98.5%, p < 0.0001]. Puncture success was also lower in the subgroup of patients with RAD <1.6 mm Vs. ≥ 1.6 mm in the DRRA group (p < 0.0001). The secondary end-point of puncture time was significantly higher (2.1 ± 1.4 min vs. 1.0 ± 0.45 min, p < 0.00001) in the DRRA Vs. RRA group. The occurrence of vascular access site complications (including access site hematomas), radial artery occlusion (RAO) and distal RAO at day 1 and day 30 were similar between RRA and DRRA groups.Non-vascular access-site complication was seen only in the DRRA group. CONCLUSION: DRRA is a safe and effective access for coronary procedures; though technically challenging in patients with SDRA (RAD<2.1 mm; mean RAD 1.63 ± 0.27 mm), with lower puncture success and higher puncture time compared to RRA.

A Randomized Controlled Trial of Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis.

OBJECTIVES: To test whether administration of prasugrel after coronary artery bypass grafting (CABG) reduces saphenous vein graft (SVG) thrombosis. Use of aspirin after CABG improves graft patency, but administration of other antiplatelet agents has yielded equivocal results. METHODS: We performed a double-blind trial randomizing patients to prasugrel or placebo after CABG at four United States centers. Almost all patients were receiving aspirin. Follow-up angiography, optical coherence tomography (OCT), intravascular ultrasound (IVUS), and near-infrared spectroscopy (NIRS) were performed at 12 months. The primary efficacy endpoint was prevalence of OCT-detected SVG thrombus. The primary safety endpoint was incidence of Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) severe bleeding. RESULTS: The study was stopped early due to slow enrollment after randomizing 84 patients. Mean age was 64 ± 6 years; 98% of the patients were men. Follow-up angiography was performed in 59 patients. IVUS was performed in 52 patients, OCT in 53 patients, and NIRS in 33 patients. Thrombus was identified by OCT in 56% vs 50% of patients in the prasugrel vs placebo groups, respectively (P=.78). Angiographic SVG failure occurred in 24% of patients in the prasugrel arm vs 40% in the placebo arm (P=.19). The 1-year incidence of major adverse cardiovascular events was 14.3% vs 2.4% in the prasugrel and placebo groups, respectively (P=.20), without significant differences in GUSTO severe bleeding (P=.32). CONCLUSION: Early SVG failure occurred in approximately one-third of patients. Prasugrel did not decrease prevalence of SVG thrombus 12 months after CABG.