Faculty Bibliography

Cardiogenic shock (CS) is critical end-organ hypoperfusion attributable to reduced cardiac output. Acute ST-segment-elevation myocardial infarction with CS (AMI-CS) has high mortality. Clinical research is challenging in such patients as they often cannot provide consent, lack available legal representatives, and require initiation of therapy. Multiple trials have enrolled patients with AMI-CS outside the United States under deferred consent. Trials in the United States have enrolled patients with out-of-hospital cardiac arrest under exception from informed consent (EFIC). However, AMI-CS has a longer therapeutic window to initiate treatment than out-of-hospital cardiac arrest, and more patients or their representatives can engage in treatment decisions. We provide a rationale for how a trial enrolling patients with AMI-CS could qualify for conduct using EFIC by meeting each criterion specified in US human subject regulations. AMI-CS is a life-threatening situation, available treatments are unsatisfactory, and collection of valid evidence is necessary. Obtaining informed consent is often not feasible, and trial participation could benefit subjects. Only enrolling consented patients is impracticable and could reduce the study's generalizability. We propose a therapeutic window of 30 minutes within the study intervention must be initiated, with consent sought within 15 minutes, respecting any refusal or objection to enrollment, and otherwise enrollment under EFIC. A trial could enroll patients with AMI-CS under EFIC and can involve both patients and their representatives. Successful use of EFIC in trials of other interventions in patients with CS or enrolling patients with other acute cardiovascular conditions could increase the available evidence base to improve care.

BACKGROUND:In the COMPLETE (Complete vs Culprit-Only Revascularization to Treat Multi-Vessel Disease After Early PCI for STEMI) trial, complete revascularization in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) reduced important outcomes compared with culprit-only percutaneous coronary intervention. Whether clinical outcomes in STEMI patients with MVD are influenced by the presence of a left anterior descending (LAD) nonculprit lesion (NCL) remains unknown. OBJECTIVES/OBJECTIVE:This study sought to compare: 1) cardiovascular outcomes among patients with an NCL in the proximal/mid-LAD to patients with an NCL in other locations; and 2) the benefit of NCL revascularization in patients with and without a proximal/mid-LAD NCL. METHODS:The COMPLETE trial enrolled patients presenting with STEMI and MVD to angiography-guided complete revascularization vs a culprit lesion-only strategy. All coronary angiograms were evaluated in a central core laboratory. In this prespecified subanalysis, treatment effect according to proximal/mid-NCL location was determined for the coprimary outcomes of: 1) cardiovascular death or new myocardial infarction; and 2) cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. Cox proportional hazards models were performed with an interaction term for treatment allocation and NCL location. RESULTS:Of the 4,041 subjects in COMPLETE, 1,666 patients had a proximal/mid-LAD NCL (41.2%). The first coprimary outcome occurred in 8.5% (2.9%/y) of patients with a proximal/mid-LAD NCL vs 9.9% (3.4%/y) in those without (adjusted HR: 0.83; 95% CI: 0.67-1.03). Complete revascularization had a similar benefit in reducing the first coprimary outcome for patients with a proximal/mid-LAD NCL (7.7% vs 9.2%; HR: 0.85; 95% CI: 0.61-1.18) and those without (8.0% vs 11.9%; HR: 0.65; 95% CI: 0.50-0.86), with no differential treatment effect (interaction P = 0.235) CONCLUSIONS: Among patients presenting with STEMI and multivessel CAD, those with a proximal/mid-LAD NCL had similar event rates to those without. The benefit of complete revascularization between the groups was similar, with no evidence of heterogeneity.

BACKGROUND AND AIMS/OBJECTIVE:Multiple randomized trials have shown that renal denervation (RDN) reduces blood pressure (BP) when compared with sham control but the antihypertensive efficacy of radiofrequency vs. ultrasound-based RDN is uncertain. We aimed to compare the outcomes of radiofrequency RDN (rRDN) and ultrasound RDN (uRDN), when compared with sham in patients with hypertension. METHODS:PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized sham-controlled trials (RCTs) of rRDN or uRDN or for trials of rRDN vs. uRDN. Primary efficacy outcome was 24-h ambulatory SBP. A mixed treatment comparison meta-analysis was performed comparing the efficacy and safety against sham and against each other. RESULTS:Among 13 RCTs that enrolled 2285 hypertensive patients, rRDN reduced 24-h ambulatory SBP [(MD = 2.34 mmHg; 95% confidence interval (95% CI): 0.72-3.95], office SBP (MD = 5.04 mmHg; 95% CI: 2.68-7.40)], and office DBP (MD = 2.95 mmHg; 95% CI: 1.68-4.22) when compared with sham. Similarly, uRDN reduced 24-h ambulatory SBP (MD = 4.74 mmHg; 95% CI: 2.80-6.67), day-time ambulatory SBP (MD = 5.40 mmHg; 95% CI: 3.68-7.13), night-time ambulatory SBP (MD = 3.84 mmHg; 95% CI: 0.02-7.67), and office SBP (3.98 mmHg; 95% CI: 0.78-7.19) when compared with sham. There was significantly greater reduction in 24-h ambulatory SBP (MD = 2.40 mmHg; 95% CI: 0.09-4.71), day-time ambulatory SBP (MD = 4.09 mmHg; 95% CI: 1.61-6.56), and night-time ambulatory SBP (MD = 5.76 mmHg; 95% CI: 0.48-11.0) with uRDN when compared with rRDN. For primary efficacy outcome, uRDN ranked #1, followed by rRDN (#2), and sham (#3). CONCLUSION/CONCLUSIONS:In hypertensive patients, rRDN and uRDN significantly reduced 24-h ambulatory and office SBP when compared with sham control with significantly greater reduction in ambulatory BP with uRDN than with rRDN at 4 months (mean) of follow-up. A large-scale randomized head-to-head trial of rRDN or uRDN is warranted to evaluate if there are differences in efficacy.

Ventricular arrhythmias (VA) are a major cause of morbidity and mortality in patients with coronary artery disease (CAD). Current guidelines recommend revascularization of significant CAD to improve survival in patients with ventricular fibrillation (VF), polymorphic ventricular tachycardia (VT), or those who are post-cardiac arrest. However, revascularization is not recommended for CAD patients with suspected scar-mediated monomorphic VT. There is a paucity of data detailing the utility of revascularization in reducing VA in CAD patients who do not present with acute coronary syndrome (ACS) and are not immediately post-cardiac arrest, which is the focus of this review. Medline, Scopus, and the Cochrane Central Register of Controlled Trials were systematically searched to identify relevant studies addressing this question. Studies that included patients presenting with ACS or those who were immediately post-cardiac arrest at the time of revascularization were excluded. In total, five studies comprising 2663 patients were reviewed.

Bleeding avoidance strategies are critical in the modern era of percutaneous coronary intervention; however, most efforts are geared toward reducing access-related complications. Improvements in procedural techniques (radial access, improved procedural anticoagulation regimens, etc) and modifications in postdischarge pharmacotherapy (shortened dual antiplatelet therapy, genotype-guided P2Y₁₂ inhibition, etc) that led to a decline in bleeding related to percutaneous procedures were largely offset by increases in complexity and performance of percutaneous coronary intervention in high-risk patients. Among patients presenting with acute coronary syndrome, aggressive antiplatelet regimens with potent P2Y₁₂ inhibitors are typically prescribed for a longer duration, prioritizing reduction in ischemic events over bleeding risk. Because postdischarge bleeding connotes an adverse prognosis similar to an ischemic event, postprocedure freedom from adverse outcomes can be best tailored by individualizing and recognizing the patient's bleeding and ischemic risks. This review of the contemporary and historical literature (PubMed, EMBASE, Cochrane Library) summarizes the available data, provides strategies to navigate these complex decisions, and helps individualize antithrombotic therapy.

Radial artery occlusion (RAO), a complication of transradial access, has an incidence of 4.0% to 9.1% in patients with advanced chronic kidney disease (CKD) and may preclude its use creation of arteriovenous fistula. Distal transradial access (dTRA) has lower rates of RAO compared with TRA, but prior studies excluded patients with advanced CKD. This was a single center study of patients with advanced CKD who underwent coronary procedures with dTRA from January 1, 2019 to May 12, 2022 who were retrospectively evaluated for radial artery patency in follow-up with reverse Barbeau testing or repeat access of the artery. Of 71 patients, 66% were on hemodialysis and the remainder had CKD 3 to 5. Access was ultrasound-guided, and all received adequate spasmolytic therapy and patent hemostasis. Proximal radial arteries were patent in 100% of the patients at follow-up. Our data suggest that dTRA is safe for patients with advanced CKD and preserves radial artery patency.

BACKGROUND/UNASSIGNED:Case-based peer review of percutaneous coronary intervention (PCI) is used by many hospitals for quality improvement and to make decisions regarding physician competency. However, there are no studies testing the reliability or validity of peer review for PCI performance evaluation. METHODS/UNASSIGNED:We recruited interventional cardiologists from 12 Veterans Affairs Health System facilities throughout the United States to provide PCI cases for review. Ten reviewers performed blinded reviews such that each case was reviewed twice. Cases were rated on a scale of 1 to 5 (with 5 being the best) for 6 care domains (Appropriateness, Lesion Suitability, Strategy, Technical Performance, Outcome, and Documentation) with a summary performance score calculated as the average of all domains. Separately, reviewers determined whether the standard of care was met. Interobserver reliability of the summary performance score was calculated using interclass correlation coefficient. We examined procedural complications and 30-day mortality and major adverse cardiac events for all PCIs performed by these operators from 2019 to 2022 when stratified in tertiles by summary performance score. RESULTS/UNASSIGNED:<0.01) compared with the highest-rated tertile. CONCLUSIONS/UNASSIGNED:Case-based peer review identifies variation in physician performance that is correlated with PCI outcomes. However, reviewer disagreements about the standard of care raise concerns about the use of peer review for high-stakes assessments of physician competency.