Efficacy and safety of a minimalistic balloon aortic valvuloplasty strategy in a centre without heart surgery.

Background: Balloon aortic valvuloplasty (BAV) is a palliative tool for patients with symptomatic severe aortic stenosis (AS) at prohibitive risk for surgery or as a bridge to surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). BAV is traditionally performed in hospitals with onsite cardiac surgery due to its potential complications. Aims: The aim of this study was to evaluate the safety of BAV procedures performed by trained high-volume operators in a centre without onsite surgery and to assess the effect of a minimalistic approach to reduce periprocedural complications. Methods: From 2016 to 2021, 187 BAV procedures were performed in 174 patients. Patients were elderly (mean age: 85.0±5.4 years) and had high-risk (mean European System for Cardiac Operative Risk Evaluation score [EuroSCORE] II: 10.1±9.9) features. According to the indications, 4 cohorts were identified: 1) bridge to TAVR (n=98; 56%); 2) bridge to SAVR (n=8; 5%); 3) cardiogenic shock (n=11; 6%); and 4) palliation (n=57; 33%). BAV procedures were performed using the standard retrograde technique via femoral access in 165 patients (95%), although radial access was used in 9 patients (5%). Ultrasound-guided vascular puncture was performed in 118 patients (72%) and left ventricular pacing was administered through a stiff guidewire in 105 cases (60%). Results: BAV safety was confirmed by 1 periprocedural death (0.6%), 1 intraprocedural stroke (0.6%), 2 major vascular complications (1%) and 9 minor vascular complications (5%). Nine cases of in-hospital mortality occurred (5%), predominantly in patients with cardiogenic shock. Conclusions: BAV is a safe procedure that can be performed in centres without onsite cardiac surgery using a minimalistic approach that can reduce periprocedural complications.

QFR for the Revascularization of Nonculprit Vessels in MI Patients: Insights From the FIRE Trial.

BACKGROUND: The role of quantitative flow ratio (QFR) in the treatment of nonculprit vessels of patients with myocardial infarction (MI) is a topic of ongoing discussion. OBJECTIVES: This study aimed to investigate the predictive capability of QFR for adverse events and its noninferiority compared to wire-based functional assessment in nonculprit vessels of MI patients. METHODS: The FIRE (Functional Assessment in Elderly MI Patients With Multivessel Disease) trial randomized 1,445 older MI patients to culprit-only (n = 725) or physiology-guided complete revascularization (n = 720). In the culprit-only arm, angiographic projections of nonculprit vessels were prospectively collected, centrally reviewed for QFR computation, and associated with endpoints. In the complete revascularization arm, endpoints were compared between nonculprit vessels investigated with QFR or wire-based functional assessment. The primary endpoint was the vessel-oriented composite endpoint (VOCE) at 1 year. RESULTS: QFR was measured on 903 nonculprit vessels from 685 patients in the culprit-only arm. Overall, 366 (40.5%) nonculprit vessels showed a QFR value ≤0.80, with a significantly higher incidence of VOCEs (22.1% vs 7.1%; P < 0.001). QFR ≤0.80 emerged as an independent predictor of VOCEs (HR: 2.79; 95% CI: 1.64-4.75). In the complete arm, QFR was used in 320 (35.2%) nonculprit vessels to guide revascularization. When compared with propensity-matched nonculprit vessels in which treatment was guided by wire-based functional assessment, no significant difference was observed (HR: 0.57; 95% CI: 0.28-1.15) in VOCEs. CONCLUSIONS: This prespecified subanalysis of the FIRE trial provides evidence supporting the safety and efficacy of QFR-guided interventions for the treatment of nonculprit vessels in MI patients. (Functional Assessment in Elderly MI Patients With Multivessel Disease [FIRE]; NCT03772743).

Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction and High Bleeding Risk: A Randomized Clinical Trial.

Importance: Patients with high bleeding risk (HBR) have a poor prognosis, and it is not known if they may benefit from complete revascularization after myocardial infarction (MI). Objective: To investigate the benefit of physiology-guided complete revascularization vs a culprit-only strategy in patients with HBR, MI, and multivessel disease. Design, Setting, and Participants: This was a prespecified analysis of the Functional Assessment in Elderly MI Patients With Multivessel Disease (FIRE) randomized clinical trial data. FIRE was an investigator-initiated, open-label, multicenter trial. Patients 75 years or older with MI and multivessel disease were enrolled at 34 European centers from July 2019 through October 2021. Physiology treatment was performed either by angiography- or wire-based assessment. Patients were divided into HBR or non-HBR categories in accordance with the Academic Research Consortium HBR document. Interventions: Patients were randomized to either physiology-guided complete revascularization or culprit-only strategy. Main Outcomes and Measures: The primary outcome comprised a composite of death, MI, stroke, or revascularization at 1 year. Secondary outcomes included a composite of cardiovascular death or MI and Bleeding Academic Research Consortium (BARC) types 3 to 5. Results: Among 1445 patients (mean [SD] age, 81 [5] years; 917 male [63%]), 1025 (71%) met HBR criteria. Patients with HBR were at higher risk for the primary end point (hazard ratio [HR], 2.01; 95% CI, 1.47-2.76), cardiovascular death or MI (HR, 1.89; 95% CI, 1.26-2.83), and BARC types 3 to 5 (HR, 3.28; 95% CI, 1.40-7.64). The primary end point was significantly reduced with physiology-guided complete revascularization as compared with culprit-only strategy in patients with HBR (HR, 0.73; 95% CI, 0.55-0.96). No indication of interaction was noted between revascularization strategy and HBR status for primary and secondary end points. Conclusions and Relevance: HBR status is prevalent among older patients with MI, significantly increasing the likelihood of adverse events. Physiology-guided complete revascularization emerges as an effective strategy, in comparison with culprit-only revascularization, for mitigating ischemic adverse events, including cardiovascular death and MI. Trial Registration: ClinicalTrials.gov Identifier: NCT03772743.