Arai T, Sakai K, Ikeda K
… +41 more, Mizukami T, Bouisset F, Zhang H, Matsumura M, Sonck J, Wilgenhof A, Matsuo H, Amano T, Ando H, Hada M, Ko B, Biscaglia S, Rivero F, Engstrøm T, Leone AM, van Nunen LX, Fearon WF, Christiansen EH, Fournier S, Desta L, Yong A, Adjedj J, Escaned J, Nakayama M, Eftekhari A, Keulards D, Zimmermann FM, Korngold E, Munhoz D, Campo G, Berry C, Collison D, Johnson TW, Perera D, Jeremias A, Ali Z, De Bruyne B, Mintz GS, Johnson N, Shinke T, Collet C
BACKGROUND: Intravascular imaging (IVI) during percutaneous coronary intervention (PCI) improves outcomes. Pullback pressure gradient characterizes coronary artery disease patterns as focal or diffuse; however, the benef...BACKGROUND: Intravascular imaging (IVI) during percutaneous coronary intervention (PCI) improves outcomes. Pullback pressure gradient characterizes coronary artery disease patterns as focal or diffuse; however, the benefit of IVI across this spectrum remains incompletely understood. We aimed to evaluate clinical outcomes after PCI with or without IVI guidance in patients with focal and diffuse disease defined by pullback pressure gradient. METHODS: Prospective, multicenter, single-arm study of 811 patients (840 vessels) undergoing PCI. Pullback pressure gradient was calculated from manual fractional flow reserve pullbacks to define focal (pullback pressure gradient ≥0.62) or diffuse coronary artery disease. IVI use was at the operator's discretion. The primary outcome was target vessel failure at 1-year follow-up. RESULTS: IVI-guided PCI was performed in 41% of patients. In the overall cohort, target vessel failure was lower with IVI guidance (adjusted hazard ratio, 0.60 [95% CI, 0.36-0.99]; =0.044), with a lower incidence of cardiac death (=0.042). The results were consistent irrespective of the baseline coronary artery disease pattern (=0.128). Among patients with focal disease, IVI-guided PCI was associated with a significantly lower incidence of target vessel failure compared with non-IVI-guided PCI (hazard ratio, 0.41 [95% CI, 0.18-0.91]; =0.029). There was no statistical difference in target vessel failure with the use of IVI among patients with diffuse disease (hazard ratio, 0.91 [95% CI, 0.48-1.73]; =0.771). CONCLUSIONS: In patients undergoing physiology-guided PCI, the use of IVI reduced clinical events at 1 year. These findings suggest that the benefit of IVI extends across the full spectrum of coronary artery disease.
Kerkouri F, Clementy N, Defaye P
… +44 more, Ait Said M, Andorin A, Anselme F, Aoudjeghout W, Badoz M, Behar N, Benhenda N, Ben Kilani M, Bodin A, Bordachar P, Bouzeman A, Citerne O, Deharo JC, Dommerc C, Echivard M, Extramiana F, Fauchier L, Garcia R, Gitenay E, Guenancia C, Guy-Moyat B, Jacon P, Jesel L, Juin C, Khoueiry Z, Kubala M, Leclercq C, Mansourati V, Marquié C, Mechulan A, Mondoly P, Narayanan K, Ollitrault P, Pasquié JL, Peret A, Poty H, Sebag F, Villejoubert O, Waintraub X, Waldmann V, Boveda S, Mansourati J, Marijon E, AV-CESAR Investigators
BACKGROUND: Evidence supporting the Micra AV leadless pacing system has largely derived from highly experienced centers, potentially limiting generalizability to routine clinical practice. METHODS: The AV-CESAR study (Fr...BACKGROUND: Evidence supporting the Micra AV leadless pacing system has largely derived from highly experienced centers, potentially limiting generalizability to routine clinical practice. METHODS: The AV-CESAR study (French Cohort Evaluating the Effectiveness of Atrioventricular Synchrony by the micRa AV) is a nationwide retrospective cohort, including the first 1000 patients implanted with a Medtronic Micra AV leadless pacemaker in France (2020-2024). Mean follow-up was 13.4±10.6 months. Primary end points were early (in-hospital) and late (postdischarge) device-related major complications; pacemaker syndrome and need for implantation of a new pacing system were centrally adjudicated. RESULTS: Among 1003 patients, device implantation was successful in 1000 (99.7%). Mean age was 72.0±15 years; 62.8% were men, 44.0% had ≥2 comorbidities, and 62.4% were unsuitable for transvenous pacemakers. The primary indication was permanent complete atrioventricular block with preserved sinus rhythm (78.0%). Early major complications occurred in 2.4%, including pericardial effusion (0.8%; 3 requiring surgery), access-site complications (0.8%), and thromboembolism (0.3%). Late major complications included pacemaker syndrome (2.5%), pacing-induced cardiomyopathy (1.2%), high thresholds (>4 V/0.24ms, 0.3%), and premature battery depletion (0.2%). No device infections or dislodgements were observed. Overall, 2.5% of patients required implantation of a new pacing system (pacing-induced cardiomyopathy n=11; pacemaker syndrome n=7; high threshold n=3; battery/software failure n=3; tricuspid regurgitation n=1) and 12.7% were permanently reprogrammed to ventricular paced/sensed, inhibited (VVI) mode. In pacing-dependent patients with ambulatory Holter monitoring (>3.4 million paced cycles), mean atrioventricular synchrony was 67.6±17.3% and correlated with device-reported AM-VP (74.8±17.1%; =0.92; <0.001). Atrioventricular synchrony declined at heart rates >90 beats per minute (5.6% of monitored time). All-cause mortality was 13.8%, with 0.2% directly device-related; 41.7% of deaths were cardiovascular. CONCLUSIONS: The Micra AV system is primarily used as an alternative when dual-chamber conventional pacemakers are not feasible. It demonstrated acceptable safety and clinical performance in a high-risk population. The marked reduction in atrioventricular synchrony at higher heart rates may suggest limited clinical benefit in patients with higher exertional heart rates. REGISTRATION:URL: https://clinicaltrials.gov/study/NCT05953558; Unique identifier: NCT05953558.
BACKGROUND: Intracardiac echocardiography (ICE) is increasingly used to guide left atrial appendage occlusion as an alternative to transesophageal echocardiography (TEE), particularly in elderly patients for whom general...BACKGROUND: Intracardiac echocardiography (ICE) is increasingly used to guide left atrial appendage occlusion as an alternative to transesophageal echocardiography (TEE), particularly in elderly patients for whom general anesthesia may pose additional risks. Real-world comparative safety data in older adults remain limited, with prior studies including only small ICE cohorts. We aimed to compare short- and long-term outcomes of ICE- versus TEE-guided left atrial appendage occlusion in adults aged ≥80 years. METHODS: We queried the TriNetX US Collaborative Network to identify patients aged ≥80 years with atrial fibrillation who underwent percutaneous left atrial appendage occlusion from 2015 to 2025. Patients were stratified by imaging modality: ICE- versus TEE-guided approach. Propensity score matching (1:1) was performed across demographics and comorbidities, yielding 2913 patients per group. Outcomes were assessed from the index procedure through 7 days, 90 days, and 1 year using Cox proportional hazards models to generate hazard ratios with 95% CIs. Outcomes included mortality, stroke, device thrombosis, pericardial effusion, pericardiocentesis, tamponade, and device leak. RESULTS: Baseline characteristics were well balanced after matching, with a mean age of 83 years and 44% women. At 90 days, ICE and TEE demonstrated no significant differences in mortality (hazard ratio, 1.18 [95% CI, 0.81-1.73]), stroke, device thrombosis, pericardial effusion, pericardiocentesis, tamponade, or device leak. At 1-year follow-up, mortality (hazard ratio, 0.93 [95% CI, 0.76-1.13]), stroke, and device thrombosis remained similar between groups. However, ICE was associated with a higher incidence of device leak compared with TEE (hazard ratio, 1.81 [95% CI, 1.11-2.97]). CONCLUSIONS: In this large propensity-matched cohort of very elderly patients undergoing left atrial appendage occlusion, ICE and TEE demonstrated comparable rates of mortality, stroke, and device thrombosis at 90 days and 1 year. ICE was associated with a higher rate of device leak at 1 year, warranting careful procedural technique and follow-up surveillance. Prospective studies are needed to define optimal intraprocedural imaging strategies in this high-risk population.
BACKGROUND: Early repolarization syndrome (ERS) is diagnosed in survivors of unexplained cardiac arrest (UCA) who exhibit a distinct ECG pattern of early repolarization (ER), defined as J-point elevation ≥0.1 mV in ≥2 co...BACKGROUND: Early repolarization syndrome (ERS) is diagnosed in survivors of unexplained cardiac arrest (UCA) who exhibit a distinct ECG pattern of early repolarization (ER), defined as J-point elevation ≥0.1 mV in ≥2 contiguous inferolateral leads. UCA survivors without ER or another identifiable cause are classified as idiopathic ventricular fibrillation (IVF). This study evaluated long-term outcomes in ERS compared with IVF. METHODS: This retrospective cohort study analyzed patients from the CASPER (Cardiac Arrest Survivors with Preserved Ejection Fraction Registry) who survived UCA and had structurally normal hearts with an Implantable Cardioverter Defibrillator. Of 709 patients, 186 with explanatory diagnoses and no ER pattern were excluded. The remaining 523 were categorized as ERS (n=48), IVF (n=463), or UCA with ER plus an additional diagnosis (Dx+ER, n=12). Patients were followed for the primary outcome of appropriate Implantable Cardioverter Defibrillator therapy, and logistic regression identified predictors of arrhythmia recurrence. RESULTS: Corrected QT interval intervals were significantly shorter in ERS than in IVF (412±25 ms versus 431±41 ms; <0.01). Over a median follow-up of 5.6 years, appropriate Implantable Cardioverter Defibrillator interventions occurred in 23% of ERS and 13% of IVF patients (=0.09), with incidence rates of 3.0 and 1.5 per 100 person-years, respectively. Four deaths occurred (0.8%), with no significant difference between groups (=0.39). In Dx+ER, appropriate Implantable Cardioverter Defibrillator therapies occurred in 42% of patients (incidence rate, 4.5 per 100 person-years). Arrhythmia-free survival was lower in ERS than in IVF (=0.03). After adjusting for age, sex, and ethnicity, ER was an independent predictor of arrhythmia recurrence (odds ratio, 2.59 [95% CI, 1.33-4.85]; =0.004). CONCLUSIONS: ERS is associated with shorter corrected QT interval intervals and reduced arrhythmia-free survival compared with IVF, with an incidence rate of 3.0 per 100 person-years. These findings underscore the importance of careful ECG review in patients with apparent UCA, to detect ER and undertake individualized risk assessment in affected individuals.
Mac Grory B, Yeh RW, Beckman JA
… +11 more, Kamel H, Lusk JB, Otto CM, Shi J, Smith EE, Xian Y, Zachrison KS, American Heart Association Stroke Council, Council on Clinical Cardiology, Council on Peripheral Vascular Disease, Council on Quality of Care and Outcomes Research
Circulation
· 2026 Jun · PMID 42158988
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Resources for observational comparative research have expanded enormously in recent years to include very large sources of granular, routinely collected health care data and modern statistical, epidemiologic, and econome...Resources for observational comparative research have expanded enormously in recent years to include very large sources of granular, routinely collected health care data and modern statistical, epidemiologic, and econometric techniques. This scientific statement provides an overview of best practices and analytic considerations in observational comparative studies from the perspective of investigators, sponsors, publishers, and consumers of observational research. Observational comparative research is a component of the research landscape that fulfills a role distinct from that of interventional studies in the evaluation of drugs, surgical procedures, medical devices, and health policies. Sources of systematic error (ie, bias) in observational comparative studies include selection bias, information bias, and confounding. Principles from statistical science and econometrics can potentially be used to make causal conclusions from observational data. Target trial emulation is a useful framework to guide the rational design and illuminate the limitations of observational studies. As with interventional research, a formal study protocol should be prepared before every observational study to enhance rigor, reduce data manipulation, and promote transparency of study reporting. Selection of the study data source is a key decision early in the design stage of a study, and should be chosen on the basis of concordance between the needs of the specific study question and the properties of the data set. We recommend the use of causal directed acyclic graphs to clearly specify the study exposure, end points, confounders, colliders, moderators, and mediators. Taken together, these recommendations promote rational design choices and cautious interpretation of the results of observational comparative studies.
Bessière F, Kronborg MB, Sommer P
… +12 more, Almorad A, Rodrigues G, Scherr D, Sebag FA, De Potter T, Grimaldi M, Reichlin T, Knecht S, Sohns C, Chierchia GB, Gardey K, Ernst S
Transvenous pacing is increasingly recognized as problematic in patients with prior or concomitant tricuspid valve intervention, owing to risks of leaflet interference, prosthetic dysfunction, and progression of tricuspi...Transvenous pacing is increasingly recognized as problematic in patients with prior or concomitant tricuspid valve intervention, owing to risks of leaflet interference, prosthetic dysfunction, and progression of tricuspid regurgitation. Leadless pacemakers offer a valve-sparing alternative; however, their safety and performance in structurally altered right heart anatomy remain incompletely defined. We conducted a systematic review to evaluate procedural feasibility, electrical performance, device-valve interaction, and clinical outcomes of leadless pacemaker implantation in patients undergoing surgical or transcatheter tricuspid valve interventions. Thirty-four studies comprising 272 patients were included, encompassing surgical repair, bioprosthetic replacement, valve-in-valve procedures, transcatheter edge-to-edge repair, and transcatheter tricuspid valve replacement. Leadless pacemakers were implanted via transfemoral, transjugular, or direct surgical approaches, achieving a procedural success rate of 99.3%. Electrical performance was consistently favorable, with stable capture thresholds, sensing amplitudes, and impedance during follow-up. Device-valve interaction was infrequent and generally manageable. Leadless pacemaker-related complications were rare (1.1%), with no device-related mortality. Within the included studies of patients undergoing surgical or transcatheter tricuspid valve interventions, no study demonstrated worsening tricuspid regurgitation attributable to the leadless pacemaker or its delivery system. Across a broad spectrum of complex tricuspid anatomies, leadless pacemakers demonstrated excellent feasibility, durable electrical performance, and a low complication profile, supporting their role as a valve-sparing pacing strategy in this population. These findings support leadless pacing in patients with prior tricuspid intervention, although prospective comparative data are required to define its role relative to alternative pacing modalities.
Aurigemma C, Costa G, Laterra G
… +74 more, Pilgrim T, Amat Santos IJ, De Backer O, Kim WK, Barbosa Ribeiro H, Saia F, Bunc M, Tchetche D, Garot P, Ribichini FL, Mylotte D, Watanabe Y, Bedogni F, Tesorio T, Rheude T, Sardella G, Tocci M, Franzone A, Valvo R, Sammartino S, Savontaus M, Wienemann H, Porto I, Gandolfo C, Iadanza A, Mach M, Latib A, Biasco L, Taramasso M, De Marco F, Frittitta V, Dipietro E, Reddavid C, Strazzieri O, Agnello F, Comis A, Calì M, Abdel-Wahab M, Stefanini GG, Tomii D, Nuyens P, Sondergaard L, Bortone AS, Zimarino M, Camara SF, Palmerini T, Orzalkiewicz M, Steblovnik K, Gautier A, Del Sole PA, Mainardi A, Lunardi M, Kawashima H, Criscione E, Cesario V, Biancari F, Zanin F, Esposito G, Adam M, Grube E, Baldus S, De Marzo V, Piredda E, Cannata S, Iacovelli F, Andreas M, Angellotti D, Sgroi C, Xhepa E, Kargoli F, Tamburino C, Burzotta F, Barbanti M, REVASC-TAVI Registry
BACKGROUND: The best management of coronary artery disease in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) is debated. We investigated the clinical impact of the residual...BACKGROUND: The best management of coronary artery disease in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) is debated. We investigated the clinical impact of the residual extent of myocardium at risk in patients undergoing TAVI. METHODS: Patients enrolled in the REVASC-TAVI (Management of Myocardial Revascularization in Patients Undergoing TAVI With Coronary Artery Disease) international multicenter registry were stratified according to the myocardium jeopardized by coronary artery disease using the British Cardiovascular Intervention Society Jeopardy Score (BCIS-JS) after a planned coronary revascularization. A planned revascularization included percutaneous coronary interventions performed before TAVI, during TAVI, or within 1 month after TAVI. The study population was divided according to the residual BCIS-JS (rBCIS-JS): patients with extensive residual myocardial at risk (rBCIS-JS >4 group) and patients without extensive residual myocardial at risk (rBCIS-JS ≤4 group). The primary study end point was the composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and rehospitalization for heart failure at 2 years. RESULTS: Among the 2407 patients enrolled, 294 pairs of patients were selected by propensity matching and compared. At 2-year follow-up, the incidence of the primary end point was higher in patients with rBCIS-JS >4 compared with patients with rBCIS-JS ≤4 (37.5% versus 23.0%, =0.004). A significantly lower rate of myocardial infarction was reported in patients with BCIS-JS ≤4 (8.2% versus 2.6%, =0.011). At multivariate analysis, rBCIS-JS >4 (hazard ratio, 1.43 [95% CI, 1.11-1.84]; =0.005) independently predicted 2-year major adverse cardiac and cerebrovascular events. CONCLUSIONS: In patients with concomitant coronary artery disease and severe aortic stenosis, the residual myocardial risk significantly affects TAVI outcomes. In particular, a rBCIS-JS >4 is associated with higher rates of major adverse cardiac and cerebrovascular events at 2 years.
BACKGROUND: Permanent pacemaker (PPM) implantation after heart transplantation (HT) is common, but contemporary data regarding utilization, outcomes, and emerging pacing technologies are limited. METHODS: We studied PPM...BACKGROUND: Permanent pacemaker (PPM) implantation after heart transplantation (HT) is common, but contemporary data regarding utilization, outcomes, and emerging pacing technologies are limited. METHODS: We studied PPM placement among 1225 bicaval HT recipients (28% women) treated at our institution from 2010 to 2025 and compared PPM recipients with HT patients without PPMs matched on sex, age, and transplant year. RESULTS: Median age at HT was 58 years (interquartile range, 48-65 years). Sixty-six (5%) patients received a PPM, with stable implantation rates over time. Median HT-to-PPM time was 4.3 months (interquartile range, 2 weeks to 4.8 years). The main indications were sinus node dysfunction (41 patients, 62%) or atrioventricular block (19 patients, 29%). Median post-HT survival was similar between PPM and non-PPM recipients (12.8 versus 11.5 years, =0.14). Older organ donor age independently predicted PPM placement (odds ratio, 1.75; =0.04). After 3.2 years of median follow-up, 1 transvenous PPM had a major complication requiring device extraction. Thirteen (20%) patients received leadless PPMs, including 3 atrial leadless PPMs and 1 dual-chamber leadless PPM. Leadless PPMs had no short-term complications over 1 year of median follow-up. CONCLUSIONS: Post-HT PPM implantation rates were low and unchanged since 2010. Most devices were implanted for sinus node dysfunction, with 44% implanted within 1 month post-HT. PPM placement was not associated with post-HT survival. Advanced organ donor age was associated with risk of PPM placement. Transvenous PPM complication rates were comparable to rates described in general populations. Leadless PPMs accounted for a substantial minority of PPM placements since their introduction in 2018, with no complications to date. Longer follow-up is needed to establish their long-term outcomes and safety in patients with HT.
Bergmark BA, Bohula EA, Marston NA
… +25 more, Park JG, Kuder JF, Murphy SA, De Ferrari GMM, Leiter LA, Nicolau JC, Averkov O, Charng MJ, Ebenbichler C, Erglis A, Gouni-Berthold I, Montalescot G, Nicholls SJ, Sigurdsson A, Sinnaeve P, Slapikas R, Tsioufis K, Verma S, Viigimaa M, Bhatia AK, Xin L, Walsh E, Ohman EM, Giugliano RP, Sabatine MS
Circulation
· 2026 May · PMID 42153665
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BACKGROUND: The clinical benefit of intensive LDL-C-lowering with evolocumab in patients with prior percutaneous coronary intervention (PCI) but without a prior myocardial infarction (MI) is not established. METHODS: VES...BACKGROUND: The clinical benefit of intensive LDL-C-lowering with evolocumab in patients with prior percutaneous coronary intervention (PCI) but without a prior myocardial infarction (MI) is not established. METHODS: VESALIUS-CV randomized patients with atherosclerosis or high-risk diabetes but without prior MI or stroke and with LDL-C ≥90 mg≥dL to evolocumab vs placebo. The median follow-up was 4.6 years. The dual primary endpoints were: coronary heart disease death, MI, or ischemic stroke (3-point MACE); and the same composite plus ischemia-driven arterial revascularization (4-point MACE). For this pre-specified subgroup analysis, patients were categorized by whether they had undergone PCI at any time prior to trial enrollment. RESULTS: Among 12,257 randomized patients, 3,627 (29.6≥) had undergone prior PCI with a median time between PCI and enrollment of 4 years. Their median age was 66 years and 30.7≥ were women. The median LDL-C at 48 weeks was 41.5 (26.0-67.0) mg/dL vs. 107.0 (84.0-135.0) mg/dL in the evolocumab vs. placebo arms (p<0.0001). Evolocumab reduced the risk of 3-point MACE by 30% (5yr KM 7.0% vs 9.5%; HR 0.70; 95%CI 0.56-0.89; P=0.004) and 4-point MACE by 18% (17.9% vs 21.7%HR 0.82; 95%CI 0.71-0.96; P=0.012), and reduced the risk of MI by 50% (3.0%vs 6.1%; HR 0.50; 95%CI 0.36-0.70; P<0.001), with the effect apparent as soon as 6 months after randomization, and of urgent coronary revascularization by 39% (HR 0.61; 95%CI 0.46-0.80; P<0.001). There were nominally lower rates of CV death (2.6% vs 3.7%; HR 0.66; 95%CI 0.45-0.96; P=0.030) and all-cause death (8.2% vs 10.2%; HR 0.76; 95%CI 0.60-0.95; P=0.016) with evolocumab. CONCLUSIONS: Evolocumab reduced the risk of major CV events in stable patients with prior PCI but no MI. These findings support intensive LDL-C-lowering in patients who have undergone PCI even in the absence of prior MI.
Yang S, Hu X, Zhang J
… +30 more, Song JE, Jiang J, Peng X, Lu D, Pan Y, Guo L, Li J, He W, Zhou H, Pu J, Huang J, Jiang F, Liu Q, Song D, Lu L, Cheng Z, Yang B, Ma J, Chen P, Li S, Meng Z, Tang L, Fan Y, Shin ES, Tu S, Nam CW, Fearon WF, Wang J, Koo BK, FLAVOUR II Study Group
BACKGROUND: While angiography-derived fractional flow reserve (AngioFFR)- and intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) yield similar outcomes, with AngioFFR associated with lower PC...BACKGROUND: While angiography-derived fractional flow reserve (AngioFFR)- and intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) yield similar outcomes, with AngioFFR associated with lower PCI rates, the relative clinical effectiveness of AngioFFR versus IVUS-guided PCI according to angiographic lesion characteristics remains unclear. METHODS: This post hoc analysis of the FLAVOUR II trial (Comparison of Angiography-Derived Fractional Flow Reserve- and Intravascular Ultrasound-Guided Intervention Strategy for Clinical Outcomes in Patients with Coronary Artery Disease) included patients with ≥50% stenosis randomized to AngioFFR- or IVUS-guided PCI. A composite lesion risk score was derived using a marginal Cox model-based linear predictor incorporating % diameter stenosis, lesion length, true bifurcation, ostial lesion, and heavy calcification. The primary end point was target vessel failure (TVF: cardiac death, target vessel myocardial infarction, and target vessel revascularization). RESULTS: Among 1726 patients, 884 (51.2%) underwent AngioFFR-guided PCI and 842 (48.8%) underwent IVUS-guided PCI. During a median 12-month follow-up, TVF occurred in 2.4% of AngioFFR-treated vessels and 1.9% of IVUS-treated vessels (=0.50). TVF risk increased progressively with a higher composite lesion risk score (adjusted hazard ratio, 2.76 [95% CI, 1.35-5.65]). This association was more pronounced in the AngioFFR group (adjusted hazard ratio, 3.93 [95% CI, 1.79-8.63]) than in the IVUS group (adjusted hazard ratio, 1.62 [95% CI, 0.42-6.22]). Compared with IVUS guidance, AngioFFR-guided vessels with high-risk lesions (score >0.32) had a higher TVF rate (5.1% versus 1.9%; =0.010), whereas outcomes were comparable in those with low-risk lesions (1.5% versus 1.9%; =0.531). AngioFFR guidance was associated with lower target vessel PCI rates in low-risk lesions (60.1% versus 76.5%; <0.001), whereas PCI rates were uniformly high and similar between groups in high-risk lesions (96.4% versus 97.4%; =0.675). CONCLUSIONS: A higher composite lesion risk score was associated with increased PCI rates and TVF risk after AngioFFR- or IVUS-guided treatment. AngioFFR guidance was associated with lower PCI rates in low-risk lesions, whereas IVUS guidance may yield more favorable outcomes in high-risk lesions. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04397211.
Chen YY, Borkowski P, Biavati L
… +14 more, Nazarenko N, Parker M, Kharawala A, Vargas-Pena C, Chowdhury I, Bock J, Garg V, Bhakta S, Faillace R, Palaiodimos L, Wu WH, Salmoirago-Blotcher E, Erqou S, Longenecker CT
Circulation
· 2026 Jun · PMID 42153290
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BACKGROUND: Heart failure is an increasingly common comorbidity among people with HIV infection, complicating care and heightening the vulnerability of this population to social adversity (SA). However, the impact of dif...BACKGROUND: Heart failure is an increasingly common comorbidity among people with HIV infection, complicating care and heightening the vulnerability of this population to social adversity (SA). However, the impact of different SA domains on outcomes in this population remains poorly understood. METHODS: We analyzed data on people with HIV infection and heart failure from the NYC 4H (NYC Health + Hospitals HIV-Heart Failure) cohort. Baseline multidimensional SA was assessed by licensed clinical social workers using standardized evaluations and grouped into 5 domains: economic hardship, health care access barriers, neighborhood or built environment instability, social support challenge, and psychobehavioral instability. We used multivariable adjusted Cox models to estimate hazard ratios (HRs) of all-cause, cardiovascular, and infection-related mortality and logistic regression to estimate odds ratios of 6-month rehospitalization risk. RESULTS: Among 1044 participants (62.9% male; mean age, 61.6 years), 601 (58%) reported at least 1 SA: economic hardship (n=130), limited health care access (n=155), unstable housing (n=129), social support challenge (n=179), or psychobehavioral instability (n=438). Over a mean follow-up of 3.8 years, exposure to any SA was associated with higher all-cause mortality (HR, 4.32 [95% CI, 3.03-6.14]), cardiovascular mortality (HR, 4.05 [95% CI, 2.17-6.83]), and infection-related mortality (HR, 2.37 [95% CI, 1.23-4.56]). Social support challenge (HR, 2.19 [95% CI, 1.35-3.55]) and psychobehavioral instability (HR, 1.96 [95% CI, 1.24-3.11]) were associated with higher cardiovascular mortality. Economic hardship (HR, 2.40 [95% CI, 1.22-4.70]) and social support challenge (HR, 3.09 [95% CI, 1.75-5.48]) were associated with higher infection-related mortality. Compared with patients without SA, those with environmental instability, psychobehavioral instability, or social support challenges had a 73% (adjusted odds ratio, 1.73 [95% CI, 1.15-2.06]), 75% (adjusted odds ratio, 1.75 [95% CI, 1.31-2.35]), and 44% (adjusted odds ratio, 1.44 [95% CI, 1.00-2.06]) higher risk of rehospitalization within 6 months, respectively. CONCLUSIONS: SA was significantly associated with mortality and rehospitalization among people with HIV infection and heart failure, with domain-specific pathways influencing specific outcomes. Multidimensional assessment of SA may offer a framework for domain-specific risk stratification in people with HIV infection and heart failure.
Lalani C, Dahabreh IJ, Cohen DJ
… +4 more, Kazi DS, Song Y, Secemsky EA, Yeh RW
Circulation
· 2026 May · PMID 42150001
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It has long been accepted that observational analyses have an important role in evaluating use patterns and assessing the safety of different treatments, including cardiovascular devices, in clinical practice. With the p...It has long been accepted that observational analyses have an important role in evaluating use patterns and assessing the safety of different treatments, including cardiovascular devices, in clinical practice. With the proliferation of large electronic databases, there has been increasing interest in using observational analyses to also examine the comparative effectiveness of devices. However, these analyses are often met with skepticism because of concerns about whether they can generate credible evidence about causal effects. This is in part a result of the difficulty in meeting the assumptions necessary to interpret observational associations as causal effects and of the wide variability in analytic rigor. In this review, we outline frameworks and review methods for using observational analyses to answer questions about the effectiveness and safety of cardiovascular devices. We highlight the target trial framework as a practical tool for guiding observational comparative effectiveness analyses. We illustrate how the framework allows investigators planning and conducting observational analyses to organize their activities as responses to 3 prompting questions. First, what is the research question of the study (ie, "What do we want?")? Second, what are the resources-including background knowledge, research concepts, principles and methods, and available data-that can be brought to bear on the research question (ie, "What do we have?")? And third, what specific steps should be taken to use the available resources to answer the research question (ie, "What do we do?")? We focus our exposition on the evaluation of cardiovascular devices, for which randomized trial data are often limited and there is a strong need for real-world evidence. In this setting, real-world evidence is usually derived from observational comparisons of the treatment of interest with relevant comparator groups using data captured during routine care. A principled approach to the planning and conduct of observational analyses can improve the quality of real-world evidence generation and ensure that the results of observational studies on medical devices can support meaningful conclusions about the risks and benefits of new devices.