BACKGROUND: As transcatheter aortic valve replacement (TAVR) expands to patients with longer life expectancy, the impact of failure mechanisms on outcomes of TAVR-explant and redo-TAVR remains uncertain. We sought to eva...BACKGROUND: As transcatheter aortic valve replacement (TAVR) expands to patients with longer life expectancy, the impact of failure mechanisms on outcomes of TAVR-explant and redo-TAVR remains uncertain. We sought to evaluate outcomes of TAVR reintervention based on the failure mechanism of the index transcatheter aortic valve. METHODS: From 2009 to 2022, 553 patients from 29 centers in the EXPLANTORREDO-TAVR registry (Explant or Redo Transcatheter Aortic Valve Replacement) underwent TAVR-explant or redo-TAVR for transcatheter aortic valve failure. Patients with endocarditis were excluded. Patients with structural valve deterioration (SVD, N=224 [64.9%]) were compared with those with nonstructural valve dysfunction (NSVD, N=121 [35.1%]), comprising paravalvular leak (86.0%) and prosthesis-patient mismatch (14.0%). Outcomes were assessed at 30 days and 1 year. RESULTS: Mean age was 75.6±9.3 years, with 42% women. There were no differences in reintervention type between groups (redo-TAVR in 58.0% SVD versus 49.6% NSVD; TAVR-explant: 42.0% versus 50.4%; =0.14). Compared with NSVD, SVD was the predominant mode of failure in balloon-expandable valves (50.7% versus 24.8%; <0.001), had a longer time to reintervention (50.7 versus 5.5 months; <0.001), and favored non-balloon-expandable valves at redo-TAVR (56.9% versus 33.3%; =0.003). Mortality at 30 days and 1 year did not differ significantly between SVD and NSVD for either redo-TAVR (30 days: 3.2% versus 1.7%, =1.00; 1 year: 18.0% versus 12.0%; =0.47) or TAVR-explant (30 days: 16.3% versus 12.1%, =0.63; 1 year: 40.0% versus 29.5%; =0.39). There were also no differences in risk-adjusted 3-year cumulative mortality between groups (redo-TAVR: hazard ratio, 1.30 [95% CI, 0.68-2.46], =0.43 [ref=NSVD]; TAVR-explant: hazard ratio, 1.24 [95% CI, 0.64-2.41]; =0.53). CONCLUSIONS: SVD and NSVD failures had distinct valve types and reintervention timing, with SVD having a longer time to TAVR reintervention, but the failure mechanism did not impact reintervention type or clinical outcomes.
Melica B, Carasso S, Butnaru A
… +6 more, Gogorishvili I, Metreveli M, Modine T, Kurashvili L, Farkash R, Meerkin D
Circ Cardiovasc Interv
· 2026 Jun · PMID 41953988
·
Full text
BACKGROUND: The AMEND implant is a semi-rigid closed D-shaped annuloplasty ring deployed through a transvenous transeptal approach. It is aimed to affect selective anteroposterior dimensional reduction, improving leaflet...BACKGROUND: The AMEND implant is a semi-rigid closed D-shaped annuloplasty ring deployed through a transvenous transeptal approach. It is aimed to affect selective anteroposterior dimensional reduction, improving leaflet coaptation, and reduce mitral regurgitation (MR). We report the 6-month outcomes of the first cohort treated. METHODS: Thirteen patients with the grade 3 or 4 functional MR were treated in 2 studies in Georgia and Israel, and with compassionate approvals in Portugal and France. They underwent mitral repair with the AMEND annuloplasty and were followed for 6 months. RESULTS: There were no deaths, myocardial infarctions, strokes or cardiac surgery. There were 2 pericardial effusions, 1 acute and the second at 4 months. There was no anchor disengagement or device dehiscence over the follow-up period. There was a single patient who was readmitted with heart failure, and the iatrogenic atrial septal defect was closed. At 6 months the overall anteroposterior dimensional reduction achieved acutely was maintained, with MR reduction being stable, with 11 of 13 patients with ≤grade 1 MR. CONCLUSIONS: In this small multicenter cohort of patients, the AMEND annuloplasty procedure demonstrated promising safety, with stable and significant reduction of MR maintained over the 6-month follow-up period.
BACKGROUND: Transcatheter mitral valve-in-valve replacement is an established therapy for intermediate and high-risk patients with degenerated bioprostheses, but restricted transcatheter valve (THV) expansion within rigi...BACKGROUND: Transcatheter mitral valve-in-valve replacement is an established therapy for intermediate and high-risk patients with degenerated bioprostheses, but restricted transcatheter valve (THV) expansion within rigid surgical frames and elevated gradients have raised durability concerns. This study aimed to evaluate midterm outcomes of mitral valve-in-valve patients according to THV expansion and sizing strategy. METHODS: Patients who underwent mitral valve-in-valve with balloon-expandable valves at Mayo Clinic Rochester between 2014 and 2023 were retrospectively analyzed. THV expansion (inflow, waist, outflow) was measured from procedural fluoroscopy and indexed to nominal size, with zero indicating expansion to nominal dimensions. Median index values were used as subgroup cutoffs to compare the incidence of the primary composite outcome of all-cause mortality, heart failure readmission, and valve reintervention. RESULTS: The analysis included 80 patients with a median follow-up of 2.5 years. A total of 53 (66%) valves were underexpanded across all 3 diameters, with median inflow, waist, and outflow expansion indices of -10.2, -16.2, and -3.2, respectively. Across all indices, THV expansion closer to nominal size was associated with lower rates of the primary outcome (<0.05). Greater expansion correlated with a larger mitral valve area and lower transvalvular mean gradient. Oversized THVs were significantly less expanded and had a higher incidence of the primary composite outcome compared with recommended-size THVs (=0.02). CONCLUSIONS: THV underexpansion in degenerated mitral bioprostheses is common and associated with elevated gradients and worse midterm outcomes. Further research is warranted to define THV expansion targets to improve midterm outcomes following mitral valve-in-valve intervention.
Adriaansen FW, Crooijmans C, Jansen TPJ
… +28 more, Yosofi B, Meeder JG, Appelman Y, Beijk MAM, van de Hoef TP, Nijkamp T, den Ruijter HM, de Vos AMJ, Paradies V, Meuwissen M, Vos NS, Olde Bijvank EGM, Al Amri I, den Haan MC, Halim J, van den Oord SCH, Arkenbout K, Kok MM, Woudstra P, Vossenberg TNE, Fagel ND, Heestermans TACM, Cornel JH, van Royen N, Elias-Smale SE, Dimitriu-Leen AC, Damman P, for NL-CFT
Circ Cardiovasc Interv
· 2026 Jun · PMID 41904793
·
Full text
BACKGROUND: Coronary vasomotor dysfunction is diagnosed by a coronary function testing (CFT). However, protocols vary, and the influence of access site and concomitant vasodilator medication on the diagnostic yield and s...BACKGROUND: Coronary vasomotor dysfunction is diagnosed by a coronary function testing (CFT). However, protocols vary, and the influence of access site and concomitant vasodilator medication on the diagnostic yield and safety of CFT is unclear. This study assessed the diagnostic yield and safety of CFT by radial access with intraarterial calcium channel blockers compared with CFT by femoral access. METHODS: Data were obtained from the Netherlands Registry of Invasive Coronary Vasomotor Function Testing, a Dutch multicenter collaboration on CFT. Patients who underwent CFT between December 2020 and July 2025 were included. RESULTS: A total of 1885 patients were included, 1436 (76.2%) with primary radial access and 380 (20.2%) with primary femoral access. In 69 (3.7%) patients conversion from radial to femoral access was necessary. The conversion group was analyzed separately. The total diagnostic yield of coronary vasomotor dysfunction was 78.5%. There was no significant difference in the prevalence of coronary vasomotor dysfunction between patients with primary radial versus femoral access (79.2% versus 75.3%; =0.1). There was also no difference in total diagnostic yield between the group without conversion and the conversion group (78.4% versus 82.6%; =0.4); however, spasm was more prevalent in the conversion group (67.7% versus 79.4%; =0.04). There were no differences in CFT complication rates between groups. CONCLUSIONS: Primary radial access with routine administration of calcium channel blockers was not associated with a lower diagnostic yield in CFT than primary femoral access. Procedural safety was comparable.
BACKGROUND: Microaxial flow pumps are emerging therapeutic devices for acute myocardial infarction-related cardiogenic shock. However, prognostic implications of hemorrhagic and ischemic complications on mortality remain...BACKGROUND: Microaxial flow pumps are emerging therapeutic devices for acute myocardial infarction-related cardiogenic shock. However, prognostic implications of hemorrhagic and ischemic complications on mortality remain limited. We aim to clarify the incidence of these complications in acute myocardial infarction-related cardiogenic shock requiring a microaxial flow pump and their associations with mortality. METHODS: We analyzed patients from the J-PVAD (Japan Registry for Percutaneous Ventricular Assist Device) who underwent microaxial flow pump implantation for acute myocardial infarction-related cardiogenic shock between 2020 and 2023. Primary composite exposures were bleeding complications (nonintracranial bleeding, including access site bleeding and nonintracranial bleeding requiring blood transfusion, and intracranial hemorrhage) and ischemic complications (lower limb ischemia, recurrent myocardial infarction, noncerebral embolism, or ischemic stroke). The primary outcome was in-hospital all-cause mortality. Cumulative incidences were estimated with death as a competing event. Cox regression with time-varying exposures assessed associations between complications and mortality, adjusting for clinical characteristics. Population attributable fractions of complications for death were calculated, indicating the proportion of mortality that could theoretically be prevented if the complications were eliminated. RESULTS: Of 2034 patients (mean age, 69.2±11.7 years; 17.6% women), 840 (41.3%) died during hospitalization. The 30-day cumulative incidence was 23.2% (95% CI, 21.4%-25.0%) for bleeding complications and 10.5% (95% CI, 9.1%-11.8%) for ischemic complications. Both complications were independently associated with increased mortality (adjusted hazard ratio, 1.60 [95% CI, 1.30-1.97] for bleeding; adjusted hazard ratio, 1.74 [95% CI, 1.24-2.44] for ischemic complications). The population attributable fraction of bleeding complications was 10.7% (95% CI, 6.6%-14.0%), compared with 4.0% (1.8%-5.6%) for ischemic complications, suggesting that bleeding events contributed substantially to the mortality burden. CONCLUSIONS: Both bleeding and ischemic complications remain frequent adverse events in acute myocardial infarction-related cardiogenic shock requiring a microaxial flow pump. While both complications were significantly associated with mortality, the higher incidence of bleeding complications contributed to a greater mortality burden. This underscores the importance of bleeding prevention strategies alongside ischemic complication management in this high-risk population.
Russo G, Pedicino D, Adamo M
… +44 more, Alessandrini H, Andreas M, Braun D, Connelly KA, Denti P, Estevez-Loureiro R, Fam N, Hahn RT, Harr C, Hausleiter J, Kalbacher D, Ho E, Latib A, Lubos E, Ludwig S, Lurz P, Metra M, Monivas V, Nickenig G, Pedrazzini G, Pozzoli A, Praz F, Rodes-Cabau J, Besler C, Rommel KP, Schofer J, Scotti A, Lentini N, Pastorino R, Piayda K, Sievert H, Tang GHL, Pascual I, Thiele H, Schlotter F, Sangiorgi GM, von Bardeleben RS, Webb J, Windecker S, Leon M, Enriquez-Sarano M, Maisano F, Bloechlinger S, Taramasso M
BACKGROUND: The impact of proportionality to heart valve regurgitation has been widely investigated in mitral regurgitation, helping to better characterize the best candidates for therapies. However, it has never been st...BACKGROUND: The impact of proportionality to heart valve regurgitation has been widely investigated in mitral regurgitation, helping to better characterize the best candidates for therapies. However, it has never been studied in tricuspid regurgitation (TR). The aim of the present study is to investigate the impact of the proportionality of TR on outcomes. METHODS: Patients undergoing tricuspid transcatheter edge-to-edge repair were selected from the TRIVALVE registry (International Multisite Transcatheter Tricuspid Valve Therapies Registry). Patients were divided according to the ratio between effective regurgitant orifice area (EROA) and right ventricular (RV) end diastolic diameter (RVEDD) into tertiles: patients with low EROA/RVEDD (RV, dominant); intermediate EROA/RVEDD (RV and TR, RV-TR, codominant), and high EROA/RVEDD (TR, dominant). The primary outcome was all-cause mortality. Median follow-up was 9.7 months (4.2-12.0). RESULTS: A total of 204 patients were included in the present study: 67 for the RV dominant, 68 for the RV-TR codominant, and 69 for the TR dominant group. The 3 groups presented different baseline characteristics. Survival analysis among the 3 groups showed a trend towards worse prognosis for the RV-dominant group, as compared with the RV-TR codominant and TR dominant groups. CONCLUSIONS: The conceptual framework of proportionality is applicable to TR with EROA/RVEDD, defining a higher risk RV-dominant phenotype with a trend towards worse survival after tricuspid transcatheter edge-to-edge repair.
De Cock E, Adriaenssens T, Stammen F
… +16 more, Vanderheyden M, Dubois C, Vanhaverbeke M, Ferdinande B, Pirlet C, Simon F, Vandeloo B, Lesizza P, Rosseel L, Aminian A, Scott B, De Vroey F, Christiaen E, le Polain de Waroux JB, Van der Heyden J, Buysschaert I
BACKGROUND: The prognostic value of rapid atrial pacing (RAP)-induced Wenckebach atrioventricular block (W-AVB) as a diagnostic test for predicting permanent pacemaker implantation (PPI) after transcatheter aortic valve...BACKGROUND: The prognostic value of rapid atrial pacing (RAP)-induced Wenckebach atrioventricular block (W-AVB) as a diagnostic test for predicting permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) remains unclear and requires further validation. The objective of this study was to evaluate the predictive value of RAP-induced W-AVB for PPI and sudden cardiac death within 30 days post-TAVR. METHODS: This prospective, investigator-initiated, multicenter study (PACE-TAVR) included 640 patients undergoing TAVR across 12 centers. RAP was performed before and after TAVR to assess for W-AVB. Using negative predictive values and negative likelihood ratios, the predictive value of W-AVB was evaluated for the primary end point: sudden cardiac death or guideline-based indications for PPI, including complete AVB or alternating bundle branch block (Class I), and preexisting conduction disturbances with new ECG changes, new-onset left bundle branch block, a positive electrophysiology study, or sinus node dysfunction (Class II). RESULTS: RAP was successfully performed post-TAVR in 556 patients, with RAP-induced W-AVB observed in 192 (34.5%). W-AVB was associated with baseline conduction disturbances, amiodarone use, pre-TAVR RAP-induced W-AVB, and anesthesia type. The primary end point was more frequent in patients with W-AVB (15.6% versus 9.3%; odds ratio, 1.80 [95% CI, 1.06-3.04]; =0.029). However, the absence of W-AVB had a negative predictive value of only 90.7% and a poor negative likelihood ratio (0.79). The test's utility declined in subgroups at high risk for PPI, including self-expanding valve recipients (odds ratio, 1.47 [95% CI, 0.84-2.58]; negative predictive value, 88.4%; negative likelihood ratio, 0.86) and patients with a baseline or new left bundle branch block (odds ratio, 1.14 [95% CI, 0.54-2.42]; negative predictive value, 81.3%; negative likelihood ratio, 0.95). CONCLUSIONS: RAP-induced W-AVB demonstrates limited utility in predicting post-TAVR PPI or sudden cardiac death, particularly in patients at high risk for PPI. Clinicians should be cautious when using this test for post-TAVR rhythm management. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT05278585.
Hainstock MR, Fleming G, Kim D
… +22 more, Aboulhosn J, Levi D, Krasuski R, Sommer R, Torres AJ, Gray R, Kereiakes D, Leventhal A, Gillespie M, Szeto W, Zajarias A, Shahanavaz S, Steinberg ZL, Jones TK, Mahadevan VS, Moore P, Elmariah S, Shirali G, Li W, Babaliaros V, Lim DS, COMPASSION 3 Trial Executive Committee and Study Investigators
BACKGROUND: The COMPASSION S3 trial (Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional Transcatheter Heart Valve) was designed to evaluate the safety and effectiveness of the...BACKGROUND: The COMPASSION S3 trial (Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional Transcatheter Heart Valve) was designed to evaluate the safety and effectiveness of the SAPIEN 3 transcatheter heart valve (THV) for transcatheter pulmonic valve replacement in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position. Here, 5-year clinical and hemodynamic outcomes for patients in the main cohort and the continued access protocol are reported. METHODS: The COMPASSION S3 trial was a single-arm, multicenter study enrolling patients with either moderate-to-severe pulmonic regurgitation, a mean RVOT gradient ≥35 mm Hg, or both. The primary end point was THV dysfunction at 1 year, a nonhierarchical composite of RVOT reintervention, ≥moderate total pulmonic regurgitation, and mean RVOT gradient >40 mm Hg. Clinical and echocardiographic outcomes were assessed at baseline, discharge, 30 days, 6 months, 1 year, and then annually to 5 years. RESULTS: Between 2016 and 2020, 69 patients were enrolled and successfully implanted with the SAPIEN 3 THV. The mean patient age was 32.1 years, and most patients (70.8%) had a conduit as the most recent prior intervention. At 5 years, the rate of THV dysfunction was 12.0%: 3 patients required reintervention, 2 patients had ≥moderate pulmonic regurgitation, and 1 patient had a mean gradient >40 mm Hg. There were 3 cases of device-related endocarditis (4.4%). One death occurred on postoperative day 560 due to cardiogenic shock. No cases of tricuspid valve injury, stent fractures, or valve malposition were reported. Post-transcatheter pulmonic valve replacement, mean gradients were low and stable through 5-year follow-up. Through 5 years, >95% of patients had ≤mild total pulmonic regurgitation, and 97.9% of patients had none/trace paravalvular regurgitation. CONCLUSIONS: Five-year results from the COMPASSION S3 trial demonstrate that the SAPIEN 3 THV provides durable RVOT relief with low rates of reintervention or endocarditis, supporting the device as a safe and versatile option for transcatheter pulmonic valve replacement across diverse anatomies and clinical scenarios. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT02744677.
Perlow GL, Yang Y, Knight JH
… +4 more, Shi CY, Thomas AS, Oster ME, Kochilas LK
Circ Cardiovasc Interv
· 2026 Jun · PMID 41867053
·
Full text
BACKGROUND: Mild congenital heart diseases such as atrial septal defect, ventricular septal defect, patent ductus arteriosus, and pulmonary valve stenosis constitute a significant public health problem. Understanding lon...BACKGROUND: Mild congenital heart diseases such as atrial septal defect, ventricular septal defect, patent ductus arteriosus, and pulmonary valve stenosis constitute a significant public health problem. Understanding long-term outcomes after interventions for mild congenital heart disease is essential to inform lifelong care. METHODS: We queried the Pediatric Cardiac Care Consortium, a multicenter US-based registry of patients with congenital heart disease interventions, for patients undergoing surgical or transcatheter procedures for atrial septal defect, ventricular septal defect, patent ductus arteriosus, and pulmonary valve stenosis; 17 407 patients were included. Statistical methods included survival analysis using Kaplan-Meier plots, multivariable Cox proportional hazards models for risk factors for death and standardized mortality ratios. RESULTS: There were 115 in-hospital deaths (0.7%), with the remaining patients included in the postdischarge. The 35-year post-discharge survival ranged from 95.5% for pulmonary valve stenosis to 92.1% for ventricular septal defect. Survival patterns differed by lesion and age at intervention, with intervention at 1≤5 years generally associated with more favorable outcomes. Lower weight-for-age at intervention was associated with an increased hazard of death across all shunt lesions but not for pulmonary valve stenosis. Compared with the general population, mortality risk remained elevated for up to 18 to 20 years after intervention. CONCLUSIONS: Long-term survival after intervention for mild congenital heart disease is excellent; yet lesion-specific risks persist for decades. Age and weight-for-age at intervention are associated with survival, together with excess mortality beyond childhood underscore the need for lifelong, lesion-tailored surveillance in this growing population.
Ahn JM, Kumar S, Ko E
… +15 more, Mohammed G, Hayashida K, Yin WH, Jilaihawi H, Makkar R, Kim WK, Palmerini T, An SY, Kim JH, Kang DY, Kim JB, Cohen DJ, Capodanno D, Park DW, Park SJ
Surgical aortic valve (AV) replacement has been the standard treatment for patients with severe symptomatic degenerative AV stenosis (AS). In recent years, transcatheter AV replacement has emerged as an established alter...Surgical aortic valve (AV) replacement has been the standard treatment for patients with severe symptomatic degenerative AV stenosis (AS). In recent years, transcatheter AV replacement has emerged as an established alternative in selected patient populations, supported by robust evidence in tricuspid AS. However, there has been limited evaluation of transcatheter AV replacement in bicuspid AV AS. Recently, several observational studies have demonstrated the feasibility and safety of transcatheter AV replacement in bicuspid AV AS, and the use of newer-generation devices has shown encouraging outcomes. However, the incidence of procedural complications such as paravalvular regurgitation, permanent pacemaker implantation, and aortic root injury was more frequent in patients with bicuspid AV AS compared with tricuspid AS. We review the clinical evidence of transcatheter AV replacement for bicuspid AV AS and suggest the appropriate criteria for patient and device selection, implantation techniques, and further management.
BACKGROUND: Clopidogrel may have ischemic benefit over aspirin as long-term monotherapy in patients receiving percutaneous coronary intervention. METHODS: Both the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplate...BACKGROUND: Clopidogrel may have ischemic benefit over aspirin as long-term monotherapy in patients receiving percutaneous coronary intervention. METHODS: Both the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy-2) and STOPDAPT-2 ACS (Short and Optimal Duration of Dual Antiplatelet Therapy-2 Study for the Patients With Acute Coronary Syndrome) were multicenter, open-label, adjudicator-blinded, randomized clinical trials in Japan, with the same protocol except that the STOPDAPT-2 ACS enrolled patients with acute coronary syndrome, exclusively. The patients after percutaneous coronary intervention with cobalt-chromium everolimus-eluting stents were randomized into 1-month dual antiplatelet therapy followed by clopidogrel monotherapy (clopidogrel group) or 12-month dual antiplatelet therapy followed by aspirin monotherapy (aspirin group). Follow-up duration was 5 years. The clinical effect between clopidogrel and aspirin monotherapy was compared by the 1-year landmark analysis in the STOPDAPT-2 ACS and STOPDAPT-2 total cohort, a pooled cohort of the 2 trials. The primary end point was the composite of cardiovascular end point (cardiovascular death, myocardial infarction, stroke, or definite stent thrombosis) and bleeding end point (Thrombolysis in Myocardial Infarction major/minor). The major secondary end points were each of the cardiovascular composite end point and the bleeding end point. RESULTS: Of 2986 patients (clopidogrel group: 1492, aspirin group: 1494) in the 5-year analysis of the STOPDAPT-2 ACS, 2875 (96.3%) completed follow-up. By the 1-year landmark analysis, clopidogrel group was superior to aspirin group for both the primary end point (6.18% and 8.27%; hazard ratio, 0.75 [95% CI, 0.57-0.997]; =0.048) and the major secondary cardiovascular end point (4.73% and 6.77%; hazard ratio, 0.70 [95% CI, 0.51-0.96]; =0.03). In the STOPDAPT-2 total cohort, including 5991 patients, the superiority of clopidogrel over aspirin for the cardiovascular end point was highly significant (hazard ratio, 0.74 [95% CI, 0.60-0.91]; =0.004), although the superiority on the primary end point was insignificant (hazard ratio, 0.86 [95% CI, 0.72-1.03]; =0.11). There was no between-groups difference in the major secondary bleeding end point, both in the STOPDAPT-2 ACS and STOPDAPT-2 total cohort. CONCLUSIONS: Clopidogrel monotherapy was superior to aspirin monotherapy for cardiovascular outcomes beyond 1 year after percutaneous coronary intervention, without increased bleeding risk. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT02619760 and NCT03462498.
Abd Razak M, Vamvakas G, McGarvey M
… +31 more, McGrath S, Rathod K, Elamin A, Yao Z, Kordis P, Simpson R, Sajjad U, Iskandar Z, Fish M, Hamilton G, Pałczyński P, Tuchacz S, Das A, Agamy S, Kalra S, Mozid A, Dworakowski R, Sieminksi M, Yeoh J, Arri S, Johnson TW, Curzen N, Noc M, Appleby C, Rees P, Keeble TR, Shah AM, MacCarthy P, Byrne J, Stahl D, Pareek N
BACKGROUND: The purpose of this study was to prospectively validate the MIRACLE score in the GLOBAL-MIRACLE registry, a multicenter, international, prospective registry of patients admitted with resuscitated out-of-hospi...BACKGROUND: The purpose of this study was to prospectively validate the MIRACLE score in the GLOBAL-MIRACLE registry, a multicenter, international, prospective registry of patients admitted with resuscitated out-of-hospital cardiac arrest of presumed cardiac cause. METHODS: From January 1, 2022 to May 31, 2023, 770 patients were recruited from 11 centers across 5 countries. The primary end point was poor neurological outcome (Cerebral Performance Category 3-5) at hospital discharge. Model discrimination was assessed by the area under the receiver operating characteristic curve. We compared the discriminatory performance of the MIRACLE score against Cardiac Arrest Hospital Prognosis, out-of-hospital cardiac arrest, Target Temperature Management, NULL-PLEASE, C-GRAPH, and rCAST. RESULTS: The primary end point occurred in 395 (51.2%) patients. The MIRACLE score had an area under the curve of 0.861 (95% CI, 0.835-0.887). A MIRACLE score ≤2 had a negative predictive value of 87.8%, while a score of ≥7 had a positive predictive value of 98.3%. The MIRACLE score had equal performance to the TTM risk tool (=0.12) but better discriminatory performance than other risk tools (<0.0001). The MIRACLE score showed good performance in those with ST-segment-elevation myocardial infarction (0.851 [95% CI, 0.816-0.886]) and without ST-segment-elevation myocardial infarction (0.873 [95% CI, 0.834-0.912]) and in those with cardiogenic shock (0.832 [95% CI, 0.789-0.875]) and without cardiogenic shock (0.853 [95% CI, 0.810-0.895]). CONCLUSIONS: The MIRACLE score is a practical risk tool that shows excellent discrimination performance for poor neurological outcome after presumed cardiac cause out-of-hospital cardiac arrest, including based on hemodynamic status and admission 12-lead ECG. Early stratification of out-of-hospital cardiac arrest patients using the MIRACLE score should be evaluated in future randomized controlled trials.
BACKGROUND: Angiography-derived fractional flow reserve (Angio-FFR) is an emerging tool for guiding percutaneous coronary intervention (PCI). Its uptake and outcomes compared with pressure wire (PW)-based assessment in t...BACKGROUND: Angiography-derived fractional flow reserve (Angio-FFR) is an emerging tool for guiding percutaneous coronary intervention (PCI). Its uptake and outcomes compared with pressure wire (PW)-based assessment in the United States are unknown. METHODS: We conducted a cohort study using US Medicare beneficiary data from January 1, 2019 to December 31, 2024. Propensity score matching (1:3) of Angio-FFR to PW was performed in patients who underwent PCI during the same procedure, and separately among those who did not undergo PCI during the same procedure. The primary outcome was the cumulative incidence of major adverse cardiovascular events through 2 years, including all-cause death, myocardial infarction, and repeat revascularization. Secondary outcomes included individual major adverse cardiovascular event components, 30-day acute kidney injury, and 30-day major bleeding. Falsification end points (hospitalization for pneumonia and hip fracture) were used to assess unmeasured confounding. RESULTS: Of 466 535 angiograms that included intraprocedural physiological assessment, 1.00% (N=4672) used Angio-FFR. Annual use increased from 0.47% in 2019 to 3.85% in 2024. Among patients with PCI, 1591 Angio-FFR and 4773 PW-matched patients with PCI had similar major adverse cardiovascular event rates through 2 years (24.8% versus 23.5%; hazard ratio, 1.01 [95% CI, 0.85-1.20]). Secondary outcomes and falsification end points were not significantly different. In non-PCI patients, 2532 Angio-FFR and 7596 PW-matched patients also had similar major adverse cardiovascular events through 2 years (24.1% versus 23.9%; hazard ratio, 0.97 [95% CI, 0.84-1.11]). CONCLUSIONS: Angio-FFR usage in the United States is modest but increasing. Angio-FFR guidance during angiography versus PW was associated with comparable outcomes through 2 years.
Sammour YM, Spertus JA, Smilowitz NR
… +13 more, Dong H, Sandesara PB, Goel SS, Khan SU, Shah A, Jones P, Wheeler N, Song Y, Rab T, Nicholson WJ, Jaber WA, Wadhera RK, Kleiman NS
BACKGROUND: Although guidelines recommend invasive management for non-ST-segment-elevation myocardial infarction (NSTEMI), there is considerable variability in the application of these recommendations across different ho...BACKGROUND: Although guidelines recommend invasive management for non-ST-segment-elevation myocardial infarction (NSTEMI), there is considerable variability in the application of these recommendations across different hospitals, reflecting a lack of standardized clinical pathways and highlighting ongoing uncertainty in real-world practice. We sought to describe site-level variability in the use and timing of invasive angiography for NSTEMI and its association with in-hospital outcomes. METHODS: Using National Cardiovascular Data Registry Chest Pain-MI registry data (2019-2024), the rates and timing of invasive coronary angiography, if any, were characterized among patients with NSTEMI. Hierarchical logistic regression models were created to describe hospital-level variability in management using median odds ratios, adjusted for patient and site characteristics. Inverse probability weighting was used to estimate the association between treatment strategy and in-hospital outcomes. RESULTS: We included 287 275 patients with type-1 NSTEMI from 541 hospitals (age, 67.6±13.3 years; 36.4% women). Invasive coronary angiography was performed in 87.1%, of whom 56.9% within 24 hours. Among those treated invasively, 66.1% received percutaneous coronary intervention. Older patients with more comorbidities were paradoxically more likely to receive conservative management or delayed intervention (>24 hours). Site-level variability for invasive strategy (versus conservative) was large (median odds ratio, 2.85 (95% CI, 2.64-3.10]), as was early invasive treatment (median odds ratio, 1.67 [95% CI, 1.62-1.74]), particularly on weekends/holidays (median odds ratio, 1.89 [95% CI, 1.81-1.98]). The use of any invasive strategy was associated with lower in-hospital mortality versus conservative management (weighted odds ratio, 0.36 [95% CI, 0.31-0.42]). This finding was consistent across all baseline risk categories (<0.001). CONCLUSIONS: Patients with type-1 NSTEMI and higher-risk clinical profiles were not consistently prioritized to undergo early invasive management with substantial variability across hospitals. Invasive management was associated with lower in-hospital mortality compared with conservative treatment. Future randomized studies in the modern percutaneous coronary intervention era are needed to confirm our findings and identify which patients benefit most and when intervention should occur.