Bangalore S, Tomalty RD, Kado H
… +16 more, Sayfo S, Raskin A, Qamar A, Vargas Estrada A, Garcia-Reyes K, Lipshutz HG, Yallapragada S, Butty S, Gandhi S, Dexter D, Trivax J, Ali F, Knox M, Ramos C, Al-Saghir Y, Bishay V
Circ Cardiovasc Interv
· 2025 Nov · PMID 40961960
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BACKGROUND: Mechanical thrombectomy offers a promising alternative to thrombolytic-based approaches for reducing thrombus burden and right heart strain in acute pulmonary embolism. This pivotal Food and Drug Administrati...BACKGROUND: Mechanical thrombectomy offers a promising alternative to thrombolytic-based approaches for reducing thrombus burden and right heart strain in acute pulmonary embolism. This pivotal Food and Drug Administration-approval trial evaluated the safety and efficacy of the Symphony Thrombectomy System (Imperative Care, Inc, Campbell, CA) in acute intermediate-risk pulmonary embolism. METHODS: Patients with intermediate-risk pulmonary embolism (systolic blood pressure ≥90 mm Hg; right ventricle-to-left ventricle ratio >0.9) were enrolled without roll-ins. The primary safety end point was the rate of major adverse events within 48 hours, defined as a composite of all-cause major bleeding, device-related mortality, and serious device-related events, adjudicated by an academic independent safety board. The primary efficacy end point was the core laboratory-assessed mean change in right ventricle-to-left ventricle ratio from baseline to 48 hours. Prespecified performance goals were set for both. Exploratory end points included immediate postprocedure change in mean pulmonary artery pressure and change in modified Miller index at 48 hours. Safety was assessed in the intention-to-treat cohort and efficacy in the modified intention-to-treat cohort, excluding patients receiving nonstudy device treatments. RESULTS: Between December 2023 and May 2025, 109 patients were treated at 17 US centers (intention-to-treat), with 106 in the modified intention-to-treat cohort. The major adverse events rate was 0.9% (1/109), with an upper 97.5% CI of 5.7%, meeting the <15% safety goal (<0.001). No device-related clinical deterioration, pulmonary vascular injury, or cardiac injury occurred at 48 hours; no mortality occurred through 30 days. The mean right ventricle-to-left ventricle ratio decrease was 0.44, with a lower 97.5% CI of 0.36, exceeding the >0.20 performance goal (<0.001). Mean pulmonary artery pressure decreased from 29.1±7.2 to 22.2±6.6 mm Hg (24%) and the modified Miller index from 24.2±4.1 to 14.9±5.4 (38%), both <0.001. CONCLUSIONS: These data support the safety and effectiveness of the Symphony Thrombectomy System in patients with acute intermediate-risk pulmonary embolism. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT06062329.
BACKGROUND: Self-expanding transcatheter pulmonary valves (TPV) offer a promising alternative to surgical pulmonary valve replacement in patients with a large patched or native right ventricular outflow tract. Little is...BACKGROUND: Self-expanding transcatheter pulmonary valves (TPV) offer a promising alternative to surgical pulmonary valve replacement in patients with a large patched or native right ventricular outflow tract. Little is known about remodeling of the implanted valve or valve-anatomy interactions. METHODS: We reviewed all patients who underwent TPV replacement with the Harmony valve (Medtronic, Inc) at our center and had a postimplant computed tomography angiogram. RESULTS: Of 63 patients who underwent TPV replacement, 36 had a computed tomography angiogram performed 0.2 to 4.9 years (median 1 year) after implant, in most cases for surveillance. Hypoattenuated leaflet thickening was identified in 28% of patients and tissue ingrowth/thickening on the luminal aspect of the device was observed in 39%. In most cases, these findings were mild and were not associated with valve stenosis or regurgitation. Most patients were discharged after TPV replacement on aspirin without anticoagulation, but addition of oral anticoagulants reversed hypoattenuated leaflet thickening in 2 patients who underwent a second follow-up computed tomography angiogram 6 months later. New frame deformation and stent fracture were uncommon, and erosion of the valve did not occur. The outflow portion of the TPV frame was frequently close to the left coronary artery, but did not cause compression. CONCLUSIONS: This study provides novel data related to hypoattenuated leaflet thickening, tissue ingrowth within the TPV frame, and proximity of the implanted valve to the coronary arteries, which should help clinicians evaluate and manage patients before and after Harmony valve implant.
Maznyczka A, Arunothayaraj S, Banning AP
… +29 more, Schmitz T, Wlodarczak A, Silvestri M, Egred M, Koning R, Spence MS, Morice MC, Lefevre T, Ferenc M, Cockburn J, Erglis A, Brunel P, Burzotta F, Kretov E, Hovasse T, Pan M, Clesham G, Chieffo A, Mylotte D, Lindsay M, Christiansen EH, Bouisset F, Vaquerizo B, Lassen JF, Darremont O, Louvard Y, Stankovic G, Hildick-Smith D, EBC MAIN (European Bifurcation Club Left Main Coronary Stent) Trial Investigators
BACKGROUND: In the randomized EBC MAIN trial (European Bifurcation Club Left Main Coronary Stent), target lesion revascularization at 3 years poststenting of left main (LM) bifurcations was more frequent with upfront dua...BACKGROUND: In the randomized EBC MAIN trial (European Bifurcation Club Left Main Coronary Stent), target lesion revascularization at 3 years poststenting of left main (LM) bifurcations was more frequent with upfront dual-stenting compared with the stepwise provisional approach. Restenosis location and its relation to stent technique are poorly characterized. The aim of this study was to investigate restenosis location after LM bifurcation stenting, and the impact of stent implantation technique. METHODS: Patients from the EBC MAIN trial who underwent target lesion revascularization during the 3-year follow-up had restenosis location assessed by the core laboratory. Restenosis was defined as ≥50% lesion diameter stenosis. RESULTS: Among 48 patients with target lesion revascularization (mean age 70.3±10.6 years, 72.9% men), 31 were randomized to and treated with upfront dual-stenting, while 17 were randomized to the stepwise provisional technique, of whom 4 had dual-stent implantation. The treatment groups therefore comprised 35 dual-stented and 13 single-stented patients. The commonest pattern of subsequent restenosis was isolated ostial circumflex restenosis (58% of patients), regardless of dual- or single-stent implantation. The ostial circumflex was the culprit lesion for target lesion revascularization in 34 (71%) patients overall (dual- versus single-stented patients: 77% versus 54%; =0.115). During the 3-year follow-up, the mean % diameter stenosis at the circumflex ostium was similar after dual- versus single-stent implantation (64.6% versus 60.5%, coefficient, -0.12 [95% CI, -0.46 to 0.22]; =0.473). Single stenting from LM to the circumflex artery was associated with worse subsequent mean % diameter stenosis in the ostium of the left anterior descending artery versus single stenting from LM- left anterior descending (49.8% versus 19.8%, coefficient, 0.57 [95% CI, 0.003-1.13]; =0.049). CONCLUSIONS: The circumflex ostium is the commonest site requiring revascularization after LM bifurcation stenting, irrespective of whether 1 or 2 stents were deployed. Strategies are needed to improve the long-term success of percutaneous coronary intervention to the circumflex artery ostium. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT02497014.
Ischemic heart disease is the leading cause of heart failure with reduced ejection fraction in the developed world. An evolution of background medical therapy over the past decade has spurred improvement in symptoms and...Ischemic heart disease is the leading cause of heart failure with reduced ejection fraction in the developed world. An evolution of background medical therapy over the past decade has spurred improvement in symptoms and a reduction in morbidity and mortality with ischemic cardiomyopathy. However, there is still ongoing debate about the role and impact of revascularization. Much of the societal guidance regarding revascularization with coronary artery bypass grafting in ischemic cardiomyopathy comes from the STICH trial (Surgical Treatment for Ischemic Heart Failure) which predates improvements in medical therapy. More recently, the REVIVED-BCIS2 trial (Revascularization for Ischemic Ventricular Dysfunction-British Cardiovascular Intervention Society) failed to show a benefit of percutaneous coronary intervention on heart failure hospitalization and mortality in ischemic cardiomyopathy over contemporary medical therapy alone. Yet, there are outstanding questions regarding the role and modality of revascularization required to improve outcomes. We review current data and future directions in the management of ischemic cardiomyopathy and the potential role of revascularization.
Rao K, Chan B, Bhatia K
… +6 more, Saad N, Baer A, Whalley D, Choong C, Hansen P, Bhindi R
Circ Cardiovasc Interv
· 2025 Nov · PMID 40948125
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BACKGROUND: The incidence of permanent pacemaker implantation (PPMI) due to high-grade atrioventricular block after transcatheter aortic valve implantation (TAVI) is 10% to 15% at 1-year, and current prediction algorithm...BACKGROUND: The incidence of permanent pacemaker implantation (PPMI) due to high-grade atrioventricular block after transcatheter aortic valve implantation (TAVI) is 10% to 15% at 1-year, and current prediction algorithms remain unreliable. METHODS: CONDUCT-TAVI (Prospective Observational STudy on the Accuracy of Predictors of Permanent Pacemaker Secondary to High-Grade Atrioventricular Conduction Block After TAVI) is a prospective observational study of 200 patients undergoing TAVI across 2 centers. Baseline demographic, anatomic, and procedural characteristics were recorded, followed by targeted electrophysiology studies and continuous rhythm monitoring using implantable loop recorders for 1 year. The primary outcome was PPMI secondary to high-grade atrioventricular block, and secondary outcomes included early (≤48 hours) and late (>48 hours) PPMI, new-onset persistent left bundle branch block, and new-onset atrial fibrillation. Predictors were assessed using multivariable logistic regression. RESULTS: PPMI due to high-grade atrioventricular block occurred in 21.0% of patients (early PPMI: 13.5%, late PPMI: 7.5%). Key predictors included preexisting right bundle branch block (adjusted odds ratio, 5.45 [95% CI, 1.67-17.84]; =0.005), ΔHV [His-Ventricle] interval >10 ms (adjusted odds ratio, 3.62 [95% CI, 1.23-10.67]; =0.020), and pre-TAVI rapid atrial pacing-induced atrioventricular Wenckebach (adjusted odds ratio, 3.70 [95% CI, 1.37-9.98]; =0.010). The CONDUCT-TAVI score combined these variables with high predictive accuracy (area under the curve=0.794) and negative predictive value (98%). New-onset persistent left bundle branch block (>24 hours) was observed in 19.1%, and new-onset atrial fibrillation in 21.7% at 1 year. CONCLUSIONS: The incidence of conduction abnormalities remains high after TAVI, and after factoring in anatomic, procedural, and electrophysiological factors, a baseline right bundle branch block and electrophysiology study-derived measures of atrioventricular conduction were the most significant predictors of PPMI. The CONDUCT-TAVI score incorporates these findings to help implanters stratify low-risk patients and tailor follow-up care.
BACKGROUND: Evidence informing clinical guidelines assumes that all transcatheter aortic valve implantation (TAVI) devices have similar effectiveness, in other words, displaying a class effect across TAVI valves. We aime...BACKGROUND: Evidence informing clinical guidelines assumes that all transcatheter aortic valve implantation (TAVI) devices have similar effectiveness, in other words, displaying a class effect across TAVI valves. We aimed to assess the comparative effectiveness of different TAVI platforms relative to other TAVI counterparts or surgical aortic valve replacement (SAVR). METHODS: MEDLINE/Embase/CENTRAL were searched from inception until April 2025, for randomized controlled trials comparing outcomes with different commercially available TAVI devices relative to other TAVI counterparts or SAVR. The certainty of the evidence was assessed following the Grading of Recommendations, Assessment, Development, and Evaluations approach. We performed a frequentist network meta-analysis to generate treatment effect estimates. All-cause, cardiovascular mortality, and stroke were considered critically important patient-centered outcomes. RESULTS: We identified 11 randomized controlled trials with 9946 participants and reporting outcomes between 1 to 10 years. TAVI with CoreValve-Evolut was associated with a similar risk of all-cause (absolute risk difference [ARD], 31/1000 from -12 to 79), and cardiovascular mortality (ARD, -8/1000 from -39 to 28) compared with SAVR (moderate certainty). Compared with SAVR, TAVI with SAPIEN and ACURATE neo were associated with an increased risk of all-cause (ARD, 109/1000 from 56 to 169, high certainty and ARD, 123/1000 from 9 to 277, moderate certainty, respectively) and cardiovascular mortality (ARD, 58/1000 from 18 to 105, high certainty and ARD, 105 from 7 to 247, moderate certainty, respectively). Moderate and high-certainty evidence showed that all TAVI platforms were associated with an increased risk of reinterventions and pacemaker implant versus SAVR. Compared with TAVI with CoreValve-Evolut, SAPIEN was associated with higher all-cause (ARD, 75/1000 from 13 to 147, high certainty) and cardiovascular mortality (ARD, 66/1000 from 15 to 130, high certainty), same scenario for ACURATE neo (ARD 113/1000 from 13 to 259, high certainty). CONCLUSIONS: TAVI with CoreValve-Evolut is probably associated with similar mortality to SAVR. TAVI with SAPIEN and ACURATE neo were associated with increased risk of mortality compared with SAVR and CoreValve-Evolut. The current body of evidence from randomized controlled trials goes against the hypothesis of a class effect across TAVI valves. REGISTRATION:URL: https://www.crd.york.ac.uk; Unique identifier: CRD42024512026.
Tartaglia F, Antonelli G, Gitto M
… +7 more, Stankowski K, Donia D, Stefanini G, Latib A, Colombo A, Mangieri A, Chiarito M
Circ Cardiovasc Interv
· 2025 Oct · PMID 40927837
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Mitral regurgitation is the most common valve disease worldwide. Despite its wide success in inoperable or high-risk surgical patients, transcatheter edge-to-edge repair remains limited by some anatomic features and the...Mitral regurgitation is the most common valve disease worldwide. Despite its wide success in inoperable or high-risk surgical patients, transcatheter edge-to-edge repair remains limited by some anatomic features and the non-negligible rate of significant residual regurgitation. Transcatheter mitral valve replacement has emerged as a viable alternative that promises to overcome these issues, but its development has been progressing slowly. This review aims to provide a comprehensive overview of the current state of transcatheter mitral valve replacement, including patient selection, procedural techniques, and currently available outcomes.
Sullivan AE, Behroozian A, Coolbaugh C
… +15 more, Shardelow E, Smith EK, Wells QS, Clair DG, Aday AW, Garrard CL, Curci JA, Holder TA, Barnett JV, Freiberg MS, Crescenzi RL, Wakeham DJ, Hearon CM, Donahue MJ, Beckman JA
Circ Cardiovasc Interv
· 2025 Oct · PMID 40905129
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BACKGROUND: Patients with peripheral artery disease experience walking impairment that is incompletely explained by large-artery atherosclerotic occlusive disease and abnormal ankle-brachial index (ABI). Microvascular dy...BACKGROUND: Patients with peripheral artery disease experience walking impairment that is incompletely explained by large-artery atherosclerotic occlusive disease and abnormal ankle-brachial index (ABI). Microvascular dysfunction is associated with adverse outcomes, including amputation, but its effect on ambulation is unknown. We tested the hypothesis that skeletal muscle microvascular function directly associates with walking distance, is a more sensitive indicator of walking distance than conduit artery blood inflow, and correlates with ambulatory improvement following peripheral artery disease interventions. METHODS: Sixty-eight participants, including 50 with peripheral artery disease (ABI ≤0.85) and 18 healthy controls, underwent vascular function assessment after sphygmomanometer cuff-induced calf ischemia using magnetic resonance imaging measures of blood oxygenation level-dependent reactivity and arterial spin labeling perfusion reactivity. Functional status was assessed using the 6-minute walk test. A subgroup of patients with peripheral artery disease underwent repeat testing after supervised exercise therapy (n=14) or revascularization (n=14). Multivariable linear regression models were used to assess the association of macrovascular reactive hyperemic blood inflow within the conduit arteries, skeletal muscle microvascular blood oxygenation level-dependent reactivity, and walking distance. RESULTS: Resting large-artery pressure by ABI (R=0.74; <0.001), macrovascular blood inflow (R=0.40; <0.001), and skeletal muscle microvascular blood oxygenation level-dependent reactivity (R=0.66; <0.001) significantly correlated with the 6-minute walk test distance in univariable vascular testing. In multivariable analysis of each vascular parameter, however, calf skeletal muscle microvascular reactivity was most strongly associated with the 6-minute walk test (β=825.3; =0.023). In those with repeat testing after intervention, the change in microvascular reactivity, but not ABI or macrovascular blood inflow, significantly correlated with the change in the 6-minute walk test distance (R=0.46; =0.014). CONCLUSIONS: Microvascular reactivity after ischemia directly associates with walking distance and was a stronger predictor of walking distance than macrovascular blood inflow and ABI. After supervised exercise therapy or revascularization, improvements in microvascular function, but not macrovascular inflow or ABI, correlate with improvement in walking distance. Further study of microvascular dysfunction as a mechanistic driver of ambulatory function is warranted. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03490968.
Dori Y, Pinto E, Biroc L
… +16 more, Gillespie MJ, Callahan R, Tang J, O'Byrne ML, Ford B, Vaiyani D, DeWitt AG, Merrill D, Shinde D, Favilla E, Shustak R, Escobar FA, Krishnamurthy G, Srinivasan A, Rome JJ, Smith CL
Circ Cardiovasc Interv
· 2025 Oct · PMID 40905128
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BACKGROUND: External drainage of the thoracic duct can temporarily reduce tissue congestion and improve symptoms in patients with heart failure. However, loss of fluid limits the duration of this approach. Here, we repor...BACKGROUND: External drainage of the thoracic duct can temporarily reduce tissue congestion and improve symptoms in patients with heart failure. However, loss of fluid limits the duration of this approach. Here, we report on our initial experience with thoracic duct drainage and autotransfusion in patients with elevated central venous pressure. METHODS: This is a retrospective review of medical records of 8 patients who underwent percutaneous thoracic duct drainage with autotransfusion as part of their medical care. We reviewed clinical and procedural outcomes, laboratory data, and imaging. RESULTS: In 5 (62.5%) patients, central venous pressure was elevated secondary to congenital heart disease, 1 (12.5%) had a lymphatic conduction disorder and trisomy 21, 1 (12.5%) had a lymphatic conduction disorder with Noonan syndrome and congenital heart disease, and 1 (12.5%) patient had severe chronic lung disease due to prematurity. Median central venous pressure was 15.5 mm Hg (range, 12-28), and all patients presented with severe multicompartment lymphatic failure including plastic bronchitis (12.5%), pleural effusions (37.5%), protein-losing enteropathy (62.5%), ascites (75%), and anasarca (100%). Over 7 (87.5%) patients survived to decannulation, and the median duration of autotransfusion was 11.5 days (range, 6-126). There was a significant reduction in creatinine from a median of 0.63 (0.3-2.4) to 0.36 (0.16-0.8) mg/dL (=0.017). There was also a significant reduction in weight (=0.017) and drainage output (=0.017). There were no intraprocedural or autotransfusion-related deaths. CONCLUSIONS: Thoracic duct drainage with autotransfusion can improve fluid status and end-organ function without significant complications and presents a new therapeutic option. Further studies are needed to better define indications for this procedure and long-term outcomes.
BACKGROUND: Among patients with intermediate-risk pulmonary embolism undergoing mechanical thrombectomy, the mean change in cardiac index (CI) is modest. We sought to identify variables associated with a hemodynamic supe...BACKGROUND: Among patients with intermediate-risk pulmonary embolism undergoing mechanical thrombectomy, the mean change in cardiac index (CI) is modest. We sought to identify variables associated with a hemodynamic super-response or a CI increase of ≥25% postthrombectomy. METHODS: This was a single-center retrospective study including patients with intermediate-risk pulmonary embolism undergoing mechanical thrombectomy with pulmonary artery catheter-derived hemodynamic indices obtained preprocedure and postprocedure. RESULTS: Overall, 105 intermediate-risk patients had complete hemodynamic profiles, with 41 patients (39%) classified as super-responders. Super-responders had a lower baseline CI (1.9±0.7 versus 2.3±0.6 L/min per m). The mean change in CI postthrombectomy was 0.8±0.4 L/min per m among super-responders versus 0.1±0.4 L/min per m among non-super-responders. Several established indices of poor right ventricular function were associated with a significant increase in the CI in a univariable model. A left ventricular outflow tract velocity-time integral ≤15 cm, tricuspid annular plane systolic excursion/pulmonary artery systolic pressure ≤0.34 mm/mm Hg, and substantial inferior vena cava contrast reflux were associated with a hemodynamic super-response with an odds ratio of 16.19 (95% CI, 1.97-133.24,), 6.5 (95% CI, 2.13-19.83), and 2.53 (95% CI, 1.09-5.88), respectively. In a multivariable model, a preprocedure CI ≤2.2 L/min per m was associated with a hemodynamic super-response (odds ratio, 3.76 [95% CI, 1.09-13.0]). CONCLUSIONS: Patients with intermediate-risk pulmonary embolism with the more severe hemodynamic derangements had the greatest improvement in CI post thrombectomy. This group can be identified with commonly available noninvasive indices of right ventricular dysfunction.
BACKGROUND: Transcatheter tricuspid valve annuloplasty (TTVA) with the Cardioband system is a safe and effective option for high-risk patients with symptomatic severe tricuspid regurgitation (TR). Hemodynamics play a cru...BACKGROUND: Transcatheter tricuspid valve annuloplasty (TTVA) with the Cardioband system is a safe and effective option for high-risk patients with symptomatic severe tricuspid regurgitation (TR). Hemodynamics play a crucial role in these patients. However, it remains unclear if hemodynamic changes after TTVA are linked to clinical outcomes. METHODS: Consecutive patients with severe functional TR who underwent TTVA between 2019 and 2022 were retrospectively analyzed. Right heart catheterization was performed before and after cinching to assess hemodynamic parameters, including XV height (difference between the V-wave and the nadir of right atrial pressure). The primary end point was 2-year survival. RESULTS: Fifty-eight patients with complete hemodynamic assessment were included. All patients presented with torrential (40%), severe (38%), or massive (22%) TR. TR was reduced by ≥2 grades in 83% and by ≥1 grade in 97%. Hemodynamics following TTVA showed significant increases in median cardiac index (2.4-2.8 L/[min·m²]), pulmonary artery pulsatility index (1.73-2.13), and right ventricle cardiac power index (0.15-0.21 W/m²). Right atrial pressure (mean/V-wave) decreased significantly, with the most notable change in XV height (12.5 to 7 mm Hg; <0.001). Lower postprocedural XV height independently predicted 2-year survival (=0.002) and was significantly associated with lower TR grade at follow-up (=0.002) and right ventricle reverse remodeling (<0.001). Immediate right ventricle remodeling was also associated with 2-year survival (=0.024). CONCLUSIONS: Postprocedural XV height was independently associated with 2-year survival and linked to TR reduction and right ventricle remodeling. TTVA improves hemodynamics even in advanced TR, and hemodynamic markers may support risk stratification.
Yilmaz Furtun B, Trivedi MK, Day P
… +21 more, Ketawaroo P, Mathevosian M, Mehta J, Sanz-Cortes M, Altman CA, Gowda S, Dooley Sutton C, G Mann D, Varma Donepudi R, Nassr AA, Eilers L, Naus C, E Stapleton G, S Heinle J, Orr Y, Tsang R, Dickerson H, A Ayres N, Qureshi AM, A Belfort M, Morris SA
BACKGROUND: Infants with hypoplastic left heart syndrome with severely restrictive or intact atrial septum (R/IAS) have low survival. In-utero creation of an atrial septal communication has been reported, with high compl...BACKGROUND: Infants with hypoplastic left heart syndrome with severely restrictive or intact atrial septum (R/IAS) have low survival. In-utero creation of an atrial septal communication has been reported, with high complication rates. METHODS: We performed a retrospective cohort study of fetuses with hypoplastic left heart syndrome, double outlet right ventricle with mitral stenosis/atresia, or mitral valve dysplasia and R/IAS from 2012 to 2024 who underwent evaluation for fetal atrial septal intervention (FASI). Excluding those with comorbidities limiting candidacy, discharge survival and overall survival were compared between (1) those undergoing and not undergoing FASI, and (2) those undergoing technically successful FASI (TS-FASI) and all others. RESULTS: Of 60 fetuses with R/IAS, 18 were considered extremely high risk and excluded from analysis. Among the remaining 42, 25 underwent FASI and 17 did not, with no significant baseline echocardiographic differences. FASI was technically successful in 18 cases, with 13 survivors (6 post-Glenn, 6 post-Fontan, 1 post-Ross). In the 7 unsuccessful FASIs, there were 5 peri-procedural deaths and 1 fetal demise that occurred post-FASI. Technical success rates improved from 58% (first 12) to 85% (last 13). Of 20 FASI patients with fetal magnetic resonance imaging, 15 (75%) had nutmeg lung; of the 9 with nutmeg lung and post-TS-FASI fetal magnetic resonance imaging, 8 improved. Survival to discharge and overall survival were 52% in the FASI group versus 29% in the non-FASI group (=0.147 and log-rank =0.376, respectively). When comparing TS-FASI to all others, survival was higher (72% versus 21% for discharge and overall survival, =0.001 and log-rank <0.001, respectively). All TS-FASI survivors with catheterization data (11/13) had pulmonary vascular resistance <3 Woods units before Glenn/Fontan. CONCLUSIONS: In our cohort, fetuses with R/IAS post-TS-FASI had significantly higher discharge and overall survival rates compared with all other fetuses with R/IAS. Nutmeg lung improved in the majority of TS-FASI cases with post-FASI imaging.
Medina FA, Mosarla RC, Kim JM
… +4 more, Li S, Song Y, Yeh RW, Secemsky EA
Circ Cardiovasc Interv
· 2025 Sep · PMID 40859835
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BACKGROUND: Racial differences in the use and outcomes of intravascular imaging (IVI) and invasive physiology (IP) during percutaneous coronary intervention (PCI) are underreported in the United States. METHODS: Medicare...BACKGROUND: Racial differences in the use and outcomes of intravascular imaging (IVI) and invasive physiology (IP) during percutaneous coronary intervention (PCI) are underreported in the United States. METHODS: Medicare Fee-For-Service claims data were used to examine the use and outcomes of IVI- and IP-guided PCI by Black versus White race (2016-2023). Multivariable logistic regression was used to assess the association between race and IVI/IP use. The primary outcome was major adverse cardiovascular events, which included myocardial infarction, repeat revascularization, and death. Outcomes were compared by race according to the device used (IVI versus none; IP versus none; and among all IVI/IP recipients). Cox regression was used to estimate the association between race and 2-year outcomes, adjusting for all baseline characteristics. RESULTS: The study included 1 481 343 PCI patients (5.9% Black patients, 63.6% male, mean age 75.3±7.0 years). IVI was used in 17.6% of PCIs in White patients and 15.0% in Black patients; IP use was 7.1% and 5.7%, respectively. After adjustment, Black adults were less likely to receive IVI (odds ratio, 0.94 [95% CI, 0.93-0.96]) or IP (odds ratio, 0.83 [95% CI, 0.81-0.85]). IVI- and IP-guided PCI had lower major adverse cardiovascular event risk at 2-years in both racial groups compared with angiography alone: IVI (White patients: hazard ratio [HR], 0.93 [95% CI, 0.92-0.94]; Black patients: HR, 0.85 [95% CI, 0.84-0.87]) and IP (White patients: HR, 0.95 [95% CI, 0.92-0.98]); Black patients: HR, 0.87 [95% CI, 0.83-0.91]). However, despite global benefits with IVI/IP, Black adults had a higher adjusted risk of major adverse cardiovascular events compared with White adults (HR, 1.02 [95% CI, 1.01-1.03]). CONCLUSIONS: IVI- and IP-guided PCI were associated with improved outcomes in both Black and White beneficiaries, yet these technologies were less frequently used in Black adults, and overall PCI outcomes remained worse for this group.
BACKGROUND: The Evoque system is the first commercially available transcatheter tricuspid valve replacement (TTVR) system in the United States. However, challenging anatomy in real-world patients could preclude successfu...BACKGROUND: The Evoque system is the first commercially available transcatheter tricuspid valve replacement (TTVR) system in the United States. However, challenging anatomy in real-world patients could preclude successful transfemoral Evoque TTVR. We aim to investigate the feasibility of the transjugular Evoque TTVR in anatomy unsuitable for a transfemoral approach. METHODS: Eleven patients with challenging anatomy underwent transjugular Evoque TTVR at a high-volume center in the United States from February 2024 to January 2025, following an unsuccessful transfemoral attempt (n=9) or anatomic unsuitability (n=2). Procedural characteristics, intraprocedural success, periprocedural outcomes, echocardiographic findings, and 30-day clinical outcomes were assessed using the Tricuspid Valve Academic Research Consortium definitions. The procedural technique is provided in the accompanying supplement. RESULTS: Intraprocedural success was achieved in all 11 patients, with reasonable procedural time and no major procedural complications, except for 1 pacemaker implantation. At 30 days, the clinical success rate was 100%. Tricuspid regurgitation was reduced to none-to-trivial in 8 patients, mild in 2 patients, and moderate in 1 patient. There was no stroke, mortality, or rehospitalization. Nine out of 11 patients experienced an improvement in New York Heart Association functional class. CONCLUSIONS: In the largest single-center cohort of patients reported to date, transjugular Evoque TTVR demonstrated favorable intraprocedural, periprocedural, and short-term clinical outcomes, and was found to be a feasible alternative for patients with anatomy unsuitable for transfemoral Evoque TTVR.
BACKGROUND: Studies suggest percutaneous coronary intervention (PCI) guided by intracoronary imaging (ICI) results in larger balloon/stent diameters and longer stents. Whether this occurs in real-world PCI is poorly unde...BACKGROUND: Studies suggest percutaneous coronary intervention (PCI) guided by intracoronary imaging (ICI) results in larger balloon/stent diameters and longer stents. Whether this occurs in real-world PCI is poorly understood. METHODS: De novo PCIs performed at 48 nonfederal Michigan hospitals between July 2019 and June 2022 were evaluated with regression modeling to evaluate associations between ICI-guided PCI and balloon/stent dimensions. The association between ICI-guided PCI and coronary dissection/perforation was assessed using adjusted odds ratios. RESULTS: ICI was used in 16 777 (22.5%) PCI-treated lesions and increased from 11.2% of cases in July 2019 to 32.1% in June 2022. Compared with angiography alone, the average patient/procedural-adjusted treatment effect of ICI use included: +0.19 mm stent diameter (95% CI +0.16 to +0.22), +0.45 mm maximum balloon diameter (95% CI +0.40 to +0.51), and +3.51 mm stent length (95% CI +2.54 to +4.48). These findings persisted when controlling for the operator. ICI use was associated with a higher risk of dissections (adjusted odds ratio, 2.55 [95% CI, 2.05-3.16]) and perforations (adjusted odds ratio, 2.25 [95% CI, 1.74-2.91]); however, increased use of ICI and larger stent/balloon sizes over the study period (<0.001 for trend for both) was not associated with a concomitant increase in rates of dissection or perforation (=0.78 and =0.33 for trend, respectively). CONCLUSIONS: In real-world practice, ICI-guided PCI was associated with larger stent/balloon diameters and longer stents. While ICI use was associated with dissections and perforations, there was no significant increase in the rate of these complications despite significant increases in ICI use and stent/balloon sizes during the study period. Further research is needed to evaluate the association between ICI use and procedural complications.