Sheth T, Rodes Cabau J, Poon K
… +17 more, Paradis JM, Fam N, Murdoch D, Al-Nasser S, Chandavimol M, Chavarria J, Dick A, Bizios A, Diamantouros P, Yap J, Chatfield A, Ihdayhid AR, Palmer S, Said Vega N, Velianou J, Parpia S, Suleman M
BACKGROUND: This study evaluated the ability of the ABC Bicuspid Sizing Algorithm to predict aortic root rupture in patients treated with transcatheter aortic valve replacement using SAPIEN 3 valves. METHODS: We conducte...BACKGROUND: This study evaluated the ability of the ABC Bicuspid Sizing Algorithm to predict aortic root rupture in patients treated with transcatheter aortic valve replacement using SAPIEN 3 valves. METHODS: We conducted a retrospective multicenter study among 15 centers in 7 countries of aortic root rupture cases and controls without root complications. Computed tomography analysis was performed blinded to rupture status. The ABC algorithm was applied to classify risk (high-risk criteria): (1) annular oversizing >10%, (2) intercommissural distance - valve diameter ≤1 mm, (3) maximum sinus diameter - valve diameter <6 mm alone, or (4) maximum sinus diameter - valve diameter 6 to 8 mm with contrast calcium volume >1000 mm and raphe + contralateral or ipsilateral leaflet calcium volume >800 mm, (5) protruding nodular intercommissural distance calcium or full-length calcification of both leaflet edges. RESULTS: A total of 170 patients were included (23 ruptures and 147 controls). Cases exhibited higher total calcium volume (median: 1498 mm versus 826 mm; <0.001), smaller intercommissural distance difference (median: -0.15 versus 1.19 mm; =0.009), smaller maximum sinus difference (median: 6.79 versus 9.19 mm; <0.001), and greater annular oversizing (median: 6.57% versus 3.51%; =0.047). The presence of any high-risk criterion had a sensitivity of 100% (95% CI, 85.7%-100%) and a specificity of 89.1% (95% CI, 83.1%-93.2%) for the identification of rupture cases. The diagnostic odds ratio was 374.5 (95% CI, 21.7-6459.9), with a positive likelihood ratio of 9.19 and a negative likelihood ratio of 0.023. CONCLUSIONS: High calcium volume, narrow sinus dimensions, and excessive valve oversizing were associated with aortic root rupture. The ABC algorithm showed promising performance for risk stratification of patients with bicuspid anatomy being considered for treatment with a SAPIEN 3 valve.
Liao M, Zhou W, Wang W
… +16 more, Yang Y, Yao Y, Zhou G, Wu Z, Zhang X, Wei B, Liang G, Li Z, Wei Z, Lu J, Wu Z, Wang Y, Lin A, Chen Y, Zhang B, Guo S
BACKGROUND: Patients with renal dysfunction remain at high risk for contrast-associated acute kidney injury despite standard peri-procedural volume administration. This study aims to investigate whether peri-procedural o...BACKGROUND: Patients with renal dysfunction remain at high risk for contrast-associated acute kidney injury despite standard peri-procedural volume administration. This study aims to investigate whether peri-procedural oral nicorandil provides additional protection in this population, and to evaluate its potential dose-response relationship. METHODS: We conducted a prospective, multicenter, randomized controlled trial enrolling patients with percutaneous coronary intervention with renal dysfunction. Participants were randomized into 3 groups, including a high-dose nicorandil group (30 mg/d, 10 mg 3× daily), a conventional-dose nicorandil group (15 mg/d, 5 mg 3× daily), and a saline hydration-only control group. The primary end point was the incidence of contrast-associated acute kidney injury. Secondary end points included changes in serum creatinine, blood urea nitrogen, CysC (cystatin C), and CRP (C-reactive protein). RESULTS: A total of 585 patients were recruited and randomized. The incidence of contrast-associated acute kidney injury was significantly lower in both nicorandil groups, with 19.8% (39/197) in the control group, compared with 10.9% (21/193) in the conventional-dose group and 8.7% (17/195) in the high-dose group (<0.001). This represented a relative risk reduction of 50% and 61% for the conventional- and high-dose groups, respectively. CONCLUSIONS: Adjunctive nicorandil, particularly at a dose of 10 mg 3× daily, significantly reduced the incidence of contrast-associated acute kidney injury in percutaneous coronary intervention patients with renal dysfunction. Oral nicorandil represents a readily available, effective, and dose-dependent prophylactic strategy to enhance renoprotection. Future studies are warranted to evaluate the long-term clinical benefits of this intervention. REGISTRATION:URL: https://www.chictr.org.cn; Unique identifier: CTR2200064264.
Lee SY, Kim GB, Carminati M
… +18 more, Giugno L, Çelebi A, Yucel IK, Eicken A, Ewert P, Georgiev S, Choi JY, Kim CS, Gutiérrez-Larraya F, Balbacid Domingo E, Odemis E, Kizilkaya MH, Luis Zunzunegui J, Ballesteros Tejerizo F, Kim SH, Jang SI, Krasemann T, Krings G
BACKGROUND: Patients with congenital or acquired right ventricular outflow tract dysfunction frequently require pulmonary valve replacement and are exposed to repeated surgical interventions due to prosthetic valve degen...BACKGROUND: Patients with congenital or acquired right ventricular outflow tract dysfunction frequently require pulmonary valve replacement and are exposed to repeated surgical interventions due to prosthetic valve degeneration. The PULSTA self-expanding transcatheter pulmonary valve was designed to address a broad spectrum of native and surgically repaired right ventricular outflow tract anatomies. This study reports the midterm safety, hemodynamic performance, and durability outcomes of the prospective, multinational PULSTA CE approval trial (PULSTA Carpentier Edwards). METHODS: This premarket, multicenter, nonrandomized study enrolled 58 patients across 11 centers in 6 countries. Successful PULSTA implantation was achieved in 57 patients (98.3%), including 4 valve-in-valve procedures. Patients were followed for a median duration of 4.1 years. Primary end points included procedural or device-related serious adverse events, hemodynamic improvement, and sustained valve function. RESULTS: At 6 months, cardiac magnetic resonance imaging demonstrated significant reverse right ventricular remodeling, with marked reductions in right ventricular end-diastolic volume index, end-systolic volume index, and pulmonary regurgitation fraction (all <0.001). Valve performance remained stable throughout follow-up, with 93.8% of patients exhibiting mild or less pulmonary regurgitation at 4.1 years. Freedom from reintervention was 98.2% at 5 years. One patient required a PULSTA-in-PULSTA implantation due to paravalvular leakage, and one case of infective endocarditis was successfully managed with antibiotic therapy. No stent fractures or structural valve deterioration were observed. CONCLUSIONS: The PULSTA transcatheter pulmonary valve demonstrated high procedural success, durable valve function, and sustained hemodynamic benefits. Its adaptability to diverse right ventricular outflow tract anatomies and favorable safety profile supports its role as an effective therapeutic option for patients with right ventricular outflow tract dysfunction. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03983512.
BACKGROUND: Recent observational studies have suggested that early treatment (<12 hours from diagnosis) of intermediate risk pulmonary embolism (PE) with catheter-based therapies may reduce morbidity and mortality. Howev...BACKGROUND: Recent observational studies have suggested that early treatment (<12 hours from diagnosis) of intermediate risk pulmonary embolism (PE) with catheter-based therapies may reduce morbidity and mortality. However, the effect of early versus late mechanical thrombectomy on acute pulmonary hemodynamics and right ventricular mechanics is less well defined. METHODS: Patients enrolled in SYMPHONY-PE were divided into one of 2 groups based on the time from baseline CT pulmonary angiography to mechanical thrombectomy: Early <12 hours versus late ≥12 hours. The primary safety end point was the rate of major adverse events within 48 hours, as adjudicated by an academic independent safety board. The primary efficacy end point was the core-lab assessed mean change in right ventricle-to-left ventricle ratio from baseline to 48 hours. RESULTS: Early thrombectomy was performed in 44% (48/109) of patients and was associated with a larger reduction, approaching statistical significance, in right ventricle-to-left ventricle ratio (0.52±0.50 versus 0.37±0.34; =0.071). Mean pulmonary artery pressure decreased significantly more in patients receiving early thrombectomy (8.6±5.2 versus 5.8±5.0 mm Hg; =0.006). The major adverse events rate was similar (=0.431) between groups, and there were no mortalities. The differences in efficacy outcomes were greatest in higher-risk patients per the Composite Pulmonary Embolism Shock score. CONCLUSIONS: Early mechanical thrombectomy was associated with larger reductions in right ventricle-to-left ventricle ratio and mean pulmonary artery pressure, with no significant differences in safety event rates compared with patients who underwent late thrombectomy. Randomized trials are needed to test these associations. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT06062329.
BACKGROUND: The relationship between fetal aortic valvuloplasty procedural volume and outcomes is crucial to understand whether regionalization should be advised worldwide. This study utilizes the International Fetal Car...BACKGROUND: The relationship between fetal aortic valvuloplasty procedural volume and outcomes is crucial to understand whether regionalization should be advised worldwide. This study utilizes the International Fetal Cardiac Intervention Registry to examine the relationship between center volume for fetal aortic valvuloplasty and outcome metrics including procedure success, complications, and fetal death. METHODS: Data were included from institutions performing ≥3 procedures (2001-2018). The primary outcome was technical success, defined as ≥1 balloon inflation across the aortic valve, with increased antegrade flow across the valve and new aortic regurgitation. Secondary end points were procedural complications and fetal periprocedural death (within 48 hours). Univariable and Classification and Regression Tree analyses were performed. RESULTS: Eleven centers, with volumes ranging from 6 to 31 cases, performed 162 fetal aortic valvuloplasties with a technical success rate of 80.2%. Higher volume was not associated with better technical success or fewer complications but was associated with fewer periprocedural fetal deaths. Employing Classification and Regression Tree modeling, the largest drivers of improved outcomes for all measures were greater estimated fetal weight and gestational age. A single cardiac puncture was associated with greater technical success and fewer procedural complications after accounting for fetal estimated fetal weight and gestational age. CONCLUSIONS: In this registry cohort, higher-volume centers did not have greater fetal aortic valvuloplasty technical success or fewer complications but did have fewer periprocedural fetal deaths. Fetal gestational age and number of cardiac punctures influenced outcomes, suggesting that unmeasured fetal selection criteria, such as different referral patterns, and technical expertise, indicative of overall center/team experience, may influence fetal survival.
BACKGROUND: The EARLY TAVR trial demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) in asymptomatic severe aortic stenosis. The relative impact of early TAVR...BACKGROUND: The EARLY TAVR trial demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) in asymptomatic severe aortic stenosis. The relative impact of early TAVR versus a CS strategy by age is unknown. METHODS: The study population of the EARLY TAVR trial was stratified into 4 age groups: 65 to 69 years (n=141), 70 to 74 years (n=263), 75 to 79 years (n=250), and ≥80 years (n=247). Associations between age and the trial primary end point of death, stroke, or unplanned cardiovascular hospitalization; the composite end point of death, stroke, or heart failure hospitalization; and its individual components were examined. Interaction tests evaluated whether the treatment effect of early TAVR versus CS differed by age. RESULTS: No interaction was detected between age and the treatment effect of early TAVR versus CS for the composite or individual outcomes. We observed lower stroke rates with early TAVR compared with CS in the youngest (65-69 years, absolute risk reduction, 13%; =0.008) and oldest (≥80 years; absolute risk reduction, 12.3%; =0.029) age groups. The absolute difference in heart failure hospitalization rates between the early TAVR and CS arms at 2 years was greatest in the oldest patients (≥80 years, 9.1%; 75-79 years, 5.9%; 70-74 years, 5.1%; 65-69 years, 4.4%). In the CS group, time to conversion to AVR was similar across all age groups (median, 11 months; =0.73). Approximately one-third of younger patients (65-69 years) in the CS arm presented with acute valve syndrome at the time of conversion, and the frequency tended to increase with age (=0.06). CONCLUSIONS: In the EARLY TAVR trial, the relative benefit of early TAVR over CS was consistent among all age groups. The greatest absolute reduction in stroke rate with early TAVR compared with CS appeared in the youngest and oldest groups, whereas reduction in heart failure hospitalization was most pronounced in the oldest patients. These data suggest that early TAVR should be considered in all age groups above 65 years. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03042104.
BACKGROUND: Complete revascularization is superior to culprit lesion-only percutaneous coronary intervention (PCI) in reducing ischemic events in patients with ST-segment-elevation myocardial infarction and multivessel d...BACKGROUND: Complete revascularization is superior to culprit lesion-only percutaneous coronary intervention (PCI) in reducing ischemic events in patients with ST-segment-elevation myocardial infarction and multivessel disease. However, the relationship between the extent of revascularization and the benefits of a complete revascularization strategy remains unclear. The aim of this substudy of the COMPLETE trial was to evaluate how the degree of anatomic completeness of revascularization, measured by the core laboratory-derived modified residual SYNTAX score (R'SS), relates to major cardiovascular events. METHODS: We conducted an exploratory post hoc analysis of the COMPLETE trial (n=3738), stratifying patients randomized in the complete revascularization group based on the R'SS assessed after staged nonculprit lesion-PCI. Complete revascularization was defined by an R'SS=0, whereas incomplete revascularization was defined by an R'SS>0. A stratified Cox proportional hazards model was used, with the culprit-only PCI arm designated as the reference group for comparison. The first coprimary outcome was a composite of cardiovascular death or new myocardial infarction. The second coprimary outcome was a composite of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. RESULTS: Among patients randomized to a complete revascularization strategy, 90% achieved complete revascularization (R'SS=0), whereas 10% did not (R'SS>0). In patients with R'SS=0, the first coprimary outcome occurred less frequently (6.6%) compared with those randomized to the culprit lesion-only PCI strategy (10.7%; adjusted hazard ratio, 0.61 [95% CI, 0.47-0.78]). Among patients with an R'SS>0, the first coprimary outcome was similar (10.7%) to those in the culprit lesion-only PCI group (10.7%; adjusted hazard ratio, 1.01 [95% CI, 0.61-1.67]). A similar result was observed for the second coprimary outcome. CONCLUSIONS: This exploratory analysis of the COMPLETE trial suggests that the benefit of a complete revascularization strategy in patients with ST-segment-elevation myocardial infarction and multivessel disease may be related to the extent of anatomic completeness of revascularization. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01740479.
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.
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.
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.