BACKGROUND: Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb events (MALE) and major adverse cardiovascular events. The VOYAGER-PAD t...BACKGROUND: Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb events (MALE) and major adverse cardiovascular events. The VOYAGER-PAD trial (Vascular Outcomes Study of Acetylsalicylic Acid Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated that rivaroxaban 2.5 mg twice daily on top of antiplatelet therapy significantly reduced this risk. Whether the risk of major adverse cardiovascular events and MALE and the effect of rivaroxaban are consistent in patients with a history of prior LER versus those without has not been described. METHODS: VOYAGER-PAD randomized patients with symptomatic PAD undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily. The history of prior LER was collected at baseline. The primary end point was a composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. RESULTS: A total of 6564 patients were enrolled with 2336 (35.5%) having a prior history of LER. Patients with a history of prior LER had a higher rate of MALE relative to those without prior LER (3-year Kaplan-Meier cumulative rates, 12.9% versus 8.0%; hazard ratio [HR], 1.58 [95% CI, 1.25-1.99]). Compared with placebo, rivaroxaban reduced the primary efficacy end point with a numerically greater relative benefit in those with (HR, 0.73 [95% CI, 0.60-0.88]) versus without prior LER (HR, 0.94 [95% CI, 0.81-1.10]; =0.036). The relative increase in Thrombolysis in Myocardial Infarction major bleeding with rivaroxaban was consistent regardless of prior LER status (prior LER: HR, 1.08 [95% CI, 0.62-1.89]; no prior LER: HR, 1.88 [95% CI, 1.09-3.25]; =0.16). CONCLUSIONS: Patients with PAD with prior LER are at particularly high risk of MALE relative to those presenting without prior LER. Rivaroxaban reduces the risk of major adverse cardiovascular events and MALE after LER for symptomatic PAD with a greater relative benefit in those with prior LER. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT02504216.
van den Broek WWA, Azzahhafi J, van de Pol QYF
… +14 more, Chan Pin Yin DRPP, van der Sangen NMR, Sivanesan S, Peper J, Harmsze AM, Walhout RJ, Tjon Joe Gin M, Breet NJ, Langerveld J, Appelman Y, van Schaik RHN, Henriques JPS, Kikkert WJ, Ten Berg JM
BACKGROUND: A genotype-guided de-escalation strategy-switching from a potent P2Y inhibitor to clopidogrel-may reduce bleeding risk in patients with acute coronary syndrome. This analysis evaluated the safety and effectiv...BACKGROUND: A genotype-guided de-escalation strategy-switching from a potent P2Y inhibitor to clopidogrel-may reduce bleeding risk in patients with acute coronary syndrome. This analysis evaluated the safety and effectiveness of routine genetic testing to guide antiplatelet therapy in clinical practice. METHODS: In this investigator-initiated, prospective, multicenter implementation study, patients received either standard care, with antiplatelet therapy at the physician discretion, or genotype-guided therapy. In the genotype-guided group, physicians were recommended to switch to clopidogrel in noncarriers of loss-of-function alleles. The coprimary end points were major adverse cardiac events, a composite of cardiovascular death, myocardial infarction, or stroke, and major or nonmajor clinically relevant bleeding, at 1 year of follow-up. Hazard ratios were adjusted for baseline differences between cohorts using multivariable Cox regression. Net adverse cardiac events comprised all-cause death, myocardial infarction, stroke, stent thrombosis, and major bleeding. A Bonferroni-adjusted significance level of =0.025 was applied. RESULTS: A total of 9907 patients were included in the analysis. Of these, 1208 (12%) were included in the genotype-guided cohort, whereas 8699 (88%) were assigned to the standard care cohort. Major adverse cardiac events occurred in 107 patients (8.9%) in the genotype-guided cohort and 897 patients (10.3%) in the standard care cohort (adjusted hazard ratio, 1.05 [95% CI, 0.85-1.29]; =0.64). Major or nonmajor clinically relevant bleeding was reported in 146 patients (12.1%) in the genotype-guided cohort compared with 1384 patients (15.9%) in the standard care cohort (adjusted hazard ratio, 0.79 [95% CI, 0.67-0.94]; =0.01). There was no significant association with net adverse cardiac events (adjusted hazard ratio, 0.91 [95% CI, 0.76-1.09]; =0.31). CONCLUSIONS: In patients with acute coronary syndrome receiving antiplatelet therapy, implementation of a genotype-guided de-escalation strategy in clinical practice was associated with a significant reduction of major and nonmajor clinically relevant bleeding compared with standard care at 12 months, without increasing ischemic events. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03823547.
Louca A, Petursson P, Sundström J
… +13 more, Hagström H, Rück A, James S, Koul S, Skoglund K, Mohammed M, Jeppsson A, Ioanes D, Völz S, Myredal A, Angerås O, Rawshani A, Råmunddal T
BACKGROUND: The optimal management of coronary artery disease in patients undergoing transcatheter aortic valve replacement (TAVR) remains unclear, and evidence supporting routine percutaneous coronary intervention (PCI)...BACKGROUND: The optimal management of coronary artery disease in patients undergoing transcatheter aortic valve replacement (TAVR) remains unclear, and evidence supporting routine percutaneous coronary intervention (PCI) beforehand is limited. This study aimed to evaluate whether PCI before TAVR provides clinical benefit compared with conservative management in patients with significant coronary artery disease, using nationwide Swedish registry data. METHODS: This observational study included 2578 Swedish patients with significant coronary artery disease (≥50% angiographic stenosis or physiologically significant lesions) who underwent TAVR between 2008 and 2023. 1182 underwent PCI before TAVR, and 1396 were managed conservatively. The primary outcome was a composite of all-cause mortality, myocardial infarction, and urgent revascularization. Secondary outcomes included the individual components, cardiovascular mortality, any revascularization, stroke, and bleeding. The primary analysis used an instrumental variable approach based on each region's quarterly PCI treatment preference to account for confounding. RESULTS: PCI was not associated with a significant difference in the primary composite outcome (instrumental variable-adjusted hazard ratio, 0.98 [95% CI, 0.85-1.14]; =0.80) or in all-cause mortality, myocardial infarction, cardiovascular death, stroke, or urgent revascularization. PCI was, however, associated with a lower risk of any revascularization (adjusted hazard ratio, 0.46 [95% CI, 0.30-0.72]; adjusted =0.002) and a higher risk of bleeding (instrumental variable-adjusted odds ratio, 1.59 [95% CI, 1.23-2.04]; adjusted =0.002). CONCLUSIONS: In this nationwide cohort, PCI before TAVR did not improve survival or reduce urgent revascularization but did reduce nonurgent revascularization at the cost of increased bleeding. Decisions should be individualized, balancing ischemic and bleeding risks and considering anticipated coronary access after TAVR.
Ruberti A, Flores-Umanzor E, Sanchis L
… +22 more, Pilgrim T, Regueiro A, Garot P, Ibrahim R, Velazquez G, Smolka G, Abdul-Jawad Altisent O, Cepas-Guillén P, Hascoët S, Occhipinti G, Cruz-Gonzalez I, Sitges M, Vidal B, Martí-Aguasca G, Onorato EM, Osten M, Rodes-Cabau J, Toth GG, Dumonteil N, Calvert PA, Horlick E, Freixa X
Paravalvular leak (PVL) is a well-known complication of valve replacement, occurring in up to 10% of aortic and 17% of mitral prosthetic valves. Although many leaks are small and clinically insignificant, ≈1% to 5% of ca...Paravalvular leak (PVL) is a well-known complication of valve replacement, occurring in up to 10% of aortic and 17% of mitral prosthetic valves. Although many leaks are small and clinically insignificant, ≈1% to 5% of cases are associated with clinically relevant complications, such as heart failure symptoms and hemolytic anemia. Surgical reoperation is currently considered the first-line option; however, it encompasses high mortality and morbidity risks. In the past years, transcatheter PVL closure has proven to be highly effective when performed in experienced centers. Transcatheter PVL closure requires advanced imaging modalities, specialized materials, and techniques, reflecting the high complexity of the procedure. We review the complex nature of PVL, including its diagnostic workup and the available transcatheter treatment strategies, with a special focus on the treatment of mitral and aortic PVL using plugging devices.
Yabumoto N, Fujino M, Kiyoshige E
… +20 more, Sugane H, Hosoda H, Kitahara S, Fujino Y, Mitsui K, Murai K, Iwai T, Sawada K, Matama H, Honda S, Nakao K, Yoneda S, Takagi K, Asaumi Y, Ogata S, Nishimura K, Kawai K, Tsujita K, Noguchi T, Kataoka Y
Circ Cardiovasc Interv
· 2026 Apr · PMID 41669840
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BACKGROUND: Calcified nodules (CNs) represent a high-risk coronary lesion phenotype associated with target lesion revascularization (TLR). Although rotational atherectomy (RA) is an established treatment for calcified le...BACKGROUND: Calcified nodules (CNs) represent a high-risk coronary lesion phenotype associated with target lesion revascularization (TLR). Although rotational atherectomy (RA) is an established treatment for calcified lesions, its benefit for CNs remains unclear. This study aimed to evaluate the impact of RA on TLR and to identify specific morphological features on intravascular ultrasound that may influence its therapeutic effect for CNs. METHODS: In a substudy of the U-SCAN registry (Coronary Intravascular Ultrasound for Calcified Nodule), 348 patients with CNs identified by intravascular ultrasound who underwent percutaneous coronary intervention were analyzed. We excluded patients with in-stent restenosis, use of alternative debulking devices, failed device passage without RA, and poor image quality. The final analysis included 209 patients, stratified by RA use. Multivariable Cox proportional hazards models were used to identify predictors of TLR and assess treatment interactions across subgroups. RESULTS: Among 209 patients, 79 patients (37.8%) underwent RA. During a median follow-up of 2.1 years (interquartile range, 0.4-4.9), TLR was required in 20 of 79 patients (25.3%) in the RA group and 41 of 130 patients (31.5%) in the non-RA group. After adjustment, RA independently predicted reduced TLR (hazard ratio, 0.34 [95% CI, 0.19-0.62], <0.001). In addition, intravascular ultrasound-derived calcification features, including greater lumen area stenosis, longer CN length, smaller final minimum lumen area, and adjacent circumferential calcification, were significantly associated with TLR. Notably, the benefit of RA on TLR was pronounced in patients with contralateral calcification (8.6% versus 51.6%, <0.001). In contrast, without this feature, the TLR rate was higher in the RA group (38.6% versus 25.3%, =0.11), resulting in a statistically significant interaction (<0.001). CONCLUSIONS: In patients with CNs, RA was associated with a reduced long-term risk of TLR. The presence of contralateral calcification identifies a subgroup deriving substantial benefit, supporting a more selective, morphology-guided approach to treatment. REGISTRATION:URL: https://jrct.mhlw.go.jp/; Unique identifier: jRCT1050240037.
Abbas AE, Kaneko T, Khalili H
… +16 more, Kapadia SR, Babaliaros VC, Greenbaum AB, Schwann TA, Yadav P, Moussa ID, Reed GW, Laham RJ, Morse MA, Villablanca P, Rodriguez E, Depta JP, McCabe JM, Bapat VN, Thourani VH, Krishnaswamy A
Circ Cardiovasc Interv
· 2026 Mar · PMID 41657207
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BACKGROUND: Lower (<10 mm Hg) discharge echocardiographic mean gradients (MGs) following transcatheter aortic valve replacement with balloon-expandable valves are associated with lower ejection fraction and higher 5-year...BACKGROUND: Lower (<10 mm Hg) discharge echocardiographic mean gradients (MGs) following transcatheter aortic valve replacement with balloon-expandable valves are associated with lower ejection fraction and higher 5-year mortality compared with higher gradients. Using the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, we studied the relationship between echocardiographic MG and patient prosthesis mismatch (PPM) following transcatheter aortic valve-in-valve replacement and clinical outcomes. METHODS: Patients who underwent aortic valve-in-valve replacement with a balloon-expandable valve from July 2015 to December 2023 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were included. Adjusted Cox models with regression splines explored the relationship between MG and 5-year mortality. Kaplan-Meier estimates and adjusted hazard ratios compared the occurrence of 5-year mortality between gradient cutoffs and PPM presence. RESULTS: A total of 13 054 patients were included; spline curves demonstrated a nonlinear relationship between discharge MG and 5-year mortality. Kaplan-Meier curves suggested higher 5-year mortality with MG <10 mm Hg compared with MG ≥10 mm Hg (hazard ratio, 1.15 [95% CI, 1.02-1.29]; =0.024). MG <10 mm Hg was associated with lower ejection fraction compared with higher MG (50.4±13.9 versus 53.2±12.8; <0.0001). Severe PPM and MG ≥20 mm Hg were not associated with worse 5-year outcomes compared with none/moderate PPM or MG ≤20 mm Hg, respectively. CONCLUSIONS: Discharge MG <10 mm Hg is associated with lower ejection fraction and increased 5-year mortality following aortic valve-in-valve replacement compared with higher MG in a nonlinear fashion. Severe PPM and MG > 20 mm Hg were not associated with worse 5-year clinical outcomes. Incorporating data on ejection fraction with PPM and MG is important before determining the need for valve optimization.
BACKGROUND: The Alterra Adaptive Prestent provides a landing zone for implantation of the 29 mm SAPIEN 3 transcatheter heart valve (THV) in patients with a dysfunctional right ventricular outflow tract (RVOT) to treat pu...BACKGROUND: The Alterra Adaptive Prestent provides a landing zone for implantation of the 29 mm SAPIEN 3 transcatheter heart valve (THV) in patients with a dysfunctional right ventricular outflow tract (RVOT) to treat pulmonary regurgitation (PR). Here, we report 3-year outcomes from a pooled analysis of patients who underwent Alterra/SAPIEN 3 THV implantation enrolled in the ALTERRA pivotal trial, Continued Access Protocol, and Pulmonic Delivery System Registry. METHODS: This multicenter, prospective trial enrolled patients with moderate or greater PR and RVOT/pulmonary valve anatomy suitable for implantation. The nonhierarchical composite end point of THV dysfunction was examined at 6 months: RVOT/pulmonary valve reintervention, moderate or greater PR, and mean RVOT/pulmonary valve gradient ≥35 mm Hg. Individual components of the composite, as well as additional clinical and echocardiographic outcomes were examined up to 3 years. RESULTS: The Alterra/SAPIEN 3 THV system was implanted in 118 patients at 14 sites. At 6 months, THV dysfunction was 3.5% (4/113). At 3 years, 97.3% of patients in the valve implant population had freedom from reintervention, 100% of patients had a mean RVOT/pulmonary valve gradients <35 mm Hg, and 93.3% of patients had mild or lesser total PR. The Kaplan-Meier estimate of all-cause mortality was 3.5% at 3 years. There were no cases of coronary artery compression, hemopericardium, or endocarditis. CONCLUSIONS: This analysis reports the longest follow-up in the largest cohort of patients from the ALTERRA trials. The Alterra Adaptive Prestent with the SAPIEN 3 THV system has shown excellent procedural outcomes and is effective in reducing PR at 3-year follow-up. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03130777.
Abaci A, Yerlikaya MG, Kapanşahin T
… +11 more, Savaş G, Akyüz AR, Uslu Ş, Çekin ME, Hoşoğlu A, Bağci A, Arslan A, Çiçekcibaşi O, Durmaz FE, Sevgican Cİ, Ari H
BACKGROUND: Isolated coronary artery ectasia (CAE) is a less common form of CAE. The clinical significance of isolated CAE has not been elucidated yet. We aimed to compare the patients with myocardial infarction (MI) due...BACKGROUND: Isolated coronary artery ectasia (CAE) is a less common form of CAE. The clinical significance of isolated CAE has not been elucidated yet. We aimed to compare the patients with myocardial infarction (MI) due to isolated CAE with the patients without CAE. METHODS: We retrospectively included patients who underwent coronary angiography with a diagnosis of first MI caused by isolated CAE. We excluded patients with >20% stenosis in any vessel other than the lesion responsible for the MI. A second group of patients with MI without CAE was selected as the control group. The primary outcome was the composite of all-cause death and nonfatal recurrent MI occurring after index hospitalization. RESULTS: A total of 404 patients were included. Overall, 63.9% of MIs were ST-elevation MI. Almost all patients in the isolated CAE group had multivessel diffuse ectasia, with 71.3% classified as Markis I, and 26.7% as Markis II. Death or MI recurrence occurred in 54 (26.7%) patients in the isolated CAE group and 33 (16.3%) patients in the control group (=0.011). Death occurred in 8 (4.0%) patients in the isolated CAE group versus 6 (3.0%) patients in the control group; recurrent MI in 46 (22.8%) versus 27 (13.4%) patients, respectively. Stent thrombosis was more common in the CAE group compared with the control group (8.9% versus 1.5%; <0.001). In multiple variable analysis, the presence of CAE was associated with death/recurrent MI (hazard ratio, 1.84 [95% CI, 1.11-3.05]; =0.017), and recurrent MI (hazard ratio, 2.07 [95% CI, 1.08-3.96]; =0.029). CONCLUSIONS: The patients with MI due to isolated CAE had a higher risk of recurrent MI and stent thrombosis compared with the patients without CAE. In this study, the rate of recurrent MI from the index infarct artery was also higher in the patients with CAE.
BACKGROUND: Cardiac structural complications (CSCs) have been recently established by the Valve Academic Research Consortium 3 consensus as a combined end point including multiple life-threatening periprocedural events f...BACKGROUND: Cardiac structural complications (CSCs) have been recently established by the Valve Academic Research Consortium 3 consensus as a combined end point including multiple life-threatening periprocedural events following transcatheter aortic valve replacement. The objective was to assess the incidence, timing, management, and clinical impact of CSCs in the contemporary transcatheter aortic valve replacement era. METHODS: Multicenter study including consecutive patients undergoing transcatheter aortic valve replacement in 18 European and Canadian centers from 2014 to 2024. According to the Valve Academic Research Consortium 3 criteria, CSCs included cardiac structure perforation, injury or compromise, new pericardial effusion, and coronary obstruction. Data was collected in a dedicated database, and patients were followed at 30 days, 1 year, and yearly thereafter. RESULTS: Among a total of 10 541 patients, CSCs occurred in 221 (2.1%), with 126 (1.2%) patients exhibiting >1 CSC: 146 (1.4%) cardiac structure compromise events (annular rupture: 41.1%, left ventricular perforation: 26.0%; right ventricular perforation: 24.0%, other injuries: 8.9%), 150 (1.4%) new pericardial effusions, and 59 (0.6%) coronary obstructions. Up to 75.6% of CSCs occurred intraprocedurally, and 61 (27.6%) patients had conversion to open heart surgery. The incidence of CSCs remained similar throughout the study period (from 1.3% to 3.2%, median annual rate of 2.3%). Thirty-day mortality was 35.3% (52.5% among patients requiring conversion to surgery), with annular rupture associated with the highest (41.0%) mortality rate. CONCLUSIONS: About 2% of contemporary transcatheter aortic valve replacement recipients presented CSCs, which did not decrease over time, required conversion to surgery in more than one-fourth of cases, and were associated with very high periprocedural mortality rates. Further research is needed regarding potential preventive strategies and optimal surgical bailout management.
BACKGROUND: Pulmonary atresia with ventricular septal defect is a rare and complex congenital heart disease. In cases where pulmonary blood flow is supplied exclusively by major aortopulmonary collateral arteries, tradit...BACKGROUND: Pulmonary atresia with ventricular septal defect is a rare and complex congenital heart disease. In cases where pulmonary blood flow is supplied exclusively by major aortopulmonary collateral arteries, traditional surgical interventions may be challenging or delayed, especially in resource-limited settings. This study evaluated the feasibility, safety, and outcomes of the right ventricular outflow tract perforation through the retrograde trans-collateral approach in patients with pulmonary atresia with ventricular septal defect and major aortopulmonary collateral arteries dependent pulmonary circulation. METHODS: The study cohort comprised 10 patients with pulmonary atresia and ventricular septal defect who underwent attempted retrograde trans-collateral right ventricular outflow tract perforation via major aortopulmonary collateral arteries from October 2021 to February 2025, including 1 unsuccessful procedure. RESULTS: The median age at intervention was 4.1 years, and the median weight was 17 kg. Post-procedure, systemic oxygen saturation increased significantly (<0.01). Follow-up imaging demonstrated substantial growth of the pulmonary arteries following retrograde trans-collateral right ventricular outflow tract recanalization, with significant improvements in both right and left pulmonary artery scores (<0.01) and a significant increase in the Nakata index from a median of 49 to 111.7 mm/m (<0.01). CONCLUSIONS: Retrograde trans-collateral right ventricular outflow tract perforation is a feasible and safe catheter-based strategy for selected patients with pulmonary atresia with ventricular septal defect, promoting central pulmonary artery growth and serving as a bridge to future surgical repair.
BACKGROUND: Chronic therapy with sodium-glucose cotransporter 2 inhibitors (SGLT2i) is associated with long-term reno-protective benefits. There are limited data on the benefits of these agents against the risk of contra...BACKGROUND: Chronic therapy with sodium-glucose cotransporter 2 inhibitors (SGLT2i) is associated with long-term reno-protective benefits. There are limited data on the benefits of these agents against the risk of contrast-associated acute kidney injury (CA-AKI). METHODS: The retrospective study population included all patients with diabetes enrolled in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium Percutaneous Coronary Intervention registry, a clinical registry of all percutaneous coronary intervention (PCI) cases at nonfederal hospitals in the state of Michigan. Included patients underwent PCI between January 2022 and September 2023. Patients on dialysis and those without post-PCI serum creatinine measurements were excluded. SGLT2i users were compared with nonusers with respect to CA-AKI outcomes, defined as an increase in serum creatinine of ≥0.5 mg/dL following PCI. Outcomes were evaluated in a risk-adjusted, propensity-matched analysis. RESULTS: Among 13 804 patients with diabetes who underwent PCI, CA-AKI occurred in 3.8% (82/2186) of SGLT2i users versus 5.2% (602/11 618) of nonusers (odds ratio, 0.71; =0.004). In propensity-matched, risk-adjusted analysis, the pre-PCI use of SGLT2i correlated with a lower incidence of CA-AKI (3.69% versus 4.68%; adjusted odds ratio, 0.72; =0.027). The protective effect of SGLT2i was preserved among higher-risk subgroups. CONCLUSIONS: Among patients with diabetes who underwent PCI, preprocedural use of SGLT2i correlated with a lower risk of CA-AKI.
Springer A, Zeymer U, Rossberg M
… +11 more, Pöss J, Freund A, Desch S, Thevathasan T, Rassaf T, Akin I, Behnes M, Ouarrak T, Schneider S, Thiele H, Tigges E