Dakroub AH, Shin D, Singh M
… +17 more, Malik S, Volleberg RHJA, Weber J, Ciftcikal Y, Fazal A, Sakai K, Sato T, Maehara A, Matsumura M, Moses JW, Mintz GS, Khalique OK, Sosa F, Shlofmitz E, Jeremias A, Shlofmitz RA, Ali ZA
BACKGROUND: Calcified nodules (CNs) remain a major challenge in percutaneous coronary intervention (PCI). We sought to compare procedural and clinical outcomes after orbital atherectomy (OA) versus intravascular lithotri...BACKGROUND: Calcified nodules (CNs) remain a major challenge in percutaneous coronary intervention (PCI). We sought to compare procedural and clinical outcomes after orbital atherectomy (OA) versus intravascular lithotripsy (IVL)-facilitated PCI in patients with CNs. METHODS: We identified patients with optical coherence tomography (OCT)-defined CNs who underwent PCI with either OA or IVL between 2012 and 2022 and had both pre- and post-PCI OCT images available. The imaging end point was the minimal stent area on final post-PCI OCT. The clinical end point was 2-year target-lesion failure, a composite of cardiac death, target-vessel myocardial infarction, or clinically driven target-lesion revascularization. A multivariable Cox proportional hazards regression model was used to estimate hazard ratio and 95% CI. Sensitivity analyses were performed using propensity score matching, incorporating covariates such as age, sex, diabetes, and pre-PCI calcium burden assessed by OCT (length, arc, and thickness). RESULTS: Among 4856 patients with evaluable pre- and post-PCI OCT images, 493 patients (10.2%) had CNs, and 167 patients underwent PCI with either OA (n=83) or IVL (n=84). The 2 groups had similar baseline demographic and lesion characteristics. After PCI, final minimal stent area was comparable between the 2 groups (OA, 5.6 mm [interquartile range, 4.8-6.7] versus IVL, 5.5 mm [interquartile range, 4.8-7.0]; =0.75). At a median follow-up of 2.4 years, there was no difference in target-lesion failure between the OA and IVL groups (12.0% versus 9.8%, respectively; log-rank =0.64; adjusted hazard ratio, 1.10 [95% CI, 0.28-4.31]; =0.89). Overall results remained consistent in the propensity score-matched population (n=68 per group), with similar minimal stent area (5.6 mm [4.8-6.7] versus 5.5 mm [4.7-6.8]; =0.73) and comparable 2-year target-lesion failure rate (9.8% versus 8.8%; log-rank =0.82). CONCLUSIONS: In patients with OCT-defined CNs, OA- and IVL-assisted PCI resulted in comparable post-PCI minimal stent area and 2-year clinical outcomes.
Bruce CG, Halaby RN, Khan JM
… +5 more, Rogers T, Jaimes AE, Babaliaros VC, Greenbaum AB, Lederman RJ
Circ Cardiovasc Interv
· 2025 Sep · PMID 40735772
·
Full text
BACKGROUND: Coronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement. Current techniques (transcatheter leaflet modification or snorkel stenting) cannot prevent obstruc...BACKGROUND: Coronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement. Current techniques (transcatheter leaflet modification or snorkel stenting) cannot prevent obstruction in all cases. METHODS: We created a transcatheter coronary artery bypass procedure, VECTOR (Ventriculo-Coronary Transcatheter Outward Navigation and Re-Entry), to bypass the proximal coronary artery with a covered stent graft. We tested the feasibility of creating a neo-ostium, 10 to 15 mm cephalad to the native, and bypassing the proximal coronary artery in swine. We established a proximal anastomosis using transcatheter electrosurgery to exit the aorta to the pericardium. The distal anastomosis was created using a guidewire to exit the proximal coronary artery and enter the pericardium. The points were connected, and a covered stent graft implanted to bypass the proximal vessel. Coronary angiography and intravascular ultrasound were used to assess graft patency and expansion. RESULTS: The VECTOR technique was developed in 11 and performed on the right coronary artery in 6 additional healthy swine. Proximal and distal anastomoses were successfully created, and up to 3 (total length 40 [35-45] mm) covered stent grafts were delivered to bypass the proximal vessel. There were no significant complications. All vessels had Thrombolysis in Myocardial Infarction III flow on completion. CONCLUSIONS: Transcatheter coronary artery bypass with VECTOR is feasible in swine and may offer an effective solution to circumvent iatrogenic coronary artery obstruction following transcatheter aortic valve replacement when other transcatheter techniques are not possible.
Spagnolo M, Giacoppo D, Laudani C
… +5 more, Greco A, Finocchiaro S, Mauro MS, Imbesi A, Capodanno D
Circ Cardiovasc Interv
· 2025 Aug · PMID 40718929
·
Full text
Efforts to enhance risk stratification in patients with coronary artery disease have driven the pursuit of early detection of rupture-prone plaques-before destabilization and the onset of life-threatening thrombosis-givi...Efforts to enhance risk stratification in patients with coronary artery disease have driven the pursuit of early detection of rupture-prone plaques-before destabilization and the onset of life-threatening thrombosis-giving rise to the concept of the vulnerable plaque (VP). Invasive diagnostic modalities closely mirror histology and provide instrumental information on VP hallmarks and their prognostic significance. However, limited positive predictive value and invasive nature restrict their use for systematic screening. Noninvasive techniques offer broader application potential, but their specificity and resolution remain inferior to those of invasive techniques. A deeper understanding of the complex interplay between traditional ischemic risk factors, anatomic settings, rheological effects and systemic influences contributing to plaque evolution and rupture has refined our approach to identifying and managing VPs. Systemic therapies have been shown to counteract plaque progression and stabilize VPs by thickening the fibrous cap, decreasing atheroma and necrotic core volumes, and reducing inflammation. In parallel, the hypothesis of sealing and passivating VPs by intravascular imaging-guided preventive stenting is gaining support after the promising results of clinical trials and substantial advances in contemporary device performance and biocompatibility. Upcoming evidence will be instrumental in defining the net benefit of novel diagnostic tools and therapeutic strategies for VPs.
Morray BH, Gillespie MJ, Cheatham JP
… +13 more, Salavitabar A, Peng L, Jones TK, Levi DS, Gray RG, Asnes J, Cabalka AK, Fujimoto K, Qureshi AM, Bergersen L, Benson LN, Haugan D, McElhinney DB
Circ Cardiovasc Interv
· 2025 Sep · PMID 40665900
·
Full text
BACKGROUND: The Harmony transcatheter pulmonary valve (TPV) is designed to treat severe pulmonary regurgitation in the native or surgically repaired right ventricular (RV) outflow tract. Early outcomes after TPV replacem...BACKGROUND: The Harmony transcatheter pulmonary valve (TPV) is designed to treat severe pulmonary regurgitation in the native or surgically repaired right ventricular (RV) outflow tract. Early outcomes after TPV replacement with the Harmony valve have been positive, but longer-term data are limited. METHODS: The study included patients who received a commercially available TPV22 or TPV25 device as part of the nonrandomized, prospective Native Outflow Tract Early Feasibility Study, Harmony Pivotal Trial, and Continued Access Study. Patients completed at least 3 years of follow-up, and outcomes to 5 years were reported when available. RESULTS: Eighty-nine patients were catheterized, and 86 were successfully implanted with a Harmony TPV. Median duration of follow-up was 5 (range 0-6) years in the TPV22 group and 3 (1-4) years in the TPV25 group. At 3 years, all patients with a TPV22 and 96% of those with a TPV25 had ≤mild pulmonary regurgitation. By magnetic resonance imaging, significant improvements from preimplant to 2 years were observed in RV end-diastolic volume index, RV to left ventricular end-diastolic volume ratio, and effective RV stroke volume (all <0.001). SF-36 quality-of-life scores improved after Harmony implantation and were sustained over 3 years. Early cases of ventricular tachycardia resolved, and there were no new arrhythmias. Adverse events up to 5 years included 3 deaths unrelated to the device or procedure, 2 cases of endocarditis that were treated (1 medically, 1 transcatheter debulking of a vegetation) and resolved, 6 patients with RV outflow tract obstruction or thrombosis resulting in valve-in valve procedures, and 1 major stent fracture resulting in surgical explant. CONCLUSIONS: At 3 to 5 years, Harmony TPV replacement resulted in sustained valve competence, beneficial cardiac remodeling, and improved quality of life. Continued monitoring is needed to assess long-term outcomes and valve performance. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01762124; NCT02979587.
BACKGROUND: Anticoagulant therapy with vitamin K antagonists is recommended in the current guidelines for 3 to 6 months following bioprosthetic valve replacement. However, in the era of direct oral anticoagulants, there...BACKGROUND: Anticoagulant therapy with vitamin K antagonists is recommended in the current guidelines for 3 to 6 months following bioprosthetic valve replacement. However, in the era of direct oral anticoagulants, there is a paucity of evidence regarding the efficacy and safety of direct oral anticoagulants in this patient group. METHODS: The ENBALV trial (Edoxaban in Anticoagulant Therapy After Surgical Bioprosthetic Valve Replacement) was an investigator-initiated, phase 3, randomized, open-label, multicenter study that aimed to evaluate the efficacy and safety of edoxaban compared with warfarin within 3 months following bioprosthetic valve replacement at the aortic or mitral position or both. The primary outcome was stroke or systemic embolism. The secondary outcomes included major bleeding, intracardiac thrombus, and a composite of stroke, systemic embolism, or major bleeding. Given the limited study period and the low event rate of the primary outcome, this study assessed the difference in the point estimates of the event rate. RESULTS: Of the 410 enrolled patients, 389 were included in the final analysis (73±6 years, 56.8% male, 79.4% sinus rhythm; edoxaban group: n=195, warfarin group: n=194). The primary outcome occurred in 0.5% (n=1) in the edoxaban group, whereas in 1.5% (n=3) in the warfarin group (risk difference, -1.03% [95% CI, -4.34 to 1.95%]). Major bleeding occurred in 4.1% (n=8) in the edoxaban group and in 1.0% (n=2) in the warfarin group (risk difference, 3.07% [95% CI, -0.67 to 7.27%]). No fatal bleeding or intracranial hemorrhage was observed in patients treated with edoxaban, whereas 1 fatal intracranial hemorrhage occurred in the warfarin group. Intracardiac thrombus did not occur in any of the patients in the edoxaban group, but did occur in 1.0% (n=2) in the warfarin group. CONCLUSIONS: Edoxaban is a potential alternative anticoagulant therapy early after bioprosthetic valve replacement. REGISTRATION:URL: https://jrct.niph.go.jp/latest-detail/jRCT2051210209; Unique identifier: jRCT2051210209.
BACKGROUND: Pediatric intraluminal pulmonary vein stenosis (PVS) occurs in a heterogeneous patient population but is unified by its cellular composition in affected pulmonary veins. Enhanced delineation of the hemodynami...BACKGROUND: Pediatric intraluminal pulmonary vein stenosis (PVS) occurs in a heterogeneous patient population but is unified by its cellular composition in affected pulmonary veins. Enhanced delineation of the hemodynamic and physiological vein consequences of PVS and its impact on vein lumen, vein pressure, wall structure, vein compliance, and wall shear stress has not been studied. The objective is to assess PVS characteristics using multimodal catheterization techniques (angiography, pulmonary vein pressure, intravascular ultrasound, balloon compliance testing, and wall shear stress calculation) and determine their association with vein outcomes. METHODS: The study is a prospective trial applying a standardized catheterization assessment to patients under 13 years of age who are undergoing cardiac catheterization for PVS. The primary outcome is vein status at 12 months, assigned by an end point committee. The secondary outcome is transplant-free survival. RESULTS: Overall, 50 patients with a median age of 2.7 years (range, 0.3-11.8) underwent assessment and included angiography of 200 veins, 171 pressure assessment, 169 intravascular ultrasound, 58 balloon compliance testing, and 141 wall shear stress calculations. The probability of a worse vein outcome increased as angiographic severity score, percent wall thickness by intravascular ultrasound, postintervention gradient, or postintervention wall shear stress increased. Multivariable analysis demonstrated veins with angiographic upstream luminal narrowing (odds ratio, 3.26 [95% CI, 1.38-7.7]; =0.007), ostial diameter <6 mm (odds ratio, 3.93 [95% CI, 1.29-12]; =0.016), and ≥35% upstream wall thickness by intravascular ultrasound (odds ratio, 5.05 [95% CI, 2.03-12.5]; <0.001) are associated with a worse vein outcome. A 3-point Invasive Pulmonary Vein Score prediction tool was created. Transplant-free survival was 92% at 12 months. CONCLUSIONS: A multimodal pulmonary vein catheterization assessment determined angiographic and intravascular ultrasound findings to be the most predictive of 12-month pulmonary vein outcome. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04696289.
BACKGROUND: Coronary artery spasm (CAS) is a common cause of angina with nonobstructive coronary arteries (ANOCA). While acetylcholine provocation testing is the diagnostic gold standard, protocol variations have led to...BACKGROUND: Coronary artery spasm (CAS) is a common cause of angina with nonobstructive coronary arteries (ANOCA). While acetylcholine provocation testing is the diagnostic gold standard, protocol variations have led to discrepancies in diagnostic accuracy. This study aimed to compare the diagnostic validity of conventional versus high-dose acetylcholine regimens in patients with ANOCA. METHODS: Multivessel acetylcholine provocation testing was systematically performed in patients with ANOCA and a control cohort undergoing invasive coronary angiography for noncoronary indications. Incremental acetylcholine doses in the left (20-200 μg) and right (20-80 μg) coronary arteries were manually injected over 20 seconds to induce CAS. RESULTS: The study included 62 patients with ANOCA with typical CAS symptoms and 20 controls. Conventional-dose acetylcholine testing identified CAS in 67.1% (55/82) of patients, while high-dose testing detected CAS in 79.3% (65/82). Among patients with inducible spasm, 93.4% (61/65) had typical angina consistent with CAS. High-dose acetylcholine demonstrated significantly higher sensitivity (98% versus 87%, =0.008), but a nonsignificant trend toward lower specificity (80% versus 95%, =0.08). The high-dose regimen also showed a higher negative predictive value (94% versus 70%, =0.01), while positive predictive values were comparable (93% versus 98%, =0.12). CONCLUSIONS: High-dose acetylcholine provocation improves the detection of CAS in patients with ANOCA but may increase the risk of overdiagnosis. This approach should be reserved for patients with a high clinical suspicion of CAS, with the results interpreted within the broader clinical context.
BACKGROUND: Patients with post-percutaneous coronary intervention (PCI) angina are challenging to manage. Comprehensive coronary function testing (CFT) can identify occult coronary abnormalities in patients with angina a...BACKGROUND: Patients with post-percutaneous coronary intervention (PCI) angina are challenging to manage. Comprehensive coronary function testing (CFT) can identify occult coronary abnormalities in patients with angina and nonobstructive coronary arteries. Its utility in patients with post-PCI persistent angina who have no obstructive coronary artery disease is unexplored. METHODS: We assessed 46 patients with a prior PCI experiencing persistent angina. CFT evaluated the presence of endothelial dysfunction, epicardial and microvascular spasm, low fractional flow reserve, coronary microvascular dysfunction, and myocardial bridging by intravascular ultrasound. The Seattle Angina Questionnaire measured symptom severity before and 1-year post-CFT. RESULTS: The median age was 60 (53-69) years, with 63% being women. Pre-PCI lesion stenosis was 80 (70-90)% and pre-PCI fractional flow reserve (n=7) was 0.72 (0.67-0.74). Left anterior descending artery PCI was performed in 47.8%. The median duration between PCI and CFT was 19.5 (11.2-57.2) months. Patients reported severe anginal symptoms and poor quality of life on the Seattle Angina Questionnaire. CFT revealed a median fractional flow reserve of 0.84 (0.82-0.87), and 19.6% had a fractional flow reserve ≤0.8. Endothelial dysfunction was diagnosed in 36.9%, of whom 64.7% had moderate to severe endothelial dysfunction. Epicardial and microvascular spasm were present in 56.5% and 17.4%, respectively. Coronary microvascular dysfunction was present in 43.5%, and 63% had myocardial bridging. Patients reported significant improvement in Seattle Angina Questionnaire scores 1-year post-CFT. CONCLUSIONS: Patients with post-PCI persistent angina have severe symptoms and poor quality of life, with the majority exhibiting endothelial dysfunction, epicardial spasm, coronary microvascular dysfunction, and myocardial bridging. Comprehensive CFT should be considered in these patients to help diagnose an underlying cause of their persistent angina and guide therapy for a better outcome.