Circulation: Cardiovascular Interventions最新文献

Background: Bioresorbable scaffolds (BRS) were developed to overcome limitations related to late stent failures of drug-eluting stents, but lumen reductions over time after implantation of BRS have been reported. This study aimed to investigate if lesion preparation with a scoring balloon compared with a standard noncompliant balloon minimizes lumen reduction after implantation of a Magmaris BRS assessed with optical coherence tomography and intravascular ultrasound.

Methods: Eighty-two patients with stable angina were randomized in a ratio of 1:1 to lesion preparation with a scoring balloon versus a standard noncompliant balloon before implantation of a Magmaris BRS. The primary end point was minimal lumen area at 6-month follow-up.

Results: Following Magmaris BRS implantation, minimal lumen area (6.4±1.6 versus 6.3±1.5 mm²; P=0.65), mean scaffold area (7.8±1.5 versus 7.5±1.7 mm²; P=0.37), and mean lumen area (8.0±1.6 versus 7.7±2.1 mm²; P=0.41) did not differ significantly in patients with lesions prepared with scoring versus standard noncompliant balloon, respectively. Six-month angiographic follow-up with optical coherence tomography and intravascular ultrasound was available in 74 patients. The primary end point, 6-month minimal lumen area, was significantly larger in lesions prepared with a scoring balloon compared with a standard noncompliant balloon (4.7±1.4 versus 3.9±1.9 mm²; P=0.04), whereas mean lumen area (7.2±1.4 versus 6.8±2.2 mm²; P=0.35) did not differ significantly. Intravascular ultrasound findings showed no difference in mean vessel area at the lesion site from baseline to follow-up in the scoring balloon group (16.8±2.9 versus 17.0±3.6 mm²; P=0.62), whereas mean vessel area (17.1±4.4 versus 15.7±4.9 mm²; P<0.001) was smaller in lesions prepared with a standard noncompliant balloon due to negative remodeling.

Conclusions: Lesion preparation with a scoring balloon before implantation of a Magmaris BRS resulted in a significantly larger minimal lumen area after 6 months due to less negative remodeling compared with lesion preparation with a standard noncompliant balloon.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04666584.

Background: The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk in patients undergoing transcatheter aortic valve replacement. The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale transcatheter aortic valve replacement population.

Methods: Multicenter study including 10 449 patients undergoing transcatheter aortic valve replacement. Based on consensus, 21 clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to the VARC-HBR definition. The primary end point was the rate of Bleeding Academic Research Consortium type 3 or 5 bleeding at 1 year, defined as the composite of periprocedural (within 30 days) or late (after 30 days) bleeding.

Results: Patients with at least 1 VARC-HBR criterion (n=9267, 88.7%) had a higher risk of Bleeding Academic Research Consortium 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very-high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under receiver operating characteristic curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very-high-risk groups (hazard ratio, 1.33 [95% CI, 1.04-1.70] and 1.97 [95% CI, 1.53-2.53], respectively).

Conclusions: The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in transcatheter aortic valve replacement. The results of the present study would support the predictive validity of the new definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.

Background: Food and Drug Administration-mandated postmarket studies for transcatheter aortic valve replacement in low-risk populations plan to use passively collected registry data linked to claims for long-term follow-up out to 10 years. Therefore, it is critically important to understand the validity of these claims-based end points. We sought to evaluate the ability of administrative claims with International Classification of Diseases-Tenth Revision (ICD-10) codes to identify trial-adjudicated end points and reproduce treatment comparisons of aortic valve replacement in the Evolut Low Risk Trial.

Methods: We linked Evolut Low Risk trial patients to the Medicare Provider Analysis and Review database. We calculated sensitivity, specificity, positive predictive value, negative predictive value, and κ agreement statistic of claims to detect clinical end points through 2 years in trial patients. We additionally compared end points across treatment arms using trial-adjudicated outcomes versus claims-based outcomes.

Results: Trial-adjudicated deaths were perfectly identified by claims. Claims had good performance in identifying trial-adjudicated disabling stroke (sensitivity 68.8%, specificity 99.0%, positive predictive value 64.7%, negative predictive value 99.1%, κ=0.66) and pacemaker placement (sensitivity 85.2%, specificity 98.4%, positive predictive value 90.4%, negative predictive value 97.5%, κ=0.86), but more modest performance in identifying trial-adjudicated myocardial infarction (κ=0.46) and vascular complications (κ=0.45). There was no difference between treatment arms for the primary end point of death or disabling stroke using trial data (hazard ratio, 0.83 [95% CI, 0.41-1.68]) or claims data (hazard ratio, 0.89 [95% CI, 0.43-1.81]; interaction P=0.71).

Conclusions: Claims-based end points performed well in ascertaining death, disabling stroke, and pacemaker placement and were able to reproduce principal trial findings. These results support the selective use of claims-based end points for transcatheter aortic valve replacement postmarketing surveillance.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283.

Background: The aim of this study was to examine the impact of early versus delayed catheter-based therapies (CBTs) on clinical outcomes in patients with acute intermediate-risk pulmonary embolism (PE).

Methods: This retrospective cohort study analyzed data from 2 academic centers involving patients with intermediate-risk PE from January 2020 to January 2024. Patients were divided into early (<12 hours) and delayed CBT (≥12 hours) groups. The primary outcome was a composite of 30-day mortality, resuscitated cardiac arrest, hemodynamic instability, and 90-day readmission. Secondary outcomes included a composite of 30-day mortality, resuscitated cardiac arrest, and hemodynamic instability. Inverse probability of treatment weighting was used to balance covariates.

Results: A total of 133 patients were included (mean age, 58.3 years; 44% women; 29% catheter-directed thrombolysis; 68% mechanical thrombectomy; and 3% both). The median time to intervention was 6.1 hours in the early group and 20.8 hours in the delayed group (P<0.001). A total of 16 patients (12% of patients) experienced the primary composite outcome. Early CBT was associated with a significantly lower rate of the primary composite outcome (4% versus 18%; log-rank P<0.001; inverse probability of treatment weighting [hazard ratio, 0.13 (95% CI, 0.03-0.58); P=0.007]) and secondary composite outcome (0% versus 9%; log-rank P=0.02). The early CBT group also had lower intensive care unit (3.0 versus 3.4 days; P=0.01) and hospital length of stay (5.0 versus 6.1 days; P=0.046). When patients were stratified by timing of CBT (early/late) and the composite PE shock score (high ≥3; low <3), all 16 patients who experienced the primary composite outcome had a high composite PE shock score, with 14/16 (87.5%) having a high composite PE shock score and delayed intervention.

Conclusions: Early CBT was associated with improved clinical outcomes in patients with acute intermediate-risk PE. The composite PE shock score may help identify patients who will benefit from early CBT. Further prospective studies are needed to validate these findings.

Background: While initial data for transcatheter aortic valve replacement (TAVR) in aortic stenosis patients with mitral stenosis (MS) suggested a poor short-term prognosis, outcomes for contemporary balloon-expandable valves remain unknown. The aim of this retrospective multicenter registry study was to compare the potential impact of MS on TAVR outcomes with balloon-expandable valves.

Methods: Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry and Centers for Medicare & Medicaid Services claims data were used to obtain a cohort of 327 925 patients who underwent TAVR with current balloon-expandable valves (SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra Resilia) between June 2015 and December 2022 across 791 sites. Severe MS (defined as >10 mm Hg mean gradient or <1.5 cm² area) was compared with mild or less MS (defined as <5 mm Hg mean gradient and >2 cm² area) using propensity matching to minimize confounding variables.

Results: Patients with severe MS (n=8500; 2.6%) had a higher number of comorbid conditions, Society of Thoracic Surgeons risk scores, and were more often women than patients with mild or less MS at the time of index TAVR. While patients with severe MS had worse outcomes at 30 days, when propensity-matched, patients exhibited similar 30-day rates of death (3.2% versus 3.0%), stroke (2.4% versus 2.2%), major vascular complications (1.6% versus 1.6%), device implant success (98.9% versus 99.2%), and new dialysis (0.7% versus 0.5%), with higher rates of pacemaker implantation (11.3% versus 9.4%; P<0.001). By 1 year, there was no difference in the change in the KCCQ (Kansas City Cardiomyopathy Questionnaire) overall score from baseline to 1 year (30.7±27.0 versus 31.9±27.0; P=0.07). By 3 years, an increase in the mortality rate (45.1% versus 40.9%; P<0.001) of patients with severe MS was observed.

Conclusions: MS in isolation is not associated with worsened short-term outcomes among patients undergoing contemporary TAVR with balloon-expandable valves.

The Fontan circuit is associated with chronically elevated systemic venous pressures and decreased cardiac output, often leading to circuit failure. Managing Fontan circuit failure is complex and requires multiple therapeutic options. Transcatheter interventions have emerged as a reliable approach. They can alleviate obstructions and improve cyanosis by enhancing pulmonary blood flow and oxygen saturation. These procedures can also increase cardiac output and reduce systemic venous pressure, contributing to patient stabilization. In addition, they help mitigate volume overload and decrease the risk of bleeding during heart or combined heart and liver transplants. In recent years, percutaneous interventions have rapidly evolved and become a key therapeutic option for addressing various aspects of Fontan circuit failure. These interventions should be considered integral to the management strategy for this specific patient population.

Background: Covered stent correction (CSC) of a superior sinus venosus atrial septal defect is an alternative to surgery in selected patients, but anatomic variation means that assessment for CSC requires a 3-dimensional anatomic understanding. Heart VR is a virtual reality (VR) system that rapidly displays and renders multimodality imaging without prior image segmentation. The aim of this study was to evaluate the performance of the Heart VR system to assess patient suitability for CSC.

Methods: In a blinded fashion, 2 interventionalists reviewed preprocedural computed tomography scans using Heart VR to assess the feasibility of CSC, including the potential need for pulmonary vein protection. The total review time using VR was recorded.

Results: Using conventional imaging, 15 patients were deemed suitable for CSC, but at catheterization, 3 cases were unsuitable. Using VR, when both interventionalists agreed that a case was suitable for CSC (n=12), all proved technically feasible. In the 3 cases that were unsuitable for CSC, the interventionalists using VR were either uncertain (n=1) or did not agree on suitability (n=2). The strategy for pulmonary vein protection was correctly identified by interventionalist 1 and 2 in 9/12 and 8/12 cases, respectively. In cases where pulmonary vein protection was required intraprocedurally (n=5), this was correctly identified using Heart VR. Using VR, in 3 cases it was determined that pulmonary vein protection would be required, but this was not the case on balloon interrogation. VR data loading and review times were 82 seconds and 7 minutes, respectively. Verbal feedback indicated that Heart VR assisted in the assessment of case suitability.

Conclusions: Heart VR is a rapid and effective tool for predicting suitability for CSC in patients with a superior sinus venosus atrial septal defect and could be a feasible alternative to segmented virtual or physical 3-dimensional models.

Background: In patients with previous coronary artery bypass grafting, computed tomography cardiac angiography (CTCA) before invasive coronary angiography (ICA) was demonstrated in the BYPASS-CTCA trial (Randomized Controlled Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery Patients) to reduce procedure time and incidence of contrast-associated acute kidney injury, with greater levels of patient satisfaction. Patient-related outcomes, utilization of further diagnostic imaging resources, and longer-term incidence of major adverse cardiac events were key secondary end points not yet reported.

Methods: Patients with prior coronary artery bypass grafting referred for ICA were randomized 1:1 to undergo CTCA before ICA or ICA alone and followed up for a median of 3 (2.2-3.4) years. Angina status was assessed using the Seattle Angina Questionnaire and overall quality of life using the EQ-5D-5L. The incidence of noninvasive imaging use and major adverse cardiac events were compared between the 2 groups.

Results: In all, 688 patients were randomized, 344 to CTCA+ICA and 344 to ICA only. The mean age of participants was 69.8 years, with 45% undergoing ICA for acute coronary syndromes and the remainder stable angina. At 3 months follow-up, patients in the CTCA+ICA group were more likely to be angina-free (51.7% versus 43.2%; P=0.03) with greater quality of life (EQ-5D-5L index, 81.6 versus 74.4; P=0.001), although these improvements did not persist. At 3 years follow-up, imaging resource use (35.8% versus 45.1%; odds ratio, 0.68 [95% CI, 0.50-0.92]; P=0.013) and incidence of major adverse cardiac events were lower in the CTCA+ICA group (35.8% versus 43.5%; hazard ratio, 0.73 [95% CI, 0.58-0.93]; P=0.010).

Conclusions: In patients with prior coronary artery bypass grafting undergoing ICA, CTCA before ICA leads to reductions in the use of imaging resources and the rate of major cardiac events out to 3 years, but with similar patient-related outcome measures. Together with the initial findings of BYPASS-CTCA, these data are supportive of routinely undertaking a CTCA before ICA in patients with prior coronary artery bypass grafting.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03736018.

Background: Transcatheter aortic valve replacement (TAVR) pushes aside the diseased native aortic valve and creates a native neo-sinus bordered by the aortic root wall and the displaced native valve. There are limited data on the progression of native valve disease post-TAVR and no previous analysis of the native neo-sinus.

Methods: Native aortic valves and native neo-sinus explants obtained post-TAVR were evaluated histologically (hematoxylin and eosin, Movat pentachrome, and Martius Scarlet Blue stains) and by immunohistochemistry (TGF-β1 [transforming growth factor-beta 1], FAP [fibroblast activation protein], and ALP [alkaline phosphatase]) to assess disease mechanisms.

Results: Native aortic valves were obtained from 20 patients from 0 to 2583 days (7.08 years) post-TAVR. Native leaflets showed persistent calcific aortic stenosis-like disease activity with positivity for ALP and FAP. Native valve remodeling was observed as changes in architecture evident in explants >1.5 years, which was observed as crumpling of the leaflets. Disease activity was also present in native neo-sinuses with transcatheter heart valve implant durations >1 year with positive staining for TGF-β1, FAP, and ALP. Extensive native neo-sinus remodeling occurred with replacement and filling-in of this space with contiguous extracellular matrix, calcific deposits, and microvessels.

Conclusions: Following TAVR, there is ongoing calcific aortic stenosis-like disease with architectural changes to native leaflets and extensive remodeling of the native neo-sinus, evidenced by replacement and contiguous filling-in of the native neo-sinus blood pool space with increasing implant duration. The dynamic nature of these tissues has potential implications for neo-sinus flow, valve degeneration, and re-intervention.