Circulation: Cardiovascular Interventions最新文献

Background: Percutaneous microaxial ventricular assist devices (pVADs) have the potential to reduce mortality of patients with cardiogenic shock (CS). However, the association between the distribution of pVAD-performing centers and outcomes of CS has not been explored.

Methods: This observational study included Medicare fee-for-service beneficiaries aged 65 to 99 years treated with pVAD for CS from 2016 to 2020. It examined the associations between patient outcomes and 2 exposure variables: hospitals' procedure volumes of pVAD and patient-hospital distances (in quintiles [Qn]). We developed Cox proportional hazards regression for 180-day mortality and heart failure readmission rates, and multivariable logistic regression for in-hospital outcomes, adjusting for patient demographics, comorbidities, concomitant treatments, and hospital characteristics, including CS volume, teaching status, and the ability to perform extracorporeal membrane oxygenation.

Results: A total of 6637 patients with CS underwent pVAD at 1041 hospitals, with the annualized hospital volume ranging widely from 0.3 to 55.6 cases/year. Patients treated at higher-volume centers experienced lower 180-day mortality compared with those treated at lower-volume centers (Qn1=reference; Qn2: adjusted hazard ratio [aHR], 0.88 [95% CI, 0.79-0.97]; Qn3: aHR, 0.88 [95% CI, 0.79-0.98]; Qn4: aHR, 0.88 [95% CI, 0.78-0.99]; Qn5: aHR, 0.84 [95% CI, 0.74-0.95]; P for trend, 0.026), while we found no evidence that patient-hospital distances were associated with mortality (Qn1=reference; Qn2: aHR, 0.99 [95% CI, 0.89-1.09]; Qn3: aHR, 0.94 [95% CI, 0.85-1.04]; Qn4: aHR, 1.01 [95% CI, 0.92-1.11]; Qn5: aHR, 0.91 [95% CI, 0.82-1.01]; P for trend, 0.160). We found no evidence that the hospital volume and patient-hospital distances were associated with in-hospital bleeding, intracranial hemorrhage, or renal replacement therapy initiation.

Conclusions: Hospital volume was more strongly associated with mortality than patient-hospital distances, suggesting that rational distribution of pVAD-performing centers while ensuring adequate procedure volumes may optimize patient mortality.

Background: A small mitral valve area (MVA) is one of the challenging anatomies for transcatheter edge-to-edge repair (TEER) for mitral regurgitation, but the relationship between baseline MVA and clinical outcomes remains unknown. This study aimed to evaluate the association of baseline MVA with procedural and clinical outcomes in patients undergoing TEER with MitraClip from the OCEAN-Mitral registry (Optimized Catheter Valvular Intervention-Mitral).

Methods: A total of 1768 patients undergoing TEER were divided into 3 groups according to baseline MVA: group 1: <4.0 cm², n=358; group 2: 4.0-5.0 cm², n=493; and group 3: ≥5.0 cm², n=917. The primary end point was a composite of all-cause death and heart failure hospitalization within 2 years of TEER and compared between the 3 groups.

Results: Patients with smaller MVA had significantly fewer clips implanted and higher postprocedural transmitral mean pressure gradient. There was no significant difference in the acute procedural success rate and postprocedural mitral regurgitation severity between the 3 groups. The incidence of the primary end point was similar in group 1 compared with groups 2 and 3 (35.2% versus 34.5% versus 34.0%; P=0.96) and was also similar in patients with MVA <3.5 cm² and those with MVA 3.5 to 4.0 cm². The adjusted risk of MVA <4.0 cm² relative to MVA of 4.0 to 5.0 cm² and MVA ≥5 cm² for the primary end point remained insignificant (hazard ratio, 1.06 [95% CI, 0.79-1.41]; P=0.68; hazard ratio, 0.99 [95% CI, 0.75-1.31]; P=0.96, respectively). At 1 year, no significant difference in the proportion of residual mitral regurgitation 3+/4+ was observed between the 3 groups (7.2% versus 4.4% versus 6.5%; P=0.49).

Conclusions: In patients undergoing TEER, a small MVA <4.0 cm² may limit the number of clips implanted and increase the transmitral pressure gradient after TEER, but baseline MVA was not associated with mitral regurgitation reduction and clinical outcomes.

Registration: URL: https://center6.umin.ac.jp/cgiope n-bin/ctr/ctr_view.cgi?recptno=R000027188; Unique identifier: UMIN000023653.

Background: In STREAM-1 (Strategic Reperfusion Early After Myocardial Infarction), excess intracranial hemorrhage occurred in patients aged ≥75 years receiving full-dose tenecteplase as part of a pharmaco-invasive strategy, whereas no further intracranial hemorrhage occurred after halving the tenecteplase dose. In STREAM-2 (Second Strategic Reperfusion Early After Myocardial Infarction), half-dose tenecteplase was an effective and safe pharmaco-invasive strategy in older patients with ST-segment-elevation myocardial infarction presenting within <3 hours, compared with primary percutaneous coronary intervention (PCI). We prespecified evaluating the efficacy and safety of a half-dose versus full-dose pharmaco-invasive strategy and compared the half-dose pharmaco-invasive strategy to primary PCI in patients aged ≥75 years.

Methods: We pooled data sets in patients aged ≥75 years from STREAM-1 and STREAM-2 receiving a pharmaco-invasive strategy versus primary PCI. Resolution of ST-segment-elevation after fibrinolysis and angiography was assessed, as was the relative risk of the primary composite of 30-day all-cause death, myocardial infarction, heart failure, and shock, along with bleeding.

Results: A total of 390 patients were included: 42 patients were randomized to full-dose pharmaco-invasive treatment, 205 patients to half-dose pharmaco-invasive treatment, and 143 patients to primary PCI. Half-dose versus full-dose pharmaco-invasive treatment resulted in similar proportions of patients achieving ≥50% ST-segment resolution posttenecteplase (63.2% versus 62.6%), with reduced intracranial hemorrhage (7.1% versus 0%, respectively). Half-dose pharmaco-invasive treatment and primary PCI also had similar proportions of patients with ≥50% ST-segment resolution postangiography (77.9% versus 72.4%; P=0.277) and comparable composite end points (23.4% versus 28.0%; relative risk, 0.90 [95% CI, 0.62-1.30]; P=0.567) without occurrence of intracranial hemorrhage.

Conclusions: Comparable efficacy exists between half- and full-dose tenecteplase pharmaco-invasive treatments with improved safety in patients with ST-segment-elevation myocardial infarction aged ≥75 years. Half-dose pharmaco-invasive therapy is a legitimate therapeutic option for elderly patients with ST-segment-elevation myocardial infarction unable to access timely primary PCI.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00623623. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02777580.

Background: The relationship between the extent and severity of stress-induced ischemia and the extent and severity of anatomic coronary artery disease (CAD) in patients with obstructive CAD is multifactorial and includes the intensity of stress achieved, type of testing used, presence and extent of prior infarction, collateral blood flow, plaque characteristics, microvascular disease, coronary vasomotor tone, and genetic factors. Among chronic coronary disease participants with site-determined moderate or severe ischemia, we investigated associations between ischemia severity on stress testing and the extent of CAD on coronary computed tomography angiography.

Methods: Clinically indicated stress testing included nuclear imaging, echocardiography, cardiac magnetic resonance imaging, or nonimaging exercise tolerance test. Among those with preserved renal function who underwent coronary computed tomography angiography, we examined relationships between ischemia and CAD by coronary computed tomography angiography, overall, and by stress test modality, regardless of subsequent randomization. Core laboratories categorized ischemia as severe, moderate, mild, or none, while the extent and severity of anatomic CAD were categorized based on the modified Duke prognostic index.

Results: Among 3601 participants with interpretable stress tests and coronary computed tomography angiography, ischemia severity was weakly associated with CAD extent/severity (r=0.27), with modest variability in strength of association by modality: nuclear (n=1532; r=0.40), echocardiography (n=827; r=0.15), cardiac magnetic resonance imaging (n=108; r=0.31), and exercise tolerance test (n=1134; r=0.18). The extent of infarction on nuclear imaging and echocardiography was weakly associated with CAD extent/severity.

Conclusions: Overall, ischemia severity on stress testing showed weak to moderate associations with the anatomic extent of CAD in this cohort with moderate or severe ischemia on local interpretation and controlled symptoms.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.

Background: Evidence from trials suggests that patent foramen ovale closure is superior to medical therapy alone in reducing stroke recurrence in men but not in women. Evidence from real-world data on the impact of sex on outcomes after patent foramen ovale closure, however, remains scarce. Therefore, the present study aimed to assess sex-based differences in long-term outcomes after transcatheter closure of patent foramen ovale.

Methods: This was a single-center, retrospective cohort study enrolling patients who underwent transcatheter patent foramen ovale closure to prevent recurrent cerebrovascular events. Detailed information from medical charts was entered into a clinical registry, which has been linked to population-based administrative health databases in Ontario. Procedural, short, and long-term outcomes have been compared by sex.

Results: Of the 783 patients included in the sample, 349 (44.5%) were women and 434 (55.5%) were men. Women were younger and had a higher rate of migraine, while men had a higher prevalence of cardiovascular risk factors. No differences were observed in procedural and 30-day outcomes by sex. At a median follow-up of 14 years, the event rates of recurrent cerebrovascular events, survival, and new-onset atrial fibrillation were not different by sex. In adjusted analysis, men experienced higher rates of pacemaker implantation (hazard ratio, 5.62 [95% CI, 1.57-20.1]).

Conclusions: No sex-based differences in recurrent cerebrovascular events, survival, or new-onset atrial fibrillation were observed in this study, suggesting equal benefits for both sexes. Future studies should report outcomes by sex to enhance the reproducibility of our findings and help support guideline development.

Background: Double-kissing (DK) crush and DK culotte are the recommended 2-stent strategies in true coronary bifurcation lesions. However, it is a matter of curiosity about which of the DK crush and DK culotte stenting techniques will have superior results. We aimed to compare the clinical outcomes of DK crush and DK culotte stenting in nonleft main coronary artery bifurcation.

Methods: Consecutive patients who received DK crush or DK culotte technique for de novo true nonleft main coronary artery bifurcation lesion were categorized according to which treatment they received. The primary end point of the study was target lesion failure as a composite end point of target lesion revascularization, target vessel myocardial infarction, and cardiac death. Secondary end points were all-cause death and definite stent thrombosis.

Results: A total of 202 patients were categorized as DK crush (101 patients) or DK culotte (101 patients) techniques. The target lesion failure had occurred frequently in the DK crush (10.9%) compared with the DK culotte (3.0%; P=0.028) that was mainly driven by increased target lesion revascularization (9.9% in the DK crush versus 3.0% in the DK culotte; P=0.045). The number of patients with target vessel myocardial infarction (3.0% in the DK crush versus 2.0% in the DK culotte; P=0.651) and cardiac death (1.0% in the DK crush versus 0.0% in the DK culotte; P=0.315) was higher in the DK crush. There were no differences in terms of definite stent thrombosis and all-cause death between groups.

Conclusions: In the present analysis, DK culotte was associated with lower 1-year target lesion failure rates compared with DK crush in true nonleft main coronary artery bifurcations.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04789161.

Background: Stent underexpansion is a significant challenge in percutaneous coronary intervention, critically impacting patient outcomes. While excimer laser coronary angioplasty (ELCA) and intravascular lithotripsy (IVL) are increasingly used to address this issue, their full impact on the integrity of drug-eluting stents remains unclear, raising concerns about their safety and efficacy.

Methods: This in vitro study assessed the effects of ELCA and IVL on the structural integrity of drug-eluting stents using scanning electron microscopy. Nine stents, 5 Onyx Frontier (with durable circumferential polymer coating) and 4 Cre8 (polymer-free), were implanted in a 3-dimensional coronary artery simulator following standardized protocols. After implantation, treatments with saline-ELCA, contrast-ELCA, IVL, and high-pressure balloon dilatation were applied. A comprehensive evaluation of the stent surface was performed at 60-fold magnification.

Results: Scanning electron microscopy analysis revealed significant differences in polymer damage between the techniques. High-pressure balloon dilatation and contrast-ELCA exhibited substantial polymer fragmentation and detachment compared with IVL, saline-ELCA, and conventional dilatation. High-pressure balloon dilatation demonstrated the highest incidence of polymer shaving and overcoating. No significant alterations were observed in polymer-free stents, regardless of the technique used.

Conclusions: IVL and saline-ELCA applied immediately after stent implantation produce minimal polymer damage, whereas high-pressure balloon dilatation and contrast-ELCA cause significant damage to the polymer coating. The integrity of polymer-free drug-eluting stent appears stable regardless of the technique used. Further research is needed to validate these findings and explore their clinical implications.