Circulation: Cardiovascular Interventions最新文献

Background: Clot-in-transit is associated with high mortality, but optimal management strategies remain uncertain. The aim of this study was to compare the outcomes of different treatment strategies in patients with clot-in-transit.

Methods: This is a retrospective study of patients with documented clot-in-transit in the right heart on echocardiography across 2 institutions between January 2020 and October 2023. The primary outcome was a composite of in-hospital mortality, resuscitated cardiac arrest, or hemodynamic decompensation.

Results: Among 35 patients included in the study, 10 patients (28.6%) received anticoagulation alone and 2 patients (5.7%) received systemic thrombolysis, while 23 patients (65.7%) underwent catheter-based therapy (CBT; 22 mechanical thrombectomy and 1 catheter-directed thrombolysis). Over a median follow-up of 30 days, 9 patients (25.7%) experienced the primary composite outcome. Compared with anticoagulation alone, patients who received CBT or systemic thrombolysis had significantly lower rates of the primary composite outcome (12% versus 60%; log-rank P<0.001; hazard ratio, 0.13 [95% CI, 0.03-0.54]; P=0.005) including a lower rate of death (8% versus 50%; hazard ratio, 0.10 [95% CI, 0.02-0.55]; P=0.008), resuscitated cardiac arrest (4% versus 30%; hazard ratio, 0.12 [95% CI, 0.01-1.15]; P=0.067), or hemodynamic deterioration (4% versus 30%; hazard ratio, 0.12 [95% CI, 0.01-1.15]; P=0.067).

Conclusions: In this study of CBT in patients with clot-in-transit, CBT or systemic thrombolysis was associated with a significantly lower rate of adverse clinical outcomes, including a lower rate of death compared with anticoagulation alone driven by the CBT group. CBT has the potential to improve outcomes. Further large-scale studies are needed to test these associations.

Background: SAPIEN3 (S3) is a ubiquitous redo-transcatheter aortic valve (TAV) replacement alternative for degenerated Evolut valves, but S3 sizing for S3-in-Evolut remains unclear. We sought to compare the impact of in vivo computed tomography (CT)-sizing on redo-TAV feasibility for S3-in-Evolut with traditional bench-sizing.

Methods: CT scans of 290 patients treated using Evolut R/PRO/PRO+ between July 2015 and December 2021 were analyzed. S3-in-Evolut was simulated using S3 outflow/neoskirt plane (NSP) at node-6, -5, and -4. CT-sizing for S3 was determined by averaging 4 areas of the Evolut stent frame at NSP level and 3 nodes below. Redo-TAV was deemed feasible if the NSP was below the coronaries, or the narrowest valve (virtual S3)-to-aorta distance was >4 mm. Risk of prosthesis-patient mismatch was estimated using predicted indexed-effective orifice area.

Results: Compared with bench-sizing, CT-sizing yielded smaller S3 size in 82% at node-6, 81% at node-5, and 84% at node-4. Factors associated with CT-sizing less than bench-sizing were larger index Evolut size, underexpansion of index Evolut, and shallower implant depth (all P<0.05). CT-sizing increased redo-TAV feasibility by +8% at node-6, +10% at node-5, and +4% at node-4. Redo-TAV feasibility increased with annulus size, sinotubular junction dimensions, coronary heights, index Evolut size, deeper Evolut implant depth, and lower NSP levels (all P<0.05). CT-sizing had a slightly higher estimated risk of severe prosthesis-patient mismatch (9% at node-6, 7% at node-5, and 6% at node-4), which could be mitigated by changing the NSP.

Conclusions: CT-sizing for S3-in-Evolut is associated with higher feasibility of redo-TAV compared with bench-sizing, potentially reducing the risk of excessive oversizing and S3 underexpansion. Further validation using real-world clinical data is necessary.

Background: The prognostic impact of functionally significant coronary artery disease, as assessed with quantitative flow ratio (QFR), in patients with severe aortic stenosis treated with transcatheter aortic valve replacement is unknown.

Methods: This is a retrospective study with blind analysis of angiographic data, enrolling consecutive patients with severe aortic stenosis treated with transcatheter aortic valve replacement at 4 Italian centers. None of the patients enrolled received pre-transcatheter aortic valve replacement or concomitant coronary revascularization, either for the absence of significant coronary stenoses or by clinical decision. Visual estimation of diameter stenosis and QFR analysis were performed in all coronary arteries. The end point was all-cause mortality at a 3-year follow-up.

Results: A total of 318 patients were enrolled. At visual estimation, 140 patients (44%) presented a diameter stenosis ≥50% in at least 1 coronary artery, whereas 78 patients (24.5%) had at least 1 vessel with QFR <0.80 and, therefore, included in the positive QFR group. Overall, 69 (21.7%) patients died during the follow-up. In the Kaplan-Meier analysis, patients with positive QFR experienced significantly higher rates of death during follow-up compared with those without (51.1% versus 12.1%; P<0.001), whereas no significant difference was evident in terms of death between patients with or without significant coronary artery disease according to angiographic evaluation (24.3% versus 19.7%; P=0.244). In a multivariate regression model, positive QFR was an independent predictor of all-cause death during follow-up (hazard ratio, 5.31 [95% CI, 3.21-8.76]).

Conclusions: Coronary QFR can predict mortality in patients with severe aortic stenosis treated with transcatheter aortic valve replacement without revascularization.

Background: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study.

Methods: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year.

Results: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients.

Conclusions: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801.

Background: The learning curve for new operators performing ultrasound-guided transfemoral access (TFA) remains uncertain.

Methods: We performed a pooled analysis of the FAUST (Femoral Arterial Access With Ultrasound Trial) and UNIVERSAL (Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures) trials, both multicenter randomized controlled trials of 1:1 ultrasound-guided versus non-ultrasound-guided TFA for coronary procedures. Outcomes included the composite of major bleeding or vascular complications and successful common femoral artery cannulation. Participants were stratified by the operators' accrued case volume. We used adjusted repeated-measurement logistic regression, with random intercepts for operator clustering, for comparison against the non-ultrasound-guided TFA group and to model the learning curve.

Results: The FAUST and UNIVERSAL trials randomized a total of 1624 patients, of which 810 were randomized to non-ultrasound-guided TFA and 814 to ultrasound-guided TFA (cases 1-10, 391; 11-20, 183; and >20, 240). Participants who had operators who performed >20 ultrasound-guided TFAs had a decreased risk for the primary end point (5/240 [2.1%] versus 64/810 [7.9%]; adjusted odds ratio, 0.26 [95% CI, 0.09-0.61]) compared with non-ultrasound-guided TFA. Operators who performed >20 ultrasound-guided procedures had increased odds of successfully cannulating the common femoral artery (224/246 [91.1%] versus 327/382 [85.6%]; adjusted odds ratio, 1.76 [95% CI, 1.08-2.89]) compared with non-ultrasound-guided TFA. The learning curve plots demonstrated growing competence with increasing accrued cases.

Conclusions: New operators should perform at least 20 ultrasound-guided TFA to decrease access site complications and increase proper cannulation compared with non-ultrasound-guided TFA. Additional accrued cases may lead to increased proficiency. Training programs should consider these findings in the transradial era.

Background: Surgery or fibrinolysis is the currently available evidence-based treatment for obstructive mechanical valve thrombus. We reported the feasibility and short-term outcomes of percutaneous transcatheter therapy with cerebral embolic protection. Mid- and long-term outcomes remain unknown.

Methods: From 2020 to 2023, 24 patients underwent percutaneous transcatheter release of stuck leaflets with cerebral embolic protection for obstructive mitral mechanical valve thrombus. The indications for the transcatheter therapy were failed fibrinolysis, contraindications for fibrinolysis, not willing for fibrinolysis, or high risk for surgery. The study participants were followed up for a median period of 344.50 (65.00-953.75) days.

Results: Technical success was achieved in 91.67% (n=22) of procedures. During the follow-up, 12.50% (n=3) all-cause death, 4.17% (n=1) stroke, and 16.67% (n=4) recurrence were seen. The mean survival time free from death was 1101.48 (95% CI, 929.49-1273.47) days, stroke was 1211.38 (95% CI, 1110.40-1312.35) days, and recurrence was 907.71 (95% CI, 760.20-1055.21) days.

Conclusions: Transcatheter release of the stuck mitral mechanical valve with cerebral embolic protection is an alternative therapy with promising mid-term outcomes where surgery or fibrinolysis is not possible or in failed fibrinolysis subsets.