Eurointervention最新文献

Background: Transcatheter edge-to-edge repair (TEER) using the TriClip tricuspid valve repair system has emerged as a therapy for tricuspid regurgitation (TR). Patients with TR undergoing TEER commonly present with an endocardial lead across the tricuspid valve (TV).

Aims: We sought to examine the effectiveness and safety of tricuspid TEER (T-TEER) in subjects with endocardial leads in the bRIGHT EU Post-Approval Study (PAS).

Methods: The bRIGHT EU PAS is a prospective, single-arm, open-label, multicentre, post-market registry conducted at 26 sites in Europe. Echocardiographic assessments of endocardial lead placement, interaction, and TR grade were performed at a core laboratory.

Results: Of the 511 enrolled subjects, a total of 110 had an endocardial lead, and in 80.7% of these subjects, TR was at least partially related to the lead. At 30 days, 71% of subjects with endocardial leads had TR of moderate or less. The percentage of subjects with endocardial leads categorised as New York Heart Association Functional Class I-II increased from 17% at baseline to 75% at 30 days (p<0.0001), and quality of life with the Kansas City Cardiomyopathy Questionnaire showed a mean improvement of 20±24 points from baseline to 30 days (p<0.0001). T-TEER was safe in subjects with endocardial leads, with similar rates of events, including TV reintervention/reoperation and TV surgery, to those in subjects without leads. No reports of lead malfunction were reported.

Conclusions: In the bRIGHT EU PAS, T-TEER using the TriClip system was safe and effective in severe TR subjects with an endocardial lead across the TV.

Background: Despite the fact that morbidity and mortality rates significantly increase with tricuspid regurgitation (TR) severity, limited treatment options are available for treating severe TR.

Aims: The single-arm, multicentre, prospective Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System (TriStar) evaluated the 1-year outcomes of the novel transcatheter K-Clip annuloplasty system in treating secondary TR.

Methods: Between May 2022 and October 2022, patients with ≥severe secondary TR despite optimal medical therapy at 11 centres in China were deemed candidates for transcatheter tricuspid repair by the local Heart Team and a multidisciplinary screening committee. Echocardiographic parameters, clinical and quality-of-life measures, and major adverse events were collected at 1 year.

Results: Ninety-six patients were enrolled (mean age 72.6±7.0 years, 60.4% female, mean TRI-SCORE 5.4±2.1). The technical success rate was 97.9%. At 1 year, echocardiographic follow-up showed an average reduction in the annular septolateral diameter of 11.3% (41.9 mm vs 37.1 mm; p<0.01), compared with baseline, with marked right ventricular remodelling. A total of 82.5% of patients had ≤moderate TR, and 97.7% had a ≥1 grade reduction. Patients experienced significant clinical improvements in New York Heart Association Functional Class I/II (32.6% to 96.5%; p<0.001), the 6-minute walk distance increased by 31.9±71.8 m (p<0.001), and the overall Kansas City Cardiomyopathy Questionnaire score increased by 7.6±17.7 points (p<0.001). Neither cardiovascular death nor reintervention were recorded at the 30-day or 1-year follow-up, while severe bleeding requiring further treatment was noted in 5 patients at 1 year. The Kaplan-Meier estimates of survival and freedom from heart failure rehospitalisation were 97.8% and 95.1%, respectively, at 1 year.

Conclusions: The 1-year experience using the K-Clip tricuspid annuloplasty system demonstrated high survival and low rehospitalisation rates with durable TR reduction and clinical benefits in functional status and quality-of-life outcomes.

Background: Vascular access site complications are associated with increased morbidity and mortality after transcatheter aortic valve implantation (TAVI). Current results comparing strategies with plug- (P-VCD; MANTA) and suture-based vascular closure devices (S-VCD; Perclose ProGlide) remain inconsistent.

Aims: It was our aim to assess the incidence of access-related vascular complications after P-VCD or S-VCD strategies after transfemoral TAVI.

Methods: The Plug or sUture based vascuLar cloSurE after TAVI (PULSE) registry retrospectively evaluated 10,120 consecutive patients who had undergone transfemoral TAVI at 10 centres from 2016 to 2021. A propensity score was used to match 900 P-VCD patients with 1,800 S-VCD patients in a 1:2 fashion. The primary outcome measures were major and minor access-related vascular complications at the primary access site, adjudicated according to Valve Academic Research Consortium 3 definitions.

Results: The median age was 81.8 years, 46.4% of patients were female, and the median European System for Cardiac Operative Risk Evaluation II was 3.50%. In matched P-VCD and S-VCD groups, large-bore access-related complications occurred in 14.9% vs 10.3% (p<0.001; major: 3.6% vs 4.6%; p=0.218; minor: 11.3% vs 5.8%; p<0.001) of patients. Bleeding accounted for most of these complications (9.6% vs 7.2%; p=0.028) and was treated with endovascular balloon inflation (5.4% vs 2.6%; p<0.001), stent implantation (4.7% vs 0.7%; p<0.001) or surgical repair (0.7% vs 1.7%; p=0.03).

Conclusions: P-VCD were associated with higher rates of primary access-related vascular complications, driven by minor complications, compared to S-VCD. Endovascular treatment was more common after P-VCD failure.

Background: Previous studies have reported the value of quantitative flow ratio (QFR) to assess the physiological significance of non-culprit lesions (NCLs) in acute myocardial infarction (AMI) patients and of optical coherence tomography (OCT)-defined thin-cap fibroatheroma (TCFA) to identify non-culprit vulnerable plaques.

Aims: We sought to systematically compare long-term NCL-related clinical prognosis in an AMI population utilising acute Murray fractal law-based QFR (μQFR) values and OCT-defined TCFA.

Methods: Three-vessel OCT imaging and μQFR assessment were conducted in 645 AMI patients, identifying 1,320 intermediate NCLs in non-infarct-related arteries. The primary endpoint was a composite of cardiac death, NCL-related non-fatal myocardial infarction (MI), and NCL-related unplanned coronary revascularisation, with follow-up lasting up to 5 years.

Results: The primary endpoint occurred in 59 patients (11.1%). OCT-defined TCFA independently predicted patient-level (adjusted hazard ratio [HR] 3.05, 95% confidence interval [CI]: 1.80-5.19) and NCL-specific primary endpoints (adjusted HR 4.46, 95% CI: 2.33-8.56). The highest event rate of 29.6% was observed in patients with NCLs that were TCFA (+) with μQFR ≤0.80, compared to 16.3% in those that were also TCFA (+) but with μQFR>0.80, 6.0% in those that were TCFA (-) with μQFR ≤0.80, and 6.6% in those that were TCFA (-) with μQFR>0.80 (log-rank p<0.001). TCFA was an independent predictor for the primary endpoint in ST-segment elevation MI (STEMI; adjusted HR 3.27, 95% CI: 1.67-6.41) and non-STEMI (adjusted HR 3.26, 95% CI: 1.24-8.54) patients, whereas μQFR ≤0.80 was not.

Conclusions: When assessing NCLs during the index procedure in AMI patients, OCT-defined TCFA serves as the dominant prognostic predictor for long-term clinical outcomes, rather than μQFR-determined physiological significance.