BACKGROUND:Due to the heightened risks and complications associated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in complex high-risk and indicated patients (CHIPs), percutaneous ventricular assist system during PCI might offer a novel alternative. AIMS:We aimed to evaluate the efficacy and safety of the CorVad percutaneous ventricular assist system in CHIPs. METHODS:One hundred and eighteen CHIPs with left ventricular ejection fraction (LVEF) ≤ 40% were enrolled for CorVad support during elective PCI. The primary endpoint was the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) including death, new myocardial infarction, stroke, and target vessel revascularization at 30 days. Performance goal (PG) was set at 22.5%. Additionally, patients underwent CABG in Fuwai Hospital with LVEF ≤ 40% were selected as historical controls. RESULTS:In the intention to treat (ITT) cohort, there were five MACCE (4.2%, 95% CI 1.4%-9.6%) within 30 days, achieving the prespecified PG. The CorVad system was successfully implanted in all patients. Compared with baseline, the LVEF had a significant increase in 48 h (30.95 ± 4.84% vs. 35.96 ± 5.84%, p < 0.001) and 30 days after PCI (30.95 ± 4.84% vs. 39.78 ± 7.82%, p < 0.001). No patient had evidence of hemolysis after PCI. Compared with CABG historical controls, there were no significant differences in the incidence of MACCE at 30 days (after propensity score matching [PSM]: 3.8% vs. 1.3%, p = 0.341) and 90 days (after PSM: 3.8% vs. 1.3%, p = 0.307). CONCLUSIONS:The CorVad percutaneous ventricular assist system is safe and effective in assisting CHIPs-PCI.

BACKGROUND:The influence of left ventricular ejection fraction (LVEF) on clinical outcomes in patients treated with drug-coated balloons (DCBs) versus drug-eluting stents (DES) for de novo coronary lesions remains uncertain. METHODS:REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, randomizing 2272 patients to paclitaxel-coated balloons with optional rescue stenting or to sirolimus-eluting stents. In this pre-specified subgroup analysis, 2194 patients with available baseline LVEF were stratified into LVEF <55% and LVEF ≥55%. The primary endpoint was the device-oriented composite endpoint (DoCE; including cardiovascular death, target-vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization) at 3 years. RESULTS:Among 2194 patients, 402 (18.3%) had an LVEF <55%, and 1792 (81.7%) had an LVEF ≥55%. At 3 years, the risk of DoCE was numerically higher in patients with an LVEF <55% versus LVEF ≥55% (9.0% vs. 6.1%; P=0.237). A significant treatment-by-LVEF interaction was observed for DoCE (Pinteraction=0.033). In patients with an LVEF <55%, DoCE occurred in 28/206 (13.7%) and 8/196 (4.2%) patients in the DCB and DES groups (DifferenceIPTW: 7.19%, 95% CI: 1.89% to 12.48%, P=0.008), respectively; in patients with an LVEF ≥55%, DoCE occurred in 62/886 (7.0%) and 47/906 (5.2%) patients in the DCB and DES groups (DifferenceIPTW: 1.93%, 95% CI: -0.37% to 4.23%, P=0.101), respectively. CONCLUSIONS:Baseline LVEF may modify clinical outcomes after DCB versus DES for de novo coronary artery disease, with excess risk of DoCE with DCB mainly observed in patients with LVEF <55%. These exploratory findings should be interpreted cautiously. CLINICAL TRIAL REGISTRATION:www. CLINICALTRIALS:gov; number, NCT04561739.

Objective To investigate the impact of baseline neutrophil-to-lymphocyte ratio (NLR) on all-cause mortality after transcatheter aortic valve replacement (TAVR) in patients with aortic regurgitation (AR). MethodsPatients with AR who underwent TAVR at Xijing Hospital of Air Force Medical University from October 2018 to June 2024 were consecutively enrolled. According to the receiver operating characteristic (ROC) curve analysis, patients were divided into low-NLR groups (NLR ＜ 2.86) and a high-NLR group (NLR≥2.86). Survival analysis was performed using the Kaplan-Meier method and compared between groups with the log-rank test. A Cox proportional hazards model was used to determine the association of NLR with post-TAVR clinical events and all-cause mortality in patients with AR. ResultsA total of 187 patients with AR were included. The low-NLR group comprised 108 patients, including 60 males and 48 females, with a mean age of (68.53±7.64) years. The high-NLR group comprised 79 patients, including 54 males and 25 females, with a mean age of (67.80±8.28) years. At a median follow-up of 18 months (maximum follow-up: 64 months), the cumulative incidence of all-cause mortality was higher in the high-NLR group than in low-NLR group (18.7% vs. 2.8%, P = 0.012). Multivariate Cox regression analysis showed that high NLR was an independent risk factor for all-cause mortality after TAVR (HR = 4.75，95%CI：1.29-17.47，P = 0.019). ConclusionA higher baseline NLR is an independent risk factor for mid- to long-term all-cause mortality after TAVR in patients with AR.

Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI), is an interventional technology in which an artificial aortic valve is compressed and assembled outside the body, then delivered through a catheter and implanted at the site of the diseased aortic valve, thereby functionally replacing the native valve. Two versions of the Chinese expert consensus on TAVR were issued in China in 2015 and 2020, respectively. To promptly update the field's understanding of TAVR and to promote its broader, more standardized, and higher-quality application in China, an expert panel has developed this new version of the consensus. This consensus includes substantial updates compared with the previous version, covering topics such as the epidemiology of aortic valve disease, recent advances in TAVR research, indications, procedural standards, post-procedural antithrombotic therapy, prevention and management of complications, management of special cases, and future development trends. This consensus integrates international research evidence and references international guidelines to ensure rigor and evidence-based recommendations, while also incorporating domestic research findings and clinical practice in China, thereby enhancing both its forward-looking perspective and practical applicability.

The anatomical and pathophysiological characteristics of coronary artery disease vary between the sexes. This study investigated the impact of sex on outcomes in patients with de novo coronary artery lesions treated with drug-coated balloons (DCB) or drug-eluting stents (DES). REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China from Feb 5, 2021, to May 1, 2022, which randomized 2,272 patients for treating de novo coronary lesions, regardless of vessel diameter. After successful lesion pre-dilatation, eligible patients were randomized (1:1) to either DCB angioplasty with the option of rescue stenting or intended DES deployment. In this prespecified subgroup analysis, patients were analyzed by sex based on their medical records. The primary endpoint was device-oriented composite endpoint (DoCE), including cardiovascular death, target-vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization at 2 years. Between-group differences were compared by Cox proportional-hazards models, and imbalances in baseline characteristics were adjusted with inverse probability of treatment weighting (IPTW). The analyses were conducted in the intention-to-treat population. A total of 2,272 participants underwent randomization, of which 698 (30.7

We investigate the impact of pulse pressure on long-term outcomes for patients treated with drug-coated balloons (DCBs) or drug-eluting stents (DESs). REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China from Feb 5, 2021, to May 1, 2022, which randomized 2272 participants to DCB or DES treatment for de novo, non-complex lesions. In this post hoc analysis, participants were stratified into three groups based on pulse pressure tertiles (< 46, 46–60, and > 60 mmHg). The primary outcome was the 2-year device-oriented composite endpoint (DoCE), including cardiovascular death, target-vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization. 2272 participants were included in the analysis. At 2 years, DoCE occurred in 35/723 (4.9

BACKGROUND:The clinical impact of angiography-based, computational pressure-flow dynamics derived FFR (caFFR) after paclitaxel‑coated balloon (DCB) angioplasty remains unclear. AIMS:To investigate the prognostic value of post-procedural caFFR in the treatment of in-stent restenosis (ISR) with DCB. METHODS:Consecutive patients undergoing DCB angioplasty for ISR at Xijing Hospital, China, between December 2015 and December 2019 were prospectively enrolled. The primary endpoint was vessel-oriented composite endpoint (VoCE), defined as a composite of vessel-related cardiovascular death, target-vessel myocardial infarction (TV-MI), and ischemia-driven target vessel revascularization (ID-TVR) at 3-year, assessed at the vessel level. RESULTS:A total of 1055 vessels treated with DCB were screened, and the post-procedural caFFR was analyzable in 999 (94.7%). At 3-year, 149 VoCE (14.9%) and 98 ID-TVR (9.8%) events occurred. Maximally-selected log-rank statistics respectively identified post-procedural caFFR value of 0.87 and post-procedural %DS of 28 as the optimal cutoff points to predict VoCE. Post-procedural caFFR demonstrates the superior predictive ability for VoCE compared to post-procedural %DS (NRI: 7.4%, p < 0.001). A negative correlation was discerned between post-procedural caFFR value and VoCE (HRper 0.1 increase: 0.72, 95% CI: 0.53-0.98, p = 0.039). Post-procedural caFFR ≤ 0.87 group was associated with a 1.5-fold increase in the risk of VoCE (HRIPTW: 1.53, 95% CI: 1.02-2.29) and a 1.8-fold increase in ID-TVR (HRIPTW: 1.82, 95% CI: 1.15-2.89). CONCLUSIONS:A higher post-procedural caFFR value is associated with improved vessel-related clinical outcomes in patients of ISR treated by DCB. Achieving a post-procedural caFFR value of 0.87 in the treated vessels may represent a reasonable procedural goal. TRIAL REGISTRATION:Clinicaltrial.gov identifier: NCT05133921.

BACKGROUND:For long coronary lesions, drug-coated balloons (DCBs) might be an attractive alternative compared with drug-eluting stents (DES); however, supporting evidence remains scarce. AIMS:To compare the efficacy of DCBs versus DES for treating long de novo coronary lesions. METHODS:REC-CAGEFREE I was a non-inferiority trial conducted at 43 sites in China, which randomized 2272 patients to paclitaxel-coated balloon angioplasty with the option of rescue stenting or sirolimus-eluting stents for treating de novo lesions, regardless of vessel diameter. In this pre-specified subgroup analysis, patients were stratified by quantitative coronary angiography-assessed lesion length into short (< 20 mm) and long (≥ 20 mm) groups. The primary endpoint was a device-oriented composite endpoint (DoCE, including cardiovascular death, target vessel myocardial infarction, or clinically and physiologically-indicated target lesion revascularization) at 3 years. RESULTS:2,223 (97.8%) participants with available angiograms were included, of which 302 (13.6%) had long lesions and 1921 (86.4%) had short lesions. At 3 years, DoCE occurred in 24/302 (8.0%) and 121/1921 (6.3%) patients in long and short groups, respectively. In the long lesions group, DoCE occurred in 14/121 (11.6%) and 10/181 (5.6%) in the DCBs and DES groups, respectively (HRIPTW: 2.46, 95% CI: 1.07-5.67, p = 0.034). In the short lesions group, DoCE occurred in 75/983 (7.7%) and 46/938 (4.9%) in the DCBs and DES groups, respectively (HRIPTW: 1.52, 95% CI: 1.03-2.22, p = 0.033). No significant interaction was observed between lesion length and DES/DCBs (Pinteraction = 0.460). CONCLUSION:DCBs were associated with a higher risk of DoCE compared to DES for treating de novo lesions, regardless of lesion length.

Background Evidence regarding the link between imaging modality and stroke prevention outcomes of left atrial appendage occlusion is currently lacking. Methods The RECORD (Registry to Evaluate Chinese Real‐World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology) trial prospectively enrolled 3096 consecutive patients undergoing left atrial appendage occlusion from 39 Chinese centers between April 1, 2019, and October 31, 2020. In the current analyses, patients were stratified into the echocardiographic guidance (transesophageal echocardiography/intracardiac echocardiography) group and the fluoroscopy‐only group. The primary end point was the composite end point of death, stroke, or systemic embolism at 3 years. Outcomes were estimated using the Kaplan–Meier method. Inverse probability of treatment weighting and 1:1 propensity score matching were performed to calculate hazard ratios (HRs) for each outcome at the time of interest. Results Among 3096 participants, 2603 (84.1%) underwent transesophageal echocardiography/intracardiac echocardiography–guided procedures and 493 (15.9%) underwent fluoroscopy‐only guided procedures. Before discharge, procedural complications occurred in 34 patients (1.4%) in the transesophageal echocardiography/intracardiac echocardiography group and 3 patients (0.6%) in the fluoroscopy‐only group (inverse probability of treatment weighting–adjusted absolute difference, −0.67 [95% CI, −1.39 to 0.05], P =0.066). At 3‐year follow‐up (completed by 2989 patients, 97.0%), the primary end point occurred in 269 (10.5%) patients in the transesophageal echocardiography/intracardiac echocardiography group and 52 (10.6%) patients in the fluoroscopy‐only group (inverse probability of treatment weighting–adjusted HR, 1.13 [95% CI, 0.81–1.57], P =0.469). Ischemic stroke was comparable between groups (3.0% versus 4.1%, inverse probability of treatment weighting–adjusted HR, 1.66 [95% CI, 0.95–2.89], P =0.073). These findings remained consistent across patient risk profiles and operator experience levels. Conclusions Fluoroscopy‐only guidance, without compromising long‐term stroke prevention efficacy, may serve as a streamlined and potentially accessible alternative for left atrial appendage occlusion procedures performed with the first‐generation WATCHMAN 2.5 device, and these findings apply to select patients and experienced centers. Registration URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT03917563.

AIMS:The long-term impact of left atrial appendage occlusion (LAAO) plus ablation for atrial fibrillation remains controversial. The present study aims to compare the three-year clinical outcomes of LAAO patients with or without one-staged ablation. METHODS AND RESULTS:The RECORD study (NCT03917563) was a prospective registry conducted in 39 participating sites in China between 1 April 2019 and 31 October 2020, which consecutively enrolled 3082 patients who successfully received the WATCHMAN LAAO device. The current study compared patients who received LAAO only to patients who underwent LAAO plus ablation. A 1:1 propensity score matching was performed to attenuate confounding. The primary outcome was a composite endpoint of cardiovascular death, stroke, and systemic embolism at 3-year. 1633/2928 (55.8%) patients received LAAO only and 1295/2928 (44.2%) received LAAO plus ablation. After propensity score matching, 1016/2032 (50.0%) were in the LAAO group and 1016/2032 (50.0%) in the LAAO plus ablation group. The mean ± SD age was 68.8 ± 9.3 years, with 815 (40.1%) participants being female. The mean ± SD CHA2DS2-VASc and HAS-BLED scores at baseline were 3.9 ± 1.8 and 2.4 ± 1.1, respectively. At three-year, compared to LAAO only, LAAO plus ablation was associated with a lower risk of cardiovascular death, stroke, systemic embolism (6.9%vs.10.4%, HRPSM:0.66, 95%CI: 0.49-0.89, P = 0.007), which was driven mainly by the lower risk of cardiovascular death (3.7% vs. 7.3%, HRPSM: 0.50, 95%CI: 0.34-0.74, P = 0.001). No significant between-group differences were noted for BARC-defined bleeding. CONCLUSION:LAAO plus ablation was associated with a lower risk of a composite of cardiovascular death, stroke, and systemic embolism than LAAO only at 3-year. However, given the observational nature of the current study, the results should be considered as hypothesis-generating only.

Abstract Background The impact of drinking status on outcomes in patients treated with drug-coated balloon (DCB) versus drug-eluting stent (DES) for de novo coronary lesions remains unclear. Methods REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, which randomized 2,272 patients to paclitaxel-coated balloon with the option of rescue stenting (DCB group) or second-generation sirolimus-eluting stents (DES group) for treating de novo coronary lesions, regardless of vessel diameter. In this subgroup analysis, participants were stratified by baseline drinking status into non-drinkers and drinkers. The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization) at 2 years. Cox proportional hazards regression with inverse probability of treatment weighting (IPTW) was used to compare between-group differences. Results Among 2,128 (93.7%) participants with available baseline drinking status, 513 (24.1%) were drinkers. At 2 years, compared to non-drinkers (83/1615 [5.2%]), drinkers (22/513 [4.3%]) were associated with a numerically similar risk of DoCE (HR IPTW : 0.89, 95%CI 0.47–1.70; P = 0.727). For non-drinkers, DoCE occurred in 53/816 (6.5%) and 30/799 (3.8%) of participants in the DCB group and DES group (HR IPTW : 1.67, 95%CI 1.05–2.67; P = 0.032) respectively. For drinkers, DoCE occurred in 15/250 (6.0%) and 7/263 (2.7%) of participants in the DCB group and DES group (HR IPTW : 2.17, 95%CI 0.80–5.84; P = 0.120) respectively. There was no significant interaction between drinking status and treatment strategies ( P interaction = 0.628). Conclusions Compared to non-drinkers, drinkers were associated with a numerically similar risk of DoCE. The treatment effect of DCB versus DES did not differ significantly according to drinking status. However, given the observational nature of the study, these results should be interpreted as hypothesis-generating only. Trial registration Registered on ClinicalTrials.gov (NCT04561739) on September 3, 2020.

BACKGROUND The optimal antiplatelet regimen in patients with acute coronary syndrome (ACS) and multivessel disease undergoing drug-coated balloon (DCB) angioplasty remains unclear. METHODS This was a prespecified subgroup analysis of the REC-CAGEFREE II trial, which was conducted at 41 sites in China and randomized 1948 exclusively DCB-treated participants with ACS to stepwise dual antiplatelet therapy (DAPT) de-escalation or standard DAPT. The primary endpoint was net adverse clinical events (NACE; including all-cause death, stroke, myocardial infarction, revascularization, and BARC type 3 or 5 bleeding) at 12 months. Participants were stratified into multivessel and single-vessel subgroups according to angiographic characteristics. RESULTS Overall, 720/1948 (37.0%) patients had multivessel disease. The multivessel subgroup was associated with a significantly higher risk of NACE compared with the single-vessel subgroup (12.5% versus 6.7%, HR IPTW:1.84, 95%CI:1.35-2.51, P<0.001). No significant interaction was observed between vessel status (multivessel or single-vessel) and treatment allocation with respect to NACE (Pinteraction=0.542). In the multivessel subgroup, NACE occurred in 44/368 (12.1%) and 45/352 (12.9%) in the stepwise de-escalation and standard DAPT groups (HR IPTW:0.95, 95%CI:0.62-1.75, P=0.818), respectively. In the single-vessel subgroup, NACE occurred in 43/607 (7.1%) and 39/621 (6.3%) in the stepwise de-escalation and standard groups (HR IPTW:1.12, 95%CI:0.72-1.70, P=0.611), respectively. For the prespecified hierarchical secondary endpoint, win ratio analyses yielded more wins for stepwise de-escalation in both subgroups. CONCLUSIONS Among patients with ACS undergoing DCB-only angioplasty, those with multivessel disease were associated with a higher risk of NACE than those with single-vessel disease. Stepwise DAPT de-escalation and standard DAPT exhibited similar risk-benefit profiles in both subgroups. ### Competing Interest Statement PWS reported receiving consulting fees from Sahajanand Medical Technologies, Novartis, Merillife, Xeltis, and Philips/Volcano outside the scope of the submitted work. Chao Gao received funding from the Noncommunicable Chronic Disease-National Science and Technology Major Project of China. Ming Yuan received funding from the Shaanxi Province Key Technology Research Project of China. All other authors declare no competing interests ### Clinical Trial NCT04971356 ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The protocol was approved by the ethics committee of Xijing Hospital (ID: KY20212080-F-1) and all participating sites, and all participants provided written informed consent. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data that support the findings of this study are available from the corresponding author upon reasonable request.

BACKGROUND:Drug-coated balloons (DCBs) are attractive for treating de novo coronary lesions, especially when involving bifurcations; however, their efficacy compared with drug-eluting stents (DES) remains uncertain. OBJECTIVES:The aim of this study was to assess the prognosis of DCBs vs DES in patients with noncomplex bifurcation and nonbifurcation lesions. METHODS:This was a prespecified subgroup analysis of the REC-CAGEFREE I (Paclitaxel-Coated Balloon for Treatment of De-Novo Non-Complex Coronary Artery Lesions) trial, which was an investigator-initiated, noninferiority trial conducted at 43 sites in China that randomized 2,272 participants to paclitaxel-coated balloons (the DCB group) or sirolimus-eluting stents (the DES group) for the treatment of de novo lesions, regardless of vessel diameter. The primary outcome was a device-oriented composite endpoint (DoCE) at 24 months. Participants were stratified according to the presence vs absence of bifurcation, and inverse probability of treatment weighting (IPTW) was performed to adjust for between-group imbalances. RESULTS:A total of 2,257 of 2,272 participants (99.3%) with available angiographic results were included. At 24 months, the DoCE had occurred in 46 of 773 patients in the bifurcation group (6.0%) and 64 of 1,484 patients in the nonbifurcation group (4.3%) (HRIPTW: 1.39; 95% CI: 0.87-2.21; P = 0.164). Of the 798 bifurcation lesions, 719 (90.1%) had DCB or DES treatment in the main vessel. A significant interaction for the DoCE was observed between bifurcation or nonbifurcation and assigned treatment (Pinteraction = 0.031). In the nonbifurcation group, the DoCE occurred in 46 of 735 patients with DCBs (6.3%) and 18 of 749 (2.4%) with DES (HRIPTW: 2.67; 95% CI: 1.64-4.33; P < 0.001); the in bifurcation group, the DoCE occurred in 26 of 394 patients with DCBs (6.7%) and 20 of 379 (5.3%) with DES (HRIPTW: 1.03; 95% CI: 0.53-2.01; P = 0.934). CONCLUSIONS:DCBs were associated with a numerically comparable risk for DoCE compared with DES in noncomplex bifurcations at 2 years. However, these findings should be interpreted as hypothesis generating only. (Paclitaxel-Coated Balloon for Treatment of De-Novo Non-Complex Coronary Artery Lesions; NCT04561739).

Background:Transcatheter edge-to-edge repair (TEER) has become an effective alternative for treating degenerative mitral regurgitation (DMR) in patients at high surgical risk. The SQ-Kyrin-M TEER system (SQ-Kyrin-M system) is a novel TEER device developed in China. This study aimed to evaluate the feasibility, safety, and 12-month clinical efficacy of the SQ-Kyrin-M system in patients with high-risk degenerative mitral regurgitation. Methods:In this prospective, multicenter, single-arm study (ClinicalTrials.gov: NCT06467110), 120 patients with symptomatic DMR (grade ≥3+) had the device implanted. The primary endpoint was the clinical success rate at 12 months. Secondary endpoints included technical, device, and procedural success rate; New York Heart Association (NYHA) class improvement; Kansas City Cardiomyopathy Questionnaire (KCCQ) score change; and mitral regurgitation (MR) reduction. Safety endpoints encompassed all-cause mortality, cardiovascular mortality, and major adverse event rate. Results:A total of 120 patients received the TEER procedure across 25 participating sites in China; the mean age was 71.9 years, and the mean Society of Thoracic Surgeons (STS) risk score was 9.3. At 12 months, the Kaplan-Meier estimates were 82.5% for clinical success, 7.6% for all-cause mortality, and 10.8% for major adverse events; MR ≤2+ and MR ≤1+ were achieved in 91.7 and 70.4% of the patients, respectively; 88.9% of patients were in NYHA class I or II; and KCCQ score had improved by 18.9 points. Favorable left ventricular remodeling was observed with sustained reductions in left ventricular end-diastolic and end-systolic volumes. Conclusions:This study demonstrates that the SQ-Kyrin-M system is a safe and effective therapeutic option for DMR patients.

BACKGROUND:The safety and efficacy of drug-coated balloon (DCB) angioplasty for the treatment of proximal left anterior descending (LAD) lesions remain unclear. We aim to assess the prognosis of DCB versus drug-eluting stent (DES) in treating de novo proximal LAD lesions. METHODS:In this prespecified, exploratory subgroup analysis of the investigator-initiated, multicenter, randomized, non-inferiority REC-CAGEFREE I trial, 2272 patients were stratified into two groups based on whether target lesion was located in proximal LAD. The primary endpoint was device-oriented composite endpoint (DoCE, a composite of cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization) at 2 years. RESULTS:Of 2272 patients randomized, 688 (30.3%) had target lesion in proximal LAD. In patients with proximal LAD lesions, compared to DES treatment, DCB treatment had a higher risk of 2-year DoCE (8.8% versus 3.4%, HRIPTW:2.68, 95%CI:1.34-5.35, P = 0.008). Similar results were observed in patients with non-proximal LAD lesions (DCB versus DES: 5.4% versus 3.3%, HRIPTW:1.72, 95%CI:1.04-2.85, P = 0.038). No significant interaction was observed between the lesion location and the treatment strategy (DES/DCB) (Pinteraction = 0.257). In patients with DCB treatment, proximal LAD had a higher risk of DoCE compared to non-proximal LAD (8.8% vs. 5.4%, HRIPTW:1.68, 95%CI:1.01-2.81, P = 0.049). CONCLUSIONS:For patients with de novo, non-complex coronary artery disease, DCB was associated with a higher 2-year risk of DoCE than DES across all lesion locations, with a numerically larger effect in proximal LAD. Due to the exploratory nature of the analysis, the results should be interpreted cautiously and considered hypothesis-generating.

BACKGROUND:Transcatheter mitral valve replacement (TMVR) is increasingly recognized as a viable therapeutic modality for complex mitral valve pathology, particularly in patients with intricate anatomical substrates. CASE SUMMARY:We present a 71-year-old woman with recurrent heart failure and severe mixed functional mitral regurgitation and a small neo-left ventricular outflow tract, at risk of left ventricular outflow tract obstruction. Given her surgical risk and complex anatomy, we chose TMVR with the Peijia HighLife Clarity valve, which features an "open-window" design to reduce left ventricular outflow tract obstruction risk. Post-procedure, the patient exhibited mild mitral regurgitation, stable hemodynamics, and significant clinical improvement. DISCUSSION:This case highlights TMVR's potential for treating complex mitral valve disease with challenging anatomy.

The Drug-Coated Balloon (DCB) Academic Research Consortium project originated from the need to overcome the lack of standardization and comparability among studies focusing on drug-coated balloon treatment. The DCB Academic Research Consortium represents a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focusing on percutaneous coronary intervention in Europe, the United States, and Asia. The present consensus document provides a classification of DCB technologies, antiproliferative drugs, and types of elution and coatings. Moreover, by reviewing the available evidence on the use of DCBs for several lesion (restenosis, de novo small and large vessels, bifurcations) and clinical (acute coronary syndromes, diabetes mellitus, multivessel disease, high bleeding risk) settings, it seeks to provide reasonable suggestions for their clinical use. Last, this paper outlines the processes involved in optimal "lesion preparation" before the use of DCBs and the criteria used for assessing results following their use.

RATIONALE:Current guidelines and expert consensus recommend different time thresholds of temporary pacemaker (TM) indwelling in patients with conduction block after transcatheter aortic valve replacement (TAVR). Accordingly, this lack of clinical evidence and effective strategies has resulted in extensive variations in permanent pacemaker (PPM) implantation patterns, potentially leading to over-early PPM implantation. The use of a temporary permanent pacemaker (TPPM), which involves an active fixation pacing lead and an external pulse generator secured to the skin surface, may be effective and safe in these patients. TPPM may improve postoperative mobility and facilitate early discharge, while providing prolonged and stable pacing for the recovery of conduction block, thereby reducing unnecessary PPM implantation. DESIGN:The RECOVER trial is a prospective, multicenter, open-label, randomized controlled study comparing TPPM vs TM in patients with conduction block after TAVR. The trial will enroll 160 subjects across 13 sites in China. Inclusion criteria include patients with persistent third-degree atrioventricular block (AVB), second-degree AVB, first-degree AVB with symptoms (PR interval >300 ms), alternating bundle branch block or bifascicular block with syncope/blackness related symptoms occurred during TAVR procedure or within 1 month after TAVR. Enrolled patients will be randomized 1:1 to the TPPM group for a 1-month bridge or the TM group for conventional 24 to 48 hours pacing. The primary effectiveness endpoint is the rate of PPM implantation at 6 months after the occurrence of AVB. Secondary effectiveness endpoint is the rate of PPM implantation at 1 month after the occurrence of AVB. Safety endpoints include all-cause mortality and TPPM/TM/PPM procedure-related complications during the 6-month follow-up. Key data collected will include sociodemographic information, medical history, electrocardiograph, HOLTER, echocardiography, contrast-enhanced cardiac CT, details of procedures and pacemaker interrogation. Indication for PPM implantation will be adjudicated by an independent pacing electrophysiologist committee. CONCLUSION:The RECOVER trial will evaluate whether TPPM is superior to conventional TM in reducing the rate of PPM implantation in patients with conduction block after TAVR, with a buffer period to distinguish whether conduction block is reversible or persistent. CURRENT STATUS:The trial is still enrolling participants (with 14 enrolled as of January 1, 2025). TRIAL REGISTRATION:Randomized controlled trial to compare temporary permanent pacemaker vs temporary pacemaker in patients with conduction block after transcatheter aortic valve replacement. Chinese Clinical Trial Registry ChiCTR2400087536. Registered at July 30, 2024. https://www.chictr.org.cn/showproj.html?proj=227719.