Catheterization and Cardiovascular Interventions最新文献

{"title":"Procedural and clinical impact of intracoronary lithotripsy in heavily calcified aorto-ostial coronary lesions.","authors":"Federico Oliveri, Maura Meijer, Martijn J H Van Oort, Ibtihal Al Amri, Brian O Bingen, Bimmer E Claessen, Aukelien C Dimitriu-Leen, Joelle Kefer, Hany Girgis, Tessel Vossenberg, Frank Van der Kley, J Wouter Jukema, Jose M Montero-Cabezas","doi":"10.1002/ccd.31233","DOIUrl":"10.1002/ccd.31233","url":null,"abstract":"<p><strong>Background: </strong>Percutaneous coronary intervention of calcified aorto-ostial lesions (AOL) pose unique challenges due to anatomical propensity for recoil, leading to poorer outcomes compared to non-AOL. Although intravascular lithotripsy (IVL) has shown excellent success and safety in heavily calcified plaques, evidence specific to AOL is limited. This study aims to evaluate the efficacy and safety of IVL in AOL versus non-AOL.</p><p><strong>Methods: </strong>Patients treated with IVL between 2019 and 2023 from an ongoing prospective multicenter registry were eligible for inclusion. Patients were therefore classified in AOL and non-AOL groups, based on anatomical location. The primary technical endpoint was device success, defined as the ability to deliver the IVL catheter and pulses at the target lesion, without angiographic complications. Secondary technical endpoint encompassed procedural success <30%, consisting of device success with residual stenosis <30%, final thrombolysis in myocardial infarction grade 3 flow, and no in-hospital major adverse cardiovascular events (MACE). The primary clinical endpoint was in-hospital MACE, including cardiac death, nonfatal myocardial infarction, or target lesion revascularization.</p><p><strong>Results: </strong>A total of 321 patients underwent IVL, including 48 with AOL. Device success showed no significant difference between AOL and non-AOL groups (100% vs. 98.2%; p = 0.35). A nonsignificant trend toward worse procedural success with residual stenosis <30% was observed in the AOL arm (AOL 81.3% vs. non-AOL 90.5%, p = 0.06). In-hospital MACE was significantly higher in AOL (4.2% vs. 0.7%, p = 0.048), attributed entirely to cardiac deaths. At 6-month follow-up, the incidence of MACE (AOL 8.3% vs. non-AOL 4.0%, p = 0.19), and cardiac deaths (AOL 4.2% vs non-AOL1.1%, p = 0.11) were comparable between groups.</p><p><strong>Conclusion: </strong>IVL treatment for heavily calcified AOL demonstrates comparable procedural and 6-month clinical outcomes when compared to non-AOL, despite a higher incidence of in-hospital MACE.</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142307169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predictors of permanent pacemaker implantation for transcatheter self-expandable aortic valve implant in the cusp overlap era.","authors":"Oscar A Mendiz, Carlos Fava, Lucas I Müller, Gustavo A Lev, Gaston Heredia, Silvina E Gómez, Joaquín Cedeño, Juan M Pérez, Pablo Lamelas","doi":"10.1002/ccd.31176","DOIUrl":"10.1002/ccd.31176","url":null,"abstract":"<p><strong>Background: </strong>Predictors of permanent pacemaker implantation (PPMI) after self-expanding transcatheter aortic valve implant (TAVI) were described. Is unknown if PPMI predictors remain in the era of high implants using the cusp overlap (COP).</p><p><strong>Methods: </strong>Single-center, prospective, consecutive case series of patients undergoing self-expanding TAVI with the COP approach. The status of PPMI and other clinical events were ascertained at 30 days.</p><p><strong>Results: </strong>A total of 261 patients were included (84% with Evolut, n = 219). Implant depth >4 mm was infrequent (13.8%). TAVI depth (OR 1.259; p = 0.005), first or second-degree auriculo-ventricular block (OR 3.406; p = 0.033), right-bundle (OR 15.477; p < 0.0001), and incomplete left-bundle branch block (OR 7.964; p = 0.036) were found to be independent predictors of PPMI. The risk of PPMI with deep implant and no electrical disturbances was 3%, and 0% with high implant and no prior electrical disturbances. Those who received PPMI had no statistically significant increased risk of death, myocardial infarction, stroke, bleeding events, or vascular complications at 30 days, but longer hospital stay (mean difference 1.43 days more, p = 0.003).</p><p><strong>Conclusions: </strong>Implant depth and prior conduction abnormalities remain the main predictors of PPMI using self-expanding TAVI in the COP era. Patients with high implants and no prior conduction abnormalities may be candidates for early discharge after uneventful self-expanding TAVI, while the rest may need inpatient monitoring regardless of achieving a high implant. The need for PPMI was associated with longer hospital stays.</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Laser ablation for preventing coronary obstruction and maintaining coronary access in redo-TAVR: A proof of concept.","authors":"John Brlansky, Dong Qiu, Ali N Azadani","doi":"10.1002/ccd.31197","DOIUrl":"10.1002/ccd.31197","url":null,"abstract":"<p><strong>Background: </strong>Redo-transcatheter aortic valve replacement (TAVR) is a promising treatment for transcatheter aortic valve degeneration, becoming increasingly relevant with an aging population. In redo-TAVR, the leaflets of the initial (index) transcatheter aortic valve (TAV) are displaced vertically when the second TAV is implanted, creating a cylindrical cage that can impair coronary cannulation and flow. Preventing coronary obstruction and maintaining coronary access is essential, especially in young and low-risk patients undergoing TAVR. This study aimed to develop a new leaflet modification strategy using laser ablation to prevent coronary obstruction and facilitate coronary access after repeat TAVR.</p><p><strong>Methods: </strong>To evaluate the feasibility of the leaflet modification technique using laser ablation, the initial phase of this study involved applying a medical-grade ultraviolet laser for ablation through pericardial tissue. Following this intervention, computational fluid dynamics simulations were utilized to assess the efficacy of the resulting perforations in promoting coronary flow. These simulations played a crucial role in understanding the impact of the modifications on blood flow patterns, ensuring these changes would facilitate the restoration of coronary circulation.</p><p><strong>Results: </strong>Laser ablation of pericardium leaflets was successful, demonstrating the feasibility of creating openings in the TAV leaflets. Flow simulation results show that ablation of index valve leaflets can effectively mitigate the flow obstruction caused by sinus sequestration in redo-TAVR, with the extent of restoration dependent on the number and location of the ablated openings.</p><p><strong>Conclusions: </strong>Laser ablation could be a viable method for leaflet modification in redo-TAVR, serving as a new tool in interventional procedures.</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142072076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcomes among patients with non-ST-elevation myocardial infarction on chronic anticoagulation: Insights from the National Inpatient Sample.","authors":"Ahmed M Younes, Ahmed Hashem, Ahmed Maraey, Mahmoud Khalil, Ahmed Elzanaty, Islam Y Elgendy","doi":"10.1002/ccd.31198","DOIUrl":"10.1002/ccd.31198","url":null,"abstract":"<p><strong>Background: </strong>Chronic systemic anticoagulation use is prevalent for various thromboembolic conditions. Anticoagulation (usually through heparin products) is also recommended for the initial management of non-ST-elevation myocardial infarction (NSTEMI).</p><p><strong>Aims: </strong>To evaluate the in-hospital outcomes of patients with NSTEMI who have been on chronic anticoagulation.</p><p><strong>Methods: </strong>Using the National Inpatient Sample (NIS) years 2016-2020, NSTEMI patients and patients with chronic anticoagulation were identified using the appropriate International Classification of Diseases, 10th version (ICD-10) appropriate codes. The primary outcome was all-cause in-hospital mortality while the secondary outcomes included major bleeding, ischemic cerebrovascular accident (CVA), early percutaneous coronary intervention (PCI) (i.e., within 24 h of admission), coronary artery bypass graft (CABG) during hospitalization, length of stay (LOS), and total charges. Multivariate logistic or linear regression analyses were performed after adjusting for patient-level and hospital-level factors.</p><p><strong>Results: </strong>Among 2,251,914 adult patients with NSTEMI, 190,540 (8.5%) were on chronic anticoagulation. Chronic anticoagulation use was associated with a lower incidence of in-hospital mortality (adjusted odds ratio [aOR]: 0.69, 95% confidence interval [CI]: 0.65-0.73, p < 0.001). There was no significant difference in major bleeding (aOR: 0.95, 95% CI: 0.88-1.0, p = 0.15) or ischemic CVA (aOR: 0.23, 95% CI: 0.03-1.69, p = 0.15). Chronic anticoagulation use was associated with a lower incidence of early PCI (aOR: 0.78, 95% CI: 0.76-0.80, p < 0.001) and CABG (aOR: 0.43, 95% CI: 0.41-0.45, p < 0.001). Chronic anticoagulation was also associated with decreased LOS and total charges (adjusted mean difference [aMD]: -0.8 days, 95% CI: -0.86 to -0.75, p < 0.001) and (aMD: $-19,340, 95% CI: -20,692 to -17,988, p < 0.001).</p><p><strong>Conclusions: </strong>Among patients admitted with NSTEMI, chronic anticoagulation use was associated with lower in-hospital mortality, LOS, and total charges, with no difference in the incidence of major bleeding.</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142072077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of residual mitral regurgitation after transcatheter edge-to-edge repair in atrial functional mitral regurgitation: Results from MITRA-PRO registry.","authors":"Dennis Rottländer, Jörg Hausleiter, Thomas Schmitz, Alexander Bufe, Melchior Seyfarth, Ralph Stephan von Bardeleben, Harald Beucher, Taoufik Ouarrak, Steffen Schneider, Peter Boekstegers","doi":"10.1002/ccd.31242","DOIUrl":"10.1002/ccd.31242","url":null,"abstract":"<p><strong>Background: </strong>Transcatheter edge-to-edge repair (TEER) has emerged to address symptomatic atrial functional mitral regurgitation (aFMR) in patients who are at high operative risk.</p><p><strong>Aims: </strong>No clinical data is available on the impact of residual mitral regurgitation (MR) following TEER in aFMR compared to ventricular functional MR (vFMR).</p><p><strong>Methods: </strong>In the MITRA-PRO registry, 846 patients with FMR and MitraScore assessment for residual MR quantification were included (722 patients with vFMR and 124 patients with aFMR).</p><p><strong>Results: </strong>Compared to vFMR similar procedural results in regard of residual MR following TEER were found in aFMR patients (MitraScore post TEER 2.5 ± 1.8 vs. 2.7 ± 1.9), while the amount of implanted TEER devices was increased in vFMR. 1-year survival was better in aFMR compared to vFMR regardless of relevant residual MR (MitraScore ≥ 4), while 1-year rehospitalization was comparable for both MR entities. Patients with aFMR and mild residual MR had a lower mortality rate (6.6% vs. 10.3%) and rehospitalization rate (29.1% vs. 46.2%) 1 year after mitral TEER. However, in contrast to vFMR a MitraScore ≥4 was no independent predictor of mortality in aFMR indicating a better tolerance toward residual MR.</p><p><strong>Conclusions: </strong>Residual MR is an independent predictor of 1-year mortality in vFMR patients, whereas in aFMR patients, a MitraScore of ≥4 is associated with higher mortality but is not an independent predictor in multivariate analysis. Therefore, minimizing MR through mitral TEER is crucial for survival in vFMR patients, while aFMR patients tolerate significant residual MR better 1 year after the procedure.</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"First-in-human: Leaflet laceration with balloon mediated annihilation to prevent coronary obstruction with radiofrequency needle (LLAMACORN) for valve-in-valve transcatheter aortic valve replacement.","authors":"Christina Mew, Arun Dahiya, Adrian A Chong, Samual M Hayman, Peter T Moore, Danielle L Harrop, Reza Reyaldeen, Christopher M W Cole, Jordan D W Ross, Shaun Roberts, Kellee A Korver, Stephen V Cox, Anthony C Camuglia","doi":"10.1002/ccd.31195","DOIUrl":"10.1002/ccd.31195","url":null,"abstract":"<p><p>Coronary obstruction (CO) is a potential pitfall for transcatheter aortic valve replacement (TAVR), especially in valve in valve procedures into degenerated surgical or transcatheter prostheses. Bioprosthetic leaflet modification techniques that incorporate electrosurgery are evolving as the preferred strategy to mitigate the risk of CO in high CO risk settings. The UNICORN method is proposed as a more predictable leaflet modification strategy than the earlier described BASILICA approach, but its proponents have hitherto mandated the use of a balloon-expandable valve (BEV) prosthesis. Many patients have small prostheses and therein face a significant risk of patient prosthesis mismatch with BEV in this setting. This risk may be curtailed if a self-expanding valve (SEV) prosthesis could be used. Herein described is a modified approach to allow for the utilization of SEV systems in this setting.</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142119082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Contrast-enhanced excimer laser coronary atherectomy.","authors":"Abhishek Chaturvedi, Brian C Case, Hayder D Hashim, Itsik Ben-Dor, Ron Waksman, Robert A Gallino, Nelson L Bernardo","doi":"10.1002/ccd.31236","DOIUrl":"10.1002/ccd.31236","url":null,"abstract":"","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142280718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of multiple ballooning on coronary lesions as assessed by optical coherence tomography and intravascular ultrasound.","authors":"Yusuke Kanzaki, Yasushi Ueki, Daisuke Sunohara, Yoshiteru Okina, Hidetomo Nomi, Keisuke Machida, Daisuke Kashiwagi, Hidetsugu Yoda, Shusaku Maruyama, Ayumu Nagae, Tamon Kato, Tatsuya Saigusa, Jouke Dijkstra, Soichiro Ebisawa, Koichiro Kuwahara","doi":"10.1002/ccd.31239","DOIUrl":"10.1002/ccd.31239","url":null,"abstract":"<p><strong>Background: </strong>Optimal lesion preparation for coronary lesions has been reappraised in the interventional community, given the increasing use of drug-coated balloons for de novo lesions; however, whether multiple ballooning could achieve more favorable angiographic results compared with single ballooning remains unknown. We aimed to investigate the incremental effect of multiple ballooning on de novo coronary lesions over single ballooning as assessed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS) among patients undergoing percutaneous coronary intervention (PCI).</p><p><strong>Methods: </strong>Patients with chronic coronary syndrome (CCS) undergoing PCI were enrolled. Ballooning before stent implantation was repeatedly performed for three times using the same semi-compliant balloon. OCT and IVUS were performed after each balloon dilatation. Primary outcome measure was the difference in the mean lumen area between post-1st ballooning (1B) and post-3rd ballooning (3B) as assessed by OCT.</p><p><strong>Results: </strong>A total of 32 lesions in 30 patients undergoing PCI between May 2021 and August 2022 were analyzed. Major plaque types of the lesions were fibrous (68.8%) and lipid (28.1%). Mean lumen area by OCT was significantly increased from 1B to 3B (5.9 ± 2.9 mm² vs. 6.0 ± 2.9 mm², difference: 0.2 ± 0.4 mm², p = 0.040). There were significant increases from 1B to 3B in minimum lumen area by OCT (3.1 ± 1.5 mm² vs. 3.6 ± 1.7 mm², difference: 0.5 ± 0.6 mm², p < 0.001) and mean dissection angle by OCT (65.6 ± 24.9° vs. 95.2 ± 34.0°, difference: 29.6 ± 25.5°, p < 0.001). Additionally, mean plaque area by IVUS was significantly decreased (8.0 ± 4.2 mm² vs. 7.8 ± 4.1 mm², difference: -0.2 ± 0.2 mm², p < 0.001).</p><p><strong>Conclusions: </strong>Among CCS patients with mainly non-calcified lesions, multiple ballooning significantly increased the lumen area and dissection angle compared with single ballooning.</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142280719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Classification of primary mitral regurgitation using extramitral cardiac involvement in patients undergoing transcatheter edge-to-edge repair.","authors":"Danon Kaewkes, Alon Shechter, Vivek Patel, Ofir Koren, Keita Koseki, Tarun Chakravarty, Mamoo Nakamura, Moody Makar, Raj Makkar","doi":"10.1002/ccd.31253","DOIUrl":"https://doi.org/10.1002/ccd.31253","url":null,"abstract":"<p><strong>Background: </strong>An enhanced classification of primary mitral regurgitation (PMR) based on extramitral cardiac involvement may refine patient selection and optimize the timing of transcatheter edge-to-edge repair (TEER).</p><p><strong>Aims: </strong>This study aimed to assess the prognostic significance of a recently established classification system that characterizes the extent of extramitral cardiac damage in patients undergoing TEER for PMR.</p><p><strong>Methods: </strong>Consecutive PMR patients who received MitraClip implantation were categorized according to the presence of extramitral cardiac damage, determined through preprocedural echocardiography. The classifications included no damage or only left ventricular dilatation (group 0), left atrial involvement (group 1), right ventricular volume/pressure overload (group 2), right ventricular failure (group 3), or left ventricular failure (group 4). Cox-proportional hazard models were used to ascertain the impact of PMR groups on the primary composite outcome of all-cause mortality or rehospitalization for heart failure (HHF) over 2 years.</p><p><strong>Results: </strong>In a cohort of 322 eligible PMR patients undergoing TEER (median age: 83 years; 41% female) between 2013 and 2020, the following distribution emerged: group 0 (10 patients, 3%), group 1 (96 patients, 30%), group 2 (117 patients, 36%), group 3 (56 patients, 18%), and group 4 (43 patients, 13%). Kaplan-Meier analysis demonstrated a significant decline in freedom from the primary outcome as group severity increased (log-rank p = 0.030). On multivariate analysis, the degree of extramitral cardiac involvement was significantly associated with the primary outcome (HR: 1.30; 95% CI: 1.02-1.67; p = 0.043), primarily driven by HHF.</p><p><strong>Conclusions: </strong>This innovative classification system for PMR, based on extramitral cardiac involvement, carries significant prognostic implications for clinical outcomes following TEER. Integrating this classification system into clinical decision-making could enhance risk stratification and optimize the timing of TEER in these patients.</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Traditional Versus Distal Radial Access for Coronary Diagnostic and Revascularization Procedures: Final Results of the TENDERA Multicenter, Randomized Controlled Study.","authors":"Avtandil M Babunashvili, Samir Pancholy, Aleksei B Zulkarnaev, Alexander L Kaledin, Igor N Kochanov, Alexander V Korotkih, Dmitriy S Kartashov, Mikhail A Babunashvili","doi":"10.1002/ccd.31271","DOIUrl":"https://doi.org/10.1002/ccd.31271","url":null,"abstract":"<p><strong>Background: </strong>Traditional transradial access (TRA) is widely used for coronary and non-coronary interventions with significant improvements in procedural outcomes; however, it is associated with RAO that precludes repeat use of the same artery for possible future TRI and other purposes. Distal radial access (DRA) has been proposed as an effective alternative to decrease RAO rates. Published literature describing the RAO rate after DRA versus TRA from various RCT and clinical registries has shown conflicting results.</p><p><strong>Objectives: </strong>This study compared the forearm radial artery occlusion (RAO) rate assessed by Doppler ultrasound between distal and conventional radial access at 1-year follow-up after the initial procedure.</p><p><strong>Methods: </strong>TENDERA was a multicenter, randomized controlled study comparing DRA versus TRA for coronary diagnostic and interventional procedures using 5 or 6F hydrophilic-coated sheaths. The primary endpoint was forearm RAO at 12 months after radial access. The secondary endpoints included puncture time, sheath insertion and total procedure time, radiation dose, and vascular access site-related complications.</p><p><strong>Results: </strong>Eight hundred and fifty patients were randomized to either TRA (n = 418) and DRA (n = 432) groups. In the intention-to-treat analysis, the rate of forearm RAO at 12 months was observed in 39 patients (4.6%) and was significantly reduced in the DRA group compared with the TRA group (2.5% vs. 6.7%, RR 2.59 [95% CI 1.29-5.59], p = 0.010). Analysis in per protocol population has shown consistent results with forearm RAO rate 2.8% in the DRA group versus 6.5% in the TRA group (p = 0.008). The crossover rate was higher (4.6% vs. 1%, p = 0.013) and median hemostasis time was shorter (156.5 min vs. 180 min, p < 0.001) with DRA. Overall bleeding (BARC 1-2) and postprocedure hematoma > 5 cm occurred less frequently in the DRA group compared with the TRA group (3.2% vs. 20.5%, p < 0.001% and 9.0% vs. 27.0%, p < 0.001, respectively). No significant differences were observed in total procedure time and radiation dose between groups.</p><p><strong>Conclusions: </strong>DRA for coronary diagnostic and interventional procedures is associated with reduced forearm RAO rate and shorter hemostasis time, but a longer sheath insertion time and higher crossover rate compared with TRA.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT04211584.</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}