Access Site Bleeding Research Articles

Post-closure With MANTA Fluoroscopic DOT Technique for Emergent Percutaneous Mechanical Circulatory Support and ‘Bail-out’ for Large Bore Arterial Hemostasis

BackgroundLarge bore arterial hemostasis for emergent MCS initiation in cardiogenic shock and during failures of suture mediated vascular closure devices (VCD) necessitates dry/post-closure technique for successful closure. Use of the alternative MANTA fluoroscopic DOT technique, without depth finder, as post closure and as ‘bail-out’ in this high-risk patient population is described. MethodsAll patients who underwent emergent percutaneous transfemoral MCS initiation, without use of upfront sutured-mediated pro-glide VCDs, and procedures where proglide-perclose technique (PPT) failed to achieve hemostasis were post-closed with the alternative MANTA fluoroscopic DOT technique (without depth finder) as primary method or as ‘bail-out’.Patient related factors, cardiovascular co-morbidities, clinical indication, distribution of 14F versus 18F MANTA, and types of procedures obtained. Primary outcomes of access site related acute flow-limiting limb ischemia or bleeding requiring intervention analyzed. Results27 patients met inclusion criteria; mean age 64 years, majority male 19 (70 %), more than half obese (56 %) with mean BMI 31.06 kg/m2. 22 (81 %) had emergent MCS initiation and 5 (19 %) PPT hemostasis failures. Types of percutaneous MCS support included; 11 (44 %) Impella CP, 2 (7 %) 15F arterial ECMO, 6 (22 %) 17F arterial ECMO, 4 (15 %) 19F ECMO. All achieved hemostasis utilizing alternative MANTA fluoroscopic DOT technique without vascular complications of bleeding or acute ischemic limb. ConclusionThe alternative MANTA fluoroscopic DOT technique (without depth finder) can be successfully applied as post-closure for emergent MCS support delayed hemostasis and as bail-out for per-close suture mediated VCD failures for large bore arterial hemostasis.

CRT-100.28 Access Site, Antithrombotic Therapy and Major Bleeding Complications in Chronic Kidney Disease Patients Undergoing Percutaneous Coronary Intervention: Here We Go Again

CRT-100.28 Access Site, Antithrombotic Therapy and Major Bleeding Complications in Chronic Kidney Disease Patients Undergoing Percutaneous Coronary Intervention: Here We Go Again

Optimal Hemostatic Band Duration After Transradial Angiography or Intervention: Insights From a Mixed Treatment Comparison Meta-Analysis of Randomized Trials.

The optimal duration of hemostatic compression post transradial access is controversial. Longer duration increases the risk of radial artery occlusion (RAO) while shorter duration increases the risk of access site bleeding or hematoma. As such, a target of 2 hours is typically used. Whether a shorter or longer duration is better is not known. A PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials of different duration (<90 minutes, 90 minutes, 2 hours, and 2-4 hours) of hemostasis banding. The efficacy outcome was RAO, primary safety outcome was access site hematoma, and secondary safety outcome was access site rebleeding. Primary analysis compared the effect of various duration in reference to the 2 hours duration using a mixed treatment comparison meta-analysis. Of the 10 randomized clinical trials included with 4911 patients, when compared to the 2-hour reference duration, there was a significantly higher risk of access site hematoma with 90 minutes (odds ratio, 2.39 [95% CI, 1.40-4.06]) and <90 minutes (odds ratio, 3.61 [95% CI, 1.79-7.29]) but not with the 2 to 4 hours duration. When compared with the 2-hour reference, there was no significant difference in access site rebleeding or RAO with shorter or longer duration but the point estimates favored longer duration for access site rebleeding and shorter duration for RAO. Duration of <90 minutes and 90 minutes ranked 1 and duration of 2 hours ranked 2 as the most efficacious duration whereas duration of 2 hours ranked 1 and 2 to 4 hours ranked 2 as the safest duration. In patients undergoing transradial access for coronary angiography or intervention, a hemostasis duration of 2 hours offers the best balance for efficacy (prevention of RAO) and safety (prevention of access site hematoma/rebleeding).

Sex-Related Bleeding Risk in Acute Coronary Syndrome Patients Receiving Dual Antiplatelet Therapy with Aspirin and a P2Y12 Inhibitor

Objective: The aim of this work was to study sex differences in major bleeding risk in relation to dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). Methods and Results: The Rijnmond Collective Cardiology Research registry was designed to evaluate the application and outcomes of DAPT after ACS/PCI in the Rijnmond region in the Netherlands. Overall, 1,172 women (median age 67.5 years) and 3,087 men (median age 62.2 years) with ACS/PCI were enrolled between August 2011 and June 2013. Based on a tailored regional DAPT guideline aiming at bleeding risk minimization, 52.6% women and 66.9% men received prasugrel as first-choice P2Y12 inhibitor, in addition to aspirin. Women more frequently had contraindications for the use of prasugrel (and therefore received clopidogrel) than men (47.9 vs. 26.9%, p < 0.001). Femoral access was more common in women than in men (47.6 vs. 38.1%, p < 0.001). Women had higher incidence of major bleeding at 1 year than men (2.6 vs. 1.6%, p = 0.018). After adjustment for established bleeding risk factors, female sex was associated with over two-fold higher risk of major bleeding (adjusted hazard ratio 2.33; 95% confidence interval 1.26–4.32). This difference was apparent at discharge and appeared to be caused by access site bleedings (0.9 vs. 0.1%, p < 0.001). No sex differences were found in non-access site-related major bleeding up to 1 year. Conclusion: Women with ACS/PCI receiving DAPT had higher major bleeding risk caused by an excess in access site bleeds, mainly in relation to the femoral approach.

Coronary procedures via distal transradial access in older as compared with non-older patients: Insights from the DISTRACTION registry.

Older patients are at a higher risk of access site complications and bleeding. Systematic reviews and meta-analysis have highlighted the benefits of distal over proximal transradial access (mainly, lower rates of radial artery occlusion and faster hemostasis). We aimed to evaluate the feasibility and safety of distal transradial access (dTRA) for routine coronary procedures in older patients compared with non-older patients. Retrospective analysis of a large and real-world sample of 5524 consecutive all-comers patients who underwent coronary procedures via dTRA were included in the DISTRACTION registry. In the older patients (greater than or equal to 65 years) group (n = 2594, 47%), there were higher rates of hypertension (83% vs 71.1%; P less than .0001), diabetes (45.1% vs 34.7%; P less than .0001), previous stroke (2.9% vs 2%; P=.0425), chronic heart failure (9.2% vs 7.1%; P=.0040), severe aortic valvar disease (4.2% vs 2.9%; P=.0070), chronic kidney disease stages 3 and 4 (8.1% vs 3.1%; P less than .0001), previous percutaneous coronary intervention (27.2% vs 24.5%; P=.0253), previous coronary artery bypass grafting (5.1% vs 2.2%; P less than .0001), cardiogenic shock at presentation (1.3% vs 0.4%; P=.0003), rotational atherectomy (0.7% vs 0.2%; P=.0050), and left main percutaneous coronary intervention (2.7% vs 1.5%; P=.0033). No significant differences were observed in the rates of access site crossovers. No major adverse cerebrovascular and cardiac events directly related to dTRA, no hand/thumb dysfunction or ischemia after any procedure, and no access site-related hematomas (early discharge after transradial stenting of coronary arteries greater than or equal to 2) were recorded. Despite more comorbidities, more complex coronary disease, and more challenging presentation, the adoption of dTRA as the default approach for routine coronary procedures in older patients, by proficient operators, appears to be safe and feasible.

How brachial access compares to femoral access for invasive cardiac angiography when radial access is not feasible: A meta-analysis.

Trans-radial access is considered the best approach for cardiac catheterization. The choice of an alternative access route may be complex and trans-femoral access (TFA) is generally preferred. However, trans-brachial approach (TBA) may represent another feasible alternative. We therefore aimed to compare TBA and TFA in terms of access site bleeding and complications in a meta-analysis study. We systematically searched principal databases for studies comparing femoral and brachial approach in terms of in-hospital vascular complications in patients undergoing cardiac catheterization (coronary angiography or percutaneous coronary intervention). Five retrospective studies and one randomized study were identified for the meta-analysis; 2756 patients undergoing a TBA and 331.208 patients undergoing a TFA for cardiac catheterization were included in the final study. No significant differences between access routes were found in terms of risk of any vascular complications (relative risk 1.18; 95% CI: 0.91-1.53; p n.s.). Brachial access was associated with a significantly lower risk of access site bleeding (relative risk 0.46; 95% CI 0.24-0.88, p = 0.02). TBA for cardiac catheterization was associated with a lower risk of access site bleeding and a comparable risk of any vascular complications compared with TFA. TBA may be considered a reasonable alternative access route for cardiac catheterization, at least as femoral approach.

Safety and Feasibility of Retrograde Recanalization of Radial Artery Occlusion in Patients with Need for Repeated Wrist Procedures

AIM: The purpose of the study was to present a new technique of retrograde recanalization of radial artery (RA) occlusion (RAO) in patients with need for repeated wrist access percutaneous angiographic procedures. MATERIALS AND METHODS: During a 10-year period from March 2011–May 2021, 53 000 patients were referred for percutaneous coronary intervention (PCI) in a high-volume transradial center. RAO on angiography was documented in 1165 patients. Retrograde recanalization of RAO was attempted in 70 patients. The selected patients were with multiple previous bilateral wrist interventions (n = 3–9). Ipsilateral ulnar artery was usually rudimented or occluded and contralateral wrist approach could not be used. We examined clinical and procedure characteristics, access site bleeding and ischemic complications and procedural success of retrograde recanalization of RAO. Visual analog scale (VAS) score forearm pain assessment was performed after procedure. Technique: All patients had palpable pulse distal of previous puncture site due to collaterals from ipsilateral ulnar and interosseous artery. The RA was punctured with an inner metallic needle with a plastic cannula. Using retrograde radial angiography performed by injecting contrast through the plastic cannula, the occluded segment was visualized and crossed with different types of hydrophilic chronic total occlusion guide wires. After sheath insertion, balloon dilatation of the occluded RA segment, successful catheterization, and/or percutaneous coronary intervention was performed. Final RA angiography was performed on all patients. RESULTS: Successful retrograde opening of RAO was achieved in 65 out of 70 patients (92%). PCI was performed in 56% of patients through the opened RAO and 5 patients underwent CAS. Procedural success through opened RA was achieved in all 65 patients. Forearm pain during procedure was present in all cases (VAS score 3 ± 2.1). Access site bleeding EASY score 3 and 4 occurred in 6 patients (8.5%). One patient had discharge of embolic material up the arm without clinical consequences. In one patient, we observed dissection of the interosseous artery. Clinical and duplex long-term follow-up with a median of 4.1 years showed patent RA in only 20 patients. There were no registered cases of hand ischemia. About 61% of patients underwent subsequent PCIs, through other alternative access sites. CONCLUSION: Retrograde recanalization of RAO is successful and safe in patients with need of repeated coronary angiography procedures and inability to use other wrist access sites. Puncturing the collateral and performing retrograde radial angiography through the cannula is a key factor in successful opening of the RAO.

Outcomes of carotid stenting in patients with fibromuscular dysplasia

ObjectiveFibromuscular dysplasia (FMD) is a noninflammatory arterial disease that affects the extracranial carotid arteries in young patients. The ideal treatment of FMD has continued to be debated, and the role of carotid artery stenting (CAS) is controversial. The aim of the present study was to assess the feasibility and outcomes of CAS for patients with FMD. MethodsA retrospective analysis of patients who had undergone CAS was performed using the Vascular Quality Initiative database from December 2012 to May 2021. Patients who had undergone CAS for atherosclerosis and FMD were included and matched 1:1 by age, gender, and clinical presentation. The demographics, clinical parameters, and procedural data were analyzed. The end points included postoperative stroke and transient ischemic attack (TIA), and adverse events (perioperative and 1-year mortality, neurologic changes, access site complications, hematoma or bleeding, infection, congestive heart failure, arrhythmia, myocardial infarction, reperfusion symptoms), and hospital length of stay. ResultsAfter matching, 55 patients had undergone CAS for FMD (mean age, 58.7 ± 14 years; 62% women; 69% White; mean body mass index, 28 ± 6 kg/m2). Most of these procedures (69%) were elective. The FMD group had had a lower rate of hypertension (55% vs 82%; P = .002), smoking (35% vs 80%; P < .001), diabetes (13% vs 45%; P < .001), and coronary artery disease (9% vs 45%; P < .001) compared with the non-FMD group. In the FMD group, prior TIA and stroke was identified in 39 (71%) and 31 (57%) patients, respectively. The mean interval from a prior stroke or TIA to the index surgery was 160 days. Additionally, 23 patients (42%) had had anatomically high lesions above the level of the second cervical vertebra. In the FMD group, the transfemoral approach was used for 43 patients (78%), with distal embolic protection used for 40 patients (93%). Flow reversal was used for nine patients (23%). Most cases were performed with local anesthesia (58%). Three patients (6%) in the FMD group had had access site complications that were managed nonoperatively. No differences were found between the FMD and non-FMD groups in perioperative stroke, TIA, or 30-day mortality. The length of stay was similar between the two groups, and the 1-year survival was 100% for both groups. All the patients in the FMD group were discharged without neurologic complications, and 50 patients (91%) were receiving dual antiplatelet therapy. The median follow-up was 328 days (interquartile range, 1-732 days) with no mortality or reinterventions during follow-up. ConclusionsCAS for FMD is a feasible and safe procedure with favorable technical success, a low incidence of neurologic complications, and good clinical outcomes at 1 year of follow-up.

Abstract 14328: The Impact of Peripheral Arterial Disease in Major Bleeding and Major Cardiac and Cerebrovascular Events in Patient Undergoing Percutaneous Coronary Intervention: A Contemporary Assessment

Introduction: Peripheral arterial disease (PAD) has been associated with adverse outcomes in patients undergoing percutaneous coronary intervention (PCI). However, there are controversial reports regarding its impact in the current era of radial interventions. Hypothesis: We assessed the hypothesis that patients with PAD and patients without PAD undergoing PCI have similar major bleeding complications and major adverse cardiac and cerebrovascular events (MACCE). Methods: This was a retrospective analysis of data collected from 6 New York metropolitan area tertiary care hospitals and submitted to the NCDR between 2010 and 2018. Major bleeding events were classified using Bleeding Academic Research Consortium (BARC) classification. Severe bleeding was defined as a BARC ≥3. Hierarchical logistic regression was utilized to assess the association of PAD with post-PCI adverse outcomes, as appropriate. Results: A total of 2,933 PAD patients (9.4%) underwent PCI (without PAD, n = 28,172). Results are shown in the Table. PAD patients had a significantly higher odds of MACCE and major bleeding complications, including blood transfusions and in-hospital mortality. Access site bleeding and the need for post PCI dialysis did not reach statistical significance. A multivariable analysis will be presented. Conclusions: In conclusion, PAD continues to be a major risk factor for patients undergoing PCI. When compared with patients without PAD, these patients are at an increased risk of major adverse outcomes, including a 67% increase in mortality risk and a 44% in major bleeding complications risk.

Abstract 14277: Comparison of Three Vascular Closure Devices for Vascular Access Closure After Cardiac Electrophysiology Procedures

Introduction: Vascular closure devices are commonly used for EP procedures to achieve rapid hemostasis. Different devices using different mechanisms of action are available, but the potential contribution of each type to the incidence of vascular complications is not clear. Methods: This is a single center, prospective study in which 138 contemporaneous patients undergoing EP procedures were categorized according to the vascular closure device type used: Vascade (collagen plug, n=57), Perclose (suture, n=41), and SiteSeal (external compression, n=40). The primary endpoint was access-related major vascular complications. Secondary endpoints included time to ambulation and delayed access-site bleeding requiring additional manual pressure. Results Mean age and BMI 68±11 years and 29.7±6.2 Kg/m 2 , 46 (33%) were female, 121 (88%) were on uninterrupted antithrombotic therapy (71% OAC, 14% OAC/APLT, 3% APLT). Femoral vein access was obtained in all, bilaterally in 113 (82%), with a mean of 3±1 access sites per patient and a sheath size ranging from 6- to 23-Fr. Femoral arterial access was obtained in 14 (10%), once per patient, with a sheath size ranging from 5- to 8-Fr. There were no arterial access complications. On the venous side, hematomas occurred in 3/57 (5%) of the Vascade group, 1/41 (2%) of the Perclose group, and 0/40 (0%) of the SiteSeal group (p=ns for all comparisons). Delayed access-site bleeding occurred in 5/57 (9%) of the Vascade group, 5/41 (12%) of the Perclose group, and 7/40 (18%) of the SiteSeal group (p=ns for all comparisons). Time to ambulation was comparable between groups (minutes: 139±51 Vascade, 137±34 Perclose, 123±11 SiteSeal, p=ns). Conclusion Vascade, Perclose, and SiteSeal are comparable in term of vascular complications and time to ambulation for patients undergoing EP procedures.

Evaluation of nurse- and anaesthetist-led sedation for selected transcatheter aortic valve implantation procedures

Background/Aims Most transcatheter aortic valve implantation procedures are now performed under conscious sedation, rather than general anaesthetic. This study evaluated nurse-led conscious sedation, compared with anaesthetist-led sedation, to determine the feasibility of the former. Methods Consecutive patients undergoing transcatheter aortic valve implantation under either nurse-led or anaesthetist-led sedation between July 2018 and September 2021 were reviewed. Assessed outcomes were analysed and compared, including 30-day mortality rate, major vascular access site bleeding, moderate or severe aortic regurgitation, stroke, new pacemaker implantation, duration of procedure and length of stay. Results A total of 212 patients who underwent nurse-led sedation and 412 who underwent anaesthetist-led sedation were identified. There were no significant differences in risk scores between the two groups. In both groups, incidence of conversion to general anaesthetic was low, with nurse sedatitionists seeking anaesthetist support in 13 (6.2%) cases. Cases with nurse-led sedation had a significantly lower average duration of the procedure (90 minutes vs 111 minutes; P=0.001) and length of stay (2 days vs 3 days, P=0.0002). Conclusions Nurse-led sedation can be safely incorporated into transcatheter aortic valve implantation practice. Nurse-led sedation delivered similar outcomes to anaesthetist-led sedation, but with shorter procedural times and legnth of stay. This could allow more flexible scheduling, increased capacity and improved access for patients.

Microaxial Left Ventricular Assist Device in Cardiogenic Shock: A Systematic Review and Meta-Analysis.

Microaxial left ventricular assist devices (LVAD) are increasingly used to support patients with cardiogenic shock; however, outcome results are limited to single-center studies, registry data and select reviews. We conducted a systematic review and meta-analysis, searching three databases for relevant studies reporting on microaxial LVAD use in adults with cardiogenic shock. We conducted a random-effects meta-analysis (DerSimonian and Laird) based on short-term mortality (primary outcome), long-term mortality and device complications (secondary outcomes). We assessed the risk of bias and certainty of evidence using the Joanna Briggs Institute and the GRADE approaches, respectively. A total of 63 observational studies (3896 patients), 6 propensity-score matched (PSM) studies and 2 randomized controlled trials (RCTs) were included (384 patients). The pooled short-term mortality from observational studies was 46.5% (95%-CI: 42.7–50.3%); this was 48.9% (95%-CI: 43.8–54.1%) amongst PSM studies and RCTs. The pooled mortality at 90 days, 6 months and 1 year was 41.8%, 51.1% and 54.3%, respectively. Hemolysis and access-site bleeding were the most common complications, each with a pooled incidence of around 20%. The reported mortality rate of microaxial LVADs was not significantly lower than extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pumps (IABP). Current evidence does not suggest any mortality benefit when compared to ECMO or IABP.

Anatomical, functional and pain hand assessment after transulnar artery access with ipsilateral RAO for percutaneous coronary interventions

Abstract Aims The purpose of our research comes from the increasing need for an alternative approach when the standard right radial is not accessible, most commonly due to the presence of RAO. The use of this approach is still controversial in the interventional community, due to lack of published studies. Our purpose was to prove its' safety and success. Material and methods In the period from September 2019 until April 2021, 103 consecutive patients underwent PCI through primarily chosen TUA with ipsilateral RAO. These patients were included in a prospective single center study of effectiveness and safety. We examined clinical and procedure characteristics, access site bleeding and ischemic complications and failure mode of initial TUA. Anatomical, functional and pain assessment of the punctured arm was performed at baseline and after the procedure and at follow-up. Using pre-procedural UA angiography, we measured the diameter of the UA and the collateral circulation for the occluded RA by QCA (Quantitative angiography). Values of UA diameter were compared with previous angiographies before RAO. Additional functional assessment of the arm was performed using JAMAR dynamometer for hand strength and self-assessment with QUICK DASH questionnaire. VAS score was used for pain assessment. Clinical and duplex ultrasound evaluation for ulnar patency were examined. Results Mean age of patients was 62.9±9 years with 30% females. Previous TRA was present in all patients, 32% of patients had multiple previous TRA (&amp;gt;3), with 10 being the largest number. Procedural success through primary chosen TUA with ipsilateral RAO was 96.2%. In 4 (3.8%) patients we had an inability to puncture the right UA and were transferred to left TRA. Procedural success after UA puncture was 100%. Number of punctures of the UA was 1.6±0.9 (1–6 punctures). Access site bleeding complications were detected in 4% (EASY score &amp;gt;2). On duplex ultrasound follow up, there wasn't a single case of UAO detected. There were no clinical or ischemic hand complications seen during long-term follow up. Local bleeding complications were found to be related to larger number of punctures, time of puncture and longer procedural time (p&amp;lt;0.0001). QCA assessment showed an increasing of UA diameter after RAO of 0.28±0.35 mm (p&amp;lt;0.0001). Dynamometer values of arm strength showed a small decrease in values 12 hours after procedure (72.6±23 vs. 71.9p, p=0.029), but without changes in initial strength on 1, 6 and up to 1 year after procedure. QUICK DASH self-assessment showed no significant changes in the follow-up period. Conclusion Transulnar approach with ipsilateral RAO is safe and successful for PCI. The existence of appropriate collateral support for the occluded RA, allows for a safe TUA with ipsilateral RAO. Anatomical, functional and pain assessment of the punctured arm affirmed the safe use of this approach as the best alternative for right TRA and preservation of wrist access benefits. Funding Acknowledgement Type of funding sources: None.

Combined strategy for large-bore arteriotomy closure after transcatheter aortic valve implantation

Abstract Background The access site vascular complications remain a relevant complication following transcatheter aortic valve implantation (TAVI). They are frequently associated with vascular closure device failure (VCD). Incidence of vascular complications depends on different factors such as patient's characteristics and clinical risk profile, femoral morphology, access sheath size or technical procedural experience. Their rate is reported between 4–19% [1]. Vascular complications negatively affect morbidity and mortality following TAVI [2]. VCDs that are most commonly used include the suture-based ProGlide and the plug-based MANTA. ProGlide was originally developed for small-bore vessel closure between 6–8F, but a combination of 2 or more devices is suitable for large-bore vessel closure &amp;gt;12F. The MANTA device is originally dedicated for large-bore vessel closure. The MANTA device was not superior to the use of 2 ProGlides in their direct comparison in terms of access site–related vascular complications or access site bleedings. Plug-based VCDs required fewer, but a different kind of bailout maneuvers [3,4]. The alternative and less frequently used strategy is intentional combination of one suture-based VCD – ProGlide with small-bore plug-based VCD AngioSeal. The data supporting this approach are very limited, but showing this concept as a safe, with lower risk of vascular or bleeding complications. Moreover, this strategy requires less additional endovascular interventions when compared with vascular closure using two suture-based VCDs [5]. Methods Retrospectively analysed single centre comparison of two different large-bore vessel closure strategies: two suture-based ProGlides (SB group) vs. intentional combination of one ProGlide with plug-based AngioSeal 8F (CB group). The primary endpoint was occurrence of access site–related vascular complications at 30-days. Results 71 consecutive patients treated between Aug/2020 and May/2021 (SB group) were compared with 68 consecutive patients treated between May/2021 and Jan/2022 (CB group). There wasn`t any significant difference in patient's characteristics between both groups: mean age 80 vs. 81 years, females 53,8% vs. 54,9%, STS score 3,46% vs. 3,47%. The only difference was higher proportion of the patients treated oral anticoagulation in SB group (46,4% vs. 38,5%). The lower rate of vascular complication was observed in CB group 2,9% vs. 7,1%. Moreover, we had to use additional VCD in 14 cases among patients from SB group to achieve haemostasis. Conclusion The intentional combination of one suture-based VCD with one plug-based VCD is effective and safe. This combined strategy was associated with lower rate of vascular complication compare the use of 2 suture-based VCDs in our patient's cohort following TAVI. Funding Acknowledgement Type of funding sources: None.

Trans-catheter edge-to-edge mitral valve repair in patients with acute decompensated heart failure due to severe mitral regurgitation – a single centre experience

Abstract Introduction Recent series have demonstrated the benefit of trans-catheter edge-to-edge mitral valve repair (TEER) in acutely ill hospitalised patients with severe mitral regurgitation (MR) and intractable heart failure despite intensive intravenous therapy. We describe our cumulative experience with such patients at the Sheba Medical Centre over a 10 year period. Purpose The purpose of this study was to evaluate the safety and efficacy of TEER in hospitalized patients with acute decompensated heart failure and severe MR that was deemed to play a major role in the patients' deterioration. Methods We included 30 hospitalised patients with intractable heart failure and MR ≥3+ (20 males; mean age 74.2±10.6 years; 10 had cardiogenic shock). MR was primary in 4, secondary in 24 and mixed in 2 patients. Acute results were assessed by echocardiography prior to discharge and safety was evaluated clinically, according to the occurrence of procedure-related adverse events. Mortality data were drawn from the national death registry. Results TEER devices were successfully implanted in 28 patients. Early (POD 1) procedure-failure was noted in one patient due to recurrence of flail. There was no peri-procedural mortality. Two patients were hemodynamically unstable during the procedure. One patient had peri-procedural access site bleeding necessitating blood transfusion. Following intervention, 16 patients required ICU care (mean stay 4.8±2.5 days), shock was recorded in 7 patients, 16 required hemodynamic support, and 8 required invasive ventilation. At 30 days 7 patients had died and an additional 4 died 1 to 6 months following intervention. However, mortality in the remaining patients was low with only 3 additional deaths up to 4 years after the procedure (80% of patients alive at 6 months). MR reduction was achieved in 24 patients (to ≤mild in 10 and to moderate in 11). At 12 months follow up MR severity was mild in 3 (37.5%) and moderate in 5 (62.5%) patients. Only 1 patient reported HF rehospitalisation during the year following the procedure. Conclusion TEER for hospitalised patients with severe MR and intractable heart failure is safe, associated with high early mortality, and good long-term outcome for patients alive 6 months after the procedure. More research is needed to better characterise patients likely to benefit from TEER in this clinical scenario. Funding Acknowledgement Type of funding sources: None.

Efficacy and safety of left atrial appendage closure in patients with atrial fibrillation and high thromboembolic and bleeding risk

Aim. To compare the incidence of thromboembolic and hemorrhagic events after left atrial appendage occlusion (LAAO) or without prevention of thromboembolic events (TEEs) during prospective follow-up of patients with atrial fibrillation (AF) and a high risk of ischemic stroke (IS) who have contraindications to long-term anticoagulant therapy.Material and methods. The study included 134 patients with AF, a high risk of IS, and contraindications to long-term anticoagulation. Patients were divided into 2 groups as follows: the first group included patients who underwent LAAO (n=74), while the second one — those who did not undergo any TEE prevention (n=60). The follow-up period was 3 years. The cumulative rate of all-cause mortality, IS, transient ischemic attacks (TIA), and systemic embolism (SE) was taken as the primary efficacy endpoint. The primary safety endpoint included major bleeding according to GARFIELD registry criteria.Results. The rate of composite efficacy endpoint in the LAAO group was significantly lower than in the group without thromboembolic prophylaxis (5,2 vs 17,4 per 100 patient-years; adjusted odds ratio (OR), 4,08; 95% confidence interval (CI): 1,7-9,5; p=0,001). The rate of major bleeding was comparable in both groups (2,4 in the LAAO group vs 1,3 per 100 patient-years in the group without thromboembolic prophylaxis; adjusted OR, 0,55; 95% CI: 0,1-3,09; p=0,509). In addition, the event rate of net clinical benefit (all-cause mortality + ischemic stroke/TIA/SE + major bleeding) in the LAAO group was also significantly lower (5,9 vs 18,2 per 100 patient-years; adjusted OR, 3,0; 95% CI: 1,47-6,36; p=0,003).Conclusion. Among patients with AF and contraindications to long-term anticoagulation after 3 years of follow-up, LAAO demonstrated the significant reduction of cumulative rate of all-cause mortality and non-fatal thromboembolic events. At the same time, the frequency of major bleeding was comparable between the groups, even taking into account access-site bleeding and postoperative antithrombotic therapy (ATT)-associated bleeding in the LAAO group. Further randomized clinical trials are required to confirm these data.

Sex-Based Differences in Periprocedural Complications Following Lower Extremity Peripheral Vascular Intervention.

Women with coronary artery disease are shown to have worse outcomes after percutaneous coronary intervention compared with men; however, less is known about sex-based outcomes following lower extremity peripheral vascular intervention (PVI) for symptomatic peripheral artery disease. The study aims to assess whether female sex is independently associated with periprocedural complications in patients undergoing PVI. Analysis includes patients undergoing lower extremity PVI from September 2016 to March 2020 from the Vascular Quality Initiative registry. Multivariate logistic regression was used to assess the independent association of female sex with post-PVI complications. Of the 119 620 patients included, 47 316 (39.6%) were women. Analysis reflected that women were at higher risk of developing access site complications, including any hematoma (odds ratio [OR], 1.45 [1.35-1.57]), hematoma requiring transfusion (OR, 2.24 [1.82-2.76]; P<0.001), hematoma requiring surgery (OR, 1.49 [1.19-1.86]; P<0.001), pseudoaneurysm (OR, 1.69 [1.39-2.05]; P<0.001), and access site occlusion (OR, 1.89 [1.15-3.08]; P<0.001). Women also faced higher risks of target lesion dissection (OR, 1.36 [1.26-1.46]; P<0.001), above-knee amputation (OR, 1.37 [1.18-1.58]; P<0.001), and in-hospital mortality (OR, 1.21 [1.07-1.38]; P=0.003). In a contemporary cohort, women undergoing lower extremity PVI for symptomatic peripheral artery disease were at higher risk than men of developing periprocedural complications, including moderate or severe access site bleeding, above-knee amputation, and in-hospital mortality. This increased risk persisted despite adjustment for differences in baseline patient or procedural characteristics and warrants further investigation.

A Modified Buddy-Wire Technique for Crossing of the Interatrial Septum With the Sapien 3 Valve During Transseptal Mitral Valve-in-Valve/Ring Procedures

BackgroundCrossing of the interatrial septum (IAS) with the Edwards Sapien-3 transcatheter heart valve (THV) may fail, despite preparatory balloon septostomy. A planned buddy guidewire placed in the left ventricle may help facilitate crossing of the IAS and mitral bioprosthesis with the THV. MethodsA retrospective study of 12 consecutive patients undergoing transseptal, mitral valve-in-valve or valve-in-ring procedures using the Edwards Sapien-3 THV since 2018 with a planned buddy-wire technique. The primary endpoint was the composite of successful delivery of the buddy wire and deployment of the first intended Sapien 3 within the mitral valve without removal from the body, additional interatrial septal puncture, or placement of a further buddy wire. Secondary objectives included safety endpoints, as follows: access-site bleeding, tamponade, stroke, intraprocedural death, sustained ventricular arrhythmia, and 30-day vascular complications. ResultsFrom January 2018 to March 2022, a total of 12 consecutive patients who underwent transseptal mitral valve-in-valve (9) or valve-in-ring (3) procedures were identified. Three patients (25%) required repeat septostomy on the buddy wire after initial THV crossing failure. Crossing of the IAS and successful deployment in the mitral valve with the THV was achieved in all cases, without removal from the body or need for an additional wire or septal puncture. No access-site bleeding, stroke, tamponade, ventricular arrhythmia, intraprocedural death, or 30-day vascular complication occurred. ConclusionsThe planned buddy-wire technique was successful in all cases and facilitated successful crossing of the IAS and deployment of the THV in the mitral position without removal from the body, additional wires, or septal punctures, with no adverse events.

Alternative Application Technique for the MANTA Vascular Closure Device for Percutaneous Large-Bore Arterial Access Closure: The Fluoroscopic DOT Technique

Background: Vascular complications are a cause of increased morbidity and mortality when performing percutaneous procedures requiring large-bore arterial access. MANTA vascular closure device (VCD) is currently the only large-bore VCD using an intraluminal foot plate and an extraluminal collagen plug. The traditional depth locator approach might be compromised in; emergent cases without the required measurements, cases of hematoma formation, or other patient, procedure, or operator-specific variables. Furthermore, this technique can be used for postclosure in cases without the required measurement of depth. We describe vascular outcomes using fluoroscopy (fluoroscopic DOT technique) rather than traditional depth locator approach for vascular closure with the MANTA VCD. Methods: Fifty patients who underwent transcatheter aortic valve implantation (TAVI) were retrospectively analyzed using fluoroscopic DOT technique with 18F MANTA VCD between May and August 2021. All patients >18 years of age who qualified for transfemoral TAVI were included. Access was obtained with ultrasound guidance with vessel diameter of at least > 6 mm and free from anterior vessel wall calcification. Patient related factors and primary outcomes of access site bleeding and acute flow-limited limb ischemia requiring intervention were prospectively analyzed. Furthermore, 1 patient who failed hemostasis with suture-mediated VCD had successful hemostasis with fluoroscopic DOT technique as dry postclosure after balloon aortic valvuloplasty. Results: In total, 50 patients were analyzed with a mean age of 81 years and majority were male (56%). Majority had comorbidities of hypertension (88%) and hyperlipidemia (94%), 24% had peripheral arterial disease, 38% coronary artery disease, and 58% were former smokers. Importantly, 40% were obese with an average body mass index (BMI) of 29 kg/m2. There were no bleeding or ischemic limb complications post MANTA VCD deployment using the fluoroscopic DOT technique. Furthermore, none of the patients required peripheral intervention from index procedure to 1 month post verified during their 1-month post TAVR follow-up. Conclusion: Fluoroscopic DOT technique using the MANTA VCD is highly reproducible and allows hemostasis in a predictable manner for procedures requiring large-bore arterial access in the absence of MANTA depth measurement.

Percutaneous Arteriovenous Fistula Creation with Intended Brachial Vein Outflow and Secondary Brachial Vein Transposition Using the WavelinQ EndoAVF System

PurposeTo assess percutaneous arteriovenous fistula (pAVF) creation with subsequent brachial vein transposition (BVT) using the WavelinQ endoAVF system. Materials and MethodsA pre-existing database was retrospectively reviewed. Nine patients underwent attempted pAVF-BVT creation between December 2017 and November 2021. Study outcomes included technical success, time to maturation, patency rates, adverse events, and secondary interventions. Maturation was defined as a pAVF flow of ≥500 mL/min, outflow vein diameter ≥5 mm, and successful 2-needle cannulations in patients on active hemodialysis (HD). ResultspAVF-BVT creation was technically successful in 8 of 9 patients (89%). Six of 8 created pAVFs remained patent and matured at 4 weeks, subsequently undergoing secondary BVT. Primary patency rates at 6, 12, and 24 months were 37.5%, 12.5%, and 12.5%, respectively. Secondary patency rates at 6, 12, and 24 months were 75%, 37.5%, and 37.5%, respectively. One patient had postprocedural access site bleeding, and 4 required secondary interventions to maintain patency. Two patients with failed pAVFs with BVT were successfully converted to surgical AVFs, probably facilitated by sufficient enlargement of superficial veins following pAVF creation. ConclusionsOff-label use of the WavelinQ system to create brachial vein outflow pAVF with BVT may be an alternative procedure for HD access creation in select patients with exhausted superficial veins.