Major Vascular Complications Research Articles

Cost of diabetes mellitus and related macrovascular complications in Turkiye.

This study aimed to identify the costs and resources used for diabetes mellitus (DM) and macrovascular complications in Turkiye. The "Cost of Illness" method and a bottom-up costing approach were used in this study. We used e-Nabiz to identify patients with DM and collected their data from 2016 to 2020. We also examined macrovascular complications such as acute coronary syndrome, unstable angina, coronary artery disease, cerebrovascular events, transient ischemic attacks, carotid artery syndrome, intracranial hemorrhage, diabetic foot, heart failure, atrial fibrillation, and peripheral vascular disease using relevant ICD codes. No sampling was done; costs were calculated based on the entire population. When calculating per patient costs, all outpatient/inpatient, medication, intervention, and laboratory/screening tests were considered. Between 2016 and 2020, the e-Nabiz database recorded 7,656,700 people diagnosed with diabetes, a prevalence of 10.4%. The total 2020 cost for treating diabetes was $4,526,212,569 (31,276,128,849 TL), with an average patient cost of $591.145. The health-care expense for 991,945 people diagnosed with major vascular complications due to diabetes was $1,013,004,565.0 (6,999,861,544.16 TL) in 2020, with a per patient average cost also of $591.145 (4048.81 TL). Breakdown of the total cost is 44% for healthcare, 34% for medication, 12% for insulin, 6% for oral antidiabetic drugs, and 1% for testing supplies. Women have a complication rate of 11.2%, while men have a higher rate of 20.8%. DM is both a significant disease burden and an important economic burden. The findings will be a guide the development of effective strategies and sound health policies.

Imbalance in Bone Morphogenic Proteins 2 and 7 Is Associated with Renal and Cardiovascular Damage in Chronic Kidney Disease.

Arterial stiffness is a major vascular complication of chronic kidney disease (CKD). The development of renal damage, hypertension, and increased pulse wave velocity (PWV) in CKD might be associated with an imbalance in bone morphogenetic proteins (BMP)-2 and BMP-7. Plasma BMP-2 and BMP-7 were determined by ELISA in CKD patients (stages I-III; n = 95) and Munich Wistar Frömter (MWF) rats. Age-matched Wistar rats were used as a control. The expression of BMP-2, BMP-7, and profibrotic and calcification factors was determined in kidney and perivascular adipose tissues (PVAT). BMP-2 was higher in stage III CKD patients compared to control subjects. BMP-7 was lower at any CKD stage compared to controls, with a significant further reduction in stage III patients. A similar imbalance was observed in MWF rats together with the increase in systolic (SBP) and diastolic blood pressure (DBP), or pulse wave velocity (PWV). MWF exhibited elevated urinary albumin excretion (UAE) and renal expression of BMP-2 or kidney damage markers, Kim-1 and Ngal, whereas renal BMP-7 was significantly lower than in Wistar rats. SBP, DBP, PWV, UAE, and plasma creatinine positively correlated with the plasma BMP-2/BMP-7 ratio. Periaortic and mesenteric PVAT from MWF rats showed an increased expression of BMP-2 and profibrotic and calcification markers compared to Wistar rats, together with a reduced BMP-7 expression. BMP-2 and BMP-7 imbalance in plasma, kidney, and PVATs is associated with vascular damage, suggesting a profibrotic/pro-calcifying propensity associated with progressive CKD. Thus, their combined analysis stratified by CKD stages might be of clinical interest to provide information about the degree of renal and vascular damage in CKD.

Retrospective Comparative Study to Assess the Safety and Efficacy of Transradial Arterial Access for Hepatic Tumor Embolizations: A Single Operator Experience

Abstract Objectives To assess the efficacy and safety of transradial arterial access (TRA) for hepatic tumor embolizations and compare the outcomes between the TRA and transfemoral arterial access (TFA). Materials and Methods A retrospective analysis of all consecutive hepatic tumor embolization procedures done through TFA or TRA by a single operator from November 2017 to April 2019 was performed. The procedural variables, including fluoroscopy time, radiation dose (reference air kerma [RAK]), conversion and complication rates, and patient preferences were recorded. The primary endpoint was technical success, which was defined as the successful completion of the embolization procedure. Procedural variables including radiation exposure and patient preferences, and complications were analyzed as secondary endpoints. Results Out of 102 procedures in 90 patients, 44 were performed through TFA and the rest by TRA. A technical success rate of 98.2% and a crossover rate of 1.7% were recorded for TRA. There were no major vascular complications and similar rates of minor complications (8.6% for TRA, 2.3% for TFA; P = 0.055), without any clinical sequelae. After the initial learning curve, no significant differences for other procedural variables were noted between the two access sites. Faster ambulation were achieved following TRA (P < 0.055). All 12 patients who underwent repeat TACE after initial TRA chose this again over TFA. Conclusions TRA is safe and effective for hepatic tumor embolization. Its safety and efficacy profile is comparable to that of TFA, with added improved patient comfort and faster ambulation. Advances in Knowledge New catheter options and modifications of the existing techniques as explained in this article proved radial arterial access as a safe and effective alternative in hepatic arterial embolization.

1050 ULTRASOUND GUIDED CANNULATION OF FEMORAL ARTERY IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT

Abstract Background Vascular access complications are a significant source of morbidity and mortality after transcatheter aortic valve replacement (TAVR). Ultrasound-guided cannulation (UGC) of central veins or arteries is a widely used approach for patients undergoing invasive procedures. Whether UGC significantly decreases the risk of vascular access complications also for large-bore access procedures, such as TAVR, lacks evidence Objectives in this study, we aimed to evaluate the benefits of routine use of UGC in patients undergoing TAVR. Methods Data were retrospectively collected from two high-volume TAVR centers from September 2009 to March 2022. UGC was performed using a two-dimensional ultrasound short-axis views, while manual palpation, fluoroscopy, or contralateral angiography were used for the other patients. The odds ratio (OR) for vascular complications was calculated using a multivariate logistic regression model including as dependent variables all relevant baseline and procedural characteristics (forward stepwise selection process). Vascular complications were adjudicated according to the Valve Academic Research Consortium definitions 3. Results Out of 874 patients included in the study, UGC access was performed in 177 subjects. Overall mean age was 80.2±5.8 years old, 60% of patients were females, 35.5% had diabetes, 61.4% had dyslipidemia, and 27.8% had chronic kidney disease, with a mean left ventricular ejection fraction of 52.7±9.7%. Looking at the procedural variables Euroscore II was 5.8±5.4, second and third valves generation have been used in 85% of the cases, while suture-based closure devices in 84% of subjects. After adjustment for clinical and procedural variables, routinely use of UGC was associated with a lower rate of total [Odds Ratio (OR): 0.38; 95% confidence interval (CI) 0.15% to 0.95%)] and major vascular complications [Odds Ratio (OR): 0.21; 95% confidence interval (CI) 0.05% to 0.75%)], while no differences were observed for minor vascular complications. Conclusions Routinely use of UGC significantly decreases the risk of vascular complications in patients undergoing TAVR. However, a dedicated randomized clinical trial assessing the safety and efficacy of this approach is warranted to confirm our results in this high-risk population.

Left Atrial Appendage Closure for Atrial Fibrillation in the Elderly >75 Years Old: A Meta-Analysis of Observational Studies

Background: Left atrial appendage closure (LAAC) is an established therapy for patients with atrial fibrillation (AF); however, there is a limited understanding of LAAC in elderly patients (≥75 years old). We conducted a meta-analysis to investigate the procedural complications and long-term outcomes after LAAC in the elderly versus the non-elderly. Methods: We screened PubMed, EMBASE, Cochrane Library, and Web of Science. Procedural endpoints of interest included successful implantation LAAC rates, in-hospital mortality, major bleeding events, pericardial effusion/tamponade, stroke, and vascular access complications related to LAAC. Long-term outcomes included all-cause mortality, major bleeding events, and stroke/transient ischemic attack (TIA) during follow-up. Results: Finally, 12 studies were included in the analysis; these included a total of 25,094 people in the elderly group and 36,035 people in the non-elderly group. The successful implantation LAAC rates did not differ between the groups, while the elderly patients experienced more periprocedural mortality (OR 2.62; 95% CI 1.79−3.83, p < 0.01; I2 = 0%), pericardial effusion/tamponade (OR 1.39; 95% CI: 1.06−1.82, p < 0.01; I2 = 0%), major bleeding events (OR 1.32; 95% CI 1.17−1.48, p < 0.01; I2 = 0%), and vascular access complications (OR 1.34; 95% CI 1.16−1.55, p < 0.01; I2 = 0%) than the non-elderly patients. The long-term stroke/TIA rates did not differ between the elderly and the non-elderly at least one year after follow-up. Conclusions: Even though successful implantation LAAC rates are similar, elderly patients have a significantly higher incidence of periprocedural mortality, major bleeding events, vascular access complications, and pericardial effusion/tamponade after LAAC than non-elderly patients. The stroke/TIA rates did not differ between both groups after at least one-year follow-up.

1019 SAFETY OF PLUG-BASED AND SUTURE-BASED VASCULAR CLOSURE DEVICES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT: A MULTICENTER OBSERVATIONAL STUDY

Abstract Background Transcatheter aortic valve replacement (TAVR), is the treatment of choice for most patients with aortic stenosis. Transfemoral access remains the most widely used peripheral vascular approach for TAVR and dedicated plug-based or suture-based vascular closure devices are available to achieve femoral hemostasis. However, the comparative safety of such strategies is controversial in patients undergoing transfemoral TAVR. Objectives in this study, we aimed to evaluate the rates of vascular access complications according to the use of plug-based or suture-based vascular closure in patients undergoing TAVR. Methods Data were retrospectively collected from two high-volume TAVR centers from September 2009 to March 2022. Patients were categorized according to the use of plug-based or suture-based vascular closure devices. The plug-based platform used was MANTA (Teleflex), while the suture-based devices were the Perclose ProGlide™ or the Prostar™ Systems (Abbott Vascular). Baseline demographic, clinical, and echocardiographic variables were compared between these groups using an independent-sample Student's t-test for continuous variables, presented as mean±SD, and the chi-square test for categorical or binary variables, presented as number and percentage, as appropriate. The odds ratio (OR) for vascular complications was calculated using a multivariate logistic regression model including as dependent variables all relevant baseline and procedural characteristics. The closure device variable was included in the multivariate model using the Prostar™ XL device group as reference. Vascular complications were adjudicated according to the Valve Academic Research Consortium definitions 3. Results Out of 874 patients, hemostasis was achieved with Prostar™ XL PVS in 120 (13.7%) patients, with Perclose ProGlide™ in 525 (60.1%), and with MANTA 229 (26.2%). No differences in age and common cardiovascular risk factors were observed between the group except for the prevalence of peripheral arterial disease (30.6% vs. 17.0%, p&amp;lt;0.0001) and dyslipidemia (58.9% vs. 68.6%, p=0.01) as well as for the echo and procedural variables except for the Euroscore II that was lower in the plug-based group (6.0±5.6 vs. 5.1±4.68), and for the higher use of new generation devices (79.1% vs. 98.3%, p&amp;lt;0.0001). After adjustment for common cardiovascular risk factors and procedural features, no differences were observed for total vascular complications [OR: 0.68 (95% confidence interval (CI): 0.33 to 1.38) and OR: 0.60 (95% CI: 0.33 to 1.53), for Perclose ProGlide™ and MANTA groups, respectively]. Likewise, no substantial differences were observed for major and minor vascular complications. Conclusions Both suture-based and plug-based devices have comparable outcomes with regard to the risk of vascular complications. Further randomized clinical trials are warranted to confirm this observation in high-risk sub-group patients with for example heavily calcified access or obesity.

735 CLINICAL EFFICACY OF CEREBRAL EMBOLIC PROTECTION IN TRANSFEMORAL TAVI PROCEDURE

Abstract Background Although in the context of Transcatheter Aortic Valve Implantation (TAVI) technological improvements, refinements in technique and increased operator experience have led to progressive reduction in most complications, periprocedural neurological ischemic event (stroke and TIA) continues to occur in up to 2% of patients undergoing TAVI. Many of these are attributed to embolic events during the procedure and can lead to potentially devastating consequences. Cerebral Embolic Protection (CEP) devices have been developed to mitigate this risk. Data regarding the clinical efficacy of these devices in preventing neurological events in TAVI are conflicting. The aim of the present study is to investigate the impact of CEP on clinical neurological events in TAVI. Methods We performed a multicentric retrospective observational case-control study to evaluate the rate of periprocedural clinical neurological ischemic event in patients undergoing transfemoral TAVI with or without using CEP (Sentinel, Boston Scientific) during the procedure. Patients were consecutively enrolled between January 2018 and December 2021 by two tertiary centers (Verona and Ancona). A total population of 1042 patients were enrolled. The primary endpoint was the rate of a periprocedural clinical neurological ischemic event. The secondary was a composite endpoint: in-hospital death, periprocedural major vascular complication and periprocedural major bleeding. Clinical events at 30-day follow-up were evaluated (death, clinical neurological ischemic event, vascular complications, major bleeding). In consideration of the retrospective study design, we performed a propensity match analysis to account for differences in the baseline characteristics of patients in the two enrolling centers. Results The overall population comprised patients who underwent TAVI without using CEP (No-CEP group, n=581) and with CEP (CEP group, n=461). The propensity match analysis yielded a final population of 922 patients: 461 patients in the No-CEP group and 461 patients in the CEP group. There were no differences in baseline characteristics between the groups. Primary endpoint occurred in 8 (0,9%) patients overall, 3 (0,7%) patients in the No-CEP group and in 5 (1,1%) patients in CEP group (p=0,725). There were no differences in secondary endpoint: 25 (5,4) patients in No-CEP group and 20 (4,3%) in CEP group (p=0,541). In particular: in-hospital death (0,7% vs 1,3%, p=0,506), periprocedural major vascular complications (2,0% vs 0,7%, p=0,143), periprocedural major bleeding (5,0% vs 3,0%, p=0,179). No differences were observed in 30-days outcomes: death (0,0% vs 0,9%, p=0,131), clinical neurological ischemic events (0,8% vs 0,7%, p=1), vascular complications (0,3% vs 0,0%, p=0,450), major bleeding (0,8% vs 0,7%, p=1). The multiple logistic regression performed to estimate the effect of CEP on the primary endpoint showed Euroscore II (OR, 1.10; 95% CI, 1.00–1.19; P=0.028) and predilatation (OR, 4.84; 95% CI, 1.21–21.64; P=0.028) was associated with an increase in primary endpoint after TAVI, while CEP and valve type did not contribute significantly. Conclusions This study suggests that using CEP devices during transfemoral TAVI is safe and does not increase vascular complications, although it does not impact the rate of periprocedural clinical neurological ischemic events.

Short-term outcome after transcatheter aortic valve replacement with anovel balloon-expandable valve.

Transcatheter aortic valve replacement (TAVR) has been expanding rapidly with numerous transcatheter heart valve (THV) systems currently available. The Myval balloon-expandable (BE) valve (Meril Life Sciences Pvt. Ltd., India) is anovel THV system indicated for the treatment of patients with severe aortic stenosis. The primary objective of this study is to assess the safety and performance of the Myval BE valve. In this prospective single-centre study, 120consecutive patients who underwent TAVR with the Myval BE valve were included. Clinical outcomes were evaluated at 30days and 6months using Valve Academic Research Consortium‑2 criteria. All-cause mortality, stroke, acute kidney injury, major vascular complications, moderate or severe paravalvular leakage (PVL) and need for apermanent pacemaker implantation (PPI) were investigated. At 6‑month follow-up, all-cause death and cardiac death were seen in 5.8% and 0.8% of the patients respectively. Periprocedural stroke and need for PPI were both seen in 3.3% of the patients. Access-site-related vascular and bleeding complications were absent. Improved valve haemodynamics and no moderate to severe PVL could be seen at 30days. An intermediate valve size was selected in 51% of the patients. The Myval BE valve demonstrates improved valve haemodynamics, absence of moderate to severe PVL and good safety outcomes at 6‑month follow-up with low cardiac death rate and acceptable rates of permanent pacemaker implantation and periprocedural stroke. Future randomised controlled trials will further establish the clinical utility of the Myval BE valve.

A new trend to reduce adverse events in patients undergoing transcatheter aortic valve implantation: cusp overlap technique: a cross sectional study.

Transcatheter aortic valve implantation (TAVI) is currently the treatment of choice for the majority of patients at moderate or high surgical risk. However, some complications occur frequently with this procedure. In this study, we aimed to assess whether the cusp-overlap view (COP) technique may be associated with a reduced incidence of some of these complications compared with the classical three-cusp view (TCV) technique. In this single-center, retrospective study we investigated; technical success, postprocedural permanent pacemaker implantation (PPMI), new-onset stroke, pericardial tamponade, arrhythmia development, acute renal failure, major bleeding, major vascular complications, procedure-related coronary obstruction, new-onset left bundle branch block (LBBB), paravalvular leak, peri-procedural myocardial infarction (MI), day of hospitalization, death, and major adverse cardiac and cerebrovascular events (MACCE) were determined as the clinical endpoints. A total of 281 consecutive patients who met the study criteria and underwent elective or emergency transfemoral TAVI using the self-expandable CoreValve Evolut valve were included. 176 consecutive patients implanted with the classical TCV technique and 105 consecutive patients implanted with the COP technique were compared. Compared with the TCV group, patients in the COP group had lower PPMI (3.8% vs. 10.8%, p = 0.039), in-hospital mortality (1.9% vs. 8.5%, p = 0.018), and 1-year death (4.8% versus 18.8%, p = 0.001), and MACCE rates (12.4% vs 31.3%, p < 0.001). The COP technique may help to reduce the conduction disturbances, PPMI requirement and complication rates that may develop following TAVI. In addition, it is an interesting result that it reduces mortality and MACCE rates in long-term follow-ups.

Comparison of Transfemoral versus Transsubclavian/Transaxillary access for transcatheter aortic valve replacement: A systematic review and meta-analysis.

Femoral access is the gold standard fortranscatheter aortic valve replacement (TAVR). Safe alternative access, that represents about 15% of TAVR cases, remains important for patients without adequate transfemoral access. We aimed to perform a systematic review and meta-analysis of studies comparing transfemoral (TF) access versus transsubclavian or transaxillary (TSc/TAx) access in patients undergoing TAVR. We searched PubMed, Cochrane CENTRAL Register, EMBASE, Web of Science, Google Scholar and ClinicalTrials.gov (inception through May 24, 2022) for studies comparing (TF) to (TSc/TAx) access for TAVR. A total of 21 studies with 75,995 unique patients who underwent TAVR (73,203 transfemoral and 2,792 TSc/TAx) were included in the analysis. There was no difference in the risk of in-hospital and 30-day all-cause mortality between the two groups (RR 0.64, 95% CI 0.36-1.13, P=0.12) and (RR 0.95, 95% CI 0.64-1.41, P=0.81), while 1-year mortality was significantly lower in the TF TAVR group (RR 0.79, 95% CI 0.67-0.93, P=0.005). No significant differences in major bleeding (RR 0.82, 95% CI 0.65-1.03, P=0.09), major vascular complications (RR 1.14, 95% CI 0.75-1.72, P=0.53), and stroke (RR 0.66, 95% CI 0.42-1.02, P=0.06) were observed. In patients undergoing TAVR, TF access is associated with significantly lower 1-year mortality compared to TSc/TAx access without differences in major bleeding, major vascular complications and stroke. While TF is the preferred approach for TAVR, TSc/TAx is a safe alternative approach. Future studies should confirm these findings, preferably in a randomized setting.

Transradial/brachial carotid artery stenting with proximal protection: technical instructions, acute results and long-term outcomes

The aim of this study was to evaluate the feasibility, safety and efficacy of transradial/brachial (TR/TB) carotid artery stenting (CAS) with proximal cerebral protection (PCP) as a first line of treatment of carotid artery stenosis. Among 556 patients with significant (>50% if symptomatic or >70% if asymptomatic by Doppler US) unilateral, lipid-rich carotid artery stenosis undergoing TR/TB CAS, 137 (24.5%) deemed at high-risk for periprocedural cerebral embolization were scheduled for PCP with Mo.MA Ultra or Mo.MA mono-balloon. In patients with very complex anatomy the standard technique was modified loading the Mo.MA catheter without mandrel on two-wire system (so called 'No MAndrel 2 wire' technique, No.MA2) to increase support and deliverability. Device, technical and procedural successes both acute and at follow-up were the main outcomes. Mean patients' age was 74±7 years (93% male), 15% were symptomatic and 59.6% owned 'high-surgical-risk' features. Stenosis degree was 85±7% with soft composition in all (by CT-angiography). TR and TB approach were selected in 92 (67%) and 45 (33%) patients, respectively. Target carotid axes were right, left bovine and left non bovine in 55%, 38% and 7% of patients. Procedures were successfully completed in all patients (intention-to-treat basis) with the standard Mo.MA Ultra system in 129 patients and the Mo.MA mono-balloon in 8 patients. No.MA2 technique was succesfully used in 16 patients as 'bailout' and in 27 patients as 'first line'). Device and technical success was 97% (133/137 patients) due to crossover to femoral access in 3 cases, and Mo.MA too short to engage the ECA in 1 patient. The procedural success was 96.7% (131/137, two minor strokes). Procedural time and fluoroscopy time were increased with No.MA2 technique. One major vascular complication occurred, in the TB group, while chronic radial occlusion was detected by Doppler ultrasound in 7/92 patients (7.1%) at 372±163 days of follow-up. The event-free survival was 91% and the stroke rate was 0%. TR/TB CAS with proximal protection is a feasible, safe and effective strategy and may be considered a first line strategy in all comer patients.

Systemic inflammatory markers in elderly patients undergoing transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) provokes an early injury response, partially represented by dynamic changes in inflammatory markers. TAVR greatly benefits the elderly and we aimed to determine whether increased inflammatory markers post-TAVR in octagenerians were different than their younger counterparts and whether it was associated with adverse clinical outcomes. Patients with severe symptomatic aortic stenosis who underwent transfemoral TAVR from January 2010 to December 2021 were enrolled. Total white blood cells (WBC) count and subpopulation dynamics were evaluated. Five-hundred and seven patients were finally included in the study, 65% of these patients were 80 or more years old (54% female, median age 84 [82-87]) years, with severe symptomatic aortic stenosis. In patients aged above 80 years (patients ≥ 80), we noticed significant kinetic changes in the WBC and their differential cellular subpopulations (P < 0.0001) between admission and early days post-procedure. This was evident by a significant increase in total WBC (median 7.1 to 9.4) and absolute neutrophil count (median 4.7 to 7.4), neutrophil-lymphocyte (NL) ratio (median 2.82 to 7.21), and a meaningful decrease in absolute lymphocyte count (median 1.5 to 1.0). Implantation of self-expandable valves (SEVs) was associated with a more pronounced inflammatory response than balloon-expandable valves (BEVs). Higher WBC and neutrophil counts were associated with higher mortality and major vascular complications at 30 days, in addition, higher neutrophil counts and NL ratios were found to be correlated to arrhythmia at 30 days with P values of 0.04 and 0.028, respectively. This is the first description of a differential age-related inflammatory response in patients after TAVR, which shows an association between inflammatory markers post procedure and clinical outcome. Nevertheless, survival rates were similar in the elderly population and in younger patients, despite the presence of comorbid conditions.

Distal Radial Artery Access for Recanalization of Radial Artery Occlusion and Repeat Intervention: A Single Center Experience

Background: Once occluded, the radial artery becomes unsuitable for repeat interventions and obligates the need for alternative vascular access, such as the femoral approach, which is not encouraged by current guidelines. With the dissemination of distal radial access (DRA), which allows the cannulation of the artery in its distal segment and which remains patent even in the case of radial artery occlusion (RAO), the option to perform angioplasty at this level becomes feasible. Methods: Thirty patients with RAO were enrolled in this pilot study. Recanalization was performed through DRA using hydrophilic guidewires. The feasibility endpoint was procedural success, namely the successful RAO recanalization, the efficacy endpoint was patency of the artery at 30 days, and the safety endpoint was the absence of periprocedural vascular major complications or major adverse cardiac and cerebrovascular events. Results: The mean age of the patients was 63 ± 11 years, and 15 patients (50%) were men. Most patients had asymptomatic RAO (n = 28, 93.3%), and only two (6.6%) reported numbness in their hands. The most common indication for the procedure was PCI (19, 63.2%). Total procedural time was 41 ± 22 min, while the amount of contrast used was 140 ± 28 mL. Procedural success was 100% (n = 30). Moreover, there were no major vascular complications (0%); only two small hematomas were described (10%) and one had an angiographically visible perforation (3%). One case of periprocedural stroke was reported (3%), with onset immediately after the procedure and recovering 24 h later. Twenty-seven radial arteries (90%) remained patent at the one-month follow-up. Conclusions: RAO recanalization is feasible and safe, and by using dedicated hydrophilic guidewires, the success rate is high without significantly increasing procedural time or the amount of used contrast.

Schwannoma at the sinonasal tract and pterygopalatine fossa: Experience at a tertiary care teaching hospital in Eastern India

Abstract Background: Schwannomas are neoplasms that are rarely found in the sinonasal tract and pterygopalatine fossa (PPF). The objective of this study is to evaluate the schwannoma in the sinonasal tract and PPF including its effectiveness of endoscopic surgical excision of the lesion. Methods: This retrospective study was done between March 2018 and April 2022. There were nine cases of benign schwannomas found in the nasal cavity, the nasal ethmoid and the PPF. All patients had undergone endoscopic endonasal removal of the tumour. Results: All the patients successfully underwent endonasal endoscopic excision of the schwannoma from the sinonasal tract and PPF. Out of nine patients, one showed recurrence after 1 year during follow-up check-ups. None of the patients showed any major vascular complications during surgery. At follow-up, one patient presented with a persistent sensory deficit in the facial area. Conclusions: The endonasal endoscopic approach for schwannoma at the sinonasal tract and PPF is a safe and effective method for biopsy and treatment. This approach is highly effective for visualisation and has the potential to reduce complications. Pre-operative imaging is an important step before successful treatment by endoscopic endonasal removal of the schwannoma.

The comparative analysis of transradial and transfemoral vascular approaches for chemoembolization of pancreatic cancer

BACKGROUND: Pancreatic cancer is one of the most aggressive malignant neoplasms, and the results of treatment of which remain extremely unsatisfactory. One of the methods to increase the effectiveness of surgical treatment of pancreatic cancer is selective oil chemoembolization of the pancreatic arteries. Transfemoral access is typically used as a vascular access during this type of intervention, in which complications from the vascular access are often observed.&#x0D; AIM: This study aimed to analyze the results of the use of transradial and transfemoral approaches for chemoembolization of pancreatic cancer.&#x0D; MATERIALS AND METHODS: We analyzed the results of chemoembolization of pancreatic arteries in 32 patients with pancreatic cancer. Transfemoral access was used in 16 (50%) patients and transradial access in 16 (50%) patients. According to the main clinical and anamnestic data, both groups were comparable. The endpoints of the study were technical success and complication rate of chemoembolization, total duration of the procedure, time needed for catheterization of the target artery, radiation exposure, and degree of discomfort for the patient.&#x0D; RESULTS: Chemoembolization of pancreatic arteries was successfully performed in 100% of patients in both groups. Major vascular complications were observed in three (18.8%) patients in the transfemoral access group and in one (6.3%) in the transradial access group (p=0.6). The total duration of the procedure and the time needed for catheterization of the target artery were 54.546.61 and 51.306.46 min (p=0.17) and 12.7 and 13.25 min (p=0.72), respectively. Radiation exposure was 0.680.10 mSv in the transfemoral access group and 0.650.10 mSv in the transradial access group (р=0.4). Transradial access was associated with a statistically significant reduction in all parameters of procedural discomfort.&#x0D; CONCLUSION: In terms of efficiency and safety of use, the transradial approach is not inferior to the traditional transfemoral approach, and in terms of patient comfort, it can be recommended as a priority for chemoembolization of the pancreatic arteries.

A Meta-Analysis on the Impact of High BMI in Patients Undergoing Transcatheter Aortic Valve Replacement.

A paradoxical association of obesity with lower risk of transcatheter aortic valve replacement (TAVR) outcomes has been reported. We aimed to systematically review the literature and compare TAVR-related morbidity and mortality among individuals with overweight or obesity and their peers with normal body mass index (BMI). PubMed and Embase databases were systematically searched for studies reporting TAVR outcomes in different BMI groups. Separate meta-analyses were conducted for studies reporting hazard ratios (HR) and odds ratios/relative risks. Short- and mid-/long-term outcomes were examined. 26 studies with a total of 74,163 patients were included in our study. Overweight was associated with lower risk of short-term mortality (HR: 0.77; 95% CI: 0.60-0.98) and mid-/long-term mortality (HR: 0.79; 95% CI: 0.70-0.89). Obesity was associated with lower risk for mid-/long-term mortality (HR: 0.79; 95% CI: 0.73-0.86), but no difference was observed in short-term mortality, although a trend was noted (HR: 0.87l 95% CI: 0.74-1.01). Individuals with obesity demonstrated an association with higher odds of major vascular complications (OR: 1.33; 95% CI: 1.05-1.68). Both overweight (OR: 1.16; 95% CI: 1.03-1.30) and obesity (OR: 1.26; 95% CI: 1.06-1.50) were associated with higher likelihood for receiving permanent pacemakers after TAVR. Individuals with overweight and obesity were associated with lower mortality risk compared to those with normal BMI but with higher likelihood of major vascular complications and permanent pacemaker implantation after TAVR.

Abstract 14021: A Meta Analysis for Clinical Outcomes of Transcatheter Aortic Valve Replacement in Patients With Bicuspid versus Tricuspid Aortic Valves Using Balloon Expandable versus Self Expanding Valves

Introduction: Over the past decade, several next generation transcatheter aortic valve replacement (TAVR) devices have been developed with the aim of improving patients’ outcomes. Bicuspid aortic valves (BAVs) are an emerging issue in TAVR practice. The goal of this study was to compare clinical outcomes of TAVR using balloon-expandable (BE) versus self-expanding (SE) transcatheter heart valves in patients with BAV vs tricuspid aortic valve (TAV). Methods: We searched PubMed, Cochrane and Embase databases systematically for relevant studies from inception to March 2022. The primary focus was 1-year all-cause mortality. Additional outcomes included short term (30-days) all-cause mortality, cardiovascular mortality, stroke, major/life threatening bleeding, permanent pacemaker (PPM) implantation and major vascular complications. Results: There were 28 studies with a total 346,033 patients who underwent TAVR, 17,835 of which had BAV stenosis. In the BE group, there was a statistically lower risk of mortality of TAVR in the BAV when compared to the TAV (OR 0.69 [95% CI 0.49-0.97]; p=0.03). In terms of short-term outcomes of BE group, the risks of all-cause mortality, stroke, PPM implantation, major bleeding, and major vascular complications were all similar between the two arms. In the SE group, there were not statistically significant in the clinical outcomes between patients in BAV and TAV. Conclusions: The use of balloon-expandable valves in TAVR was associated with a lower risk of 1-year mortality in patients with BAV compared to patients with TAV. These data support the need for a randomized trial to compare the balloon-expandable valves in BAV patients.

Abstract 13412: Updated Meta-Analysis on Safety and Efficacy of Cerebral Embolic Protection Devices Among Patients Undergoing Transcatheter Aortic Valve Replacement

Introduction: Cerebral embolic protection devices (CEP) have been introduced to capture embolic debris and reduce the risk of stroke during Transcatheter Aortic Valve Replacement (TAVR). Available evidence regarding the safety and efficacy of CEP is inconclusive. Therefore, we aimed to determine the safety and efficacy of CEP use during TAVR. Methods: Major electronic databases were searched for the relevant articles with appropriate search terms. All relevant data from 17 studies were extracted into a standardized form. Statistical analyses were performed using Revman 5.4. Odds Ratio (OR) or mean differences (MD) were used to estimate the desired outcome with a 95% confidence interval (CI). Results: A total of 17 studies involving 204,875 patients (15,880 in the CEP arm and 188,995 in the non-CEP arm) were included. No significant difference in 30-day stroke was observed with the use of CEP between the two groups (OR 0.75, 95% CI 0.55 to 1.03). The use of CEP was associated with a lower odds of 30-day mortality by 39% (OR 0.61, 95% CI 0.53 to 0.70). Based on diffusion weighted-magnetic resonance imaging (DW-MRI), there were no differences in the occurrence of new lesions, the total volume of lesions, and the number of new lesions. In addition, the use of CEP in patients undergoing TAVR was associated with a reduction in major or life-threatening bleeding events (OR 0.89, 95% CI 0.81 to 0.98). No differences were observed in the outcomes of acute kidney injury and major vascular complications between both arms. Conclusion: No significant difference in 30-day stroke was observed with the use of CEP in TAVR patients. The use of CEP was associated with significantly lower odds of 30-day mortality and lower rates of major or life-threatening bleeding compared with no CEP in patients undergoing TAVR. Further studies are needed to confirm current findings

Abstract 12852: Transcatheter Aortic Valve Replacement for Aortic Stenosis in Small Aortic Annulus: Medium-Term Follow-Up

Introduction: Small aortic annulus (SAA) is a clinical challenge in managing aortic stenosis (AS). The SAA has been associated with poorer outcomes after surgical AVR with an increased risk of perioperative and overall mortality, suboptimal valvular hemodynamics, and adverse cardiovascular events. Hypothesis: TAVI could be a therapeutic alternative in these patients. Methods: We performed a retrospective analysis of all patients with AS treated with TAVI from 2015 to 2021 in our center, with SAA defined as the aortic annulus of ≤22mm perimeter-derived diameter (PDD), measured by CT. Results: Sixty-eight patients were included (85.3% women, 83.2± 6.5 years) with a mean PDD of 20.7 ± 1.1 mm. The 14.7% had LVEF &lt;50% and 1.4% had bicuspid aortic valve. The Access route was transfemoral in 64 patients (94.2%) and 4 transapical (5.8%). Self-expanding prostheses were used in 78% of the cases, balloon-expandable prostheses in 17.6%, and mechanically-expandable prostheses in 4.4%. The size of the aortic prostheses was 23mm in 82.3% and &gt;23mm in 17.7%. The perioperative implant success rate was 100% defined as single prosthesis implantation with a mean gradient &lt;20mmhg and angiographic paravalvular leak &lt;2. The rate of new permanent pacemaker implantation was 13.2%. The in-hospital complications rate was 5.8% (4 patients): major vascular complication in 1 patient (1.4%), acute kidney injury stage ≥2 in 1 (1.4%), disabling stroke in 2 (2.9%). There were no deaths in the first 30 days of the procedure. At discharge, the TTE máximum gradient was 19.8 ± 9.2mmhg, the mean gradient 9 ± 4.8mmhg, and 4 patients had paravalvular leak grade ≥2 (5.9%). During a mean follow-up of 27.8 ±7.6 months, 45 patients were in NYHA functional class I (66.2%), 19 in NYHA 11 (27.9%), and 3 in NYHA III (4.4%). Eight patients (11.7%) were readmitted due to heart failure, 10 died (14.7%) due to all-cause mortality, and only 3 of them died due to cardiovascular causes (4.4%). Conclusions: Although the optimal approach for treating patients with AS and SAA remains controversial. TAVI is a very attractive option in these patients, allowing the implantation of prostheses with excellent immediate hemodynamic results, a low rate of complications, and significant clinical improvement in the follow-up.

Abstract 9599: Impact of Sex on Outcomes After WATCHMAN FLX Implantation

Introduction: Female sex is an established, non-modifiable risk factor for adverse outcomes in atrial fibrillation (AF) patients. Left atrial appendage occlusion (LAAO) has been shown to be generally safe and effective for stroke prevention in patients with AF. Data on sex-based outcomes with WATCHMAN FLX is lacking. Methods: WATCHMAN FLX patients from the National Cardiovascular Data Registry LAAO Registry between August 5th 2020 and March 31st 2021 were analyzed. Results: Women at baseline had a higher average CHA 2 DS 2 -VASc score, were more likely to have a history of transient ischemic attack, thromboembolic event, peripheral or carotid artery disease, fall risk, and chronic lung disease than men. Conversely, history of congestive heart failure, left ventricular dysfunction, hypertension, diabetes, vascular disease, abnormal renal function, cardiomyopathy, non-paroxysmal atrial fibrillation, myocardial infarction, prior cardiac interventions, alcohol use, antiplatelet medication use and non-steroidal anti-inflammatory drug use were all reduced in women compared to men. The early safety endpoint was similar between women and men ( Table ). At 45 days, unadjusted rates of major adverse events were higher in women than men mainly due to differences in major bleeding and pericardial effusion ( Table ). The risk of death was lower in women than men at 45 days. Rates of stroke, major vascular complications, systemic thromboembolism, myocardial infarction, and device-related thrombus were not significantly different between sexes. Adjusted outcomes will be available at the time of the presentation. Conclusions: In this national unselected cohort, there are significant sex-based differences in baseline characteristics and comorbidity burden. Women experienced more major adverse events after LAAO than men. Additional research to determine the underlying mechanisms of the increased risk in women and strategies for closing the gap between sexes are needed.