Access Site Complications Research Articles

Embolic Protection with the TriGuard 3 System in Nonagenarian Patients Undergoing Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis.

Background: Transcatheter aortic valve replacement (TAVR) improves the survival and life quality of nonagenarian patients with aortic stenosis. Stroke remains one of the most worrisome complications following TAVR. Cerebral embolic protection devices (CEPDs) may reduce neurological complications after TAVR. This study evaluated the safety and efficacy of CEPDs during TAVR in nonagenarian patients. Methods: Between January 2018 and October 2021, 869 patients underwent transfemoral TAVR (TF-TAVR) at our center. Of these, 51 (5.9%) patients were older than ninety years. In 33 consecutive nonagenarian patients, TF-TAVR was implanted without CEPDs using balloon-expandable valves (BEVs) and self-expandable valves (SEVs). Eighteen consecutive nonagenarians underwent TF-TAVR using a CEPD (CP group). Follow up period was in-hospital or 30 days after the procedure, respectively. Results: Minor access site complications occurred in two patients (3.9%) and were not CEPD-associated. Postinterventional delirium occurred in nine patients (17.6%). Periprocedural minor non-disabling stroke and delirium occurred in ten patients (19.6%). Periprocedural major fatal stroke occurred in two patients in the BEV group (3.9%). Two patients in the BEV group died due to postinterventional pneumonia with sepsis. The mortality rate was 7.8%. The results did not differ between the groups. Conclusions: Age alone is no longer a contraindication for TAVR. CEPD using the Triguard 3 system in nonagenarian TAVR patients was feasible and safe and did not increase access site complications.

Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial.

The aim of this study was to compare transradial access (TRA) with transfemoral access (TFA) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). TRA reduces the risk for vascular access complications but may make complex PCI, such as CTO PCI, more challenging. FORT CTO (Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion) (NCT03265769) was a prospective, noninferiority, randomized controlled study of TRA vs TFA for CTO PCI. The primary study endpoint was procedural success, defined as technical success without any in-hospital major adverse cardiovascular events. The secondary study endpoint was major access-site complications. Between 2017 and 2021, 610 of 800 patients referred for CTO PCI at 4 centers were randomized to TRA (n=305) or TFA (n=305). Mean J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 0.1 vs 2.2 ± 0.1; P=0.279), PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (1.3 ± 0.9 vs 1.1± 1.0; P=0.058) and PROGRESS CTO complication (2.4 ± 1.8 vs 2.3 ± 1.8; P=0.561) scores and use of the retrograde approach (11% vs 14%; P=0.342) were similar in the TRA and TFA groups. TRA was noninferior to TFAfor procedural success (84% vs 86%; P=0.563) but had fewer access-site complications (2.0% vs 5.6%; P=0.019). There was no difference between TFA and TRA in procedural duration, contrast volume, or radiation dose. TRA was noninferior to TFA for CTO PCI but had fewer access-site complications.

Vascular access complications in patients undergoing veno-arterial ecmo and their impact on survival in patients with refractory cardiogenic shock: A retrospective 8-year study.

Introduction:Veno-arterial extracorporeal membrane oxygenation (ECMO) is well-recognized treatment modality for patients with refractory cardiogenic shock. Uncomplicated cannulation is a prerequisite and basis for achieving a successful outcome in ECMO. Vascular access is obtained either by surgical cut-down. Common vascular access complications are bleeding and limb ischemia.Objective:To evaluate cannulation technique, the incidence of vascular complications, and their impact on the outcome.Methods:A retrospective data analysis conducted on 95 patients receiving ECMO from 2013 to 2020 was done. The patients were divided into two groups: no vascular access complications (non-VAC group) and vascular access complications (VAC group). The groups were compared related to the hospital and ICU stays and blood transfusion.Results:The patients in both groups were demographically and clinically comparable. The Non-VAC group had 75 patients, whereas the VAC group had a total of 20 patients. The main complication observed in the VAC group was bleeding from the cannulation site which required more blood transfusion than the non-VAC group (6.8 ± 1.02 vs 4.2 ± 1.26). Limb ischemia was another complication seen in the VAC group (4.2%, n = 4). Two patients had delayed bleeding after decannulation. The overall average length of stay in the hospital was statistically similar in both the groups (22 days in the VAC group vs 18 days in the non-VAC group), but the average ICU stay was more in the VAC group compared to the non-VAC group (18 days vs 12.06 days).Conclusion:Bleeding and limb ischemia are the important vascular access site complications, which increase blood transfusion requirements, ICU stay, and overall hospital stay.

Percutaneous proximal axillary artery versus femoral artery access for endovascular interventions

ObjectiveThe primary objective of this study is to describe and illustrate the technique of ultrasound-guided percutaneous proximal axillary artery (PAA) access, and secondarily to evaluate the versatility and safety of this approach in peripheral, visceral, and aortic endovascular interventions. MethodsThis is a single-center retrospective review of all peripheral, visceral, and aortic endovascular cases using percutaneous PAA access from February 2019 to March 2021 compared with a sample of an equivalent number of consecutive cases completed via percutaneous common femoral artery (CFA) access during the same time period. Access entry success, minor and major access site complications within 30 days, major adverse events within 30 days, demographics, and procedural details were analyzed using standard statistical analyses. ResultsA total of 115 accesses—59 PAA and 56 CFA—were reviewed during the study period. Group demographics were not significantly different. Access entry success was achieved in 58 (98.3%) and 56 (100%) of PAA and CFA accesses, respectively, with no statistically significant difference. There were no significant differences in minor access-site complications (13.6% vs 5.4%; P = .21) major access site complications (3.4% vs 7.1%; P = .43), or major adverse events (6.8% vs 5.4%). between the PAA and CFA groups. With respect to versatility, PAA cases had a significantly greater mean number of vessels intervened on per procedure compared with CFA access (2.59 ± 1.31 vs 1.95 ± 0.98; P < .01). A wide range of target vessels were intervened on in both groups. PAA cases had significantly more bilateral lower leg interventions (28.8% vs 12.5%; P = .04). PAA access had a significantly longer mean procedure time (103.2 minutes vs 58.63 minutes; P < .001) and fluoroscopy time (18.21 minutes vs 12.87 minutes; P = .02). ConclusionsThe PAA is a feasible, versatile, and safe percutaneous access option for endovascular intervention. The in-line trajectory from this site facilitates visceral, renal, aortic, and bilateral lower extremity interventions with ease. Outcomes, complications, and major adverse events are similar to those of conventional CFA access in the short term.

Short-Term Postoperative Use of Rivaroxaban to Prevent Radial Artery Occlusion After Transradial Coronary Procedure: The RESTORE Randomized Trial.

Adequate procedural anticoagulation is crucial for radial artery occlusion (RAO) prevention in patients undergoing transradial access coronary catheterization, although the effect of postprocedural anticoagulation lack thorough investigation. The aim of this study was to evaluate the clinical value of short-term postoperative anticoagulation with rivaroxaban for 24 hours and 1-month RAO prevention in patients who received transradial coronary procedures. A total of 382 patients were randomized to receive either placebo (control group) or rivaroxaban 10 mg once daily for a period of 7 days (rivaroxaban group) to evaluate the effect of the rivaroxaban in the prevention of 24 hours and 1-month RAO assessed by Doppler ultrasound. There was no significant difference in the incidence of 24-hour RAO (8.9% versus 11.5%; P=0.398) between the rivaroxaban group and control group (odds ratio, 0.75 [95% CI, 0.39-1.46]; P=0.399). In contrast, the 1-month RAO (3.8% versus 11.5%; P=0.011) was significantly reduced in patients who received rivaroxaban as compared with those who did placebo (odds ratio, 0.22 [95% CI, 0.08-0.65]; P=0.006). For patients with 24-hour RAO, the rivaroxaban group was associated with higher recanalization rate of the radial artery (69.2% versus 30.0%; P=0.027) compared with the control group. No significant differences can be observed between the 2 groups for access-site complications or bleeding events. Short-term postoperative anticoagulation with rivaroxaban did not reduce the rate of 24-hour RAO but improved 1-month RAO, because of higher recanalization of the radial artery. However, larger clinical trials are needed to prove our results. URL: https://www.chictr.org.cn; Unique identifier: ChiCTR1900026974.

Rotational atherectomy via the transradial access: success rates, procedural parameters and complications

Radial access is recommended for percutaneous coronary intervention (PCI), but rotational atherectomy remains frequently performed via femoral access. Analyzing the procedural parameters, success rate and complications of rotational atherectomy, performed via radial in comparison to femoral access. We retrospectively analyzed 427 consecutive patients undergoing rotational atherectomy. Procedural parameters and outcome were determined in 171 patients, scheduled for radial and compared to 256 patients with femoral access use. In the radial access group (74 ± 9 years, 84% male), the LAD was most frequently treated (49%). Sheath size was 7F in 59% and 6F in 41%, burr size was 1.5 mm in 46% and 1.25 mm in 14% of patients. A temporary pacemaker was inserted in 14%. Procedural success rate stood at 97%. Access site complications occurred in 4% of patients, which was significantly less frequent than in in 256 patients treated via femoral access (13% p = 0.003). Compared to radial access, femoral access was associated with the use of larger sheaths (p < 0.001), more frequent treatment of non-LAD vessels (58.2% vs. 44.4%, p = 0.013) and a higher rate of temporary pacemaker use (27%; p = 0.001). No differences could be seen in procedural success (p = 0.83) and burr size (p = 0.51). Femoral access (OR 3.33; 95% CI 1.40–7.93), and female sex (OR3.40 95% CI 1.69–6.63) were independent predictors for access site complications. For coronary rotational atherectomy, radial access has a high success rate with overall use of smaller sheaths, but of equally sized burrs as well as a significant lower rate of access site-related complications than femoral access.

Iliofemoral Tortuosity Increases the Risk of Access-Site-Related Complications After Aortic Valve Implantation and Plug-Based Access-Site Closure

BackgroundAccess-site-related complications are often related to high-risk anatomy and technical pitfalls and impair the outcomes of transfemoral aortic valve implantations (TAVIs). Calcification and tortuosity are widely recognized risk factors, and their impact on procedural planning is left to the implanting experts’ discretion. To facilitate decision-making, we introduced a quantitative measure for iliofemoral tortuosity and assessed its predictive value for access-site-related vascular and bleeding complications. MethodsWe performed a single-centre prospective cohort study of consecutive, percutaneous transfemoral TAVI performed between April 2019 and March 2020. Medical history and all-cause mortality were extracted from the electronic patient files. Arterial anatomy and calcifications were evaluated using 3mensio Structural Heart software. The primary outcome was access-site-related vascular or bleeding complications. ResultsIn this elderly, intermediate-risk population, we registered the primary outcome in 43 patients (39%), and major access-site complications in 10 patients (9.2%). Complete hemostasis was achieved in 77 patients (70.6%), by the application of the MANTA plug alone. In the group with access-site-related adverse events, compared with the group without, the tortuosity index was higher median (26% interquartile range [IQR 18%-33%] vs median 19% [IQR 13%-29%], respectively; P = 0.012), as was maximal angulation median (50° [IQR 40°-59°] vs median 43° [IQR 36°-51°], respectively; P = 0.026) were higher. Both variables had a significant effect on our primary outcome, with odds ratios (OR) of 3.1 (tortuosity, P = 0.005) and 2.6 (angulation, P = 0.020). The degree of angulation was a predictor of major complications too (odds ratio 7 [1.4-34.8]; P = 0.017). ConclusionsSteeper angles and greater arterial elongation increase the risk of vascular and bleeding complications after femoral TAVI with the utilization of a plug-based closure device.

Perceived importance of silent cerebral ischemia following endovascular procedures

PurposeThe clinical significance of iatrogenic diffusion-weighted imaging lesions following endovascular procedures is currently not well understood, partly because they do not result in immediate clinical deficits (“silent brain infarcts” [SBI]) and often remain undiagnosed. Conversely, access site complications are well-documented. With the SILENT survey, we sought to gain an understanding of physicians' opinions regarding the relative importance of SBI compared to the more commonly discussed access site complications. MethodsSeven scenarios of access site complications of varying severity were provided. Within each scenario, participants were asked whether they would choose the access site complication or an increasing number of periprocedural SBI. Logistic regression clustered by respondent was performed to assess participant and scenario factors associated with preferential choice of SBI versus access site complications. Results67 participants (13 women; 19.4%) provided 469 responses to the survey. The majority (45; 67.2%) were neurointerventionalists. Regardless of scenario, any number of SBI was deemed unacceptable in 42.4% of cases, whereas 10.5% of physicians would accept >15 SBI to avoid any access site complications. Significant group differences for career stage (p=0.001) and specialty (p=0.007) for the number of tolerated SBI were observed. Regression analyses revealed that only hematoma severity was significantly associated with the willingness to accept an increasing number of SBI. ConclusionIn this survey, 4/10 physicians would accept even severe access site complications to avoid any SBI. The perceived importance of SBI among experienced physicians, and the uncertainty regarding their long-term sequelae, support their systematic assessment and reporting.

Radial Artery Access for Acute Coronary Syndromes: a Review of Current Evidence.

To review the evidence supporting the use of transradial access (TRA) for percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS). There have been five major randomized controlled trials (RCTs) and two recent meta-analyses comparing outcomes of TRA and femoral access (FA) in ACS. Additional studies have explored the impact of TRA on STEMI door-to-balloon (D2B) times, TRA in high-risk ACS patients, the potential conflict between TRA and coronary artery bypass graft (CABG) surgery employing the radial artery, and distal radial artery (DRA) access. TRA is associated with a reduction in net adverse clinical events, major bleeding, acute renal injury, and access site complications compared to FA in ACS patients undergoing PCI. TRA is not associated with significant delays in STEMI D2B times that impact patient outcomes. Further studies are needed to evaluate the role of TRA in high-risk ACS patients, the interplay between TRA and radial artery CABG, and use of DRA in ACS.

The association of transradial access and transfemoral access with procedural outcomes in acute ischemic stroke patients receiving endovascular thrombectomy: A meta-analysis

ObjectiveThere is an ongoing debate regarding the benefits of using transradial access (TRA) over transfemoral access (TFA) in endovascular therapies including endovascular thrombectomy (EVT) for acute ischemic stroke (AIS) patients. This study sought to investigate the association of TRA and TFA with procedural success, access-site complications, first-pass reperfusion (FPR), puncture-to-recanalisation (PTR) time and hemorrhagic transformation (HT) by performing a meta-analysis. Materials and methodsPubMed, EMBASE and Scopus were searched. Studies with patients aged ≥ 18 years and head-to-head TRA vs TFA comparisons were included. Random-effects modeling was performed to obtain summary effects and forest plots were plotted to study the association of TFA with access site complications, FPR, HT, PTR time and procedural success. ResultsSix studies encompassing 945 patients (347 TRA and 598 TFA) were included in the meta-analysis. Meta-analysis revealed that in AIS patients receiving EVT, TRA was significantly associated with a decreased risk of access-site complications (RR 0.17, 95% CI 0.05 0.54; p = 0.003, z = −2.957) and HT (RR 0.07, 95% CI 0.02 0.27; p < 0.0001, z = −3.8841). However, TRA was not significantly associated with procedural success (RR 0.96, 95% CI 0.90 1.01; p = 0.141, z = −1.473), FPR (RR 0.91, 95% CI 0.79 1.05; p = 0.194, z = −1.299) and PTR time (SMD −0.14, 95% CI −0.42 −0.14; p = 0.323, z = −0.989). ConclusionOur meta-analysis demonstrated that TRA is a safe alternative to TFA, in AIS patients receiving EVT, with significantly decreased access-site complications and HT with TRA, albeit with comparable procedural success, FPR and PTR time to TFA. Data availability statementThe original contributions presented in the study are included in the article/Supplementary information, further inquiries can be directed to the corresponding author.

Transbrachial Secondary Vascular Access in Transcatheter Aortic Valve Replacement Procedures: A Single-Centre Retrospective Analysis

Transfemoral transcatheter aortic valve replacement (TAVR) procedures require secondary vascular access for inserting accessory catheters and performing percutaneous repair of femoral artery injury. Use of the transbrachial approach for secondary vascular access in TAVR procedures has not been reported. This study identified 48 patients at the current institution who had undergone transfemoral TAVR utilising transbrachial secondary vascular access. Efficacy and safety of this strategy for achieving a successful totally percutaneous procedure were examined. Study endpoints were occurrence of vascular complications and bleeding related to transbrachial access, as well as periprocedural and 1-year mortality. Mean patient age was 80±7 years and Society of Thoracic Surgeons Predicted Risk of Mortality score was 10.6±3.1. Sizes of sheaths inserted into the brachial artery were 6 Fr (85%), 8 Fr (2%), and 9 Fr (13%). Transbrachial access was used for delivering stent grafts to the femoral artery in 13% of the patients, inflation of an occlusive balloon within the iliac artery in 10%, and treatment of iatrogenic femoral artery stenosis in 2%. Successful valve replacement was achieved in all cases. Brachial sheaths were removed by manual compression following administration of protamine sulfate. There were no major access site complications or VARC-3 type ≥2 bleeding related to the brachial vascular access. Brachial artery occlusion occurred in two patients (4%) who underwent surgical vascular repair. Two (2) additional patients developed mild arm ischaemia, which was treated conservatively. Periprocedural mortality was 0% and early mortality was 8%. Transbrachial secondary access in TAVR procedures was feasible and enabled percutaneous vascular repair in cases of femoral artery injury.

Treatment and Management of Upper Extremity Dysfunction Following Transradial Percutaneous Coronary Intervention: A Prospective Cohort Study.

The transradial artery access is the benchmark approach in transradial percutaneous coronary intervention (TR-PCI). The purpose of this study was to evaluate the different complications, treatments, and outcome of upper extremity dysfunction following a TR-PCI. This was a prospective cohort substudy of patients with access-site complications. The study population consisted of 433 patients treated with TR-PCI. Referral to the hand center was mandated if the patient experienced new-onset or increase of preexistent symptoms in the upper extremity. Patients were followed up to the last control visit (5-7 months after the index procedure) at the hand center. Outcome results were categorized in "symptom-free," "improvement of symptoms," and "no improvement." Forty-one (9% of total) patients underwent assessment at the hand center. Most frequent referral indication was pain in the intervention arm. Women, preexisting sensibility disorder, and osteoarthritis in the intervention arm were associated with increased odds of referral. The most common complications diagnosed were carpal tunnel syndrome (n = 18) and osteoarthritis (n = 15). Thirty patients required further medical treatment. Immobilization therapy was most applied. Seventeen (4% of total) patients had persisting symptoms despite medical treatment. The occurrence of complications in the upper extremity after a TR-PCI is small. Despite medical treatment, symptoms persisted in 4% of all patients treated with TR-PCI. Possible explanations for the persisting symptoms are exacerbation of latent osteoarthritis and carpal tunnel syndrome by trauma-induced edema. Awareness of TR-PCI-induced complications among all specialists is essential to optimize patient care.

Four French sheath-based transradial cerebral angiographies in the elderly: A single neurointerventionalist's experience.

Catheter angiography via transradial access (TRA) is better at reducing access site complications and morbidity than via transfemoral access (TFA). The rate of periprocedural complications increases in elderly populations and using a smaller sheath can help reduce access site complications. The aim of this study was to assess the feasibility and safety of 4 F sheath-based TRA cerebral angiography in elderly patients (≥65 years) and compare it to TFA cerebral angiography. The medical records of elderly patients undergoing diagnostic cerebral angiography with a single neurointerventionalist via TRA (57 cases, from July 2019 to December 2020) versus TFA (69 cases, from January 2018 to June 2019) were retrospectively reviewed. All TRA angiographies were performed via right radial artery access with a 4 F sheath and a 4 F Simmons 2 catheter. There were no significant differences (TRA vs. TFA) in age (71.1 ± 4.0 vs. 72.1 ± 4.6 years, p = 0.189), accessed vessels (3.9 ± 0.5 vs. 3.9 ± 0.6, p = 0.852), fluoroscopy time (7.1 ± 3.3 vs. 7.6 ± 3.5 min, p = 0.068), and radiation exposure (42.1 ± 15.8 vs. 47.0 ± 13.7 Gy-cm2, p = 0.067). However, the procedure duration was significantly shorter in the TRA group (17.2 ± 3.9 vs. 19.0 ± 6.0 min, p = 0.003). Painful groin hematoma occurred in 2 of the 69 cases (2.9%) in the TFA group. In the TRA group, access site complications were not occurred; however, catheter kinks occurred in 2 of 57 cases (3.5%). The 4 F sheath-based TRA is a feasible option for diagnostic cerebral angiography in elderly patients. However, care should be taken during catheter manipulation.

Antegrade Access for Peripheral Vascular Disease Intervention of the Lower Limb – Our Experience at a Tertiary Center

Purpose: Antegrade superficial femoral artery (SFA) access for peripheral artery disease reduces the time, radiation, and contrast required as compared with contralateral common femoral access (CFA). However, this technique remains underutilized and understudied in the treatment of SFA, popliteal and tibial disease, and there remains limited data on the safety and efficacy of antegrade SFA access. Materials and Methods: An observational review of lower extremity peripheral arterial interventions was conducted from January 2014 to July 2021. Interventions necessitating CFA access such as iliac, common femoral, or deep femoral artery revascularization were excluded. In addition, interventions potentially requiring large sheaths were excluded. Relevant demographic and treatment variables including postoperative complications were abstracted. Results: We identified 482 patients, who underwent revascularization of the SFA, popliteal and tibial arteries. Antegrade SFA access was chosen in all these patients. Access was attained either through ultrasound or fluoroscopy guidance in 94.6% of patients. The overall rate of complications was low (access site complications, hematoma, pseudoaneurysm, etc.). Conclusions: Percutaneous antegrade SFA access can be performed safely and remains an effective alternative to retrograde CFA access with significantly less complications and is also associated with lesser utilization of fluoroscopy and contrast.

Should coronary catheter laboratories be used in the treatment of ischemic stroke? Endovascular treatment in acute ischemic stroke performed by interventional cardiologists.

The aim of this study was to investigate the technical success and in-hospital outcomes of endovascular thrombectomy (ET) in acute ischemic stroke (AIS) patients performed by interventional cardiologists. ET for AIS provides fast, effective and safe recanalization. Insufficient number of catheter laboratories for stroke interventions and experienced interventional neurologists are limiting the widespread application of such a promising treatment method. 123 patients with AIS and eligible for ET were evaluated retrospectively. 65 patients were female (52.8%) and the mean age of the patients was 71.5 ± 11.9 years. Most of the patients had a middle cerebral artery (MCA) occlusion (112 patients, 91%). Successful recanalization (thrombolysis in cerebral infarction grading 2b or higher) was achieved in 109 patients (88.6%). Access site complication was observed only in 3 patients (2.4%). Intracranial bleeding was observed in 17 patients (13.8%) and only 8 of them were symptomatic (6.5%). In-hospital death occurred in 19 patients (15.4%). The initial National Institutes of Health Stroke Scale (NIHSS) was 16.8±3.3 (median 18) which improved significantly to 10.4±7.2 (median 11) at 24 hours (p<0.001). Dramatic neurologic improvement was observed in 60 of 123 patients (48.8%). The modified rankin score of the patients was significantly lower at discharge compared to admission (4.2±0.7 vs. 2.9±2, p<0.001). ET in AIS can be performed safely with high success rates by trained interventional cardiologists within the stroke team. Until the number of stroke centers is sufficient, endovascular treatment of AIS can be supported by experienced interventional cardiologists.

Transfemoral Tricuspid Valve Replacement in Patients With TricuspidRegurgitation: TRISCEND Study 30-Day Results.

The TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) is evaluating the safety and performance of transfemoral transcatheter tricuspid valve replacement in patients with clinically significant tricuspid regurgitation (TR) and elevated surgical risk. Transcatheter valve replacement could lead to a paradigm shift in treating TR and improving patient quality of life. In the prospective, single-arm, multicenter TRISCEND study, patients with symptomatic moderate or greater TR, despite medical therapy, underwent percutaneous transcatheter tricuspid valve replacement with the EVOQUE system. A composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures were assessed at 30days. Fifty-six patients (mean age of 79.3 years, 76.8% female, 91.1% TR severe or greater, 91.1% atrial fibrillation, and 87.5% New York Heart Association functional class III or IV) were treated. At 30days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 26.8% at 30days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association significantly improved to functional class I or II (78.8%; P< 0.001), 6-minute walk distance improved 49.8m (P< 0.001), and Kansas City Cardiomyopathy Questionnaire score improved 19 points (P< 0.001). Early experience with the transfemoral EVOQUE system in patients with clinically significant TR demonstrated technical feasibility, acceptable safety, TR reduction, and symptomatic improvement at 30days. The TRISCEND II randomized trial (NCT04482062) is underway.

Percutaneous arteriovenous fistula creation with the 4F WavelinQ EndoAVF System

Background Percutaneous devices for creation of native arteriovenous fistulae offer an alternative to traditional open surgical techniques. The 4F WavelinQ EndoAVF System was developed as a lower profile alternative to facilitate access through smaller vessels and minimize access site complications; The current report is the original first experience of this device, assessing outcome in 120 patients followed for 6 months.

Real-World Experience With a Large Bore Vascular Closure Device During TAVI Procedure: Features and Predictors of Access-Site Vascular Complications.

BackgroundsAmong vascular closure devices (VCDs), the novel collagen plug-based MANTA VCD is the first designed for large bore percutaneous access. We aimed to assess the features and predictors of access-site vascular complications in an unselected trans-femoral transcatheter aortic valve replacement (TF-TAVR) population.MethodsPatients undergoing large bore arteriotomy closure with 18F MANTA VCD following TF-TAVR at a large tertiary care center from September 2019 to January 2021 were prospectively analyzed. Primary Outcome was the MANTA VCD access-site-related complications according to Valve Academic Research Consortium-3 (VARC) definitions. Its incidence and predictors were evaluated.ResultsEighty-eight patients (median age 82 years, 48% male, 3.3 median Society of Thoracic Surgeons score) undergoing TF-TAVR were included, mostly (63%) treated with a self-expandable device and with outer diameter sizes varied from 18F to 24-F. MANTA VCD technical success rate was 98%, while 10 patients (11%) experienced MANTA VCD access-site vascular complications which included 8% of minor complications and only to 2% of major events resulting in VARC type ≥2 bleeding. Vessel occlusion/stenosis (60%), perforation (20%), and pseudoaneurysm/dissection/hematoma (20%) occurred, but all were managed without surgical treatment. Independent predictors of failure were age (p = 0.04), minimum common femoral artery diameter (CFA) (p < 0.01), sheath-to-femoral-artery ratio (SFAR) (p < 0.01), and a lower puncture height (p = 0.03). A CFA diameter <7.1 mm with a SFAR threshold of 1.01 were associated with VCD failure.ConclusionsIn a more comers TF-TAVR population, MANTA VCD was associated with reassuring rates of technical success and major access-site vascular complications. Avoiding lower vessel size and less puncture site distance to CFA bifurcation might further improve outcomes.

Transcatheter aortic valve replacement – 10 years experience at Gottsegen György National Cardiovascular Center in Hungary

Transcatheter aortic valve implantation (TAVI) is an alternative treatment to surgical aortic valve replacement for elderly, high surgical risk patients. The aim of this study was to evaluate the short- and long-term outcomes of those 463 patients who underwent TAVI during the first 10 years in our TAVI program. We compare the first 200 patients' results with the further 263 patients' results. Between 11th November 2008 and 31st December 2018, 463 patients underwent TAVI. The average age of the patients was 79.6 years, the average logistic EuroSCORE was 19.0%, the average STS score was 5.2%. 72% of the patients were in NYHA III or IV stage before TAVI. 92% of TAVIs were performed from femoral arteries. Average mean gradient was 50.0 mmHg and aortic valve area was 0.55 cm2, respectively. In 2% of the cases, "valve-in-valve" intervention was performed because of the restenosis of former aortic valve prosthesis. 30-day mortality was 5.2% and the 1-year mortality was 16.4% after TAVI. Post-TAVI complications were evaluated according to the VARC-2 definitions. Major stroke occurred in 2.2% after TAVI. The most common complication was pacemaker implantation (19.9%), but their incidence was significantly reduced between the 2 groups (26.5% vs. 14.8% [p = 0.002]). The incidence of vascular access site complications was significantly higher between the 2 groups (10% vs. 20.2% [p = 0.016]), but it did not affect the mortality. Based on our results, TAVI is a safe alternative treatment for patients with severe, symptomatic aortic stenosis in our institute as well. Orv Hetil. 2022; 163(6): 229-235.

Abstract WMP25: Incidence Of Access Site Complications In Patients Receiving Tenecteplase As Bridging Therapy To Endovascular Treatment

Introduction: Mechanical thrombectomy (EVT) is the standard of endovascular care for acute ischemic stroke secondary to large vessel occlusion. Alteplase in conjunction with EVT has a strong safety profile with low incidence of complications including groin hematoma. Our objective was to evaluate the incidence of groin hematoma in EVT following bridging therapy tenecteplase (TNK) as this is not well-described in the literature. Methods: Retrospective review of prospectively collected data for patients with acute ischemic stroke who underwent mechanical thrombectomy at a University Hospital. Incidence of access site complication including groin hematoma, retroperitoneal hematoma, blood loss and femoral artery pseudoaneurysm with or without the need for surgical intervention were reviewed. Rates of use of other antithrombotic agents were also noted. Social Science Statistics was used for data analysis. Results: From October of 2020 to April of 2021, of 348 ischemic stroke patients, 16 had LVO identified on CT and received TNK prior to mechanical thrombectomy (Females = 6; age, 63.25 95% CI [54.9207, 71.5793]); Mean weight =78kg, 95% CI [67.68, 88.32]). Five subjects (31.25%) received intra-arterial non-thrombolytics. None received intra-arterial thrombolytics. Three patients (18.75%) received therapeutic heparin during the procedure. Four patients (25%) were started on non-thrombolytic infusion during the periprocedural period. One subject (6.25%) was started on stroke nomogram heparin infusion less than 24 hours post-intervention. One subject (6.25%) developed groin hematoma that did not require intervention. This subject received intra-arterial non-thrombolytics during procedure and IV non-thrombolytics during the peri-procedural period. Conclusion: Our single center experience with TNK outside of the clinical trial setting with concomitant use of other antithrombotics suggests safety of bridging strategy. Larger prospective ‘real-life’ studies are required to validate our findings.