Access Site Hematoma Research Articles

Comparison of radial artery occlusion between traditional radial access and distal radial access for coronary angiography and intervention: A prospective cohort study

BackgroundThe radial approach is now recommended as the default strategy in diagnostic coronary angiography and percutaneous coronary intervention. Radial artery occlusion (RAO) is the most common complication that limits subsequent angiographic procedures through this access. Recently, distal radial access (DRA) has been recommended as an alternative access site. Despite lower RAO rates in DRA in some recent clinical trials, concerns remain regarding possible complications and limitations due to the small size of the distal radial artery. ObjectiveThe present study aimed to compare traditional radial access (TRA) and DRA concerning RAO in percutaneous coronary procedures. MethodsIn the present prospective cohort study, percutaneous coronary procedures were performed via DRA or TRA in 2 study groups. All consecutive participants underwent DRA from September 2021 to March 2022 and TRA from April 2022 to June 2022. Ultrasonography was performed preprocedurally in the DRA group, and patients with small distal artery diameters (<2 mm) were excluded. The same 6-Fr sheaths and standard air-filled compression devices were used in both groups. The primary endpoint was RAO in ultrasound sonography on the first postprocedural day, and the secondary endpoints were the success rate, access time, angiography time, radial artery spasms, and vascular access complications. ResultsA total of 298 patients were assigned to the DRA group and 278 to the TRA group. The RAO rate was significantly higher in the TRA group than in the DRA group (10.1 % vs 0.9 %; P = 0.0001; OR, 0.08, 95 % CI, 0.01–0.27). The success rate was significantly higher in the TRA group (96 % vs 90.2 %; P = 0.009). Access crossovers were done on 12 patients (4.0 %) in the TRA group and 24 patients (9.8 %) in the DRA group (P < 0.001). The mean access time was significantly lower in the TRA group than in the DRA group (1.9 min vs 2.9 min; P < 0.001). The mean angiography time did not significantly differ between the groups (10.2 min in the TRA group vs 9.9 min in the DRA group). The rate of radial artery spasms was not significantly different between the 2 groups (13.8 % in the TRA group vs 14.5 % in the DRA group). The rates of access site hematoma (12.4 % vs 2.3 %; P < 0.001) and bleeding (10.7 % vs 4.1; P = 0.005) were significantly higher in the TRA group. ConclusionsDRA was safe and feasible with lower rates of RAO and access site complications than TRA. Thus, it could be used as an alternative approach in percutaneous coronary procedures. However, the trade-off for these advantages of DRA is an increase in cross-over rate, and a decrease in puncture success rate.

Suture closure AFtEr large bore vein access (SAFE-VEIN): A randomized, prospective study of the efficacy and safety of venous closure device.

Perclose ProGlide (PPG) Suture-Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). In this physician-initiated, randomized, single-center study [clinicaltrials.gov ID: NCT04632641], single-stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular-related complications and mortality. Wilcoxon rank-sum test was used to compare TTH, TTA, and TTD. TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p < 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same-day discharge in these patients.

Early identification of vascular access site complications and frequent heart rate and blood pressure monitoring after cardiac catheterization: A scoping review

BackgroundNurses perform frequent heart rate (HR) and blood pressure (BP) monitoring, a widespread and longstanding practice, after cardiac catheterization (CC) to identify vascular access site complications for femoral and radial arterial approach in adult patients. ObjectiveThe objective of this scoping review was to answer two questions: (1) how does the available evidence support frequent HR and BP monitoring after CC via femoral and radial approach in adult patients and (2) how does this practice prompt bedside nurses in identifying the procedure's major vascular access site complications, including bleeding, hematoma, and pseudoanurysm? MethodFollowing the scoping review approach, literature search was conducted (PubMed, CINAHL, Google Scholar) by two co-authors and medical librarian. We reviewed, evaluated, and analyzed the evidence from twenty articles. ResultsThe reviewed medical and nursing literature revealed findings challenging the present practice. Out of fifteen research studies, five found frequent HR and BP monitoring after CC to be uninformative while the remaining ten did not report frequent vital signs. Two research articles reported that vascular complications after CC were discovered by RNs directly assessing the access site or by the patients themselves, unrelated to HR and BP. Five non-research articles were included, which all recommended frequent HR and BP monitoring. ConclusionsFrequent HR and BP assessment during the recovery period is not supported by empirical research despite being consistently recommended by nursing guidelines and expert opinion articles. Current evidence supports frequent vascular access site assessments and patient education.

Serial dilation to enable ulnar artery access for endovascular neurointervention: Technical report and systematic review of the literature

BackgroundFor rare neuro-endovascular cases in which transfemoral access is not feasible and the palmar circulation is insufficient for radial artery access, ulnar artery access may be considered. Materials and methodsMechanical thrombectomy via ulnar artery access was performed to preserve the dominant radial artery. The ulnar artery was serial dilated to 7-French with microdilator. Angiography was performed using a diagnostic catheter. The sheath was exchanged for a guide catheter, and a triaxial system was inserted. A mechanical thrombectomy was performed. The systematic literature review included all studies pertaining to techniques for ulnar artery access for neurointervention in the last 20 years (2003–2023) published in the PubMed, Web of Science, and Embase databases. Results67-year-old male developed left MCA syndrome in the setting of an infected abdominal aortic endograft. A transfemoral approach was ruled out due to concern for crossing the infected endograft. Allen test and ultrasound demonstrated that the right radial artery was of adequate size for access, but the ulnar artery was insufficient to support the palmar arch. Mechanical thrombectomy resulted in TICI 3 reperfusion. Systematic review of the literature yielded 2 case series and 1 case report of transulnar neurovascular procedures. Access site complications were rare and included 3 access site hematomas and 1 ulnar artery occlusion. ConclusionWe report our technique of serial dilation of the ulnar artery for neuroendovascular procedures and provide a systematic review of the literature for complication avoidance in ulnar artery access.

Procedural Outcomes With Femoral, Radial, Distal Radial, and Ulnar Access for Coronary Angiography: A Network Meta-Analysis.

Radial artery access for coronary angiography or percutaneous coronary intervention (PCI) reduces the risk of death, bleeding, and vascular complications and is preferred over femoral artery access, leading to a class 1 indication by clinical practice guidelines. However, alternate upper extremity access such as distal radial and ulnar access are not mentioned in the guidelines despite randomized trials. We aimed to evaluate procedural outcomes with femoral, radial, distal radial, and ulnar access sites in patients undergoing coronary angiography or PCI. PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials that compared at least 2 of the 4 access sites in patients undergoing PCI or angiography. Primary outcomes were major bleeding and access site hematoma. Intention-to-treat mixed treatment comparison meta-analysis was performed. From 47 randomized clinical trials that randomized 38 924 patients undergoing coronary angiography or PCI, when compared with femoral access, there was a lower risk of major bleeding with radial access (odds ratio [OR], 0.46 [95% CI, 0.35-0.59]) and lower risk of access site hematoma with radial (OR, 0.34 [95% CI, 0.24-0.48]), distal radial (OR, 0.33 [95% CI, 0.20-0.56]), and ulnar (OR, 0.50 [95% CI, 0.31-0.83]) access. However, when compared with radial access, there was higher risk of hematoma with ulnar access (OR, 1.48 [95% CI, 1.03-2.14]). Data from randomized trials support guideline recommendation of class 1 for the preference of radial access over femoral access in patients undergoing coronary angiography or PCI. Moreover, distal radial and ulnar access can be considered as a default secondary access site before considering femoral access. URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: 42024512365.

Femoral versus radial access for middle meningeal artery embolization for chronic subdural hematomas: multicenter propensity score matched study

BackgroundWith transradial access (TRA) being more progressively used in neuroendovascular procedures, we compared TRA with transfemoral access (TFA) in middle meningeal artery embolization (MMAE) for chronic subdural hematoma (cSDH).MethodsConsecutive patients...

Single-center experience with the JETi Hydrodynamic Thrombectomy System for acute limb ischemia

ObjectiveAcute limb ischemia (ALI) remains a vascular emergency with high morbidity and mortality. While the JETi Hydrodynamic Thrombectomy System (Abbott) offers a percutaneous approach to fragment and aspirate the thrombus in patients with arterial occlusions, data on its efficacy and safety are limited. This study reports our early experience using the JETi device to treat ALI at our institution. MethodsThis is a single-center, retrospective review of patients with ALI treated with the JETi device between September 2020 and December 2022. Patients were included if the JETi device was used either as a primary intervention or as an adjunct procedure. The primary endpoint was technical success defined as <50% residual thrombus after intervention. Secondary endpoints included achieving complete resolution of the thrombus on angiogram, acute kidney injury (AKI), major bleeding, 30-day major amputation, and 30-day mortality. ResultsA total of 59 JETi procedures for ALI (median age 62 years [interquartile range: 56-71 years]) were performed on 39 male and 20 female patients. The median time from onset of symptoms to hospitalization was 24 hours (interquartile range: 4-168 hours). Rutherford classifications were I (10), IIa (27), IIb (14), and undocumented (8). Etiology of ALI was native vessel thrombosis (27), embolism (16), graft/stent thrombosis (14), and iatrogenic (2). A total of 124 vessels were treated, with an average of 2.1 vessels per procedure. The primary outcome was achieved in 86% (107/124) of the arteries, with 82% (102/124) successfully opened using the JETi device alone without the need for any adjunctive therapy. Complete resolution of the thrombus using JETi was achieved in 81% (101/124) arteries, with or without the use of adjunctive therapy. A total of 6.7% (4/59) patients required a major limb amputation within 30 days despite successful recanalization, and one 30-day mortality was recorded. Complications included distal embolization (5), access site hematoma (2), and AKI (4). No major bleeding, hemolysis-induced AKI, or vessel dissection or perforation was observed. ConclusionsThe JETi device appears to be a safe and effective percutaneous treatment option in the management of ALI. It provides definitive treatment with a high technical success rate of 86% and a good safety profile.

Safety and Efficacy of Radial Artery Access for Peripheral Vascular Intervention: A Single-Center Experience

Radial artery (RA) access has been increasingly utilized for coronary procedures due to lower rates of access-site complications and improved patient satisfaction. However, limited data are available for RA access for peripheral vascular intervention (PVI). We performed a retrospective review of 143 patients who underwent PVI via RA access from February 2020 to September 2022 at a single institution. Baseline characteristics and follow-up data were ascertained from a prospectively maintained institutional database. Of 491 PVI, 156 (31.8%) were performed through the RA. Anatomical location for intervention were the femoral (44.8%), iliac (31.1%), popliteal (9.6%) peroneal (2.7%), tibial (9.9%), and subclavian (1.9%) arteries. Procedural access was obtained through the right RA (92.9%), left RA (4.5%), or right ulnar artery (2.6%) using the 6 French R2P Destination Slender sheath in 85 cm, 105 cm, and 119 cm lengths. Atherectomy was used in 34.7%. Mean contrast volume was 105.5 mL and the average fluoroscopy time was 18.5 minutes. Conversion to femoral access occurred in 3 cases (1.9%) due to arterial spasm and non-crossable lesions. Concomitant pedal access occurred in 2 cases (1.3%). Periprocedural complication rate was 3.84%, of which access-site hematoma was most common (3.2%); none required blood transfusion, surgical intervention, or additional hospital stay. There was 1 case (0.64%) of in-hospital stroke. The mortality rate at 30-day, 6-month, and 1-year was 1.4%, 2.8%, and 4.2%, respectively. In conclusion, RA access is feasible for diverse PVI, and future studies are needed to assess safety and benefit compared to femoral artery access.

Impact of omitting the intravenous heparin bolus on outcomes of leadless pacemaker implantation.

Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear. We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion. Among 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow-up after LP implant was 14.3 (interquartile range [IQR]: 8.4-27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p = .15). Implant-related adverse events were also similar between heparin bolus and no bolus groups: access-site hematoma requiring intervention (7 vs. 5, p = .99), pseudoaneurysm (1 vs. 1, p = .99), cardiac perforation (1 vs. 1, p = .99), intraprocedural device thrombus formation (2 vs. 4, p = .41), 30-day rehospitalization (21 vs. 15, p = .98), and 30-day all-cause mortality (16 vs. 14, p = .70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p = .10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p = .52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p = .34). Long-term device performance was also similar between groups. Omission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications.

Aetiology and predictors of major bleeding events in patients with heart failure with reduced ejection fraction undergoing percutaneous coronary intervention

ObjectivesWe sought to determine the relationship between the degree of left ventricular ejection fraction (LVEF) impairment and the frequency and type of bleeding events after percutaneous coronary intervention (PCI).DesignThis was...

Iliocaval and iliofemoral venous stenting for obstruction secondary to tumor compression

BackgroundCancer patients with pelviabdominal masses can suffer from lower extremity symptoms due to venous compression. The effectiveness of venous stenting has been established in extrinsic venous compression in benign conditions like May-Thurner syndrome. In this retrospective study we evaluate the efficacy and safety of caval, iliocaval and iliofemoral venous stenting for cases of extrinsic venous compression caused by malignant masses in cancer patients.MethodsIRB-approved retrospective review of patients who underwent iliofemoral venography with venoplasty and stenting between January 2018 and February 2022 was performed. Patients with extrinsic venous compression caused by malignant masses were included. Data on patient demographics, pre-procedure symptoms, procedural technique, stent characteristics, outcomes and follow-up were collected. Descriptive statistics were used to assess technical success, clinical success, primary stent patency and adverse events of the procedure.ResultsThirty-seven patients (19 males, 18 females) who underwent 45 procedures were included. Deep venous thrombosis (DVT) was present in 21 (57%) patients. Twenty-nine patients (78%, 95% CI 62–90%) reported clinical improvement of the presenting symptoms. The median overall survival after the procedure was 4.7 months (95% CI 3.58–5.99). Eight (22%) patients were alive at last follow up with median follow up of 10.33 months (Range 2–25 months). Twenty-six patients had patent stents on their last follow up imaging (70%, 95% CI 61%-91%). Two patients had a small access site hematoma which resolved spontaneously. Two patients developed moderate, and 1 patient developed severe adverse events related to post procedure therapeutic anticoagulation.ConclusionVenous stenting is a safe procedure and should be considered as part of the palliative care for patients with debilitating lower extremity symptoms related to iliocaval and iliofemoral venous compression.Graphical

Cerebral thromboembolic complications during cerebral angiography and their risk factors in different subgroups: Analysis of 2,457 procedures.

Diagnostic cerebral digital subtraction angiography (DSA) is an invasive examination that involves catheterization of the major supra-aortic arterial trunks and evaluation of intracranial vessels for diagnostic purposes. Although considered the gold standard method for investigating cerebrovascular diseases, DSA carries measurable and potentially serious complication rates. This report describes the frequency of neurological and non-neurological complications of DSA performed in five hospitals in the state of São Paulo, Brazil, and analyzes them in different disease subgroups. It has a special focus on thromboembolic cerebral complications. We retrospectively reviewed clinical records of all adult patients who underwent DSAs between January 2019 and December 2022. Demographic variables, DSA reports, CT/MRI reports, and clinical follow-up notes were reviewed. Twenty-four patients experienced some type of complication among 2,457 diagnostic DSAs (0.97%). Thromboembolic complications were recorded in 9 patients (0.36%), and access site hematomas larger than 5cm were registered in six patients (0.24%). There was a statistical trend for thromboembolic complications in patients with cervical and/or intracranial atherosclerosis (p = 0.07), but age was not associated with them (p = 0.93). Patients who received heparin had lower rates of embolic complications than those who did not receive it, but there was no statistically significant difference (p = 0.17). Intravenous administration of heparin showed a trend toward significance with groin hematoma (p = 0.10). Diagnostic catheter DSAs have low complication rates.

Safety, Efficacy, Feasibility of Trans Radial Approach Compared with Trans Femoral Approach in Patients Undergoing Coronary Catheterization

Background: Percutaneous Coronary Intervention has been done traditionally through Trans femoral route. Trans Radial route is coming up in the practice. We compared Trans Radial with Trans femoral accesses for ease of operability, time of procedure, complications, and failure rates through a cross sectional study. Objectives: To evaluate the safety, efficacy, feasibility and procedural variables in Trans radial approach compared with the Trans femoral Approach in patients undergoing coronary catheterization. Methods: A total of 180 patients with both chronic and acute coronary syndromes were enrolled in this study, 140cases with Radial 28 of whom were crossed to Femoral access(hence 112 Radials with 108 Right Radial and 4 Left Radial)and 68 cases with Femoral access. Results: Procedural time between Trans Radial and Trans femoral accesses were similar (17.39±10.33 vs19.68±16.62 minutes p 0.36) respectively while among Femoral crossover group was higher (33.50±20.30 minutes p0.01). Fluoroscopy time was (5.51±4.70 in Trans Radial Vs. 7.18 ±7.65 minutes in Trans femoral p 0.07) were similar in both groups. Post procedure access site complications seen in (9% in Trans Radial compared to 7.35% in Trans femoral P 0.048), Access site Hematoma being the most common one (6.25% in Trans Radial vs 4.4% in Trans femoral), Non-flow limiting dissections occurred in (0.89% in Trans Radial VS 1.4% Trans femoral), Radial artery perforation occurred in 1.78%, 1.4% of patients in Femoral group had Femoral artery perforation and had major bleeding. Conclusion: The overall local complications were lower in Trans femoral access, except for major bleeding which is still a big concern. Both vascular Access techniques should not be considered opposite or mutually exclusive, but rather provide the Interventionist a wide spectrum of the therapeutic options.

Safety of Prostatic Artery Embolization via Transradial Access versus Transfemoral Access

PurposeTo compare prostatic artery embolization (PAE) via transradial access (TRA-PAE) versus transfemoral access (TFA-PAE) to assist access selection. Material and MethodsProcedural outcomes and adverse events were evaluated in 998 patients who underwent PAE at a single center from April 2014 to August 2022; 821 (82%) underwent TRA-PAE (Group R) and 177 (18%) underwent TFA-PAE (Group F). Mean age and prostate size of Groups R and F were 69.2 years (SD ± 8.4) and 117.4 g (SD ± 63.1) and 75.2 years (SD ± 12.1) and 127.2 g (SD ± 83.6), respectively (P < .01 and P = .16; postpropensity matching: P = .38 and P = .35, respectively). Indications for PAE included lower urinary tract symptoms, acute or chronic urinary retention, and hematuria. Procedural and patient-specific metrics were reviewed. Technical success was defined as bilateral PAE. Adverse events were recorded according to the Society of Interventional Radiology (SIR) adverse events classification. Statistical significance was defined as P < .05. ResultsTechnical success was achieved in 798 (97.2%) patients in Group R and 165 (93.2%) patients in Group F. Mean procedural time, single- and continuous-rotation fluoroscopy time, dose area product, and air kerma were significantly lower in Group R than in Group F (P < .001). Moreover, 6 (0.7%) patients in Group R and 9 (5.5%) patients in Group F had access site ecchymoses, whereas 5 (0.6%) patients in Group R and 6 (3.6%) in Group F had access site hematomas. Two patients experienced transient ischemic attacks (TIAs) after TRA-PAE and recovered without intervention. Two occult radial artery occlusions were noted, but no patient experienced hand ischemia. ConclusionsIn a large single interventional radiologist cohort, TRA-PAE demonstrated similar technical success to that of TFA-PAE with lower access site hemorrhagic complications and radiation requirements; however, TIA and occult radial artery occlusions remain a concern.

Early Experience and Lessons Learned Using Implanted Hemodynamic Monitoring in Patients With Fontan Circulation.

Data on the use of implanted hemodynamic monitoring (IHM) in patients with Fontan circulation are limited. This study reports our experience using the CardioMEMS HF system in adults with Fontan circulation. This single-center, retrospective study evaluated heart failure hospitalizations, procedural complications, and device-related complications in patients with Fontan circulation referred for IHM placement (2015-2022). The association of pulmonary artery pressure (by most recent catheterization and median IHM pressure within 30 days of placement) with both death and follow-up Model for End-Stage Liver Disease Excluding International Normalized Ratio score were evaluated. Of 18 patients referred for IHM placement, 17 were successful (median age, 30 [range 21-48] years, 6 women). Procedural complications (access site hematomas, pulmonary artery staining) occurred in 3 patients, without device-related procedural complications. In follow-up (median, 35 [range, 6-83] months), 1 patient developed a pulmonary embolism (possibly device-related). Heart failure hospitalizations/year were similar before and after IHM (median, 1 [interquartile range, 0-1.0] versus 0.6 [0-2.3]; P=0.268), though only 46% of heart failure hospitalizations had associated IHM transmissions. IHM pressures were associated with Model for End-Stage Liver Disease Excluding International Normalized Ratio scores (R2=0.588, P<0.001), though catheterization pressures were not (R2=0.140, P=0.139). The long-term mortality rate was 53% in this cohort. On unadjusted survival analysis, IHM pressures ≥18 mm Hg were associated with mortality (log rank P=0.041), which was not reproduced with catheterization pressures (log rank P=0.764). In patients with Fontan circulation, IHM did not reduce heart failure hospitalizations, though patient adherence to transmission was low. Device-related complications were low. IHM pressures may better represent real-life conditions compared with catheterization given associations with mortality and Model for End-Stage Liver Disease Excluding International Normalized Ratio score.

Open Radial Artery Study

Radial artery occlusion (RAO) has been the most common postprocedural complication of transradial artery access. The optimal method of prevention of RAO is still lacking. In our study, we aimed to evaluate the effect of patent hemostasis on early (24hours) and late (2weeks) RAO prevention. The Open Radial Artery Study was a single-arm, prospective, and multicenter study. The primary end points were early and late RAO at the vascular access site after transradial coronary procedures. Secondary end points were access site hematoma, pseudoaneurysm formation, arteriovenous fistula, and nerve injury. A total of 2,181 patients were analyzed (67% male, mean age 68years). The mean interventional duration and hemostatic times were 75.6 ± 55.6 and 60 ± 5.6minutes, respectively. Radial artery spasm occurred in 10% of patients (n=218). Catheter kinking, radial artery rupture, or dissection were not observed during the procedure. RAO, hematoma, pseudoaneurysm, arteriovenous fistula, or nerve damage was not observed in any of the patients in the early or late period. In patients who undergo coronary diagnostic or interventional procedures through transradial artery access, the patent hemostasis method seems a critical step in the prevention of early and late RAO.

Risk of complications in patients undergoing pulmonary vein antrum isolation: a single centre experience

Abstract Background Pulmonary vein antrum isolation (PVAI) is the gold standard approach to treat symptomatic atrial fibrillation (AF) refractory to medical therapy. While PVAI may result in a number of potential complications, there is a growing body of literature supporting safety of same day discharge post-PVAI. Purpose To retrospectively evaluate the incidence of post-procedure acute adverse events (AE), and elucidate factors associated with increased risk of such complications in patients undergoing PVAI. Methods Patients underwent PVAI between 2004-2021 at a tertiary care centre, and were followed-up at 3, 6 and 12 months post-PVAI. All procedures were performed utilizing intra-cardiac echocardiography. Baseline characteristics of patients who experienced acute AE were compared with those in patients who did not. Univariate and multivariate logistic regression models adjusted for age, sex, type of AF, left atrial size, and comorbidities were employed to evaluate risk factors for acute AE. Results 2829 patients (mean age: 61.5±10.4 years, 33.7% female, 64.1% paroxysmal AF) were included in this study. Overall incidence of acute AE was 92 (3.3%), which included: 60 (2.1%) patients with access site hematoma, 20 (0.7%) patients with hematoma requiring treatment, and 12 (0.4%) patients with cardiac tamponade. Other complications included: 5 (0.18%) strokes or transient ischemic attacks (TIA), 3 (0.10%) esophageal fistulas, and 1 (0.03%) phrenic nerve injury. Females (4.2% vs 2%, P=0.001), patients older than 75 years (3.3% vs 2.7%, P=0.8), non-paroxysmal AF (3.4% vs 2.4%, P=0.1), body mass index ≥ 35 kg/m2 (3.6% vs 2.7%, p=0.04), those with an implanted device (6.7% vs 2.3%, p=0.004), and sinus node dysfunction (SND) (6.6% vs 2.5%, p=0.001) had a greater rate of acute AEs. Patients with comorbidities, including hypertension (3.4% vs 2%, P=0.04), Type 2 diabetes ( 3.2% vs 2.7%, p=0.7), congestive heart failure (5.6% vs 2.5%, P=0.008), and coronary artery disease (3.9% vs 2.6%, p=0.1) also manifested higher rate of acute AE. In the multivariate logistic regression model, female sex (OR= 2.5 [1.4, 4.4]), CHF (OR= 2.6 [1.3, 4.9]) and SND (OR=2.6 [1.1, 5.5] were associated with increased AE risk when adjusted for age, AF type, and other comorbidities. Conclusion In the multivariate model, female sex, a history of congestive heart failure, and SND were independently associated with a greater risk of AE following PVAI.

Abstract 12244: Gender Differences in Leadless Pacemaker Peri-Procedural Adverse Events, Long-Term Device Functions, and Clinical Outcomes

Introduction: Some studies suggested gender differences in procedural complication rates and long-term outcomes for trans-venous pacemakers. Little is known about gender differences associated with leadless pacemaker (LP) implantation. Methods: We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. Device parameters (R wave sensing, impedance, and capture threshold), right ventricular pacing burden (RVP), left ventricular ejection fraction (LVEF), and 30-day adverse events post implant were obtained. Results: Among 489 patients, 50.9% were men. Mean follow-up was 1.7 ± 1.5 years. Women were older than men at the time of LP implant (78.1 ± 14.7 vs 75.5 ± 15.3 years old, p=0.04). There were no significant differences in R wave sensing and RVP between genders. Impedance and LVEF were higher in women and capture thresholds were higher in men at both baseline and last follow up. Despite significant differences in device parameters between genders, differences were small and not clinically relevant in most cases (Figure). Mean number of device deployments required at implant was similar: women 1.3 ± 0.6 vs men 1.4 ± 0.9, p=0.16). Implant related complications were similar between women and men: access site hematoma (5 vs 9, p=0.42), pseudoaneurysm (0 vs 2, p=0.49), cardiac perforation (2 vs 1, p=0.62), 30-day re-hospitalization (16 vs 25, p=0.19) and 30-day mortality (16 vs 17, p=0.99). LVEF decreased over time in both genders (Figure). During follow-up, 4 women and 6 men required transvenous cardiac resynchronization therapy (CRT) implantation (p=0.75) and 4 women vs 2 men required transvenous dual chamber pacemaker implantation (p=0.44). Conclusion: Outcomes of leadless pacemaker implantation are similar between women and men. Long-term device function is excellent in both genders. However, about 3% of all patients required device upgrade, highlighting the need for close electrophysiology follow-up after LP implant in both genders.

Abstract 14849: Impact of Intravenous Heparin Bolus on Outcomes of Leadless Pacemaker Implantation

Background: During Micra leadless pacemaker (LP) implantation, continuous heparin is infused to prevent thrombus within the sheath and on the device. Early guidance from the manufacturer (Medtronic) recommended an initial systemic heparin bolus to further prevent thrombus formation. However, systemic heparin may increase the risk of implant complications. Thus, many operators have moved away from routine boluses. However, there is a paucity of data on the impact of heparin bolus on outcomes. Methods: We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at the operator discretion. Results: Among 621 LP implants, 326 received a heparin bolus, 243 did not, and 52 patients had unknown bolus status. In the cohort, 50.4% were men. Mean age at implant was 76.8 ± 14.9 years. Mean follow up was 1.7 ± 1.4 years. There were no significant differences in device electrical parameters (R wave sensing, impedance, and capture thresholds), right ventricular pacing burden (RVP), or left ventricular ejection fraction (LVEF) comparing heparin bolus vs. no bolus at both initial interrogation and long-term follow up (Figure). There was no difference between groups in the number of attempted device deployments per implant procedure (1.42 ± 0.81 vs 1.31 ± 0.66, p=0.15). Implant-related adverse events were also similar between bolus and no-bolus groups: access-site hematoma (5 vs 7, p=0.99), pseudoaneurysm (1 vs 1, p=0.99), cardiac perforation (1 vs 1, p=0.99), 30-day re-hospitalization (15 vs 21, p=0.98) and 30-day all-cause mortality (14 vs 16, p=0.57). There was 1 additional non-fatal cardiac perforation in a patient with unknown bolus status. Conclusion: Routine systemic bolus of heparin can be safely omitted in appropriately selected patients undergoing LP implant. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients with high risk for thrombotic complications.

Comparative effectiveness and safety of laser, needle, and "quick fenestrater" in in situ fenestration during thoracic endovascular aortic repair.

Special instruments are needed for the revascularization of aortic branches in in situ fenestration during thoracic endovascular aortic repair (TEVAR). This prospective study compared the effectiveness and safety of three currently used fenestraters: laser, needle, and Quick Fenestrater (QF). In all, 101 patients who underwent TEVAR for aortic disease (dissection, n = 62; aneurysm, n = 16, or ulcer, n = 23) were enrolled. All patients were randomly assigned to three groups: 34 were assigned to laser fenestration, 36 to needle fenestration, and 31 to QF fenestration. The epidemiological data, treatment, imaging findings, and follow-up outcomes were analyzed using data from the medical records. The technical success rates of the laser, needle, and QF fenestration groups were 94.1%, 94.4%, and 100% (p > 0.05). After correction of mixed factors such as age and gender, it was showed the average operative time (Laser group: 130.01 ± 9.36 min/ Needle group: 149.80 ± 10.18 min vs. QF group: 101.10 ± 6.75 min, p < 0.001), fluoroscopy time (Laser group: 30.16 ± 9.81 min/ Needle group: 40.20 ± 9.91 min vs. QF group: 19.91 ± 5.42 min, p < 0.001), fenestration time (Laser group 5.50 ± 3.10 min / Needle group 3.50 ± 1.50 min vs. QF group 0.67 ± 0.06 min, p < 0.001), and guide wire passage time after fenestration (Laser group 5.10 ± 1.70 min / Needle group 4.28 ± 1.60 min vs. QF group 0.07 ± 0.01 min, p < 0.001) were all shorter with QF fenestration than with the other two tools. The overall perioperative complication rates of the laser, needle, and QF fenestration groups were 5.9%, 5.6%, and 0% (p > 0.05): One case of sheath thermal injury and one case of vertebral artery ischemia occurred in the laser fenestration group; one case each of access site hematoma and brachial artery thrombosis were reported in the needle fenestration group. 89 (88.1%, 89/101) patients were followed for a median of 12.6 ± 1.6 months. The overall postoperative complication rates of the laser, needle, and QF fenestration groups were 3.3%, 6.5%, and 0% (p > 0.05): In the laser fenestration group, there was one death due to postoperative ST-segment elevation myocardial infarction; in the needle fenestration group, one patient developed occlusion of the bridge stent; no complications occurred in the QF group. All three fenestration methods were effective in reconstructing supra-arch artery during TEVAR. QF fenestration required less contrast agent, with a shorter surgery duration and fewer complications than laser and needle fenestration.