Femoral Access Site Research Articles

Splenic Artery Embolism in Liver Transplant Patients: A Single-Center Experience.

Hypersplenism, portal hypertension, and ascites have been seen after liver transplants. Patients are usually treated medically with refractory patients potentially undergoing splenectomy. Splenic artery embolism (SAE) is an alternative that can be performed to limit the surgical intervention that may have the benefit of improving portal hypertension. Few studies have studied the effect on main portal vein (MPV) velocities and hepatic artery resistive indices (HARIs) which may be beneficial as markers of portal hypertension. This study aims to evaluate the efficacy and safety of interventional radiology (IR)-guided SAE for the management of portal hypertension in patients who have had liver transplants. A retrospective analysis was conducted on liver transplant patients who had undergone IR-guided SAE post-transplant at a single tertiary transplant center from 2012 to 2022. The primary outcome of intervention efficacy was quantified by peak HARIs and MPV velocities. Ultrasound with Doppler obtained before and after the intervention was reviewed for these parameters. Secondary outcomes included adverseeventsat the time of the procedure and within one year of the procedure, the need for splenectomy, and spleen size. Twenty-eight patients met the criteria for inclusion. The mean age of patients was 52.5 years (21-71 years) and the time after transplant was 149.5 days (2-1588 days). About 96.4% of SAEs were technically successful (n=27). Twenty-one patients had MPV velocities available, and 24 had peak HARIs available. In these patients, HARIs decreased by an average of 0.063 (95% CI 0.014-0.112) after SAE. MPV velocity decreased by an average of 47.2 cm/s (95% CI 27.3-67.1) after SAE. About 10.4% of patients (n=3) developed a procedure-related complication, all of which were femoral access site aneurysms. No (0) patients suffered from bleeding, infections, or abscesses after the procedure. About 10.7% of patients (n=3) required splenectomy after SAE: one splenectomy was due to technical failure and two were due to refractory symptoms. We performed one of the first analyses on MPV and RI and showed that our patients saw an improvement post-embolization with a theoretical improvement in portal hypertension. The complication rate and risk of infection seem to be acceptable risks, making SAE a feasible option for management.

Obesity and vascular complication in percutaneous transfemoral transcatheter aortic valve insertion.

Obesity has been associated with an increased risk of vascular complication during percutaneous coronary intervention, but there are no data on the risk of vascular complication during percutaneous transfemoral transcatheter aortic valve insertion (TAVI). We hypothesized there would be a similar increased risk associated with TAVI. We reviewed the records of 1176 patients who received percutaneous transfemoral transcatheter aortic valve insertion from September 2015 to September 2020. All patients received 1) preoperative computed tomoraphy angiography assessment of the abdomen and pelvis to delineate iliofemoral artery anatomy, 2) ultrasound-guided percutaneous femoral arterial access, and 3) pre-closure of the delivery sheath femoral access site. Vascular complication was recorded based on definitions set forth by Valve Academic Research Consortium 3. The median age of patients was 81 years, and 60% were men. The median body mass index (BMI) was 29 kg/m2 (range, 11-67), and 91 (8%) patients had a value ≥40 kg/m2 (i.e., morbid obesity). Delivery sheath size was 14-French in 859 (73%) patients, 16-French in 311 (26%), and 18-French in 6 (1%). Vascular complication occurred in 53 (5%) patients, including 39 (7%) among the first half of procedures and 14 (2%) among the second half (p < 0.001). When stratified by obesity status (BMI < or ≥30 kg/m2 , p < 0.001), the complication rate was 4% in nonobese patients and 5% in obese patients. Multivariable analysis showed no overall association between risk of vascular complication and BMI categories (p = 0.583)BMI continuous values (p = 0.529), or sheath size (p = 0.217). Obesity is not associated with a vascular complication during percutaneous transfemoral transcatheter aortic valve insertion. The operation should not be denied in obese patients.

Predictors of Complications at Common Femoral Artery Access Site among Patients on Oral Anticoagulants and Undergoing a Cardiac Catheterization

Introduction: It is not clear whether patients receiving oral anticoagulants (OC) during surgery involving access to the common femoral artery would experience more adverse effects than those not receiving OC. In this analysis, we determine whether patients receiving oral anticoagulants undergoing cardiac catheterization are at high risk of complications related to femoral site than subjects not receiving OACs. Study Settings: This study was held in the Cardiology department of Qazi Hussain Ahmed Medical Complex, Nowshera and Peoples University of Medical and Health Sciences for Women PUMHSW (SBA) Nawabshah for one-year duration from January 2021 to December 2021. Methods: A total of 300 patients were selected for the study. We regularly reviewed data from patients undergoing cardiac surgery at the same tertiary care center. A patient was classified as fully or partially anti-coagulated (Group A) if his international normalized ratio (INR) was greater than 1.6 on the surgery day or if he received new OAC or warfarin within 48 hours or less after surgery. The group without anticoagulants (Group B) had an INR of 1.6 or had stopped the new OAC and warfarin more than 48 and 24 hours prior to surgery, respectively. Results: A total of 300 patients (mean age 65.6±12.2, 60% male) were registered in the study. 20 (6.7%) were in Group A and Group B included 280(93.3%) patients. The intervention was done among 162/300 (54%) patients and received treatment with Intra-procedural anticoagulation with heparin (50.0%), bivalirudin (23.3%) or both (3.3%). GpIIb/IIIa inhibitors were used infrequently (1%). Conclusions: Compared to patients who did not receive anticoagulants during the procedure, OAC patients experienced no major serious adverse events after 30 days. Keywords: Oral anticoagulant, Common femoral artery, complications, access site.

Standardized pre-procedural clinical workup for protected percutaneous coronary intervention.

In addition to appropriate patient screening, pre-procedural preparation is essential to optimize both technical success and patient outcome for protected percutaneous coronary intervention (PCI). A critical component of optimization is the identification and preparation of a suitable femoral access site. Here, we describe several options for both imaging and image-guided access to optimize the approach.

Abstract 14484: Shockwave Lithotripsy as a Non Surgical Modality for Calcified Carotid Stenosis

An 80-year-old gentleman with significant bilateral carotid artery stenosis and previous right carotid endarterectomy underwent a CT Angiogram of the Head and Neck due to multiple episodes of syncope. The study revealed heavily calcified atherosclerotic disease at the left carotid bulb and bifurcation, causing high-grade luminal stenosis of 80 to 82% at the origin of the internal carotid artery. Hence, a decision was made to obtain a cerebral angiogram. Aortic arch angiogram revealed a type III arch, following which a cerebral catheter wire was engaged in the left carotid artery. A selective angiogram showed 80% calcified stenosis at the level of bifurcation, with the left external carotid artery being 100% occluded. Given the heavily calcified lesion, supra core guidewire was crossed across the lesion, followed by advancement of protection device into the distal segment of the left internal carotid artery. Balloon angioplasty was performed twice from the ostial to the proximal segment of the left internal carotid artery. An attempt was made to place a stent without any success. Subsequently, a decision was made to proceed with shockwave lithoplasty. We inserted a transvenous pacemaker with a backup rate of 40 bpm. A Shockwave catheter was inserted and shockwaves were delivered with multiple inflation techniques at 4 atmospheric pressure for 15 seconds each. Periodic neuro assessments were normal. This was followed by the placement of stents in the distal left common carotid and ostial to proximal left internal carotid artery reducing the calcified 80% stenosed lesion to 10% with excellent angiographic results. Subsequently, the filter and the catheter were removed and the femoral artery access site was secured. The patient tolerated the procedure very well without any immediate or delayed complications. The intracerebral vasculature remained intact as confirmed by a cerebral angiogram. TVP was removed and the patient was discharged in a stable condition after 2 days. Hence, Shockwave lithotripsy can be successfully used for critical carotid artery stenosis in patients that pose a high surgical risk. It helps soften the lesion for better dilatation of the vessel and achieve improved luminal gain for appropriate stent expansion.

Real-world VASCADE closure device versus manual compression use and outcomes in patients with severe common femoral artery disease.

The VASCADE closure device deploys an extravascular collagen plug. Its use in those with access site disease undergoing peripheral vascular intervention (PVI) is unknown. We aimed to evaluate the efficacy and safety of the VASCADE closure device compared to manual compression (MC) in patients with moderate femoral access site disease. We performed a single-center, retrospective review of patients undergoing PVI with at least moderate access site disease. Our institutional database was linked to the Vascular Quality Initiative database, and 200 patients were selected from a 1:1 propensity-matched cohort. Data on procedural metrics and outcomes up to 30-days were abstracted. There were 103 procedures that used VASCADE and 97 used MC. Baseline variables were similar between groups. The mean age was 68.2 ± 11.2 years and 37.6% were women. Closing mean activated clotting time (ACT) was shorter in VASCADE (198 s VASCADE vs. 213 s MC; p = 0.018). There was a nonsignificant decrease in external compression device use with VASCADE (VASCADE 19.0% vs. MC 28.1%; p = 0.15). At 30-days, there was a nonsignificant reduction in hematoma with VASCADE (3.8% vs. 7.8% MC; p = 0.25) and no difference in retroperitoneal bleeding (0.5%). Pseudoaneurysm rate was similar (1.3% VASCADE vs. 1.7% MC; p = 0.79). The 30-day mortality rate was similar between the two groups and not related to the procedure (1.3% VASCADE vs. 0.9% MC; p = 0.79). In patients undergoing PVI with at least moderate access site disease, safety and efficacy after using VASCADE was comparable withMC.

Transradial Versus Transfemoral Approach for Endovascular Thrombectomy of Left Anterior Circulation Stroke With Bovine Arch

Transradial Versus Transfemoral Approach for Endovascular Thrombectomy of Left Anterior Circulation Stroke With Bovine Arch

D-51 | Complications and Failure Methods of The Mynx Vascular Closure Devices: Insights from MAUDE Database

The Mynx (AccessClosure, Inc., Mountain View, California, USA) is a vascular closure device (VCD) that was approved by the US FDA to provide immediate sealing of femoral arterial access sites. While the device has proven to be safe in clinical trials, real world data are minimal.

Interarterial Pseudoaneurysm

Femoral artery pseudoaneurysm (FAP) is one of the most troublesome complications related to femoral artery access site after cardiovascular catheterization procedures and occurs in 0.8%–2.2% of the cases of cardiovascular interventional procedures. Management is by ultrasound-guided compression repair (UGCR). A 75-year-old male presented with anterior wall ST-elevation myocardial infarction and after percutaneous transluminal coronary angioplasty, developed FAP. This pseudoaneurysm had an interarterial communication between superficial femoral artery and deep femoral artery. It is unusual to have communication of pseudoaneurysm with two branches of femoral artery. Diagnosis was made using vascular sonography and Doppler study. Closure of this aneurysm was done by simple pressure with Doppler probe at both the narrow ends of the aneurysm. Arterial color Doppler is the mainstay for diagnosing FAPs. This case describes an interarterial pseudoaneurysm which is a rare entity to witness and the different modalities for its management, the most common one being UGCR.

Extremity Dysfunction After Large-Bore Radial and Femoral Arterial Access.

BackgroundThe use of large‐bore (LB) arterial access and guiding catheters has been advocated for complex percutaneous coronary intervention. However, the impact of LB transradial access (TRA) and transfemoral access (TFA) on extremity dysfunction is currently unknown.Methods and ResultsThe predefined substudy of the COLOR (Complex Large‐Bore Radial PCI) trial aimed to assess upper and lower‐extremity dysfunction after LB radial and femoral access. Upper‐extremity function was assessed in LB TRA‐treated patients by the Quick Disabilities of the Arm, Shoulder, and Hand questionnaire and lower‐extremity function in LB TFA‐treated patients by the Lower Extremity Functional Scale questionnaire. Extremity pain and effect of access site complications and risk factors on extremity dysfunction was also analyzed. There were 343 patients who completed analyzable questionnaires. Overall, upper and lower‐extremity function did not decrease over time when LB TRA and TFA were used for complex percutaneous coronary intervention, as represented by the median Quick Disabilities of the Arm, Shoulder, and Hand score (6.8 at baseline and 2.1 at follow‐up, higher is worse) and Lower Extremity Functional Scale score (56 at baseline and 58 at follow‐up, lower is worse). Clinically relevant extremity dysfunction occurred in 6% after TRA and 9% after TFA. A trend for more pronounced upper‐limb dysfunction was present in female patients after LB TRA (P=0.05). Lower‐extremity pain at discharge was significantly higher in patients with femoral access site complications (P=0.02).ConclusionsFollowing LB TRA and TFA, self‐reported upper and lower‐limb function did not decrease over time in the majority of patients. Clinically relevant limb dysfunction occurs in a small minority of patients regardless of radial or femoral access.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT03846752.

Efficacy and Safety of Nepcell STM in Achieving Hemostasis After Removal of a 15-Fr Femoral Venous Sheath in Patients Undergoing Cryoballoon Ablation for Atrial Fibrillation.

Background: Hemostasis at the femoral venous access site after cryoballoon ablation (CA) for atrial fibrillation (AF) is often prolonged because of aggressive anticoagulation and the use of 15-Fr-caliber sheaths. The Nepcell STM (NC) is a newly developed hemostatic pad made of fibrosed calcium alginate extracted from natural seaweed. The calcium ions from the NC accelerate the clotting cascade. This single-center randomized clinical trial assessed the efficacy and safety of the NC in patients undergoing CA for AF. Methods and Results: In all, 62 patients undergoing CA for non-valvular paroxysmal AF were randomly assigned to either the NC or control group. The primary endpoints of this study were time to hemostasis, internal hemorrhage, and rebleeding. Secondary endpoints were the length of hospital stay (LOS) and vascular complications at 1 month. The time to hemostasis was significantly shorter in NC than control group (mean [±SD] 377±216 vs. 505±241 s; P=0.031). The frequency of internal hemorrhaging (6% vs. 37%; P=0.003) and rebleeding (0% vs. 13%; P=0.033) was lower in the NC than control group, contributing to a decreased LOS in the NC group (3.56±0.67 vs. 4.23±0.73 days; P<0.001). There were no NC-related vascular complications at the 1-month echographic examination. Conclusions: The use of NC was associated with a shorter hemostasis time and fewer bleeding complications in patients undergoing CA for AF, leading to a shorter LOS.

Distal Radial Secondary Access for Transcatheter Aortic Valve Implantation: The Minimalistic Approach

BackgroundAlthough not yet recommended by the guidelines, distal radial access, a new site for cardiovascular interventions, has been rapidly acknowledged and adopted by many centers due to its high rate of success, safety and fewer complications. We present our experience using secondary distal radial access during transcatheter aortic valve implantation (TAVI), proposing a new, even more minimal approach. MethodsAs of November 2020, a systematic distal radial approach as secondary access site for TAVI was adopted in our center. Primary endpoints were technical success and major adverse events (MAEs). Secondary endpoints: the access site complication rate, hemodynamic and clinical results of the intervention, procedural related factors, crossover rate to the femoral access site, and hospitalization duration (in days). ResultsFrom November 2020, 41 patients underwent TAVI using this strategy. Patients had a mean age of 76 ± 11.2 years, 41% were male. Six (14.63%) patients received a balloon-expandable valve and 35 (85.37%) received a self-expandable valve. TAVI was successful in all cases. No complications occurred due to transradial access. Puncture success, defined as completed sheath placement was maximum (N = 41/41,100%) and emergent transfemoral secondary access was not required in any case. Primary transfemoral vascular access site complications occurred in 7 cases (17%) of which 4 (13.63%) were resolved through distal radial access: one occlusion, two flow-limiting stenoses and four perforations of the common femoral artery. There were no additional major vascular complications at 30 days. Overall MACE rate was 2.4%. ConclusionThe use of the distal radial approach for secondary access in TAVI is safe, feasible and has several advantages over old access sites.

Abstract 13427: Identification of Patients Who Can Safely Undergo Same Day Discharge Following Atrial Fibrillation Ablation: Lessons Learned in the COVID-19 Era

Background: Historically, pts have been admitted for overnight observation following atrial fibrillation (AF) ablation. The COVID-19 pandemic ushered the need to consider same day discharge (SDD). It remains unclear how to identify pts who can safely undergo SDD. Objective: To evaluate acute (within 4 hrs) and subacute (within 24 hrs) safety of SDD post AF ablation; we also sought to identify predictors of safe discharge. Methods: All pts undergoing AF ablation at our center following the end of the COVID imposed lockdown were enrolled. In each pt, ICE guided single transseptal puncture using the VersaCross® (Baylis) system was performed. Following ablation, protamine was not administered; all femoral venous access sites were closed with Vascade™ (Cardiva Medical) closure devices. Pts ambulated after 2 hrs of bedrest. Pts who had SDD were compared to those who stayed for overnight observation. Results: The cohort included 226 pts (65 ± 10 yrs, 157 [69%] male, 118 [52%] PAF, CHA 2 DS 2 -VASc 2.4 ± 1.7). Cryo PVI was performed in 193 (85%) pts; 34 (15%) pts had a redo procedure. SDD was attempted in 126 pts and successfully accomplished in 115 (91%) pts at 251 + 72 minutes from procedure end. The most common reason for failed SDD attempt was access site oozing necessitating additional bedrest. No SDD pt had a major complication. Overnight observation was performed in 100 (44%) pts, most commonly due to physician/pt preference. Compared to pts who had SDD, these pts were older and more likely to have heart failure and history of TIA/stroke. Oozing within the first 4 hrs was observed at a similar rate to SDD pts. A minor complication was seen in 1 pt each in SDD and overnight stay group between 4 and 24 hrs of ablation (Figure). Conclusions: Our study shows that when attempted, SDD after AF ablation can be accomplished in &gt;90% of pts. Venous access site oozing was the greatest hinderance to pts going home. However, if pts had no issue 4 hrs after AF ablation, they had an uneventful course over the next 24 hrs.

Sheath Size Up and Down With Single Proglide – A Technique for Achieving Hemostasis With Use of Large Size Delivery System During Endovascular Graft Placement

A total percutaneous approach for management of aortic pathologies with endovascular grafts requires the use of large size delivery-systems. The diameter of these delivery systems usually exceeds the recommended sizes for most of the currently available percutaneous closure devices. A safe, effective and simple vascular access site closure device is desirable for success for percutaneous procedures for aortic pathologies. Hence, we aim to study safety and effectiveness of the use of a single suture based vascular access closure device (ProGlide) using a technique involving serial up and downsizing of the sheath size to achieve access site hemostasis in patients undergoing endovascular graft placement using femoral artery approach. We studied all consecutive patients who underwent endovascular grafting from January 2018 to December 2019. It is a retrospective observational study comparing procedural and short-term outcomes between single ProGlide use and surgical cut-down for femoral access site closure. We excluded patients with femoral artery minimal luminal diameter less than 5 mm, the presence of an aneurysm of the femoral artery, ≥180 degrees of calcium present at femoral/ external iliac artery and history of any vascular closure device use in the last six months. We included 30 patients in single ProGlide group and 30 patients in the surgical cut-down group. One-third of the procedures were urgent procedures in the single Proglide group. Single ProGlide was successful in 93.34% patients and failure (6.66%) was seen due to hematoma and pseudoaneurysm in one patient each detected before discharge. The primary end-point defined by the success of procedure did not differ between the two groups. There were higher complications in the surgical group till 30 days as evidenced by infection, hematoma and neuronal injury. The secondary end-point, defined by the composite of complication events after discharge till 30 days was significantly higher in the surgical group (P-0.005) CONCLUSION: In patients with suitable femoral artery anatomy who undergo endovascular graft placement, effective hemostasis can be achieved safely using up and downsizing of the sheath with a single suture-based technique (Proglide). The results of the study could be considered hypothesis generating and needs to be confirmed in a randomized controlled trial before being adopted in clinical practice.

Comparison of Success Rate and Complications of Totally Percutaneous Decannulation in Patients With Veno-Arterial Extracorporeal Membrane Oxygenation and Endovascular Aneurysm Repair.

Background: Total percutaneous closure for the site of femoral arterial puncture using Perclose ProGlide (PP) has become prevalent post-percutaneous endovascular aortic repair (EVAR) and veno-arterial extracorporeal membrane oxygenation (VA-ECMO).Objective: To evaluate the safety and efficacy of total percutaneous closure of the femoral artery access site post-EVAR compared with VA-ECMO.Methods: This was a retrospective observational study conducted over 4 years, including 88 patients who underwent EVAR (64 patients) and VA-ECMO (24 patients). Perclose ProGlide devices were used in the femoral artery puncture sites closed percutaneously. In this study, technical success was defined as successful arterial closure of the common femoral artery (CFA) without additional surgical or endovascular procedures to prevent vessel leaking. Access site complications, including overt bleeding requiring transfusion or surgical intervention, minor bleeding, tinea cruris, pseudoaneurysm, and lymphocele, were recorded 24 h and 30 days after arterial closure.Results: Each group's technical success rates were 95.8% (VA-ECMO) and 92.2% EVAR, respectively. There were no differences in the periprocedural complications of major bleeding, pseudoaneurysm, minor bleeding, acute limb ischemia, and groin infection. Furthermore, we did not observe any complications such as arterial thrombosis, dissection, stenosis, arteriovenous fistula, hematoma, groin infection, or lymphocele at the access site by following-up an ultrasound examination. There was no significant difference in the technical success rate of percutaneous closure by the PP device in the EVAR and VA-ECMO oxygenation groups. Also, no periprocedural or 30-day complications were observed at the access site of the EVAR and VA-ECMO patients.

Impact of Access Site Choice on Outcomes of Inferior Vena Cava Filter Placement

Limited studies have evaluated optimal access site choice during placement of inferior vena cava (IVC) filters. In this study, we aim to compare the outcomes of IVC filter placement between femoral and internal jugular vein access sites.

A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization

The primary objective of this study (STEP trial) was to compare the efficacy of the polymer-based FemoSeal® vascular closure device (VCD) and the suture-based ProGlide® VCD in achieving hemostasis at the femoral access site after lower-limb arterial endovascular revascularization. STEP was a multicenter randomized clinical trial including patients undergoing lower-limb arterial endovascular revascularization. The primary endpoint was technical success 5h after the VCD intervention, defined as achievement of hemostasis without the need for a follow-up intervention at the access site and without a 2-g/dL drop in hemoglobin. Between December 2017 and April 2019, 113 patients were assigned to the FemoSeal® group (FS) and 117 to the ProGlide® group (PG). VCD interventions were technically successful for 90 FS patients (80%) and 58 PG patients (50%) (odds ratio, 3.98; 95%CI, 2.22 to 7.14; p < 0.0001). This difference in success rates between FS and PG is partly explained by more frequent recourse to manual compression (FS: n = 19; PG: n = 45) and an additional VCD (FS: n = 0; PG: n = 23) in the latter group. After 5h, 87% of FS patients and 69% of PG patients resumed ambulation (odds ratio: 3.07; 95%CI: 1.93 to 6.15; p = 0.0016). In patients undergoing lower-limb arterial endovascular revascularization, FemoSeal® was superior to ProGlide® in terms of technical success. Step trial was registered on http://ClinicalTrials.gov (NCT03192033).

Secondary Femoral Access Hemostasis During Transcatheter Aortic Valve Replacement: Impact of Vascular Closure Devices.

Vascular and bleeding complications related to secondary femoral access site are frequent in patients undergoing transcatheter aortic valve replacement (TAVR), and their occurrence is associated to poorer outcomes. We aimed to evaluate the clinical impact of vascular closure devices (VCDs) for secondary femoral access hemostasis in TAVR procedures. This was a multicenter study including 4031 patients who underwent TAVR (mean age, 81 ± 8 years; mean Society of Thoracic Surgeons [STS] score, 4.9 [interquartile range, 3.3-7.6]), and had a secondary femoral access. The 30-day clinical outcomes were analyzed according to femoral access-site hemostasis (manual compression vs VCD), and according to the type of VCD (Perclose [Abbott Cardiovascular] vs Angio-Seal [Terumo Interventional Systems]) using a propensity-matched, multivariable, logistic regression model. Manual compression was used in 941 patients (23.3%) and VCDs were used in 3090 patients (76.7%; Perclose in 1549 patients [38.4%] and Angio-Seal in 1541 patients [38.2%]) for secondary femoral access hemostasis. Vascular complications related to secondary access site occurred in 162 patients (4%), and were more frequent in patients who underwent manual compression (7.2%) compared with VCD hemostasis (3%; adjusted P<.001). In the VCD group, the use of Angio-Seal (vs Perclose) was associated with a higher rate of vascular complications (3.7% vs 2.4%, respectively; adjusted P=.02), femoral artery pseudoaneurysm (1.3% vs 0.4%, respectively; adjusted P<.01), invasive treatment requirement for treating vascular complications (surgery: 0.8% vs 0.3%, respectively [adjusted P=.03]; and thrombin injection: 0.9% vs 0%, respectively [adjusted P<.001]). VCDs represented a safer and more effective alternative compared with manual compression for secondary femoral access-site hemostasis in patients undergoing TAVR procedures, and the Perclose VCD was associated with the lowest risk of vascular complications. Future randomized studies are warranted.

Clinical outcomes of leadless pacemaker: a systematic review.

Introduction Transvenous pacemakers are associated with a significant amount of complications. Leadless pacemakers (LP) are emerging as an alternative to conventional devices. This article provides a systematic review of patient eligibility, safety and clinical outcomes of the LP devices. Evidence acquisition A systematic search for articles describing the use of LP was conducted. Out of two databases, 24 articles were included in the qualitative analysis. These articles comprised a total of 4739 patients, with follow-up times of 1-38 months. Further information was obtained from 10 more studies. Evidence synthesis From a population of 4739 patients included in the qualitative analysis, 4670 LP were implanted with success (98.5%). A total of 248 complications were described (5.23%) during the follow-up. The most common were pacing issues such as elevated thresholds, dislodgements or battery failure (68 patients), events at the femoral access site such as hemorrhage, hematoma or pseudoaneurysms (64 patients) and procedure related cardiac injuries such as cardiac perforation, tamponade or pericardial effusion (47 patients). There were 360 deaths during the follow-up and 11 were described as procedure or device related. Four studies presented the strategy of using a combined approach of atrioventricular node ablation (AVNA) and LP implantation. Conclusions Leadless pacemakers seem to have a relatively low complication rate. These devices may be a good option in patients with an indication for single-chamber pacing, in patients with conditions precluding conventional transvenous pacemaker implantations. Studies directly comparing LP and transvenous pacemakers and data on longer follow-up periods are needed.

Abstract No. 76 ▪ FEATURED ABSTRACT Intravascular ultrasound-guided transvenous biopsy of retroperitoneal targets inaccessible by percutaneous iopsy: technique and initial clinical experience

Retroperitoneal lymph nodes and masses adjacent to the inferior vena cava (IVC) or iliac veins can be inaccessible by a conventional percutaneous needle biopsy (PNB) approach due to surrounding vascular and osseous structures. The purpose of this study was to report initial clinical experience with the use of intravascular ultrasound-guided transvenous biopsy (IVUS-TVB) of difficult to access extravascular lymph nodes and masses. From October 2018 to August 2020, 41 IVUS-TVB procedures were performed under fluoroscopy in 38 patients (n = 19 males, mean age = 63) using side viewing intracardiac echocardiography IVUS catheters (ViewFlex Xtra, St. Jude Medical) and 18-gauge transjugular liver biopsy kits (Argon) through separate 10 French sheaths. All cases were initially reviewed for feasibility by PNB but were deemed unacceptably high risk. Patient demographics, target locations and sizes, success rates, and 30-day complications were recorded. Forty biopsies were performed, and 1 lesion was determined to be a vascular malformation by IVUS. Lymph nodes were interaortocaval (n = 11), porta hepatis (n = 5), right paracaval (n = 3), retrocaval (n = 3), iliac chain (n = 3), and retrocrural (n = 2), and masses were in liver (caudate n = 2, dome n = 2, segment 6 n = 2), right adrenal (n = 3), pancreas (n = 2), aortic wall (n = 1) and IVC (n = 1). The average short axis size was 2.6 cm (range 1.0-6.8). IVUS access was jugular (n = 27) or femoral (n = 13), and biopsy access was jugular (n = 28), femoral (n = 11), or portal (n = 1) with passes made from the IVC (n = 37), iliac (n = 2), or portal vein (n = 1). In 32 procedures (80%) IVUS visualization was good. Final pathology was diagnostic of malignancy in 29 procedures (73%), correctly excluded malignancy in 4 (10%), and was non-diagnostic in 7 (18%) with subsequent diagnosis made via repeat IVUS-TVB (n = 3) or surgical biopsy (n = 2) or remaining unknown (n = 2). There were 3 minor complications requiring no treatment (hyperbilirubinemia attributed to hemobilia; contrast induced acute kidney injury; small non-occlusive IVC thrombus at the biopsy site). There was 1 major complication directly related to the biopsy (bleeding at the femoral vein access site requiring transfusion) and 1 other major complication (aortic pseudoaneurysm in a patient with preexisting salmonella aortitis). IVUS-TVB achieves high diagnostic yields similar to accepted thresholds for PNB. Complications rates may be higher but should be weighed relative to the risks of difficult PNB, surgical biopsy, or clinical management without biopsy.