Radiofrequency guidewire-facilitated recanalization of chronic thoracic central venous occlusions in hemodialysis patients.

PURPOSE: To assess the outcome and safety of radiofrequency (RF) wire recanalization in patients with end-stage renal disease (ESRD) and chronic central venous occlusions (CVO). MATERIALS AND METHODS: A retrospective review of ESRD patients who underwent RF-wire recanalization of symptomatic chronic thoracic CVO from January 2017 to August 2022 yielded 20 patients who underwent 21 procedures. All patients had undergone at least one prior unsuccessful attempt at central venous recanalization using conventional catheter-based techniques. Technical success was defined by the ability to cross the CVO using RF-wire recanalization enabling endovascular treatment. Access circuit patency was evaluated based on follow-up imaging and symptomatic improvement. RESULTS: Radiofrequency wire recanalization was successful in 17/21 procedures (81%) with all patients (100%) reporting resolution of arm ± facial swelling. Three major complications occurred (14%): two hemothoraces and one hemopericardium. Medial stent diameter was 13 mm (range, 9-14 mm). Mean duration of hospital stay was 2 days ± 3 days. Mean procedure time was 158 ± 46 min with a mean fluoroscopy time of 31.7 ± 16.3 min. Primary unassisted patency at 6 and 12 months was 94 ± 6% and 85 ± 10%, respectively. Additional interventions resulted in significantly increased stent graft patency (P = 0.006). CONCLUSION: Radiofrequency wire-enabled recanalization of CVO in symptomatic dialysis patients has a high rate of technical success with resolution of arm and facial swelling and resumed use of the ipsilateral dialysis access. Although a superior safety profile was seen than with needle-based techniques such as sharp recanalization, major complications were not infrequent indicating that this RF-wire procedure should be performed in centers equipped to manage central venous perforations.

Percutaneous Management of Dialysis Access Steal Syndrome: Interventions and Outcomes from a Single Institution's 20-Year Experience.

PURPOSE: To determine safety and effectiveness of percutaneous interventions performed by interventional radiologists at a single institution over 2 decades in patients with dialysis access steal syndrome (DASS). MATERIALS AND METHODS: A retrospective review of fistulograms from 2001 to 2021 (N = 11,658) was performed. In total, 286 fistulograms in 212 patients with surgically created dialysis accesses met inclusion criterion of fistulography for suspected DASS. Chart review collected data regarding patient demographics, comorbidities, access characteristics, fistulography findings, intervention(s) performed, and outcomes. Procedures with and without DASS intervention were compared. Odds ratios (ORs), adjusted for age, sex, comorbidities, access characteristics, and multiple within-patient events, were calculated using logistic regression to determine associations between steal intervention status and outcome variables: (a) major adverse events, (b) access preservation, and (c) follow-up surgery. A percutaneously treatable cause of DASS was present in 128 cases (45%). Treatment of DASS lesions was performed in 118 cases. Fifteen embolizations were also performed in patients without DASS lesions. RESULTS: Technical success of DASS interventions, defined by the Society of Interventional Radiology (SIR) reporting standards, was 94%; 54% of interventions resulted in DASS symptom improvement at a median follow-up of 15 days. Patients with steal intervention had 60% lower odds of follow-up surgery (OR, 0.4; P = .007). There was no difference in major adverse events (P = .98) or access preservation (P = .13) between groups. CONCLUSIONS: In this retrospective cohort study, approximately half of DASS fistulograms revealed a percutaneously treatable cause of steal. Over half of DASS interventions resulted in symptomatic relief. Percutaneous intervention was associated with lower odds of follow-up surgery without compromising access preservation.

Association between End-Stage Renal Disease and Major Adverse Limb Events after Peripheral Vascular Intervention.

PURPOSE: To examine the effect of end-stage renal disease (ESRD) on the likelihood of major adverse limb events (MALEs) in patients with Rutherford Category 4-6 critical limb ischemia (CLI) who underwent percutaneous vascular intervention (PVI). MATERIALS AND METHODS: Two contemporaneous cohorts of patients who underwent PVI for symptomatic CLI from 2012 to 2022, differing in ESRD status, were matched using propensity score methods. This database identified 628 patients who underwent 1,297 lower extremity revascularization procedures; propensity score matching yielded 147 patients (180 limbs, 90 limbs in each group). Kaplan-Meier and Cox proportional hazard analyses were used to assess the effect of ESRD status on MALEs, stratified into major amputation (further stratified into above-knee amputation and below-knee amputation [BKA]) and reintervention (PVI or bypass). RESULTS: After PVI, 31.3% of patients in the matched cohorts experienced a MALE (45.7% ESRD vs 18.2% non-ESRD), and 15.6% experienced a major amputation (27.1% ESRD vs 5.2% non-ESRD). Cox proportional hazards analysis revealed that ESRD was an independent predictor of MALE (hazard ratio [HR], 3.15; 95% CI, 1.58-6.29; P = .001), major amputation (HR, 7.00; 95% CI, 2.06-23.79; P = .002), and BKA (HR, 7.56; 95% CI, 1.71-33.50; P = .008). CONCLUSIONS: ESRD is strongly predictive of MALE and major amputation risk, specifically BKA, in patients undergoing PVI for Rutherford Category 4-6 CLI. These patients warrant closer follow-up, and new methods may become necessary to predict and further reduce their amputation risk.

Dialysis Access-Associated Steal Syndrome and Management.

Dialysis-associated steal syndrome (DASS) occurs in 1-8% of hemodialysis patients with arteriovenous (AV) access. Major risk factors include use of the brachial artery for access creation, female sex, diabetes, and age > 60 years. DASS carries severe patient morbidity including tissue or limb loss if not recognized and managed promptly, as well as increased mortality. Diagnosis of DASS requires a directed history and physical exam supported by non-invasive testing. Prior to definitive therapy, detailed arteriography, fistulography, and flow measurements are performed to delineate underlying etiologies and guide management. To optimize success, DASS treatment should be individualized according to access location, underlying vascular disease, flow dynamics, and provider expertise. Possible causes of DASS include extremity inflow or outflow arterial occlusive disease, high AV access flow rate, and reversal of distal extremity arterial blood flow; DASS may also exist without any of the prior features. Depending on the DASS etiology, various endovascular and/or surgical interventions should be considered. Regardless, in the majority of patients presenting with DASS, access preservation can be achieved.

Endovascular creation of hemodialysis arteriovenous fistulae: the current status and future perspective-a literature review.

Background and Objective: End-stage renal disease (ESRD) is increasingly prevalent among Americans. Traditionally, the gold standard of dialysis fistulae creation is surgical arteriovenous fistulae (AVF), which is preferred over central venous catheter (CVC) and arteriovenous graft (AVG). However, it is associated with many challenges, particularly its high primary failure rate, which is partially attributed to neointimal hyperplasia. Endovascular creation of arteriovenous fistulae (endoAVF) is a recently emerging method, and is thought to circumvent many of the surgical challenges. It is theorized to reduce the peri-operative trauma to the vessel, thus reducing the amount of neointimal hyperplasia. In this article, we aim to review the current status and future perspectives of endoAVF. Methods: An electronic search was performed on MEDLINE and Embase to identify relevant articles from 2015 to 2021. Key Content and Findings: The initial trial data has been promising, resulting in the increased adoption of endoAVF devices in clinical practice. Further, short- and mid-term data has shown that endoAVF has been associated with good maturation rate, re-intervention rate, primary and secondary patency rates. In comparison to historical surgical data, endoAVF has been shown to be comparable in certain aspects. Lastly, endoAVF has been used in an increasing range of clinical applications, including wrist AVF and two-stage transposition procedure. Conclusions: Although current data has been promising, endoAVF is associated with a host of unique challenges, and the current data has mostly been derived from selective patient population. Further studies are required to further assess its usefulness and its role in the dialysis care algorithm.

Outcomes of Transarterial Embolization for Acute Nonvariceal Upper Gastrointestinal Bleeding: Correlation with Periprocedural Endoscopy.

PURPOSE: To evaluate gastric and intestinal mucosal changes on postembolic endoscopy and mortality after transarterial embolization (TAE) for upper gastrointestinal bleeding (UGIB). MATERIALS AND METHODS: An institutional review board-approved retrospective review of patients who underwent arteriography for refractory UGIB at a multicenter health system from December 2003 to August 2019 was performed. Two hundred sixty-nine patients underwent TAE for UGIB. Data on etiology of bleeding, embolization technique, pre-embolic and postembolic endoscopic results, blood product requirements, and mortality were collected from the medical record. Endoscopy results were compared at the site of the target lesion before and after TAE. Multivariable logistic regressions were performed to assess predictors of new adverse mucosal responses and mortality. RESULTS: The most common etiology of UGIB was peptic ulcer. Twenty-five percent (n = 68) of the patients had clinical evidence of rebleeding after TAE, and the 30-day mortality rate was 26% (n = 73). Eighty-eight (32%) patients underwent post-TAE endoscopy, with only 15% showing new adverse mucosal changes after embolization. Procedural characteristics, including vascular territory and embolic choice, were not significantly predictive of increased risk of development of adverse mucosal response after TAE or increased mortality risk. No patients in the study were found to have bowel lumen stenosis at the time of post-TAE endoscopy or at 6 year follow-up. CONCLUSIONS: TAE is a safe and effective intervention for patients with UGIB. Post-TAE endoscopy demonstrated that most patients had either stability or improvement in the target lesion after TAE, and only a minority of patients demonstrated adverse mucosal changes.

Preintervention Computed Tomography Improves the Performance of Endovascular Intervention in Patients with Abdominopelvic Trauma.

PURPOSE: To evaluate the role of computed tomography (CT) and CT angiography in guiding endovascular arteriography (EA) and embolization in hemodynamically (HD) stable and unstable patients with abdominal and/or pelvic (AP) trauma. MATERIALS AND METHODS: A retrospective review was performed of patients with AP trauma who underwent EA with or without embolization (from January 2012 to August 2020) at an urban, level I trauma center. Patients aged <18 years or those undergoing EA outside of the abdomen and/or pelvis were excluded. Demographics, imaging findings, procedure length, contrast agent administration, laboratory values, and outcomes were compared on the basis of preprocedural imaging technique and hemodynamic status. RESULTS: A total of 190 patients with AP trauma underwent EA with or without embolization; among them, 123 were HD stable and underwent CT/CT angiography, whereas 67 were initially HD unstable and underwent operative management prior to EA. Of these patients, 38 underwent CT/CT angiography after hemodynamic stability was achieved prior to postoperative EA. The incidence of therapeutic embolization for arterial injury on EA was significantly higher in patients with preprocedural CT/CT angiography (65.8% vs 44.8%, P = .04). The positive and negative predictive values of CT angiography for arterial injury at the time of EA were 92.3% and 100%, respectively. Prior imaging was associated with a reduced contrast agent requirement at the time of EA and reduced transfusion requirement (P = .05 and P = .02). No significant differences were observed in adverse outcomes for patients undergoing preprocedural imaging. CONCLUSIONS: CT or CT angiography prior to EA for HD stable and unstable patients with AP trauma may improve the likelihood of therapeutic embolization and enable improved procedure metrics without increasing adverse outcomes.

Transjugular intrahepatic portosystemic shunt for the management of symptomatic malignant pseudocirrhosis.

Background: Pseudocirrhosis is defined by radiologic changes of the liver parenchyma secondary to metastatic disease and/or cancer treatments, and portends a high rate of morbidity and mortality from sequelae of portal hypertension. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment for portal hypertension; however, TIPS is relatively contraindicated in the setting of hepatic metastases. The study aims to determine the technical efficacy and clinical outcomes of patients undergoing TIPS for symptomatic pseudocirrhosis. Methods: Retrospective analysis of patients with hepatic malignancy who underwent TIPS between 2008 and 2020 at a single tertiary care center. Patients with imaging findings of pseudocirrhosis and without history of primary liver malignancy or confounding causes of cirrhosis were included. West Haven scores assessing hepatic encephalopathy were obtained from chart review. Technical success was defined as successful TIPS creation with reduction in the portosystemic gradient (PSG). Clinical success was defined as resolution of variceal bleeding and/or ascites. Results: Nine patients (4 female/5 male), average (± SD) age 61.2±9.5 years with metastatic pseudocirrhosis were included for analysis. Primary malignancy was colorectal adenocarcinoma (n=5), neuroendocrine tumor (n=3), and malignant endothelial hemangioendothelioma (n=1). Average Model for End Stage Liver Disease (MELD-Na) score was 15.7±3.7. Technical success was 8/9 (89%) with average PSG reduced from 23.5±11.0 to 6.5±2.8 mmHg (P=0.001). Clinical success was 6/9 (67%). Two patients required TIPS revision after initial clinical success. Mild-moderate HE occurred in 6/9 patients post TIPS (67%), with a highest West Haven score of 2. Time from TIPS to death for acute variceal bleeding and ascites was 4.9±4.2 and 12±16.5 months, respectively. Cause of death was disease progression (n=5), variceal bleeding (n=1), or unavailable (n=2). Conclusions: TIPS in the setting of malignant pseudocirrhosis can be created safely with similar clinical outcomes to TIPS performed for benign disease. Rates of low-grade hepatic encephalopathy may be higher amongst patients undergoing TIPS for pseudocirrhosis.

Discovery of signatures of fatal neonatal illness in vital signs using highly comparative time-series analysis.

To seek new signatures of illness in heart rate and oxygen saturation vital signs from Neonatal Intensive Care Unit (NICU) patients, we implemented highly comparative time-series analysis to discover features of all-cause mortality in the next 7 days. We collected 0.5 Hz heart rate and oxygen saturation vital signs of infants in the University of Virginia NICU from 2009 to 2019. We applied 4998 algorithmic operations from 11 mathematical families to random daily 10 min segments from 5957 NICU infants, 205 of whom died. We clustered the results and selected a representative from each, and examined multivariable logistic regression models. 3555 operations were usable; 20 cluster medoids held more than 81% of the information, and a multivariable model had AUC 0.83. New algorithms outperformed others: moving threshold, successive increases, surprise, and random walk. We computed provenance of the computations and constructed a software library with links to the data. We conclude that highly comparative time-series analysis revealed new vital sign measures to identify NICU patients at the highest risk of death in the next week.

Atherosclerotic Renovascular Disease: A KDIGO (Kidney Disease: Improving Global Outcomes) Controversies Conference.

The diagnosis and management of atherosclerotic renovascular disease (ARVD) is complex and controversial. Despite evidence from the ASTRAL (2009) and CORAL (2013) randomized controlled trials showing that percutaneous renal artery revascularization did not improve major outcomes compared with best medical therapy alone over 3-5 years, several areas of uncertainty remain. Medical therapy, including statin and antihypertensive medications, has evolved in recent years, and the use of renin-angiotensin-aldosterone system blockers is now considered the primary means to treat hypertension in the setting of ARVD. However, the criteria to identify kidneys with renal artery stenosis that have potentially salvageable function are evolving. There are also data suggesting that certain high-risk populations with specific clinical manifestations may benefit from revascularization. Here, we provide an overview of the epidemiology, diagnosis, and treatment of ARVD based on consensus recommendations from a panel of physician experts who attended the recent KDIGO (Kidney Disease: Improving Global Outcomes) Controversies Conference on central and peripheral arterial diseases in chronic kidney disease. Most focus is provided for contentious issues, and we also outline aspects of investigation and management of ARVD that require further research.

Retrospective Analysis of 77 Hemodialysis Patients Shows No Cases of Steal Syndrome from Graft Taper Reduction.

PURPOSE: To review the immediate flow response and incidence of steal syndrome after taper reduction of tapered dialysis grafts. MATERIAL AND METHODS: This was a retrospective review of a quality assurance database of all hemodialysis access interventions performed between 2005 and 2017. It identified 77 patients who underwent a taper reduction procedure, involving angioplasty of the arterial limb of the graft and the arterial anastomosis for graft thrombosis/poor flow. A subset of patients underwent 5-, 6-, or 7-mm balloon taper reduction angioplasty coupled with intravascular direct flow measurement (n = 15 with 16 dialysis grafts). A two-tailed Wilcoxon matched-pairs signed-rank test was used to compare pre- and post-taper reduction flows. Mean duration of follow-up was 3.5 years (range, 0-12.5 years). RESULTS: Mean access survival after taper reduction was 20.2 months (range, 0.10-94.4 months). Pre- and post-taper reduction access flows (mean Qb ± standard deviation) were 574 ± 315 ml/min and 929 ± 352 ml/min, respectively (P < .0001). The mean ratio of post- to pre-taper reduction flows was 1.6 (range, 1.1-10.2). No patients developed steal syndrome within 6 months after taper reduction. CONCLUSIONS: Dialysis graft arterial anastomotic taper reduction did not result in the development of steal syndrome within 6 months. In the subset of patients who underwent flow measurements, taper reduction was associated with nearly a 2-fold improvement in access flow, which is a key predictor of access function.

Safety and Efficacy of Arterial Closure Devices Following Antegrade Femoral Access: A Case-Control Study.

PURPOSE: Vascular closure device (VCD) use following antegrade femoral access may present unique challenges relative to retrograde access. We retrospectively compared safety and efficacy of these devices between antegrade and retrograde patient cohorts undergoing percutaneous intervention. MATERIALS AND METHODS: Over a 5-year period, a consecutive series of 107 limbs in 84 patients underwent VCD arteriotomy closure following percutaneous revascularization using an antegrade approach (VCD-A). Device deployment success rates, time to ambulation, and complication rates were compared to a contemporaneous control group of 401 limbs in 305 patients who underwent closure following retrograde access (VCD-R) during revascularization or embolization procedures. RESULTS: Closure was attempted in VCD-A using 53 StarClose, 35 Perclose, and 19 Angio-Seal devices. Hemostasis (without supplemental manual compression) was achieved in 86/107 (80.4%) limbs. Closure was attempted in VCD-R using 215 StarClose, 119 Perclose, and 67 Angio-Seal devices with hemostasis in 357/401 (89.0%) limbs. Device deployment failure occurred in 7/107 (6.5%) of VCD-A and 20/401 (5.0%) of VCD-R (P = .52), independent of specific device type. Femoral pseudoaneurysm developed in 1/107 and 1/401 of VCD-A and VCD-R (P = .31), and minor hematoma developed in 3/107 and 8/401 of the VCD-A and VCD-R (P = .61). Mean time to ambulation was 204.1 minutes in VCD-A and 204.8 minutes in VCD-R (P = .97). CONCLUSION: Antegrade femoral closure was associated with high rates of technical success and low complications, similar to retrograde closure. Time to ambulation was the same in both groups despite higher heparin doses in the antegrade patients.

Comparison of Clinical Performance of VectorFlow and Palindrome Symmetric-Tip Dialysis Catheters: A Multicenter, Randomized Trial.

PURPOSE: To compare clinical performance of 2 widely used symmetric-tip hemodialysis catheters. MATERIALS AND METHODS: Patients with end-stage renal disease initiating or resuming hemodialysis were randomized to receive an Arrow-Clark VectorFlow (n = 50) or Palindrome catheter (n = 50). Primary outcome was 90-d primary unassisted catheter patency. Secondary outcomes were Kt/V ([dialyzer urea clearance × total treatment time]/total volume of urea distribution), urea reduction ratio (URR), and effective blood flow (QB). RESULTS: Primary unassisted patency rates with the VectorFlow catheter at 30, 60, and 90 d were 95.5% ± 3.3, 87.2% ± 7.3, and 80.6% ± 9.8, respectively, compared with 89.1% ± 6.2, 79.4% ± 10.0, and 71.5% ± 12.6 with the Palindrome catheter (P = .20). Patients with VectorFlow catheters had a mean Kt/V of 1.5 at 30-, 60-, and 90-day time points, significantly higher than the mean Kt/V of 1.3 among those with Palindrome catheters (P = .0003). URRs were not significantly different between catheters. Catheter QB rates exceeded National Kidney Foundation-recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min). Catheter failure, ie, poor flow rate requiring guide-wire exchange or removal, within the 90-day primary outcome occurred in 3 VectorFlow subjects and 5 Palindrome subjects (P = .72). Infection rates were similar, with 0.98 infections per 1,000 catheter days for VectorFlow catheters compared with 2.62 per 1,000 catheter days for Palindrome catheters (P = .44). CONCLUSIONS: The 90-day primary patency rates of Palindrome and VectorFlow catheters were not significantly different, and both achieved sustained high QB through 90 day follow-up. However, dialysis adequacy based on Kt/V was consistently better with the VectorFlow catheter versus the Palindrome.

Impact of PTFE-covered stent position and extension on TIPS patency.

PURPOSE: The objectives of this study were to determine the effects of expanded polytetrafluoroethylene (PTFE)-covered stent location and TIPS extension on primary patency. METHODS: This retrospective cohort study examined patients with PTFE-covered TIPS creation between 07/2002 and 06/2016. Clinical information and patency outcomes at 24 months were extracted. At TIPS creation, extension was performed at the discretion of the operator. Kaplan-Meier curves of primary patency were generated with conditional variables of HVO-HCJ distance, extension status, and covered versus uncovered extensions. Additional logistic regression analyses of distances were performed. RESULTS: Of 393 patients, 115 patients (29%) underwent stent extension, 79 (20% of total cohort) of which were at the HVO end alone. Primary patency for all TIPS was 75%, 68%, and 54% at 3, 6, and 12 months. The data endpoint were transplant or death in 92 (23%) and 116 (30%). Kaplan-Meier curves showed no statistically significant difference between the variables and primary patency at 12 and 24 months: distance up to versus greater than 10 mm (p = 0.32, 0.81); extension versus no extension (p = 0.83, 0.85); uncovered versus covered extensions (p = 0.58, 0.70). Logistic regression analyses showed a trend toward statistical significance. CONCLUSION: In the setting of PTFE-covered TIPS creation, extended TIPSs and unextended well-positioned TIPSs have no difference in primary patency rates. Stent position and extension length may have an effect on primary patency, but were likely obscured by "user recognition" effects.

Diagnosis and Treatment of Nonmaturing Fistulae for Hemodialysis Access via Transradial Approach: A Case-Control Study.

PURPOSE: To compare outcomes of transradial access for endovascular treatment of nonmaturing hemodialysis fistulae compared to brachial arteriography followed by unidirectional or bidirectional fistula access for intervention. MATERIALS AND METHODS: In this institutional review board-approved, retrospective, case-control study, 56 consecutive patients with nonmaturing arteriovenous fistulae underwent percutaneous intervention between 2015 and 2018. The transradial group (n = 28) underwent radial artery access for diagnostic fistulography and intervention. The control group (n = 28) underwent retrograde brachial artery access for fistulography followed by unidirectional/bidirectional fistula access for intervention. Both groups had similar demographics, fistula characteristics, and stenosis locations. RESULTS: Fewer punctures were required in the transradial group compared to controls (1.2 vs 2.4, P < .0001), and procedure time was shorter (64.9 vs 91.3 minutes, P = .0016). Anatomic, technical, and clinical success rates trended higher in the transradial group compared to controls (93% vs 86%, 96% vs 89%, and 82% vs 64%, respectively). Nonmaturation resulting in fistula abandonment was lower in the transradial group (3.7% vs 25%, P = .025). Primary unassisted patency at 3, 6, and 12 months was 77.1% ± 8.2%, 73.1% ± 8.7%, and 53.3% ± 10.6% in the transradial group, respectively, and 63.0% ± 9.3%, 55.6% ± 9.6%, and 48.1% ± 9.6% in the control group, respectively (P = .76). Primary assisted patency at 12 months was 92.3% ± 5.3% in the transradial group compared to 61.8% ± 9.6% at 12 months in the control group (P = .021). No major complications occurred. Minor complications were lower in the transradial group than in the control group (14% vs 39%, P = .068). CONCLUSIONS: Treatment of nonmaturing fistulae via a transradial approach was safe, improved midterm patency, and was associated with lower rates of fistula abandonment.

Randomized Trial of Radial Hemostasis Using Focused vs Balloon Compression Devices.

BACKGROUND: Radial artery hemostasis devices differ in compression mechanisms, which may influence time to hemostasis and hand perfusion. METHODS: Subjects (n = 52) undergoing transradial diagnostic coronary catheterization or percutaneous coronary intervention (PCI) were randomized 1:1 to either focused compression (VasoStat; Forge Medical) or balloon compression device (TR Band; Terumo Medical) for radial artery hemostasis. Time to complete hemostasis enabling device removal was measured in each subject. Hand perfusion was quantitated using the perfusion index (PI) with oximetry (1) before; (2) during device use; (3) during device use with ulnar artery compression; and (4) following device removal. RESULTS: Focused compression resulted in a significantly shorter time to complete hemostasis vs balloon compression (208 min [IQR, 115-320 min] vs 242 min [IQR, 120-439 min], respectively; P=.04). This difference was greatest among the subset undergoing PCI, where the VasoStat resulted in a 43-minute reduction until complete hemostasis (P=.04). Baseline PI was similar between the focused and balloon compression groups (4.9 vs 3.9, respectively; P=.09). Focused compression resulted in a similar reduction in median PI from baseline to during device use compared with balloon compression (-27% vs -18%, respectively; P=.26). Both devices decreased PI over 50% from baseline during simultaneous ulnar artery compression (P<.01), and increased PI over 50% from baseline following device removal (P=.02). No radial artery occlusion occurred, and rates of device manipulation and access-site bleeds were low in both groups. CONCLUSION: Complete hemostasis was achieved earlier with the VasoStat focused compression device compared with the TR Band balloon compression device. Both devices transiently reduced hand perfusion, particularly during ulnar compression, which increased from baseline following device removal. Larger trials comparing these radial hemostasis devices and outcomes are warranted.

Nonfemoral Arterial Hemostasis Following Percutaneous Intervention Using a Focused Compression Device.

PURPOSE: Upper extremity and tibiopedal arterial access are increasingly used during endovascular therapies. Balloon compression hemostasis devices in these anatomic locations have been described, but most utilize a compression surface extending well beyond the puncture site. We report single-center experience with an arterial puncture-focused compression device following upper extremity and tibiopedal access. PATIENTS AND METHODS: A series of 249 focused compression hemostasis devices (VasoStat, Forge Medical, Bethlehem, Pennsylvania, USA) were used in 209 patients following lower extremity (n = 63) and upper extremity (n = 186; radial: 90%) arterial access procedures using 4-7 French sheaths. Demographic, operative, and follow-up data were collected. Logistic regression was used to evaluate potential association between patient/operative variables and time to hemostasis. RESULTS: Primary hemostasis was achieved in 97.2% (242/249) following sheath removal; in 7 cases (2.8%) puncture site oozing occurred after initial device removal and required reapplication. Secondary hemostasis was 100% (249/249). Seven complications (2.8%) were recorded: 5 minor hematomas (2%) and 2 transient access artery occlusions (0.8%). Mean time to hemostasis enabling device removal was 55 ± 28 min. Elevated body mass index (BMI) was not associated with increased time to hemostasis (p = 0.31). Accessed artery, sheath size, and heparin dose were also not associated with time to hemostasis (p = 0.64; p = 0.74; p = 0.75, respectively). CONCLUSIONS: The focused compression hemostasis device enabled rapid hemostasis with a low complication rate. Time to hemostasis was independent of BMI, access site, sheath size, or heparin dose.