Nonfemoral Arterial Hemostasis Following Percutaneous

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L X Barrette et al Nonfemoral Arterial Hemostasis Following Percutaneous Intervention Using a 715. tibioperoneal arterial access although published outcomes or dorsalis pedis or upper extremity radial ulnar or. are generally limited to their indicated use for radial artery brachial arterial access followed by use of the VasoStat. hemostasis Band devices employing balloon compression device to achieve hemostasis the VasoStat is FDA cleared. or compressive plates such as the TR Band Terumo and CE marked for upper extremity arterial and tibioper. Somerset NJ SafeGuard Radial compression device oneal hemostasis Patient demographic and operative data. Merit Medical South Jordan UT Zephyr Device Ad were collected data were accessed and protected according. vanced Vascular Devices Milwaukie OR and the Radi to institutional protocols for retrospective clinical studies. stop Abbott Vascular Santa Clara CA have been used to Operators were attending interventional radiologists and. achieve hemostasis following radial artery access 12 15 interventional radiology fellows working at a single insti. These devices apply broad C 6 cm2 area of compression tution In accordance with institutional practice all acces. force over the volar surface of the wrist and may inad sed arteries were also evaluated prior to upper extremity. vertently compress the ulnar artery or overly compress the and transpedal access using ultrasound to measure vessel. radial artery which are potential contributors to radial diameter using electronic calipers Ultrasound guided. artery occlusion RAO and patient discomfort 16 18 micropuncture access was used in all patients VasoStat use. RAO has been reported in up to 8 31 of procedures using was according to the manufacturer s instructions for use. these devices for radial hemostasis when assessed by patent hemostasis technique was used for all device. ultrasound 4 19 23 A randomized control trial of the TR applications With the sheath still in place at the conclusion. Band and Radistop demonstrated early RAO rates of 8 9 of the interventional procedure the adhesive base of the. and 9 6 as well as long times to hemostasis of 5 3 and device was aligned over clean and dry skin so that the. 4 8 h respectively 13 Moreover achieving hemostasis aperture of the base was centered over the point of arterial. after tibiopedal access an approach useful in traversing entry The base was then secured to the skin with gentle. infrainguinal stenoses in patients with critical limb ische pressure applied over the adhesive wings Next the fen. mia is not currently cleared by the Food and Drug estrated elastomeric adhesive band was adhered over the. Administration for most existing radial compression devi aperture of the base and circumferentially applied around. ces including the TR Band the upper or lower extremity The compressive plunger of. The VasoStat hemostasis device Forge Medical Inc the device was inserted into the base of the device and. Bethlehem PA recently introduced in the United States progressive pressure applied through the integrated ratch. and Japan was developed to address several limitations of eting mechanism to apply initial compression to the. existing hemostasis devices by utilizing more focused puncture site Next as the sheath was withdrawn additional. B 2 cm2 area of compression and mechanically graded 2 4 ratchet positions of compression determined by. compression of the artery to achieve hemostasis Fig 1 patient anatomy were applied with the device to achieve. The VasoStat device is FDA cleared and CE marked for puncture site hemostasis The pulse distal to the device was. hemostasis after both upper extremity and transpedal then verified with palpation and or duplex ultrasound if the. access and its focused compression mechanism may lead pulse was weak or absent the compression was released by. to more rapid hemostasis compared to larger compression a single ratchet position to enable return of the pulse This. surfaces by band devices such as the TR Band 24 26 maneuver was repeated as needed in 1 ratchet increments. This study investigated the use of the focused compression to ensure patency of the accessed artery during device. device following upper and lower extremity arterial access compression. and assessed patient and operative variables influencing Age sex and BMI were recorded as well as operative. times to hemostasis details including sheath size heparin dose fluoroscopy. time used as a proxy of procedural complexity and time. of hemostasis device placement Time to hemostasis, Patients and Methods enabling device removal was documented in the electronic. medical record Epic Verona Wisconsin by the inter, A prospectively maintained quality assurance database Hi ventional radiology nurses Nurses assessed the puncture. IQ Conexsys Lincoln RI identified over a 36 month site for device removal beginning 45 min following. period 249 focused compression devices VasoStat used in VasoStat placement by uncoupling the central compressive. 209 unique patients following upper and lower extremity plunger of the device by a single ratchet position If no. arterial access performed during upper and lower extremity puncture site bleeding was observed the plunger was. revascularization or visceral embolization procedures uncoupled an additional ratchet position the puncture site. Fig 1 This study was retrospective and received insti visually reassessed for hemostasis and the device removed. tutional IRB exemption Inclusion criteria were patients using gentle traction of the adhesive footplates If puncture. who underwent transpedal anterior tibial posterior tibial site oozing was observed the compressive plunger was. 716 L X Barrette et al Nonfemoral Arterial Hemostasis Following Percutaneous Intervention Using a. Fig 1 VasoStat Hemostasis Device A central convex compression elastomeric adhesive pad further maintains alignment over the arterial. surface provides graded puncture site compression using a ratcheting access site A B Isometric and front views of device C radial. mechanism incorporated within the base of the device An overlying D distal radial E combined posterior tibialis and dorsalis pedis. advanced a single ratchet position to stop bleeding and the cohorts were divided based on transpedal versus upper. puncture site was reassessed for device removal following extremity access of which 90 were radial and the. an additional 10 15 min remainder ulnar and brachial Time to hemostasis was. Complications related to VasoStat application were compared using Student s t test and analysis of variance. documented using a prospectively maintained quality ANOVA Rates of complications were compared using. assurance database and confirmed by comparison with Fisher s exact test Univariate and multivariate logistic. operative and IR clinic notes patients were seen in the IR regression was performed with Stata Stata College Sta. clinic within 30 days of each procedure during which the tion TX using the above cutoff values to explore associ. accessed artery was assessed with Doppler and or duplex ation between these variables and time to hemostasis. examination Arterial diameter at each access site was exceeding mean time for the entire patient cohort A p value. measured using electronic calipers from ultrasound images 0 05 was considered the threshold of statistical. in the picture archival and communication system PACS significance. Sectra AB Linko ping Sweden,Statistical Analysis Results. Time to hemostasis and complications were compared In a 36 month period a total of 186 upper extremity. between patient subsets based on BMI heparin dose arterial access sites and 63 tibiopedal arterial access sites. sheath size and arterial access site upper extremity versus had hemostasis achieved with the VasoStat hemostasis. lower extremity Patient subsets for BMI comparison were device Patient characteristics are listed in Table 1 and. separated based by BMI 30 kg m2 or BMI C 30 kg m2 procedural details in Table 2 Mean access artery diameters. Subsets for heparin dose were heparin B 3000 units the ranged from 2 1 to 2 9 mm excluding one peroneal artery. median heparin dose or heparin 3000 units Patient measuring 3 9 mm Table 3 Six patients underwent. subsets for sheath size were B 5 F and 6 F Access site radial artery access on the dorsum of the hand in the. L X Barrette et al Nonfemoral Arterial Hemostasis Following Percutaneous Intervention Using a 717. anatomic snuffbox with successful hemostasis achieved in hemostasis was achieved 2 8 In instances where con. all six cases Mean time to hemostasis using the VasoStat tinued puncture site oozing was noted the cumulative time. device for the entire patient cohort was 55 min S D to hemostasis was utilized for analysis after a another. 28 min When stratified by sheath size no significant VasoStat was applied and subsequently removed. differences in time to hemostasis were seen Table 4 Five Two cases of access artery occlusion developed within. minor hematomas developed which did not require further 30 days 0 8 Both cases of occlusion involved the radial. intervention 2 0 7 instances of continued oozing artery and presented without symptoms at routine 2 week. occurred from the puncture site after premature device IR clinic visits radial artery occlusion was diagnosed with. removal which were managed with VasoStat reapplication duplex ultrasound In both patients the radial artery. or supplemental manual compression until complete recanalized with duplex ultrasound confirmation within. an additional 30 days of puncture site follow up after one. patient received a 2 week course of rivaroxaban Xarelto. Table 1 Patient characteristics Johnson Johnson New Brunswick NJ and the other. Patient characteristic All patients n 249 patient received three weeks of aspirin and clopidogrel no. further intervention was required, Age mean SD year 60 0 14 7 Patient cohorts were divided by BMI access site sheath. BMI mean SD kg m2 30 6 8 5 size and heparin dose no significant differences were. Female sex 42 6 found between time to hemostasis in the subsets analyzed. Table 5 Univariate logistic regression was performed to. Table 2 Operative details Operative details n 249, Heparin units median 25 75th IQR range 3000 3000 5000 0 18 000.
Sheath size F 25 75th IQR range 5 5 5 4 7,Fluoroscopy time min mean S D 19 4 15 9. Time to hemostasis min mean S D 55 28,S D standard deviation. Table 3 Artery dimensions mean SD, Artery Number accessed Diameter mm Time to hemostasis min S D p value. Radial volar wrist 162 2 5 0 5 54 21 0 37a,Distal radial snuffbox 6 2 5 0 2 47 8. Ulnar 4 2 1 0 9 47 18,Brachial 14 2 9 0 9 68 44,Anterior tibialis 8 2 4 0 6 41 9.
Dorsalis pedis 31 2 3 0 5 56 26,Posterior tibialis 23 2 6 0 6 46 20. Peroneal 1 3 9 47,Analysis of Variance ANOVA,Requires more than two observations for analysis. Table 4 Time to hemostasis by Sheath size French Number Time to hemostasis min S D p value. sheath size,4 52 63 26 0 39a,5 152 51 22,6 44 49 19. t test combining 4 5 French versus 6 7 French to account for group size heterogeneity. 718 L X Barrette et al Nonfemoral Arterial Hemostasis Following Percutaneous Intervention Using a. Table 5 Patient subset times to Patient characteristic Mean time to hemostasis min p value. hemostasis,BMI 30 C 30 57 53 0 31, Access site Lower extremity upper extremity 53 56 0 62. Sheath size B 5 6 56 53 0 74,Heparin B 3000 3000 units 56 54 0 75.
Table 6 Univariate logistic Variable Odds ratio Standard error p value Confidence interval 95. regression analysis,Age 60 years 1 5 0 48 0 25 0 77 2 8. BMI 30 kg m2 0 66 0 22 0 21 0 34 1 3,Male female F 0 95 0 32 0 89 0 50 1 8. Access site upper versus lower 1 4 0 57 0 39 0 64 3 1. Sheath size 5 F 1 8 0 27 0 22 0 71 4 4,Heparin 3000 units 0 77 0 28 0 48 0 38 1 6. Fluoroscopy time 20 min 0 82 0 28 0 56 0 42 1 6, identify interactions between patient and operative char Mean times to hemostasis in a randomized trial by. acteristics and longer time to hemostasis time to Rathore et al comparing the TR Band n 395 and. hemostasis greater than the cohort mean of 55 min Radistop n 395 were 5 3 and 4 8 h respectively The. Table 6 Cutoff points for logistic regression were authors reported early RAO rates at discharge of 8 9 and. determined based on mean and median values for age 9 6 for the TR Band and Radistop decreasing to 5 6 and. BMI heparin dose and fluoroscopy time To explore 8 0 chronic RAO at follow up ranging 4 6 months after. whether interaction existed between covariates to predict intervention Hematoma rates for the TR Band and. longer times to hemostasis multivariate logistic regression Radistop were 5 4 and 2 2 while oozing at the arteri. was performed using mean time to hemostasis threshold of otomy site occurred in 6 1 and 7 1 respectively 13. 55 min No variable was associated with longer times to Another prospective study comparing the TR Band and. hemostasis p 0 64 results not shown HemoBand HemoBand Portland OR found the TR Band. led to 4 4 early RAO n 250 compared to 11 2,n 250 of HemoBand subjects at 24 h Late RAO doc.
Discussion umented at 30 days was 3 2 and 7 2 of TR Band and. HemoBand patients respectively 12 More recent studies. Upper extremity and tibiopedal arterial access provide sig have reported shorter times to hemostasis as well as lower. nificant patient and operator benefits during percutaneous rates of RAO In a randomized trial comparing the TR

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