Experience with percutaneous suture system for larger caliber vascular access Bruno Freitas, Prof., MD
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1 Experience with percutaneous suture system for larger caliber vascular access Bruno Freitas, Prof., MD Department of Interventional Angiology, University Hospital Leipzig, Germany Division of Vascular Surgery, Federal University of Vale do São Francisco, UNIVASF, Brazil Biotechnological and Biomedical Center- Biocity, University Hospital Leipzig, Germany Faculty of Medicine, State University of Alagoas, Maceió, Brazil Division of Vascular Surgery, Arthur Ramos Memorial Hospital, Maceió, Brazil
2 Experience with percutaneous suture systems for larger caliber vascular access Declaration of competing interest Speaker: Bruno Freitas... No conflict of interest
3 Vascular Closure Devices (VCDs) Endovascular Revolution Large delivery devices Larger arteriotomy Prolonged wound exposure Access site complications New challenges on access management and closure Repetitive and preloaded use of VCDs Increasing Age, re-do procedures, hostile access sites Evolving scenario Safety Efficiency Feasibility
4 Preclosing for Large Bore Devices 2 Proglide-systems preloaded 24 French Stentgraft
5 Percutaneous Access or Cut-Down for Stentgraft-Implantations
6 Percutaneous Access or Cut-Down for Stentgraft-Implantations
7 Percutaneous Access or Cut-Down for Stentgraft Implantations
8 p-evar is safe and effective, with minimal access-related complications, and it is noninferior to standard open femoral exposure Nelson et al., J Vasc Surg 2014
9 in the published literature, and is therefore highly confidential. Information should not be quoted or disseminated until public reporting of clinical trial data has been specifically approved). Percutaneous EVAR: Mean PEVAR Procedure time (with ProGlide) = minutes Mean SEVAR Procedure time = minutes cost Difference analysis in Mean procedure time = from 34.7 minutes pevar trial Table 4 EVAR Procedure Times from the PEVAR Study Procedure Time (minutes) PEVAR ProGlide N = 50 SEVAR N = 50 Total N = 100 Difference 95% CI 2 Mean ± SD (n) ± 44.9 (50) ± 73.4 (50) ± 63.0 (100) Median (Q1, Q3) 93.5 (76.0, 124.0) (87.0, 175.0) (78.5, 157.0) Range (min, max) (49.0, 292.0) (50.0, 414.0) (49.0, 414.0) [95% Confidence Interval] [93.7, 119.2] [120.3, 162.0] [111.3, 136.3] [-58.9, -10.4] Abbott Vascular Source: S:\SHRDATA\ASE\PEVAR\PMA\rpgm\rand\PG\PVR_rand_TPG_TrtProc_Sum.sas could present a compelling financial benefit story (June for 22, 2012 their (15:35)) ProGlide device, using this well documented assumption: Results of the Medicare physician procedure time analysis revealed intra-operative/cath lab times of and minutes for EVAR and TEVAR respectively. The Medicare time data for EVAR procedures was about 22% greater than the average time for SEVAR in the Abbott study. It should be noted that time values could be overestimated because they are based on physician surveys recalling the amount of time to complete the procedures. Additionally, there have likely been improvements and efficiencies in technique o Reduction since the in time cost of due the survey. to ProGlide: 34.7 minutes x $19.40/minute = $ Mean reduction in EVAR procedure time when using vascular closure vs. surgical closure = 34.7 minutes Range = $ $28.60 per minute o Reduction in cost due to ProGlide: 34.7 minutes x $28.60/minute = $ Total value (cost-savings) due to ProGlide (low end of range) Economic o When Assessment 1 ProGlide device of Vascular is used: Closure $ for - EVAR $295 = and $ TEVAR FINAL REPORT o When 2 ProGlide Data devices on file from are used: Abbott $ based- on $590 PEVAR = $83.18 Trial Total value (cost-savings) due to ProGlide (high end of range)
10 Predicting the learning curve and failures of total percutaneous endovascular aortic aneurysm repair The complications rate during p-evar decreases significantly with increasing operator experience Bechara CF et al., J Vasc Surg 2013
11 Preclosing for Large Bore Devices To high Re-puncture
12 The Leipzig Experience with Double Proglide Technique in PEVAR
13 The Leipzig Experience with Double Proglide Technique in PEVAR Patient population Institutional review board retrospective study May 2012 to December patients 3406 vascular closure devices deployments Routine basis not included in trials Freitas B, et al J Cardiovasc Surg, Nov 2016
14 Methods Periprocedural vascular assessment Eight attending interventionist Lower/upper limbs, iliac, supra-aortic/visceral, abdominal/thoracic aorta Sheath diameters: 5 to 24-French Vascular Closure Devices Perclose ProGlide (Abbott Vascular, CA, USA) Angio-SealTM (St. Jude Medical Inc., MN, USA) Exoseal (Cordis, NJ, USA)
15 Single center experience with Double Proglide Preloaded Technique in PEVAR: The Leipzig Initial Report OPEN SURGICAL REPAIR EVAR w/ CUTDOWN PEVAR 407 Patients 763 Vascular Access Sites Preloaded Double Deployment Technique
16 Single center experience with Double Proglide Preloaded Technique in PEVAR: The Leipzig Initial Report Table 1. Clinical characteristics of 407 patients treated with VCD Age (years) 77.1 ± 9.9 Men 232 (57.0) Medical history Smoking 147 (36.1) Diabetes 93 (22.9) Insulin-dependent DM 12 (12.3*) Previous total anticoagulation 22 (5.4) Hypertension 274 (67.3) Medical history (cont.) Hyperlipoproteinemia 252 (61.9) Coronary artery disease 115 (28.3) Cerebrovascular disease 54 (13.3) Renal Impairment 35 (8.6) Dialysis 13 (3.2) Obesity 133 (32.7) Values are means ± SD or numbers (%) of observations; *among diabetic; ** overall percentage
17 Single center experience with Double Proglide Preloaded Technique in PEVAR: The Leipzig Initial Report Table 2. Means (95% confidence interval) of anthropometric measurements and prevalence of obesity among patients, stratified by sex Women Men Body height (cm) ( ) ( ) Body Weight (Kg) 73.6 ( ) 84.2 ( ) BMI* (kg/m 2 ) 28.7 ( ) 27.6 ( ) Obesity N=58(33.1%) ( ) n=75(32.3 %) ( ) Morbid Obesity (Grade III) 3.6 ( ) 1.7 ( ) *Body Mass Index
18 Single center experience with Double Proglide Preloaded Technique in PEVAR: The Leipzig Initial Report Table 3a. Angiographic and procedural characteristics n (%) Total Vascular Access Sites 763 n (%) Vascular closure devices 1795 Intervention area Abdominal Aorta Thoracic aorta Thoraco-abdominal Aorta Other/miscelaneous 317 (77.9) 46 (11.3) 39 (9.6) 5 (1.2) Abdominal Aorta Thoracic Aorta Thoraco-abdominal Aorta Other/miscelanous 1505 (83.9) 99 (5.5) 168 (9.4) 23 (1.3) Calcification 763 No/mild 703 (92.1) Moderate 54 (7.1) Severe 6 (0.8) Sheath diameter (French) 763 up to (28.5) (71.5) Values are means ± SD or numbers (%) of observations
19 Single center experience with Double Proglide Preloaded Technique in PEVAR: The Leipzig Initial Report Table 3b. Angiographic and procedural characteristics n (%) Previous use of VCD 119 (15.6) Previous use in up to 14F 64 (29.5) Previous use in 15F 55 (10.1) Arterial puncture location High 28 (3.7) Adequate 735 (96.3) Low 0 (0) Values are means ± SD or numbers (%) of observations
20 Single center experience with Double Proglide Preloaded Technique in PEVAR: The Leipzig Initial Report Immediate results Total vascular access sites: 763 Technical success : 711 (93.2% ) Main performed procedure PEVAR: 317 (77.9%) TEVAR: 46 (11.3%) Overall Failure: 52 (6.8%) Total VCD deployed: 1795
21 Table 4. Success and failures rates among risk factors : Descriptive and comparative result (n=763 accesses/1795 VCDs) Factors Overall Success Rate n= 1673 (93.2 %) Overall Failure n= 122 (6.8 %) Age 67 (range 23-84) 71 (range 47-95) Hypertension 959 (57.2) 218 (72.5) Smoking 531 (31.7) 131 (43.1) CAD ⱡ 660 (39.4) (44.7) CVD Ⱡ 204 (12.2) 64 (21.2) Diabetes Mellitus 479 (28.6) 60 (19.9) Renal impairment 221 (13.2) 53 (17.6) Previous total anticoagulation 102 (6.1) 108 (35.8)* No/mild arterial calcification 1245 (74.3) 175 (57.9) Moderate calcification 250 (14.9) 65 (21.6) Severe calcification 97 (5.8) 38 (28.6) High puncture 21 (1.25) 18 (13.5)* Low puncture 27 (1.6%) 5 (133) Obesity 417 (24.9) 39 (29.3) Grade III Obesity (morbid) 13 (0.8) 29 (21.8)* Values are rate numbers (%) of observations ; * p<0.05; Loss of 271 puncture sites due to inadequate angiogram images; ⱠCerebro-vascular Disease ; Coronary Artery Disease
22 Table 5. Access related complications n (%) Overall complication 61 (9.9) Minor complication 45 (7.3) - Small hematomas 32 (5.2) - Superficial infection 4 (0.6) - Small pseudoaneurysm 9 (1,5) Major complication 15 (0.6) - Big hematoma + intervention 7 (1.1) - Deep infection + surgery 2 (0.3) - Occlusion/embolism + intervention 4 (0.6) - Big pseudoaneurysm + intervention 3 (0.5) - Arteriovenous fistula Values are means ± SD or numbers (%) of observations;
23 Axillary Artery Preclosing with Proglide-Sysems Anterior and posterior circumflex humeral arteries
24 Axillary Artery Access for: - TAVI (18 French) - Branched stentgrafts - Chimney / snorkel grafts (12 French) - Iliac-femoral intervention (6-9 French)
25 Axillary Artery Access Experience 5Fr After 12 Fr Angio via axillary artery before preclosing Angio via femoral artery after closing
26 What to be aware of: CFA Size Arterial Calcification Anterior/Circunferential Level of CFA bifurcation Don t hesitate to re-puncture! USG-assisted puncture?! Watch out for potential severe bleeding disorders Fat Patient (morbid obesity) - careful preparation Don t let the lines loose during the procedure Adequate technique Take your time!!!! Adequate patient selection Antecipate potential problems Get familiar with it!!!
27 Conclusions 1- The use of Vascular Closure Devices proved to be safe and efficient and cost-effective; 2- Higher Overall Failure rates were related in our experience to the presence of: Previous chronic total oral anticoagulation Grade III obesity (morbid) Dislodged puncture site (high) Calcification (anterior wall, circunferencial)
28 Conclusions 3- There is a need for more prospective randomized data regarding PEVAR/TEVAR procedures
29 Experience with percutaneous suture system for larger caliber vascular access Bruno Freitas, Prof., MD
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