Complication rates following 4-Fr versus 6-Fr transfemoral vascular access – prospective audit at a single centre Chung R1, Weller A1, Bowles C1, Sedgwick P2, Ratnam L1 1Interventional Radiology, St. George’s Hospital, London, UK. 2Division of Population Health Sciences & Education, St. George’s Medical School, London, UK. Background Safe Femoral Artery Puncture Results The principles of safe femoral arterial puncture forms the stepping stone to many endovascular procedures. Training in safe femoral arterial puncture technique and regular audit of outcomes are essential in minimising the morbidity associated with complications from arterial puncture. We present the results of a 3 year audit at a UK trauma centre that has allowed us to evaluate both patient related risk factors and the impact of utilising 4Fr vs 6Fr sheaths to reduce complications. Table 3 – Arterial puncture complications Figure 1 –Antegrade puncture (a), retrograde puncture (b), and confirmatory angiogram post procedure to assess suitability for arterial closure device (c). (a) Inguinal ligament puncture into CFA wire in SFA (b) (c) Complication 4-Fr 6-Fr Total Haematoma 2 15 17 Pseudoaneurysm 1 Distal embolism - Arterial dissection Other Need for surgical intervention 3 (0.8%) Aims A) Identify potential risk factors for trans-femoral arterial entry site complications, including: Patient co-morbidities (DM/HTN): obesity; vessel calcification; clotting; anti-coagulation. Procedure related factors: Vascular access sheath size (4-Fr versus 6-Fr systems). B) To evaluate the cost implications of using 4-Fr versus 6-Fr systems. • 392 procedures performed total. • 26 (6.6%) complications, of which 23 were either 4 or 6-Fr system (sheath size not recorded in 3 cases ). Post procedure complication rates were significantly greater using 6-Fr sheath catheterisations than 4-Fr sheath systems, 19/157 (12.1%) versus 4/177 (2.3%), p<0.001. However, of the 19 complications seen in the 6-Fr group, 9 were minor resulting in no delay in discharge or escalation of treatment (no significant difference between 4 vs 6-Fr systems for major complications). Antegrade punctures (11/97 – 11.3%) were also associated with significantly greater complication rates than retrograde punctures (15/295 – 5.1%), p<0.05. However; comparison of complications rates between seniority of operator, number of arterial passes, vessel calcification, scarred groin, body habitus, use of closure device, artery punctured (CFA vs SFA) or puncture safeguarding techniques (manual palpation vs image guided) did not reach statistical significance. Patients and Methods Prospective single centre study at a UK trauma centre, over three 6 month audit cycles. Vascular interventions performed between 07/04/2010 and 10/05/2013 included. Procedure related complications were recorded on an audit pro-forma immediately following each procedure and by clinical review of each patient prior to discharge. Parameters recorded include: patient co-morbidities; body habitus; vessel calcification; clotting; anti-coagulation; operator experience; sheath size and number of passes for access. Association of these factors, especially sheath size, with post-procedural complications was evaluated using chi-squared analysis or Fisher’s exact test (SPSS software) and adjusted for confounding factors. In our institution, all inexperienced operators received formal training in the basics of safe femoral arterial puncture, followed by close senior supervision, until competent in gaining safe femoral arterial access. Competence is assessed on the basis of 50 observed retrograde and 50 observed antegrade punctures. Results Table 2 – Arterial puncture characteristics Patient side of puncture Left 172, Right 217 (unavailable 3) Seniority of operator Junior Fellow Consultant 34 298 58 Direction of puncture Retrograde Antegrade 295 97 Artery punctured EIA CFA SFA Brachial Popliteal 2 364 15 9 Number of passes 1 >1 329 63 Sheath size 4-Fr 6-Fr Other 177 157 Vessel calcification Nil 135 257 Groin scarred Not scarred 65 327 Habitus Not obese Obese Not recorded 278 109 5 Puncture safeguarding technique Manual palpation Screening Ultrasound Combination 56 19 175 142 Anticoagulation during procedure Intraarterial heparin (3-5000 Units) 183 209 Closure method Manual compression Angioseal Exoseal Additional femstop 307 68 12 3 Cost Implications The 4-Fr system has the following additional costs compared with 6-Fr: Assuming a straightforward procedure using a single wire/balloon combination, the 4-Fr system requires an additional 0.018 wire, with an average cost of £73.90 per 0.018 wire in our institution Average balloon costs are £86.66 for the 4-Fr system compared with £46.25 for 6-Fr. This leads to a minimum extra cost of £114.31 for the 4-Fr system, in a procedure requiring no extra balloons or wires. Even in the event of using an available closure device in the 6-Fr system, the overall procedural cost of using a 4-Fr system is £9.85 greater. Table 1 – Patient demographics Age – mean (range) years 64.9 (20-94) Sex M:F 227:165 Hypertension (HTN) 151 Diabetes (DM) 108 Anticoagulation Nil Warfarin Aspirin Clopidogrel Treatment dose heparin Prophylactic dose heparin Multiple 206 7 58 9 52 43 INR <1.5 >1.5 377 16 Platelets <50 >50, <100 >100 2 381 Conclusion Intuitively, due to their smaller size, 4-Fr vascular access sheaths are expected to reduce the risk of post-procedural complications. Our data supports this hypothesis, however most of these complications are minor. The overall number of groin complications is low, with an even smaller number of major complications. Larger numbers are required to assess differences in major complication rates between 4-Fr and 6-Fr systems. Antegrade punctures are also associated with significantly greater groin access complications. Given the higher cost and practical limitations encountered when using a smaller system, the results to date do not suggest that the routine use of 4-Fr sheath system is indicated as the primary sheath size for all endovascular procedures.