03 aimradial2016 fri2 A Patel
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This study evaluated the safety and feasibility of using a combined dual access radial and pedal approach for treating chronic total occlusions of the superficial femoral arteries. 86 patients underwent endovascular intervention using a primary pedal access and dual access if the pedal approach failed. For 49 lesions where the pedal approach failed, dual transpedal and transradial access was used. The technical success rate was 98% and procedural success rate was 96%, with no peri-procedural complications. The study demonstrated the dual access approach is a safe and feasible alternative to treat complex superficial femoral artery chronic total occlusions.
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03 aimradial2016 fri2 A Patel
- 1. SAFETY AND FEASIBILITY OF NOVEL ENDOVASCULAR TECHNIQUES: COMBINED DUAL ACCESS RADIAL AND PEDAL APPROACH FOR CHRONIC TOTAL OCCLUSIONS OF SUPERFICIAL FEMORAL ARTERIES Apurva Patel, Joseph A. Puma, Roosha Parikh, Tak W. Kwan
- 2. Disclosure Information Apurva Patel and co-authors FINANCIAL DISCLOSURES: None UNLABELED/UNAPPROVED USES DISCLOSURE: None
- 3. • ~ 50% PAD = CTO • Open Surgical vs transfemoral • Emerging Radial (TR)/Pedal (TP) access - improved technique and equipments - patient comfort, vascular complication - Paucity of outcomes on failed TR/TP approach - only anecdotal reports on dual access
- 4. Study Design • Prospective Study • Endovascular intervention of SFA CTO for symptomatic PAD • Dual TP and TR access • February 2015 – June 2016 • Evaluate the safety and feasibility of using dual TP and TR approach for treatment of SFA CTO.
- 5. • TP Access - Dorsalis Pedis - Anterior Tibial - Posterior Tibial • US guidance • 21 G echogenic needle • 4 Fr Sheath • Initial retrograde ipsilateral angiography - upsized to 6 Fr for intervention Method
- 6. Method • Failure post single access attempt - dual access using a 4 Fr TR • All access sites - anti-spasmodic cocktail (verapamil, nitroglycerine) and systemic heparin (ACT > 300 s) • US pedal/radial artery, clinical assessment at 1 month.
- 9. Results 86 Patients with SFA CTO Primary Pedal Strategy for crossing Procedural Success 100% (N=56) Crossing Success 53% (N=56) Crossing Unsuccessful 47% (N=49) 105 SFA CTO Lesions Dual Access (N=49, 38 patients) 86 Patients
- 10. Results 38 Patients CART Technique 90% (n=44) Landmark Technique 10% (n=5) 49 SFA CTO Lesions
- 11. Demographics Age (years) 79.0 ± 8.8 Female, % 53.1 Hypertension, % 83.7 Hyperlipidemia, % 69.4 Tobacco use, % 46.9 Coronary artery disease, % 65.3 Myocardial infarction, % 15.8 CVA, % 4.1 Diabetes mellitus, % 57.1 Prior PVD intervention, % 51.0
- 12. Rutherford Class Rutherford Class, % 1 0 2 0 3 28.6 4 63.3 5 6.1 6 2.0
- 13. Procedural Details Pedal sheath, % 4 65.3 4/5 22.4 4/6 10.3 4/7 2 Hemostasis – radial, % TR Band 79.6 Vasostat 20.4 Hemostasis – pedal, % TR band 42.8 Vasostat 57.2 Fluoro Time (min) 34.1 ± 14.8 Radiation dose (mGy) 230.4 ± 172.1 Procedure time (min) 96.3 ± 24.7
- 14. Success Rate • CTO Crossing Success Rate: 98% • Procedural Success Rate: 96%
- 15. Outcomes • Peri-procedural complication - None • 30 day major adverse events - None • All access sites patent at 1 month
- 16. Limitations • Single center - Generalizability • Learning curve
- 17. Conclusion • Dual TPA and TRA for treatment of SFA CTO - Feasible - Safe - Avoid femoral access
- 18. Thank You
- 19. Vessel run-off Pre Post Below the knee vessel run off, % 0 28.6 28.6 1 40.8 36.7 2 16.3 6.1 3 14.3 28.6
Editor's Notes
- Good Morning everyone!! On behalf of my research team, I would like to thank the AIM Radial organizing team for allowing us to present our data today
- We have nothing to disclose
- Nearly half of patients who present for treatment of symptomatic peripheral arterial disease (PAD) are found to have a chronic total occlusion (CTO) of their superficial femoral artery (SFA). Historically these patients were treated with open surgical or transfemoral endovascular revascularization. Improved equipment and techniques has led to the use of the radial (TR) or pedal (TP) artery individually as the access site for intervention to reduce vascular complications and improve patient comfort. There is a paucity of data on outcomes of patients with a failed individual TR or TP approach to an SFA CTO and only anecdotal reports of the dual access approach.
- We analysed prospectively collected data on patients with symptomatic PAD who underwent endovascular for SFA CTO intervention using dual TP and TR access, between February 2015 and June 2016. The objective of this study was to evaluate the safety and feasibility of using dual transpedal and transradial approach for treatment of SFA CTO.
- Transpedal access includes access to either the dorsalis pedis, anterior tibial or posterior tibial artery It is obtained under US guidance and confirming with color doppler with a 21 G echogenic needle , after which a 4 Fr sheath is placed Initial planned retrograde ipsilateral TP angiography was done, then was upsized to 6 Fr for intervention.
- After failure of this single access attempt, dual access using a 4 Fr TR access was accomplished. All access sites were injected with an anti-spasmodic cocktail and systemic heparin to achieve an ACT > 300 s was administered. Ultrasound pedal/radial artery and clinical assessment was performed at baseline and at 1 month.
- This slide demonstrates the the key steps of the procedure Figure A – retrograde angiogram showing CTO of the mid-distal left SFA (0.018” V-18 ControlWire 300cm (Boston Scientific, Mass, USA) loaded inside a 125 cm, 4 Fr Tempo Aqua Vertebral Catheter (Cordis Corporation, NJ, USA) Figure B - Inability of the wire to puncture the distal cap of the CTO, enters subintimally, unable to enter the true lumen, remained in the subintimal plane of the proximal SFA. LRA achieved, 110 cm sheath in the abdominal aorta, aquatrack stiff angled wire advanced to the proximal SFA, using CART technique, balloon inflated in the subintimal area via the retrograde wire. The antegrade wire advanced into the subintimal space and then into the true lumen of the popliteal artery Figure C – the antegrade wire is snare out and externalized throught the pedal access (0.035” Aquatrack Regular Angled 260 cm Glidewire (Cordis Corporation, NJ, USA) loaded inside Vertebral Catheter was advanced to the distal SFA. Attempts were made to puncture the extensive calcified distal cap of the occlusion and the wire remained in the subintimal plane in the proximal SFA.) Subsequently, the left radial artery (RA) was cannulated using a 4Fr Glidesheath (Terumo Medical Corporation, Somerset, NJ). A 4 Fr 110 cm Flexor Shuttle Sheath (Cook Corporation, MN, USA) was exchanged and positioned into the lower abdominal aorta. This was exchanged for a 4 Fr Terumo Multicurve 150cm Catheter (Terumo Medical Corporation, Somerset, NJ) for selective angiogram which showed complete occlusion of the left mid SFA . A 0.035” Aquatrack (Stiff Angled) 260cm Glidewire was advance antegradely into the ostial left SFA CTO. Using the controlled antegrade and retrograde tracking (CART) technique, a 6.0 x 100mm SABER Balloon (Cordis Corporation, NJ, USA) was inflated in the subintimal space via the retrograde wire The antegrade wire was advanced into the subintimal place and subsequently into the true lumen of the popliteal artery. A 3Fr Amplatz Goose Neck Microsnare 175 cm (ev3 Endovascular, Inc, MN, USA) was inserted through the pedal access. The antegrade wire Aquatrack wire was captured and externalized through the pedal access (Figure 2(B)).
- Figure D - Over the externalized wire, vertebral cather is advanced and positioned into the common iliac exchanged for a 0.035 glidewire. The lesion is treated with balloon angioplasty and stent deployment , figure E shows the excellent re-establishement of normal flow through the SFA Now the 4 Fr Tempo Aqua Vertebral 125cm Catheter was advanced over the externalized wire and positioned into the left CIA. Then exchanged for a 0.035” 260cm Advantage Glidewire (Terumo Medical Corporation, Somerset, NJ), following which the vertebral catheter was removed. A 6.0 x 100.0 mm SABER Balloon was inflated at the lesion in the proximal left CIA and left EIA followed by deployment of a Smart Stent 9.0 x 100.0mm (Cordis Corporation, NJ, USA) (Figure 3(A)). Then the same balloon was inflated at the lesion in the left proximal, mid and distal SFA followed by deployment of two Smart Flex Stents 7.0 x 150.0mm (Cordis Corporation, NJ, USA) in the SFA (Figure 3(B)). Another 3.5 x 100 mm Saber Balloon (Cordis Corporation, NJ, USA) was inflated at the lesion in the mid ATA (Figure 3(C)). Final results showed excellent reestablishment of normal flow to the infrainguinal vessel (Figure 4 (A, B, C)).
- This is the consort diagram demonstrating patient flow. 86 patients were identified who had symptomatic PAD, were found to have SFA CTO – total 105 CTO lesions. Retrograde approach via pedal access was undertaken as the primary strategy for revascularization. The success rate for crossing (utilizing wire-catheter strategy) was 53% in 56 lesions, the procedure was successful achieving < 30% residual stenosis after angioplasty/stent in all 100% of these 56 lesions. In the 49 lesions in 38 patients where the CTO crossing was unsuccessful, second access was obtained in the radial artery (preferably left) for antegrade approach.
- Attempt was made to intervene endovascularly via dual TP and TR using controlled antegrade and retrograde tracking (CART) technique in 90% and landmark technique in 10% lesions.
- This slides shows the demographic characteristics of the patients Mean age 79 years, there was a high prevalence of hypertension, hyperlipidemia, tobacco use, DM, h/o CAD and prior PAD intervention.
- All the 38 patients had Rutherford Class 3-6 symptoms
- This slide highlights some of the procedural details Mean Procedural time was 96 minutes minutes. The mean contrast amount used was 54 ml; mean fluoroscopy time was 35 minutes; mean radiation dose was 230 mGy.
- The CTO crossing success rate was 98%, procedural success rate was 96%.
- There were no peri-procedural complications. At 1 month follow up, there were no major adverse events or access site complications, all pedal and radial arteries were patent.
- Our study has some linitations. It was a single center experience which limit generalizability. Absence of data with primary radial antegrade approach for CTO intervention for comparison
- The routine use of dual TPA and TRA for treatment of SFA CTO with CART/landmark technique is feasible and safe without femoral access.
- Thank you!!