Alternative Minimally Invasive Treatment Options for Saphenous Vein

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Alternative Minimally Invasive Treatment Options for Saphenous Vein Reflux Michael J. Singh, MD FACS

Alternative Minimally Invasive Treatment Options for Saphenous Vein Reflux Michael J. Singh, MD FACS RPVI UPMC Heart and Vascular Institute Director, UPMC Shadyside Vein Care Center March 2018

Michael Singh, MD FACS RPVI I have a relevant financial relationship related to this

Michael Singh, MD FACS RPVI I have a relevant financial relationship related to this presentation. Speaker’s Bureau: Medtronic Inc.

Chronic Venous Insufficiency • • US, >30 million people suffer from chronic venous insufficiency

Chronic Venous Insufficiency • • US, >30 million people suffer from chronic venous insufficiency Prevalence 25 -40% Pathology- great/small saphenous reflux Traditional open surgical treatments have been replaced by minimally invasive thermal ablation techniques Ø Few complications, less patient discomfort, quick recovery 3 Mc. Lafferty JVS 2008 Dermody Phlebology 2015 Morrison Vein 2015 Hamann Eur J Vasc Endo Surg 2017

Radiofrequency Ablation (RFA) • • • VNUS Closure (RFA), Medtronic Inc. FDA approved in

Radiofrequency Ablation (RFA) • • • VNUS Closure (RFA), Medtronic Inc. FDA approved in 1999 CPT 36475, 36476 Most widely used and studied device for saphenous vein reflux Requires tumescent anesthesia Radiofrequency energy segmentally heats vein to 120 o C (Closure. Fast)

Endovenous Laser Ablation (EVLA) • • • Endovenous laser- FDA approved in 2000 CPT

Endovenous Laser Ablation (EVLA) • • • Endovenous laser- FDA approved in 2000 CPT 36478, 36479 Various laser fibers – wavelengths of 810 nm to 1470 nm – higher wavelengths associated with less postprocedure pain • • Technique similar to RFA, requires tumescent anesthesia Delivery of 70 -90 joules/cm

Cochrane Collaboration Review • • 6 13 RCT (screened 545), 3081 randomized patients •

Cochrane Collaboration Review • • 6 13 RCT (screened 545), 3081 randomized patients • LASER v. surgery- 8 studies (1760) • RFA v. surgery- 5 studies (642) Results: • EVLA, RFA as effective as ligation & stripping • Reduced post procedural pain, better QOL and faster recovery Ø Paucity of robust data The Cochrane Library 2014, Issue 7

Established Guidelines & Recommendations 2014, Clinical Practice Guidelines of the SVS and the AVF

Established Guidelines & Recommendations 2014, Clinical Practice Guidelines of the SVS and the AVF 2014, Management of Venous Leg Ulcers: clinical practice guidelines for the SVS and AVF 2013, National Institute for Health and Care Excellence (NICE) 2012, Endovenous Thermal Ablation for Varicose Vein Disease Consensus General agreement: Stripping and Ligation • grade 2 B Radiofrequency Ablation (RFA) • grade 1 B safe and effective Endovenous Laser Ablation (EVLA) • grade 1 B superior to stripping • grade 1 B not inferior to RFA 7 Gloviczki JVS 2011 Gibson EVT 2015

Patient Dissatisfaction with Thermal Ablation • • Pain Bruising Erythema Hematoma Pigmentation Paresthesia Phlebitis

Patient Dissatisfaction with Thermal Ablation • • Pain Bruising Erythema Hematoma Pigmentation Paresthesia Phlebitis EHIT 1 -50% 1 -20% 1 -33% 1 -12% 2 -35% 1 -10% 1 -7% Procedure discomfort 11 -60% 8 Pavlovic Phlebology 2015 Murad JVS 2011 1) Tumescence 2) Thermal injury 3) Compression

Nonthermal Saphenous Vein “Lunchtime” Treatments 1) Clarivein- mechanical occlusion chemical ablation 2) Vena. Seal-

Nonthermal Saphenous Vein “Lunchtime” Treatments 1) Clarivein- mechanical occlusion chemical ablation 2) Vena. Seal- cyanoacrylate adhesive 3) Varithena- polidocanol microfoam Ø No heat, no tumescence, limited compression Ø Medline- 2018, only 74 nonthermal ablation articles 9

Non-thermal Ablation Treatment Sites Saphenous vein (GSV, SSV): Clarivein Vena. Seal Varithena Todd Phlebology.

Non-thermal Ablation Treatment Sites Saphenous vein (GSV, SSV): Clarivein Vena. Seal Varithena Todd Phlebology. 2013 Gloviczki J Vasc Surg. 2011 Varicosities & perforators: Varithena

Clarivein (Vascular Insights LLC) • • • MOCA- mechanical occlusion endovenous ablation – 2015

Clarivein (Vascular Insights LLC) • • • MOCA- mechanical occlusion endovenous ablation – 2015 FDA approval Combination: mechanical endothelial damage + sclerotherapy Wire rotates at 3, 500 RPM – induces endothelial injury and venospasm – sclerosant injected from dispersion tip 11 Ramon JVS July 2014 Whitte Surg Int 2015 Van Eekeren JVS 2014

Clarivein Technique • • • Perc U/S guided access 4 F sheath, flexible 2.

Clarivein Technique • • • Perc U/S guided access 4 F sheath, flexible 2. 7 F catheter – place 2 -3 cm below SFJ 3% STS or 2% Polidocanol – 2 ml in first 10 cm – 1. 5% remainder of vein • • • 12 Ramon JVS July 2014 Whitte Surg Int 2015 Van Eekeren JVS 2014 • GSV 6 -10 ml, SSV 2 -4 ml Withdraw catheter 1 -2 mm/1 sec Pump calf, immediate ambulation Compression for 1 week

Clarivein Dutch MOCA Results • Ramon- Dutch MOCA study, 92 pts • 6 month

Clarivein Dutch MOCA Results • Ramon- Dutch MOCA study, 92 pts • 6 month vein closure 93% • 1 year vein closure 88% • Treatment time: 11 minutes • NL QOL 1 day • 1 year clinical success 93% • 12 failures (8 partial, 4 total) • No DVT or MAE • phlebitis 3%, pigmentation 5% 13 Ramon JVS July 2014

Clarivein Results • • • Bootun et al. 2016 – Clarivein vs. RFA Van

Clarivein Results • • • Bootun et al. 2016 – Clarivein vs. RFA Van Eeken et al. 2013 – Clarivein vs. EVLA 2 year closure rates 94% Less pain, faster recovery, improved QOL Lower incidence MAE Ø CPT 36473, 36474 January 2017 Ø Device >$700 plus sclerosant 14 Bootun Phlebology 2016 Van Eekeren JVS 2013

Vena. Seal Closure (Medtronic, Inc. ) • CAVA- cyanoacrylate vein ablation • FDA approval

Vena. Seal Closure (Medtronic, Inc. ) • CAVA- cyanoacrylate vein ablation • FDA approval Feb 2015 • Implantable device • Proprietary cyanoacrylate adhesive • No tumescent or thermal energy • No compression • Disposable single use Ø CPT 36482, 36483 Ø Out of pocket expense $1, 750 15

Vena. Seal Closure Technique Vena. Seal™ Closure System Position catheter 5 cm from SFJ

Vena. Seal Closure Technique Vena. Seal™ Closure System Position catheter 5 cm from SFJ 16 Images courtesy of Medtronic Inc. Access GSV using catheter technique Compress cephalad to catheter

Vena. Seal Closure Technique 17 Inject 0. 10 cc adhesive into the vein, pull

Vena. Seal Closure Technique 17 Inject 0. 10 cc adhesive into the vein, pull back 1 cm, inject 0. 10 cc pull back 3 cm Compress 3 minutes Inject 0. 10 cc, pull back 3 cm, compress for 30 seconds Repeat process throughout vein Images courtesy of Medtronic Inc.

Vena. Seal Closure Results • • >2, 000 patients treated worldwide, proven effective in

Vena. Seal Closure Results • • >2, 000 patients treated worldwide, proven effective in 3 clinical trials: US Vena. Seal feasibility study – 92% closure at 12/24 months, improved QOL scores – no DVT Ve. CLOSE Pivotal Study – 92% closure at 24 months, not inferior to RFA – 14 -20% phlebitis European Sapheon Study (e. SCOPE) – 92. 9% at 12 months, improved QOL score – 11% phlebitis, no DVT Gibson EVT 2015 Proebstle JVS 2014 Almeida JVS 2013 18

Varithena (BTG International Ltd. ) • • FDA approval 2014 Treats: SV and varicosities

Varithena (BTG International Ltd. ) • • FDA approval 2014 Treats: SV and varicosities 1% Polidocanol- low density microfoam displaces blood and ablates endothelium Soluble gas mixture • • 65% O 2: 35% CO 2 nitrogen content <0. 8% 1: 7 liquid to gas ratio small consistent bubble size <100 μm 19 Todd JVS 2015 King Eur J Vasc Endo Surg 2015 Todd Phlebology 2014

Varithena Facts • Varithena canister- 45 m. L of usable foam • Must dispense

Varithena Facts • Varithena canister- 45 m. L of usable foam • Must dispense within 30 days • Diameters up to 25. 9 mm • 5 m. L per injection (max 15 m. L/session) • elevate leg 45 degree • perforator and SFJ compression • inject 0. 5– 1 ml/sec • apply compression Ø CPT 36465, 36466 Ø Cost $3, 195/45 m. L canister 20

Varithena Durability- VANISH 2 Study • Todd 2015 - randomized blinded trial (polidocanol 0.

Varithena Durability- VANISH 2 Study • Todd 2015 - randomized blinded trial (polidocanol 0. 5 v. 1%) – – • Vein closure 89% 8 weeks, 73% 1 year Varithena demonstrated consistent, durable, clinically meaningful improvement of symptoms King 2015 - validated VANISH 2 results – – – Technical success 80% No difference in concentrations Improved patient satisfaction scores, vein appearance, VCSS and VEINES-QOL scores at 1 year Ø MAE 60 -78% – – Pain, tenderness, phlebitis DVT- Todd 8%, King 2% Todd JVS 2015 King Eur J Vasc Endovasc Surg 2015 Kugler JVS 2017

Comparison of Current Ablation Techniques 1 yr closed 2 yr closed 3 yr closed

Comparison of Current Ablation Techniques 1 yr closed 2 yr closed 3 yr closed 4 yr closed CMS 2017 office reimbursement (US $) RFA 90 -98% 85 -96% 68 -92% 89% $1, 546 EVLT 89 -100% 74 -97% 79 -100% 76 -96% $1, 224 Varithena 67 -93% 53 -97% 53 -79% NA $1, 624 Clarivein 88 -97% 96 -97% NA NA $1, 522 Vena. Seal 92 -93% 92% NA NA $2, 162 22 Kugler NW, JVS 2017

Conclusion 23 • Thermal ablation remains the standard of care for symptomatic saphenous vein

Conclusion 23 • Thermal ablation remains the standard of care for symptomatic saphenous vein reflux • Nonthermal ablation has demonstrated improvements in technique, success and durability in the past 5 years • Nonthermal ablation reduces procedure related discomfort, improves patient satisfaction scores and lowers DVT risk • Recent CMS approval (CPT codes) will expand utilization of nonthermal ablation techniques

Thank you Pittsburgh, PA 24

Thank you Pittsburgh, PA 24

FDA recommended Varithena Training 25 • Catheter based procedure performed with U/S guidance •

FDA recommended Varithena Training 25 • Catheter based procedure performed with U/S guidance • Physician performs 18 step procedure • Requires 2 professionals • FDA- physician training, Risk Management Plan (RMP) • Physician ≥ 100 vein procedures in 2 yrs. • Complete four online training modules • Clinical specialist supports first few cases