Chapter 3: CLARIVEIN® MECHANOCHEMICAL ABLATION

Welcome to the Vein Experts Online Educational CME Program.

Original Release Date: _04/15/13_____ Termination Date: 1/31/2016 Price: 25.00 for Vein Experts Members & $40.00 for Non-Members Processing/CME Fees

Accreditation: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of The University of Toledo and VeinExperts.org.

The University of Toledo is accredited by ACCME to provide continuing medical education for physicians.

The University of Toledo designates this enduring activity for a maximum of 1.00 AMA PRA Category Credits™. Physicians should claim only credit commensurate with the extent of their participation in the activity.

For nurses, we are also able to issue a certificate of attendance stating the course is AMA approved, which may be eligible for credit. Nurses are responsible for submitting the certificate to their board. Please note only one certificate can be issued for each purchase.

Disclosure: Ronald Bush, MD, FACS, faculty and planning member discloses he is on the Speaker’s Bureau for Dornier/Refine USA and is employed by Midwest Vein & Laser Center.

Richard L. Mueller, MD, faculty and planning member, discloses he receives travel expenses & honoraria from Vascular Insights, LLC Peggy Bush, APN, planning member, has no disclosures or financial interests and is employed by Midwest Vein & Laser Center.

!

1!

Becky Roberts, planning member, has no financial interest or other relationships with any manufacturer of commercial product or service to disclose.

Mission: Our objective is to provide current evidence based information, as well as new technology that is being developed for the treatment of venous disease presented in a virtual format.

Target Audience: The target audience for this activity includes physicians and other health care professionals in Cardiology, Dermatology, Interventional Radiology, Phlebology, Surgery, Vascular Surgery, and Wound Care Specialists who care for patients with venous disease.

CME Credit Instructions Steps to successfully complete this activity: 1. Register for CME activity & pay your CME fees.

2. Read the Vein Journal entitled ‘Current Status of Treatment Options for Venous Ablation: Mechano Chemical Ablation’ 3. Take the post test (score of 80% or greater must be achieved. (A pdf copy of the exam can be emailed to you if requested).

4. Scan and email post-test and evaluation to pbush@veinexperts.org or you can fax completed paperwork to 937-281-0200.

5. You will be contacted by the University of Toledo CME office for instruction of how to sign on and print your certificate.

Technical Support Email your questions/concerns to pbush@veinexperts.org or you can call us at 407-900-8346 and we will respond in 24 hours.

!

2!

Current Status of Treatment Options for Venous Ablation: Mechano Chemical Ablation 4/1/13 Richard Mueller, MD, FACC, RVT, RPVI

This activity will describe the current status of treatment options for venous ablation: Mechano Chemical Ablation (MOCA) ® Learning Objectives As a result of this activity, the participant should be able to: 1) Review the timeline of development and labeling in the US and abroad of mechano chemical ablation (MOCA) ® 2) Describe a thorough conceptual framework of the unique basis of non-thermal dual mechanical and chemical ablation.

3) Identify the pros and cons of MOCA vs. thermal ablation; patient selection and applicability, contraindications.

4) Identify all salient procedural details of MOCA. 5) Review the database on MOCA – published studies (all observational), select presentations/abstracts.

6) Identify the future trajectory of the device: randomized trials, larger numbers/longer follow-up, dosing issues, and technical refinements.

!

3!

Timeline & Labeling FDA approval: “Infusion of physician specified agents in the peripheral vasculature” 2005 –

Invented by Michael Tal, MD

5/08 –

FDA approval

5/10 –

CE mark, Europe; Canada

6/10 –

Introduced 4 European sites

2009 –

First in man trial (Steve Elias, MD)

2010 –

First clinical use in US

2011 –

First publications

2012 –

Start of first randomized trial

2013 -

~ 12,000 cases worldwide

!

4!

What is it? Is it just a fancier Catheter Directed Sclerotherapy?

MOCA – Mechanically enhanced endovenous chemical ablation; dual injury; not just fancy sclerotherapy Mechanical – rotating angled wire, 3500 rpm motor abrades the endothelium Chemical - liquid (in vitro foaming) sclerosant 1-1.5% STS or 2% Polidocanol®

Unpublished experiments by Tal – neither with high closure rates alone; requires both together

Features / Benefits / Risks of MOCA: with high efficacy of thermal ablation, improvements will be in safety/applicability PROS: •

No risk thermal damage – nerves, arteries, veins, skin, or of fragments

•

Wider range of patients: calf, ankle, SSV, mod. tortuous, superficial veins, IPV, ulcers, collateral closure refluxing trunks / VV / IPV

!

5!

•

No tumescent! Minimal 1% LA at access site only (shortages)

•

Decreased pain/bruising intra & post procedure

•

No capital expense for generator / disposable; no repair / downtime

•

Rapid treatment (can be done in 15 minutes)

•

Simple access: (3) or 4 or 5F micro introducer, or 18G angiocath

•

Low profile: catheter .035” = 0.89 mm – 2.7F; navigable; no wires or catheter exchanges after access

CONS: •

No randomized trial data, but trials now enrolling

•

Follow up to date: 2 years, moderate but growing pt. numbers

•

All the risks of sclerotherapy (very low risk of serious risks); avoid STS in asthma (POL permissible); avoid in PFO, or where sclerosants are contraindicated

•

Not reusable; catheter expensive (approx. $700)

•

Maximum sclerosant dose limitations (10-12 ml STS GSV, 4 ml STS GSV; POL is weight based)

•

Maximum vein size to date 19 mm (GSV); minimum 2 mm

•

VTE: FDA database 2010-11: 5 DVT’s (4 Popliteal after using inappropriate sclerosant GSV volumes in the SSV), 1 PE (discharged); DVT’s all treated conservatively. 1 DVT reported

by Dutch group, of their several hundred reported cases.

•

!

Retreatment recanalized / SVT veins – MOCA® often not feasible

6!

•

Proprietary Polidocanol® only available in 1% in US; ? Compensate with slower pullback and higher volume

PERSONAL EXPERIENCE: We have performed over 100 MOCA® procedures in 15 months, with high satisfaction to patient and provider, and with a low initial failure & recanalization rate, similar to the literature. The learning curve is short and relates primarily to coordination of the 2 hands performing separate tasks (right hand performing trigger activation of motor and intermittent sclerosant injection every centimeter of pullback, left hand performing timed catheter pullback). Case selection is as always of paramount importance. Important niches for this device include ulcer patients, calf segments (no risk of saphenous or sural neuropraxis), SSV thigh extensions, tortuous truncal veins, very superficial veins (minimizing the risk of pigmented cords), and patients with low pain thresholds or needle phobias (no tumescent, rare phlebitis). When pain occurs after MOCA®, it is invariably due to what we call ‘collateral phlebitis;’ not even a phlebitis of the main treated truncal vein (which does sometimes occur), but typically a focal phlebitis of superficial tributaries into which sclerosant has invaded and has caused occlusion.

This is managed conservatively and resolves spontaneously in 2-3 weeks without sequelae, but can sometimes cause temporary

!

7!

hyperpigmentation like any phlebitis. This collateral phlebitis is often a positive as refluxing tributaries are often occluded and the patient receives ‘one stop shopping’ and treatment of multiple treatment targets. Unlike EVLA, we do not routinely prescribe any standing dose analgesics post procedure; we tell the patient to take Acetaminophen and/or Ibuprofen PRN in case collateral phlebitis occurs. Keep the catheter moving at all times. Snagging of the catheter on valve cusps and vein walls occurs in nearly every case, usually a few times, and can be prodigious, requiring at times vigorous pullback to release the catheter (re-sheath the wire first, and turn the catheter to try to make the release favorable). After doing so, always re-image the bent wire tip before re-spinning the wire to be sure where you are in the vein.

Snagging is heralded by an audible change in motor sound or speed, or patient report of pain, or resistance in your pullback. Pseudosnagging is vein spasm causing any of the aforementioned; it is differentiated by sliding the catheter freely back and forth; if it slides freely, proceed carefully. I advise reading my review article for detailed technical tips and a review of every published series on MOCA® (Vasc Endovascular Surg, 2013).

!

8!

Procedure: Skin local anesthesia; no tumescent; Access / micro-introducer.

Attach stopcock / sclerosant / flush catheter / insert catheter Initial Wire Tip Position - GSV: 0.5-2 cm distal to SFJ or just distal to IEV, whichever is more proximal; SSV: just distal - 1 cm distal to fascial curve. (underlined distances = favored by author, but several options exist).

Test/attach handle, final positioning (ball at end angled tip).

Start rotation x 3 cm (1/2 cm) with pullback, then inject .

Slow pullback (1.5 mm/s, ~ 7 sec/cm), Slow injection (volume depends on vein length/diameter; volume & infusion rate via online table).

Sclerosant / Concentration: STS: GSV – 1.5%; SSV – 1%. POL: 2% for both.

Sclerosant maximum volume is 4 ml for the SSV for both STS and POL. POL volume is weight based (2 mg/kg). Maximum volume of STS is 10 ml for GSV and 8-10 ml for a large Giacomini vein.

Triple action: dominant thumb: infusion; dominant index finger: motor; both hands: pullback. Don’t bend catheter. Pull sheath back prior to pullback.

Can use saline flush to release dead space sclerosant (0.7-1.0 ml) or can add this amount of sclerosant to calculated dose (European table).

Turn motor speed down if pain occurs; can use tumescent. Manual compression during procedure for vein diameters > 10 mm.

If snagging occurs (pain/visual/auditory cues), release motor, push proximally, rotate, then tug firmly distally to release. Slide to distinguish

!

9!

pseudo-snagging. Stop 2-3 cm distal to white mark, check occlusion, resheath, flap foot to active calf muscle pump & flush sclerosant out.

Data Published Studies (English) (All observational) Elias S & Raines J; Phlebology 2012;27:67-72. (epub 2011) Van Eekeren R, et al; J Endovasc Ther 2011;18:328-334.

Van Eekeren R, et al; JVS in press, 2013 (published online 11/12) Boersma D, et al; EJVS in press 2013 (published online 1/10/13) Select presentations / Abstracts Elias S. SVS 6/12. Abstract S221 Bishawi M, et al. Multicenter observational study (poster) VEITH 2011 Reijnen M & de Vries J. Bonner Venentage, Bonn 2/11 Reijnen M & de Vries J. ESVS, Athens 9/11 De Vries J & Reijnen M. LIC, Leipzig 1/12

!

10!

Review Article / Technical Details Mueller R & Raines J. Vasc Endovascular Surg 2013;47:195-206.

Elias & Raines 2011 (updated by presentations & SVS 2012 abstract) First in Man, began 2/09; single arm, 9 mo. f/u 30 limbs (GSV), C2-4; minimum 6 month f/u mean size 8 mm (5.5-13 mm), 36 cm length 12 ml 1.5% liquid STS (all); open vein = 5 cm GSV treatment time 5 min (14 min total) 29/30 closed except 1st patient (between 1 wk & 1 mo.)

97%, 96%, 96% occlusion @ 6, 12, & 24 mo.

(29/30, 29/30, 27/28) 10% ecchymoses; no DVT/skin/nerve injury, pain Van Eekeren R, et al. JET 2011 Pilot safety study, 2 centers in Netherlands Technical success 100% in 30 GSV (4-12 mm) 1.5% POL; mean dose 6.8 ml; 1 ml/mm diam.

30% ecchymoses, 13% phlebitis 87% complete occlusion @ 6 wks, 97% partial + complete 88% patient satisfaction, improved VCSS Pain score 9 > 2 / 100 within the first week

!

11!

Van Eekeren R, et al. JVS 2012 68 GSV, prospective observational study MCA (POL) or RF ablation Post op pain 5 vs. 19 / 1o0 VAS (mean 14 days) p < .001 Earlier return to normal activities (1.2 vs. 2.4

days, P = .02)

Earlier return to work (3.3 vs. 5.6 days, P = .02) Both improved QOL (VCSS) @ 6 wks (P = .21) No DVT/PE/burns/paresthesia; no significant difference in hematoma, phlebitis, induration (trend for less for MCA), pigmentation Boersma D, et al â&#x20AC;&#x201C; EJVS 2013 50 SSV, prospective, non-controlled, observational study (Netherlands); no anticoagulated pts MCA (POL 1.5% initially, then 2% [prox. 10-15 cm] / 1.5%); mean dose 4.4 ml (SD 1.1); 2.5 â&#x20AC;&#x201C; 11 mm 100% initial & 6 wks. Occlusion; 94% @ 1 yr.

(97% at higher dose) 3 recanalizations (1 at higher dose) > 10 cm VAS pain 2/10 during procedure; 6 wk. satisfaction 8/10 VCSS 3 > 1 @ 6 wks. & 1 yr.

!

12!

No major complications; 12% ecchymosis, & induration at access site, 14% phlebitis (10% > 1 wk); no additional complications at 6 wks & 1 yr.

Reijnen & de Vries â&#x20AC;&#x201C; Presentations (1) 2/11 Bonn, Germany: Efficacy/Pivotal Study

97 limbs (GSV, SSV, AGSV)

Initial occlusion rate 100% 97% @ 6 wks 3% > 4 cm proximal GSV partial recanal.

27% minor hematoma, 22% induration, 13% phlebitis No DVT, no nerve/skin injury No neurologic side effects Reijnen & de Vries â&#x20AC;&#x201C; Presentations (2) 9/11 ESVS Athens: Registry Study 64 limbs (GSV) 94% occlusion @ 6 wks (2 open, 2 prox open) 91% occlusion @ 6 mo. (1 open, 1 prox open) 6% hematoma, 6% induration No major complications 1/12 LIC Leipzig: Clinical Series Summary 210 GSV, 44 SSV, 14 AGSV; 2.5-13 mm, C1-6 98%, 100%, 100% @ 6 wks

!

13!

93%, 94%, 100% @ 6 mo.

1/268 DVT (< 0.5%); ↓ VCSS; Pain < 1/100 wk. 1 26% ecchymosis, 21% phlebitis, 16% discomfort

Bishawi M, et al. – Presentation Multicenter observational study, unpublished presentation – VEITH 2011 419 patients (GSV, SSV, AGSV, other) Mean diameter 7 mm Sclerosant volume 1 – 13 ml (mean 7) STS in most (1.5%, some 1.0%); POL 3% Short term f/u (2-7 days): 97% occlusion No univariate predictors of failure Future Large Registries Randomized Trials:

800 patient RMT trial

(MARADONA) vs. RFA;

2012-2014; pain as 1° endpoint; 2° = occlusion rates, QOL, clinical results, return to work, cost; 6 mo. f/u Dosing issues: Foam vs. liquid POL, RMT, 600 pts, 2% liq. Vs. 3% liq.

Vs. 1% foam, 6 mo. occlusion rate = 1° endpoint; clinical = 2° Longer catheter, technical refinements Specific CPT codes, indications

!

14!

Current Status of MOCA Broadens applicability of endovenous ablation to nearly all patients / scenarios Easy, fast procedure; numerous niches; No significant neurotoxicity reported Several DVTâ&#x20AC;&#x2122;s reported, 1 PE, no deaths Occlusion rates comparable to thermal ablation at 2-year follow up (small numbers) Safe, effective; another tool in toolbox; larger numbers accruing with shorter f/u Awaiting dosing studies, randomized trials, & larger safety data

!

15!

Complete the exam & evaluation below and email your results to pbush@veinexperts.org along with your contact information.

A score of 80% or greater must be achieved on the post-test and be completed in less than 3 attempts.

Exam Which of the following technical details is false regarding MOCA? a. At onset of treatment, start wire rotation while stationary (no pullback) x 3 seconds, then pullback, then inject b. While motor is on, always keep catheter moving, i.e. maintain pullback movement c. If snagging occurs, shut off motor, and give a firm tug distally to release the caught wire tip d. For SSV treatment, place wire tip anywhere from just distal to 1 cm distal to the fascial curve e. Liquid STS or Polidocanol速 is used, but in vitro foaming is observed anecdotally to at least some extent 2. Which of the following is false regarding advantages of MOCA over thermal ablation? a. No risk of nerve injury b. Can treat distal calf segments easily

!

16!

c. Can treat ulcerated segments easily d. Can treat patients with stroke and PFO e. Can treat patients with moderately tortuous truncal veins 3. Which of the following is false about studies to date regarding MOCA? a. All published studies to date are observational and nonrandomized b. Longest duration of follow up is 1 year c. Largest series to date is 419 patients d. Comparative data now available versus RF ablation, assessing post op pain and return to normal activities

!

17!

Evaluationჼჼ ჼ 1. How well did this activity present the objectives?

Excellent

Good

Satisfactory

Poor

2. How do you rate the overall usefulness of the online material to meeting your needs?

Excellent

Good

Satisfactory

Poor

3. How do you rate the overall presentation material?

Excellent

Good

Satisfactory

Poor

4. Was any commercial bias presented in the material?

No

Yes (Please explain)

___________________________________________________ _ 5. I will be able to change my clinical practice as a result of participating in this activity.

Yes

No

6. What topics about venous disease would you like to hear about in the future? ___________________________________________________ _ 7. Additional comments/recommendations: ___________________________________________________ _ ___________________________________________________

!

18!

Contact Information Name & Credentials_______________________________________________ Address ________________________________________________________ Phone Number ___________________________________________________ Email address ___________________________________________________

!

19!