New technology new technique radiofrequency results 5 years

Steve Elias MD FACS FACPh

Director, Division of Vascular Surgery

Vein Programs

Columbia University and Medical Center

NY NY USA

NEW TECHNOLOGY, NEW TECHNIQUE:

RADIOFREQUENCY RESULTS 5 YEARS

vein disease is an incurable disease

VEIN DISEASE IS AN INCURABLE DISEASE

RFA = CAROTID ENDARTERECTOMY?

• About as good as it gets

• Most studied

• Most durable

• Excellent results

• Minimal complications

• Technique/Technology matters

MEEVA:

MODERN ERA OF ENDOVENOUS ABLATION

• After initial learning curve – 1999 -2002

• After global learning curve – 2003 – 2007

• MEEVA – 2007 on

• Laser and RF during MEEVA – the rest is just history

• Segmental positioning

• Continuous temp – watts

• No char on catheter

• Short procedure

• Continuous pullback

• Bipolar heating -impedance

• Char on catheter – stop

• Long procedure

RF: WHAT HAS CHANGED?

Before MEEVA After MEEVA

OLD CATHETER: ANCIENT HISTORY

RF CATHETER: CLOSURE FAST™/VENEFIT™

RF SEGMENTAL ABLATION: 7 CM

CLOSUREFASTTM 3CM CATHETER

60cm

working

length

Shaft markings are

2.5cm apart

3cm heating

element

11cm and 7cm

sheath

markings

CHOICES: 2013

• 810 nm

• 940 nm

• 980 nm

• 1320 nm

• 1470 nm

• Radiofrequency

• Polidocanol Endovenous Microfoam

• Mechanochemical – MOCA

• Cyanoacrylate – glue

• Steam

• V Block

ENDOVENOUS ABLATION: STEPS - APET

• A - Access

• P – Position in GSV/SSV/AAGSV/BK GSV/ Anything

straight

• E – Exsanguinate – tumescence

•

• T – Treat from within (destroy)

RF CATHETER: CLOSURE FAST™/VENEFIT™

RF: TECHNOLOGY CHANGE 1

RF: TECHNOLOGY CHANGE 2

RF TECHNIQUE CHANGE:

SEGMENTAL ABLATION

RF: 5 YEAR RESULTS

• Really good

• Carotid endarterectomy

• Approximately 92% occlusion rate

CEAP: BASELINE

CEAP: 5 YEARS

OCCLUSION RATE: 5 YRS

REFLUX FREE: 5 YRS

VCSS: 5 YR

RF: SPECIFIC THOUGHTS

• Operator independent – just position each segment

• Segmental treatment – eliminates pullback variability

• Delivers consistent energy – needed to overcome

• Position and device does the rest

META – ANALYSIS RESULTS 3 YEARS:

WHERE WE WERE (BEFORE MEEVA)

• Only literature up to 2007 (12,320 limbs)

• Did not include any of MEEVA

• EVLA – 94%

• RFA – 84% (92% MEEVA)

• USG Foam – 77%

• Stripping – 78%

• QoL – not really addressed

van den Bos, Renate et al. Endovenous therapies of lower extremity varicosities:

a meta-analysis. JVS 2009; 49: 230-39.

RANDOMIZED CONTROLLED TRIAL:

WHERE WE ARE - QOL

• Randomized clinical trial comparing endovenous laser

ablation, radiofrequency ablation, foam sclerotherapy and

surgical stripping for great saphenous varicose veins

• L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings

and B. Eklof

• British Journal Surgery 2011; 98:1079-1087

WHERE WE ARE: QOL

• Five hundred consecutive patients (580 legs) with GSV reflux were

randomized to endovenous laser ablation (980 and 1470 nm, bare

fibre), radiofrequency ablation, ultrasound-guided foam

sclerotherapy or surgical stripping using tumescent local

anaesthesia with light sedation. Miniphlebectomies were also

performed.

• The patients were examined with duplex imaging before surgery,

and after 3 days, 1 month and 1 year.

WHERE WE ARE: QOL

• Disease-specific quality-of-life and Short Form 36 (SF-36 ) scores

had improved in all groups by 1-year follow-up. In the SF-36

domains bodily pain and physical functioning, the radiofrequency

and foam groups performed better in the short term than the

others.

• All treatments were efficacious. The technical failure rate was

highest after foam sclerotherapy, but both radiofrequency ablation

and foam were associated with a faster recovery and less

postoperative pain than endovenous laser ablation and stripping.

SHOULD WE DO EVA?

• SVS/AVF Guidelines – 1B recommendation for EVA, compression if not a candidate for EVA

• NICE: (National Institute for Health Care Excellence): EVAFoamSurgeryStockings

• Good data based on: efficacy, safety and QoL

• QALY – takes everything into the equation: cost,QoL,RTW

QOL: MOST IMPORTANT

• Not closure rates

• Not patency rates

• QoL

• It’s about the patient, not the procedure

TAKE HOME MESSAGE: RF AT 5 YRSGOOD DATA THAT IT HELPS PATIENTS

• Percutaneous

• 30 minutes - average

• Outpatient, local/sedation anesthesia

• Resume normal activities in a few days

• Improve QoL – look/feel 75-80% better

• Durable and long lasting effects

• Any age – walking, talking, functioning

THINGS WE’VE LEARNED: 5 YRS LATER

• Distance from SFJ/SPJ can be greater for good results

• Post activity – doesn’t matter

• Compression – maybe not

• Treat to lowest level of incompetence

• Improve technology/simplfy technique = Improve results

VEIN DISEASE IS AN INCURABLE DISEASE