Chiva today 2014

1. CHIVA TODAY 2014 From theory to scientific evidence C. Franceschi (Paris France Cremona ITALY)

2. To raise new questions, new possibilities, toTo raise new questions, new possibilities, to regard old problems from a new angle,regard old problems from a new angle, requires creative imagination and marks realrequires creative imagination and marks real advance in scienceadvance in science Albert EinsteinAlbert Einstein

3. CHIVA cure -Conservative -Hemodynamic -Venous Insufficiency -Ambulatory Treatment

4. CHIVA’S STORY -An hemodynamic pattern proposed 26 years ago. -Proved 20 years later by Controlled Randomized Trials and COCHRANE review

5. Friedrich TRENDELENBURG 1890 Benjamin BRODIE 1846 Tomaso RIMA 1775- 1843 Everard HOME 1799 Ambroise PARE 1509-1590 CHIVA Precursors Georg Clemens PERTHES 1900 William HARVEY 1578-1657

6. 1788-1899: Ligation of Saphena Vein Trendelenburg 1988: CHIVA Varicocentric Ablative 1906 Stripping Mayo Babcok 1947 Sclerosis 2000 RF, Laser, Foam Short Story 90 years90 years blackoutblackout Varicocentric Ablative Emodinamicocentric Conservative

7. 1977 1986 CHIVA was possible thanks to diagnosis improvement based on Ultrasound Duplex Scan 1988 2009

8. HEMODYNAMIC CONCEPTS PUBLISHED IN 1988. Varicose veins and trophic changes are not the cause but the effect of overloading pressure/flow The consequent treatment consists of correcting this hemodynamic impairment in order to collapse the varicose veins, restore the tissue health and reduce the varicose recurrence thanks to overloading flows disconnection and draining veins conservation, included varicose.

9. HEMODYNAMIC CONCEPTS PUBLISHED IN 1988. AND BY THE WAY preservation of the saphena veins, possibly vital in case of necessary arterial bypass

10. HEMODYNAMIC CONCEPTS 1-Dynamic Fractioning of the Hydrostatic Pressure 2-Closed and Open Shunts 3-Vicarious Varicose Recurrence 4-Saphena Conservation for Future Arterial By-pass 5-Anato-functional Mapping.

11. i P o P p P c P s g P ig P i P o P p P c P gs P g s P 20032003 Identification of pelvic leak points: Inguinal (IP) Perinaeal (PP), Clitorudian (CP) Obturator OP) Gluteal ( SGP and IGP) Franceschi C, Bahnini A. Treatment of lower extremity venous insufficiency due to pelvic leak points in women. Ann Vasc Surg. 2005 Mar;19(2):284-8 ANATOMIC LOCATION OF PELVIC LEAK POINTS

12. Hemodynamic aspects of Venous Insufficiency Diagnosis and Treatment

13. Signs: Edema, Varices, trophic changes, Ulcer ONE cause TransMural Pressure Excess TMP Venous Insufficiency Disease

14. TMP = Pressure Extra-Venous Extra-Capillary Pressure Endo-Venous Endo-Capillary minus

15. TPM is increased by 1-Hydrostatic Pressure Overloading ( gravitational) Causes Valve Incompetence, flow block 2-Residual Pressure Overloading ( micro-circulation) 3-M.Pump Pressure Overloading ( shunts)

16. CHIVA cure : 1/Hydrostatic Pressure column fractionning : restore the dynamic fractionning of the hydrostatic column during walking 2/Closed and deviated shunts disconnection : suppresses flow/pressure overloading supplied by the VM Pump during walking 3/Draining Veins conservation: avoids residual pressure excesses responsible for spider veins and varicose recurrence 4/ Venous Capital Conservation for future possible need of arterial by-pass

17. CHIVA doesn’t depend on the varicose veins evolution, downwards or upwards

18. Treatments Venous Sysytem Impairment Venous Blocks P.Residual P↑ Valve Incompetence Hydrostatic P ↑ Shunts VM Pump P ↑ Hemodynamic Disfunction Trans Mural Pressure PTM ↑ causes Genetic Malformazioni Biological Infezione Flebiti Infiamazione Iatrogenic Veins ablation Effects Dilation Venous Varicose Veins Draiange Impairement Edema Hypodermitis Ulcer Vicious Circle PTM↓ Posture Compression Veinblock: liberation, bypass Valve repair CHIVA Venous Hypertension posture, obesity according to the cause

19. Varico Centric Hemodinamico Centric TMP REDUCTIONTMP REDUCTION P ExtraVenous Pressure IncreaseP ExtraVenous Pressure Increase -Compression-Compression IntraVenous Pressure DecreaseIntraVenous Pressure Decrease -Posture-Posture -Liberation-Liberation VEINS ABLATIONVEINS ABLATION -Phlebectomy-Phlebectomy -Sclerosis-Sclerosis -Laser-Laser -Radio Frequency-Radio Frequency IMPAIRS the DRAINAGEIMPAIRS the DRAINAGE Tissue sufferingTissue suffering Vicarious RecurrenceVicarious Recurrence Destruction of the VENOUSDestruction of the VENOUS CAPITALCAPITAL CHIVACHIVA -HP Fragmentation-HP Fragmentation -Shunt Disconnection-Shunt Disconnection --Drainage respectDrainage respect -Venous capital preservation-Venous capital preservation TREATMENTS

20. OOSS OO SFSF vv aa MM Flow/pressurFlow/pressur e overloade overload VicariousVicarious flowflow FistoleFistole Artéro-Artéro- VenosusVenosus fistulefistule ClosedClosed shuntshunt VenousVenous malformationmalformation TMPTMP increases with flow and pressure overload due toincreases with flow and pressure overload due to various causesvarious causes HydrostaticHydrostatic PressurePressure excessexcess

21. CHIVA is not only avaricose treatment CHIVA is also the treatment of the cause of the venous insuficiency i.e the TMP excess. When TMP is reduced to normal, all signs and symptoms are cured: Varicose veins, Edema, Hypodermitis, Ulcer

22. CHIVA doesn’t depend on the direction of the varicose progression , downwards or upwards

23. CHIVA cure - EVIDENCE BASED MEDICINE - Randomized Controlled Trials

24. 1- Varicose Vein Surgery Stripping versus the CHIVA method: a Randomized Controlled Trial Josep oriol Pares and al Annals of Surgery * Volume 251, Number 4, April 2010 [ISRCTN52861672].[ISRCTN52861672]. (international(international standard randomised controlled trial number )www.controlled-trials.comstandard randomised controlled trial number )www.controlled-trials.com 2- Minimally Invasive Surgical management of primary venous Ulcer vs. Compression Treatment: a randomized Clinical Trial P.Zamboni and all Eur J vasc Endovasc Surg 00,1 6 (2003) 3- Clinical and random study comparing two, surgical techniques for varicose vein treatment : immediate results Iborra and all Angiologia 2000:6, 253-258 4-Varicose Vein Stripping vs Haemodynamic Correction (CHIVA): a Long Term Randomised Trial. Carandina, C. and al. Eur J Vasc Endovasc Surg xx, 1e8 (2007) doi:10.1016/j.ejvs.2007.09.011

26. 0 10 20 30 40 50 60 70 464 465 459 453 458 457 6m 12m 24m 36m 48m 60m % Ph-M Ph-ED TC St -MC St -ED TC 5ans. 550 Patients Up to 18 months: NO differenceUp to 18 months: NO difference Difference increases with time after 2 yearsDifference increases with time after 2 years CHIVA Stripp. Duplex guided Stripp. Clinical 5 years follow up : Recurrence rate:5 years follow up : Recurrence rate: CHIVA vs strippingCHIVA vs stripping

27. 0 10 20 30 40 50 60 70 464 465 459 453 458 457 6m 12m 24m 36m 48m 60m % Ph-M Ph-ED TC St -MC St -ED TC 5ans. 550 Patients Duplex Guided Vs Clinical : NO differenceDuplex Guided Vs Clinical : NO difference Duplex is USLESS for strippingDuplex is USLESS for stripping CHIVA Stripp. Duplex guided Stripp. Clinical 5 years follow up : Recurrence rate:5 years follow up : Recurrence rate: CHIVA vs strippingCHIVA vs stripping

29. KAPLAN-MEIR ESTIMATIONKAPLAN-MEIR ESTIMATION 1.01.0 0.80.8 0.60.6 0.40.4 0.20.2 00 1.01.0 0.80.8 0.60.6 0.40.4 0.20.2 00 00 250250 500500 500500750750 10001000 TIME (days)TIME (days) CHIVACHIVA compressioncompression Minimally invasive surgical management of primary venousMinimally invasive surgical management of primary venous ulcers vs. compression treatment: a randomized clinical trial..ulcers vs. compression treatment: a randomized clinical trial.. Zamboni Pand al A.Zamboni Pand al A. EJ V E S. 2003EJ V E S. 2003

31. Clinical and random study comparing two, surgical techniques for varicose vein treatment : immediate results Iborra and all Angiologia 2000:6, 253-258 immediate results: NO DIFFERENCE In accordance with O.Pares where CHIVA vs Stripping difference starts after the 18th month!

33. 1,75 1,8 1,85 1,9 1,95 2,05 2,1 2,15 2,2 2,25 2 P<0.038 Stripping CHIVACHIVA BEST SCORESBEST SCORES 18% 35% 0 5 10 15 20 25 30 35 CHIVA Stripping RECIDIVE 1O years follow up : Recurrence rate:1O years follow up : Recurrence rate: CHIVA vs strippingCHIVA vs stripping Objective evaluation S.Carandina, and alS.Carandina, and al.. E J V E Surg. 2008E J V E Surg. 2008 CHIVA Stripping

34. 1 COCHRANE REVIEW CHIVA vs Stripping Less recurrences, less complications Bellmunt-Montoya S, Escribano JM, Dilme J, Martinez- Zapata MJ. CHIVA method for the treatment of chronic venous insufficiency. Cochrane Database of Systematic Reviews 2012 , Issue 2 . Art. No.: CD009648. DOI:10.1002/14651858.CD009648 .

35. EVIDENCES Level Grade meta-analyses de RCT Ia A Strong Au moins un RCT Ib Au moins une étude clinique bien conduite sans randomisation IIa B Mid Au moins un autre type d’étude clinique bien programmé et quasi expérimental IIb Au moins un autre type d’étude clinique bien programmée et non expérimentale III Opinions de comités d’experts ou expérience d’autorités reconnues IV C Weak Other venous technics at this level???? Stripping still Gold standard? CHIVA ? CHIVA (4 RCT) CHIVA (4 RCT) + Cochrane Library REVEW

36. Retrospective study CHIVA vs LASER . Chan, C.-Y.a , Chen, T.-C.b , Hsieh, Y.-K.a , Huang, J.- H.c Retrospective comparison of clinical outcomes between endovenous laser and saphenous vein-sparing surgery for treatment of varicose veins (2011) World Journal of Surgery, 35 (7), pp. 1679-1686. Conclusion: The CHIVA patients had less pain postoperatively and a significantly higher sclerotherapy-free period compared to patients in the EVL group.

37. GUIDELINES • The care of patients with varicose veins and associated chronic venous diseases: Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum • Peter Gloviczki, MD, and al. JVS 2011 • Results with preservation of the saphenous vein. Results with CHIVA. Two RCTs188,191 compared standard treatment(compression or high ligation, stripping, and phlebectomy) with CHIVA approaches with specific anatomic patterns of reflux (types I and III shunts). For the specific venous anatomy evaluated in these trials, such techniques were better than compression in preventing ulcer recurrence and were at least equivalent to stripping of varicose veins. Although the first two RCTs focused on a small group of patients with varicose veins, the trial of Pares et al deserves credit for including the full spectrum of patients with primary varicose veins. CHIVA is a complex approach, and a high level of training and experience is needed to attain the results presented in this RCT. However, the results achieved by a few outstanding interventionists does not support offering this procedure to all practitioners.Although CHIVA has called attention to the importance of directing surgical procedures toward the patient’s venous anatomy and function, it still requires considerable education of venous interventionists willing to learn this approach.

38. CHIVA requires considerable education of venous interventionists willing to learn this approach” (Peter Gloviczki, MD, and al. JVS 2011) because it relies on new hemodynamic concepts of the venous pathophysiology and a proper DUS assessment method. CHIVA performed by who doesn’t know enough about them is not CHIVA and leads to failure as a study demonstrated it (Milone M, Salvatore G, Maietta P, Sosa Fernandez LM, Milone Recurrent varicose veins of the lower limbs after surgery. Role of surgical technique (stripping vs. CHIVA) and surgeon's experience.F. G Chir. 2011 Nov- Dec;32(11-12):460-3).So, conservation is possible in all the patients and CHIVA

39. …..today, treatments are performed in accordance with the evidence based medicine supplied by Randomized Controlled Trials ….and after a comprehensive information and consent of the patient. President of Medicine Academy

40. CHIVA preserves the GSV for future arterial bypass Optimal management of infrainguinal arterial occlusive disease Authors: Pennywell DJ, Tan TW, Zhang WW Full text: available on http://www.dovepress.com/article_18926.t34346121 Risk factors:Age is the most important, nonmodifiable risk factor for PAD, with a prevalence of 0.9% in people under age 50 and 23.2% in people over the age of 80.1 Open reconstruction:The most important determinant of success of an Infrainguinal lower extremity bypass (LEB) is the type and quality of conduit selected.2,17,52 Autogenous vein is superior to synthetic graft as conduit for LEB,2,53–55 and the great saphenous vein (GSV) is superior to other autologous alternatives.2,55,56 An essential step in preoperative planning is evaluation of the GSV with duplex mapping and identification of alternative vein conduits, if needed. An ideal vein conduit should be soft, compressible, at least 3 mm in diameter, and should not be calcified or sclerotic. If the ipsilateral GSV is unsuitable or unavailable, the contralateral GSV should be used. Conclusion Open infrainguinal bypass remains the gold standard for revascularization in CLI, especially for patients at appropriate surgical risk and with suitable bypass conduit.

41. Is it professional not to give the best scientifically proved treatment to the patient? Is it honest to tell the patient his saphena wouldn’t be usefull in case of arterial by-pass necessity?

Chiva today 2014

Claude Franceschi

Chiva today 2014