Venocuff IITM Facts

Venocuff II Facts
TM
The Venocuff and Venocuff IITM have been used in Australia for 15 years with
approximately 2000 procedures performed.Over this period important changes
have been made to patient assessment,surgical procedures and the Venocuff itself.
The following statistics have been collected over 15 years of clinical use;
1.Infection and Superficial clots occur
very rarely (less than 1%).There have
been no instances of major DVT and 2 in
the surrounding vessels.None required
additional treatment.
2.The Venocuff IITM surgery can be less
aggressive than other vein related surgery.
As illustrated,the vast majority of patients
that have had both forms of vein surgery
indicate that they prefer the Venocuff IITM
Recurrence Rates:Surgical Stripping v’s Venocuff IITM
Venocuff II
Information
Common femoral artery
Common femoral vein
Patient Preference (Stripping v. Venocuff II
TM
3.Current alternatives
such as Sclerotherapy and
Laser treatment (EVLT)
and other progressive
techniques whilst claiming
to be minimally invasive
still ablate or destroy the
vein trunk,which in comparison to Venocuff IITM,
considerably increases the
chance of recurrent varicose veins.This adds up to
potentially tens of thousands of dollars over a ten
year period.
4.The Venocuff IITM is the only clinically proven device of its type available anywhere in the world.The procedure preserves the major veins rather than removing them.This philosophy underpins the surgical dictums of "first do no harm" and
"preserve rather than destroy".
Sapheno- femoral
junction
For further Information please contact:
TM
Venous Disease and the Venocuff II TM
Lower Limb Venous Disease
How do Veins Work ?
Essentially the venous system is divided into two interconnected groups:
SUPERFICIAL and DEEP connected by
communicating veins called perforators.The veins bring blood back to the
heart and then on to the lungs to be
oxygenated. Veins do not have the
direct driving force of the heart and
must also work against gravity. Muscles
in the legs contract to squeeze blood
through the veins. A series of small
valves situated along the length of the
vein helps the flow of blood back to
the heart. These one-way valves prevent blood from falling backwards
because of gravity or excess pressure.
What causesVaricoseVeins ?
Varicose veins are primarily caused by
weakening or stretching of the valve ring
or valve support structure. When the
valve ceases to function normally, blood
falls back through the valve. Because the
vein is not adequately emptied, the pressure within it increases and remains much
higher than normal. The walls, which in
most patients with venous disease are
inherently weak, stretch and the vein
enlarges. Dilated veins may appear as a
knotted rope and are called varicose veins.
Venous diseases is often inherited and is
also associated with pregnancy, obesity and
standing for long periods.
What is the Venocuff?
As mentioned each valve consists of two
cusps or halves
that when separated cease to
function.
The
Venocuff is a
Diagram of Venocuff II
small,
thin
Dacron-reinforced Silicone cuff or band
that is surgically implanted around a malfunctioning valve and tightened until the
valve resumes its normal function. The
aim of using the Venocuff is to realign the
two cusps to prevent leakage and once
implanted it is left in the body permanently. It should be emphasised that this
type of silicone is solid and inert and not
the same type as that used in cosmetic
or reconstructive breast surgery.
Diametres for known
Phenotypes
Belt
Notch for insertion
at the SFJ
TM
For the treatment of simple varicose veins,
the Venocuff procedure is less traumatic
than vein stripping. Placed around the main
valve in the groin, the greatest advantage
of this technique is that most of the vein is
not removed or damaged. This results in
essentially a physiologically normal superficial system. Conversely, ligation or removal
of veins is a destructive procedure that
may result in the production of new veins
which are always abnormal and called
recurrent varicose veins.
The Venocuff is only applicable to major
valve sites. Small superficial veins may
require more conventional management
such as avulsion or sclerotherapy. Some
small superficial veins may lighten following the procedure as the Venocuff reduces
significantly the pressure placed on the
lower parts of the leg.
What advantages are there Is the Venocuff right for
to using the Venocuff?
every patient?
The Venocuff
has
several
advantages
over
other
methods of
BEFORE
AFTER
treatment for
Venocuff II positioned around
a diseased valve
varicose veins
and deep venous disease. The Venocuff
will, if valves are present and undamaged,
restore them to working condition alleviating the symptoms of the disease.This
may require anything from one to several Venocuff(s) placed at strategic points
along the length of the vein. At present
the Venocuff is the only method for
treating deep venous disease which produces good long-term results.
TM
Valve Function
Venous valves are "non-return" valves which allow blood to flow in one direction
only. Normally, as you walk the muscles around the vein contract squeezing the vein
which propels blood upward through the valve. Due to gravity , the blood falls back
towards the valve onto the cusps and outwards towards the vein wall. These two
actions push the cusps together closing the valve. In venous disease, the supporting
"valve-ring" weakens or the valve cusps themselves are either damaged or missing. In
the early stages of venous disease the valve-ring weakens and the vein stretches
pulling the cusps away from each other. As a result the cusps no longer meet allowing blood to move freely in both directions and the valve is said to be "incompetent".
The Venocuff procedure is not suitable for
some patients whose venous valves are
either missing, damaged by a blood clot or
have been subjectCommon femoral artery
ed to excessive
Common femoral vein
pressure for too
Sapheno-femoral
long. The Venocuff is
junction
also not applicable in
some cases of recurrent varicose veins
especially where
there has been an
incision in the groin
and veins removed.
Venocuff in position
around the main valves
of the superficial system
Why Use theVenocuffII ?
TM
The Venocuff IITM has many advantages over conventional
superficialand deep venous surgicaltreatment.These include;
• IT IS RESTORATIVE NOT ABLATIVE!!!
• In 90% of cases reflux is completely abolished creating physiologically normal upward flow.
Significant reductions are observed
in remaining cases;
• Allows LSV smooth muscle to
regain tone at the SFJ and lower leg
resulting in distal competence;
• Prevents further dilation of the
valve ring at the SFJ;
• No obstruction/damage of normal
tributaries;
• No increase in load on deep system, and residual superficial veins;
• Decreased venous neogenisis and
subsequent recurrences compared
with stripping.
VenocuffII
Information
Common femoral artery
Common femoral vein
Sapheno-femoral
junction
Recurrence Rates: Surgical Stripping v’s Venocuff IITM
The Venocuff IITM is applicable to the following patients
previously ineligiblefor surgical treatment;
• Young Patients;
• Females prior to pregnancy;
• Coexisting deep venous disease;
• Early coincidental SFJ incompetence;
• Strong Family history of peripheral
arterial and heart disease;
• Lateral/anterior accessory system
with
competent distal long saphenous;
• Mild to moderate varicose veins
For further Information please contact:
Patient Preference: Stripping v’s Venocuff IITM
Finally, 15 years of clinical practice has found that PATIENTS
PREFERTHE VENOCUFF IITM.
TM
Venocuff IITM
The Venocuff IITM associated pre-assessment and
intra-operative tests represent an improvement
on the original VenocuffTM.
Operative Procedure
1
Design changes include;
1. The introduction of a left and right notch for
implantation at the Left and Right SFJ.
2. Markers for sizing of the vein ID.
3.Widening of the belt buckle design, which allows
the Venocuff IITM to become elliptical in-situ.
4. Implantation no longer utilises a dispensing gun
giving the surgeon more freedom to make fine
adjustments to the final vein ID.
5. Venocuff IITM is supplied as a pack of three
LEFT, RIGHT and DEEP, which affords the
surgeon more options at the time of surgery.
Part
art 1. Identificationof the terminal valve
valve at SFJ.
2. The end of the stent is slipped through
the buckle and tightened to a predetermined
diameter.
2➔
3
1
Venocuff IITM with “Left”, “Right”
, & “Deep” cuffs pictured
Pre-assessment;
Part
art 2. Positioningof the corr
correct Venocuff.
With technical advances in ultrasound technology the criteria for selection of suitable patients
has been fully developed and documented.
Intra-operativ
e testing;
Guidelines on intra-operative testing of valve competence have been defined.
The recommended tests
ensure that patients do
not leave the operating
room until valve competence has been achieved.
This ensures competency
rates of 90% + at 5 years
follow-up.
1. A standard incision in the groin allows
access to the SFJ.The valve commissures can
usually be seen through the vein adventitia.
Tributaries are clipped however, it is important that at least 1/2cm of the common
femoral vein is exposed. A VessiloopTM is
placed around the LSV 3cm below the SFJ
and right angle forceps are used to position
the stent around the terminal valve.
Ultrasound image of vein valve
Part
art 3. Completing the circle
circle..
3. The valve repair is then tested using
one of the following two techniques.
i.The "Valsalva Maneuver":A tributary is
left untied below the valve repair whilst
ensuring inflow is blocked using a
VessiloopTM . No bleeding should
occur until the VessiloopTM is loosened.
ii. The "Milking Test": The distal LSV
inflow is blocked and the segment of the
LSV between the VessiloopTM and the
stent is milked free of blood. This segment of the LSV should remain empty if
the valve is competent.
4. If the valve is competent the diameter of
the stent is secured with a 5.0 Prolene
suture through the buckle, belt and vein on
either side of the stent.
Intraoperative testing of Venocuff IITM in-situ
Part
art 4. Suturing the Venocuff into position.
An Alternative The rapy for Recurrent Stasis Ulce rs in Chronic Venous Insufficiency:
Venocuff
Short Title; Venocuff for Venous Stasis Ulcers
Authors;
Celal YAVUZ, MD, Medical School of Dicle University, Department of Cardiovascular
Surgery, Diyarbakir/TURKEY [email protected]
Sinan DEMIRTAS, Medical School of Dicle University, Department of Cardiovascular
Surgery, Diyarbakir/TURKEY [email protected]
Orkut GUCLU, Medical School of Dicle University, Department of Cardiovascular Surgery,
Diyarbakir/TURKEY [email protected]
*Oguz KARAHAN, Medical School of Dicle University, Department of Cardiovascular
Surgery, Diyarbakir/TURKEY [email protected]
Suleyman YAZICI, Medical School of Dicle University, Department of Cardiovascular
Surgery, Diyarbakir/TURKEY [email protected]
Ahmet CALISKAN, Medical School of Dicle University, Department of Cardiovascular
Surgery, Diyarbakir/TURKEY [email protected]
Binali MAVITAS, Medical School of Dicle University, Department of Cardiovascular
Surgery, Diyarbakir/TURKEY [email protected]
Corresponding Author Address: Oguz KARAHAN, MD
Medical School of Dicle University, Department of Cardiovascular Surgery,
Diyarbakir/TURKEY
Phone: 0090346-2581941
Fax: 00903462191284
Email: [email protected]
ABSTRACT
Chronic venous insufficiency may have cause to stasis ulcers that significantly
deteriorate the life quality since early ages. Many treatment methods were described to
preventing or treating for these ulcers. However, stasis ulcers have recurring property due to
continuing venous insufficiency.
Here we report a 30 years old male patient with chronic venous insufficiency. He
admitted to hospital due to recurrent stasis ulcers especially in medial side of his left tibial
skin. He had a history of various flavonoid drug usage and compression therapy since past 6
years. Doppler ultrasonography was revealed combine sapheno- femoral and deep femoral
venous insufficiency. Venocuff applied in to prejunctional, postjunctional part of femoral vein
and sapheno- femoral junction. Patient was discharged postoperative second day and low
molecular weight heparin and composed of calcium alginate dressing in to ulcer wound was
received for one week after the operation. The stasis ulcer wound was totally healed after one
month of operation. Patient was followed up during the six month a fter operation and
postoperative complication or new ulceration was not observed.
Recurrent stasis ulcers are major hospitalization reasons in patients with chronic
venous insufficiency. These ulcers may treatable despite recurrence potential. Venocuff
application for reducing the venous insufficiency may be a good option for adjunctive ulcer
therapy and preventing the recurrences.
Key Words; Venous insufficiency; stasis ulcer; venocuff therapy
INTRODUCTION
Chronic venous insufficiency may have cause to stasis ulcers that significantly
deteriorate the life quality since early ages. Many treatment methods were described to
preventing or treating for these ulcers. However, stasis ulcers have recurring property due to
continuing venous leakage (1,2). Described surgical methods (high ligation, stripping,
radiofrequency ablation, and endovenous laser therapy etc.) are widely performed. These are
safe and effective procedures that can achieve good short- and long-term outcomes for most
patients in experienced hands. However, the loss of the saphenous vein as a potential bypass
graft and possible risk for continuous deep venous reflux are the important disadvantages of
these procedures (1-3).
The approaches that focused to provide venous valve sufficiency are applicable for a
long time. External wrapping is one of the available procedure such these conditions. The
main purpose of this approach is to restore the function of the venous valves that settle
between saphenous and deep veins through extraluminal wrapping of the dilated vein, thereby
reducing its diameter and bringing the valve cusps together (3).
Here we report a case with chronic venous insufficiency whom complaint recurrent
non-healing venous ulcers.
CASE
A 30 years old male patient with chronic venous insufficiency admitted to hospital due
to recurrent stasis ulcers especially in ½ medial side of his left tibial skin. He had a history of
various flavonoid drug usage and compression therapy since past 6 years. Venous doppler
ultrasonography was revealed combine saphenofemoral and deep femoral venous leakage.
Venocuff applied in to prejunctional, postjunctional part of femoral vein and saphenofemeral
junction (Figure 1). Patient was discharged postoperative second day and low molecular
weight heparin and composed of calcium alginate dressing in to ulcer wound was received for
one week after the operation. The stasis ulcer wound was totally healed after one month of
operation. Patient was followed up during the six month after operation and postoperative
complication or new ulceration was not observed.
Figure 1.A: Exploration of Sapheno-Femoral Venous Junction. B: Veins was turned and
Venocuff was placed around C: The view of the veins after the Venocuff placement
DISCUSSION
Chronic venous insufficiency is a common Worldwide disorder that affecting onethird of the European population (4). The impact of chronic venous insufficiency is correlated
to the affected population and socioeconomic regression due to the manpower loss and
treatment costs (5).
Venous diseases are responsible for over 70% of chronic wounds in the lower
extremities. Usually symptomatic therapies such as palliative wound healing strategies are
available in current modalities. However, definitive treatment methods required due to
significant recurrences rates of venous leg ulcers is 72% (6). Therefore, venous leakage
should be prevented and collaborative clinical approaches must be applied such these cases.
External venocuff strategies were suggested from many significant reports in the
literature. There were lots of available positive data that claimed external banding of the
superficial femoral vein or saphenofemoral junction may abolish the reflux and correct
venous hypertension, preventing recurrences (1,3). Karapolat and Ozdemir present successful
applications for such cases in three patients with chronic venous insufficiency (8). They
reported as “is less invasive compared to other methods may provide an effective
reconstruction in the existence of isolated valvular incompetence and reflux in
saphenofemoral junction.”
To sum up, recurrent stasis ulcers are major hospitalization reasons in patients with
chronic venous insufficiency. These ulcers may treatable despite recurrence potential.
Venocuff application for reducing the venous leakage may be a good option for adjunctive
ulcer therapy and preventing the recurrences.
REFERENCES
1. Guarnera G, Furgiuele S, Mascellari L, Bianchini G, Camilli S. External banding
valvuloplasty of the superficial femoral vein in the treatment of recurrent varicose veins. Int
Angiol. 1998;17(4):268-71.
2. Perrin M. Surgery for deep venous reflux in the lower limb. J Mal Vasc. 2004;29(2):73-87.
3. Joh JH, Lee KB, Yun WS, Lee BB, Kim YW, Kim DI. External banding valvuloplasty for
incompetence of the great saphenous vein: 10- year results. Int J Angiol. 2009;18(1):25-8.
4. Sándor T. Chronic venous disease. A state of art Orv Hetil. 2010;151(4):131-9.
5. Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005;111(18):2398409.
6. Ross DS. Venous Stasis Ulcers: A Review. Northeast Florida Medicine 2012; 63(2): 29-51
7. Karapolat S, Ozdemir C, Use of External Valvular Stenting on Isolated Saphenofemoral
Junction Incompetence: Report of 3 Cases. ADÜ Tıp Fakültesi Dergisi 2008; 9(3): 33-39
VENOCUFF II™
Klinik Çalışma Özet Bölümleri
Long Term Results of Multiple Deep Venous Valve Repairs Using the Venocuff II™, RJ Lane, Fracs, MI,
Cuzzilla DMU (Vasc), C G McMahon MB BS FACASHP, Journal of Vascular Surgery, February 2001.
( Venocuff II kullanılarak Çoklu Derin Ven Valf Tamirinin Uzun Dönem Sonuçları )
Bu çalışma ile Venocuff ( Venöz Valf Stent implantı) kullanılarak çoklu derin ven valf tamirinin
etkinliği ve güvenliği değerlendirmek amaçlanmıştır. 1987-1991 yılları arasında Kronik Venöz
hastalığı olan 42 uzuv opere edilmiştir. Bu seriye dahil olan hastalar ortalama 7.9 ila 5.4 ile 11.9
yıl aralığında değişen bir 5 yıllık bir takipleri vardır. Çoğu hasta primer derin venöz yetmezliği
vardır. Yüzeysel femoral ve popliteal ven dahil toplamda 125 valf tamiri yapılmıştır. Cerrahi
işlemi takiben ülserli bölgeler ortalama operasyon öncesi 12.9cm2 den 1.2cm2 ye 86 ayda
yaklaşık %80 iyileşme elde edilmiştir. Bütün semptomlar, ağrı, şişkinlik, kramplar ve
pigmentasyon statistik olarak önemli bir seviyede iyileşmiştir. %90 kızılötesi PPGRT iyileşme
zamanı yaklaşık operasyon öncesi 6.7 saniyeden, operasyon sonrası 36 ayda 12.4 saniye
çıkmıştır ve bu oran uzun dönemde değişmeden kalmıştır. Venöz basınç post implantasyonda
sadece 12 ayda önemli derecededir. Çoklu değişken analiz kullandığımızda implante edilen
Venocuff sayısı artan derecede ülser iyileşmesi ile bağlantılıdır. Venöz valf bölgesi tamiri diğer
değişkenlerden bağımsızdır. Sonuç olarak, çoklu venöz valf tamiri uygundur ve primer derin
venöz yetmezliği bulunan seçilmiş bireyler için en iyi tedavi formudur.
Indications to Repair the Sapheneofemoral Junction with External Valvular Stenting, RJ Lane
and ML Cuzzila, Vascular Specialists Investigations & Managemnet Dalcross Private Hospital,
Mater Private Hsopital and North Shore Private Hospital, Sydney, NSW Australia, Australian &
New Zealand Journal of Phlebology, Vol 5 (1) June 2001.
Abstract ( Özet)
Amaç : Özellikle Lateral ve Anterior Aksesuar Safen Sistemi etkileyen varikoz damarlı hastalarda
Safenfemoral bileşkede Venocuff ile striplemenin karşılaştırlmasıı için yapılan radomize uzun
dönem perpektifli bir sunumdur
Metod : 100 ard arda Safenfemoral bileşkeye Venocuff II™ yerleştirldi. Bunların arasında 11
tane hastaya Venocuff II™ uygu olmasına karşın farklı nedenlerden dolayı stripleme tercih
edilmiştir.
Sonuçlar : Stripleme gruplarında 5.7 yılda 4 uzuvda nüks etmesine karşın Venocuffta 4.9 yılda 2
nüks mevcuttur. Bu ikisi safen femoralbileşkede yeterlilik mevcut ve hamiledirler. Venocuff
grubunda bir kişide trombofelbit gerçekleşmiştir.
Özet : Striplemeye karşın Venocuff II tedavisi uzun dönemde mükemmel sonuçlara sahiptir.
İnkompetant Venöz Valflerin Tamiri : Yeni Bir Teknik
George Jessup, MB,BS and Rodney J. Lane, MS,DDU Sydney , Avustralya
Venöz Valf yetersizliğinden kaynaklanan kronik venöz hastalığının tedavisi için mevcut tekniklerin
hepsinin eksiklikleri mevcuttur. Venöz sistemde çoklu bölgelerdeki hastalıklı valfleri tekrar eski
fonksiyonuna kazandırmak için basit bir tekniğe ihtiyaç vardır. Venocuff, veni çevresini azaltarak venöz
valf yeterliliğini tekrar kandıran implante edilebilir bir implanttır. Venöz valf yetersizliği çalışmasında
kullanılabilir iki hayvan modeli tanımlanmıştır: cihaz koyun şahdamarından iki modelde test edildi. İlk
model doğal olarak yetersiz valfi olan modeldi. Cihaz 11 adet tamamen yetersiz, 7 tanesi kısmi yetersiz
valf üzerinde uygulandı. İkinci model dört koyunda şahdamarında yetersizlik oluşturmak için
arteriovenöz fistüller kullanıldı. Implant çevresindeki basınç 16 ila 68mmHg arasında değişen aralıklarla
uygulandı. Çalışılan iki hayvan çalışmasında Venocuff’un valf yeterliliğini tekrar kazandırmada etkili
oldugu tespit edilmiştir. Şu açıktır ki elde edilen sonuçlar ve bu modellerdeki valf yetersizlikleri sonuçları
Venocuff’ın İnsanlarda Venöz yetmezlik tedavisinde uygulanabilir .
Safenfemoral yetemezlikle bağlantılı varislerin içi yapılan Standard tedavisi ya yüksek ligasyon ya da
sekleroterapi yöntemidir. Bu yöntemlerin en büyük dezavantajları bu damarların artık koroner ya da
periferik damar grefti yerine kullanılamamasıdır. Ligasyon tek başına damarı muhafaza etmek için
kullanılır fakat flebit oluşturma riski vardır. Kronik Venöz yetmezliği bulunan hastalarda Safenefemoral
bileşkenin okülizyonu şüpheli bir faydası vardır ve ve bazı durumlarda basıncı artırarak zararlı bir durum
oluşturabilir. İleri doğru akışa izin verirken akışı sınırlandırabilir. Kronik venöz yetmezlik yüksek
sosyoekonomik boyutu olan bir maliyetdir fakat geleneksel tedavilerin başarısız olduğu kişilerde genel
bir cerrahi operasyon tedavi yoktur. Reflüyü engellemek için bir çok method denenmiştir; valf
transplantasyonu, femoral yada popliteal ven ligasyonu, Ayrıca suni mekanizma üretici bazı tekniklerde
denenmiştir. Bütün metodların problemleri vardır. Çoklu valf tamiri ve yetmezliğin nüks etmesinin
giderilmesi için çoklu bir tekniğe ihtiyaç vardır. Bu çalışma Venöz valf yetmezliğin giderilmesinde
kullanılan yeni bir tekniğin güvenirliği ve etkinliğinin belirlemek amacı ile yapılmıştır.
Materyal ve Metodlar
Cerrahi İmplant. Venocufff Vaso Products Pty LTD tarafından üretilen güçlendirilmiş dakron ve
silikondan imal bir kılıftır. Kılıf 1.5mm enindedir ve valf kapakçıklarını aynı pozisyona getirmek amacı ile
valf bölgesinin çapını azaltarak yerleştirilen bir implanttır. Yeterlilik aşağıda tarif edilerek test edilmiştir
Optimal yeterlilik elde edilince çelik telden imal cerrahi stapl ile dairesel şekilde sabitlenir. Sütür fasia
çevresine dikilir. Bu kemerin ven üzerinde hareket etmesini engellemek için gereklidir. Ven duvarına
herhangi bir sütür implante edilmez. Bir ek takılarak be deneyde uygulama basite indirgenmiştir.
Cerrahi İşlem: Bu çalışmada Merinos koyunları kullanılmıştır. Bütün işlemler antestezi altına spontone
ventilasyon uygulanarak gerçekleştirilmiştir. Dış şah damarı bilateral olarak 15 koynda kesilmiştir ve
unilateral olarak iki koyunda kesilmiştir toplamda 32 ven oluşturulmuştur.