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Short stripping of the incompetent great saphenous vein by InvisiGrip ® vein stripper

Short stripping of the incompetent great saphenous vein by InvisiGrip ® vein stripper

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Phlebologie 2/2010
77
© Schattauer 2010Original article
Short stripping of the incompetentgreat saphenous vein by InvisiGrip
®
vein stripper
A new scarless surgical technique
G. M. J. M. Welten¹; A. G. Krasznai
2
; E. C. M. Bollen
2
; J. C. van der Kley
3
; R. J. Th. J. Welten
2
 
¹Department of Vascular Surgery, Erasmus Medical Center, Rotterdam, the Netherlands;
2
Department of Vascular Surgery, Atrium Medical Center Parkstad, Heerlen, the Netherlands;
3
Department of Phlebology, Atrium Medical Center Parkstad, Heerlen, the Netherlands
Keywords
Varicose veins, short stripping, InvisiGrip
®
,saphenous vein, vascular surgery
Summary
Ouraimis to describe the results of a newshort stripping technique for the treatment of the incompetent great saphenous vein (GSV)using a new developed surgical device.Pa-tients, methods:397 patients (498 legs) weretreated with the InvisiGrip
®
Vein Stripper,which removes the GSV through a single groinincision, endovascular cutting and antegradestripping by inversion. We reported the sur-gical success rate and postprocedural compli-cations.Results:The mean age was 51 years,74% were women. The success rate for re-moval of the GSV was 95%. The 23 failureswere half patient related, half device related.In 82% of the strippings, one or two attemptswere needed to successfully remove the GSV,which was done by invagination in 80%. Age,gender, BMI
30 kg/m
2
and male GSV dia-meter were not associated with the number oattempts. Superficial wound infection, haema-toma and temporary saphenous and femoralnerve injury occurred in 6 (1.6%), 0, 3 (0.8%)and 7 (1.9%) patients, respectively.Con-clusion:The InvisiGrip
®
is highly successful forthe removal of the GSV using short invertingstripping. Furthermore, it is simple, safe, as-sociated with good cosmetic results and nopreoperative selection of patients is necessary.
Correspondence to:
Dr. R. J. Th. J. WeltenHead of the Department of Vascular SurgeryAtrium Medical Center ParkstadPO box 4446, 6401 CX Heerlen, The NetherlandsTel. +31/45/576 65 99, Fax +31/45/576 68 81E-mail: r.welten@atriummc.nl
Schlüsselwörter
Variköse Venen, kurzes Stripping, InvisiGrip
®
,Vena saphena magna, Gefäßchirurgie
Zusammenfassung
Ziel:Ergebnisse einer neuen Technik des kurzenStrippings zur Behandlung der insuffizienten V.saphena magna (VSM) mit einem neuen chirur-gischen Instrument sollen beschrieben werden:dem InvisiGrip Venenstripper mit einer einzigenInzision in der Leiste.Patienten, Methoden: Zwischen 2004 und 2007 wurden insgesamt397 Patienten (498 Beine) mit dem InvisiGripVenenstripper behandelt. Alle Patienten hattenBeschwerden infolge einer Insuffizienz derVSM; präoperativ wurde die venöse Insuffi-zienz der Krosse und der VSM mittels Duplex-Ultraschall nachgewiesen. Mit dem InvisiGripkann die VSM über einen einzigen Schnitt in derLeiste (für die Krossektomie), einen endovasku-lären Schnitt und durch antegrades Strippingmit Inversion entfernt werden. Es handelt sichdabei um einen 60 cm langen Einmalkatheter,der aus einem zweiteiligen Schneidekopf sowieeinem Griff auf der Gegenseite besteht. Eine Li-gatur des Venenstumpfes auf Kniehöhe istnicht erforderlich. Bei allen Eingriffen doku-mentierten wir die Baselinecharakteristika, dieHäufigkeit erfolgreich entfernter VSM undpostoperativer Komplikationen (z. B. Hämatomim Kniegelenk, oberflächliche Wundinfektion,Nervenschädigung, sonstige).Ergebnisse:Dasmittlere Alter betrug 51 (
±
12,5) Jahre, 74% wa-
Kurzes Stripping der insuffizienten Vena saphenamagna mit dem InvisiGrip VenenstripperPhlebologie 2010; 39: 77–81
Received: January 4, 2010accepted: February 28, 2010
ren weiblich. Frauen wiesen im Vergleich zuMännern einen größeren VSM-Querschnittauf (7,7 mm gegenüber 7,0 mm). Insgesamtwurden 98% der Patienten ambulant operiert,vorzugsweise in Spinalanästhesie (95%). DieRate erfolgreich entfernter VSM lag bei 95%.Das Versagen in 23 Fällen war zur Hälfte durchdie Patienten bedingt (VSM zu gewunden)und zur Hälfte auf den Katheter (der 5 mmSchneidekopf war zu breit für die insuffizienteVSM) zurückzuführen. Bei 82% der Strippingswurden ein oder zwei Versuche benötigt, umdie VSM erfolgreich zu entfernen, was in 80 %durch Invagination erfolgte. Alter, Geschlecht,BMI
30 kg/m
2
und männlicher VSM-Quer-schnitt waren nicht mit der Anzahl der Versu-che assoziiert. Oberflächliche Wundinfektio-nen in der Leiste, Hämatome im Kniegelenkund vorübergehende Schädigungen des N. sa-phenus und N. femoralis traten bei 6 (1,6%),0, 3 (0,8%) bzw. 7 (1,9%) der Patienten auf.Nicht durch das Stripping bedingte Komplika-tionen traten bei 6 Patienten (1,6%) auf: eineLungenembolie am zweiten postoperativenTag, vier oberflächliche Wunden infolge zustrammer postoperativer Verbände und eineSchädigung des N. peroneus durch die Spinal-anästhesie.Schlussfolgerung:Der InvisiGrip
®
 Venenstripper kann sehr erfolgreich zur Ent-fernung der VSM bei kurzem Stripping mit In-version und ohne distale Inzision im Knie ein-gesetzt werden. Er ist einfach, sicher und er-bringt gute kosmetische Resultate. Ein weite-rer Vorteil: Eine präoperative Patientenselekti-on ist nicht erforderlich.
 
78
Phlebologie 2/2010 © Schattauer 2010
G. M. J. M. Welten et al.: Short stripping of the GSV
After the first successful exeresis of the greatsaphenous vein (GSV) by inversion by Wil-liam L. Keller in 1905 (9), stripping of theGSV has become one of the most perform-ed surgical interventions. In 2008, theDutch prevalence for this surgical pro-cedure was 1.2 per 1000 inhabits, resultingin the top three most performed operationsin the Netherlands. Consequently, it is notamazing that in the past a large number of surgical devices were developed for surgicaltreatment of the GSV.The first vein stripper developed by Wil-liam W. Babcock in 1907 was an intralumi-nal wire with an acorn head and removedthe GSV from ankle to groin by an ac-cordion strip, and was the golden standardfor many years (1). Unfortunately, the wireused with this technique was said to be tooshort, too straight and too rigid, resultingin subcutaneous trauma and high inci-dence of saphenous nerve damage.In 1971, a more elegant way of strippingwas developed, using the perforate invagi-nation stripper (PIN stripper, CredenhillLtd., Derbyshire, UK). Compared to con-ventional stripping PIN stripping was as-sociated with (2, 12)
less tissue trauma,
fewer infections,
neuralgia and
better cosmetics.However, randomised trails failed to dem-onstrate its clear benefit and tearing of theveins during invagination was a majorcomplication (2, 3).In the same period, long stripping of theGSV became disputable and the short stripof the GSV from groin to knee becamepopular (6, 10). Apart from some parts inthe south of Europe and in America, thisshort saphenous stripping technique isstate of the art. In the Netherlands it isrecommended by the Dutch NationalGuidelines 2007.Vein stripping has a extensive cosmeticaspect and up to now all known surgical de-vices to remove the GSV need a distal inci-sion at the knee joint apart from the groinincision, either to introduce the stripper orto control the device during the procedure.
InvisiGrip
®
Vein Stripper
In 2004, a new surgical device called the In-visiGrip
®
Vein Stripper (LeMaitre VascularInc., Burlington, USA) became available.This stripper combines a short strip withcosmetic demands and the principles of minimal endovascular surgery. It is cur-rently used in America, Europe and Japan.However, information concerning theresults of the InvisiGrip
®
is scarce. The only study describing them was performed inJapan (5). Hatano and colleagues reporteda technical success of 100%. However, they investigated a very small study population(34 patients, 44 limbs).In recent years, some non-surgical tech-niques (i. e. laser, radioablation, steam,thermoablation, foamtherapy) have be-come popular to treat an insufficient GSV.Despite this evolution surgical treatment-will maintain its place. It will remain com-petitive the easier, the cheaper and thebetter the cosmetic outcome.Our large observational study is the firstto describe the results of a innovative shortstripping technique for the extirpation of the incompetent GSV in a large non-aca-demic teaching hospital in the Nether-lands. It demonstrates the effectiveness,ease and results of this new vein stripperand its new surgical technique.
Patients, material, methods
Study design and patient selection
Between March 2004 and October 2007, acohort of 397 patients older than 18 yearswere admitted at the Atrium MedicalCenter, Heerlen, The Netherlands. All pa-tients suffered from incompetent GSV. Ve-nous incompetence of the saphenofemoral junction and GSV was proven by duplexsonography. All patients were classified ac-cording to the CEAP classification asC2-C6 (4). Their GSV was removed with anew short stripping device. Patient's datawere entered into a computerized database.For all patients the following informationon baseline characteristics was recorded:age, gender, body mass index (BMI), dia-meter of the GSV at knee joint, the side of the GSV (left or right leg) and uni- or bilat-eral removal. The medical ethics commit-tee of the Atrium Medical Center Parkstadwas informed, and per institutional prac-tice, no official approval was requested.Prospective data were collected for thisretrospective analysis.
Short GSV stripping
We used the InvisiGrip
®
Vein Stripper forshort GSV stripping. The InvisiGrip
®
is a60 cm long disposable surgical device con-sisting of a two-parts cutting head that canbe opened in two parts with an outer diam-eter of 5 mm and a handle on the oppositeside showing the cutting or neutral status of the device (
Fig. 1).After crossectomy and before actualstripping, flexible catheters with differentdiameters of the olive head were intro-duced into the vein as far as the knee (only for the purpose of this study). And thesmallest diameter of the GSV wasmeasured. Then, the InvisiGrip
®
was intro-duced into the vein. Because of the proveninsufficiency of the GSV by duplex, therewas no valvular resistance during travel to-wards the knee. At knee level the strippinghead was palpated, opened and by slightpressure on the skin the vein was forcedinto the open cutting head. After traction,catching and 360° rotation of the stripperthe cutting head was closed and the vein
Fig. 1
The InvisiGrip
®
Vein Stripper, illustratedwith an opened cutting head (printed with kindpermission of LeMaitre Vascular GmbH, Sulzbach/Ts., Germany)
 
© Schattauer 2010 Phlebologie 2/2010
79
G. M. J. M. Welten et al.: Short stripping of the GSV
firmly trapped into the head. By increasedtraction, the GSV was cut endovascular andantegrade stripped by inversion. There wasno incision at knee level and no specificmethods were necessary to close the proxi-mal stump of the lower GSV.After stripping, a rolled gauze wasapplied over the full length of the bed of theGSV and completed with a compressionbandage up to groin for three days. In thefirst years of this study, a compressionstocking for four weeks was subscribed.However, in recent years the stockings wereomitted because of proven ineffectiveness(7).During the procedure, the following in-formation was recorded: The number of at-tempts to successfully strip the GSV, thetype of the removed GSV (true invagi-nation or false invagination by accordion,telescoping the vein), the ease of palpation,the tip of the stripper inside the GSV in thelevel of the knee joint (easy palpable, mod-erate palpable or not palpable) and thetravel of the stripper inside the GSV (easy maneuverable, difficult maneuverable ornot possible).
Follow-up and end point
Clinical information was retrieved fromthe hospital electronic database of patients.The primary end point of this study is theincidence of the successfully removal of theGSV. The secondary end point is the com-plication rate after surgery. During the in-hospital stay and at the out-patient clinicvisit four weeks after the index procedure,we recorded the following complications:haematoma at knee joint due to a bleedingof the open residual proximal part of theGSV, neurological injury of the saphenousand femoral nerve distal to the groin inci-sion (minor sensory changes),superficialwound infections and other non-specificcomplications.Because of unknown reasons 31 patients(47 legs) were lost during follow-up.
Data analysis
Continuous data are described as meanvalues and standard deviations (SD), anddichotomous data are described as percen-tage frequencies. The chi-square test wasused for categorical variables and theanalysis of variances (ANOVA) test wasused for continuous variable to evaluatedifferences in baseline characteristics be-tween females and males and the numberof attempts to successfully remove the GSV.To describe the study population, we in-cluded all patients. For the description of the peri-procedural outcome and the as-sociation between all baseline character-istics and the number of attempts to suc-cessfully remove the GSV, we included allperformed procedures (many patients hadbilateral removal of the GSV). So the pro-cedure was the index of analysis, not the pa-tients.A p-value of <0.05 was considered to besignificant. All computations were per-formed with SPSS software version 17.0.1(SPSS Inc., Chicago, Illinois, USA.
Results
Patient characteristics
In this study, 397 consecutive patients wereincluded. The mean age of this study popu-lation was 50.5 (
±
12.5) years and 74% werewomen (
Tab. 1). Women had a greater di-ameter of the GSV, compared to men. Noother differences between baseline char-acteristics and gender were observed. In25.4% of our patients, the GSV was re-moved bilaterally. The total number of pro-cedures amounted to 498. The number of bilateral strippings was comparable be-tween women and men. Furthermore, atotal of 98% of the patients were operatedin day surgery, usually by spinal anesthesia(95%).
Primary end point
The success rate for stripping the GSV withthe InvisiGrip
®
was 95.4% (
Tab. 2). Inmost cases, one or two attempts were needed
Tab. 1
Baseline characteristics of patients according to gender
Tab. 2
Peri-procedural outcomes
all patients women men pvalue
mean age (years) (
±
SD) 50.5 (
±
12.5) 50.0 (
±
12.4) 52.2 (
±
12.9) 0.13body mass index(kg/m
2
)mean
±
SD 26.2 (
±
4.7) 26.1 (
±
5.1) 26.4 (
±
3.6) 0.61> 30 (%) 17.3 18.2 14.6 0.42diameter greatsaphenous vein (mm)mean
±
SD 7.2 (
±
1.5) 7.0 (
±
1.3) 7.7 (
±
1.7) <0.001> 9 (%) 12.3 9.5 20.6 0.003location (%) unilateral 74.6 73.6 77.5 0.43bilateral 25.4 26.4 22.5side (%) left 33.2 33.9 31.4 0.64right 66.8 66.1 68.6n (%) 397 (100%) 295 (74%) 102 (26%)number of attempts1 256 51.42 154 30.9> 3 65 13.1not possible 23 4.6type of invaginationtrue 395 79.3false 76 15.3not possible 27 5.4feeling stripperpalpableeasy 409 82.1moderate 66 13.3not 23 4.6travel strippermaneuverableeasy 432 86.7difficult 43 8.6not possible 23 4.6all procedures 498 100
n %

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