Feasibility of vessel sealing devices in surgical excision of vascular malformations– novel approach

Feasibility of vessel sealing devices in surgical excision of vascular malformations– novel approach

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International Journal of Surgery Open xxx (xxxx) xxx

Contents lists available at ScienceDirect

International Journal of Surgery Open journal homepage: www.elsevier.com/locate/ijso

Research Paper

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Feasibility of vessel sealing devices in surgical excision of vascular malformationse novel approach

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Ahmed Samir Hosny, Ahmed Elmahrouky, Ahmed Balboula, Marwan Yousry, M. Sharkawy* Vascular Surgery Department, Cairo University, Egypt

a r t i c l e i n f o

a b s t r a c t

Article history: Received 24 December 2019 Received in revised form 25 January 2020 Accepted 27 January 2020 Available online xxx

Introduction: Vascular malformations are localized defects in vascular morphogenesis that are believed to be caused by dysfunction in embryogenesis and vasculogenesis. However, with the development of new vessel sealing devices, surgical removal of the vascular malformations can be safely undertaken. The aim of this study was to test the feasibility of vessel sealing devices in the complete excision of vascular malformations. Methods: We retrospectively analyzed medical records of all patients with vascular malformation who underwent a surgical excision of vascular malformations at our institution from January 2015 to June 2018. All patients were followed up after 1 week; 1, 3, 6 months; and 1 year. Results: We assessed 14 patients with vascular malformation (median age, 21 years; malformation: arteriovenous, n ¼ 5; venous, n ¼ 7; lymphatic, n ¼ 1; and combined, n ¼ 1). These vascular malformations were localized in the right lower (n ¼ 5) and left upper (n ¼ 3) limbs, right upper limb (n ¼ 2), head and neck (n ¼ 3), and chest wall (n ¼ 1). Using vessel sealing instruments, the nidus in AVM was excised, and complete excision of vascular malformations was achieved without depriving the skin of dermal blood supply. One patient died three weeks later due to secondary hemorrhage. Complication related to gangrenous skin over the patella was healed by vacuum-assisted closure therapy. Post-excision MRI after 18 months suggested recurrence in one patient. Conclusion: The use of vessel sealing devices was found to be feasible, for surgical excision of vascular malformations. However, further evidence from larger studies, prefereably randomized controlled trials, is required to support the routine use of these devices. © 2020 Published by Elsevier Ltd on behalf of Surgical Associates Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Keywords: Vascular malformation Surgical excision Vessel sealing devices

1. Introduction Vascular malformations are localized defects in vascular morphogenesis that are caused by dysfunction in embryogenesis and vasculogenesis. Vascular malformations are divided into 2 types: ‘low flow’ and ‘high flow’ malformations. Low-flow malformations are further divided into 3 types: capillary malformation, venous malformation (VM), and lymphatic malformation (LM). High-flow malformations are like areteriovenous fistula and arteriovenous malformation, and combined vascular malformation (CVM) [1]. Some of these vascular malformations are congenital, while some are acquired after a trauma. Vascular malformations are considered difficult to treat, disturbing, and have a bad reputation

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* Corresponding author. E-mail address: [email protected] (M. Sharkawy).

among surgeons. Most of the patients with vascular malformations need to be referred to tertiary care centers that employ highly skilled surgeons and interventionists and are well equipped with facilities for a multidisciplinary treatment approach. The reported incidence of vascular malformation is not low. It is about 0.1%e0.2%, which is considered higher than that of congenital heart disease [2]. The clinical presentation of vascular malformation may be asymptomatic when it appears at birth, but symptoms may appear later in life. The clinical presentation may be symptomatic in patients with a history of trauma. When classified according to the site, truncal vascular malformations are more common than extratruncal (limbs), and head and neck vascular malformations [3]. Management of vascular malformations may include conservative management (observation and follow up), endovascular intervention, interstitial laser intervention, sclerotherapy, and surgery [4]. Surgical excision is considered curable, but the complete excision of the vascular malformation tissue is not feasible in all cases

https://doi.org/10.1016/j.ijso.2020.01.005 2405-8572/© 2020 Published by Elsevier Ltd on behalf of Surgical Associates Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/ by/4.0/).

Please cite this article as: Hosny AS et al., Feasibility of vessel sealing devices in surgical excision of vascular malformationse novel approach, International Journal of Surgery Open, https://doi.org/10.1016/j.ijso.2020.01.005

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due to the complexity of the surgical procedure or associated postsurgical complications. With the development of new vessel sealing devices and instruments, the approach of surgical removal of the vascular malformation can be safely performed in most cases while preserving the nearby important anatomical structures [5] Therefore, the present study evaluated the feasibility of using vessel sealing devices in the complete excision of vascular malformations. 2. Methods We retrospectively analyzed medical records of all patients with vascular malformation who presented to our institution hospital, from January 2015 to June 2018. We excluded those who opted for endovascular embolization and conservative management. Only

Fig. 1. Bipolar vessel sealing device e LigaSure® exact dissector (Medtronic).

patients with vascular malformation who opted for surgical excision (including those who had previous surgical procedures) were included in the study. The work has been reported in line with the PROCESS 2018 criteria [6] and has been registered with the Research Registry with the reference number 5324. All patients were clinically examined after noting their medical history. Along with routine investigations, special investigations like duplex ultrasonography, magnetic resonance imaging (MRI), computed tomography angiography, indirect laryngoscopy were done for all the patients before surgery to exclude a rare but fatal possibility of any vascular malformation over the vocal cords, which may endanger a patient's life during intubation. Some patients were presented to the emergency room (ER), and the required emergency procedures were carried out after cross-matching of blood and mortality consent taken post-operatively. All patients were operated in the operating theater. All patients were clinically examined by expert vascular surgeons. Blood was preserved for some cases as clinically required. General anesthesia was used in all patients. None of the patients needed extra measures to be taken before surgery. Antibiotic prophylaxis was given during the induction of anesthesia. For all extratruncal lesions, the pneumatic tourniquet was used, if applicable, without exsanguination of the limb to discriminate the malformation from normal tissue and nearby anatomical structures. Some patients were operated using staged procedures to preserve the overlying skin, which is usually intimately adherent to the underlying vascular malformation. Usually, the incision in truncal vascular malformation is linear overlying the malformation or elliptical overlying the malformation. Some of the vascular malformations are adherent to the overlying skin that necessitates excision of the excess skin. Vessel sealing devices used in the procedures include LigaSure® exact dissector (Medtronic; Fig. 1), Focus Ultracision Harmonic Scalpel® (Johnson and Johnson Medical Devices Company), or Bowa Lotus Torsional Ultrasonic Scalpel (Fig. 2), (Table 1), according to their availability in the operating theater. Postoperative close suction drain (not routine) and elastic bandage were applied to the operated limb, where possible, to avoid postoperative hematoma. Care was taken on planning the site of incision; incision always started in a healthy area and extended to the malformation area. Also, care was entertained for the use of vessel sealing devices so as not to endanger the blood supply (dermal plexus) of the overlying skin that was to be thinned out and would have undergone necrosis if not handled appropriately. All patients remained hospitalized for 2e3 days postoperatively and were then followed-up after 1 week; 1, 3, and 6 months; and 1 year.

Fig. 2. Ultrasonic cutting coagulation devices e (A) Focus Ultracision Harmonic Scalpel® (Johnson and Johnson); (B) BOWA LOTUS® torsional ultrasonic scalpel.

Please cite this article as: Hosny AS et al., Feasibility of vessel sealing devices in surgical excision of vascular malformationse novel approach, International Journal of Surgery Open, https://doi.org/10.1016/j.ijso.2020.01.005

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Focus Ultracision Harmonic Scalpel® (Johnson and Johnson)

Bowa Lotus Torsional Ultrasonic Scalpel

Mechanism of action

 Automated bipolar which combines mechanical compression with bipolar to do vessel fusion [12]

Advantage

No collateral damage

 Coagulates as it cuts.  vibrating in the range of 55,500 Hz.  causing protein denaturation and vessel sealing [13] No charring, not sticky

disadvantage

Charring, sticky [15]

 mechanical instrument with a vibrating blade.  Oscillating at a frequency of 36,000 Hz,  Coagulate as it cuts. Efficient torsional movement in the waveguide to direct strong compression energy to the target tissue. This technology also reduces the effects of energy loss at the distal tip, making it safer for surgeons (14) Potential collateral damage due to heat

minimal energy transfer to surrounding tissue, potentially limiting collateral damage [13]

Table 2 Vascular malformation cases. S. No. Age Sex Presentation (years) (M/F) 4

F

2

18

M

3

46

M

Type

PI

Procedure

Tourniquet Staged

Complications

Blood transfusion

Recurrence

EM/EL Follow up

Compressible lump U/S, MRI at left lower chest wall CTA Bleeding 20 days before presentation, thrill lump over left occipital behind the ear & upper post neck.

LM

No

Surgical excision

N/A

No

No

No

No

EL

Uneventful

AVM (fast flow)

Yes (surgery)

No

No

No

Missed

EM

Missed

CTA, U/S Pulsatile lump below right ear with continuous machine-like sound (as felt by the patient)

AVM (fast flow)

Yes (surgery)

N/A Skeletonization of left external carotid artery then excision of the bleeding ulcer in scalp, then plan to excise with plastic surgery & injection of sclerosing agent but the patient refused (went back to his country) N/A Skeletonization of right external carotid artery with excision of the nidus in the lower parotid

No

No Injury of internal carotid during having a sling & TIA

No

EL

No recurrence

(continued on next page)

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INV

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Please cite this article as: Hosny AS et al., Feasibility of vessel sealing devices in surgical excision of vascular malformationse novel approach, International Journal of Surgery Open, https://doi.org/10.1016/j.ijso.2020.01.005

Table 1 Difference between vessel sealing devices.

3

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INV

Type

PI

Procedure

Tourniquet Staged

Complications

Blood transfusion

Recurrence

EM/EL Follow up

4

18

M

CTA, conventional angiography

AVM (fast flow)

Yes (sclerotherapy) in other country, 3 days before presentation

Right transknee amputation then AKA after 2 weeks

Yes

No

Died of secondary hemorrhage 3 weeks later

Yes

Died

EM

Died

5

35

M

U/S, MRI

VM

No

Surgical excision

Yes

Yes

No

No

No

EL

No recurrence

6

32

F

CTA, U/S

AVM (fast flow)

No

Surgical excision No with plastic surgery

No

No

No

Yes, after 1 year

EL

Recurrence then did embolization

7

12

M

CTA, U/S

VM

No

Surgical excision

Yes

No

No

No

No

EL

Uneventful

8

45

M

Ulcerating bleeding right lower limb with gangrenous leg; the AVM was starting in the pelvis, then right leg; there was thrill felt in the lower right abdomen & pelvis & the right upper thigh Compressible right forearm lump extending longitudinally along extensor tendons and extending into the dorsum of the hand, index & middle finger Right eye pain, headache, compressible lump in the right forehead Compressible lump at left forearm along the ulnar side Gigantism of left Upper limb

CTA, conventional angiography

AVM (fast flow)

Yes (surgery)

Surgical excision

Yes

No

No

EL

Uneventful

9

18

M

MRI, U/S

CVM

No

Surgical excision

No

No

No

EL

Uneventful

10

5

F

Pain, disfigurement, localized partially compressible lump at medial aspect of left arm Painful lump at the medial aspect of right hand

Yes, but the No patient refused as satisfied by the results of the first stage No No

MRI, U/S

VM (arising from vasa nervosa of the palmar cutaneous branch of the ulnar nerve)

No

Surgical excision

Yes

No

No

No

Yes, after 1.5 years

EL

11

19

F

Warm disfiguring lump on medial aspect of right foot and another at the tip of the big toe

MRI, U/S

VM (arising from vasa nervosa) from saphenous nerve

No

Surgical excision

Yes

No Yes, the patient refused for the procedure at the tip of big toe

No

No

EL

After recurrence (no pain, no disfigurement just follow up MRI) Uneventful and the patient refused to excise the malformation over the big toe

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S. No. Age Sex Presentation (years) (M/F)

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Please cite this article as: Hosny AS et al., Feasibility of vessel sealing devices in surgical excision of vascular malformationse novel approach, International Journal of Surgery Open, https://doi.org/10.1016/j.ijso.2020.01.005

Table 2 (continued )

66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130

M 23 14

M 4 13

AVM ¼ arteriovenous malformation; AKA ¼ above knee amputation; CTA ¼ computerized tomography angiography; EM ¼ emergency; EL ¼ elective; F ¼ female; INV ¼ investigations; LM ¼ lymphatic malformation; M ¼ male; MRI ¼ Magnetic resonance imaging; N/A ¼ not applicable; PI ¼ previous intervention; TIA ¼ transient ischemic attack; U/S ¼ ultrasound; VAC¼Vacuum-assisted closure; CVM ¼ combined vascular malformation; VM ¼ venous malformation.

Uneventful EL No No No No Yes No VM

Surgical excision

Follow up after 3 years with no problem in knee function; however, still disfigurement in skin of the thigh & knee skin EL No No No VM

Surgical excision

Yes

No

1-skin necrosis 2-tensor fascia lata flap that failed; 2- VAC therapy then Thiersch graft

No No 22

M

Warm painful lump MRI, U/S inside right vastus medialis muscle Warm painful right CTA, MRI, U/S knee and lower thigh, no complete extension of the knee, can't play, the malformation was inside the knee joint, right prepatellar, and under the deep fascia of lower thigh Warm painful lump MRI, U/S suprapatellar

VM (inside vastus medalis muscle)

Surgical excision

Yes

No

No

No

EL

Uneventful

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3. Results From January 2015 to June 2018, 31 patients underwent a treatment for vascular malformation. Of these, 17 patients were excluded based on the exclusion criteria (endovascular embolization, n ¼ 6; opted for observation and follow-up, n ¼ 11), and 14 were analyzed (female, n ¼ 4; male, n ¼ 10; median age, 21 years, range, 4e46 years). All patients were operated under general anesthesia (Table 2) [7e10]. According to the anatomical site, the vascular malformations among the 14 patients were as follows: 5 in the right lower limbs, 3 in the left upper limb, 2 in the right upper limb, 3 in the head and neck, and 1 in the chest wall. According to the type of vascular malformation, there were 5 AVMs, 7 VMs, 1 LM, and 1 CVM. (Figs. 3e5). The clinical presentation was as follows: 2 patients were presented in the emergency department with bleeding (one with bleeding AVM and gangrenous leg due to tourniquet for 3 days, the other with the bleeding AVM in the scalp). The other 12 patients were presented to the outpatient clinic with disfigured, warm, painful or painless lump. For all the patients with limb vascular malformations, a tourniquet was applied with the exception of one patient with CVM where the tourniquet was not applicable (Fig. 6). The vessel sealing instruments were used to excise the nidus in AVM or completely excise the vascular malformations without depriving the skin of its dermal blood supply and by preventing injury to the important nearby anatomical structures. After excision, the viability of the skin was assessed because the tourniquet or the vessel sealing device may affect skin viability (Fig. 3). Concerning the complications, the Case 3 patient presented with a machine-like sound (as felt by the patient) on the right side of the face who had a previous surgical procedure. The carotid bifurcation was high, the internal carotid artery was injured while putting a sling; though an appropriate repair was done, the patient developed a transient ischemic attack. In Case 4, the patient presented to the emergency department with a gangrenous right leg, the patient underwent life-saving emergency transknee amputation, using a tourniquet, followed by an above-knee amputation, and finally died 3 weeks later due to secondary hemorrhage. In the Case 13 patient (Fig. 7), there was a complication in the form of gangrenous skin over the patella. The complication was managed by tensor fascia lata fasciocutaneous flap procedure that failed. Then, vacuum-assisted closure therapy was given that healed. The tensor fascia lata flap led to disfigurement. However, the movement of the knee joint was normal as the intra-articular knee VM was removed. With regard to recurrences, in Case 6, the patient was free of recurrence after one year of complete excision. The recurrence was observed in the form of throbbing pain in the right eye, no malformation was observed. The patient was referred for conventional angiography for embolization as it was not amenable to surgery. In Case 10 (Fig. 5), the patient had VM arising from the vasa nervosa of the palmar cutaneous branch of the ulnar nerve. Recurrence was detected on MRI after 18 months of complete excision; however, recurrence was not annoying to the patient. The histopathology was VM, and no increase in size was observed on MRI during follow-up after recurrence. 4. Discussion Vascular malformations are difficult to treat and still have a bad reputation among patients and doctors. The surgical excision is usually curable, but the complexity of the surgical procedure remains a problem. With the development of new technologies and devices, many new surgical instruments have appeared in the market, such as vessel sealing devices, which have made these

Please cite this article as: Hosny AS et al., Feasibility of vessel sealing devices in surgical excision of vascular malformationse novel approach, International Journal of Surgery Open, https://doi.org/10.1016/j.ijso.2020.01.005

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Fig. 3. (Case 11): (A) Venous malformation of the right foot preoperative; (B) 2 Months postoperative.

Fig. 4. (Case 14): (A) Right suprapatellar venous malformation (arrow); (B) Excised venous malformation above the right patella.

procedures less complicated. Most popular vessel sealing devices available in the market include LigaSure exact dissector by Medtronic, Focus Ultracision Harmonic Scalpel by Johnson and Johnson, and Bowa Lotus torsional ultrasonic scalpel. The preferred device used in this study was LigaSure exact dissector. If LigaSure was not available, Focus Ultracision Harmonic Scalpel or torsional ultrasound scalpel, even laparoscopic handles, were used. LigaSure exact dissector (bipolar vessel sealing device) makes cutting and sealing simple. The LigaSure exact dissector is designed to cool down fast for secure and atraumatic tissue grasping. It stays cool over multiple activations, seals vessels up to 7 mm in diameter and can sustain against blood pressure up to 3 times the normal systolic blood pressure. The fine, curved jaw of the LigaSure exact dissector allows for precision around critical structures such as nearby nerves, vessels, tendons, or skin. It enhances the ability to work in tight spaces and maximizes the line of sight. Its jaw also applies equal force on opposing tissue planes for effective blunt dissection. It also offers working length that has been optimized to provide precise control. A cutting trigger that is aligned with the handle helps in eliminating any interference with the wound edge. The fast cooling time of the LigaSure exact dissector ensures fewer instrument exchanges and more efficient hemostasis. It provides a reliable performance.

The Focus Ultracision Harmonic Scalpel is similar to LigaSure when it comes to the features; however, it emits ultrasonic waves for dissection and cutting. There is some heat transmission from the ultrasonic radiations, but the scalpel is safe to use. It can seal vessels up to 5 mm in diameter. The Bowa Lotus torsional ultrasound is similar to Focus Harmonic Scalpel in the mechanism of action because it also produces heat from the ultrasonic radiations and is safe to use as well. Some studies have compared the efficacy of the three devices. To the best of our knowledge, there is no report available showing a significant difference between their efficacies either in vivo or in vitro. There is no comparison between the mode of action and the effect on the nearby structures due to heat transmission [11]. In the past, the surgeons used vascular clamps and polypropylene sutures for hemostasis. These are considered difficult techniques. Similarly, diathermy, either monopolar or bipolar, is either unsafe or inadequate to safely excise the nidus or the malformation [12]. There are two different surgical techniques for partial and total excision of a vascular malformation. First is elliptical incision with linear skin closure technique, and the other is a circular excision and purse-string closure technique. Some surgeons use the squeezing technique to remove most of the vascular malformation. While others use a special clamp that can be assembled and disassembled [13]. In this type of surgery, blood losses are not major,

Please cite this article as: Hosny AS et al., Feasibility of vessel sealing devices in surgical excision of vascular malformationse novel approach, International Journal of Surgery Open, https://doi.org/10.1016/j.ijso.2020.01.005

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Fig. 5. (Case 10): (A) Right hand venous malformation (arrow); (B) and (C) MRI of right hand showing venous malformation (arrow); (D) excised venous malformation with phlebolith.

Fig. 6. Case 9: (A) mixed venous lymphatic malformation (B); elliptical incision done without tourniquet as it is not applicable; (C)excised malformation with the black lines are those of the vessel sealing device LigaSure exact dissector®(Medtronic).

but they become relevant in the case of patients with low body weight. In order to minimize bleeding by reducing the lesion's vascular supply, a technique of “squeezing” at the tumor's base can be employed to remove the most voluminous tumors. A special

clamp has been designed for this purpose [12]. A detachment of the vascular tumor from the underlying and surrounding tissues can be achieved using monopolar diathermy. After resection, the clamp is released, and complete bleeding control is accomplished using

Please cite this article as: Hosny AS et al., Feasibility of vessel sealing devices in surgical excision of vascular malformationse novel approach, International Journal of Surgery Open, https://doi.org/10.1016/j.ijso.2020.01.005

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Fig. 7. (Case 13): (A) and; (B)The right knee appears swollen and not fully extended due to prepatellar and intraarticular venous malformation; (C)The prepatellar venous malformation before excision; (D)Lotus (vessel sealing device excising the prepatellar part); (E) The intraarticular venous malformation before excision; (F) Complication in the form of gangrenous skin.

bipolar diathermy on the residual afferent blood vessels that normally show a radial distribution. Linear closure by side-to-side approximation of the wound edges is finally obtained. In the current study, however, the vessel sealing devices were used to separate the skin from the underlying vascular malformation and the nearby anatomical structures. The advantage of using the vessel sealing devices is that no sutures are needed to control the bleeding. For the vascular malformations that involve the skin, the round-block technique, as described by Mulliken [14] and more recently adopted by the authors is indicated, especially for the excision of smaller lesions (less than 30 mm in diameter). The purse-string closure technique was used in this study. The advantage of using the purse-string closure technique over the traditional linear closure technique is in the minimization of the

subsequent scar length (i.e., up to 50% shorter scar results from this technique). Also, the purse-string closure technique helps in minimizing the adjacent structure distortion because an equal tension is applied along multiple radial lines with symmetrical concentric distribution pattern rather than tension along the main axis perpendicular to the linear wound closure axis. Some authors prefer to use preliminary hydrostatic undermining by saline injection before performing the circular skin incision in order to detach the vascular malformation from the underlying and surrounding tissues and encourage symmetrical distortion of adjacent structures by the concentric distribution of tension lines. When conspicuous blood loss is expected, a running polypropylene or nylon 2/0 nontraumatic suture can also be temporarily placed around the lesion base [15]. The monopolar or bipolar diathermy is generally used to

Please cite this article as: Hosny AS et al., Feasibility of vessel sealing devices in surgical excision of vascular malformationse novel approach, International Journal of Surgery Open, https://doi.org/10.1016/j.ijso.2020.01.005

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complete the vascular malformation excision. In this study, all the conventional techniques and instruments like the monopolar/bipolar diathermy, sutures, vascular clamps were successfully replaced by the vessel sealing devices. Pertaining to the use of tourniquet, where applicable, we used the tourniquet in extratruncal vascular malformation without exsanguination, which made the vascular malformation engorged and easily delineated from surrounding anatomical structures, and thus, easily excised. The use of pneumatic tourniquet along with the vessel sealing devices made surgery easier, and safer excision of the vascular malformation was achieved. Coming to the recurrence, some vascular malformations were excised during the proliferative phase where the vascular malformation was still growing. This may explain the recurrence in some cases. With regards to the complications, the most important complication noted was skin necrosis, which might have occurred due to several reasons such as the vascular malformation involved the skin or intimately adherent to it; vessel sealing device may generate heat that could have affected the vitality of the skin; the dissection and excision might be too close to the dermal skin plexus; and the application of the tourniquet might have worsened the skin blood supply problem. 5. Conclusion The use of vessel sealing devices was found to be a feasible technique, and the devices were easy to use for surgical excision of vascular malformations. However, the utility of these devices requires further experimentation to elucidate the best device to be used with least complication in a particular scenario. Ethical approval Not applicable Funding Nothing to declare Author contribution Sharkawy M e Study design, data collection, data analysis, writing. Hosny AS e Data collection, data analysis, writing. Elmahrouky A eData collection, data analysis, writing. Balboula A e Study design, writing, Yousry M e Study design, writing. Guarantor M. Sharkawy

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Please cite this article as: Hosny AS et al., Feasibility of vessel sealing devices in surgical excision of vascular malformationse novel approach, International Journal of Surgery Open, https://doi.org/10.1016/j.ijso.2020.01.005