Flip-over of blood vessel intima caused by vascular closure device:A case report

lNTRODUCTlON

Vascular closure devices overcome the limitations of traditional hemostasis methods,achieve rapid hemostasis and shorten the in-bed time after surgery.However,they also have some complications,with the most common being bleeding and the least common stenosis or occlusion caused by vascular injury[1].At present,clinical reports on the complications of vascular injury caused by vascular closure devices are rare.In this article,one case of severe acute limb ischemia after using vascular closure device(StarClose)is reported.

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CASE PRESENTATlON

Chief complaints

The patient was a 54-year-old man who was admitted due to cyanotic necrosis and severe pain in the second toe.

History of present illness

The patient had the necrosis of the second toe of the left foot for 2 mo.

History of past illness

The patient had a history of smoking for 30 years and type 2 diabetes for 1 mo.

Physical examination

After the four children had shared their dreams, I looked at the mom. She smiled and said, I just want my family to be safe, warm and content-just like they are right now.

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Laboratory examinations

Blood routine examination showed white blood cell count 9.46 × 10/L,absolute neutrophils 6.43 × 10/L,absolute monocytes 0.78 × 10/L,absolute basophils 0.07 × 10/L,erythrocytes 9.46 × 10/L,hemoglobin 148 g/L,and platelets 299 × 10/L.Blood biochemical results indicated blood potassium 4.63 mmol/L,alanine aminotransferase 50 U/L,aspartate aminotransferase 22 U/L,total bilirubin 9.2 mol/L,creatinine of 47 mol/L,glomerular filtration rate 120.06 mol/L,homocysteine 11.2 mol/L,glucose 6.48 mmol/L,glycosylated hemoglobin 10.6%,and erythrocyte sedimentation rate 22 mm/h.Blood coagulation test suggested international standardized ratio 1.03,plasma prothrombin time 13.6 s,activated partial thromboplastin time 42.6 s,plasma fibrinogen 5.76 g/L,and thrombin time 16.5 s.

Imaging examinations

Color Doppler ultrasound showed left femoral artery stenosis,and occlusion of the left popliteal,posterior tibial,peroneal,anterior tibial and dorsalis pedis arteries.The diagnosis of arteriosclerosis obliterans of the lower extremity accompanied with gangrene and type 2 diabetes was made.Under local anesthesia,the interventional procedure of drug-eluting balloon in the left lower limb was performedantegrade puncture of the left common femoral artery.The operation went smoothly.However,1 h after the puncture point was closed by the StarClose vascular closure device,the patient developed manifestations of acute ischemia,including severe pain,numbness,pale skin,low skin temperature and weakened sensation in the left foot.The pulse of the left common femoral artery disappeared by palpation.Arterial angiography of the left lower extremity showed occlusion of the middle and distal segment of the common femoral artery,but no thrombus was observed(Figure 1).

FlNAL DlAGNOSlS

For a long time,manual compression of the puncture point was the traditional method of hemostasis after vascular interventional therapy.However,this required no less than 30 min of continuous compression and several or even dozens of hours of immobilization after the operation[2,3].To overcome the limitations of traditional hemostasis methods,the vascular closure devices have been developed since the 1990s.However,the vascular closure devices have complications during clinical application.Bleeding is the most common one,and the incidence of stenosis or occlusion caused by vascular injury is the lowest[4].In the present case,the patient had acute limb arterial ischemia after intervention.It is considered that during the placement of StarClose vascular closure device,due to incorrect operation,the nickel-titanium alloy clip of the device clamped the intima of the blood vessel.When it was pulled out violently,the intima of the blood vessel was flipped over,resulting in arterial stenosis and occlusion,and causing ischemic symptoms at the distal end of the limb.Finally,the occluded segment of the intima was removed through femoral artery incision,and the femoral artery was repaired to restore the blood supply of the affected limb.Dzieciuchowicz[1]also reported a case of acute limb arterial ischemia caused by the incorrect release of the StarClose vascular closure device in a 31-year-old woman.In our case and the case reported by Dzieciuchowicz[1],surgical incision was used to restore the blood supply of the affected limb.Although some scholars have suggested that the stenosis and occlusive complications should be resolved through endovascular treatment[5,6],surgical incision has to be performed in some cases according to the type and location of the lesion as well as the severity of limb ischemia.

TREATMENT

Exploratory surgery was performed on the left common femoral artery.Occlusion at the puncture point was observed with bulged vascular lumen.There was intima tissue in the vascular lumen.An incision of about 1.5 cm was made at the puncture point.We observed that the intima embedded with the nickel-titanium alloy clip of the StarClose vascular closure device flipped over and blocked the lumen(Figure 2A).The flipped intimal tissue of about 4 cm was removed during the operation(Figure 2B).A jet-like blood flow was observed at the distal end of the common femoral artery incision.The common femoral artery incision was sutured and repaired without using the StarClose vascular closure device.

OUTCOME AND FOLLOW-UP

Arterial angiography showed smooth blood flow in the common and superficial femoral artery.Color Doppler ultrasound of the left lower limb artery showed that the blood flow of the left common iliac,common femoral,popliteal,anterior tibial and peroneal arteries was unobstructed.The patient was given antiplatelet,anticoagulation,anti-infection and microcirculatory improvement drugs after surgery.The patient was discharged after hospitalization for 11 d.During follow-up at 6 mo after surgery,the patient recovered well.The patient is under constant follow-up.

The pulse of the femoral artery of the left lower limb was weakened,and those of the popliteal,posterior tibial,and dorsal foot arteries were not palpable.

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DlSCUSSlON

The injury of the common femoral artery intima was considered.

According to previous reports,complications occur in 3%-4% of cases intervened with StarClose vascular closure devices[7-9],with bleeding as the most common complication.The inguinal complications are classified into self-limiting hematoma,hematoma requiring blood transfusion,other/minor(pseudoaneurysm and infection)or other/severe(vascular complications)complications.For example,McTaggar[10]used StarClose in 281 patients undergoing interventional surgery and found that the incidence of self-limiting hematoma was the highest,and no patients had other/minor complications.Gaba[11]observed 83 patients with liver tumors using StarClose vascular closure device as interventional treatment and found that only three(3.6%)developed small inguinal hematomas after the operation.The least common complication of the vascular closure device was acute limb ischemia,vascular stenosis or occlusion.Rodriguez[4]reported that among 603 patients receiving intervention with StarClose vascular closure,only two had this complication,including one case of common femoral artery occlusion,and another of common femoral artery stenosis.Another common complication[12]is that the nickel-titanium alloy clip of the vascular closure device is compressed or stuck by the scar tissue or normal tissue at the puncture site and cannot be removed percutaneously.The Medical Device Adverse Events database of the US FDA showed that from July 2009 to October 2010,there were 224 cases with complications of stuck StarClose vascular closure device[13].The surgeon should pull the handle of the closure device linearly[14]and then remove it smoothly.Studies have shown that the release of the vascular closure device under ultrasound guidance can reduce the number of complications[15-17].In addition,although the vascular closure device has significant advantages in closing large-sized blood vessels,its operation is complicated[18].Once the operation fails,it will not only fail to stop bleeding,but also cause some delayed complications(such as secondary thrombosis and pseudoaneurysm)[10,19-21].The complications secondary to StarClose are summarized in Table 1.Therefore,the proficiency of the surgeons handling the vascular closure device should be improved,and the operation should be cautious and standardized,so as to avoid the occurrence of complications.

CONCLUSlON

Informed written consent was obtained from the patient for publication of this report and any accompanying images.

FOOTNOTES

The authors have read the CARE Checklist(2013),and the manuscript was prepared and revised according to the CARE Checklist(2016).

the Traditional Chinese Medicine Science,No.2017-057,2017-058 and 2019-0969;and Technology Development Project of Shandong Province,No.2019-0971.

This article reports a rare case of acute limb ischemia after using a vascular closure device.This case suggests that the vascular closure device should be operated carefully and standardized within the scope of the instructions to reduce complications.In addition,strengthening the training andsupervision of clinicians is also important.

The authors declare that they have no conflict of interest.

Life just hadn’t turned out the way I’d planned. Sure, I was happy. I had a wonderful husband and two great kids in the center of my life. But somehow, working part-time as a secretary and mom hardly fit my definition of someone my classmates had voted as “most likely to succeed.” Had I really wasted 20 years?

Hao QZ designed the study and collected the fund;Sun LX,Yang XS,Zhang DW,and Zhao B collected the case,analyzed the data;Li LL and Zhang Q searched the literatures;and Sun LX wrote the manuscript.

This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers.It is distributed in accordance with the Creative Commons Attribution NonCommercial(CC BYNC 4.0)license,which permits others to distribute,remix,adapt,build upon this work non-commercially,and license their derivative works on different terms,provided the original work is properly cited and the use is noncommercial.See:http://creativecommons.org/Licenses/by-nc/4.0/

China

Li-Xia Sun 0000-0002-4737-9500;Xue-Song Yang 0000-0001-5243-8125;Da-Wei Zhang 0000-0002-7833-4866;Bo Zhao 0000-0001-5300-9103;Lian-Lian Li 0000-0002-0063-6178;Qi Zhang 0000-0002-0466-8150;Qing-Zhi Hao 0000-0002-7415-987X.

When I married, I told my wife Susan about the significant part the lowly pickle jar had played in my life as a boy. In my mind, it defined, more than anything else, how much my dad had loved me. No matter how rough things got at home, Dad continued to doggedly15 drop his coins into the jar. Even the summer when Dad got laid off from the mill, and Mama had to serve dried beans several times a week, not a single dime10 was taken from the jar. To the contrary, as Dad looked across the table at me, pouring catsup over my beans to make them more palatable16, he became more determined17 than ever to make a way out for me. When you finish college, son, he told me, his eyes glistening18, you ll never have to eat beans again unless you want to.

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