New skin closure system facilitates wound healing after cardiovascular implantable electronic device surgery

The manuscript describes the efficacy of a new skin closure system(Zip Line?) for wound closure after pacemaker/implantable cardioverter defibrillator surgery. The system is particularly useful when wound healingis difficult with traditional methods and in patients at high risk for surgical site infections(SSIs). This skin closure option is easy and quick to apply and remove, and produces excellent cosmetic results. Although it is associated with a minimal expense upcharge, the benefits, including the potential for decrease in SSI, make it attractive and worth considering for skin closure in device patients, particularly those at increased risk of complications.

New devices and techniques for endoscopic closure of gastrointestinal perforations

Gastrointestinal perforations,which need to be managed quickly,are associated with high morbidity and mortality. Treatments used to close these perforations range from surgery to endoscopic therapy. Nowadays,with the development of new devices and techniques,endoscopic therapy is becoming more popular. However,there are different indications and clinical efficacies between different methods,because of the diverse properties of endoscopic devices and techniques. Successful management also depends on other factors,such as the precise location of the perforation,its size and the length of time between the occurrence and diagnosis. In this study,we performed a comprehensive review of various devices and intro-duced the different techniques that are considered effective to treat gastrointestinal perforations. In addition,we focused on the different methods used to achieve successful closure,based on the literature and our clinical experiences.

Korean single-center experience with femoral access closure using the ExoSeal device

AIM To report 17-mo experience of femoral artery puncture site closure during angiographic procedures using Exo Seal vascular closure devices(VCDs).METHODS Between November 2015 and April 2017, we performed 179 diagnostic and interventional angiographic procedures via a common femoral arterial access.The Exo Seal VCD was used at the puncture site to achieve hemostasis in 125 patients.We evaluated the technical and procedural success rates, the complications, and the factors affecting the hemostasis time of the ExoSeal VCDs.RESULTS Technical and procedural successes were achieved in 176 cases(98.0%) and 128 cases(71.5%), respectively.Device failure occurred in 3(1.7%) cases.In 1 case(0.6%) a small hematoma developed, but there were no major complications.Among the hemostasis-relevant variables, a history of drinking alcohol, low platelet(PLT) count, and high prothrombin time-international normalized ratio(commonly known as PT-INR) values were the statistically significant predictors of the need for longer manual compression(MC).There was no difference in the success rates between the repeat and single Exo Seal procedure groups, and repeated use of the ExoSeal did not affect hemostasis time.CONCLUSION The ExoSeal VCD effectively achieves hemostasis, with few complications.Longer light MC may be needed with alcohol drinkers, low PLT count, and high PT-INR values.

Medical management of connector pin thrombosis with the Amplatzer cardiac plug left atrial closure device

Transcatheter closure of the left atrial appendage with the Amplatzer cardiac plug device and double antiplatelet treatment for 3 mo has become an alternative treatment for patients with atrial fibrillation at high embolism risk and contraindications for chronic oral anticoagulation.The inadequate implantation of the left atrial appendage closure device and the discontinuation of double antiplatelet therapy are well-known as factors related to device thrombosis.Nevertheless,device thrombosis after adequate implantation requiring surgical treatment or restarting chronic oral anticoagulation has been reported and can reach 15% of patients.The connector pin thrombosis of the Amplatzer cardiac plug,despite a good adherence to antiplatelet treatment,has been recently described as a potential mechanism for device thrombosis.Our clinical case reports the management of this condition for the first time,showing that the early detection of thrombotic complications by transesophageal echocardiography permits solving this serious complication with medical treatment only.

Device-related thrombosis on atrial septal defect occluder after simultaneous closure of left atrial appendage and atrial septal defect: a case report

An atrial septal defect (ASD) may cause right heart dysfunction, pulmonary hypertension and atrial fibrillation (AF), and atrial septal defect occlusion (ASDO) is the first choice for treating secundum defects when the morphology permits. ASD and AF frequently coexist, and the risk of AF and stroke persists after ASDO.[1] In recent years, left atrial appendage occlusion (LAAO) has been recognized as an effective treatment for stroke prevention in nonvalvular AF patients with a high risk of stroke, systemic embolism and bleeding who are unwilling to take oral anticoagulants or cannot tolerate them.

Open Surgery for Retrieval of Patent Foramen Ovale Closure Device Embolized into Right Pulmonary Artery

Percutaneous Patent Foramen Ovate PFO/Atrial Septal Defect (ASD) closure has become an increasingly simplified procedure over the past decade. The main advantages of a percutaneous approach include avoidance of surgery, short procedure time and hospital stay. Device embolization is seen rarely but it can be fatal. We report this complication following a percutaneous PFO closure in a 44-year-old man. The device was embolized into the distal part of the right pulmonary artery. We removed the device surgically and closed the PFO/ASD.

Double Intervention in Single Sitting: Percutaneous Device Closure and Permanent Pacemaker Implantation in a Patient with Atrial Septal Defect

Context: Atrial septal defect may rarely be associated with other cardiac diseases such as arrhythmia, and may require additional intervention. Case report: A 16-year-old boy presented with effort dyspnea, tiredness, and fatigue. The electrocardiograph revealed right bundle branch block, atrioventricular block, and left axis deviation. Ostium secundum type of atrial septal defect was detected by transthoracic echocardiography and was confirmed by transesophageal echocardiography. The patient was advised to undergo percutaneous device closure. Permanent pacemaker implantation was also suggested considering the risk of fatal arrhythmias associated with atrioventricular block. Consequently, patient underwent percutaneous atrial septal defect closure and implantation of pacemaker in a single sitting. Both the procedures were successful, after which the patient showed remarkable symptomatic improvement. Conclusion: In atrial septal defect patients with unexplained atrioventricular block, closure of atrial septal defect and implantation of pacemaker in single sitting appear to be an attractive modality.

Perpulmonary Device Closure of Patent Ductus Arteriosus with Minimum Diameter More Than 4 mm in Infants

Background:Closure of large patent ductus arteriosus(PDA)in older children has been accomplished using surgical and percutaneous techniques with remarkable outcomes.However,outcomes amongst infants have been variable with several drawbacks.Here we describe a novel minimally invasive technique,a product of mini-thoracotomy and traditional percutaneous technique skills,accomplished exclusively under echocardiography guidance.Methods:Symptomatic infants with a significant left-to-right shunt from PDA measuring more than 4 mm were selected.The symptoms were varying degrees of tachypnea,tachycardia,heart failure,failure to thrive,recurrent respiratory tract infections,or intensive care unit treatment for a longer duration.Through a left parasternal mini-thoracotomy,two parallel purse-string sutures were placed on the pulmonary trunk.After purse-string circle puncture,under exclusively transesophageal echocardiography guidance,a device secured to the safety-suture was implanted on the ascending aorta via pulmonary trunk using a specially designed set.The safety-suture prevented device migration in case of dislocation.The basic demographics,PDA size,device size and type,intrapulmonary manipulation time,operation time,PDA parameters(length,diameter,type of duct),redeployment of the device,residual shunt,and retention of safety-suture were all recorded and analyzed.The follow-up was done with transthoracic echocardiography on the 2^(nd)postoperative day,1,3,6,and 12 months,and yearly thereafter.Results:Fifty-two infants with a mean age of 8 months±2.8 months(Interquartile range=0)underwent Perpulmonary device closure of PDA.Successful PDA occlusion was accomplished event-free in all subjects.The mean PDA,mean device,and mean operation time were 5.6 mm±1.4 mm,7.9 mm±1.7 mm,and 61.2 min±12.9 min,respectively.The immediate acceptable residual shunt was noted among 3 subjects and disappeared at a 1-month follow-up.Eighteen infants had retained safety-suture for added safety.There were no reports of the device or procedure-related complications.Conclusion:Perpulmonary device closure is an effective and safe approach to PDA with a diameter measuring>4 mm among infants.The safety-suture,in case of dislocation,prevents migration and associated complications.

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

BACKGROUND Complications of vascular closure devices mainly include bleeding,vascular injury,and trapped device that cannot be removed percutaneously.However,arterial stenosis or occlusion induced by vascular injury is rare.This article introduces a rare case with severe acute limb ischemia after using the vascular closure device(StarClose).CASE SUMMARY A 54-year-old man was admitted because of necrosis of the second toe of the left foot for 2 mo.Ultrasound showed left femoral artery stenosis,and occlusion of the left popliteal,posterior tibial,peroneal,anterior tibial and dorsalis pedis arteries,suggesting arteriosclerosis obliterans of low extremities,gangrene and type 2 diabetes.He underwent an interventional procedure of drug-eluting balloon in the left lower limb via antegrade puncture of the left common femoral artery.He developed acute limb ischemia after 1 h,and severe pain,numbness,pale skin,low skin temperature and weakened sensation in the left foot.Injury of the common femoral artery intima was considered.Exploratory surgery showed occlusion at the puncture point accompanied with bulged vascular lumen and flipped vascular intima caused by StarClose.The flipped intima was removed.The limb blood supply was restored and the limb was saved post-surgery.He recovered well at final follow-up.CONCLUSION Incorrect use of the vascular closure device was the main cause of severe acute limb ischemia in this case.

Treatment of inadvertent subclavian artery cannulation with a percutaneous vascular closure device

Inadvertent puncture of the subclavian artery is an uncommon but potentially fatal complication of the commonly performed internal jugular vein catheterization.We report a case of accidental subclavian artery catheterization close to the vertebral artery during internal jugular venous cannulation,which was successfully managed in the interventional suite with catheter removal and use of a vascular closure device.

The role of echocardiography in mini-invasive surgical device closure of ventricular septal defect

Objective To assess the application of echocardiography in mini-invasive surgical device closure of ventricular septal defect (VSD) . Methods 73 VSD patients including 35 with aneurysm formation and among them 21 with multi-defects in the aneurysm were treated by mini-invasive device closure. A closure device was positioned to the defect through parasternal mini-incision in all patients. TEE was used to monitor the whole procedure。

Percutaneous closure of secundum type atrial septal defects:More than 5-year follow-up

AIM: To investigate long-term efficacy of two different devices more than five years after percutaneous atrial septal defect(ASD) closure in adults.METHODS: All patients who underwent percutaneous closure of an ASD in the St. Antonius Hospital, Nieuwegein, The Netherlands, between February 1998 and December 2006 were included. Percutaneous closure took place under general anaesthesia and transesophageal echocardiographic moni toring. Transthoracic echocardiography(TTE) was performed 24 h post-procedure to visualize the device position and to look for residual shunting using color Doppler. All complications were registered. All patients were invited for an outpatient visit and contrast TTE more than 5-years after closure. Efficacy was based on the presence of a residual right-to-left shunt(RLS), graded as minimal, moderate or severe. The presence of a residual left-to-right shunt(LRS) was diagnosed using color Doppler, and was not graded. Descriptive statistics were used for patients' characteristics. Univariate analysis was used to identify predictors for residual shunting.RESULTS: In total, 104 patients(mean age 45.5 ± 17.1 years) underwent percutaneous ASD closure using an Amplatzer device(ASO) in 76 patients and a Cardioseal/Starflex device(CS/SF) in 28 patients. The mean follow-up was 6.4 ± 3.4 years. Device migration occurred in 4 patients of whom two cases occurred during the index hospitalization(1 ASO, 1 CS/SF). The other 2 cases of device migration occurred during the first 6 mo of follow-up(2 CS/SF). The recurrent thrombo-embolic event rate was similar in both groups: 0.4% per follow-up year. More than 12 mo post-ASD closure and latest follow-up, new-onset supraventricular tachyarrhythmia's occurred in 3.9% and 0% for the ASO and CS/SF group, respectively. The RLS rate at latest follow-up was 17.4%(minimal 10.9%, moderate 2.2%, severe 4.3%) and 45.5%(minimal 27.3%, moderate 18.2%, severe 0%) for the ASO- and CS/SF groups, respectively. There was no residual LRS in both groups.CONCLUSION: Percutaneous ASD closure has good long-term safety and efficacy profiles. The residual RLS rate seems to be high more than 5 years after closure, especially in the CS/SF. Residual LRS was not observed.

Percutaneous closure of patent foramen ovale: “Closed” door after the last randomized trials?

Patent foramen ovale(PFO) percutaneous closure has previously been an accepted intervention for the prevention of recurrent cryptogenic stroke on the basis of observational studies. However, randomized trials have been lacking until now. Three recently published randomized trials(CLOSURE I, PC and RESPECT) do not demonstrate the superiority of this intervention versus optimal medical therapy, therefore making this practice questionable. Nonetheless, these trials have had certain pitfalls, mainly a lower than initially estimated number of patients recruited, therefore lacking sufficient statistical power. On the other hand, different closure devices were used in the three trials. In two of them(PC and RESPECT), the Amplatzer PFO Occluder was used and the STARflex device was used in the other one(CLOSURE I). Taken altogether, a meta-analysis of these three trials does not demonstrate a statistically significant benefit of percutaneous PFO closure(1.9% vs 2.9%; P = 0.11). However, if we analyze only the PC and RESPECT trials together, in which the Amplatzer PFO Occluder was used, a statistically significant benefit of percutaneous PFO closure is observed(1.4% vs 3.0%, P = 0.04). In conclusion, our interpretation of these trials is that the use of a dedicated, specifically designed Amplatzer PFO device could possibly reducethe risk of stroke in patients with PFO and cryptogenic stroke. This consideration equally applies to patients who have no contraindications for anticoagulant or antithrombotic therapy.

Percutaneous closure of congenital Gerbode defect using Nit-Occlud^®LêVSD coil

We present a case report about percutaneous closure of a congenital Gerbode defect using Nit-Occlud~? Lê VSD coil. The patient was referred to our hospital with a diagnosis of ventricular septal defect(VSD) and severe pulmonary arterial hypertension. But transthoracic echocardiography revealed a communication between the left ventricle(LV) and the right atrial(RA), called Gerbode defect. Catheterization confirmed the shunt from the LV to the RA. We successfully closed the defect with a VSD coil. After uneventful 6 mo follow-up, the patient was out of dyspnea, the symptom urged him to have medical attention. This case report is to discuss the diagnosis and percutaneous treatment approach for this rare congenital heart disease.

冠状动脉介入术后closure wire血管封堵临床疗效评价

目的:评价冠状动脉介入治疗后closure wire血管封堵器的临床疗效。方法:经皮穿刺股动脉途径行冠脉造影术及冠脉介入治疗术患者336例,其中手工压迫组221例,closure wire封堵器组115例。观察止血时间、制动时间及术后相关并发症的发生情况。结果:封堵器组止血时间和制动时间较手工压迫组显著缩短(P<0.05),封堵器组相关血管并发症较手工压迫组显著减少(P<0.05),手工压迫组1例因腹膜后血肿而急需输血,封堵器组无严重血管并发症出现。结论:closure wire封堵器在经股动脉途径行冠脉造影及冠脉成型术中是安全有效的,其较手工压迫法能够显著缩短止血时间和制动时间,相关血管并发症有减少的趋势,特别是严重的出血并发症。

Modification of Serum Galectin-3 and Reversal of Cardiac Remodeling Following Pediatric Transcatheter Atrial Septal Defect Closure

Objectives:We aimed to evaluate the effect of percutaneous atrial septal defect(ASD)closure in children using right heart indices and serum galectin-3(Gal-3),as potential biomarkers of right heart remodeling.Methods:This case–control prospective study included 40 children with ASD and 25 control subjects.An echocardiographic evaluation was performed before the procedure,as well as 24 h,1 month,and 6 months after intervention.Serum Gal-3 was measured before,and 1 month after the procedure.Results:Serum Gal-3 concentration,right atrial(RA)dimensions,right ventricular(RV)dimensions,indexed RA area,and right index of myocardial performance(RIMP)were significantly increased in children with ASD compared with control subjects while tricuspid annular plane systolic excursion(TAPSE)was significantly decreased.Six months after closure,RA,and RV dimensions significantly decreased and RVfunction improved(RIMP decreased and TAPSE increased).Gal-3 oncentration significantly decreased 1 month after ASD closure,but it did not reach normal range compared with control subjects.A positive correlation between Gal-3 and age at closure,RA area,RV dimensions,and RIMP was observed.A positive correlation was observed between the decrease in Gal-3 concentration and the decrease in RA area and RV dimensions 1 month after ASD closure.A significant negative correlation was observed between TAPSE and Gal-3 concentration before and after intervention.Conclusions:Percutaneous ASD closure can improve right-sided indices and decrease serum Gal-3 concentration.Gal-3 can be used as a sensitive biomarker of right heart remodeling,with a decrease in Gal-3 concentration suggesting reversal of maladaptive remodeling.

Immediate and Long-Term Results of Transcatheter Closure of Patent Ductus Arteriosus—Comparison of Two Decades before and after Change in Antibiotic Infective Endocarditis Prophylaxis Guidelines

Objectives:To determine immediate and long-term follow-up of transcatheter closure of patent ductus arteriosus(PDA)in children.Background:National antibiotic prophylaxis(AP)guideline for infective endocarditis changed after 2009,the effect on practice of PDA closure is unknown.Methods:Observational single center study analyzing follow-up of PDA closure comparing two time periods before(2002–2009)and after(2010–2019)changes in AP guideline.Results:332 patients(68.1%female),median(interquartile range)age 3.0 years(1.5–5.7)and body weight 14.0 kg(10.0–19.3),were enrolled.PDA morphology was conical type A(50.3%),window type B(1.2%),tubular type C(40.1%),complex type D(2.1%),elongated type E(0.9%)and other(5.4%).Minimal PDA diameter and length were 1.9 mm(1.3–2.5)and 8.0 mm(6.2–10.2).PDA was closed using coils(56.3%),Amplatzer Duct Occluders(41.9%)and others(1.8%).Complete closure rate was 61.1%at catheter intervention,72.3%on day 1,87.7%after 6 months and 98.4%at last follow-up on echocardiography.Moderate complication rate(severity level 3)was 4.2%and major complication rate(severity level 4)0.3%,with no catastrophic complications(severity level 5).Annual PDA closure rate declined in the second time period(22.6/year vs.15.5/year,p=0.018),PDA size increased(1.6 mm vs.2.0 mm,p=0.002)and proportion of coils decreased(72.4%vs.37.1%,p<0.001).Conclusions:Interventional closure of PDA is associated with excellent closure rates during follow-up(>98%)and only a small number of complications leading to reintervention or surgery.Change in AP guidelines changed indication for and practice of PDA closure.

The ASD that Wouldn’t Go Away:An Unusual Case of ASD Device Failure in a Patient with Marfan Syndrome

Marfan syndrome patients have connective tissue abnormalities that predispose them to intracardiac defects and postoperative complications.We present a case of late onset ASD device failure secondary to device movement within the atrial septum in a girl with Marfan syndrome.This case study suggests that further studies are necessary to determine the optimal device and approach for ASD repair in this patient cohort.

经导管主动脉瓣置换术预留两把ProGlide缝合失败后联合应用ExoSeal血管闭合器的单中心研究

目的评价ExoSeal血管闭合器在经导管主动脉瓣置换术预留两把ProGlide缝合失败患者中的应用效果。方法回顾性分析2020年5月至2024年1月在河北医科大学第一医院心内科住院行TAVR后应用两把ProGlide缝合失败后联合应用ExoSeal血管闭合器的35例患者。总结ExoSeal血管闭合器的疗效,观察患者术后止血时间、徒手压迫时间、下肢制动时间、弹力绷带压迫时间、压迫过程出血量、术后股动脉并发症发生情况以及股动脉超声情况。通过上述指标评价ExoSeal血管闭合器在经导管主动脉瓣置换术患者中的疗效。结果(1)术后止血效果:股动脉入路的术后止血时间(6.89±2.66)min、徒手压迫时间(4.65±1.33)min、弹力绷带压迫时间(3.79±1.57)h、下肢制动时间(13.74±5.51)h、压迫过程出血量(12.74±3.61)g。(2)股动脉并发症发生情况:止血成功率为85.7%;需要止血的局部出血、血肿4例(11.4%);发生假性动脉瘤、动静脉瘘、血管撕裂伤或腹膜后出血1例(2.8%);无同侧血管功能不全或栓塞表现、穿刺处感染、入路相关神经损伤、需要手术或非手术技术修复血管发生。(3)术前及术后股动脉超声情况:股总动脉平均直径和股总动脉收缩期峰值流速差异均无统计学意义(均P>0.05)。结论ExoSeal血管闭合器在经导管主动脉瓣置换术两把ProGlide缝合失败患者中的应用安全有效。

ExoSeal血管封堵器在急性缺血性脑卒中桥接治疗中的安全性和有效性

目的 探讨ExoSeal血管封堵器在接受桥接治疗的急性缺血性脑卒中(AIS)患者中的安全性和有效性。方法 回顾性分析2018年6月至2020年12月在潍坊市人民医院接受全量重组组织型纤溶酶原激活剂(rt-PA)溶栓后桥接血管腔内机械取栓治疗的142例AIS患者临床资料。所有患者在血管腔内机械取栓手术时均使用8 F股动脉鞘,术毕股动脉穿刺点由指压法封堵68例,7 F ExoSeal封堵器封堵74例。比较指压法组和封堵器组股动脉穿刺点封堵成功率及穿刺点相关并发症发生率。结果 封堵器组与指压法组相比,手术成功率显著增高(94.6%比83.8%,P=0.037)。指压法组、封堵器组患者术后至出院前分别有11例(16.2%)、4例(5.4%)发生穿刺点相关并发症(P=0.030),6例(8.8%)、2例(2.7%)发生深静脉血栓(P=0.109),均未发生动静脉瘘、假性动脉瘤、同侧下肢急性缺血、穿刺点相关大出血及需要血管外科手术或介入治疗的并发症。结论 ExoSeal封堵器可安全地应用于溶栓后桥接血管腔内机械取栓治疗的AIS患者,股动脉穿刺点封堵成功率较高,且降低穿刺点血肿发生率。