Complications associated with transcatheter closure of perimembranous ventricular septal defects

Objectives : To identify the complications associated with transcatheter closure of perimembranous ventricular septal defects (PmVSD) using the Amplazter PmVSD occluder (AGA Medical, USA). Methods : Between October 2002 and November 2006, transcatheter closure PmVSD was attempted in 210 patients and performed in 206 patients. Those patients were followed‐up for 6–24 months (mean, 10.6 ± 3.9 months) to identify the complications. Results : Device implantation was successfully accomplished in 206 of the 210 patients (98%). Serious complications such as high degree atrioventricular block (AV block), infective endocarditis, and device embolization occurred in eight cases (3.8%). Other complications including mild aortic or tricuspid regurgitation, femoral pseudoaneurysm, and femoral arteriovenous fistula occurred in four cases. Conclusions : Transcathter closure of PmVSD can be performed safely and successfully. But further studies should continue to evaluate the potential complications associated with this procedure. © 2008 Wiley‐Liss, Inc.     

Percutaneous thoracic aortic aneurysm repair through transcaval aortic access

Transcaval aortic access has been used for deployment of transcatheter aortic valves in patients in whom conventional arterial approaches are not feasible. This access can be vital in other situation when large bore access is needed. We described a case of 65‐year‐old man who had large thoracic descending aortic aneurysm with diffuse bilateral iliac disease precluding the arterial access required for the procedure. The patient underwent successful transcaval access with placement of 22‐Fr balloon expandable sheath followed with successful deployments of 32 mm × 32 mm × 150 mm Valiant stent graft (Medtronic, Minneapolis, MN). The aorto‐vena cava tract was closed successfully using 12 × 10 PDA occluder device with no residual flow at the end of the case, which was confirmed on repeated CT next day.     

Closure of Atrial Septal Defects With the Amplatzer Occlusion Device: Preliminary Results

Objectives. This study reports our clinical experience with transcatheter closure of secundum atrial septal defects (ASDs) in children, using the Amplatzer, a new occlusion device.Background. None of the devices previously used for transcatheter closure of interatrial communications has gained wide acceptance.Methods. We examined the efficacy and safety of the Amplatzer, a new self-centering septal occluder that consists of two round disks made of Nitinol wire mesh and linked together by a short connecting waist. Sixteen patients with secundum ASD met established two- and three-dimensional echocardiographic and cardiac catheterization criteria for transcatheter closure. The Amplatzer’s size was chosen to be equal to or 1 mm less than the stretched diameter. The device was advanced transvenously into a 7F long guiding sheath and deployed under fluoroscopic and ultrasound guidance. Once its position was optimal, it was released.Results. The mean ASD diameter by transesophageal echocardiography was 14.1 ± 2.3 mm and was significantly smaller (p < 0.001) than the stretched diameter of the ASD (16.8 ± 2.4 mm). The mean device diameter was 16.6 ± 2.3 mm. No complications were observed. After deployment of the prosthesis, there was no residual shunt in 13 (81.3%) of 16 patients. In three patients there was trivial residual shunt immediately after the procedure that had disappeared in two of them at the 3-month follow-up.Conclusions. The Amplatzer is an efficient prosthesis that can be safely applied in children with secundum ASD. However, a study including a large number of patients and a longer follow-up period are required before this technique can be widely used.     

Midterm follow‐up results of transcatheter treatment in patients with unroofed coronary sinus

Objective : We present the midterm results of transcatheter treatment of unroofed coronary sinus (CS) using the Amplatzer septal occluder. Background : The unroofed CS is a rare atrial septal defect communicating the left atrium and CS. Surgery has been the mainstay of treatment. Methods : In a 4.5‐year period, nine patients (five males) with ages ranging from 26 to 69 years (median 39 years) diagnosed with an unroofed CS but without a persistent left superior vena cava (LSVC) underwent transcatheter treatment. Computerized tomography (CT) was performed in eight patients. Transesophageal echocardiography (TEE) was used to monitor the procedure. Results : The mean Qp/Qs ratio was 2.4 ± 1 and mean systolic pulmonary artery pressure was 35 ± 19 mm Hg. An Amplatzer septal occluder was deployed in all nine patients. The device was implanted in the defect in one patient and at the CS ostium in the other eight patients. The median device size used was 22 mm (16–28 mm). The left disc herniated into the CS in the single patient in whom the device was implanted within the defect. All patients were available for the 3‐month follow‐up. None had a residual shunt on the 3‐month follow‐up echocardiography. One patient died of a stroke 4.5 months after the procedure. At mean follow‐up of 42.6 ± 18.3 months, symptomatic improvement was documented in the remaining eight patients. All eight patients had an O₂ saturation above 96%. Conclusion : Transcatheter treatment for unroofed CS without persistent LSVC using Amplatzer septal occluder is safe and feasible. © 2013 Wiley Periodicals, Inc.     

Lung perfusion studies after transcatheter closure of persistent ductus arteriosus with the Amplatzer duct occluder

Background : Reduced left lung perfusion has been described after transcatheter closure of the patent ductus arteriosus (PDA) with several prostheses. Although the Amplatzer ductal occluder (ADO) device is currently the most widely used occluder for closure of large‐sized PDAs, the potential consequences of flow distribution to the lungs of this device have not been completely clarified. We evaluated lung perfusion following occlusion of PDA with the ADO device. Methods : Forty‐seven patients underwent successful transcatheter PDA occlusion using the ADO device were included in this study. Lung perfusion scans were performed 6 months after the procedure. Results : Decreased perfusion to the left lung (defined as < 40% of total lung flow) was observed in 17 patients (36%), 5 of whom were low‐weight symptomatic infants. Ductal ampulla length was significantly shorter and minimal ductal diameter to ampulla diameter ratio was significantly higher in patients with decreased left lung perfusion and correlated well with left lung perfusion values (r = 0.516 and r = ?0.501, respectively). A cut‐off value of ≤5.8 mm for the ductal ampulla length and ≥1.9 for ampulla diameter to ampulla length ratio showed high sensitivity and specificity for reduced lung perfusion. Conclusions : The incidence of abnormal left lung perfusion is high 6 months after transcatheter closure of PDA with the ADO, more likely in the low weight symptomatic infants and in patients with a short duct or a relatively shallow duct having abrupt narrowing of a large ampulla. © 2010 Wiley‐Liss, Inc.     

Further experience with transcatheter closure of the patent ductus arteriosus using the Amplatzer duct occluder

OBJECTIVE: The aim of this study was to report further experience with transcatheter closure of the patent ductus arteriosus (PDA) using the Amplatzer duct occluder (ADO). BACKGROUND: The design of previously used devices is not ideal for this purpose, and their use has been associated with several drawbacks, especially in large PDAs. METHODS: Forty-three patients, aged 0.3 to 33 years (mean 6.4+/-6.7 years), with a moderate to large, type A to E PDA, underwent attempted transcatheter closure using the ADO. The device is a plug-shaped repositionable occluder made of 0.004-in. nitinol wire mesh. It is delivered through a 5F to 6F long sheath. The mean PDA diameter (at the pulmonary end) was 3.9+/-1.2 mm (range 2.2 to 8 mm). All patients had color flow echocardiographic follow-up (6 to 24 months) at 24 h, 1 and 3 months after closure, and at 6-month intervals thereafter. RESULTS: The mean ADO diameter was 6.1+/-1.4 mm (range 4 to 10 mm). Complete angiographic closure was seen in 40 of 43 patients (93%; 95% confidence interval [CI] 85.4% to 100%). The remaining three patients had a trivial angiographic shunt through the ADO. At 24 h, color flow mapping revealed no shunt in all patients. A 9F long sheath was required for repositioning of a misplaced 8-mm device into the pulmonary artery. The mean fluoroscopy time was 7.9+/-1.6 min (range 4.6 to 12 min). There were no complications. No obstruction of the descending aorta or the pulmonary artery branches was noted on Doppler follow-up studies. Neither thromboembolization nor hemolysis or device failure was encountered. CONCLUSIONS: Transcatheter closure using the ADO is an effective and safe therapy for the majority of patients with patency of the arterial duct. Further studies are required to establish long-term results in a larger patient population.     

Transcatheter closure of perimembranous and intracristal ventricular septal defects with the SHSMA occluder

Objectives : The objective of this study was to evaluate the safety and efficacy of transcatheter closure of perimembranous ventricular septal defect (pmVSD) and intracristal VSD (icVSD) using the Shanghai Shape Memory Alloy (SHSMA) pmVSD occluder. Background : There is still limited experience with transcatheter closure of pmVSD and icVSD. Methods : Between January 2003 and September 2010, 348 patients with pmVSD and 47 patients with icVSD underwent transcatheter closure using a SHSMA pmVSD occluder. Results : The total successful closure rate in pmVSD and icVSD subjects was 97.4 and 78.7%, respectively. During the perioperative period, no death, major bleeding or hemolysis occurred in both groups. In pmVSD group, one case of occluder dislodgement, one case of pericardial tamponade, and two cases of thromboembolism occurred. None in icVSD group had these complications. During a median of 3.2 years of follow‐up, there was no evidence of significant residual shunt and device‐related valve regurgitation. None in icVSD group and 10 patients (2.9%) in pmVSD group had a persistent arrhythmia. Overall, only one patient (0.3%) with pmVSD acquired complete atrioventricular block requiring implantation of a permanent pacemaker. The rim from the tricuspid valve to the defect < 4 mm was the only predictor of arrhythmic complications after procedure (OR = 4.24; P = 0.021). Conclusions : Transcatheter closure of pmVSD in selected patients using the SHSMA occluder is effective and safe. Transcatheter closure of icVSD in experienced hands using this device is also feasible and safe. © 2011 Wiley Periodicals, Inc.     

Role of "buttoned" double-disc device in the management of atrial septal defects.

Sixteen patients seen over a 9-month period ending in August 1990 were offered transcatheter closure of their ASD with a custom-made "buttoned" double-disc device. The study was approved by the Institutional Review Board and informed consent was obtained in each case. The device consists of an occluder, a counteroccluder, and a loading wire and is delivered to the ASD site via an 8F sheath. Parents of two children elected surgical closure. In five children the stretched diameter of the ASD was too large (greater than 20 mm) and transcatheter closure was not attempted. These seven children underwent elective surgical closure without incident. In one child the defect measured 5 mm and the Qp:Qs was 1.4:1 and therefore ASD closure was not recommended. In the remaining eight children transcatheter closure was attempted. In two of the children the occluder pulled through the ASD and was successfully retrieved and the children later underwent uneventful elective surgical closure. The device was implanted across the ASD in six children. In one child the device dislodged from the ASD site within minutes after implantation and the child was sent to emergency surgery, where the device was removed and the ASD was closed. In the remaining five patients, aged 7 months to 45 years (weight 3.6 to 50 kg), with a Qp:Qs range of 1.3 to 2.3 and a stretched diameter of 10 to 19 mm, the ASD closure was successful with 25 to 40 mm size devices. Repeat echo-Doppler studies 2 weeks and 3 months after the procedure in all patients and 6 months later in two children did not reveal any residual shunt. It is concluded that (1) the custom-made "buttoned" double-disc device can be implanted across the ASD safely and effectively via an 8F sheath, thus making transcatheter ASD closure feasible even in very young infants; (2) measurement of stretched diameter of the ASD in the catheterization laboratory is a useful guide for selection of an appropriate-sized device; and (3) additional clinical trials are warranted to confirm the efficacy and safety of the device.     

Comparative Changes of Pulmonary Artery Pressure Values and Tricuspid Valve Regurgitation Following Transcatheter Atrial Septal Defect Closure in Adults and the Elderly

Objectives. Opinions vary widely regarding the effectiveness of transcatheter atrial septal defect (ASD) closure in adults, especially in elderly patients. The purpose of this study was to evaluate and compare the hemodynamic changes after transcatheter ASD closure in two groups of patients, one aged 40–59 years (group 1) and one 60 years of age and older (group 2). Methods. Retrospective analysis of patient files. Results. Forty‐six patients were evaluated (23 in each group). Older patients had a higher prevalence of cardiovascular risk factors and established coronary artery disease. There was no statistically significant difference between the two groups in Qp/Qs values, ASD diameter and occluder size. The elderly patients had significantly higher baseline systolic pulmonary artery pressure (PAp) levels ?53 ± 16.2 vs. 39 ± 7.7 mm Hg, P = 0.003. One year following the procedure, the mean reduction in PAp values was 11.3% in group 1 and 19% in group 2 (P = 0.099). While significant baseline tricuspid regurgitation (TR) was more frequent in the elderly patients, no significant TR was observed in either group 1 year following the procedure. Conclusion. Transcatheter ASD closure resulted in significant hemodynamic improvement in all patients, but was even more beneficial in the elderly patient cohort.     

Perimembranous ventricular septal defect with aneurysm: two options for transcatheter closure

We present our experience with 2 options for device closure of perimembranous ventricular septal defect with aneurysm. Thirty-four patients with perimembranous ventricular septal defect with aneurysm, aged from 14 to 42 years, underwent transcatheter closure with modified double-disk occluders. A sheath was used to deliver the occluder after establishment of a stable "arteriovenous loop" under fluoroscopy. Electrocardiography and transthoracic echocardiography were used for follow-up. All but 1 patient experienced successful transcatheter closure of perimembranous ventricular septal defect with aneurysm, when occluders were used in 2 different positions. There were 19 patients whose perimembranous ventricular septal defects were closed at the inlet of the aneurysm and 15 patients whose defects were closed at the outlet. Eight patients had a residual shunt immediately after the procedure, which disappeared during follow-up. One patient developed minor aortic regurgitation. Four patients who manifested different types of conductive block were all in the group that underwent closure at the inlet of the aneurysm. No other complications were observed during follow-up.We infer that perimembranous ventricular septal defect with aneurysm can be successfully closed with modified double-disk occluders. Each of the 2 options that we have presented for transcatheter closure of perimembranous ventricular septal defect with aneurysm has its advantages and disadvantages. Ultimately, the configuration of the lesion should decide the type and position of the device.     

Novel streamlined technique for left atrial appendage closure using a radiofrequency wire-based large access system

Introduction

Transseptal puncture (TSP) to allow for large delivery sheath left atrial (LA) access remains a challenging aspect of LA appendage closure (LAAC) in patients with prior history of TSP, thick or lipomatous septum, atrial septal aneurysms, or other complex cardiac anatomies. This study investigates the use of the VersaCross large access (VLA) system (Baylis Medical/Boston Scientific) to improve procedural efficiency of LAAC compared to the standard needle workflow.

Methods and Results

Fifty LAAC procedures using WATCHMAN FLX between November 2021 and September 2022 were retrospectively analyzed comparing the VLA workflow (n = 25) to the standard needle workflow (n = 25). Study primary endpoint was time to procedural efficiency, and secondary endpoints included TSP time, acute LAAC success, fluoroscopy use, device recaptures, and periprocedural complications. Acute LAAC was successfully completed in all cases with no intraprocedural complications. TSP time was faster, but not significant, using the VLA workflow compared to the standard RF needle workflow (2.6 ± 1.1 min vs. 3.0 ± 1.8 min, p = 0.38). Time to WATCHMAN sheath in LA from TSP was 27% faster (1.5 ± 0.8 min vs. 2.1 ± 0.9 min; p = 0.03), and time to WATCHMAN release from TSP was 19% faster (10.5. ± 2.5 min vs. 13.0 ± 3.7 min; p = 0.01) with the VLA workflow. Overall procedure time was 15% faster (30.4 ± 5.1 min vs. 36.0 ± 6.6 min; p = 0.003) using VLA. Fluoroscopy time was 25% lower (4.0 ± 2.2 min vs. 5.5 ± 2.3 min; p = 0.003) and fluoroscopy dose was 60% lower (97.0 ± 91.7 mGy vs. 241.8 ± 240.6 mGy; p = 0.01) and more consistent [F-test, p ˂ 0.0001] using the VLA workflow compared to the needle workflow.

Conclusion

The VLA system streamlines LAAC procedures, improving LAAC efficiency and reducing fluoroscopy use by allowing for de novo dilation of the septum for large-bore delivery sheaths, and reducing device exchanges and delivery sheath manipulation.     

Transcatheter closure of moderate to large patent ductus arteriosus with the Amplatzer duct occluder.

OBJECTIVES: To investigate the acute and follow-up results of transcatheter closure of moderate to large patent ductus arteriosus (PDA) with the Amplatzer duct occluder. METHODS: Between April 2000 and June 2005, 237 patients underwent attempted transcatheter closure of PDA, of whom Amplatzer duct occluder was used in 68 patients with moderate-to-large-sized PDA (45 females, with ages ranging from 56 days to 75 years, median 3.3 years). Moderate to large PDA is defined as ductus diameter > or =2.5 mm (> or =3 mm in early phase of this study) in infants and young children, or > or =4 mm in adolescents and adults. The size of device selected was generally at least 1-2 mm larger than ductus diameter. RESULTS: The ductus diameter ranged from 2.5 to 8.5 mm (4.1 +/- 1.3 mm). Amplatzer duct occluder was successfully deployed in 66 out of 68 patients. The size of device deployed ranged from 4 to 12 mm (6.3 +/- 1.6 mm). The causes of failure in the 2 patients included calcification of ductus resulting, in failure in advancing a sheath to descending aorta in 1 and kinking of a Cook sheath in the other. Distal embolization of the device occurred several hours later in one. After the device was retrieved percutaneously, the patient was sent to surgery. No other significant complications occurred. In the 3-month follow-up, complete occlusion was achieved in all patients. No patient had left pulmonary artery stenosis. CONCLUSIONS: Transcatheter closure of moderate-to-large-sized ductus with Amplatzer ductus occluder is effective and safe.     

经导管介入性治疗动脉导管未闭68例临床疗效分析

目的 :应用Amplatzer堵闭器经导管介入性治疗动脉导管未闭 (PDA)并对其疗效进行初步分析。方法 :于主动脉弓降部造影 ,测量PDA大小 ,在透视下经传送装置将Amplatzer堵闭器置入PDA内 ,使之在PDA最窄处固定 ,即刻或 10min后再次造影。术后 2 4h行超声心动图 (UCG)检查。结果 :全组技术成功率 10 0 %。术后 6 1例 (89 7% )即刻无分流 ;7例 (10 3% )即刻有少量残余分流 ,其中 4例术后2 4hUCG示分流消失 ;肺动脉高压者术后均有所下降。结论 :应用Amplatzer堵闭器治疗动脉导管未闭操作方法简便、治疗范围广、成功率高 ,不失为很有前途的代替开胸手术的介入性治疗方法     

Transcatheter closure of a traumatic VSD in an adult requiring an ASD occluder device

Traumatic ventricular septal defects (VSD) can occur after blunt or penetrating chest trauma or cardiac procedures. There are few publications reporting the safety and efficacy of transcatheter closure of traumatic VSDs. We report a case of a large VSD resulting from penetrating chest trauma that was not repaired at the initial surgical procedure on the disrupted right ventricle. Because of the late identification of the VSD postoperatively, transcatheter closure after the original surgical procedure was recommended and performed requiring an Amplatzer atrial septal defect occluder device because of defect size and configuration. This case describes the technique and postprocedure imaging leading to a cautionary note regarding VSD closure device techniques. © 2009 Wiley‐Liss, Inc.     

Initial clinical experience with cardiac resynchronization therapy utilizing a magnetic navigation system

Introduction: The placement of left ventricular (LV) leads during cardiac resynchronization therapy (CRT) involves many technical difficulties. These difficulties increase procedural times and decrease procedural success rates. Methods and Results: A total of 50 patients with severe cardiomyopathy (mean LV ejection fraction was 21 ± 6%) and a wide QRS underwent CRT implantation. Magnetic navigation (Stereotaxis, Inc.) was used to position a magnet‐tipped 0.014″ guidewire (Cronus? guidewire) within the coronary sinus (CS) vasculature. LV leads were placed in a lateral CS branch, either using a standard CS delivery sheath or using a “bare‐wire” approach without a CS delivery sheath. The mean total procedure time was 98.1 ± 29.1 minutes with a mean fluoroscopy time of 22.7 ± 15.1 minutes. The mean LV lead positioning time was 10.4 ± 7.6 minutes. The use of a delivery sheath was associated with longer procedure times 98 ± 32 minutes vs 80 ± 18 minutes (P = 0.029), fluoroscopy times 23 ± 15 minutes vs 13 ± 4 minutes (P = 0.0007) and LV lead positioning times 10 ± 6 minutes vs 4 ± 2 minutes (P = 0.015) when compared to a “bare‐wire” approach. When compared with 52 nonmagnetic‐assisted control CRT cases, magnetic navigation reduced total LV lead positioning times (10.4 ± 7.6 minutes vs 18.6 ± 18.9 minutes; P = 0.005). If more than one CS branch vessel was tested, magnetic navigation was associated with significantly shorter times for LV lead placement (16.2 ± 7.7 minutes vs 36.4 ± 23.4 minutes; P = 0.004). Conclusions: Magnetic navigation is a safe, feasible, and efficient tool for lateral LV lead placement during CRT. Magnetic navigation during CRT allows for control of the tip direction of the Cronus? 0.014″ guidewire using either a standard CS delivery sheath or “bare‐wire” approach. Although there are some important limitations to the 0.014″ Cronus? magnetic navigation can decrease LV lead placement times compared with nonmagnetic‐assisted control CRT cases, particularly if multiple CS branches are to be tested.     

应用Amplatzer封堵器经导管治疗直径≥8mm动脉导管未闭的疗效评价

目的 :应用 Amplatzer封堵器经导管治疗直径≥ 8mm的大型动脉导管未闭 （PDA）并对其疗效进行评价。方法 :全组 5 0例 ,年龄 2 6 .4± 2 3.2 （4.0～ 6 0 .0 ）岁。 PDA最窄处直径为 10 .2± 2 .3（8.0～ 15 .0 ） mm。封堵 10 m in后行侧位降主动脉造影 ,术后 1d及 1月行超声心动图检查 ,观察有无残余分流及 PDA再通。结果 :47例 PDA采用Amplatzer PDA封堵器治疗 ,2例采用 Amplatzer ASD封堵器治疗 ,1例 PDA伴有阻力性肺动脉高压未行介入治疗。术后 10 min降主动脉造影显示 ,19例存在微～少量残余分流 ,30例封堵完全无残余分流。术后 2 4h、术后 1月超声心动图未见残余分流及再通。结论 :应用 Am platzer封堵器治疗直径≥ 8mm的大型动脉导管未闭是一种安全有效的介入方法。     

Transthoracic echocardiography guidance during percutaneous closure of patent foramen ovale

Background: Percutaneous closure of patent foramen ovale (PFO) has been increasingly performed for several indications; mostly due to cryptogenic stroke. In this study we aimed to evaluate the safety and efficacy of transthoracic echocardiographic (TTE) guidance during percutaneous closure of PFO in using the Amplatzer and Occlutech Figulla PFO occluder devices. Methods: Between October 2005 and March 2011, 139 patients (74 male, mean age: 40.4 ± 10.3) underwent transcatheter PFO closure. In all patients transesophageal echocardiography performed subsequently to diagnose, assess the size and evaluate for suitability of the defect for percutaneous closure. During the procedure fluoroscopy and TTE were used for guidance. Results: Among 139 patients, Amplatzer PFO occluder was used in 74 patients and in 65 of them Occlutech Figulla device was selected for occlusion. The indications for PFO closure were ischemic stroke in 98 (70.5%), recurrent transient ischemic attacks (TIA) in 40 (28.7%), peripheral embolism in 1 (0.8%) of the patients. In all patients, percutaneous intervention was performed successfully under TTE guidance. There have been no neurologic (recurrent strokes or TIAs) and cardiovascular complications during the immediate and long‐term follow‐up period (2–67 months, median 29). There was significant difference between the mean fluoroscopic time from the beginning which is 8.6 ± 3.4 min in the former versus 3.4 ± 1.9 min in the latter (P < 0.05). Conclusion: Our study confirms the efficacy and safety of TTE guidance during percutaneous closure of PFO, which shortens the procedural time and obviates the need for general anesthesia or endotracheal intubation. (Echocardiography 2011;28:1074‐1080)     

Transcatheter occlusion of gigantic persistent ductus arteriosus (PDA) using a custom‐made persistent ductus arteriosus occluder

We reported transcatheter closure of gigantic persistent ductus arteriosus (PDA) complicated by severe pulmonary hypertension (PH) using a custom‐made PDA occluder. A 19‐year‐old lady weighing 45 kg visited to our Heart Saving Project in Mongolia with a chief complaint of shortness of breath. Contrast CT scan showed ellipsoidal section of PDA whose long axis being 28 mm, and the short axis of 21 mm. A custom‐made PDA occluder, whose retention skirt, the aortic side, and the pulmonic side diameter of the body were 54, 36, 34 mm, respectively, was successfully deployed using 14‐Fr sheath. Pulmonary pressure decreased around a half compared to before closure. A custom‐made duct occluder could be a reasonable and cost‐effective choice for transcatheter closure of gigantic PDA complicated by severe PH. © 2015 Wiley Periodicals, Inc.     

First‐in‐human experience of left atrial appendage occlusion with the steerable FuStar sheath

Background

Due the wide variability of left atrial appendage morphology left atrial appendage occlusion (LAAO) remains a challenging procedure. The steerable FuStar delivery sheath was designed to allow both, transseptal access and delivery of percutaneous devices. We here report the first‐in‐human experience of LAAO with the FuStar sheath.

Methods

Twenty patients (76.6 ± 8.4 years; 12 (60%) males; CHA₂DS₂‐VASc score: 5.0 ± 2) with non‐valvular fibrillation and contraindications to oral anticoagulation underwent LAAO with the LAmbre device using the FuStar steerable sheath (Lifetech Scientific Corp., Shenzhen, China) at two german centers.

Results

Successful device implantation was achieved in all patients (100%). No periprocedural complications were observed. Procedure time, fluoroscopy time, contrast media, and radiation dose were 23.4 min ± 9.2, 11.9 min ± 4.1, 96.2 mL ± 45.7, and 2718.4 cG*cm² ± 3835.3, respectively.

Conclusion

This study demonstrates the feasibility and safety of the steerable FuStar sheath for LAAO.

     

Right Ventricular Remodeling after Transcatheter Closure of Atrial Septal Defect

Background: Right ventricular (RV) volume overload is a well‐known cardiac consequence of atrial septal defect (ASD) shunt, accounting for most of its long‐term complications. Thus cardiac volumetric unloading is a major aim of transcatheter ASD closure. We set to study the right ventricular remodeling after transcatheter ASD closure in patients with secundum ASD. Methods: We enrolled 46 patients who underwent successful transcatheter closure of ASD. We performed routine transthoracic echocardiographic studies, including three‐dimensional echocardiography and right ventricular myocardial performance index (RVMPI), before transcatheter ASD closure, and 3 days, 1 month after transcatheter ASD closure. Results: We found that: (1) the right ventricular end‐diastolic volume (RVEDV) and right ventricular end‐systolic volume (RVESV) (respectively 106.54±25.97 vs 69.78±10.46 mL, P < 0.05; 59.73±17.59 vs 33.84±7.18 mL, P < 0.05) were enlarged in patients with ASD compared with those in control subjects, resulting in a marked decrease of the right ventricular ejection fraction (RVEF) (44.82%±4.51% vs 54.11%±5.89%, P < 0.05) from normal values; (2) the isovolumic relaxation and isovolumic contraction times (respectively [77.61±16.49] ms vs (64.09±11.82) ms, P < 0.05; [28.04±9.57] ms vs [20.45±6.53] ms, P < 0.05) were prolonged and ejection time ([250.02±24.21] ms vs [272.73±20.51] ms, P < 0.05) was shortened in patients with ASD compared with that in control subjects, resulting in a marked increase of the MPI (0.41±0.07 vs 0.31±0.05, P < 0.05) from normal values; and (3) after transcatheter closure, the RVEDV and RVESV decreased and the RVEF increased markedly and RVMPI decreased markedly. Conclusions: Transcatheter closure of ASD results in rapid normalization of RV volume overload and improvement of RV function. (ECHOCARDIOGRAPHY, Volume 26, November 2009)