Qi-Ling Cao

Catheter closure of perimembranous ventricular septal defects using the new Amplatzer membranous VSD occluder: initial clinical experience.

The surgical closure of membranous ventricular septal defects (VSDs) is associated with morbidity and low mortality. Six patients with VSDs located in the membranous part of the ventricular septum underwent an attempt of catheter closure using a new device specifically designed for the membranous septum. Patients ranged in age from 3.5 to 19 years (median, 10.5 years) and in weight from 15 to 45 kg (median, 29 kg). One patient with associated pulmonary valve stenosis had shortness of breath. The median Qp/Qs ratio was 1.6 (range, 1.1–3) and the median left ventricle end‐diastolic dimension (LVEDD) was 44 mm (range, 38–52 mm). The devices were deployed via the femoral vein using 7–8 Fr sheaths. There was immediate complete closure in all patients. One patient developed trivial aortic regurgitation. There were no other complications. The median fluoroscopy time was 15.5 min (range, 10.3–53.4 min). At 24 hr, all patients were doing well. The median LVEDD decreased to 38 mm (range, 34–47 mm). One patient continued to have trace aortic regurgitation. All patients were discharged home after 24 hr. Transcatheter occlusion of membranous VSDs is safe and effective. Further clinical trials are underway to assess the long‐term safety and results. Cathet Cardiovasc Intervent 2002;56:508–515.

Transcatheter left atrial appendage occlusion with Amplatzer devices to obviate anticoagulation in patients with atrial fibrillation

It is assumed that over 90% of clinically apparent embolisms in atrial fibrillation originate from the left atrial appendage. Recently, a percutaneous method (PLAATO technique) to occlude the left atrial appendage to the end of preventing thromboembolic complications of atrial fibrillation has been introduced into clinical practice. This technique is quite intricate and requires general anesthesia. The Amplatzer atrial septal occluder lends itself for a more simple approach to this intervention. The first 16 patients treated at four centers are described. Their age varied from 58 to 83 years. All suffered from atrial fibrillation but eight of them were in sinus rhythm at the time of implantation. All but two procedures were done under local anesthesia of the groin only. There was one technical failure (device embolization) requiring surgery. All other patients left the hospital a day after the procedure without complications. There were no problems or embolic events during an overall follow‐up of 5 patient‐years and all left atrial appendages were completely occluded without evidence of thrombosis at the atrial side of the device at the latest follow‐up echocardiography. With the Amplatzer technique, the left atrial appendage can be percutaneously occluded with a venous puncture under local anesthesia, without echocardiographic guidance, and at a reasonable risk. It remains to be evaluated in larger series or randomized trials how the simpler Amplatzer technique compares with the complex PLAATO technique, and whether left atrial appendage closure is competitive with oral anticoagulation with warfarin or the novel ximelagatran to prevent thromboembolism in atrial fibrillation. Catheter Cardiovasc Interv 2003;60:417–422.

Transcatheter closure of single muscular ventricular septal defects using the Amplatzer muscular VSD occluder : Initial results and technical considerations

Surgical closure of multiple muscular ventricular septal defects (MVSDs) is associated with mortality and morbidity; therefore, both surgeons and cardiologists welcome a nonsurgical safe approach. We report our initial results of catheter closure of MVSD using the new Amplatzer muscular VSD occluder delivered via the venous or arterial routes. Eight patients with MVSD underwent closure of their VSDs using the Amplatzer VSD occluder under general endotracheal anesthesia. The mean ± SD of age was 5.4 ± 3.1 years (2–10 years) and mean weight was 18.4 ± 6.5 kg (11.5–29 kg). All patients had left ventricular volume overload with mean Qp/Qs ratio of 1.7 ± 0.6 (1.4–3). The location of the VSD was mid muscular in four, anterior in two, apical in one, and posterior in one. The systolic pulmonary artery pressure ranged from 25 to 85 mm Hg (mean, 39.9 ± 18.8 mm Hg). The device was implanted successfully in all eight patients. In five patients (four mid muscular and one apical), the deployment of the device was anterograde from the right internal jugular vein and in three patients (two anterior and one posterior VSD), the initial attempt at anterograde deployment was unsuccessful due to kinking in the delivery sheath; therefore, retrograde deployment was attempted successfully. The size of the device used ranged from 6 to 14 mm (the size of the connecting waist). In patients with elevated pulmonary artery pressure, repeat measurements immediately after closure revealed normalization in all. There was immediate complete closure of the defect in two patients and six patients had trivial residual shunt (foaming through the device), which disappeared completely within 24 hr in five and at 6‐month follow‐up in the sixth patient. The mean fluoroscopy time was 37.1 ± 13 min (11.7–55 min). Complications encountered included transient junctional rhythm in one patient. No blood transfusion was required. On follow‐up evaluation, there has been no episode of endocarditis, thromboembolism, hemolysis, or wire disruption. we conclude that the Amplatzer MVSD occluder is a safe and effective device for closure of MVSDs up to 12 mm in diameter. Further clinical trials with this device are underway. Cathet. Cardiovasc. Intervent. 49:167–172, 2000.

Perventricular device closure of muscular ventricular septal defects on the beating heart: technique and results

OBJECTIVE Both surgical management and percutaneous device closure of muscular ventricular septal defects have drawbacks and limitations. This report describes our initial experience with intraoperative device closure of muscular ventricular septal defects without cardiopulmonary bypass in 6 consecutive patients. METHODS A median sternotomy or a subxiphoid minimally invasive incision was performed. Under continuous transesophageal echocardiographic guidance, the right ventricle free wall was punctured, and a wire was introduced across the largest defect. The Amplatzer (AGA Medical Corporation, Golden Valley, Minn) muscular ventricular septal defect occluding device (a self-expandable double-disk device) was used. An introducer sheath was fed over the wire, with the sheath tip positioned in the left ventricle cavity. The device was then advanced inside the sheath and deployed by retracting the sheath. Associated cardiac lesions, if any, can then be repaired during cardiopulmonary bypass. A similar technique can also be applied for periatrial closure of complex atrial septal defects. RESULTS The initial 6 patients are presented. Cardiopulmonary bypass was not needed in any patient for placement of the device and needed in 4 patients for repair of concomitant malformations only (double-outlet right ventricle, aortic arch hypoplasia, pulmonary artery band removal). No complications from using this technique occurred. Discharge echocardiograms showed no significant shunting across the ventricular septum. CONCLUSIONS Perventricular closure of multiple muscular ventricular septal defects is safe and effective. We believe that this could become the treatment of choice for any infant with muscular ventricular septal defects or any child with muscular ventricular septal defect and associated cardiac defects.

Transcatheter closure of perimembranous ventricular septal defects using the amplatzer membranous VSD occluder: Immediate and midterm results of an international registry

Objective: To report the immediate and midterm results of transcatheter closure of perimembranous ventricular septal defect (PmVSD) using the Amplatzer membranous VSD occluder (AMVSD). Methods: Between April 2002 and August 2004, 100 patients underwent an attempt of percutaneous device closure of PmVSD using the AMVSD in 24 international centers. The median age was 9.0 years (0.7–58 years) and the median weight was 27.5 kg (7–121 kg). Results: A device was successfully deployed in 93/100 (93%) patients. Reasons for procedural failure were an increased gradient across the left ventricle outflow tract in one patient, aortic regurgitation in 2 patients, and inability to securely position the device in 4 patients. The median VSD size by TEE was 7.0 mm (1.5–13 mm), median device size 10 mm (4–16 mm) and median fluoroscopy time 22.1 min (8.9–96.0 min). Weight below 10 kg (P = 0.0392), inlet extension of the VSD (P = 0.0139) and aortic cusp prolapse into the VSD (P = 0.0084) were significantly associated with a lower procedural success. Patients have been followed up for a median of 182 days (1–763 days). There were no procedure‐related deaths. Complications were encountered in 29/100 (29%) patients, including rhythm or conduction anomalies in 13 patients (two with complete heart block requiring permanent pacemaker implantation), new or increased aortic (9 patients) or tricuspid (9 patients) regurgitation, most of which were classified as trivial or mild. Patients with a weight below 10 kg had a significantly higher incidence of adverse events than patients with a weight above 10 kg (58.3% versus 25.0%, P = 0.0285). Immediately after device release complete closure of the defect was present in 54/93 (58.1%) patients, increasing to 46/55 (83.6%) patients at 6‐months follow‐up (P = 0.0012). Left ventricle end‐diastolic diameter decreased from a median of 44 mm prior to device closure to a median of 39 mm at 6‐months postprocedure (P = 0.0015). Conclusion: Closure of PmVSDs using the AMVSD occluder is safe and effective. However, longer follow‐up period is warranted prior to the wide spread use of this device.

Multicenter Experience with Perventricular Device Closure of Muscular Ventricular Septal Defects

Hybrid procedures are becoming increasingly important, especially in the management of congenital heart lesions for which there are no ideal surgical or interventional options. This report describes a multicenter experience with perventricular muscular venticular septal defect (VSD) device closure.Three groups of patients (n = 12) were identified: infants with isolated muscular VSDs (n = 2), neonates with aortic coarctation and muscular VSDs (n = 3) or patients with muscular VSDs and other complex cardiac lesions (n = 2), and patients with muscular VSDs and pulmonary artery bands (n = 5). Via a sternotomy or a subxyphoid approach, the right ventricle (RV) free wall was punctured under transesophageal echocardiography guidance. A guidewire was introduced across the largest defect. A short delivery sheath was positioned in the left ventricle cavity. An Amplatzer muscular VSD occluding device was deployed across the VSD. Cardiopulmonary bypass was needed only for repair of concomitant lesions, such as double-outlet right ventricle, aortic coarctation, or pulmonary artery band removal. No complications were encountered using this technique. Discharge echocardiograms showed either mild or no significant shunting across the ventricular septum. At a median follow-up of 12 months, all patients were asymptomatic and 2 patients had mild residual ventricular level shunts. Perventricular closure of muscular VSDs is safe and effective for a variety of patients with muscular VSDs.

Transcatheter pulmonary valve implantation using the edwards SAPIEN™ transcatheter heart valve†

Conduits placed in the right ventricular outflow tract (RVOT) have limited longevity which often requires increasingly complex reoperations. Transcatheter pulmonary valve implantation improves conduit hemodynamics through a minimally invasive approach. We present data for 7 patients treated with the Edwards SAPIEN™ transcatheter heart valve (THV).

Early ECG Abnormalities Associated with Transcatheter Closure of Atrial Septal Defects Using the Amplatzer® Septal Occluder

AbstractConduction abnormalities and arrhythmias may occur in patients following secundum atrial septal defect (ASD) closure using the Amplatzer® septal occluder (ASO). Therefore, the aim of this study was to prospectively perform ambulatory ECG monitoring to assess the electrocardiographic effects of transcatheter closure (TCC) of ASD using the ASO device.From 5/97 to 3/99, 41 patients with secundum ASD, underwent TCC using the ASO device at a median age of 9.2[emsp4 ]y. (0.5–87[emsp4 ]y.) and median weight of 34[emsp4 ]kg (5.6–88[emsp4 ]kg.). Ambulatory Holter monitoring was performed pre- and immediately post TCC. Holter analysis included heart rate (HR), ECG intervals, supraventricular ectopy (SVE), ventricular ectopy (VE), and AV block.No change in baseline rhythm was noted in 37 patients (90%). Changes in AV conduction occurred in 3 patients (7%), including intermittent second degree AV block type II, and complete AV dissociation post closure. SVE was noted in 26 patients (63%) post closure, ranging from 5–2207 supraventricular premature beats (SVPB), including 9 patients (23%) with non-sustained supraventricular tachycardia (SVT), 3 of whom had short runs of SVT prior to closure. A significant increase in post-closure number of SVPB per hour (p=0.047) was noted. No significant difference was noted in PR interval, ventricular premature beats per hour, or QRS duration. Conclusions: Based on ambulatory ECG analysis, TCC of ASD with the ASO device is associated with an acute increase in SVE and a small risk of AV conduction abnormalities, including complete heart block. Long term follow-up studies will be necessary to determine late arrhythmia prevalence and relative frequency compared with standard surgical ASD repair.

Measurement of Atrial Septal Defect Size: A Comparative Study Between Three-Dimensional Transesophageal Echocardiography and the Standard Balloon Sizing Methods

Abstract. Atrial septal defect (ASD) size measurement is of paramount importance for the successful deployment of a transcatheter septal occluder. The stretched balloon diameter (SBD) has long been regarded as the gold standard for selection of the size of any device. Three-dimensional (3-D) transesophageal echocardiography (TEE) can visualize the overall structure of the atrial septum, therefore rendering an accurate size of the ASD. In this study we aimed to validate the accuracy of ASD size measurement by 3-D TEE and to elucidate the reason for the difference between balloon sizing and 3-D measurement. Forty-one consecutive patients were enrolled in this protocol for ASD device closure using the Amplatzer septal occluder. Thirty-nine patients were diagnosed by 2-D transthoracic echocardiography as secundum ASD and 2 patients were diagnosed as patent foramen ovale. Two measurements of the balloon size were sequentially obtained by 2-D TEE after the balloon was fully inflated in the left atrium. First, no residual shunt across the septum could be seen while the balloon was pulled back against the septum. This measurement was called the balloon occlusive diameter (BOD). Second, with balloon deflation, a slight deformity of the balloon was seen just prior to its popping through the septum. This measurement was called the stretched balloon diameter (SBD). Three-dimensional TEE was performed in all patients at the beginning of the procedure before device deployment and within 15 minutes after device release. Three-dimensional TEE provided superior views of the ASDs, showing the spatial relationship between the ASD and the neighboring structures. For maximal ASD size measurement, balloon sizing was larger than 3-D TEE examination, whereas 2-D was smaller than the other two methods. The best correlation was found between 3-D TEE measurements and the BOD (r= 0.98, p < 0.0001). Three-dimensional TEE provides en face view of ASD; thus, it can accurately measure the size of ASD. Three-dimensional TEE measurement of ASD can be used instead of balloon sizing for the selection of transcatheter ASD occluder size.

Long-term outcome of transcatheter coil closure of small to large patent ductus arteriosus.

Coil closure of patent ductus arteriosus (PDA) has become an accepted alternative to surgical closure in most pediatric cardiac centers. However, little is known about the mid‐ to long‐term outcome of this procedure. Therefore, we evaluated the immediate, short‐, and long‐term outcome of transcatheter coil closure (TCC) of PDA using single or multiple Gianturco coils or the Gianturco‐Grifka Vascular Occlusive Device (GGVOD). One hundred forty‐nine patients underwent an attempt at TCC of their PDAs at a median age of 2.4 years (2 weeks to 55 years) and median weight of 13.5 kg (2.3–87 kg). There were 33 patients < 1 year of age. The median PDA minimal diameter was 2 mm (0.4–7 mm) with 26 patients whose PDA minimal diameter was > 4 mm. A 4 Fr catheter was used for coil deployment in 136 patients, a 3 Fr in 4, and an 8 Fr in 4 patients who received the GGVOD. A single coil was used in 77 patients and multiple coils (2–6) were used in 66 patients. One hundred forty‐six patients had successful closure (142 had immediate complete closure and 4 had residual shunt), 3 patients failed the initial attempt (2 underwent surgical ligation and 1 had a successful second attempt a year later). Of the four patients with residual shunt, three underwent a second procedure with implantation of 1–3 coils resulting in complete closure in all and one patient had spontaneous resolution of the residual shunt. Complications were encountered in nine patients: six had coil migration with successful retrieval in four; two had left pulmonary artery stenosis (2.4 kg and 6.3 kg infants), and one patient had loss of femoral arterial pulse. The median fluoroscopy time was 16 min (2–152 min). One hundred forty‐two patients had the procedure as an outpatient, five patients stayed greater than 24 hr, and two of these patients were in hospital for 1 month for noncardiac reasons. At a median follow‐up interval of 3.0 years (1 month to 5.1 years), there were no episodes of delayed coil migration, delayed recanalization, thromboembolic episodes, or bacterial endocarditis. Lung perfusion scans performed at a median follow‐up interval of 1.6 years in 31 patients who received multiple coils revealed 45% ± 5% blood flow to the left lung. Long‐term follow‐up of coil closure of PDA indicates that the technique is safe and effective for most pa‐tients with PDA up to a diameter of 7 mm. Cathet. Cardiovasc. Intervent. 47:457–461, 1999.