Transcatheter Occlusion of Patent Ductus Arteriosus With a New Detachable Coil System (DuctOcclud)

Transcription

1 Jpn Circ J 1998; 62: Transcatheter Occlusion of Patent Ductus Arteriosus With a New Detachable Coil System (DuctOcclud) a Multicenter Clinical Trial Shinichi Oho, MD; Akira Ishizawa, MD; Kazuyuki Koike, MD*; Toshiki Kobayashi, MD*; Toshio Nakanishi, MD**; Kazuo Momma, MD**; Toshihiro Ino, MD***; Kei Nishimoto, MD***; Mataichi Ohkubo, MD***; Yasuo Ono, MD****; Tetsuro Kamiya, MD****; Teiji Akagi, MD*****; Hirohisa Kato, MD***** A multicenter clinical trial of DuctOcclud, a new detachable coil for transcatheter occlusion of patent ductus arteriosus (PDA), was conducted. DuctOcclud was used in 35 patients (12 male and 23 female) for transcatheter occlusion of PDA between January, 1996, and April, The age of the patients ranged from 0.5 to 27.2 years (median 7.6years) and weight from 6.3 to 70.0kg (median 23.0kg). The smallest diameter of PDA was 2.0±0.7 mm (range mm). Pulmonary-systemic flow ratio (Qp/Qs) was 1.3±0.3 (range ). The coils were successfully implanted in 32 (91%) patients. Of 31 patients who were followed 6 months after the procedure, 26 (84%) had no residual shunt and 5 (16%) had trivial residual shunt. One patient had infective endocarditis 1 month after the procedure but recovered completely. There were no incidences of coil embolization, hemolysis, late coil migration, or pulmonary artery stenosis. We conclude that DuctOcclud is a safe and effective device of transcatheter occlusion of PDA. (Jpn Circ J 1998; 62: ) Key Words: Patent ductus arteriosus; Transcatheter occlusion: Detachable coil; DuctOcclud Closure of patent ductus arteriosus (PDA) soon after diagnosis is recommended, as congestive heart failure with or without pulmonary hypertension can result from moderate to large PDA, and an increased risk of infective endocarditis from small PDA. 1 3 Although surgical closure of PDA is safe and effective, several devices for transcatheter occlusion of PDA have been developed. Porstmann et al 4 described the first non-surgical closure of PDA in The technique did not gain wide popularity, however, as it requires a very large arterial sheath. Only a few institutes in Japan perform the procedure, mainly on larger patients. The Rashkind PDA occluder was once widely used, 5 8 but it too requires a large sheath, seems to have a relatively high rate of residual shunt (17 30%), and may cause pulmonary artery stenosis, especially in small children. The device is not available in the United States because of concerns about fracture of the arm. 9 Its use is not yet allowed in Japan, although clinical (Received November 10, 1997; revised manuscript received February 9, 1998; accepted February 19, 1998) Division of Cardiology, National Children s Hospital, Tokyo, Japan, *Division of Pediatric Cardiology, Saitama Heart Institute, Saitama Medical School, Saitama, Japan **Department of Pediatric Cardiology, Heart Institute of Japan, Tokyo Women s Medical College, Tokyo, Japan ***Department of Pediatrics, Juntendo University School of Medicine, Tokyo, Japan ****Department of Pediatrics, National Cardiovascular Center, Osaka, Japan *****Department of Pediatrics, Kurume University School of Medicine, Kurume, Japan Mailing address: Shinichi Oho, MD, Division of Cardiology, National Children s Hospital, Taishido, Setagaya-ku, Tokyo 154, Japan trials have been completed. Other methods, such as the use of a buttoned device, 10 the Botallo occluder, 11 or the Gianturco Grifka vascular occlusion device, 12 are not widely used. Gianturco coils have been used to occlude PDA since the early 1990s, but embolization of the coil is likely to occur because it does not have a detachable mechanism The Cook detachable coil reduces the risk of embolization and is being used increasingly in Europe and Japan. 18,19 However, clinical trials of the Cook detachable coil have not yet been carried out in Japan. The DuctOcclud (PFM, Germany) is a new detachable coil for occlusion of PDA developed by Dr Redel at the University of Bonn in Germany. 20 It is hourglass shaped and has a unique snap-on detachable mechanism that is different from the Cook detachable coil. The coil has been implanted in more than 400 patients in Europe and other parts of the world Methods Patients DuctOcclud was used in 35 patients (12 male and 23 female) for transcatheter occlusion of PDA between January, 1996, and April, 1997, at 6participant institutes (Table1). The age of the patients ranged from 0.5 to 27.2 years (median 7.6 years) and weight from 6.3 to 70.0 kg (median 23.0 kg). In 2 patients (patients 9 and 10) PDA was associated with Down syndrome, 3patients had associated cardiac lesions, 1 had a ventricular septal defect (patient 32), 1 an aortic stenosis (patient15), and 1 a pulmonary artery stenosis associated with congenital rubella syndrome (patient 8). Two patients underwent reparative

2 490 OHO S et al. Table 1 Summary of Patient Characteristics and Results Patient Age Weight No. (years) (kg) Minimal diameter (mm) PDA shape Qp/Qs Coil implantation Size of coil distal prox. (mm) Funnel mm 5 mm Aneurysm mm 6 mm Funnel mm 5 mm Aneurysm mm 6 mm Funnel mm 5 mm Funnel mm 5 mm Aneurysm mm 6 mm Funnel mm 5 mm Funnel mm 5 mm Funnel mm 5 mm Funnel mm 5 mm Funnel mm 5 mm. 6 mm 5 mm Funnel mm 6 mm, 6 mm 5 mm Hourglass mm 4 mm Funnel mm 5 mm Funnel mm 6 mm. 6 mm 5 mm Funnel mm 5 mm Funnel mm 5 mm Funnel mm 5 mm Funnel mm 6 mm. 7 mm 5 mm Funnel mm 6 mm Funnel mm 6 mm, 6 mm 5 mm Funnel mm 5 mm Tubular mm 4 mm Funnel mm 6 mm Tubular mm 4 mm Funnel mm 6 mm Funnel mm 6 mm +* Hourglass mm 6 mm, 7 mm 6 mm Funnel mm 6 mm Funnel mm 5 mm Funnel 2.2** + 5 mm 4 mm Funnel Tubular mm 6 mm Funnel 1.6 *Underwent subsequent occlusion adding another brand of coil and excluded from the follow-up protocol. **Also had ventricular septal defect. Residual shunt surgery: 1 for atrial septal defect (ASD) (patient 24) and 1 for total anomalous pulmonary venous return (patient 26). Thirty patients (85.7%) were asymptomatic, 5 patients had a history of recurrent respiratory infection, 2 patients had failure to thrive. Twenty-eight patients (80.0%) had continuous murmur, 6 patients (17.1%) had systolic murmur, and 1 patient with postoperative ASD had no murmur. Patients with a PDA with a minimum diameter of more than 3.5mm or with elevated pulmonary vascular resistance (Rp/Rs >0.3) were excluded. The study protocol was approved by the Institutional Review Boards of all the participating centers, and informed written consent was obtained in all cases from the patient or parent. Device The DuctOcclud spiral coil is in the shape of a double cone coil, has shape memory, and is made of inch stainless-steel wire (Fig1). A number of coil configurations are available. The configuration of the coil is defined by the diameter of the distal cone and of the proximal cone and by the configured length (Fig 2). The coil is mounted in a straightened profile on the distal end of a core wire to which it is secured by a snap-on mechanism and a circumferential groove. The proximal end of the core wire is covered by a pusher, a movable hollow wire that pushes the coil off the core wire. As the coil is pushed off the end of the core wire, it takes on an hourglass shape and is detached from the core wire. Before final release of the coil, it can be completely retrieved. The coil assembly is connected to the specially designed handle (OccluGrip, PFM), which is used for configuration and final release of the coil (Fig 3). A coil of the appropriate size for the dimensions of the PDA is selected from a range of sizes where the distal cone of the coil is 1 2 mm greater than the diameter of the aortic ampulla, and the length of the configured coil is at least 10% shorter than the length of the PDA (Fig 4). Procedure Procedures were performed under general anesthesia or deep sedation. Appropriate sheaths were placed in the femoral vein and artery, and routine right- and left-sided cardiac catheterization was performed. After descending aortography (Fig 5A), a coil of appropriate size was selected. A 4F delivery catheter (OccluCath, PFM) was placed in the descending aorta through the PDA in an anterograde manner. If it was not possible to pass the guide wire through the PDA from the venous side, an arteriovenous loop of the guide wire was formed by passing the guide

3 Coil Occlusion of Patent Ductus Arteriosus wire into the pulmonary artery from the descending aorta. The delivery catheter was then advanced over the loop into the descending aorta. The coil assembly was connected to the handle and advanced to the tip of the delivery catheter. As the pusher carriage of the handle was slid forward, the core wire was withdrawn inside the catheter. The coil assembly was pushed through the catheter until the second or third loops of the coil were configured in the descending aorta (Fig 5B). The coil assembly and the catheter were retracted, and the configured loops were positioned in the aortic ampulla. Most of the remaining loops of the coil were configured in the PDA with about 1loop of the coil remaining on the pulmonary artery side (Fig5C). Two coils were implanted simultaneously from the pulmonary side and the aortic side when one coil was easily pulled through into the pulmonary artery. An aortogram was performed to confirm the optimal position. The position or size of the coil can be totally retrieved and repositioned or exchanged if the placement is not optimal. The coil was released from the retrieval mechanism by sliding the pusher carriage towards the tip of the handle when the coil was the proper size and in a good position. A final aortogram was performed about 10min later to document the position of the coil and the occlusion of the PDA (Fig 5D). A few doses of antibiotics were given to all patients before and after implantation. Echocardiography and chest radiography were performed before discharge. Patients underwent physical examination, chest radiography, electrocardiography, and echocardiography 1, 3, and 6 months after the procedure. Prophylaxis with antibiotics against infective endocarditis was recommended for 6 months after successful occlusion. Fig 1. shape. 491 Long-axis view of the configured coil showing the hourglass D P L L P D (mm) Fig 2. Coil specifications. D, distal diameter; P, proximal diameter; L, configured length. Statistical Analysis Data are expressed as means±sd or median and range. Differences between the 2groups were analyzed with the Mann-Whitney U test. Differences between variables in different categories were calculated using the chi-square test. A p value 0.05 was considered to be statistically significant. Results Data are listed in Table1. The minimum diameter of the PDA that we treated was 2.0±0.7mm (range mm). Twenty-six patients had funnel-type PDA, 4 had the tubular type, 3 had the aneurysm type, and 2 had the hourglass type. Pulmonary-systemic flow ratio (Qp/Qs) was 1.3±0.3 (range ). The DuctOcclud coil was successfully implanted in 32 of 35patients (91%). One coil was sufficient in 26patients, but 2coils were necessary in 6patients. The minimum diameter of PDA in the patients who could not have the coil implanted was greater than 2mm. In 2 patients (patients 33 and 35), even the largest coil was pulled through into the pulmonary artery and the procedure had to be abandoned. In 1patient (patient34), almost all the loops of the coil except for 2 or 3 protruded into the main pulmonary artery several minutes after the coil was released. The DuctOcclud coil was retrieved with a snare wire and the PDA was occluded with another brand of coil. Of those who had the coil implanted, complete occlusion was achieved in 11 patients (34%) just after the procedure. One patient (patient 28), who had residual shunt immediately after the procedure and underwent subsequent occlusion adding another brand of coil in the same catheteriza- OccluGrip. 1, safety ring; 2, pusher carriage; 3, core wire car- Fig 3. riage. Pul. 1 PDA Ao L3 0 2 Fig4. Measurement of PDA dimensions. 0, axis of PDA; 1, minimum diameter of PDA; 2, diameter of the aortic ampulla; L3, length of PDA.

4 492 OHO S et al. Fig 5. Implantation procedures. (A) Lateral view of descending aortogram. The dimensions of PDA were measured. (B) The distal loops of the coil were configured in the descending aorta. (C) Most of the loops of the coil were configured in PDA and about 2loops on the pulmonary artery side. The coil was not detached. (D) The descending aortogram after detachment of the coil. % min 48 hrs months Fig 6. The occlusion rate at follow-up. tion, was excluded from the follow-up protocol. Twentytwo patients (71%) had complete occlusion within 48 h, 25 (81%) at 1 month, and 26 (84%) at 6 months (Fig 6). All residual shunts seen in 5patients were trivial. The minimum PDA diameter was significantly larger in patients with residual shunt than in those without (2.6±0.5 mm vs 1.8±0.6 mm, p<0.01). Other factors such as age, weight, the diameter of the aortic ampulla, the length of the PDA and Qp/Qs were not significantly different between the patients with and without residual shunt. All 17patients with a minimum PDA diameter of less than 2 mm had the coil successfully implanted and had no residual shunt. Of 18patients who had PDA with a minimum diameter greater than 2mm, 3 patients (17%) failed the coil implantation and 5patients (36%) had a residual shunt (p<0.01). No deaths or other serious complications occurred. Patient 18 had infective endocarditis 1 month after the procedure, but recovered completely. No embolization of the coil occurred. The coil was detached unintentionally at the final stage of implantation in patient 16, but it did not migrate and stayed in a good position. There were no arterial or venous complications, or clinical evidence of hemolysis. There were no patients with late coil migration or significant pulmonary artery stenosis. Discussion The implantation rate of the DuctOcclud coil was 100% in PDAs with a minimum diameter less than 2 mm. It was more difficult and time consuming to implant the coil into PDAs with a minimum diameter greater than 2 mm, with an implantation ratio of 83%. The complete occlusion rate was 84% at 6 months and slightly lower than those with DuctOcclud in previous reports (91% at 24 h 22 and 97% at 1 year 23 ). Although all PDAs with a minimum diameter of less than 2mm were completely occluded, 36% of patients with PDAs greater than 2mm had residual shunt. The residual shunt was significantly related to the size of the PDA. To increase the implantation ratio and the occlusion rate of PDAs greater than 2mm, some modification of the coil is necessary. A new modified coil that is stiffer and has a larger diameter but shorter configured length has been developed recently. Use of the modified coil may increase the implantation rate for larger PDAs. No serious adverse effects occurred, although there were a few complications. One patient (patient 18) had infective endocarditis 1 month after the procedure but recovered with

5 Coil Occlusion of Patent Ductus Arteriosus antibiotic therapy. This patient was given antibiotics during and after the procedure according to the protocol and had complete occlusion soon after the implantation. The cause of the endocarditis and its relation to the procedure in this patient was uncertain. No embolization of the coil occurred in any patient, but in patient34 most of the loops of the coil protruded into the pulmonary artery after detachment of the coil. The coil was retrieved and the patient underwent another coil occlusion. The coil was detached unintentionally just before release of the coil in patient16, but it did not migrate. These cases could have resulted in embolization. Embolization of the DuctOcclud coil has been reported. 22,23 As embolization may occur even when using the detachable coil, careful manipulation is important and attention should be paid to embolization after detachment of the coil. Apparent hemolysis was not observed in this trial nor in another study. 23 Hemolysis related to incomplete occlusion with a Gianturco coil or a Cook detachable coil has been reported. 24,25 It is unclear why hemolysis is uncommon shortly after implantation, despite the relatively high incidence of residual shunt. Thrombi adhering to the unfibered surface of DuctOcclud coil are finer than those adhering to fibered coils (personal communication), which may decrease the risk of hemolysis with residual shunt. There were no cases of left pulmonary artery stenosis. Although the low profile and unfibered wire of the coil may be less likely to cause narrowing of the vessel, the number of loops in the coil that remain in the pulmonary artery should be less than 1. Conclusion Thirty-five patients underwent transcatheter occlusion of PDA using the DuctOcclud coil with an implantation rate of 91% and occlusion rate of 84%. 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