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J Am Coll Cardiol, 2002; 39:1836-1844 © 2002 by the American College of Cardiology Foundation |
* Section of Pediatric Cardiology, Department of Pediatrics, University of Chicago Children’s Hospital and Pritzker School of Medicine, Chicago, Illinois, USA
Nemours Cardiac Center, Orlando, Florida, USA
Pediatric Cardiology, University of California San Francisco, San Francisco, California, USA
¶ University of Minnesota, School of Medicine, Minneapolis, Minnesota, USA
* Reprint requests and correspondence: Dr. Ziyad M. Hijazi, Section of Pediatric Cardiology, University of Chicago Children’s Hospital, 5841 S. Maryland Avenue, MC 4051, Chicago, Illinois 60637, USA.
zhijazi{at}peds.bsd.uchicago.edu
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Abstract |
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 Top Abstract MethodsResultsDiscussionAppendix IAppendix IIReferences |
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BACKGROUND: The clinical utility of a device such as the ASO can only be judged against the results of contemporaneous surgery.
METHODS: A multicenter, nonrandomized concurrent study was performed in 29 pediatric cardiology centers from March 1998 to March 2000. The patients were assigned to either the device or surgical closure group according to the patients’ option. Baseline physical exams and echocardiography were performed preprocedure and at follow-up (6 and 12 months for device group, 12 months for surgical group).
RESULTS: A total of 442 patients were in the group undergoing device closure, whereas 154 patients were in the surgical group. The median age was 9.8 years for the device group and 4.1 years for the surgical group (p < 0.001). In the device group, 395 (89.4%) patients had a single ASD; in the surgical group, 124 (80.5%) (p = 0.008) had a single ASD. The size of the primary ASD was 13.3 ± 5.4 mm for the device group and 14.2 ± 6.3 mm for the surgery group (p = 0.099). The procedural attempt success rate was 95.7% for the device group and 100% for the surgical group (p = 0.006). The early, primary and secondary efficacy success rates were 94.8%, 98.5% and 91.6%, respectively, for the device group, and 96.1%, 100% and 89.0% for the surgical group (all p > 0.05). The complication rate was 7.2% for the device group and 24.0% for the surgical group (p < 0.001). The mean length of hospital stay was 1.0 ± 0.3 day for the device group and 3.4 ± 1.2 days for the surgical group (p < 0.001). Mortality was 0% for both groups.
CONCLUSIONS: The early, primary and secondary efficacy success rates for surgical versus. device closure of ASD were not statistically different; however, the complication rate was lower and the length of hospital stay was shorter for device closure than for surgical repair. Appropriate patient selection is an important factor for successful device closure. Transcatheter closure of secundum ASD using the ASO is a safe and effective alternative to surgical repair.
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Methods |
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TopAbstractMethodsResultsDiscussionAppendix IAppendix IIReferences |
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Patients were enrolled into device or surgical closure group. The inclusion criteria for both groups included: 1) the presence of a secundum ASD (diameter of 
38 mm by echocardiography for the device group; no limit for the surgical group); 2) a left-to-right shunt with a Qp/Qs ratio of 
1.5:1 or the presence of right ventricular volume overload: and 3) patients with minimal shunt in the presence of symptoms (arrhythmias, transient ischemic attacks). Additional inclusion criteria for the device group required the presence of a distance of >5 mm from the margins of the ASD to the coronary sinus, atrioventricular valves and right upper pulmonary vein as measured by echocardiography. Exclusion criteria for both groups included: 1) the presence of associated congenital cardiac anomalies requiring surgical repair; 2) primum ASD; 3) sinus venosus ASD (including partial anomalous pulmonary venous drainage); 4) pulmonary vascular resistance >7 Woods units; 5) a right-to-left shunt at the atrial level with a peripheral arterial saturation <94%; 6) patients with recent myocardial infarction; and 7) unstable angina and decompensated congestive heart failure and patients with right and/or left ventricular decompensation with ejection fraction of <30%. An additional exclusion criterion for the device group was patients with multiple defects that could not be adequately covered by device(s). Also excluded from the study were patients with: 1) sepsis; 2) history of repeated pulmonary infection; 3) any type of serious infection <1 month before the procedure; 4) malignancy where life expectancy was <2 years; 5) intracardiac thrombi; 6) weight <8 kg; 7) inability to obtain informed consent; and 8) other contraindications to aspirin or other antiplatelet agents.
Once a patient met the enrollment criteria, the patient or the guardian was fully informed of the treatment options, then decided which option they would choose with their cardiologists. Nine participating institutions did not offer device closure during the study period. The collection of data was largely prospective; however, in 21 centers offering device closure, surgical patients were permitted to be enrolled retrospectively as well as prospectively if the surgery was performed after the date the IRB in that institution had approved the device closure protocol. This was done in an effort to expedite enrollment in the surgical arm and to ensure that the surgical data were contemporaneous. Informed consent was obtained from all patients or their guardians.
Device and delivery system. The ASO (AGA Medical Corp., Golden Valley, Minnesota) is a self-centering device made of 0.004 to 0.0075 in Nitinol wire. A full description of the device has been reported previously (12, 13). In brief, the device consists of two expandable round discs with a 4-mm long connecting waist. Polyester mesh was added to the left and right atrial discs and the connecting waist to enhance thrombogenicity. The device size is dictated by the diameter of its waist. The device was available in various sizes ranging from 4 to 38 mm. The two flat discs extend radially beyond the central waist to provide secure anchorage. Both discs are angled slightly towards each other to ensure firm contact with the atrial septum. The delivery system consists of a cable, loader, delivery sheath and dilator and a pin vise. The delivery sheath initially had a platinum marker band at its tip. However, because of embolization of this band in three patients, this marker band has been removed.
Device implantation or surgical procedure. The protocol of device closure has been reported previously in detail (12,13). Briefly, all procedures were performed under general anesthesia with endotracheal intubation and with continuous transesophageal echocardiographic (TEE) monitoring. After percutaneous entry of the femoral vein, a complete hemodynamic evaluation was performed. This was followed by an angiogram in the right upper pulmonary vein in the hepatoclavicular projection to further delineate the atrial septum. A sizing balloon catheter was introduced over an extra-stiff guide wire positioned in the left upper pulmonary vein to measure the balloon stretched diameter. Two methods of sizing (pulling technique and the stationary balloon dilation technique) were followed. The device chosen for closure was within 2 mm of the balloon-stretched diameter. The appropriate size device equivalent to the stretched diameter was then screwed on the cable and advanced inside the proper size sheath (6–14F). The sheath was usually positioned over the guide wire inside the left upper pulmonary vein or in the middle of the left atrium. Under fluoroscopic and TEE guidance, both discs of the device were deployed across the defect. Once the device has been deployed and released, repeat TEE and angiogram were performed to assess the result of closure. A dose of an appropriate antibiotic was given during the procedure and two doses at 8 h interval were given after. Patients were usually observed overnight and discharged home the following day. All patients were instructed about infective endocarditis prophylaxis for a total of six months after device placement. Aspirin 3–5 mg/kg was initiated 48 h before closure and continued for six months after.
For patients who underwent surgical closure, standard ASD repair under general endotracheal anesthesia was performed (2). The right atrium was opened after a sternotomy. The ASD was closed either by direct suture or using a pericardial or Goretex patch (W.L. Gore Associates, Flagstaff, Arizona). Patients were discharged home after three to five days in the hospital, depending on their clinical condition.
Echocardiographic interpretations. Experienced echocardiographers from the participating institutions interpreted all echocardiograms (procedural and follow-up points). A study was classified to have complete closure, trivial residual shunt, small residual shunt, moderate residual shunt or large residual shunt according to a protocol reported by Boutin et al. (9). All of these echocardiograms were sent on SVHS tapes to the data management center at the manufacturing company’s headquarters. Echocardiograms of 108 patients in the device group and 87 patients in the surgical group were reviewed and interpreted by two independent experienced echocardiographers from institutions not participating in the trial. There were no discrepancies between the original interpretation and those of the independent reviewers.
Follow-up and end point measurements. Patients who had device closure underwent a physical examination, an electrocardiogram, a chest radiograph and a transthoracic echocardiogram (TTE) with color Doppler at 24 h, six months and one year after the procedure. Patients who had surgical closure underwent the same tests at discharge from the hospital and at one-year follow-up.
Patients were considered to have successful ASD closure if they had no, trivial (<1-mm color jet width) or small (color jet width 1 to 2 mm) residual shunt as assessed by color Doppler echocardiography. Patients with moderate (color jet width >2–4 mm) or large (color jet width >4 mm) residual shunts were considered to have a failed procedure. End point measures for clinical utility were: 1) early efficacy success: successful closure of the defects by a device or operation without major complication, surgical reintervention, embolization or moderate or large residual shunt at discharge from hospital; 2) primary efficacy success (12-month success): successful closure of the ASD within 12 months postprocedure without the need for surgical repair; and 3) secondary efficacy success: successful device or surgical attempt in the absence of a major complication, or a surgical reintervention within the study period (March 1998 to March 2000).
Safety was defined as the absence of death or major complications, by a monitoring board at the manufacturer’s headquarters that was organized to classify the events as major and minor complications. Major complications included cerebral embolism, cardiac perforation with tamponade, endocarditis, repeat operation, death due to the procedure, cardiac arrhythmias requiring permanent pacemaker placement or long-term antiarrhythmic medication, or device embolization requiring immediate surgical removal. Minor complications included device embolization with percutaneous retrieval, cardiac arrhythmia with treatment, phrenic nerve injury, access site hematoma, other vascular access site complications, retroperitoneal hematoma, surgical wound complications and other procedural complications, as listed in the protocol. Pericardial effusion requiring medical management, evidence of device-associated thrombus formation without embolization (with or without treatment) and marker band embolization without known sequelae are also considered as minor complications.
Sample size and data analysis. Sample size estimates were based on published statistics formulae (16). Previous studies have demonstrated rates of device and surgical closure to be between 90% and 98% (2,12,13). Therefore, 106 patients per study arm would be needed to provide an 80% probability of finding a significant difference using a one-tailed test at the 0.05 level. With an increase of 15% to allow for possible attrition, 125 patients in each study arm were required to yield a power over 80%.
Comparability of the retrospective and prospective surgical patients was performed before pooling the data for comparisons to the device group (in order to ascertain that there were no systematic differences between these two groups). Binary data were analyzed using Fisher’s exact test. Comparisons of continuous data measured at baseline for the study groups were analyzed using Welch’s modified t test, assuming the possibility of unequal variances. Mann-Whitney U test was used to compare the age between two groups because it was not normally distributed. Cox proportional hazards regression models were computed for the device and surgical group. Covariate analysis was used to find potential risks for complication. Confidence intervals (CI) were calculated as appropriate. SPSS 10.0 for Windows (SPSS Inc., Chicago, Illinois) was used for the analysis. Data are expressed as mean ± SD or median and range as appropriate. A value of <0.05 was considered statistically significant.
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Results |
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TopAbstractMethodsResultsDiscussionAppendix IAppendix IIReferences |
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The mean balloon stretched diameter of the primary ASD was 17.8 ± 6.2 mm (range 6 to 40 mm) and of the secondary ASD was 8.7 ± 1.4 mm (range 5 to 23 mm). The mean Qp/Qs ratio was 2.1 ± 0.8 (range 0.7 to 7.7). Of the 441 patients in whom data described the direction of atrial shunting, 404 (91.6%) had a left-to-right shunt, 34 (7.7%) had a bidirectional shunt and 3 (0.7%) had a right-to-left shunt. The mean device size for the primary ASD was 18.1 ± 6.1 mm (range 6 to 38 mm) and 10.4 ± 4.2 mm (range 6 to 20 mm) for the secondary ASD. The mean fluoroscopy time was 20.7 ± 12.8 min (range 3.3 to 75.5 min). A total of 413 patients (97.6%) (95% CI 95.7% to 98.9%) had immediate successful closure, including 130 (30.7%) with complete closure, 227 (53.7%) with trivial residual shunt and 56 (13.2%) with small residual shunt. Ten patients (2.4%) had moderate (n = 7) or large (n = 3) residual shunt.
In the surgical closure group, all patients had a successful operation. The comparison of immediate closure results, procedure time and length of hospital stay are demonstrated in Table 2.
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A total of 387 (91.5%) patients in the device group had complete six-month follow-up. Of those, 376 patients had successful closure. Therefore, the success rate at the six-month follow-up was 97.2% (95% CI 95.0% to 98.6%). Eleven patients (2.8%) had moderate (n = 9) or large (n = 2) residual shunt. Because the six-month follow-up was not part of the surgical follow-up protocol, only 19 surgical patients had six-month follow-up data. All had successful closure (one patient had trivial residual shunt) as documented by color Doppler TTE.
At 12-month follow-up, 331 patients from the device group had their evaluation completed. Of those, 326 patients had successful closure. Therefore, the success rate was 98.5% (95% CI 96.5% to 99.5%). Five (1.5%) patients had moderate (n = 4) or large (n = 1) residual shunt. One hundred nine patients from the surgical group completed the 12-month follow-up. Ninety-four had color Doppler TTE examination, and all had a successful closure (four patients had trivial residual and three patients had small residual shunt). Of the remaining 60 patients in the surgical group, five were excluded because of IRB lapse, 14 were confirmed closed at six months by TTE and 41 were assumed closed at the 12-month follow-up. Comparison of clinical outcomes between the two groups is demonstrated in Table 2.
Although closure results at 24-month follow-up was not the end point measure of this study, 52 patients from the device group had their 24-month evaluation. Forty-nine had complete closure, two had small residual shunt and one had moderate residual shunt. Thus the successful closure rate was 98.1%. The five patients with residual shunt (four moderate, one large) at the 12-month follow-up were evaluated at the two-year follow-up. Three of these patients had spontaneous closure of their shunt; one had a second procedure with implantation of a second device had complete closure and one patient still had large residual shunt being followed medically. No data on 24-month follow-up were available for the surgical group.
Comparison of complications. There was no device-or surgical-related death in either group. Table 3 summarizes the complications encountered during the study period. Seven major complications occurred in the device group. Device or marker band embolization requiring surgical removal was the most common complication, which occurred in four patients in three different hospitals. Cardiac arrhythmias requiring major treatment occurred in two patients. Complete atrioventricular block was found at six-month follow-up in a 6-year old girl with an 11-mm ASD and aneurysm of the atrial septum. The patient had sinus rhythm alternating with slow junctional rhythm documented by 24-h ambulatory electrocardiogram before the procedure (17). A DVD Thera DR pacemaker (Medtronic Inc., Minneapolis, Minnesota) was implanted. Atrial fibrillation occurred in an 81-year-old patient requiring antiarrhythmic medication. Cerebral embolism occurred in a 14-year-old girl with a 17-mm ASD. This patient had an episode of numbness and weakness in her right leg, right arm and the right side of her mouth seven days after the procedure. These symptoms resolved completely within 20 min. The patient had a normal neurological evaluation at the six-month follow-up.
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Minor complications occurred in 27 patients in the device group and 29 in the surgical group (p < 0.001) (Table 3). Two embolized devices were successfully retrieved percutaneously in the catheterization laboratory in two patients. The most common minor complication was cardiac arrhythmias in both groups. The incidence of any complications was significantly greater in the surgical group (p < 0.001). Cox proportional hazards regression models also demonstrated that the device group had significantly lower rates of complications (p < 0.001). Adding covariates of age, history of congestive heart failure, failure to thrive and respiratory infection did not change this conclusion. None of the covariates contributed significantly to the Cox regression model. Figure 2 demonstrates the curves of probability of freedom from any complications in the device and surgical groups. All but one patient with complications (major or minor) returned for the one-year follow-up; all were well with no sequelae.
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Discussion |
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TopAbstractMethodsResultsDiscussionAppendix IAppendix IIReferences |
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Comparisons of efficacy and utility. Surgical closure of ASD has been considered the standard treatment for ASD for more than 45 years (2). Although the perioperative mortality in most cardiac surgical centers approaches zero, residual shunting after surgical closure is not rare, and its incidence varies from 2% to 7.9% in the long-term follow-up data (19,20).
In this study, the 12-month follow-up of our 94 surgical patients with color Doppler TTE data indicated no residual shunt in 87 patients. Seven patients had trivial (n = 4) and small (n = 3) residual shunts. Even assuming that all surgical patients had successful closure, the early, primary and secondary efficacy success rates were not significantly higher than in the patients who underwent device closure of their ASDs. This is in accordance with a previous report from a single institution with a large experience in surgical and device closure of ASD (21). Their 61 patients with ASD who underwent closure using the ASO had the same immediate successful closure rate (98%) achieved by open surgical repair. Therefore, our multicenter study confirms that the efficacy and utility of ASO for closing secundum ASD is the same as those of surgical closure.
In our study, 4.3% of patients in the device group had a failed procedural attempt for various reasons. Most of these failures were due to the large size of ASD and the unavailability of larger devices at the time. With the availability of larger devices (>34 mm in diameter), some of those patients could have undergone successful closure of their ASD. The ASO manufacturer has also modified the delivery sheath by removing the marker band positioned at the tip of the sheath to prevent further embolization of the marker band. Anatomical conditions such as insufficient rims or the presence of anomalous pulmonary drainage are limitations for device closure of ASD. Therefore, although transcatheter closure of ASD by an ASO has similar efficacy to surgical closure, surgical intervention will still be required for patients with defects unsuitable for device closure.
Comparison of safety. The mortality in both groups of patients was zero. This is in accordance with the previous reports in the current era (2,10–13,22–24). However, there were complications in both surgical patients and device closure patients. Most of the major complications in the surgical patients were due to large pericardial effusion with tamponade or other severe symptoms. Pericardiocentesis or catheter drainage was required to treat the effusion. Thus, these patients required prolonged intensive care unit or hospital stay and other treatments. Minor morbidity occurred in 17.8% of the surgical patients. Those complications were mainly cardiac arrhythmias and pericardial effusion. The overall morbidity in this surgical cohort was lower than previously reported in other series (24). Galal et al. reported a major complication rate of 8.8%, a moderate complication rate of 6.1% and a mild complication rate of 67% in their 232 adult patients who underwent surgical repair of isolated secundum ASD. This difference might have been due to the younger age of our surgical patients. Other complications of surgical ASD repair reported by others such as sepsis, renal failure (24), duodenal ulcer (21) and atrial flutter/fibrillation identified at long-term follow-up (25,26) were not encountered in our patients.
One patient who underwent device closure had a rare major complication of a cerebral embolism. This patient had complete recovery.
Cardiac arrhythmias and conduction abnormalities were the most common complications encountered. Although most of these were transient, one patient required pacemaker implantation. Another problem of device closure is the chance of device embolization, which occurred in 1.1% of the patients in this study. But this still compares favorably with previous studies using either the ASO or other devices (4,21). For patients with embolization occurring during or immediately after the procedure, the device could be easily retrieved percutaneously in the catheterization laboratory or by operation. One patient who came for follow-up inadvertently after one week from implantation was found to have a 24-mm device embolized to the pulmonary artery. This patient was playing American football within 72 h from closure. The device was successfully retrieved in the catheterization laboratory. The manufacturer has recommended no contact sports for a month and has also recommended a chest radiograph after one week in all patients after that case. We believe that device embolization can be prevented or minimized. Most of the cases of embolization occurred during the early learning curve of the operators. Increased operator experience and the use of TEE during implantation should minimize this complication.
Nevertheless, our study indicates that the overall complication rate was much lower in the device closure patients than the current surgical patients. Furthermore, there are other potential advantages favoring device closure of ASD. These include avoidance of thoracotomy and cardiopulmonary bypass and shortened hospital stay, with less use of hospital resources with potential money saving. Additionally, there are other advantages that could not be objectively measured. These include the psychological advantages for patients and their families and the economic use of time for family and patients due to the shorter recuperation period (27). The use of fluoroscopy to guide device placement is a disadvantage; however, the fluoroscopy time needed to implant the ASO is short and compares favorably with other devices (7,9,10,11). Radiation time can be reduced further with increased operator experience and with the aggressive use of TEE or intracardic echocardiographic monitoring of the procedure (28). Some investigators even have performed catheter closure of ASD using the ASO under TEE guidance alone without fluoroscopy (29). We believe that the use of TEE with judicious use of fluoroscopy should result in improved success and minimize device embolization. Finally, the U.S. FDA has approved the ASO for routine clinical use in children and adults with secundum ASD. Furthermore, the FDA required formal supervised training of physicians planning to use the ASO for closure of ASD. The manufacturer requires physicians planning to use the device to be proctored by a physician experienced in the use of ASO.
Study limitations. The first limitation of this study is that the design was not a randomized trial. It would have been difficult if not impossible to perform a randomized study for ASD closure for many logistic and ethical reasons. The second limitation is that the two groups of patients were not comparable in age and in number of patients with multiple ASDs. The disparity in age was due to a high number of adult patients in the device group that were referred by cardiologists in centers not involved with transcatheter device closure. The age disparity explains the differences in body weight and height. Nevertheless, although the device group included a large number of adult patients with age up to 82 years, which might have increased the chance of complications, the efficacy was similar to and the complication rate was lower than surgical patients. Furthermore, the incidence of complications in the surgical group was not age related. Appropriate patient selection and operator’s experience are important factors for successful device closure.
In conclusion, despite the limitations of this study, our results demonstrate that the early successful closure rate and primary and secondary efficacy success rates were not statistically different in patients with ASD who underwent transcatheter device closure using the ASO and those patients who underwent surgical repair. However, the complication rate was lower and the length of hospital stay was shorter for device closure compared with surgical closure. Therefore, transcatheter device closure using an ASO seems to be a safe and effective alternative treatment for secundum ASD.
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Appendix I |
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TopAbstractMethodsResultsDiscussionAppendix IAppendix IIReferences |
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The investigators in the surgical group are listed by the order of numbers of patients as: Thomas Zellers, MD, University of Texas, SW Medical School; Andrew N. Pelech, MD, Children’s Hospital of Wisconsin; Albert Rocchini, MD, University of Michigan; Donald Hagler, MD, Mayo Clinic; William S. McMahon, MD, The University of Alabama at Birmingham; Daniel E. Miga, MD, Cook Children’s Heart Center; Harm Velvis, MD, Albany Medical Center Hospital; Mark H. Hoyer, MD, University of Florida College of Medicine; John Moore, MD, St. Christopher’s Children’s Hospital; David Balzer, MD, Washington University at St. Louis; Michael S. Vance, MD, Children’s Hospital of the Kings Daughter; Elman G. Frantz, MD, University of North Carolina at Chapel Hill; Wolfgang Radtke, MD, Medical University of South Carolina; Hitendra Patel, MD, New England Medical Center; Thomas K. Jones, MD, Children’s Hospital and Medical Center–Seattle; Jose Ettedgui, MD, Children’s Hospital of Pittsburgh; John Murphy, MD, duPont Hospital for Children; Makram R. Ebeid, MD, University of Mississippi Medical Center, John Bass, MD, Fairview University; Zahid Amin, MD, University of Nebraska and Creighton University; David Wax, MD, Children’s Memorial Medical Center.
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Appendix II |
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TopAbstractMethodsResultsDiscussionAppendix IAppendix IIReferences |
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Footnotes |
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References |
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TopAbstractMethodsResultsDiscussionAppendix IAppendix IIReferences |
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A. Hanslik, U. Pospisil, U. Salzer-Muhar, S. Greber-Platzer, and C. Male Predictors of Spontaneous Closure of Isolated Secundum Atrial Septal Defect in Children: A Longitudinal Study Pediatrics, October 1, 2006; 118(4): 1560 - 1565. [Abstract] [Full Text] [PDF]
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N. Dagres, G. Karatasakis, F. Panou, G. Athanassopoulos, T. Maounis, E. Tsougos, K. Kourea, I. Malakos, D. Th. Kremastinos, and D. V. Cokkinos Pre-treatment with Irbesartan attenuates left atrial stunning after electrical cardioversion of atrial fibrillation Eur. Heart J., September 1, 2006; 27(17): 2062 - 2068. [Abstract] [Full Text] [PDF]
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A. W. Nugent, A. Britt, K. Gauvreau, G. E. Piercey, J. E. Lock, and K. J. Jenkins Device Closure Rates of Simple Atrial Septal Defects Optimized by the STARFlex Device J. Am. Coll. Cardiol., August 1, 2006; 48(3): 538 - 544. [Abstract] |
