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J Thorac Cardiovasc Surg 1999;118:674-678
© 1999 Mosby, Inc.
SURGERY FOR CONGENITAL HEART DISEASE |
From the Klinik für Angeborene Herzfehlera und Klinik für Herz-, Thorax- und Gefäßchirurgie,b Deutsches Herzzentrum, Berlin, Germany.
Address for reprints: Felix Berger, MD, Deutsches Herzzentrum, Augustenburger Platz 1, 13353 Berlin, Germany (E-mail: fberger{at}dhzb.de).
| Abstract |
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| Introduction |
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Complete closure of ASDs has been achieved less frequently with transcatheter techniques than with surgery.
8 On the other hand, surgery results in a significant morbidity.
9 However, no formal comparison has been reported concerning results, closure rates, morbidity, and complications of transcatheter and surgical closure of ASDs performed at the same time and in the same institution. The purpose of our study was to compare results and complications of both treatment modalities in patients with a defect in the oval fossa (ostium secundum ASD) with a pulmonary/systemic flow ratio (Qp/Qs) of 1.5:1 or larger who were treated during a 1-year period.
| Methods |
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The following patients were referred immediately to the surgeon without cardiac catheterization: (1) those in whom echocardiography revealed a single defect too large for occlusion, multiple defects unsuitable for interventional closure, or a defect too close to the superior vena cava, pulmonary veins, coronary sinus, or atrioventricular valves (predictable failure of interventional closure) and (2) those patients who objected to closure by a device (missing consent declaration). All others underwent cardiac catheterization with angiography and balloon sizing of the ASD so that interventional occlusion could be performed.
At cardiac catheterization, standard fluid-filled catheters were used and the Qp/Qs flow ratio was measured by oximetry by means of the Fick principle. The size of the ASD was determined with balloon catheters. To determine the size of the ASD, we used the size of the balloon deformed by the ASD monitored by transesophageal echocardiography as it was pulled through the ASD in all 108 patients who went to the catheterization laboratory. The largest balloon that could be pulled through the defect was considered to represent the balloon-stretched size of the ASD.
10 In the remaining 14 patients, who did not undergo cardiac catheterization, the size of the ASD was measured only by transesophageal echocardiography before the operation, but without balloon sizing.
All patients gave written informed consent to Amplatzer device closure, and the implantation protocol had been approved by the local institutional review board. The technical details of the implantation of the Amplatzer device have been described elsewhere.
6,7,11 A 7F or 8F long sheath was used to deliver the Amplatzer device. Transesophageal echocardiography with a multiplane transesophageal probe interfaced with a Vingmed 800 (Vingmed Sound, Horten, Norway) sector scanner or a monoplane probe interfaced with a Siemens Sonoline 1200 (Siemens, Erlangen, Germany) sector scanner to monitor device placement was performed in all. The following patients were referred to the surgeon: patients with a single ASD and a balloon-stretched ASD diameter of more than 26 mm, those with multiple ASDs, and those with a distance of less than 5 mm between the margins of the ASD and the mitral or tricuspid valves, superior vena cava, right upper pulmonary vein, and coronary sinus. All patients were sedated with intravenous midazolam in a dose of 0.1 to 0.2 mg/kg 30 minutes before entering the catheterization laboratory. This dose was followed by a continuous infusion of propofol (3-5 mg/kg per hour) during the procedure. Neither endotracheal intubation nor mechanical ventilation was required in any patient.
Patients who underwent surgery were operated on under general anesthesia with the aid of cardiopulmonary bypass. The right atrium was opened after a median thoracotomy. The ASD was closed either by direct suture (n = 9) or by a pericardial patch (n = 52). In 13 (41%) of 29 female patients older than 12 years, a lateral thoracotomy was used. Before hospital discharge all patients underwent complete physical examination, color Doppler echocardiographic study, and chest radiography. In the patients with Amplatzer occluder treatment, chest radiography was repeated at the 3-month follow-up visit. A residual ASD was considered to be present if color Doppler flow mapping performed on the day of hospital discharge revealed a left-to-right shunt across the atrial septum.
Statistical analysis.
Results are expressed as median, range, and 25% and 75% quartiles, respectively. Also, the differences between the medians have been calculated, as has an estimate of the 95% confidence interval around that difference. A bootstrap method was used to calculate that 95% confidence interval.
12 The Mann-Whitney U test was used to compare the group treated by surgery with the one treated by catheter intervention. Only ASDs that had been measured by balloon sizing were compared between the 2 groups. To prove both methods, the 95% confidence interval for a difference of event rates was calculated by means of the Fleiss formula.
13 The surgical and interventional methods showed equivalent success with respect to frequency of atrial arrhythmias and evidence of residual shunt if the 95% confidence interval lies between 0.1 and 0.1.
14
| Results |
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Patients data are summarized in Table I. Median age at intervention in the 61 patients undergoing Amplatzer device closure was 12 years (0.877.7 years), with 19 patients being older than 18 years, whereas in the patients undergoing surgery the median age was 20 years (0.574.0 years), with 34 patients being in the adult age group (P > .2). Duration of follow-up in the group treated by surgery was 8 months (2-13 months) and in the group treated by intervention, 7 months (1-13 months) (P = .19). The 5 patients who were treated by either method in the first 2 years of life had symptoms consisting of failure to thrive, frequent chest infections, or both. The patients who underwent surgery had a larger ASD with a larger shunt than those who had an Amplatzer device implanted (Table I
). In the surgical group, shunt size could be calculated in only 47 of the 61 patients who underwent cardiac catheterization; the other 14 patients were not catheterized before the operation. Complete closure of the ASD was achieved in 98% of patients with both methods (Table I
).
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Complications of surgery and Amplatzer implantation were rare and are summarized in Table II. Only those atrial arrhythmias that occurred de novo from sinus rhythm before closure were considered a complication of treatment. The 10 patients with arrhythmias were successfully treated by cardioversion (n = 4) or administration of verapamil (n = 2) and sotalol (n = 2). Two patients have persistent atrial fibrillation and are receiving warfarin sodium.
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| Discussion |
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Complications of surgery.
Mortality and morbidity of surgical closure of ASDs in the current era has recently been reported in detail.
9 As in our series, incomplete closure of the ASD after surgery is rare.
9 Mortality and serious morbidity are also rarely seen.
9 In the present series, surgical complications (Table II
) occurred because of attempted minimally invasive repair with a lateral thoracotomy.
15 The exacerbation of a duodenal ulcer under stress in the hospital, however, could have happened without regard to the type of ASD closure. A minor but frequently observed morbidity is associated with the postpericardiotomy syndrome,
16 which did not lead to pericardial tamponade or the need for pericardiocentesis in our series. The occurrence of atrial flutter/fibrillation after closure of an intra-atrial communication was slightly more frequent in patients treated surgically (Table II
), is known to increase with age,
17 as in the present series, and is probably related to the pre-treatment distention of the right atrium.
18 Morbidity unique to surgical therapy is related to the possible risks of blood transfusions, which were not required in patients undergoing Amplatzer device closure. Morbidity related to endotracheal intubation and general anesthesia required for surgery was not apparent in our patient group but is a potential hazard.
Complications of nonoperative closure.
Real and potential problems with device closure of ASDs have been reported, including early death after the procedure, possibly related to dislodgment of an iliac vein thrombus while the sheath was being advanced,
1 late device dislocation with left atrial thrombus formation and systemic embolism,
19 failure to retrieve a misplaced device necessitating surgery,
20 and incomplete closure of the ASD.
1,2,3,7,11 The fact that previous experience with smaller patient numbers treated with the novel Amplatzer device
7,6,11 did not include device embolization illustrates the need for multicenter studies in a large number of patients. The complication could not be attributed to our learning curve, because it occurred late in our experience after implantation of more than 100 Amplatzer devices. Embolization has previously been reported with the use of other devices
21 and, as in our case, was not associated with particularly large defects. Retrospectively, we assume that the rim of the ASD was too floppy to secure the device.
Incomplete closure can occur with the use of different devices,
1,2,8 and its incidence may not be different with the Amplatzer septal occluder.
6,7,11 This study, however, demonstrated a closure rate identical to that of surgery. One of the potential advantages of the Amplatzer septal occluder is the previously reported retrievability.
6,11 Although retrieval was necessary in 1 patient, we were able to extract the embolized device from the left ventricle without damage to the cardiac valves; vascular surgery was necessary to retrieve it from the peripheral vessel.
Compared with published reports on alternative devices,
2,5,21 the fluoroscopy time needed to implant the Amplatzer device appears to be short
6 (Table I
). This time can be reduced further if more Amplatzer devices will be implanted with echocardiographic guidance alone without the need for fluoroscopy, completely avoiding any potential morbidity to the patient or operator from irradiation.
22
In the future it may become possible to close multiple defects and those with a diameter larger than 26 mm.
23
Limitations of this study.
We could not perform a randomized study designing patients to a particular treatment protocol, because the patients treated with surgery had larger defects, multiple defects, or defects too close to the atrioventricular valves, coronary sinus, and superior or inferior venae cavae. Second, access to the heart in the surgically treated patients was achieved in a different manner depending on age and sex of the individual patient and the individual surgeons preference. Third, the difference in shunt size may have influenced the incidence of postoperative atrial flutter/fibrillation. Fourth, the length of hospital stay after closure may vary from country to country, so that our result of a significant difference in length of hospital stay after surgery cannot necessarily be extrapolated to the medical systems of other countries.
This is a nonrandomized study with evidence of significant patient selection bias, which limits the possibility of comparing the 2 strategies and may influence our conclusions.
| Conclusions |
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| Acknowledgments |
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| References |
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