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J Thorac Cardiovasc Surg 2007;134:731-737
© 2007 The American Association for Thoracic Surgery
Surgery for Congenital Heart Disease |
a Universität Leipzig, Herzzentrum, Klinik für Herzchirurgie, Leipzig, Germany
b Kinderkardiologie, Leipzig, Germany.
Read at the Eighty-sixth Annual Meeting of The American Association for Thoracic Surgery, Philadelphia, Pa, April 29-May 3, 2006.
Received for publication January 3, 2006; revisions received April 16, 2007; accepted for publication April 23, 2007. * Address for reprints: Prof Dr Thomas Walther, Universität Leipzig, Herzzentrum, Klinik für Herzchirurgie, Strümpellstrasse 39, 04289 Leipzig, Germany. (Email: walt{at}medizin.uni-leipzig.de).
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Abstract |
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 Top Abstract IntroductionPatients and MethodsResultsDiscussionReferences |
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Methods: From September 1996 until December, 2005, 418 patients received interventional and 297 patients underwent surgical closure of an ostium secundum atrial septal defect at our center. Another 15 patients (local, 5; regional, 5; and national, 5 referrals) had complications after occluder placement, and they form the study population.
Results: Indications for surgical repair in these 15 patients were dislocation of the occluder in 5, neurologic events after occluder placement in 5, residual defects in 4, and sepsis with questionable occluder infection in 1 patient. A total of 7 patients had neurologic events, 5 of embolic origin. The interval between interventional occluder placement and definitive surgical repair was 319 ± 416 days (median 123 days; range 0–1395 days). Patient age at operation was 34.9 ± 18.6 years. Nine patients were operated on via an anterolateral minithoracotomy, and 6 received a conventional sternotomy. One patient with sepsis underwent abdominal surgery on postoperative day 1 and subsequently died of multiorgan failure; there was no proof of occluder endocarditis. At 2.2 ± 1.9 years of follow-up, all other patients had returned to full-time work without residual neurologic impairment.
Conclusions: Complications may arise after interventional ostium secundum atrial septal defect closure. This must be evaluated against the extremely low risk of a standard surgical closure. The functional outcome after secondary surgical ostium secundum atrial septal defect closure with removal of an occluder system is excellent.
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Introduction |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionReferences |
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Interventional therapy with ASD occluder systems has gained widespread acceptance during the past few years. It is performed whenever technically feasible, usually in patients with ostium secundum ASD. By comparison, standard surgical therapy is performed whenever patients are referred by the cardiologists because of defects not amenable for interventional closure. Thus, the cardiologist is the "gatekeeper," deciding on which therapeutic option to choose. Most patients, without knowing too many details, are in favor of avoiding an operation. There are no randomized studies comparing interventional and surgical therapies, nor are there any regarding short- or long-term outcomes at the present time.
Despite the success of occluder placement in most circumstances, some patients need to be referred for standard surgical therapy after failure of the procedure. These patients have different diagnoses, comprising a rather heterogeneous population. Indications for definitive surgical therapy may be residual defects, occluder dislocations, thrombus formation, embolization, and infection. The aim of this study was to evaluate the results after secondary surgical closure of ostium secundum ASD after occluder placement, gathered from a heterogenous population of local, regional, and distant referrals.
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Patients and Methods |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionReferences |
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All patients admitted for ASD closure are routinely evaluated by transthoracic and transesophageal echocardiography preoperatively. Specific criteria for optional occluder placement include the presence of at least a 3-mm wide rim at all margins of the defect to allow for safe anchoring of the device. During the early years of occluder placement, from 1995 until 1999, patients having defects larger than 30 mm were directly referred for surgical therapy. Since then, in parallel with the development of larger devices, patients with defects up to 40 mm have been accepted for occluder placement.
The following numbers should give an idea of the regular caseload of patients treated with ASD at our center: From September 1996 until December 2005, a total of 418 patients were scheduled for interventional ASD closure. Of these patients, 38 had ASDs that were more complex, that is, larger or consisting of several defects. The Amplatzer system was used to treat 96.7% of these patients. A total of 36 patients (9.4% of the total) were referred for surgical treatment, mostly on an elective basis without any complications. Reasons for elective referral were no attempt at occluder placement owing to larger defect size or missing tissue rim to anchor the device in 12 patients, interrupted placement procedure owing to technical reasons, mostly during the learning curve in 18 patients, residual defects in 3 patients, and late embolization in 1 patient. Early embolization requiring urgent surgical therapy occurred in 2 patients in this series. Mostly independent of this series during the same time interval, a total of 15 patients (equal numbers of local, regional, and national referrals) had complications after unsuccessful occluder placement. These patients formed the study population.
Indications for Surgical Repair
Indications for surgical repair in these 15 patients were dislocation of the device in 5 patients, a neurologic event (transient ischemic attack) with or without embolism in 5 patients, residual defects with significant shunting causing clinical symptoms in 4 patients, and sepsis with the suspicion of an infected device in 1 patient.
From the study population of 15 patients, a total of 7 had had neurologic incidents at any time, 5 resulting from residual defects, 1 resulting from endocarditis, and 1 resulting from heparin-induced thrombocytopenia. Patient age was 34.9 ± 18.6 years and 11 were female.
Surgical Technique
A standard surgical technique using a lateral minithoracotomy for ASD closure is routinely applied at out institution whenever feasible, as described previously.2 This approach is being used in patients with sufficiently large femoral vessels for extracorporeal circulation (ECC) and a body weight of more than 30 kg. In the presence of additional diagnoses, a conventional sternotomy approach was chosen. All operations were performed with transesophageal echocardiographic monitoring. One venous return cannula was introduced percutaneously in the right or left internal jugular vein by the anesthetists. The anterior aspect of the right or left femoral artery and vein was dissected through a 3-cm incision in the inguinal fold for ECC access. Secured by purse-string sutures (Prolene 5–0; Ethicon, Inc, Somerville, NJ), a 16F to 20F arterial and a 30F venous return cannula were positioned by the Seldinger technique. The heart was accessed via a right anterolateral minithoracotomy in the submammary fold through the fourth intercostal space. The lung (single-lumen intubation) was disconnected under ECC support. The pericardium was entered with a horizontal incision at least 2 cm anterior to the phrenic nerve (Figure 1). The superior and inferior venae cavae were dissected and snared or a large bulldog clamping device was applied. A purse-string suture was made on the right lateral aspect of the ascending aorta to apply cardioplegic solution. The aorta was partially dissected from the pulmonary artery at the anterior and posterior aspects. A special endoscopic aortic clamp was then introduced through the second intercostal space in the right anterior axillary line. The heart was fibrillated, the aorta clamped, a long needle inserted in the ascending aorta, and cardioplegic solution administered. In parallel, the right atrium was opened. After cardioplegia was finished, the ASD occluder was inspected, and the correction performed. The aortic clamp was released after definitive ASD closure, usually with an autologous pericardial patch. The right atrium was then closed on the beating and reperfused heart.
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Results |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionReferences |
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ECC duration was 65 ± 12 minutes and aortic crossclamp time was 30 ± 11 minutes. Duration of postoperative intubation was 7.4 ± 6 hours and mean left ventricular ejection fraction was 66% ± 7%. An example of a residual defect at the superior rim of the occluder is shown in Figure 2.
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Discharge and Follow-up
The 14 survivors were discharged from the hospital without further complications. Transthoracic echocardiography revealed good functional results in all of them. There were no relevant further lesions, especially no relevant tricuspid valve incompetence in any of the patients and good aortic valve function in the 1 patient undergoing reconstruction of the noncoronary aortic sinus.
All patients were contacted by telephone interview for further follow-up. All were alive. The interval between surgical correction and the follow-up interview was 2 ± 1.9 years. All patients had returned to full-time work. Most important, there was no relevant residual neurologic impairment in any of the patients. None of the patients had had any repeat symptoms. All patients were in New York Heart Association class I. Regarding quality of life, 12 patients mentioned that it had improved and 2 that it was unchanged compared with the preoperative status.
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Discussion |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionReferences |
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Interventional approaches involving approved and commercially available occluder systems have been performed in patients who have ostium secundum ASDs since the 1990s.10-12 Recently, more complex and larger defects are being treated interventionally, and overall numbers are increasing. Future directions may aim at avoiding the implantation of relatively large discs of foreign material by using a direct suturing technique. At present, only patients with complex defects are being referred for definitive surgical therapy. Another group of referrals includes those who have had unsuccessful attempts to place an occluder or who have experienced complications after undergoing interventional procedures for ASD closure. Communication with several cardiac surgeons from different centers reveals that most have experience with explanting a smaller number of devices for different reasons. However, the overall number of patients requiring explantation of occluder devices may be low in relation to the total implantation rate.
One important and interesting article has been recently published by Divekar and colleagues.13 They focused on device-related cardiac events and especially on the incidence of cardiac perforations. From among more than 34,000 implanted occluder devices, a total of 29 cardiac events were reported, including 5 deaths and 3 neurologic events. This underlines the fact that there is a low but inherent risk. Another overview on potential erosion of the Amplatzer septal occluder device identified 28 patients, at an overall incidence of 0.1%, in the United States.14 Patients with deficient aortic and/or superior rim were judged as being at higher risk to have such a complication.14 Unfortunately, it seems that few patients know much about these potential risks. For planned occluder placement, informed consent will most certainly be obtained by the cardiologists only before starting the procedure. Patient knowledge about potential complications, however, might lead to a change in the preferred treatment approach of some. Nevertheless, most patients will not choose surgery as an option because they believe that interventional therapy is safe. Furthermore, cardiologists see the patients first, underlining their specific role as "gatekeepers" for further referral while keeping their own interests of interventional closure in mind. Obviously, problems with occluder devices are rare. However, patients should be informed objectively about all potential risks. Definitive surgical therapy has some perioperative impact but hardly any risk and, most important, excellent long-term functional outcome. Use of a flexible autologous pericardial patch for defect closure guarantees an almost perfect physiologic outcome without any reported risk of endocarditis. There is essentially no mortality in the current era. Minimally invasive techniques have evolved as very reliable and have become the clinical standard in experienced hands.
The most important result from this study is that definitive surgical therapy can be performed safely with good functional outcome after complications of occluder placement. This is even true in the presence of severe complications: for example, impairment of tricuspid valve function or penetration of the device into the aortic root. Another important finding is that a significant number of these patients—one third after occluder placement and almost half of the patients in total—had some form of neurologic insult before definitive surgical closure of the defect. Despite this, the postoperative functional outcome was good. This is clearly underlined by the fact that all patients fully returned to their preoperative routine work.
When evaluating the overall data, cardiologists and surgeons should agree on what has to be considered a complication and what complication rate with interventional ASD closure should be considered as being acceptable. From the patient’s perspective, any nonoptimal outcome, a residual defect or additional complication, is unfavorable. Therefore, the cardiologist and surgeon must strive for an optimal result regardless of the technique that is chosen. The attempt at interventional ASD closure during routine cardiac catheterization with subsequent elective referral to surgical therapy was occurring in close to 10% of patients from our local series, but this should not be considered a complication. This rate reflects the current practice of attempted interventional closure, triggered by the patient's interest, whenever a minimal chance of successful percutaneous treatment is present. In contradiction, any residual defect with imperfect outcome or a severe complication, such as a neurologic event, should lead to surgical therapy. The incidence of severe complications should be well below 1% in experienced centers.
Interventional cardiologists are gaining experience with occluder placement. With the exception of the rare event of partial embolizations, no real life-threatening complication will arise from failed attempts. Therefore, no surgical standby will be required. However, the conduct of interventional approaches in close proximity to a surgical center with some cardiac surgical backup will always be preferable in our opinion.
Are there any factors that will enable cardiologists and surgeons to foresee potential complications? There may be a relation between occluder size and the risk of complications.14 The size of the relatively stiff discs being implanted may be one factor, and the direct distance to the aortic root and especially the presence of a sufficient rim at the superior aspect may be important when judging the risks of cardiac perforation. However, as we evaluate our own data, the patients requiring surgical therapy after occluder device placement are a rather heterogenic population. Equal numbers of patients having complications after device placement have been referred over the years. Therefore, at present, no clear risk factors can be identified.
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References |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionReferences |
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