Ventricular septal defects (VSD) are one of the most

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1 Treatment of Isolated Ventricular Septal Defects in Children: Amplatzer Versus Surgical Closure Pierre Oses, MD, Nicolas Hugues, MD, Nagib Dahdah, MD, Suzanne J. Vobecky, MD, Joaquim Miro, MD, Michel Pellerin, MD, and Nancy C. Poirier, MD Cardiovascular Surgery Department and Cardiac Department, Sainte-Justine Hospital, and Cardiac Surgery Department, Montreal Heart Institute, Montreal, Quebec, Canada Background. Isolated hemodynamically significant ventricular septal defects (VSD) were previously treated surgically. Since the introduction of percutaneous (PC) devices, the management of isolated VSD has evolved. In our center, Amplatzer devices have been implanted for selected isolated perimembranous VSD since Methods. The charts of all isolated PC perimembranous VSD closures and all surgical closures performed since 2002 were reviewed retrospectively. Clinical, electrocardiographic, and echocardiographic data were analyzed. The preclosure, immediate postclosure, and 1-month, 6-month, and 12-month postclosure results were assessed. Results. Thirty-seven patients underwent PC closure, and 34 had surgical treatment. Mean follow-up was months. The PC group was significantly older (p < 0.01) and larger in size (p < 0.001). Surgical patients had more severe congestive heart failure and a significantly lower VSD gradient (p < 0.004). At follow-up, there were no differences in the incidence of residual shunting between the two groups (p 0.92). All valvular regurgitations improved over time, except for 3 aortic regurgitations (5.4%) in the PC group that got worse. Two permanent pacemakers were implanted for early complete heart block in the PC group, and one was implanted in the surgical group (p 0.94). Conclusions. The surgical results in our population were excellent. The selection of patients with perimembranous VSD remains a challenge to avoid post-pc intervention complications such as heart block and aortic insufficiency. For isolated VSD, PC closure, which avoids the morbidity of open heart surgery, should be considered as part of the therapeutic armamentarium. (Ann Thorac Surg 2010;90:1593 8) 2010 by The Society of Thoracic Surgeons Ventricular septal defects (VSD) are one of the most frequent congenital cardiac abnormalities. Among these, perimembranous VSD (PMVSD) are the most common hemodynamically significant VSD. Since 1954, when the first surgical closure of a PMVSD took place, there have been considerable changes in the surgical strategy for closure in terms of timing, perfusion modalities, and approach, making surgical closure a relatively low risk procedure [1, 2]. In the last decade, percutaneous (PC) closure techniques have been developed for all types of VSD. Initial attempts at PC PMVSD closure were largely unsuccessful [3, 4]. This approach appears to be more promising with the recent introduction of the Amplatzer VSD and PMVSD devices (AGA Medical Corp, Golden Valley, MN) [5 12]. Short-term and medium-term follow-up have shown encouraging results especially with respect to technical feasibility, shunt occlusion, and valvular compromise. However, device-related complications have been reported, with complete heart block (CHB) being a particular concern [13 16]. Accepted for publication June 16, Presented at the Poster Session of the Forty-sixth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 25 27, Address correspondence to Dr Oses, Department of Cardiothoracic Surgery, 1 Ave de Magellan, Pessac, France; pierre.oses@ chu-bordeaux.fr. At the CHU-ME Sainte-Justine Hospital in Montreal, Amplatzer devices have been implanted for selected isolated PMVSD and muscular VSD since We carried out a retrospective study comparing the results of surgical and device closure of isolated VSD since the introduction of these devices in our center. The short-, medium-, and long-term incidence of CHB, residual shunting, valvular integrity, and other complications associated with device closure or surgery were investigated. In addition, the influence of the PC approach on clinical practice was assessed in view of the fact that surgical closure is a time-proven procedure. Patients and Methods A review of the cardiac database identified all patients who underwent isolated VSD closure with either an Amplatzer VSD Occluder or surgically using a synthetic patch between January 2002 and January The clinical records, angiograms, electrocardiograms, and echocardiograms of these patients were reviewed. The study was approved by the local Research Ethics Board at the CHU-ME Sainte-Justine. Individual patient consent was Dr Miro discloses that he has a financial relationship with AGA Medical Corp by The Society of Thoracic Surgeons /$36.00 Published by Elsevier Inc doi: /j.athoracsur

2 1594 OSES ET AL Ann Thorac Surg TREATMENT OF VENTRICULAR SEPTAL DEFECTS 2010;90: waived in this quality review study as no patient identifiers were used. Data for patients who underwent PMVSD closure were also reviewed specifically. Patient Population The demographic and preoperative clinical data for the study population are shown in Table 1. Indications for Percutaneous Device Ventricular Septal Defect Closure To be eligible for PC closure of a VSD, patients were required to have presented with either heart failure or failure to thrive after 3 months of age, left-side heart chamber dilation or pulmonary congestion, or both, after 1 year of age. For VSD greater than 6 mm in size, patients had to weigh at least 6 kg or be more than 6 months of age. No limit was placed on weight or age for VSD less than 6 mm in size. Patients with more than mild aortic valve prolapse or insufficiency, a maximal orifice diameter greater than 14 mm (by angiography), absence of a membranous septum aneurysm, pulmonary vascular resistance index greater than 7 WU/m 2 that was unresponsive to oxygen, associated lesions requiring open heart surgery, or parental preference for surgical intervention were not considered for PC closure and were referred for surgery. Surgical Indications Surgical closure was performed in infants with large VSD who remained in intractable congestive heart failure despite medical treatment, patients with a large left-toright shunt ( 2:1), and children with contraindications for PC device closure. Ventricular Septal Defect Sizing and Percutaneous Device Implantation The PMVSD patients were evaluated initially by transthoracic echocardiography (TTE). General cardiac anatomy was assessed to determine whether there were any associated lesions and/or contraindications to closure using the Amplatzer VSD Occluder. Diagnostic catheterization was initially performed under general anesthesia to assess pulmonary pressure and resistance, cardiac output, and the Qp:Qs ratio, where Qp is the pulmonary resistance and Qs is the systemic resistance. The VSD was then traversed with a wire from the left ventricular side, snared in the pulmonary artery, and pulled through to the femoral vein by a second catheter. The device was then implanted through a long sheath crossing the VSD from the right to the left ventricle. Transesophageal echocardiography (TEE) was used to assist in the assessment of defect size and device position, and to detect distortion of adjacent cardiac structures. Sizing and deployment of the PC devices were assessed by TEE using parasternal short-axis and apical four-chamber views to measure the short- and long-axis diameters of the VSD. The device size had to be 0 mm to 2 mm larger than the VSD orifice on the right ventricular side, measured by the diameter of the central circumference of an inflated low pressure balloon. If the VSD had a larger diameter on the left ventricular side than on the right, a larger device was selected for optimal occlusion. This allowed better endothelialization, avoided deployment of a left ventricular disk inside a septal aneurysm, and occluded multiple VSD. The Amplatzer VSD Occluder is available in various sizes ranging from 4 mm to 18 mm, increasing in 2-mm increments. After deployment of the device, all patients underwent a left ventricular angiogram to confirm adequate device position and to identify residual shunting, in addition to TEE evaluation. Surgical Intervention Surgical correction of the VSD was performed through a midline sternotomy, using cardiopulmonary bypass with patients cooled to 32 C to 34 C and the heart arrested with cold blood cardioplegia. The VSD was accessed Table 1. Preoperative Baseline Characteristics of Patients Undergoing Percutaneous or Surgical Closure of Ventricular Septal Defects Characteristic Percutaneous Closure (n 37) Surgery (n 34) p Value Sex 0.32 Male 16 (43.2) 19 (55.8) Female 21 (56.8) 15 (44.1) Age, months (1 219) (1 176) Body surface area, m ( ) ( ) Preoperative treatment None 29 (78.4) 5 (14.3) Lanoxin 3 (8.1) 27 (78.6) Furosemide 7 (18.9) 29 (85.7) Spironolactone 1 (2.7) 10 (28.6) Hb preoperative, g/l ( ) ( ) LVEF, % LV-RV gradient, mm Hg (54 138) (14 134) Data are presented as number (%) of patients, or mean SD (range). Hb hemoglobin; LV left ventricle; LVEF left ventricular ejection fraction; RV right ventricle.

3 Ann Thorac Surg OSES ET AL 2010;90: TREATMENT OF VENTRICULAR SEPTAL DEFECTS 1595 through a right atriotomy in all patients, except for 1 who underwent a transpulmonary approach. To facilitate exposure of the VSD through the right atrium, the tricuspid valve was detached in 9 cases (26.4%). All VSD were closed with a Dacron (C.R. Bard, Haverhill, PA) patch using a continuous suture. Tricuspid valve competence was always evaluated before closure of the right atriotomy. Postoperative TEE was performed in all patients with two-dimensional and color Doppler to assess tricuspid and aortic valve function, as well as possible residual shunting. Residual Shunt and Valve Regurgitations A residual shunt was considered to be present when color Doppler flow mapping showed a shunt across the interventricular septum. A shunt was defined as trivial ( 1 mm color jet width), small (1 2 mm color jet width), or moderate (2 4 mm color jet width) (17). Valve regurgitations were evaluated by color Doppler flow imaging and graded as absent, trivial, mild, moderate, or severe, based on the area and length of the color jet (18). Postclosure Treatment PERCUTANEOUS DEVICE. All patients were monitored in the hospital for 24 hours after device implantation. Chest roentgenography, echocardiography, and TTE were performed before discharge. Platelet antiaggregation therapy with aspirin (5 mg/kg daily) and endocarditis prophylaxis were prescribed for 6 months. Patients were followed at our outpatient clinic at 1 week, 1 month, 6 months, 1 year, and then yearly thereafter. Follow-up echocardiograms were reviewed to assess residual shunt and valvular regurgitation. SURGICAL TECHNIQUE. The duration of pediatric intensive care unit (PICU) stay was mainly dependent on chest drain output and the presence or absence of arrhythmias. After discharge from the PICU, patients were observed for 48 hours on a regular ward. Before definitive discharge, chest roentgenography, echocardiography, and TTE were performed. Patients were also followed at our outpatient clinic by their physician with a chest roentgenogram, echocardiogram, and TTE at 1 week, 3 months, 1 year, and then yearly thereafter. Statistical Analysis The analysis of categorical variables was performed using the 2 test with Yates correction when necessary. Continuous variables, reported as mean SD, were analyzed using Student s t test. Statistical significance was defined as a p value of 0.05 or less. Results Study Population The demographic and clinical preoperative data for the study population are shown in Table 1. The mean VSD diameter on preclosure TTE was mm (range, 3.6 to 16 mm) with a mean VSD/body surface area ratio of (range, 2.6 to 42.6) in the surgical group; this was significantly larger than in the PC group (p 0.02). The patients in the surgical group were also significantly smaller (p 0.001) and had more severe congestive heart failure (Table 1). Follow-Up Follow-up was complete for both treatment cohorts. The follow-up data on the presence of a residual shunt on TTE, PR and QRS duration, and evaluation of valve regurgitations was available for 36 patients (97.3%) in the PC group and 34 (100%) in the surgical group. Mean duration of follow-up for patients who underwent PC device and surgical closure was and months, respectively (p 0.6). Procedural Data PERCUTANEOUS DEVICE CLOSURE. The basic procedural data are reported in Table 2. During the study period, 37 children underwent cardiac catheterization with the intention to treat the VSD percutaneously. In 36 of 37 patients the defect was closed successfully (97.3%). In 2 patients, the procedure was aborted; in 1, an 8-year-old girl, it was impossible to obtain a stable position of the long sheath, but a second attempt was successful 6 months later; in the other, a 4-year-old girl, one device embolized into the left ventricle, requiring emergency surgical removal and VSD repair. SURGICAL. Mean cardiopulmonary bypass time was minutes (range, 37 to 187) with a mean cross-clamp time of minutes (range, 12 to 148). To enhance exposure, the tricuspid valve was detached in 9 cases (26.5%). Comparative Data at Discharge The data collected at discharge for the two cohorts are shown in Table 3. No patients were transfused in the PC group, whereas 30 patients (88.2%) received red blood cells in the surgical group (p 0.001). The mean ventilation support time in the PICU was hours (range, 1 to 24) for the PC group and hours (range, 0 to 105) for the surgical group (p 0.016). The mean hospital stay was days (range, 1 to 7) for the PC group and days (range, 4 to 35) for the surgical group (p 0.001). EARLY POSTPROCEDURAL COMPLICATIONS. No deaths occurred Table 2. Procedural Data and Characteristics of Devices Used Variable Mean SD (Range) Qp/Qs ratio ( ) Mean PA pressure, mm Hg (9 65) VSD diameter on TTE, mm (2.4 18) VSD/BSA ( ) Mean size of device used, mm (5 16) Device diameter/vsd diameter ( ) Fluoroscopic time, minutes (9.9 64) Procedure time, minutes (76 192) BSA body surface area; PA pulmonary artery; Qp/Qs pulmonary to systemic flow ratio; TTE transthoracic echocardiography; VSD ventricular septal defect.

4 1596 OSES ET AL Ann Thorac Surg TREATMENT OF VENTRICULAR SEPTAL DEFECTS 2010;90: Table 3. Comparative Data at Discharge Percutaneous Device Surgery p Value LVEF (%) ( ) ( ) 0.63 Residual shunting 4 (11.1) 8 (23.5) 0.26 Trivial 2 (5.5) 4 (11.7) Small 2 (5.5) 3 (8.8) Moderate 0 (0) 1 (2.9) Rhythm at discharge Sinusal 35 (97.2) 33 (97.1) Incomplete RBBB 7 (19.4) 28 (82.3) Complete RBBB 0 (0) 5 (14.7) Permanent pacemaker 2 (5.5) 1 (2.9) QRS duration at discharge, ms Data are presented as number (%) of patients, or as mean SD (range). LVEF left ventricular ejection fraction; RBBB right bundle branch block. in either group. A total of 7 significant complications (27%) occurred in 10 patients in the PC group, and 5 significant complications (23.5%) occurred in 8 patients in the surgical group. PERCUTANEOUS DEVICE. A mismatch between the device and VSD dimensions required replacement with a larger device during the same session in 2 cases (5.4%). Mild hemolysis was recorded in 1 case (2.7%), but this resolved spontaneously 7 days after the procedure. A transient device thrombus without embolization was detected in 2 cases (5.4%). Femoral arterial thrombosis occurred in a 9-year-old girl (23.5 kg) and was successfully controlled with heparin. Transient clonic movements occurred in a 1-month-old girl but a cerebral scan was normal in this child, and no deficit was observed thereafter. Permanent CHB appeared within 24 hours postprocedure in a 15- year-old boy and a 9-year-old girl. Both underwent pacemaker implantation despite trying corticotherapy. Finally, one device embolized into the left ventricle requiring emergency surgery and VSD repair. SURGERY. Temporary pacing was necessary in 3 patients (8.8%): 2 for junctional ectopic tachycardia during the first postoperative day, and 1 for a transient CHB. Two patients (5.8%) required drainage of a pericardial effusion. Postoperative bronchopneumonia occurred in 1 patient (2.9%), requiring prolonged ventilatory support. A 4-month-old boy had a pulmonary hypertensive crisis resulting in cardiorespiratory arrest in the PICU. Fortunately, the crisis was quickly resolved, and the patient suffered no sequelae. Permanent CHB occurred immediately after surgery in 1 case (2.9%), a 3-month-old boy, and a permanent pacemaker was implanted into this child 15 days after surgery. Long-Term Follow-Up The long-term follow-up data are summarized in Table 4. No late deaths or cases of endocarditis were reported. All children were described as New York Heart Association functional class I, except for 2 surgical patients who are currently in class II. Late follow-up echocardiography showed that the PR interval was significantly longer in the device closure group (p 0.005). However, 27 children (82.4%) had incomplete right bundle branch block after surgery. There were no late pacemaker implantations in either group. A periprosthetic residual shunt was present at discharge in 4 patients (11.1%) in the PC group and in 8 patients (23.5%) in the surgical group (p 0.26). On late follow-up TTE, all residual shunts had either decreased or remained unchanged in both groups (p 0.92). Preoperative aortic valve regurgitations (n 11, 30.5%) remained unchanged immediately after PC closure. After surgery, aortic valve regurgitations (n 6, 17.6%) were Table 4. Follow-Up Data Percutaneous Device Surgery p Value No. consultations since hospital discharge Treatment None 28 (80) 28 (82.4) Antiplatelet therapy 3 (8.5) 0 Bronchodilators 4 (11.4) 6 (17.6) Electrocardiogram PR duration (ms) QRS duration (ms) Rhythm Sinusal 33 (94.2) 33 (97.1) Incomplete RBBB 10 (28.5) 27 (82.4) Complete RBBB 3 (8.5) 6 (17.6) Permanent pacemaker 2 (5.7) 1 (2.9) LVEF (%) NS Residual shunting 2 (5.4) 3 (8.8) 0.92 Trivial 1 (2.8) 1 (2.9) Small 1 (2.8) 1 (2.9) Moderate 0 (0) 1 (2.9) Data are presented as number (%) of patients, or as mean SD. LVEF left ventricular ejection fraction; NS not significant; RBBB right bundle branch block.

5 Ann Thorac Surg OSES ET AL 2010;90: TREATMENT OF VENTRICULAR SEPTAL DEFECTS 1597 either unchanged or had decreased. Tricuspid valve regurgitations immediately after PC closure worsened in 1 patient (2.7%) and disappeared in 5 others (13.9%). Immediately after surgery, tricuspid valve regurgitations (n 8, 23.5%) were either unchanged or increased in 5 patients (14.7%). During follow-up, valvular failure improved in both groups, except for 2 patients (5.4%) in whom aortic valve failure increased in severity from trivial to mild. Comment Many teams have already published their results on either PC or surgical closure of VSD. However, our series reports a single-center retrospective review of both techniques during the same period. It is interesting to note that the two populations differed significantly. The PC group was significantly older and had a higher body surface area than the surgical group. Furthermore, fewer of these patients had congestive heart failure compared with surgical patients, more had no treatment before the procedure, and the lesions were more restrictive with a mean left ventricle/right ventricle gradient of mm Hg (range, 54 to 138 mm Hg). The VSD sizes were similar in both groups, but the VSD/BSA ratio was more than twofold higher in the surgical group. Overall hospital stay was shorter after PC closure. However, hospitalization after surgery is often multifactorial and is not solely due to the use of cardiopulmonary bypass. Nine patients (26.4%) were infants in poor preoperative condition who had high pulmonary artery pressure, necessitating a longer PICU stay. Furthermore, reintroduction of feeds can be difficult, and therefore take longer in these critically ill infants, the majority of whom were gavaged preoperatively. There was no early mortality in our study, and there were only few near-miss situations with 1 patient in each group (device embolization, and cardiac arrest on pulmonary hypertensive crisis), but neither patient suffered any sequelae. At discharge and follow-up, the complete closure rate was 88.5% and 76.5%, respectively, for the PC group, and 94.6% and 91.18%, respectively, for the surgical group, respectively, as reported previously [6, 12, 19 22]. There were no significant differences in terms of residual shunt between the two groups (p 0.92). All residual shunts were mild or absent, except for a moderate shunt in 1 boy (2.9%) in the surgical group. Bol-Raap and associates [23] demonstrated that all trivial surgical residual shunts closed within 10 years, with a median time of 4 years. In our experience, the two groups seemed to behave in a similar way, and only moderate residual shunts should be considered for possible treatment and close monitoring. In recent years, published reports of acute and late CHB with PC device closure have emerged with a reported incidence of 5% to 22% [14, 24]. In 2007, Butera and coworkers [13] reported a CHB incidence of 8.7%, and a permanent pacemaker was required in 5.7% of patients (follow-up at a median of 38.5 months). It is difficult to clearly identify the risk factors for deviceassociated CHB. Device oversizing, young age, and low weight seem to be most often associated with the occurrence of this complication [15, 16, 24]. In our study, the 2 patients (5.6%) in the PC group who had CHB requiring a permanent pacemaker were older, and the prostheses were not oversized: a 14-year-old boy with a VSD size to device size ratio of almost 1, and a 9-year-old girl with a VSD size to device size ratio of 1.3. Meanwhile, 1 patient in the surgical group (2.9%), a 2-month-old boy weighing 4.3 kg, with a VSD with inlet extension, presented with postoperative CHB. Follow-up of nearly 4 years has revealed no late-onset CHB in either group, and the mean QRS duration in the two groups has remained relatively stable. Although chronic inflammation or fibrosis is responsible for late CHB, it is interesting to note that the PR duration after PC closure increased over time. This trend is concerning and requires close monitoring and a longer follow-up. Several studies have reported aortic and tricuspid regurgitation during the postoperative period [6, 7, 25].In our study, no patient in either group required treatment for acute valve regurgitation. There was no difference between the two groups in terms of quantity, quality, or variation in time for valve regurgitation, and these remained stable during the follow-up period. Conclusion This study describes the results from a single center where two VSD closure techniques are used. Although surgery remains the gold standard, it seems reasonable to suggest that transcatheter VSD closure using the Amplatzer device should be offered as a nonsurgical alternative in selected patients, namely, older infants and children with small VSD. This selection remains a challenge to avoid post-pc intervention complications such as late CHB. The PC closure of isolated VSD, which avoids the morbidity of open heart surgery, should remain part of the therapeutic armamentarium. However, a new design of prosthesis will probably be necessary to treat a wider population. This work was supported by postdoctoral study grants from the French Society of Cardiology (Dr Oses) and the foundation of CHU-ME Ste-Justine. References 1. Roos-Hesselink JW, Meijboom FJ, Spitaels SE, et al. Outcome of patients after surgical closure of ventricular septal defect at young age: longitudinal follow-up of years. Eur Heart J 2004;25: Nygren A, Sunnegardh J, Berggren H. 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Doppler color flow mapping assessment of residual shunt after closure of large ventricular septal defects. Circulation 1991;84(Suppl): Yang SG, Novello R, Nicolson S, et al. Evaluation of ventricular septal defect repair using intraoperative transesophageal echocardiography: frequency and significance of residual defects in infants and children. Echocardiography 2000; 17: Arora R, Trehan V, Kumar A, Kalra GS, Nigam M. Transcatheter closure of congenital ventricular septal defects: experience with various devices. J Interv Cardiol 2003;16: Bol-Raap G, Weerheim J, Kappetein AP, Witsenburg M, Bogers AJ. Follow-up after surgical closure of congenital ventricular septal defect. Eur J Cardiothorac Surg 2003;24: Predescu D, Chaturvedi RR, Friedberg MK, Benson LN, Ozawa A, Lee KJ. Complete heart block associated with device closure of perimembranous ventricular septal defects. J Thorac Cardiovasc Surg 2008;136: Carminati M, Butera G, Chessa M, et al. Transcatheter closure of congenital ventricular septal defects: results of the European Registry. Eur Heart J 2007;28: INVITED COMMENTARY Oses and colleagues [1] describe a contemporaneous, singlecenter experience with ventricular septal defect repair by either percutaneous closure using the Amplatzer device (AGA Medical, Plymouth, MN) or surgical closure. Although the patient groups are admittedly dissimilar in age, size, and degree of pre-procedural congestive heart failure, we believe that the authors experience is worthy of review. Increasingly, less invasive therapies including transcatheter approaches will become the standard of care for certain patient populations. Patient choice, physicians, and insurance companies will be the driving force to cause these changes in therapy. However, these changes must equate to higher standards than the currently available techniques. At the present time, the Amplatzer perimembranous device (AGA Medical) for a ventricular septal defect is not available on either a commercial or research basis, because the device has been withdrawn in North America. Complete heart block has been shown to occur both early and late with this device. Despite the attempts of the authors to avoid complete heart block by not oversizing the device and choosing older and larger patients, complete heart block developed in 2 patients (aged 9 and 15 years), who also required a pacemaker. The prolongation of the PR interval post-device closure is a worrisome finding that requires vigilant follow-up. In their study of a select group of patients, Oses and colleagues [1] have shown that transcatheter closure can be successful and may have a role in therapy. However, at this time devices need to be safer and prospective, randomized trials in comparable patients need to occur. Raymond T. Fedderly, MD Andrew N. Pelech, MD Department of Pediatric Cardiology Children s Hospital of Wisconsin Medical College of Wisconsin 9000 W Wisconsin Ave Milwaukee, WI fedderly@mcw.edu Reference 1. Oses P, Hugues N, Dahdah N, et al. Treatment of isolated ventricular septal defects in children: Amplatzer versus surgical closure. Ann Thorac Surg 2010;90: by The Society of Thoracic Surgeons /$36.00 Published by Elsevier Inc doi: /j.athoracsur