Absorbable pulmonary artery banding: a strategy for reducing reoperations

Transcription

1 European Journal of Cardio-Thoracic Surgery 51 (2017) doi: /ejcts/ezw409 ORIGINAL ARTICLE Cite this article as: Daley M, Brizard CP, Konstantinov IE, Brink J, Jones B, d Udekem Y. Absorbable pulmonary artery banding: a strategy for reducing reoperations. Eur J Cardiothorac Surg 2017;51: a b c d Absorbable pulmonary artery banding: a strategy for reducing reoperations Michael Daley a,b,christianp.brizard a,b,c, Igor E. Konstantinov a,b,c, Johann Brink a,brynjones b,c,d and Yves d Udekem a,b,c, * Department of Cardiac Surgery, The Royal Children s Hospital, Melbourne, Australia Murdoch Children s Research Institute, Melbourne, Australia Department of Paediatrics, The University of Melbourne, Melbourne, Australia Department of Cardiology, The Royal Children s Hospital, Melbourne, Australia * Corresponding author. Department of Cardiac Surgery, Royal Children s Hospital, 50 Flemington Road, Melbourne 3052, Australia. Tel: ; fax ; yves.dudekem@rch.org.au (Y. d Udekem). Received 4 September 2016; received in revised form 16 November 2016; accepted 21 November 2016 Abstract OBJECTIVES: Pulmonary artery banding (PAB) remains in the armamentarium of techniques for several congenital cardiac anomalies, but necessitates a reoperation for eventual removal. We sought to assess the efficacy of an absorbable PAB in obviating the requirement for reoperation. METHODS: From 2003 to 2015, 45 consecutive patients with a median age of 1.6 months (2 days 11 months) underwent placement of a polydioxanone absorbable PAB. In 28 patients (62%), the band was placed concomitantly to a ventricular septal defect (VSD) closure and in 17 (38%), the band was the sole procedure for the VSDs. Fourteen patients had additional cardiac anomalies and 9 patients had aortic arch anomalies, which were repaired at the time of absorbable PAB placement. RESULTS: There was 1 hospital death. The band was removed early in 3 patients. Mean time to follow-up was 5.2 ± 3.5 years. Overall, 32 of the 41 patients discharged from hospital with absorbable PABs did not require reoperation on the VSDs or the band, resulting in a singlestage definitive repair of 78%. Median time to absorbable PAB resorption was 7.2 months (interquartile range, ). Freedom from reoperation related to residual VSDs or PAB obstruction was 78% (95% CI: 61 87%) at 10 years. CONCLUSIONS: The use of absorbable polydioxanone PABs is an effective method of reducing reoperations for multiple VSDs. Their use should be incorporated in the surgical strategy for repair of muscular and residual VSDs. Keywords: Absorbable pulmonary artery banding INTRODUCTION Pulmonary artery banding (PAB), first reported in 1952, remains in the contemporary armamentarium of techniques of paediatric cardiac surgery [1]. It remains useful (i) to adjust pulmonary blood flow in neonates with single ventricle physiology and high pulmonary blood flow, (ii) to postpone procedures in patients directed to biventricular repair such as neonates with atrioventricular septal defects (AVSDs) in heart failure or those requiring complex outflow tract reconstructions and finally and (iii) to promote spontaneous closure of muscular ventricular septal defects (VSDs) or residual small VSDs [2, 3]. In these latter indications, the defects may close in a matter of months, but the presence of the banding usually requires an additional procedure. Since 2003, we have adopted the application of an absorbable band custom-made out of a polydioxanone tape (10 mm PDS, Johnson and Johnson, St Stevens-Woluwe, Belgium). This material was initially designed for augmentation of ruptured anterior cruciate ligaments, however the evolution of the techniques of anterior cruciate ligament reconstruction is making this material obsolete and the company has now decided to discontinue its production. We retrospectively analysed the patients at our institution who received an absorbable polydioxanone PAB as part of their surgical treatment to assess speed of resorption, efficacy in avoiding reoperation and development of complications. MATERIALS AND METHODS Patients Presented at the 30th Annual Meeting of the European Association for Cardio-Thoracic Surgery, Barcelona, Spain, 1 5 October The design of the study was approved by the Hospital Research Ethics Committee and the need for consent was waived because VC The Author Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

2 736 M. Daley et al. / European Journal of Cardio-Thoracic Surgery of the retrospective nature of the study. A total of 45 patients aged 2 days 10.8 months (median, 1.6 months) underwent placement of an absorbable polydioxanone PAB at the Royal Children s Hospital in Melbourne, Australia between 2003 and Data were obtained through retrospective review of hospital databases, patient files and operation reports, while recent follow-up was extracted from hospital outpatient clinic follow-up and letters from current cardiologists. Definitions Operative mortality was defined as death occurring prior to hospital discharge or within 30 days of absorbable polydioxanone PAB placement. Late mortality was defined as death occurring after discharge from hospital and greater than 30 days after absorbable polydioxanone PAB placement. Reoperations were documented if they were in relation to the absorbable polydioxanone PAB, VSDs or complications arising from band placement. Early reoperation was defined as return to the operating theatre prior to initial hospital discharge, or within 30 days of absorbable polydioxanone PAB placement. Late reoperation was defined as reoperation occurring after discharge and more than 30 days after absorbable polydioxanone PAB placement. Complete resorption of the absorbable polydioxanone PAB was defined as the earliest postoperative echocardiogram that noted the absence of the hyperechoic band, or failed to mention the presence of a PAB and the absence of main pulmonary artery (MPA) gradient, unless otherwise noted. For all end-points, time was measured from placement of the absorbable polydioxanone PAB. Complex intracardiac anomalies were defined as intracardiac anomalies other than VSDs or arch obstruction (coarctation or aortic arch hypoplasia). Simple defects such as patent foramen ovale, ostium secundum atrial septal defects or patent ductus arteriosus were not included. Surgical technique Strips of approximately 5 mm width were cut from a polydioxanone tape, made of flat, woven polydioxanone filaments. The placement of all absorbable polydioxanone PAB was performed through a midline sternotomy. The absorbable polydioxanone PAB were tightened, where haemodynamically tolerated, reducing MPA pressure distal to the band to between a third and a half of systemic arterial pressure. The bands were secured with either 5/0 or 6/0 polypropylene sutures or 2 ligating clips (LIGACLIP, Johnson and Johnson, St Stevens-Woluwe, Belgium) with conventional method of PAB placement, ensuring that it caused no obstruction of the left and right pulmonary arteries. Standard cardiopulmonary bypass was performed in cases requiring intracardiac repair (n = 34). Statistical analysis All analyses and graphs were performed in Stata version 13 (StataCorp., College Station, TX, USA). Mean (+/- standard deviation), or median [with interquartile range (IQR) and range] were reported for continuous variables and counts and percentages for categorical variables. Freedom from reoperation was measured from the date of placement of the absorbable polydioxanone PAB to the date of first reoperation and was estimated using the Kaplan Meier method. RESULTS Patient demographics The characteristics of the 45 patients undergoing absorbable polydioxanone PAB are summarized in Table 1. The median age at operation was 49 days (interquartile range: days); 42% (19/ 45) were male and 58% (26/45) were female. Four patients (9%) had the following genetic anomalies: Holt-Oram syndrome (2), VACTERL syndrome (1) and Trisomy 21 (1). Nine patients had aortic arch anomalies (coarctation and hypoplastic transverse arch), while 14 patients had complex intracardiac anomalies: transposition of the great arteries (TGA) (6), AVSD (5), double outlet right ventricle (2), congenitally corrected transposition (1) and tricuspid atresia (1). Two patients had undergone a procedure for muscular VSDs prior to the placement of an absorbable polydioxanone PAB. One patient underwent a previous periventricular muscular VSD occluder device closure (Amplatzer muscular VSD occluder, AGA Medical Corporation, Golden Valley, MN, USA) 2 days prior to the placement of an absorbable polydioxanone PAB for residual VSDs with significant left-to-right shunting. The second patient initially underwent an aortic arch repair and placement of a conventional non-absorbable PAB at another institution, however after a period of 3 months, the PAB migrated and caused partial occlusion of the left pulmonary artery. The patient then underwent debanding, direct VSD closure of the remaining perimembranous defect and absorbable polydioxanone PAB placement for residual shunting at the apical septum. Operative data are summarized in Table 2. Of the 34 patients requiring cardiopulmonary bypass, the mean bypass time was ± 73.9 min, while aortic cross-clamp time was ± 50.1 min. A combination of VSD closure and absorbable polydioxanone PAB placement was performed in 62% (28/45) of patients, while exclusive placement of absorbable polydioxanone PAB was Table 1: Patient demographics Patients, n 45 Age at absorbable PAB placement in days 49 [15 89] (median [IQR]) Sex Male, n (%) 19 (42) Female, n (%) 26 (58) Genetic syndrome, n (%) 4 (9) Weight at absorbable PAB placement (kg) 3.8 [ ] [median (IQR) (range)] Preoperative CHF, n (%) 31 (67) Prior operations for multiple VSD, n (%) 2 (4) Cardiac diagnosis, n (%) Multiple VSDs exclusively 22 (49) Multiple VSDs with aortic arch anomaly 9 (20) Multiple VSDs with complex intracardiac anomalies 14 (31) PAB: pulmonary artery band; IQR: interquartile range; CHF: congestive heart failure; VSD: ventricular septal defect.

3 M. Daley et al. / European Journal of Cardio-Thoracic Surgery 737 performed in 38% (17/45) of patients. Patients with aortic arch and intracardiac anomalies underwent concurrent repair of their respective defects. Early outcomes Early mortality occurred in 1 patient (2%). This patient initially presented in congestive cardiac failure with a TGA and multiple VSDs and underwent an arterial switch operation, direct closure of a VSD and absorbable polydioxanone PAB placement for a muscular VSD. The patient s postoperative course was complicated by low-cardiac output state. He required de-banding and eventually died from sepsis and multi-organ failure. Early reoperation occurred in 5 patients (11%) of patients. In 3 patients, the band was removed. Two of them returned to theatre to undergo a second VSD closure of a residual defect around an initial AVSD in 1 and a complex mid-muscular VSD in the other. The third patient who underwent removal of the band is the patient who ultimately died. One patient underwent absorbable polydioxanone PAB tightening in the presence of large residual shunting and 1 patient underwent direct closure of a residual VSD around a patch on the first postoperative day after a perimembranous VSD closure, leaving the absorbable polydioxanone PAB for a separate apical VSD. Of the 45 patients who underwent absorbable polydioxanone PAB placement, 42 patients were discharged from hospital with the absorbable polydioxanone PAB in place. Late outcomes One patient was lost to follow-up. Follow-up was available in 41 of the 42 remaining patients. Mean time to follow-up was 5.2 ± 3.5 years ranging from 25 days to 11.7 years. Three patients died from causes deemed unrelated to the absorbable polydioxanone PAB surgery. One patient with congenitally corrected transposition had the band positioned at birth to Table 2: Intraoperative details Bypass time (min) ± 73.9 Cross-clamp time (min) ± 50.1 Multiple VSD repair, n (%) Placement of absorbable PAB without VSD closure 17 (38) Exclusive absorbable PAB placement 8 (18) Absorbable PAB placement with aortic arch repair 5 (11) Absorbable PAB placement with ASO 2 (4) Absorbable PAB placement with partial AVSD repair 1 (2) Absorbable PAB placement with BCPS 1 (2) Placement of absorbable PAB with VSD closure 28 (62) closure 16 (36) 3 (7) closure and aortic arch repair 4 (9) closure and ASO 4 (9) closure and AVSD repair 1 (2) closure and LPA reconstruction wait for a double switch performed at 3 months of age. She ultimately died of sepsis in the setting of deteriorating heart failure. One patient with AVSD and multiple apical muscular VSDs was observed to have a reduction in the size of the muscular VSDs and the resorption of the band within 5 months. She ultimately died of ischaemic brain injury after mechanical valve replacement at the age of 17 months. The last patient presented to their local emergency department a few weeks after initial discharge with sudden deterioration, which was attributed to a viral illness, and died soon after presentation. Ventricular septal defect spontaneous closure and re-interventions Overall, 32 of the 41 patients discharged from hospital with absorbable PAB did not require reoperation on the VSDs or the band, resulting in a single-stage definitive repair of 78%. Nine of these 41 patients required the following reoperations (Table 3). One patient with tricuspid atresia and a perimembranous VSD who had a bidirectional cavopulmonary shunt and a restricted forward flow with an absorbable PA band later underwent PA division and extracardiac conduit Fontan. Seven patients required a reoperation involving a VSD closure. Three patients had a patch closure of a large perimembranous defect (including the patient with double discordance who ultimately died) and 4 underwent closure of a muscular defect. The muscular defects were closed with a patch in 2 patients, a double patch sandwiching the septum in 1 patient [4] and a periventricular insertion of a muscular VSD occluder device (Amplatzer muscular VSD occluder, AGA Medical Corporation, Golden Valley, MN, USA) [5]. The patient who underwent the sandwich technique required the addition of a second absorbable PA band which effectively resulted in the closure of the residual VSD and underwent resorption within 7 months. Two patients were felt to have failed the strategy of placement of absorbable PA band as they kept large muscular VSDs that did not seem suitable for closure. They were reoperated to have a nonabsorbable PAB implanted 5 and 7 months after the initial band placement. Out of the 29 patients who had PA band implanted for muscular VSDs only (16 with concomitant VSD closure), only 6 required a reoperation on the VSDs resulting in a one-stage repair of 81%. Table 3: Reoperation Late reoperation/re-intervention Absorbable polydioxanone PAB removal, 1 perimembranous VSD closure and Senning procedure VSD repair Direct patch closure 4 Replacement with conventional 2 non-absorbable PAB Sandwich technique + absorbable 1 polydioxanone PAB replacement Periventricular device 1 Re-intervention Balloon dilation for MPA obstruction 1 Patients PAB: pulmonary artery band; VSD: ventricular septal defect; ASO: arterial switch operation; AVSD: atrioventricular septal defect; BCPS: bidirectional cavopulmonary shunt; LPA: left pulmonary artery. PAB: pulmonary artery band; VSD: ventricular septal defect; MPA: main pulmonary artery.

4 738 M. Daley et al. / European Journal of Cardio-Thoracic Surgery Thirteen patients had all VSDs close completely (45%), 13 were left with non-significant residual VSDs (45%) and 3 (10%) had still haemodynamically significant VSDs 9,14 and 24 months after PAB placement, including the 2 patients reoperated to have a non-absorbable band implanted. These last 3 patients are being treated medically. Pulmonary artery band resorption The polydioxanone band underwent resorption in all but 1 patient who required a percutaneous balloon dilation of the MPA 48 months after placement of the band for a mean residual gradient of 30 mmhg. At the last follow-up echocardiogram, no obstruction or restriction could be seen in 36 of the 41 patients; a small restriction was seen in 3 patients whose mean gradients through the MPA were 26, 23, 10 mmhg at 4.5 years, 5 years and 6 years, respectively, post band placement. The evolution of the peak gradient (mmhg) across the band site is detailed in Fig. 1. Three monthly postoperative echocardiography reports were available in 26 patients. These reports were used to assess time to resorption of the absorbable polydioxanone PAB as described by the absence of any identifiable obstruction in the MPA. In 1 patient left with a peak gradient of 26 mmhg, the morphological aspect of the MPA could not be assessed because the hyperechogenicity of the area. In the 25 remaining patients, median time to absorbable PAB resorption was 7.2 months (interquartile range, ). After 3 months, the peak gradient had reduced to less than 30 mmhg in 24% (6/25) of patients, after 6 months, 60% (15/25) of patients, and after 9 months, 84% (21/25) of patients. Five of the 6 patients whose gradient was reduced by 3 months had been noted to have loose absorbable PAB placement at surgery, with postoperative gradients inferior to 30 mmhg. Only 4 patients continued to have a significant gradient (>30 mmhg) beyond 9 months. Freedom from reoperation related to residual VSD or PAB obstruction was 78% (95% CI: 61 87%) at 10 years (Fig. 2). DISCUSSION Despite all advances in the field of paediatric heart surgery, we still need at times to use conventional approaches such as PAB. Multiple small VSDs such as those seen in the interventricular septum described as Swiss cheese, muscular VSDs with a complex tract, distal apical VSDs and residual lesions that cannot be identified are sometimes best left alone because the surgery required to close them is quite destructive and they are prone to spontaneous closure with PA banding. Unfortunately, conventional PA banding with non-absorbable material is bound to a need for reoperation to relieve the created stenosis. Today, there seem to be only 2 options to address these reoperations after the placement of a PAB: the adjustable PAB (FloWatch PAB device, EndoArt, Lausanne, Switzerland) and the polydioxanone absorbable PAB. The FloWatch is a telemetrically adjustable pulmonary band but has predominantly been used as a device to progressively increase the gradient rather than to decrease it [6]. Adjustable PABs have undergone significant trials recently with good outcomes compared to conventional PAB [7 9]. However, adjustable PABs still require reoperation for removal of the device, and carry high associated costs with the device. The use of polydioxanone PAB was first reported in 1991 by Vince et al. [10] and Gutierrez de Loma et al. [11]. The reports showed that absorbable PAB was as safe and effective as conventional PAB, with the benefit of avoiding reoperation through either balloon dilation of the MPA or through resorption. Bonnet et al. (1999) incorporated the use of absorbable polydioxanone PAB in the surgical treatment of aortic coarctation with muscular VSDs in 11 patients, in an attempt to reduce the rate of reoperation [12]. This single-stage repair approach resulted in adequate closure of the VSD in 91% of patients, with only 1 out of 11 patients requiring reoperation and direct closure of the VSD. We have also previously documented the use of absorbable PAB after repair of complex multiple VSDs in 15 patients, as well as investigating the rate of resorption of polydioxanone absorbable PAB in patients with muscular or residual VSDs [2]. The median time to absorbable PAB resorption in our previous study was 7.9 months, which is comparable to our current overall median time to resorption of 7.2 months. Our results show that patients with only muscular VSDs avoided reoperation 81% of the time when absorbable polydioxanone PAB was incorporated in the repair strategy. With 90% of patients having either haemodynamically insignificant interventricular shunting or no VSD at latest follow-up, there is a good rate of closure of muscular VSDs with the use of absorbable polydioxanone PAB. Today, the use of the absorbable polydioxanone PAB is our preferred choice in all patients who may benefit from a single-stage repair. We still use a conventional non-absorbable PAB made from a strip of eptfe (Gore-Tex, W.L. Gore & Figure 1: Peak gradient across absorbable pulmonary artery banding (PAB) site. Figure 2: Freedom from reoperation.

5 M. Daley et al. / European Journal of Cardio-Thoracic Surgery 739 Associates, Inc., Flagstaff, AZ, USA) in patients who are destined for re-intervention, such as neonates with AVSD in heart failure and patients with complex biventricular circulations in whom the band is placed to postpone a difficult repair. Unfortunately, while we demonstrated the benefits in the use of an absorbable polydioxanone PAB, the company has decided to stop its production. We are now compelled to explore other materials with similar characteristics. Resorption of the band was variable between patients, as was the gradient across the band site. We noted the majority of patients experienced a reduction of the peak gradient to less than 30 mmhg within the first 6 months. However, 4 patients continued to have higher gradients 9 months after band placement. As our unit does not schedule postoperative echocardiography at intervals of less than 3 months, it is difficult to ascertain the exact time of resorption retrospectively. Monthly follow-up echocardiography collected prospectively would be necessary to confirm the exact time to resorption and assess the gradual closure of VSDs. With increasing experience with this strategy, we have come to realize that when several muscular VSDs are present, our chances of performing an effective single-stage operation are higher if we close the largest of these defects. In the situations when the total cumulative shunting of the defects is such that there is no pressure gradient between the 2 ventricles, we believe that there is little stimulus for the interventricular septum to thicken and to promote spontaneous VSD closure. In our experience, incorporating a combined approach of VSD closure and absorbable polydioxanone PAB has yielded the best results for closure of muscular VSD. We have become so confident in the absorbable polydioxanone PAB that we focus on closing only the largest VSDs. In conclusion, PAB with a strip of absorbable polydioxanone is useful adjunct to our armamentarium of techniques. It results in the closure of muscular VSD in a single operation in the majority of patients avoiding the need for reoperation on the pulmonary arteries in almost all patients. Funding The authors acknowledge support provided to the Murdoch Children s Research Institute through the Victorian Government s Operational Infrastructure Support Programme. Yves d Udekem is a NHMRC Clinician Practitioner Fellow ( ). Conflict of interest: Yves d Udekem is a consultant for companies MSD and Actelion. Christian P. Brizard is a member of the advisory board for Admedus. REFERENCES [1] Muller WH Jr, Danimann JF Jr. The treatment of certain congenital malformations of the heart by the creation of pulmonic stenosis to reduce pulmonary hypertension and excessive pulmonary blood flow; a preliminary report. Surg Gynecol Obstet 1952;95: [2] Oka N, Brizard CP, Liava a M, D Udekem Y. Absorbable pulmonary arterial banding: an optimal strategy for muscular or residual ventricular septal defects. J Thorac Cardiovasc Surg 2011;141: [3] Bonnet D, Sidi D, Vouhe PR. Absorbable pulmonary artery banding in tricuspid atresia. Ann Thorac Surg 2001;71: [4] Brizard CP, Olsson C, Wilkinson JL. New approach to multiple ventricular septal defect closure with intraoperative echocardiography and double patches sandwiching the septum. J Thorac Cardiovasc Surg 2004;128: [5] Crossland DS, Wilkinson JL, Cochrane AD, D Udekem Y, Brizard CP, Lane GK. Initial results of primary device closure of large muscular ventricular septal defects in early infancy using perventricular access. Catheter Cardiovasc Interv 2008;72: [6] Bonnet D, Corno AF, Sidi D, Sekarski N, Beghetti M, Schulze-Neick I et al. Early clinical results of the telemetric adjustable pulmonary artery banding FloWatch-PAB. Circulation 2004;110:II [7] Corno AF. FloWatch device for adjustable pulmonary artery banding. J Thorac Cardiovasc Surg 2013;145:1144. [8] Corno AF, Kandakure PR, Dhannapuneni RR, Gladman G, Venugopal P, Alphonso N. Multiple ventricular septal defects: a new strategy. Front Pediatr 2013;1:16. [9] Talwar S, Kumar MV, Choudhary SK, Airan B. Conventional versus adjustable pulmonary artery banding: which is preferable? Interact CardioVasc Thorac Surg 2014;18: [10] Vince DJ, Culham JA, LeBlanc JG. Human clinical trials of the dilatable pulmonary artery banding prosthesis. Can J Cardiol 1991;7: [11] Gutierrez de Loma J, Ferreiros Mur M, Castilla Moreno M, Garcia Pena R, Gonzalez de Vega N. [Reabsorbable banding. Our initial experience]. Rev Esp Cardiol 1991;44: [12] Bonnet D, Patkai J, Tamisier D, Kachaner J, Vouhe P, Sidi D. A new strategy for the surgical treatment of aortic coarctation associated with ventricular septal defect in infants using an absorbable pulmonary artery band. J Am Coll Cardiol 1999;34: