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Application of hybrid Stage I palliation for patients with two ventricular cavities and hypoplastic left heart structures†

Application of hybrid Stage I palliation for patients with two ventricular cavities and... OBJECTIVES: To assess the feasibility of hybrid Stage I palliation consisting of bilateral pulmonary artery bandings and ductal stenting for patients with 2 ventricular cavities and hypoplastic left heart structures. METHODS: Eleven consecutive patients who underwent hybrid Stage I palliation between 2010 and 2017 were enrolled. The diagnoses were interrupted aortic arch/coarctation of the aorta, ventricular septal defect and significant left ventricular (LV) outflow tract obstruction in 5 patients, critical aortic stenosis and reduced LV contraction in 3 patients and hypoplastic left heart complex in 3 patients. RESULTS: The median age at definitive surgery was 12 months (range 6–22 months). During the mean follow-up period of 24 months (range 9–83 months) following the definitive surgery, there was 1 death. Two patients with interrupted aortic arch/coarctation of the aorta did not undergo the Yasui operation but underwent arch repair and ventricular septal defect closure after the growth of the aortic valve and LV outflow tract. For 2 of the 3 patients with critical aortic stenosis, biventricular repair was performed. Of the 3 patients with hypo- plastic left heart complex, 2 patients showed growth of the mitral valve and left ventricle following LV rehabilitation by balloon pulmonary artery dilatation or surgical debanding of the banded pulmonary arteries and subsequently underwent biventricular repair, which resulted in 1 death. CONCLUSIONS: Hybrid Stage I palliation would be a safe and beneficial treatment for patients with 2 ventricles, as a bridge to decide whether and how to achieve a biventricular repair and whether it should be preceded by a preliminary LV rehabilitation. Keywords: Hybrid Stage 1 palliation � Biventricular repair � Left ventricular rehabilitation � Hypoplastic left heart alternative to the Norwood procedure for high-risk patients with INTRODUCTION hypoplastic left heart syndrome [7]. Since 2010, we have used this strategy for patients with 2 ventricular cavities to determine In addition to revealing late clinical features of the Fontan circu- the necessity for BVR, to determine BVR procedures or to facili- lation, the importance of biventricular repair (BVR) is increasing. tate BVR following a preliminary left ventricular (LV) rehabilita- Although technically complex BVR for neonates with hypoplastic tion. In this study, we reviewed our institutional experience with left heart structures may be possible [1–4], the decision for an appropriate procedure is not easy, because the evaluation of size HS1P for patients with 2 ventricular cavities and hypoplastic left and function of left heart structures is sometimes inaccurate dur- heart structures. ing the early neonatal period. In addition, the growth potential of borderline-sized left heart structures usually cannot be confirmed soon after birth. It is also unclear whether subsequent rehabilita- MATERIALS AND METHODS tion promotes their growth sufficiently to obtain biventricular cir- culation [5, 6]. Patients Hybrid Stage I palliation (HS1P), consisting of bilateral pulmo- nary artery bandings and ductal stenting with or without balloon The National Cerebral and Cardiovascular Center Institutional atrial septectomy or intra-atrial stenting, was developed as an Review Board approved this retrospective study and waived the need for obtaining patient consent. Since 2010, 11 patients with 2 †Presented at the 31st Annual Meeting of the European Association for Cardio- Thoracic Surgery, Vienna, Austria, 7-11 October 2017. ventricular cavities and hypoplastic left heart structures underwent The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/906/4823620 by Ed 'DeepDyve' Gillespie user on 20 June 2018 A. Higashida et al. / Interactive CardioVascular and Thoracic Surgery 907 HS1P (Table 1). The main diagnoses were interrupted aortic arch/ coarctation of the aorta complex (n =5) with LV outflow tract Table 1: Patient characteristics obstruction (n= 4) or respiratory failure (n= 1), critical aortic steno- sis with reduced LV function (n = 3) and hypoplastic left heart com- Number of patients (n)11 Male: female (n) 7:4 plex (n = 3). The median gestational age and birthweight were Diagnosis (n) 38 weeks (range 34–40 weeks) and 2.7 kg (range 1.4–3.1 kg), IAA/CoA complex with LVOTO 5 respectively. Of the 11 patients, 1 (9.1%) patient was a preterm HLHC 3 delivery. There were 5 low-birthweight infants (45.4%). A chromo- cAS with reduced LV contraction 3 Gestational age (weeks), median (range) 38 (34–40) somal abnormality was detected in 4 (36.4%) patients; of these <37 weeks (n)1 patients, 2 patients had 22q11.2 deletion syndrome, 1 patient had Birthweight (kg), median (range) 2.6 (1.4–3.1) 5p deletion syndrome and 1 had partial trisomy 8. <2.5 kg (n)5 Body surface area at birth (m ), median (range) 0.18 (0.12–0.2) Chromosomal abnormality (n)4 Procedure of hybrid stage I palliation Age at bPAB (days), median (range) 7 (3–50) Age at DS (days), median (range) 24 (5–78) Because of the lack of a hybrid operating theatre and the inter- ventional cardiologist’s preference, HS1P was not performed as a bPAB: bilateral pulmonary artery bandings; cAS: critical aortic stenosis; CoA: coarctation of aorta; DS: ductal stenting; HLHC: hypoplastic left single procedure. Bilateral pulmonary artery bandings were per- heart complex; IAA: interrupted aortic arch; LV: left ventricle; LVOTO: formed following ductal stenting in all patients, except 1 patient left ventricular outflow tract obstruction. who developed ductal shock prior to his arrival via median full sternotomy, at a median age of 7 days (range 3–50 days). After careful dissection, the branch pulmonary arteries were banded to reduce their inner diameter to <1.5 mm, confirmed by intraoper- For patients with hypoplastic left heart complex, subsequent ative direct 2D echocardiography. For patients with hypoplastic LV rehabilitation following HS1P by balloon pulmonary artery left heart complex, banding tape was fixed with absorbable dilatation at banded sites or surgical debanding was performed sutures to facilitate later dilation of the banded site by percutane- to gradually increase the LV volume preload. Notably, the term ous balloon pulmonary artery dilation. At 1.5 mm from the inside ‘LV rehabilitation’ is different from its original meaning, as previ- fixation with an absorbable suture, an additional fixation was ously reported [9]. HS1P with subsequent LV rehabilitation indi- placed with a non-absorbable suture to prevent excessive cated for patients with z-values of LV end-diastolic diameter dilatation. greater than -5, and z-values of mitral valve diameter greater V TM Ductal stenting was performed with PALMAZ GENESIS on than -4, was estimated with the apical 4-chamber view of 2D TM OPTA Pro (Cordis, Cardinal Health Inc., Fremont, CA, USA) transthoracic echocardiography. During rehabilitation, small at the median age of 27 days (range 5–78 days) and was atrial communication (3 mm) was maintained by balloon atrial approached via the femoral vein. The size of the implanted stent septostomy. After LV rehabilitation, BVR was indicated, if the z- was 6 mm in 6 patients and 8 mm in 5 patients; the length of the value of LV end-diastolic diameter was above 0. stent was 15 mm in 4 patients, 18 mm in 6 patients and 24 mm in 1 patient. No patient required redilatation of the implanted stent, Management of ductal stent and bilateral but additional stent implantation was needed in 1 patient for in- pulmonary artery during definitive surgery stent stenosis. During definitive surgery, ductal stenting was completely Indication of hybrid Stage I palliation and removed under hypothermic (18 C) lower body circulatory arrest with selective cerebral perfusion. After removal of the banding institutional criteria for biventricular repair and its tapes, branch pulmonary arteries were dilated from inside with a procedures Hegar dilator in 4 patients, augmented by an autopericardial patch in 5 patients or expanded polytetrafluoroethylene in 1 Patients with interrupted aortic arch/coarctation of the aorta patient. Selection of the repair method mainly depended on the complex should have 2 balanced ventricles; therefore, the aim of time between HS1P and definitive surgery. HS1P was to provide alternative BVR procedures. Selection of the BVR procedure was based on the size of the aortic valve diameter and LV outflow tract diameter in systole, estimated by a paraster- Study method nal long-axis view of transthoracic 2D echocardiography. When the z-value of the aortic valve diameter was less than -3, the This study was a retrospective, single-institutional study. From Yasui operation was selected. If the z-value of the aortic valve electronic clinical records, operative records, echocardiography diameter was greater than -3, but the LV outflow tract diameter and cardiac catheterization reports and outpatient clinical was less than -3, LV outflow tract myectomy and the closure of records, the following variables were evaluated: (i) overall out- ventricular septal defect (VSD) were selected. comes, (ii) individual clinical courses after HS1P based on main For patients with critical aortic stenosis and reduced LV func- diagnoses and (iii) complications following definitive surgeries. tion associated with endocardial fibroelastosis, HS1P and subse- Data were analysed using JMP 11 (SAS Institute Inc., Cary, NC, quent balloon aortic valvotomy were performed to confirm the USA). During the study period, heart transplantation or LV assist recovery of both LV systolic and diastolic function, as previously device implantation were not indicated for patients with post- reported [8]. cardiotomy heart failure in Japan. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/906/4823620 by Ed 'DeepDyve' Gillespie user on 20 June 2018 WORK IN PROGRESS REPORT 908 A. Higashida et al. / Interactive CardioVascular and Thoracic Surgery 3 years following the definitive surgery was 90%. There was 1 in- RESULTS hospital mortality, and no late mortalities. Overall outcomes Individual clinical courses by main diagnosis All patients underwent definitive surgery, except 1 patient with hypoplastic left heart complex, and the median follow-up period Interrupted aortic arch/coarctation of the aorta complex. from definitive surgery was 22 months (range 4–45 months). The One patient who was not premature but experienced respiratory median age, body weight and body surface area at definitive sur- failure soon after birth (later diagnosed as congenital central gery were 12 months (range 6–34 months), 6.0 kg (range 5.2– hypoventilation syndrome) was free from LV outflow tract 2 2 11.4 kg) and 0.31 m (range 0.28–0.51 m ), respectively (Table 2). obstruction before and after HS1P and underwent arch repair The median duration between HS1P and definitive surgery was and VSD closure as the definitive surgery (Fig. 1A). Of the remain- 11.6 months (range 4.8–21.6 months). The actual survival rate at ing 4 patients with LV outflow tract obstruction, growth of the LV outflow tract and aortic valve was confirmed in 2 patients (Fig. 2), 1 patient underwent arch repair and VSD closure, and 1 patient underwent arch repair, VSD closure and LV outflow tract myectomy. Table 2: Late complications following definitive surgeries Definitive surgery was performed at the median weight of 6 kg (n =9) (5.5–7.2 kg) and the median age of 17 months (5–20 months), and no patient showed significant lower body cyanosis prior to the Variables n (%) operation. However, 1 patient who awaited definitive surgery Complications until 20 months developed left bronchial stenosis due to com- LVOTO required reoperation 0 pression by the ductal stent. Instead of direct anastomosis, the Recurrent CoA 0 aortic arch of the patient was reconstructed with interposition of Bronchial stenosis 0 Pacemaker implantation 0 glutaraldehyde-treated autopericardial roll during the definitive Surgical intervention surgery, and relief of left bronchial stenosis was confirmed CRT implantation 1 (11) 1 month later by computed tomography. MVR + re-RVOTR 1 (11) Re-RVOTR 1 (11) Catheter intervention Critical aortic stenosis with reduced left ventricular PTA for branch pulmonary artery 4 (44) function. As mentioned earlier, the clinical courses of 2 of the 3 Ablation for atrial tachyarrhythmia 1 (11) patients has already been described in our previous report [8]. For the third patient, who was born with a body weight of 1.8 kg CoA: coarctation of aorta; CRT: cardiac resynchronization therapy; LVOTO: left ventricular outflow tract obstruction; MVR: mitral valve and associated with aortic arch obstruction, LV systolic function replacement; PTA: percutaneous transluminal angioplasty; RVOTR: right smoothly recovered following HS1P and subsequent balloon ventricular outflow tract obstruction. aortic valvotomy, and thus a Ross operation was scheduled (Fig. 1B). However, a further careful estimation of the aortic valve Figure 1: Individual clinical courses following hybrid Stage 1 palliation by main diagnosis. (A) IAA or CoA complex, (B) cAS and (C) HLHC. AVP: aortic valve plasty; BAS: balloon atrial septostomy; BDG: bidirectional Glenn; BVR: biventricular repair; cAS: critical aortic stenosis; CoA: coarctation of aorta; HLHC: hypoplastic left heart complex; IAA: interrupted aortic arch; MVP: mitral valve plasty; OAC: open aortic commissurotomy; PA: pulmonary artery; PTAV: percutaneous transluminal aortic val- votomy; PTBD: percutaneous balloon dilation at the banded site; SAS: subaortic stenosis; SV: single ventricle; VSD: ventricular septal defect. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/906/4823620 by Ed 'DeepDyve' Gillespie user on 20 June 2018 A. Higashida et al. / Interactive CardioVascular and Thoracic Surgery 909 12 months, arch repair, VSD closure and papillary muscle splitting for the parachute-like mitral valve were successfully performed. The second patient was complicated by high LV end-diastolic pressure and high pulmonary vascular resistance during the LV rehabilitation. BVR was performed at the age of 6 months (Fig. 5). This was followed by a redo surgery consisting of mitral valve replacement for iatrogenic significant regurgitation and relief of previously underestimated valvular and supravalvular aortic stenosis 1.5 months later. However, low cardiac output syndrome and pulmonary hypertension continued after that. Although sin- gle ventricular conversion was attempted at 4 months after the BVR, low cardiac output syndrome and cyanosis became critical. Figure 2: Changes of AVD and LVOTD in patients with interrupted aortic arch Late complications after definitive surgeries or coarctation of the aorta and VSD after hybrid Stage 1 palliation. AVD: aortic valve diameter; LVOTD: left ventricular outflow tract diameter; VSD: ventricular Recurrent LV outflow tract obstruction, aortic arch obstruction, septal defect. bronchial stenosis or pacemaker implantation were not observed during the entire follow-up period (Table 2). The rate of freedom from reoperation at 3 years after definitive surgeries was 75%. A total of 3 surgical interventions were required in 2 patients (Table 2). Patients with critical aortic stenosis who had undergone a Ross–Konno operation developed heart failure due to ventricular dys-synchrony originating from complete left bundle branch block; hence, cardiac resynchronization therapy had been introduced since 1 year after discharge. After that, mitral regurgitation progressed, and mitral valve replacement and redo right ventricle-to-pulmonary artery conduit replacement were concomitantly performed 3 years later. The other patient who had undergone the Yasui operation required a redo right ventricle-to- pulmonary artery conduit replacement. As for the catheter-based interventions, balloon pulmonary artery dilatation was performed for postoperative branch pulmo- nary stenosis in 4 of the 9 (44%) patients. One patient with hypo- plastic left heart complex who had undergone BVR developed atrial tachycardia, and so catheter ablation was repeated. Figure 3: Changes of LVEDD and MVD in patients with hypoplastic left heart complex after hybrid Stage 1 palliation. BVR: biventricular repair; LVEDD: left DISCUSSION ventricular end-diastolic diameter; MVD: mitral valve diameter; SV: single ven- tricle; SVR: single ventricle repair. This study reviewed mid-term clinical outcomes of HS1P for patients with hypoplastic left heart structures and 2 ventricular detected a still fused commissure, and nodule-like thickness of cavities. HS1P contributed to the appropriate selection of BVR the leaflets restricted their mobility; so BVR, which consisted of procedure, choice of candidate for BVR and growth of left heart aortic arch reconstruction, aortic valve commissurotomy and structures sufficient to go on to BVR, but resulted in 1 in-hospital leaflet slicing, was successfully performed at 10 months. At the mortality for a patient who underwent BVR following LV time of BVR, the development of secondary left pulmonary vein rehabilitation. stenosis was also relieved with a primary sutureless technique. At There are several surgical options to enlarge hypoplastic aortic the last follow-up, the pressure gradient across the aortic valve valves and LV outflow tracts, such as the surgical aortic valvulo- was 19 mmHg, and regurgitation was trivial. plasty, Ross–Konno ventriculoplasty or Yasui operation (Norwood/Rastelli procedure) if VSD exists [10]. However, these Hypoplastic left heart complex. One of the 3 patients devel- surgeries are technically complex, especially during the neonatal oped significant pulmonary hypertension and severe hypoxia period, and so reoperation is inevitable. For patients with inter- during the first balloon pulmonary artery dilatation (Fig. 1C). rupted aortic arch or coarctation of the aorta complex, growth of Then, balloon atrial septostomy was concomitantly performed, the aortic valve after bilateral pulmonary artery banding with which meant BVR was no longer indicated. A Norwood opera- keeping prostaglandin E1 administration had been previously tion concomitant with bidirectional Glenn anastomosis was reported [11]. It showed that 1-month interval was believed to be scheduled. sufficient to decide the type of definitive surgical procedure. Two patients showed sufficient growth of the LV end-diastolic Also, recovery of the LV function could be confirmed within diameter (Fig. 3). Chronological changes of the LV end-diastolic 1 year after balloon aortic valvotomy [12]. Based on these find- diameter, mitral valve diameter and pulmonary vascular resist- ings, we may decide on the definitive surgery so late that several ance of the first patient are shown in Fig. 4. At the age of complications, such as bronchial stenosis and pulmonary veins Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/906/4823620 by Ed 'DeepDyve' Gillespie user on 20 June 2018 WORK IN PROGRESS REPORT 910 A. Higashida et al. / Interactive CardioVascular and Thoracic Surgery Figure 4: Apical 4-chamber view (A) before and (B) after HS1P and (C) chronological changes of z-values of MVD and LVEDD and PVR in 1 patient in the hypoplastic left heart complex group. BVR: biventricular repair; HS1P: hybrid Stage I palliation; LV: left ventricle; LVEDD: left ventricular end-diastolic diameter; MVD: mitral valve diameter; PTBD: percutaneous balloon dilation at the banded site; PVR: pulmonary vascular resistance; RV: right ventricle. Figure 5: Apical 4-chamber view and parasternal short-axis view (A) before and (B) after HS1P and (C) chronological changes of z-values of MVD and LVEDD PVR and LVEDP after HS1P in 2 patients in the hypoplastic left heart complex group. BVR: biventricular repair; HS1P: hybrid Stage I palliation; LV: left ventricle; LVEDD: left ven- tricular end-diastolic diameter; LVEDP: left ventricular end-diastolic pressure; MVD: mitral valve diameter; PVR: pulmonary vascular resistance; PTBD: percutaneous balloon dilation at banded site; RV: right ventricle. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/906/4823620 by Ed 'DeepDyve' Gillespie user on 20 June 2018 A. Higashida et al. / Interactive CardioVascular and Thoracic Surgery 911 obstruction, occurred during the inter-stage period. Moreover, experiences is mandatory to reveal suitable candidates to reconstruction of banded branch pulmonary arteries is difficult undergo HS1P and LV rehabilitation, instead of neonatal single- long after bilateral pulmonary artery bandings. Now, we believe ventricle palliation. that less than 6 months after HS1P is the suitable timing to per- form definitive surgery. Conflict of interest: none declared. On the contrary, effective options to enlarge LV inflow and the cavity itself are scarce [9]; therefore, the process of LV rehabilita- tion is never too long if sufficient growth is obtained. Indeed, REFERENCES responses to the LV rehabilitation and clinical outcomes were quite different in our 3 study cohorts. As mentioned earlier, the [1] Tchervenkov CI, Tahta SA, Jutras LC, Belan MJ. Biventricular repair in second patient could not tolerate BVR; nevertheless growth of neonates with hypoplastic left heart complex. Ann Thorac Surg 1998;66: the left ventricle seemed to be sufficient to proceed. Although 1350–7. insufficient surgical relief of both LV inflow and outflow obstruc- [2] Hoashi T, Bove EL, Devaney EJ, Hirsch JC, Ohye RG. Intermediate-term clinical outcomes of primary biventricular repair for left ventricular out- tions must have been a serious matter, significant pulmonary flow tract obstruction and ventricular septal defect. J Thorac Cardiovasc hypertension and high left atrial pressure under the presence of Surg 2011;141:200–6. tiny atrial communication had been noted just prior to BVR pro- [3] Serraf A, Piot JD, Bonnet N, Lacour-Gayet F, Touchot A, Bruniaux J et al. cedure. The previous report showed that 1 of the 2 patients who Biventricular repair approach in ducto-dependent neonates with hypo- undergone coarctation repair and immediately developed signifi- plastic but morphologically normal left ventricle. J Am Coll Cardiol 1999; 33:827–34. cant backwards pulmonary hypertension derived from hypoplas- [4] Tani LY, Minich LL, Pagotto LT, Shaddy RE, McGough EC, Hawkins JA. tic left heart structures could proceed a BVR 3 months after a Left heart hypoplasia and neonatal aortic arch obstruction: is the Rhodes palliative Van Praagh shunt [13] combined with bilateral pulmo- left ventricular adequacy score applicable? J Thorac Cardiovasc Surg nary artery bandings [14]. From this, we realize that BVR should 1999;118:81–6. have been postponed until the normalization of elevated ventric- [5] Ahmad F, Mangano R, Shore S, Polimenakos A. Critically underdevel- ular end-diastolic pressure was confirmed, otherwise BVR would oped left heart morphology associated with prematurity and low birth weight: conditional staged rehabilitation towards biventricular repair have not been indicated when significant backwards pulmonary and time-related growth of left heart structures. Pediatr Cardiol 2017;38: hypertension remained. 1519–21. A previous report already showed that the application of HS1P [6] Brown SC, Boshoff D, Eyskens B, Gewillig M. Hybrid approach as bridge allowed 36 of 40 patients with hypoplastic left heart complex to to biventricular repair in a neonate with critical aortic stenosis and bor- achieve BVR [15] ‘without’ subsequent LV rehabilitation, but all derline left ventricle. Eur J Cardiothorac Surg 2009;35:1080–2. [7] Gibbs JL, Wren C, Watterson KG, Hunter S, Hamilton L. Stenting of the cohorts had relatively large-sized mitral valve prior to HS1P (z- arterial duct combined with banding of the pulmonary arteries and atrial value of more than -2.97), and its growth was statistically signifi- septectomy or septostomy: a new approach to palliation for the hypo- cant but limited (before HS1P vs at BVR, P = 0.05). The other plastic left heart syndrome. Br Heart J 1993;69:551–5. report showed that growth of the hypoplastic mitral valve (but z- [8] Misumi Y, Hoashi T, Kagisaki K, Yazaki S, Kitano M, Kurosaki K et al. The value of more than -3.7) was normalized after the relief of left- importance of hybrid stage 1 palliation for neonates with critical aortic stenosis and reduced left ventricular function. Pediatr Cardiol 2015;36: sided obstructive lesions [16]. From these findings and our expe- 726–31. riences, LV rehabilitation may be recommended for patients with [9] Emani SM, Bacha EA, McElhinney DB, Marx GR, Tworetzky W, Pigula FA z-values greater than -4 for the mitral valve diameter and a LV et al. Primary left ventricular rehabilitation is effective in maintaining end-diastolic diameter greater than -5. However, further accu- two-ventricle physiology in the borderline left heart. J Thorac mulation of experiences is mandatory to reveal suitable candi- Cardiovasc Surg 2009;138:1276–82. [10] Hickey EJ, Yeh T Jr, Jacobs JP, Caldarone CA, Tchervenkov CI, McCrindle dates who should undergo HS1P and LV rehabilitation, instead of BW et al. Ross and Yasui operations for complex biventricular repair in neonatal single-ventricle palliation. infants with critical left ventricular outflow tract obstruction. Eur J Cardiothorac Surg 2010;37:279–88. [11] Fuchigami T, Nishioka M, Akashige T, Higa S, Takahashi K, Nakayashiro Limitations M et al. Growing potential of small aortic valve with aortic coarctation or interrupted aortic arch after bilateral pulmonary artery banding. This study is not a comparative study between the HS1P and the Interact CardioVasc Thorac Surg 2016;23:688–3. neonatal primary repair, and the number of patients is limited. [12] McElhinney DB, Lock JE, Keane JF, Moran AM, Colan SD. Left heart So far, this is not an overview investigation but a series of case growth, function, and reintervention after balloon aortic valvuloplasty reports. Further accumulation of experiences is required, and for neonatal aortic stenosis. Circulation 2005;111:451–8. [13] Van Praagh R, Bernhard WF, Rosenthal A, Parisi LF, Fyler DC. Interrupted randomization should be conducted to reveal the superiority of aortic arch: surgical treatment. Am J Cardiol 1971;27:200–11. the presented surgical strategy. [14] Brown SC, Eyskens B, Boshoff D, Cools B, Heying R, Rega F et al.Bailout shunt/ banding for backward left heart failure after adequate neonatal coarctectomy in borderline left hearts. Interact CardioVasc Thorac Surg 2016;23:929–32. CONCLUSIONS [15] Yerebakan C, Murray J, Valeske K, Thul J, Elmontaser H, Mueller M et al. Long-term results of biventricular repair after initial Giessen hybrid approach for hypoplastic left heart variants. J Thorac Cardiovasc Surg In summary, HS1P would be a safe and beneficial palliation as a 2015;149:1112–20. bridge to a decision for the indication of BVR in patients with 2 [16] Avitabile CM, Mercer-Rosa L, Ravishankar C, Rome JJ, Gaynor JW, Spray ventricular cavities and hypoplastic left heart structures, to a TL et al. Experience with biventricular intervention for neonates with decision regarding BVR procedure or to a bridge to BVR follow- mitral valve abnormalities in the setting of critical left-side heart obstruc- ing subsequent LV rehabilitation. Further accumulation of tion. Ann Thorac Surg 2015;99:877–83. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/906/4823620 by Ed 'DeepDyve' Gillespie user on 20 June 2018 WORK IN PROGRESS REPORT http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Interactive Cardiovascular and Thoracic Surgery Oxford University Press

Application of hybrid Stage I palliation for patients with two ventricular cavities and hypoplastic left heart structures†

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Oxford University Press
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© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
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Abstract

OBJECTIVES: To assess the feasibility of hybrid Stage I palliation consisting of bilateral pulmonary artery bandings and ductal stenting for patients with 2 ventricular cavities and hypoplastic left heart structures. METHODS: Eleven consecutive patients who underwent hybrid Stage I palliation between 2010 and 2017 were enrolled. The diagnoses were interrupted aortic arch/coarctation of the aorta, ventricular septal defect and significant left ventricular (LV) outflow tract obstruction in 5 patients, critical aortic stenosis and reduced LV contraction in 3 patients and hypoplastic left heart complex in 3 patients. RESULTS: The median age at definitive surgery was 12 months (range 6–22 months). During the mean follow-up period of 24 months (range 9–83 months) following the definitive surgery, there was 1 death. Two patients with interrupted aortic arch/coarctation of the aorta did not undergo the Yasui operation but underwent arch repair and ventricular septal defect closure after the growth of the aortic valve and LV outflow tract. For 2 of the 3 patients with critical aortic stenosis, biventricular repair was performed. Of the 3 patients with hypo- plastic left heart complex, 2 patients showed growth of the mitral valve and left ventricle following LV rehabilitation by balloon pulmonary artery dilatation or surgical debanding of the banded pulmonary arteries and subsequently underwent biventricular repair, which resulted in 1 death. CONCLUSIONS: Hybrid Stage I palliation would be a safe and beneficial treatment for patients with 2 ventricles, as a bridge to decide whether and how to achieve a biventricular repair and whether it should be preceded by a preliminary LV rehabilitation. Keywords: Hybrid Stage 1 palliation � Biventricular repair � Left ventricular rehabilitation � Hypoplastic left heart alternative to the Norwood procedure for high-risk patients with INTRODUCTION hypoplastic left heart syndrome [7]. Since 2010, we have used this strategy for patients with 2 ventricular cavities to determine In addition to revealing late clinical features of the Fontan circu- the necessity for BVR, to determine BVR procedures or to facili- lation, the importance of biventricular repair (BVR) is increasing. tate BVR following a preliminary left ventricular (LV) rehabilita- Although technically complex BVR for neonates with hypoplastic tion. In this study, we reviewed our institutional experience with left heart structures may be possible [1–4], the decision for an appropriate procedure is not easy, because the evaluation of size HS1P for patients with 2 ventricular cavities and hypoplastic left and function of left heart structures is sometimes inaccurate dur- heart structures. ing the early neonatal period. In addition, the growth potential of borderline-sized left heart structures usually cannot be confirmed soon after birth. It is also unclear whether subsequent rehabilita- MATERIALS AND METHODS tion promotes their growth sufficiently to obtain biventricular cir- culation [5, 6]. Patients Hybrid Stage I palliation (HS1P), consisting of bilateral pulmo- nary artery bandings and ductal stenting with or without balloon The National Cerebral and Cardiovascular Center Institutional atrial septectomy or intra-atrial stenting, was developed as an Review Board approved this retrospective study and waived the need for obtaining patient consent. Since 2010, 11 patients with 2 †Presented at the 31st Annual Meeting of the European Association for Cardio- Thoracic Surgery, Vienna, Austria, 7-11 October 2017. ventricular cavities and hypoplastic left heart structures underwent The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/906/4823620 by Ed 'DeepDyve' Gillespie user on 20 June 2018 A. Higashida et al. / Interactive CardioVascular and Thoracic Surgery 907 HS1P (Table 1). The main diagnoses were interrupted aortic arch/ coarctation of the aorta complex (n =5) with LV outflow tract Table 1: Patient characteristics obstruction (n= 4) or respiratory failure (n= 1), critical aortic steno- sis with reduced LV function (n = 3) and hypoplastic left heart com- Number of patients (n)11 Male: female (n) 7:4 plex (n = 3). The median gestational age and birthweight were Diagnosis (n) 38 weeks (range 34–40 weeks) and 2.7 kg (range 1.4–3.1 kg), IAA/CoA complex with LVOTO 5 respectively. Of the 11 patients, 1 (9.1%) patient was a preterm HLHC 3 delivery. There were 5 low-birthweight infants (45.4%). A chromo- cAS with reduced LV contraction 3 Gestational age (weeks), median (range) 38 (34–40) somal abnormality was detected in 4 (36.4%) patients; of these <37 weeks (n)1 patients, 2 patients had 22q11.2 deletion syndrome, 1 patient had Birthweight (kg), median (range) 2.6 (1.4–3.1) 5p deletion syndrome and 1 had partial trisomy 8. <2.5 kg (n)5 Body surface area at birth (m ), median (range) 0.18 (0.12–0.2) Chromosomal abnormality (n)4 Procedure of hybrid stage I palliation Age at bPAB (days), median (range) 7 (3–50) Age at DS (days), median (range) 24 (5–78) Because of the lack of a hybrid operating theatre and the inter- ventional cardiologist’s preference, HS1P was not performed as a bPAB: bilateral pulmonary artery bandings; cAS: critical aortic stenosis; CoA: coarctation of aorta; DS: ductal stenting; HLHC: hypoplastic left single procedure. Bilateral pulmonary artery bandings were per- heart complex; IAA: interrupted aortic arch; LV: left ventricle; LVOTO: formed following ductal stenting in all patients, except 1 patient left ventricular outflow tract obstruction. who developed ductal shock prior to his arrival via median full sternotomy, at a median age of 7 days (range 3–50 days). After careful dissection, the branch pulmonary arteries were banded to reduce their inner diameter to <1.5 mm, confirmed by intraoper- For patients with hypoplastic left heart complex, subsequent ative direct 2D echocardiography. For patients with hypoplastic LV rehabilitation following HS1P by balloon pulmonary artery left heart complex, banding tape was fixed with absorbable dilatation at banded sites or surgical debanding was performed sutures to facilitate later dilation of the banded site by percutane- to gradually increase the LV volume preload. Notably, the term ous balloon pulmonary artery dilation. At 1.5 mm from the inside ‘LV rehabilitation’ is different from its original meaning, as previ- fixation with an absorbable suture, an additional fixation was ously reported [9]. HS1P with subsequent LV rehabilitation indi- placed with a non-absorbable suture to prevent excessive cated for patients with z-values of LV end-diastolic diameter dilatation. greater than -5, and z-values of mitral valve diameter greater V TM Ductal stenting was performed with PALMAZ GENESIS on than -4, was estimated with the apical 4-chamber view of 2D TM OPTA Pro (Cordis, Cardinal Health Inc., Fremont, CA, USA) transthoracic echocardiography. During rehabilitation, small at the median age of 27 days (range 5–78 days) and was atrial communication (3 mm) was maintained by balloon atrial approached via the femoral vein. The size of the implanted stent septostomy. After LV rehabilitation, BVR was indicated, if the z- was 6 mm in 6 patients and 8 mm in 5 patients; the length of the value of LV end-diastolic diameter was above 0. stent was 15 mm in 4 patients, 18 mm in 6 patients and 24 mm in 1 patient. No patient required redilatation of the implanted stent, Management of ductal stent and bilateral but additional stent implantation was needed in 1 patient for in- pulmonary artery during definitive surgery stent stenosis. During definitive surgery, ductal stenting was completely Indication of hybrid Stage I palliation and removed under hypothermic (18 C) lower body circulatory arrest with selective cerebral perfusion. After removal of the banding institutional criteria for biventricular repair and its tapes, branch pulmonary arteries were dilated from inside with a procedures Hegar dilator in 4 patients, augmented by an autopericardial patch in 5 patients or expanded polytetrafluoroethylene in 1 Patients with interrupted aortic arch/coarctation of the aorta patient. Selection of the repair method mainly depended on the complex should have 2 balanced ventricles; therefore, the aim of time between HS1P and definitive surgery. HS1P was to provide alternative BVR procedures. Selection of the BVR procedure was based on the size of the aortic valve diameter and LV outflow tract diameter in systole, estimated by a paraster- Study method nal long-axis view of transthoracic 2D echocardiography. When the z-value of the aortic valve diameter was less than -3, the This study was a retrospective, single-institutional study. From Yasui operation was selected. If the z-value of the aortic valve electronic clinical records, operative records, echocardiography diameter was greater than -3, but the LV outflow tract diameter and cardiac catheterization reports and outpatient clinical was less than -3, LV outflow tract myectomy and the closure of records, the following variables were evaluated: (i) overall out- ventricular septal defect (VSD) were selected. comes, (ii) individual clinical courses after HS1P based on main For patients with critical aortic stenosis and reduced LV func- diagnoses and (iii) complications following definitive surgeries. tion associated with endocardial fibroelastosis, HS1P and subse- Data were analysed using JMP 11 (SAS Institute Inc., Cary, NC, quent balloon aortic valvotomy were performed to confirm the USA). During the study period, heart transplantation or LV assist recovery of both LV systolic and diastolic function, as previously device implantation were not indicated for patients with post- reported [8]. cardiotomy heart failure in Japan. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/906/4823620 by Ed 'DeepDyve' Gillespie user on 20 June 2018 WORK IN PROGRESS REPORT 908 A. Higashida et al. / Interactive CardioVascular and Thoracic Surgery 3 years following the definitive surgery was 90%. There was 1 in- RESULTS hospital mortality, and no late mortalities. Overall outcomes Individual clinical courses by main diagnosis All patients underwent definitive surgery, except 1 patient with hypoplastic left heart complex, and the median follow-up period Interrupted aortic arch/coarctation of the aorta complex. from definitive surgery was 22 months (range 4–45 months). The One patient who was not premature but experienced respiratory median age, body weight and body surface area at definitive sur- failure soon after birth (later diagnosed as congenital central gery were 12 months (range 6–34 months), 6.0 kg (range 5.2– hypoventilation syndrome) was free from LV outflow tract 2 2 11.4 kg) and 0.31 m (range 0.28–0.51 m ), respectively (Table 2). obstruction before and after HS1P and underwent arch repair The median duration between HS1P and definitive surgery was and VSD closure as the definitive surgery (Fig. 1A). Of the remain- 11.6 months (range 4.8–21.6 months). The actual survival rate at ing 4 patients with LV outflow tract obstruction, growth of the LV outflow tract and aortic valve was confirmed in 2 patients (Fig. 2), 1 patient underwent arch repair and VSD closure, and 1 patient underwent arch repair, VSD closure and LV outflow tract myectomy. Table 2: Late complications following definitive surgeries Definitive surgery was performed at the median weight of 6 kg (n =9) (5.5–7.2 kg) and the median age of 17 months (5–20 months), and no patient showed significant lower body cyanosis prior to the Variables n (%) operation. However, 1 patient who awaited definitive surgery Complications until 20 months developed left bronchial stenosis due to com- LVOTO required reoperation 0 pression by the ductal stent. Instead of direct anastomosis, the Recurrent CoA 0 aortic arch of the patient was reconstructed with interposition of Bronchial stenosis 0 Pacemaker implantation 0 glutaraldehyde-treated autopericardial roll during the definitive Surgical intervention surgery, and relief of left bronchial stenosis was confirmed CRT implantation 1 (11) 1 month later by computed tomography. MVR + re-RVOTR 1 (11) Re-RVOTR 1 (11) Catheter intervention Critical aortic stenosis with reduced left ventricular PTA for branch pulmonary artery 4 (44) function. As mentioned earlier, the clinical courses of 2 of the 3 Ablation for atrial tachyarrhythmia 1 (11) patients has already been described in our previous report [8]. For the third patient, who was born with a body weight of 1.8 kg CoA: coarctation of aorta; CRT: cardiac resynchronization therapy; LVOTO: left ventricular outflow tract obstruction; MVR: mitral valve and associated with aortic arch obstruction, LV systolic function replacement; PTA: percutaneous transluminal angioplasty; RVOTR: right smoothly recovered following HS1P and subsequent balloon ventricular outflow tract obstruction. aortic valvotomy, and thus a Ross operation was scheduled (Fig. 1B). However, a further careful estimation of the aortic valve Figure 1: Individual clinical courses following hybrid Stage 1 palliation by main diagnosis. (A) IAA or CoA complex, (B) cAS and (C) HLHC. AVP: aortic valve plasty; BAS: balloon atrial septostomy; BDG: bidirectional Glenn; BVR: biventricular repair; cAS: critical aortic stenosis; CoA: coarctation of aorta; HLHC: hypoplastic left heart complex; IAA: interrupted aortic arch; MVP: mitral valve plasty; OAC: open aortic commissurotomy; PA: pulmonary artery; PTAV: percutaneous transluminal aortic val- votomy; PTBD: percutaneous balloon dilation at the banded site; SAS: subaortic stenosis; SV: single ventricle; VSD: ventricular septal defect. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/906/4823620 by Ed 'DeepDyve' Gillespie user on 20 June 2018 A. Higashida et al. / Interactive CardioVascular and Thoracic Surgery 909 12 months, arch repair, VSD closure and papillary muscle splitting for the parachute-like mitral valve were successfully performed. The second patient was complicated by high LV end-diastolic pressure and high pulmonary vascular resistance during the LV rehabilitation. BVR was performed at the age of 6 months (Fig. 5). This was followed by a redo surgery consisting of mitral valve replacement for iatrogenic significant regurgitation and relief of previously underestimated valvular and supravalvular aortic stenosis 1.5 months later. However, low cardiac output syndrome and pulmonary hypertension continued after that. Although sin- gle ventricular conversion was attempted at 4 months after the BVR, low cardiac output syndrome and cyanosis became critical. Figure 2: Changes of AVD and LVOTD in patients with interrupted aortic arch Late complications after definitive surgeries or coarctation of the aorta and VSD after hybrid Stage 1 palliation. AVD: aortic valve diameter; LVOTD: left ventricular outflow tract diameter; VSD: ventricular Recurrent LV outflow tract obstruction, aortic arch obstruction, septal defect. bronchial stenosis or pacemaker implantation were not observed during the entire follow-up period (Table 2). The rate of freedom from reoperation at 3 years after definitive surgeries was 75%. A total of 3 surgical interventions were required in 2 patients (Table 2). Patients with critical aortic stenosis who had undergone a Ross–Konno operation developed heart failure due to ventricular dys-synchrony originating from complete left bundle branch block; hence, cardiac resynchronization therapy had been introduced since 1 year after discharge. After that, mitral regurgitation progressed, and mitral valve replacement and redo right ventricle-to-pulmonary artery conduit replacement were concomitantly performed 3 years later. The other patient who had undergone the Yasui operation required a redo right ventricle-to- pulmonary artery conduit replacement. As for the catheter-based interventions, balloon pulmonary artery dilatation was performed for postoperative branch pulmo- nary stenosis in 4 of the 9 (44%) patients. One patient with hypo- plastic left heart complex who had undergone BVR developed atrial tachycardia, and so catheter ablation was repeated. Figure 3: Changes of LVEDD and MVD in patients with hypoplastic left heart complex after hybrid Stage 1 palliation. BVR: biventricular repair; LVEDD: left DISCUSSION ventricular end-diastolic diameter; MVD: mitral valve diameter; SV: single ven- tricle; SVR: single ventricle repair. This study reviewed mid-term clinical outcomes of HS1P for patients with hypoplastic left heart structures and 2 ventricular detected a still fused commissure, and nodule-like thickness of cavities. HS1P contributed to the appropriate selection of BVR the leaflets restricted their mobility; so BVR, which consisted of procedure, choice of candidate for BVR and growth of left heart aortic arch reconstruction, aortic valve commissurotomy and structures sufficient to go on to BVR, but resulted in 1 in-hospital leaflet slicing, was successfully performed at 10 months. At the mortality for a patient who underwent BVR following LV time of BVR, the development of secondary left pulmonary vein rehabilitation. stenosis was also relieved with a primary sutureless technique. At There are several surgical options to enlarge hypoplastic aortic the last follow-up, the pressure gradient across the aortic valve valves and LV outflow tracts, such as the surgical aortic valvulo- was 19 mmHg, and regurgitation was trivial. plasty, Ross–Konno ventriculoplasty or Yasui operation (Norwood/Rastelli procedure) if VSD exists [10]. However, these Hypoplastic left heart complex. One of the 3 patients devel- surgeries are technically complex, especially during the neonatal oped significant pulmonary hypertension and severe hypoxia period, and so reoperation is inevitable. For patients with inter- during the first balloon pulmonary artery dilatation (Fig. 1C). rupted aortic arch or coarctation of the aorta complex, growth of Then, balloon atrial septostomy was concomitantly performed, the aortic valve after bilateral pulmonary artery banding with which meant BVR was no longer indicated. A Norwood opera- keeping prostaglandin E1 administration had been previously tion concomitant with bidirectional Glenn anastomosis was reported [11]. It showed that 1-month interval was believed to be scheduled. sufficient to decide the type of definitive surgical procedure. Two patients showed sufficient growth of the LV end-diastolic Also, recovery of the LV function could be confirmed within diameter (Fig. 3). Chronological changes of the LV end-diastolic 1 year after balloon aortic valvotomy [12]. Based on these find- diameter, mitral valve diameter and pulmonary vascular resist- ings, we may decide on the definitive surgery so late that several ance of the first patient are shown in Fig. 4. At the age of complications, such as bronchial stenosis and pulmonary veins Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/906/4823620 by Ed 'DeepDyve' Gillespie user on 20 June 2018 WORK IN PROGRESS REPORT 910 A. Higashida et al. / Interactive CardioVascular and Thoracic Surgery Figure 4: Apical 4-chamber view (A) before and (B) after HS1P and (C) chronological changes of z-values of MVD and LVEDD and PVR in 1 patient in the hypoplastic left heart complex group. BVR: biventricular repair; HS1P: hybrid Stage I palliation; LV: left ventricle; LVEDD: left ventricular end-diastolic diameter; MVD: mitral valve diameter; PTBD: percutaneous balloon dilation at the banded site; PVR: pulmonary vascular resistance; RV: right ventricle. Figure 5: Apical 4-chamber view and parasternal short-axis view (A) before and (B) after HS1P and (C) chronological changes of z-values of MVD and LVEDD PVR and LVEDP after HS1P in 2 patients in the hypoplastic left heart complex group. BVR: biventricular repair; HS1P: hybrid Stage I palliation; LV: left ventricle; LVEDD: left ven- tricular end-diastolic diameter; LVEDP: left ventricular end-diastolic pressure; MVD: mitral valve diameter; PVR: pulmonary vascular resistance; PTBD: percutaneous balloon dilation at banded site; RV: right ventricle. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/906/4823620 by Ed 'DeepDyve' Gillespie user on 20 June 2018 A. Higashida et al. / Interactive CardioVascular and Thoracic Surgery 911 obstruction, occurred during the inter-stage period. Moreover, experiences is mandatory to reveal suitable candidates to reconstruction of banded branch pulmonary arteries is difficult undergo HS1P and LV rehabilitation, instead of neonatal single- long after bilateral pulmonary artery bandings. Now, we believe ventricle palliation. that less than 6 months after HS1P is the suitable timing to per- form definitive surgery. Conflict of interest: none declared. On the contrary, effective options to enlarge LV inflow and the cavity itself are scarce [9]; therefore, the process of LV rehabilita- tion is never too long if sufficient growth is obtained. Indeed, REFERENCES responses to the LV rehabilitation and clinical outcomes were quite different in our 3 study cohorts. As mentioned earlier, the [1] Tchervenkov CI, Tahta SA, Jutras LC, Belan MJ. 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Experience with biventricular intervention for neonates with decision regarding BVR procedure or to a bridge to BVR follow- mitral valve abnormalities in the setting of critical left-side heart obstruc- ing subsequent LV rehabilitation. Further accumulation of tion. Ann Thorac Surg 2015;99:877–83. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/906/4823620 by Ed 'DeepDyve' Gillespie user on 20 June 2018 WORK IN PROGRESS REPORT

Journal

Interactive Cardiovascular and Thoracic Surgery – Oxford University Press

Published: Jun 1, 2018

Keywords: Hybrid Stage 1 palliation; Biventricular repair; Left ventricular rehabilitation; Hypoplastic left heart

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