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a The Heart Center, Nationwide Children's Hospital, The Ohio State University, Columbus, Ohio
b Division of Cardiothoracic Surgery, The Ohio State University, Columbus, Ohio
c Division of Pediatric Cardiology, The Ohio State University, Columbus, Ohio
Accepted for publication February 4, 2008.
* Address correspondence to Dr Galantowicz, 700 Children's Drive, Columbus, OH 43205 (Email: mark.galantowicz{at}nationwidechildrens.org).
Presented at the Forty-third Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 29–31, 2007.
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Abstract |
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Methods: This is a review of prospectively collected data on patients treated for HLHS using a hybrid approach (n = 40) between July 2002 and June 2007. The hybrid approach includes pulmonary artery bands, a ductal stent, and atrial septostomy as a neonate, comprehensive stage 2 procedure resulting in Glenn shunt physiology at six months and Fontan completion at two years.
Results: Forty patients had a hybrid stage 1 with 36 undergoing a comprehensive stage 2 procedure. Fifteen patients have completed the Fontan procedure with 17 pending. Overall survival was 82.5% (33 of 40). The seven deaths included one at stage 1, two between stages 1 and 2, three at stage 2, and one between stages 2 and 3. One patient had successful heart transplantation during the interstage period.
Conclusions: The hybrid approach can yield acceptable intermediate results that are comparable with a traditional Norwood strategy. Potential advantages of the hybrid approach include the avoidance of circulatory arrest and shifting the major surgical stage to later in life. These data provide the platform for a prospective trial comparing these two surgical options to assess whether there is less cumulative impact with the hybrid approach, thereby improving end organ function, quality, and quantity of life.
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Introduction |
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TopAbstractIntroductionPatients and MethodsResultsCommentDiscussionReferences |
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Patients and Methods |
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TopAbstractIntroductionPatients and MethodsResultsCommentDiscussionReferences |
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Comprehensive stage 2
The open heart surgery consists of removal of the PDA stent and PA bands, repair of the aortic arch and pulmonary arteries (if necessary), division of the diminutive ascending aorta with reimplantation into the pulmonary root, main PA to reconstructed aorta anastomosis, atrial septectomy, and a bidirectional cavopulmonary anastomosis (Fig 3). Procedures were performed on cardiopulmonary bypass with aortic cross-clamping. Circulatory arrest is not needed because of the transverse arch growth, which allows it to be directly cannulated with advancement of the cannula into the innominate artery during arch reconstruction. The PDA stent was completely removed and the aortic arch reconstructed with a patch of pulmonary homograft in all patients. The right PA was only augmented by positioning the cavopulmonary anastomosis across the area of the previous band. Left PA patch augmentation was judged necessary in nearly half the patients.
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Results |
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One patient underwent successful heart transplantation six months after the hybrid stage 1 for ventricular failure. Six weeks after an uncomplicated hybrid stage 1 the patient required stenting of a restrictive atrial septum. This was complicated by heart block requiring a pacemaker. Over the ensuing months his ventricular function deteriorated without any evidence of obstruction, flow limitation, or imbalance in the circulation.
There were two reoperations. One to replace a left PA band that opened after the stitch broke one month postoperatively. The second reoperation was to recover an embolized atrial septal stent deployed to treat a restricted atrial septum five weeks after the hybrid stage 1. Both patients went on to a successful comprehensive stage 2.
There were 12 reinterventions in the catheterization laboratory in ten patients; all successfully relieved the level of obstruction and all patients went on to a comprehensive stage 2. Two interventions were aimed at the atrial septum (one balloon + one stent), seven interventions were aimed at antegrade flow through the PDA (two angioplasty + five stent), and four stents were placed to relieve retrograde stenosis into the transverse aortic arch. Feeding gastrostomy tubes were required in six patients.
Prior to the comprehensive stage 2, the echocardiographic assessment of right ventricular function was graded as normal in all but two patients in whom it was graded as mildly depressed. Tricuspid regurgitation was trivial in all but three patients, mild in two, and only one with moderate tricuspid regurgitation, which required valvuloplasty at the comprehensive stage 2.
Comprehensive Stage 2
A comprehensive stage 2 procedure was performed in 36 patients at a median age of 180 days and 5.7 kg weight. Median bypass and cross-clamp times were 291 and 85 minutes, respectively. Only the first two patients had a period of circulatory arrest. Milrinone (0.25 mcg/kg/min) was started routinely on all patients. The postoperative echocardiographic assessment of right ventricular function was graded as normal in 80% with only one patient having greater than mild dysfunction or greater than mild tricuspid regurgitation. Postoperative data are listed in Table 3. Eighty-six percent (31 of 36) of patients were extubated within the first 24 hours. Median inotrope score the first day was 0. Median lactate level was 2.3 mmol/L on arrival to the ICU, and 1.1 mmol/L on POD 1. Eighty-one percent of patients returned to enteral feeds within 24 hours. The median length of stay in the ICU was four days (mean, 5.4) and hospital stay was median 7.5 (mean, 9.5). One patient had a subdural hematoma that required no intervention, while no patient had a seizure. No patient required dialysis and the urinary output was greater than 1 cc/kg/hour during the first 24 hours in all patients. No patient required a delayed sternal closure or ECMO support. All patients were in normal sinus rhythm except one patient who had transient accelerated junctional rhythm.
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Interstage 2 - 3
One patient died six months postoperatively of a nosocomial infection, multisystem organ failure after being readmitted with a chylothorax. Five patients required placement of a left PA stent. No patient required reintervention at the aortic arch.
Fontan Completion
Fifteen patients underwent a successful Fontan completion with no mortality, while 17 are awaiting Fontan completion. One patient had a tricuspid valve repair at the time of surgery, while no patient required further pulmonary artery augmentation.
Hybrid Stage 1 + Comprehensive Stage 2
Table 4
combines postoperative variables for the hybrid stage 1 plus comprehensive stage 2 procedures. The parameters of cardiopulmonary bypass have continued to shorten with experience; median bypass and cross-clamp times were 291 and 85 minutes, respectively. Two patients received no blood products through both hybrid stage 1 and 2 procedures, nor at the Fontan completion. Overall utilization of all blood products was a median of 88 mL/kg (mean, 87 mL/kg) with no patient requiring reoperation for bleeding. Total hours on the ventilator were median 9 (mean, 31). Total combined number of days in the ICU were median 8 (mean, 10.8) and in-hospital were median 21 (mean, 24.4). Total hospital charges were a median $179,759 (mean, $205,428).
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Comment |
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TopAbstractIntroductionPatients and MethodsResultsCommentDiscussionReferences |
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An alternative to the traditional Norwood approach is the hybrid approach for the management of HLHS. The primary goal of the approach is to create a stable, balanced circulation without the use of open heart surgery (bypass, cross-clamp, circulatory arrest) with its associated risks in a neonate. The major open heart surgical procedure is thereby shifted to later in life at an age when a circulation in series can be established with a cavopulmonary anastomosis. Early reports on the initial outcomes of the hybrid approach [1, 3, 4] were limited by the impact of the learning curve of this new therapy, small cohorts of patients with mixed diagnoses and risk stratification, as well as short follow-up. Subsequent reports have focused on the use of the hybrid approach in high risk HLHS patients [11–13]. Importantly, to truly assess the risks of the hybrid approach as compared with the Norwood approach, both stage 1 and 2 results as well as the interstage period need to be considered.
The goal of our report is to evaluate the benefits and risks of the hybrid approach in a uniform cohort of patients with HLHS, including stage 1 and 2, so that a reasonable comparison can be made to patients treated with the Norwood approach. This is the largest single institution experience with this hybrid approach, which is offered to all patients with HLHS. The only exclusion criterion is echocardiographic evidence of restricted flow into the retrograde transverse aorta from the ductus arteriosus. This was noted in three patients who went on to a successful traditional Norwood procedure. Although Norwood, hybrid, and transplant surgical options are offered to all families, there were no primary transplants performed and only eight Norwood procedures reflecting an institutional bias for the hybrid approach.
In this report patients with weights greater than 1.5 kg were included, even though 2.5 kg is commonly used as the cutoff for high risk. We consider weight less than 1.5 kg to be higher risk, but not the range between 1.5 kg and 2.5 kg for the hybrid approach.
Our results of the hybrid stage 1 procedure indicate a low impact, low risk procedure, where 80% are extubated and on enteral feeds within 24 hours, blood usage and inotropic support are rare, delayed sternal closure or ECMO are not necessary, the ICU stay is short, and hospital survival is 97.5%.
Interstage mortality (5%) and reintervention rate (36%) are similar to those reported for the Norwood procedure. Our reintervention rate may be high because we utilize close interstage monitoring with echocardiography and take an aggressive approach to maintaining unrestricted flow through the PDA stent, both antegrade and retrograde, as well as maintaining an unrestricted atrial septal opening.
Our treatment of the atrial septum has evolved. The key is not allowing the atrial septum to become restrictive because this is associated with significant thickening of the atrial septum making subsequent interventions more complicated and less effective. This was evident in two patients with serious complications (embolization and heart block) related to atrial septal stenting. Now we perform a balloon atrial septostomy before the child is discharged but separate this procedure from the PA banding-PDA stent component of the hybrid stage 1. This simple delay allows some enlargement of the left atrium in a more stable patient, which enables the interventional cardiologist to perform a more aggressive balloon (2 mL) atrial septostomy resulting in a significant enlargement and durable tear of the septal tissue. We have not needed to reintervene at the atrial septum on any patient treated with this technique.
Only 10% (4 of 40) of patients developed significant retrograde stenosis into the transverse aorta. All were effectively treated by placing an additional retrograde stent and went on to a successful comprehensive stage 2. Given this low incidence we do not recommend a prophylactic reverse central shunt [5]. Moreover, given our experience in three patients with this type of shunt, the unknown physiology it creates with the potential of a coronary steal, and the more complicated postoperative course in patients with this shunt reported in the literature [14], we no longer use a reverse central shunt.
Although the comprehensive stage 2 procedure is a long operation involving essentially all the steps of a traditional Norwood stage 1+2 procedure, plus removal of the PDA stent and PA bands, the results show that the postoperative course is more similar to that of a Norwood stage 2 only. Our results indicate that the majority (85%) are extubated within 24 hours, inotropic support greater than the empiric use of milrinone is rare, right ventricular function is preserved, and indicators of overall perfusion are normal by lactate, renal function, lack of seizures, and no ECMO requirements. This picture is presumably because the patients have a low risk profile (normal ventricular function, no end organ dysfunction, protected pulmonary bed) going into the operation. Then the conduct of the operation minimizes end organ ischemia with the majority of the procedure performed on bypass with a beating heart and no circulatory arrest time, while the resultant circulation in series with a cavopulmonary shunt is more stable than a circulation in parallel such as the case with a Norwood stage 1.
Two published series from the Children's Hospital Boston [8, 9] and the Children's Hospital of Philadelphia [10] include information on patients with HLHS through Norwood stage 1+2. The focus of these contemporary reports is to compare outcomes of patients initially treated with a BT shunt versus a RV-PA conduit. Both institutions conclude that the overall outcomes are not different between shunt types. Please note that these reports include both standard and high risk patients with HLHS. Table 5 lists outcome variables for the hybrid approach with similar information, where available, from these published series [8–10] for the Norwood approach. Overall survival for the hybrid approach was 82.5% (33 of 40). One series [10] had an overall survival of 86% among a subgroup of patients with a "usual risk" profile that was comparable with the cohort in our report. Interstage mortality was low for the hybrid approach, similar to rates reported for the RV-PA shunt patients but lower than that for the BT shunt patients. The need for interstage reintervention was similar across all groups. Some potential indicators of morbidity in terms of the need for delayed sternal closure, ECMO support, or right ventricular dysfunction were less with the hybrid approach. Nonetheless the overall combined time spent in the hospital was similar across all groups. Long-term follow up will be necessary to see if these differences impact the outcomes after the Fontan completion in terms of end organ function, quality of life, and longevity. We will continue to follow our patients to specifically evaluate neurologic, cardiac, and psychosocial measures of outcome.
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While the patient data were collected prospectively, this review is a descriptive assessment, limited by a small, nonrandomized patient population and an institutional bias, for the hybrid approach. In conclusion, our study supports the use of the hybrid approach for the management of HLHS patients with the usual risk profile.
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Discussion |
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Do you have any data along those lines yet because I think that's really where the money is going to be. If people can do what Jim Tweddell was talking about with the conventional approach and do what you're talking about with the hybrid approach, we can probably expect survival in the 80% to 85% range at a year with usual-risk patients. I think those data are pretty clear.
But if one group has to take Ritalin or Adderall or similar medications and is a real bear to take care of, and the other group are doing fine and are nice little kids, I think I know which way I'd go.
DR GALANTOWICZ: I appreciate your comments, and you're absolutely right that it will be important to see whether these midterm differences carry forth.
One of the concerns with the hybrid approach is with the stage I. The cerebral blood flow is dependent on that retrograde orifice, which is not as large as the orifice will be after a Norwood stage I arch augmentation. And although there's no clinical evidence of neurologic impact at this point, there may be important subclinical neurologic impact.
And so we now almost have enough patients that are three years or more out to appropriately look at that. At this point we can make no comment or have no important information to share about that.
DR MARSHALL L. JACOBS (Philadelphia, PA): These are spectacular results, and the lessons from this presentation are immense.
I think for a lot of institutions the learning curve associated with the Norwood procedure, both from a technical operative standpoint and an ICU management standpoint, was perhaps substantial in a variable length from one place to another. You were very, very candid in your introduction about the difference between this experience you report today and the earlier experience that you reported previously.
With respect to this entire experience, what fraction of it is accounted for as your period of learning curve and what fraction is the later period where you think you've ironed out most of the kinks? And, of course, one hopes that in your manuscript the lessons of the learning curve period will all be articulated so that people won't have to reproduce them.
My compliments. But how long was the learning curve period compared to this period of stunning results?
DR GALANTOWICZ: I appreciate your comments, Dr Jacobs. The nine patients were considered part of the learning curve and were excluded from this series. We did publish a paper that talks about the lessons learned that specifically try to limit the learning curve for others embarking on this approach.
Our goal, really, here today was to try and give a picture of the usual hypoplast patient with a standard risk profile to help everybody that's looking at this approach whether or not it is reasonable to use in their institution given their own results. And many places are using the hybrid approach for high risk patients, and it's harder to decipher the value or the potential benefits or risk of the approach.
So this was a uniform patient population of true hypoplast with a very standard risk profile.
DR JAMES S. TWEDDELL (Milwaukee, WI): I thought it was an excellent study, excellent outcomes, and I think you are really on to something. I applaud your innovation and your willingness to take the road less traveled.
This is highly dependent on technology. Could you speculate on what new technological innovations might help bring the hybrid approach to its fullest potential? Two areas in particular in which technological innovations might be helpful include the management of proximal arch obstruction that is observed in some patients. Could that be stented? What about ASD [atrial septal defect] creation, is there a way to more reliably create an ASD noninvasively? Thank you. I really appreciate it. Nice study.
DR GALANTOWICZ: Those are excellent questions. Sort of moving backwards, the ASD was initially the Achilles heel for us with this procedure, and most of the reinterventions were at the atrial septal defect.
With the simple modification of delaying addressing the atrial septum to just prior to discharge, which is about a week later, there's some growth in the left atrium, there's stabilization of the child, and it allows the interventional cardiologist to use a larger or really a standard Rashkind balloon and get a very formidable tear such that at the comprehensive stage II procedure there's really no atrial septum to take out. So once we adopted that technique, there's only been one reintervention at the atrial septum.
I think the retrograde flow into the arch, we have started at this point to not prospectively treat the retrograde flow by stenting it open and only treating it if it shows evidence of stenosis, and then you can put a stent through the PDA [patent ductus arteriosus] stent into the retrograde orifice and stent it open.
Whether that can be addressed initially, and certainly the group in Toronto have tried to address that by doing a sort of reverse BT [Blalock-Taussig] shunt, if you will, from the main PA [pulmonary artery] to the arch, I think that will be an important question. Whether the amount of blood flow that's getting through there is adequate, we don't have the answer to that until we have further neurologic follow-up.
In terms of what your team would need and the technological demands of this, they're really not out of the realm of what all of our groups are doing. Banding is a very straightforward technique surgically. The stenting of the PDA in this context, where the sheath is placed in the main pulmonary artery for an interventional cardiologist, is really within their usual armamentarium.
I think the spirit of collaboration and the close follow-up and the need to reintervene frequently is probably the most important aspect of a successful hybrid approach.
DR PETROS V. ANAGNOSTOPOULOS (Phoenix, AZ): Would you please comment a little bit about the technical aspects of this second operation? Especially touch on the technical difficulties of taking the stent out from the duct.
DR GALANTOWICZ: Your question and Jim's tie together. The hardest part of this whole procedure, I and II combined, is taking the stent out of the aortic arch. As the child grows in that intervening six months, the aorta or the stent moves downstream and posteriorly in the patient, and it's harder to get to that area in a six-month old than it is in a six-day old. And as we all know, if you get a tear there, your treatment options are limited and certainly significant.
So we have designed the conduct of the operation so that period of taking the stent out of the aortic arch is not under circulatory arrest. You can take your time, and it's essentially an endarterectomy, if you will, or a peeling out of the stent. But you're left with half of the media and only adventitia, so it is a thin area. And then it's augmented in the usual way that a Norwood arch augmentation is done.
You have to believe that in the future there will be absorbable stents. When that day comes, this will be very easy because you'll just fillet open the arch and use your patch augmentation, and that main hurdle will be taken away.
So part of our group's hope is that as technology advances, the soundness of this approach will only improve with improved technology.
DR CHRISTOPHER A. CALDARONE (Toronto, Ontario, Canada): Mark, when you resect the stent, invariably there's some tissue left behind that has been stented open. And looking at it, it's difficult to tell whether it's duct that's been stented open and stuck in that position or if it's aorta; very difficult to tell.
Do you always resect all tissue that's been underneath the stent, or do you leave some tissue behind which may or may not include some old ductal tissue?
DR GALANTOWICZ: No, we do not resect all tissue that's been covered by the stent because we purposely stent past the transverse arch past what you would think anatomically is the ductus into the descending thoracic aorta. So if we were to resect that area, we would have a pretty significant gap.
You have raised this question to me before, and we're starting to collect some of the tissue to see whether it's ductal tissue, aortic tissue, what it is that's left behind. At this point I can't say for sure, and we just patch augment it.
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O. Honjo, L. N. Benson, H. E. Mewhort, D. Predescu, H. Holtby, G. S. Van Arsdell, and C. A. Caldarone Clinical Outcomes, Program Evolution, and Pulmonary Artery Growth in Single Ventricle Palliation Using Hybrid and Norwood Palliative Strategies Ann. Thorac. Surg., June 1, 2009; 87(6): 1885 - 1893. [Abstract] [Full Text] [PDF]
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S. C. Brown, D. Boshoff, B. Eyskens, and M. Gewillig Hybrid approach as bridge to biventricular repair in a neonate with critical aortic stenosis and borderline left ventricle Eur J Cardiothorac Surg, June 1, 2009; 35(6): 1080 - 1082. [Abstract] [Full Text] [PDF]
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 J. E. Deanfield, R. Yates, F. J. Meijboom, and B. J.M. Mulder CHAPTER 10 Congenital Heart Disease in Children and Adults ESC Textbook of Cardiovascular Medicine, January 1, 2009; 2(1): med-9780199566990-chapter - med-9780199566990-chapter. [Abstract] [Full Text] [PDF]
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