Eur J Cardiothorac Surg 2000;18:683-689
© 2000 Elsevier Science NL
The short- and mid-term results of bidirectional cavopulmonary shunt with additional source of pulmonary blood flow as definitive palliation for the functional single ventricular heart
Kazunori Yamadaa,
Xavier Roquesa,
Nicolas Eliaa,
Marie-Nadine Labordea,
Maria Jimenezb,
Alain Choussatb,
Eugene Baudeta
a Department of Cardiovascular Surgery, Haut-Lévêque's Cardiological Hospital, University of Bordeaux II, Bordeaux-Pessac, France
b Department of Pediatric Cardiology, Haut-Lévêque's Cardiological Hospital, University of Bordeaux II, Bordeaux-Pessac, France
Received 25 October 1999;
received in revised form 22 August 2000;
accepted 11 September 2000.
Corresponding author. Department of Cardiovascular Surgery, Akane-Foundation, Tsuchiya General Hospital, 3-30 Nakajima-Chou, Naka-ku, Hiroshima, 730 8655 Japan. Tel.: +81-82-243-9191; fax: +81-82-241-1865
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Abstract
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Objective: The purpose of this study was to demonstrate the early and late outcomes of bidirectional cavopulmonary shunt (BCPS) as a definitive procedure for the functional single ventricular heart. Method: From September 1991 to December 1997, 34 patients underwent a BCPS procedure without a routine conversion to Fontan circulation. The additional source of pulmonary blood flow was left in all patients. Conversion was performed only when it was required for excessive cyanosis. Results: The hospital mortality rate was 8.8% (3/34, 95% confidence limit; 1.9–23%) and the 5-year survival rate was 75% for a mean follow-up period of 33±22 months. Seven patients underwent a conversion procedure for remnant or recurrent cyanosis and deterioration of exercise tolerance. Four of these patients died after conversion to Fontan circulation. Twenty-five long-term survivors with BCPSs maintained an arterial oxygen saturation of 84±6.1%, and 52% of them had a normal exercise tolerance or mild limitation. No patients developed severe late complications other than recurrent cyanosis. Conclusion: Due to the high mortality after conversion to Fontan circulation in patients whose conditions had deteriorated, we could not demonstrate the clear superiority of long-term BCPS over the construction of Fontan circulation for management of the functional single ventricular heart. If deteriorated conditions were successfully managed in the late period, the outcome of long-term BCPS would have been better.
Key Words: Bidirectional cavopulmonary shunt • Single ventricular heart • Surgical repair
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1. Introduction
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Since the first report by Fontan and Baudet in 1971 [1], the outcome of the Fontan operation has been improved using a number of technical modifications, such as the application of a total cavopulmonary shunt technique [2], as well as advances in postoperative management. Currently, Fontan-type operations are widely performed for patients with a functional single ventricular heart [3–6]. They may be performed with a staging strategy [6–8] or with a fenestration technique [2] according to the condition of the patient. The incidence of some complications, such as arrhythmia or thrombosis, has been reduced, however, some late complications, such as renal and hepatic dysfunction, protein-losing enteropathy and intractable ascites, remain a great problem after Fontan-type repairs.
The bidirectional cavopulmonary shunt (BCPS) or bidirectional Glenn operation was introduced clinically by Azzolina in 1972 [9] and is a well-established palliative procedure for single ventricular heart [7,10–15]. At present, BCPS is typically performed as one step of the staging procedure in preparation for a Fontan procedure [6–8], or as a long-term palliation for high-risk Fontan candidates [13,16,17]. Since September 1991, we have regarded BCPS as a definitive procedure for the functional single ventricular heart. The object of the present study is to investigate the validity of this principle of management for functional single ventricular hearts.
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2. Materials and methods
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2.1. Patients
From September 1991 to December 1997, 38 patients with functional single ventricular hearts underwent BCPS procedures in Haut-Lévêque's Cardiological Hospital, Bordeaux-Pessac. Four of these patients were excluded from the present study because these patients, who had come from Africa, went back to their countries soon after discharge and contact with them was lost. Therefore, the study group for the present report consisted of 34 patients. The age of patients at the time of BCPS operation ranged from 12 months to 46 years (median age, 4.7 years). Fourteen patients were younger than 4 years and four patients were older than 18 years. These four adult patients had been left for many years after some palliative procedures in their infancy. Weights ranged from 7.2 to 62 kg (median weight, 16.5 kg). The main diagnoses are shown in Table 1. Transposition of the great arteries was associated with single ventricular heart in 16 patients (47%). One patient had situs atrial ambiguus, and three other patients had a left superior vena cava (SVC) without a brachiocephalic connection. In one of the patients with left SVC without a brachiocephalic connection, the left SVC was very small. No patients had anomalies of systemic or pulmonary venous return.
BCPS was the sole surgical procedure in six patients (18%), while the remaining 24 patients had undergone at least one prior palliative procedure, including one systemic to pulmonary shunt (n=12), two systemic to pulmonary shunts (n=6), pulmonary artery banding (PAB; n=6), right ventricular out-flow tract enlargement and removal of the systemic to pulmonary shunt (n=2), PAB and atrial septectomy (n=1), and PAB and coarctation repair (n=1). Balloon atrial septectomy was performed in two patients, and one patient underwent a balloon right pulmonary artery plasty.
The systemic arterial oxygen saturation level was 75±6.6% when blood was withdrawn from resting patients breathing room air. The mean values of hemoglobin and hematocrit were 17.6±2.5 g/dl and 51.6±6.6%, respectively. Preoperative catheterization was performed in all patients. The mean pulmonary artery pressure (PAP; n=26) was 18±8 mmHg and this exceeded 13 mmHg in 13 patients (13/26; 50%). The mean dominant or single ventricular end-diastolic pressure (VEDP; n=33) was 9±5 mmHg and this was above 12 mmHg in seven patients (7/33; 21%). The pulmonary to systemic blood flow ratio (n=16) averaged at 1.6±1.1. All patients underwent a preoperative echocardiogram; mild and moderate atrioventricular valve regurgitations were revealed in three and two cases, respectively. Ventricular fractional shortening (FS) averaged at 0.43±0.13.
2.2. Surgical technique
Thirty-three patients underwent BCPS through a standard median sternotomy, while one patient underwent left BCPS through a left thoracotomy. The SVC was detached carefully to avoid injuring the sinus node. The distal side was anastomosed to the right pulmonary artery in a termino-lateral fashion and the proximal end was directly closed. A bilateral BCPS was performed in one patient and two patients underwent left BCPS. The left SVC was ligated in one patient with a small left SVC. BCPS was attempted without cardiopulmonary bypass (CPB), but if the patient could not endure clamping of pulmonary arteries and SVC, CPB was applied to assist circulation. We did not use a veno-atrial shunt during this period. In 17 patients, the BCPS was performed without the aid of CPB, but CPB was required in the other 17 patients. Of the 17 patients who required CPB, 12 patients had undergone systemic to pulmonary shunting and three patients had undergone PAB. The patients who required CPB were significantly older (11±12 vs. 6±10 years; P=0.0125; Mann–Whitney), had higher weights (27±17 vs. 16±13 kg) and had had higher arterial oxygen saturations (78±5.6 vs. 73±6.6%; P=0.024; Mann–Whitney) than those who underwent BCPS without CPB. An additional procedure was performed at the time of BCPS operation in 16 patients. This included removal of the systemic to pulmonary shunt (n=10), enlargement of restrictive bulboventricular foramen (n=2), PAB (n=1), reinforcement of PAB (n=2) and right pulmonary artery augmentation (n=1). A pacing generator was implanted in one patient who had an episode of complete atrioventricular block before surgery. When high PAP was suspected after the completion of cavopulmonary anastomosis, the PAP was measured by direct puncture (n=22). We tried to maintain the mean PAP under 20 mmHg by eliminating the systemic to pulmonary shunt or by placing or reinforcing PAB. The antegrade flow, through a banded or stenotic main pulmonary artery (n=19), a systemic to pulmonary shunt (n=3), or both (n=12), was left in all patients as an additional source of pulmonary blood flow.
2.3. Follow-up and statistical analysis
An early event was defined as an event that occurred within 30 days after the operation or before discharge from the hospital. BCPS failure was defined as death or necessity for cardiac reintervention. The postoperative arterial oxygen saturation data were measured by withdrawing blood from resting patients breathing room air at discharge from the hospital, 4–8 months after discharge and at the most recent follow-up. Postoperative hemoglobin and hematocrit data were obtained from patients 4–8 months after discharge. Almost all of the patients discharged from the hospital were followed at our institution with outpatient assessments every 3–6 months. In these patients, the functional status in the late period was assessed by the author (A.S.) by interviewing the patients themselves or their parents if necessary, and by evaluating performance on a treadmill. Patients were categorized into four groups, consisting of one group with almost normal tolerance for exercise, and three groups with mild, moderate and severe exercise limitations, respectively. Three patients were followed by primary physicians, and the follow-up information about these patients was obtained from the referring physician. The medical and surgical records of all patients were collected in February 1998 and were reviewed retrospectively. Data evaluation was carried out using a computer statistical package (JMP, version 3.0.1, SAS Institute, Inc., Cary, NC) and are expressed as means±SD or as medians and ranges. Preoperative and postoperative variables were compared using the Wilcoxon signed rank test. The relationships between independent preoperative and operative variables and the early outcome measures were investigated by univariate analysis using the Wilcoxon two-group test for continuous numeric data and Fisher's exact probability test or the Pearson Chi-square test for nominal data. A P value of 0.05 was required for retention in the multivariate model. The postoperative survival rate and the rate of freedom from BCPS failure were obtained by Kaplan–Meier analysis, and the cumulative risk was estimated by the log-rank test and proportional hazard analysis. The independent preoperative and operative variables analyzed are shown in Appendix A.
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3. Results
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3.1. Early outcome
One patient died within 30 days after the operation, giving an operative mortality rate of 2.9% with a 95% confidence limit (CL) of 0–15%. Two additional patients died during hospitalization (hospital mortality rate, 8.8%; 95% CL, 1.9–23%). The one operative death was a 17-month-old girl with complete atrioventricular canal and hypoplastic right ventricle. A standard BCPS was performed with the aid of CPB to give adequate hemodynamics and a satisfactory oxygen saturation. However, immediately after the operation, she developed a high fever and fell into a fit of convulsion. The patient died on the day of operation. A brain abscess was found on the autopsy. The clinical impression was that a preexisting brain abscess led to sepsis and convulsions.
One of the hospital deaths was a 2.5-year-old girl who presented with mitral atresia complicated by a double-outlet right ventricle and had already undergone PAB. Preoperative catheterization showed a mean PAP of 26 mmHg, a SVC pressure of 9 mmHg and a VEDP of 11 mmHg. The PAB was functioning satisfactorily with a pressure gradient of 90 mmHg. There was no atrioventricular valve regurgitation and the FS was 0.45. A standard BCPS was performed with CPB. Soon after the operation, she developed chylothorax that necessitated drainage. Despite improvements, chylothorax recurred repeatedly and her clinical state gradually deteriorated. At the 93rd postoperative day, the patient underwent catheterization and angiography that revealed a mean PAP of 28 mmHg, a SVC pressure of 25 mmHg and an inverted flow from the right pulmonary artery to the SVC. She died from an episode of bradycardia and subsequent cardiac arrest that occurred immediately after catheterization.
The other hospital death was a 5-year-old girl with a double-inlet left ventricle with subvalvular pulmonary stenosis. A right-modified Blalock–Taussig shunt had previously been inserted. Her preoperative VEDP was 8 mmHg and the FS was 0.50. Atrioventricular valve regurgitation was not detected. She underwent a standard BCPS procedure, during which the systemic to pulmonary shunt was removed while antegrade flow through a stenotic main pulmonary artery was maintained. After the operation, her arterial oxygen saturation remained low (75 for 77% preoperatively) and a chylothorax that needed drainage appeared. Chylothorax recurred repeatedly and the patient began to show signs of cardiac failure. Angiography showed an inverted flow at the BCPS anastomosis and her mean PAP was 20 mmHg. At the 92nd postoperative day, another surgical intervention was performed. The mean PAP was measured during the operation to be 17 mmHg, but the mean right PAP was 13 mmHg while calamping the site of the right pulmonary artery, and therefore, a conversion to Fontan-type repair was performed to relieve the remaining cyanosis. However, this patient died 2 h after the operation from low cardiac output syndrome.
Twelve early complications developed in seven patients, including seven occurrences of pleural effusion, one of SVC syndrome, one of pericardial effusion, one of lung infection, one of wound-infection and one occurrence of transient atrial flutter. Pleural effusion disappeared without drainage in five cases, while drainage was required in the two cases corresponding to the two hospital deaths described above. All other complications improved with conservative therapies. Among the 31 patients discharged from the hospital, the arterial oxygen saturation at the time of discharge was 83±6.1%, significantly higher than the preoperative level of 76±6.1% (P<0.0001; Wilcoxon signed rank test). The oxygen saturation rose to 84.7±3.5% several months after discharge, a level that was significantly higher than preoperative (P<0.0001; Wilcoxon signed rank test) and discharge (P=0.0359; Wilcoxon signed rank test) levels. Postoperative hematocrit and hemoglobin levels were lower than in the preoperative period (45±4.7 vs. 51±6.9%, P=0.0004; and 15.5±1.8 vs. 17.5±2.5 g/dl, P<0.0001, respectively; Wilcoxon signed rank test). There were four adult patients aged 25–45 years in our cohort. They obtained oxygen saturations of 85±4.7% (range, 78–88%) after BCPS. No preoperative variables were found to be correlated with hospital death. An operation in the years 1991 and 1992 was determined to be a preoperative predictor for a inverted flow from pulmonary artery to SVC using univariate analysis (P=0.0499; Fisher; odds ratio, 16.5).
3.2. Late outcome
Thirty-one patients discharged from hospital were followed up for a mean length of 33±22 months from the BCPS procedure (range, 2.3–67 months). One patient underwent a balloon atrial septectomy for congestive heart failure 2.5 years after the BCPS operation and subsequently remained in good health. Another patient developed recurrent cyanosis 53 months after BCPS as a result of growth of the left SVC, but he received no further intervention as his clinical status is currently good with only a moderate exercise limitation. Six patients (19% of hospital survivors) underwent conversion to Fontan circulation 23±12 months (range, 3–33 months) after BCPS operation for recurrent cyanosis or deteriorated exercise tolerance. Fenestration was not placed in all of these patients. Three of these patients died in the early period after conversion, while the other three patients are now doing well. There were no other late deaths. Eighteen patients underwent postoperative angiography 20±15 months after BCPS and one patient was found to have a growth of the left SVC as described above, while others had neither obvious pulmonary arteriovenous fistulae (PAVF) nor systemic venous collateral channels. The mean PAP was 17.3±8.3 mmHg (n=16). The other 13 patients who did not undergo postoperative angiography had no clear clinical signs of PAVF or systemic venous collateral channels. No other late complications were observed. Twenty-five long-term survivors with BCPS maintained arterial oxygen saturation levels of 84±6.1% at the most recent follow-up, 30±22 months after the BCPS (range, 2–66 months), and in five patients, the arterial oxygen saturation level was greater than 90%. There was no clear correlation between the follow-up length after BCPS and oxygen saturation at the time of the most recent follow-up (Fig. 1)
. The exercise tolerance levels of these patients are shown in Fig. 2
. At the time of the most recent follow-up, 14 patients took one or two drugs, including digoxin in six, diuretics in five, a vasodilator in one, and an antiarrhythmic drug in one patient with a transient atrial flutter that began during hospitalization and continued at the time of data collection less than 4 months after the operation. As of the most recent follow-up, 11 patients had received no treatment other than the administration of aspirin (n=15).
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Fig. 1. Scatter plot of the most recent arterial oxygen saturation and length of follow-up among patients discharged from the hospital after BCPS. There is no clear correlation between these variables. A trend of arterial oxygen saturation decreasing with time was not observed.
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Fig. 2. The distribution of the degree of exercise tolerance before and after bidirectional shunt. Exercise tolerance after bidirectional shunt was assessed at the most recent consultation.
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Of the patients who required reintervention, the main diagnoses included tricuspid atresia (n=3), double-inlet single left ventricle (n=2) and right ventricle (n=1), and pulmonary atresia with intact ventricular septum (n=1). Among these patients, one patient who underwent balloon atrial septectomy underwent PAB prior to BCPS. All six patients who underwent conversions to Fontan circulation in the late period had previously undergone a systemic to pulmonary shunt procedure before the BCPS operation, and in two of these patients, the shunt was eliminated at the time of BCPS operation. Before the conversion procedure, the additional source of pulmonary blood flow (shunt and/or stenotic main pulmonary artery) was patent in all these patients. No patient had an inverted flow from the right pulmonary artery to the SVC.
The 5-year survival rate for all patients and the rate of freedom from BCPS failure at 5 years after the operation for patients discharged from the hospital are 75 and 62%, respectively (Figs. 3 and 4) . An operation in the years 1991 and 1992 was determined to be a preoperative predictor for both lower survival rate and lower rate of freedom from BCPS failure.
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Fig. 3. Survival curve (Kaplan–Meier) after BCPS for all 34 patients. (A) All deaths occurred within 3 years after the operation. (B) The outcome was significantly different between patients who underwent the operation before and after 1992.
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Fig. 4. Freedom from BCPS failure rate (Kaplan–Meier) for the 31 patients discharged from the hospital. (A) All observed BCPS failures occurred within 3 years after the operation. (B) The outcome was significantly different between patients who underwent the operation before and after 1992. BCPS failure is defined as total deaths and cardiopulmonary reinterventions after BCPS.
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3.3. Outcome of conversion to Fontan circulation
A conversion to Fontan circulation was performed in seven patients (one in the early period and six in the late period) at an age of 11±9.1 years (range, 3.5–29 years) for remnant or recurrent cyanosis and deterioration of exercise tolerance. The mean PAP in those seven patients was measured to be 12±4.6 (range, 9–20 mmHg) before conversion. Four patients died in the early period after operation, giving an operative mortality rate of 57%. These patients accounted for 67% of six total deaths. One patient who died after conversion was a 29-year-old woman with a single ventricular heart and subvalvular pulmonary stenosis. A bilateral Blalock–Taussig shunt had been inserted during her childhood and, after that, she had been left for many years. She underwent BCPS at the age of 27 for cyanosis and dyspnea on effort. However, cyanosis and dyspnea reappeared 1 year after BCPS. The function of BCPS was normal and the mean PAP was measured to be 9 mmHg. A conversion was performed, however, she died from low cardiac output syndrome 15 days after conversion. The second death occurred in a 7-year-old girl who presented tricuspid atresia with valvular and subvalvular pulmonary stenosis. A BCPS was performed when she was 4 years old and conversion was performed 3 years after BCPS for recurrent cyanosis. At the end of conversion procedure, the mean PAP was measured to be 22 mmHg. She died from low cardiac output syndrome in 24 h after the operation. The pulmonary artery, which should normally have a diameter of 15 mm, was quite underdeveloped (9 mm) in this patient and that should be the cause of the unfavorable result. The third death was in a 3.5-year-old girl with tricuspid atresia with valvular and subvalvular pulmonary stenosis. A conversion was performed for recurrent cyanosis 2 years after BCPS. Her postoperative hemodynamics and urination were relatively correct, however, progressive hyperkalemia appeared. Though peritoneal dialysis was carried out, the hyperkalemia did not diminish and she died 48 h after operation. The cause of hyperkalemia is unknown. The other death is presented in Section 3.1. We regret that early take-down of Fontan circulation should have been carried out in some of these patients.
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4. Discussion
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Fontan circulation is generally regarded as the final step in management of the functional single ventricular heart, because it can provide higher oxygen saturation and prevent paradoxical embolism by separating systemic and pulmonary circulations. BCPS is usually performed for only high-risk candidates or as one step of the staging procedure in preparation for a Fontan-type repair.
Since we considered that BCPS can provide adequate pulmonary blood flow in most patients with single ventricular heart and complications after BCPS are less serious than those after Fontan-type repairs, we used BCPS as a definitive repair in the present study and only performed conversion to Fontan circulation if the condition of the patient deteriorated significantly.
One of the advantages of BCPS over Fontan-type repairs is a reduced change in hemodynamics in the early period after operation [6,13]. For this reason, good early outcomes have been reported, even for high-risk candidates [17]. The operative mortality rate of 2.9% in our series compares favorably with a reported outcome after Fontan operation with an early mortality of 6.9% [18].
Half of our patients required the aid of CPB to undergo BCPS. A necessity for CPB depended on the patient's size rather than patient's anatomic condition. Smaller patients might be able to maintain a more collateral venous flow during SVC clamping. Anyway, the use of CPB did not influence the early outcome. We think that CPBs have to be employed without hesitation if necessary.
The question is whether patients with BCPS must necessarily be converted to Fontan circulation or not. It is true that the arterial oxygen saturation cannot reach normal levels with BCPS; in our series, the arterial oxygen saturation was 84±6.1% in patients with BCPS. However, exercise tolerance can be influenced by cardiac output as well as arterial oxygen saturation. An acute experiment with dogs showed that greater blood flow of a right heart bypass led to a lower systemic arterial oxygen saturation, but better ventricular performance [19]. In a series circuit with Fontan circulation, the cardiac output is strictly regulated by pulmonary blood flow, while a partially parallel circuit with BCPS increases the ability to meet a demand for higher cardiac output. We believe that the status of the 25 survivors with BCPS in our series is adequate for patients with single ventricular heart.
In BCPS circulation, the thoracic duct pressure rises causing the abdominal lymphatic pressure to subsequently rise, however, the abdominal venous pressure remains low. Both the abdominal lymphatic pressure and venous pressure are elevated in Fontan circulation which can cause major late abdominal complications. None of our patients developed any abdominal complications. Laboratory data about renal or hepatic function were not collected, nevertheless, no patients showed edema or hepatomegaly.
A deterioration of late clinical status, such as recurrent cyanosis, is the most common problem after BCPS operation. In the present study, the BCPS failure rate at 5 years was 38%. Recurrent cyanosis has been explained by a lowering of the SVC to inferior vena cava (IVC) blood flow ratio with age [20] and the development of PAVF and systemic venous collateral channels, the incidence of which increases with the length of time after operation [21,22], however, four adult patients in our cohort obtained adequate oxygen saturation, and a tendency for oxygen saturation to lower with length of follow-up was not observed in the present study. None of our patients developed PAVF, and that should be the reason why the late survivors with BCPS in our series were able to maintain an adequate status. The additional source of pulmonary blood flow, that was left in all patients, might contribute to these findings by providing a pulsatile flow and a ‘hepatic factor’.
The 5-year survival rate of 75% in the present study was inferior to that after Fontan-type operation which was previously reported to be 86% [23]. This might be due to the fact that our cohort included some high-risk patients. Four of six deaths occurred after conversions to Fontan circulation which were performed for remnant or recurrent cyanosis. The outcome of conversion was poor with an early mortality of 57%, in comparison with recently reported outcomes of only 4.8–8% early deaths [6,7,15]. We considered a shortage of blood supply from SVC as the cause of the deteriorated status after BCPS in these patients, as neither PAVF nor systemic venous collateral channels were detected by angiography. Therefore, we performed a conversion. However, in some patients, the deteriorated status may have been caused by elevated pulmonary vascular resistance (PVR), though the PVR was not measured before the conversion procedure in five patients who died after conversion to Fontan circulation. In this case, a take-down of BCPS or creation of axillary arteriovenous fistulae, as well as cardiac or cardiopulmonary transplantation, should be performed. If deteriorated patients were successfully managed in the late period after BCPS, the overall outcome would be improved.
In conclusion, we could not demonstrate a clear superiority of long-term BCPS over the construction of Fontan circulation. However, we believe that the use of BCPS as a definitive procedure for the functional single ventricular heart is worth examining in further studies. The incidence of incurable deterioration of late status and long-term quality of life (QOL) must be compared prospectively between a cohort with non-staged or staged Fontan-type repairs, and another with BCPS, to determine the effectiveness of BCPS alone.
4.1. Limitations
The most significant drawback of this study is the lack of a cohort who underwent a Fontan-type operation with which to compare late morbidity. Thus, we cannot provide an exact conclusion about the management strategy that was applied in the present study. We measured systemic arterial oxygen saturation levels with blood taken by direct puncture in awake patients in order to collect data in the natural condition without giving oxygen artificially. However, data from infants and children can be influenced by crying which may reduce the pulmonary blood flow. The evaluation of exercise tolerance was determined subjectively. Although an objective judgment is desirable, it is difficult to obtain for young children. Renal and hepatic functions were not assessed in the present study, but need to be assessed to compare late morbidity.
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Appendix A. Preoperative and operative variables
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References
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Abstract
1. Introduction
