The Fate of Homograft Versus Polytetrafluoroethylene Conduits After Neonatal Truncus Arteriosus Repair

Abstract

Background:

Despite significant improvement in outcomes with truncus arteriosus (TA) repair, right ventricular outflow tract (RVOT) reconstruction with a right ventricular to pulmonary artery (RV-to-PA) conduit remains a source of long-term reintervention and reoperation. This study evaluated our experience with reintervention in homograft and polytetrafluoroethylene (PTFE) RV-to-PA conduits in neonates.

Methods:

Primary TA repairs from 2004 to 2016 at a single institution were included. Stratification was based on RVOT reconstruction with PTFE or homograft conduit. Primary outcome was operative conduit replacement. Secondary outcomes included the rates and types of catheter-based conduit interventions.

Results:

Twenty-eight patients underwent primary TA repair and 89.3% (n = 25) of them had RVOT reconstruction with a homograft (28.0%, n = 7) or PTFE (72.0%, n = 18) conduit. Rates of reoperation for conduit replacement and catheter-based interventions were similar between those with PTFE and homograft conduits (85.7% vs 72.2%, P = .49 and 57.1% vs 83.3%, P = .11, respectively). Additionally, the median time to conduit replacement and catheter-based conduit interventions were comparable. In multivariable analysis, conduit size, but not conduit type, was a predictor of conduit revision (hazard ratio: 1.66, 95% confidence interval: 1.11-2.49, P = .02). At five-year and ten-year follow-up, patients with PTFE conduits had better survival than those with homograft conduits (100.0% vs 71.4%, P = .02); however, no mortalities were associated with conduit reoperations or catheter-based reinterventions.

Conclusions:

Polytetrafluoroethylene and homograft RVOT reconstruction in neonatal TA repair demonstrate similar durability as defined by reoperation and reintervention rates. The validation of the durability of PTFE conduits in neonatal TA repair requires confirmatory studies in larger cohorts.

Keywords

truncus arteriosus neonate homograft restenosis (conduit)

Introduction

The surgical outcomes following truncus arteriosus (TA) repair have been steadily improving over the past decades with a recent aggregate operative mortality of 9.9% and 10.1% reported in high- and low-volume centers, respectively.¹ Despite improvements in mortality, continued somatic growth combined with conduit stenosis or insufficiency limits the long-term freedom from catheter-based interventions and reoperations for right ventricular to pulmonary artery (RV-to-PA) conduit replacement in TA patients. Although the surgical landscape of available conduits for RV-to-PA reconstruction has broadened over the past decade, the utility and patient-specific application of each conduit type is still not fully delineated.^2,3 The aim of this case series was to evaluate long-term clinical outcomes of homograft and polytetrafluoroethylene (PTFE) conduits in contemporary neonatal TA patients.

Methods

The study population included patients under 28 days of age who underwent a single-stage, TA repair at a single institution between July 2004 and May 2016. The diagnosis of TA in these neonates was confirmed by review of the preoperative echocardiogram as well as operative reports. The anatomical classifications of TA were designated using a modified Van Praagh classification. Neonates with TA as well as associated interrupted aortic arch, hypoplastic aortic arch, pulmonary artery atresia, or coronary anomalies were included. Patients were stratified based on the conduit material utilized, homograft, or PTFE, at the time of primary TA repair. The institutional review board at the University of Pittsburgh approved this study.

Baseline Characteristics

Baseline preoperative characteristics including demographics, preoperative risk factors, and noncardiac congenital anomalies were evaluated.

Outcomes

The primary outcome was operative conduit replacement. The secondary outcomes included the rates and types of catheter-based conduit interventions. Other outcomes included operative mortality, longitudinal survival, and major postoperative complications, which included reoperation for bleeding, planned or unplanned delayed sternal closure, acute renal failure, stroke, all-cause reoperation, and sternal wound infection. The criteria for defining these complications were derived from the clinical definitions set forth by the Society of Thoracic Surgery. Operative mortality was defined as mortality within 30 days or prior to hospital discharge. Indications for catheter-based reintervention and operative conduit replacement were obtained through a review of echocardiograms, fluoroscopic images from cardiac catheterizations, and available medical charts. Conduit stenosis was defined as a conduit gradient >40 mm Hg, right ventricular systolic pressure greater than one-half systemic with conduit gradients <40 mm Hg, or evidence of reduced right ventricular ejection fraction. Further analysis to determine the time to RV-to-PA conduit gradients >40 mm Hg was performed using all available echocardiographic and cardiac catheterization data during follow-up.

Data Analysis

Kaplan-Meier and Nelson-Aalen estimates were conducted to compare survival and the cumulative hazards for conduit replacement and a cumulative outcome of all conduit interventions, which included operative conduit replacement and catheter-based interventions, between PTFE and homograft patients. If multiple conduit replacements or catheter-based conduit interventions occurred, the first operation and first catheter-based intervention was considered the failure event. Furthermore, Kaplan-Meier estimates were also used to determine the freedom from RV-to-PA conduit gradients of greater than 40 mm Hg. If patients underwent conduit replacement or catheter-based intervention prior to achieving a gradient of 40 mmHg, it was considered to be a failure event. To adjust for temporal variations in postoperative echocardiography and cardiac catheterizations, all gradient data were sequentially ordered with the date of surgery serving as time zero. Multivariable Cox regression incorporating univariate predictors (inclusion criteria of two-tailed P < .05) were conducted to evaluate the risk-adjusted impact of conduit type on conduit replacement. The variables included in the model were limited to ensure that there were only ten events per variable. Continuous data are presented as mean ± standard deviation or median (interquartile range [IQR]) and all categorical data as number (percentage). Fisher exact test was used for categorical data and the expected values were less than 5. Normally distributed continuous data and categorical data were compared with two-sided Student t tests, while non-Gaussian distributions were evaluated using quantile regression.

Results

Baseline Characteristics

A total of 28 patients underwent TA repair at our institution during the study period and were included in the case series. The median age at repair was seven days and the majority of patients were male (Table 1). The rate of low birth weight (<2.5 kg) infants undergoing TA repair was 14.3%. The most common TA type was type 1 in 53.6%. The truncal valve morphology was most frequently tricuspid (55.6%). Interrupted or hypoplastic arch was present in 25.0% of patients. At the time of TA repair, 14.3% had mild, 7.1% had moderate, and 25.9% had severe truncal valve regurgitation.

Table 1.

Preoperative Baseline Characteristics.

Truncus Arteriosus Patients	n = 28
Median age, days	7 (IQR: 6-10)
Gender
Female	25.0% (7)
Male	75.0% (21)
Noncardiac congenital anomaly	25.0% (7)
DiGeorge syndrome	35.7% (10)
Weight <2.5 kg	14.3% (4)
Preterm birth	10.7% (3)
Truncus type
1	53.6% (15)
2	42.9% (12)
3	3.6% (1)
Truncal valve morphology
Bicuspid	11.1% (3)
Tricuspid	55.6% (15)
Quadricuspid	33.3% (9)
Interrupted or hypoplastic aortic arch	25.0% (7)
Truncal valve regurgitation
None	53.5% (15)
Mild	14.3% (4)
Moderate	7.1% (2)
Severe	25.9% (7)

Abbreviation: IQR, interquartile range.

Intraoperative and Postoperative Outcomes

At the time of primary TA repair, a conduit was used for RV-to-PA reconstruction in 89.3% (n = 25) of patients, which included 28.0% (n = 7) homografts and 72.0% (n = 18) PTFE conduits. Three patients underwent right ventricular outflow tract (RVOT) reconstruction with a direct anastomosis (Supplemental Table S1). Truncal valve replacement was required in one patient at the time of primary repair. Delayed sternal closure occurred in 71.4% (n = 20) of patients following repair (Table 2). Extracorporeal membrane oxygenator support was utilized in 7.1% (n = 2) postoperatively. Reoperation for bleeding occurred in 3.5% (n = 1). There were no operative mortalities. The median length of stay was 16 days (IQR: 11-25 days) and 85.7% of patients were discharged home. Readmission within 30 days occurred in 26.9%. Truncal valve repair was required in 14.3% at a median interval of 26.5 months (IQR: 10-131 months) from primary repair. At ten-year follow-up, truncal valve replacement was required in 28.6% at a median interval of 25.0 months (14-110 months).

Table 2.

Intraoperative and Postoperative Outcomes.

	n = 28
Intraoperative outcomes
Cardiopulmonary bypass time, minutes	101 ± 23
Cross-clamp time, minutes	41 ± 23
Deep hypothermic circulatory arrest, minutes	9 ± 17
RV-to-PA reconstruction
Homograft	25.0% (7)
PTFE	64.3% (18)
Direct RV-to-PA connection	10.7% (3)
Truncal valve replacement	3.6% (1)
Truncal valve repair	0.0% (0)
Postoperative outcomes
Delayed sternal closure	71.4% (20)
ECMO support	7.1% (2)
Renal failure	0.0% (0)
Prolonged ventilation	14.3% (4)
Reoperation for bleeding	3.5% (1)
Median length of stay	16 (IQR: 11-25)
Discharged location home	85.7% (24)
Readmission within 30 days	26.9% (7)
Operative mortality	0.0% (0)
Truncal valve repair	14.3% (4)
Median time to truncal valve repair, months	26.5 (IQR: 10-131)
Truncal valve replacement	28.6% (8)
Median time to truncal valve replacement, months	25.0 (IQR: 14-110)
Freedom from truncal valve repair or replacement at 1 year	92.9% (26)
Freedom from truncal valve repair or replacement at 5 years	60.8% (17)

Abbreviations: ECMO, extracorporeal membrane oxygenation; IQR, interquartile range; PTFE, polytetrafluoroethylene; RV-to-PA, right ventricular to pulmonary artery.

Conduit Interventions

The rates of primary operative conduit replacements throughout the entirety of follow-up were 85.7% in the homograft group and 72.2% in the PTFE group (P = .49), while rates of secondary conduit replacements were 42.9% in the homograft group and 16.7% in the PTFE group (P = .19; Table 3). The primary indication for conduit revision and second conduit revision in both groups was stenosis. Catheter-based interventions were performed in 57.1% of homograft conduits and 83.3% of PTFE conduits prior to reoperation (P = .11). The median preintervention conduit gradient was similar between the groups (homograft 40 mm Hg [IQR: 40-43 mm Hg] vs PTFE 40 mm Hg [IQR: 31-51 mm Hg], P = .89). The indications for catheter-based interventions were isolated pulmonary artery stenosis (homograft 25.0% vs PTFE 33.3%) and conduit stenosis (homograft 75.0% vs PTFE 66.6%; P = .43). The median time to catheter-based conduit intervention was 50.4 months (IQR: 21.7-99.1 months) in the homograft cohort and 57.4 months (IQR: 21.7-119.5 months) in the PTFE cohort (P = .81).

Table 3.

Conduit Interventions Stratified by the Conduit Material Utilized.

Operative Conduit Replacements	Homograft, n = 7	PTFE, n = 18	P Value
Reoperations for conduit replacements
Conduit replacement	85.7% (6)	72.2% (13)	.49
Second conduit replacement	42.9% (3)	16.7% (3)	.19
Conduit size at primary operation, mm	10 ± 2	11 ± 1	.11
Indication for conduit replacement
Stenosis	100.0% (6)	100.0% (13)	.99
Median time to conduit replacement, months	57.4 (IQR: 21.8-149.5)	75.7 (IQR: 34.3-169.9)	.77
Conduit size at conduit replacement, mm	16 ± 4	16 ± 4	.97
Conduit type at conduit replacement			.52
Homograft	16.7% (1)	7.1% (1)
PTFE	83.3% (5)	92.9% (13)
Indication for second conduit replacement
Stenosis	100% (3)	100% (3)	-
Median time to second conduit replacement, months	76.3 (IQR: 34.0-104.2)	91.9 (IQR: 42.8-113.2)	.98
Conduit size at second replacement, mm	18 ± 5	18 ± 3	.99
Conduit type at second replacement			-
Homograft	0.0% (0)	0.0% (0)
PTFE	100.0% (3)	100.0% (3)
Freedom from conduit replacement
1 year	85.7% (6)	100.0% (18)	.10
5 years	71.4% (5)	81.8% (15)	.44
10 years	28.5% (2)	27.3% (5)	.47
Catheter-based interventions
Conduit angioplasty or stenting	57.1% (4)	83.3% (15)	.11
Median conduit gradient, mm Hg	40 (IQR: 40-43)	40 (IQR: 31-51)	.89
Indication for catheter-based intervention			.43
PA stenosis	25.0% (1)	33.3% (5)
Conduit stenosis	75.0% (3)	66.6% (10)
Median time to conduit intervention, months	50.4 (IQR: 21.7-99.1)	57.4 (IQR: 21.7-149.5)	.81

Abbreviations: IQR, interquartile range; PA, pulmonary artery; PTFE, polytetrafluoroethylene.

Multivariate Predictors for Conduit Replacement

We analyzed whether conduit material was a predictor for conduit replacement when adjusted for conduit size. There was no difference in the rates of conduit replacements between homograft and PTFE conduits (hazard ratio [HR]: 0.46, 95% confidence interval [CI]: 0.15-1.42, P = .18) (Table 4). Not surprisingly, smaller sized conduits at initial TA repair portended higher hazards for conduit replacement (HR: 1.66, 95% CI: 1.11-2.49, P = .02).

Table 4.

Predictors of Conduit Replacement in Multivariate Cox Regression Analysis.

	Hazard Ratio	95% Confidence Interval	P Value
Conduit replacement
Homograft	Reference	Reference	Reference
PTFE	0.46	(0.15-1.42)	.18
Conduit size (decreasing, per mm)	1.66	(1.11-2.49)	.01

Abbreviation: PTFE, polytetrafluoroethylene.

^a Other nonsignificant variables used for adjustment: age, weight, surgery year, preterm birth status, truncal valve regurgitation, and interrupted or hypoplastic arch.

Estimated Hazards for Conduit Intervention and Survival

The median follow-up time was 7.2 years (IQR: 3.1-9.3 years) and was similar between patients who received a homograft and a PTFE conduit at primary repair. The Nelson-Aalen cumulative hazards for catheter-based conduit interventions were similar between patients with homografts and PTFE RV-to-PA reconstructions at all time intervals (P = .91; Figure 1). Reoperations for conduit replacement were also similar between the groups at all time intervals (P = .69; Figure 2A). Freedom from a composite outcome of catheter-based and surgical conduit replacements was limited at ten-year follow-up but similar between the conduit groups (28.5% vs 16.6%, P = .65; Figure 2B). At one-year follow-up, survival was similar between patients who received homograft and PTFE conduits; whereas at five-year and ten-year follow-up, there was a divergence in the curves with survival favoring patients with PTFE conduits (100.0% vs 71.4%, P = .02; Figure 3 and Supplemental Table S2). However, no late mortalities were associated with subsequent operative conduit replacements or catheter-based interventions.

Conduit Gradients and Freedom From Significant Conduit Stenosis

There were 129 conduit gradients measured with either echocardiography or cardiac catheterization during the study period. These data were aggregated and plotted to demonstrate the trend toward developing conduit stenosis, especially during the first five years of follow-up (Figure 4A). When evaluating freedom from a conduit gradient of greater than 40 mm Hg, we found no difference between homograft and PTFE conduits at one year (85.7% vs 100.0%, P = .11) and five years (71.4% vs 57.8%, P = .19; Figure 4B).

Comment

The natural progression of RV-to-PA conduits following TA repair is stenosis or insufficiency requiring catheter-based interventions and surgical conduit replacement. Homografts have been the most extensively used conduits for RVOT reconstruction, although their use is limited by durability and size availability.⁴ Over the past two decades, conduits for RV-to-PA reconstruction have expanded to include valved PTFE conduits. Mercer et al compared RVOT reconstruction with homograft and bicuspid PTFE conduits in 55 patients aged less than two years and found similar rates of operative conduit replacement when adjusted for z-score but shorter hospital length of stay in the PTFE group (14 vs 25 days, P = .013).⁵ A single-center observational study that included 192 patients undergoing RVOT reconstruction demonstrated an 82% freedom from conduit replacement at ten years.⁶ Moreover, there is extensive experience with PTFE RV-to-PA conduits in Japan, where homografts are unavailable. The utilization of monocusp, bicuspid, and tricuspid PTFE conduits as well as expanded PTFE conduits with sinus segments has been described with excellent outcomes.^7
–9 Ando and Takahashi have described their long-term outcomes of tricuspid PTFE conduits in RVOT reconstruction in both teenagers and infants with an 88% freedom from operative conduit replacement at ten years.¹⁰ Importantly, despite impressive outcomes, most prior studies have included a combined population of older children with infants and conduit reoperations with primary repairs, which may increase freedom from conduit replacement. Additionally, the majority of studies include a minority of TA patients.

Study Findings

The current case series demonstrates the outcomes of homograft and PTFE conduits in neonatal TA patients undergoing primary repair. There are several implications of the findings from this case series. Foremost, we show that the rates of conduit replacement and catheter-based conduit interventions were similar regardless of the conduit type utilized. Although the conduit material was not an independent predictor of conduit replacement, smaller conduit size at primary repair had a 66% increased hazard for conduit replacement. The median length of hospital stay and postoperative complications were similar between the groups. We found no difference in the rates of 30-day readmission between the patients who underwent homograft or PTFE reconstruction.

This case series reaffirms that PTFE conduits are a safe option for primary RVOT reconstruction in neonates with TA. Although conduit reinterventions are inevitable for neonatal TA patients with any of the currently available conduits, both conduits in our study carried comparable hazards for conduit revision and catheter-based interventions. A lower mortality rate was appreciated at five year follow-up in the patients who had undergone primary TA repair with PTFE conduits (100.0% vs 71.4%, P = .02). This difference in survival represents two patients with DiGeorge syndrome who underwent neonatal TA repair who both succumbed to pneumonia at 41 and 39 months, respectively, from operative intervention. Patients with DiGeorge syndrome have been shown to have a five-fold increased hazard for late mortality compared to their counterparts (HR: 5.4, 95% CI: 1.6-17.8, P = .006).¹¹ Considering that both deaths in this series were isolated from conduit interventions, the difference in mortality could potentially be attributed to DiGeorge syndrome rather than conduit choice. As such, the possible mechanisms for these associations require further study and validation in larger cohorts.

In alignment with prior studies, our series demonstrated a 66% increased hazard for postoperative conduit interventions as conduit size decreased per millimeter. Poynter et al demonstrated in a retrospective analysis of 429 infants that conduits with smaller z-scores were at higher risk for surgical explant and replacement.¹² In another retrospective review of 143 neonates who survived to hospital discharge after RVOT reconstruction, the freedom from conduit or branch PA reintervention at one year was 68%, with smaller conduit diameter as the only significant predictor of reintervention (HR: 0.66, 95% CI: 0.55-0.82, P < .001).¹³

Prior Studies of Conduit Outcomes in TA Repair

In the current era, numerous valved conduit options are available for RVOT reconstruction, including aortic or pulmonary homografts, stentless and stented xenografts, and valved PTFE conduits.¹⁴ Each type of conduit offers important advantages and fundamental limitations, although there is no current evidence to support any one conduit type as superior since many of the available studies reach contradictory conclusions.

In a multicenter, retrospective study of 216 neonates that evaluated homografts versus Contegra (Medtronic Inc, Minneapolis, Minnesota) bovine jugular vein conduits, the authors appreciated a two-fold increased risk for reintervention when bovine jugular vein conduits were used (HR: 1.9, 95% CI: 1.2-3.1, P = .02) at all intervals of follow-up, regardless of conduit size.¹¹ Contradistinctively, in a retrospective, single-center study, which included 145 patients and compared cryopreserved homografts, bovine jugular vein conduits, and porcine-valved Dacron conduits, the overall durability of the conduits was found to be similar; however, conduit stenosis and insufficiency occurred earlier in patients with bovine jugular vein conduits.¹⁴ In another retrospective analysis of 586 children who underwent RVOT reconstruction, for multiple congenital cardiac diagnoses including TA, with homograft, bovine jugular vein, or porcine heterograft conduits, bovine jugular vein conduits were found to have higher rates of late endocarditis. However, the bovine jugular vein conduits also had lower rates of conduit replacement overall (HR: 0.5, 95% CI: 0.4-0.7, P = .0002) when compared to homografts.¹⁵ Importantly, in this study, TA was also an independent predictor of conduit replacement (HR: 1.5, 95% CI: 1.0-2.1, P = .03) when compared to other etiologies of congenital heart disease. A recent retrospective analysis of 216 children from 15 different centers showed that when adjusted for conduit size and center variation, the type of conduit utilized was not a predictor of postoperative major adverse cardiac events.¹⁶ Although this study did not interrogate postdischarge events, the authors did identify that a conduit size >50 mm/m² had a five-fold increase in the odds for mortality, irrespective of the conduit type (odds ratio: 4.7, 95% CI: 2.0-11.1, P < .01).

Limitations

There are several limitations to this case series. Foremost, this is a retrospective study with all the inherent limitations related to its design. There is also variability in surgeon decision-making for conduit selection as well as intraoperative availability of homograft sizes at the time of primary TA repair or conduit replacement. Additionally, this is case series with a limited sample size. Kaplan-Meier estimates are not as robust in small sample sizes with heavy censoring and lack of uniformity of follow-up, which may underestimate the actual variance and limit the information that can be gleaned from these analyses. Furthermore, this is a single-center case series, and the generalizability of the findings is unknown.

Conclusions

This case series of patients undergoing primary TA repair suggests that PTFE conduit can be safely used in neonates, without an adverse impact on clinical outcomes. Furthermore, durability, including reoperation and catheter-based interventions, is similar between those with PTFE and homograft RVOT reconstructions. The validation of the durability of PTFE conduits in neonatal TA repair requires confirmatory studies in larger cohorts.

Supplemental Material

Supplemental_Data - The Fate of Homograft Versus Polytetrafluoroethylene Conduits After Neonatal Truncus Arteriosus Repair

Supplemental_Data for The Fate of Homograft Versus Polytetrafluoroethylene Conduits After Neonatal Truncus Arteriosus Repair by Laura M. Seese, Harma K. Turbendian, Carlos E. Diaz Castrillon and Victor O. Morell in World Journal for Pediatric and Congenital Heart Surgery

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Supplemental Material

Supplemental material for this article is available online.

Abbreviations and Acronyms

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