Publications by authors named "Zachary A Spigel"

12 Publications

  • Page 1 of 1

Total anomalous pulmonary venous connection: Influence of heterotaxy and venous obstruction on outcomes.

J Thorac Cardiovasc Surg 2021 Apr 2. Epub 2021 Apr 2.

Division of Congenital Heart Surgery, Department of Surgery, Baylor College of Medicine and Texas Children's Hospital, Houston, Tex. Electronic address:

Background: Previous studies have demonstrated increased early mortality and pulmonary vein reintervention for patients with total anomalous pulmonary venous connection (TAPVC) and heterotaxy syndrome (HTX+) compared with patients with TAPVC without heterotaxy syndrome (HTX-). We aimed to evaluate the longitudinal risk of pulmonary vein reintervention and mortality in HTX + patients.

Methods: A retrospective review was performed to identify longitudinal interventions in patients with TAPVC seen at a single center from 1995 to 2019. The mean cumulative interventions were described for all patients using the Nelson-Aalen estimator. Survival with TAPVC was described using Kaplan-Meier estimates.

Results: A total of 336 patients were identified with TAPVC, of whom 118 (35%) had heterotaxy syndrome. Functional single ventricles were identified in 106 of these 118 HTX + patients (90%) and in 14 of 218 HTX- patients (6%) (P < .001). Obstructed TAPVC (OBS+) was present in 49 of 118 HTX + patients (42%) and in 87 of 218 HTX- patients (40%) (P = .89). The median duration of follow-up was 6.5 years. Five-year survival was 69% for HTX+/OBS + patients, 72% for HTX+/OBS- patients, 86% for HTX-/OBS + patients, and 95% for HTX-/OBS- patients (P < .0001, log-rank test). The mean number of pulmonary vein interventions at the median follow-up time was greater in the HTX+/OBS + patients compared with HTX+/OBS- patients (mean, 2.0 vs 1.1; P = .030), HTX-/OBS + patients (mean, 1.3; P = .033), and HTX-/OBS- patients (mean, 1.3; P = .029).

Conclusions: Among the 4 cohorts, HTX+ was associated with a higher rate of mortality, and HTX+/OBS+ was associated with a greater number of pulmonary vein interventions. This may be due in part to the high prevalence of single ventricle physiology in the HTX + cohort.
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http://dx.doi.org/10.1016/j.jtcvs.2021.03.058DOI Listing
April 2021

The intraoperative use of recombinant activated factor VII in arterial switch operations.

Cardiol Young 2021 Mar 19;31(3):386-390. Epub 2020 Nov 19.

Texas Children's Hospital, Houston, TX, USA.

Background: The rate of bleeding complications following arterial switch operation is too low to independently justify a prospective randomised study for benefit from recombinant factor VIIa. We aimed to evaluate factor VIIa in a pilot study.

Methods: We performed a retrospective cohort study of patients undergoing arterial switch operation from 2012 to 2017. Nearest-neighbour propensity score matching on age, gender, weight, and associated cardiac defects was used to match 27 controls not receiving recombinant factor VIIa to 30 patients receiving recombinant factor VIIa. Fisher's exact test was performed to compare categorical variables. Wilcoxon's rank-sum test was used to compare continuous variables between cohorts.

Results: Post-operative thrombotic complications were not associated with factor VIIa administration (Odds Ratio (OR) 0.28, 95% CI 0.005-3.77, p = 0.336), nor was factor VIIa administration associated with any re-explorations for bleeding. No intraoperative transfusion volumes were different between the recombinant factor VIIa cohort and controls. Post-operative prothrombin time (10.8 [10.3-12.3] versus 15.9 [15.1-17.2], p < 0.001) and international normalised ratio (0.8 [0.73-0.90] versus 1.3 [1.2-1.4], p < 0.001]) were lower in recombinant factor VIIa cohort relative to controls.

Conclusions: In spite of a higher post-bypass packed red blood cell transfusion requirement, patients receiving recombinant factor VIIa had a similar incidence of bleeding post-operatively. With no difference in thrombotic complications, and with improved post-operative laboratory haemostasis, a prospective randomised study is warranted to evaluate recombinant factor VIIa.
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http://dx.doi.org/10.1017/S1047951120004072DOI Listing
March 2021

N1c colon cancer and the use of adjuvant chemotherapy: a current audit of the National Cancer Database.

Colorectal Dis 2021 Mar 24;23(3):653-663. Epub 2020 Nov 24.

Division of Colorectal Surgery, Department of Surgery, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York, USA.

Aim: Colorectal cancer staging has evolved to define N1c as the presence of tumour deposits without concurrent positive lymph nodes. Work to date reports poor prognosis in N1c colon cancer, with Stage III categorization and adjuvant chemotherapy (AC) recommended. No study has yet evaluated the prevalence, treatment compliance or treatment-related outcomes on a national scale. We aimed to evaluate the prevalence of N1c colon cancer, use, outcomes and factors associated with AC in the USA.

Method: The National Cancer Database was reviewed for N1cM0 colon adenocarcinomas that underwent resection from 2010 to 2016. Cases were stratified into 'AC' or 'no AC' cohorts. The Kaplan-Meier method was used to estimate overall survival (OS) and compare the AC and no AC cohorts using the log-rank test. Multivariable logistic regression identified factors associated with AC. The main outcome measures were the prevalence and factors associated with AC use and its impact in N1c disease.

Results: Of the 5684 (1.59% of 357 752) colon adenocarcinomas that were N1c, 55% (n = 3071) received AC. AC significantly improved 1-, 3- and 5-year OS compared with no AC (96.2%, 80%, 67.4% and 72.9%, 48.5%, 33.8%, respectively; P < 0.001). Compared with the no AC group, AC patients were younger, had less comorbidity, were of the male gender and received minimally invasive surgery at an academic treatment centre (all P < 0.05). Socioeconomic and procedural factors significantly impacted the use of AC.

Conclusion: In the USA, AC is underutilized in N1c colon cancer despite significantly improved OS. Socioeconomic and procedural factors associated with AC were identified, highlighting disparities in AC use and opportunities to improve oncological outcomes and survival.
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http://dx.doi.org/10.1111/codi.15406DOI Listing
March 2021

Predictors of Transplant-Free Survival After the Norwood Procedure.

Ann Thorac Surg 2021 08 17;112(2):638-644. Epub 2020 Aug 17.

Division of Congenital Heart Surgery, Department of Surgery, Texas Children's Hospital/Baylor College of Medicine, Houston, Texas. Electronic address:

Background: Birth weight, preterm delivery, and size for gestational age are surrogate markers for development that are commonly used in congenital heart surgery. Understanding the associations of these variables with patient outcomes is of great importance.

Methods: This study included all patients with hypoplastic left heart syndrome who underwent a Norwood procedure at a single institution from 1995 to 2018. Low birth weight was defined as weight less than 2.5 kg, and preterm delivery occurred at less than 37 weeks' gestation. Overall and conditional analyses were performed to evaluate for association with outcomes after the Norwood procedure. Secondary analyses evaluated the association of development measures with postoperative length of stay and ventilator duration.

Results: In total, 303 neonates (60% male) underwent the Norwood procedure and were followed for a median of 3.9 years (interquartile range, 0.5 to 10.4 years). Median birth weight was 3.1 kg (interquartile range, 2.8 to 3.4 kg). Patients with low birth weight had decreased transplant-free survival compared with patients with a normal birth weight (hazard ratio, 1.7; 95% confidence interval, 1.03 to 2.82; P = .039). When conditioning on survival to second-stage palliation, patients born small for gestational age had decreased transplant-free survival compared with patients born at appropriate size for gestational age (hazard ratio, 2.8; 95% confidence interval, 1.31 to 6.09; P = .008). Patients delivered preterm had a longer hospital length of stay (median, 55 days vs 31 days; P = .02) and more ventilator days compared with patients delivered at term (median, 7 days vs 4 days; P = .004).

Conclusions: Various developmental markers have differing prognostic importance for patients undergoing the Norwood procedure. Understanding these differences can help guide preoperative decision making and patient selection.
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http://dx.doi.org/10.1016/j.athoracsur.2020.06.024DOI Listing
August 2021

Younger Age at Operation Is Associated With Reinterventions After the Warden Procedure.

Ann Thorac Surg 2021 06 24;111(6):2059-2065. Epub 2020 Jul 24.

Division of Congenital Heart Surgery, Department of Surgery, Texas Children's Hospital/Baylor College of Medicine, Houston, Texas.

Background: Multiple techniques are available for repair of supracardiac partial anomalous pulmonary venous return (PAPVR); however, most series fail to compare the techniques in contemporary cohorts. This study aimed to describe outcomes of the Warden procedure with a single-patch repair cohort to serve as a control.

Methods: A retrospective cohort analysis of all patients at a single institution (Texas Children's Hospital, Houston, TX) included patients undergoing either the Warden procedure or single-patch repair from 1996 to 2019 for PAPVR. Reintervention was defined as any catheter or surgical procedure on the superior vena cava (SVC) or pulmonary veins. Subgroup analysis was performed within the Warden cohort to evaluate for association between an SVC patch and reintervention-free survival.

Results: In total, 158 patients (122 in the Warden group and 36 in the single-patch group) were identified. The median age at operation was younger for patients in the Warden cohort (5.4 years; interquartile range, 3.3 to 10.2 years) compared with patients in the single-patch cohort (13.3 years; interquartile range, 6.5 to 18.7 years; P < .001). One patient in each cohort died. One patient required reoperation after the Warden procedure for dehiscence of the intracardiac patch. Ten patients required transcatheter reinterventions. Reintervention-free survival was not different between patients in the Warden cohort and patients in the single-patch cohort (P = .54) or within the Warden cohort in patients with an SVC patch (P = .27). When controlling for repair type, older age at repair was associated with longer reintervention-free survival (hazard ratio, 0.81; 95% confidence interval, 0.71 to 0.93; P = .002).

Conclusions: The Warden procedure is a viable option for younger patients requiring supracardiac PAPVR repair, although these younger patients are likely at greatest risk for reintervention regardless of surgical technique.
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http://dx.doi.org/10.1016/j.athoracsur.2020.05.143DOI Listing
June 2021

Recurrent Pulmonary Artery Interventions Following the Norwood Procedure Are Not Associated With Conduit Type.

Semin Thorac Cardiovasc Surg 2021 Spring;33(1):195-201. Epub 2020 Jun 5.

Department of Surgery, Division of Congenital Heart Surgery, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas. Electronic address:

Given pulmonary artery interventions following the Norwood procedure can recur, the average number of occurrences per patient over time is likely more informative than the crude percentage of patients who required an intervention. Pulmonary artery intervention was defined as any surgical or catheter-based procedure after the Norwood procedure. The number of pulmonary artery interventions for patients with hypoplastic left heart syndrome were compared between patients with modified Blalock-Taussig Shunts (MBTS) and right ventricle-to-pulmonary artery conduits (RVPA) at a single institution from 2011 to 2018. The comparison was replicated using data from the Single Ventricle Reconstruction Trial (SVR), a nonoverlapping dataset. The mean number of pulmonary artery interventions per patient over time (mean cumulative function, MCF) is described using Nelson-Aalen estimates and compared using the pseudo-score test. The number of patients requiring intervention was compared using the chi-square test. Using our institutional dataset, the Norwood operation was performed on 117 patients (59 MBTS, 58 RVPA). In total, 73 patients had a pulmonary artery intervention, including 32 of 58 (55%) after MBTS and 41 of 59 (69%) after RVPA (P= 0.11). The MCF did not vary between cohorts (P = 0.55). Using the SVR trial dataset, 140 of 549 patients required pulmonary artery intervention, including 55 (21%) after MBTS and 85 (30%) after RVPA (P = 0.0090). The MCF did not vary between cohorts (P = 0.067). Although more patients with RVPA than MBTS require pulmonary artery interventions after the Norwood procedure, the MCFs are not different, which may be of greater importance to patients and families.
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http://dx.doi.org/10.1053/j.semtcvs.2020.05.028DOI Listing
May 2021

Durability of the St. Jude Epic Supra Bioprosthetic Valve in the Pulmonary Position.

Semin Thorac Cardiovasc Surg 2021 Spring;33(1):184-191. Epub 2020 Jun 4.

Texas Children's Hospital/Baylor College of Medicine, Department of Surgery, Division of Congenital Heart Surgery, Houston, Texas. Electronic address:

Epic Supra valves have been used off-label in the pulmonary position. We aim to evaluate the durability of Epic valves in the pulmonary position. We performed a retrospective review of all Epic valves placed in the pulmonary position from October 2008 to May 2019. Time-to-event analysis was performed using Kaplan-Meier estimates to evaluate freedom from valve intervention, moderate pulmonary regurgitation, and peak velocity greater than 3.5 m/s. Valve dysfunction was a composite of all 3 end points. A total of 79 patients had Epic valves implanted in the pulmonary position. Median age was 18.5 years (15th-85th percentile 11.2-41.0). In total, 1 (1%) 19 mm valve, 4 (5%) 21 mm valves, 8 (10%) 23 mm valves, 23 (29%) 25 mm valves, and 43 (54%) 27 mm valves were implanted. There were no deaths or transplants. Median follow-up was 3.1 years (interquartile range 1.0-5.5). At 5 years, freedom from valve intervention was 95%, freedom from valve dysfunction was 68%, freedom from moderate pulmonary regurgitation was 73%, and freedom from peak velocity greater than 3.5 m/s was 82%. Epic Supra valves provide an acceptable valve replacement in the pulmonary position for children and adults. Longer follow-up is needed to determine valve durability through the entirety of the valve life expectancy.
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http://dx.doi.org/10.1053/j.semtcvs.2020.05.026DOI Listing
May 2021

Pulmonary Artery Banding for Children With Dilated Cardiomyopathy: US Experience.

Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu 2020 ;23:69-76

Baylor College of Medicine and Texas Children's Hospital, Houston, Texas. Electronic address:

Pulmonary artery band placement is a recently described therapeutic strategy for dilated cardiomyopathy with preserved right ventricular function, originally reported from Germany.1 We present the results of the multicenter retrospective study of pulmonary artery band experience in the United States, with comparison to the German experience. Five centers contributed a total 14 patients (median age 5 months, interquartile range 3.5-10). Mechanical ventilation was required in 9/12 (75%) patients and inotropes were used in 13/14 (93%) patients preoperatively. Ultimately, 4 (29%) patients experienced cardiac recovery, 8 (57%) were bridged to cardiac transplantation (6 with ventricular assist device placement), and 2 (14%) died. Although both the US and Germany series demonstrated high prevalence of achieving patients' individual target (either cardiac recovery or transplant), the mode of success was different (recovery rate: <1/3 in the United States and >2/3 in Germany). Lower recovery rate may be a reflection of sicker preoperative status, and thereby a more advanced stage of heart failure (preoperative intubation: >2/3 in the United States vs <1/3 in Germany). Further studies would be warranted to gain more insight into patient selection as well as optimal timing for the intervention.
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http://dx.doi.org/10.1053/j.pcsu.2020.03.002DOI Listing
March 2021

Current status of pediatric mechanical circulatory support.

Curr Opin Organ Transplant 2020 06;25(3):231-236

Division of Congenital Heart Surgery, Michael E. DeBakey Department of Surgery, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA.

Purpose Of Review: The field of pediatric mechanical circulatory support has experienced exponential evolution in recent decades. With favorable complication profiles, implantable continuous-flow ventricular assist devices (VADs) have become a standard option in children, as has been seen in the adult counterpart. Nevertheless, there still exists room for further advances, not just for survival, but throughout the whole trajectory of treatment courses. With reviewing the current state of pediatric VAD support, including existing challenges, we aim to highlight the targets clinicians should focus on for further improvement of pediatric VAD support.

Recent Findings: The field of pediatric VAD has been steadily growing, as evidenced by an increasing number of total VAD implants, particularly with continuous-flow VAD. Currently, HeartWare HVAD (Medtronic Inc., Mounds View, MN) is the most widely used continuous-flow VAD in children with excellent performance. However, only half of the children with HVAD are discharged home, which is drastically different from adult patients, suggesting that the pediatric field is still in the process of maturation. Additionally, outcomes of VAD support for complex congenital heart defect, particularly single ventricle physiology, remain suboptimal, despite an increasing number of such patients.

Summary: With the ongoing advancement, the field of pediatric VAD support is undergoing a rapid maturation process. This will eventually lead to further paradigm changes, including the use of VAD as permanent therapy.
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http://dx.doi.org/10.1097/MOT.0000000000000761DOI Listing
June 2020

Current clinical management of dysfunctional bioprosthetic pulmonary valves.

Expert Rev Cardiovasc Ther 2020 Jan 30;18(1):7-16. Epub 2020 Jan 30.

The Lillie Frank Abercrombie Section of Cardiology, Department of Pediatric Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA.

: As with any bioprosthetic valve, bioprosthetic valves in the pulmonary position have a finite life span and patients with bioprosthetic pulmonary valves require lifetime management to treat valve dysfunction.: In this article, authors discuss the current medical management for the treatment of dysfunctional bioprosthetic valves. This review is based on both an extensive review of the recent cardiac surgical/interventional cardiology literature (PubMed and MEDLINE database searches from 1958 to 2019) and personal experience.: Valve technology is rapidly progressing and with a coordinated effort from cardiac surgeons and interventional cardiologists, patients suffering from bioprosthetic pulmonary valve dysfunction can expect to have a decreased number of procedures and less invasive procedures over their lifetime now.
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http://dx.doi.org/10.1080/14779072.2020.1715796DOI Listing
January 2020

Right Ventricle-Dependent Coronary Circulation: Location of Obstruction Is Associated With Survival.

Ann Thorac Surg 2020 05 30;109(5):1480-1487. Epub 2019 Sep 30.

Division of Congenital Heart Surgery, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas. Electronic address:

Background: Pulmonary atresia with intact ventricular septum (PAIVS) with right ventricle-dependent coronary circulation (RVDCC) carries suboptimal outcomes primarily due to cardiac ischemia. We hypothesize clinical outcomes are affected by the level of coronary obstruction, a surrogate for vulnerable myocardium.

Methods: We conducted a single-institution retrospective analysis of all neonates with PAIVS with RVDCC from 1995 to 2017. RVDCC was defined as the presence of any coronary-cameral fistula with coronary obstruction proximal to the fistula and angiographic evidence of RV perfusion of the myocardium through the fistulous communication. Location of coronary obstruction was categorized as either proximal or distal segments, using the SYNTAX score criteria. Transplant-free survival was compared between patients with proximal and distal obstruction, then these groups were compared with patients without RVDCC.

Results: Of 103 neonates with PAIVS, 28 (27%) had RVDCC: 18 proximal (64%), 10 distal (36%). Median age at last follow-up for patients with RVDCC was 1.8 years (interquartile range, 0.3-8.1 years). All deaths (10 of 28, 36%) occurred at 6 months old or earlier. Proximal coronary artery obstruction was associated with decreased transplant-free survival relative to distal obstruction (hazard ratio = 3.63; 95% confidence interval, 1.01-13.00; P = .048). Transplant-free survival at 1 year was 33% and 70% in the proximal and distal obstruction groups, respectively. Compared with patients without RVDCC, patients with proximal obstruction had significantly lower transplant-free survival (P < .001), whereas patients with distal obstruction did not (P = .217).

Conclusions: The location of coronary artery obstruction affects clinical outcome and may represent a potential branch point in the management for PAIVS with RVDCC.
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http://dx.doi.org/10.1016/j.athoracsur.2019.08.066DOI Listing
May 2020

Reoperation after isolated subaortic membrane resection.

Cardiol Young 2019 Nov 26;29(11):1391-1396. Epub 2019 Sep 26.

Division of Congenital Heart Surgery, Baylor College of Medicine, Texas Children's Hospital, Houston, TX, USA.

Background: The resection of a subaortic membrane remains far from a curative operation. We sought to examine factors associated with reoperation and the degree of aortic valve regurgitation as a potential long-term source for reoperation.

Methods: All patients who underwent resection of an isolated subaortic membrane between 1995 and 2018 were included. Patients who underwent other procedures were excluded. Paired categorical data were compared using McNemar's test. Univariate time-to-event analyses were performed using Kaplan-Meier methods with log-rank tests for categorical variables and univariate Cox models for continuous variables.

Results: A total of 84 patients (median age 6.6, 31% females) underwent resection of isolated subaortic membrane. At a median follow-up of 9.3 years (interquartile range 0.6-22.5), 12 (14%) patients required one reoperation and 1 patient required two reoperations. Median time to first reoperation was 4.6 years. The degree of aortic valve regurgitation improved post-operatively from pre-operatively (p = 0.0007); however, the degree of aortic valve regurgitation worsened over the course of follow-up (p = 0.010) to equivalence with pre-operative aortic valve regurgitation (p = 0.18). Performance of a septal myectomy was associated with longer freedom from reoperation (p = 0.004).

Conclusions: In patients with isolated subaortic membranes, performance of a septal myectomy can minimise risk for reoperation. Patients should be serially monitored for degradation of the aortic valve, even if aortic regurgitation is not present post-operatively.
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http://dx.doi.org/10.1017/S1047951119002336DOI Listing
November 2019
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