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Nancy S. Ghanayem - One of the best experts on this subject based on the ideXlab platform.

  • Predictors of Transplant-Free Survival After the Norwood Procedure
    The Annals of thoracic surgery, 2020
    Co-Authors: Zachary A. Spigel, Nancy S. Ghanayem, Christopher A. Caldarone, Alyssa B. Kalustian, Michiaki Imamura, Iki Adachi, E. Dean Mckenzie, Jeffrey S. Heinle, Ziyad M. Binsalamah
    Abstract:

    Abstract Background Birth weight, preterm delivery, and size for gestational age are surrogate markers for development commonly used in congenital heart surgery. Understanding the associations of these variables with patient outcomes are of great importance. Methods We included all patients with hypoplastic left heart syndrome (HLHS) who underwent a Norwood Procedure at a single institution from 1995-2018. Low birth weight was defined as less than 2.5 kilograms 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. Secondary analyses evaluated the association between development measures and post-operative length of stay (LOS) and ventilator duration. Results In total 303 neonates (60% male) underwent the Norwood Procedure and were followed for a median 3.9 years (IQR 0.5-10.4). Median birth weight was 3.1 kilograms (interquartile range [IQR] 2.8-3.4). Patients with low birth weight had decreased transplant-free survival compared to patients with a normal birth weight (HR 1.7, 95%CI 1.03-2.82, p=0.039). When conditioning on survival to second stage palliation, patients born small for gestational age had decreased transplant-free survival compared to patients born at appropriate size for gestational age (HR 2.8, 95%CI 1.31-6.09, p=0.008). Patients delivered preterm had longer hospital LOS (median 55 days vs 31 days, p=0.02) and more ventilator days compared to patients delivered at term (median 7 days vs 4 days, p=0.004). Conclusions Various development markers have differing prognostic importance for patients undergoing the Norwood Procedure. Understanding these differences can help guide pre-operative decision-making and patient selection.

  • Norwood Procedure difficulty in weaning from cardiopulmonary bypass and implications for outcomes
    Seminars in Thoracic and Cardiovascular Surgery, 2020
    Co-Authors: Jaclyn A. Gellings, James S. Tweddell, George M. Hoffman, Nancy S. Ghanayem, William K. Johnson, Michael E. Mitchell, Viktor Hraska, Evelyn M. Kuhn, Ronald K. Woods
    Abstract:

    Difficulty weaning from cardiopulmonary bypass (CPB) or the need to return to CPB (collectively D-CPB) may occur after the Norwood Procedure. We sought to evaluate the relationship between D-CBP and survival. This was a retrospective chart review of all patients undergoing a Norwood Procedure at our institution during the interval 2005–2017. Primary outcome was survival for the Norwood Procedure. Secondary outcomes included various measures of morbidity. Successful wean from CBP (S-CPB) was defined as no need to return to full-flow CPB during the initial definitive wean or after separation from CPB; otherwise, the classification was difficulty with wean (D-CBP). Successful rescue in the D-CPB group was defined as not requiring extracorporeal life support either in the operating room or within the first 3 postoperative days. Of the 196 patients in the cohort, 49 were D-CPB. Survival for S-CPB was 92.5% (136/147) vs 71.4% (35/49) for D-CPB (P = 0.001). Major morbidity occurred in 29.9% (44/147) in S-CPB vs 69.4% (34/49) in D-CPB (P

  • Selective Use of Inpatient Interstage Management After Norwood Procedure
    The Annals of thoracic surgery, 2019
    Co-Authors: Garick D. Hill, Nancy S. Ghanayem, Jena Tanem, Nancy Rudd, Nicholas J. Ollberding, Julie Lavoie, Michele A. Frommelt
    Abstract:

    Background We report our intermediate-term results after Norwood Procedure, including use of an interstage inpatient management strategy for high-risk patients, and seek to create a predictive model for probability of discharge. Methods A single-site retrospective review was conducted for all patients undergoing Norwood Procedure from 2006 to 2016 (N = 177). We compared those discharged home with those who either remained hospitalized until Glenn Procedure or died before Norwood Procedure discharge. Multivariable logistic regression was used to develop a predictive model for discharge. Results During the study period, 120 (68%) patients were discharged home, 45 (25%) remained hospitalized, and 12 (7%) died before Glenn Procedure (median age: 71 days). Interstage survival for those discharged after Norwood Procedure was 100%. Longitudinal survival for the cohort was 86%, 81%, and 77% at 1, 5, and 10 years, resepectively. Ten-year survival was significantly greater for the discharged group compared with the interstage inpatients (86% vs 56%, P Conclusions Survival up to 10 years after Norwood Procedure is good using a strategy of inpatient care for a subset of high-risk patients to mitigate home interstage mortality. A probabilistic model used after Norwood Procedure was able to predict interstage discharge with good accuracy, but will require external validation to ensure generalizability. Further work is also needed to determine optimal palliative pathways for the high-risk patients because of the notable attrition beyond successful bidirectional Glenn Procedure.

  • Norwood Procedure—Difficulty in Weaning From Cardiopulmonary Bypass and Implications for Outcomes
    Seminars in thoracic and cardiovascular surgery, 2019
    Co-Authors: Jaclyn A. Gellings, James S. Tweddell, George M. Hoffman, Nancy S. Ghanayem, William K. Johnson, Michael E. Mitchell, Viktor Hraska, Evelyn M. Kuhn, Ronald K. Woods
    Abstract:

    Difficulty weaning from cardiopulmonary bypass (CPB) or the need to return to CPB (collectively D-CPB) may occur after the Norwood Procedure. We sought to evaluate the relationship between D-CBP and survival. This was a retrospective chart review of all patients undergoing a Norwood Procedure at our institution during the interval 2005–2017. Primary outcome was survival for the Norwood Procedure. Secondary outcomes included various measures of morbidity. Successful wean from CBP (S-CPB) was defined as no need to return to full-flow CPB during the initial definitive wean or after separation from CPB; otherwise, the classification was difficulty with wean (D-CBP). Successful rescue in the D-CPB group was defined as not requiring extracorporeal life support either in the operating room or within the first 3 postoperative days. Of the 196 patients in the cohort, 49 were D-CPB. Survival for S-CPB was 92.5% (136/147) vs 71.4% (35/49) for D-CPB (P = 0.001). Major morbidity occurred in 29.9% (44/147) in S-CPB vs 69.4% (34/49) in D-CPB (P

  • Interstage mortality after the Norwood Procedure: Results of the multicenter Single Ventricle Reconstruction trial.
    The Journal of thoracic and cardiovascular surgery, 2012
    Co-Authors: Nancy S. Ghanayem, Andrew M. Atz, Martha L. Clabby, Pirooz Eghtesady, Peter J. Gruber, Sarah Tabbutt, Peter C. Frommelt, Kerstin Allen, David S. Cooper, Kevin D. Hill
    Abstract:

    Objective For infants with single ventricle malformations undergoing staged repair, interstage mortality is reported at 2% to 20%. The Single Ventricle Reconstruction trial randomized subjects with a single morphologic right ventricle undergoing a Norwood Procedure to a modified Blalock–Taussig shunt (MBTS) or a right ventricle-to-pulmonary artery shunt (RVPAS). The aim of this analysis was to explore the associations of interstage mortality and shunt type, and demographic, anatomic, and perioperative factors. Methods Participants in the Single Ventricle Reconstruction trial who survived to discharge after the Norwood Procedure were included (n = 426). Interstage mortality was defined as death postdischarge after the Norwood Procedure and before the stage II Procedure. Univariate analysis and multivariable logistic regression were performed adjusting for site. Results Overall interstage mortality was 50 of 426 (12%)—13 of 225 (6%) for RVPAS and 37 of 201 (18%) for MBTS (odds ratio [OR] for MBTS, 3.4; P P  = .008), Hispanic ethnicity (OR, 2.6; P  = .04), aortic atresia/mitral atresia (OR, 2.3; P  = .03), greater number of post-Norwood complications (OR, 1.2; P  = .006), census block poverty level ( P  = .003), and MBTS in subjects with no or mild postoperative AVVR (OR, 9.7; P Conclusions Interstage mortality remains high at 12% and is increased with the MBTS compared with the RVPAS if postoperative AVVR is absent or mild. Preterm delivery, anatomic, and socioeconomic factors are also important. Avoiding preterm delivery when possible and close surveillance after Norwood hospitalization for infants with identified risk factors may reduce interstage mortality.

Richard G. Ohye - One of the best experts on this subject based on the ideXlab platform.

  • technical performance score is associated with outcomes after the Norwood Procedure
    The Journal of Thoracic and Cardiovascular Surgery, 2014
    Co-Authors: Meena Nathan, Christian Pizarro, James S. Tweddell, Richard G. Ohye, Christopher A. Caldarone, Lynn A. Sleeper, Gail D. Pearson, Peter C. Frommelt, William J Gaynor, Ismee A Williams
    Abstract:

    Objectives The technical performance score (TPS) has been reported in a single center study to predict the outcomes after congenital cardiac surgery. We sought to determine the association of the TPS with outcomes in patients undergoing the Norwood Procedure in the Single Ventricle Reconstruction trial. Methods We calculated the TPS (class 1, optimal; class 2, adequate; class 3, inadequate) according to the predischarge echocardiograms analyzed in a core laboratory and unplanned reinterventions that occurred before discharge from the Norwood hospitalization. Multivariable regression examined the association of the TPS with interval to first extubation, Norwood length of stay, death or transplantation, unplanned postdischarge reinterventions, and neurodevelopment at 14 months old. Results Of 549 patients undergoing a Norwood Procedure, 356 (65%) had an echocardiogram adequate to assess atrial septal restriction or arch obstruction or an unplanned reintervention, enabling calculation of the TPS. On multivariable regression, adjusting for preoperative variables, a better TPS was an independent predictor of a shorter interval to first extubation ( P  = .019), better transplant-free survival before Norwood discharge ( P P P  = .004), and a higher Bayley II psychomotor development index at 14 months ( P  = .031). The TPS was not associated with transplant-free survival after Norwood discharge, unplanned reinterventions after stage II, or the Bayley II mental development index at 14 months. Conclusions TPS is an independent predictor of important outcomes after Norwood and could serve as a tool for quality improvement.

  • Variation in Feeding Practices following the Norwood Procedure
    The Journal of pediatrics, 2013
    Co-Authors: Linda M. Lambert, Nancy A. Pike, Barbara Medoff-cooper, Victor Zak, Victoria L. Pemberton, Lisa Young-borkowski, Martha L. Clabby, Kathryn Nelson, Richard G. Ohye, Bethany Trainor
    Abstract:

    Objectives To assess variation in feeding practice at hospital discharge after the Norwood Procedure, factors associated with tube feeding, and associations among site, feeding mode, and growth before stage II. Study design From May 2005 to July 2008, 555 subjects from 15 centers were enrolled in the Pediatric Heart Network Single Ventricle Reconstruction Trial; 432 survivors with feeding data at hospital discharge after the Norwood Procedure were analyzed. Results Demographic and clinical variables were compared among 4 feeding modes: oral only (n = 140), oral/tube (n = 195), nasogastric tube (N-tube) only (n = 40), and gastrostomy tube (G-tube) only (n = 57). There was significant variation in feeding mode among sites (oral only 0%-81% and G-tube only 0%-56%, P R 2 = 0.65, P z -score was significantly higher in the oral-only group (−1.4) vs the N-tube–only (−2.2) and G-tube–only (−2.1) groups ( P = .04 and .02, respectively). Conclusions Feeding mode at hospital discharge after the Norwood Procedure varied among sites. Prolonged hospitalization and greater number of medications at the time of discharge were associated with tube feeding. Infants exclusively fed orally had a higher weight-for-age z score pre–stage II than those fed exclusively by tube. Exploring strategies to prevent morbidities and promote oral feeding in this highest risk population is warranted.

  • Comparison of Shunt Types in the Norwood Procedure for Single-Ventricle Lesions
    The New England journal of medicine, 2010
    Co-Authors: Richard G. Ohye, Jane W Newburger, Caren S. Goldberg, Lynn A. Sleeper, Lynn Mahony, Gail D. Pearson, Sarah Tabbutt, Peter C. Frommelt, Nancy S. Ghanayem
    Abstract:

    Background The Norwood Procedure with a modified Blalock–Taussig (MBT) shunt, the first palliative stage for single-ventricle lesions with systemic outflow obstruction, is associated with high mortality. The right ventricle–pulmonary artery (RVPA) shunt may improve coronary flow but requires a ventriculotomy. We compared the two shunts in infants with hypoplastic heart syndrome or related anomalies. Methods Infants undergoing the Norwood Procedure were randomly assigned to the MBT shunt (275 infants) or the RVPA shunt (274 infants) at 15 North American centers. The primary outcome was death or cardiac transplantation 12 months after randomization. Secondary outcomes included unintended cardiovascular interventions and right ventricular size and function at 14 months and transplantation-free survival until the last subject reached 14 months of age. Results Transplantation-free survival 12 months after randomization was higher with the RVPA shunt than with the MBT shunt (74% vs. 64%, P=0.01). However, the R...

  • design and rationale of a randomized trial comparing the blalock taussig and right ventricle pulmonary artery shunts in the Norwood Procedure
    The Journal of Thoracic and Cardiovascular Surgery, 2008
    Co-Authors: Richard G. Ohye, Jane W Newburger, Nancy S. Ghanayem, Peter C. Laussen, Caren S. Goldberg, Gail D. Pearson, Sarah Tabbutt, Peter C. Frommelt, William J Gaynor, Gil Wernovsky
    Abstract:

    Objective The initial palliative Procedure for patients born with hypoplastic left heart syndrome and related single right ventricle anomalies, the Norwood Procedure, remains among the highest risk Procedures in congenital heart surgery. The classic Norwood Procedure provides pulmonary blood flow with a modified Blalock–Taussig shunt. Improved outcomes have been reported in a few small, nonrandomized studies of a modification of the Norwood Procedure that uses a right ventricle–pulmonary artery shunt to provide pulmonary blood flow. Other nonrandomized studies have shown no differences between the two techniques. Methods The Pediatric Heart Network designed a randomized clinical trial to compare outcomes for subjects undergoing a Norwood Procedure with either the right ventricle–pulmonary artery or modified Blalock–Taussig shunt. Infants with a diagnosis of single, morphologically right ventricle anomaly who are undergoing a Norwood Procedure are eligible for inclusion in this study. The primary outcome is death or cardiac transplant 12 months after random assignment. Secondary outcomes include postoperative morbidity after Norwood and stage II palliation Procedures, right ventricular function and pulmonary arterial growth at stage II palliation, and neurodevelopmental outcomes at 14 months old. Incidence of adverse events will also be compared between treatment groups. Conclusion This study will make an important contribution to the care of patients with hypoplastic left heart syndrome and related forms of single, morphologically right ventricle. It also establishes a model with which other operative interventions for patients with congenital cardiovascular malformations can be evaluated in the future.

  • Design and rationale of a randomized trial comparing the Blalock–Taussig and right ventricle–pulmonary artery shunts in the Norwood Procedure
    The Journal of thoracic and cardiovascular surgery, 2008
    Co-Authors: Richard G. Ohye, Jane W Newburger, Nancy S. Ghanayem, J. William Gaynor, Peter C. Laussen, Caren S. Goldberg, Gail D. Pearson, Sarah Tabbutt, Peter C. Frommelt, Gil Wernovsky
    Abstract:

    Objective The initial palliative Procedure for patients born with hypoplastic left heart syndrome and related single right ventricle anomalies, the Norwood Procedure, remains among the highest risk Procedures in congenital heart surgery. The classic Norwood Procedure provides pulmonary blood flow with a modified Blalock–Taussig shunt. Improved outcomes have been reported in a few small, nonrandomized studies of a modification of the Norwood Procedure that uses a right ventricle–pulmonary artery shunt to provide pulmonary blood flow. Other nonrandomized studies have shown no differences between the two techniques. Methods The Pediatric Heart Network designed a randomized clinical trial to compare outcomes for subjects undergoing a Norwood Procedure with either the right ventricle–pulmonary artery or modified Blalock–Taussig shunt. Infants with a diagnosis of single, morphologically right ventricle anomaly who are undergoing a Norwood Procedure are eligible for inclusion in this study. The primary outcome is death or cardiac transplant 12 months after random assignment. Secondary outcomes include postoperative morbidity after Norwood and stage II palliation Procedures, right ventricular function and pulmonary arterial growth at stage II palliation, and neurodevelopmental outcomes at 14 months old. Incidence of adverse events will also be compared between treatment groups. Conclusion This study will make an important contribution to the care of patients with hypoplastic left heart syndrome and related forms of single, morphologically right ventricle. It also establishes a model with which other operative interventions for patients with congenital cardiovascular malformations can be evaluated in the future.

Andrew M. Atz - One of the best experts on this subject based on the ideXlab platform.

  • Validation of a Simple Score to Determine Risk of Hospital Mortality After the Norwood Procedure.
    Seminars in thoracic and cardiovascular surgery, 2016
    Co-Authors: Shahryar M. Chowdhury, Scott M. Bradley, Andrew M. Atz, Eric M Graham, M. Kavarana, Ryan J. Butts
    Abstract:

    The ability to quantify patient-specific hospital mortality risk before the Norwood Procedure remains elusive. This study aimed to develop an accurate and clinically feasible score to assess the risk of hospital mortality in neonates undergoing the Norwood Procedure. All patients (n = 549) in the publically available Pediatric Heart Network Single Ventricle Reconstruction trial database were included in the analysis. Patients were randomly divided into a derivation (75%) and validation (25%) cohort. Preoperative factors found to be associated with mortality upon univariable analysis (P 10). Mortality differed significantly between risk groups in both the derivation (6% vs 22% vs 77%, P < 0.01) and validation (4% vs 30% vs 53%, P < 0.01) cohorts. This mortality score is accurate in determining risk of hospital mortality in neonates undergoing planned Norwood operations. The score has the potential to be used in clinical practice to aid in risk assessment before surgery. Clinical trial registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00115934.

  • Abstract 10384: Validation of a Simple Score to Determine Risk of Hospital Mortality After the Norwood Procedure
    Circulation, 2015
    Co-Authors: Shahryar M. Chowdhury, Scott M. Bradley, Andrew M. Atz, Eric M Graham, M. Kavarana, Ryan J. Butts
    Abstract:

    Background: The NIH/NHLBI Pediatric Heart Network Single Ventricle Reconstruction (SVR) trial identified risk factors for hospital mortality after the Norwood Procedure. However, the ability to qua...

  • Interstage mortality after the Norwood Procedure: Results of the multicenter Single Ventricle Reconstruction trial.
    The Journal of thoracic and cardiovascular surgery, 2012
    Co-Authors: Nancy S. Ghanayem, Andrew M. Atz, Martha L. Clabby, Pirooz Eghtesady, Peter J. Gruber, Sarah Tabbutt, Peter C. Frommelt, Kerstin Allen, David S. Cooper, Kevin D. Hill
    Abstract:

    Objective For infants with single ventricle malformations undergoing staged repair, interstage mortality is reported at 2% to 20%. The Single Ventricle Reconstruction trial randomized subjects with a single morphologic right ventricle undergoing a Norwood Procedure to a modified Blalock–Taussig shunt (MBTS) or a right ventricle-to-pulmonary artery shunt (RVPAS). The aim of this analysis was to explore the associations of interstage mortality and shunt type, and demographic, anatomic, and perioperative factors. Methods Participants in the Single Ventricle Reconstruction trial who survived to discharge after the Norwood Procedure were included (n = 426). Interstage mortality was defined as death postdischarge after the Norwood Procedure and before the stage II Procedure. Univariate analysis and multivariable logistic regression were performed adjusting for site. Results Overall interstage mortality was 50 of 426 (12%)—13 of 225 (6%) for RVPAS and 37 of 201 (18%) for MBTS (odds ratio [OR] for MBTS, 3.4; P P  = .008), Hispanic ethnicity (OR, 2.6; P  = .04), aortic atresia/mitral atresia (OR, 2.3; P  = .03), greater number of post-Norwood complications (OR, 1.2; P  = .006), census block poverty level ( P  = .003), and MBTS in subjects with no or mild postoperative AVVR (OR, 9.7; P Conclusions Interstage mortality remains high at 12% and is increased with the MBTS compared with the RVPAS if postoperative AVVR is absent or mild. Preterm delivery, anatomic, and socioeconomic factors are also important. Avoiding preterm delivery when possible and close surveillance after Norwood hospitalization for infants with identified risk factors may reduce interstage mortality.

  • Laryngopharyngeal dysfunction after the Norwood Procedure
    The Journal of thoracic and cardiovascular surgery, 2005
    Co-Authors: Margaret L. Skinner, Lucinda A. Halstead, Catherine S. Rubinstein, Andrew M. Atz, Diane Andrews, Scott M. Bradley
    Abstract:

    Objective We sought to evaluate the incidence and significance of recurrent laryngeal nerve and swallowing dysfunction after a Norwood Procedure compared with that after biventricular aortic arch reconstruction. Methods From April 2003 through December 2004, 36 neonates underwent a Norwood Procedure; 33 of 36 had postoperative fiberoptic laryngoscopy and modified barium swallow. Study results were used to guide the transition from nasogastric tube to oral feeding and placement of gastrostomy tubes. During the same time period, 18 neonates underwent aortic arch reconstruction as part of a biventricular repair. Results After a Norwood Procedure, laryngoscopy showed left true vocal fold (cord) paralysis in 3 (9%) of 33 patients. The results of a modified barium swallow were abnormal in 16 (48%) of 33 patients, with aspiration in 8 (24%) of 33 patients. Of the 3 patients with vocal fold paralysis, 2 had a normal modified barium swallow result, and 1 had aspiration. Gastrostomy tubes were placed in 6 (18%) of 33 patients, all with an abnormal modified barium swallow result. Hospital stay was longer in patients with an abnormal modified barium swallow result: 34 ± 13 versus 22 ± 7 days ( P Conclusions After a Norwood Procedure, swallowing dysfunction occurs in 48% of patients, with aspiration in 24%, and results in increased length of hospital stay. Left recurrent laryngeal nerve injury, seen in 9% of patients, is an uncommon cause of swallowing dysfunction. Postoperative aspiration generally resolves over time, whereas vocal fold paralysis does not. Systematic evaluation of swallowing function allows appropriate tailoring of feeding regimens and might contribute to decreased hospital and interstage mortality.

  • Outcome following, and impact of, prenatal identification of the candidates for the Norwood Procedure.
    Cardiology in the young, 2004
    Co-Authors: Robin R Fountain-dommer, Scott M. Bradley, Andrew M. Atz, Martha R. Stroud, Geoffrey A. Forbus, Girish S Shirali
    Abstract:

    OBJECTIVES: Our study evaluates hospital survival following prenatal identification of candidates for the Norwood Procedure, and the impact of prenatal diagnosis on survival, preoperative stability, and postoperative morbidity. METHODS: We reviewed records of all patients who were identified prenatally as candidates for the Norwood Procedure, and compared them to all postnatally diagnosed patients who underwent the Norwood Procedure between August 1995 and May 2002. RESULTS: Of the 98 patients studied, 45 (46%) were diagnosed prenatally. Of these, 35 underwent the Norwood Procedure, 29 (83%) of who survived. Thus, 29 of 45 (64%) patients survived from prenatal diagnosis to discharge following the Norwood Procedure. Of the 53 postnatally diagnosed patients who underwent the Norwood Procedure, 42 (79%) survived. Prenatal diagnosis was not associated with improvement in survival, preoperative stability, or postoperative morbidity. By multivariate analysis, ascending aortic diameter equal to or greater than 2 mm (p = 0.01), and gestational age 36 weeks or greater (p = 0.01) independently predicted survival. Based on this, patients were stratified into groups at low risk, consisting of 69 patients, and at high risk, consisting of 19 patients. Prenatal diagnosis was unassociated with improved survival in either group. Results were unchanged when the analysis was restricted to patients with hypoplasia of the left heart. CONCLUSION: From the time of prenatal diagnosis, 64% of patients survived to discharge following the Norwood Procedure. Prenatal diagnosis did not affect preoperative stability, survival or postoperative morbidity. This remained the case after stratifying patients by risk, or restricting analysis to patients with hypoplasia of the left heart. Ascending aortic diameter and gestational age independently predicted survival.

Peter C. Frommelt - One of the best experts on this subject based on the ideXlab platform.

  • technical performance score is associated with outcomes after the Norwood Procedure
    The Journal of Thoracic and Cardiovascular Surgery, 2014
    Co-Authors: Meena Nathan, Christian Pizarro, James S. Tweddell, Richard G. Ohye, Christopher A. Caldarone, Lynn A. Sleeper, Gail D. Pearson, Peter C. Frommelt, William J Gaynor, Ismee A Williams
    Abstract:

    Objectives The technical performance score (TPS) has been reported in a single center study to predict the outcomes after congenital cardiac surgery. We sought to determine the association of the TPS with outcomes in patients undergoing the Norwood Procedure in the Single Ventricle Reconstruction trial. Methods We calculated the TPS (class 1, optimal; class 2, adequate; class 3, inadequate) according to the predischarge echocardiograms analyzed in a core laboratory and unplanned reinterventions that occurred before discharge from the Norwood hospitalization. Multivariable regression examined the association of the TPS with interval to first extubation, Norwood length of stay, death or transplantation, unplanned postdischarge reinterventions, and neurodevelopment at 14 months old. Results Of 549 patients undergoing a Norwood Procedure, 356 (65%) had an echocardiogram adequate to assess atrial septal restriction or arch obstruction or an unplanned reintervention, enabling calculation of the TPS. On multivariable regression, adjusting for preoperative variables, a better TPS was an independent predictor of a shorter interval to first extubation ( P  = .019), better transplant-free survival before Norwood discharge ( P P P  = .004), and a higher Bayley II psychomotor development index at 14 months ( P  = .031). The TPS was not associated with transplant-free survival after Norwood discharge, unplanned reinterventions after stage II, or the Bayley II mental development index at 14 months. Conclusions TPS is an independent predictor of important outcomes after Norwood and could serve as a tool for quality improvement.

  • Interstage mortality after the Norwood Procedure: Results of the multicenter Single Ventricle Reconstruction trial.
    The Journal of thoracic and cardiovascular surgery, 2012
    Co-Authors: Nancy S. Ghanayem, Andrew M. Atz, Martha L. Clabby, Pirooz Eghtesady, Peter J. Gruber, Sarah Tabbutt, Peter C. Frommelt, Kerstin Allen, David S. Cooper, Kevin D. Hill
    Abstract:

    Objective For infants with single ventricle malformations undergoing staged repair, interstage mortality is reported at 2% to 20%. The Single Ventricle Reconstruction trial randomized subjects with a single morphologic right ventricle undergoing a Norwood Procedure to a modified Blalock–Taussig shunt (MBTS) or a right ventricle-to-pulmonary artery shunt (RVPAS). The aim of this analysis was to explore the associations of interstage mortality and shunt type, and demographic, anatomic, and perioperative factors. Methods Participants in the Single Ventricle Reconstruction trial who survived to discharge after the Norwood Procedure were included (n = 426). Interstage mortality was defined as death postdischarge after the Norwood Procedure and before the stage II Procedure. Univariate analysis and multivariable logistic regression were performed adjusting for site. Results Overall interstage mortality was 50 of 426 (12%)—13 of 225 (6%) for RVPAS and 37 of 201 (18%) for MBTS (odds ratio [OR] for MBTS, 3.4; P P  = .008), Hispanic ethnicity (OR, 2.6; P  = .04), aortic atresia/mitral atresia (OR, 2.3; P  = .03), greater number of post-Norwood complications (OR, 1.2; P  = .006), census block poverty level ( P  = .003), and MBTS in subjects with no or mild postoperative AVVR (OR, 9.7; P Conclusions Interstage mortality remains high at 12% and is increased with the MBTS compared with the RVPAS if postoperative AVVR is absent or mild. Preterm delivery, anatomic, and socioeconomic factors are also important. Avoiding preterm delivery when possible and close surveillance after Norwood hospitalization for infants with identified risk factors may reduce interstage mortality.

  • Comparison of Shunt Types in the Norwood Procedure for Single-Ventricle Lesions
    The New England journal of medicine, 2010
    Co-Authors: Richard G. Ohye, Jane W Newburger, Caren S. Goldberg, Lynn A. Sleeper, Lynn Mahony, Gail D. Pearson, Sarah Tabbutt, Peter C. Frommelt, Nancy S. Ghanayem
    Abstract:

    Background The Norwood Procedure with a modified Blalock–Taussig (MBT) shunt, the first palliative stage for single-ventricle lesions with systemic outflow obstruction, is associated with high mortality. The right ventricle–pulmonary artery (RVPA) shunt may improve coronary flow but requires a ventriculotomy. We compared the two shunts in infants with hypoplastic heart syndrome or related anomalies. Methods Infants undergoing the Norwood Procedure were randomly assigned to the MBT shunt (275 infants) or the RVPA shunt (274 infants) at 15 North American centers. The primary outcome was death or cardiac transplantation 12 months after randomization. Secondary outcomes included unintended cardiovascular interventions and right ventricular size and function at 14 months and transplantation-free survival until the last subject reached 14 months of age. Results Transplantation-free survival 12 months after randomization was higher with the RVPA shunt than with the MBT shunt (74% vs. 64%, P=0.01). However, the R...

  • design and rationale of a randomized trial comparing the blalock taussig and right ventricle pulmonary artery shunts in the Norwood Procedure
    The Journal of Thoracic and Cardiovascular Surgery, 2008
    Co-Authors: Richard G. Ohye, Jane W Newburger, Nancy S. Ghanayem, Peter C. Laussen, Caren S. Goldberg, Gail D. Pearson, Sarah Tabbutt, Peter C. Frommelt, William J Gaynor, Gil Wernovsky
    Abstract:

    Objective The initial palliative Procedure for patients born with hypoplastic left heart syndrome and related single right ventricle anomalies, the Norwood Procedure, remains among the highest risk Procedures in congenital heart surgery. The classic Norwood Procedure provides pulmonary blood flow with a modified Blalock–Taussig shunt. Improved outcomes have been reported in a few small, nonrandomized studies of a modification of the Norwood Procedure that uses a right ventricle–pulmonary artery shunt to provide pulmonary blood flow. Other nonrandomized studies have shown no differences between the two techniques. Methods The Pediatric Heart Network designed a randomized clinical trial to compare outcomes for subjects undergoing a Norwood Procedure with either the right ventricle–pulmonary artery or modified Blalock–Taussig shunt. Infants with a diagnosis of single, morphologically right ventricle anomaly who are undergoing a Norwood Procedure are eligible for inclusion in this study. The primary outcome is death or cardiac transplant 12 months after random assignment. Secondary outcomes include postoperative morbidity after Norwood and stage II palliation Procedures, right ventricular function and pulmonary arterial growth at stage II palliation, and neurodevelopmental outcomes at 14 months old. Incidence of adverse events will also be compared between treatment groups. Conclusion This study will make an important contribution to the care of patients with hypoplastic left heart syndrome and related forms of single, morphologically right ventricle. It also establishes a model with which other operative interventions for patients with congenital cardiovascular malformations can be evaluated in the future.

  • Design and rationale of a randomized trial comparing the Blalock–Taussig and right ventricle–pulmonary artery shunts in the Norwood Procedure
    The Journal of thoracic and cardiovascular surgery, 2008
    Co-Authors: Richard G. Ohye, Jane W Newburger, Nancy S. Ghanayem, J. William Gaynor, Peter C. Laussen, Caren S. Goldberg, Gail D. Pearson, Sarah Tabbutt, Peter C. Frommelt, Gil Wernovsky
    Abstract:

    Objective The initial palliative Procedure for patients born with hypoplastic left heart syndrome and related single right ventricle anomalies, the Norwood Procedure, remains among the highest risk Procedures in congenital heart surgery. The classic Norwood Procedure provides pulmonary blood flow with a modified Blalock–Taussig shunt. Improved outcomes have been reported in a few small, nonrandomized studies of a modification of the Norwood Procedure that uses a right ventricle–pulmonary artery shunt to provide pulmonary blood flow. Other nonrandomized studies have shown no differences between the two techniques. Methods The Pediatric Heart Network designed a randomized clinical trial to compare outcomes for subjects undergoing a Norwood Procedure with either the right ventricle–pulmonary artery or modified Blalock–Taussig shunt. Infants with a diagnosis of single, morphologically right ventricle anomaly who are undergoing a Norwood Procedure are eligible for inclusion in this study. The primary outcome is death or cardiac transplant 12 months after random assignment. Secondary outcomes include postoperative morbidity after Norwood and stage II palliation Procedures, right ventricular function and pulmonary arterial growth at stage II palliation, and neurodevelopmental outcomes at 14 months old. Incidence of adverse events will also be compared between treatment groups. Conclusion This study will make an important contribution to the care of patients with hypoplastic left heart syndrome and related forms of single, morphologically right ventricle. It also establishes a model with which other operative interventions for patients with congenital cardiovascular malformations can be evaluated in the future.

James S. Tweddell - One of the best experts on this subject based on the ideXlab platform.

  • Norwood Procedure difficulty in weaning from cardiopulmonary bypass and implications for outcomes
    Seminars in Thoracic and Cardiovascular Surgery, 2020
    Co-Authors: Jaclyn A. Gellings, James S. Tweddell, George M. Hoffman, Nancy S. Ghanayem, William K. Johnson, Michael E. Mitchell, Viktor Hraska, Evelyn M. Kuhn, Ronald K. Woods
    Abstract:

    Difficulty weaning from cardiopulmonary bypass (CPB) or the need to return to CPB (collectively D-CPB) may occur after the Norwood Procedure. We sought to evaluate the relationship between D-CBP and survival. This was a retrospective chart review of all patients undergoing a Norwood Procedure at our institution during the interval 2005–2017. Primary outcome was survival for the Norwood Procedure. Secondary outcomes included various measures of morbidity. Successful wean from CBP (S-CPB) was defined as no need to return to full-flow CPB during the initial definitive wean or after separation from CPB; otherwise, the classification was difficulty with wean (D-CBP). Successful rescue in the D-CPB group was defined as not requiring extracorporeal life support either in the operating room or within the first 3 postoperative days. Of the 196 patients in the cohort, 49 were D-CPB. Survival for S-CPB was 92.5% (136/147) vs 71.4% (35/49) for D-CPB (P = 0.001). Major morbidity occurred in 29.9% (44/147) in S-CPB vs 69.4% (34/49) in D-CPB (P

  • Norwood Procedure—Difficulty in Weaning From Cardiopulmonary Bypass and Implications for Outcomes
    Seminars in thoracic and cardiovascular surgery, 2019
    Co-Authors: Jaclyn A. Gellings, James S. Tweddell, George M. Hoffman, Nancy S. Ghanayem, William K. Johnson, Michael E. Mitchell, Viktor Hraska, Evelyn M. Kuhn, Ronald K. Woods
    Abstract:

    Difficulty weaning from cardiopulmonary bypass (CPB) or the need to return to CPB (collectively D-CPB) may occur after the Norwood Procedure. We sought to evaluate the relationship between D-CBP and survival. This was a retrospective chart review of all patients undergoing a Norwood Procedure at our institution during the interval 2005–2017. Primary outcome was survival for the Norwood Procedure. Secondary outcomes included various measures of morbidity. Successful wean from CBP (S-CPB) was defined as no need to return to full-flow CPB during the initial definitive wean or after separation from CPB; otherwise, the classification was difficulty with wean (D-CBP). Successful rescue in the D-CPB group was defined as not requiring extracorporeal life support either in the operating room or within the first 3 postoperative days. Of the 196 patients in the cohort, 49 were D-CPB. Survival for S-CPB was 92.5% (136/147) vs 71.4% (35/49) for D-CPB (P = 0.001). Major morbidity occurred in 29.9% (44/147) in S-CPB vs 69.4% (34/49) in D-CPB (P

  • technical performance score is associated with outcomes after the Norwood Procedure
    The Journal of Thoracic and Cardiovascular Surgery, 2014
    Co-Authors: Meena Nathan, Christian Pizarro, James S. Tweddell, Richard G. Ohye, Christopher A. Caldarone, Lynn A. Sleeper, Gail D. Pearson, Peter C. Frommelt, William J Gaynor, Ismee A Williams
    Abstract:

    Objectives The technical performance score (TPS) has been reported in a single center study to predict the outcomes after congenital cardiac surgery. We sought to determine the association of the TPS with outcomes in patients undergoing the Norwood Procedure in the Single Ventricle Reconstruction trial. Methods We calculated the TPS (class 1, optimal; class 2, adequate; class 3, inadequate) according to the predischarge echocardiograms analyzed in a core laboratory and unplanned reinterventions that occurred before discharge from the Norwood hospitalization. Multivariable regression examined the association of the TPS with interval to first extubation, Norwood length of stay, death or transplantation, unplanned postdischarge reinterventions, and neurodevelopment at 14 months old. Results Of 549 patients undergoing a Norwood Procedure, 356 (65%) had an echocardiogram adequate to assess atrial septal restriction or arch obstruction or an unplanned reintervention, enabling calculation of the TPS. On multivariable regression, adjusting for preoperative variables, a better TPS was an independent predictor of a shorter interval to first extubation ( P  = .019), better transplant-free survival before Norwood discharge ( P P P  = .004), and a higher Bayley II psychomotor development index at 14 months ( P  = .031). The TPS was not associated with transplant-free survival after Norwood discharge, unplanned reinterventions after stage II, or the Bayley II mental development index at 14 months. Conclusions TPS is an independent predictor of important outcomes after Norwood and could serve as a tool for quality improvement.

  • Patients at risk for low systemic oxygen delivery after the Norwood Procedure
    The Annals of thoracic surgery, 2000
    Co-Authors: James S. Tweddell, George M. Hoffman, Raymond T. Fedderly, Stuart Berger, Nancy S. Ghanayem, John M Kampine, Kathleen A. Mussatto, S. Bert Litwin
    Abstract:

    Abstract Background . Identification of patients at risk for inadequate systemic oxygen delivery following the Norwood Procedure could allow for application of more intensive monitoring, provide for earlier intervention of decreased cardiac output, and result in improved outcome. Methods and Results . Superior vena cava saturation (SvO 2 ) and arteriovenous oxygen content difference were prospectively monitored as indicators of systemic oxygen delivery and recorded hourly for the first 48 hours in 29 of 33 consecutive patients following the Norwood Procedure. Risk factors were evaluated using multiple linear regression to determine their impact on SvO 2 and arteriovenous oxygen content difference. Age less than 8 days, weight less than 2.5 kg, aortic atresia, and prolonged cardiopulmonary bypass time were risk factors for low SvO 2 and wide arteriovenous oxygen content difference ( p 2 and narrower arteriovenous oxygen content difference ( p Conclusions . Aortic atresia, low weight, younger age, and prolonged cardiopulmonary bypass, previously identified risk factors for mortality, were associated with decreased SvO 2 and narrower arteriovenous oxygen content difference in the early postoperative period. The impact of this hemodynamic vulnerability on mortality was minimized by continuous SvO 2 monitoring.

  • Phenoxybenzamine improves systemic oxygen delivery after the Norwood Procedure.
    The Annals of thoracic surgery, 1999
    Co-Authors: James S. Tweddell, George M. Hoffman, Raymond T. Fedderly, Stuart Berger, John P. Thomas, Nancy S. Ghanayem, Maryanne W. Kessel, S. Bert Litwin
    Abstract:

    Abstract Background . Achieving adequate systemic oxygen delivery after the Norwood Procedure frequently is complicated by excessive pulmonary blood flow at the expense of systemic blood. We hypothesized that phenoxybenzamine could achieve a balanced circulation through reduction of systemic vascular resistance. Methods . In this prospective, nonrandomized study, oximetric catheters were placed in the superior vena cava for continuous monitoring of systemic venous oxygen saturation. Postoperative hemodynamic variables were compared between 7 control patients and 8 patients who received phenoxybenzamine. Results . The hospital survival rate was 93% (14 of 15 patients). Improvements in postoperative hemodynamics in the phenoxybenzamine group included a higher systemic venous oxygen saturation, a narrower arteriovenous oxygen content difference, a lower ratio of pulmonary to systemic flow, and a lower indexed systemic vascular resistance. In the phenoxybenzamine group, mean arterial blood pressure was related directly to systemic oxygen delivery, in contrast to the control group, where mean arterial pressure was related directly to indexed systemic vascular resistance and the ratio of pulmonary to systemic circulation. Conclusions . Continuous postoperative monitoring of systemic venous oxygen saturation in a patient who has undergone the Norwood Procedure provides early identification of low systemic oxygen delivery and an elevated ratio of pulmonary to systemic circulation. In this pilot study, phenoxybenzamine appeared to improve systemic oxygen delivery during the early postoperative period after the Norwood Procedure. Further studies are indicated to confirm these results.