Trial Outcomes & Findings for Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network (NCT NCT00115934)

Results Overview

The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

555 participants

Primary outcome timeframe

Measured at 12 months

Results posted on

2025-03-11

Participant Flow

Subjects undergoing a Norwood were randomized to MBTS or RVPAS at 15 North American centers.

There were no pre-assignment requirements beyond the initial screening criteria.

Participant milestones

Participant milestones
Measure	MBTS Blalock-Taussig pulmonary artery shunt	RVPAS Right ventricular to pulmonary artery shunt
Overall Study STARTED	279	276
Overall Study COMPLETED	275	274
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	MBTS Blalock-Taussig pulmonary artery shunt	RVPAS Right ventricular to pulmonary artery shunt
Overall Study Lost to Follow-up	1	0
Overall Study Did not receive intervention	3	2

Baseline Characteristics

Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MBTS n=275 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=274 Participants Right ventricular to pulmonary artery shunt	Total n=549 Participants Total of all reporting groups
Age, Categorical <=18 years	275 Participants n=5 Participants	274 Participants n=7 Participants	549 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	5.1 days STANDARD_DEVIATION 4.1 • n=5 Participants	5.0 days STANDARD_DEVIATION 4.0 • n=7 Participants	5.1 days STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	102 Participants n=7 Participants	209 Participants n=5 Participants
Sex: Female, Male Male	168 Participants n=5 Participants	172 Participants n=7 Participants	340 Participants n=5 Participants
Region of Enrollment United States	268 participants n=5 Participants	266 participants n=7 Participants	534 participants n=5 Participants
Region of Enrollment Canada	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at 12 months

Population: 555 subjects were enrolled in the study; 5 of these subjects were excluded from analyses because a Norwood procedure was not performed; 1 subject was excluded because the subject withdrew before the 12-month follow-up, 12-month status was unknown. The data were analyzed on an intention to treat basis, subjects were analyzed as randomized.

The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.

Outcome measures

Outcome measures
Measure	MBTS n=275 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=274 Participants Right ventricular to pulmonary artery shunt
Proportion of Patients Who Died or Received a Heart Transplant	100 Participants	72 Participants

SECONDARY outcome

Timeframe: From Randomization to the End of the Trial, an average of 32 months

This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial.

Outcome measures

Outcome measures
Measure	MBTS n=275 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=274 Participants Right ventricular to pulmonary artery shunt
Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial	107 Participants	88 Participants

SECONDARY outcome

Timeframe: Measured post-Norwood, an average of 17 days post-Norwood

Population: 241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or measures were not able to be obtained to calculate the volumes.

Right ventricular end-diastolic volume indexed to BSA\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

Outcome measures

Outcome measures
Measure	MBTS n=173 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=194 Participants Right ventricular to pulmonary artery shunt
Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)	91.2 ml/m^2.6 Interval 76.3 to 108.1	86.5 ml/m^2.6 Interval 73.8 to 104.3

SECONDARY outcome

Timeframe: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery

Population: 181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.

Right ventricular end-diastolic volume indexed to BSA\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

Outcome measures

Outcome measures
Measure	MBTS n=127 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=151 Participants Right ventricular to pulmonary artery shunt
Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA	113.4 ml/m^2.6 Interval 94.1 to 138.6	105.2 ml/m^2.6 Interval 86.8 to 125.3

SECONDARY outcome

Timeframe: Measured at 14 months of age

Population: 184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.

Right ventricular end-diastolic volume indexed to BSA\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

Outcome measures

Outcome measures
Measure	MBTS n=107 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=129 Participants Right ventricular to pulmonary artery shunt
Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA	83.3 ml/m^2.6 Interval 69.4 to 100.3	88.9 ml/m^2.6 Interval 72.6 to 104.7

SECONDARY outcome

Timeframe: Measured post-Norwood, an average of 17 days post-Norwood

Population: 241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.

Right ventricular end-systolic volume indexed to BSA. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

Outcome measures

Outcome measures
Measure	MBTS n=173 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=194 Participants Right ventricular to pulmonary artery shunt
Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA	50.1 ml/m^2.6 Interval 40.2 to 61.9	44.2 ml/m^2.6 Interval 36.6 to 57.1

SECONDARY outcome

Timeframe: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery

Population: 181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.

Right ventricular end-systolic volume indexed to BSA\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

Outcome measures

Outcome measures
Measure	MBTS n=127 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=151 Participants Right ventricular to pulmonary artery shunt
Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA	63.2 ml/m^2.6 Interval 49.9 to 83.0	57.9 ml/m^2.6 Interval 44.6 to 69.9

SECONDARY outcome

Timeframe: Measured at 14 months of age

Population: 184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.

Right ventricular end-systolic volume indexed to BSA\^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

Outcome measures

Outcome measures
Measure	MBTS n=107 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=129 Participants Right ventricular to pulmonary artery shunt
Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA	45.4 ml/m^2.6 Interval 38.5 to 56.6	50.5 ml/m^2.6 Interval 39.7 to 60.8

SECONDARY outcome

Timeframe: Measured post-Norwood, an average of 17 days post-Norwood

Population: 241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes used to calculate the ejection fraction.

Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

Outcome measures

Outcome measures
Measure	MBTS n=173 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=194 Participants Right ventricular to pulmonary artery shunt
Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction	44.5 Percentage of RV end-diastolic volume Standard Deviation 7.6	48.5 Percentage of RV end-diastolic volume Standard Deviation 7.6

SECONDARY outcome

Timeframe: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery

Population: 181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.

Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

Outcome measures

Outcome measures
Measure	MBTS n=128 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=151 Participants Right ventricular to pulmonary artery shunt
Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction	42.9 Percentage of RV end-diastolic volume Standard Deviation 7.9	44.7 Percentage of RV end-diastolic volume Standard Deviation 8.3

SECONDARY outcome

Timeframe: Measured at 14 months of age

Population: 184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.

Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

Outcome measures

Outcome measures
Measure	MBTS n=107 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=129 Participants Right ventricular to pulmonary artery shunt
Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction	42.7 Percentage of RV end-diastolic volume Standard Deviation 7.4	42.7 Percentage of RV end-diastolic volume Standard Deviation 8.0

SECONDARY outcome

Timeframe: Measured pre-stage II surgery, on average 26 days prior to stage II palliation

Population: These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.

Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).

Outcome measures

Outcome measures
Measure	MBTS n=159 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=191 Participants Right ventricular to pulmonary artery shunt
Angiographic Findings: Left Pulmonary Artery Size	5.2 mm Standard Deviation 1.5	5.4 mm Standard Deviation 1.7

SECONDARY outcome

Timeframe: Measured pre-stage II surgery, on average 26 days prior to stage II palliation

Population: These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.

Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).

Outcome measures

Outcome measures
Measure	MBTS n=159 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=191 Participants Right ventricular to pulmonary artery shunt
Angiographic Findings: Right Pulmonary Artery Size	6.1 mm Standard Deviation 2.0	5.4 mm Standard Deviation 1.7

SECONDARY outcome

Timeframe: From Randomization to 12 months

Unintended cardiovascular procedures included balloon dilation of the shunt or branch pulmonary arteries, stent placement in the shunt or branch pulmonary arteries, shunt revision, crossover between MBTS and RVPAS shunt, balloon dilation, stent placement or surgical revisions of the neo-aorta, and pulmonary artery reconstructions, other than those undertaken as a standard component of the stage II procedure. The number of cardiovascular procedures was analyzed; trial participants may have had more than one unintended cardiovascular. procedure.

Outcome measures

Outcome measures
Measure	MBTS n=275 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=274 Participants Right ventricular to pulmonary artery shunt
Unintended Cardiovascular Interventional Procedures	192 procedures	252 procedures

SECONDARY outcome

Timeframe: Norwood Hospitalization, an average of 36 days

Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.

Outcome measures

Outcome measures
Measure	MBTS n=275 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=274 Participants Right ventricular to pulmonary artery shunt
Complications: Total Number Experienced During Norwood Hospitalization	850 complications	792 complications

SECONDARY outcome

Timeframe: From Norwood Discharge to Stage II discharge, an average of 4.2 months

Population: These numbers reflect those patients who were discharged from the hospital after the Norwood procedure and were transplant free.

Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.

Outcome measures

Outcome measures
Measure	MBTS n=219 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=233 Participants Right ventricular to pulmonary artery shunt
Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge	367 complications	515 complications

SECONDARY outcome

Timeframe: From Stage II Discharge to 14 Months of Age, an average of 8.9 months

Population: These numbers reflect the number of patients who were discharged from the hospital after the Stage 2 procedure and were transplant-free.

Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.

Outcome measures

Outcome measures
Measure	MBTS n=176 Participants Blalock-Taussig pulmonary artery shunt	RVPAS n=202 Participants Right ventricular to pulmonary artery shunt
Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age	81 complications	145 complications

Adverse Events

MBTS

Serious events: 146 serious events

Other events: 249 other events

Deaths: 0 deaths

RVPAS

Serious events: 112 serious events

Other events: 251 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MBTS n=275 participants at risk Blalock-Taussig pulmonary artery shunt	RVPAS n=274 participants at risk Right ventricular to pulmonary artery shunt
Cardiac disorders Cardiac arrhythmia	2.5% 7/275 • Number of events 8 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	3.3% 9/274 • Number of events 10 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Cardiac disorders Cardiac general	35.3% 97/275 • Number of events 111 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	23.0% 63/274 • Number of events 73 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Blood and lymphatic system disorders Coagulation	0.36% 1/275 • Number of events 1 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	0.36% 1/274 • Number of events 1 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Gastrointestinal disorders Gastrointestinal	1.1% 3/275 • Number of events 3 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	1.1% 3/274 • Number of events 3 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Blood and lymphatic system disorders Hemorrhage/bleeding	1.5% 4/275 • Number of events 4 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	2.2% 6/274 • Number of events 6 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Infections and infestations Infection	2.5% 7/275 • Number of events 7 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	3.3% 9/274 • Number of events 9 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Metabolism and nutrition disorders Metabolic/laboratory	0.36% 1/275 • Number of events 1 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	0.73% 2/274 • Number of events 2 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue	0.36% 1/275 • Number of events 1 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	0.00% 0/274 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Nervous system disorders Neurology	1.8% 5/275 • Number of events 6 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	1.5% 4/274 • Number of events 4 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory	4.0% 11/275 • Number of events 11 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	4.0% 11/274 • Number of events 11 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Renal and urinary disorders Renal/genitourinary	1.1% 3/275 • Number of events 3 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	1.1% 3/274 • Number of events 3 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Surgical and medical procedures Surgery/intra-operative injury	1.5% 4/275 • Number of events 4 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	1.5% 4/274 • Number of events 4 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Vascular disorders Vascular	12.7% 35/275 • Number of events 36 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	10.6% 29/274 • Number of events 29 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.

Other adverse events

Other adverse events
Measure	MBTS n=275 participants at risk Blalock-Taussig pulmonary artery shunt	RVPAS n=274 participants at risk Right ventricular to pulmonary artery shunt
Cardiac disorders Cardiac disorders	58.5% 161/275 • Number of events 316 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	54.0% 148/274 • Number of events 266 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Gastrointestinal disorders Gastrointestinal	33.8% 93/275 • Number of events 138 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	34.3% 94/274 • Number of events 133 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Blood and lymphatic system disorders Hematologic	17.5% 48/275 • Number of events 64 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	20.8% 57/274 • Number of events 73 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Infections and infestations Infectious	56.7% 156/275 • Number of events 313 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	62.8% 172/274 • Number of events 401 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Nervous system disorders Neurological	12.7% 35/275 • Number of events 51 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	19.3% 53/274 • Number of events 77 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Respiratory, thoracic and mediastinal disorders Respiratory	56.0% 154/275 • Number of events 285 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	62.8% 172/274 • Number of events 387 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Renal and urinary disorders Renal	14.2% 39/275 • Number of events 41 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	9.9% 27/274 • Number of events 28 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Vascular disorders Vascular	11.6% 32/275 • Number of events 34 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.	12.4% 34/274 • Number of events 38 • Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented. Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.

Additional Information

Lynn Sleeper, ScD

New England Research Institutes

Phone: 617-972-3235

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place