Condition

Congenital heart anomalies

Clinical trials and treatment information for Congenital heart anomalies

15.8M

People Affected

150

Active Trials

1.6M

New Cases/Year

251K

Deaths/Year

Treatment Rankings

Ranked by evidence volume first. Medicine has spent centuries ranking things by vibes. This is an improvement.

Catheter-based Atrial Septal Defect (ASD) Closure

98% Effectiveness• 98% Confidence• 60% Safety• 1 trials• 80K participants

HIGH EvidenceExcellent Value

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Comparative Safety Scale(Higher is safer)

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DangerousModerateSafe

Time to Effect

Immediate (shunt closure), recovery over days-weeks

Duration

Single procedure, long-term monitoring

Response Rate

98%

Remission Rate

95%

Common Side Effects:

Device embolization/malposition: 1%

Perforation/tamponade: 0.5%

Arrhythmias (transient): 5%

Groin hematoma/vascular injury: 5%

Residual shunt: 2%

Device erosion: 0.1%

Annual Cost of Care

Drug Cost

$50

Monitoring

$500

Side Effects

$50

Total Annual

$600

Cost-Effectiveness

EXCELLENT

QALYs Gained

ICER

$30,000/QALY

Cost per Remission

$631.58

Cost per Responder

$612.24

Treatment Outcomes

Primary Outcomes

Qp/Qs Ratio (Left-to-Right Shunt)2.0

-50% (-1.0)

Right Ventricular End-Diastolic Volume Index (RVEDVI)120 mL/m^2

-25% (-30 mL/m^2)

6-Minute Walk Distance (6MWD)300 meters

+33.3% (+100 meters)

Mean Pulmonary Artery Pressure (mPAP)35 mmHg

-28.6% (-10 mmHg)

Secondary Benefits

SF-36 Physical Component Summary (PCS) Score40 points

+20% (+8 points)

Right Atrial Volume Index (RAVI)50 mL/m^2

-30% (-15 mL/m^2)

Brain Natriuretic Peptide (BNP)150 pg/mL

-50% (-75 pg/mL)

Common Side Effects

Device embolization/malposition

+1%

Perforation/tamponade

+0.5%

Arrhythmias (transient)

+5%

Clinical Trial Phases:

Phase 4

Prostaglandin E1 (Alprostadil) Infusion

98% Effectiveness• 99% Confidence• 40% Safety• 1 trials• 10K participants

HIGH EvidenceExcellent ValueDose: 0.05-0.1 mcg/kg/min continuous IV infusion

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Comparative Safety Scale(Higher is safer)

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DangerousModerateSafe

Time to Effect

Minutes to hours

Duration

Hours to days (until surgical/catheter intervention)

Response Rate

98%

Remission Rate

Number Needed to Treat (NNT)

Common Side Effects:

Apnea: 10%

Fever: 10%

Hypotension: 5%

Flushing: 5%

Bradycardia: 2%

Seizures: 1%

Edema: 5%

Annual Cost of Care

Drug Cost

$5,000

Monitoring

$10,000

Side Effects

$1,000

Total Annual

$16,000

Cost-Effectiveness

EXCELLENT

QALYs Gained

0.5

ICER

$5,000/QALY

Cost per Responder

$16,326.53

Treatment Outcomes

Primary Outcomes

Arterial Oxygen Saturation (SpO2)55-70%

+25% (+15 percentage points)

Mean Arterial Pressure (MAP)30-40 mmHg

+30% (+10 mmHg)

Partial Pressure of Oxygen (PaO2)25-35 mmHg

+70% (+20 mmHg)

Blood pH7.18

+2.1% (+0.15 pH units)

Secondary Benefits

Serum Lactate5.5 mmol/L

-40% (-2.2 mmol/L)

Urine Output0.3 mL/kg/hr

+200% (+0.6 mL/kg/hr)

Capillary Refill Time4 seconds

-50% (-2 seconds)

Common Side Effects

Apnea

+10%

Fever

+10%

Hypotension

+5%

Clinical Trial Phases:

Phase 4

Surgical Ventricular Septal Defect (VSD) Repair

95% Effectiveness• 95% Confidence• 50% Safety• 4 trials• 150K participants

HIGH EvidenceExcellent Value

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Comparative Safety Scale(Higher is safer)

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DangerousModerateSafe

Time to Effect

Immediate (hemodynamic improvement), full recovery over weeks-months

Duration

Single procedure, lifetime monitoring

Response Rate

95%

Remission Rate

90%

Common Side Effects:

Arrhythmias (e.g., heart block): 3%

Residual VSD: 3%

Pleural/pericardial effusion: 7%

Infection: 2%

Bleeding requiring reoperation: 1%

Stroke: 0.5%

Mortality: 1%

Annual Cost of Care

Drug Cost

$100

Monitoring

$750

Side Effects

$100

Total Annual

$950

Cost-Effectiveness

EXCELLENT

QALYs Gained

ICER

$25,000/QALY

Cost per Remission

$1,055.56

Cost per Responder

$1,000

Treatment Outcomes

Primary Outcomes

Left-to-Right Shunt Qp:Qs Ratio2.5:1

-60% (Reduction from 2.5:1 to 1.0:1)

Pulmonary Artery Systolic Pressure45 mmHg

-44.4% (-20 mmHg)

Ross Heart Failure Score8 points (out of 12)

-75% (-6 points)

Secondary Benefits

Weight-for-Age Z-score-2.0 SD

+75% (+1.5 SD)

Peak Oxygen Consumption (VO2 max) % predicted60% of predicted

+50% (+30% of predicted)

Hospitalizations for Respiratory Infections per Year3 hospitalizations/year

-83.3% (-2.5 hospitalizations/year)

Common Side Effects

Arrhythmias (e.g., heart block)

+3%

Residual VSD

+3%

Pleural/pericardial effusion

+7%

Clinical Trial Phases:

Phase 4

Arterial Switch Operation (ASO) for Transposition of Great Arteries (TGA)

95% Effectiveness• 98% Confidence• 45% Safety• 1 trials• 50K participants

HIGH EvidenceExcellent Value

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Comparative Safety Scale(Higher is safer)

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DangerousModerateSafe

Time to Effect

Immediate (hemodynamic correction), critical early recovery, long-term monitoring

Duration

Single procedure (neonatal), lifetime specialized cardiac care

Response Rate

95%

Remission Rate

90%

Common Side Effects:

Coronary artery stenosis: 5%

Supravalvular pulmonary stenosis: 10%

Neoaortic root dilation/regurgitation: 15%

Arrhythmias: 5%

Mortality: 3%

Annual Cost of Care

Drug Cost

$200

Monitoring

$1,500

Side Effects

$400

Total Annual

$2,100

Cost-Effectiveness

EXCELLENT

QALYs Gained

ICER

$40,000/QALY

Cost per Remission

$2,333.33

Cost per Responder

$2,210.53

Treatment Outcomes

Primary Outcomes

Arterial Oxygen Saturation75-85%

+22.5% (+15-20 percentage points (to >95%))

Right Ventricular Systolic Pressure (RVSP)Systemic pressure (e.g., 70-90 mmHg)

-70% (-50-60 mmHg (to pulmonary levels, e.g., <30 mmHg))

B-type Natriuretic Peptide (BNP)200-500 pg/mL

-60% (-240 pg/mL (towards age-appropriate normal))

Cardiothoracic Ratio0.60-0.65 (cardiomegaly)

-20% (-0.12 (towards normal <0.55))

Secondary Benefits

VO2 Max60-70% of predicted (for age-appropriate patients)

+30.7% (+15-20 percentage points of predicted VO2 max)

Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score50/100 (significant impairment)

+40% (+20 points (towards higher quality of life))

Weight Gain Velocity10-15 g/day (suboptimal for age, e.g., 3-month-old infant)

+50% (+6 g/day (towards age-appropriate growth rate))

Common Side Effects

Coronary artery stenosis

+5%

Supravalvular pulmonary stenosis

+10%

Neoaortic root dilation/regurgitation

+15%

Clinical Trial Phases:

Phase 4

Surgical Coarctation of Aorta Repair

95% Effectiveness• 95% Confidence• 50% Safety• 4 trials• 50K participants

HIGH EvidenceExcellent Value

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DangerousModerateSafe

Time to Effect

Immediate (pressure gradient relieved), blood pressure normalization over days-weeks

Duration

Single procedure, lifetime monitoring (especially for hypertension)

Response Rate

95%

Remission Rate

90%

Common Side Effects:

Recurrent coarctation: 5%

Paradoxical hypertension: 10%

Spinal cord ischemia/paraplegia: 0.1%

Chylothorax: 2%

Nerve injury (recurrent laryngeal, phrenic): 2%

Mortality: 1%

Annual Cost of Care

Drug Cost

$100

Monitoring

$750

Side Effects

$100

Total Annual

$950

Cost-Effectiveness

EXCELLENT

QALYs Gained

ICER

$30,000/QALY

Cost per Remission

$1,055.56

Cost per Responder

$1,000

Treatment Outcomes

Primary Outcomes

Upper Extremity Systolic Blood Pressure155 mmHg

-22.6% (-35 mmHg)

Peak Systolic Pressure Gradient across Coarctation (Doppler)50 mmHg

-90% (-45 mmHg)

Left Ventricular Mass Index (LVMI)110 g/m^2

-13.6% (-15 g/m^2)

Secondary Benefits

Upper-to-Lower Extremity Systolic Blood Pressure Gradient45 mmHg

-88.9% (-40 mmHg)

Maximal Workload (Cardiopulmonary Exercise Testing)120 Watts

+20.8% (+25 Watts)

Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score70/100

+17.1% (+12 points)

Common Side Effects

Recurrent coarctation

+5%

Paradoxical hypertension

+10%

Spinal cord ischemia/paraplegia

+0.1%

Clinical Trial Phases:

Phase 4

Surgical Tetralogy of Fallot (TOF) Repair

90% Effectiveness• 95% Confidence• 48% Safety• 10 trials• 100K participants

HIGH EvidenceExcellent Value

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Comparative Safety Scale(Higher is safer)

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DangerousModerateSafe

Time to Effect

Immediate (defect correction), full recovery over weeks-months, long-term monitoring

Duration

Single procedure, lifetime specialized cardiac care

Response Rate

90%

Remission Rate

85%

Common Side Effects:

Pulmonary regurgitation: 20%

Residual VSD/outflow tract obstruction: 5%

Arrhythmias: 5%

Infection: 2%

Bleeding: 1%

Mortality: 2%

Annual Cost of Care

Drug Cost

$200

Monitoring

$1,200

Side Effects

$300

Total Annual

$1,700

Cost-Effectiveness

EXCELLENT

QALYs Gained

ICER

$35,000/QALY

Cost per Remission

$2,000

Cost per Responder

$1,888.89

Treatment Outcomes

Primary Outcomes

Peripheral Oxygen Saturation75% (pre-repair)

+20% (+15 percentage points)

Right Ventricular Outflow Tract Peak Gradient70 mmHg (pre-repair)

-85.7% (-60 mmHg)

Right Ventricular / Systemic Pressure Ratio0.80 (pre-repair)

-75% (-0.60)

Peak Oxygen Consumption (Peak VO2) during exercise60% of predicted for age/sex (pre-repair)

+33.3% (+20% of predicted)

Secondary Benefits

Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score50/100 (pre-repair)

+40% (+20 points)

Percentage of Ideal Body Weight80% (pre-repair)

+18.75% (+15 percentage points of ideal body weight)

Ross Functional Class3 (pre-repair, on a 1-4 scale)

-50% (-1.5 classes)

Common Side Effects

Pulmonary regurgitation

+20%

Residual VSD/outflow tract obstruction

+5%

Arrhythmias

+5%

Clinical Trial Phases:

Phase 4

Fontan Procedure

80% Effectiveness• 90% Confidence• 45% Safety• 58 trials• 30K participants

HIGH EvidenceGood Value

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Comparative Safety Scale(Higher is safer)

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DangerousModerateSafe

Time to Effect

Immediate (hemodynamic change), staged over months to years, long-term management

Duration

Staged procedures over years, lifetime specialized cardiac and multi-organ care

Response Rate

85%

Remission Rate

30%

Common Side Effects:

Protein-losing enteropathy: 10%

Plastic bronchitis: 5%

Arrhythmias: 20%

Liver dysfunction/cirrhosis: 15%

Thromboembolism: 10%

Heart failure/Fontan failure: 15%

Mortality: 5%

Annual Cost of Care

Drug Cost

$500

Monitoring

$2,000

Side Effects

$1,500

Total Annual

$4,000

Cost-Effectiveness

GOOD

QALYs Gained

ICER

$60,000/QALY

Cost per Remission

$13,333.33

Cost per Responder

$4,705.88

Treatment Outcomes

Primary Outcomes

Oxygen Saturation (SpO2)80-85%

+14.7% (+12%)

Ross Classification (functional class)Ross Class III (score 3)

-66.7% (-2 classes (e.g., from III to I))

6-Minute Walk Test (6MWT) Distance300 meters

+50% (+150 meters)

Mean Fontan Circuit Pressure15 mmHg

-20% (-3 mmHg)

Secondary Benefits

PedsQL Cardiac Module Score (Quality of Life)60/100

+33.3% (+20 points)

Systemic Ventricular Ejection Fraction (SVEF)50%

+10% (+5 percentage points)

Hospitalization days per year for cardiac causes15 days/year

-66.7% (-10 days/year)

Common Side Effects

Protein-losing enteropathy

+10%

Plastic bronchitis

+5%

Arrhythmias

+20%

Clinical Trial Phases:

Phase 4