Can bilateral vocal cord paralysis following a Blalock-Taussig (BT) shunt in a pediatric patient be considered malpractice?

Bilateral Vocal Cord Paralysis Following BT Shunt in Pediatric Patients: Medical-Legal Considerations

Bilateral vocal cord paralysis following a Blalock-Taussig (BT) shunt in a pediatric patient should be considered a predictable but not preventable complication rather than malpractice, provided proper surgical technique was employed and appropriate informed consent was obtained. 1

Understanding Recurrent Laryngeal Nerve Injury in Cardiac Surgery

Recurrent laryngeal nerve (RLN) injury is a recognized complication in thoracic procedures, including BT shunts in pediatric patients with congenital heart disease. The anatomy of the RLN makes it vulnerable during these procedures:

• The right RLN lies in a more superficial plane along the lateral esophageal edge, making it potentially more susceptible to injury 1, 2
• During BT shunt procedures, the nerve pathway may be in close proximity to the surgical field, particularly when the shunt originates from the innominate artery 1

Factors That Determine Malpractice vs. Unavoidable Complication

Several key factors determine whether bilateral vocal cord paralysis constitutes malpractice:

1. Surgical technique documentation:

   • A precise and comprehensive surgical report demonstrating RLN identification and integrity at procedure completion is critical 1
   • Documentation showing that the intervention met the standard of practice performed by a qualified surgeon

2. Informed consent:

   • An informed consent form containing an accurate description of all potential complications, including RLN injuries, must be clearly discussed and signed 1
   • Failure to include vocal cord paralysis as a potential complication may constitute inadequate informed consent

3. Pre-operative assessment:

   • Pre-operative flexible laryngoscopy to identify any pre-existing vocal fold alterations 1, 2
   • This establishes baseline vocal cord function before the procedure

4. Post-operative management:

   • Prompt recognition and management of vocal cord paralysis when suspected 1
   • Immediate flexible laryngoscopy for any patient with post-operative stridor, respiratory distress, or voice changes 1, 2

Legal Precedent and Outcomes

According to medical-legal analysis:

• In 80% of reported lawsuits related to RLN injury, patients won legal claims primarily due to 1:

  • Inadequate surgical documentation
  • Insufficient informed consent
  • Delayed communication of neural damage to the patient
  • Inability to demonstrate meticulous surgical technique

• In cases where surgeons prevailed, court-appointed physicians were able to demonstrate the anatomical and surgical difficulties that made the complication unavoidable 1

Management of Bilateral Vocal Cord Paralysis

When bilateral vocal cord paralysis occurs following a BT shunt:

• Immediate airway management is critical, potentially requiring reintubation or tracheostomy in severe cases 2, 3
• Conservative management with voice therapy may be appropriate for mild cases, with monitoring for spontaneous recovery (which may occur within 6 months) 2
• For persistent cases, vocal cord injection or medialization procedures may be considered 2, 4
• Newer techniques like endoscopic anterior and posterior cricoid split (EAPCS) may help avoid tracheostomy in infants 3

Risk Reduction Strategies

To minimize the risk of RLN injury and subsequent malpractice claims:

• Use meticulous surgical technique with visual identification of the nerve 1, 2
• Avoid excessive traction, which is often the main cause of injury 1
• Use intermittent tension and cautious dissection 1
• Consider preoperative vocal cord assessment in high-risk cases 2
• Maintain empathetic relationships with patients and provide clear communication about outcomes 1

Conclusion

Bilateral vocal cord paralysis following a BT shunt represents a serious but recognized complication of pediatric cardiac surgery. While devastating for both patient and surgeon, it should not automatically be considered malpractice. The determination hinges on proper surgical technique, adequate documentation, appropriate informed consent, and prompt recognition and management of the complication when it occurs.