A 38-year-old female with supra-ventricular tachycardia sought surgical treatment so she could stop taking medication, in hopes of having another child. During an ablation procedure, she developed a complete heart block, resulting in placement of a permanent pacemaker and continuation of medications.
- Effective informed consent is a process, not just a one-time event
- A breakdown in communication can deplete the patient’s trust in his/her physician.
A 38-year-old female, married with three children, wanted to conceive another child. She sought medical advice and treatment in order to safely stop the beta-blockers she was taking. For the prior 20 years, she had had recurrent supraventricular tachycardia (SVT) with periodic symptoms that included shortness of breath, diaphoresis and mild lightheadedness. The frequency and duration of these symptoms had been increasing, resulting in several visits to the ED over the previous couple of years. For treatment of her SVT she had been taking a number of medications with varying degrees of success and/or ability to tolerate their side effects. Her family history included both parents with myocardial infarctions (the mother probably had SVT as well); and a brother who sustained a cardiac arrest at age 55 (diagnosed with hypertrophic cardiomyopathy).
Her primary care physician referred the patient to a highly-regarded cardiologist who was board-certified in internal medicine, cardiology, and electrophysiology, with extensive experience performing radiofrequency catheter ablations. After an echocardiogram revealed both a normal ejection fraction and LV function, the cardiologist recommended that the patient undergo an electrophysiology study (EPS), followed by a radio-frequency ablation procedure. That day, the cardiologist reviewed with the patient both the risks and benefits of the EPS and the ablation. He provided written literature regarding both. The patient signed a consent form for both the study and procedure, which included the following language regarding potential risks: “…other complications…damage to heart’s normal conduction system requiring a permanent pacemaker.” The surgery was scheduled for several weeks later.
Several days prior to surgery, the cardiologist found he had a conflict with his schedule and arranged for one of his associates, a physician unknown to the patient and not board-certified, to step in (the medical record has no indication that this was explained to the patient). The associate cardiologist performed the EPS, which provoked the expected typical AV node re-entrant tachycardia (AVNRT). The patient was noted to have sinus tachycardia (HR 120), which was felt to be inappropriate sinus tachycardia (IST); the patient had a history of such episodes with palpitations independent of SVT. The IST condition requires ongoing treatment with beta blockers, even with an ablation procedure. Prior to initiating the radio-frequency ablation, the cardiologist contacted the original cardiologist and explained the findings—both the AVNRT, as well as discovery of the IST. He was instructed to proceed with the ablation. During that procedure a junctional rhythm developed and within one second of seeing the heart block (HB), the cardiologist terminated the radio-frequency energy.
The patient was observed overnight in the ICU; however, a complete heart block persisted and the patient required the implantation of a permanent pacemaker. Two weeks post procedure, she was again placed on beta-blockers for the IST.
The patient sued both cardiologists, alleging failure to obtain adequate informed consent and improper performance of the radio-frequency ablation procedure, resulting in complete heart block that resulted in placement of a permanent pacemaker, continued symptoms, chronic shoulder and arm discomfort, and an ongoing need for medication.
A jury found against both defendants and the case settled for more than $4 million against the two cardiologists during the appeal.
- Informed consent was limited to one conversation and a form, weeks before the operation.
Proper informed consent begins with a philosophy that patients are active decision-makers in their own care. By ensuring that patients fully understand and voluntarily submit themselves for surgery, providers create a foundation of trust with their patients. A thorough informed consent helps to set the expectations, and a single, perfunctory conversation is not enough. The goal is to ensure that the patient understands the planned procedure, including the risks of doing it and not doing it, as well as alternative treatments. The type of information to be disclosed and discussed with the patient (and family if appropriate) includes the:
- nature of the patient’s condition and procedure(s) to be performed;
- nature and probability of potential risks involved with having the procedure;
- benefits to be reasonably expected of the procedure;
- physician’s inability to predict results;
- irreversibility of the procedure, if that is the case;
- available alternative treatments/procedures, including their risks and benefits; and
- likely result of no treatment or procedure.
- The patient was left out of two decisions: 1. transferring the procedure to a different, less experienced surgeon, and 2. Going forward with the ablation after the discovery of IST meant the operation would no longer give the patient the ability to quit medications—her main treatment goal.
An attitude that informed consent is a chore or an outside requirement can cause providers to overlook the need to involve a patient at a new decision point. When one stage of a procedure reveals something that changes the risk-benefit calculus of going forward, consider including the patient in the decision. It may be appropriate to stop, allow any sedation to wear off, and apprise the patient of the situation.
- The jury rejected the defense argument that the complication can occur in the most experienced hands, siding instead with evidence that experience and skill lead to lower rates of complications; the two parties reached a settlement after the verdict.
When expert reviewers from the same specialty as the defendant are supportive of the care, a malpractice claim usually goes to trial. Even after a jury award for the patient, a settlement is sometimes best for both sides, to avoid a lengthy, unpredictable appeal process.