Table 5.
Serious adverse events in the first year
| Surgery (n=183) | Medical therapy (n=183) | |||
|---|---|---|---|---|
| Surgery-related | 43 events in 36 patients | 0 events in 12 patients* | ||
| Haemorrhage | 4 (including 1 death)† | 0 | ||
| Infection | 16 | 0 | ||
| DBS-specific adverse events | 13 events in 12 patients | 0 | ||
| Postoperative confusion | 5 | 0 | ||
| Neck pain | 2 | 0 | ||
| Seizures | 2 | 0 | ||
| Deteriorating control of Parkinson's disease because battery was switched off | 1 | 0 | ||
| Psychosis | 1 | 0 | ||
| Unresponsive on operating table (possibly because of levodopa withdrawal) | 1 | 0 | ||
| Visual neglect from oedema | 1 | 0 | ||
| General surgery problems | 10 events in 9 patients | 0 events | ||
| Urinary retention | 4 | 0 | ||
| Pulmonary embolism | 2 | 0 | ||
| Anxiety attack | 1 | 0 | ||
| Difficulty removing catheter | 1 | 0 | ||
| Postoperative hypotension | 1 | 0 | ||
| Pyrexia | 1 | 0 | ||
| Parkinson's-disease related and drug-related | 25 events in 20 patients | 14 events in 13 patients | ||
| Falls | 3 | 7 | ||
| Constipation | 4 in 3 patients | 2 | ||
| Worsening of Parkinson's disease symptoms or uncontrolled Parkinson's disease symptoms | 12 in 11 patients | 2 | ||
| Psychiatric problems | 4 | 1 | ||
| Neuropsychiatric disturbances (including hallucinations or paranoia) | 3 | 0 | ||
| Breakdown | 0 | 1 | ||
| Suicide attempt | 1 | 0 | ||
| Parkinson's disease drug-related | 2 | 2 | ||
| Other | 26 events‡ in 19 patients | 14 events§ in 13 patients | ||
| Deaths | 2 (haemorrhage and pneumonia) | 1 (stroke) | ||
| Total | 96 events in 65 patients | 29 events in 26 patients | ||
Serious adverse events were any event that prolonged a patient's stay in hospital, resulted in the patient being admitted to hospital, was considered to be life-threatening, or resulted in death. DBS=deep brain stimulation.
12 patients randomly assigned to medical therapy received surgery between baseline and 1 year.
One patient had a haemorrhage 5 months after surgery and this was probably not treatment related.
Five urinary problems; five leg swelling or knee swelling, or both; three pain; two chest pain or angina; two chest infection; one collapse; one deep vein thrombosis (more than 8 months after surgery); one pulmonary embolism (more than 8 months after surgery); one polymyalgia rheumatica; one vertigo; one renal colic; one fainting episode; one lacerated wound to forearm; and one head injury.
Four chest pain or angina; two urinary problems; two pain; one abscess on chest wall leading to infection; one deep vein thrombosis; one cauda equina syndrome; one fainting episode; one confusion; and one chest problems.