Table 2.
Summary of the published renal denervation trials, including number of trials published, number of patients denervated using different catheters, and reported complications
| Study types | Uncontrolled68–109 | Case-control110–114 | Randomized control7,9,53–58 | Total |
|---|---|---|---|---|
| Number published | 42 (76%) | 6 (11%) | 7 (13%) | 55 |
| Number denervations | 2,713 (73%) | 276 (7%) | 743 (20%) | 3,732 |
| Symplicity™ | 2,533 | 237 | 730 | 3,500 (94%) |
| EnligHTN™ | 58 | 0 | 0 | 58 (2%) |
| Paradise™ | 11 | 0 | 0 | 11 (<1%) |
| Vessix™ | 8 | 0 | 0 | 8 (<1%) |
| Iberis™ | 6 | 0 | 0 | 6 (<1%) |
| OneShot™a | 9 | 0 | 0 | 9 (<1%) |
| EP | 88 | 39 | 13 | 140 (4%) |
| Complications | 38 (1.4%) | 5 (1.8%) | 13 (1.7%) | 56 |
| Renal artery | 13 | 0 | 4 | 17 (0.5%) |
| Renal function | 8 | 0 | 4 | 12 (0.3%) |
| Femoral artery | 17 | 5 | 5 | 27 (0.7%) |
Notes:
a
The OneShot denervation system is no longer produced. Renal artery complications include dissection and stenosis. Renal function complications include >50% deterioration in renal function or new end-stage renal failure. Femoral artery complications include pseudoaneurysm or significant hematoma.
Abbreviation: EP, cardiac electrophysiological study catheter.