Recent Studies Using The Sensei Robotic System
Since there are no completed randomised controlled trials comparing robotic ablation to manual ablation, comparing the modalities remains difficult. Techniques, complication rates and clinical results vary widely between centres for both manual and robotic procedures, making registry data difficult to compare. Typical ranges for procedures performed manually are: major complication rates of 3-5%, and success rates of approximately 80-90% for paroxysmal AF and 70-75% for persistent AF (depending on the length of follow-up). The following are recent reports in medical journals detailing experience of the Sensei system in the catheter ablation of AF, and demonstrate approximate success and complication rates at the time of writing:
| Study | Parameter | Robotic ablation | Manual ablation | |
|---|---|---|---|---|
| Prague 2011 |
Number of subjects | 100 total
All paroxysmal |
(No comparator group) | |
| Pulmonary vein isolation achieved acutely | 100% | |||
| Procedure time | 3.7 ± 0.9 hours | |||
| Fluoroscopy time | 11.9 ± 7.8 minutes | |||
| Clinical success
(Freedom from AF ) |
63% at 15 ± (3-28) month,
86% after 21 patients had a repeat procedure |
|||
| Safety | Total complications 0% | |||
| Texas Group 2009 |
Number of subjects | 193 total
135 paroxysmal 55 persistent 6 long-lasting persistent |
197 total (registry cohort)
127 paroxysmal 55 persistent 11 long-lasting persistent |
|
| Pulmonary vein isolation achieved acutely | 100% | 100% | ||
| Procedure time | 3.1 ± 0.8 hours | 3.1 ± 0.8 hours | ||
| Fluoroscopy time | 48.9 ± 24.6 minutes | 58.4 ± 20.4 minutes | ||
| Clinical success
(Freedom from AF ) |
Overall 85% at 14 ± 1 month
Paroxysmal AF 90% Persistent AF 71% Long-lasting 100% (of only 6) |
Overall 81% at 14 ± 1 month
Paroxysmal AF 85% Persistent AF 73% Long lasting 67% |
||
| Safety | Total complications 1.5% 1% tamponade | Total complications 1.0% 0.5% tamponade | ||
| Hamburg 2010 |
Number of subjects | 64 total (all paroxysmal) | (No comparator group) | |
| Pulmonary vein isolation achieved acutely | 100% | |||
| Procedure time | 3.0 (2.5- 3.8) 1.5 hours | |||
| Fluoroscopy time | 24 (12-34) minutes | |||
| Clinical success
(Freedom from AF) |
81% at 12 months | |||
| Safety | Total complications 0% | |||
| Hamburg 2009 |
Number of subjects | 65 total
Paroxysmal 43 Persistent 22 |
||
| Pulmonary vein isolation achieved acutely | 95%
(remainder completed manually) |
|||
| Procedure time | 3.3 ± 0.7 hours | |||
| Fluoroscopy time | 17 ± 7 minutes | |||
| Clinical success
(Freedom from AF ) |
73% at 8 months
76% Paroxysmal 78% persistent |
|||
| Safety | Total complications 5%
Tamponade 1.5% |
|||
| Prague 2009 |
Number of subjects | 22 total
All paroxysmal |
16 total (registry cohort)
All paroxysmal |
|
| Pulmonary vein isolation achieved acutely | 100% | 100% | ||
| Procedure time | 3.5 ± 0.5 hours | 4.2 ± 1.0 hours | ||
| Fluoroscopy time | 15 ± 5 minutes | 27 ± 9 minutes | ||
| Clinical success
(Freedom from AF ) |
91% at 5 ± 1 month | 81% at 9 ± 3 month | ||
| Safety | Total complications 0% | Total complications 0% | ||
| Multicenter group (France, Germany, Italy, Prague, USA) 2008 |
Number of subjects | 40 total
Paroxysmal 29 Persistent 11 |
(No compartor group) | |
| Pulmonary vein isolation achieved acutely | 100% | |||
| Procedure time | 2.8 ± 1.5 hours | |||
| Fluoroscopy time | 64 ± 33 minutes | |||
| Clinical success
(Freedom from AF ) |
98% at 12 months | |||
| Safety | Total complications 5%
Tamponade 5% (nil else) |
Read more about this topic: Sensei Robotic Catheter System
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