TABLE 4:

Comparison of safety and efficacy results

Previous Device ProcedureSuccessComplications
No.P ValueaNo.P Valuea
0 (n = 337)320 (95)NA2 (0.6)NA
1 (n = 90)88 (98)>.050>.05
2 (n = 34)31 (91)>.051 (2.9)>.05
3 (n = 9)7 (78).0256b0>.05c
4 (n = 4)3 (75)>.05b0>.05c
5 (n = 1)1 (100)>.05b0>.05c
  • Note.—Data in parentheses are percentages. NA = not applicable.

  • a Compared with results for 0 previous procedures.

  • b Groups with three to five procedures pooled, P = .0096.

  • c Groups with three to five procedures pooled, P > .05.