Table 13. Peri-implant risks for cardiac resynchronization therapy

Studyn/NSimple Pool
Risk % [95% CI]
Peri-implant deaths
MUSTIC-SR 200174 0/640
MUSTIC-AF 200275 0/590
PATH-CHF 200262 0/410
MIRACLE 200261 2/5710.4 [0.1,1.4]
MIRACLE-ICD 200394 0/4290
COMPANION unpub60 5/6170.8 [0.3,2.0]
COMPANION-ICD unpub60 3/5950.5 [0.1,1.6]
Cazeau 199699 1/714.3 [8.4,54.0]
Filho 200298 0/240
Leclercq unpub104 0/1390
Total [N=10] 13/3113 0.4 [0.2,0.7]
Sensitivity Total [N=16] 13/3456 0.4 [0.2,0.7]
Implant successes
MUSTIC-SR 200174 59/6492.2 [82.0,97.1]
MUSTIC-AF 200275 54/5991.5 [80.6,96.8]
MIRACLE 200261 528/57192.5 [89.9,96.8]
PATH-CHF 200262 41/41100
MIRACLE-ICD 200394 379/42988.3 [84.8,91.1]
COMPANION unpub60 538/61787.2 [84.2,89.7]
COMPANION-ICD unpub60 540/59590.8 [88.1,92.9]
CONTAK-CD unpub73 501/56788.4 [85.4,90.8]
RD-CHF unpub# 45/5680.4 [67.2,89.3]
Cazeau 199699 6/785.7 [42.0,99.2]
Gras 2002100 125/13989.9 [83.4,94.2]
Krahn 2002101 40/4588.9 [75.2,95.8]
Kuhlkamp 2002102 81/8496.4 [89.2,99.1]
Leon 2002106 20/20100
Filho 200298 24/24100
Molhoek 2002103 40/40100
Leclercq unpub104 125/13989.9 [83.4,94.2]
Total [N=16]* 3124/3475 89.9 [88.8,90.9]
Related to left ventricular lead
MUSTIC-SR 200174 5/647.8 [2.9,18.0]
MUSTIC-AF 200275 5/598.5 [3.2,19.4]
MIRACLE-ICD 200336 31/4297.2 [5.0,10.2]
CONTAK-CD unpub73 17/5173.3 [2.0,5.3]
Gras 2002100 12/11710.3 [5.6,17.6]
Krahn 2002101 6/4513.3 [5.5,27.5]
Kuhlkamp 2002102 4/844.8 [1.5,12.4]
Filho 200298 0/240
Total [N=8] 80/1339 6.0 [4.7,7.2]
Sensitivity Total [N=14]** 80/2055 3.9 [3.1,4.8]
Related to the device and battery
PATH-CHF 200262 3/417.3 [1.9,21.0]
MIRACLE 200261 2/5710.4 [0.06,1.4]
MIRACLE-ICD 200394 3/4290.7 [0.2,2.2]
CONTAK-CD unpub73 7/5171.4 [0.6,2.9]
Filho 200298 0/240
Total [N=5] 15/1582 0.9 [0.6,1.6]
Sensitivity Total [N=14]** 15/2055 0.7 [0.4,1.2]
Related to implant procedure and/or tools
MIRACLE 200261 35/5716.1 [4.4,8.5]
MIRACLE-ICD 200394 19/4294.4 [2.8,7.0]
CONTAK-CD unpub73 50/5179.7 [7.3,12.6]
Gras 2002100 3/1172.6 [0.7,7.9]
Krahn 2002101 4/458.9 [2.9,22.1]
Kuhlkamp 2002102 4/844.8 [1.5,12.4]
Leon 2002106 0/200
Filho 200298 0/240
Total [N=8] 115/1807 6.4 [5.3,7.6]
Sensitivity Total [N=14]** 115/2055 5.6 [4.7,6.7]
Related to heart function
MIRACLE 200261 1/5710.2 [0.009,1.1]
MIRACLE-ICD 200394 11/4292.6 [1.4,4.7]
Cazeau 199699 1/714.3 [8.4,54.0]
Filho 200298 0/240
Total [N=4] 13/1031 1.3 [0.7,2.2]
Sensitivity Total [N=14]** 13/2055 0.6 [0.4,1.1]
*

only safety outcome that includes data from RD-CHF

**

COMPANION omitted - full report not available; Leclercq 2002 omitted, - there was 10% or 14/139 failed implants but they did not specify the event

From: 3, Results

Cover of Cardiac Resynchronization Therapy for Congestive Heart Failure
Cardiac Resynchronization Therapy for Congestive Heart Failure.
Evidence Reports/Technology Assessments, No. 106.
McAlister F, Ezekowitz J, Wiebe N, et al.

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