THE BILITCH REPORT*
Performance of Implantable Cardiac Rhythm Management Devices Prepared by SUSAN L. SONG From the University of Southern California School of Medicine, Pacemaker Center, Los Angeles, California
Longevity of Implantable Cardioverter Defibrillator Patients March, 1982 through March 31, 1992 Number of Patients Section A 1869:1586:283* Number Exposed Section B 1869:1492:377" Number Exposed Active Lost to foilow-upt Inactive Deceased No Replacements! Infection Heart transplant Elective, M.D./Patient Battery depletion Lead system Inappropriate shock
6 Months
12 18 Months Months
24 30 Months Months
42 36 Months Months
48 54 Months Months
72 60 Months Months
84 Months
93.5% ± 1.2%
90.7% 88.5% ± 1.4% ± 1.6%
85.9% 83.3% ± 1.8% ± 2.1%
81.1% 79.6% ± 2.3% ± 2.5%
77.7% 74.0% ± 2.8% ± 3.6%
67.4% 71.0% ± 4.2% ± 5.2%
60.0% ± 9.8%
1574 92.2% ± 1.3% 1574
1304
1073
88.4% 85.0% ± 1.6% ± 1.8% 1304
1073
847
678
81.4% 78.2% ± 2.1% ± 2.3% 847
678
506
390
75.2% 73.1% ± 2.5% ± 2.7% 506
390
272
175
70.5% 66.0% ± 3.1% ± 3.8% 272
175
123
52
59.2% 63.3% ± 4.2% ± 5.3% 123
52
106 Months
39.3% ± 22.4%
28
1
51.0% ± 8.2%
25.7% ± 19.9%
28
1
1368 124 283 94 31 31 22 7 2 1
' Numbers in Series:Alive:Deceased " Numbers in Series:Active:lnactive Number of deceased patients at 1 month is 51. t These numbers for no replacements and lost to follow-up are subject to continued analysis of potential revision and may, therefore, present an apparent inconsistency from the previous report.
* Originated by Michael Bilitch, M.D., 1932-1987. Seymour Furman, Jay Gross, Rosemary Frame, and Debra Johnston, Montefiore Medical Center, Bronx, New York. Victor Parsonnet, Stephen T. Rothbart, and John Zimmerman, Pacemaker Center, Inc., Newark Beth Israel Medical Center, Newark, New Jersey. David T. Kawanishi, Josef Widerhorn, Susan L. Song, and Kay K. Hashimoto, University of Southern California School of Medicine, Pacemaker Center, Los Angeles, California. Thomas A. Buckingham, Marshall D. Coldin, and Elizabeth A. Wimer, Rush-Presbyterian/St. Luke's Medical Center, Chicago, Illinois. Bernard J. Staller and Stephen T. Denker, St. Luke's Hospital, Milwaukee, Wisconsin. Irving H. Lipton, The
PACE, VoL 15
Toronto Hospital, Toronto, Ontario, Canada. James D. Maloney and Lon W. Castle, The Cleveland Clinic Foundation, Cleveland, Ohio. J. Warren Harthorne, Jeremy N. Ruskin, Hasan Caran, and Brian A. McGovern, Massachusetts General Hospital, Boston, Massachusetts. Jerry C. Griffin, Melvin M. Scheinman, and Michael D. Lesh, Moffitt Hospital, University of California San Francisco, San Francisco, California. Paul Dorian and David Newman, St. Michael's Hospital, Toronto, Ontario, Canada. Pablo Denes and Wendy Dahl, St. Paul-Ramsey Medical Center, St. Paul, Minnesota. Sanjeev Saksena and Ryszard B. Krol, Eastern Heart Institute, Passaic, New Jersey. Richard N. Fogoros, Allegheny General Hospital, Pittsburgh, Pennsyl-
July 1992
1095
Implantable Cardioverter Defibrillators March, 1982 to March 31, 1992 (n = 2521+) 12 Months
18 24 Months Months
30 Months
CARDIAC PACEMAKERS, INC. 1510 97.5% 96.6% 128:12:77:2:37 ± 2.8% ± 3.2%
93.9% 79.0% ±: 4.4% ± 7.8%
37.5% ± 9.9%
16.1% ± 8.4%
11.9% 46M ± 8.1%
1520 429:95:184:18:132
99.0% ± 1.0%
98.0% ± 1.4%
96.6% 90.6% ±: 1.8% ± 3.1%
80.3% ± 4.3%
57.1% ± 5.7%
34.6% ± 6.2%
1550 729:580:20:12:117
99.2% ± 0.7%
99.0% ± 0.8%
98.3% 96.3% ±: 1.1% ± 1.9%
93.3% ± 3.8%
93.3% 38M ± 3.8%
Model Number*
1555 60:54:0:0:6 1600 231:206:7:1:16
6 Months
100% 99.5% ± 0.9%
42 Months
48 Months
54 Months
28.1% 24.1% 59M ± 6.8% ± 9.3%
100% 17M 98.2% ± 2.7%
1700" 22:21:0:0:1
100%
1705** 19:19:0:0:0
100% 10M
96.7% 94.7% ±: 4.0% ± 5.5%
94.7% ± 5.5%
81.2% 73.0% 41M ± 18.0% ± 22.1%
100% 16M
INTERMEDICS 101-01** 6:5:0:1:0
100%
100%
100%
MEDTRONIC 7216A** 13:11:0:0:2
100%
100%
100%
7217B** 136:126:0:0:10
100%
100%
100% 19M
7217IB** 6:6:0:0:0
100%
100%
100%
100%
100%
100%
4202** 90:68:3:0:19
98.8% ± 2.4%
4203** 24:22:1:0:1 4204** 3:3:0:0:0
95.6% ± 8.5%
4210** 42:33:1:3:5
97.4% ± 5.0%
97.4% ± 5.0%
97.4% 97.4% 25M ±: 5.0% ± 5.0%
VENTRITEX V-100** 98:90:3:1:4
98.6% ± 2.8%
95.2% ± 5.3%
95.2% 95.2% ±: 5.3% ± 5.3%
TELECTRONICS 4201** 7:3:1:1:2
36 Months
100% 28M
100%
100%
98.8% ± 2.4%
95.7% 95.7% ±: 4.8% ± 4.8%
95.7% ± 4.8%
95.6% ± 8.5%
95.6% 95.6% ±: 8.5% ± 8.5%
80.0% ± 35.1%
80.0% 45M ± 35.1%
95.7% 38M ± 4.8%
100% 8M
The following data i s no longer reported Manufacturer Model Number CPI 1400/1410/1420 CPI 1500
95.2% ± 5.3%
Date of Last Report April 1991 October 1991
* Numbers in Series:Active:Fail:Elective:General " These models are in clinical investigations. t The number includes 350 devices from CPI Models 1400/1410/1420.
1096
July 1992
PACE, Vol. 15
THE BILITCH REPORT
Implantable Cardioverter Defibrillator Failures January 1, 1992 to March 31, 1992 Manufacturer & Model Number
Number in Series
Number Faiied
Cardiac Pacemakers, Inc. 1520
429
14
729
1550 1600 Telectronics 4202
Impiant Duration (Months)
Faiiure Mode
26, 33, 33, 33, 34, 35, 35, 38,38, 39, 39,40, 41,42
Battery depletion
5
17, 20, 24, 28,37
Battery depletion
231
3
21,35, 38
Battery depletion
90
2
14, 18
Battery depletion
Please see full text in PACE 1992; 15:475-486.
PACE, Vol. 15
July 1992
1097
Performance of Implantable Cardiac Rhythm Management Devices Prepared by SUSAN L. SONG From the University of Southern California School of Medicine, Pacemaker Center, Los Angeles, California
Longevity of Implantable Cardioverter Defibrillator Patients March, 1982 through March 31, 1992 Number of Patients Section A 1869:1586:283* Number Exposed Section B 1869:1492:377" Number Exposed Active Lost to foilow-upt Inactive Deceased No Replacements! Infection Heart transplant Elective, M.D./Patient Battery depletion Lead system Inappropriate shock
6 Months
12 18 Months Months
24 30 Months Months
42 36 Months Months
48 54 Months Months
72 60 Months Months
84 Months
93.5% ± 1.2%
90.7% 88.5% ± 1.4% ± 1.6%
85.9% 83.3% ± 1.8% ± 2.1%
81.1% 79.6% ± 2.3% ± 2.5%
77.7% 74.0% ± 2.8% ± 3.6%
67.4% 71.0% ± 4.2% ± 5.2%
60.0% ± 9.8%
1574 92.2% ± 1.3% 1574
1304
1073
88.4% 85.0% ± 1.6% ± 1.8% 1304
1073
847
678
81.4% 78.2% ± 2.1% ± 2.3% 847
678
506
390
75.2% 73.1% ± 2.5% ± 2.7% 506
390
272
175
70.5% 66.0% ± 3.1% ± 3.8% 272
175
123
52
59.2% 63.3% ± 4.2% ± 5.3% 123
52
106 Months
39.3% ± 22.4%
28
1
51.0% ± 8.2%
25.7% ± 19.9%
28
1
1368 124 283 94 31 31 22 7 2 1
' Numbers in Series:Alive:Deceased " Numbers in Series:Active:lnactive Number of deceased patients at 1 month is 51. t These numbers for no replacements and lost to follow-up are subject to continued analysis of potential revision and may, therefore, present an apparent inconsistency from the previous report.
* Originated by Michael Bilitch, M.D., 1932-1987. Seymour Furman, Jay Gross, Rosemary Frame, and Debra Johnston, Montefiore Medical Center, Bronx, New York. Victor Parsonnet, Stephen T. Rothbart, and John Zimmerman, Pacemaker Center, Inc., Newark Beth Israel Medical Center, Newark, New Jersey. David T. Kawanishi, Josef Widerhorn, Susan L. Song, and Kay K. Hashimoto, University of Southern California School of Medicine, Pacemaker Center, Los Angeles, California. Thomas A. Buckingham, Marshall D. Coldin, and Elizabeth A. Wimer, Rush-Presbyterian/St. Luke's Medical Center, Chicago, Illinois. Bernard J. Staller and Stephen T. Denker, St. Luke's Hospital, Milwaukee, Wisconsin. Irving H. Lipton, The
PACE, VoL 15
Toronto Hospital, Toronto, Ontario, Canada. James D. Maloney and Lon W. Castle, The Cleveland Clinic Foundation, Cleveland, Ohio. J. Warren Harthorne, Jeremy N. Ruskin, Hasan Caran, and Brian A. McGovern, Massachusetts General Hospital, Boston, Massachusetts. Jerry C. Griffin, Melvin M. Scheinman, and Michael D. Lesh, Moffitt Hospital, University of California San Francisco, San Francisco, California. Paul Dorian and David Newman, St. Michael's Hospital, Toronto, Ontario, Canada. Pablo Denes and Wendy Dahl, St. Paul-Ramsey Medical Center, St. Paul, Minnesota. Sanjeev Saksena and Ryszard B. Krol, Eastern Heart Institute, Passaic, New Jersey. Richard N. Fogoros, Allegheny General Hospital, Pittsburgh, Pennsyl-
July 1992
1095
Implantable Cardioverter Defibrillators March, 1982 to March 31, 1992 (n = 2521+) 12 Months
18 24 Months Months
30 Months
CARDIAC PACEMAKERS, INC. 1510 97.5% 96.6% 128:12:77:2:37 ± 2.8% ± 3.2%
93.9% 79.0% ±: 4.4% ± 7.8%
37.5% ± 9.9%
16.1% ± 8.4%
11.9% 46M ± 8.1%
1520 429:95:184:18:132
99.0% ± 1.0%
98.0% ± 1.4%
96.6% 90.6% ±: 1.8% ± 3.1%
80.3% ± 4.3%
57.1% ± 5.7%
34.6% ± 6.2%
1550 729:580:20:12:117
99.2% ± 0.7%
99.0% ± 0.8%
98.3% 96.3% ±: 1.1% ± 1.9%
93.3% ± 3.8%
93.3% 38M ± 3.8%
Model Number*
1555 60:54:0:0:6 1600 231:206:7:1:16
6 Months
100% 99.5% ± 0.9%
42 Months
48 Months
54 Months
28.1% 24.1% 59M ± 6.8% ± 9.3%
100% 17M 98.2% ± 2.7%
1700" 22:21:0:0:1
100%
1705** 19:19:0:0:0
100% 10M
96.7% 94.7% ±: 4.0% ± 5.5%
94.7% ± 5.5%
81.2% 73.0% 41M ± 18.0% ± 22.1%
100% 16M
INTERMEDICS 101-01** 6:5:0:1:0
100%
100%
100%
MEDTRONIC 7216A** 13:11:0:0:2
100%
100%
100%
7217B** 136:126:0:0:10
100%
100%
100% 19M
7217IB** 6:6:0:0:0
100%
100%
100%
100%
100%
100%
4202** 90:68:3:0:19
98.8% ± 2.4%
4203** 24:22:1:0:1 4204** 3:3:0:0:0
95.6% ± 8.5%
4210** 42:33:1:3:5
97.4% ± 5.0%
97.4% ± 5.0%
97.4% 97.4% 25M ±: 5.0% ± 5.0%
VENTRITEX V-100** 98:90:3:1:4
98.6% ± 2.8%
95.2% ± 5.3%
95.2% 95.2% ±: 5.3% ± 5.3%
TELECTRONICS 4201** 7:3:1:1:2
36 Months
100% 28M
100%
100%
98.8% ± 2.4%
95.7% 95.7% ±: 4.8% ± 4.8%
95.7% ± 4.8%
95.6% ± 8.5%
95.6% 95.6% ±: 8.5% ± 8.5%
80.0% ± 35.1%
80.0% 45M ± 35.1%
95.7% 38M ± 4.8%
100% 8M
The following data i s no longer reported Manufacturer Model Number CPI 1400/1410/1420 CPI 1500
95.2% ± 5.3%
Date of Last Report April 1991 October 1991
* Numbers in Series:Active:Fail:Elective:General " These models are in clinical investigations. t The number includes 350 devices from CPI Models 1400/1410/1420.
1096
July 1992
PACE, Vol. 15
THE BILITCH REPORT
Implantable Cardioverter Defibrillator Failures January 1, 1992 to March 31, 1992 Manufacturer & Model Number
Number in Series
Number Faiied
Cardiac Pacemakers, Inc. 1520
429
14
729
1550 1600 Telectronics 4202
Impiant Duration (Months)
Faiiure Mode
26, 33, 33, 33, 34, 35, 35, 38,38, 39, 39,40, 41,42
Battery depletion
5
17, 20, 24, 28,37
Battery depletion
231
3
21,35, 38
Battery depletion
90
2
14, 18
Battery depletion
Please see full text in PACE 1992; 15:475-486.
PACE, Vol. 15
July 1992
1097
