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 September 30, 1991 Number of Patients Section A 1610:1350:260* Number Exposed Section B 1610:1265:345" Number Exposed Active Lost to follow-uptt Inactive Deceased No Replacementsft Infection Heart transplant Elective, M.D./Patlent Battery depletion Lead system Inappropriate shock
6 Months
12 Months
18 Months
24 Months
30 Months
36 Months
42 Months
48 Months
54 Months
60 Months
72 Months
84 Months
100 Months
92.9% ± 1.3% 1350
89.9% ± 1.6% 1121
87.5% ± 1.8% 896
84.6% ± 2.1% 706
81.7% ± 2.4% 546
78.9% ± 2.7% 409
77.3% ± 2.9% 289
75.5% ± 3.2% 193
72.0% ± 4.0% 134
68.5% ± 4.8% 82
64.9% ± 6.1% 44
55.1% ± 10.6% 19
45.9% ±18.6%t 3
91.5% ± 1.4% 1350 1191 74
87.6% ± 1.7% 1121
83.7% ± 2.0% 896
79.9% ± 2.3% 706
76.1% ± 2.6% 546
72.8% ± 2.9% 409
70.3% ± 3.1% 289
67.5% ± 3.5% 193
63.8% ± 4.1% 134
60.8% £ 4.7% 82
56.4% ± 6.0% 44
45.5% ± 10.1% 19
38.0% ± 16.0%t 3
260 63 31 25 20 7 1 1
' Numbers In Serles:Allve:Deceased " Numbers in Series:Active:lnactlve Number of deceased patients at 1 month Is 50. t Greatest duration at 102 months, patient with an ICD removed and not replaced. t 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 Biiitch, 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
120
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 Garan, 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-
January 1992
PACE, Vol. 15
Implantable Cardioverter Defibrillators March, 1982 to September 30, 1991 (n = 2198t) Modal Numbar*
6 Months
12 Months
18 Months
CARDIAC PACEMAKERS. INC. 1500 97.6% ±3.7% 95.7% ±3.7% 92.8% ±4.8% 128:2:76:6:44 96.7% ±3.2% 93.9% ±4.4% 1510 97.5% ±2.8% 128:13:76:4:35 98.0% ±1.4% 96.6% ±1.8% 1520 99.0% ±1.0% 429:130:150:17:132 98.9% ±0.8% 97.7% ±1.6% 1550 99.1%±0.7% 697:581:12:9:95 1555 100% 11M 26:22:0:0:4 1600 100% 96.8% ±4.3% 96.8% ±4.3% 142:129:2:1:10 10M 1700" 100% 19:18:0:0:1 INTERMEDICS 101-01" 100% 100% 6:6:0:0:0 MEDTRONIC 7216A" 100% 100% 22M 100% 13:11:0:0:2 7217B" 100% 100% 50:47:0:0:3 7217IB" 100% 100% 6:6:0:0:0 TELECTRONICS 4201" 100% 100% 100% 7:5:0:0:2 4202" 98.7% ±2.5% 98.7% ±2.5% 98.7% ±2.5% 62:67:1:0:14 100% 100% 4203" 100% 19:19:0:0:0 100% 100% 19M 4210" 100% 25:18:0:3:4 VENTRITEX 94.6% ±7.6% 94.6% ±7.6% V-100" 100% 71:66:2:1:2
48 Months
36 Months
42 Months
84.0%±7.3% 40.3%±10.4%
8.2% ±6.6%
5.5% ±6.3%
39M
79.0%±7.9% 35.5%±10.0%
11.2% ±8.3%
3.4% ±6.6%
40M
90.5%±3.1%
80.7%±4.3%
57.0% ±6.3% 32.5% ±7.9%
96.5% ±2.3%
96.5% ±2.3%
96.8% ±4.3%
96.8% ±4.3% 35M
24 Months
100%
30 Months
20.8% ±9.5% 53M
32M
100%
100% 39M
96.7% ±2.5% 98.7% ± 2.5% 32M
94.6% ±7.6%
* 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.
Implantable Cardioverter Defibrillators Failures June 1 , 1991 to September 30, 1991
Manufacturer & Model Number
Number In Series
Number Failed
CARDIAC PACEMAKERS, INC. 1500 1510 1520
128 128 429
1 6 17
697 142
2 1 1
71
1
1550 1600 VENTRITEX V-100
implant Duration (Montiis)
38
28,29,31,32,35,38 22,22,26,26,29,31, 34, 35, 37, 37, 38, 38, 39, 40, 40, 44, 47 18,26
Faiiure Mode
Battery depletion Battery depletion Battery depletion
20 9
Sensing malfunction Battery depletion Inappropriate charge time
11
Battery depletion
Please see full text in PACE 1991:14:589-602.
PACE, Vol. 15
January 1992
121
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 September 30, 1991 Number of Patients Section A 1610:1350:260* Number Exposed Section B 1610:1265:345" Number Exposed Active Lost to follow-uptt Inactive Deceased No Replacementsft Infection Heart transplant Elective, M.D./Patlent Battery depletion Lead system Inappropriate shock
6 Months
12 Months
18 Months
24 Months
30 Months
36 Months
42 Months
48 Months
54 Months
60 Months
72 Months
84 Months
100 Months
92.9% ± 1.3% 1350
89.9% ± 1.6% 1121
87.5% ± 1.8% 896
84.6% ± 2.1% 706
81.7% ± 2.4% 546
78.9% ± 2.7% 409
77.3% ± 2.9% 289
75.5% ± 3.2% 193
72.0% ± 4.0% 134
68.5% ± 4.8% 82
64.9% ± 6.1% 44
55.1% ± 10.6% 19
45.9% ±18.6%t 3
91.5% ± 1.4% 1350 1191 74
87.6% ± 1.7% 1121
83.7% ± 2.0% 896
79.9% ± 2.3% 706
76.1% ± 2.6% 546
72.8% ± 2.9% 409
70.3% ± 3.1% 289
67.5% ± 3.5% 193
63.8% ± 4.1% 134
60.8% £ 4.7% 82
56.4% ± 6.0% 44
45.5% ± 10.1% 19
38.0% ± 16.0%t 3
260 63 31 25 20 7 1 1
' Numbers In Serles:Allve:Deceased " Numbers in Series:Active:lnactlve Number of deceased patients at 1 month Is 50. t Greatest duration at 102 months, patient with an ICD removed and not replaced. t 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 Biiitch, 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
120
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 Garan, 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-
January 1992
PACE, Vol. 15
Implantable Cardioverter Defibrillators March, 1982 to September 30, 1991 (n = 2198t) Modal Numbar*
6 Months
12 Months
18 Months
CARDIAC PACEMAKERS. INC. 1500 97.6% ±3.7% 95.7% ±3.7% 92.8% ±4.8% 128:2:76:6:44 96.7% ±3.2% 93.9% ±4.4% 1510 97.5% ±2.8% 128:13:76:4:35 98.0% ±1.4% 96.6% ±1.8% 1520 99.0% ±1.0% 429:130:150:17:132 98.9% ±0.8% 97.7% ±1.6% 1550 99.1%±0.7% 697:581:12:9:95 1555 100% 11M 26:22:0:0:4 1600 100% 96.8% ±4.3% 96.8% ±4.3% 142:129:2:1:10 10M 1700" 100% 19:18:0:0:1 INTERMEDICS 101-01" 100% 100% 6:6:0:0:0 MEDTRONIC 7216A" 100% 100% 22M 100% 13:11:0:0:2 7217B" 100% 100% 50:47:0:0:3 7217IB" 100% 100% 6:6:0:0:0 TELECTRONICS 4201" 100% 100% 100% 7:5:0:0:2 4202" 98.7% ±2.5% 98.7% ±2.5% 98.7% ±2.5% 62:67:1:0:14 100% 100% 4203" 100% 19:19:0:0:0 100% 100% 19M 4210" 100% 25:18:0:3:4 VENTRITEX 94.6% ±7.6% 94.6% ±7.6% V-100" 100% 71:66:2:1:2
48 Months
36 Months
42 Months
84.0%±7.3% 40.3%±10.4%
8.2% ±6.6%
5.5% ±6.3%
39M
79.0%±7.9% 35.5%±10.0%
11.2% ±8.3%
3.4% ±6.6%
40M
90.5%±3.1%
80.7%±4.3%
57.0% ±6.3% 32.5% ±7.9%
96.5% ±2.3%
96.5% ±2.3%
96.8% ±4.3%
96.8% ±4.3% 35M
24 Months
100%
30 Months
20.8% ±9.5% 53M
32M
100%
100% 39M
96.7% ±2.5% 98.7% ± 2.5% 32M
94.6% ±7.6%
* 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.
Implantable Cardioverter Defibrillators Failures June 1 , 1991 to September 30, 1991
Manufacturer & Model Number
Number In Series
Number Failed
CARDIAC PACEMAKERS, INC. 1500 1510 1520
128 128 429
1 6 17
697 142
2 1 1
71
1
1550 1600 VENTRITEX V-100
implant Duration (Montiis)
38
28,29,31,32,35,38 22,22,26,26,29,31, 34, 35, 37, 37, 38, 38, 39, 40, 40, 44, 47 18,26
Faiiure Mode
Battery depletion Battery depletion Battery depletion
20 9
Sensing malfunction Battery depletion Inappropriate charge time
11
Battery depletion
Please see full text in PACE 1991:14:589-602.
PACE, Vol. 15
January 1992
121
