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

Introduction The actuarial performance of implantable cardiac rhythm management devices (ICRMD) is of interest to manufacturers, regulatory agencies, fiscal groups, and clinical practitioners. Implantable devices may be used to controi bradycardia (the traditional pacemaker), tachyarrhythmias [either atrial or ventricular), or ventricular fibrillation. This performance report has segregated ICRMDs into the performance of cardiac pacemaker pulse generators and implantable cardioverter defibrillators.

Pacemakers The Six Center Pacemaker Study Group has evaluated 20,165 pacemaker pulse generators over

•Originated by Michael Bilitch, M.D., 1932-1987. Seymour Furman, )ay 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. Goldin, and Elizabeth A. Wimer, Rush-Presbyterian/St. Luke's Medical Center, Chicago, Illinois. Bernard |. Staller and Stephen T. Denker, St. Luke's Hospital, Milwaukee, Wisconsin. Irving H. Lipton. The Toronto Hospital. Toronto, Ontario, Canada. |ames 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 |ersey. Richard N. Fogoros, Allegheny General Hospital, Pittsburgh, Pennsyl-

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a 17.5-year period (July 1,1974 through December 31, 1991). We have summarized data from 18,050 pulse generators with Lithium chemistry and Nuclear [P^^^) power sources. Actuarial survival by chemistry is shown in Table 1 and Figure 1. Gumulative survival was the same for Lithium Iodide and Lithium Cupric Snifide chemistries up to 10 years. The equivalent survival rate for nuclear powered unit is clearly higher than any type of reported Lithium chemistry beyond the sixth year. Report of actuarial survival by chemistry does not distinguish between power source depletion and other causes of failure, such as component malfunction. Thus, the performance of the chemistry alone would be somewhat better than the data shown.

Implantable Cardioverter Defibrillators Table IV summarizes a 13 center experience with 2,361 implantable cardioverter defibrillators (IGD) in 1,737 patients over the period from March 1982 through December 31, 1991. The models with at least 40 implants in the group are represented in Figure 2. Table V are IGD failures reported in October through December 1991. The display of Table VI, Sections A and B, of actuarial patient data following IGD implantation involves different assumptions. Both present patient longevity data, from two different perspectives. Review of Table IV and additional data, not available in the Bilitch registry, is required. In presenting longevity data, patients are placed into three categories: (1) patients implanted with an IGD who have died (DEAD) for any reason whether related to the ICD, to cardiac function, or unrelated to cardiac disease; (2) patients who have been

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Table 1. Overall Actuarial Survival Lithium and Nuclear 1 Year

Power Sourcs Number*

S Years

3 Yesrs

4 Years

5 Years

6 Years

7 Years

8 Years

9 Years

10 Years

11 Years

12 Years

13 + Years

A. Lithium Chemistry Iodine—Lji 13547:6688:1130:302:5427

99.4% :^ 0.1%

98.9% i 0.2%

97.8% £ 0.3%

96.5% ± 0.4%

93.9% ± 0 6%

69.4% :^ 0.8%

85.1% ± 1.1%

81.1% ± 1.2%

77.7% ± 1.4%

72.7% - 1.8%

66.6% ± 2.3%

55.4% ± 4.0%

35.6% ± 12.0%

17Y

Cuprjc Sultide—LiCuS 3473:834:449:410:1780 B. Nuclear 156:45:17:9:85

99.4% ± 0.3% 99.4% :t 1.3%

98.1% ± 0.5% 98.7% ± 1.9%

95.6% + 0.8% 97.2% ± 2.6%

92.5% ± 1.1% 96.4% = 3.2%

89.2% ± 1.3% 96.4% ± 3.2%

85.2% ± 1.6% 92.7% ± 4.7%

81.3% ± 1.8% 92.7% ± 4.7%

76.1% ± 2.1% 91.6% ± 5.1%

76.1% -L 2.2% 91.6% * 5.1%

73.8% ± 2.5% 89.2% ± 6.0%

72.0% ± 2.9% 87.8% ± 6.5%

65.8% ± S.4% 87.8% ± 8.5%

65.6% ± 5.4% 72.9% ± 17.6%

15.3Y

• Number in SeriesiActive:Fail-Elective:General

LOST TO FOLLOW-UP after implantation and for whom no further idata exists; and (3) those who have had the ICD removed for one of a variety of reasons [infection, heart transplant, elective, etc.) and have not had it replaced {REMOVED/NOT REPLACED]. Section A displays the proportion of those who are known to be alive. As a patient is categorized to be LOST TO FOLLOW-UP or REMOVED/NOT REPLACED, the database is contracted in size. If a patient is known to be DEAD, the database is debited. The percentage displayed at each interval is, therefore, the proportion of all patients implanted who remain alive. Section B, the inactive patients who are DEAD, and have had the ICD REMOVED/NOT REPLACED are all debited to survival. The percentage displayed at each interval is of those patients known to be alive and active with an ICD in place.

The NUMBER EXPOSED is defined as living patients with an ICD implanted at each interval. A NUMBER EXPOSED that changes prior to the designated interval and continnes through it, could be represented differently between Section A and B. Follow-up data has been confirmed by Bilitch registry records, reviewed with the participating institutions, referring physicians, and manufacturer's database. Lost to follow-up is defined as absence of data, despite intensive inquiries, both, within 6 months of statistical analysis.

Device Performance Table II is the compilation of all documented pulse generator failures that occurred during 1991. IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

LrTHIUM AND NUCLEAR

Lil In. 135471 LiCuS (n.3473) Nuclear (n. 156)

o—

1 2

3

4 5 6

9 10 11 12 13 14 15 16 17 IB Years

17^1

Figure 1. Overall pulse generator performance by basic power sources. This is a graphic representation of data given in Table I.

476

Figure 2. Performance of impJantabJe cardioverter de/ibriJ/afors. This is a graphic representation of the models with at least 40 implants in the group: data given in Tabie IV.

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17.2Y

BILITCH REPORT

Table II. Pulse Generator Failures January 1, 1991—December 31, 1991

Manufacturer & Model Number

Number in Series

Cardiac Pacemakers. Inc. 503 505 507 521 522 525 530 531 603 630 631 925

590 69 14 91 1 201 83 18 61 21 140

Number Failed

Implant Duration (Months)

1 1 1 1 1 1 5 2 1 2 1 13 1

145 134 138 107 85 96 36, 81, 100, 105, 114 81, 83 156 84,84 87 56, 58, 59, 61, 64, 65, 65, 66, 69, 73, 74, 79. 82 43

Unable to program

1 19

1 1

82 197

Rate decrease Rate decrease

Cordis 190F

262

217A 233F

111 229

2 1 1 5 1 1

135, 140 139 130 76, 86, 86, 87, 102 79 90

233G 240G 334A

85 26 152

337A

360

402B 415A

251 286

418A

41

2 3 1 1 1 1 1 4 1 6 2 1

75, 66, 86 70 71 87 90 61, 83 78, 60, 74

Rate decrease Rate increase Rate decrease Rate decrease No output Electronic malfunction Rate decrease Rate decrease Rate decrease Rate increase Loss of capture No output Rate decrease Rate decrease Sensing malfunction Rate decrease Rate decrease No output

1 2 1 1

106 72, 82 127 131

Coratomic Ovalith P2L C100

Intermedics 227-05 229-05 253-03 253-05

135

2 2 3 115

82 72, 74

72, 75, 95 80, 89, 93, 94, 104 80

Failure Model (Clinical)

Rate Rate Rate Rate Rate Rate Rate Rate Rate Rate Rate Rate

Rate Rate Rate Rate

decrease decrease decrease decrease decrease decrease decrease decrease decrease decrease decrease decrease

decrease decrease decrease decrease (Continued)

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Table II. (Continued)

Manufacturer & Model Number

Number in Series

Number Failed

1 253-07

253-09 253-19 254-06 254-09 254-10 259-01 283-01

6

59 190 37 11 14 241 219

4

46

2 3 1

1 3 5

Implant Duration (Months)

Failure Model

(Clinical)

142 72, 89, 101, 113, 117, 118

No output

64, 74, 85, 102 66, 78 87, 107. 111 91 98 118, 119, 126 64, 67, 70, 72, 78

Rate Rate Rate Rate Rate Rate Rate

decrease decrease decrease decrease decrease decrease decrease

Rate Rate Rate Rate Rate Rate

decrease decrease decrease decrease decrease decrease

Rate Rate Rate Rate Rate

decrease decrease decrease decrease decrease

Rate Rate Rate Rate Rate Rate Rate Rate Rate

decrease decrease decrease decrease decrease decrease decrease decrease decrease

Rate decrease

Medtronic 5941 5967 5973 5983 5984 5985

354 ®7

1 1 5 1 3 13

5994 5995 7000 7000A 7005

54 171 73 144 532

2 1 1 2 12

7006 8329 8341 8400 8402 8420 8422 8423 8438

216 25 51 190 66 266 173 510 19

1 1 1 1 1 2 2 2 1

82 112 144, 145, 147, 148, 150 140 126, 127, 129 109, 113, 114, 119, 120, 125, 126, 127, 127, 128, 128, 129, 137 140. 141 140 111 88, 98 57, 66, 71, 72, 74, 77, 79, 79,80, 81, 87,87 68 54 25 77 58 84. 103 85, 115 112, 126 70

152 53 187 89

1 1 1 1

141 71 56 13

Rate decrease Rate decrease No output Unable to program

96 26 96 155 122 25

1 1 1 1 1 1

110 97 83 55 11 12

Rate Rate Rate Rate Loss Rate

Pacesetter 221 241 283 201 OT

Telectronics 155 174 2291 5281B 8220 8222

478

11

e

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decrease decrease decrease decrease of capture decrease

PACE. Vol. 15

BILITCH REPORT

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