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ACRYLIC CEMENT AND THE CARDIOVASCULAR SYSTEM
1002
1949-51 (table i) coincided with an increased supply of fibre-free energy foods, sugar, fat, and increased energy supplies, while at the same time the fibre content of the National flour decreased. There is only one conclusion and it is basic to medical statistics. "The exclusion of observations from the tabulated series on any ground whatever must be stated, the criteria upon which exclusion was determined clearly set out and usually the number of exclusions stated " 33 Fibre has been excluded, inadequately defined,23 and inaccurately estimated 34 I thank Mrs Priscilla Milton for secretarial assistance. This out with the aid of a grant from the British Heart Foundation.
investigation has been carried
REFERENCES 1.
Marks, H. H. in Joslin’s Diabetes Mellitus (edited by A. Marble, P. White, R. F. Bradley, and L. P. Krall); p. 234. Philadelphia, 1971.
Stocks, P. J. Hyg. Camb. 1944, 43, 242. Registrar General’s Statistical Review of England and Wales 1938 and 1939; Text, p. 97. H.M. Stationery Office, 1947. 4. Registrar General’s Statistical Review of England and Wales 1940 1945; Text, vol. I, p. 187. H.M. Stationery Office, 1949. 5. Registrar General’s Statistical Review of England and Wales, 1940 1954; part I, tables, medical, tables 1 and 21. H.M. Stationery
2. 3.
Office, 1945-56. 6.
Registrar General’s Statistical Review of England and Wales for 1942-57; table 8 or 9 and part 2, Text, for 1940-45, and vol. I, Medical, p. 6. H.M. Stationery Office, 1946-53.
Special Article ACRYLIC CEMENT AND THE
CARDIOVASCULAR SYSTEM THE final report of the Working Party on Acrylic Cement in Orthopaedic Surgery (W.P.A.C.O.S.)* has been accepted by the Standing Medical Advisory Committee of the Department of Health and Social Security (D.H.S.S.).1 This working-party was set up in 1971 to examine the cardiovascular toxicity of acrylic cement and to assess the carcinogenic potential of the material. Subsequently, after an interim terms of the reference of the working-party report,2 were extended to include an assessment of the effect of cement on wound infection, and more specifically of the necessity for providing ultra-clean ventilating systems in operating-rooms for major prosthetic orthopaedic surgery 3; this is now the subject of a Medical Research Council working-party. Four working groups were set up by the W.P.A.C.O.S. to examine: the cement and its components; the cement and wound infection; the cement and hypotension and cardiac arrest; and the cement and tissue reactions. All the working groups restricted their attention to cement of British manufacture-namely, ’CMW’ andSimplex ’ products.t Members of W.P.A.C.O.S.: Prof. R. G. BURWELL (chairman); Dr C. N. DENNIS (convener); Dr A. F. Ross (secretary); Dr J. M. BARNES; Prof. R. BARNES; Prof. M. BRADEN; Prof. C. D. CALNAN; Prof. J. CHARNLEY; Dr P. V. COLE; Mr R. W. H. COOK; Mr M. A. R. FREEMAN; Dr P. GpAsso; Dr 0. M. LIDWELL; Mr R. S. M. LING; Dr E. J. L. LOWBURY; Prof. P. N. MAGEE; Mr G. K. McKEE ; Dr J. F. NUNN; Prof. J. T. SCALES; Dr S. SEVITT; Prof. D. W. STRAUGHAN; Dr R. Y. FORBES (Welsh Office); Dr N. LEITCH; Dr H. MILLER (Scottish Home and Health Department). t CMW bone cement marketed by CMW Laboratories Ltd., Bone Cement Division, Clifton Road, Blackpool FY4 4QF. Simplex bone cement marketed by North Hill Plastics Ltd., 49 Grayling Road, London N16 OBP. Each commercial product consists of a powder (including the polymer P.M.M.A.) and a liquid (including M.M.A. monomer) which are mixed immediately before use.
*
7.
Registrar General’s Statistical Review of England and Wales for 1958-70; part I, tables, medical, table 10. H.M. Stationery Office,
8.
Ministry of Agriculture, Fisheries and Food. Board Trade J. 1968, 194, 753. McCance, R. A., Widdowson, E. M. Spec. Rep. Ser. med. Res. Coun.
1960-72.
9.
1960, no. 297. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25.
26. 27. 28.
29. 30.
31. 32. 33. 34.
Trowell, H. Proc. Nutr. Soc. 1973, 32, 150. Trowell, H. Plant Foods Man, 1974, 1, 91. Himsworth, H. P. Proc. R. Soc. Med. 1949, 42, 323. Cleave, T. L. The Saccharine Disease; p. 80. Bristol, 1974. Hill, A. B. Principles of Medical Statistics; p. 203. London, 1971. Malins, J. Clinical Diabetes; pp. 54, 68. London, 1968. Pyke, D. A. Postgrad. med. J. 1969, 45, 796. Malins, J. Clinical Diabetes; p. 466. London, 1968. Malins, J. ibid. p. 469. Malins, J. ibid. p. 470. Malins, J. ibid. p. 473. Malins, J. ibid. pp. 473-4. Trowell, H. Plant Foods Man (in the press). Trowell, H. Lancet, 1974, 1, 503. Coleman, D. L., Hummel, D. L. Diabetologia, 1967, 3, 328. Kramer, M. W., Liberman, D. F., Soeldner, J. S., Gleason, R. E. ibid. 1969, 5, 353. Gleason, R. E., Lauris, V., Soeldner, J. S. ibid. 1967, 3, 175. Haines, H. B., Hackel, D. B., Schmidt, K. Am. J. Physiol. 1965, 208, 297. Hackel, D. B., Lebovitz, H. E., Frohman, L. A., Mihat, E., SchmidtNielsen, K. Metabolism, 1967, 16, 1133. Hackel, D. B., Frohman, L. A., Mihat, E. Diabetes, 1966, 15, 105. Like, A. A., Jones, E. E. Diabetologia, 1967, 3, 179. Miki, E., Like, A. A., Steinke, J., Soeldner, J. S. ibid. p. 135. Hamilton, C. L., Kuo, P. T., Feng, L. Y. Proc. Soc, exp. Biol. Med. 1972, 140, 1005. Hill, A. B. Principles of Medical Statistics; p. 69. London, 1971. Van Soest, P. J., McQueen, R. W. Proc. Nutr. Soc. 1973, 32, 123.
Charnley reported that in some 3700 total hip replacements (T.H.R.S) over ten years, using two doses of acrylic or polymethacrylate (P.M.M.A.) cement in most patients, there were only 4 patients with a cardiac arrest on the operating-table, 2 of whom died.’4 McKee reported one cardiac arrest among 600 T.H.R.s shortly after inserting the cementHowever, in 1970 there were several clinical reports of acute cardiovascular insufficiency, cardiac arrest, and death associated with the use of P.M.M.A. bone cement in orthopaedic surgical operations,6-10 and these reports were followed by still more.1l-28 There have been further studies of blood-pressure (and other) recordings in patients undergoing orthopxdic surgery involving the use of P.M.M.A. bone cement,2,9-41 and of M.M.A. monomer in man and animals 42-i.e., using implanted polymerising P.M.M.A. bone cement and the injected liquid component of the cement and pure M.M.A.
monomer.43-48
After
reviewing published reports and privately reported case-histories,452 the W.P.A.C.O.S. report concludes that
undertaken for arthritis and using P.M.M.A. bone cement is not associated with any greater risk of cardiac arrest than any other type T.H.R.
of
major surgery in patients of similar age. However, most of the adverse cardiovascular reactions occurred with Thompson’s prosthetic replacement of femoral head (T.P.R.F.H.), with cement for transcervical fracture of the femur. Acute cardiovascular insufficiency developed in 18 patients during the operation; 13 of these were reported to have had cardiac arrest, which was confirmed by electrocardiogram in 3; 7 of the patients were resuscitated; 9 died preoperatively and 2 after temporary resuscitation. Necropsy revealed fat embolism in 5 patients, 7,9,12,16 widespread fat and marrow emboli in 2,14,20 and pulmonary thromboembolism in 1 patient." 3 more patients had disturbances of consciousness
1003 after the operation was completed and died within thirty-six hours, death being attributed to fat embolism.ï,12 In view of these clinical reports and the absence of sufficiently large numbers of patients to establish the incidence of acute cardiovascular insufficiency after T.P.R.F.H., Sevitt, on behalf of W.P.A.C.O.S. undertook a retrospective review of fat He embolism in patients with fractured hips 53 reported 4 deaths from fat embolism in 88 subjects who had undergone T.P.R.F.H. using cement, and concluded that fat embolism accounted for all the deaths within seven days of Thompson’s arthroplasty. Cardiac arrest on removing the tourniquet after total knee replacement (T.K.R.) involving prostheses with intramedullary stems and P.M.M.A. bone cement has been reported in one or more patients.8 There was a sudden fall in arterial blood-pressure thirty seconds after impaction of the femoral component in another patient.24 W.P.A.C.O.S. heard of 8 more patients who had had cardiac arrest or had not regained consciousness soon after completion of a T.K.R.; 4 of these patients died, apparently from fat embolism .111-12 Arden reported a death from fat embolism and a death from pulmonary embolism in a series of 81 T.K.R.S,54 and in a subsequent review of 193 Shiers T.K.R.S he reported fat embolism in 2 patients.55 In another who five after died a T.K.R. yet patient, days without regaining consciousness, fat embolism and boundary-zone cerebral and cerebellar infarction were found at necropsy; the brain infarcts were attributed to postoperative hypotension and not to fat embolism.56 Most, if not all, of these patients undergoing T.K.R. had rheumatoid arthritis. The report examines the possible aetiology of the hypotension and the cardiac arrests, and includes a consideration of vasodilatation caused by M.M.A. monomer absorbed from the site of the prosthetic replacement,6,42,45,57,s8 fat embolism/,9,12,53,59-62 pharmacologically active substances,63 such as vasoactive amines, kinins, and prostaglandins released from tissues as a result of cytotoxicity 64 and/or exotherm,4.42 raised and hypersensiintramedullary pressure,38-41,6:>-68 tivity.4,69 The report concludes that in the present state of ignorance of the pathogenesis of acute cardiovascular insufficiency during T.P.R.F.H., it would be prudent to consider whether the factors involved insoon
clude cement,
marrow
fat, osteoporosis, anaesthetic
agents and other drugs,70-72 hypoxaemia, hypersensitivity, chronic cardiovascular disease, age, and sex.’3 Also thromboplastic elements may possibly cause platelet aggregation and fibrin deposition as microemboli in the lungs 25e° There is no evidence to implicate nervous reflexes; air embolism twas found at necropsy in one patient." H M.M.A. monomer attacks some disposable syringes (e.g., those made of polymethylmethacrylate and of polystyrene), and the effect, if any, of such plastic dissolved in the monomer of implanted P.M.M.A. bone cement is unknown. The report recommends that all-glass syringes should be used for drawing up the monomer from the ampoules, and that materials which are acceptable foi syringes, mixing bowls, and blades used in the preparation of the cement mixture should be specified in the manufacturer’s instructions. Blood-pressure changes in T.H.R.s seem to be asso-
with the use of cement for the femoral than with its use for the acetabular comprosthesis ponent. In T.K.R.S, this is true only when a prosthesis with an intramedullary stem is used. The report also comments upon the absence of any reports of cardiovascular reactions associated with the use of P.M.M.A. cement polymerised in situ by faciomaxillary surgeons.75 The pathogenesis of adverse cardiovascular reactions during prosthetic replacement with cement is being further investigated in at least three centres in the U.K. As regards prophylaxis, the report draws attention to Charnley’s recommendation for the correct handling of the cement and its insertion at the proper time 4.32 (together with a comment on this recommendation 11); and the need for careful monitoring and readiness for immediate resuscitation of elderly patients with transcervical fracture of the femur undergoing T.P.R.F.H. with cement and of patients undergoing T.K.R. with stemmed prostheses fixed with cement. The report recommends that evaluation of the cardiovascular effects of sucking out the marrow 60 and of venting the shaft by a drill hole 65 in the cortical bone, which may minimise the raised intramedullary pressure created by inserting the stem of a prosthesis into cement at the end of the long bone,9.41,53 should be considered. It also recommends prospective study by pre and post opcrative skin testing to establish the possible role of development of specific hypersensitivity to P.M.M.A. bone cement or its components. Dandy suggested that it is probably safer not to use acrylic cement to secure femoral prostheses in patients with subcapital fractures of the femur." However, there do seem to be advantages of using T.P.R.F.H. with cement rather than a Moore’s prosthesis without cement for such patients.78-80 Additionally, it has been suggested that cement should rarely, if ever, be used for T.H.R. in those patients in whom acute cardiovascular changes are poorly tolerated,",’4 but there is no clinical evidence for this.32 The W.P.A.C.O.s. report does, then, substantiate the place now held by acrylic cement in orthopaedic surgery. However, its correct use in orthopaedic operations, and especially in T.P.R.F.H. and T.K.R. and in patients with pre-existing cardiovascular disease, demands careful monitoring, readiness for resuscitation, and, when appropriate, exact replacement of blood-loss. ciated
more
REFERENCES 1.
2. 3. 4.
Acrylic Cement in Orthopædic Surgery. Final report to D.H.S.S. Copies are available free from Department of Health and Social Security, HS2D, Room 1107, Hannibal House, Elephant and Castle, London SE1 6TE. First interim report to D.H.S.S., August, 1971. Second interim report to D.H.S.S., May, 1972. Charnley, J. Acrylic Cement in Orthopædic Surgery. Edinburgh,
Working Party
on
1970.
5. McKee, G. K. W.P.A.C.O.S. first meeting, March 29, 1971. 6. Powell, J. N., McGrath, P. J., Lahiri, S. K., Hill, P. Br. med. J. 7. 8. 9. 10. 11. 12. 13. 14.
1970, iii, 326. Gresham, G. A., Kuczynski, A. ibid. p. 465. Harris, N. H. ibid. p. 523. Burgess, D. M. ibid. p. 588. Hyland, J., Robins, R. H. C. ibid. 1970, iv, 176. Ratliff, A. H. C., Clement, J. A. ibid. 1971, ii, 532. Gresham, G. A., Kuczyhski, A., Rosborough, D. ibid. p. 617. Michelinakis, E., Morgan, R. H., Curtis, P. J. ibid. 1971, iii, 639. Phillips, H., Cole, P. V., Lettin, A. W. F. ibid. p. 460. vide Radford, P. ibid. p. 639.
15.
Schulitz, K. P., Koch, H., Dustmann, H. O. Arch. orthop. Unfallchir. 1971, 71, 307.
1004 16. 17.
Dandy, D. J. Injury, 1971, 3, 85. Thomas, T. A., Sutherland, I. C., Waterhouse, T. D. Anæsthesia, 1971, 26, 298. 18. Cohen, C. A., Smith, T. C. Anesthesiology, 1971, 35, 547. 19. Newens, A. F., Volz, R. G. ibid. 1972, 36, 298. 20. Kepes, E. R., Underwood, P. S., Becsey, L. J. Am. med. Ass. 1972, 222, 576. 21. Rosborough, D. Br. med. J. 1972, ii, 528. 22. Zichner, L. Helv. chir. Acta, 1972, 39, 717. 23. Kirwan, W. O. Ir. J. med. Sci. 1973, 142, 342. 24. Milne, I. S. Anæsthesia, 1973, 28, 538. 25. Modig, J., Olerud, S., Malmberg, P. Acta anæsth. scand. 1973, 17, 276. intens. Care, 1973, 1, 244. 26. Nice, E. J. M. 27. Angelis, J. De, Jacques, K. Anesth. Analg. curr. Res. 1973, 52, 298. 28. Nicholson, M. J. ibid. p. 299. 29. Frost, P. M. Br. med. J. 1970, iii, 524. 30. Ling, R. S. M., James, M. L. ibid. 1971, ii, 404. 31. James, M. L., Ling, R. S. M. ibid. 1971, iii, 474. 32. Brittain, G. J. C., Ryan, D. J. ibid. 1972, iv, 667. 33. Cadle, D., James, M. L., Ling, R. S. M., Piper, R. F., Pryer, D. L., Wilmshurst, C. C. ibid. p. 107. 34. Ling, R. S. M. J. Bone Jt Surg. 1972, 54B, 760. 35. Hughes, J. D., Convery, F. R., Drucker, J. P. Am. Rev. resp. Dis. 1972, 105, 974. 36. Hulands, G. H., Gregory, I. C. Personal communication. 37. Fearn, C. B. D’A., Burbridge, H. C., Bentley, G. J. Bone Jt Surg. 1973, 55B, 210. 38. Phillips, H., Lettin, A. W. F., Cole, P. V. ibid. p. 210. 39. Hallin, G., Modig, J., Nordgren, L., Olerud, S. Upsala J. med. Sci. 1974, 79, 51. 40. Modig, J., Busch, C., Olerud, S., Saldeen, T. Acta anæsth. scand. 1974, 18, 133. 41. Tronzo, R. G., Kallos, T., Wyche, M. Q. J. Bone Jt Surg. 1973, 55A, 1316; ibid. 1974, 56A, 714. 42. Homsy, C. A., Tulles, H. S., King, J. W. J. Bone Jt Surg. 1969, 51A, 805; Clin. Orthop. 1969, 67, 169. 43. Homsy, C. A., Tullos, H. S., Anderson, M. S., Diferrante, N. M., King, J. W. Clin. Orthop. 1972, 83, 317. 44. Peebles, D. J., Ellis, R. H., Stride, S. D. K., Simpson, B. R. J. Br. med. J. 1972, i, 349. 45. Dustmann, H. O., Schulitz, K. P., Koch, H. Arch. orthop. Unfallchir. 1972, 72, 114. 46. Ellis, R. H., Mulvein, J. Br. med. J. 1972, ii, 528; Anesthesiology, 1973, 38, 102; J. Bone Jt Surg. 1974, 56B, 59. 47. Pelling, D., Butterworth, K. R. Br. med. J. 1973, ii, 638. 48. McLaughlin, R. E., DiFazio, C. A., Hakala, M., Abbott, B., MacPhail, J. A., Mack, W. P., Sweet, D. E. J. Bone Jt Surg. 1973, 55A, 1621. 49. Scales, J. T. W.P.A.C.O.S. first meeting, March 29, 1971. 50. Sevitt, S. ibid. 51. Bain, A. M., Robson, P. N. Letter to W.P.A.C.O.S. second meeting, June 21, 1971. 52. May, J. M. B. Personal communication. 53. Sevitt, S. Br. med. J. 1972, ii, 257. 54. Arden, G. P. J. Bone Jt Surg. 1971, 53B, 150. 55. Arden, G. P., Kamdar, B. A. in Conference on Total Knee Replacement; p. 118. Institution of Mechanical Engineers, 1 Birdcage Walk, London, Sept. 16-18, 1974. 56. Adams, J. H., Graham, D. I., Mills, E., Sprunt, T. G. Br. med. J. 1972, iii, 740. 57. Coventry, M. B. J. Am. med. Ass. 1973, 223, 442. 58. Laing, P. G. Anesth. Analg. curr. Res. 1973, 52, 999. 59. Charnley, J., Murphy, J. C. M., Pitkeathly, D. A. Br. med. J. 1971, iii, 474. 60. Fowler, A. W. ibid. 1972, iv, 108. 61. Modig, J., Olerud, S., Malmberg, P., Busch, C. Injury, 1973, 5, 161. 62. Herndon, J. H., Bechtol, C. O., Crickenberger, D. P. J. Bone Jt Surg. 1974, 56A, 850. 63. James, M. L. Visit to Exeter by W.P.A.C.O.S., Oct. 19, 1971, reported at third meeting Jan. 17, 1972. 64. Hulliger, L. Arch. orthop. Unfallchir. 1962, 54, 581. 65. Glen, E. S. Br. med. J. 1970, iii, 523. 66. Parsons, D. W. ibid. p. 710. 67. Ohnsorge, J. J. Bone Jt Surg. 1971, 53B, 758. 68. Cohen, C. A., Kallos, T. J. Am. med. Ass. 1972, 219, 757. 69. Calnan, J. S. Letter to W.P.A.C.O.S., April 25, 1973. 70. Vandwater, S. L. Anesth. Analg. curr. Res. 1973, 52, 1000. 71. Nicholson, M. J. ibid. p. 1001. 72. Angelis, J. De, ibid. p. 1002. 73. O’Malley, K., Crooks, J., Duke, E., Stevenson, I. H. Br. med. J. 1971, iii, 607. 74. Dandy, D. J. Personal communication. 75. Nesling, A. E. Visit to Plymouth by W.P.A.C.O.S., April 5, 1972. 76. Ellis, R. H. Br. med. J. 1973, i, 236. 77. Dandy, D. J. Injury, 1973, 5, 169. 78. Follacci, F. M., Charnley, J. Clin. Orthop. 1969, 62, 156. 79. Durbin, F. C., Jeffery, C. C., Blundell Jones, G., Ling, R. S. M., Scott, P. J., Woodyard, J. E., Wrighton, J. D. Br. med. J. 1970, iv, 176. 80. Wrighton, J. D., Woodyard, J. E. Injury, 1971, 2, 287.
Talking Politics JOSEPH IN BIRMINGHAM THE ironic thing about Sir Keith Joseph’s Birmingham speech last weekend, which, with its reference to the threat to " our human stock ", has imperilled his chances of winning the Tory succession, is that he himself clearly saw it as a straightforward development of themes he had started to put forward during his largely uncontroversial term as Secretary of State for Social Services. It is indeed his success in that Department which has led to his being considered as a possible leader at all. Even a year ago, when he had a spectacular ovation at the Party conference, he had not looked to be a front-runner. But an astonishing change has come over the Conservative Party since then. Mr Whitelaw, then wrestling with Northern Ireland and the universal cynosure of affection and respect, is now judged to be dangerously wordy and alarmingly insubstantial in dealing with economic issues. Mr Barber, after the collapse of his economic strategy, has disappeared altogether. Sir Keith had no part in the economic strategy : instead he worked with great dedication and, it is generally thought, with considerable success, at his departmental tasks. Moreover, he became identified as a man of compassion, and that has helped to recruit the support of the Left of the Conservative Party, who might otherwise have been disturbed by the laissez-faire economic teachings, the austere emphasis on thrift and self-reliance, and, latterly, the stem monetary doctrines which have so endeared Sir Keith to the Right. It was Sir Keith, after all, who time and again disappointed Conservative conferences by refusing to cut benefits for the families of strikers : " this conference would be the first to howl," he said last year, " if we really did have pictures on television of children going hungry for lack of benefit." And he pointed out, courteously but insistently, that the widespread belief among the rank and file that the social services were being battened on by vast armies of scroungers " I think this conwas not supported by the facts : ference ought to face the fact that there are large numbers of people who are not employable, who cannot manage their own lives effectively enough to hold down ajob." It was this concern, this preoccupation with " people who cannot manage their own lives effectively," which caused Sir Keith to develop, as Secretary of " State, the theme of a cycle of deprivation," in which people who were born in poverty and social inadequacy and who failed to climb out of it became the parents of subsequent generations in which their problems were faithfully repeated and multiplied. The other theme running through his speeches on the cycle of deprivation was that of the family as the basically most important and health-giving unit in society-something to which Sir Keith’s Jewish background and his own family life have also clearly contributed. He is fully justified in arguing, as he did in the midst of the turmoil over the speech he delivered last weekend, that the central message of the Birmingham speech is SIR KEITH
1949-51 (table i) coincided with an increased supply of fibre-free energy foods, sugar, fat, and increased energy supplies, while at the same time the fibre content of the National flour decreased. There is only one conclusion and it is basic to medical statistics. "The exclusion of observations from the tabulated series on any ground whatever must be stated, the criteria upon which exclusion was determined clearly set out and usually the number of exclusions stated " 33 Fibre has been excluded, inadequately defined,23 and inaccurately estimated 34 I thank Mrs Priscilla Milton for secretarial assistance. This out with the aid of a grant from the British Heart Foundation.
investigation has been carried
REFERENCES 1.
Marks, H. H. in Joslin’s Diabetes Mellitus (edited by A. Marble, P. White, R. F. Bradley, and L. P. Krall); p. 234. Philadelphia, 1971.
Stocks, P. J. Hyg. Camb. 1944, 43, 242. Registrar General’s Statistical Review of England and Wales 1938 and 1939; Text, p. 97. H.M. Stationery Office, 1947. 4. Registrar General’s Statistical Review of England and Wales 1940 1945; Text, vol. I, p. 187. H.M. Stationery Office, 1949. 5. Registrar General’s Statistical Review of England and Wales, 1940 1954; part I, tables, medical, tables 1 and 21. H.M. Stationery
2. 3.
Office, 1945-56. 6.
Registrar General’s Statistical Review of England and Wales for 1942-57; table 8 or 9 and part 2, Text, for 1940-45, and vol. I, Medical, p. 6. H.M. Stationery Office, 1946-53.
Special Article ACRYLIC CEMENT AND THE
CARDIOVASCULAR SYSTEM THE final report of the Working Party on Acrylic Cement in Orthopaedic Surgery (W.P.A.C.O.S.)* has been accepted by the Standing Medical Advisory Committee of the Department of Health and Social Security (D.H.S.S.).1 This working-party was set up in 1971 to examine the cardiovascular toxicity of acrylic cement and to assess the carcinogenic potential of the material. Subsequently, after an interim terms of the reference of the working-party report,2 were extended to include an assessment of the effect of cement on wound infection, and more specifically of the necessity for providing ultra-clean ventilating systems in operating-rooms for major prosthetic orthopaedic surgery 3; this is now the subject of a Medical Research Council working-party. Four working groups were set up by the W.P.A.C.O.S. to examine: the cement and its components; the cement and wound infection; the cement and hypotension and cardiac arrest; and the cement and tissue reactions. All the working groups restricted their attention to cement of British manufacture-namely, ’CMW’ andSimplex ’ products.t Members of W.P.A.C.O.S.: Prof. R. G. BURWELL (chairman); Dr C. N. DENNIS (convener); Dr A. F. Ross (secretary); Dr J. M. BARNES; Prof. R. BARNES; Prof. M. BRADEN; Prof. C. D. CALNAN; Prof. J. CHARNLEY; Dr P. V. COLE; Mr R. W. H. COOK; Mr M. A. R. FREEMAN; Dr P. GpAsso; Dr 0. M. LIDWELL; Mr R. S. M. LING; Dr E. J. L. LOWBURY; Prof. P. N. MAGEE; Mr G. K. McKEE ; Dr J. F. NUNN; Prof. J. T. SCALES; Dr S. SEVITT; Prof. D. W. STRAUGHAN; Dr R. Y. FORBES (Welsh Office); Dr N. LEITCH; Dr H. MILLER (Scottish Home and Health Department). t CMW bone cement marketed by CMW Laboratories Ltd., Bone Cement Division, Clifton Road, Blackpool FY4 4QF. Simplex bone cement marketed by North Hill Plastics Ltd., 49 Grayling Road, London N16 OBP. Each commercial product consists of a powder (including the polymer P.M.M.A.) and a liquid (including M.M.A. monomer) which are mixed immediately before use.
*
7.
Registrar General’s Statistical Review of England and Wales for 1958-70; part I, tables, medical, table 10. H.M. Stationery Office,
8.
Ministry of Agriculture, Fisheries and Food. Board Trade J. 1968, 194, 753. McCance, R. A., Widdowson, E. M. Spec. Rep. Ser. med. Res. Coun.
1960-72.
9.
1960, no. 297. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25.
26. 27. 28.
29. 30.
31. 32. 33. 34.
Trowell, H. Proc. Nutr. Soc. 1973, 32, 150. Trowell, H. Plant Foods Man, 1974, 1, 91. Himsworth, H. P. Proc. R. Soc. Med. 1949, 42, 323. Cleave, T. L. The Saccharine Disease; p. 80. Bristol, 1974. Hill, A. B. Principles of Medical Statistics; p. 203. London, 1971. Malins, J. Clinical Diabetes; pp. 54, 68. London, 1968. Pyke, D. A. Postgrad. med. J. 1969, 45, 796. Malins, J. Clinical Diabetes; p. 466. London, 1968. Malins, J. ibid. p. 469. Malins, J. ibid. p. 470. Malins, J. ibid. p. 473. Malins, J. ibid. pp. 473-4. Trowell, H. Plant Foods Man (in the press). Trowell, H. Lancet, 1974, 1, 503. Coleman, D. L., Hummel, D. L. Diabetologia, 1967, 3, 328. Kramer, M. W., Liberman, D. F., Soeldner, J. S., Gleason, R. E. ibid. 1969, 5, 353. Gleason, R. E., Lauris, V., Soeldner, J. S. ibid. 1967, 3, 175. Haines, H. B., Hackel, D. B., Schmidt, K. Am. J. Physiol. 1965, 208, 297. Hackel, D. B., Lebovitz, H. E., Frohman, L. A., Mihat, E., SchmidtNielsen, K. Metabolism, 1967, 16, 1133. Hackel, D. B., Frohman, L. A., Mihat, E. Diabetes, 1966, 15, 105. Like, A. A., Jones, E. E. Diabetologia, 1967, 3, 179. Miki, E., Like, A. A., Steinke, J., Soeldner, J. S. ibid. p. 135. Hamilton, C. L., Kuo, P. T., Feng, L. Y. Proc. Soc, exp. Biol. Med. 1972, 140, 1005. Hill, A. B. Principles of Medical Statistics; p. 69. London, 1971. Van Soest, P. J., McQueen, R. W. Proc. Nutr. Soc. 1973, 32, 123.
Charnley reported that in some 3700 total hip replacements (T.H.R.S) over ten years, using two doses of acrylic or polymethacrylate (P.M.M.A.) cement in most patients, there were only 4 patients with a cardiac arrest on the operating-table, 2 of whom died.’4 McKee reported one cardiac arrest among 600 T.H.R.s shortly after inserting the cementHowever, in 1970 there were several clinical reports of acute cardiovascular insufficiency, cardiac arrest, and death associated with the use of P.M.M.A. bone cement in orthopaedic surgical operations,6-10 and these reports were followed by still more.1l-28 There have been further studies of blood-pressure (and other) recordings in patients undergoing orthopxdic surgery involving the use of P.M.M.A. bone cement,2,9-41 and of M.M.A. monomer in man and animals 42-i.e., using implanted polymerising P.M.M.A. bone cement and the injected liquid component of the cement and pure M.M.A.
monomer.43-48
After
reviewing published reports and privately reported case-histories,452 the W.P.A.C.O.S. report concludes that
undertaken for arthritis and using P.M.M.A. bone cement is not associated with any greater risk of cardiac arrest than any other type T.H.R.
of
major surgery in patients of similar age. However, most of the adverse cardiovascular reactions occurred with Thompson’s prosthetic replacement of femoral head (T.P.R.F.H.), with cement for transcervical fracture of the femur. Acute cardiovascular insufficiency developed in 18 patients during the operation; 13 of these were reported to have had cardiac arrest, which was confirmed by electrocardiogram in 3; 7 of the patients were resuscitated; 9 died preoperatively and 2 after temporary resuscitation. Necropsy revealed fat embolism in 5 patients, 7,9,12,16 widespread fat and marrow emboli in 2,14,20 and pulmonary thromboembolism in 1 patient." 3 more patients had disturbances of consciousness
1003 after the operation was completed and died within thirty-six hours, death being attributed to fat embolism.ï,12 In view of these clinical reports and the absence of sufficiently large numbers of patients to establish the incidence of acute cardiovascular insufficiency after T.P.R.F.H., Sevitt, on behalf of W.P.A.C.O.S. undertook a retrospective review of fat He embolism in patients with fractured hips 53 reported 4 deaths from fat embolism in 88 subjects who had undergone T.P.R.F.H. using cement, and concluded that fat embolism accounted for all the deaths within seven days of Thompson’s arthroplasty. Cardiac arrest on removing the tourniquet after total knee replacement (T.K.R.) involving prostheses with intramedullary stems and P.M.M.A. bone cement has been reported in one or more patients.8 There was a sudden fall in arterial blood-pressure thirty seconds after impaction of the femoral component in another patient.24 W.P.A.C.O.S. heard of 8 more patients who had had cardiac arrest or had not regained consciousness soon after completion of a T.K.R.; 4 of these patients died, apparently from fat embolism .111-12 Arden reported a death from fat embolism and a death from pulmonary embolism in a series of 81 T.K.R.S,54 and in a subsequent review of 193 Shiers T.K.R.S he reported fat embolism in 2 patients.55 In another who five after died a T.K.R. yet patient, days without regaining consciousness, fat embolism and boundary-zone cerebral and cerebellar infarction were found at necropsy; the brain infarcts were attributed to postoperative hypotension and not to fat embolism.56 Most, if not all, of these patients undergoing T.K.R. had rheumatoid arthritis. The report examines the possible aetiology of the hypotension and the cardiac arrests, and includes a consideration of vasodilatation caused by M.M.A. monomer absorbed from the site of the prosthetic replacement,6,42,45,57,s8 fat embolism/,9,12,53,59-62 pharmacologically active substances,63 such as vasoactive amines, kinins, and prostaglandins released from tissues as a result of cytotoxicity 64 and/or exotherm,4.42 raised and hypersensiintramedullary pressure,38-41,6:>-68 tivity.4,69 The report concludes that in the present state of ignorance of the pathogenesis of acute cardiovascular insufficiency during T.P.R.F.H., it would be prudent to consider whether the factors involved insoon
clude cement,
marrow
fat, osteoporosis, anaesthetic
agents and other drugs,70-72 hypoxaemia, hypersensitivity, chronic cardiovascular disease, age, and sex.’3 Also thromboplastic elements may possibly cause platelet aggregation and fibrin deposition as microemboli in the lungs 25e° There is no evidence to implicate nervous reflexes; air embolism twas found at necropsy in one patient." H M.M.A. monomer attacks some disposable syringes (e.g., those made of polymethylmethacrylate and of polystyrene), and the effect, if any, of such plastic dissolved in the monomer of implanted P.M.M.A. bone cement is unknown. The report recommends that all-glass syringes should be used for drawing up the monomer from the ampoules, and that materials which are acceptable foi syringes, mixing bowls, and blades used in the preparation of the cement mixture should be specified in the manufacturer’s instructions. Blood-pressure changes in T.H.R.s seem to be asso-
with the use of cement for the femoral than with its use for the acetabular comprosthesis ponent. In T.K.R.S, this is true only when a prosthesis with an intramedullary stem is used. The report also comments upon the absence of any reports of cardiovascular reactions associated with the use of P.M.M.A. cement polymerised in situ by faciomaxillary surgeons.75 The pathogenesis of adverse cardiovascular reactions during prosthetic replacement with cement is being further investigated in at least three centres in the U.K. As regards prophylaxis, the report draws attention to Charnley’s recommendation for the correct handling of the cement and its insertion at the proper time 4.32 (together with a comment on this recommendation 11); and the need for careful monitoring and readiness for immediate resuscitation of elderly patients with transcervical fracture of the femur undergoing T.P.R.F.H. with cement and of patients undergoing T.K.R. with stemmed prostheses fixed with cement. The report recommends that evaluation of the cardiovascular effects of sucking out the marrow 60 and of venting the shaft by a drill hole 65 in the cortical bone, which may minimise the raised intramedullary pressure created by inserting the stem of a prosthesis into cement at the end of the long bone,9.41,53 should be considered. It also recommends prospective study by pre and post opcrative skin testing to establish the possible role of development of specific hypersensitivity to P.M.M.A. bone cement or its components. Dandy suggested that it is probably safer not to use acrylic cement to secure femoral prostheses in patients with subcapital fractures of the femur." However, there do seem to be advantages of using T.P.R.F.H. with cement rather than a Moore’s prosthesis without cement for such patients.78-80 Additionally, it has been suggested that cement should rarely, if ever, be used for T.H.R. in those patients in whom acute cardiovascular changes are poorly tolerated,",’4 but there is no clinical evidence for this.32 The W.P.A.C.O.s. report does, then, substantiate the place now held by acrylic cement in orthopaedic surgery. However, its correct use in orthopaedic operations, and especially in T.P.R.F.H. and T.K.R. and in patients with pre-existing cardiovascular disease, demands careful monitoring, readiness for resuscitation, and, when appropriate, exact replacement of blood-loss. ciated
more
REFERENCES 1.
2. 3. 4.
Acrylic Cement in Orthopædic Surgery. Final report to D.H.S.S. Copies are available free from Department of Health and Social Security, HS2D, Room 1107, Hannibal House, Elephant and Castle, London SE1 6TE. First interim report to D.H.S.S., August, 1971. Second interim report to D.H.S.S., May, 1972. Charnley, J. Acrylic Cement in Orthopædic Surgery. Edinburgh,
Working Party
on
1970.
5. McKee, G. K. W.P.A.C.O.S. first meeting, March 29, 1971. 6. Powell, J. N., McGrath, P. J., Lahiri, S. K., Hill, P. Br. med. J. 7. 8. 9. 10. 11. 12. 13. 14.
1970, iii, 326. Gresham, G. A., Kuczynski, A. ibid. p. 465. Harris, N. H. ibid. p. 523. Burgess, D. M. ibid. p. 588. Hyland, J., Robins, R. H. C. ibid. 1970, iv, 176. Ratliff, A. H. C., Clement, J. A. ibid. 1971, ii, 532. Gresham, G. A., Kuczyhski, A., Rosborough, D. ibid. p. 617. Michelinakis, E., Morgan, R. H., Curtis, P. J. ibid. 1971, iii, 639. Phillips, H., Cole, P. V., Lettin, A. W. F. ibid. p. 460. vide Radford, P. ibid. p. 639.
15.
Schulitz, K. P., Koch, H., Dustmann, H. O. Arch. orthop. Unfallchir. 1971, 71, 307.
1004 16. 17.
Dandy, D. J. Injury, 1971, 3, 85. Thomas, T. A., Sutherland, I. C., Waterhouse, T. D. Anæsthesia, 1971, 26, 298. 18. Cohen, C. A., Smith, T. C. Anesthesiology, 1971, 35, 547. 19. Newens, A. F., Volz, R. G. ibid. 1972, 36, 298. 20. Kepes, E. R., Underwood, P. S., Becsey, L. J. Am. med. Ass. 1972, 222, 576. 21. Rosborough, D. Br. med. J. 1972, ii, 528. 22. Zichner, L. Helv. chir. Acta, 1972, 39, 717. 23. Kirwan, W. O. Ir. J. med. Sci. 1973, 142, 342. 24. Milne, I. S. Anæsthesia, 1973, 28, 538. 25. Modig, J., Olerud, S., Malmberg, P. Acta anæsth. scand. 1973, 17, 276. intens. Care, 1973, 1, 244. 26. Nice, E. J. M. 27. Angelis, J. De, Jacques, K. Anesth. Analg. curr. Res. 1973, 52, 298. 28. Nicholson, M. J. ibid. p. 299. 29. Frost, P. M. Br. med. J. 1970, iii, 524. 30. Ling, R. S. M., James, M. L. ibid. 1971, ii, 404. 31. James, M. L., Ling, R. S. M. ibid. 1971, iii, 474. 32. Brittain, G. J. C., Ryan, D. J. ibid. 1972, iv, 667. 33. Cadle, D., James, M. L., Ling, R. S. M., Piper, R. F., Pryer, D. L., Wilmshurst, C. C. ibid. p. 107. 34. Ling, R. S. M. J. Bone Jt Surg. 1972, 54B, 760. 35. Hughes, J. D., Convery, F. R., Drucker, J. P. Am. Rev. resp. Dis. 1972, 105, 974. 36. Hulands, G. H., Gregory, I. C. Personal communication. 37. Fearn, C. B. D’A., Burbridge, H. C., Bentley, G. J. Bone Jt Surg. 1973, 55B, 210. 38. Phillips, H., Lettin, A. W. F., Cole, P. V. ibid. p. 210. 39. Hallin, G., Modig, J., Nordgren, L., Olerud, S. Upsala J. med. Sci. 1974, 79, 51. 40. Modig, J., Busch, C., Olerud, S., Saldeen, T. Acta anæsth. scand. 1974, 18, 133. 41. Tronzo, R. G., Kallos, T., Wyche, M. Q. J. Bone Jt Surg. 1973, 55A, 1316; ibid. 1974, 56A, 714. 42. Homsy, C. A., Tulles, H. S., King, J. W. J. Bone Jt Surg. 1969, 51A, 805; Clin. Orthop. 1969, 67, 169. 43. Homsy, C. A., Tullos, H. S., Anderson, M. S., Diferrante, N. M., King, J. W. Clin. Orthop. 1972, 83, 317. 44. Peebles, D. J., Ellis, R. H., Stride, S. D. K., Simpson, B. R. J. Br. med. J. 1972, i, 349. 45. Dustmann, H. O., Schulitz, K. P., Koch, H. Arch. orthop. Unfallchir. 1972, 72, 114. 46. Ellis, R. H., Mulvein, J. Br. med. J. 1972, ii, 528; Anesthesiology, 1973, 38, 102; J. Bone Jt Surg. 1974, 56B, 59. 47. Pelling, D., Butterworth, K. R. Br. med. J. 1973, ii, 638. 48. McLaughlin, R. E., DiFazio, C. A., Hakala, M., Abbott, B., MacPhail, J. A., Mack, W. P., Sweet, D. E. J. Bone Jt Surg. 1973, 55A, 1621. 49. Scales, J. T. W.P.A.C.O.S. first meeting, March 29, 1971. 50. Sevitt, S. ibid. 51. Bain, A. M., Robson, P. N. Letter to W.P.A.C.O.S. second meeting, June 21, 1971. 52. May, J. M. B. Personal communication. 53. Sevitt, S. Br. med. J. 1972, ii, 257. 54. Arden, G. P. J. Bone Jt Surg. 1971, 53B, 150. 55. Arden, G. P., Kamdar, B. A. in Conference on Total Knee Replacement; p. 118. Institution of Mechanical Engineers, 1 Birdcage Walk, London, Sept. 16-18, 1974. 56. Adams, J. H., Graham, D. I., Mills, E., Sprunt, T. G. Br. med. J. 1972, iii, 740. 57. Coventry, M. B. J. Am. med. Ass. 1973, 223, 442. 58. Laing, P. G. Anesth. Analg. curr. Res. 1973, 52, 999. 59. Charnley, J., Murphy, J. C. M., Pitkeathly, D. A. Br. med. J. 1971, iii, 474. 60. Fowler, A. W. ibid. 1972, iv, 108. 61. Modig, J., Olerud, S., Malmberg, P., Busch, C. Injury, 1973, 5, 161. 62. Herndon, J. H., Bechtol, C. O., Crickenberger, D. P. J. Bone Jt Surg. 1974, 56A, 850. 63. James, M. L. Visit to Exeter by W.P.A.C.O.S., Oct. 19, 1971, reported at third meeting Jan. 17, 1972. 64. Hulliger, L. Arch. orthop. Unfallchir. 1962, 54, 581. 65. Glen, E. S. Br. med. J. 1970, iii, 523. 66. Parsons, D. W. ibid. p. 710. 67. Ohnsorge, J. J. Bone Jt Surg. 1971, 53B, 758. 68. Cohen, C. A., Kallos, T. J. Am. med. Ass. 1972, 219, 757. 69. Calnan, J. S. Letter to W.P.A.C.O.S., April 25, 1973. 70. Vandwater, S. L. Anesth. Analg. curr. Res. 1973, 52, 1000. 71. Nicholson, M. J. ibid. p. 1001. 72. Angelis, J. De, ibid. p. 1002. 73. O’Malley, K., Crooks, J., Duke, E., Stevenson, I. H. Br. med. J. 1971, iii, 607. 74. Dandy, D. J. Personal communication. 75. Nesling, A. E. Visit to Plymouth by W.P.A.C.O.S., April 5, 1972. 76. Ellis, R. H. Br. med. J. 1973, i, 236. 77. Dandy, D. J. Injury, 1973, 5, 169. 78. Follacci, F. M., Charnley, J. Clin. Orthop. 1969, 62, 156. 79. Durbin, F. C., Jeffery, C. C., Blundell Jones, G., Ling, R. S. M., Scott, P. J., Woodyard, J. E., Wrighton, J. D. Br. med. J. 1970, iv, 176. 80. Wrighton, J. D., Woodyard, J. E. Injury, 1971, 2, 287.
Talking Politics JOSEPH IN BIRMINGHAM THE ironic thing about Sir Keith Joseph’s Birmingham speech last weekend, which, with its reference to the threat to " our human stock ", has imperilled his chances of winning the Tory succession, is that he himself clearly saw it as a straightforward development of themes he had started to put forward during his largely uncontroversial term as Secretary of State for Social Services. It is indeed his success in that Department which has led to his being considered as a possible leader at all. Even a year ago, when he had a spectacular ovation at the Party conference, he had not looked to be a front-runner. But an astonishing change has come over the Conservative Party since then. Mr Whitelaw, then wrestling with Northern Ireland and the universal cynosure of affection and respect, is now judged to be dangerously wordy and alarmingly insubstantial in dealing with economic issues. Mr Barber, after the collapse of his economic strategy, has disappeared altogether. Sir Keith had no part in the economic strategy : instead he worked with great dedication and, it is generally thought, with considerable success, at his departmental tasks. Moreover, he became identified as a man of compassion, and that has helped to recruit the support of the Left of the Conservative Party, who might otherwise have been disturbed by the laissez-faire economic teachings, the austere emphasis on thrift and self-reliance, and, latterly, the stem monetary doctrines which have so endeared Sir Keith to the Right. It was Sir Keith, after all, who time and again disappointed Conservative conferences by refusing to cut benefits for the families of strikers : " this conference would be the first to howl," he said last year, " if we really did have pictures on television of children going hungry for lack of benefit." And he pointed out, courteously but insistently, that the widespread belief among the rank and file that the social services were being battened on by vast armies of scroungers " I think this conwas not supported by the facts : ference ought to face the fact that there are large numbers of people who are not employable, who cannot manage their own lives effectively enough to hold down ajob." It was this concern, this preoccupation with " people who cannot manage their own lives effectively," which caused Sir Keith to develop, as Secretary of " State, the theme of a cycle of deprivation," in which people who were born in poverty and social inadequacy and who failed to climb out of it became the parents of subsequent generations in which their problems were faithfully repeated and multiplied. The other theme running through his speeches on the cycle of deprivation was that of the family as the basically most important and health-giving unit in society-something to which Sir Keith’s Jewish background and his own family life have also clearly contributed. He is fully justified in arguing, as he did in the midst of the turmoil over the speech he delivered last weekend, that the central message of the Birmingham speech is SIR KEITH