Do Cosmetic Surgeons Consider Estrogen-Containing Drugs to Be of Significant Risk in the Development of Thromboembolism?

June 11, 2018 | Author: Sanjiv Dhital | Category: Documents


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Aesth Plast Surg (2008) 32:743–747 DOI 10.1007/s00266-008-9156-4

ORIGINAL ARTICLE

Do Cosmetic Surgeons Consider Estrogen-Containing Drugs to Be of Significant Risk in the Development of Thromboembolism? R. L. Johnson Æ S. J. Hemington-Gorse Æ S. K. Dhital

Received: 2 January 2008 / Accepted: 17 January 2008 / Published online: 30 April 2008 Ó Springer Science+Business Media, LLC 2008

Abstract Background Well-documented evidence shows that estrogen increases the risk of deep vein thrombosis (DVT), and that the effects of DVT are compounded by the stress of surgery and an anesthetic. Methods This study sought to determine the current views and practice of plastic surgeons regarding combined oral contraceptive and surgery. In the United Kingdom, 285 consultant plastic surgeons were identified, and postal questionnaires were distributed to each surgeon. Results Of 286 postal questionnaires distributed to consultant plastic surgeons, 53% were returned and analyzed. Most of the surgeons considered combined oral contraceptive and surgery to be a risk factor for DVT, although only 54% discontinued it before surgery. Approximately 50% believed hormone-replacement therapy (HRT) is a risk, but fewer than a one-fourth of surgeons stopped its use before surgery. There was a range of distribution for the length of time HRT was discontinued for surgery. The majority of consultants discontinue HRT use for 5 to 6 weeks before surgery and until full ambulation after surgery. Data retrieved were used to compare documented evidence relating to combined oral contraceptive and surgery and its association with DVT. Conclusion This survey shows that the management of patients taking estrogen-containing medication before plastic surgery varies, and guidelines regarding this should be sought.

R. L. Johnson (&)  S. J. Hemington-Gorse  S. K. Dhital Department of Plastic Surgery, The Countess of Chester Hospital, Liverpool Road, Chester, UK e-mail: [email protected]

Keywords Combined oral contraceptive  Estrogen  Deep vein thrombosis  DVT  Hormone-replacement therapy  HRT

Surgery increases the risk for thromboembolism [9, 17]. Virchow’s triad describes the factors associated with the development of thromboembolism: decreased blood flow, changes in the vessel wall, and changes in blood composition [8]. Anesthesia and postoperative immobility contribute to decreased blood flow, with both pregnancy and combined oral contraceptive changing the composition of blood [3, 17]. Combined oral contraceptive was first marketed as a birth control pill in 1959 [8]. By the early 1960s, the association was made between the use of this pill and an increased risk for deep vein thrombosis (DVT) [4–6, 12]. According to well-documented evidence, the risk of postoperative DVT increases from 0.5% in nonusers to 1% in users of the pill, a twofold increase in risk [3, 12, 13, 15, 18]. Much debate surrounds the risk associated with hormone-replacement therapy (HRT) and thromboembolism. A two- to fourfold increase in risk has been demonstrated [10, 17], but only within the first year of HRT use [1, 7]. The British National Formulary (BNF) advocates that combined oral contraceptive be discontinued 4 to 6 weeks before major operations and leg surgery, and when long postoperative immobilization is anticipated. It is stated that combined oral contraceptive should not be recommenced until 2 weeks after surgery or full ambulation [17]. Regarding HRT, the BNF states that evidence associating an increase in DVT is questionable but continues to list thrombophlebitis and thromboembolic disorders as contraindications to usage [1]. Thus, recommendations

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similar to those for combined oral contraceptive are suggested for HRT [13]. Well-documented evidence shows that estrogen-containing drugs, particularly combined oral contraceptive, are important factors in the development of DVT postoperatively and must be considered at consultation before surgery. As outlined, guidelines exist regarding protocols associated with surgery and estrogen-containing drugs. Because much debate surrounds this subject, in October 2004, we conducted a survey of the current practice among plastic surgeons in the United Kingdom to determine whether the management of estrogen-containing drugs and elective surgery was standardized.

Methods A total of 285 consultant plastic surgeons were identified from the British Association of Plastic Surgery Members handbook. A postal questionnaire (Fig. 1) was distributed to each surgeon with a personally addressed letter explaining the aim of the questionnaire to determine current views and practice regarding estrogen-containing drugs and plastic surgery. A postage-paid return envelope was included. The first question aimed to determine whether surgeons obtained information about the use of estrogen-containing drugs during consultation. The questionnaire continued to establish concerns for the use of HRT and combined oral contraceptive in elective surgery and to determine whether such drugs were discontinued before or after surgery. Questions were asked about procedures considered to be high risk and whether protocols existed to reduce the risk of DVT associated with the use of estrogen-containing drugs.

Aesth Plast Surg (2008) 32:743–747 1. Are patients specifically asked in clinic whether they take any hormonal medication (i.e., combined oral contraceptive pill [COCP], hormone replacement therapy [HRT])? Yes

No

2. Do you consider HRT a risk factor for thromboembolism? Yes

No

3. Do you consider combined oral contraceptive as a risk factor for thromboembolism? Yes

No

4. Do you stop HRT or OCP before surgery? HRT — Yes

HRT — No

OCP — Yes

OCP — No

5. Do you distinguish between progesterone-only OCP and combined OCP? Yes

No

6. If you stop OCP before elective procedure, a. How long before? _________ weeks How long after? _________ weeks

b. For what procedures?

_______________________________________________________________ _______________________________________________________________ ______________

Results From the total number of consultants contacted, 151 completed questionnaires were returned, giving a response rate of 53%. The findings showed that 84% of the consultants specifically asked patients whether they take any hormonal medications, but that only 41% distinguished between the progesterone-only pill and the combined oral contraceptive. The vast majority of plastic surgeons (90%) consider the combined oral contraceptive to be a risk factor for the development of thromboembolism, compared with slightly more than half (52%) who considered HRT to be a risk factor. Despite this, only 54% considered stopping the combined oral contraceptive, and only 20% considered stopping HRT (Table 1, Fig. 2). The highest number of consultants ([30%) discontinued use of combined oral

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7. Do you have a DVT protocol? Yes

No

8. If so, what is your DVT protocol?

_______________________________________________________________ __________

Fig. 1 Questionnaire on estrogen-containing drugs and deep vein thrombosis (DVT) distributed to consultant plastic surgeons

contraceptive 5 to 6 weeks before surgery and commenced it 1 to 2 weeks after surgery or after complete ambulation. Almost 20% of surgeons discontinued combined oral contraceptive 3 to 4 weeks before surgery, with 2% of them stopping it 1 to 2 weeks and 6 weeks before surgery. When recommencing the combined oral contraceptive, 10

Aesth Plast Surg (2008) 32:743–747

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Table 1 Comparing hormone replacement therapy (HRT) and combined oral contraceptive pill (COCP) with regard to risk and discontinuation before surgerya HRT

Table 2 Comparing the differences in the weeks of discontinued combined oral contraceptive pill (COCP) before and after surgerya No. of weeks

Before

After

0

63

81

COCP

A risk

78

136

1–2

4

23

No risk

73

15

3–4

28

14

30 121

82 89

5–6

52

10

[6

4

0

Stopped Continued a

The number of consultants that believe that estrogen-containing drugs are a risk for the development of deep vein thrombosis (DVT) after elective surgical procedures and the number of consultants that discontinue these drugs before surgery

Fig. 2 A graph representing the number of consultants who consider estrogen-containing drugs to be a risk for the development of deep vein thrombosis (DVT) and the number who discontinue the drugs before elective plastic surgery

to 15% of the consultants omitted it for a further 3 to 6 weeks after surgery (Table 2, Fig. 3). When asked to comment on the procedures for which combined oral contraceptive is discontinued, several consultants believed that it should be stopped for all general anesthetic procedures. The majority omitted combined oral contraceptive for general anesthesia lasting longer than 1 h, whereas many stopped it only before major operations including major lower limb surgery, abdominoplasty, and breast reduction.

Discussion The first case in which DVT was linked with combined oral contraceptive was described in 1961 [8, 12]. Evidence shows that estrogen increases the biologic activity of procoagulant

a

The number of weeks that consultants discontinue estrogen-containing drugs before and after plastic surgery procedures

Fig. 3 A graph representing the number of weeks that drugs containing estrogen are discontinued before and after elective plastic surgery

factors including factors 2, 7, 10, and 12 as well as fibrinogen while decreasing the activity of coagulation inhibitors such as antithrombin 3 and protein S [4, 5, 13]. The synthetic estrogen component of combined oral contraceptive therefore increases the risk of DVT by creating a net increase in enzyme thrombin, thereby altering blood coagulation and fibrinolysis [5, 8, 10, 13]. Studies have shown that prothrombotic changes in the coagulation system directly correlate with estrogen dose [4, 5, 10, 11, 14, 15]. The first-generation pills contained much higher doses of ethinyloestradiol ([50 lg) than the subsequent second- and third-generation pills, which contain less than 35 lg. With lower doses, fewer clotting factors are affected, and thus the risk for DVT is reduced, although not removed [2, 3, 7, 15]. In 1967, it was first reported that the pill increased the risk of DVT threefold. Approximately 15 in 100,000 users of the second-generation pill experienced DVT compared with only 5 in 100,000 nonusers [18]. These figures were corroborated with further studies in 1990 [8].

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Despite the ample evidence to prove that combined oral contraceptive increases the risk for DVT development, 1 in 10 plastic surgeons surveyed still believe that the combined oral contraceptive is not a risk factor. It is documented that within 4 weeks, the potential hemostatic changes that occur during combined oral contraceptive administration have been corrected, thus decreasing the risk for a thromboembolic event to that for the nonuser [13]. Therefore, BNF’s recommendation seems reasonable, which states that for elective operations carrying a significant risk for DVT, the combined oral contraceptive should be discontinued at least 4 weeks before surgery. Only 20% of the surgeons in our survey discontinue the pill as necessary for 3 to 4 weeks. The largest number of consultants actually stop it for a longer period of 5 to 6 weeks. Despite these recommendations, specialist groups have advocated that there is insufficient evidence for discontinuation of the combined oral contraceptive before surgery. Some believe there is a small and poorly qualified increased risk for postoperative DVT with combined oral contraceptive use. This view is believed by 46% of the plastic surgeons who do not discontinue the combined oral contraceptive before surgery. It must be considered that discontinuing combined oral contraceptive may result in an unwanted pregnancy, with surgical and anesthetic risks for the pregnancy and ultimate termination [15, 17]. As is well documented, pregnancy itself increases the risk of DVT development, with quoted figures ranging from 30 to 100 per 100,000 [17, 18]. It is therefore suggested that each patient be considered as an individual. The risks of not stopping the combined oral contraceptive must be balanced against the possibility of an unwanted pregnancy because pregnancy carries a higher risk for DVT [12, 17, 18]. Alternatives to discontinuing the combined oral contraceptive often are considered and include changing to a progesterone-only pill or depo injection 4 weeks before surgery (progesterone poses no increased risk) [13, 17]. If combined oral contraceptive is to be continued, then other thromboprophylaxis must be considered including subcutaneous heparin, graduated elastic stockings, and intermittent pneumatic calf compression. The results from the questionnaire show that many plastic surgery units have set protocols incorporating alternative prophylaxes such as these for procedures considered high risk for the development of DVT. Above all, the patient’s preference must be considered [17] and it must be ensured that an effective alternative contraception is sought [3, 15, 16, 18]. The procedure to be performed must be considered. Even elective cosmetic surgery lasting longer than 1 h for patients older than 40 years automatically carries a

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Aesth Plast Surg (2008) 32:743–747

moderate risk of thromboembolism. Most of the plastic surgeons surveyed discontinue combined oral contraceptive before major surgery. Even so, all other factors predisposing to DVT also must be evaluated, irrespective of the surgery to be performed [9]. Despite similar recommendations with regard to HRT, specialist groups believe there is insufficient evidence to stop HRT preoperatively and that thromboprophylaxis can be used routinely [15, 17]. By continuing HRT, the risks of withdrawal including the recurrence of depressed mood, frequent daytime flushes, and nocturnal sweats are avoided [3, 15, 17]. Only 20% of the plastic surgeons surveyed discontinue HRT before surgery, and the majority do not consider it to be a significant risk for thromboembolism. Several articles have suggested that cosmetic surgeons should ignore the requirement for discontinuing combined oral contraceptive and HRT before surgery. It is claimed that if thromboembolism develops in a patient postoperatively who has not been warned about the implications of continuing estrogen-based drugs, then the surgeon exposes himself to medical malpractice litigation [10]. Evidence demonstrates that ideally, estrogen-containing drugs, particularly combined oral contraceptive, should be stopped 4 weeks before major surgery, lower limb procedures, and operations lasting longer than 1 h [10]. Estrogen alters the ratio of coagulation factors, thereby increasing the risk in a well-documented dose-dependent manner. Based on our findings, we advocate stopping combined oral contraceptive 4 weeks before major plastic surgery such as abdominoplasty and breast reduction, as well as for general anesthesia lasting longer than 1 h and lower limb surgery. Combined oral contraceptive should be recommenced 2 weeks postoperatively or after full ambulation. As an artificial estrogen, HRT must be considered to increase the risk of DVT, although very little evidence exists to support this. Further studies are necessary to determine the risk, but until evidence proves otherwise, HRT must be managed much the same as combined oral contraceptive. Formal guidelines are recommended to enable the audit of combined oral contraceptive and HRT-related DVTs to determine a gold standard for management.

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Aesth Plast Surg (2008) 32:743–747 5. Levi M, Middeldorp S, Buller HR (1999) Oral contraceptives and hormonal replacement therapy cause an imbalance in coagulation and fibrinolysis which may explain the increased risk of venous thromboembolism. Cardiovasc Res 41:21–24 6. Lewis MA (1998) The epidemiology of oral contraceptive use: a critical review of the studies on the oral contraceptives and the health of young women. Am J Obstet Gynecol 179:1086–1098 7. Mammen EF (2000) Combined oral contraceptives and hormonal replacement therapy and thromboembolic disease. Pregnancy Gynecol 14:1045–1059 8. Rosendaal FR (2002) Female hormones and thrombosis. Arterioscler Thromb Vasc Biol 22:201–210 9. Shiffman MA (2000) Guidelines for the prevention of venous thromboembolism. Am J Cosmetic Surg 17:103–105 10. Shiffman MA (2002) Estrogen and thromboembolic problems. Plast Reconstr Surg 110:713–714 11. Shiffman MA (2003) Estrogen and thromboembolic disorders: should patients stop hormones prior to cosmetic surgery? J Women’s Health 12:853–855

747 12. Sue-Ling H, Hughes LE (1988) Should the pill be stopped preoperatively. BMJ 296:447–448 13. Whitehead EM, Whitehead MI (1991) The pill, HRT, and postoperative thromboembolism: cause for concern? Anaesthesia 46:521–522 14. Weiss N (1995) Third-generation oral contraceptives: how risky? Lancet 346:1570 15. Thromboembolic Risk Factors Consensus Group (1992) Risk of and prophylaxis for venous thromboembolism in hospital patients. BMJ 305:567–574 16. Drugs in the peri-operative period: 1. Stopping or continuing drugs around surgery. DTB 37:62–64, 1999 17. Drugs in the peri-operative period: 3. Hormonal contraceptives and hormone replacement therapy. DTB 37:78–80, 1999 18. Prophylaxis of venous thromboembolism: Section 10. Oral contraceptives and hormone replacement therapy. Scottish Intercollegiate Guidelines Network, 2003

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