The physiological changes that occur during pregnancy can be deleterious to women with a cardiovascular condition. Evidence-based contraceptive counseling and provision is essential in this patient population. Although long-acting reversible contraception (LARCs), which include the intrauterine device (IUD) and the etonogestrel contraceptive implant, have been found to be safe and effective in healthy women, there are inadequate data regarding LARC use in patients with cardiovascular conditions. We conducted a retrospective chart review of women diagnosed with cardiovascular disease who had a copper IUD, levonorgestrel-releasing intrauterine system or contraceptive implant placed at the University of Washington Medical Center from 2007 to 2012. We abstracted and analyzed patient demographic characteristics, medical conditions, indications for LARC placement, and complications. The sample included 470 women with cardiovascular conditions. The mean age was 34.6 years. One hundred twenty-four patients (26.11%) were nulligravid and 169 patients (35.58%) were nulliparous. Four hundred ten chose the levonorgestrel-releasing intrauterine system (87.23%), 33 patients (7.02%) opted for the copper IUD, and 23 patients (4.89%) chose the etonogestrel implant. Eighteen patients (3.83%) had a confirmed IUD expulsion, 2 patients (0.43%) became pregnant, and there were 4 cases of pelvic inflammatory disease (0.85%). There were no cases of perforation. There were no confirmed cases of infective endocarditis associated with LARC insertion. In conclusion, LARC devices appear safe with few complications for women with cardiovascular conditions. Clinicians can be reassured that LARC may be offered as an appropriate option when counseling women with cardiovascular disease on safe contraceptive methods.
In patients with cardiovascular conditions, there are limited data regarding the safety and efficacy of long-acting reversible contraception (LARC). This lack of data is evident in the Centers for Disease Control and Prevention United States Medical Eligibility Criteria for Contraceptive Use clinical recommendations: “theoretical concern exists about the effect of levonorgestrel (LNG) on lipids,” and “no direct evidence exists on the safety of IUDs in women with peripartum cardiomyopathy. Limited indirect evidence from noncomparative studies did not demonstrate any cases of arrhythmia or infective endocarditis in women with cardiac disease who used IUDs.” The present study examined the safety and efficacy of LARC use in women with cardiovascular conditions.
Methods
We conducted a retrospective chart review of women previously diagnosed with a cardiac condition who had an LARC device (IUD or contraceptive implant) placed at the University of Washington from January 1, 2007 to March 1, 2012. The University of Washington Institutional Review Board approved the study. Data were both abstracted and extracted from the electronic medical records from the University of Washington Medical Center, Harborview Medical Center, and other University of Washington–affiliated clinics using Microsoft Amalga Unified Intelligence System. Study data were collected and managed using research electronic data capture tools hosted at the University of Washington. We identified subjects using International Classification of Diseases (ICD-9) codes for a wide range of cardiovascular conditions (see Appendix 1 ). We included the following categories of cardiovascular conditions: cardiac arrhythmias, congenital heart disease, heart failure, valvular heart disease, coronary heart disease, pulmonary heart disease, cardiomyopathy, venous and arterial vascular disease, rheumatic heart disease, and hypertensive heart disease. We analyzed patient characteristics, indications, and complications after LARC placement. All analyses were performed in Stata 13.
Results
There were 470 women with cardiovascular conditions who had the LARC device placed during the study period. Baseline patient characteristics, time of LARC device placement, and the type of LARC device chosen are summarized in Table 1 .
| Patient Characteristics (n = 470) | |
|---|---|
| Age, mean±SD (range) years | 34.6±10.9 (16-77) |
| Nulligravid | 123 (26.2%) |
| Nulliparous | 168 (35.7%) |
| Insurance Status | |
| Private | 202 (43.0%) |
| Public | 219 (46.6%) |
| Self-pay | 20 (4.3%) |
| Unknown | 29 (6.2%) |
| Time of Placement | |
| Clinic | 270 (57.5%) |
| Operating Room | 75 (16.0%) |
| Post-partum visit ∗ | 53 (11.3%) |
| Post-partum | 23 (4.9%) |
| Vaginal Delivery † | 12 (60.0%) |
| C-Section † | 8 (40.0%) |
| Post-abortion | 38 (8.1%) |
| Type of LARC ‡ Device | |
| LNG-IUS § | 410 (87.2%) |
| Cu-IUD ¶ | 33 (7.0%) |
| Etonogestrel Implant | 23 (4.9%) |
∗ Postpartum visit indicates LARC placement at a separate visit within 6 weeks of delivery. This is separate from placement immediately after partum.
† IUD only. Excludes etonogestrel implant.
‡ Long-acting reversible contraception.
§ Levonorgestrel intrauterine system.
The most common category of cardiovascular diagnosis was cardiac arrhythmia ( Table 2 ). ICD-9 diagnosis codes included in each category of cardiovascular condition and the frequencies for each are listed in Appendix 1 (Supplementary Materials). Many patients were noted to have more than one cardiovascular diagnosis.
| Category | n |
|---|---|
| Cardiac Arrhythmia | 425 |
| Congenital Heart Disease | 334 |
| Other | 319 |
| Heart Failure | 181 |
| Valvular Heart Disease | 130 |
| Coronary Heart Disease | 129 |
| Cardiac Device | 113 |
| Pulmonary Heart Disease | 110 |
| Cardiomyopathy ∗ | 98 |
| Maternal Cardiovascular Disease † | 71 |
| Venous Disease ‡ | 72 |
| Rheumatic Heart Disease | 66 |
| Arterial Disease § | 25 |
| Hypertensive Heart Disease | 8 |
∗ Cardiomyopathy includes the following diagnoses: hypertrophic obstructive cardiomyopathy, alcoholic cardiomyopathy, primary and secondary cardiomyopathy, and endocardial fibroelastosis.
† Maternal cardiovascular disease includes peripartum cardiomyopathy including antepartum and postpartum conditions, congenital cardiovascular disease of mother antepartum, other cardiovascular diseases of mother complicating pregnancy, and other cardiovascular diseases of mother antepartum.
‡ Venous disease includes venous embolism and thrombosis.
§ Arterial disease includes dissection of the aorta, aortic aneurysm, and arterial dissection.
There were 328 women (69.79%) who had the LARC device placed for contraception. Medical records for 159 women (33.83%) indicated that the LARC device was placed for treatment of dysmenorrhea or abnormal uterine bleeding, including menorrhagia, metrorrhagia, perimenopausal bleeding, and postmenopausal bleeding. Thirty-nine women (8.21%) had LARC placement to treat a gynecologic condition not related to bleeding, including carcinoma of the vulva, polycystic ovary syndrome, endometriosis, uterine polyps, ovarian neoplasm, endometrial hyperplasia, and dysplasia of the cervix. Finally, 2 women chose the LARC method for a reason coded as “Other” in the chart. One experienced migraine headaches related to her menstrual cycle and reported a desire for menstrual suppression. The second opted for an LNG-releasing intrauterine system because she believed that the progestin hormone replacement therapy she was previously using was causing urinary incontinence.
Complications after LARC insertion are summarized in Table 3 . Four women (0.85%) developed pelvic inflammatory disease (PID) or endometritis after IUD insertion. Notably, 2 of these had the IUD inserted immediately after an abortion procedure: one underwent suction dilation and curettage at 14 5/7-week gestation and PID was diagnosed 7 days following the procedure, and the other had a suction dilation and curettage at 8-week gestation, with PID diagnosed 29 days after the procedure. The third case of PID was diagnosed in a patient who experienced multiple IUD expulsions. One patient (0.21%) developed endometritis after IUD insertion in the setting of a complicated gynecologic history of multiple fibroids and polyps as well as long-standing menorrhagia. This patient’s IUD became malpositioned and embedded in the myometrium.
