Sex differences in selection of pacemakers: retrospective observational studyBMJ 1998; 316 doi: https://doi.org/10.1136/bmj.316.7143.1492 (Published 16 May 1998) Cite this as: BMJ 1998;316:1492
- Reinhart Schüppel, lecturera,
- Gisela Büchele, research assistantb,
- Lothar Batz, physicistc,
- Wolfgang Koenig, senior lecturer in cardiologyd
- a Department of Psychotherapy and Psychosomatic Medicine, University of Ulm Medical Centre, D-89081 Ulm, Germany,
- b Department of Biometry and Medical Documentation, University of Ulm, D-89075 Ulm, Germany
- c Institute for Medical Technology, Justus Liebig University Giessen, D-36392 Giessen, Germany,
- d Department of Internal Medicine II, University of Ulm Medical Centre, Ulm, Germany
- Correspondence to: Dr Schüppel.
- Accepted 4 February 1998
Objective: To evaluate the effect of patients' sex on selection of pacemakers.
Design: Retrospective univariate and multivariate analysis of a large database.
Setting: German central pacemaker register.
Subjects: Records collected at the register for 1992 and 1993 (n=31 913), covering 64% of all implantations in Germany.
Main outcome measure: Probability of receiving a single chamber, dual chamber, or rate responsive pacemaker in relation to sex.
Results: Univariate analysis showed that women were more likely to receive single chamber pacemakers and less likely to receive dual chamber or rate responsive systems than men. After demographic and clinical variables were controlled for, women were still more likely to receive a single chamber system (atrial pacing: odds ratio 0.89, 95% confidence interval 0.74 to 1.07; ventricular pacing: 0.85, 0.80 to 0.92) and less likely to receive a dual chamber (1.20, 1.12 to 1.30) or a rate responsive system (1.26, 1.17 to 1.37) than men.
Conclusions: The data suggest sex differences in the selection of a pacemaker system which cannot be explained by the underlying cardiac disorder. Further research is needed to evaluate why guidelines for implanting pacemakers are not better adhered to.
Use of pacemakers varies despite guidelines, and the reasons for this are unclear
In this study women were more likely to receive single chamber pacemakers and less likely to receive dual chamber and rate responsive pacemakers than men
Demographic and clinical variables cannot fully explain these differences
Prospective studies are needed to evaluate the effect of sex and other non-medical variables on the selection of pacemakers
Pacemakers are the standard treatment for symptomatic bradyarrhythmia. Professional societies have issued guidelines for the implantation of cardiac pacemakers.1–3 Although these guidelines have all been similar, considerable differences have been reported in the frequency of implantation of pacemakers and in the system selected.4 Relatively little is known about the reasons for these differences.5 There is some evidence that patients' sex might play a part in clinical decision making.6–8 We used a large database to analyse whether sex can explain differences in the selection of pacemaker systems.
Subjects and methods
Doctors who perform implants transfer information available from the European pacemaker patient identification card to the German central pacemaker register on a voluntary basis. Customs' statistics and manufacturers' sales figures suggest that the register comprises 64% of all implantations in Germany. Of the 880 German hospitals in which implants are done (number estimated by a survey), 634 (72%) sent their reports to the register.9 Our analysis is based on complete data for the years 1992 and 1993. We excluded cases that had classification errors (for example, non-existent categories) from the total of 15 914 patients in 1992 and 15 999 patients in 1993. Table 1 gives the characteristics of the patients.
We examined the pooled data for 1992 and 1993 according to patient characteristics (age, sex, clinical symptoms, underlying disease, electrocardiographic findings), type of pacemaker (single chamber, dual chamber), and rate responsive systems. The χ2 test was used to analyse discrete variables and Student's t test used for continuous variables.
For logistic regression we defined the type of pacemaker as the dependent variable and age, sex, clinical symptoms, underlying disease, and electrocardiographic findings as independent variables. Explanatory variables for the selection of a specific pacemaker were first determined in a univariate logistic regression. We then used a multivariate model adjusting for age, clinical symptoms, underlying disease, and electrocardiographic findings to determine the effect of sex on choice of pacemaker. Cases with more than one missing value were excluded from univariate regression, and only complete datasets were used in the multivariate regression. All data were processed with SAS 6.08 software. A P value <0.05 was considered significant. All tests were two tailed.
Table 1 shows that single chamber systems were implanted in a higher proportion of women (atrial 492 (3.2%), ventricular 11 065 (71.9%)) than men (atrial 429 (2.7%), ventricular 10 499 (66.1%)). In contrast, men received more dual chamber (4892 (30.8%)) and rate responsive systems (4273 (26.9%)) than women (3770 (24.5%), 3186 (20.7%)). Sex differences were also found for various clinical variables.
In the univariate analysis, where 21 858 patients could be included (68.5% of the sample), age, sex, several clinical symptoms, underlying disease, and electrocardiographic findings were significantly associated with the pacemaker system selected for implantation (table 2). After the effects of age, clinical symptoms, underlying disease, and electrocardiographic findings had been adjusted for in a multivariate analysis (n=16 289 (51.0% of the data)), women were still more likely to receive a ventricular single chamber pacemaker and less likely to receive a dual chamber or rate responsive system than men (table 3).
Analysis of data from over 15 000 patients suggests a sex bias in choice of a pacemaker system. Women were more likely to receive single chamber systems and less likely to receive dual chamber or rate responsive systems than men. Can these findings be explained by differences in the underlying cardiac disorders or demographic data? In our cohort a higher proportion of men presented with an atrioventricular block than women. It is generally accepted that dual chamber pacemakers achieve better haemodynamic results than single chamber systems in atrioventricular block. 2 10 Women, on the other hand, had a higher frequency of sinus node dysfunction. In this disorder a single chamber system often seems to be sufficient, although several authors have found that dual chamber pacemakers produce better outcomes in terms of haemodynamics, subjective symptoms, the development of atrial fibrillation, and prognosis.11 Finally, cardiovascular diseases occur at a later age in women than in men.12 In our cohort women were on average 3.8 years older than men. Doctors generally implant single chamber pacemakers in elderly patients rather than dual chamber systems.13
Several studies of factors influencing cardiovascular interventions showed that sex was no longer a determinant once demographic and clinical variables had been adjusted for. 14 15 In our study, however, even after we controlled for demographic and various clinical variables sex remained independently associated with the selection of a pacemaker system. Our results agree with two retrospective studies in the United States in which women were found to receive a dual chamber system less frequently than men. 16 17 The clinical importance of the suggested undertreatment of women with dual chamber and rate responsive pacemakers is not easy to evaluate. In addition to the advantages of dual chamber pacemakers in patients with atrioventricular block and sinus node dysfunction mentioned above, rate responsive systems have been shown to offer haemodynamic advantages over fixed rate systems in patients with chronotropic incompetence receiving ventricular single chamber pacing or dual chamber pacing.18 Although there is evidence that patients treated by advanced pacing have a better quality of life,19 it is not known whether this improvement is equal in men and women.
Is there sex discrimination?
What other reasons could there be for doctors deciding in favour of a single chamber pacemaker in women? Firstly, there are some “soft” indications for implanting pacemakers (class II indications in the American College of Cardiology/American Heart Association guidelines2 and corresponding recommendations in many countries, including Germany) Furthermore, guidelines are not always unanimously adhered to in clinical practice. 5 20 Doctors are known to behave differently towards men and women as far as both diagnostic and therapeutic strategies are concerned.21 Doctors seeing women with “soft” indications may tend to implant single chamber pacemakers whereas they choose dual chamber for men. Some of the “hard” indications may also be being neglected in women. Women often present their symptoms differently from men.22 They are more likely to receive the same treatment as men if they present their symptoms as men do.23 Finally, we found some published evidence that women sometimes reject sophisticated care in favour of more simple treatments. They may therefore choose not to have dual chamber systems.24
The database we used represents two thirds of the implantations performed in Germany. Since the percentage of reporting hospitals slightly exceeds the percentage of reported implantations, hospitals with a lower frequency of implantations may be overrepresented. However, for this majority of hospitals (72%) sex differences were present in selection of pacemakers. Sex was an independent determinant of choice of pacemaker, with women receiving roughly 20% fewer rate responsive and dual chamber systems then men. Missing data meant that we could include only 16 289 of the 31 913 records in the multivariate logistic regression analysis, and we could not control our data for variables such as left ventricular function, intermittent dysrhythmia, or multimorbidity that might have contributed to the differences found. In addition, our results do not necessarily apply to other countries. However, a similar sex bias has been shown to be likely in the United States at least. 16 17 Study limitations and the retrospective design of our analysis do not allow a definite explanation for the sex bias. Prospective studies that include clinical endpoints such as survival or quality of life are needed to investigate this difference in more detail and reveal its potential implications.
Contributors: RS drafted the design of the study, contributed to the analysis of data, coordinated the writing of paper, and is the guarantor. GB contributed to the study design and carried out the statistical analyses. LB collected the data from the pacemaker register and helped interpret the data. WL contributed to the analysis and interpretation of the data. All authors contributed to writing the paper.
Conflict of interest: None.