The prevalence of sexual dysfunction (SD) in men with hypertrophic cardiomyopathy (HC) remains unknown, yet its clinical relevance may be high given that its treatment—phosphodiesterase 5 inhibitors (PDE5i)—can increase the left ventricular outflow tract pressure gradient. In this retrospective study, we evaluated the medical records of consecutively seen men with HC for the evidence of SD (defined as SD diagnosis noted in the medical record, the use of medications unique for SD, or SD reported by the patient on a routine clinical questionnaire). Of the 283 consecutively seen men with HC (mean age 52.9 ± 14.1 years), 63 patients (22%) with SD were identified. Of those with SD, 38% were recorded as regularly using PDE5i. In conclusion, SD and the use of PDE5i present a relatively common occurrence in men with HC, and further studies are needed to develop an evidence-guided algorithm for safe implementation of SD therapies in this most common inherited cardiomyopathy.
Hypertrophic cardiomyopathy (HC) presents the most common inherited cardiomyopathy in the United States, affecting approximately 600,000 Americans. An increased left ventricular outflow tract pressure gradient (LVOT PG) contributes to symptoms in HC, including dyspnea, heart failure, and even risk of death. Current guidelines support the use of β-adrenergic blocking medications (class I recommendation, level of evidence B) for patients with symptomatic HC, but these therapeutic agents are associated with male sexual dysfunction (SD) which in turn is commonly treated by phosphodiesterase 5 inhibitors (PDE5i), a medication known to increase LVOT PG in susceptible patients with HC. Current guidelines do not detail recommendations regarding the clinical question of how to best treat SD in HC in part because data on the prevalence of SD and PDE5i use in men with HC are lacking. Therefore, we conducted a retrospective analysis of the electronic medical record and patient questionnaires from consecutively seen men with HC, proposing that if SD was commonly self-reported by patients with HC, further studies aimed at evaluating the most appropriate treatment algorithm of SD in HC could be substantiated.
Methods
We searched our medical records for unselected consecutive patients with HC evaluated at Mayo Clinic, Rochester, Minnesota, from January 2006 to December 2009. The inclusion criteria were male gender, age >18 years, and a diagnosis of HC confirmed by echocardiography according to the current guidelines. Demographic data and relevant co-morbidities were extracted from the electronic medical record and from the routinely administered clinical patient questionnaires. Patients who met at least one of the following criteria were deemed as having SD: (1) documented history of SD, (2) use of PDE5i in the absence of pulmonary hypertension as the primary indication, (3) use of intracavernous papaverine injections, and (4) SD self-reported on any patient questionnaire. Patients with incomplete documentation in the electronic medical record were excluded.
The analysis of SD prevalence and PDE5i use in the various subgroups according to the presence of a significant resting or provocable LVOT PG was performed using the cutoff of 50 mm Hg for a clinically significant gradient measured by a transthoracic echocardiography. The maximum LVOT PG as defined as the greatest measured gradient either during the baseline resting study or during a provocation maneuvers.
Values were expressed as mean ± standard deviation for continuous variables and number and percentage for categorical variables, where appropriate. Wilcoxon rank sum test and the Pearson chi-square test were used to compare continuous and binary variables across the SD and non-SD groups. Data management and analyses were performed using JMP Pro version 9.0.1. Differences were considered statistically significant if p <0.05. Study protocol was approved by the Mayo Clinic Institutional Review Board.
Results
This study included 283 male patients with echocardiographically confirmed HC whose baseline characteristics are summarized in Table 1 . From this study cohort, 63 men (22.3%) were identified as having SD according to our definition: 42 patients noted SD on the clinical patient questionnaire, 13 patients had the diagnosis of SD listed in their electronic patient record, and 24 patients noted regular use of PDE5i in their medical record. The active therapy documented in the medical record was PDE5i in 38.1% of all the men with SD (sildenafil in 17 patients, tadalafil in 7 patients), and 1 patient was using intracavernosal papaverine injections ( Figure 1 ).
| Variable | All HC men (N = 283) | Documented SD | p | |
|---|---|---|---|---|
| No (N = 220) | Yes (N = 63) | |||
| Phosphodiesterase-5-inhibitor use | 24 (9%) | — | — | — |
| Age (years) | 52.9±14.1 | 51.6±14.6 | 57.0±11.6 | 0.02 |
| Weight (kg) | 98.5±18.5 | 97.7±18.6 | 101.4±17.9 | 0.21 |
| Height (cm) | 179.6±6.1 | 179.2±6.7 | 180.7±6.8 | 0.24 |
| Body mass index (kg/m 2 ) | 30.5±4.9 | 30.3±5.1 | 31.0±4.5 | 0.36 |
| Hypertension | 112 (40%) | 78 (36%) | 34 (54%) | <0.01 |
| Diabetes mellitus | 22 (8%) | 17 (8%) | 5 (8%) | 0.96 |
| Smoking | 118 (42%) | 89 (41%) | 29 (46%) | 0.44 |
| Beta-blocker use | 217 (77%) | 167 (76%) | 50 (79%) | 0.57 |
| Calcium-channel antagonist use | 86 (30%) | 66 (30%) | 20 (32%) | 0.79 |
| Nitrates | 8 (3%) | 4 (2%) | 4 (7%) | 0.05 |
| Coronary artery disease | 35 (12%) | 27 (12%) | 8 (13%) | 0.93 |
| Left ventricular ejection fraction (%) | 67.9±7.9 | 68.6±7.1 | 65.8±9.8 | 0.10 |
| Left ventricle mass index, (g/m 2 ) | 147.8±50.6 | 149.4±53.4 | 142.2±39.3 | 0.12 |
| Interventricular basal septal thickness (mm) | 19.1±5.2 | 19.1±5.3 | 18.9±4.8 | 0.38 |
| Left atrial volume index, mm 3 /m 2 | 48.4±21.6 | 47.5±22.1 | 51.4±19.4 | 0.91 |
| Resting peak left ventricular outflow tract pressure gradient (resting) ≥50 mmHg | 57 (20%) | 46 (21%) | 11 (17%) | 0.61 |
| Maximum peak left ventricular outflow tract pressure gradient (either with provocation or at rest), ≥50 mmHg | 130 (46%) | 106 (48%) | 24 (38%) | 0.20 |
| Syncope (history) | 35 (12%) | 32 (15%) | 3 (5%) | 0.04 |
HC patients with SD were older than those without SD, and hypertension presented a more common co-morbidity in HC patients with SD compared to those without SD. No significant differences in body mass index, prevalence of coronary disease, or diabetes mellitus between the groups with and without SD were identified in our study sample. Regarding additional SD risk factors, no significant difference existed between patients with and without SD in terms of β-blocking drug use or tobacco use history.
Echocardiographic parameters are listed at the bottom of Table 1 . The lack of a statistically significant or clinically meaningful difference between men with HC with and without SD was noted. The prevalences of SD and PDE5i use in high-risk subgroups of HC men with high LVOT PGs (≥50 mm Hg) or in those with history of syncope are shown in Figure 2 .
Results
This study included 283 male patients with echocardiographically confirmed HC whose baseline characteristics are summarized in Table 1 . From this study cohort, 63 men (22.3%) were identified as having SD according to our definition: 42 patients noted SD on the clinical patient questionnaire, 13 patients had the diagnosis of SD listed in their electronic patient record, and 24 patients noted regular use of PDE5i in their medical record. The active therapy documented in the medical record was PDE5i in 38.1% of all the men with SD (sildenafil in 17 patients, tadalafil in 7 patients), and 1 patient was using intracavernosal papaverine injections ( Figure 1 ).
