International Journal of Cardiology 187 (2015) 658–659
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
Severe recurrent vasovagal syncope and multidisciplinary rehabilitation: A prospective randomized pilot study Edouard Siméon a,1, Anne Bernard a,1, Nicolas Clémenty a,1, Géraldine Herault d,1, Wissam El-Hage b,c,1, Catherine Monpère d,1, Fabrice Ivanés a,1, Théodora Angoulvant e,1, Dominique Babuty a,⁎,1 a
Université François Rabelais, CHRU de Tours, Cardiology Department, Tours, France Université François Rabelais, Inserm U930, Tours, France CHRU Tours, Clinique Psychiatrique Universitaire, Tours, France d Cardiovascular Prevention and Rehabilitation Center Bois Gibert, Ballan-Miré, France e CHRU Tours, Pharmacology Department, Tours, France b c
a r t i c l e
i n f o
Article history: Received 19 March 2015 Accepted 21 March 2015 Available online 2 April 2015 Keywords: Vasovagal syncope Tilt test Rehabilitation Post-traumatic stress disorder
Syncope is one of the most frequent causes of admission to an emergency room [1]. Vasovagal syncope (VVS) accounts for about 50% of syncopes [2]. Recurrence of VVS affects physical, psychological and psychosocial aspects of life quality leading to an impaired quality of life [QoL; 3]. The first-line recommended treatment for a VVS is nonpharmacological measures; no medication has shown any substantial effect in large clinical trials, but sometimes pacemaker implantation can be discussed [4]. Physiotherapeutic measures and psychological approaches, have been evaluated in studies, but with no definitive conclusion [5,6]. We hypothesized that severe recurrent VVS treatment should include the simultaneous control of dietetic, physical, and psychological parameters by a multidisciplinary team. Thus, we conducted a prospective randomized pilot study assessing the effectiveness of multidisciplinary rehabilitation, piloted in a cardiac rehabilitation center, in comparison with standard recommended care [2]. The study protocol resulted from the Hospital Program of Clinical Research recommended by the Rehabilitation Cardiac Center of Bois
⁎ Corresponding author at: CHU de Tours, Hôpital Trousseau, Avenue de la République, 37170 Chambray-lès-Tours, France. E-mail address: [email protected] (D. Babuty). 1 These authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
http://dx.doi.org/10.1016/j.ijcard.2015.03.340 0167-5273/Crown Copyright © 2015 Published by Elsevier Ireland Ltd. All rights reserved.
Gibert (Ballan-Miré, France) in 2011. The study received approval from the Institutional Ethical Committee of Tours (CCP 2011-S2 and ID number RCB 2011-A00201-40). Participants received full details about the experimental protocol and provided written informed consent before the beginning of the trial. Patients aged 18 to 75 years referred to our syncope unit for recurrent vasovagal syncope (n ≥ 2) during at least one year with tilttesting reproducing the usual symptoms (plus hypotension and/or bradycardia) were included in this study. We excluded patients with structural heart disease, abnormal ECG, cardiac arrhythmias, positive active standing test, neurological disease, or pregnant/breastfeeding women or patients receiving psychological treatment. All recruited patients were randomized on the day of inclusion, using numbered opaque envelopes, into 2 separate groups: rehabilitation versus control. The randomization list was performed on the website: www.graphpad.com/quickcalcs/randomize1.cfm. In the rehabilitation group a comprehensive three-week rehabilitation program was carried out in a cardio-vascular rehabilitation center including 4 approaches. Medical consultation included reassurance about the benign nature of VVS, a symptom-limited stress-test to evaluate the patient's response to exercise, and to determine training modalities. The physical rehabilitation program included learning physical counter-pressure maneuvers and exercise training. The dietetic program consisted of nutritional assessment and patient education on hydration and high sodium intake. Psychological care first involved an assessment on the Hospital Anxiety and Depression Scale [HADS; 7], the Rosenberg self-esteem scale [8] and the personal history of traumatic events according to the DSM-IV classification. In case of psychological trauma, the patient received specific psychotherapy by Eye Movement Desensitization and Reprocessing [EMDR; 9]. In the control group, patients were treated according to the ESC guidelines [2]. Patients were evaluated at 6 months. The primary endpoint was health-related QoL, assessed using two valid scales: the Syncope Functional Status Questionnaire [SFSQ; 10] and the Impact of Syncope on Quality of Life [ISQL; 2]. Secondary endpoints were the number of syncope and pre-syncope recurrences and the number of medical consultations and hospitalizations.
E. Siméon et al. / International Journal of Cardiology 187 (2015) 658–659
Study size was based on previous results of a preliminary study. 19 per group were needed to demonstrate the superiority of the rehabilitation program over controls. All patients were analyzed (intention-totreat analysis). The randomization was reported in Fig. 1. The two groups were comparable with regard to baseline characteristics (Table 1). Participants had high SDS and ISQL scores, showing a high negative impact of syncope on their QoL. Psychological assessment showed severe anxiety symptoms in 40% of patients in the rehabilitation group. No patient had severe depressive symptoms, while moderate symptoms were found in 3 patients (18.6%). Fourteen patients (87.5%) had a low or very low self-esteem score according to the Rosenberg self-esteem scale. Finally, 10 patients (55.5%) had experienced at least one lifetime traumatic psychological event. The nature of traumas varied from ‘sudden unexpected death of a loved one’ (n = 3), to ‘rape’ (n = 2), and ‘illness-related trauma in childhood’ (n = 6). The delay between trauma occurrence and the first syncope varied substantially (5.6 ± 7 years). At 6 months, both primary endpoints were significantly improved in the rehabilitation group: −61% and +50% on SDS and ISQL scores respectively (p b 0.001) while no improvement was observed in the control group. Differences between baseline and follow-up showed significant improvements in SDS and ISQL scores for the rehabilitation group, as compared to control (ΔSDS: −30 ± 25.5 versus −2.5 ± 1.5, p b 0.001; ΔISQL: 15.2 ± 12.3 versus 2.9 ± 7.4, p b 0.001). For secondary endpoints the rehabilitation program provided significant decreases in the number of syncope and pre-syncope recurrences, with no significant decreases in the control group (−13.4 ± 17.6 versus −8 ± 24.5, p b 0.05). The number of medical consultations was significantly lower at 6 months in both groups but the decrease was higher in the rehabilitation group (2.9 ± 2.4 versus 0.4 ± 0.8, p b 0.01) than in the control group (2.9 ± 1.3 versus 1.1 ± 1.6, p b 0.05). The same results were observed for the number of hospitalizations. The psychological aspects of VVS syncope were brought out dramatically in our study. Thus, we identified a high prevalence of anxiety symptoms (50%), as had already been shown in a previous study [3]. We also noticed for the first time that many VVS patients have low self-esteem (87.5%), and that many of them had experienced traumatic psychological events (62.5%). Psychological trauma is defined in the DSM-IV as an emotional response to a terrible event like exposure to death, serious injury, or physical/sexual assault (as a direct victim or
659
Table 1 Baseline characteristics of patients.
Age (years) Male gender, n (%) Beginning of syncopes (years) In the previous 6 months Total syncope, n Syncope, n Pre-syncope, n Quality of life SFSQ Fear/worry Impairment, % SDS ISQL In the previous 6 months Medical consultation, n Hospitalization, n Prodromal symptoms, n (%) Injury at syncope, n (%) Tilt test Bradycardia, % Hypotension, %
Rehabilitation group (n = 18)
Control group (n = 19)
37.7 ± 19 8 (44.4) 8.1 ± 5.9
44.7 ± 20 7 (35) 10.4 ± 9
16.4 ± 19 2.6 ± 2 13.8 ± 19.8
23.3 ± 39 4.2 ± 5.1 19.1 ± 39
57.5 ± 24.3 41.3 ± 22.7 46.6 ± 21 31.3 ± 10.6
55.9 ± 21.6 39 ± 21.7 47.5 ± 18.7 32.8 ± 11.6
2.9 ± 2.4 1.5 ± 1 16 (88.8) 9 (50)
2.9 ± 3 1.2 ± 0.7 15 (79) 9 (50)
63.2 94.7
73.7 94.7
SFSQ: Syncope Functional Status Questionnaire; SDS: syncope dysfunction score; ISQL: Impact of Syncope on Quality of Life. No significant differences between two groups.
witness of the event). Traumatic events are more likely to cause chronic post-traumatic stress disorder (PTSD) characterized by long-lasting symptoms of re-experiencing the traumatic situation through flashbacks and nightmares, avoidance, emotional numbing, difficulty in concentrating, changes in sleep patterns, increased psycho-physiological arousal and reactivity and neurovegetative clinical manifestations [9]. Somatoform symptoms may be the only complaint reported by the patients. As recommended treatments for PTSD include cognitivebehavioral therapy, exposure therapy, and EMDR. This first pilot prospective randomized controlled study demonstrates the superiority of multidisciplinary rehabilitation for recurrent severe VVS patients in terms of QoL and a reduction in the recurrence of syncope or pre-syncope. Moreover, this study emphasized the high frequency of traumatic psychological events in the history of VVS patients. Conflict of interest The authors report no relationships that could be construed as a conflict of interest. References [1] J.J. Blanc, C. L'Her, A. Touiza, et al., Prospective evaluation and outcome of patients admitted for syncope over a 1-year period, Eur. Heart J. 23 (2002) 815–820. [2] A. Moya, R. Sutton, F. Ammirati, et al., Guidelines for the diagnosis and management of syncope of the European Society of Cardiology, Eur. Heart J. 30 (2009) 2631–2671. [3] M.S. Rose, M.L. Koshman, S. Spreng, R. Sheldon, The relationship between healthrelated quality of life and frequency of spells in patients with syncope, J. Clin. Epidemiol. 12 (2000) 1209–1216. [4] P. Saklani, A. Krahn, Klein, Syncope, Circulation 127 (2013) 1330–1339. [5] B. Flint, C. Baker, M. Freeston, J.L. Newton, Level of psychosocial impairment predicts early response to treatment in vasovagal syncope, Europace 11 (2009) 231–236. [6] J. Gracie, J.L. Newton, M. Norton, et al., The role of psychosocial factors in response to treatment in neurocardiogenic (vasovagal) syncope, Europace 8 (2006) 636–643. [7] I. Bjelland, A.A. Dahl, T.T. Haug, D. Neckelmann, The validity of the hospital and depression scale. An updated literature review, J. Psychosom. Res. 52 (2002) 69–77. [8] E. Silber, J. Tippett, Self-esteem: clinical assessment and clinical validation, Psychol. Rep. 16 (1965) 1017–1071. [9] W.A. Tol, C. Barbui, M. Van Ommeren, Management of acute stress, PTSD, and bereavement: WHO recommendations, JAMA 310 (2013) 477–478. [10] N. Van dijk, K.R. Boer, W. Wieling, et al., Reliability, validity and responsiveness of the Syncope Functional Status Questionnaire, J. Gen. Intern. Med. 22 (2007) 1280–1285.
Fig. 1. Study design.
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
Severe recurrent vasovagal syncope and multidisciplinary rehabilitation: A prospective randomized pilot study Edouard Siméon a,1, Anne Bernard a,1, Nicolas Clémenty a,1, Géraldine Herault d,1, Wissam El-Hage b,c,1, Catherine Monpère d,1, Fabrice Ivanés a,1, Théodora Angoulvant e,1, Dominique Babuty a,⁎,1 a
Université François Rabelais, CHRU de Tours, Cardiology Department, Tours, France Université François Rabelais, Inserm U930, Tours, France CHRU Tours, Clinique Psychiatrique Universitaire, Tours, France d Cardiovascular Prevention and Rehabilitation Center Bois Gibert, Ballan-Miré, France e CHRU Tours, Pharmacology Department, Tours, France b c
a r t i c l e
i n f o
Article history: Received 19 March 2015 Accepted 21 March 2015 Available online 2 April 2015 Keywords: Vasovagal syncope Tilt test Rehabilitation Post-traumatic stress disorder
Syncope is one of the most frequent causes of admission to an emergency room [1]. Vasovagal syncope (VVS) accounts for about 50% of syncopes [2]. Recurrence of VVS affects physical, psychological and psychosocial aspects of life quality leading to an impaired quality of life [QoL; 3]. The first-line recommended treatment for a VVS is nonpharmacological measures; no medication has shown any substantial effect in large clinical trials, but sometimes pacemaker implantation can be discussed [4]. Physiotherapeutic measures and psychological approaches, have been evaluated in studies, but with no definitive conclusion [5,6]. We hypothesized that severe recurrent VVS treatment should include the simultaneous control of dietetic, physical, and psychological parameters by a multidisciplinary team. Thus, we conducted a prospective randomized pilot study assessing the effectiveness of multidisciplinary rehabilitation, piloted in a cardiac rehabilitation center, in comparison with standard recommended care [2]. The study protocol resulted from the Hospital Program of Clinical Research recommended by the Rehabilitation Cardiac Center of Bois
⁎ Corresponding author at: CHU de Tours, Hôpital Trousseau, Avenue de la République, 37170 Chambray-lès-Tours, France. E-mail address: [email protected] (D. Babuty). 1 These authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
http://dx.doi.org/10.1016/j.ijcard.2015.03.340 0167-5273/Crown Copyright © 2015 Published by Elsevier Ireland Ltd. All rights reserved.
Gibert (Ballan-Miré, France) in 2011. The study received approval from the Institutional Ethical Committee of Tours (CCP 2011-S2 and ID number RCB 2011-A00201-40). Participants received full details about the experimental protocol and provided written informed consent before the beginning of the trial. Patients aged 18 to 75 years referred to our syncope unit for recurrent vasovagal syncope (n ≥ 2) during at least one year with tilttesting reproducing the usual symptoms (plus hypotension and/or bradycardia) were included in this study. We excluded patients with structural heart disease, abnormal ECG, cardiac arrhythmias, positive active standing test, neurological disease, or pregnant/breastfeeding women or patients receiving psychological treatment. All recruited patients were randomized on the day of inclusion, using numbered opaque envelopes, into 2 separate groups: rehabilitation versus control. The randomization list was performed on the website: www.graphpad.com/quickcalcs/randomize1.cfm. In the rehabilitation group a comprehensive three-week rehabilitation program was carried out in a cardio-vascular rehabilitation center including 4 approaches. Medical consultation included reassurance about the benign nature of VVS, a symptom-limited stress-test to evaluate the patient's response to exercise, and to determine training modalities. The physical rehabilitation program included learning physical counter-pressure maneuvers and exercise training. The dietetic program consisted of nutritional assessment and patient education on hydration and high sodium intake. Psychological care first involved an assessment on the Hospital Anxiety and Depression Scale [HADS; 7], the Rosenberg self-esteem scale [8] and the personal history of traumatic events according to the DSM-IV classification. In case of psychological trauma, the patient received specific psychotherapy by Eye Movement Desensitization and Reprocessing [EMDR; 9]. In the control group, patients were treated according to the ESC guidelines [2]. Patients were evaluated at 6 months. The primary endpoint was health-related QoL, assessed using two valid scales: the Syncope Functional Status Questionnaire [SFSQ; 10] and the Impact of Syncope on Quality of Life [ISQL; 2]. Secondary endpoints were the number of syncope and pre-syncope recurrences and the number of medical consultations and hospitalizations.
E. Siméon et al. / International Journal of Cardiology 187 (2015) 658–659
Study size was based on previous results of a preliminary study. 19 per group were needed to demonstrate the superiority of the rehabilitation program over controls. All patients were analyzed (intention-totreat analysis). The randomization was reported in Fig. 1. The two groups were comparable with regard to baseline characteristics (Table 1). Participants had high SDS and ISQL scores, showing a high negative impact of syncope on their QoL. Psychological assessment showed severe anxiety symptoms in 40% of patients in the rehabilitation group. No patient had severe depressive symptoms, while moderate symptoms were found in 3 patients (18.6%). Fourteen patients (87.5%) had a low or very low self-esteem score according to the Rosenberg self-esteem scale. Finally, 10 patients (55.5%) had experienced at least one lifetime traumatic psychological event. The nature of traumas varied from ‘sudden unexpected death of a loved one’ (n = 3), to ‘rape’ (n = 2), and ‘illness-related trauma in childhood’ (n = 6). The delay between trauma occurrence and the first syncope varied substantially (5.6 ± 7 years). At 6 months, both primary endpoints were significantly improved in the rehabilitation group: −61% and +50% on SDS and ISQL scores respectively (p b 0.001) while no improvement was observed in the control group. Differences between baseline and follow-up showed significant improvements in SDS and ISQL scores for the rehabilitation group, as compared to control (ΔSDS: −30 ± 25.5 versus −2.5 ± 1.5, p b 0.001; ΔISQL: 15.2 ± 12.3 versus 2.9 ± 7.4, p b 0.001). For secondary endpoints the rehabilitation program provided significant decreases in the number of syncope and pre-syncope recurrences, with no significant decreases in the control group (−13.4 ± 17.6 versus −8 ± 24.5, p b 0.05). The number of medical consultations was significantly lower at 6 months in both groups but the decrease was higher in the rehabilitation group (2.9 ± 2.4 versus 0.4 ± 0.8, p b 0.01) than in the control group (2.9 ± 1.3 versus 1.1 ± 1.6, p b 0.05). The same results were observed for the number of hospitalizations. The psychological aspects of VVS syncope were brought out dramatically in our study. Thus, we identified a high prevalence of anxiety symptoms (50%), as had already been shown in a previous study [3]. We also noticed for the first time that many VVS patients have low self-esteem (87.5%), and that many of them had experienced traumatic psychological events (62.5%). Psychological trauma is defined in the DSM-IV as an emotional response to a terrible event like exposure to death, serious injury, or physical/sexual assault (as a direct victim or
659
Table 1 Baseline characteristics of patients.
Age (years) Male gender, n (%) Beginning of syncopes (years) In the previous 6 months Total syncope, n Syncope, n Pre-syncope, n Quality of life SFSQ Fear/worry Impairment, % SDS ISQL In the previous 6 months Medical consultation, n Hospitalization, n Prodromal symptoms, n (%) Injury at syncope, n (%) Tilt test Bradycardia, % Hypotension, %
Rehabilitation group (n = 18)
Control group (n = 19)
37.7 ± 19 8 (44.4) 8.1 ± 5.9
44.7 ± 20 7 (35) 10.4 ± 9
16.4 ± 19 2.6 ± 2 13.8 ± 19.8
23.3 ± 39 4.2 ± 5.1 19.1 ± 39
57.5 ± 24.3 41.3 ± 22.7 46.6 ± 21 31.3 ± 10.6
55.9 ± 21.6 39 ± 21.7 47.5 ± 18.7 32.8 ± 11.6
2.9 ± 2.4 1.5 ± 1 16 (88.8) 9 (50)
2.9 ± 3 1.2 ± 0.7 15 (79) 9 (50)
63.2 94.7
73.7 94.7
SFSQ: Syncope Functional Status Questionnaire; SDS: syncope dysfunction score; ISQL: Impact of Syncope on Quality of Life. No significant differences between two groups.
witness of the event). Traumatic events are more likely to cause chronic post-traumatic stress disorder (PTSD) characterized by long-lasting symptoms of re-experiencing the traumatic situation through flashbacks and nightmares, avoidance, emotional numbing, difficulty in concentrating, changes in sleep patterns, increased psycho-physiological arousal and reactivity and neurovegetative clinical manifestations [9]. Somatoform symptoms may be the only complaint reported by the patients. As recommended treatments for PTSD include cognitivebehavioral therapy, exposure therapy, and EMDR. This first pilot prospective randomized controlled study demonstrates the superiority of multidisciplinary rehabilitation for recurrent severe VVS patients in terms of QoL and a reduction in the recurrence of syncope or pre-syncope. Moreover, this study emphasized the high frequency of traumatic psychological events in the history of VVS patients. Conflict of interest The authors report no relationships that could be construed as a conflict of interest. References [1] J.J. Blanc, C. L'Her, A. Touiza, et al., Prospective evaluation and outcome of patients admitted for syncope over a 1-year period, Eur. Heart J. 23 (2002) 815–820. [2] A. Moya, R. Sutton, F. Ammirati, et al., Guidelines for the diagnosis and management of syncope of the European Society of Cardiology, Eur. Heart J. 30 (2009) 2631–2671. [3] M.S. Rose, M.L. Koshman, S. Spreng, R. Sheldon, The relationship between healthrelated quality of life and frequency of spells in patients with syncope, J. Clin. Epidemiol. 12 (2000) 1209–1216. [4] P. Saklani, A. Krahn, Klein, Syncope, Circulation 127 (2013) 1330–1339. [5] B. Flint, C. Baker, M. Freeston, J.L. Newton, Level of psychosocial impairment predicts early response to treatment in vasovagal syncope, Europace 11 (2009) 231–236. [6] J. Gracie, J.L. Newton, M. Norton, et al., The role of psychosocial factors in response to treatment in neurocardiogenic (vasovagal) syncope, Europace 8 (2006) 636–643. [7] I. Bjelland, A.A. Dahl, T.T. Haug, D. Neckelmann, The validity of the hospital and depression scale. An updated literature review, J. Psychosom. Res. 52 (2002) 69–77. [8] E. Silber, J. Tippett, Self-esteem: clinical assessment and clinical validation, Psychol. Rep. 16 (1965) 1017–1071. [9] W.A. Tol, C. Barbui, M. Van Ommeren, Management of acute stress, PTSD, and bereavement: WHO recommendations, JAMA 310 (2013) 477–478. [10] N. Van dijk, K.R. Boer, W. Wieling, et al., Reliability, validity and responsiveness of the Syncope Functional Status Questionnaire, J. Gen. Intern. Med. 22 (2007) 1280–1285.
Fig. 1. Study design.
