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Vasovagal syncope management Mexico City 2016

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Vasovagal syncope management Mexico City 2016

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Talk given at National Institute of Cardiology, Mexico City on November 17, 2016

Talk given at National Institute of Cardiology, Mexico City on November 17, 2016

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Vasovagal syncope management Mexico City 2016

  1. 1. Vasovagal Syncope:Vasovagal Syncope: Current Management and Role ofCurrent Management and Role of Cardiac PacingCardiac Pacing Antonio Raviele, MD, FESC, FHRSAntonio Raviele, MD, FESC, FHRS ALFA – Alliance to Fight Atrial fibrillation, Mestre – Venice, ItalyALFA – Alliance to Fight Atrial fibrillation, Mestre – Venice, Italy Curso de Actualizaciòn en Arritmias, Mexico City, Mexico - 16-18 November, 2016
  2. 2. Treatment of VVS Only rarely necessary
  3. 3. Vasovagal Syncope •Is a begnin condition •Is not a threat to life •Does not impair quality of life Majority of casesMajority of cases
  4. 4. Patient Reassurance • Benign nature of VVS Patient Counseling • Recognition premonitory symptoms • Avoidance of precipitating conditions
  5. 5. • Prolonged Sitting - Standing • Crowded - Hot Places • Strenuous Exercise in Warm Enviroment • Dehydration - Volume Depletion • Potentially Hypotensive Drugs • Venipuncture – Emotional/Stressful Situations VVS - Triggering factors
  6. 6. Treatment - VVS • Frequent syncopal episodes • No predictable circumst. / warning sympt. • Important physical injury • Potential occupational hazard IndicatedIndicated
  7. 7. Therapeutical Options NON PHARMACOLOGICAL • alpha-agonists • betablockers • fludrocortisone • serotonin inhibitors • disopyramide • scopolamine • teophylline/clonidine • ACE-I PHARMACOLOGICAL ELECTRICAL • pacemaker • ablation • reassurance • counseling • high salt diet • ↑ water intake • support stockings • counter-maneuvers • tilt training
  8. 8. Therapeutical Options NON PHARMACOLOGICAL • reassurance • counseling • high salt diet • ↑ water intake • support stockings • counter-maneuvers • tilt training
  9. 9. Leg CrossingLeg Crossing && MuscleMuscle HandgripHandgrip Arm muscleArm muscle tensingtensing Counter-Pressure Maneuvers SquattingSquatting BendingBending forwardforward CrashCrash positionposition
  10. 10. Mechanism of action • ↑ Venous Return • ↑ Cardiac Output • ↑ Blood Pressure • Interruption of VV Reaction
  11. 11. J Am Coll Cardiol 2006; 48: 1652-7
  12. 12. Van Dijk N et al.J Am Coll Cardiol. 2006;48:1652-1657 Kaplan-Meier syncope-free survival curve of time to first syncopal recurrence 31.6%31.6% 50.9%50.9% FU = 14 mthsFU = 14 mths
  13. 13. Comparison between Kaplan–Meier curves of freedom from syncope recurrence in patients who performed PCM training and control untreated group of patients. Tomaino M et al. Europace 2014;16:1515-1520 PCM No Therapy ISSUE-3 trial subanalysis
  14. 14. PACE 1998;21:193-196PACE 1998;21:193-196
  15. 15. HUTT / Tilt Training • 5 in-hospital head-up tilt sessions for a planned duration of 10-50 minutes at 60° (once a day for 5 days) • daily tilt training at home by standing against a wall for a planned duration of up to 40 minutes (twice a day)
  16. 16. Tilt TrainingTilt Training In the literature there are discordant results regarding the real efficacy of this measure
  17. 17. Vyas A, et al. Int J Cardiol 2012; 167: 1906-1911 • However, the effect is lost if only randomized studies are included. • Moreover, tilt training is hampered by the low compliance of the patients to continue the treatment for a long period of time. A recent metanalysis of all studies performed with tilt training has shown that this therapy is effective in preventing recurrences of VVS with 70% decrease
  18. 18. HUTT /HUTT / Tilt TrainingTilt Training • Tilt training, at best, and if really effective, may be recommended only in a very selected group of highly motivated patients.
  19. 19. Therapeutical Options • alpha-agonists • betablockers • fludrocortisone • serotonin inhibitors • disopyramide • scopolamine • teophylline/clonidine • ACE-I PHARMACOLOGICAL
  20. 20. VVS Open Studies – Drug EfficacyVVS Open Studies – Drug Efficacy • alpha-agonists 73% 86% 12 • betablockers 74% 81% 15 • fludrocortisone 47% 68% 13 • serotonin inhibitors 55% 92% 13 • disopyramide 87% 91% 24 • scopolamine 44% 93% 14 • teophylline 33% 50% 11 Drug Acute Chronic FU
  21. 21. In all these studies, with only few exceptions, no difference was found in the recurrence rate of syncope during follow-up between pts treated with drugs and those treated with placebo Placebo – Controlled Trials Ammirati F et al. In: Alboni P, Furlan R (eds), Vasovagal Syncope, Springer 2015; 237-245
  22. 22. Liao Y, et al. Acta Paediatrica 2009; 98: 1194-1200 Midodrine This drug has given positive results in 4 studies, with a consistent risk reduction of syncopal recurrences of more than 60%,
  23. 23. • These studies are not placebo-controlled • Studied children or extraordinarily symptomatic pts • Used tilt test outcomes as the main measure • Regarded a limited number of patients • Had a short period of follow-up Midodrine & VVS / Positive results
  24. 24. Europace 2011; 13: 1639-1647
  25. 25. Metanalysis of prespecified, prestratified substudy of POST I and a large earlier observational study showed evidence of benefit of metoprolol in pts older than 42 years Sheldon RS et al. Circ Arrhythm Electrophysiol. 2012;5:920-926 (Metoprolol) (Metoprolol) Metoprolol
  26. 26. • However, these data need to be confirmed by an ongoing prospective, multicenter, randomized trial (POST 5) with results expected in 2017, before they can be largely applied in daily clinical practice. Metoprolol & VVS / Positive results
  27. 27. Sheldon R. et al.J Am Coll Cardiol. 2016; 68: 1-9 49% Fludrocortisone Fludrocortisone, at a dose of 0.2 mg daily, significantly reduced by 49% the syncopal recurrence rate after the initial 2 weeks of dose stabilization.
  28. 28. However, the study did not meet its primary objective of demonstrating that fludrocortisone reduces the likelihood of vasovagal syncope by the specified risk reduction of 40%. Indeed the reduction was more modest, only 31% 31%
  29. 29. Drug Therapy for Vasovagal SyncopeDrug Therapy for Vasovagal Syncope “To date there are not sufficient data to support the use of any pharmacological therapy for vasovagal syncope” ESC Guidelines on Management of Syncope Brignole et al. Eur Heart J 2001; 22: 1256-1306
  30. 30. Therapeutical OptionsTherapeutical Options ELECTRICAL • pacemaker • ablation
  31. 31. VVS / Rationale for pacingVVS / Rationale for pacing To counteract the cardioinhibitory component of the pathological reflex
  32. 32. Pacing for VVS / StudiesPacing for VVS / Studies • Randomized open-label controlled • Randomized double-blind placebo-controlled
  33. 33. VPS VASIS SYDIT Pts no. 54 42 93 Mean age 43 60 58 Median no. of syncopes 14-35 5.5 7-8 Tilt test + + + Control arm no pm no pm atenol Recurrence (Pm arm) 22% 5% 4% Recurrence (control arm) 70% 61% 25% p value 0.000 0.000 0.004 Pacemaker RDR DDI 45-80 RDR Randomized open-label controlled studies VPS. J Am Coll Cardiol 1999; 33: 16-20 VASIS. Circulation 2000; 102: 294-299 SYDIT. Circulation 2001;104:52-57 RiskRisk ↓↓ 83%83% 92%92% Mean FU: few mo – 3.7 yrs
  34. 34. VPS II SYNPACE Pts no. 100 29 Mean age 49 53 Median no. of syncopes 16 14-10 Tilt test + / - + Control arm pm off pm off Recurrence (Pm arm) 33% 50% Recurrence (control arm) 42% 38% p value ns ns Pacemaker RDR RDR Randomized double-blind placebo-controlled trials RiskRisk ↓↓ -21%-21% +32%+32% VPS II. JAMA 2003; 289: 2224-2229 SYNPACE. Eur Heart J 2004; 25: 1741-8
  35. 35. a substantial placebo effect of pacemaker implantation Randomized double-blind placebo-controlled trials
  36. 36. VVS / Limitation of pacingVVS / Limitation of pacing The vasodepressor component is not affected by pacing and may be responsible for the LoC at the time the pathological reflex develops
  37. 37. It has been suggested that selecting patients with vasovagal syncope for PM implantation on the basis of the results of implantable loop recorder may give better results Pacing for VVSPacing for VVS
  38. 38. Eur Heart J 2006; 27: 1085-92
  39. 39. Brignole M et al. Eur Heart J 2006; 27: 1085-92 90% 59% 1 year Patients with documentation of asystole by ILR at the time of spontaneous syncope PM
  40. 40. Time to first recurrence of syncope according to the intention-to- treat analysis (ISSUE III) Brignole M et al. Circulation. 2012;125:2566-2571 75% 43% PM 2 years
  41. 41. Patients who seem to benefit mostly from pacemaker implantation are those with tilt test negative. Brignole M et al. Circ Arrhythm Electrophysiol. 2014;7:10-16 This is because a positive tilt test might identify patients who are likely to also have a vasodepressor response during VVS, and therefore not respond as well to permanent pacing
  42. 42. Eur Heart J 2009; 30: 2631-2671
  43. 43. VVS / Pacing indication Class IIa recommendation Cardiac pacing is recommended in patients 40 years of age or older, with frequently recurrent and unpredictable syncope, and with documented spontaneous pauses during electrocardiographic monitoring (≥3 sec if symptomatic and ≥6 sec if asymptomatic). Moya A et al. Eur Heart J 2009; 30: 2631-2671
  44. 44. VVS / Pacing indication However, owing to the risk of complications following pacemaker implantation and the fact that electrical therapy may be ineffective in a significant percentage of patients considered to be appropriate candidate (25% at 2 years in ISSUE III trial), pacing should be considered only in highly selected patients, especially those with repeated injury and limited or absent prodromes. Sheldon RS et al. Heart Rhythm 2015; 12(6): e41-e63
  45. 45. Therapeutical OptionsTherapeutical Options ELECTRICAL • pacemaker • ablation
  46. 46. Europace 2005; 7: 1-13
  47. 47. J Cardiovasc Electropysiol 2009; 20: 558-563
  48. 48. It consists in performing a transcatheter endocardial ablation of the parasympathetic post-ganglionic neurons located inside the atrial wall that allows selective vagal denervation and elimination or attenuation of the cardioinhibitory reflex of the vasovagal syncope Pachon JCM et al. Europace 2011;13:1231-1242
  49. 49. Pachon JCM et al. Europace 2011;13:1231-1242 Cardioneuroablation was performed in 43 patients with recurrent VVS and important cardioinhibition at tilt testing 93%  of syncopal recurrence during a mean follow-up of 41 months
  50. 50. Considerations • It is clear that these results, although interesting, need to be confirmed by future randomized, multicenter trials before considering cardioneuroablation a consolidated therapy for vasovagal syncope

Editor's Notes

  • Mister Chairmen, Ladies and Gentlemen, the topic of my presentation today is “Vasovagal syncope: current management and role of cardiac pacing”.
  • First of all, let me start by emphasizing (stressing) that a specific treatment of VVS is only rarely necessary in clinical practice.
  • Indeed, in the majority of subjects, vasovagal syncope is a benign condition that does not represent a threat to life and that does not significantly impair quality of life
  • and syncope may be easily prevented by patient reassurance about the benign nature of his or her condition and other educational measures, in particular recognition of premonitory symptoms, and avoidance of precipitating conditions
  • such as prolonged sitting – standing, crowded – hot places, strenous exercise in warm enviroment, dehydration – volume depletion, potentially hypotensive drugs, venipuncture and emotional – stressful situations.
  • So, a specific treatment is only indicated in patients with frequent syncopal episodes, absence of predictable circumstances or warning symptoms that allow the patient to assume supine position or other evasive action, important physical injury and potential occupational hazard.
  • The main therapeutical mesaures, that are currently available for the treatment of vasovagal syncope, include non pharmacological, pharmacological, and electrical options.
  • Among the non pharmacological options, besides patient reassurance and counseling, we have to mention, high salt diet, increased water intake, support stocking, counter-pressure maneuvers, and tilt training,
  • Counterpressure maneuvers are simple measures, such as handgrip, arm muscle tensing, leg crossing and muscle tensing, squatting, bending forward, and crash position, that patients may activate at the time prodromal symptoms develop
  • All these maneuvers act in interrupting the vasovagal reaction by increasing venous return, cardiac output and blood pressure.
  • The effectiveness of these maneuvers have been confirmed in a multicentre prospective trial, the PC Trial in 2006
  • During a mean follow-up of 14 months patients trained in counterpressure maneuvers had a significantly lower syncopal recurrence rate compared to patients conventionally treated: 31.6% vs 50.9%.
  • However, in a recent subanalysis of ISSUE-3 trial, no statistical difference in terms of freedom from syncope recurrence was found between patients who performed PCM training and control untreated patients.
  • Tilt training was initially proposed by Ector and coworkers in 1998
  • and consists of 5 in-hospital head-up tilt sessions for a planned duration of 10-50 minutes at 60° (once a day for 5 days), followed by daily tilt training at home by standing against a wall for a planned duration of up to 40 minutes (twice a day)
  • In the literature there are discordant results regarding the real efficacy of this measure.
  • A recent metanalysis of all studies performed with tilt training has shown that this therapy is effective in preventing recurrences of VVS. However, the effect is lost if only randomized studies are included. Moreover, tilt training is hampered by the low compliance of the patients to continue the treatment for a long period of time.
  • So, tilt training, at best, and if really effective, may be recommended only in a very selected group of highly motivated patients.
  • Coming to pharmacological options, several drugs with different effects have been proposed for the prevention of vasovagal syncope. They include alpha-agonists, betablockers,fludrocortisone, serotonin inhibitors, disopyramide, scopolamine, teophylline/clonidine, and ACE-I.
  • In open studies, almost all these drugs have shown to be quite helpful, as you can see in this slide, with an acute efficacy during tilt testing ranging from 33% to 87%, and with a chronic efficacy during the follow-up ranging from 50% to 93%
  • These apparently good results of open studies are in sharp contrast with those of the long-term placebo-controlled trials that have been performed till now in patients with vasovagal syncope. Indeed, in all these studies, with only few exceptions, no difference was found in the recurrence rate of syncope during follow-up between patients treated with drugs and those treated with placebo, raising serious doubts about the real value of current drug therapy for treatment of vasovagal syncope.
  • One of the few drugs that has shown some efficacy is midodrine. This drug, has given positive results in 4 studies, with a consistent risk reduction of syncopal recurrences of more than 60%,
  • However, these studies are not placebo-controlled, studied children or extraordinarily symptomatic pts, used tilt test outcomes as the main measure, regarded a limited number of patients, and had a short period of follow-up.
  • Moreover, the effectiveness of midodrine was not confirmed in STAND-trial, a randomized cross-over trial of Midodrine against placebo in patients with VVS not responding to non-pharmacological treatment.
  • Another drug that can be used but only in patients older than 42 years is metoprolol. Indeed, a metanalysis of prespecified, prestratified substudy of POST I and a large earlier observational study, has shown benefit of metoprolol in these patients, differently from younger patients who did worse with beta-blockers..
  • However, these data need to be confirmed by an ongoing prospective, multicenter, randomized trial (POST 5) with results expected in 2017, before they can be largely applied in daily clinical practice.
  • Finally, also fludrocortisone seems to be useful at least in young patients. Indeed, in the POST2 trial recently published in JACC, fludrocortisone, at a dose of 0.2 mg daily, significantly reduced by 49% the syncopal recurrence rate after the initial 2 weeks of stabilization.
  • However, the study did not meet its primary objective of demonstrating that fludrocortisone reduce the likelihood of vasovagal syncope by the specified risk reduction of 40%. Indeed the reduction was more modest, only 31%.
  • Thus, according to the initial 2001 ESC guidelines on management of syncope, we can still state that to date there are not sufficient data to support the use of any pharmacological therapy for vasovagal syncope
  • Finally, electrical options . To this regard, we have 2 possibilities, pacemaker and ablation. Let me start with pacemaker implantation.
  • The rationale for using a pacemaker for vasovagal syncope is to counteract the cardioinhibitory component of the pathological reflex
  • The main studies performed on the value of pacing for vasovagal syncope include prospective randomized open-label studies and randomized double—blind placebo-controlled trials.
  • In the three randomized open-label controlled studies, VPS VASIS and SYDIT, a highly significant reduction of syncopal recurrence was observed in patients treated with dual-chamber pacemaker, from 83% to 92%, during a mean follow-up ranging from few months to 3.7 years
  • By contrast, in the two randomized double-blind placebo-controlled trials, the VPS II and the SYNPACE, no significant benefit of active pacing over inactive pacing was found in the prevention of syncopal recurrence,
  • thus indicating a substancial placebo effect of pacemaker implantation.
  • This is not surprising because the vasodepressor component, that is always present and often precedes the carioinhibitory component, is not affected by pacing and, thus, may be responsible for the loss of consciousness, despite the correction of bradycardia, at the time the pathological reflex develops.
  • However, it has been suggested that selecting patients with vasovagal syncope for pacemaker implantation on the basis of the results of implantable loop recorder, may give better results
  • This seems to be confirmed by the results of the ISSUE trials. In the ISSUE 2 trial
  • patients with documentation of asystole by ILR at the time of spontaneous syncope that were assigned to pacemaker therapy showed a significantly higher freedom from syncopal recurrence compared to patients that were not treated with pacemaker, 90% vs 59% at 1 year.
  • Similarly, in the ISSUE III trial, the freedom from syncopal recurrence was significantly higher in patients randomized to pacemaker on than in those randomized to pacemaker off, 75% vs 43% at 2 years.
  • Patients who seem to benefit mostly from pacemaker implantation are those with tilt test negative. This is because a positive tilt test might identify patients who are likely to also have a vasodepressor response during VVS, and therefore not respond as well to permanent pacing.
  • According to these data, the 2009 Guidelines on syncope management of the ESC
  • give a Class IIa recommendation for cardiac pacing in patients 40 years of age or older, with frequent and unpredictable syncope, and with documented spontaneous pauses during electrocardiographic monitoring (≥3 sec if symptomatic and ≥6 sec if asymptomatic).
  • However, owing to the risk of complications following pacemaker implantation and the possibility that pacing is ineffective in a significant percentage of patients considered to be appropriate candidate (25% in ISSUE III trial) pacing should be considered only in highly selected patients, especially in those with repeated injury and limited or absent prodromes.
  • Finally, cardioneuroablation for vaso-vagal syncope.
  • This therapy was first proposed da Pachon in 2005
  • and subsequently utilized also by other brazilian groups, in particular Sao Paulo group.
  • It consists in performing a transcatheter endocardial ablation of the parasympathetic post-ganglionic neurons located inside the atrial wall that allows selective vagal denervation and elimination or attenuation of the cardioinhibitory reflex of the vasovagal syncope
  • In the last publication of Pachon in Europace in 2011, cardioneuroablation was performed in 43 patients with recurrent VVS and important cardioinhibition at tilt testing and was associated with a 93% reduction of syncopal recurrence during a mean follow-up of 41 months.
  • It is clear that these results, although interesting, need to be confirmed by future randomized, multicenter trials before considering cardioneuroablation a consolidated therapy for vasovagal syncope .
    Thank you very much for your attention.
  • Finally, class III indications, that is contraindications to therapy are represented by the use of beta-blocking abents and cardiac pacing in the absence of a documwnted cardioinhibitory reflex.

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