Presentation on theme: "Syncope A Diagnostic and Treatment Strategy Developed by: David G. Benditt, M.D. Richard Sutton, DScMed University of Minnesota Medical Center Royal Brompton."— Presentation transcript:
Syncope A Diagnostic and Treatment Strategy Developed by: David G. Benditt, M.D. Richard Sutton, DScMed University of Minnesota Medical Center Royal Brompton Hospital, London, UK
Presentation Overview I.Prevalence & Impact II.Etiology III.Diagnosis & Evaluation Options IV.Specific Conditions V.Treatment Options VI.Insights into more efficient and effective diagnosis and treatment of patients with syncope
The Significance of Syncope The only difference between syncope and sudden death is that in one you wake up. 1 1 Engel GL. Psychologic stress, vasodepressor syncope, and sudden death. Ann Intern Med 1978; 89: 403-412.
The Significance of Syncope 1 National Disease and Therapeutic Index on Syncope and Collapse, ICD-9-CM 780.2, IMS America, 1997 2 Blanc J-J, L’her C, Touiza A, et al. Eur Heart J, 2002; 23: 815-820. 3 Day SC, et al, AM J of Med 1982 4 Kapoor W. Evaluation and outcome of patients with syncope. Medicine 1990;69:160-175
Individuals <18 yrs Military Population 17- 46 yrs Individuals 40-59 yrs* Individuals >70 yrs* 15% 20-25% 16-19% 23% Syncope Reported Frequency *during a 10-year period Brignole M, Alboni P, Benditt DG, et al. Eur Heart J, 2001; 22: 1256-1306.
The Significance of Syncope 500,000 new syncope patients each year 5 170,000 have recurrent syncope 6 70,000 have recurrent, infrequent, unexplained syncope 1-4 explained: 53% to 62% infrequent, unexplained: 38% to 47% 1-4 1 Kapoor W, Med. 1990;69:160-175. 2 Silverstein M, et al. JAMA. 1982;248:1185-1189. 3 Martin G, et al. Ann Emerg. Med. 1984;12:499-504. 4 Kapoor W, et al. N Eng J Med. 1983;309:197-204. 5 National Disease and Therapeutic Index, IMS America, Syncope and Collapse #780.2; Jan 1997-Dec 1997. 6 Kapoor W, et al. Am J Med. 1987;83:700-708.
1 Day SC, et al. Am J of Med 1982;73:15-23. 2 Kapoor W. Medicine 1990;69:160-175. 3 Silverstein M, Sager D, Mulley A. JAMA. 1982;248:1185-1189. 4 Martin G, Adams S, Martin H. Ann Emerg Med. 1984;13:499-504. Some causes of syncope are potentially fatal Cardiac causes of syncope have the highest mortality rates The Significance of Syncope
Impact of Syncope 1 Linzer, J Clin Epidemiol, 1991. 2 Linzer, J Gen Int Med, 1994. Anxiety/ Depression Alter Daily Activities Restricted Driving Change Employment 73% 1 71% 2 60% 2 37% 2 Proportion of Patients
Syncope Diagnostic Objectives Distinguish ‘True’ Syncope from other ‘Loss of Consciousness’ spells: Seizures Psychiatric disturbances Establish the cause of syncope with sufficient certainty to: Assess prognosis confidently Initiate effective preventive treatment
Syncope Basic Diagnostic Steps Detailed History & Physical Document details of events Assess frequency, severity Obtain careful family history Heart disease present? Physical exam ECG: long QT, WPW, conduction system disease Echo: LV function, valve status, HOCM Follow a diagnostic plan...
Conventional Diagnostic Methods/Yield Test/ProcedureYield (based on mean time to diagnosis of 5.1 months 7 History and Physical (including carotid sinus massage) 49-85% 1, 2 ECG2-11% 2 Electrophysiology Study without SHD*11% 3 Electrophysiology Study with SHD49% 3 Tilt Table Test (without SHD)11-87% 4, 5 Ambulatory ECG Monitors: Holter2% 7 External Loop Recorder (2-3 weeks duration) 20% 7 Insertable Loop Recorder (up to 14 months duration) 65-88% 6, 7 Neurological † (Head CT Scan, Carotid Doppler) 0-4% 4,5,8,9,10 *Structural Heart Disease † MRI not studied 1 Kapoor, et al N Eng J Med, 1983. 2 Kapoor, Am J Med, 1991. 3 Linzer, et al. Ann Int. Med, 1997. 4 Kapoor, Medicine, 1990. 5 Kapoor, JAMA, 1992 6 Krahn, Circulation, 1995 7 Krahn, Cardiology Clinics, 1997. 8 Eagle K,, et al. The Yale J Biol and Medicine. 1983; 56: 1-8. 9 Day S, et al. Am J Med. 1982; 73: 15-23. 10 Stetson P, et al. PACE. 1999; 22 (part II): 782.
Syncope Evaluation and Differential Diagnosis Complete Description From patient and observers Type of Onset Duration of Attacks Posture Associated Symptoms Sequelae History – What to Look for
12-Lead ECG Normal or Abnormal? Acute MI Severe Sinus Bradycardia/pause AV Block Tachyarrhythmia (SVT, VT) Preexcitation (WPW), Long QT, Brugada Short sampling window (approx. 12 sec)
Carotid Sinus Massage Site: Carotid arterial pulse just below thyroid cartilage Method: Right followed by left, pause between Massage, NOT occlusion Duration: 5-10 sec Posture – supine & erect
Carotid Sinus Massage Outcome: 3 sec asystole and/or 50 mmHg fall in systolic blood pressure with reproduction of symptoms = Carotid Sinus Syndrome (CSS) Contraindications Carotid bruit, known significant carotid arterial disease, previous CVA, MI last 3 months Risks 1 in 5000 massages complicated by TIA
Conventional AECG Low Yield, Poor Symptom / Arrhythmia Concordance* 8 studies, 2612 patients 19% pts had symptoms with AECG Only 4% had arrhythmia with symptoms 79% pts were without symptoms 14% had arrhythmia despite absence of symptoms * ACC/AHA Task Force, JACC 1999;912-948
MethodComments Holter (24-48 hours)Useful for infrequent events Event Recorder Useful for infrequent events Limited value in sudden LOC Loop Recorder Useful for infrequent events Implantable type more convenient (ILR) Wireless (internet) Event Monitoring In development Ambulatory ECG
Head-up Tilt Test (HUT) Unmasks VVS susceptibility Reproduces symptoms Patient learns VVS warning symptoms Physician is better able to give prognostic / treatment advice
Head-Up Tilt Test (HUT) DG Benditt, UM Cardiac Arrhythmia Center
Electroencephalogram Not a first line of testing Syncope from Seizures Abnormal in the interval between two attacks – Epilepsy Normal – Syncope
Value of Event Recorder in Syncope Linzer M. Am J Cardiol. 1990;66:214-219. * Asterisk denotes event marker
Patient ActivatorReveal ® Plus ILR9790 Programmer Reveal ® Plus Insertable Loop Recorder
ILR Recordings* 56 yo woman with syncope accompanied with seizures. Infra-Hisian AV Block: Dual chamber pacemaker 65 yo man with syncope accompanied with brief retrograde amnesia. VT and VF: ICD and meds *Medtronic data on file
Randomized Assessment of Syncope Trial Usual care including: External loop recorder Tilt test, EPS and others Unexplained Syncope after history, physical exam, ECG, Holter Low Risk (EF > 35%) ILR Diagnosis + + - - ILR External loop recorder Tilt test, EPS, others Krahn A, Klein GJ, Skanes Y. Circulation 2001; 104:46-51.
RAST Methods Prospective randomized trial 60 patients with unexplained syncope referred for cardiac investigation Inclusion: Recurrent unexplained syncope Referred to the arrhythmia service for cardiac investigation No clinical diagnosis after history, physical, ECG and at least 24 hours of cardiac monitoring Exclusion: LVEF < 35% Unable to give informed consent Major morbidity precluding one year of follow-up Krahn A, Klein GJ, Skanes Y. Circulation 2001; 104:46-51.
RAST Results Unexplained Syncope n=60 ILR n=30 Conventional n=30 In Follow-up n=3 Diagnosed n=14 Undiagnosed n=13 Diagnosed n=6 Undiagnosed n=24 Krahn A, Klein GJ, Skanes Y. Circulation 2001; 104:46-51.
RAST Crossover Results Krahn A, Klein GJ, Skanes Y. Circulation 2001; 104:46-51. Unexplained Syncope n=60 13/30 Undiagnosed after monitoring 6 accepted crossover to conventional 24/30 Undiagnosed after conventional 21 accepted crossover to ILR Diagnosed n=1 Undiagnosed n=5 Diagnosed n=8 Undiagnosed n=5 In follow-up n=8
RAST - Diagnoses number of patients Krahn A, Klein GJ, Skanes Y. Circulation 2001; 104:46-51.
Conventional EP Testing in Syncope Limited utility in syncope evaluation Most useful in patients with structural heart disease Heart disease……..50-80% No Heart disease…18-50% Relatively ineffective for assessing bradyarrhythmias Brignole M, Alboni P, Benditt DG, et al. Eur Heart Journal 2001; 22: 1256-1306.
EP Testing in Syncope: Useful Diagnostic Observations Inducible monomorphic VT SNRT > 3000 ms or CSRT > 600 ms Inducible SVT with hypotension HV interval ≥ 100 ms (especially in absence of inducible VT) Pacing induced infra-nodal block
Objectives: Understand the mechanism of syncope in tilt-positive and tilt- negative (isolated) patients Use the ILR to assess the correlation of rhythms captured during tilt testing and spontaneous recurrent episodes Inclusion Criteria: Patients with three or more syncopal episodes in the last 2 years Groups matched in age, sex, history of syncope, ECG, Echo abnormalities, SHD and arrhythmias ISSUE Study International Study of Syncope of Uncertain Etiology Moya A. Circulation. 2001; 104:1261-1267
ISSUE Study Design Multicenter, prospective 111 syncope patients 3 episodes in 2 years, first and last episode >6 months apart History, physical exam, ECG, CSM, echo, Holter (24 hr), other tests as appropriate Tilt test followed by implant of Reveal Insertable Loop Recorder Follow-up to recurrent spontaneous episode Moya A. Circulation. 2001; 104:1261-1267
ISSUE Study Results Results Tilt-Negative Syncope (Isolated) n=82 Tilt-Positive Syncope n=29 Recurrent Event Occurrence (#)34% (28)34% (10) Mean Time to Recurrent Event (range) 105 days (47-226)59 (22-98) ILR ECG Documented (#)29% (24)28% (8) Tachyarrhythmia 2% (2) Bradycardia 16% (13)21% (6) –Sinus Brady 2% (2)3% (1) –Sinus Arrest 12% (10)17% (5) –AV Block 1% (1) Total Arrhythmic18% (15)21% (6) Normal Sinus Rhythm11% (9)7% (2) Moya A. Circulation. 2001; 104:1261-1267
ISSUE Study Conclusions: Homogeneous findings from tilt-negative and tilt- positive syncope patients were observed (clinical characteristics and outcomes). Most frequent finding was asystole secondary to progressive sinus bradycardia, suggesting a neuromediated origin In this study tilt-negative patients had as many arrhythmias (18%) as tilt-positive patients (21%) In tilt-positive patients the spontaneous episode ECG was more frequently asystolic than what was predicted by tilt test Moya A. Circulation. 2001; 104:1261-1267
ISSUE Study Implications HUT outcome was not predictive of vasodepressor vs. cardioinhibitory response Bradycardia is common in spontaneous VVS - independent of HUT outcome Bradycardia is more prevalent in spontaneous events vs. HUT induced VVS Clinical Implication: Consider a strategy of postponing treatment until a spontaneous episode can be documented Moya A. Circulation. 2001; 104:1261-1267
Symptom-Rhythm Correlation Auto Activation Point Patient Activation Point
Diagnostic Limitations Difficult to correlate spontaneous events and laboratory findings Often must settle for an attributable cause Unknowns remain 20-30% 1 1 Kapoor W. In Grubb B, Olshansky B (eds) Syncope: Mechanisms and Management. Armonk NY; Futura Publishing Co, Inc: 1998; 1-13.
Unexplained Syncope Diagnosis History and Physical Exam Surface ECG Neurological Testing Head CT Scan Carotid Doppler MRI Skull Films Brain Scan EEG CV Syncope Workup Holter ELR or ILR Tilt Table Echo EPS Other CV Testing Angiogram Exercise Test SAECG Psychological Evaluation ENT Evaluation Endocrine Evaluation Adapted from: W.Kapoor.An overview of the evaluation and management of syncope. From Grubb B, Olshansky B (eds) Syncope: Mechanisms and Management. Armonk, NY: Futura Publishing Co., Inc.1998.
Typical Cardiovascular Diagnostic Pathway History and Physical, ECG Syncope Known SHD No SHD Echo EPS + Treat > 30 days; > 2 Events Tilt ILR Tilt Holter/ ELR ILR Tilt/ILR < 30 days - Adapted from: Linzer M, et al. Annals of Int Med, 1997. 127:76-86. Syncope: Mechanisms and Management. Grubb B, Olshansky B (eds) Futura Publishing 1999 Zimetbaum P, Josephson M. Annals of Int Med, 1999. 130:848-856. Krahn A et al. ACC Current Journal Review,1999. Jan/Feb:80-84.
NM Reflex Syncope: Pathophysiology Multiple triggers Variable contribution of vasodilatation and bradycardia
NMS – Basic Pathophysiology Cerebral Cortex Vascular Bed Bradycardia/ Hypotension Baro- receptors Heart Feedback via Carotid Baroreceptors Other Mechanoreceptors Parasympathetic (+) sympathetic (+) ¯ Heart Rate ¯ AV Conduction _ Vasodilatation Benditt DG, Lurie KG, Adler SW, et al. Pathophysiology of vasovagal syncope. In: Neurally mediated syncope: Pathophysiology, investigations and treatment. Blanc JJ, Benditt D, Sutton R. Bakken Research Center Series, v. 10. Armonk, NY: Futura, 1996
Neurally Mediated Physiologic Reflex Mechanism with two Components: Cardioinhibitory ( HR ) Vasodepressor ( BP ) Both components are usually present Vasovagal Syncope (VVS): Clinical Pathophysiology
Prevalence of VVS Prevalence is poorly known Various studies report 8% to 37% (mean 18%) of cases of syncope (Linzer 1997) In general: VVS patients younger than CSS patients Ages range from adolescence to elderly (median 43 years) Pallor, nausea, sweating, palpitations are common Amnesia for warning symptoms in older patients
DG Benditt, UM Cardiac Arrhythmia Center 16.3 sec Continuous Tracing 1 sec Spontaneous VVS
Management Strategies for VVS Optimal management strategies for VVS are a source of debate Patient education, reassurance, instruction Fluids, salt, diet Tilt Training Support hose Drug therapies Pacing Class II indication for VVS patients with positive HUT and cardioinhibitory or mixed reflex
Carotid Sinus Syndrome (CSS) Syncope clearly associated with carotid sinus stimulation is rare (≤1% of syncope) CSS may be an important cause of unexplained syncope / falls in older individuals
Etiology of CSS Sensory nerve endings in the carotid sinus walls respond to deformation “Deafferentation” of neck muscles may contribute Increased afferent signals to brain stem Reflex increase in efferent vagal activity and diminution of sympathetic tone results in bradycardia and vasodilation Carotid Sinus
Carotid Sinus Hypersensitivity(CSH) Abnormal response to CSM Absence of symptoms attributable to CSS CSH reported frequent in ‘fallers’ (Kenny) CSH CSS
CSS and Falls in the Elderly 30% of people >65 yrs of age fall each year 1 Total is 9,000,000 people in USA Approximately 10% of falls in elderly persons are due to syncope 2 50% of fallers have documented recurrence 3 Prevalence of CSS among frequent and unexplained fallers unknown but… CSH present in 23% of >50 yrs fallers presenting at ER 3 1 Falling in the Elderly: U.S. Prevalence Data. Journal of the American Geriatric Society, 1995. 2 Campbell et al: Age and Aging 1981;10:264-270. 3 Richardson DA, Bexton RS, et al. Prevalence of cardioinhibitory carotid sinus hypersensitivity in patients 50 years or over presenting to the Accident and Emergency Department with “unexplained” or “recurrent” falls. PACE 1997
Midodrine for Neurocardiogenic Syncope Journal of Cardiovascular Electrophysiology Vol. 12, No. 8, Perez-Lugones, et al. Months p < 0.001 Symptom – Free Interval 180160140120100806040200 100 80 60 40 20 0 Fluid Midodrine
Status of Pacing in VVS Perception of pacing for VVS changing: VVS with +HUT and cardioinhibitory response a Class IIb indication 1 Recent clinical studies demonstrated benefits of pacing in select VVS patients: VPS I VASIS SYDIT VPS II –Phase I ROME VVS Trial 1 Gregoratos G, et al. ACC/AHA Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmic Devices. Circulation. 1998; 97: 1325-1335.
Status of Pacing in VVS Benefits of specific device features evolving: Some success with DDD/DDI hysteresis 1 “False positives” may result in prolonged high rate intervention Tied to lower rate intervention Rate drop therapies designed for treating VVS syncope appear to be successful 2-4 1 Sutton R, et al. Circulation. 2000; 102:294-299. 2 Connolly S, et al. J Am Coll Cardiol 1999; 33:16-20. 3 Ammirati F, et al. Circulation. 2002; 104: 52-57. 4 Ammirati F, et al. NASPE Abstract #307. PACE, Vol. 24, April 2002, Part II.
VPS-I Vasovagal Pacemaker Study I Connolly S, et al. J Am Coll Cardiol 1999; 33: 16-20. Study Design: 54 patients randomized, prospective, single center _ 27 DDD pacemaker with rate drop response (RDR) _ 27 no pacemaker Patient Inclusion Criteria: 6 syncopal events ever +HUT Relative bradycardia* *a trough heart rate <60/min if no isoproterenol used, <70/min if up to 2 mcg/min isoproterenol used, or <80/min if over 2 mcg/min isoproterenol used
VPS- I Connolly S, et al. J Am Coll Cardiol 1999; 33: 16-20. Endpoints: Time to first syncope Outcome: RESULTS PACEMAKER (n= 27) CONTROL (n=27) Number of patients w/syncopal recurrence6 (22%)19 (70%) Mean time to first recurrence (days)11254 Relative risk reduction of syncope*85.4%- *2p = 0.000022
VPS- I Connolly S, et al. J Am Coll Cardiol 1999; 33: 16-20. Cumulative Risk (%) 100 90 80 70 60 50 40 30 20 10 0 15129630 Control (No Pacemaker) 2P=0.000022 Pacemaker Time in Months Number At Risk C2794210 P27211712118
VPS-I Conclusion: Dual-chamber pacing with rate drop response reduces the likelihood of syncope in patients with recurrent VVS. Connolly S, et al. J Am Coll Cardiol 1999; 33: 16-20.
VASIS Vasovagal Syncope International Study Sutton, R, et al. Circulation. 2000; 102:294-299. Study Design: 42 patients, randomized, prospective, multicenter _ 19 DDI pacemaker (80 bpm) with rate hysteresis (45 bpm) _ 23 no pacemaker Patient Inclusion Criteria: > 3 syncopal events in 2 years and last event occurring within 6 months of enrollment and, Positive VASIS type 2A or 2B cardioinhibitory response to HUT and, Age > 40 years or drug refractory if < 40 years
VASIS Sutton, R, et al. Circulation. 2000; 102:294-299. Outcome: RESULTS Pacemaker (n= 19) No Pacemaker (n=23) Number of patients w/syncopal recurrence1 (5%)14 (61%) Median time to first recurrence (months)*155 *P= 0.0006 Endpoints: Time to first syncope
VASIS Pacemaker No-Pacemaker p=0.0004 Years % syncope-free 100 80 60 40 20 023456 7121415233140 # of pts Sutton, R, et al. Circulation. 2000; 102:294-299.
VASIS Conclusion: Dual-chamber pacing (at a rate of 80 bpm ) with rate hysteresis reduces the likelihood of syncope in patients with tilt-positive, cardioinhibitory syncope. Sutton, R, et al. Circulation. 2000; 102:294-299.
SYDIT Syncope Diagnosis and Treatment Study Study Design: 93 patients randomized, prospective, multicenter _ 46 DDD pacemaker with rate drop response (RDR) _ 47 Atenolol 100 MG/D Patient Inclusion Criteria: > 55 yrs > 3 syncopal episodes in 2 years + HUT with relative bradycardia (trough HR <60 bpm) Ammirati F, et al. Circulation. 2001; 104:52-57.
SYDIT Endpoints: Time to first syncope Outcome: RESULTS PACED (n= 46) DRUG (n= 47) Number of patients w/syncopal recurrence*2 (4%)12 (25%) Median time to first recurrence (days)390135 *P=0.004 Ammirati, et al. Circulation. 2001; 104:52-57.
Syncope-free Survival: Intention-to-Treat (n=46/paced, 47/drug). Ammirati F, et al. Circulation. 2001; 104:52-57. SYDIT 1.0 Time (days) 100 0.9 0.8 0.7 0.6 20030040050060070080090010000 P = 0.0032 drug pacemaker % of syncope free pts
SYDIT Conclusion: Dual-chamber pacing + RDR is superior to Atenolol in prevention of recurrent syncope in highly symptomatic patients with relative bradycardia during tilt-induced syncope. Ammirati F, et al. Circulation. 2001; 104:52-57.
VPS-II: Phase I Vasovagal Pacemaker Study-II Study Design: 100 patients, randomized, prospective, multicenter _ 50 DDD pacemaker with rate drop response (RDR) _ 50 ODO pacemaker (inactive mode) Patient Inclusion Criteria: > 6 syncope events ever or > 3 syncope events in 2 years or > 1 syncope event in 6 months and, Positive HUT with syncope or presyncope and a heart rate blood pressure product <9000 Presented at the 23 rd Annual Scientific Sessions of the North American Society of Pacing and Electrophysiology. Late Breaking Clinical Trials, May 11, 2002.
VPS-II: Phase I Endpoints: Time to first syncope Outcome: RESULTS DDD Pacemaker (n= 50) ODO Pacemaker (n= 50) Number of patients w/syncopal recurrence16 (32%)22 (44%) Relative Risk Reduction*28.7%- *P=0.153 Presented at the 23 rd Annual Scientific Sessions of the North American Society of Pacing and Electrophysiology. Late Breaking Clinical Trials, May 11, 2002.
0.4 0.3 0.2 ODO DDD P = 0.153 (one-sided) Number at Risk ODO403735323121 DDD393634333317 0123456 0.1 0.0 Cumulative Risk of Syncope Presented at the 23 rd Annual Scientific Sessions of the North American Society of Pacing and Electrophysiology. Late Breaking Clinical Trials, May 11, 2002. VPS-II: Phase I
Conclusions: Lower than anticipated syncope event rate in the control arm. Higher than anticipated event rate in the treatment group. Consequence: treatment effect was less than VPS-I. Results favored pacing but the treatment effect was not statistically significant. Presented at the 23 rd Annual Scientific Sessions of the North American Society of Pacing and Electrophysiology. Late Breaking Clinical Trials, May 11, 2002.
VVS Pacing Trials Conclusions DDD pacing reduces the risk of syncope in patients with recurrent, refractory, highly-symptomatic, cardioinhibitory vasovagal syncope.
SAFE PACE Study Design Randomized controlled trial (N=175): Pacing (87) vs. No Pacing (88) Single center: Royal Victoria Infirmary, Newcastle, UK Recruitment began: April 1998 12 month follow-up per patient Study concluded: May 2000 Kenny RA, J Am Coll Cardiol 2001; 38:1491-1496.
SAFE PACE Inclusion Criteria Consecutive adults attending accident and emergency department > 50 Years - Experienced non-accidental fall Positive response to CSM Kenny RA, J Am Coll Cardiol 2001; 38:1491-1496.
SAFE PACE Screening Process Accident and Emergency Attendees > 50 Yrs Falls or Syncope Non-accidental Fall CSM Performed Cardioinhibitory or Mixed CSH RCT ControlPacemaker Kenny RA, J Am Coll Cardiol 2001; 38:1491-1496.
SAFE PACE Screening Results RCT (n=175) Control (n=88) Pacemaker (n=87) No pacing interventionMedtronic Thera DR (Rate Drop Response Algorithm) Kenny RA, J Am Coll Cardiol 2001; 38:1491-1496.
SAFE PACE Results Number of Falls Control n=87 Pacemaker n=84 % Participants w/Falls 60%58% Total Number of Falls* 699216 Mean Number of Falls** 9.34.1 * Falls during 12 months post randomization ** Crude adjustment calculation Kenny RA, J Am Coll Cardiol 2001; 38:1491-1496. 70% Reduction [OR 0.42; 95% CI: 0.23, 0.75]
Control N=87 Pacemaker N=84 % Participants w/Syncopal Events 22%11% Total Number of Syncopal Events 4722 Mean Number Syncopal Events 1.140.20 SAFE PACE Results Number of Syncopal Episodes 50% Reduction [OR 0.53; 95% CI 0.23; 1.20 ns] * Syncopal events 12 months past randomization ** Crude adjustment calculation Kenny RA, J Am Coll Cardiol 2001; 38:000-000.
Control n= 87 Pacemaker n= 84 % Participants w/Injurious Events 41%35% Total Number Injury Events 20261 -Fractures -Soft Tissue Injury 4 198 3 58 SAFE PACE Results Number of Injury Events 70% Reduction * Injurious events 12 months post randomization Kenny RA, J Am Coll Cardiol 2001; 38:1491-1496.
SAFE PACE Conclusions In patients with unexplained falls and a diagnosis of Cardioinhibitory CSH, cardiac pacing reduced the total number of: Falls by 70% Syncopal events by 53% Injurious events by 70% Kenny RA, J Am Coll Cardiol 2001; 38:1491-1496.
Role of Pacing in CSS -- Syncope Recurrence Rate Brignole et. Al. Diagnosis, natural history and treatment. Eur JCPE. 1992; 4:247-254 57% %6 % Recurrence Class I indication for pacing (AHA and BPEG) Limit pacing to CSS that is: Cardioinhibitory Mixed DDD/DDI superior to VVI (Mean follow-up = 6 months)
Section VI: Insights into More Efficient and Effective Diagnosis and Treatment
Syncope Due to Arrhythmia or Structural CV Disease: General Rules Often life-threatening and/or exposes patient to high risk of injury May be warning of critical CV disease Aortic stenosis, Myocardial ischemia, Pulmonary hypertension Assess culprit arrhythmia / structural abnormality aggressively Initiate treatment promptly
Principal Causes of Syncope due to Structural Cardiovascular Disease Acute MI / Ischemia Acquired coronary artery disease Congenital coronary artery anomalies HOCM Acute aortic dissection Pericardial disease / tamponade Pulmonary embolus / pulmonary hypertension Valvular abnormalities Aortic stenosis, Atrial myxoma
Syncope Due to Cardiac Arrhythmias Bradyarrhythmias Sinus arrest, exit block High grade or acute complete AV block Tachyarrhythmias Atrial fibrillation / flutter with rapid ventricular rate (e.g. WPW syndrome) Paroxysmal SVT or VT Torsades de pointes
Rhythms During Recurrent Syncope Krahn A, et al. Circulation. 1999; 99: 406-410 Normal Sinus Rhythm 58% Normal Sinus Rhythm 58% Bradycardia 36% Tachyarrhythmia 6%
AECG: 74 yr Male, Syncope From the files of DG Benditt, UM Cardiac Arrhythmia Center
Syncope: Torsades From the files of DG Benditt, UM Cardiac Arrhythmia Center
83 yo woman Bradycardia: Pacemaker implanted 28 yo man in the ER multiple times after falls resulting in trauma VT: ablated and medicated Reveal ® ILR recordings; Medtronic data on file.
Infra-His Block From the files of DG Benditt, UM Cardiac Arrhythmia Center
Treatment of Syncope Due to Bradyarrhythmia Class I indication for pacing using dual- chamber system wherever adequate atrial rhythm is available Ventricular pacing in atrial fibrillation with slow ventricular response
Treatment of Syncope Due to Tachyarrhythmia Atrial Tachyarrhythmias; AVRT due to accessory pathway – ablate pathway AVNRT – ablate AV nodal slow pathway Atrial fib – Pacing, linear / focal ablation, ICD selected pts Atrial flutter – Ablation of reentrant circuit Ventricular Tachyarrhythmias; Ventricular tachycardia – ICD or ablation where appropriate Torsades de Pointes – withdraw offending Rx or ICD (long- QT/Brugada) Drug therapy may be an alternative in many cases
Conclusion Syncope is a common symptom, often with dramatic consequences, which deserves thorough investigation and appropriate treatment of its cause.
Disclaimer INDICATIONS 9526 Reveal ® Plus Insertable Loop Recorder The Reveal Plus Insertable Loop Recorder (ILR) is an implantable patient activated monitoring system that records subcutaneous ECG and is indicated for patients who experience transient symptoms that may suggest a cardiac arrhythmia. 9790 Programmer The Medtronic 9790 Programmers are portable, microprocessor based instruments used to program Medtronic implantable devices. 6191 Activator The Model 6191 Activator is intended for use in combination with a Medtronic Model 9525 Reveal ® and the Model 9526 Reveal Plus Insertable Loop Recorders. CONTRAINDICATIONS There are no known contraindications for the implantation of the Reveal Plus ILR. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. WARNINGS/PRECAUTIONS 9526 Reveal Plus Insertable Loop Recorder Patients with the Reveal Plus ILR should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing. 6191 Activator Operation of the Model 6191 Activator near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device. See the appropriate technical manual for detailed information regarding indications, contraindications, warnings, and precautions. Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
Disclaimer INDICATIONS Medtronic.Kappa 700 Series Pacemakers The Medtronic.Kappa 700 Series pacemakers are indicated for rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity and are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac output and VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. 9790 Programmer The Medtronic 9790 Programmers are portable, microprocessor based instruments used to program Medtronic implantable devices. 9462 The Model 9462 Remote Assistant is intended for use in combination with a Medtronic implantable pacemaker with Remote Assistant diagnostic capabilities. CONTRAINDICATIONS The Medtronic.Kappa 700 Series pacemakers are contraindicated for the following applications: · Dual chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias. · Asynchronous pacing in the presence (or likelihood) of competitive paced and intrinsic rhythms. · Unipolar pacing for patients with an implanted cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of ICD therapy. WARNINGS/PRECAUTIONS Medtronic.Kappa 700 Series patients should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation to avoid electrical reset of the device, inappropriate sensing and/or therapy. See the appropriate technical manual for detailed information regarding indications, contraindications, warnings, and precautions. Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
Pacing in VVS Two randomized, controlled trials suggest benefit in selected patients with multiple (>5 lifetime) syncope recurrences and one or more of: prominent cardioinhibitory features asystolic pause >10 seconds sustained HR<40/minute
VVS Recurrences 35% of patients report syncope recurrence during follow-up ≤3 years Positive HUT with >6 lifetime syncope episodes: recurrence risk >50% over 2 years Sheldon et al. Circulation 1996; 93: 973-81. Savage et al. STROKE 1985; 16: 626-29.
SAFE PACE 2: Syncope and Falls in the Elderly 30% of individuals >65 yrs fall each year 5% of falls result in fractures 1% of falls result in hip fractures SAFEPACE Pilot Study 18% prevalence of CSH in unexplained ‘fallers’ 31% in ‘fallers’ >80 yrs Kenny RA, J Am Coll Cardiol 2001; 38:1491-1496.
Both Rate Drop Response Overview Detection Options Drop Detect Drop Detect Low Rate Detect Low Rate Detect Detects relative heart rate drops of a pre- determined size Detects heart rate that falls to a user-defined lower rate Detection occurs when either Drop Detection or Low Rate Detection criteria are met Rate Drop Detection in Medtronic Kappa® Series Pacemakers
Drop Detection with Intervention Drop Detection Method: Drop Size 25, Drop Rate 70 40 50 60 70 80 90 100 110 Ventricular Rate Drop Size=25 bpm Drop Rate Peak Rate=90 bpm 2 consecutive beats< Drop Size and Drop Rate Rate Drop Detection in Medtronic Kappa® Series Pacemakers
Drop Detect Peak Rate Drop Detection Method: Drop Size 25 40 50 60 70 80 90 100 110 120 Ventricular Rate Drop Size=25 bpm Peak Rate=90 bpm Rate Drop Detection in Medtronic Kappa® Series Pacemakers
Using Both Detection Algorithms When both detection algorithms are used: Detection occurs when either Drop Detection or Low Rate Detection criteria are met Intervention Rate, Duration and Termination are programmed the same as when using the individual detection modes Rate Drop Detection in Medtronic Kappa® Series Pacemakers
Rate Drop Intervention Therapy DDD or DDI pacing Pacing intervention Paces at programmed Intervention Rate for programmed duration Pacing termination Pacing rate decreases until there are three consecutive atrial senses or Lower Rate is reached Rate Drop Detection in Medtronic Kappa® Series Pacemakers
Challenges of Syncope Cost Cost/year Cost/diagnosis Quality of Life Implications Work/financial Mobility (automobiles) Psychological Diagnosis & Treatment Diagnostic yield and repeatability of tests Frequency and clustering of events Difficulty in managing/treating/controlling future events Appropriate risk stratification Complex Etiology
Diagnosing VVS Patient history and physical exam Positive tilt table test (ACC Consensus Protocol) Overnight fast ECG Blood pressure Supine and upright Tilt to 60-80 degrees Isoproterenol Re-tilt DG Benditt, Tilt Table Testing, 1996. 60° - 80°