Implantable loop recorders Michele Brignole Arrhythmologic Center, Lavagna, Italy

Transcription

1 Implantable loop recorders Michele Brignole Arrhythmologic Center, Lavagna, Italy

2 DECLARATION OF CONFLICT OF INTEREST Medtronic, minimal

3 ILR: available devices Reveal DX/XT, Medtronic Confirm, St Jude

4 ECG monitoring and syncope Diagnostic power In-hospital monitoring 1-7 Holter Monitoring 1-7 External loop recorder 30 Implantable loop recorder

5 SYNCOPE ISSUE 2 Syncope-free survival Eur Heart J 2006; 27, % 80% 83% Phase I 76% 67% 60% Total 51% Total: 392 pts 40% 20% 0% Days No. at risk Total

6 The PICTURE registry: Edvardsson et al. Europace 2010 Total 570 patients Total syncopes ILR-documented 36% 30%

7 Diagnostic yield of very prolonged ILR observation Arrhyhmologic Centre - Lavagna % Cumulative incidence % % 43% 52% Months Number at risk Furukawa T et al. Additional diagnostic value of very prolonged observation by ILR in patients with unexplained syncope. J Cardiovasc Electrophysiol 2011

8 Diagnostic yield of very prolonged ILR observation Arrhyhmologic Centre - Lavagna Furukawa T et al. Additional diagnostic value of very prolonged observation by ILR in patients with unexplained syncope. J Cardiovasc Electrophysiol Cumulative incidence % P= syncopes (n=80) <3 syncopes (n=77) Months

9 Diagnostic yield of very prolonged ILR observation Arrhyhmologic Centre - Lavagna Cumulative incidence % P= years (n=93) < 70 years (n=64) Months Furukawa T et al. Additional diagnostic value of very prolonged observation by ILR in patients with unexplained syncope. J Cardiovasc Electrophysiol 2011

10 Diagnostic yield of very prolonged ILR observation Arrhyhmologic Centre - Lavagna Furukawa T et al. Additional diagnostic value of very prolonged observation by ILR in patients with unexplained syncope. J Cardiovasc Electrophysiol Cumulative incidence % P=0.79 Female (n=70) Male (n=87) Months

11 Diagnostic yield of very prolonged ILR observation Arrhyhmologic Centre - Lavagna Cumulative incidence % P=0.20 No SHD/BBB (n=82) SHD (n=30) BBB (n=43) Months Furukawa T et al. Additional diagnostic value of very prolonged observation by ILR in patients with unexplained syncope. J Cardiovasc Electrophysiol 2011

12 Diagnostic yield of very prolonged ILR observation Arrhyhmologic Centre - Lavagna Adverse Events Non-sudden cardiovascular death 3 (1.9%) Ventricular tachycardia 1 (0.6%) Undocumented syncope recurrence (technical problem) 8 (5.1%) ILR explants for pocket infection 2 (1.3%) No syncope-related death Furukawa T et al. Additional diagnostic value of very prolonged observation by ILR in patients with unexplained syncope. J Cardiovasc Electrophysiol 2011

13 Implantable Loop Recorder: Diagnosis of Unexplained Syncope Take home message (I) Be prepared to wait even for a long time before obtaining a diagnosis

14 Diagnostic yield of very prolonged ILR observation Arrhyhmologic Centre - Lavagna ISSUE classification Type 4: Tachycardia 12% Type 3: Normal SR 34% 51% Type 1: Asystole 3% Type 2: Bradycardia Furukawa T et al. Additional diagnostic value of very prolonged observation by ILR in patients with unexplained syncope. J Cardiovasc Electrophysiol 2011

15 Cumulative incidence % Long term outcome after specific therapy guided by ILR Arrhyhmologic Centre - Lavagna Actuarial recurrence rate 1 year 5 year Total 3% 8% Pacemaker 4% 4% Months Total PM Total patients Pacemaker Furukawa et al. J Cardiovasc Electrophysiol 2011

16 A Type 1A, sinus arrest 7 min B 4 s 4 s 5 s 9,5 s 9,5 s 15 s Vasovagal

17 A Type 1C, BBB +AV block 2 min B P P P * P P P P P P P P P P P P P P P Re13 26/02/99 Intrinsic AV block 2 sec

18 Syncope due to idiopathic paroxysmal AV block: long-term follow-up of a distinct form of AV block J Am Coll Cardiol 2011; 58: Michele Brignole, Jean-Claude Deharo, Luc De Roy, Carlo Menozzi, Dominique Blommaert, Lara Dabiri, Jean Ruf, Regis Guieu Lavagna (I), Marseille (F), Reggio Emilia (I) and Louvain (B)

19 Idiopathic AV block Clinical features Absence of cardiac and ECG abnormalities Long history of recurrent unpredictable syncope Paroxysmal AV block with long pauses, abrupt onset, no P-P variation No progression to persistent AV block Efficacy of cardiac pacing therapy Laboratory findings Low plasmatic Adenosine level (APL) AV block reproduced by exogenous adenosine injection (ATP test) J Am Coll Cardiol 2011; 58:

20 CG, 68 m APL=0.27 µm Idiopathic (adenosine-mediated?) AV block

21 LG, 26 f APL=0.20 µm Idiopathic (adenosine-mediated?) AV block

22 J Am Coll Cardiol 2011; 58: Adenosine plasma levels APL (µm)

23 Implantable Loop Recorder: Diagnosis of Unexplained Syncope Take home message (II) A long pause is responsible of unexplained syncope in >50% of cases The mechanism is heterogeneous Permanent cardiac pacing is highly effective in preventing syncopal recurrences

24 Recommendations: Indications for ILR in patients with syncope Clinical situation In an early phase of evaluation of patients with recurrent syncope of uncertain origin who have: absence of high-risk criteria that require immediate hospitalization or intensive evaluation, and a likely recurrence within battery longevity of the device Class Level I B In high-risk patients in whom a comprehensive evaluation did not demonstrate a cause of syncope or lead to specific treatment ILR may be indicated to assess the contribution of bradycardia before embarking on cardiac pacing in patients with suspected or certain neurally mediated syncope presenting with frequent or traumatic syncopal episodes I IIa B B ILR may be indicated in patients with T-LOC of uncertain syncopal origin in order to definitely exclude an arrhythmic mechanism EHRA Position Paper & ESC Guidelines on Management of Syncope 2009 IIb B

25 Syncope Unit Project (SUP) Indications for ILR 700 patients underwent DIAGNOSTIC TESTS 541 DIAGNOSIS at conventional investigation 159 UNEXPLAINED SYNCOPE despite complete work-up evaluation 49 (31%) ILR NOT INDICATED (per protocol) 110 (69%) ILR POTENTIALLY INDICATED (per protocol) 7 (14%) LR ACTUALLY IMPLANTED (potentially inappropriate) 21 (18%) LR ACTUALLY IMPLANTED (appropriate) Vitale et al. Europace 2010 ; 12,

26 Syncope Unit Project (SUP) Indications for ILR Class I indications (unexplained syncope) Total patients with unexplained syncope n=159 ILR potentially indicated (estimated) n=110 ILR implanted (observed) n=28 ILR not implanted (observed) n= ILR not indicated n= Vitale et al. Europace 2010 ; 12, kappa test = 0.03 [CI ]

27 Syncope Unit Project (SUP) Indications for ILR Class I indications (unexplained syncope) Observed incidence: 30 per million inhabitants per year (CI 23-39) Estimated incidence: 118 per million inhabitants per year (CI ). Vitale et al. Europace 2010 ; 12,

28 Implantable Loop Recorder: Diagnosis of Unexplained Syncope Take home message (III) Currently ILRs are largely underused