SEVEN YEARS OF CRYO-BALLOON CATHETER ABLATION
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1 SEVEN YEARS OF CRYO-BALLOON CATHETER ABLATION. FOLLOW-UP ANALYSIS, RESULTS, RECURRENCES, COMPLICATIONS AND SIDE EFFECTS IN PATIENTS TREATED FOR PAROXYSMAL ATRIAL FIBRILLATION, WITH A PROSPECTIVE PROTOCOL GUIDED BY COMPLETE BIDIRECTIONAL LEFT ATRIUM- PULMONARY VEINS DISCONNECTION AFTER ADENOSINE AS MAIN TARGET END POINT. A SINGLE CENTER REPORT. Disclosure None Conflict Of Interest Jesus M. Paylos, C. Ferrero, L. Azcona, A. Morales, M. A. Vargas, L. Lacal, C.M. Cilleros, T.G. Delange. Arrhythmia Unit and Electrophysiology Lab. Moncloa University Hospital European University of Madrid Madrid (Spain)!
2 INTRODUCTION) Complete pulmonary veins isolation (PVI) from the left atrium (LA) is CRUCIAL to cure patients with Atrial Fibrillation.
3 INTRODUCTION) PVI with Cryo-Balloon (CB) has demonstrated it s effectiveness for the treatment of Paroxysmal Atrial Fibrillation (PAF).
4 INTRODUCTION) However, Cryo-Energy CB application doesn t produce a homogeneous circumferential lesion (*) in all PV, wich is related to their anatomical shape and size. (*) Paylos J.M. et.al. Gadolinium Delayed-Enhancement MRI to asses the extension of residual cryo-balloon catheter induced lesion at the Left-Atrium-PV-Junction level in patients treated for Paroxismal Atrial Fibrillation. Heart Rhythm Vol. 7. No.5 May Supplement 2010.
5 INTRODUCTION) And a better cuantification of the Cryoablation zone and the anatomical extent of pulmonar vein have been better clarify in recent years(*). (*) Chierchia G.B. et.al. Anatomical extent of pulmonary vein isolation after cryoballon ablation for atrial Fibrillation: Comparison between the 23 and 28mm balloons. J. Cardiovasc Med (Hagerstown) 2011 ; 12: (*) Kenigsberg D.N. et. al. Quantification of the cryoablation zone demarcated by pre- and postprocedural electroanatomic mapping in patients with atrial fibrillation using the 28-mm second-generation cryoballoon.heart Rhythm. 2015;12 No2:
6 INTRODUCTION) Incomplete lesions with dormant tissue (despite a perfect occlusion) can occur leading to a residual conduction (RC) gaps causing (or responsible) for PV reconduction wich is the principal cause of RECURRENCE.
7 INTRODUCTION) Adenosine (AD) has been used to unmask RC in apparently isolated PV with Radiofrequency (RF). Routine use of AD after acute CB-PVI allows to identify incomplete lesions with dormant tissue not evident in basal conditions. Focal/ Freeze/RF applications eliminates such RC.
8 INTRODUCTION) The Only No Evidence of PV/Electrical activity on the circular-mapping-catheter at the LA-PV Junction level after CB-PVI is Not Enough to assure complete acute PVI, and checking for Entry and Exit Block is Mandatory to confirm it.
9 INTRODUCTION) We analyzed our seven years follow-up experience of our patients, initially treated with CB for PAF, with demonstration of complete bidirectional electrical isolation (CBEI) of the pulmonary veins (PV) from the left atrium (LA) after AD as the main target end point to achieve, in all cases.
10 INTRODUCTION) (Protocol) Exit block By pacing PV from all 20 poles of the circular catheter at high amplitude voltage with consistent 1:1 PV capture and no evidence at all of Any atrial response. Entry block By pacing LA from the CS-Catheter at three different cycle lengths (600, 500, 400 ms) with consistent 1:1 LA capture and no evidence at all of Any PV electrical activity in any of the 20 poles of circular-catheter mapping placed into the vein at the LA-PV Junction level.
11 METHODS) With this approach: Checking for Entry and Exit / Block. After Basal / Acute PVI, and repeating / After AD. Elimination of Residual gaps by Freeze/Focal RF / Applications. Since November 2008 to July 2015: 114 Patients Highgly symptomatic, suffering from recurrent PAF, refractory to medical treatment, were treated with the CB and Followed-Up
12 METHODS) 114 Patients (mean age 56±13 years). 86 Male (75.4%) mean age 53 ± Female (24.6%) mean age 61 ±10! Mean / Years / PAF: 5 ±5 (1-25)! Folow-up time/days: 1693 ±653 ( )! Mean / Episodes PAF / Year: 58±66 (2-200)! None Structural Heart Disease.)! Mean LVEF: 67 ±5 %.
13 METHODS) All patients previously treated with antiarrhythmic:! ßß (87%)! Class III (1.7%)! Class 1C (89.5%)! ßß + 1C (76.3%).
14 METHODS) Morphological and structural data: LA Diameters (mm) LA/ AREA (cm²) PV(mm) 434 CT 22 LVEF AP:37±6 (21-50) AP:18±5 (8-32) AP: 26±6 (18-35) LAT: 47±7 (35-61) 22±4 (11-32) SI:20±4 (10-28) SI: 26±5 (17-31) 67±5% (59-79) SI: 54±7 (40-75)
15 METHODS) " First-Generation Cryoballoon: 74 Patients. 28 mm: 73 patients 23 mm: 1 Patient " Second-Generation Cryoballoon: *40 Patients ) 28 mm: 37 Patients 23 mm: 4 Patients *!In!1!pa'ent!28mm!CB!was!used!(Proximal!applica'on)!&!23mm!CB!(Distal!applica'on).!
16 METHODS) PV CARTOGRAPHY / MAPPING ) Circular!Duodecapolar!7!French!with!adjustable!diameter!catheter.!(Saint!Jude! Reflexion!Spiral).!! Grade(*) of CB /Application / Occlusion / for PVI III ( 12.9 %) 143 Applications IV ( 80 %) 885 Applications (*) Neumann T, et. al. Circumferential pulmonary vein isolation with the cryoballoon technique results from a prospective 3- center study. J Am Coll Cardiol. 2008;52:273-8.
17 METHODS) Cryo-Ablation (Mean Temperature Reached) Occlusion Occlusion Grade III : Grade IV : Temperature: 42±5 ºC Temperature: - 51±8 ºC Nº Occlusions: 2±1 Nº Occlusions: 2±1
18 METHODS) Adenosine / Protocol Bolus administration of increasing doses ( mgrs). Pacing PV / LA (600, 500, 400 ms CL). WHEN A-V Conduction Block Ocurred.
19 METHODS) Freeze/ RF protocol Residual Conduction gaps (RC) Basal After checking (Basal) for Entry and Exit Block After checking (Adenosine) for Entry and Exit Block Were eliminated by Freeze/Focal RF Applications. Only the most Extensive RC required 2 RF Focal Applications to Abolished. RC >2 Pair / Electrode / Circular Catheter Repeated New CB / Application (Occlusion)
20 RESULTS) A total of 434 PV and 22 Common Trunks (CT) were treated with CB CBEI demonstrated in 392 (90.3%). Acute reconduction post CB showed 42 (9%) PV. 14 (3,2%) Residual Conduction (gap). 16 (3,5%) /392 PV Reconduction after Adenosine. 10 patients 12 (2,7%) Extrapulmonary Muscular Connections (EMC)(*) 9 patients (*) Cabrera J.A. Ho S.Y., Climent V. et al, Morphological evidence of muscular connections between contiguous pulmonary venous orifices: Relevance of the interpulmonary isthmus for Catheter ablation in Atrial Fibrillation Heart Rhythm 2009;6: (*) Squara F., Liuba I., Chik W. et al. Electrical connection between ipsilateral pulmonary veins: Prevalence and implications for ablation and adenosine testing Heart Rhythm 2015;12:
21 METHODS) Oclussion Degree III with contrast / Leakage RF / RSPV gap gap After Adenosine
22 METHODS) LIPV / Basal Oclussion Degree IV / LIPV LIPV Post-Crio
23 METHODS) Pacing (Circular 1,2) PV Exit Block Adenosine 12 mg. i.v. RC / gap / Pacing (Circular 1,2) Conduction 1:1 PV/LA
24 RF / Residual Potential / gap METHODS) Adenosine 12 mg. i.v. Pacing gap / RF Catheter Conduction 1:1 PV/LA RF / Residual Potential / gap
25 RESULTS) BB after Adenosine 422/434 PV 96.5 % The)Remaining)12/434)PV! Extrapulmonary Muscular Connection Were Demonstrated and All finally abolished by Focal RF applications distal into the vein.
26 METHODS) EXTRAPULMONARY MUSCULAR CONNECTION Pacing Proximal Antrum (Circular 13-14) Exit Block Pacing Distal Vein (Circular 13-14) Conduction 1:1 PV/LA
27 METHODS) EXTRAPULMONARY MUSCULAR CONNECTION Pacing gap Distal Vein / RF Catheter Conduction 1:1 PV/LA Pacing Distal / Post Focal RF Exit Block RF
28 RESULTS) FOLLOW-UP First / 3 months / after CB / ablation All patients were under medical treatment, including:! Flecainide Atenolol Oral Anticoagulation (Dicumarine) And completely / stopped and discontinued / After this period.! Follow-Up 1693 ± 653 / days (3 ±84 months)
29 RESULTS) FOLLOW-UP 14 pts. (12.3%) had clinical recurrence. 12 M (52 ± 8) years 2 F (63 ±13) years Early Recurrences. Occurred when medication stopped after three months blanking-period in 9 male. Late Recurrences. Presented 3 male at 24, 27 and 60 months and 2 female at 7 and 40 months respectively.
30 RESULTS) FOLLOW-UP RECURRENCES 14 Patients out of 114 RECURRED % Second procedure (REDO) 14 /14 (100%)
31 RESULTS) RECURRENCES) REDO Cases (Second Procedure) 14 patients with 54 PV. Including 2 CT. 54 PV 29 ))(53,7%))Reconducted SEGMENTS SUPERIOR INFERIOR ANTERIOR POSTERIOR 2 3 Same Patient
32 RESULTS) RECURRENCES 14)PATIENTS) (REDO)) LS PV 1 Basal RS PV 1 SEGMENT/)LOCATION!!! 1 st.)procedure) 2 LI PV RI PV 1 SEGMENTS SUPERIOR INFERIOR 6)PATIENTS) 9)PV! Adenosine LS PV RS PV 1 ANTERIOR POSTERIOR TOTAL:)9)Segments! (Different segment location First/Second Procedure) LI PV RI PV 1 1
33 RESULTS) We have not done any protocol to rule out Non PV-Foci (as a potential cause of Arrhythmia recurrence)*, because all recurrences were REDO, and PV-LA reconduction demonstrated in all cases. (*) Hayashi K, An Y, Nagashima M. et. al. Importance of nonpulmonary vein foci in catheter ablation for paroxysmal atrial fibrillation. Heart Rhythm 2015;12:
34 RESULTS) In a REDO follow-up (40±14 months) All 14 pts remain in Sinus Rhythm with not medication. The REMAINING 100 Patients Follow-up 1693±653 days (3-84 months) 87.7 % Are Asymptomatic, Free of Drugs, in Sinus Rhythm.
35 RESULTS) SIDE)EFFECTS)AND)COMPLICATIONS:)!! Aphonia(*):!6!pts!(5.7%).!!! Phrenic!paresia(**):!7!(6.7%).!!! Phrenic!palsy(**):)2)(1.9%).!! Pulmonary!infiltrates*:!5!(4.8%).!! Dyspepsia:!2!(1.9%).!! Bronchospasm:!2!(1.9%).!!! IntraTnodal!reentry:!2)(1.9%).!!! InThospital!arrhythmia:!1!(0.9%).! *! Pulmonary infiltrates (*) Cabrera J.A., Murillo M, Climent V. et. al. Relationship between the left Recurrent Lariyngeal nerve and left atrium: A postmortem study in patients with and without Atrial Fibrillation. Heart Rhythm. 2011;S413: PO (**) Mugnai G. De Asmundis C, Ciconte G. et. al. Incididence and Characteristics of complications in the setting of secondgeneration cryoballoon ablation: A large single-center study of 500 consecutive patients. Heart Rhythm. 2015;12:
36 RESULTS) SIDE)EFFECTS)AND)COMPLICATIONS))! RSPV) CB)applicaWon.) TRANSIENT)PHRENIC))NERVE))PARESIA) T!ºC! Seconds! CB!mm.! CB!Genera'on! 1! T68! 122! 28! FIRST! 2! T73! 222! 28! FIRST! 3! T55! 89! 28! SECOND! 4! T56! 165! 23! SECOND! 5! T60! 115! 28! SECOND! 6! T68! 100! 28! SECOND! 7! T65! 190! 28! SECOND! 78%) Mean!T.ºC!! ) Y60ºC) PERMANENT)PHRENIC)NERVE))PALSY) 1! T70! 100! 28! FIRST! 2! T68! 156! 28! FIRST!
37 RESULTS) SIDE)EFFECTS)AND)COMPLICATIONS)) Follow-up.! - Aphonia: Lasting 72 hours. - Permanent Phrenic Nerve Palsy: Chest X-Ray (1-3 years) - Pulmonary Infiltrates: (No Symptoms). Showed at first month CT-Scan control. No evidence at 3 months CT-Scan control. - Dyspepsia: Quick complete resolution 72 hours (Omeprazol).
38 RESULTS) SIDE)EFFECTS)AND)COMPLICATIONS))! Mortality))))))))))))))))))))))))))))))))))0) ) Atrioesophageal)fistula))))))))))0) ) PV)Stenosis)))))))))))))))))))))))))))))))0)
39 CONCLUSIONS) 1. Cryo-Energy PV application doesn t produce a homogeneus circumferential lesion in all PV. 2. Checking for BB and Adenosine protocol allow to identify 19% of patients with potential substrate for PV/ LA Reconduction and possibly recurrence of the Arrhythmia. 3. Routine use of AD after acute CB-PVI allows to identify incomplete lesions with dormant tissue, and eliminate them by freeze or focal RF applications, Improves the long-term rate of the possible definitive cure of patients suffering PAF.
40 CONCLUSIONS) 4. CB technique alone is very effective and safe for the definitive treatment of PAF, with 68.7% success rate, increasing up to 87.7% when this protocol is applied, remaining Patients in sinus rhythm, free of arrhythmia, without medication, in a very long-term followup.
41 CONCLUSIONS) 5. However, Late Recurrences, generates some concern about a greater increase number of patients with recurrent arrhythmia in a longer term, specially in the future patients who don t feel symptoms of the arrhythmia
42 CONCLUSIONS) To the best of our Knowlegde This serie includes the largest follow-up described, so far.
43
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