Κατάλυση παροξυσμικής κολπικής μαρμαρυγής Ποια τεχνολογία και σε ποιους ασθενείς; Χάρης Κοσσυβάκης Καρδιολογικό Τμήμα Γ.Ν.Α. «Γ. ΓΕΝΝΗΜΑΤΑΣ»
Rhythm control antiarrhythmic drugs vs catheter ablation
Summary of randomized control trials comparing catheter ablation versus antiarrhythmic therapy. Roderick Tung et al. Circulation. 2012;126:223-229
Pulmonary Vein Isolation is the Cornerstone of Paroxysmal and Persistent AF Ablation Haïssaguerre M et al NEJM 1998 339:659-666 86% Paroxysmal AF PVI Only 2012 34% Persistent AF PVI Only
Percutaneous PVI Ablation Techniques Point to point pulmonary vein isolation Uses Radiofrequency catheter ablation (RFCA) circumferential ablation systems Laser balloon catheter Pulmonar vein ablation catheter PVAC balloon-based cryoablation
2012 HRS Consensus Statement point-by-point RF energy and Cryoballoon ablation are the two standard ablation systems used for catheter ablation of AF today... Radiofrequency (RF) catheter ablation (RFCA) balloon-based cryoablation
Radiofrequency (RF) catheter ablation (RFCA) Point to point pulmonary vein isolation Imaging via fluoroscopy and venography
ΣΥΣΤΗΜΑΤΑ ΗΛΕΚΤΡΟΑΝΑΤΟΜΙΚΗΣ ΧΑΡΤΟΓΡΑΦΗΣΗΣ CARTO Nav-X
ostial isolation PV Ostial Isolation Reasonable efficacy for paroxysmal AF Modest efficacy for persistent AF Requires less RF Risk considerations: rare <1% PV stenosis, phrenic nerve injury (right) wide area encircling Extensive antral ablation Wide area / antral Isolation Better efficacy for persistent AF, still modest Requires irrigated or 8 mm electrode Facilitated with a mapping system Risk considerations: esophageal injury,phrenic nerve injury (left)
Freedom from AT one procedure 47% multiple procedures 80%
significant decrease in the acute complication rate in 2007 to 2012 compared with 2000 to 2006 (2.6% versus 4.0%; P=0.003) The acute complication rate has decreased significantly in recent years.
THERMOCOOL SMART TOUCH
Cryoballoon Has Experienced Rapid Growth in Worldwide Adoption and Clinical Experience 200.000 180.000 180.00 0 160.000 140.000 120.000 100.000 80.000 60.000 50.00 40.000 20.000 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Arctic Front Cryoballoon US approval for Artic Front Arctic Front Advance Cryoballoon 15
cryoballoon ablation first-generation (CB-1) vs the second-generation (CB-2) CB-2 offers a greater cooling surface area 16
Single Procedure Freedom from AF, AT and AFL Arctic Front Advance Cryoballoon Single Center Published Studies Single Procedure Freedom From AF, most off AAD p=0.038 p=0.008 p=ns p=0.012 P<0.001 Di Giovanni, et al. J Cardiovasc Electrophysiol. 2014; 25(8):834-9, Fürnkranz, et al. Journal of Cardiovascular Electrophysiology 2014 ;25(8):840-4, Aryana, et al. J Interv Card Electrophysiol 2014;41(2):177-186, Aytemir, et al. Europace; 2015;17(3):379-87, Metzner, et al. Circ Arrhythm Electrophysiol. 2014; 7(2):288-292, Chierchia, et al. Europace 2014; 16(5):639-644, Kumar et al. J Interv Card Electrophysiol 2014;41(1):91-7, Jourda, et al. Europace 2015;17(2):225-31, Ciconte, et al. Heart Rhythm 2015;12(4):673-80, Wissner, et al. Europace 2015, In Press. 17
5 years success rate after single CB ablation procedure was 53% Europace (2013) 15, 1143 1149
RFC Ablation ( FIRE ) vs Cryoballoon Ablation ( ICE ) Cryoballoon Ablation of PV Kuck K-H, et al. Cryoballoon or Radiofrequency Ablation of Paroxysmal Atrial Fibrillation. The New England Journal of Medicine. Epub ahead of print (NEJM 16-02014). 19
Primary Efficacy Endpoint Met Primary Safety Endpoint Met Kuck K-H, et al. Cryoballoon or Radiofrequency Ablation of Paroxysmal Atrial Fibrillation. The New England Journal of Medicine. Epub ahead of print (NEJM 16-02014).
Kuck et al, European Heart Journal (2016) 37, 2858 2865
Procedural Characteristics Shorter, More Consistent* Procedure Times with the Cryoballoon Time Measurement (minutes) RFC (n=376) Cryoballoon (n=374) P-value ** Procedure Time *** 140.9 ± 54.9 124.4 ± 39.0 <0.0001 LA Dwell Time *** 108.6 ± 44.9 92.3 ± 31.4 <0.0001 Fluoroscopy Time 16.6 ± 17.8 21.7 ± 13.9 <0.0001 * Standard deviations were smaller in the cryoballoon group for all three procedure time measures, indicating more consistent times with less variation from the mean. ** t-test *** Protocol required 30 min. waiting period after last application to assess PV isolation. Kuck K-H, et al. Cryoballoon or Radiofrequency Ablation of Paroxysmal Atrial Fibrillation. The New England Journal of Medicine. Epub ahead of print (NEJM 16-02014). 22
Cardiovascular rehospitalization cryoballoon group had lower cardiovascular rehospitalization rates in each subgroup but more significant in the CHA2DS2-VASc 0 1 subgroup Kuck et al, European Heart Journal (2016) 37, 2858 2865
On the other hand, RF was the first technology approved for AF ablation and therefore has the longest track record the availability of contract force sensing has also allowed more consistent and durable lesion formation Skilled RF operators should not abandon an approach with which they have been getting good results cryoablation with the cryoballoon is designed only for ablation of the pulmonary veins patients who have both atrial fibrillation and atrial flutter non pulmonary vein triggers
Electroanatomical mapping
CB is associated with efficacy and safety comparable to that of RF Buiatti et al, Europace,July 2016
CB ablation increases the risk of persistent phrenic nerve palsy RF ablation increases the risk of cardiac tamponade Buiatti et al, Europace,July 2016
Catheter ablation for atrial fibrillation (AF) is done to reduce symptoms European Heart Journal 2016
JAMA. 2010;303(4):333-340
success rates of catheter ablation (CA) and antiarrhythmic drug (AAD) therapy complication rates of catheter ablation (CA) and antiarrhythmic drug (AAD) therapy Circ Arrhythm Electrophysiol. 2014;7:739-746.
Cost comparison of catheter ablation vs antiarrhythmic drug therapy as a first-line therapy for atrial fibrillation young patients with minimal structural heart disease ablation must be performed in expert centres Circ Arrhythm Electrophysiol. 2014;7:739-746.
Factors influencing patient selection 1)type and duration of atrial fibrillation, 2)Symptom 3)patient age 4)underlying cardiac structure 5)left atrial size.
1838 patients, mean follow-up 23 months LVEF improved significantly during follow-up by 13% Efficacy in maintaining sinus rhythm with repeat procedures was 60% Key point Catheter ablation performed early in the natural history of AF and heart failure Circ Arrhythm Electrophysiol. 2014;7:1011-1018.
LEFT ATRIAL SIZE Europace (2013) 15, 1143 1149
Age Afib ablation appropriate therapy only for young patients? most studies have excluded patients older than 70 years of age incidence of tamponade and thromboembolic events was four times higher in patients who were> 70 years than in patients who were <70 years (Circulation 2004;110:348.) Age greater than 50 years was found to be an independent preprocedural predictor of AF recurrence J Cardiovasc Electrophysiol 2004, 15:692 697.
mean follow-up of 18 ± 6 months after a single procedure 69% octogenarians free from AF recurrence vs 71% in patients < 80 years after 2 procedures success rate reached 87% The rate of procedure-related complications was also not significantly different between the 2 age groups J Cardiovasc Electrophysiol, Vol. 23, pp. 687-693, July 2012
What about prognosis?
Rate or rhythm control? AFFIRM RACE Randomized trial of rate-control versus rhythm-control in persistentatrial fibrillation: the Strategies of Treatment of Atrial Fibrillation (STAF) study. J Am Coll Cardiol 2003;41:1690 1696 Rhythm or rate control in atrial fibrillation: Pharmacological Intervention in Atrial Fibrillation (PIAF): a randomised trial. Lancet 2000;356:1789 1794.
low rate of restoration and maintenance of SR. patients at relatively late stages of the disease process high percentage of persistent AF, dilated left atria Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Study Circulation 2004;109:1509 1513. Optimal treatment strategy for patients with paroxysmal atrial fibrillation: J-RHYTHM Study. Circ J 2009;73:242 248.
3058 patients with paroxysmal or persistent AF 10 years of follow-up. low risk ( Absence of symptomatic or documented recurrences of AF after RFA is associated with a significant 60% lower risk of cardiac mortality, irrespective of the blanking period or antiarrhythmic or anticoagulant drug use Heart Rhythm 2014;11:1503 1511
Mortality incidence of ischaemic stroke catheter ablation was associated with: lower risk of ischaemic stroke [hazard ratio (HR) 0.69, 95% confidence interval (CI) 0.51 0.93) lower mortality risk (HR 0.50, 95% CI 0.37 0.62 European Heart Journal (2016) 37, 2478 2487
Thromboembolic risk beyond 3 months after RFA was relatively low compared with a matched non-ablated AF cohort with and without OAC European Heart Journal (2015) 36, 307 314
CONTINOUS AFIB AND ATRIAL REMODELLING atrial fibrillation begets atrial fibrillation
THE SOONER THE BETTER AF Treatment Must be Provided Before the Fibrosis Process Makes Intervention More Difficult Human Atrial Fibrogenesis is Enhanced with Increasing Duration of AF A. Patients in sinus rhythm (SR) with no history of AF, B. Patients with paroxysmal (self-terminating) and early persistent (not spontaneously self-terminating) AF were defined as one or more episodes of documented AF, the longest episode being less than 6 months in duration, C. Persistent AF with failed or unattempted cardioversion was defined as AF of >6 months duration.
percentage of AF progression at 1 year ranged from 10% to 20%. Studies that included a longer follow-up detected a higher percentage of progression (from 50%to 77% after 12 years). In patients treated with catheter ablation, the percentage of progression was significantly lower (from 2.4% to 2.7% at 5 years follow-up). JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 1, NO. 3, 2015 JUNE 2015:105 1 5
The progression from paroxysmal atrial fibrillation (AF) to persistent or long-term persistent forms a significant morbidity and mortality associated with this transition. J Am Coll Cardiol 2010;55:725 31
Catheter ablation in asymptomatic patients? Atypical and asymptomatic AF conferred higher risks of cerebrovascular events compared to typical AF after adjustment for CHA2DS2-VASc score and age (hazard ratio [HR] 3.51, 95% confidence interval [CI] 1.65 7.48, and HR 2.70, 95% CI 1.29 5.66, respectively) Asymptomatic AF was associated with an increased risk of cardiovascular (HR 3.12, 95% CI 1.50 6.45) and all-cause mortality (HR 2.96, 95% CI 1.89 4.64) compared to typical AF after adjustment for CHA2DS2- VASc score and age Heart Rhythm 2016;13:1418 1424
Catheter ablation in asymptomatic patients? primary justification for an AF ablation procedure at this time is the presence of symptomatic AF, with the goal of improving patient quality of life. the majority of the responding European Centers followed a rhythm control strategy, particularly in young patients and in patients with a first detected AF episode even if AF was well tolerated. Europace (2013) 15, 478 481
Young asymptomatic patients may be an exception to this rule 1. window of opportunity to maintain sinus rhythm exists (only) early in the course of management 2. maintenance of sinus rhythm may prevent not only AF progression but also improve outcome. 3. a patient may develop debilitating symptoms later on when AF has become more difficult to treat
Arguments contra catheter ablation in asymptomatic patients a relevant risk of major complications and the complexity of the procedure AF ablation success rates on and off antiarrhythmic drugs do not exceed 80% and frequently require repeat procedures to achieve these success patients undergoing PVI may develop atrial tachycardias transforming a previously asymptomatic individual in a highly symptomatic patient
conclusions Pulmonary vein isolation remains the gold standard for paroxysmal afib catheter ablation Radiofrequency contact force catheter ablation and 2 nd generation cryobaloon ablation have similar efficacy and safety Catheter ablation in early stage improves efficacy and safety Multicenter, prospective, randomized studies need to reconfirm the improved outcome in patients undergoing catheter ablation