optimal method and outcomes of catheter ablation of persistent af: the star af 2 trial
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Optimal Method and Outcomes of Catheter Ablation of Persistent AF: The STAR AF 2 Trial. Atul Verma, Jiang Chen-yang, Tim Betts, John Radcliffe, Jian Chen, Isabel Deisenhofer, Roberto Mantovan, Laurent Macle, Carlos Morillo, Prashanthan Sanders on behalf of the STAR AF 2 Investigators - PowerPoint PPT PresentationTRANSCRIPT
Optimal Method and Outcomes of Catheter Ablation of Persistent AF:
The STAR AF 2 Trial
Atul Verma, Jiang Chen-yang, Tim Betts, John Radcliffe, Jian Chen, Isabel Deisenhofer, Roberto Mantovan, Laurent Macle,
Carlos Morillo, Prashanthan Sanderson behalf of the STAR AF 2 Investigators
ClinicalTrials.gov NCT01203748
The STAR AF 2 trial was funded by St Jude Medical Inc.
Disclosures
• Dr Verma reports having served on advisory boards for and receiving grant support from Bayer, Boehringer Ingelheim, Medtronic, Biosense Webster, and St Jude Medical.
• Dr Betts reports lecture fees and grant support from St Jude Medical.
• Dr Macle reports receiving consulting fees from St Jude Medical, Biosense Webster, Bristol Meyers Squibb, and Pfizer and grant support from St Jude Medical and Biosense Webster.
• Dr Morillo reports receiving consulting fees from Boston Scientific, Medtronic, St Jude Medical, and Boehringer Ingelheim and grant support from Boston Scientific, Biosense Webster, Pfizer, and Merck.
• Dr Sanders reports having served on advisory boards for and receiving grant support and lecture fees from Biosense-Webster, Medtronic, St Jude Medical, Sanofi-Aventis, and Merck; receiving lecture fees and grant support from Biotronik; and receiving grant support from Sorin.
• Drs. Jiang, Chen, Deisenhofer, and Mantovan do not have any disclosures.
Background
• Catheter ablation is an effective treatment for symptomatic paroxysmal atrial fibrillation (AF)
• Pulmonary vein isolation (PVI) is considered the cornerstone for catheter ablation of AF
• Ablation of persistent AF is challenging and typically has less favorable outcomes compared to paroxysmal AF
Background
• To improve outcomes for persistent AF, guidelines suggest that “operators should consider more extensive ablation based on linear lesions or complex fractionated electrograms” in addition to PV isolation
• Whether more extensive ablation improves outcomes is unclear
Purpose
• To compare the efficacy of three different AF ablation strategies in patients with persistent AF:
(1) Pulmonary vein isolation (PVI) alone
(2) PVI plus complex fractionated electrograms (PVI+CFE)
(3) PVI plus linear ablation (PVI+Lines).
Methods - Patients
• 589 patients were recruited from 48 experienced ablation centers in 12 countries
• Inclusion: symptomatic persistent AF (a sustained episode > 7 days and < 3 years) refractory to at least one antiarrhythmic drug undergoing first-time ablation
• Exclusion: paroxysmal AF, sustained AF episode > 3 years, left atrial diameter > 60 mm
Methods – Trial Design
• Patients were randomized 1:4:4 to the three strategies:
– PVI, PVI+CFE, PVI+Lines
• Patients were blinded to the strategy (single blind)
• Repeat ablation procedures allowed between 3-6 months using the same randomized strategy as the first ablation
Methods – Ablation Strategy
• PVI = PV antral isolation with endpoint of entrance and exit block by a circular mapping catheter
• PVI+CFE = PVI followed by mapping and ablation of complex fractionated electrograms during AF identified by validated software in the 3D mapping system (Ensite Velocity)
• PVI+Lines = PVI followed by a left atrial roof line and a line along the mitral valve isthmus with endpoint of bidirectional block confirmed by pre-specified pacing maneuvers
Methods – Ablation Strategy
Linear strategy
CFE strategy
Methods – Follow-up
• Patients were followed for 18 months
• Visit, ECG and 24 hour Holter at 3, 6, 9, 12 and 18 months
• Weekly TTM transmissions for 18 months
• TTM transmissions every time symptoms felt
– Tele-ECG-Card, Vitaphone, Germany
Outcomes
• Primary Outcome– Freedom from documented AF episode > 30 seconds after one ablation
procedure with or without antiarrhythmic medications*• Episodes during initial 3 month “blanking period” excluded from analysis
• Secondary Outcomes– Freedom from documented AF > 30 seconds after 2 procedures with or
without antiarrhythmic medications– Freedom from any atrial arrhythmia (AF/AFL/AT) after one or two
procedures– Procedural time– Incidence of repeat procedures– Procedural complications**– Use of antiarrhythmic medications
* TTMs and recurrences blindly adjudicated, ** blinded events committee adjudication
Results - Baseline CharacteristicsCharacteristic PVI PVI+CFE PVI+Lines
Age - year 58 ± 10 60 ± 9 61 ± 9Male sex – n (%) 52 (78) 213 (82) 196 (76)Ejection fraction (%) 55 ± 11 57 ± 10 57 ± 10Left atrial diameter (mm) 44 ± 6 44 ± 6 46 ± 6
Time from first AF diagnosis (yrs) 4.3 ± 6.3 4.2 ± 5.0 3.6 ± 4.2
AF burden at Baseline* (hr/month) 83 ± 36 85 ± 33 80 ± 37
Constantly in AF >6 months – n (%) 52 (78) 207 (80) 186 (72)
Medical history – n (%)Hypertension 32 (48) 143 (55) 158 (62)Diabetes 6 (9) 31 (12) 26 (10)Coronary disease 2 (3) 21 (8) 29 (11)Stroke/TIA 6 (9) 14 (5) 19 (7)Heart failure 3 (4) 10 (4) 15 (6)
CHADS2 score - n (%)0 31 (46) 93 (36) 81 (32)1 25 (37) 126 (48) 127 (50)2 6 (9) 31 (12) 29 (11)>2 5 (7) 10 (4) 19 (7)
Results - Ablation characteristics
• 79% of patients presented to EP lab in spontaneous AF
• Successful PV isolation obtained in 97% of all patients (all groups)
• CFE were eliminated in 80% of patients– 11% not ablated because AF non-inducible after PVI– 9% all CFE could not be eliminated
• Both lines with block achieved in 74% of patients– Roof line only 93%– Mitral line only 75%
PVI PVI+CFE PVI+LINES p value
Procedure time (min) 166.95 ± 54.83 229.16 ± 83.20 222.56 ± 89.37 <0.0001
Mapping time (min) 13.89 ± 6.64 18.75 ± 14.01 14.38 ± 7.68 <0.0001
Fluoroscopy time (min) 29.35 ± 16.21 42.11 ± 21.70 40.91 ± 24.97 0.0003
Results - Procedural Characteristics
Results - Primary Outcome
p=0.15
Documented AF > 30 seconds after one procedure with or without AAD
59%
48%
44%
PVI PVI+CFE PVI+LINES p value
Freedom from AF/AFL/AT after 1 procedure 49 % 41 % 37 % 0.15
Freedom from AF after 2 procedures 72 % 60 % 58 % 0.18
Freedom from AF/AFL/AT after 2 procedures 60 % 50 % 48 % 0.24
Percentage of patients still on AAD at 18 mo 11 % 12 % 12 % 0.35
Results - Secondary Outcomes
* AAD = antiarrhythmic drug
Results - Subgroups
Results - Complications
CategoryPVI
(n=64)PVI+CFE(n=254)
PVI+Lines(n=250)
Total(n=568)
Access site hematoma 2 0 3 5Access site arteriovenous fistula or pseudoaneurysm 0 3 3 6
Pericarditis 0 1 2 3
Fluid overload 0 1 3 4Sedation related complication 0 3 5 8
Skin burn 1 0 0 1
Cardiac tamponade 1 0 2 3
Transient ischemic attack or Stroke 0 2 1 3
Atrial esophageal fistula - procedural death 0 1 0 1
Conclusions
• Largest randomized trial to examine outcomes of catheter ablation in persistent AF
• Additional CFE or Lines ablation increased procedural time (may increase risk)
• No benefit in AF reduction when additional substrate ablation (CFE or Lines) was performed in addition to PVI
• PVI alone achieved freedom from recurrence in about 50% of patients – comparable to published success rates from randomized, multicenter trials in paroxysmal AF