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

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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

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, BoehringerIngelheim, 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 BoehringerIngelheim 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

CFE strategy

Linear 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 Characteristics


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%


Results - Procedural Characteristics


Results - Primary Outcome

Documented AF > 30 seconds after one procedure with or without AAD

p=0.15

59%

48%

44%


Results - Secondary Outcomes

* AAD = antiarrhythmic drug


Results - Subgroups


Results - Complications


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


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