A Tale of two Patients A Tale of two Patients 1) 71 yo with - - PDF document

9/14/2019 1

Should We Ablate Asymptomatic AF?

CHRS 2019 Edward Paul Gerstenfeld, MD, FHRS

@Ed_Gerst

Professor of Medicine University of California, San Francisco

Disclosures I have ablated patients with asymptomatic AF….

A Tale of two Patients…

1) 71 yo with persistent AF since 2018. OSA uses CPAP. Presents for 3rd opinion. Cardioversion x2 with recurrence weeks later. Meds: ASA. Resting HR 62 bpm. Echo: Moderate biatrial enlargement, EF 66% Options offered: 1) Hybrid surgical/catheter AF ablation 2) Catheter PVI, success rate ~40% 2) 74 yo with longstanding persistent AF. Paroxysmal AF diagnosed 1992 Became persistent 2007. Asymptomatic. EF 67%. Rx ASA+digoxin. 2018 developed DOE. Echo: EF 40-45%, severe RAE, LAE, mod MR/mild-mod TR Holter: Mean rate 82 bpm

A Tale of two Patients…

9/14/2019 2 Why not to ablate asymptomatic AF…

Assumption: truly asymptomatic

➢ 4060 pts randomized to rate vs. rhythm control ➢ Enrolled 1996-1999. Followed for mean 3.5 years

AFFIRM

Wyse et al. N Engl J Med. 2002 Dec 5;347(23):1825-33.

AFFIRM – Predictors of Survival

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CABANA Trial Design

Ablation Therapy (1108)

Primary ablation:

• PVI/WACA

Ancillary ablation:

• Linear lesions
• CFAE

Anticoagulation

Drug Therapy (1096)

• Rate Control or
• Rhythm Control
• Anticoagulation

R 1:1

Key Inclusion Criteria

• 65 years of age
• <65 years of age with 1

CVA/CV risk factor

• Eligible for ablation and ≥2

rhythm or rate control drugs Enroll patients with new onset or under-treated paroxysmal, persistent, or longstanding persistent AF who warrant therapy No Exclusion Criteria Identified

Packer D. et al JAMA. 2019;321(13):1261-1274.

Primary Endpoint (Death, Disabling Stroke, Serious Bleeding, or Cardiac Arrest) (ITT)

Packer D. et al JAMA. 2019;321(13):1261-1274.

Estimates of All-Cause Mortality Risk (ITT)

Packer D. et al JAMA. 2019;321(13):1261-1274.

AF Ablation Complications

Deshmuk et al. Circulation 2013;128:2104-2112

Operator Volume Hospital Volume <25 >50 <50 >100 Complications Complications

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CTA of L MCA Stroke After PVI (HCM)

• 150 patients with persistent AF (mean 13 mos)
• Repeat ablation in 73%
• 1°end point: freedom from asx or sx AF lasting >30s

74% 65%

8.5%/year recurrence

Why Not to Ablate Asymptomatic AF

➢ You can’t help an asymptomatic patient feel better ➢ Complications in an asymptomatic patient would be devastating ➢ Recurrences after ablation for persistent AF not uncommon; multiple procedures may be required ➢ Zero prospective data support mortality benefit

So why consider ablating asymptomatic AF…

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AF-Mediated Cardiomyopathy

10 20 30 40 50 60 70 80 LVEF Baseline LVEF Follow up

LVEF

44% 57% Gentlesk et al. JCE 2004.

➢ LV EF increased by > 5% in 82% patients ➢ LV EF normalized to ≥ 55% in 72% patients

➢ 67 pts with baseline EF ≤ 50% and “controlled” ventricular rate (<90 bpm)

CASTLE AF

Primary endpoint: All-cause death or unplanned hospitalization due to worsening of heart failure

Marrouche et al. NEJM 2018 378(5):417.427.

Overall Mortality

Marrouche et al. NEJM 2018 378(5):417.427. 25.0% 13.4%

CHF Trials: Total Mortality

20 40 60 80 100 9.8 24.6 36.1 25 7.2 20.4 28.9 13.4

Control Intervention

Mortality (%)

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Ablated 1006 (90.8%)

repeat ablation 215 (19.4%)

Ablation Therapy 1108 Drug Therapy 1096 Drug Treated 1092 (99.6%)

rhythm control 953 (87.2%) rate control only 126 (11.5%)

Completed FU 1002 (90.4%) 48.9 mo Completed FU 966 (88%) 48.2 mo Not ablated 102 (9.2%) Cross Over Ablated 301 (27.5%)

CABANA: Patient Randomization

Subjects 2204

Crossovers

* Withdrew <3 years

Primary and Secondary Outcomes (Treatment Received)*

Ablation (N = 1307) Drug (N = 897) Hazard Ratio (95% CI) P- Value Primary Outcome 92 (7.0%) 98 (10.9%) 0.67 (0.50, 0.89) 0.006

Secondary Outcomes

All-cause mortality 58 (4.4%) 67 (7.5%) 0.60 (0.42, 0.86) 0.005 Death or CV hospitalization 538 (41.2%) 672 (74.9%) 0.83 (0.74, 0.94) 0.002

*pre-specified

Packer D. et al JAMA. 2019 Apr 2;321(13):1261-1274.

* Minority=Hispanic or Latino or non-white race

Primary Endpoint Sub-group Analysis All-Cause Mortality, Disabling Stroke, Serious Bleeding, Cardiac Arrest

1 year 3 years

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STAR AF II - Primary Outcome

p=0.15

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

59% 48% 44%

Verma et al N Engl J Med. 2015 May 7;372(19):1812-22

STAR AF II AF Burden

Verma et al N Engl J Med. 2015 May 7;372(19):1812-22

N=583 N=309 N=768 N=378

Leong-Sit et al. Circ Arrhythm Electrophysiol. 2010;3(5):452-7.

Reasons to consider ablating

asymptomatic AF:

➢ Randomized trial data only extend for 3-5 years. No data on 20-30+ years with AF. ➢ Patients with AF who underwent ablation in CABANA had lower mortality over only 3.5 years. ➢ For young AF patients, future risk of LA dilatation -> MR -> CHF. May be too late to address AF later. Early ablation better success. ➢ Association of AF with dementia may be modifiable

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HRS/EHRA/ECAS 2017 Atrial Fibrillation Consensus Statement

∗∗ A decision to perform AF ablation in an asymptomatic patient requires additional discussion with the patient because the potential benefits of the procedure for the patient without symptoms are uncertain

When is it appropriate to consider ablation for asymptomatic AF*?

➢ Young age (< ~60 years old) ➢ Paroxysmal or recent persistent (<1 year) AF (echo surrogate mild-mod LAE) ➢ Tachy or AF-mediated cardiomyopathy ➢ Tachy/brady with conversion pauses otherwise requiring pacemaker ➢ High risk occupation (pilot) with AF

*After a thorough discussion of the risks/benefits

Thank you

A healthy 50 yo athletic patient presents with recent onset asymptomatic, persistent AF. AF recurs 2 weeks after CV. She has normal LV function, mild LAE. I would: A) Pursue a rate control strategy B) Try cardioversion + AAD C) Refer for standard catheter ablation D) Refer for PVI + LAA isolation

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42 yo Commercial Airline Pilot AF Onset

R I P V C S R A LSP V

First Recurrence AF – Post Blanking* (ITT)

*Using CABANA Monitors

Packer D. et al Heart Rhythm Late Breaking Clinical Trials 2018

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Adverse Events in CABANA