Rối loạn nhịp tim có gì mới trong năm 2015 2016

• Open-label, randomized multi-centre study to determine whether catheter ablation CA was superior to amiodarone AMIO for the treatment of persistent AF in patients with heart failure

Cardiac Arrhythmias in the year Review: 2015-2016

Dr Reginald Liew

MA, MB BS (Hons), PhD, FRCP, FACC, FESC, FAsCC

Director/ Senior Consultant Cardiologist

The Harley Street Heart and Cancer Centre

Mount Elizabeth Novena Specialist Centre, Singapore

Verma et al for the STAR AF II Investigators

• The duration of follow-up was 18 months

• The primary end point was freedom from any documented recurrence of AF lasting longer than 30 seconds after a single ablation procedure

STAR II study results- Freedom from AF

• There were also no significant differences among the three groups for the secondary end points, including freedom from AF after two ablation procedures

• Prospective randomized study comparing PVI alone

vs PVI + CFAE + linear lesions in patients with

persistent AF

• Methods

underwent de novo ablation for persistent AF

randomized to either PVI alone (n = 78) or full defrag (n = 75), with 52 patients not randomized due to AF termination with the original PVI

arrhythmia after a blanking period of 3 months

Volger et al JACC 2015, Vol 66, No 24

CHASE AF study- results

• Results No difference in arrhythmia-free survival between the two methods (p =

0.468) Procedure duration, fluoroscopy time, and radiofrequency duration were significantly longer in the full-defrag group (all p < 0.001)

• Conclusions A stepwise approach aimed at AF termination does not seem to

provide additional benefit over PVI alone in patients with persistent AF, but it is

associated with significantly longer procedural and fluoroscopic duration as well as

RF application time

• Open-label, randomized multi-centre study to

determine whether catheter ablation (CA) was

superior to amiodarone (AMIO) for the treatment of persistent AF in patients with heart failure

• Study group- NYHA II-III HF, LVEF<40% with dual chamber ICD or CRT-D device

• 203 pts randomized (N=102 in CA group and 101 in AMIO group)

• Pts followed up for minimum of 24 months

• Primary end point- recurrence of AF

Di Base et al, Circulation 2016; 133: 1637-1644

Main results- AATAC study

• Success rate of CA after a single procedure 29-61%

• AMIO therapy found to be significantly more likely to fail

• CA group showed a significant reduction in:

– unplanned hospital admissions (RRR 0.55; CI 0.39-0.76) – Mortality (8% in CA group vs 18% in AMIO group; P=0.037)

• Objectives To evaluate the role of cardiorespiratory fitness and the

incremental benefit of cardiorespiratory fitness improvement on rhythm control in obese individuals with AF

• Methods

– 1,415 consecutive patients with AF, 825 had a BMI ≥27 kg/m2 and were offered risk factor management and participation in a tailored exercise program

– After exclusions, 308 patients were included in the analysis

– Patients underwent exercise stress testing to determine peak

metabolic equivalents (METs) To determine a dose response, cardiorespiratory fitness was categorized as: low (<85%), adequate (86% to 100%), and high (>100%)

– Impact of cardiorespiratory fitness gain was ascertained by the

objective gain in fitness at final follow-up (≥2 METs vs <2 METs) AF rhythm control was determined using 7-day Holter monitoring and AF severity scale questionnaire

Pathak et al JACC 2015, Vol 66, No 9

CARDIOFIT study results

• Results Improved arrhythmia free survival in patients with high cardiorespiratory

fitness compared to adequate or low cardiorespiratory fitness (p < 0.001 for both)

• Less AF burden and symptom severity in the group with cardiorespiratory fitness gain ≥2 METs (p < 0.001 for all)

• Conclusions Cardiorespiratory fitness predicts arrhythmia recurrence in obese

individuals with symptomatic AF Improvement in cardiorespiratory fitness augments the beneficial effects of weight loss

% improvement from baseline CRF

CARDIOFIT study

TOCCASTAR study

• Prospective, multi-centre RCT

• 300 pts with drug-refractory PAF

randomized to RF ablation with a novel

contact force (CF) sensing catheter or non-CF

catheter (control)

• Primary effectiveness endpoint- acute PV

isolation and freedom from recurrent AF and

off AADs at 12 months

• Primary safety endpoint- device-related

SAEs

Reddy et al Circulation 2015; 132: 907-915

TOCCASTAR study results

• All PVs successfully isolated in both groups

• 67.8% in CA group and 69.4% in control group (non-inferior)

• Primary effectiveness similar in study and control groups

• Within study group, greater success when optimal contact force

(>80%) was achieved

TOCCASTAR study- effect of contact force

• Analysis of optimal vs nonoptimal contact force (CF) by operator showed improved treatment success in cases where operators achieved >80% of

optimal CF

• No significant difference in SAE between optimal and nonoptimal CF cases

Cryoballoon ablation of PV

Freeze AF study- results

Conclusions:

• First large randomized trial demonstrating that cryoballoon was non inferior to

RF ablation

• More complications in cryo group, but resolved within 12 months

• Technically easier and less training required for cryo technique

Main result:

• After 12 months, 70.7% free from AF in RF group and 73.6% in CB group

(31 redo procedures in each group)

• More complications in CB group (12.2% vs 5.0%), mainly due to phrenic

nerve palsies

FIRE AND ICE STUDY

• Multicentre RCT investigating

• Primary endpoints- time to AF

recurrence, atrial flutter or atrial

tachy, use of AADs or repeat

procedure

Kuck KH et al, NEJM 2016; 374;23

Results- fire and ice study

- No sig difference in efficacy or safety between cryoballoon and RF ablation

- No sig difference in complications:

• Groin complications (16 in RF and 7 in cryo group)

• 10 phrenic nerve injuries cryo group (2.7%)- most resolved after 3 months

Sapp et al NEJM July 2016, vol 372, no.2

cardiomyopathy, ICD and recurrent VT despite being on

AADs

(amiodarone or mexiletine if already on 300mg amiodarone per day; 127 pts)

appropriate ICD shock

Study question- should patients with ischaemic CM,

ICDs and recurrent VT undergo catheter abaltion or

escalation of AADs?

Sapp JL et al N Engl J Med 2016;375:111-121

Lower rate of primary endpoint in pts undergoing VT ablation

Defibrillator implantation in patients with ischaemic systolic heart failure

non-Kober et al NEJM Aug 2016

failure (LVEF ≤35%) not caused by coronary artery

disease were assigned to receive an ICD, and 560 patients were assigned to receive usual clinical care (control

group)

secondary outcomes were sudden cardiac death and

cardiovascular death

Study question- are ICDs beneficial in patients with

non-ischaemic systolic heart failure?

• No sig difference in 1ry

outcome (death from any cause) between ICD and control group

• Sig reduction of SCD in

ICD group (2ry outcome)

Bansch et al European Heart Journal 2015; 36 (37)

METHODS:

• 1077 patients were randomly assigned (1 : 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing

• The intra-operative DF testing was standardized across all participating

centres, and all ICD shocks were programmed to 40 J irrespective of DF test results

• The primary end point was the average first shock efficacy (FSE) for all true ventricular tachycardia and fibrillation (VT/VF) episodes during follow-up

• The secondary end points included procedural data, serious adverse events, and mortality

STUDY QUESTION-

Is shock efficacy during follow-up impaired in patients implanted without

defibrillation (DF) testing during first ICD implantation?

NORDIC ICD study- results

RESULTS:

• During a median follow-up of 22.8 months, the model-based FSE was found to

be non-inferior in patients with an ICD implanted without a DF test

• A total of 112 procedure-related serious adverse events occurred within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients

(13.9%) not tested (P = 0.095)

CONCLUSION:

• Defibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing

• Defibrillation testing during first time ICD implantation should no longer be

recommended for routine left-sided ICD implantation

Reynolds et al NEJM 2016; 374:6

Medtronic micra leadless pacemaker

Reynolds et al- patient characteristics

Results

Adverse effects

Conclusions

– AF ablation strategies-

• PVI alone sufficient for persistent AF?

• Importance of weight reduction and cardiofitness

– AF ablation techniques-

• Contact force catheter

• Cryoballoon- non inferior to RF ablation

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