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R.Mantovan Conegliano
Curiosare tra le raccomandazioni
delle nuove Linee Guida ESC 2016 ...
Fibrillazione atriale
Roberto Mantovan, MD, PhD
Cardiologia
Conegliano
R.Mantovan Conegliano
R.Mantovan Conegliano
CRYptogenic STroke and underlying AtriaL Fibrillation (CRYSTAL AF):
Long-Term Follow-Up Results
Rod S. Passman, MD, Johannes Brachmann, MD, Ph.D. Carlos Morillo,
MD, Tommaso Sanna, MD,
Richard Bernstein, MD, Ph.D., Vincenzo Di Lazzaro, MD,
Hans-Christoph Diener, MD, Ph.D., Marilyn Rymer, MD,
Frank Beckers, Ph.D, Tyson Rogers, M.S., Paul Ziegler, M.S.
for the Crystal AF Investigators
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Objectives of CRYSTAL-AF
• Assess whether a long-term cardiac monitoring strategy with
an insertable cardiac monitor (ICM) is superior to standard
monitoring for the detection of AF in patients with cryptogenic
stroke
• Determine the proportion of patients with cryptogenic stroke
that are subsequently found to have AF
• Determine actions taken after patient is diagnosed with AF
R.Mantovan Conegliano
Primary Endpoint: AF at 6 Months • At 6 months AF was detected in 8.9% in the ICM group compared
with 1.4% in controls (19 vs 3 pts.)
• Median time to AF detection: 41 d, 74% asymptomatic
Sanna T. N Engl J Med 2014; 370: 2478-2486
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CRYSTAL AF: Conclusion
• AF monitoring with an ICM is superior to conventional
follow-up in cryptogenic stroke pts.
• AF was mostly asymptomatic and paroxysmal so
unlikely to be detected by non continuous monitoring
Sanna T. N Engl J Med 2014; 370: 2478-2486
Time ICM (%) Control (%) Hazard
Ratio P
6 months 8.9 1.4 6.4 0.0006
12 months 12.4 2.0 7.3 0.0001
3 years 30.0 3.0 8.8 0.0001
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• By 3 months, subclinical atrial tachyarrhythmias
detected by implanted devices had occurred in 261
patients (10.1%).
• Subclinical atrial tachyarrhythmias were associated
with an increased risk of clinical atrial fibrillation
(hazard ratio, 5.56; 95% confidence interval [CI],
3.78 to 8.17; P<0.001) and of ischemic stroke or
systemic embolism (hazard ratio, 2.49; 95% CI, 1.28
to 4.85; P = 0.007).
n engl j med 366;2 nejm.org january 12, 2012
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Hypertension is a stroke risk factor in AF;
uncontrolled high blood pressure
enhances the risk of stroke and bleeding
events and may lead to recurrent AF.
Therefore, good blood pressure control
should form an integral part of the
management of AF patients
Hypertension
R.Mantovan Conegliano ESC AF guidelines 2010
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Amiodarone: 400 mg Ibersartan:
150 o 300 mg sec PA
Circulation 2002;106:331-336
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The intervention group showed a
significantly greater reduction,
compared with
the control group, in weight (14.3
and 3.6 kg, respectively; P < .001)
and in atrial fibrillation
symptom burden scores (11.8 and
2.6 points, P < .001), symptom
severity scores (8.4 and 1.7
points, P < .001), number of
episodes (2.5 and no change, P =
.01), and cumulative duration
(692-minute decline and 419-
minute increase, P = .002).
JAMA. 2013;310(19):2050-2060.
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Europace (2014) 16, 1309–1314
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Europace (2009) 11, 1156–1159
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European Heart Journal (2012) 33, 2692–2699
It consisted of nurse-led outpatient
care steered by decision
support software based on the
guidelines and supervised by a
cardiologist. (dedicated software
CardioConsult AF)
Visits to the nurse were scheduled to
last 30 min. Follow-up visits were
planned at 3, 6, and 12 months, and
every 6 months thereafter.
Patients in the control group received
usual care by a cardiologist in the
outpatient clinic during visits
scheduled to last 20 min for the first
visit and 10 min for follow-up visits.
R.Mantovan Conegliano Esc guidelines 2016
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ESC WG on Thrombosis - J Am Coll Cardiol 2012;59:1413-25
Comparable Primary Efficacy Endpoints
of Stroke or Systemic Embolism
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Comparable Primary Safety Endpoints of Major Bleeding
ESC WG on Thrombosis - J Am Coll Cardiol 2012;59:1413-25
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Antithrombotic therapy after acute coronary
syndromes and percutaneous coronary intervention
• When a NOAC is used, the consensus
recommendation is that the lowest dose
effective for stroke prevention in AF
should be considered.
• Dose reduction beyond the approved dosing
tested in phase III trials is not currently
recommended, and awaits assessment in
ongoing controlled trials.
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(Circulation . 2012;125:23-30.)
124 patients with antiarrhythmic drug–refractory atrial fibrillation with left atrial
dilatation and hypertension (42 patients, 33%) or failed prior CA (82 patients,
67%) were randomized to CA (63 patients) or SA (61 patients)
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The Atrial Fibrillation Heart Team
• this Task Force proposes that decisions involving
AF surgery or extensive AF ablation should be
based on advice from an AF Heart Team
• An AF Heart Team should consist of a
cardiologist with expertise in antiarrhythmic drug
therapy, an interventional electrophysiologist, and
a cardiac surgeon with expertise in appropriate
patient selection, techniques, and technologies for
interventional or surgical AF ablation (Figure 20)
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GanesanJ Am Heart Assoc. 2013;2:e004549 doi: 10.1161/
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?
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?
R.Mantovan Conegliano ESC AF guidelines 2010
R.Mantovan Conegliano n engl j med 372;19 nejm.org May 7, 2015
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Secondary Outcomes
Documented AF > 30 seconds after one or two procedures with or without AAD
p=0.18
72%
60%
58%
R.Mantovan Conegliano
Abbiamo qualcosa di meglio da
offrire al paziente?
• Pazienti, sintomatici, refrattari ai farmaci, per l’80% in f.a. persistente da almeno 6 mesi
• Dopo un anno e mezzo 2 su 3 sono senza aritmia (per l’89% senza antiaritmici)
• .. E circa il 95% sta nettamente meglio (per netta riduzione del burden aritmico)
R.Mantovan Conegliano
Conclusioni
• Le nuove linee guida pongono una
maggiore attenzione ai fattori di rischio
della fibrillazione atriale (obesità, OSAS,
sport esasperato) e sulla diagnostica della
f.a. asintomatica
• Propongono modelli organizzativi
(approccio integrato, AF heart Team)
sicuramente auspicabili, ma di difficile
realizzazione nella pratica clinica
quotidiana
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Conclusioni
• I NOA sono pienamente “sdoganati” dalla
nuove linee guida ESC, anche se
permangono delle complessità nella terapia
di associazione con antiaggreganti
• Meno chiare sono invece le linee
comportamentali sulla terapia
interventistica, particolarmente nella f.a.
persistente
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