Roberto Mantovan, MD, PhD Cardiologia · PDF fileRoberto Mantovan, MD, PhD Cardiologia...

R.Mantovan Conegliano

Curiosare tra le raccomandazioni

delle nuove Linee Guida ESC 2016 ...

Fibrillazione atriale

Roberto Mantovan, MD, PhD

Cardiologia

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


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


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


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


• 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


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


Amiodarone: 400 mg Ibersartan:

150 o 300 mg sec PA

Circulation 2002;106:331-336


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.


Europace (2014) 16, 1309–1314


Europace (2009) 11, 1156–1159


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


ESC WG on Thrombosis - J Am Coll Cardiol 2012;59:1413-25

Comparable Primary Efficacy Endpoints

of Stroke or Systemic Embolism


Comparable Primary Safety Endpoints of Major Bleeding

ESC WG on Thrombosis - J Am Coll Cardiol 2012;59:1413-25


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.


(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)


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)


GanesanJ Am Heart Assoc. 2013;2:e004549 doi: 10.1161/


?

R.Mantovan Conegliano ESC AF guidelines 2010

R.Mantovan Conegliano n engl j med 372;19 nejm.org May 7, 2015


Secondary Outcomes

Documented AF > 30 seconds after one or two procedures with or without AAD

p=0.18

72%

60%

58%


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)


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


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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