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FIBRILLAZIONE ATRIALE E ICTUS CARDIOEMBOLICO
Opportunità terapeutiche e sostenibilità economica: confronto e dibattito con gli esperti
“Spending review, payback e … DRG nei 21 SSR”
Dr.ssa Caterina Bisceglia
Dr. Paolo Della Bella
Unità Operativa di Aritmologia e
Laboratori di Elettrofisiologia
Ospedale San Raffaele
Milano
Background
 Prevalenza attuale di Fibrillazione Atriale doppia rispetto a quanto riportato 10 anni fa (1)
 Stima: 15-20 milioni di pazienti con FA in Europa nel 2030
 Costo medio annuale dei pazienti con FA: 3200 euro/paziente
Approssimativamente 1/3 dei pazienti con FA non manifesta sintomi chiaramente
riconducibili all’aritmia
Roche F, Pacing Clin Electrophysiol 2002;25:1587–93.
Camm AJ, Am J Cardiol 2012;110:270–6.
1 Massimo
Dr.ssa Caterina Bisceglia
ZB, et al. Clinical Epidemiology. 2014
Roma, 15 Febbraio 2016
Obiettivi
1. Aumentare la sensibilità diagnostica della Fibrillazione Atriale
2. Prevenire le recidive di Fibrillazione Atriale
 Ablazione Transcatetere
3. Ridurre il rischio cardioembolico:
 Ruolo dei NOACs
 Terapie non farmacologiche (LAAC)
Dr.ssa Caterina Bisceglia
Roma, 15 Febbraio 2016
Aumentare la sensibilità diagnostica della FA
30
%
30
HR 6.4
95% CI
[1.9-21.7]
p<0.001
25
20
NEJM 2014
15
 447 pazienti arruolati (441 randomizzati)
 221 pazienti = gruppo ICM
 220 pazienti = controllo
HR 7.3
95% CI
[2.6-20.8]
p<0.001
HR 8.8
95% CI
[3.5-22.2]
p<0.001
ICM
12.4
Control
8.9
10
1.4
5
2
3
0
End point primario: tempo al primo evento registrato di FA
durante FU di 6 mesi.
Anticoagulant use after AF detection
12 months data
6 months 12 months 36 months
Symptoms related to AF
12 months data- ICM group-% of episodes
3
21
Asymptomatic
OAC
97
no OAC
Cortesia: Dr. Tommaso Sanna- Policlinico Universitario “A. Gemelli”-ROMA
79
With symptoms
Roma, 15 Febbraio 2016
Reveal LINQ & MyCareLink - Monitoring System
Il Sistema di Monitoraggio Reveal LINQ è progettato per un semplice utilizzo da parte del medico e
del paziente, dal momento dell’impianto e per tutto il monitoraggio remoto.
• Miniaturizzato
• Preciso
• Wireless
• Completi
• Automatici
• Semplificati
Dr.ssa Caterina Bisceglia
• Standard
• Riproducibile
• Mini-Invasiva
Reveal LINQ
Strumenti
per la
Procedura
Report
MyCarelink
Patient
Monitor
• Semplice
• Connesso
• Trasportabile
Roma, 15 Febbraio 2016
Esperienza OSR
Gennaio 2013 – Aprile 2015
 114 Dispositivi impiantati (33 Reveal XT; 81 LINQ); 86 dispositivi in
HM attivo
 Gennaio 2015 – Dicembre 2015: 10780 trasmissioni
 39,7% pazienti: impianto per FA asintomatica (monitoraggio
terapia; post-ATC FA)
 Trasmissioni: event-based (automatico) + timeframe
programmabile (30-45-60 gg)
Degenza media:
DRG cod. 117
Dr.ssa Caterina Bisceglia
1.5 ± 0.7 giorni
RRL: €3547
Roma, 15 Febbraio 2016
Criticità del sistema
Elevatissimo volume di dati/trasmissioni, di cui solo una
percentuale ridotta si rivela significativa ai fini delle scelte cliniche
Necessità di un modello organizzativo ad-hoc
(«ambulatorio virtuale»)
Italia
Affidato alla organizzazione
volontaristica dei medici e
del personale
infermieristico
Dr.ssa Caterina Bisceglia
Mancanza di adeguate
coperture economiche
VS
Soggetti privati
promuovono nuove
formule organizzative per
migliorare l’efficienza del
modello
Germania, Francia,
Inghilterra, Spagna
Sistema ad hoc finanziato
con fondi pubblici/privati
Roma, 15 Febbraio 2016
Home Monitoring Expert Alliance
 HMEA è una iniziativa permanente di data sharing strutturato tra centri che
utilizzano normalmente l’Home Monitoring nella loro pratica clinica
 Strutturazione di un database per l’immediata fruibilità di una grossa mole di dati
utilizzabili per verificare ipotesi scientifiche
Dr.ssa Caterina Bisceglia
Roma, 15 Febbraio 2016
Obiettivi
1. Aumentare la sensibilità diagnostica della Fibrillazione Atriale
2. Prevenire le recidive di Fibrillazione Atriale
 Ablazione Transcatetere
3. Ridurre il rischio cardioembolico:
 Ruolo dei NOACs
 Terapie non farmacologiche (LAAC)
Dr.ssa Caterina Bisceglia
Roma, 15 Febbraio 2016
Prevenire le recidive di FA – ablazione transcatetere
Aronsson M.; Europace (2015) 17, 48–55
 Studio multicentrico
 Ablazione transcatetere vs terapia medica in pazienti con PAF
 294 pazienti eligibili; 286 pazienti assegnati a trattamento
Dr.ssa Caterina Bisceglia
Roma, 15 Febbraio 2016
Prevenire le recidive di FA – ablazione transcatetere
Ablazione associata a riduzione
statisticamente significativa del burden
totale FA nei pazienti ≤50 anni
(nei primi 24 mesi di FU)
Dr.ssa Caterina Bisceglia
Roma, 15 Febbraio 2016
Esperienza OSR
Gennaio 2010 – Dicembre 2015
 1972 Ablazioni Transcatetere di FA/Flutter atipico
• 29 procedure con approccio chirurgico
 569 procedure REDO
 Vol Asin: 81 ± 42 mL
FA
parossistica
Dr.ssa Caterina Bisceglia
FA
persistente
Long-lasting
FA
Flutter/TA
Roma, 15 Febbraio 2016
Esperienza OSR
Agosto 2010 – Dicembre 2015
60.9% pazienti non assume terapia AA
39% dei pazienti non assume OAC
Complicanze
Tamponamenti
Ictus
TIA
Vascolari
Altro
Morte
Complicanze totali: 57
FA parossistica
Degenza media:
DRG cod. 518:
Dr.ssa Caterina Bisceglia
FA persistente
N°
26
7
3
13
8
1
(2.8%)
Long-lasting FA
2,5 ± 0,7 giorni
RRL: €4971
Roma, 15 Febbraio 2016
Obiettivi
1. Aumentare la sensibilità diagnostica della Fibrillazione Atriale
2. Prevenire le recidive di Fibrillazione Atriale
 Ablazione Transcatetere
3. Ridurre il rischio cardioembolico:
 Ruolo dei NOACs
 Terapie non farmacologiche (LAAC)
Dr.ssa Caterina Bisceglia
Roma, 15 Febbraio 2016
Rognoni C. Clin Drug Investig 2014
Dr.ssa Caterina Bisceglia
Roma, 15 Febbraio 2016
Occlusione percutanea auricola sinistra
Europace 2014;16:1397–416.
Dr.ssa Caterina Bisceglia
Roma, 15 Febbraio 2016
Occlusione percutanea auricola sinistra
Stroke Dicembre 2014
Dr.ssa Caterina Bisceglia
Roma, 15 Febbraio 2016
A. The Centers for Medicare & Medicaid Services (CMS) proposes that the evidence is sufficient to determine percutaneous left atrial appendage closure (LAAC) therapy using an implanted device is not reasonable
and necessary to diagnose or treat an illness or injury or to improve the functioning of a malformed body member and, therefore, is not covered under § 1862(a)(1)(A) of the Social Security Act.
B. In order to support evidence development for technologies likely to show benefit for the Medicare population, CMS proposes to cover items or services that are reasonable and necessary for research under
§1862(a)(1)(E) of the Social Security Act using the Coverage with Evidence Development (CED) paradigm. We propose that coverage would be limited to items and services in clinical studies that meet the conditions
specified below:
Percutaneous LAAC therapy is covered for patients with non-valvular atrial fibrillation only, when all of the following conditions 1-7 are met.
1.The device is FDA approved for patients with non-valvular atrial fibrillation.
2. The patient has:
1.
A high CHADS2 (Congestive heart failure, Hypertension, Age >75, Diabetes, Stroke/transient ischemia attack/thromboembolism) or CHA2DS2-VASc score (Congestive heart failure, Hypertension, Age
≥ 65, Diabetes, Stroke/transient ischemia attack/thromboembolism, Vascular disease, Sex category); and
2.
A high HAS-BLED score (Hypertension, Abnormal renal function and/or liver function, Stroke, prior Bleeding, Labile anticoagulation range, Elderly age>65, Drug therapy such as antiplatelet drugs),
and
3.
A contraindication to warfarin.
3. The procedure is furnished in a hospital that meets the following institutional requirements:
1.
Cardiac catheterization lab or electrophysiology (EP) lab with fluoroscopy capability
2.
Non-invasive imaging (i.e. transesophageal echocardiography) with dedicated echocardiography support
3.
Anesthesiology support for administration of general anesthesia specific to this procedure
4.
Cath lab, operating room (if required), post anesthesia recovery, intensive care and step down unit space to accommodate cases with and without complications
5.
On-site emergency cardiac surgery services
4. The procedure is performed by physicians with the following qualifications and experience:
1.
The primary implanting physician has performed ≥ 25 interventional cardiac procedures involving a trans-septal puncture (TSP) in their total experience, with at least 10 TSP procedures performed
over the past 12 month period.
2.
The primary implanting physician(s) must be an interventional cardiologist and/or an electrophysiologist. They may jointly participate in intra-procedural aspects of the implant or perform the
implant procedure individually.
5. The interventional cardiologist(s) and electrophysiologist(s) must receive the training prescribed by the manufacturer on the safe and effective use of the device prior to performing implant procedures. Training
should also include a physician who already has experience implanting the device, but who is not a representative of the manufacturer, as well as a minimum of two supervised and two observed cases.
6. The patient is enrolled in, and the treating physician team is participating in a prospective national registry that consecutively enrolls LAAC patients and tracks the following annual outcomes at the patient data
level for a period of at least five years from the time of the LAAC procedure.
1.
Operator-specific complications
2.
Device-specific complications including device thromboses
3.
Stroke, adjudicated, by type
4.
TIA
5.
Systemic embolism
6.
Death
7.
Major bleeding, by site and severity
7.A formal shared decision-making interaction between the patient and provider using an evidence-based decision tool on anticoagulation in patients with NVAF must occur prior to LAAC, must be documented in the
medical records, must include a discussion of the benefits and harms, must document an appropriate rationale to seek a non-pharmacologic alternative to anticoagulants, taking into account the safety and
effectiveness of the device compared to anticoagulants, and have, after being informed of the reported risks of LAAC and reasonable alternative management strategies, given informed consent.
1. The patient has:
1. A high CHADS2 (Congestive heart failure, Hypertension, Age >75,
Diabetes, Stroke/transient ischemia attack/thromboembolism) or
CHA2DS2-VASc score (Congestive heart failure, Hypertension, Age
≥ 65, Diabetes, Stroke/transient ischemia attack/
thromboembolism, Vascular disease, Sex category); and
2. A high HAS-BLED score (Hypertension, Abnormal renal function
and/or liver function, Stroke, prior Bleeding, Labile anticoagulation
range, Elderly age>65, Drug therapy such as antiplatelet drugs),
and
3. A contraindication to warfarin.
Roma, 15 Febbraio 2016
The Centers for Medicare & Medicaid Services (CMS) covers percutaneous left atrial appendage closure (LAAC) for non-valvular atrial fibrillation (NVAF) through Coverage with Evidence
Development (CED) under 1862(a)(1)(E) of the Social Security Act with the following conditions:
A. Left Atrial Appendage Closure devices are covered when the device has received Food and Drug Administration (FDA) Premarket Approval (PMA) for that device’s FDA-approved
indication and meet all of the conditions specified below:
•The patient must have:
• A suitability for short-term warfarin but deemed unable to take
long term oral anticoagulation following the conclusion of shared
decision making, as LAAC is only covered as a second line therapy
to oral anticoagulants. The patient (preoperatively and
postoperatively) is under the care of a cohesive, multidisciplinary
team (MDT) of medical professionals. The procedure must be
furnished in a hospital with an established structural heart disease
(SHD) and/or electrophysiology (EP) program.
•
•
•
•
A CHADS2 score ≥ 2 (Congestive heart failure, Hypertension, Age >75, Diabetes, Stroke/transient ischemia attack/thromboembolism) or CHA2DS2-VASc score ≥ 3
(Congestive heart failure, Hypertension, Age ≥ 65, Diabetes, Stroke/transient ischemia attack/thromboembolism, Vascular disease, Sex category)
A formal shared decision making interaction with an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation in patients
with NVAF prior to LAAC. Additionally, the shared decision making interaction must be documented in the medical record.
A suitability for short-term warfarin but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making, as LAAC is only
covered as a second line therapy to oral anticoagulants. The patient (preoperatively and postoperatively) is under the care of a cohesive, multidisciplinary team (MDT) of
medical professionals. The procedure must be furnished in a hospital with an established structural heart disease (SHD) and/or electrophysiology (EP) program.
The procedure must be performed by an interventional cardiologist(s), electrophysiologst(s) or cardiovascular surgeon (s) that meet the following criteria:
•
Has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing LAAC; and
•
Has performed ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum; and
•
Continues to perform ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum, of which at least 12 are LAAC, over a two
year period.
•
The patient is enrolled in, and the MDT and hospital must participate in a prospective, national, audited registry that: 1) consecutively enrolls LAAC patients and 2) tracks the following
annual outcomes for each patient for a period of at least four years from the time of the LAAC:
•
Operator-specific complications
•
Device-specific complications including device thrombosis
•
Stroke, adjudicated, by type
•
Transient Ischemic Attack (TIA)
•
Systemic embolism
•
Death
•
Major bleeding, by site and severity
Roma, 15 Febbraio 2016
Reddy VY; JACC 2015
Dr.ssa Caterina Bisceglia
Roma, 15 Febbraio 2016
Esperienza OSR
Agosto 2010 – Gennaio 2016
135 Pazienti sottoposti a chiusura percutanea di Auricola sinistra
Watchman
39%
61%
40%
Female
ACP
Male
10%
CHA2DS2-VASc: 2,9 ± 1,7
Dr.ssa Caterina Bisceglia
50%
Amplatzer
Amulet
HAS-BLED: 2,7 ± 1,4
Roma, 15 Febbraio 2016
Esperienza OSR
Agosto 2010 – Gennaio 2016
Dimensione media del device:
Successo procedurale (device normoposizionato senza leak o con leak < 3 mm):
Dr.ssa Caterina Bisceglia
23,8 ± 3 mm
99%
Roma, 15 Febbraio 2016
Esperienza OSR
Agosto 2010 – Gennaio 2016
2
1.4
1.5
%
0.74
1
0.74
0.74
0.74
0.5
0
0
0
Complicanze totali: 6 (4,4%)
Degenza media:
DR codice 518:
Dr.ssa Caterina Bisceglia
2,3 ± 1,5 giorni
RRL: €4133
Roma, 15 Febbraio 2016
Conclusioni
 Aumento della incidenza di Fibrillazione Atriale e dei i costi sanitari/sociali
associati
 Percorsi assistenziali strutturati ed integrati nella realtà territoriale
 Individuazione di strategie diagnostico-terapeutiche a maggiore impatto
sull’outcome “salute”
 Sensibilizzazione verso una efficiente distribuzione delle risorse economiche
Dr.ssa Caterina Bisceglia
Roma, 15 Febbraio 2016