FIBRILLAZIONE ATRIALE E ICTUS CARDIOEMBOLICO Opportunità terapeutiche e sostenibilità economica: confronto e dibattito con gli esperti Dr.ssa Caterina.

Presentazione sul tema: "FIBRILLAZIONE ATRIALE E ICTUS CARDIOEMBOLICO Opportunità terapeutiche e sostenibilità economica: confronto e dibattito con gli esperti Dr.ssa Caterina."— Transcript della presentazione:

1 FIBRILLAZIONE ATRIALE E ICTUS CARDIOEMBOLICO Opportunità terapeutiche e sostenibilità economica: confronto e dibattito con gli esperti Dr.ssa Caterina Bisceglia Dr. Paolo Della Bella Unità Operativa di Aritmologia e Laboratori di Elettrofisiologia Ospedale San Raffaele Milano “Spending review, payback e … DRG nei 21 SSR”

2 Background Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016  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. 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 ZB, et al. Clinical Epidemiology. 2014

3 Obiettivi Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016 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)

4 Aumentare la sensibilità diagnostica della FA Cortesia: Dr. Tommaso Sanna- Policlinico Universitario “A. Gemelli”-ROMA Roma, 15 Febbraio 2016 Anticoagulant use after AF detection 12 months data  447 pazienti arruolati (441 randomizzati)  221 pazienti = gruppo ICM  220 pazienti = controllo End point primario: tempo al primo evento registrato di FA durante FU di 6 mesi. NEJM 2014 HR 6.4 95% CI [1.9-21.7] p<0.001 HR 7.3 95% CI [2.6-20.8] p<0.001 HR 8.8 95% CI [3.5-22.2] p<0.001 Symptoms related to AF 12 months data- ICM group-% of episodes

5 Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016 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. Semplice Connesso Trasportabile Completi Automatici Semplificati Standard Riproducibile Mini-Invasiva Miniaturizzato Preciso Wireless Reveal LINQ Strumenti per la Procedura MyCarelink Patient Monitor Report Reveal LINQ & MyCareLink - Monitoring System

6 Dr.ssa Caterina Bisceglia 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: 1.5 ± 0.7 giorni DRG cod. 117 RRL: €3547 Degenza media: 1.5 ± 0.7 giorni DRG cod. 117 RRL: €3547

7 Dr.ssa Caterina Bisceglia 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 Soggetti privati promuovono nuove formule organizzative per migliorare l’efficienza del modello Mancanza di adeguate coperture economiche Affidato alla organizzazione volontaristica dei medici e del personale infermieristico Germania, Francia, Inghilterra, Spagna Sistema ad hoc finanziato con fondi pubblici/privati

8 Dr.ssa Caterina Bisceglia 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

9 Obiettivi Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016

10 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

11 Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016 Ablazione associata a riduzione statisticamente significativa del burden totale FA nei pazienti ≤50 anni (nei primi 24 mesi di FU) Prevenire le recidive di FA – ablazione transcatetere

12 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 Long-lasting FA parossistica FA persistente Flutter/TA

13 Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016 Esperienza OSR Agosto 2010 – Dicembre 2015 ComplicanzeN° Tamponamenti26 Ictus7 TIA3 Vascolari13 Altro8 Morte1 60.9% pazienti non assume terapia AA 39% dei pazienti non assume OAC Degenza media: 2,5 ± 0,7 giorni DRG cod. 518: RRL: €4971 Degenza media: 2,5 ± 0,7 giorni DRG cod. 518: RRL: €4971 Complicanze totali: 57 (2.8%) Long-lasting FA FA parossisticaFA persistente

14 Obiettivi Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016

15 Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016 Rognoni C. Clin Drug Investig 2014

16 Occlusione percutanea auricola sinistra Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016 Europace 2014;16:1397–416.

17 Occlusione percutanea auricola sinistra Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016 Stroke Dicembre 2014

18 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.

19 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 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 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.

20 Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016 Reddy VY; JACC 2015

21 Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016 Reddy V. Europace 2016. Epub ahead of print

22 Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016 Esperienza OSR Agosto 2010 – Gennaio 2016 135 Pazienti sottoposti a chiusura percutanea di Auricola sinistra CHA 2 DS 2 -VASc: 2,9 ± 1,7HAS-BLED: 2,7 ± 1,4

23 Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016 Esperienza OSR Agosto 2010 – Gennaio 2016 Dimensione media del device:23,8 ± 3 mm Successo procedurale (device normoposizionato senza leak o con leak < 3 mm) : 99% Dimensione media del device:23,8 ± 3 mm Successo procedurale (device normoposizionato senza leak o con leak < 3 mm) : 99%

24 Dr.ssa Caterina Bisceglia Roma, 15 Febbraio 2016 Esperienza OSR Agosto 2010 – Gennaio 2016 Degenza media: 2,3 ± 1,5 giorni DR codice 518:RRL: €4133 Degenza media: 2,3 ± 1,5 giorni DR codice 518:RRL: €4133 Complicanze totali: 6 (4,4%)

25 Dr.ssa Caterina Bisceglia 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