Chiusura dell’auricola: attualità e prospettive future

Convention della Cardiologia Lombarda

Emanuela Piccaluga Milano

Villa Porro Pirelli, 27-28 marzo 2015 Induno Olona

Rationale for LAA occlusion in Patients with NVAF

• Non-rheumatic AF pts:

– Thrombus present in 12.6% of patients.

– 90% of the thrombi were found in the LAA

Blackshear JL, Odell JA.. Ann Thorac Surg 1996;61:755–9.

Camm AJ et al Europace 2012; 14: 1385 - 1413

First successful LAA closure

Aug 30,2001

72 yr male,

multiple contraindications to TAO

Procedure time 85 min

Complete seal

No complications

Coumadin off since 2001

No neurological events

Participated in other FIM trials

PROTECT AF STUDY

Holmes D et al. Lancet 2009;374: 534 - 42

LAA Closure vs Warfarin for Atrial Fibrillation Long term results

Reddy V et al. JAMA 2014;312 (19): 1988-98

7.4%

LAA closure Safety Profile

pts = 1298

Holmes D et al. JACC 2014; 64: 1 - 12

LAA closure vs OAC - Net clinical Benefit

Gangireddy SR et al. Eur H Journ 2012;33 : 2700-2108

Expected based on CHADS2 score

Expected if copidogrel was used

Observed rate in ASP

ASAP Study

Non randomized, 150 pts with NVAF&OAC contraindication

FU 14.4 ± 8.6 months

6m DAPT ASA lifelong

Reddy V et al. JACC 2013;61: 2551-6

Studies with the ACP device

SAFETY Initial

European

N=143

European

prospective

N=203

Belgium

N=90

Canada

N=52

European

post market

N=47

Multicenter

N=969

Procedural

Success

132 (96%) 197 (97%) 89 (99%) 51 (98%) 46 (98%) 942 (97.2%)

Stroke during

hospitalization

3 (2.1%) 0 (0%) 0 (0%) 1 (1.9%) 0 (0%) 7 (0.7%)

Serious per.

effusion

5 (3.5%) 3 (1.5) 3 (3.3%) 1 (1.9%) 0 (0%) 12 (1.2%)

Device

embolization

2 (1.4%) 3 (1.5) 0 (0%) 1 (1.9%) 1 (2.1%) 2 (0.2%)*

Other ** - - 2 (2.2%) - 13 (1.3%)

Death 0 (0%) 0 (0%) 1 (1.1%) 0 (0%) 0 (0%) 6 (0.6%)

Total reported

safety events

10 (7%) 6 (2.9%) 6 (6.7%) 3 (5.8%) 1 (2.1%) 40 (4.1%)

*Needing major intervention, **Air embolism, MI, and/or major bleeding

1. Park, J-W. et al(2011) Left atrial appendage closure with ACP in AF– initial European experience. Catheterization and Cardiovascular Interventions. 77:700–706

2. Walsh, K. (2012) left atrial appendage closure with the ACP: Results of the European Prospective Observational Study. Presented at EuroPCR. Paris May 17th.France

3. Kefer, J. et al. (2013) Transcatheter percutaneous left atrial appendage closure for stroke prevention in atrial fibrillation: the Belgian Registry. Paper presented at : euroPCR: May 24th Paris France.

4. Urena M, et al. (2013) Percutaneous Left Atrial Appendage Closure with the ACP in Patients with Non-Valvular AF and Contraindications for Anticoagulation Therapy. J Am Coll Cardiol. Jul 9;62(2):96-

102.

5. Sievert, H, et al. (2013), P2187: Horst Sievert. Long term follow-up from ACP EU multicenter post market observational study. ESC 2013 – Amsterdam. September 1. Posters - Village 9

6. TTzikas, LAAO for stroke prevention in AF, a multicenter experience with the ACP. TCT, San Francisco, October 2013

ACP Device Recent Publications: Safety

1° End Point: Efficacy of device in preventing Stroke, TIA & systemic embolism

Tzikas A et al. EuroInterv 2015

Results from the Multicentre experience with

the AMPLATZER Cardiac Plug

22 centres 1047 pts

Results from the Multicentre experience with

the AMPLATZER Cardiac Plug

Tzikas A et al. EuroInterv 2015

Meier B et al. EuroInterv 2015; 10: 1109-1125

GISE/AIAC 2014 - Documento di posizione

GISE/AIAC 2014

Indicazioni alla chiusura

Le linee guida GISE-AIAC considerano la chiusura dell’auricola sinistra un possibile

approccio terapeutico in pazienti con FA non valvolare ad alto rischio tromboembolico

(CHA2DS2-VASc score ≥2) e controindicazioni alla TAO.

La procedura è indicata in pazienti:

Con controindicazioni assolute o relative alla TAO (diatesi emorragica, pregressa

emorragia cerebrale in anamnesi, ulcera peptica attiva, recente sanguinamento

gastrointestinale, genitourinario o respiratorio, anemia di origine non chiarita, grave

insufficienza epatica o renale, grave ipertensione)

In condizioni che riducono la compliance alla TAO o aumentano il rischio

emorragico (demenza, alcolismo, disturbi psichiatrici, tendenza a frequenti cadute)

La procedura può essere presa in considerazione in pazienti:

Che presentano un ictus nonostante una corretta TAO

Ad alto rischio emorragico ed indicazione alla triplice terapia antitrombotica, con

attenta valutazione del rapporto rischio-beneficio del singolo paziente.

La procedura NON è indicata nei pazienti che possono assumere la TAO

GISE/AIAC 2014 - Documento di posizione

On March 13, 2015, the FDA approved LAA closure with the Watchman

device

Boston Scientific Corporation announced that the US Food and Drug

Administration (FDA) has finally approved the Watchman left atrial

appendage closure device as an option for high-risk patients with non-

valvular atrial fibrillation who are seeking an alternative to long-term warfarin

therapy.

According to the company, the Watchman device is indicated to reduce the

risk of thromboembolism from the left atrial appendage in patients with non-

valvular atrial fibrillation who: are at increased risk for stroke and systemic

embolism based on CHADS2 or CHA2DS2-VASc scores; are deemed by

their physicians to be suitable for warfarin; and have an appropriate rationale

to seek a non-pharmacologic alternative to warfarin.

SICILIA

Ferrarotto – Catania

Civico – Palermo

Villa Sofia – Palermo

Paternò Arezzo – Ragusa

CAMPANIA Moscati – Avellino Pineta Grande - Castelvolturno Montevergine – Mercogliano Federico II – Napoli Fatebenefratelli – Benevento

PIEMONTE

ASL TO 4 – Ciriè S. Biagio e Arrigo – Alessandria

Villa Maria Pia – Torino Molinette – Torino

Mauriziano – Torino Città di Alessandria – Alessandria

Cardinal Massaja – Asti S. Croce e Carle – Cuneo

VENETO

Sacro Cuore – Negrar ULSS 13 – Mirano

ULSS 12 – Venezia /Mestre ULSS 3 – Bassano del Grappa Ospedale di Treviso – Treviso Università di Padova – Padova

San Bortolo – Vicenza Pederzoli – Peschiera del Garda

LOMBARDIA

San Raffaele – Milano Humanitas – Milano Sacco – Milano Macchi – Varese San Gerardo – Monza Niguarda – Milano Mellino Mellini – Chiari Monzino – Milano Ospedale di Legnano – Legnano Istituto San Rocco – Ome Sant’Ambrogio – Milano Bolognini – Seriate Carlo Poma – Mantova San Pellegrino - Castiglione Multimedica – Milano

SARDEGNA

Brotzu – Cagliari

San Francesco – Nuoro

EMILIA-ROMAGNA

Ospedale S Orsola – Bologna

Ospedale Maggiore – Bologna

Ospedale Parma – Parma

Hesperia Hospital – Modena

Kronosan – Cotignola

Morgagni Pierantoni – Forlì

ABRUZZO

Clinica Pierangeli – Pescara

San Salvatore – L’Aquila

PUGLIA Policlinico Bari – Bari Città di Lecce – Lecce Miulli – Bari

LIGURIA San Paolo – Savona ICLAS – Rapallo San Martino – Genova ASL3 genovese – Sampierdarena

LAZIO Gemelli – Roma Umberto I – Roma Campus Biomedico – Roma San Camillo – Roma TorVergata – Roma San Filippo – Roma

MARCHE

Ospedale Lancisi – Ancona

Italian Implanters

TOSCANA

G Monasterio – Massa Careggi – Firenze Cisanello – Pisa

BASILICATA San Carlo – Potenza

22

Dati GISE: Chiusure Auricola Sn

Conclusioni

• LAAC è una valida alternativa per la prevenzione dello stroke in

pazienti con NVAF e controindicazioni alla OAT

• Efficacia: I trial randomizzati hanno dimostrato la non-inferiorità e la

superiorità vs TAO (Watchman 4 yrs FU data).

• FDA approval il 13 marzo 2015

• Sicurezza: LAAC non è una procedura semplice. Importanza della

curva di apprendimento.

• I pazienti che possono beneficiare della procedura sono:

– Alto rischio tromboembolico (CHA2DS2VaSc > 2)

– Contraindicazione a OAT : alto rischio emorragico (HASBLED ≥ 3)

– Prevenzione secondaria: ictus in OAT in range terapeutico

Sviluppi futuri

• E’ necessario un confronto tra device e i NOAC

• Trial randomizzati che includano un adeguato numero di pazienti ad

alto rischio

• Valutazione del miglior regime antitrombotico dopo LAAC

• Validazione dei nuovi device

Lifetech Occlutech Cardia Wavecrest

Cordis/Biosense

Product on hold

More to come….