The CardiAQ Transcatheter Mitral Valve

Cardiologia interventistica nelle
cardiopatie strutturali
Prof. Francesco Romeo
Universita’ degli Studi di Roma “Tor Vergata”
Genova 13/11/2015
CORONARY ARTERY DISEASE
Where is Interventional Cardiology going?
Interventional cardiology has moved from
time it was important to stress:
“How to do”
“When and to whom”
Come si può trattare
un’emergenza trombotica?
Per anni la trombolisi è stato il trattamento di scelta
nei pazienti con infarto miocardico acuto ottenendo
una significativa riduzione della mortalità in fase
acuta.
PCI in CAD is Here to Stay
L’introduzione nell’ultimo decennio dell’angioplastica
primaria ha posto il problema di un corretto iter
terapeutico che permettesse di utilizzare nella
sequenza migliore entrambe le metodiche sfruttando i
vantaggi di entrambe
PROBLEMI APERTI:
•DES vs BMS nello STEMI
•Culptit lesion o rivascolarizzazione completa
•TC / patologia trivasale
•Stent diretto o tromboaspirazione
•Trattamento dei pazienti anziani
•Trombolisi:quando farla?a chi farla?quando
eseguire una PCI dopo una trombolisi “efficace”
•No Reflow
•Trattamento delle biforcazioni
•Come trattare al meglio lo shock cardiogeno
Structural Cardiology
The new frontier of interventional cardiology
Congenital Heart Disease
Mitral Stenosis
Left Atrial Appendage
Percutaneous Closure of Para-prosthetic Leak
Aortic Stenosis
Mitral Regurgitation
Heart Failure Devices
Storia della Sostituzione Valvolare
Aortica
Homograft – 1962
Chirurgica
Mechanical heart valve – 1962
Treatment of high surgical risk
patients has been modified
Porcine valve – 1965
with the introduction of TAVI
First Edwards/PVT Transapical Beating
Heart AVR – Webb, Lichtenstein
November 29, 2005
Pericardial tissue valve – 1969
1960
1970
Endovascolare
2002
2004
First PVT Transcatheter AVR
by Antegrade Approach
Alain Cribier – 2002
First CoreValve Transcatheter AVR
by Retrograde Approach
Laborde, Lal, Grube – July 12, 2004
2006
First CoreValve PURE Percutaneous
AVR – Serruys, DeJaegere, Laborde
October 12, 2006
First CoreValve Percutaneous AVR
WITHOUT cardiac assist or pacing
Grube, Gerckens – November 6, 2006
Storia Naturale
Braunwald E. Aortic stenosis.
Circulation 1968
“Surgical intervention should be performed
promptly once even …minor symptoms occur”
GP Ussia
GP Ussia
7
1989
Henning Rud Andersen, the
inventor of TAVI
Andersen, a cardiologist at Aarhus University
Hospital, Denmark, recalls the interventional
meeting he attended in February 1989 in the
USA: "I was sitting in the auditorium listening
to Julio Palmaz describing his experience of
using coronary stents in dogs, when I
suddenly thought ‘why not make the stents
larger and place a biological valve inside.’"
April 16, 2002: First human case
description trans-catheter aortic valve
Epidemiology
Class I
 Symptomatic Severe Aortic Stenosis
Severe Aortic Stenosis in patients who undergoes
other cardiac surgery (CABG, mitral valve repair …)
Asymptomatic Severe Aortic Stenosis with left
ventricular disfunction ( EF<50%)
GP Ussia
10
GP Ussia
Which Patient?
Transcatheter Valve implantation for pts
with aortic stenosis: a position statement
from EACTS-ESC-EAPCI
European Heart Journal 2008
• Diagnosis of Aortic Valve Stenosis
• Cardiac surgery risk and life expectancy
– STS score/ log EuroScore
– Comorbidities: liver chirrosis, porcelain aorta, cachexia,
hostile thorax, respratory insufficiency (FEV1<1 liter),
pulmonary hypertension (PAPS>60 mmHg)
• Feasibility assessment of TAVI and exclusion criteria
- Porcelain aorta,
- Previous chest wall radiation;
- Hepatic failure;
- Chest wall malformation;
-
Frailty;
Active endocarditis;
Active cancer;
Low-flow low-gradient AS
- Left ventricular hypertrophy;
- Left ventricular dilatation;
- Diastolic dysfunction;
- Preoperative 6 min walk test;
- Hypoalbuminemia /poor nutritional status;
- Anaemia;
- Morbid obesity;
- Right ventricular dysfunction..
Patient assessment
 Echocardiogram
 Aortography
 Angio CT scan
G.P. Ussia
CT Scan Examination
Annulus 23.7 x 30.5 mm
Sinus 33. 7mm
Perimeter 82.3 mm
Accesso Arteria Femorale Comune
Access Alternative
Accesso Arteria Succlavia/ascellare
prossimale
Direct Aortic Surgical Technique
• Additional approach for
those patients who are
not candidates for
either femoral or
subclavian access
options.
• Familiar access through
a mini-sternotomy or
mini-thoracotomy
• No pericardial
dissection or direct
heart muscle
manipulation.
1J
Bruschi G, et al. Direct Aortic Access Through Right
Minithoracotomy for Implantation of Self-Expanding Aortic
Bioprosthesis Valves 1
Brushi G, De Marco F, Fratto P, Oreglia J, Colombo P, Botta L, Klugmann S, Martinelli L. Alternative approaches for trans-catheter selfexpanding aortic bioprosthetic valves implantation: single-center experience. Euro J Cardio-Thoracic Surg. 2011; 39: e151-e158.
Prognostic factor of long term death
•
•
•
•
•
Procedural complications
Chronic kidney disease
COPD
Frailty
Atrial Fibrillation
Most frequent Complications
•
•
•
•
•
•
Implant failure
Paravalvular leak
Major vascular complications
Atrio-ventricular block
Left and right ventricular perforation
Cerebrovascular accident
Current Generation device
Medtronic CoreValve
Edwards-Lifesciences
>50,000 patients treated thru
2012 in >500 interventional
centers outside the U.S.!
Optimal positioning
Indications for aortic valve replacement in aortic stenosis
ESC/EACTS GUIDELINES 2012
Accepted Date: 4
March 2015
Eltchaninoff H. London Valve 2014
EVOLUT R (Medtronic)
EVOLUT R (Medtronic)
Corevalve & Edwards
•
•
•
•
150.000 impianti
800 centri nel mondo
Trial randomizzati ( Partner A, Corevalve US trial)
Registri (ADVANCE, SOURCE, TCVT pilot, Registri
Nazionali: UK, FRANCE 1 & 2, GARY …)
• Linee guida ESC 2012, ACC/AHA 2013
• FDA
Nuove Indicazioni
TAV in SAV for degenerated
bioprosthesis
Insufficienza Aortica
ACURATE neo™ & ACURATE TF™ Delivery System
The surgical repair or replacement of
the mitral valve is the gold standard in
severe treatment of the IM.
Without surgical treatment the
prognosis of patients with IM
and heart failure is poor.
Actual management of IM in the “real world”
da Euro Heart Survey
No Intervento CCH
n=193 (49%)
• disfunzione VS
IM isolata
(n=877)
• NYHA IV
IM <3+
• etiologia non ischemica
(n=347)
• età avanzata
IM severa
(n=540)
• ↑ indice di Charlson per comorbidità
Asintomatici
• IM grado 3+
Sintomatici
n=396
n=144
No Intervento
n=193 (49%)
Mirabel. Eur Heart J 2007
Intervento CCH
n=203 (51%)
Concept: Percutaneous Mitral Valve
Repair
• Double-orifice suture technique developed by
Prof. Ottavio Alfieri
• First published results in 1998 illustrated
proven benefit
• Suggested procedure best suited for minimally invasive
approach
• Dr. Fred St. Goar, interventional cardiologist had patient
successfully treated with edge-to-edge surgery
• Conceived several ideas for percutaneous valve repair
• Founded Evalve 1999 to develop device to treat valvular
disease
Edge-to-Edge Technique
Human S/P Surgical Alfieri
Circulation 2002;106:e173
eValve Clip repair in porcine heart (6 mos post)
Circulation 2003;108 (supp IV):493
MitraClip System
• Percutaneous repair of the MV
• Beating heart procedure
• Real time MR assessment
• Allow for repositioning of the
device
Procedural Overview
Procedural Overview
Procedural Overview
Procedural Overview
Procedural Overview
Worldwide Clinical Experience
FDA Approval
•
•
1.
*
Over 10,500 patients have been treated with the MitraClip Therapy
worldwide.1
–
75% are considered high risk* for mitral valve surgery
–
67% have functional mitral regurgitation (MR)
–
96% Implant Rate
The use of the MitraClip is supported by a rigorous clinical trial program.1
–
50% are considered high risk* for mitral valve surgery
–
60% have functional MR
Data as of September 2013.Source: Abbott Vascular
Determination of high surgical risk based on: logistic EuroSCORE ≥ 20%, or STS calculated mortality ≥ 12%, or pre-specified high surgical risk co-morbidities specified in EVEREST II High
Risk Study protocol.
N Engl J Med 2011;364:1395–1406
MR Severity
Functional Status
MitraClip therapy reduces functional Mitral regurgitation in
patients with endstage heart failure and marked LV disfunction
and entails clinical benefit at 6 months
Circulation. 2013;127:1018-1027
MitraClip in Specific Patient
Populations
Patient groups in which significant clinical benefits have been
reported:
– Severe Heart Failure, despite optimal medical therapy1
– CRT non-responders2
– Severe LV dysfunction refractory to medical therapy3
– Degenerative MR, declined for surgery4
– Bivalvular Disease: Severe Aortic Stenosis and Mitral
Regurgitation5
1. Franzen et al. MitraClip Therapy In Patients With End-Stage Systolic Heart Failure. Eur J Heart Failure. 2011; 13: 569-576.
2. Auricchio et al. Correction of Mitral Regurgitation in Nonresponders To Cardiac Resynchronization Therapy By MitraClip Improves Symptoms And Promotes Reverse Remodeling. JACC 2011; 58: 2183-2189.
3. Franzen O, Baldus S, Rudolph V, et al. Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: Emphasis on adverse valve morphology and severe left ventricular dysfunction.
Eur Heart J. 2010; 31:1373-1381
4. Reichenspurner, H. et al. Clinical Outcomes through 12 months in patients with Degenerative Mitral Regurgitation treated with the MitraClip device in the ACCESS-Europe Phase I trial. Eur J Cardiothoracic
Surgery. 2013: July 17. [Epub ahead of print]
5. Rudolph V, Schirmer J, Franzen O, Schlüter M, Seiffert M, Treede H, Reichenspurner H, Blankenberg S, Baldus S. Bivalvular transcatheter treatment of high-surgical-risk patients with coexisting severe aortic
stenosis and significant mitral regurgitation. Int J Cardiol. 2013; 167(3):716-2
Patient Selection
 Confirmation of MR severity (3+ or 4+) and symptoms
 Analysis of surgical risk (STS-score >10%; LogES>20%;
adjunctive criteria not included in the scores)
 Evaluation of life expectancy (>1 y)
 Assessment of the procedure feasibility and any
controindication to percutaneous treatment
Key Anatomic Elegibility Criteria
EVEREST Trial
 Sufficient leaflet tissue for mechanical coaptation
 Non-rheumatic valve morphology
 Non-endocarditic valve morphology
 Absence of severe calcification
 AVM > 4.0 cm2
 FUNCTIONAL MR
•
Coaptation depth ≤ 11mm
•
Coaptation length ≥ 2mm
 DEGENERATIVE MR
•
Flail gap ≤10mm
•
Flail width ≤ 15mm
Pregi
Difetti
 Basso rischio di
• Curva apprendimento
complicanze
lunga
intraprocedurali
• Rischio di
 Successo procedurale
intrappolamento nelle
immediato
corde tendinee in caso
 Monitoraggio ETE in
di ripetute manovre
tempo reale con ↓
• Prognosi invariata
complicanze
nelle funzionali in
 Possibilità di ripetere
scompenso cardiaco
impianti sino al migliore
avanzato
possibile
Pregi
 IM funzionali:
stabilizzazione clinica,
riduzione dei ricoveri
per scompenso
 miglioramento qualità
della vita
 IM degenerative con
rotture di corde
complicate ma ottimo
outcome clinico
 Miglioramento quadro
clinico e classe NYHA
Difetti
• IM degenerative
mixomatose
complesse con
risultato subottimale
(manca anuloplastica)
• Recidiva di
insufficienza mitralica
ad un mese
• Costo del dispositivo
• Rimborso variabile da
regione a regione
The CardiAQ Transcatheter Mitral Valve
CAUTION: Investigational device, limited by Federal (or United States) law to investigational use. Exclusively for Clinical
Investigation. Not approved for sale in any country.
The CardiAQ Transcatheter Mitral Valve
•
ONE VALVE, MULTIPLE DELIVERY SYSTEMS
TS – Transseptal approach
TA – Transapical approach
•
UNIQUE ANCHORING MECHANISM
Preserves chords and utilizes native leaflets
Promotes load distribution among annulus, leaflets and
chords
•
DESIGNED TO PROMOTE PHYSIOLOGIC FLOW
Eliminate mitral regurgitation
Supra-annular position and tapered outflow to minimize
risk of LVOT obstruction
Intra-annular sealing skirt to minimize PV leak
Open frame cells to promote atrial flow
CardiAQ Percutaneous
The CardiAQ Transcatheter Mitral Valve
Supra-annular Position
• Minimizes risk of LVOT obstruction even in the
presence of an acute aorto-mitral angle
• Left atrium easily accommodates atrial profile
The CardiAQ Transcatheter Mitral Valve
Supra-annular Position
• Patients treated with aorto-mitral angle 50.5° to 80.9°
• No LVOT obstruction
TF-001: 60.0°
TA-001: 80.9°
TA-002: 68.5°
TA-003: 50.5°
The CardiAQ Transcatheter Mitral Valve
Intra-annular Sealing Skirt
• Designed to minimize paravalvular leak
• Animal studies demonstrate intra-annular sealing
and no paravalvular leak
The CardiAQ TMVR Procedure
One Valve, Multiple Delivery Systems
Leaflet Capture
1
Transseptal
Transapical
Valve Expansion
2
Valve Release
3
CardiaQ: 2° GEN
• Sistema ancoraggio atraumatico
–
–
–
–
Punte delle ancore imbottite
Spazio aperto tra le punte delle ancore atriali e ventricolari
Ridotta pressione sub-annulare delle punte ventricolari
Migliore distribuzione del carico tra annulus e corde
CardiaQ
25 marzo 2015 – Università di Roma “Tor Vergata”
•Paziente di 72 anni ,
insufficienza mitralica severa,
classe NYHA 3
•Approvazione Comitato
Etico per uso
compassionevole
TRANSAPICALE
TRANSAPICALE
18 giugno – Università di Roma “Tor Vergata”
TRANSFEMORALE
TRANSFEMORALE
TRANSFEMORALE
TRANSFEMORALE
Conclusioni
• La mitraclip è indicata
– nella IM primaria nei pazienti ad alto rischio
cardiochirurgico
– Nella IM secondaria sintomatica
• Nella IM secondaria puo essere utilizzata
come bridge al trapianto cardiaco quando la
comparsa della IM peggiora il quadro di
compenso emodinamico
Conclusioni
• L’intervento di riparazione transcatetere
dell’insufficienza mitralica secondaria interrompe il
circolo vizioso dello scompenso
• Migliora la qualità della vita del paziente riducendo il
numero di scompensi cardiaci
• Non si hanno ancora dati controllati sulla sopravvivenza
possiamo ipotizzare che
– nelle IM secondaria alla CMPD la storia naturale della
cardiopatia non venga modificata
– Nelle forme secondarie a cardiopatia ischemica il corretto
timing possa ridurre la mortalità a lungo termine
Trans-Catheter Valve Treatment long-term Registry
EURObservational Research Programme
GRAZIE