Raul m oreno cardioinnova pdf

27 y 28 Noviembre 2014SANTIAGO DESede: Hotel San Francisco

COMPOSTELA

IntervencionismoSCQ 2014

Válvula Lotus. Innovación en

intervencionismo estructural de

Boston.

Raúl Moreno Hospital La Paz

Madrid

• Comp. vasculares. • Hemorragias. • Rotura aórtica. • Oclusión coronaria. • Parada cardiaca. • Bloqueo AV. • Regurgitación paravalvular. • Embolización prótesis. • Taponamiento cardiaco. • Ictus. • Infección.

• Rotura aórtica? • Oclusión coronaria. • Regurgitación paravalvular. • Embolización prótesis. • Bloqueo AV.

Relacionadas con el posicionamiento

Complicaciones del TAVI

Margen de mejora en relación con el diseño de las prótesis

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Válvula Lotus: innovación en intervencionismo estructural de Boston.

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✓ Ocurre en el 2% (0-8%). !✓ Casi exclusivamente durante el procedimiento. !✓ Más frecuente a la aorta pero más grave al ventrículo. !✓ Factores predisponentes: hipertrofia severa basal, fallo del “rapid-pacing”, malposicionamiento de la válvula, escasa calcificación, diámetro demasiado pequeño, prótesis mitral metálica. !✓ “Dispositivo-dependiente”.



Embolización de la prótesis

Válvula ES embolizada hacia aorta e implantada en aorta

descendente

Válvula ES embolizada hacia ventrículo izquierdo



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✓ Ocurre (moderada o severa) en el 15-40%. !✓ Cuando ocurre, peor pronóstico (función VI, cirugía, muerte).

Circulation. 2011; 124: A12656 Circulation 2011;123:299-308.

Predictores de mortalidad tardía (1-12 meses) con Core-valve (n=663)

HR P value

Prior stroke 5.468 0.01

Post- paravalvular leak ≥2 3.785 0.003

Prior acute edema 2.696 0.03

Chronic kidney disease 2.532 0.048



Insuficiencia para-valvular

Bovine Pericardium Proven long-term

material

Locking Mechanism Enables operator control of implant

Adaptive Seal Minimizes paravalvular leak

by confirming to irregular anatomical surfaces

Braided Nitinol Frame Designed for strength, flexibility, and ability to retrieve, reposition, and redeploy

Central Radiopaque Positioning Marker Aids precise positioning

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Válvula Lotus: descripción

Delivery system Pre-shaped to facilitate advancement through the aorta

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2. Intermediate Configuration 3. Final Locked

Configuration

~70mm

1. Elongated Configuration (for Delivery)



19 mm

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Valve is repositionable throughout entire deployment process

• Ability to assess valve in final position

• Valve still repositionable & retrievable prior to release.

(even when 100% of the valve is out of the catheter!!!).

Lotus

23mm Lotus Valve 25mm Lotus Valve 27mm Lotus Valve

Native Annulus Diameter ≥20 mm - ≥23mm ≥23 mm - ≥25m ≥25 mm - ≥27mm

Deployed Valve OD 23mm 25mm 27mm

Deployed Valve Height 19mm 19mm 19mm

*As measured by baseline diagnostic imaging28 Nov 2014



Medidas disponibles

Next: 21 F , 29 F

▪ LIS - (Lotus Introducer Sheath – Small ▪ Access vessels 6.0 mm or larger ▪ Review IFU prior to use

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▪ LIS - (Lotus Introducer Sheath – Large ▪ Access vessels 6.5 mm or larger ▪ Review IFU prior to use

Lotus Introducer for 23 mm

Lotus Introducer for 25 mm and 27 mm

The Lotus™ Introducer Set is manufactured by Creganna-Tactx Medical and distributed by Boston Scientific Corporation



Introductor

Next: 14 F OD• Unexpanded: 5.6 mm • Expanded: 7.2 mm

18 F

20 F

Overall Length: 260 cm or 300 cm Core Material: Stainless Steel Coil Material: Stainless Steel Coating: LUBRIGREEN™ PTFE

Small curve configuration Large curve configuration

0.035” (0.889mm) outer diameter 0.035” (0.889mm) Outer Diameter

246 cm 244 cm

16 cm Distal Grind 18 cm Distal Grind

4.25 cm 5.05 cm

4.20 cm 4.90 cm

The SafariTM Guidewire is manufactured by Lake Region Medical and distributed by Boston Scientific Corporation. Image provided courtesy of Lake Region Medical.

!• Pre-shaped architecture designed for

consistent, reliable performance. • Double curve designed to facilitate

stable, atraumatic placement. • PTFE coating allows for less force during

device delivery. • Two curve sizes accommodate varying

anatomies and systolic contractions of LV.



Guía Safari

REPRISE I

REPRISE II

REPRISE II Extension

RESPOND

REPRISE III

Feasibility Study; Acute Safety & Performance (Extreme/High Risk) N=11; single arm; 23mm valve size Primary Endpoint: Device success (VARC-1) without MACCE Meredith et al, EuroIntervention 2014 Mar 20;9(11):1264-70

CE Mark Study; Safety & Performance (Extreme/High Risk) N=120; single arm; 23 & 27mm valve sizes Primary Device Performance Endpoint: Mean pressure gradient at 30d Meredith et al, JACC 2014; In Review

Safety & Performance Study (Extreme/High Risk) N=130; single arm; 23 & 27mm valve sizes Primary Safety Endpoint: All-cause mortality at 30d Enrollment Complete

Post Market Safety & Performance Study (Real World) N=1000; single arm; 23, 25 & 27mm valve sizes Primary Endpoint: All-cause mortality at 30d & 1y Currently Enrolling

FDA Approval Study; Safety & Efficacy (Extreme/High Risk) N~1000; Global RCT vs. comparator; 23, 25 & 27mm valve sizes Anticipated start: 2H 2014

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Programa clínico

Meredith IT, et al. EuroIntervention 2014;9:1264-1270

Primary end-point: discharge/7 days

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REPRISE I

28 Nov 2014Meredith IT, et al. EuroIntervention 2014;9:1264-1270



REPRISE I

Successful access, delivery, deployment and system retrieval 100.0% (120/120)

Successful valve repositioning, if attempted (n=31) 100.0% (31/31)Partial valve resheathing (n) 25Full valve resheathing (n) 6Successful valve retrieval, if attempted (n=6) 100.0% (6/6)

Aortic Valve Malpositioning 0.0 % (0/120)Valve migration 0.0 % (0/120)Valve embolization 0.0 % (0/120)Ectopic valve deployment 0.0 % (0/120)TAV-in-TAV deployment 0.0 % (0/120)

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REPRISE II

Meredith IT, et al. J Am Coll Cardiol 2014;64:1339-48.

* Repeated measures and random effects ANOVA

All p<0.001

Performance goal: 18 mmHg. Primary Device Performance Endpoint

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REPRISE II


No moderate or severe paravalvular leak at 1 year

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REPRISE II


Events at 1 year Patients (n= 119)*

All-cause mortality (primary safety endpoint) 10.9 % (13)

Cardiovascular mortality 6.7 % (8)

Disabling stroke 3.4% (4)

No disabling stroke 5.9% (7)

† All patients were assessed by a neurologist before and after TAVR * One patient withdrew consent after the discharge/7d time point

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REPRISE II


* Pacing status at 1 year was unknown for 11 patients and 5 died before 1 year and were not evaluable

Variable PatientsNewly implanted pacemaker 31.9% (38/119) Baseline RBBB 15.8% (6/38) New conduction disturbance post valvuloplasty 36.8% (14/38) LVOT area overstretch ≥10 % 57.9% (22/38) Annulus area overstretch ≥10 % 39.5% (15/38) Paced rhythm at 1 year 68.2% (15/22)*

Indication Patients3rd degree AV block 30New LBBB, symptomatic bradycardia 1LBBB, EP study showing severe infranodal dis. 3Trifascicular block 1New or worsened AF, symptomatic bradycardia 3

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REPRISE II


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REPRISE III1.032 pacientes, randomizados 2:1 a Lotus o Corevalve

anillo aórtico 20-27 mm 60 centros de USA, Canadá, Europa, Australia

Safety

Efficacy

Composite of all-cause mortality, stroke, life-threatening and major bleeding, 2-3 acute kidney injury, or major vascular complications at 30 days

Moderate or greater paravalvular aortic regurgitation (based on core lab assessment)

at 1 year

Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular

aortic regurgitation at 1 year

Primary end-points

Secondary end-point

Experiencia La Paz

• 12 pacientes en 5 meses. • No embolización, no necesidad de 2ª válvula. • No insuficiencia peri-valvular moderada o severa. • No mortalidad a 30 días. • No ictus. • Nuevo marcapasos: n=5. • Exito de implantación: 100%.

• Recaptura parcial: n=2. • Recaptura total: n=1.

• Implantación directa en 5 casos.28 Nov 2014



Sheath advancement Safari wire

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Caso 1

Valvuloplasty (required?)

Delivery system (aortic curve preformed)

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Too low position !

the valve is completely out of the catheter !!!!!)

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Caso 2

Recapture of the valve

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Replacement in an optimal position

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Conclusiones

Válvula completamente reposicionable y recapturable.

Minimiza riesgo de desplazamiento o embolización.

El “Adaptive seal” minimiza riesgo de insuficiencia peri-valvular.

Resultados de estudios REPRISE muestran excelentes resultados que corroboran las ventajas del dispositivo.

Esta minimización de los riesgos ayudará a expandir las indicaciones de la TAVI.

Raul m oreno cardioinnova pdf

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