Mitraclip: esiste l’indicazione clinica e anatomica ideale?

Jacopo Oreglia

Emodinamica

ASST Fatebenefratelli Sacco, Milano

Background EVEREST II RCT

1Feldman et al. NEJM 2011;364:1395-406

PML04247 Rev. A

Feldman T, ACC 2014 Washington

Etiology

Treating Centers 777

Patients (clinical and commercial) Over 43,000

Implant Rate1 97%

1. First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients

2. OUS Commercial Experience3. Etiology not inclusive of U.S. cases as of 14/04/2014. Data As of November 30, 2016. Source: Data on file at Abbott Vascular

Etiology

MitraClip Therapy Current Global Adoption

The main objective of the EVEREST Criteria was to ensure acute efficacy. By the time, most criteria have been surpassed, since experienced physicians dedicated to TMVR have found technical solutions to achieve acute successful reduction of MR

The increasing number of elderly polymorbidpatients with an inacceptable risk for surgery are part of the real world and should not be neglected. With the worldwide spreading post-market use of the MitraClip, the indications have rapidly been expanded towards FMR and inoperable patients, especially in Europe

The «unmet need»• 2000-2008: identificati 5.737 con MR

≥ 3• 1095 pz. con IM severa ed HF (814

FMR, 226 DMR)

• 577 pz NON operati (~52%), Follow-Up a 5 anni:- mortalità 50%- ospedalizzazioni 90%

Main Factors prohibiting Surgery:

• Impaired LVEF (<30%)

• Multiple comorbidities

• Advanced age

518 operati (~47,3%) 577 non operati (~52%)

Access EUN = 487

SENTINELN = 628

Etiology Etiology

Etiology

Grasp-ITN = 304

EtiologyTRAMIN = 749

EU Registries in the Real Word: Etiology

Different expectations in high risk MR patients?

DMR FMR

Valve disease: valve treatment = patient recovery

Heart disease: recovery unlikely?

Clinical benefit have been reported in:

• Degenerative MR, declined for surgery• EHJ 2013;44:280

• Functional MR in severe heart failure refractory to medical treatment

• Eur Heart J 2010;31:1373

• Functional MR in severe heart failure, despite optimalmedical treatment

• Eur Heart J 2011;13:569

• CRT non responders• JACC 2011;58:2183

Risk assessment?

Ferrarotto Hospital A.O.U. Policlinico-Vittorio Emanuele

Catania, Italy

D. Capodanno TCT 2016, October 26 - November 2, 2016 – Slide 12

TRAMI

Hamburg GRASP-IT

Predictors of

Mitraclip

OutcomesIs there a

“futile” patient?

NYHA class IV

Ischaemic

aetiology

Procedural failure

NT-ProBNP

Peripheral

artery disease

Age

Dilated

cardiomiopathy

CKD

Anemia

Prior valve

intervention

LVEF <30%

Tricuspid

regurgitation

Dyslipidemia

TimingPotential outcome benefit

Outcome benefit unlikely

Between 2011 and 2016, 126 consecutive patients were were treated and grouped in 42 consecutive patients each for further analysis in three groups

The Impact of growing experience

APPARATO MITRALICO:Anulus APx ML 40x 48 mmArea valvolare 6,18 cmqCoaptation depth 1,47cm Coaptation length 0,57 cmLPM 1,5 cm

Criteri morfologici e MitraClipOTTIMALE POSSIBILE SFAVOREVOLE

SEDE A2-P2 A1/P1 A3/P3PERFORAZIONE,

(CLEFT)

CALCIFICAZIONI ASSENTILIEVI AL DI FUORI DELLA SEDE DI

GRASPING, ANULARI,

SEVERE NELLA

SEDE DI GRASPING

AREA VALVOLARE AVM>4 cmq AVM>4 cmq

STENOSI V.

AVM <4 cmq

ΔP >5 mmHg

TENTING/MOBILITA’

LPM length>10 mm <7-10 mm < 7mm

COAPT. DEPTH <11 mm >11 mm

FLAIL WIDTH <15 mm>15 mm , SE AMPI ANELLI E POSSIBILITA’ DI

CLIP MULTIPLE

BARLOW S. CON PROLASSI

MULTIPLI

FLAIL GAP <10 mm >10

Criteri morfologici e MitraClipOTTIMALE

SEDE A2-P2

CALCIFICAZIONI ASSENTI

AREA VALVOLARE AVM>4 cmq

TENTING/MOBILITA’

LPM length>10 mm

COAPT. DEPTH <11 mm

FLAIL WIDTH <15 mm

FLAIL GAP <10 mm

Criteri morfologici e MitraClipOTTIMALE

SEDE A2-P2

CALCIFICAZIONI ASSENTI

AREA VALVOLARE AVM>4 cmq

TENTHING/MOBILITA’

LPM lenght>10 mm

COAPT. DEPTH <11 mm

FLAIL WIDTH <15 mm

FLAIL GAP <10 mm

Criteri morfologici e MitraClipSFAVOREVOLE

SEDEMULTIPLA/ COMMISS.,

PERFOR. / CLEFT

CALCIFICAZIONISEVERE NELLA

SEDE DI GRASPING

AREA VALVOLARE

STENOSI V.

AVM <4 cmq

ΔP >5 mmHg

TENTING/MOBILITA’

LPM length< 7mm

COAPT. DEPTH

FLAIL WIDTHBARLOW S. CON PROLASSI

MULTIPLI

FLAIL GAP >10

Criteri morfologici e MitraClipSFAVOREVOLE

SEDEPERFORAZIONE,

CLEFT

CALCIFICAZIONISEVERE NELLA

SEDE DI GRASPING

AREA VALVOLARE

STENOSI V.

AVM <4 cmq

ΔP >5 mmHg

TENTING/MOBILITA’

LPM length< 7mm

COAPT. DEPTH

FLAIL WIDTHBARLOW S. CON PROLASSI

MULTIPLI

FLAIL GAP >10

Criteri morfologici e MitraClipSFAVOREVOLE

SEDEPERFORAZIONE,

CLEFT

CALCIFICAZIONISEVERE NELLA

SEDE DI GRASPING

AREA VALVOLARE

STENOSI V.

AVM <4 cmq

ΔP >5 mmHg

TENTING/MOBILITA’

LPM length< 7mm

COAPT. DEPTH > 11 mm

FLAIL WIDTHBARLOW S. CON PROLASSI

MULTIPLI

FLAIL GAP >10

Criteri morfologici e MitraClipSFAVOREVOLE

SEDEPERFORAZIONE,

CLEFT

CALCIFICAZIONISEVERE NELLA

SEDE DI GRASPING

AREA VALVOLARE

STENOSI V.

AVM <4 cmq

ΔP >5 mmHg

TENTING/MOBILITA’

LPM length< 7mm

COAPT. DEPTH

FLAIL WIDTHBARLOW S. CON PROLASSI

MULTIPLI

FLAIL GAP >10

Heart Team

• Moderate to severe MR (DMR or FMR)

• Echocardiographic criteria for eligibility

• Level of surgical risk

• Greater than 1 year life exectancy

• Expected result

Severe symptomatic MR

Low acceptable surgicalrisk

Surgery

High-prohibitivesurgical risk

Favourableanatomy

Mitraclip:

Curative goal

(residual MR < 2+)

Intermediate anatomy

Mitraclip

individualtherapeutic goal

(residual MR < 3+)

Unfavourableanatomy

OMT

Palliation

Other options ifpossible

Indicazione clinica:- Rischio chirurgico basso o accettabile: chirurgia- Rischio chirurgico alto o proibitivo: Mitraclip

Anatomia- Favorevole: l’obiettivo è un intervento curativo: MR>2+- Anatomia difficile: considerare risultato parziale MR <3+- Anatomia estremamente difficile: considerare altre opzioni (palliazione)

Il timing dell’intervento è cruciale, per evitare di trattare pazienti che potrebbero non avere alcun beneficio

Occorre tuttavia considerare che I confini anatomici sono mobili e si spostanoverso morfologie sempre più complesse

Occorre trovare un modo di stratificare il rischio, probabilmente gli score di rischiochirurgico non sono adeguati, ci si deve basare sui predittori identificati dagli studi suMitraclip