Vvvv Trial TMVR 2017

AffiliationFinancial Relationship Research Grant Support, Proctor Company Edwards Lifesciences The MITRAL Trial was partially supported by a research grant from Edwards Lifesciences Off label use of products and investigational devices will be discussed in this presentation 2017 MFMER slide-2.

Lves 91 patients extremely high surgical risk (STS PROM 15 or MM 50) Inclusion Criteria SAPIEN XT Valve-in-Valve n30 Severe MS (MVA 1.

At least Moderate-Severe MR 100 Transseptal NYHA II or greater Valve-in-Ring n30 Severe MS (MVA 1.

At least Moderate-Severe MR 100 Transseptal SAPIEN 3 Native MV (MAC) n31 Severe MS (MVA 1.

Severe MR Moderate MS 48.

Transapical First 2 patients in MAC arm were treated with SAPIEN XT, al subsequent patients were treated with SAPIEN 3 valves 1 withdrew consent 3 weeks post TMVR 2017 MFMER slide-3.

Vvvv Trial TMVR 2017

Hg) MV Pathology Stenosis Regurgitation Both MS and MR 1 patient withdrew consent while being discharged after successful transatrial TMVR 2017 MFMER slide-6.

V and PVL closure.

One transseptal MVIV and 1 Transatrial TMVR.

Acute Kidney Injury requiring new onset hemodialysis Bleeding One spontaneous intracranial microhemorrhage found on MRI done for headache (no focal deficit), and one genitourinary bleed.

One after 30 days treated conservatively.

Acute Kidney Injury requiring new onset hemodialysis Bleeding 2017 MFMER slide-12.

Subclinical: Incidental finding on 1 -year echo in a patient not receiving anticoagulation.

Mean MVG 4. 5 mm.

Hg, trivial central MR unchanged from post-procedure.

Successfully treated with warfarin without sequela.

MAC and MVi. R than MVi.

MAC and MVi. R Patients who survive have sustained improvement of symptoms at 1 year Valve performance is maintained at 1 year in all groups Low thrombosis rate was observed at 1 year (1.

It should be standard of care for all patients who have favorable anatomy Transseptal MVi.

Outcomes of Vi. MAC have improved with adequate screening and patient selection.

It may become a reasonable alternative for high surgical risk patients.

Vvvv For Mac