Sapien Valve an Option in 'No-Option' Severe Secondary Mitral-Valve Disease

November 10, 2017

DENVER, CO — Experts here were impressed on hearing details from a small observational study showing early success using the Sapien 3 THV (Edwards Lifesciences) valve off-label in small cohorts of patients with two types of severe, secondary mitral-valve (MV) disease[1].

The patients, all ruled out as candidates for surgery, included 30 who received the Sapien for repair of failed mitral annuloplasty rings (valve-in-ring patients) and 30 with severe mitral-annular calcification (MAC) in a native valve (valve-in-MAC patients)

The technical success rate was about 70% with reasonable 30-day echocardiographic outcomes, there were no cases of valve embolization or thrombosis, and 30-day mortality was lower than predicted risk based on STS scores and compared with rates reported from registries.

The FDA-approved investigational-device exemption trialwas essentially a feasibility study showing that at least some kind of transcatheter-valve prosthesis can be use in these difficult-to-treat patients, Dr Mayra E Guerrero (Evanston Hospital, IL) told | Medscape Cardiology.

Guerrero presented results from the two cohorts, part of the Mitral Implantation of Transcatheter Valves (MITRAL) study, here at TCT 2017.

A Sapien XT was used in the first two patients, she said, but was replaced in the remainder by the Sapien 3 once it became available.

Approved indications for the Sapien 3, predominantly used for transcatheter aortic-valve replacement (TAVR), recently broadened to include replacement of failed MV prostheses in symptomatic high-surgical-risk patients.

"What Dr Guerrero has presented is groundbreaking," Dr Harry Suryapranata (Radboud University Medical Center, Nijmegen, the Netherlands) said at media briefing on the study. Suryapranata, an interventional cardiologist, isn't connected with the MITRAL study.

"What she has done is taken a pathology that is extreme for mitral disease and shown that we can use off-the-shelf devices to be successful," he said.

Also not involved in the study, interventionalist Dr Dean J Kereiakes (Christ Hospital Heart and Vascular Center, Cincinnati, OH) was impressed at how the patients fared after the two different MV procedures.

They were "no-option" patients, he said in an interview. "And guess what? These guys were given options!"

One key message based on the valve-in-ring cohort, Kereiakes said, is that surgeons should choose annuloplasty rings with an eye to possible later transcatheter repair.

"Not all rings are created equal," he said. The message for surgeons is "make sure you use a ring in the context that you may have a percutaneous transcatheter fix. You want a ring that is not too stiff, you want a ring that is not discontinuous. . . . The ring that you use today will be the landing zone of the transcatheter mitral valve of the future."

After her formal presentation of the study here, Guerrero made the same pitch to the panel, which included several valve surgeons, who may have missed her earnestness. Some on the panel and in the audience seemed to laugh, and moderator Prof Francesco Maisano (UniversitätsSpital Zürich, Switzerland) said, "Thank you for the suggestion; we'll think about it."

The 30-patient valve-in-ring cohort qualified for the study by having severe mitral stenosis, with an MV area ≤1.5 cm2, "or at least moderate to severe mitral regurgitation."

Of note, of the 92 valve-in-MAC patients initially considered, 30 were selected for the cohort after exclusion of those considered at high risk of LV outflow tract (LVOT) obstruction, embolization, or both.

Mortality Outcomes for Valve-in-Ring and Valve-in-MAC Procedures

End points In-hospital 30 d
Valve-in-ring n=30 n=29
All-cause mortality (%) 6 6.8
CV death (%) 3 3.4
Valve-in-MAC (%) n=30 n=26
All-cause mortality (%) 16.7 19.2
CV death (%)      3.3 3.8

The rates of procedural technical success in the valve-in-ring and valve-in-MAC groups were 70% and 73.3%, respectively.

Of the remainders, six valve-in-ring patients needed a second transcatheter valve and three were left with 2+ mitral regurgitation. Of the valve-in-MAC patients, three had LVOT obstructions, one needed a second valve, two were left with 2+ mitral regurgitation, and LV perforation and ventricular septal defect occurred in one patient each, both of whom had procedures with transatrial access.

No or only trace mitral regurgitation was seen in 75% of both cohorts. One valve-in-MAC patient (6.25%) had mitral regurgitation of at least grade 3. There were no cases of valve embolization or thrombosis at 30 days.

Adverse Events at 30 Days for Valve-in-Ring and Valve-in-MAC Procedures

Event Valve-in-ring, n=29 (%) Valve-in-MAC, n=26 (%)
Reintervention 3.4 3.8
Ischemic stroke 0 3.8
Intracranial hemorrhage 3.4 0
Hemolytic anemia 3.4 11.5
Acute renal failure requiring dialysis 10.3 3.8
Transfusion 20.6 34

Guerrero said one goal of the study was to support expansion of the FDA approval for the Sapient 3 to treat patients with failing annuloplasty rings.

But she cautions against "premature" approval of the of the MAC indication, and she cautioned centers against forging ahead with cases like those in MITRAL without partnering with and learning from groups that have already developed the expertise.

Without that collaboration, she said, "there could be a lot of complications, like going back to our earlier experiences when our complication rate and mortality were much higher."

Echocardiographic Findings at 30 Days for Valve-in-Ring and Valve-in-MAC Procedures

Parameter Valve-in-ring, n=24 (%) Valve-in-MAC, n=17 (%)
LVEF (%) 45.4 61.1
Mean MV gradient (mm Hg) 8.4 6.6
Mean MV area (cm2) 2.1 3.2
Peak LVOT gradient (mm Hg) 47.5 51.4
Systolic PAP (mm Hg) 4.9 8.2
MV=mitral valve
LVOT=left ventricular outflow tract
PAP=pulmonary artery pressure

MITRAL was partially supported by Edwards Lifesciences. Guerrero discloses receiving grant support from Edwards Lifesciences, consulting for Tendyne Holdings/Abbott, and being on a speaker's bureau for Abiomed. Suryapranata discloses receiving grant support or having a research contract with OrbusNeich. Kereiakes discloses consulting or serving on a speaker's bureau for or receiving honoraria from Abbott Vascular, Boston Scientific, Svelte Medical Systems, Micell Technologies, and SINOMED. Vahanian discloses consulting or serving on a speaker's bureau for or receiving honoraria from Abbott Vascular and Edwards Lifesciences. Maisano discloses grant support or research contracts with Abbott Vascular, Bioventrix, Medtronic, Edwards Lifesciences, and Xeltis; and receiving royalties from or holding intellectual property rights with 4Tech Cardio, Affix, and TSP Medical.

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