TranscatheterMitral Valve Implantation A self‐centering ... · CorradoTamburino, MD, PhD FerrarottoHospital, Catania University. FerrarottoHospital ... A.O.U. Policlinico-Vittorio

Ferrarotto Hospital A.O.U. Policlinico-Vittorio EmanueleUniversity of Catania, Italy

Transcatheter Mitral Valve ImplantationA self‐centering & self‐axing device

Corrado Tamburino, MD, PhDFerrarotto Hospital, Catania University


Potential conflicts of interest

Speaker's name: Corrado Tamburino

Speakers Honoraria: Abbott, Medtronic, Biosensors, Stentys


HighLifeDevice Characteristics and Unique Features

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• The valve• 31mm TA valve• Bovine pericardium• Nitinol frame• Polyester cover

• The ring TF implant• Polymer tube• Nitinol hook• Polyester cover


3‐step approach

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Step 1 : Guide wire looped around mitral leafletsStep 2 : Ring implanted over guide wire loopStep 3 : Valve‐in‐ring implantation


Referral criteria and anatomical limitations

• Anatomy sizes that can currently be treated• Annulus range : 32‐45mm

• Virtual implantation on CT data to assess• LVOTO risk• LAA patency• Contact areas with LV wall

• Exclusions• Calcified native leaflets

• Potential risks• LVOTO• Entanglement in chords• contact with pap. muscles• LAA coverage

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Compassionate use patient• 68 year old Male (173 cm, 107 kg, BMI 36)• Functional severe mitral valve regurgitation• NYHA III• Risk scores

• ES 1: 32.8% ‐ ES 2: 8.6% ‐ STS: 2.9%

• Past medical history• CABG in 2015 (LAD, LCx, RCA)• Severe left ventricular dysfunction (EF 30%)• Moderate to severe pulmonary hypertension • Atrial septum not favorable for transeptal puncture

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Baseline mitral regurgitation

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Ring insertion and closure


Trans‐apical valve delivery


Guidewire retrieval and final LV gram


Assessment of valve function



Stable valve function at 30 days


Clinical outcome N=8

• Procedure success 6 out of 8• 1 entanglement of ring in LV false chord

• 1 chordal entanglement upon trans‐apical delivery

• Clinical outcomes• 2 deaths from MOF at POD 4• Improvement of NYHA class by one grade in all patients after 3 months

• No major adverse events at follow‐up

• No valve related complication @6M FU

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Patie

nts

Acute success, LV dysfunction + MOF

Re-intervention, MOF

Re-intervention


Lessons learned

• Procedure reveals feasible and safe• Reversibility of loop placement is confirmed• Ring insertion and closure is efficient• Valve delivery over trans‐apical site is efficient• No PVL, no gradient• Up to 45mm annulus can be treated currently

• Multi‐modality imaging very important• Pre and intra procedural planning with CT is critical• Echocardiography is instrumental for loop position


Conclusion

• Clinical proof of concept achieved with trans‐apical access

• Steep learning curve • Better patient selection• Improved procedure planning based on CT• Procedure time reduction

• True self‐axing and self‐centering within the ring implant

• Well suited for trans‐septal access and trans‐apical access

• Valve delivery perceived as easy by multiple users

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Documents

TranscatheterMitral Valve Implantation A self‐centering ... · CorradoTamburino, MD, PhD FerrarottoHospital, Catania University. FerrarottoHospital ... A.O.U. Policlinico-Vittorio