Overview Percutaneous Paravalvular Leak Closure When it works and - PDF document

10/1/16 Overview Percutaneous Paravalvular Leak Closure When it works and when it doesn’t • Disclosures: • Nothing to disclose. • Off label use of devices. Christian Spies, MD Interventional Cardiologist The Queen’s Center for Valve and Structural Heart Disease Associate Professor of Medicine University of Hawaii Honolulu, HI Center for Valve and Structural Heart Disease Center for Valve and Structural Heart Disease Overview Overview • Paravalvular Leaks following Surgical Mitral and Aortic • Why and when • Incidence Valve Replacement • Indications to consider closure • Paravalvular Leaks following Transcatheter Aortic Valve • Problems with surgery Replacement • How • Basic technique • Devices • Pitfalls • Examples • Literature Center for Valve and Structural Heart Disease Center for Valve and Structural Heart Disease 1

10/1/16 Overview Paravalvular Leaks • Why and when • 210,000 surgical valve replacements worldwide • Incidence • Incidence of paravalvular leaks: • Indications to consider closure • 2-10% aortic valve replacement surgery • Problems with surgery • 7-17% mitral valve replacement surgery • How • 1-3% of paravalvular leaks require reoperation • Basic technique because of symptoms • Devices • Symptoms of paravalvular leaks: • Pitfalls • Heart failure • Examples • Hemolysis • Literature • Combination, may be sequential Spiliopoulos et al. Interact Cardiovasc Thorac Surg 2009;8:252 Hammermeister et al. JACC 2000;36:1152 Genomi et al. Eur J Cardiothoracic Surg 2000;17:14 Center for Valve and Structural Heart Disease Center for Valve and Structural Heart Disease Miller et al. J Heart Valve Dis 1995;4:160 Paravalvular Leaks Paravalvular Leaks • Risk factors: • Concerns with surgery: • Extensive calcifications of annulus • Mortality: 13%+ • Presence of endocarditis at time of surgery • Morbidity: considerable • Large atria • 20% recurrence rate • Renal insufficiency • Older age • First percutaneous paravalvular leak closure in 1992 • Malnutrition with double umbrella device • ?? Type of valve • ??? surgeon Exposito et al. Rev Esp Cardiol 2009;62:929 Echevarria et al. Eur J Cardiothoracic Surg 1991;5:523 Genomi et al. Eur J Cardiothoracic Surg 2000;17:14 Center for Valve and Structural Heart Disease L Latson. Expert Rev Cardiovasc Ther 2009;7:507 Center for Valve and Structural Heart Disease Hourihan et al. JACC1992;20:1371 2

10/1/16 Guidelines Overview • Why and when PRACTICE GUIDELINE • Incidence 2014 AHA/ACC Guideline for the Management CLASS I 1. Surgery is recommended for operable patients with mechanical of Patients With Valvular Heart Disease • Indications to consider closure heart valves with intractable hemolysis or HF due to severe A Report of the American College of Cardiology/American Heart Association • Problems with surgery prosthetic or paraprosthetic regurgitation (617,618). (Level of Task Force on Practice Guidelines Evidence: B) • How • Basic technique CLASS IIa • Devices 2. Percutaneous repair of paravalvular regurgitation is reasonable in patients with prosthetic heart valves and intractable hemo- • Pitfalls lysis or NYHA class III/IV HF who are at high risk for surgery and • Examples have anatomic features suitable for catheter-based therapy when performed in centers with expertise in the procedure • Literature (620 – 622). (Level of Evidence B) Surgery is a viable therapeutic option in many patients Center for Valve and Structural Heart Disease Center for Valve and Structural Heart Disease Nishimura et al. JACC 2014: 63 (22): e57-185 Percutaneous PVL Closure Overview Pre-procedural Evaluation • Why and when Suspicion is key for diagnosis !!! • Incidence • 3D-TEE is key • Indications to consider closure • Problems with surgery • Shape (oval, crescentic) • How • Track (straight, serpiginous) • Basic technique • Aortic valve: ? proximity to coronary ostia • Devices • Mitral valve: location is key • Pitfalls • ? 1/3 of circumference • Examples • ? Rocking motion of valve • Literature Center for Valve and Structural Heart Disease Center for Valve and Structural Heart Disease 3

10/1/16 Percutaneous PVL Closure Percutaneous PVL Closure Pre-procedural Evaluation Pre-procedural Evaluation Center for Valve and Structural Heart Disease Center for Valve and Structural Heart Disease Mahjoub et al. JACC Interv 2011;4:107 Percutaneous PVL Closure Percutaneous PVL Closure Setup Devices AVP II AVP II ADO VSD • General anesthesia (usually) • Intraprocedural 3D-TEE • Biplane imaging (tangential and en face view) • Use of low frame rate • Small delivery • Larger delivery • Small delivery sheath sheath sheath • Thinner nitinol • More rigid • Thick nitinol • More flexible • Single • Rigid • No protruding discs retention disc • Protruding • Unilateral discs orientation Center for Valve and Structural Heart Disease Center for Valve and Structural Heart Disease 4

10/1/16 Percutaneous PVL Closure Percutaneous PVL Closure Aortic Valve Approach Mitral Valve Approach • Retrograde • Antegrade • General anesthesia +/- • Trans-apical • Retrograde/Transaortic • Cross leak with Glidewire • Leak location • Rail-wire +/- • Mechanical AV • TEE/TTE • Interatrial septum • Exchange for • Device deliverability • MP Guider 6Fr. • AV loop • Shuttle sheath (90cm) • Single device • AVP II or ADO • Rail wire • Double device Center for Valve and Structural Heart Disease Center for Valve and Structural Heart Disease Percutaneous PVL Closure Percutaneous PVL Closure Antegrade Mitral Valve Approach Antegrade Mitral Valve Approach • Triple telescope technique • 8.5Fr. Transseptal (67 cm) • 6Fr. JR4 guider (100 cm) • 4Fr. Berenstein (110 cm) • Agilis sheath • AV loop if tight turns • Alternative to AV loop: Amplatz ES or SS with short tip Center for Valve and Structural Heart Disease Center for Valve and Structural Heart Disease 5

10/1/16 Percutaneous PVL Closure Percutaneous PVL Closure Antegrade Mitral Valve Approach Antegrade Mitral Valve Approach Center for Valve and Structural Heart Disease Center for Valve and Structural Heart Disease Percutaneous PVL Closure Percutaneous PVL Closure Published Case Series Published Case Series Long-Term Follow-Up of Percutaneous Repair Clinical Outcomes in Patients Undergoing Percutaneous Closure of Periprosthetic Paravalvular Leaks • Largest single center of Paravalvular Prosthetic Regurgitation experience (n=126) • 43 patients/57 procedures • Indication CHF 16% Carlos E. Ruiz, MD, P H D, Vladimir Jelnin, MD, Itzhak Kronzon, MD, Yuriy Dudiy, MD, • Average age 69 • Indication hemolysis 14% • Report only outcome of Raquel Del Valle-Fernandez, MD, Bryce N. Einhorn, Paul T. L. Chiam, MD, Claudia Martinez, MD, Paul Sorajja, MD,* Allison K. Cabalka, MD,† Donald J. Hagler, MD,† Charanjit S. Rihal, MD* Rocio Eiros, MS, Gary Roubin, MD, P H D, Howard A. Cohen, MD successful closures • Average thoracotomies 1.8 • Indication both 70% Rochester, Minnesota New York, New York • 78% mitral PVL • Average age 67 • 55% ≥ 2 prior stenotomies • 65% bioprosthesis • Average STS score 6.7 • 78.5% mitral PVL • 38.9% bioprosthesis • 30 day mortality 2.4% • Of those with CHF 72% had improvement Center for Valve and Structural Heart Disease Sorajja et al. JACC 2011;58(21):2218 Ruiz et al. JACC 2011;58(21):2210 6