Hans R. Figulla, M.D., PhD ; Ali Hamadanchi, M.D. Medicine, Pneumology Universitity Hospital, Jena, Germany Successful Percutaneous Closure of Mitral Bioprosthetic Paravalvular Leak Using Figulla ASD Occluder
Background: > 60,000 prosthetic valves are implanted surgically in the USA annually 5% 17% of : some degree of Paravalvular regurgitation, Rehal et al : JACC Intv 2012;5:121 30)
Paravalvular Leaks : SURGERY : Gold standard Rx High Mortality : ~16 % First Redo 35 % second and Third Redo Asymptomatic hemolysis heart failure, Endocarditis Device CLOSURE : New alternative Extremely facilitated by 3D TEE Limited experience Success rate ~ 80% Symptom relief ~ 60 % Complex morphology! No ideal device yet usually related to tissue friability, annular calcification, infection
Paravalvular leaks : First started in 1992, but still a long way to go Paravalvular leaks are possibly one of the most challenging problems in interventional cardiology Recent innovations in devices and cardiac imaging have significantly changed the results Multiple devices have been introduced with variable success rates Device closure is regarded as a suitable alternative to redo surgery in patients with high surgical operative risks and appropriate defect characteristics ( shape, location, etc.) Kim et al, JACC interv, 2009 ; 2:81 90 Rehal et al : JACC Intv 2012;5:121 30)
Paraprosthetic leaks: Steps for Rx 5 4 2 3 1 Clinically significant Mitral Paraprosthetic Leak
Mayo Clinic Experience : 2012 141 defects, 115 patients (mean age: 67 12 years; 53% men) Para mitral (78%); the rest were para aortic. Severe heart failure was present in 93% of patients, Hemolysisin 37%. 19 patients : had multiple treated defects. The technical success rate for device deployment was 89%, Mean procedure time was 147 +/ 54 min In 90% of cases, regurgitation severity decreased considerably to 2 + or less; in 77% of cases, severity decreased to 1+ The total 30 day complication rate was 8.7%. Sorajja P, et al. Percutaneous repair of paravalvular prosthetic regurgitation: acute and 30 day outcomes in 115 patients. Circ Cardiovasc Interv 2011;4:314 21.
Results of Device closure :.the newest data :
Echo in PCPVL Defect morphology : Anatomy Location Number Shape Exclusion of ENDOCARDITIS Selection of a suitable device Procedural guidance, navigation Result Follow Up
From : Dr. Nina Wundelich
Case Presentation : Male- 68 Y/o Smoker, DM, HTN, h/o CVA, Colon Cancer, severe PAD s/p bio MVR + bio AVR because of IE ( S.bovis) in 2007 Now : CHF with FC-III, ~ 5 yrs under the evaluation for pulmonary HTN clinic (resting PAP ~ 60 mmhg ) Presented for follow up ECHO ( TTE ) Lab : Mild to moderate hemolytic anemia, normal CRP, high LDH,
Echo findings and clinical course : Mildly impaired LV /RV function Severe Pulmonary Artery Hypertension, PAP ~ 65 mmhg at rest with HR ~ 60 bpm Elevated Transmitral prosthesis gradients Functionally normal MV bioprosthesis, functionally normal AV bioprosthesis Paravalvular leak, eccentric jet likely underestimated Mildly impaired RV function TEE planned
TEE : A large crescent shaped defect anterior laterally close to LAA para valvlar leak, severe 4+ MR with flow reversal in all pulmonic veins, associated with No evidence of vegetation Retrospective evaluation of patients charts revealed a known but underestimated Paravalvular defect for 4 yrs. Surgery? vs. Device closure?
Elevated Mitral Transprosthtic Gradient in the absence of prolonged pressure half time : The first clue for the Diagnosis
EROA : 0,7 cm 2 PAP ~ 65 mmhg Large PISA around the valve MV Apical 2Ch
MR jet TEE LA LV
TEE : Flow reversal in PV s 3D TEE of defect
Crescent like defect LAA MV bioprosthesis
Procedure : Because of High Surgical mortality, device closure was decided. Endocarditis was excluded Following exact measurement of defect, application of # 9 Figulla ASD occluder was planned Antegrade approach, via septostomy under fluoroscopic and RT 3D TEE guidance the device was successfully deployed with mild residual MR.
3D comprehensive evaluation of defect Exact measurement of size, area and depth of the defect Evaluation of defect prosthetic ring distance ( to avoid post deployment interference of the device with prosthesis )
3D evaluation of defect
Decision making for selection of device
Device used : Occlutech Figulla ASD Flex device
Agilis Sheath, St.Jude LA LV Probing of the defect : Fluoroscopic / TEE 2D, RT 3D
Probing of the defect passing the catheter : Fluoroscopic / TEE 3D live images
Passing the delivery catheter : Fluoroscopic / RT 3D images
Delivery of lower disc in LV : LA LV 3D TEE
Angulation between Pusher and Device >90 Both discs delivered
Final result :
Post device closure MV bio prosthetic Fx : LV view No interference with MV function
Severity of MR Before After
POST op ECHO: before discharge PAP post : 40-45 mmhg Mn PG ~ 5 mmhg
SUMMARY : ASD Occluder device was successfully deployed in a patient with severe mitral prosthetic paravalvular leak. The Occlutech Figulla ASD Flex Device was easy to deploy, because of possible angulation /tilt between Pusher and Occluder. In carefully selected cases, Device closure of Paraprosthetic defects is safe and feasible with almost 85 90 % success rate. Effective for management of heart failure symptoms, reduction in PAP and Hemolytic anemia. Team work is very important. Improvement in cardiac imaging has significantly helped the teamwork approach.