Valvular Heart Disease and Adult Congenital Intervention. A Pichard, MD. Director Cath Labs, Washington Hospital Center. Georgetown University.
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1 Valvular Heart Disease and Adult Congenital Intervention. A Pichard, MD Director Cath Labs, Washington Hospital Center. ProfessorofMedicine (Cardiology), Georgetown University.
2 Conflict of Interest Proctor for Edwards Lifesciences Speaker Bureau St Jude Medical
3 T AVR Percutaneous Valve Replacement has initiated a revolution in the treatment of Valvular Heart Disease. The Heart Team concept has been established as indispensable for success. Precise, collective data collection and analysis is needed to trace the future.
4 PARTNER Study Design Cohort A High Risk N = 699 Symptomatic High-Risk AVR Candidates 3,105 Patients Screened 1,057 patients Cohort B Inoperable N = 358 Transfemoral (TF) Transapical (TA) 1:1 Randomization N = 244 TF TAVR 1:1 Randomization N = 248 N = 104 N = 103 AVR TA TAVR AVR N = 179 TF TAVR 1:1 Randomization N = 179 Standard Therapy Not In Study Non-inferiority) o Superiority
5 PARTNER Trial Cohort B Inoperable Patients. TCT 2010
6 Cohort B. Inoperable Patients
7 Partner Cohort B Conclusion T AVR is the now the Gold Standard for the treatment of symptomatic ti AS in patients t not amenable to surgical AVR.
8 Partner Trial Cohort A: High Surgical Risk ACC 2011 Robert Bonow Craig Smith
9 Cohort A: High risk patients. All-Cause Mortality at 1 Year TAVR AVR HR [95% CI] = 0.93 [0.71, 1.22] P (log rank) = No. at Risk Months TAVR AVR (Age 84, STS 12, EuroScore 29)
10 Partner Trial Cohort A Conclusion T AVR (trans femoral and trans apical) is non inferior to surgical AVR for patients with severe AS and high surgical risk.
11 Hemodynamics at 2 years. Edwards Valve EOA Error bars at ± 1 Standard Deviation Mean Gr radient Baseline 30 days 3 months 6 months 1 year 18 2 years * REVIVE, REVIVAL, TRAVERCEand PARTNER EU
12 Partner Trial Cohort B. Functional Recovery 6 min walk test
13 Six-Minute Walk Test Cohort A (n=699) 200 P = 0.73 P = P = 0.33 P = tance, meters Me edian Dis Baseline 30 Days 6M Months 1Y Year AVR TAVR
14 PARTNER TRIAL: Complications Per Cen nt (%) Mortality (TF) Maj Stroke Maj Vascular Maj Bleed New PM PVL (1 yr) Inoperable High-Risk
15 Complications of T AVR are associated with higher mortality Major Vascular Complications Major Stroke
16 Eliminating Stroke Protection devices (SMT. Embrella, Claret). Most strokes occur after the procedure: new anticoagulation strategies been evaluated
17 Valve in Valve (Percutaneous Valve for degenerated Bioprosthetic ti Vl Valve) Simple and safe option. Surgeons have decreased or almost eliminated the use of mechanical valves. Dedicated dpercutaneous valves for this use are in development.
18 T AVR for Aortic Regurgitation Number of Centers using the Corevalve for this purpose, p with success. No series published yet.
19 Percutaneous Mitral Valve Repair
20 Feldman et al. New England J of Medicine. April 2011
21 Everest II Randomized Trial University Heart Center Jena/ Germany Preclinical Research Survival
22 Freedom from Surgery (Clip arm) University Heart Center Jena/ Germany Preclinical Research or Reoperation p (Surgical ( g arm). )
23 Mitral Clip. European Experience 56 Sites Funct, degen,mixed: 64,29 and 8% Avg Implant Time 1h:52min 1,2,3,4 Clips: 67,30,2 and 1%
24 Multiple MV Clips for severe MR Huseyin Ine and Christoph Nienaber Rostok Group.Snowmass 2011 EF 18%, 4+MR. Got 4 clips. Final MVA 2.8 cm2 21% 1 clip 60% 2 clips 12% 3 clips 7% 4 clips 21% 1 clip, 60% 2 clips, 12% 3 clips, 7% 4 clips 2/3 functional MR
25 Neo Chord for Ruptured Chordae. p Bajona et al. JTCVS 2009;137:188-93
26 Percutaneous MV Implantation Preclinical work making rapid progress. Edwards Medtronic Endovalve Mitraltech CardiacQ We should soon have a mitral valve prosthesis We should soon have a mitral valve prosthesis to implant percutaneously
27 Transcatheter Mitral Valve Implantation Engineering Prototype Sheep Implant No MR at 6 hours post CPB Mean transmitral gradient = 2 mm Hg No LVOT gradient
28 CardiaQ Valve Technologies
29 Percutaneous Closure of Perivalvular Leaks Indications: Severe MR with significant symptoms Severe Hemolysis requiring transfusions
30 Percutaneous Closure of Perivalvular Leaks. Carlos Ruiz. CRT Success rate (66 patients): 76% aortic 89% mitral 30 day all cause mortality: 3.4% Hemolysis Resolved 46/50 (92%) in 1 week to 6 months Deteriorated and required surgical correction 2 pts NYHA Functional Class: 3.0 pre, 1.9 post
31 Percutaneous Valves for Severe Tricuspid Regurgitation. Hans Figula. CRT 2011 Implantation of valved stents in central venous position to reduce venous congestion p g
32 Adult Congenital Heart Disease
33 ASD Percutaneous Closure Ostium Secundum Percutaneous Closure of Ostium Secundum Percutaneous Closure of Ostium Secundum ASD is now the Standard of Care
34 PFO Closure in Cryptogenic Stroke Windecker S, JACC 44: , 2004 Stroke, TIA or Periph Embolism incidence e(%) Cum mulative No. at risk PFO closure Medical n=206 patients Propensity Score Matching. Hazard Ratio = % CI P=0.033 Medical Treatment 21.4% PFO Closure 10.7% Follow-up, years
35 Randomized Controlled Trials on PFO Closure to Prevent Recurrent Paradoxical Ischemic Events Device Used Starting Year Target Enrollment, n Final Status Projected Publication PC* Amplatzer PFO Finished 2011 occluder enrollment at 420 Closure I STARFlex Finished i Negative occluder enrollment Trial RESPECT Amplatzer PFO (endpoint Enrolling 2013 occluder driven) CLOSE Free choice Enrolling 2014 Gore REDUCE HELEX occluder Enrolling 2016
36 Randomized Controlled Trials for PFO Closure in Migraine i Headache Patients Acronym Place Sham Device Status Procedure MIST UK + STARFlex Negative Trial PRIMA Global Amplatzer Recruiting PREMIUM US + Amplatzer Recruiting MIST II US + BioSTAR* Abandoned ESCAPE US + Premere Abandoned? Global + FlatStent Planned
37 Conclusions Percutaneous treatment of valvular l and adult congenital heart disease has revolutionized Medicine. New technology will improve safety and efficacy. Cardiac team approach required. Careful data collection, trial interpretation and training i are indispensable for sustainable ti success and definitive patient benefit.
38 The end
Valvular Intervention
Valvular Intervention Outline Introduction Aortic Stenosis Mitral Regurgitation Conclusion Calcific Aortic Stenosis Deformed Eccentric Calcified Nodular Rigid HOSTILE TARGET difficult to displace prone
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