Post on 12-Jan-2016
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©2015 MFMER | 3428638-1
Robotic Repair of Simple vs. Complex Degenerative Mitral Valve DiseaseClinical and Echocardiographic OutcomesDuring Mid-Term Follow-up
RM Suri, A Taggarse, H Burkhart, R Daly, W Mauermann, H Michelena, Z Li, R Nishimura, M Enriquez-SaranoDivision of Cardiovascular Surgery,Mayo Clinic, Rochester, Minnesota
©2015 MFMER | 3428638-2
Disclosure Mayo Clinic Division of Cardiovascular Surgery
• Research funding• Edwards Lifesciences• St. Jude Medical• Sorin Group
• Current technology licensing agreements• Sorin Group and St. Jude
• Principle Investigator• FDA Perceval Trial – Sorin Group
• Co-Investigator• PARTNER II, COAPT, SURTAVI, PORTICO
• No personal relationships with Industry
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A. At risk
B. Progressive
C. Asymptomatic severeC1: Asymptomatic – ventricle compensatedC2: Asymptomatic – decompensated ventricle
D. Symptomatic severe
2014 ACC/AHA Guideline SummaryStages of Progression of VHD
Unknown mid-term outcomes• Complex disease• Minimally invasive approaches
When leaflet dysfunction is sufficiently limited so that only annuloplasty and repair of the posterior leaflet are necessary… superior outcomes … 80% freedom from recurrent moderate/severe (≥3+) MR 20 years after operation.
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Hypothesis
In patients undergoing robotic correction of
severe primary degenerative MR, overall
survival, rate of recurrence of mitral
regurgitation and mitral reoperation are
influenced by repair complexity.
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Inclusion and Methods
• Jan. 2008 – Jan. 2015: 520 pt. robotic mitral valve repair for primary degenerative disease
• Study consent 487 pt. – analysis
• Stratified simple vs. complex disease
• Two surgeon approach:
• HMB / RMS 85%
• RCD / RMS 15%
• Procolized follow up
• Data collection
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Results
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Posterior57.9%
Bileaflet39.0%
Anterior2.9%
Traditional StratificationProlapse Categories
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New Classification – Complexity Intervention Categories
Simple59%
Complex41%
Repair rate – 100%1 Death – 0.2%
4 Neurologic events – 0.8%
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Patient Characteristics
Total(n=487)
Simple(n=289)
Complex (n=198) P
NYHA III/IV 25 (5.1) 13 (4.5) 12 (6.1) 0.443
Congestive heart failure 12 (2.5) 7 (2.4) 5 (2.5) 0.943
Atrial fibrillation 43 (8.8) 23 (8.0) 20 (10.1) 0.413
Ejection fraction, mean (SD) 64.8 (6.3) 64.9 (6.4) 64.6 (6.1) 0.568
LVEDD, mm, mean (SD) 58.0 (5.3) 57.8 (5.3) 58.4 (5.4) 0.278
LVESD, mm, mean (SD) 35.6 (4.3) 35.5 (4.3) 35.6 (4.4) 0.772
LAVI, mL/m2, mean (SD) 56.3 (18.0) 55.4 (18.4) 57.6 (17.4) 0.191
Age, years, mean (SD) 55.6 (11.0) 56.7 (10.1) 53.9 (12.1) 0.005
Male sex 360 (73.9) 235 (81.3) 12 (63.1) <0.001
Regurgitant volume,mL, median (IQR) 76 (63-96) 79 (64-102) 73 (61-90) 0.009
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Total(n=487)
Simple(n=289)
Complex (n=198) P
Plication 39 (8.0) 11 (3.8) 28 (14.1) <0.001
Gore-Tex Neochord 111 (22.6) 3 (1.0) 107 (54.0) <0.0001
Annuloplasty 487 (100.0) 287 (100.0) 200 (100.0) >0.99
Cryoablation maze 29 (5.9) 16 (5.5) 13 (6.6) 0.524
Left atrial appendage ligation 29 (5.9) 17 (5.7) 12 (6.1) 0.524
Post-op ICU stay, hrs, median (IQR) 8 (6.5-19.5) 8 (6.5-19.0) 8 (6.0-20.0) 0.734
Blood bank RBC requirement,median (IQR) 0 (0-0) 0 (0-0) 0 (0-0) 0.936
MR grade at dismissal None to trivial 436 (89.7) 259 (89.6) 177 (89.8) 0.935Mild 50 (10.3) 30 (10.4) 20 (10.2)
Procedure and Early Outcomes
Leaflet resection 430 (88.3) 276 (95.5) 154 (77.8) <0.001
Commissuroplasty any 148 (30.4) 43 (15.0) 105 (52.5) <0.001
X-clamp time, min, median (IQR) 53 (45-66) 50 (42-62) 58 (49-72) <0.001
Post-op ventilation, hrs, median (IQR) 0 (0-0) 0 (0-0) 0 (0-0) 0.291
Perfusion time, min, median (IQR) 76 (66-94) 74 (64-91) 81 (70-98) 0.002
98.8% Complete follow-up
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0.5 1 1.5 2 2.5 3 3.5 4 4.50
20
40
60
80
100
Overall SurvivalRepair Complexity
%
P = 0.51
289 156 77 46 27 12198 111 60 38 23 10
ComplexitySimple repairComplex repair
Follow-up time (year)
99.5% 99.5%
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0.5 1 1.5 2 2.5 3 3.5 4 4.50
20
40
60
80
100
Probability Mitral Regurgitation RecurrenceRepair Complexity
Re
curr
en
ce ≥
Mod
era
te M
R %
Follow-up time (year)
289 153 75 44 24 9198 110 57 37 21 10
ComplexitySimple repairComplex repair
P = 0.67
0.6% 5.4%
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X-Clamp Time (per 15 min)
Regurgitation Volume 90
Prolapse: Anterior & Posterior
Prolapse: Anterior
Plication
Myxo Disease: Yes
LVESD preop 40
LVEDD preop 60
Leaflet Resection
Gore-Tex Neochord
Gender: Male
EF Preop: 60
Complex
Comissuroplasty: Any
Age 70
0 10 20 30
Predictors Mitral Regurgitation Recurrence Univariate
Hazard ratio
*
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0.5 1 1.5 2 2.5 3 3.5 4 4.50
20
40
60
80
100
Probability Mitral Re-operationRepair Complexity
Follow-up time (year)
289 154 76 45 25 10198 109 58 38 22 10
ComplexitySimple repairComplex repair
P = 0.13
1.2% 2.3%Mitr
al R
eo
pera
tion
%
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X-Clamp Time (per 15 min)
Regurgitation Volume 90
Prolapse: Anterior & Posterior
Prolapse: Anterior
Plication
Myxo Disease: Yes
LVESD preop 40
LVEDD preop 60
Leaflet Resection
Gore-Tex Neochord
Gender: Male
EF Preop: 60
Complex
Comissuroplasty: Any
Age 70
0 10 20 30
Mitral ReoperationUnivariate
Hazard ratio
*
*
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Conclusions
• First mid-term clinical and echocardiographic stratify - repair complexity
• 100% repair, 0.2% mortality, 0.8% neurologic
• Simple vs. complex - similar mid-term survival, freedom from MR and reoperation
• Univariate anterior prolapse may be associated with:• MR recurrence• Reoperation
• Robotic mitral repair• High quality alternative to traditional approaches• Relevant comparator percutaneous technology
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Division of Cardiovascular Surgery