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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