TERMS TOTAL ENDOSCOPIC ROBOTIC MITRAL SURGERY 3/17/2016 ROBOTIC MITRAL VALVE HISTORY PREPARED BY: DIANA FROEHLICH, CCP & AKILAH RICHARDS, CCP

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1 TERMS TOTAL ENDOSCOPIC ROBOTIC MITRAL SURGERY PREPARED BY: DIANA FROEHLICH, CCP & AKILAH RICHARDS, CCP ROBOTIC MITRAL VALVE HISTORY 1 st Robotic MV Repair performed Carpentier using early prototype of da Vinci surgical system Minimally invasive Mitral Valve surgery began by using a Right anterolateral thoracotomy approach Showed comparable results to sternotomy Videoscope assistance 1996 Chitwood clamp Currently using endoscopic camera and endoscopic instruments Chitwood WR Jr, Nifong LW. Minimally Invasive and Robotic Valve Surgery. In: Cohn LH, Edmunds LH Jr, eds. Cardiac Surgery in the Adult. New York: McGraw-Hill, 2003:

2 Da Vinci Xi Approved by FDA for MV Repair Surgery D HD vision system for clear and magnified view Da Vinci Xi Da Vinci EndoWristinstruments bend and rotate far greater than human wrist Surgeons movements are translated into smaller more precise movements of the instruments COMING TO TERMS: PREPARATION 10 Mock Cases Performed in preparation for actual cases Operating Room Set-Up was standardized Required Checklists were performed at the different stages of the case. ex. Equipment and Supplies checklist, Patient Position checklist, Pre-arrest checklist Online training modules were accessible through Intuitive website. All required personnel completed and passed the da Vinci Xi Robot training module 2

3 PREPARATION Mock cases were used to Determine flaws in setup and organization Helped build surgical skills with the use of realistic valve models Run emergency drills for surgical equipment failures Simulate CPB initiation, cardioplegia delivery and CPB termination Observed Robotic Cases at 2 high volume institutions Doing Mocks helped decrease flow disruption Frequently caused by: Coordination, DEDICATED ROBOTIC TEAM High Performance Interdisciplinary Teamwork in Robotic Cardiac Surgery is Absolutely Essential to Safe & Successful Robotic Surgery The complex teamwork required for these procedures will generally improve cardiac surgery teamwork overall 1-2 Anesthesiologists 1 Surgeon 1 Bedside Assistant 1 Scrub tech or RN 1-2 Circulator 1-2 Perfusionist IV Access and Arterial lines Prep & Drape Wean CPB Anesthesia Double Lumen Tube TEE Probe Explore Femoral Vessels Right Chest Ports Initiate CPB Inflate EndoClamp TM Repair Femoral Vessels Close ports Coronary Sinus Catheter PA Catheter Cannulate & Place EndoClamp TM Dock Robot Cardioplegia Deflate EndoClamp TM Single Lumen Tube Exchange Steps for Mitral Valve Repair using the L.E.A.R. Technique Traction sutures and Pericardiotomy MV Repair Left Atriotomy Left Atrial Closure & Deairing Anesthesia Surgeon at the OR Table Surgeon at the Robotic Console 3

4 Cornell/NYP Robotic MVR Room Setup Large Wall Monitor N Circulating Nurse Monitor Instrum ent Table P Scop e War mer Scrub Mayo N S 1 CT Attendi ng Console First Assist A TEE A A CT Reside nt Consol e Anesthesia Attending Anesthesia Fellow S 2 P Perfusionists Mock Setup Mock Case 4

5 Standard LEAR Port Pattern Retract or Arm Endoscop e Left Arm Working Port Right Arm 15 mm Angiocath Angiocath Angiocath Incisions Hemodynamic Monitor Setup Right Radial/Brachial- White Left Radial/Brachial- Lavender Aortic Root-Red PAP- Yellow CVP- Blue Coronary Sinus- Orange 5

6 CARDIOPULMONARY BYPASS 3/8-3/8 Loop Del Nido Cardioplegia 1000ml Antegrade 500 ml Retrograde Subsequent doses: 750 ml delivered retrograde VAVD every case Hemoconcentration Pump Suckers- Aortic Root Vent, LV Vent, Field Suction, PA Vent Standardly cooling to 32 degrees Celcius Cannulas and Catheters ProPlege- Retrograde EndoVent Pulmonary Catheter SVC Cannula IntraClude Intra-Aortic Device EndoReturn Arterial Cannula Quick Draw Venous Cannula Distal Perfusion Catheter ProPlege Peripheral Retrograde Cardioplegia Device Delivers Retrograde Cardioplegia Balloon to occlude Coronary Sinus Monitors Coronary Sinus Pressure 6

7 EndoVent Pulmonary Catheter Removes Blood from PA Assists in decompression of the heart Designed to maintain a dry operative field Venous Cannulation Femoral Quick Draw Cannula Sizes: 22 Fr & 25 Fr SVC Cannula: Optisite 16 Fr ProPlege balloon should be inflated before venous cannula placement to prevent dislodgement Arterial Cannulation EndoReturn Cannula Sizes: 21 Fr & 23 Fr Cannula Selection based on patient anatomy InterClude Device passed through side port Distal perfusion catheter placed to perfuse leg 7

8 IntraClude Intra-Aortic Device Occludes Ascending Aorta Used to deliver Antegrade Cardioplegia Vents Aortic Root Monitors Aortic Root Pressure Monitors Balloon Occlusion Pressure TEE Assistance POTENTIAL BENEFITS OF TERMS Less Blood Loss Less Pain Less time required on ventilator Quicker healing time Small scars/less adhesions for re-operations Shorter hospital stays Competition for Transcatheter Repair or Replacement of MV More attractive to patients Better visualization of the valve 8

9 Date of Discharge Procedure Date of Surgery Date of Discharge Patient 1 MV Repair/MAZE 1/20/16 1/26/16 6 Patient 2 Patient 3 MV Repair/TV Repair MV Repair/PFO Closure 1/21/16 * >6 1/28/16 2/2/16 5 Patient 4 MV Repair 2/4/16 2/7/16 3 Patient 5 MV Repair 2/10/16 2/13/16 3 Patient 6 MV Repair 2/17/16 2/19/16 2 Patient 7 MV Repair/MAZE 3/2/16 3/7/16 5 Patient 8 MV Repair 3/3/16 3/7/16 4 Patient 9 MV Repair/PFO Closure 3/9/16 3/12/16 3 Patient 10 MV Repair 3/10/16 3/13/16 3 Post Op Day * Patient 2 had complications following procedure, could not find discharge date STERNOTOMY VS. TERMS SO FAR.. Mitral Valve Repair with Sternotomy Routine length of stay is 7 days with a range of 4-14 days Mitral Valve Repair with TERMS So far LOS is 3 days with a range of 2-6 days Average x-clamp= 81 min Average CPB = 116 min Murphy Robotic Mitral Series-Saint Joseph s Hospital/Emory 1,257 Patients Robotic Endoscopic Mitral Largest series to date 93% Repair 7% Replacement 18% MAZE 0.9% Mortality 9

10 OBJECTIVE: Recent reports have shown that robotic mitral valve repair is effective in treating posterior leaflet disease; however, comparison with trans-sternal (open) valvuloplasty for all prolapse categories has not been performed. Moreover, data from the recently published EVEREST II trial infer that adverse event rates after mitral valve repair for degenerative disease are high. We therefore compared early outcomes of robotic versus open mitral valve repair for patients with mitral valve prolapse. METHODS: Among 745 consecutive patients undergoing open or robotic mitral repair for degenerative disease, 95 propensity-matched pairs were identified. Leaflet prolapse categories were similar between groups. Complete mitral valve repair was performed using identical techniques. RESULTS: Median crossclamp and bypass times were longer in the robotic group but decreased significantly over time (P <.001). There were no conversions to open sternotomy, repair rate and early survival were 100%, dismissal mitral regurgitation grade was similar (P = 1.00), and all patients in the robotic group had mild or less mitral regurgitation at 1 month after repair. There were no differences in adverse events (5% open vs 4% robotic, P = 1.00). Patients in the robotic group had shorter postoperative ventilation time, intensive care unit stay, and hospital stay. CONCLUSIONS: Robotic mitral valve repair allows complete anatomic correction of all categories of leaflet prolapse using techniques identical to open approaches. Robotic repair effectively corrects mitral regurgitation, offers excellent freedom from adverse events, and facilitates rapid weaning from ventilation, translating into earlier hospital dismissal. Safety and efficacy after both open and robotic mitral valve repair are higher than recently reported in the EVEREST II trial and establish a benchmark against which nonsurgical therapies should be evaluated. Robotic mitral valve repair for all prolapse subsets using techniques identical to open valvuloplasty: establishing the benchmark against which percutaneous interventions should be judged. Mayo Clinic Experience All Leaflet Prolapse 95 propensity matched pairs Adverse events similar OR times longer but improved with time 100% repair rate, all prolapse patients Shorter ventilation time, ICU stay, hospital stay Suri RM et al. J Thorac Cardiovasc Surg Nov;142(5): BACKGROUND: Early mitral valve (MV) repair of degenerative mitral regurgitation is associated with superior clinical outcomes compared with prosthetic replacement and restores normal life expectancy, even in those without symptoms. Although current guidelines recommend prompt referral for effective MV repair in those with severe mitral regurgitation, some are reluctant to pursue early correction due to the perception that short-term quality of life (QOL) may be adversely affected by the operation. METHODS: Between January 2008 and November 2009, 202 patients underwent conventional transsternotomy or minimally invasive port-access robot-assisted MV repair, with or without patent foramen ovale closure or left Maze, and were mailed a postsurgical QOL survey. RESULTS: Unadjusted QOL scores for patients undergoing MV repair were excellent early after the operation using both approaches. Robotic repair was associated with slightly improved scores on the Duke Activity Status Index, the Short Form-12 Item Health Survey Physical domain, and the Linear Analogue Self- Assessment frequency of chest pain and fatigue indices during the first postoperative year; however, differences between treatment groups became indistinguishable after 1 year. Robotic repair patients returned to work slightly quicker (median, 33 vs 54 days, p<0.001). CONCLUSIONS: Functional QOL outcomes within the first 2 years after early MV repair are excellent using open and robotic platforms. A robotic approach may be associated with slightly improved early QOL and return to employment-based activities. These results may have implications regarding future evolution of clinical guidelines and economic health care policy.. Quality of life after early mitral valve repair using conventional and robotic approaches. Mayo Clinic 202 patients Improved QOL of robotic over sternotomy or port access-non robotic approaches Earlier return to work Suri RM et al. Ann Thorac Surg Mar;93(3): OBJECTIVE: Robotic mitral valve repair is the least invasive approach to mitral valve repair, yet there are few data comparing its outcomes with those of conventional approaches. Therefore, we compared outcomes of robotic mitral valve repair with those of complete sternotomy, partial sternotomy, and right mini-anterolateral thoracotomy. METHODS: From January 2006 to January 2009, 759 patients with degenerative mitral valve disease and posterior leaflet prolapse underwent primary isolated mitral valve surgery by complete sternotomy (n = 114), partial sternotomy (n = 270), right minianterolateral thoracotomy (n = 114), or a robotic approach (n = 261). Outcomes were compared on an intent-to-treat basis using propensity-score matching. RESULTS: Mitral valve repair was achieved in all patients except 1 patient in the complete sternotomy group. In matched groups, median cardiopulmonary bypass time was 42 minutes longer for robotic than complete sternotomy, 39 minutes longer than partial sternotomy, and 11 minutes longer than right mini-anterolateral thoracotomy (P <.0001); median myocardial ischemic time was 26 minutes longer than complete sternotomy and partial sternotomy, and 16 minutes longer than right mini-anterolateral thoracotomy (P <.0001). Quality of mitral valve repair was similar among matched groups (P =.6,.2, and.1, respectively). There were no in-hospital deaths. Neurologic, pulmonary, and renal complications were similar among groups (P >.1). The robotic group had the lowest occurrences of atrial fibrillation and pleural effusion, contributing to the shortest hospital stay (median 4.2 days), 1.0, 1.6, and 0.9 days shorter than for complete sternotomy, partial sternotomy, and right mini-anterolateral thoracotomy (all P <.001), respectively. CONCLUSIONS: Robotic repair of posterior mitral valve leaflet prolapse is as safe and effective as conventional approaches. Technical complexity and longer operative times for robotic repair are compensated for by lesser invasiveness and shorter hospital stay. Robotic repair of posterior mitral valve prolapse versus conventional approaches: potential realized Cleveland Clinic Experience Posterior Leaflet Prolapse 261 robotic approach Longer OR times but not by much High and comparable repair rate Lower afib, effusions in robotic group Shorter LOS Mihaljevic T. J Thorac Cardiovasc Surg Jan;141(1):

11 Robotic-assisted mitral valve repair is becoming more frequently performed in cardiac surgery. However, little is known about its utilization and safety at a national level. METHODS: Patients undergoing mitral valve repair in the United States from 2008 to 2012 were identified in the National Inpatient Sample. Inhospital mortality, complications, length of stay, and cost for patients undergoing robotic-assisted mitral valve repair were compared with patients undergoing nonrobotic procedures. RESULTS: We identified 50,408 isolated mitral valve repair surgeries, of which 3,145 were done with robotic assistance. In a propensity score matched analysis of 631 pairs of patients, we found no difference between patients undergoing robotic-assisted and nonrobotic-assisted mitral valve repair with respect to inhospital mortality, complications, or composite outcomes in unadjusted or multivariable analyses. Robotic-assisted mitral valve repair surgery was associated with a shorter median length of stay (4 versus 6 days, p < 0.001), and there was no difference in median total costs between the two procedures. CONCLUSIONS: In our analysis of a large national database with its inherent limitations, robotic-assisted mitral valve repair was found to be safe, with an acceptable morbidity and mortality profile. A population-based analysis of roboticassisted mitral valve repair. Paul S, Isaacs AJ, Jalbert J, Osakwe NC, Salemi A, Girardi LN, Sedrakyan A. Ann Thorac Surg May;99(5): National Inpatient Sample 50K Isolated MV Repairs No difference in mortality or complications Decreased LOS No difference in cost Incisions During and After Totally Endoscopic Ports Vs. Sternotomy 11

12 Thank You! Bill DeBois Director of Perfusion Weill Cornell Dr. T. Sloane Guy- Cardiac Robotic Surgeon Dr. Leonard Girardi Chairman of Cardiac Surgery Dan Brown- Edwards Lifesciences Melissa Perlmutter Intuitive Weill Cornell Robotic Team Akilah Richards- Perfusion Partner Questions? 12