Minimally Invasive Insertion of HVAD

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1 Minimally Invasive Insertion of HVAD Simon Maltais, MD PhD Vice-Chair of Clinical Practice Director of MCS Program Department of Cardiovascular Surgery Mayo Clinic, Rochester, MN AATS MCS 2018, Houston (TX)

2 Disclosures Relevant financial relationship(s) with industry: Paid consultant for Medtronic, Abbott, and Clearflow Inc. I do NOT intend to discuss offlabel/investigative uses(s) of commercial product(s)/devices(s) during this presentation

Growing Experience for Alternative Strategies Hetzer, Ann Thorac Surg, 2004 Selzman, J Card

Borovic, JHLT, 2011 Cheung, Ann Thoracic Surg, 2011 Popov, Ann Thorac Surg,2012 Schmitto, J

Medical Devices, 2013 Riebandt J Ann Thorac Surg 2013 Duese, ASAIO Journal, 2014 Haberla, Eur J

3 Growing Experience for Alternative Strategies Hetzer, Ann Thorac Surg, 2004 Selzman, J Card Surg, 2007 Schmitto. J Am Coll Cardiol, 2010 Anyanwu, Semin Thorac Cardiovasc Surg, Borovic, JHLT, 2011 Cheung, Ann Thoracic Surg, 2011 Popov, Ann Thorac Surg,2012 Schmitto, J Thorac Cardiovasc Surg, 2012 Mohite, J Thorac Cardiovasc Surg, 2012 Sabashnikov, Expert Review Medical Devices, 2013 Riebandt J Ann Thorac Surg 2013 Duese, ASAIO Journal, 2014 Haberla, Eur J Cardo Thorac Surg, 2014 Maltais, ACS, 2014 Maltais, JHLT 2015, ASAIO Journal

4 Natural Evolution Will a standard sternotomy be really necessary?

Survival is Now an Expected Outcome HeartMate II HVAD Laphor Miller Pagani Starling Strueber Aaronson Slaughter Strueber Maltais CE Mark BTT BTT (18 mo) PAS BTT CE Mark ADVANCE ADVANCE/ CAP Post CE

5 Survival is Now an Expected Outcome HeartMate II HVAD Laphor Miller Pagani Starling Strueber Aaronson Slaughter Strueber Maltais CE Mark BTT BTT (18 mo) PAS BTT CE Mark ADVANCE ADVANCE/ CAP Post CE Registry PAS BTT N = 571 N = 133 N = 281 N = 169 N = 50 N = 140 N = 322 N= 254 N = 600 % % % % % % % % 180 day survival year survival year survival NR NR NR NR NR NR

6 LVAD Patients are Not Created Equal What should the technique for implant be?

7 Standard & Alternative Strategies for HVAD Implantation ON-pump or OFF-pump when suitable Inflow: Median sternotomy Minimally invasive left thoracotomy Subcostal diaphragmatic approach

8 Outflow: Standard & Alternative Strategies for HVAD Implantation Ascending aorta Full/partial upper hemisternotomy/intercostal Descending aorta Single incision left thoracotomy Left subclavian artery Left axillary approach

9 But a word of caution!

10 Learn the Basics First Careful assessment of preoperative risk (LM, Kormos, etc) Careful review of preoperative echocardiography Valve anomalies (AI, TR, MR?) LV thrombus PFO Have a plan (for the patient, for you, the team) Manage risk and prepare team for pitfalls

11 Standard Sternotomy ON-PUMP Approach Driveline placement before heparin Initiation and cannulation of CPB (based on preoperative plan), maintain ACT over 400! Venting and minimize risks of air Identification LV coring site Anterolateral (facing mitral valve) TEE, Spine needle, foley for small LV

12 Standard Sternotomy ON-PUMP Approach Outflow graft Standard end-to-side cobra anastomosis Use punch to ease anastomosis and improve flow (proportional to radius) Use anastomosis for pump deairing and connect the pump (1800 rpm) Deair outflow graft before clamp with the pump running

13 The Quest for the Right Operation!

14 Why Should We Evolve to Find the Right Operation for the Right Patient? Avoid extensive dissection with reoperations, decrease risks of cardiac injury Shorten implant, facilitate inflow positioning, reduce CPB time Avoid median sternotomy or multiple reentries for patients undergoing heart transplantation? Decrease blood product requirements and potential risks of sensitization Preserve RV dysfunction through preservation of pericardial function?

15 Maltais et al: Operative Techniques in Thoracic and Cardiovasculary Surgery 19:276, 2014

16 INFLOW Why Should We Do It OFF-Pump? Reduce Inflammation and coagulopathy associated with cardiopulmonary bypass Reduced blood product transfusions Avoid aortic and venous cannulation with their potential complications Right heart protection? Reduce costs?

17 OFF-Pump: Tips and Pitfalls Inflow position No compromise! (LV needle, TEE, communication with anesthetist, repositioning) Assessment of LV cavity impossible Detailed TTE, TTE and epiaortic analysis Increased risk of potential urgent CPB LV tear, HD compromise, insertion problems

18 Maltais et al: Operative Techniques in Thoracic and Cardiovasculary Surgery 19:276, 2014

19 Direct Approach for Ring Placement

20 OFF-Pump Inflow Strategy ACT always above 350 Adenosine (30 mg 2) to induce short bradycardic asystole, allows LV coring and pump placement Decreases arterial pressure Lowers heart rate Pulmonary vasodilatation Pelleg et al: Pharmacotherapy 10:157, 1990

21 Maltais et al: Operative Techniques in Thoracic and Cardiovasculary Surgery 19:276, 2014

22 Maltais et al: Operative Techniques in Thoracic and Cardiovasculary Surgery 19:276, 2014

23 Adequate Pump Deairing

24 Early HVAD Left Thoracotomy Experience BTT recipients (n=81) implanted between 01/2013 and 10/2014 with HVAD (LT vs CS) Retrospective and outcome analysis Kaplan-Meier, Pearson test

25 Thoracotomy Implants Maltais et al: Operative Techniques in Thoracic and Cardiovasculary Surgery 19:276, 2014

26 Patients n =81 HVAD (27 LT vs. 54 CS) Age years 62 19

27 Clinical Characteristics All n=81 LT n=27 CS n=54 P value Age (yrs.) 52 ±13 55±12 51 ± Gender (male %) HF etiology (isch %) Redo-sternotomy (%) Kormos Score 0.5 ± ± ± Leitz-Miller Score 8 ±5 8 ±6 9 ± Creatinine (mg/dl) 1.4 ± ± ± Pre-op IABP (%)

28 Early Perioperative Outcomes All n=81 LT n=27 CS n=54 P value ICU LOS (days) 8 ±10 10 ±12 9 ± Total LOS (days) 15 ±9 15 ±11 15 ± RVAD (%) Dialysis (%) OR Blood Products (U) 6 ±10 6 ±5 8 ± Total Blood Products (U) 12 ±18 9 ±16 14 ± Time on MV (days) 4 ±9 4 ±8 4 ± Inotrope duration (days) 7 ±8 6 ±7 7 ± day mortality (%) Follow-up Time (years) 0.6 ± ± ±

29 Clinical Outcomes All n=81 LT n=27 CS n=54 P value Ischemic CVA (%) Hemorrhagic CVA (%) TIA (%) GI Bleeding (%) Driveline infection (%) Other infections (%) RV failure, RVAD (%) Thrombus/hemolysis (%) Readmission (#) 1.0 ± ± ± Cardiac Readmit (#) 0.3 ± ± ± N-Cardiac Readmit (#) 0.7 ± ± ± Follow-up Time (years) 0.6 ± ± ±

30 Survival

31 Conclusions Left thoracotomy approach for HVAD implantation is increasingly utilized for bridged patients Early perioperative results compare favorably to a conventional sternotomy approach Benefits LT for blood product utilization?

32 Conclusions Adverse event profile is comparable between intervention strategies (6 months) Maltais et al. ASAIO 2015

33 A Prospective, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the Thoracotomy Implant Technique of the HeartWare HVAD System in Patients with Advanced Heart Failure: Results of the LATERAL Trial M.R. Danter, E.C. McGee, M. Strueber, Simon Maltais, N.A. Mokadam, G.M. Wieselthaler, K. Leadley, S.W. Boyce, and A. Cheung STS Annual Meeting and Scientific Sessions

34 Primary Endpoint Success

35 Key Adverse Events at 30 Days Bleeding: Requiring re-operation* Requiring transfusion Gastrointestinal Lateral (n=144) 3.5%* 9.0% 4.2% Device malfunction/failure 6.3% Driveline infection 1.4% Line Sepsis 0.0% Myocardial Infarction 0.0% Stroke HCVA ICVA TIA 2.1% 2.1% 0.7% Respiratory failure 7.6% Right Heart Failure Req. RVAD 0.7% Cardiac Arrhythmia Ventricular Arrhythmia 22.2% 13.9% HVAD BTT+CAP (n=382) 11.5% 13.9% 3.9% 5.2% 2.6% (3.9%) 0.3% 2.9% 1.8% 1.6% 16.0% 2.6% 23.3% 9.2% BTT+CAP data is historical, not a study control. The data are presented for perspective only. * Statistically significant reduction, P<0.05.

36 What s Next? Alternative Implant Strategies 2011 MFMER

37 Descending Aorta / Subclavian Outflow Graft Anastomosis Bridge patients with previous sternotomy Patients with other hostile mediastinal reentry challenges (pectoral flap, interpositions, etc) Patients with severe vascular calcifications or porcelain aorta Challenges Careful evaluation of other cardiac anomalies Several technical pitfalls, arm edema Adverse event rate?, long-term efficacy?, true forward flow improvement?

38 Maltais et al: Operative Techniques in Thoracic and Cardiovasculary Surgery 19:276, 2014

39 Descending Aorta - Management Maintain 1:1 aortic valve opening to prevent aortic root thrombus formation Implications May require higher blood pressure Patient will be pulsatile, optimize calculated MAP (2/3 DBP + 1/3 SBP = mmhg) Lower pump speeds? Partial support - persistent HF symptoms? Increased risk of pump thrombosis/stroke

40 Results Descending Aorta Maltais et al: ASAIO J 59(6): , 2013

41 Left Subclavian Anastomosis LVAD flow to left upper extremity and cerebral vasculature with backflow to systemic circulation Increases forward flow and native ejection Implications Left upper extremity hyperemia and edema Technical considerations for anastomosis Arterial flow to LUE restricted (banded) TED hose on LUE x 10 days postop Elevate LUE to improve venous return Blood pressure always assessed on right side

42 Left subclavian implantation Maltais et al: Operative Techniques in Thoracic and Cardiovasculary Surgery 19:276, 2014

43 Maltais et al: Operative Techniques in Thoracic and Cardiovasculary Surgery 19:276, 2014

44 Maltais et al: Operative Techniques in Thoracic and Cardiovasculary Surgery 19:276, 2014

45 Alternative Support for Bridged Patients with Previous Cardiac Surgery : Are we there yet? S Maltais, ASAIO Journal 2015

46 Survival Analysis Comparable adverse events (6 months)

47 The Times They Are-a-Changin Learn the basics first Alternative LVAD implant techniques may have advantages in specific patient populations Medication and device management should be personalized and tailored to pump implant strategy to maximize pump performance and minimize complications Indications for alternative approaches and implications for long-term management require further investigation

48 Thank you! 2011 MFMER

Aortic Insufficiency: How Often Does It Occur and When To Treat

Aortic Insufficiency: How Often Does It Occur and When To Treat Simon Maltais, MD PhD Vice-Chair of Clinical Practice Director of MCS Program Department of Cardiovascular Surgery Mayo Clinic, Rochester,