LVAD Complications, Recovery - PDF Free Download

LVAD Complications, Recovery Abbas Ardehali, M.D., F.A.C.S. Professor of Surgery and Medicine, Division of Cardiac Surgery William E. Connor Chair in Cardiothoracic Transplantation Director, UCLA Heart, Lung, & Heart-Lung Transplant Programs David Geffen School of Medicine at UCLA

Disclosure statement There are no Conflicts of Interest to disclose

Kirklin, J.K., et.al., J Heart Lung Transplant 2014;33:555-564

Patient survival Adapted from Fang JC, et al., NEJM, 2009;22:261

Competing Outcomes Analysis (n=281) Pagani F, Miller L, Russell S, JAAC: Vol 54, No 4, 2009. 8

Post-transplant Survival 30 Days Post-Transplant 150/157 (96%) 1 Year Post-Transplant 135/157 (86%) John, ISHLT 2009 9

Adverse Events (1 of 2) Patients (n=281) Adverse Event pts % of pts Bleeding: requiring re-exploration 72 26% Infection: Local non-device related 84 30% Sepsis 49 17% Device-related: percutaneous lead / (pump pocket) 37 (5) 13% (2%) Ventricular arrhythmias: cardioversion / defibrillation 56 20% Renal failure 30 11% Pagani F, Miller L, Russell S, JAAC: Vol 54, No 4, 2009. 10

Adverse Events (2 of 2) Patients (n=281) Adverse Event pts % of pts Right heart failure* (RVAD subset) 53 (17) 19% (6% RVAD) Perioperative stroke (day 0-2) 5 2% Ischemic stroke (after day 2) 11 4% Hemorrhagic stroke (after day 2) 9 3% Other neurological events (eg, TIA, seizures, confusion, etc) 21 8% Hemolysis 11 4% *Use of RVAD or extended inotrope use > 14 days, or starting after 14 days Pagani F, Miller L, Russell S, JAAC: Vol 54, No 4, 2009. 11

HeartMate II Freedom from Major Device Failure or Replacement Freedom from major malfunction (%) 100 90 80 70 60 50 40 30 20 10 0 6 mo: 96±1% 0 6 12 18 Months 12 12 mo: 93±2% 18 mo: 92±3% Remaining at risk 281 131 72 52 Pagani F, Miller L, Russell S, JAAC: Vol 54, No 4, 2009.

VAD Complications Peri-operative Events Bleeding RV dysfunction Aortic and Tricuspid regurgitation Bleeding complications Thrombotic Device-related infections

Peri-Operative Events Reasons for surgical bleeding: redo procedures, coagulopathy related to hepatic dysfunction Incidence 15.6% to 44% Surgical technique, topical hemostatics, systemic procoagulants John R, et.al., Ann Thorac Surg 86(4):1227 1234. Starling RC, et.al., J Am Coll Cardiol 57(19):1890 1898

Peri-Operative Events Right ventricular failure: Incidence 6-35% Definition: mechanical support, > 14 day of inotropic support Predictions of RV failure: Echo: TAPSE< 7.5 mm Moderate/severe TR CVP:PCWP >0.63 RVEDV:LVEDV >0.72 Krabatsch T, et.al., J Cardiovasc Transl Res 4(3):332 339. Slaughter MS, et.al., N Engl J Med 361(23):2241 2251

Management of RV Failure Early Recognition Optimization of RV function, heart rate, inotropy, management of pulmonary vasoconstriction: NO, IABP RVAD

Tricuspid Regurgitation Functional TR: dilated annulus from volume/pressure overload TR worse in 50% of LVAD patients in about 7.4 months after LVAD Retrospective review of 115 patients with > moderate TR undergoing LVAD 31 patients underwent TV repair (worse RV function) had a lower incidence of RVAD support, duration of inotropic support, hospital stay Surgical repair for > mod TR Piacentino V, et.al., Clinical impact of concomitant tricuspid valve procedures during left ventricular assist device implantation. Paper presented at the Society of Thoracic Surgeons Annual Meeting, San Diego, CA

Aortic Regurgitation AI: recirculation of blood, device wear & tear AI can also occur de novo, with longer support times Risk factors for progression of AI, female, small BSA, large aortic root, lower LV volume on support, and minimal AV opening Conventional wisdom: repair (more than mild AI) replacement over repair/suture Cowger J, et.al., Circ Heart Fail 2013: 3(6):668 674

Drive-Line Infections Incidence is 15-20% Superficial, skin flora Prevention: avoidance of traction, local wound care, positioning Management: antibiotics, local debridement, negative pressure wound therapy Bomholt T, et.al., Scand Cardiovasc J 45(5):273 278

Device-Related Infections Device-line infection Device infection Ref 97

Bleeding Complications Incidence: 25-55% per year Causes: Acquired von Willebrand Factor deficiency-similar to AS AV malformations: non-pulsatile flow Management: Conservative management, decrease anticoagulation, increase pulsatile flow

Hemorrhagic stroke Incidence: 2-15% HMII BTT trial 2%-post-approval <2% Jarvik as high as 18%, Heartware BTT, especially if MAP>90 mm Hg Stop/decrease anti-coagulation Expectant management

Thrombotic Stroke Incidence: 8% HMII DT Trial 6% HMII BTT Trial Most contemporary cohort of HMII: 4% Heartware BTT: 7.2% Unclear if from the pump or LA appendage or Miller LW, et.al., N Engl J Med 357(9):885 896. John R, et.al., (2011) Outcomes with a continuous flow left ventricular assist device in over 1,000 patients in commercial use compared to clinical trial experience. Paper presented at the Society of Thoracic Surgeons, San Diego, CA. Slaughter MS, et.al., N Engl J Med 361(23):2241 2251

Starling RC et.al., N Engl J Med 2014 2;370(1):33-40

Pump Thrombosis Incidence varies Changed over time Anti-coagulation protocol, surgical technique, pump speed, Characterized by increase in LDH, Bilirubin, plasma free Hemoglobin, decrease in Haptoglobin Presentation: low output, power surges, decreased PI Diagnosis: clinical, echo, labs Management: increased anticoagulation, (heparin or direct thrombin inhibitor), thrombolysis, pump replacement

Myocardial recovery after LVAD <5% in most centers Ischemic vs non-ischemic (valvular, hypertrophic, ) 2 phases of pharmacological therapy: High dose Beta blockade, ACE inhibitors, aldosterone antagonists, digoxin for remodelling Frequent testing with flow of 6000 RPM Clenbuterol after remodelling to induce physiologic hypertrophy

Birks, E.J., et.al., Circulation 2011;123:381-390

Myocardial recovery Reversal of non-ischemic heart failure can be achieved in selected patients with mechanical and pharmacologic therapies Dilated cardiomyopathy, young, short duration of heart failure, not very dilated, adequate mechanical unloading with frequent loading

Conclusions Axial flow pumps offer a durable device for supporting failing LV Adverse events have steadily decreased Post-approval Most Common events: Infections Bleeding Thrombotic

Longest-Supported Patient The longest-supported recipient of a single heart assist device in history over 8 years on a single HeartMate II! I didn t even realize my journey was so significant. I was too busy living my life to the fullest. It s certainly something special to be given a second chance, and it s even more of a blessing to know that my story can give others with heart failure the same hope I have every day, which is to continue to be saved by my wonderful doctors and my HeartMate II. - Joe Ann Bivins