Deutsches Herzzentrum Berlin

Transcription

1 Deutsches Herzzentrum Berlin

2 DECLARATION OF CONFLICT OF INTEREST I have nothing to disclose

3 Background Unloading-promoted reversal of HF allows long-term transplant-free outcome after VAD removal. Because only few patients with chronic cardiomyopathy (CCM) were weaned from VADs and most of them only recently, the long-term outcome of patients and the reliability of criteria used for weaning decisions to predict long-term success of VAD removal is barely known.

4 Weaning from Long-Term Assist Devices Primarily Designed as Bridge-to-Transplant Therapy (DHZB 3/1995-7/2011) 82.1% Patients weaned from LVADs n= 78 Patients weaned from VADs* n = % Patients weaned from BVADs n = % Patients weaned from RVADs n = 3 IDCM n = 44 CAD n = 20 Myocarditis n = 5 Others n = 9 Myocarditis n = 7 Others n = 7 Graft failure n = 2 Others n = 1 Post - weaning cardiac stability > 5 years = 20 patients > 15 years = 2 patients (still alive) Post-weaning cardiac stability > 5 years = 2 patients (patients still asymptomatic) * Switching from BVAD to LVAD by RVAD removal not included

5 AIM Evaluation of the feasibility of weaning from VADs and search for criteria which can predict long-term cardiac stability after VAD removal in pts. with CCM in order to improve - future weaning decisions and - post-weaning patient management

6 Methods (I) Evaluated Patients All 46 CCM patients (> 14 years old) weaned from VADs between 3/1995 and 2/2010 Exclusion criteria: acute myocarditis, cardiac valve protheses. Diagnoses before VAD implantation: - IDCM: n = 40 (87.0%) - Histol. evidence of chron. myocarditis: n = 4 (8.7%) - Chronic ischemic cardiomyopathy with severe LV dilation: n = 2 (4.3%) Before VAD insertion all patients had irreversible end-stage HF and required continuous positive inotropic support ( non-ischemic / ischemic CCM: 44 / 2 ). No attempts have been made to use VADs electively with the aim of myocardial recovery only.

7 Methods (II) Evaluated Aspects - preservation of stable cardiac function without VAD support - survival after weaning - echo-parameters: before VAD implantation and explantation and their time course early after VAD removal - history of HF and duration of mechanical support until cardiac recovery Explanted VADs: LVADs / BVADs 44/2 30 (65.2%) of LVADs were pulsatile

8 Evaluation of Unloading-Induced Myocardial Improvement after LVAD Implantation Screening with normal VAD function Patient selection for off-pump trials (LVEDD 60 mm; only moderate global hypokinesia) Reduction of pump-rate in pts. selected for off-pump trials Off-pump trials (Pump-Stop-Echo) in pts. with cardiac and hemodynamic stability during pump-rate reduction: pump-stops during one off-pump trial - trials were repeated weekly in pts with relevant recovery until there was no further improvement Right heart catheterization (with off-pump hemodynamic measurements was routinely scheduled only for pts who were selected by ECHO for VAD removal and was performed 1h before VAD explantation. Only those with hemodynamic stability underwent VAD explantation.

9 Results Kaplan-Meier estimates of patient survival after VAD removal A B A: Probability of overall post-weaning survival with inclusion of post-transplant survival for patients with recurrence of HF. B: Probability of post-weaning survival from HF recurrence or weaning-related complications

10 Results Kaplan-Meier estimates of freedom from HF recurrence after VAD removal 66 5

11 Source of the curve Pre-explant. LVEF value Pre-explant. LVEF decrease Area under the curve % Confidence Interval Receiver - Operating Characteristic Curves for Prediction of Cardiac Stability after VAD Removal in Patients with Chronic HF Reversal after Ventricular Unloading. Source of the curve Pre-explant. RWT RWT-decrease during final off-pump trial Area under the curve % Confidence Interval The high values for areas under the curves, which measure discrimination, indicate a high ability of pre-explantation LVEF (A), RWT ED (B), LVEDD (C) and the duration of HF before VAD implant. (C) to correctly classify patients with and without cardiac stability after VAD removal. Source of the curve Pre-expl. LVEDD Pre-expl. LVEDD changes Duration of HF Area under the curve 95% Confidence Interval

12 Predictive Parameters for Long-Term (> 5 years) Cardiac Stability Predictive value Pre-weaning off-pump LVEF 45% at LVEDD 55mm 86.4% Pre-weaning off-pump LVEF 50% at LVEDD 55mm 91.7% Final off-pump LVEF 45% at stable LVEDD 55 mm (not > 10% larger than best off-pump LVEDD value) 94.1% Pre-weaning off-pump Sm 8 cm/s, stable after max. improvement (not >10% lower than best off-pump value) 85.0% Pre-weaning LVEF 45% without alteration during the 1 st post-weaning month 90.0%

13 Sm Before and During Off Pump Trials Sm = 9 cm/s Sm = 9 cm/s stable Sm = 11 cm/s Further Improvement few weeks later Sm = 11 cm/s stable

14 Distribution of Selected Major Risk Factors for HF Recurrence in Patients with and without Recurrence of HF during the first 5 Post-Weaning Years LVEF change during the 1st post-weaning month [%] Final off-pump LVEF [% ] Final off-pump LVEDD [mm] Final off-pump LVEDD change in comparison to best off-pump value LV diastolic RWT RWT change during the final off-pump trial LVEF LVEDD LV enddiastolic RWT Final off-pump LVEF (%) Recurrence of HF Stable cardiac function Recurrence of HF Stable cardiac function Recurrence of HF Stable cardiac function 15 Recurrence of HF Stable cardiac function Recurrence of HF Stable cardiac function Recurrence of HF Stable cardiac function P < 0.01

15 Selected Risk Factors for HF Recurrence during the First 3 Years after Weaning probability for HF recurrence Pre-weaning LVEF < 45% 88.9% Pre-weaning off-pump LVEF < 45% plus history of HF > 5 years 100% Pre-weaning off-pump LVEF < 50% plus LVEDD > 55mm 90.0% Pre-explant. LVEF < 50% and pre-weaning alteration of > 10% of best value 87.5% LVEF < 50% plus RWT decrease of > 10% during the final off-pump trial 83.3%

16 Conclusions For selected pts with unloading-promoted reversal of chronic heart failure, VAD explantation is feasible and can be a clinical option with potentially successful results over > 15 years even after incomplete cardiac recovery. Parameters of pre-explantation off-pump cardiac function, LV size and geometry, their stability during off-pump trials and heart failure duration before VAD implantation allow detection of patients with the potential to remain stable for > 5 post-weaning years.

17 Thank You! Deutsches Herzzentrum Berlin

18 LV Function before LVAD Implantation and Explantation 14 Months Longit. Strain Longit. Strain Longit. Strain Rate Longit. Strain Rate