VAD come Destination therapy nell adulto con Scompenso Cardiaco

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1 VAD come Destination therapy nell adulto con Scompenso Cardiaco Francesco Santini Division of Cardiac Surgery, IRCCS San Martino IST University of Genova Medical School, Italy

2 Heart Transplantation is the gold standard treatment for CHF albeit its inability to serve to the current demand.

3 imbalance between supply and demand The increasing routine use of ventricular assist devices (VADs) to keep patients alive until heart transplantation paved the way to their clinical use as an established treatment for end-stage heart failure (DT).

5 European Society of Cardiology (ESC) guidelines for the use of LVAD therapy Eur J Heart Fail 2012;14:803-69

6 The Destination Therapy SAGA

Extracorporeal systems The pump and the source of energy were placed outside of the

fixed to the patient s external surface (smaller compressors) => out of bed and walk

fed first via pneumatic systems, and subsequently electrically (LVAD).

7 Extracorporeal systems The pump and the source of energy were placed outside of the patient body Para-corporeal systems The power source was external and the pump was fixed to the patient s external surface (smaller compressors) => out of bed and walk around Intra- corporeal systems Totally implantable pulsatile-flow pumps, fed first via pneumatic systems, and subsequently electrically (LVAD). The implant, due to its size, must be placed in the abdominal cavity (intra- or extra-peritoneal).

8 Pulsatile / Volume Displacement Varying the rate can increase flow/output and change ventricular dimension and volume

9 First-generation devices: pulsatile-volume displacement pumps The quality of life was significantly improved at one year in the device group. The frequency of serious adverse events in the device group was 2.35 times that in the medical-therapy group, with a predominance of infection, bleeding, and malfunction of the device.

10 Survival improvement J Am Coll Cardiol 2007;50:741 7 QoL improvement The frequency of serious adverse events in the device group higher than in the medical-therapy group, First-generation devices: pulsatile-volume displacement pumps with a predominance of neurologic events, infection, bleeding.

11 First-generation devices: pulsatile-volume displacement pumps

12 Continuous / Rotary Varying the speed of the rotor can increase flow/output and change ventricular dimension and volume

14 HeartMate II Investigators Second-generation continuous axial-flow pump N Engl J Med 2009;361:

15 The Second-generation HeartMate II continuous was approved axial-flow by pump the FDA for DT in 2010 N Engl J Med 2009;361:

16 Heart Mate II (HM II) (Thoratec Inc.USA) Berlin Heart Incor (Berlin Heart AG, Germany) DuraHeart (Terumo, USA) HeartWare Ventricular Assist System (HeartWare Inc. USA) 16

17 continuous centrifugal-flow pump

The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) is a North American registry established in 2005 for patients who are receiving mechanical circulatory support

19 The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) is a North American registry established in 2005 for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. Intermacs was established as a joint effort of : National Heart, Lung and Blood Institute (NHLBI), Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services, Clinicians, Scientists, Industry representatives. University of Alabama at Birmingham

20 J Heart Lung Transplant 2009;28:535 41

26 EUROMACS unites individuals and institutions with the goal of running a European registry for data from patients with mechanical circulatory support systems. The data collected will then be made available for research purposes.

27 EJCTS 2015;47:

28 The Destination Therapy SAGA

Young age is the only predictor Development of a PSI

31 PSIs occur in approximately 19% of continuous-flow LVAD recipients by 12 months after implant. Young age is the only predictor Development of a PSI adversely affects survival J Heart Lung Transplant 2012;31:1151 7

Ann Thorac Surg 2014;97:1373 8 Between 2004 and October 2012, 12,969

The incidence of percutaneous lead dysfunction was 1,418 events

32 Ann Thorac Surg 2014;97: Between 2004 and October 2012, 12,969 Heart-Mate II pumps were implanted worldwide. The incidence of percutaneous lead dysfunction was 1,418 events occurring in 1,198 pumps (9.2% of pumps) over a cumulative support period of 13,932 patientyears.

33 The free-range resonant electrical energy delivery (FREE-D) concept. Ann Thorac Surg 2014;97:

34 Systematic review to estimate the risk of stroke in patients with different types of LVADs and various antithrombotic regimes: (i) (ii) (iii) (iv) (v) (vi) heparin low-molecular-weight heparin (LMWH) coumarins acetylsalicylic acid (ASA) dipyridamole clopidogrel 1. Heparin => coumarins / ASA / dipyridamole 2. Heparin => coumarins / ASA 3. Coumarins / ASA / dipyridamole 4. ASA / dipyridamole 5. Heparin => ASA / dipyridamole or clopidogrel 6. Heparin => coumarins 7. Heparin => coumarins / ASA / clopidogrel 8. LMWH => antiplatelets 9. LMWH => antiplatelets (ASA and clopidogrel) / coumarins 10. Heparin => coumarins / ASA / dipyridamole /clopidogrel Postoperative antithrombotic regimens analized EJCTS 2012;42:

35 The mean proportion of patients affected with stroke was 20% (range 0 55%), with a mean incidence of 0.74 (range ) events/patient-year. EJCTS 2012;42:

factors: infection bleeding anticoagulation Delayed Post operative

37 837 patients (55+14yrs) at three institutions, 895 devices implanted (2004- mid-2013) Device design and manufacturing Pump settings Patient-level factors: infection bleeding anticoagulation Delayed Post operative anticoagulation-no heparin Lower INR due to avwd Frequent GI bleeds N Engl J Med 2014;370:33-40

38 N Engl J Med 349;4

39 79 patients (mean age years) with a HM II (64 BT; 15 DT) J Am Coll Cardiol 2010;56:

Severe AI following LVAD implantation can lead to ineffective

AI progresses with the duration of LVAD support Worsening AI

HeartMate-II model increasing aortic sinus diameters

40 Severe AI following LVAD implantation can lead to ineffective cardiac output and heart failure symptomatology. AI progresses with the duration of LVAD support Worsening AI post-lvad correlates with: female sex smaller body surface area HeartMate-II model increasing aortic sinus diameters postoperatively Aortic valve that did not fully open on systole Circ Heart Fail. 2010;3:

41 JACC CV Interv 2012;5:

45 Curr Opin Cardiol 2013, 28:

46 In recent series using continuous flow devices the incidence of RVF is between 20 and 40%. Evaluation of pre-operative risk factors for post-operative RHF. Risk scoring systems: Matthews score Fitzpatrick s score Drakos score Curr Opin Cardiol 2013, 28:

47 Curr Opin Cardiol 2013, 28:

Total Artificial Heart Patients with different

The indications are reserved for patients waiting

50 Total Artificial Heart Patients with different devices for DT SynCardia TAH (ex Jarvik-7-CardioWest) CARMAT Abiomed AbioCor TAH It is mostly used as a bridge to transplant. The indications are reserved for patients waiting for a heart transplant for which any other type of assistance is excluded.

51 The Destination Therapy SAGA

52 REMATCH INTrEPID CUBS ReVOLVE ADVANCE RELIEVE ENDURANCE REVIVE-IT ROADMAP PREVENT CONSENSUS-DT DAVID

53 Acta Clin Belg 2014:69;165 Direct transplantation without bridging is the most cost-efficient treatment. The cost per patient per year for DT is similar to HTX considering its bridging activity

54 Conclusions DT represents an increasing LVAD application and currently accounts for one third of overall MCS activity. Evolution from pulsatile to continuous flow technology has dramatically improved 1- and 2-year survivals. Important subsets of DT patients now enjoy survival that may be competitive with heart transplantation out to about 2 years. Future studies will focus on transplant-eligible subsets who may benefit from informed discussions about MCS as an alternative long-term option. Patient selection and timing. Device design / Energy source /Complications.

55 Prof. Francesco Santini Divisione e Cattedra di Cardiochirurgia Università degli Studi di Genova francesco.santini@unige.it

Ventricular Assist Devices for Permanent Therapy: Current Status and Future

Ventricular Assist Devices for Permanent Therapy: Current Status and Future Prospects Francis D. Pagani MD PhD Professor of Cardiac Surgery University of Michigan April 28 th, 2012 Disclosures NHLBI and