Bridging With Percutaneous Devices: Tandem Heart and Impella

Transcription

1 Bridging With Percutaneous Devices: Tandem Heart and Impella DAVID A. BARAN, MD, FACC, FSCAI SYSTEM DIRECTOR, ADVANCED HEART FAILURE, TX AND MCS SENTARA HEART HOSPITAL NORFOLK, VA PROFESSOR OF MEDICINE (CARDIOLOGY) EASTERN VIRGINIA MEDICAL SCHOOL

2 Disclosures Research funding Astellas, Abbott Consulting TandemLife, Maquet, Luitpold Lectures Otsuka, Novartis

3 Outline Cardiogenic shock Tools IAB Impella 2.5 CP 5.0 Tandem Heart Conclusions

4 Cardiogenic Shock: SHOCK trial definition Trial of AMI shock. Question of emergency revascularization vs initial medical stabilization End organ hypoperfusion due to cardiac failure Cool extremities Poor urine output or poor mental status SBP < 90 for at least 30 min Cardiac Index 2.2 with support LVEDP 15 Hochman J et al. NEJM 1999; 341:

5 Shock Pathophysiology Reynolds and Hochman. Circulation 2008; 117:

6 Is Cardiogenic Shock Just a Pump Problem? Starts with the pump Hypoperfusion is associated with a cascade of events Vasoconstrictors utilized to raise blood pressure which worsens afterload, further reduces capillary perfusion due to drugassociated spasm Interrupting the vicious circle should help

7 Tools to Address the Pump Problem Intra-aortic balloon pump LV- Aorta pump Left Atrium to Aorta / Femoral Artery pump Extracorporeal membrane oxygenation (VA ECMO) Right Sided Pumps

8 Intra-Aortic Balloon Pump Different sizes depending on height of patient Inflates during diastole leading to diastolic augmentation and systolic unloading (lower afterload) Increased coronary perfusion Most common mechanical circulatory assist? Increases cardiac output 0.5 L

9 ACC AHA 2013 Guidelines I IIa IIb III I IIa IIb III The use of intra-aortic balloon pump counterpulsation can be useful for patients with cardiogenic shock after STEMI who do not quickly stabilize with pharmacological therapy. Alternative LV assist devices for circulatory support may be considered in patients with refractory cardiogenic shock.

10 ESC 2016 Acute HF Guidelines

11 SHOCK-2 IAB Trial

12 SHOCK-2, 1 Year Results Thiele H, et al. Lancet 2013; 382:

13 IAB Pro / Con SHOCK-2 only addressed STEMI and only those randomized Excluding the sickest patients where equipoise doesn t exist 40 cc Balloon pumps (newer technology available) IAB is cheap (<$ ) and readily usable without cath lab environment if needed Tolerant of minimal anticoagulation The expensive pumps are not superior!

14 IAB

15 Survival

16 16

17 Follow-Up Study 76 of the 150 patients had PA catheter monitoring prior and after the IAB Responder defined as 0.01 L/Min increase in cardiac output 60 / 76 (79%) responders 37 patients (49 % of the responders) had care escalated 27 VAD s (temporary or durable) 10 direct to transplant 17

18 Responders to IAB 5 Delta Cardiac Output: Responders vs. Non-Responders ± 1.1 L/min Non- Responder Responder Baran, et al. Cathet Card Diagnosis 18

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20 Escalation of Care Successful wean 3 21 Unable to wean (no escalation) 3 12 Escalated to VAD 6 21 Bridge to OHT 4 6 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Non-Responder Responder 20

21 Impella Family

22 USPELLA REGISTRY 154 patients undergoing PCI with CS All Impella 2.5 CHF shock excluded O Neill et al. J Interven Cardiol 2014; 27:1-11

23 USPELLA 2.5 Results

24 USPELLA- Real World Registry Results, Impella 2.5 No percutaneous MCS device is benign 9.5% vascular complication with surgical repair 10.3 % hemolysis 1.9 % CVA

25 Impella 25

26 IMPRESS- IAB vs Impella CP for Shock Multicenter, open label, randomized, N= 48 IAB vs Impella CP, 1:1 randomization STEMI with immediate PCI CS as defined by SBP < 90 for 30 minutes or requirement for inotropes / pressors to maintain SBP > 90 ALL Pts were VENTILATOR dependent to be enrolled! Informed consent WAIVED!

27 BASELINE Systolic BP mm Hg % had cardiac arrest Time to ROSC minutes mean Lactate mean ph % had LVEF < % had therapeutic hypothermia

28 IMPRESS- IAB vs Impella CP for Shock Zeymer and Thiele. JACC Jan p

29 Impella With ECMO Pappalardo et al. European J HF 2017; 19:

30 Outcomes

31 Gaudard et al. Critical Care 2015; 19:363

32 N= 40 (Impella 5.0 device)

33 Tandem Heart: Left Atrium to Femoral Artery Bypass

34 TandemHeart vs IAB Burkhoff et al, Am Heart Journal 2006; 152:469 e1-e8

35 Tandem LA-FA Bypass Support vs IAB Prospective, randomized 12 site trial 42 patients but if a site had not placed Tandem they could rollin a patient directly to Tandem Cardiogenic shock criteria: CI 2.2, PCWP 15 and hypoperfusion Could have IAB as long as still in CG shock

36 Outcomes: 33 Randomized Patients TH: 32 % death on support, 6/19 patients No significant difference in Plasma Free HgB (hemolysis)

37 Single Center Experience 117 pts Severe Refractory Cardiogenic Shock SBP < 90, CI < 2.0 Above hemodynamics ON IABP and pressors 48 % of the patients were UNDERGOING CPR during insertion of TH Of these, 43 % (of the 48 %) survived 30 days

38 Outcomes

39 Next Generation?

40 Possible Link Johannson et al. Critical Care 2017; 21:25

41 Why Does This Mechanism Exist? Cardiogenic shock is a hypercoagulable state Endothelial injury releases heparin and other molecules from the endothelial cells This anticoagulant effect balances the hypercoagulability of shock

42 Shock Team Multidisciplinary team is essential in shock Team that works together can handle extreme stress of crashing patients Support early and aim to reverse hypoperfusion Vigilant monitoring and be prepared to escalate therapy

43 Conclusions Complex spiral from insult to multiorgan dysfunction No one tool will suffice for all patients Risk / benefit profile of each device is unique and is weighed by the team when choosing a support device Regardless of device, the mortality is high and relatively unchanged Future advances will involve understanding the process of progression of shock to design inhibitors along with better pumps

44 Thank You

45 Which Device Do I Pick? Confidence- Spider Sense that device will provide sufficient support Competence Ability to rapidly place Changeability Ability to change to another device if needed Capability Inherent capability / flow / characteristics of the device