Bridging With Percutaneous Devices: Tandem Heart and Impella

DAVID A. BARAN, MD, FACC, FSCAISYSTEM DIRECTOR, ADVANCED HEART FAILURE, TX AND MCSSENTARA HEART HOSPITALNORFOLK, VAPROFESSOR OF MEDICINE (CARDIOLOGY)EASTERN VIRGINIA MEDICAL SCHOOL

Disclosures

• Research funding• Astellas, Abbott

• Consulting• TandemLife, Maquet, Luitpold

• Lectures• Otsuka, Novartis

Outline

• Cardiogenic shock

• Tools• IAB• Impella

• 2.5• CP• 5.0

• Tandem Heart

• Conclusions

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: 625-634

Shock Pathophysiology

Reynolds and Hochman. Circulation 2008; 117: 696-697

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 drug-associated spasm

• Interrupting the vicious circle should help

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

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

ACC AHA 2013 Guidelines

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.

I IIa IIb III

I IIa IIb III

ESC 2016 Acute HF Guidelines

SHOCK-2 IAB Trial

SHOCK-2, 1 Year Results

Thiele H, et al. Lancet 2013; 382:1638-45

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 (<$700-800) and readily usable without cath lab environment if needed

• Tolerant of minimal anticoagulation

• The expensive pumps are not superior!

IAB

Survival

16

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

Responders to IAB

18

Delta Cardiac Output: Responders vs. Non-Responders

-2

-1

0

1

2

3

4

5

Non-Responder

Responder

1.6 ± 1.1 L/min

Baran, et al. Cathet Card Diagnosis

Escalation of Care

20

4

6

3

3

6

21

12

21

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Bridge to OHT

Escalated to VAD

Unable to wean (no escalation)

Successful wean

Non-Responder Responder

Impella Family

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

USPELLA 2.5 Results

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

Impella

25

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!

BASELINE

• Systolic BP 81-84 mm Hg

• 85-92 % had cardiac arrest

• Time to ROSC 21-27 minutes mean

• Lactate 7.5-8.9 mean

• pH 7.14-7.17

• 60 + % had LVEF < 40

• 71-79 % had therapeutic hypothermia

IMPRESS- IAB vs Impella CP for Shock

Zeymer and Thiele. JACC Jan 2017. p 288-290

Impella With ECMO

Pappalardo et al. European J HF 2017; 19: 404-412

Outcomes

Gaudard et al. Critical Care 2015; 19:363

N= 40 (Impella 5.0 device)

Tandem Heart: Left Atrium to Femoral Artery Bypass

TandemHeart vs IAB

Burkhoff et al, Am Heart Journal 2006; 152:469 e1-e8

Tandem LA-FA Bypass Support vs IAB

• Prospective, randomized 12 site trial

• 42 patients but if a site had not placed Tandem they could “roll-in” 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

Outcomes: 33 Randomized Patients

TH: 32 % death on support, 6/19 patients

No significant difference in Plasma Free HgB (hemolysis)

• 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

Outcomes

Next Generation?

Possible Link

Johannson et al. Critical Care 2017; 21:25

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

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

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

Thank You

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