bridging with percutaneous devices: tandem heart and impella · bridging with percutaneous devices:...
TRANSCRIPT
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