Post on 07-Aug-2020
Complex, High RiskIndicated Interventional
ProceduresHemodynamic Support
Usman Baber, MD MSAssistant Professor of Medicine (Cardiovascular Disease)
Icahn School of Medicine at Mount Sinai New York, NY
Conflict of Interest Disclosure
• Boston Scientific/Astra Zeneca¡ Speaking fees
Defining the CHIP Population
Patient Comorbidities
Ventricular Function/
Hemodynamics
Anatomic Considerations
Are these patients being undertreated?
In order for revascularization to provide a benefit to patients…
• The revascularization being performed has to be performed on disease that is ¡ actually prognostically important or ¡ causing a reduction in quality of life
• The revascularization must be able to be done safely and with high quality and/or durability
Two Goals of Therapy inPatients with SIHD
1. Improve Symptoms and/or Quality of Life– TRY MEDICAL Rx first
Anti-Anginal Agents:An Alternate Perspective
Non-AdherencePolypharmacySide-Effects
Cost
Agent Issues for Patients
“Hard Outcomes” in SIHD
Beta-blockers Sluggishness, fatigue
No benefit unless post-MI or low EF
Nitrates Really need to push for effect No benefit
Ca++ Channel Blockers
Reasonably tolerated No benefit
Ranolazine Cost No benefit
A point rarely discussed: For most patients, GDMT with the ability to affect “hard endpoints” is limited to only aspirin, statins, ACE-I and lifestyle
Two Goals of Therapy inPatients with SIHD
1. Improve Symptoms and/or Quality of Life
2. Improve Prognosis
ACC/AHA SIHD Guidelines:CAD Prognostic Index
*Assuming medical treatment only.
Risk Assessment Algorithm for SIHD Patients
CONFIRM: Association of
Revascularization with All-Cause Mortality
15,223 stable patients without known CAD undergoing CTA
Revascularization of “High-Risk” Anatomy (7.3%) was independently
associated with 62% lower Mortality at 2.1 yrs (adjusted HR 0.38 [0.18,0.83])
Number of Vessels with Severe (>70%) Stenosis
P=0.45 P=0.02 P=0.07
Min JK et al, Eur Heart J 2012
All-
Cau
se M
orta
lity
at
Med
ian
2.1
year
s
LVEF Improvement Post PCI in High-Risk Patients
p=0.02
Pre-PCI Follow-up
31�7
41�1332%
2 Italian Ctrs Study (n=10)Burzotta et al J Card Med 2008
p=0.003
26�634�11
31%
PROTECT I (n=16)Dixon et al. JACC Interv 2009
Pre-PCI Follow-up
p<0.0001
31�1536�14
USpella Registry (n=89)Maini et al. CCI 2012
16%
Pre-PCI Follow-up
p<0.001
27�933�11
PROTECT II (n=175)O�Neill et al. Circ 2012
22%
Pre-PCI Follow-up
Complex, High Risk (Symptomatic) Patients Align with Appropriate Use
• A shift is is afoot in patients presenting to the cath lab
• More risk on stress testing, medications, more symptoms, more anatomy = more likely “appropriate”
Coronary Revascularization Appropriateness Guidelines
Patient Trends
Patel, et al, JACC 2012*
Sym
ptom
s
Complexity
STICH: Mortality in Per-Protocol and Crossover Groups
Doenst et al. Circ Heart Fail. 2013;6:443-450
Mor
talit
y R
ate
1.000.900.800.70
0.40
0.00
Years Following Randomization
Treatments
0 0.5 5.0
MED/MEDCABG/CABG
CABG/MEDMED/CABG
Assigned/Received Assigned/Received
Patients at risk:CABG/CABGCABG/MEDMED/MEDMED/CABG
5555553765
4.54.03.53.02.52.01.51.0
0.10
4874547161
4523443057
4283138154
3192127636
1677
13915
0.300.20
0.500.60
CABG/CABGCABG/MEDMED/CABG
MED/MEDCABG/CABG
MED/MED
:::
HR0.762.010.50
95% CI0.62, 0.921.36, 2.960.30, 0.85
P value0.005
<0.0010.008
How to Improve Complex PCI OutcomesPatient Selection and
Optimization Technical Considerations
Objective assessment of rationale for revascularization
Functionally complete revascularization
Hemodynamic assessment (including valvular disease)
Hemodynamic management(e.g. support)
DAPT candidacy Best-in-class DES,appropriate pharmacology
Comorbidity assessment and management (e.g. Renal fxn)
Lesion preparation / Stent optimization (+/- imaging)
Truly informed consent High-risk lesion expertise(e.g. CTO/LMCA)
Hollenberg Ann Int Med 1999; 131:47-99
Hemodynamic Compromise Pathophysiology
• When a critical mass of LV is necrotic and fails to pump, stoke volume and CO falls
• Myocardial and coronary perfusion are compromised causing tachycardia and hypotension
• Increased LVEDP further decreases coronary perfusion
• Increase LV wall stress increases myocardial oxygen demand
• Lactic acidosis worsens myocardial performance
Patients That Benefit from SupportProtected PCI Cardiogenic Shock Therapy
Why are hemodynamics so essential?
• Catheters can obstruct native aorto-ostial flow (especially
larger catheters). Wires, balloons, stents, devices can obstruct
flow and when inflated by definition are producing ischemia
• Contrast does not contain hemoglobin and is a myocardial
depressant
• Patients may have acute or longstanding LV dysfuction and
CHF
• Adverse hemodynamics will make it difficult to complete the
case and can worsen short/long term outcomes by allowing
…disasters!
Revascularization Strategy by Risk Category
1. Levine GN, et al. J Am Coll Cardiol, 2011 Dec 6;58(24):e44-122, 2 Amsterdam EA, et al. Circulation. 2014 Dec 23; 130(25):e344-426
Low Medium High
Low PCI PCI PCI
Medium CABG or PCI
PCI or CABG Support & PCI
High CABG CABG or PCI Support & PCI
Surgical Risk
Ana
tom
ic R
isk
Protected PCIFDA Indicated
Safe & Effective
ACC/AHA PCI Guidelines1,2
SYNTAXStudy
Often inoperable
Finke et al JACC 2004; 44:340
Cardiac Power Is The Most Important Mortality Predictor in the SHOCK Trial
(Mean Arterial Pressure x Cardiac Output)
451
Cardiac Power =
0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0
0
10
20
30
40
50
60
70
80
90
100
Estim
ated
In-h
ospi
tal M
orta
lity
(%)
Cardiac Power Output
• Multicenter, open-label, randomized study• 600 patients with AMI and cardiogenic shock randomized• Patients allocation in a 1:1 fashion to IAPB support vs. no
support¡ 87% received IABP after PCI
• Efficacy endpoint: 30 days all-cause mortality• Safety endpoint: severe or life-threatening bleeding
according to GUSTO
Thiele et al. NEJM 2010
IABP Shock II: In-hospital and 30 days Results
Thiele et al. NEJM 2010
IABP Shock II: 1-year Results
Thiele et al. Lancet 2013
Impella LV assist device
O2 Demand Cardiac Power OutputO2 Supply
Coronary Flow
MechanicalWork
WallTension
MicrovascularResistance
EDV, EDP AOP Flow
Inflow(ventricle)
Outflow(aortic root)
aorticvalve
Myocardial Protection Systemic Hemodynamic Support
PROTECT-II Trial Design
IMPELLA 2.5 +PCI
IABP + PCI
Primary Endpoint = 30-day Composite MAE* rate
1:1R
Patients Requiring Prophylactic Hemodynamic Support During Non-Emergent High Risk PCI on
Unprotected LM/Last Patent Conduit and LVEF≤35% OR3 Vessel Disease and LVEF≤30%
Follow-up of the Composite MAE* rate at 90 days*Major Adverse Events (MAE) : Death, Stroke/TIA, MI (>3xULN CK-MB or Troponin) , Repeat Revasc, Cardiac or Vascular Operation of Vasc. Operation for limb ischemia, Acute Renal Dysfunction, Increase in Aortic insufficiency, Severe Hypotension, CPR/VT, Angio Failure
Hemodynamic Support Effectiveness:
PROTECT II
CPO= Cardiac Power Output = Cardiac Output x Mean Arterial Pressure x 0.0022
(Fincke R, Hochman J et al JACC 2004; 44:340-348)
Cardiac Power Output
Maximal Decrease in CPO on device
Support from Baseline (in x0.01 Watts)
IABP Impella
N=138 N=141
- 4.2 � 24
- 14.2 � 27
p=0.001
Impella Reduces Peri & Post Procedural MACCE
Dangas et al, Am J Cardiol 2014; 113(2):222-8
MACCE = Death, Stroke, MI, Repeat revasc.
Impella
Time Post Procedure (day)
MA
CC
E (%
)
100 20 30 40 50 60 70 80 90
10
15
20
25
30
p=0.042
IABP
29% reduction
In MACCE
N=216
N=211
MACCE
FDA Approved Randomized
Controlled TrialProtect II
PROTECT II Multivariate analysispredictors of MACCE at 90 days
Odds Ratio Estimate 95% confidence interval P-Value
Per-Protocol Population
Use of atherectomy rotablation during index procedure
1.2984 0.9374 – 1.7983 0.1161
Renal Insufficiency 1.2324 0.9545 – 1.5912 0.1089
Baseline worst TIMI flow: 0-1 1.3112 0.9596 - 1.7918 0.00889
Device: IMPELLA vs IABP 0.7651 0.6099 - 0.9298 0.0206
Intention-To-treat Population
Use of atherectomy rotablation during index procedure
1.2787 0.9251 - 1.7676 0.1366
Renal Insufficiency 1.2466 0.9717 - 1.5992 0.0829
Baseline worst TIMI flow: 0-1 1.2340 0.9089 - 1.6752 0.1777
Device: IMPELLA vs IABP 0.7944 0.6365 - 0.9914 0.0417
Dangas et al, Am J Cardiol 2014; 113(2):222-8
Pump outflow in PA
Pump Outflow
in IVC
Impella RP: Percutaneous Right Ventricular Assist Device (RVAD)
• Transfemoral venous insertion
• 3D shaped cannula
• 22 Fr motor housing
• Pump mounted on a 11Fr catheter
• Flow: 4 L/min @ 33,000 rpm
• Anticoagulation: ACT ~ 160-180 sec
• Approved indication: Extracorporeal circulatory support for up to 6 hrs.
• Medtronic Bio-Medicus arterial cannula, percutaneous access (15-17F)
• Flow 3.5-5 l/minCannula Controller Pump
Tandem Heart : System Components
TandemHeart Randomized trials
• Single center, prospective randomized study between August 2000 and December 2003
• 41 patients with cardiogenic shock complicating AMI enrolled and randomized:
¡ 20 to intra-aortic balloon pump
¡ 21 to TandemHeart
• Primary endpoint:
¡ Haemodynamic improvement • (CPI within 2h post implantation)
• Secondary endpoints:
¡ Heamodynamic and metabolic
parameters
¡ Mortality at 30 days
¡ Device related complications
Thiele et al. EHJ 2004
Thiele et al. EHJ 2004
Complications
• Bleeding
• Limb Ischemia
• DIC
• SIRS
ECMO Percutaneous heart-lung machine
• Centrifugal pump• Hemodynamic support >4.5 l/min• Can increase preload and afterload• No randomized control trials or large
cohorts yet
For VA-ECMO, due to arterial cannula size (in iliacs!), may need to include distal perfusion cannula based upon limb exam, and typically needs surgical explant
ECMO data• Retrospective analysis of 334 patients that underwent PCI due to
AMI and complicated by cardiogenic shock
• Patients undergone procedure in two different periods:¡ 1993-2002à115 patients¡ 2002-2009à219 patients
• ECMO was available in patients in group 2
• Endpoints:¡ TIMI flow¡ 30 days mortality
• Shock versus “profound” shock
Sheu et al. Crit Care Med 2010
Results
Sheu et al. Crit Care Med 2010
P=0.003
Open Questions in Hemodynamic Support
• How much support is necessary?
• What is the role of IABP / Do we believe IABP SHOCK II?
• Which patients should get upfront treatment with an LVAD?
• What is the optimal use for Impella LVAD support?
• Relevance of cost/complications vs. benefit of active LVADs
• How do we manage biventricular failure?
• Is there even a good definition for Shock?
NCDR CathPCI•Cardiogenic shock is defined as a sustained (>30 min) episode of systolic blood pressure <90 mm Hg and/or cardiac index <2.2 L/min per square meter determined to be secondary to cardiac dysfunction and/or the requirement for parenteral inotropic or vasopressor agents or mechanical support (eg, IABP, extracorporeal circulation, VADs) to maintain blood pressure and cardiac index above those specified levels.
NEW YORK STATE•Cardiogenic Shock is defined as an episode of systolic blood pressure <90 mmHg and/or Cardiac Index <2.2 L/min/m2 determined to be secondary to cardiac dysfunction and the requirement for parenteral inotropic or vasopressor agents or mechanical support (e.g., IABP, extracorporeal circulation, VADs) to maintain blood pressure and cardiac index above those specified levels.
Lack of Standard Definitions
Conclusions• There is a large underserved patient population
that can benefit from revascularization!¡ Rather than focusing on low-risk patients who
may be “easy to treat”, we need to focus upon higher-risk patients who have the most to gain
¡ These patients will be more commonly seen¡ The development of comprehensive specialists
trained with advanced technical and cognitive skills to perform these complex, high risk procedures with high quality is sorely needed