Impella and Acute Kidney Injury: Implications on Practice ... · Impella and Acute Kidney Injury:...

Impella and Acute Kidney Injury: Implications

on Practice, Decision Making, and Integration

into Protocols

Michael P. Flaherty, M.D., Ph.D.

Director, Cardiac Catheterization Lab

Director, Adult Structural Heart Disease

Director, Research Interventional Cardiology

Heart Institute, Kentuckiana Medical Center

Overview

• Our data → Renal protection with Impella in HR-PCI

with reduced LVEF (≤35%)

• New data → Europe and cVAD

• Risk stratification → should there be an indication

for Impella in patients at high-risk for CKD?

Flaherty MP, et al. 2017. Circ Res;120(4):692-700

Objective

Does hemodynamic support from Impella during

HRPCI protect against acute kidney injury when

compared to the same revascularization strategy in

patients without hemodynamic support


Design

Retrospective, control-matched study (2011-2014): Single-center

catheterization laboratory database

consecutive patients, high-risk cardiac procedures with Impella support with LV systolic

dysfunction

153 patients (Impella support)

38 Excluded

• 22 EP procedures, 9 CP insertions

• 7 either no PCI or EF>35%

115 patients

Elective/Urgent/Emergent PCI

•EF ≤35%.

115 patients


•EF ≤35%.

Controls (data query)

Matched

• age, gender

• EF (range 10-35%), acuity of presentation

• Contrast load used

No IABP included

115 patients


•EF ≤35%.

Controls (data query)

Matched

• age, gender



No IABP included

115 patientsControls (data query)

Matched

• age, gender



No IABP included


Primary Outcome Measure

Primary outcome: defined as the development of acute kidney injury

(AKI) periprocedurally from insertion of the Impella 2.5 device/sheath

up to 72h; all Impella inserted pre-PCI

Classification of AKI, AKIN criteria

• stage 1, ≥0.3 mg/dl absolute or 1.5 to 2.0-fold relative increase in

serum creatinine

• stage 2, >2- to 3 fold increase in serum creatinine

• stage 3, >3-fold increase in serum creatinine or serum creatinine >4.0

mg/dl with an acute increase of >0.5 mg/dl).


Incidence of AKI during high-risk PCI (EF ≤35%)


Periprocedural Creatinine Levels

1

1.2

1.4

1.6

1.8

2

2.2

0 1 2 3

Impella

ControlsP=0.04

P<0.001

Cre

ati

nin

e(m

g/d

L)


Postprocedure Day


AKI Incidence ≈ Baseline CKD Severity in Unsupported Patients

Impella support *

Ejection fraction (%)

eGFR

Procedural time (min)

Contrast volume (50 ml)

AOR 95% CI p

0.09-0.31

0.12-0.28

0.25-0.83

0.71-1.13

1.28-5.14

< 0.001

<0.001

0.038

0.072

<0.001

0.13

0.16

0.63

0.98

2.14

Independent Predictors

4 620.50

Determined Whether Impella CONTINUED to Protect against AKI in

Supported vs. Unsupported HR PCI Patients (Multivariate logistic regression: controlling for clinical/procedural variables)

Despite >↓EF, >CKD,

the renal protective

effect of Impella

persisted

When controlling for contrast volume,

AKI risk was ~2 fold greater despite

Impella support

Impella CONTINUED

to be independently

associated with a

significant reduction

in AKI


<<AKI less likely AKI more likely>>

Summary

• The incidence of post-procedural AKI during high-

risk PCI without Impella 2.5 support is ~28% and

~5% with support; despite severely reduced EF

and baseline CKD.

The incidence of post-procedural AKI is more closely related to the

severity of baseline CKD in controls.

• Patients without Impella support presenting with severe CKD at baseline

(eGFR <30) had the highest incidence of both AKI and AKI-HD (20.5% vs. 2.7%

and 3.6% vs. <1%, respectively; p<0.05)


What Now?

AKI in PCI

AKI in all-comers with PCI 7-12%

Protect II: 64% non-surgical, EF-24%, CKD prevalence was 26%

and ~4% developed “acute renal dysfunction” (AKI and HD);

definition of renal failure somewhat loosely defined.

Our CKD prevalence was 50% and AKI incidence (including HD)

was ~5% ( 28% in unsupported pts)

Impella is renal protective

Tsai TT. JACC : Cardiovasc Interventions. 2014;7:1-9

Fox CS. Circulation. 2012;125:497-504

O’Neill WW, et al. Circulation. 2012;126:1717-1727

Acute Kidney Injury (AKI) is a Significant Risk

• High-risk patients face elevated

risk of AKI

Chronic Kidney Disease is a

common co-morbidity

High levels of contrast

Long procedures

• Low Ejection Fraction and baseline

hemodynamic compromise may

result in renal hypoperfusion

• Risk of AKI also exists in patients

with normal kidney function pre-

PCI

Heart Failure,

Advanced Age,

Diabetes, Chronic

Kidney Disease,

Gender, Race

Increased

Contrast

Volume

Hypotension

Risk Factors for AKI1

1. Mehran R, et al., JACC 44(7), 2004

2. Flaherty MP, et al. 2017. Circ Res;120(4):692-700

What Now?

Develop Renal Protection Risk Stratification Strategy

Our patients received ~280 cc contrast

• 2-fold incremental increase in AKI in Impella supported when

controlling for procedural and baseline characteristics

– vs. >6-fold increase in unsupported patients – contrast matters

• When feasible, patients received prehydration, high-dose statins and

non-ionic low osmolar contrast

– Did not seem to protect unsupported patients

Contrast sparing and pre-treatment are STILL less effective than Impella

Mehran: Contrast Nephropathy Risk Score

Mehran R. JACC . 2004;44:1394-99

Renal Protection Risk Stratification Strategy

• 34% - Female 22%

• 51% - DM 18%

• 62% - Previous PCI 86%

• 37% - ACS 25%

• 66% - HTN 85%

• ↑ Lesions treated 3%

• 32% - Smokers 85%

• 47% - CHF 80%

• 50% - CKD 12%

• 17% - LM disease 44%

• 91% - MVD 20%

• ↑ Procedure time (/min) 15%

• 20%, Anemia (/mg/dL) 89%

• 68% - HLD 85%

Univariate analysis14 Predictors for AKI in unsupported

AKI less likely AKI less likelyImpella Impella


Mehran’s co-variatesage 75 years

female gender

hypertension

hyperlipidemia

diabetes

peripheral vascular disease

previous stroke

chronic kidney disease

Advanced CHF [class III/IV]

anemia

acute coronary syndrome

multivessel disease

Hypotension

IABP use

contrast media type

contrast amount 150 ml

Mehran’s Independent

Predictors for CIN (“cath AKI”)age 75 years

hypotension,

elective use of IABP

CHF (class III-IV)

CKD

anemia

diabetes

contrast volume


AKI Incidence ≈ Baseline CKD Severity in Unsupported Patients

Preprocedural variables (Mehran’s CIN Risk Calculator)

Using the baseline characteristics of the Impella supported

patients

• Age 66, male, white (77%)

• 51% DMII

• Hypotension (no)

• IABP (no)

• Hct > 38

• Contrast 200-300 cc

• Cr 1.49 mg/dL

CIN risk score of 14 ~26.1%, if IABP used 57%


Apply the Mehran CIN risk

predicting (or AKI-predicting)

scheme to each of our patients and

compare their predicted risk for AKI

with those that developed AKI.

Absolute RR

- 21%

NNT

- 5 pt

to prevent 1 AKI eventAbsolute RR

- 52%

NNT

- 2 pt

to prevent 1 AKI event

Mehran R. JACC . 2004;44:1394-99

The cVAD Study – Observed AKI in Impella Supported

HRPCI

• N=223 Patients enrolled in

prospective cVAD Study (January

2017 to March 2018)

• Elective or urgent HRPCI, supported

with Impella 2.5 (85) or Impella CP

(138) pre-PCI

• Baseline creatinine, and at least 1

follow-up creatinine within 48-72

hours of PCI, for assessment of AKI

21.4%

6.3%

8.20%

5.10%

Predicted AKI

Rate(Mehran Risk)

Score)

Observed

AKI Rate

All Impella

N=223

Impella 2.5

N=85

Impella CP

N=137

35.0%31.0%

AKI is Lower in HRPCI Patients Supported with Impella

Compared to ECMO

ECMO Impella CP

Predicted AKI Rate(Mehran Risk Score)

p= 0.55

55.0%

12.0%

Incidence of AKI

p= 0.03

ECMO Impella CP

Wiora J and Westenfeld R, et al. Presented at ACURE 2017 and Submitted to EuroInterventions. 2018

N = 28

20.0%

27.0%

AKI is Lower in Normal EF HRPCI Patients Supported with

Impella Compared to Unspupported PCI

No Support Impella

Predicted AKI Rate(Mehran Risk Score)

p= 0.1432.0%

8.0%

Incidence of AKI

p= 0.03

No Support Impella

Westenfeld R et al., ESC 2018

N = 50

Absolute RR

- 24%

NNT

- 4.2 pt

to prevent 1 AKI event

6.7%8.23%

5.79%

All

Impella

Impella

2.5

Impella

CP

cVAD Study5

32.0%

8.0%

27.8%

5.2%

Summary of AKI Data with Impella Unloading

p= 0.001

No Support Impella

2.5

55.0%

12.0%

p= 0.03

ECMO Impella

CP

Flaherty et al.1 Westenfeld et al.3,5

p= 0.001

No Support Impella

CP

Westenfeld et al.2

N=115 N=115 N=25 N=25 N=11 N=17 N=223 N=85 N=138

1. Flaherty MP, et al. Circ Res. 20:692-700 2017

2. Westenfeld R et al., ESC 2018

3. Westenfeld R et al., ACURE 2017

4. Wiora J, et al. Submitted to EuroInterventions.TCT 2018

5. Unpublished cVAD Study data, 2018


Our baseline Creatinine

1.26 mg/dL control

1.29 mg/dL Impella

Predictors for CIN

-age 75 years

-Hypotension,

-CHF (class III-IV)

-Anemia

-Diabetes

-Likelihood of high

contrast volume

-Consider use of

IABP

CKD III-V

Renal Protection

Risk Score 14-26% risk of AKI

Our pt had a risk score 14

and a 1 yr, Mortality risk of 14%

Reduce mortality, morbidity and costs

Cath PCI registry-based study of ~1 million pts • AKI associated with

– 10% in-hospital mortality

– AMI rates of 4%

– Major bleeding 6%

• AKI-HD associated with

– 34% in-hospital mortality

– AMI rates of 8%

– Major bleeding 16%

LOS significantly lower in Impella arm (3.5 vs 5.7 days)

We can better predict which pts will benefit from AKI risk reduction and, in the process, improve in-hospital AMI, mortality and bleeding rates and decrease LOS.


Tsai TT. JACC : Cardiovasc Interventions. 2014;7:1-9

Fox CS. Circulation. 2012;125:497-504


Risk stratification

• Apply the Mehran CIN risk predicting (or AKI-predicting) scheme to each of

our patients and compare their predicted risk for AKI with those that

developed AKI.

Determine the level of protection against AKI observed with Impella.

Can we then support the use of Impella as renal protection in these patients

at high risk for AKI?

Mortality

• Is there a true AKI risk reduction associated with the use of Impella during

high contrast requiring or lengthy PCI? Does this translate into a mortality

benefit and a reduction in LOS and would this improve overall cost-

effectiveness?


Thank You

2626

IMPELLA® DEVICE INDICATION & SAFETY INFO.INDICATIONS FOR USE

High-Risk PCI

The Impella 2.5®, Impella CP® and Impella CP® with SmartAssist™ Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during

high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a

heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5, Impella CP, and Impella CP with

SmartAssist Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur

during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Cardiogenic Shock

The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist™, Impella 5.0® and Impella LD® Catheters, in conjunction with the Automated Impella® Controller

(collectively, "Impella® System Therapy"), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5, Impella CP, and the

Impella CP with SmartAssist, and ≤ 6 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately

(< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a

result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use

of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary

to allow heart recovery and early assessment of residual myocardial function.

Important Risk Information for Impella devices

CONTRAINDICATIONS

The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD are contraindicated for use with patients experiencing any of the following

conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an

orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding

placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including

post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade*

* This condition is a contraindication for the cardiogenic shock indication only.

POTENTIAL ADVERSE EVENTS

Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction,

Renal failure, Thrombocytopenia and Vascular injury

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices.

Visit http://www.abiomed.com/important-safety-information to learn more.

IMP-408

http://www.abiomed.com/important-safety-information

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