R EF P S - Abiomed

JASON WOLLMUTH, MD

SINGLE ACCESS

RESTORE EF PROSPECTIVE STUDY

FOR INVESTORS ONLY

CASE PRESENTATION

• 74 yo female referred for MV PCI

• Recent admit OSH acute respiratory

failure, elevated troponin 3 months

• LVEF 30%, MV CAD at cath

• Severe PAD – prior RCIA stent, R CEA

• At diagnostic cath, occluded left

subclavian, 60 mm Hg gradient

brachiocephalic. Access LCFA

• Surgical turndown, severe COPD and

PVD

2

CASE PRESENTATION

• CTA prior transfer

– Occluded RCIA, REIA

– Occluded left CFA

• Plan

– Left CFA single access with

Impella® assisted MV PCI

– Back up – Facilitated right

axillary single access vs.

CFA/transcarotid

cutdown/single access

3

SUMMARY OF SAFETY DATA BY DEVICES*

Impella®

IABP

* Impella® data is derived from 7 FDA studies and 5 post-approval studies. PROTECT II FDA Randomized Controlled Trial compared adverse events directly to IABP. There are no

independent FDA IDE studies for ECMO and IABP. Impella® is the only FDA approved device for High-Risk PCI and Cardiogenic Shock.

1. PROTECT II Study, Data on File

2. U.S. Impella Study, 2010-2011

3. Kapur, et al. Circulation, STEMI-DTU Pilot Study, 2019

4. Patel et al, CRISP AMI Supplementary Material, JAMA, 20111.9% 4.3%1.4% 4.0%8.6%

2.4% 1.9%0.9% 2.0% 4.2%STROKE

VASCULAR

COMPLICATIONS

MAJOR

BLEEDING

4.4% 3.1%

14.3%

5.7% 6.0%10.1%

40.8%

HIGH-RISK PCI STEMI CARDIOGENIC SHOCK

11

4

14.3% 16.9%4

43

3

3

1 1

1 2

5

5

5

6

7

7

8,9

8

8

13% - 20%

2% - 8%

1.9% 4.3%1.4% 4.0%8.6%

2.4% 1.9%0.9% 2.0% 4.2%STROKE

VASCULAR

COMPLICATIONS

MAJOR

BLEEDING

4.4% 3.1%

14.3%

5.7% 6.0%10.1%

40.8%


11

4

14.3% 16.9%4

43

3

3

1 1

1 2

5

5

5

6

7

7

8,9

8

8

13% - 20%

2% - 8%

1.9% 4.3%1.4% 4.0%8.6%

2.4% 1.9%0.9% 2.0% 4.2%STROKE

VASCULAR

COMPLICATIONS

MAJOR

BLEEDING

4.4% 3.1%

14.3%

5.7% 6.0%10.1%

40.8%


11

4

14.3% 16.9%4

43

3

3

1 1

1 2

5

5

5

6

7

7

8,9

8

8

13% - 20%

2% - 8%

1.9% 4.3%1.4% 4.0%8.6%

2.4% 1.9%0.9% 2.0% 4.2%STROKE

VASCULAR

COMPLICATIONS

MAJOR

BLEEDING

4.4% 3.1%

14.3%

5.7% 6.0%10.1%

40.8%


11

4

14.3% 16.9%4

43

3

3

1 1

1 2

5

5

5

6

7

7

8,9

8

8

13% - 20%

2% - 8%

1.9% 4.3%1.4% 4.0%8.6%

2.4% 1.9%0.9% 2.0% 4.2%STROKE

VASCULAR

COMPLICATIONS

MAJOR

BLEEDING

4.4% 3.1%

14.3%

5.7% 6.0%10.1%

40.8%


11

4

14.3% 16.9%4

43

3

3

1 1

1 2

5

5

5

6

7

7

8,9

8

8

13% - 20%

2% - 8%

1.9% 4.3%1.4% 4.0%8.6%

2.4% 1.9%0.9% 2.0% 4.2%STROKE

VASCULAR

COMPLICATIONS

MAJOR

BLEEDING

4.4% 3.1%

14.3%

5.7% 6.0%10.1%

40.8%


11

4

14.3% 16.9%4

43

3

3

1 1

1 2

5

5

5

6

7

7

8,9

8

8

13% - 20%

2% - 8%

1.9% 4.3%1.4% 4.0%8.6%

2.4% 1.9%0.9% 2.0% 4.2%STROKE

VASCULAR

COMPLICATIONS

MAJOR

BLEEDING

4.4% 3.1%

14.3%

5.7% 6.0%10.1%

40.8%


11

4

14.3% 16.9%4

43

3

3

1 1

1 2

5

5

5

6

7

7

8,9

8

8

13% - 20%

2% - 8%

1.9% 4.3%1.4% 4.0%8.6%

2.4% 1.9%0.9% 2.0% 4.2%STROKE

VASCULAR

COMPLICATIONS

MAJOR

BLEEDING

4.4% 3.1%

14.3%

5.7% 6.0%10.1%

40.8%


11

4

14.3% 16.9%4

43

3

3

1 1

1 2

5

5

5

6

7

7

8,9

8

8

13% - 20%

2% - 8%

1.9% 4.3%1.4% 4.0%8.6%

2.4% 1.9%0.9% 2.0% 4.2%STROKE

VASCULAR

COMPLICATIONS

MAJOR

BLEEDING

4.4% 3.1%

14.3%

5.7% 6.0%10.1%

40.8%


11

4

14.3% 16.9%4

43

3

3

1 1

1 2

5

5

5

6

7

7

8,9

8

8

13% - 20%

2% - 8%

2.4%1

1.9%4

7

SINGLE ACCESS TECHNIQUE

• Access gained through

diaphragm of Impella® sheath

• Allows placement of 0.035 wire

• Once wire in place, sheath can

be advanced through the

Impella® sheath diaphragm

without pre-dilation

Access site

8

SINGLE ACCESS TECHNIQUE9

SINGLE ACCESS TECHNIQUEA NOVEL TECHNIQUE FOR PLACING SHEATH/GUIDE FOR PCI THROUGH IMPELLA® SHEATH

FOR PROTECTED PCI

10

LVEF IMPROVEMENT DEMONSTRATED IN IMPELLA® SUPPORTED

HIGH-RISK PCI

11

Baseline Follow-up

LVEF at 180 days

p < 0.001

31±9

39±9

+26%

p<0.0001

30±15

35±15

+17%

Baseline At Discharge

p<0.001

27±9

33±11

LVEF at 90 days

+22%

Baseline Follow-up

1. Maini et al,.Catheter Cardiovasc Interv. 2012 Nov 1;80(5):717-25.

2. Dixon SR et al. JACC Cardiovasc Inter. 2009 Feb;2(2):91-6

LVEF at Discharge

Roma-Verona Registry4

(n=79)

PROTECT II RCT STUDY3

(n=156)

U.S. Impella Registry1

(n=175)

P=0.003

26±6

34±11

LVEF at 30 days

+31%

Baseline Follow-up

PROTECT I Prospective STUDY2

(n=20)

3. O’Neill et al. Circulation. 2012 Oct. 2:126(14):1717-27. Impella Arm

4. Burzotta et al. Long-Term Outcomes of Extent of Revascularization in Complex High Risk Indicated Patients JIC. 2019

7%

44%31%

30%45%

18%

17%8%

NYHA CLASS IMPROVEMENT IN QUALITY OF LIFE POST

IMPELLA® SUPPORTED HIGH-RISK PCI

Class I

Class II

Class III

Class IV

p<0.001

Baseline 90 days

O’Neill WW et al. Circulation. 2012 Oct 2:126(14):1717-27

58% Reduction

in Class III, IV

FDA Approved Randomized Controlled

Trial Protect II, N=223

12

RESTORE EF STUDY DESIGNED TO VALIDATE BEST PRACTICES: COMPLETE REVASCULARIZATION IN A SINGLE SETTING, AKI RISK REDUCTION,

ATHERECTOMY, AND LARGE BORE ACCESS TECHNIQUES

• Design

– Multi-center, single-arm, prospective clinical study

– Patients post Impella® supported high-risk PCI

– Up to 30 centers, ongoing enrollment >500 patients

• Primary Endpoint

– LVEF at 90-day follow-up (60-180 window)

– Excludes cardiogenic shock, active STEMI

– Additional subgroup analysis based on LVEF baseline, vessel treatment, viability

testing

13

Physician Institution

Jon Robken Genesis

Joel Carver Washington Regional

Michael Green Northwest Springdale

Hursh Naik St Joseph Phoenix

Thomas Waggoner Pima

Thom Dahle St Cloud

Nathan Valin Advent Health Daytona

Aditya Bharadwaj Loma Linda

Michael Flaherty Baptist

D. Lynn Morris ECU/Vidant

James Park Presbyterian Dallas

Louis Salvaggio Lafayette GMC

Jeff Chambers Mercy Coon Rapids

Timothy Smith Christ Cincinnati

Robert Salazar Kingwood Medical Center

Matthew Whitbeck Mercy Coon Rapids

Mitul Patel UCSD

Ehtisham Mahmud UCSD

Jason Wollmuth Providence St Vincent

Craig Thompson NYU Langone

Justin Levisay Northshore Evanston

Mark Ricciardi Northshore Evanston

The Restore EF includes 22 investigators

at 19 US Hospitals

Study Characteristics

• Study of operators active in the lab

• IRB approved, Informed consent waiver

• Electronic data capturing system

• Personal information not collected

• Data is not monitored

• Enrollment target > 500 subjects

• Number of operators up to 30

RESTORE EF PI OPERATORS | INSTITUTIONS | STUDY

CHARACTERISTICS

14

IMPELLA® SUPPORTED HIGH-RISK PCI 90-DAY LVEF AT FOLLOW-UP

(EF<50 SUBGROUP)

30 [20 35]

45 [31 55]

N=36N=36

Pre-PCI LVEF Follow-up LVEF

LVEFP<0.0001

As of 03/03/2020Follow-up period:

Mean±SD = 104±31 days

Median (Q1 Q3) = 96 [ 82 128] days

1515

2320

25

3025 25

20

30

40

35

65

34

45

60

40

55

42

37

50

45

55

Pre-Impella LVEF Follow-up LVEF

N=36

LVEFP<0.0001

®

15

HEART FAILURE SYMPTOMS IMPROVEMENT AT FOLLOW-UP

NYHA Heart Failure Classification

Follow-up period:


Median (IQR) = 101 [64 146] days 15%

35%5%

35%

45%

30%35%

0%

Baseline Follow-up

Class IV

Class III

Class II

Class I

63% Reduction

In NYHA Class III, IV

N=20

p<0.001

16

ANGINA SYMPTOMS IMPROVEMENT AT FOLLOW-UP

13%

47%

0%

30%

4%

20%

30%

3%

53%

0%

Baseline Follow-up

Class IV

Class III

Class II

Class I

Class 0

96% Reduction

In CCS Angina Class

III,IV

N=30

p<0.0001

CCS Angina Classification

Follow-up period:


Median (IQR) = 80 [33 119] days

17

CONCLUSION

• Single access is a new, efficient technique; limits need for secondary

access site and subsequent risk of complications

• Complete revascularization in a single setting improves patient’s quality

of life due to improvement in LVEF

• Restore EF is an innovative study designed to validate best practices in

high-risk PCI; precursor to Protect IV

18

R EF P S - Abiomed

Documents

Transcript of R EF P S - Abiomed