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Protected PCI > Clinical Dossier > Flashcards

Clinical Dossier Flashcards

2018

1
Q

When did impella 2.5 receive its PMA approval from the US FDA?

A

March 23rd, 2015

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2
Q

When did impella CP receive PMA approval from the US FDA for the indication of Protected PCI?

A

December 2nd, 2016

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3
Q

When did the Impella 2.5 and CP receive an expanded PMA approval for high-risk PCU with or without depressed EF?

A

February 14th, 2018

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4
Q

True or False: The Impella Heart Pumps are the only percutaneous temporary ventricular support devices that are FDA approved as safe and effective for High Risk PCI

A

True

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5
Q

List 7 examples of comorbidites

A
  1. Surgical Ineligibility
  2. Prior Cardiac Surgery
  3. Heart Failure
  4. Diabetes
  5. Advanced Age
  6. Unstable Anina/NSTEMI
  7. Renal Insufficiency
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6
Q

The clinical data demonstrating the Impella heart pumps safety and effictiveness includes > ______ Patients from an FDA- randomized, controlled trial and what?

A

1600

FDA-audited, IRB approved, multi-center registry

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7
Q

Over 200 ____ ____ _____ in the high risk PCI settings demonstrate safety and efficacy

A

Peer-reviewed publications

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8
Q

Impella 2.5 and CP maintain patient hemodynamics during planned temporary coronary occlusion by doing what?

A

Maintaining MAP, which may allow for a more through procedure and a more complete revasculariztion in a single session

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9
Q

Use of Impella device is associated with reduction of kidney injury during a:

A

High Risk PCI procedure

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10
Q

There is a 6x increased risk in _______ without the impella device

A

Dialysis

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11
Q

Clincial outcomes of the Protect II randomized controlled trial demonstrated a ________ % reduction in MACCE at 90 days

A

29%

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12
Q

______ ______ was also associated with the largest reduction of adverse events.

A

Extensive Revascularization

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13
Q

At 90 days, there is a _______ % reduction in repeat revascularization

A

52% (0.024)

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14
Q

At 90 days, there was a _______ % recused length of stay in hospital.

A

22%

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15
Q

At 90 days, there was a ____ % reduction in NYHA class of heart failure

A

58%

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16
Q

______ _____ is critical high-risk procedures are usually longer and use higher levels of contrasts, chronic kidney disease is a common comorbitity.

A

Kidney protection

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17
Q

A retrospective study showed incidence of all AKI was ____ % without Impella compared to ____ % with impella.

A
  1. 8%

5. 2%.

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18
Q

Study observation included what?

A

Few readmissions, less days in the hospital, and a better quality of life through reduced heart failure symptom after a protected PCI procedure

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19
Q

The impella 2.5 and CP directly unload the LV and propels blood forward, from the left ventricle into the aorta, in a ___________.

A

Manner consistent with normal physiology.

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20
Q

Impella heart pumps provide both _____ forward flow and _____ aortic pressure contribution.

A

Active

Systemic

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21
Q

Active forward flow and systemic aortic pressure contribution leads to an efficiency increase in ____ and overal _____

A

MAP

CPO.

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22
Q

Combined with LV unloading, Impella support reduces what and augments what?, leading to favorable alteration of the balance of myocardial oxygen supply and demand.

A

EDV & EDP

Peak coronary flow

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23
Q

When was Impella commercially used under a 510K clearance?

A

2008

24
Q

Where is the device approved?

A 
Europe 2004
Canada 2007
Latin and South America 2008-2012
China 2013
India 2017
Japan 2016
25
Q

In the US, the device has been used since _____, beginning with the Protect 1 FDA approved trial for thigh risk PCI

A

2006

26
Q

How many peer reviewed publications has impella been investigated in, making it the most studied circulatory support device on the market ?

A

400

27
Q

In 2011, ACC/AHA/SCAI PCI guidelines considered the house of hemodynamic support devices as “an adjunct to PCI to be reasonable in carefully selected high - risk patients” as a category

A

IIB )i.e., benefit > or equal to risk for high risk PCI

28
Q

How many patients have been studied support the PMA indication of impella 2.5 and CP in protected PCI ?

A

2,403

29
Q

List 5 scientific evidence sources to support PMA Applications

A 
Protect 1
Protect 2
US Impella Registry
Literature Review
CVAD registry
30
Q

What was Protect 1?

A

Prospective, single arm, multi-center feasibility study designed under FDA guidance to examine the safety and feasibility of the Impella device in patients undergoing high-risk angioplasty.

31
Q

Who could enroll?

A

Patients with an LVEF <35% and undergoing PCI to LM or last patent conduit.

32
Q

What was protect II?

A

Prospective, multi-center randomized trial comparing outcomes between impella 2.5 and IABP in patients that required hemodynamic support during elective or ugentent high risk procedures

33
Q

Beyond the goal of establish a reasonable asssurance for safety and effectiveness, the objective of the study was to do what?

A

Demonstrate that prophylactics use of Impella 2.5 is superior to the IABP in preventing peri and post procedural major adverse events (MAE) in this patient population.

34
Q

How many people the Protect II trial enroll and how many sites?

A

452 at 112 sites

35
Q

What was the primary efficacy endpoint?

A

Composite MAE at 30 days with follow up analysis at 90 days

36
Q

Who was enrolled in protect II?

A

High risk PCI on an unprotected LM or last patent conduit, with an LVEF <35% or patients who had 3 vessel disease and an LVEF < 30%. O

37
Q

Operators identified target lesions and aimed for the most complete revasculature prior to what?

A

Randomization

38
Q

What was the average STS score?

A

6 +- 6 %

39
Q

What was the average EF?

A

24 +- 6

40
Q

What percentage of patients in Protect II had prior CABG?

A

34%

41
Q

Patients discharged from the cath lab supported by a device was lower in Impella group compared to the IABP group.

A

Impella: 5.9 %
IABP: 36.7%

42
Q

What was the composite MAE event at 90 days for IABP?

A

51%

43
Q

What was the composite MAE event at 90 days for Impella?

A

40% p value = 0.023

44
Q

In 2010, the composite 90 dat MAE event rate of IABP vs Impella was what? And Why

A

Learning Curve: 36.8% vs 50.8% p = 0.104. Learning curve

45
Q

______ the amount of atherectomy was used in the Impella arm vs IABP

A

Twice

46
Q

What percent of the population received athetherectomy ?

A

12%

47
Q

Less repeat revasc procedures were observed in the Impella arm compared to the IABP at 90 days.

A

IABP: 30.8%
Impella: 4%

48
Q

What percent of the population did not receive atherectomy?

A

88%

49
Q

What were the MAE rates for both arms at 90 days in the group that did not receive atherectomy?

A

IABP: 50.5%
Impella 35.5 %
P value = 0.003

50
Q

What percent of the population had 3 vessels disease?

A

76%

51
Q

What was the composite MAE rates for both arms at 90 days in Patients with 3-vessel disease?

A

IABP:51%
Impella: 39%
P valued = 0.039

52
Q

What percent of the population had an STS score <10%?

A

83%

53
Q

What was the composite MAE at 90 days for patients with STS <10?

A

IABP: 50.6%
Impella 36.1%
P values = 0.006

54
Q

Why was an 8x ULN threshold for CKMB bump used In a post hoc analysis by DANGAS?

A

To reflect a contemporary and prognostically relevant definition of MI.

55
Q

In the Post Hoc Analysis DANGAS, ___ rates were observed

A

MACCE

56
Q

In the DANGAS, post hoc anaysis, what were the composite primary endpoint MACCE rates at 90 days for IABP vs Impella?

A

IABP: 31%
Impella: 22%
P value- 0.033

57
Q

Post-hoc analysis of the composite MACCE rates using a meaningful, contemporary definition of peri-procedural MI 8x ULN showed what?

A

P=0.042

Decrease MACCE rates at 90 days.

Protected PCI (3 decks)

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