Trials Flashcards

Provides a review of key studies, inclusion criteria and findings. Currently not weighted in the CCDS exam; however is foundational to understanding how indications and therapy selections are informed.

1
Q

Which trial concluded the following?

‘ICD therapy incur a 30% reduction in mortality vs’ Amiodarone alone’.

A

The AVID trial.

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2
Q

What did AVID, CASH and CIDS investigate?

A

ICD therapy as a way to reduce mortality.

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3
Q

What percentage of AVID, CASH and CIDS patients had CAD?

A

73-83%.

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4
Q

ICD is preferred treatment therapy for what 6 secondary prevention diseased states?

A
  1. CAD / MI
  2. Non ischaemic DCM
  3. HCM
  4. ARVC
  5. Genetic arrhythmia (brugada, CPVT)
  6. Syncope with inducible VF in lab
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5
Q

MADIT I found what % relative risk reduction with ICD therapy?

A

Relative risk reduction of 54%.

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6
Q

List the 4 MADIT I inclusion criteria.

A
  1. Prior MI
  2. NSVT
  3. Inducible VT
  4. EF <35%
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7
Q

True / False

MUSTT highlighted AAD was as effective as ICD therapy

A

False - ICD pts had a 75% relative risk reduction compared to AAD therapy

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8
Q

List the 4 MUSTT inclusion criteria.

A
  1. Prior MI
  2. NSVT
  3. Inducible VT
  4. EF <40%
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9
Q

What % relative risk reduction for the ICD group did MADIT II conclude?

A

31% relative risk reduction in ICD group.

Mortality = 20% in medical control group vs. 14.2% in ICD group.

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10
Q

SCD-HeFT concluded what, with respect to relative risk reduction and Amiodarone?

A
  1. Mortality relative risk reduction of 23% for ICD group
  2. Amiodarone has no effect on survival
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11
Q

On average what is the net risk reduction in mortality with ICD theapy?

A

20-30%.

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12
Q

Which two trials failed to show improved survival with ICD therapy?

A
  1. CABG-Patch
  2. DINAMIT
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13
Q

Which study found the following with respect to mortality?

‘6.2% absolute & 35% relative risk reduction with ICD implantation for DCM’.

A

The DEFINITE study.

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14
Q

List the 4 inclusion criteria for the DEFINITE study.

A
  1. Non ichaemic cardiomyopathy
  2. NYHA 1, 2 or 3
  3. LVEF <35%
  4. >10 PVCs/Hr
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15
Q

List the 3 inclusion criteria for the COMPANION study.

A
  1. NYHA 3 or 4
  2. DCM
  3. QRS >120ms
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16
Q

COMPANION concluded CRT-D reduced all cause mortality by ____% vs. drugs alone.

A

CRT-D reduced all cause mortality by 36% vs. drugs alone.

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17
Q

What percentage of children with non compacted LV demonstrate arrhythmia?

A

40%.

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18
Q

Yes / No

Is secondary prevention ICD therapy justified for short QT and idiopathic VF?

A

Yes.

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19
Q

True / False

ICD therapy is indicated in patients with life expectancy <12m and class IV symptoms.

A

False.

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20
Q

True / False

QRS duration and Dyssynchrony are strong predictors of worsening HF.

A

True.

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21
Q

True / False

CRT therapy is shown to reduce hospitalisations by 50%.

A

False - Hospitalisations = 30% decrease.

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22
Q

True / False

The COMPANION study highlighted significant differeces between CRT-D vs. CRT-P with respect to mortaility outcome.

A

False - The study data was inconclusive.

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23
Q

What % reduction of mortality did the CARE-HF study find?

A

36% death rate reduction vs. medication alone.

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24
Q

Most CRT studies highlight response is best in patients with QRS duration > ____ms.

A

150ms.

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25
Q

True / False

Most studies highlight QRS <150ms is a risk factor for failure to respond to CRT.

A

True.

26
Q

According to MADIT CRT, is an apical RV lead position preferable or to be avoided?

A

Avoided - RV Apical lead position worsened HF symptoms.

27
Q

The DAVID trial found >____% RV pacing worsened HF symptoms.

A

>40% RV pacing worsened HF symptoms.

28
Q

The MADIT II found >_____% RV pacing worsened HF symptoms.

A

> 50% RV pacing worsened HR symptoms.

29
Q

Which gender shows greater success with CRT-D?

A

Women.

30
Q

True / False

The RAFT study found ICD therapy was preferable to CRT therapy.

A

False - Mortality was 33% in CRT group vs. 40% in ICD group.

31
Q

What are the 3 inclusion criteria for RAFT?

A
  1. QRS >120ms
  2. NYHA 2 or 3
  3. LVEF <30%
32
Q

What are the 3 inclusion criteria for REVERSE?

A
  1. NYHA 1 or 2
  2. LVEF <40%
  3. QRS >120ms
33
Q

Across CRT trials, what is the average % reduction in mortality offered by CRT therapy?

A

35% reduction in mortality.

34
Q

True / False

CRT improves mortality only for those at NYHA 2 and above.

A

True - No improvement observed in NYHA I patients.

35
Q

What is the waiting period for implantation of an ICD post myocardial infarction?

A

3 months with optimal therapy or 40 days if no PCI performed.

36
Q

Which study concluded pacing therapy should not be considered 1st line for patients with neurosyncope?

A

VPS-II.

37
Q

Which study concluded the following?

‘RV pacing (vs BiV) resulted in reduced EF and larger systolic volumes’.

A

BLOCK HF.

38
Q

List the 3 inclusion criteria of BLOCK HF.

A
  1. AV block requiring ventricular pacing
  2. Mild/Moderate LV dysfunction (EF<50%)
  3. NYHA 1, 2 or 3
39
Q

True / False

There is an absence of data to show DDDR > DDD.

A

True - Never program rate response unless strong clinical need.

Rate response promotes RV pacing = worsening HF.

40
Q

True / False

Shocked VT associated with 32% increased risk of mortality vs. ATP alone.

A

True.

41
Q

Which study found the following?

‘Prolonged detection 30/40 beats = lower 1yr risk of shocks (17% to 9%), lower morbidity and doesn’t increase adverse sequelae’.

A

The PREPARE study.

42
Q

Building on PREPARE findings, which study found long detection equates to 81% reduction of ICD interventions?

A

RELEVANT.

Long detection = Less ICD intervention = Less hospitalisations.

43
Q

MADIT RIT concluded prolonged detection results in a _____% risk reduction of first occurrence of inappropriate therapy.

A

76%.

44
Q

What were the 3 arms of MADIT RIT?

A
  1. Conventional - VF 1sec // VT 2.5sec
  2. High rate cut off VF>200
  3. Delayed therapy 170-199=60sec // 200-249=12sec // >250=2.5sec
45
Q

Which 5 landmark trials investigated prolonged ICD detection?

A
  1. PREPARE
  2. RELEVANT
  3. MADIT-RIT
  4. PROVIDE
  5. ADVANCE III
46
Q

PROVIDE found that extended beat detection resulted in a ____% reduction in 2yr shock rate.

A

36%.

47
Q

True / False

Extended detection (30/40) doesn’t negatively impact the rate of syncopal events.

A

True.

Evidenced by REPARE // RELEVANT // MADIT RIT // ADVANCE III.

48
Q

What did ADVANCE III include that PREPARE, RELEVANT, MADIT RIT & PROVIDE did not?

A

ADVANCE III = Primary and Secondary prevention.

All others investigated Primary Prevention only.

49
Q

Meta-analysis of all delayed detection ICD studies found that inappropriate shocks were reduced by ____%.

A

50% reduction in inappropriate shocks.

50
Q

True / False

The PAINFREE RX II trial found a 40% relative risk shock reduction.

A

False.

PAINFREE RX II found a 71% relative risk shock reduction.

51
Q

True / False

According to EMPIRIC, physician tailored therapies are more successful than standardised therapies.

A

False.

Standardised VT, VF & ATP therapies > Physician Tailored.

52
Q

True / False

The ADVANCE-D trial found 8 ATP pulses are optimal.

A

True.

8 pulse ATP train is just as effective as 15 pulses.

53
Q

Which study concluded the following?

‘88% coupling BURST is more effective than 91% coupling RAMP’.

A

PITAGORA ICD.

54
Q

Which study concluded the following?

‘HF hospitalisation increase by 20% for every 10% increase in RV pacing up to 40%’.

A

MOST.

HF hospitalisation increased 20% for every 10% increase in RV pacing. Beyond 40% RV pacing there is no statistically significant increase.

55
Q

Which study concluded the following?

‘DFT testing doesn’t improve shock efficacy or reduce incidence of arrhythmic death’.

A

SIMPLE.

(8% vs 7% primary outcome).

56
Q

What was the patient LVEF % range across AVID, CASH and CIDS trails?

A

LVEF = 32-45%.

57
Q

True / False

CRT Therapy demonstrates a mortality rate benefit of 24-36% in suitable patients.

A

True.

58
Q

Which study concluded the following?

‘BiVp = 26% reduction in combined end point mortality’.

A

BLOCK HF.

59
Q

Meta-analysis of all delayed detection ICD studies found that risk of death and all cause mortality were reduced by ____%

A

30% reduction in risk of death and all cause mortality.

60
Q

Which study concluded the following?

‘RV pacing >40% = 2.5x greater risk of hospitalisation vs. RV pacing <40%’.

A

MOST.

61
Q

Which study proved the ‘Bear Dropping Theory’?

A

CAST.

62
Q

Anti arrhythmic suppression of frequent PVCs >10/hr was dangerous and is called what theory?

A

Bear Dropping Theory.