Mechanical Circulatory Support Flashcards

1
Q

REMATCH Trial - primary endpoint and result

A

Survival at 1yr

50% - HeartMate XVE

25% - Control

Survival at 2yrs

20% - HeartMate XVE (Impacted by device failure/complications)

10% - Control

(NEJM 2001)

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2
Q

Trial demonstrating feasibility and safety of Continuous Flow vs. Pulsatile Flow devices

A

HeartMate II BTT/DT Trial (NEJM 2009/ATS 2006)

Compared HeartMate VE (continuous) vs. HeartMate XVE (pulsatile)

BTT

Primary Endpoint: 2-year Composite ⇒ 45% vs. 10%

  1. Death
  2. Disabling Stroke
  3. Reop for Device Failure

DT

HeartMate VE improved

  1. Adverse Event Profile (device malfunction)
  2. Hospital Readmission
  3. Functional capacity
  4. Survival
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3
Q

ENDURANCE Trial Primary Endpoint and Results

A

(NEJM 2017) RCT

HeartWare vs. HeartMate II

Primary Endpoint: 2-year Composite ⇒ 55% vs. 60% non-inferior

  1. Death
  2. Disabling Stroke
  3. Reop for Device Failure

HeartWare ⇒ more device failure

HeartMate II ⇒ more strokes

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4
Q

Momentum III Trial Primary Endpoint and Results

A

(NEJM 2016) RCT

HeartMate III vs. II

Primary Endpoint: 6-month Composite ⇒ 85% vs. 75%

  1. Death
  2. Disabling Stroke
  3. Reop for Device Failure

HeartMate III ⇒ less pump failure

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5
Q
A
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6
Q

Pulsatile vs. Continuous Flow Device - Adverse Event Profile

A

Table

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7
Q

Temporary MCS Devices

A

IABP

ECMO

Impella (2.5/5.0/CP/RP)

CentriMag

TandemHeart (pVAD)

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8
Q

Compare/Contrast the ACC/AHA vs. NYHA Classifications of CHF

A

Table

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9
Q

What does INTERMACS stand for?

A

Inter-Agency Registry for Mechanically Assisted Circulatory Support

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10
Q

INTERMACS Classification System

A

1) “Crash and Burn” - persistent HoTN despite increasing inotropes; MSOF; increasing lactate, worsening acidosis

2) “Sliding on Inotropes” - worsening renal function, nutritional delpetion, refractory volume overload

3) “Dependant Stability” - stable BP, oragn function and nutritional status but unable to wean inotropes

4) “Frequent Flyer” - recurrent episodes of volume overload and hospital readmissions

5) “Housebound” - NYHA IV; fatigues with ADLs

6) “Walking Wounded” - comfortable at rest but fatigues with exertion

7) “Placeholder” - Advanced NYHA III

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11
Q

Contraindications to Longterm MCS Device Implantation

A

Irreversible End Organ Dysfunction

Severe Hemodynamic Instability

Profound Coagulopathy

Complex Congenital Abnormalities

Restrictive Cardiac Disease (small LV dimensions)

Questionable Neurological Status

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12
Q

HeartMate II Multivariate Risk Score (HMRS)

A

Predicts 90-day postoperative mortality

Variables:

  1. Age
  2. Albumin
  3. Creatinine
  4. INR
  5. Implanting Center Volume

Low Risk < 1.5 ⇒ 5%

Medium Risk 1.5-2.5 ⇒ 15%

High Risk > 2.5 ⇒ 30%

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13
Q

MELD vs. MELD-XI vs. MELD-Na Scores

A

MELD

  1. Bilirubin
  2. Creatinine
  3. INR

MELD-XI (anticoagulation compatible)

  1. Bilirubin
  2. Creatinine

MELD-Na

  1. Bilirubin
  2. Creatinine
  3. INR
  4. Sodium
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14
Q

Cardiac lesions that should be addressed at the time of longterm VAD implantation

A

Moderate to severe AI

PFO/ASD

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15
Q

How do you deal with AI at the time of LVAD inplantation?

A
  1. Park Stich
  2. Bicuspidize
  3. Oversew the Valve
  4. Bioprosthesis
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16
Q

Causes of Acquired AI with LVAD

A
  1. Elevated Sheer Stress
  2. Elevated Transvalvular Gradient
  3. Decreased AoV Opening
  4. Abnormal AoV Biomechanics
17
Q

Guidelines for when to address AI, PFO, MS and TR at the time of LVAD Impantation

A

Class I

Presence of PFO ⇒ Close

AI > mild ⇒ Park Stitch, Oversew, BioAVR

MS > mild ⇒ Repair or BioMVR

Class IIa

TR > mild ⇒ Repair

MR reasonable to repair if bridge to recovery

18
Q

Risk Factors for RHF after LVAD Implantation

A
  1. Preop Mechanical Ventilation
  2. Increased CVP
  3. Increased CVP/PCWP
  4. Decreased RV Stroke Work Index
  5. RV Dysfunction
  6. TR
  7. Elevated WBC
  8. Elevated BUN
19
Q

Echocardiographic Predictors of RHF after LVAD

A
  1. Reduced free-wall strain
  2. RV/LV diameter ratios
  3. TR severity
  4. RVEF
20
Q

Which devices are currently FDA approved for…

Bridge-to-Transplant?

Destination Therapy?

A

Bridge-to-Transplant:

  1. HeartMate II
  2. HeartMate III
  3. Heartware (HVAD)
  4. SynCardia TAH

Destination Therapy

  1. HeartMate II
21
Q

Factors Required to meet Indication for Destination Therapy

A
  1. Not a Transplant Candidate
  2. Refractory HF despite OMT
    1. ​NYHA III-IV
    2. Frequent Flyer
    3. Diruetic Dependant
    4. VO2 < 14mL/kg/min
  3. Life Expectancy > 2-years
  4. No Irreversable End Organ Damage
  5. No Hx of Non-Compliance or Psychosocial Limitations
22
Q

Durable (Longterm) MCS Devices

A
  1. HeartMate II
  2. HeartMate III
  3. HeartWare (HVAD)
  4. SynCardia TAH (pulsitile)
23
Q

TEE Parameters used to adjust LVAD speed intraoperatively

A
  1. Chamber Size
  2. Interventricular Septum Position
  3. Degree of MR
  4. RV Function
  5. Aortic Valve Opening
24
Q

Direct and Calculated VAD Parameters

A

Direct

  1. Speed (rpm)
  2. Power expenditure (watts)

Calculated

  1. Flow (L/min)
  2. Pulsitility Index (HeartMate II only)
25
Q

Causes of Increased Velocity at the Inflow Cannula

A
  1. Suction Event (hypovolemia or inadequate preload)
  2. Poor Cannula Placement (spetum or trabeculae)
  3. Pump Thrombosis
26
Q

Standardized Markers of RV Dysfunction following LVAD

A
  1. Inability to wean from CPB
  2. MAP < 55mmHg
  3. CVP > 16mmHg
  4. SvO2 < 55%
  5. LV Flow Rate Index < 2L/min/m2
  6. Significant Inotrope Dependence
27
Q

Management of RHF after LVAD Implantation

A
  1. Inotropes (Milrinone, Dobutamine, Isoproterenol, Epinephrine)
  2. Diuresis
  3. Sinus Rhythm
  4. Redeuce PVR (Inhaled NO)
  5. RVAD
28
Q

ISHLT Guidelines for Anticoagulation with Durable VAD Therapy

A

POD #1

  1. IV Heparin

POD #3

  1. Aspirin
  2. Warfarin (INR 2-3)
29
Q

Surivival following LVAD Implantation

A

30-day Survival - 90%

1-year Survival - 85%

(HeartWare ADVANCE Trial and INTERMACS Registry)

30
Q

Risk Factors Predicting Poor Survival After LVAD Implantation

A
  1. INTERMACS 1 or 2
  2. Renal Dysfunction
  3. Age > 70
  4. RV Dysfunction
  5. Need for BiVAD
  6. Increased Surgical Complexity
31
Q

LVAD vs. Rx pre-Transplant Mortality and QOL

A

30-day, 1 and 2-year Survival is Statistically equivalent

30-day Survival - 95%

1-year Survival - 80%

2-year Survival - 70%

QOL improves with LVAD while awaiting transplant

32
Q

Adverse Event Rates of LVAD Therapy

A
  1. Bleeding (Reop for bleeding 30% with >50% requiring blood products; GI bleeding rates 20-30% )
  2. Device Malfunction
  3. Renal Failure (15-30%)
  4. Infection (10-20% driveline infections by 1-year)
  5. Stroke (10/20% at 1-/2-years - ischemic = hemorrhagic)
  6. Death

30-days - 40%

1-year - 70%

2-years - 80%

3-years - 85%

33
Q

Proposed causes of increased GI bleeding with CF VADs

A
  1. Acquired von Willebrand Syndrome
  2. AVM Formation (Non-Pulsitile flow)
  3. Anticoagulation
34
Q

Suspected vs. Confirmed Pump Thrombosis

A

Suspected

  1. Hemolysis (Serum-free hemoglobin >40mg/dL or LDH >600IU/L)
  2. Unexplained CHF Symptoms
  3. Abnormal Pump Parameters

Confirmed

  1. Direct Inspection
  2. Radiographic Imaging
35
Q

Histologic and Hormonal Features of Reverse Remodeling for BTR

A

Histologic

  1. Decreased Collagen/Fibrosis
  2. Decreased MMP Activity
  3. Decreased Myocardial Apoptosis
  4. Decreased Myocardial Hypertrophy/Myofibrillar Disarray
  5. Increased SR Calcium

Hormonal

  1. Decreased Sympathetic Tone
  2. Decreased BNP
  3. Decreased RAAS
  4. Decreased ET-1
  5. Decreased Infalmmatory Cytokines (IL-6, IL-8, TNFa)