Mechanical Circulatory Support Flashcards
REMATCH Trial - primary endpoint and result
Survival at 1yr
50% - HeartMate XVE
25% - Control
Survival at 2yrs
20% - HeartMate XVE (Impacted by device failure/complications)
10% - Control
(NEJM 2001)
Trial demonstrating feasibility and safety of Continuous Flow vs. Pulsatile Flow devices
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%
- Death
- Disabling Stroke
- Reop for Device Failure
DT
HeartMate VE improved
- Adverse Event Profile (device malfunction)
- Hospital Readmission
- Functional capacity
- Survival
ENDURANCE Trial Primary Endpoint and Results
(NEJM 2017) RCT
HeartWare vs. HeartMate II
Primary Endpoint: 2-year Composite ⇒ 55% vs. 60% non-inferior
- Death
- Disabling Stroke
- Reop for Device Failure
HeartWare ⇒ more device failure
HeartMate II ⇒ more strokes
Momentum III Trial Primary Endpoint and Results
(NEJM 2016) RCT
HeartMate III vs. II
Primary Endpoint: 6-month Composite ⇒ 85% vs. 75%
- Death
- Disabling Stroke
- Reop for Device Failure
HeartMate III ⇒ less pump failure
Pulsatile vs. Continuous Flow Device - Adverse Event Profile
Table
Temporary MCS Devices
IABP
ECMO
Impella (2.5/5.0/CP/RP)
CentriMag
TandemHeart (pVAD)
Compare/Contrast the ACC/AHA vs. NYHA Classifications of CHF
Table
What does INTERMACS stand for?
Inter-Agency Registry for Mechanically Assisted Circulatory Support
INTERMACS Classification System
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
Contraindications to Longterm MCS Device Implantation
Irreversible End Organ Dysfunction
Severe Hemodynamic Instability
Profound Coagulopathy
Complex Congenital Abnormalities
Restrictive Cardiac Disease (small LV dimensions)
Questionable Neurological Status
HeartMate II Multivariate Risk Score (HMRS)
Predicts 90-day postoperative mortality
Variables:
- Age
- Albumin
- Creatinine
- INR
- Implanting Center Volume
Low Risk < 1.5 ⇒ 5%
Medium Risk 1.5-2.5 ⇒ 15%
High Risk > 2.5 ⇒ 30%
MELD vs. MELD-XI vs. MELD-Na Scores
MELD
- Bilirubin
- Creatinine
- INR
MELD-XI (anticoagulation compatible)
- Bilirubin
- Creatinine
MELD-Na
- Bilirubin
- Creatinine
- INR
- Sodium
Cardiac lesions that should be addressed at the time of longterm VAD implantation
Moderate to severe AI
PFO/ASD
How do you deal with AI at the time of LVAD inplantation?
- Park Stich
- Bicuspidize
- Oversew the Valve
- Bioprosthesis
Causes of Acquired AI with LVAD
- Elevated Sheer Stress
- Elevated Transvalvular Gradient
- Decreased AoV Opening
- Abnormal AoV Biomechanics
Guidelines for when to address AI, PFO, MS and TR at the time of LVAD Impantation
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
Risk Factors for RHF after LVAD Implantation
- Preop Mechanical Ventilation
- Increased CVP
- Increased CVP/PCWP
- Decreased RV Stroke Work Index
- RV Dysfunction
- TR
- Elevated WBC
- Elevated BUN
Echocardiographic Predictors of RHF after LVAD
- Reduced free-wall strain
- RV/LV diameter ratios
- TR severity
- RVEF
Which devices are currently FDA approved for…
Bridge-to-Transplant?
Destination Therapy?
Bridge-to-Transplant:
- HeartMate II
- HeartMate III
- Heartware (HVAD)
- SynCardia TAH
Destination Therapy
- HeartMate II
Factors Required to meet Indication for Destination Therapy
- Not a Transplant Candidate
- Refractory HF despite OMT
- NYHA III-IV
- Frequent Flyer
- Diruetic Dependant
- VO2 < 14mL/kg/min
- Life Expectancy > 2-years
- No Irreversable End Organ Damage
- No Hx of Non-Compliance or Psychosocial Limitations
Durable (Longterm) MCS Devices
- HeartMate II
- HeartMate III
- HeartWare (HVAD)
- SynCardia TAH (pulsitile)
TEE Parameters used to adjust LVAD speed intraoperatively
- Chamber Size
- Interventricular Septum Position
- Degree of MR
- RV Function
- Aortic Valve Opening
Direct and Calculated VAD Parameters
Direct
- Speed (rpm)
- Power expenditure (watts)
Calculated
- Flow (L/min)
- Pulsitility Index (HeartMate II only)
Causes of Increased Velocity at the Inflow Cannula
- Suction Event (hypovolemia or inadequate preload)
- Poor Cannula Placement (spetum or trabeculae)
- Pump Thrombosis
Standardized Markers of RV Dysfunction following LVAD
- Inability to wean from CPB
- MAP < 55mmHg
- CVP > 16mmHg
- SvO2 < 55%
- LV Flow Rate Index < 2L/min/m2
- Significant Inotrope Dependence
Management of RHF after LVAD Implantation
- Inotropes (Milrinone, Dobutamine, Isoproterenol, Epinephrine)
- Diuresis
- Sinus Rhythm
- Redeuce PVR (Inhaled NO)
- RVAD
ISHLT Guidelines for Anticoagulation with Durable VAD Therapy
POD #1
- IV Heparin
POD #3
- Aspirin
- Warfarin (INR 2-3)
Surivival following LVAD Implantation
30-day Survival - 90%
1-year Survival - 85%
(HeartWare ADVANCE Trial and INTERMACS Registry)
Risk Factors Predicting Poor Survival After LVAD Implantation
- INTERMACS 1 or 2
- Renal Dysfunction
- Age > 70
- RV Dysfunction
- Need for BiVAD
- Increased Surgical Complexity
LVAD vs. Rx pre-Transplant Mortality and QOL
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
Adverse Event Rates of LVAD Therapy
- Bleeding (Reop for bleeding 30% with >50% requiring blood products; GI bleeding rates 20-30% )
- Device Malfunction
- Renal Failure (15-30%)
- Infection (10-20% driveline infections by 1-year)
- Stroke (10/20% at 1-/2-years - ischemic = hemorrhagic)
- Death
30-days - 40%
1-year - 70%
2-years - 80%
3-years - 85%
Proposed causes of increased GI bleeding with CF VADs
- Acquired von Willebrand Syndrome
- AVM Formation (Non-Pulsitile flow)
- Anticoagulation
Suspected vs. Confirmed Pump Thrombosis
Suspected
- Hemolysis (Serum-free hemoglobin >40mg/dL or LDH >600IU/L)
- Unexplained CHF Symptoms
- Abnormal Pump Parameters
Confirmed
- Direct Inspection
- Radiographic Imaging
Histologic and Hormonal Features of Reverse Remodeling for BTR
Histologic
- Decreased Collagen/Fibrosis
- Decreased MMP Activity
- Decreased Myocardial Apoptosis
- Decreased Myocardial Hypertrophy/Myofibrillar Disarray
- Increased SR Calcium
Hormonal
- Decreased Sympathetic Tone
- Decreased BNP
- Decreased RAAS
- Decreased ET-1
- Decreased Infalmmatory Cytokines (IL-6, IL-8, TNFa)