Emergency
Actions
Suction alarm with falling flow ↓ P-level first to refill the inlet, then assess filling before fluids. Think hypovolemia · RV failure · malposition. Never ↑ P-level to chase a falling flow.
"Position Unknown / Wrong" Unknown may reflect low pulsatility or signal failure — look at the patient: MAP, A-line, flow before you touch it. Suspected migration → echo before adjustment (P.8).
Purge pressure low / "purge open" Risk of blood ingress and pump stop. Inspect purge circuit + cassette for leak/disconnect and follow the current alarm sequence urgently (P.7).
Cola-colored urine / ↑ LDH Hemolysis — urgent imaging and plasma-free Hb. Assess suction, position and thrombus. Maintain perfusion at the lowest tolerable P-level. Reposition only if indicated (P.10).
01

What Impella Does

Trans-valvular axial unloading
Mechanism
A catheter-mounted microaxial pump sits across the aortic valve: it draws blood from an inlet in the LV and expels it from an outlet in the ascending aorta. It directly unloads the LV while providing systemic flow. Other support configurations can also unload the left heart.
  • Unloads ↓ LVEDP · ↓ LVEDV · ↓ wall stress → ↓ myocardial O2 demand, ↓ LAP, less pulmonary congestion, may improve myocardial oxygen balance. Routine infarct-size reduction in stable STEMI was not demonstrated (P.14).
  • Perfuses provides LV-to-aorta flow without rhythm synchronization. The perfusion response still depends on filling, pressure load and the rest of the circulation.
  • Preload-dependent output needs a filled LV and adequate pulmonary venous return. Inadequate filling promotes suction.
  • Unmasks the RV unloading changes venous return, pulmonary pressure and septal geometry. RV reserve may limit the response (P.6, P.10).
02

vs the other tMCS

load vs unload
 IABPImpellaVA-ECMO
Flow mechanismCounterpulsation, no pump-flow lumenLV → aorta, model-dependentVenous drainage → arterial return
LV effectmild unloadunloadsloads (↑ afterload)
Oxygenatesnonoyes
TimingInflate in diastole, deflate before ejectionContinuous flowContinuous flow
RV supportnoRP / RP Flexyes
The unloading point: VA-ECMO returns blood to the aorta and raises LV afterload (distension, pulmonary edema). Impella does the opposite — it vents the LV forward. That's why an Impella is added to ECMO ("ECpella") to unload (P.10).
▦

The platform — three pumps, one console

full specs · P.11
Impella CP3.3–3.7 L/min mean
AccessPercutaneous femoral (14 Fr) retrograde across AoV · flexible pigtail
UseAMI / HF shock · high-risk PCI
Label≤4 days shock · ≤6 h PCI
Impella 5.5≤ 5.5 L/min
AccessSurgical axillary graft (or direct aortic) · no pigtail, soft tip
UseFull LV support · bridge · ambulatory
Labelup to 14 days
Impella RP / RP Flex> 4 L/min
AccessFemoral vein (RP) / IJ or femoral (RP Flex) → RA → PA
UseIsolated / predominant RV failure
Labelup to 14 days
Enlarge CP anatomy

Scroll horizontally to inspect the labels. Select again to return to the overview.

Impella CP: LV inlet, transaortic cannula and aortic outletLong-axis left-heart schematic. The inlet lies in the LV away from the mitral apparatus. The CP cannula crosses the aortic valve to an aortic outlet and motor. Its pigtail remains in the LV. Impella 5.5 has no pigtail. LALV Ascending aortaMotor + outletAortic valve Mitral valveInlet in LVCP pigtail CP · LV long-axis cutawayLV → aorta5.5: same blood route,soft tip without pigtailPosterior / LA ← → Anterior / LV outflow
Enlarge RP anatomy

Scroll horizontally to inspect the labels. Select again to return to the overview.

Impella RP: IVC inlet, RV route and PA outletRight-heart cutaway for a femoral RP. Blood enters at the IVC inlet beside the motor and travels through the cannula across the tricuspid valve, right ventricle and pulmonary valve to the PA outlet and pigtail. Venous access shaft is not a blood-return tube. RARV RP · right-heart cutawaySVCTricuspid valveIVC inletMotor PA → lungsPA outlet + tipPulmonary valve IVC → PABoth valves crossedNo gas exchange in pumpFemoral RP example · chambers selectively opened
Schematic cutaways, not to scale. Red = oxygenated blood, blue = venous blood, gold = device. Moving marks follow pump flow, not measured speed. The pump does not oxygenate blood. CP and RP shown, with model-specific variants discussed on P.5 and P.15. Anatomy informed by BodyParts3D and the Minnesota atlas.
Two separate routes on ECMO: peripheral VA return is retrograde in the aorta. Left Impella moves blood forward from LV to aorta to relieve distension. Neither route guarantees aortic-root washout. Follow valve opening, stasis and congestion (P.10).
1

Indications

shock · HR-PCI · RV failure · bridge
Cardiogenic shock (SCAI C–E)
Select by cause, LV/RV phenotype, organ injury, access risk and exit strategy. STEMI-shock benefit is trial-supported in selected patients (P.14). Pre-PCI timing associations are not randomized proof.
Protected high-risk PCI
Complex / last-patent-conduit or unprotected left-main PCI with severe LV dysfunction — elective hemodynamic support (CP / 2.5).
Isolated / predominant RV failure
Acute RV failure after LVAD, MI, transplant or open-heart surgery → consider RP / RP Flex within labeling (P.15). PE is not a labeled indication.
Bridge — name it at insertion
To recovery · decision · durable LVAD · transplant (5.5 supports up to 14 days by US label, mobilization possible).
2

Device choice — by phenotype and trajectory

shock-team decision
First define the shock phenotype. Integrate cause, trajectory, perfusion, echo and invasive hemodynamics when appropriate. CPO, PAPi and filling pressures support judgment, but no isolated value selects a device.

LV predominant

Poor LV output with adequate RV delivery and no major oxygenation failure.

Consider CP or 5.5 if expected benefit, access and labeling fit.

CP offers percutaneous support. 5.5 requires surgical access and can support an ambulatory bridge.

RV predominant

RV failure limits pulmonary flow and LV filling. Assess pulmonary vascular load and LV reserve.

Consider RP / RP Flex or another RVAD in an appropriate candidate.

RP pumps venous blood to the PA. The lungs must oxygenate it and the LV must accept it.

Both ventricles / gas exchange

Biventricular failure, severe hypoxemia or selected refractory arrest needs a broader support plan.

Consider VA-ECMO or tailored combined support through the shock team.

Assess LV distension on VA-ECMO and the need for unloading. Two pumps do not guarantee adequate support.

Before insertion → check reversibility, neurological prognosis, contraindications, vascular/valve anatomy and the exit strategy. After insertion → reassess perfusion, oxygenation, unloading and complications. Escalation follows the cause and trajectory.
3

High-risk PCI — support before you start?

heart-team assessment
Patient factors
  • LV reserve and active heart failure
  • Valve disease may increase risk or contraindicate Impella
  • Unstable rhythm despite therapy
  • Frailty, renal injury and bleeding/access risk
Procedure complexity
  • Multivessel PCI
  • PCI on the last patent conduit
  • CTO via retrograde through the last conduit
  • Large ischemic territory during planned occlusion
Hemodynamic findings
  • Elevated PCWP / LVEDP
  • Low output, perfusion and pressure reserve
  • Revascularization and surgical alternatives
  • No single factor mandates MCS. Balance procedural benefit against access and bleeding risk.
4

Contraindications — check before you cross

mostly anatomic
Left-sided (CP / 5.5)
  • LV thrombus absolute — embolic stroke on crossing.
  • Mechanical AoV absolute — can't cross the disc.
  • Significant AS (area ≤0.6 cm² by US labeling) — can't seat / valve injury.
  • ≥ moderate AI regurgitation and recirculation can undermine forward support.
  • Access severe arterial disease. Also exclude septal defect, rupture and tamponade under the applicable label.
Right-sided (RP)
  • Mechanical TV/PV can't cross.
  • RA/caval thrombus or inaccessible venous route, including an obstructing caval filter.
  • Valve / PA anatomy severe TV/PV stenosis or regurgitation, or PA wall disease preventing safe position.
Pre-insertion echo is mandatory — rule out LV thrombus, define the aortic valve, document RV function. Significant RV or combined cardiorespiratory failure is excluded by the isolated-LV shock label.
1

Before you insert — checklist

access · purge · anticoag · imaging
2

Access routes

arterial vs venous · percutaneous vs surgical
CP

Percutaneous femoral arterial

RP/RP Flex use venous routes
  • CP access US-guided femoral arterial micropuncture, single anterior-wall stick above the bifurcation. Angio to size. RP uses femoral venous access. RP Flex permits IJ or femoral venous access.
  • CP pre-close place a suture-mediated closure for the large-bore arteriotomy.
  • Cross backload over the 0.018″ wire. Retrograde across the AoV. Adjust orientation only under imaging by a trained operator. Avoid force and mitral/septal contact.
  • Seat inlet to depth (CP 3.5 cm). Slowly ramp the P-level.
5.5

Surgical axillary — 10 steps

graft conduit
1–3 expose & graftIsolate the axillary artery (vessel loops). Sew a 10 mm × 20 cm vascular graft end-to-side. Clamp & check hemostasis.
4–6 sheath & wireInsert introducer, secure with graft lock(s). Advance 0.018″ placement wire to LV. Confirm procedural anticoagulation and use the specified lubrication dilator.
7–8 place & seatBackload the catheter. Clamp the graft to avoid blood loss. Cross the AoV under fluoro. cannula bend at the annulus, inlet ~5 cm deep. Start support.
9–10 trim & secureShorten the graft. Peel the introducer. Slide & suture the blue suture hub into the graft.
3

Securement & first-hour targets

don't let it migrate
  • Fix 3-point external fixation. forward suture on the repositioning unit. preserve the angle of entry. Touhy valve locked. Remove the yellow lock pin.
  • Securement use the approved fixation system and access-specific movement precautions. Recheck external depth after movement.
  • Chart the cm marking at the catheter lock unit daily. Confirm the suture hub/anchor each shift. No alcohol on the purge sidearm.
Position
Re-confirm by echo (TEE/TTE) on ICU arrival — inlet 5 cm (5.5) / 3.5 cm (CP) (P.5).
P-level
To goal MAP 65–75, CPO >0.6. don't run < P2.
Anticoag
ACT 160–180 s per IFU or an institutional anti-Xa/aPTT protocol. Reassess q4–6h (P.7).
Limb
Pulses · Doppler · NIRS on the access limb q1–2h.
4

Axillary graft conduit & post-insertion check

5.5 access · confirm before you leave
Route through the graft
  • Conduit a 10 mm × 20 cm vascular graft is sewn end-to-side onto the axillary artery.
  • Device route graft → axillary artery → aorta → across the aortic valve, with the inlet in the LV.
  • Securement the suture hub is secured to the graft. Follow the current 5.5 IFU for graft preparation, locking and fixation.
Before leaving the OR / lab
  • cannula bend at the annulus. Inlet ~5 cm (5.5) / 3.5 cm (CP) on echo
  • signals assessed against clinical state. Purge functioning
  • yellow lock pin removed. Touhy valve locked
  • 3-point fixation + forward suture. Angle of entry preserved
  • peel-away sheath removed. Cm mark charted. Access-limb pulse documented
24/7 manufacturer clinical support for insertion, purge, anticoagulation, and alarm questions — use the current number on the device labeling or official support directory and call early, especially for heparin-delivery and positioning issues.
Read
every
round
P-level P0–P9
Pump speed → flow. Set to the hemodynamic goal, not a number. < P2 risks retrograde flow.
Flow max/min/mean
A calculated estimate, not a measured value — confirm perfusion (MAP, lactate, CPO).
Placement signal
Aortic pressure pattern supports location. Low pulsatility needs clinical and imaging correlation.
Motor current
Reflects the changing pressure load. A flat trace alone does not diagnose migration.
Purge mmHg · mL/h
Pressure & flow trend (P.7). Rising pressure suggests resistance. Falling pressure suggests leak or disconnection. Check the system.
1

The placement screen — waveforms inform position

aortic signal + motor current
  • Placement signal the pressure pattern sensed by the device. An aortic pattern supports expected position, while a ventricular pattern raises concern for deep placement. Confirm with imaging.
  • Motor current energy the motor draws across the cycle. Pulsatility can support a transvalvular pressure gradient. Flattening may reflect low native ejection, sensor problems or malposition.
  • Pattern change may reflect suction, loading, position or sensor error. Waveforms help frame the question, but do not identify the cause alone.
  • Low pulsatility ≠ migration in deep shock / full support / arrhythmia the signal flattens and the controller may alarm "Position Unknown" — confirm position rather than assuming migration or normal placement. Correlate with MAP, the A-line, flow and echo (P.8).
  • SmartAssist combines measured and derived parameters. Derived LV pressure and flow do not replace independent hemodynamics or imaging.
  • Flow is an estimate derived from current & speed — confirm perfusion clinically, especially at low P.
Controller check: interpret signals with perfusion and echo. RP/RP Flex sensor drift can corrupt flow, PA/CV signals and PAPi. Use independent hemodynamics and model-specific IFU ranges (P.15).
2

P-levels — the one knob you turn

P0 off → P9 max
P0
off
P1
min
P2
floor
P3
 
P4
 
P5
 
P6
 
P7
 
P8
support
P9
max
  • Higher = more flow each step raises speed. CP P9 mean flow is 3.3–3.7 L/min (systolic peak up to 4.3). Delivered flow varies with loading and position. Titrate to perfusion.
  • Don't go below P2 at very low speed blood can flow retrograde (aorta → LV) through the pump.
  • Going up for low MAP / rising lactate / CPO < 0.6 — but only if the LV is filled. An empty LV just suctions.
  • Coming down weaning is a stepwise P-level reduction with stability checks (P.9).
3

Suction physiology — the diastolic clue

why flow falls
A

Under-filled

Most common
  • Hypovolemia / bleeding, vasoplegia, or RV failure not delivering preload.
  • Signal diastolic suction can suggest inadequate filling, but is not specific.
  • Fix ↓ P-level, assess filling and RV function, then treat the cause.
B

Malpositioned

Inlet on a wall
  • Inlet against septum / mitral apparatus, or device too deep.
  • Signal persistent suction may suggest wall contact. Confirm with imaging.
  • Fix echo + reposition. Don't just turn the pump up.
C

Over-pumped

P too high for filling
  • Demanding more than the LV can supply → repetitive suction + hemolysis.
  • Signal suction alarms cycle. PfHb / LDH climb (P.10).
  • Fix ↓ P-level to a sustainable flow. Treat low preload.
The reflex: a suction alarm → reduce the P-level while assessing the cause to refill the inlet, then diagnose (volume · RV · position). Turning the pump up deepens suction and shreds red cells.
The placement signal can raise concern for migration. echo tells you where it is. Confirm at insertion, after every transfer, and whenever flow or the waveform changes — inlet in the LV, outlet above the valve, and measure the depth.
1

Verify proper placement — five checks

device IFU landmarks
  • Stable catheter in the mid-ventricular space, directed toward the apex.
  • Inlet free clear of the mitral subvalvular apparatus and the LV walls. Free-floating, surrounded by blood.
  • Depth annulus → mid-inlet ≈ 5 cm (Impella 5.5) · 3.5 cm (CP).
  • Outlet in the aorta well above the valve — confirm with color Doppler (outflow confined to the ascending aorta).
  • Windows TTE: parasternal long-axis · TEE: mid-esophageal long-axis. Use off-axis cuts to follow the whole catheter.
  • Every echo assess LV unloading, RV function, new MR/AR, effusion and thrombus. Use TEE if TTE is inconclusive.
2

Echo landmarks — confirm in multiple views

TTE PLAX · TEE ME-LAX
Identify the whole catheter: parallel cannula lines, the bend at the annulus, a free inlet in the LV, and outflow confined to the ascending aorta on color Doppler. Measure annulus to mid-inlet and verify against the current device IFU.
Paired parasternal long-axis echo images with Impella outlet A and color flow B in the ascending aorta above the aortic valve
Outlet above the valve. In this published PLAX example, A marks the outlet and B its aortic color-flow signal.
Paired parasternal long-axis echo images showing Impella A and outlet color flow B below the aortic valve in the LV outflow tract
Outlet too low. A marks the catheter and B the outlet flow below the valve in the LVOT. Confirm in multiple views before adjustment.
Images unchanged from Anand, Barry, Arsanjani & LeMond, Echocardiography in Cardiac Assist Devices, 2022, Figs. 8 and 10. © The Authors, CC BY 4.0. These illustrate outlet position, not a depth prescription.
3

Reading the cannula — and repositioning

find the inlet, fix the depth
A

The cannula

railroad tracks
  • Tracks two parallel echogenic lines = the cannula shaft.
  • Bend the cannula bends at the aortic annulus — a reliable landmark.
B

The inlet

teardrop
  • Teardrop the inlet area. The ends of the double lines mark it.
  • Anechoic can look black when the beam passes through inflowing blood.
  • Reverb artifact posterior to the distal cannula helps locate it.
C

Reposition

echo-guided
  • Technique trained operator, real-time imaging and device-specific instructions. No fixed-distance blind adjustment.
  • Outlet color jet confined to the ascending aorta. If at/below the valve → too deep.
  • Persistent hemolysis obtain additional views/TEE and assess suction, obstruction and thrombus (P.10).
4

Pitfalls & when to re-image

don't get fooled
  • Foreshortening an off-axis cut makes the inlet look too shallow — center the LV & AoV, follow the whole catheter.
  • Inlet at the MV a posteriorly-directed cannula bend points the inlet at the mitral apparatus → hemolysis, low/turbulent flow → reposition.
  • Anechoic inlet don't mistake the black inflow column for malposition — use the teardrop + reverberation.
Re-image whenever
  • on ICU arrival & after every transfer / proning.
  • flow falls or a waveform decouples / dampens.
  • suction alarms or a position alarm fires.
  • hemolysis (cola urine, ↑ LDH/pf-Hb) — obtain additional views if the first study is inconclusive.
  • before ambulation (5.5) — confirm the lock unit & inflow depth.
RP / RP Flex: confirm the outlet in the main PA and the inlet at the IVC/RA for femoral access or SVC/RA for IJ RP Flex access. The cannula crosses the tricuspid & pulmonic valves. Migration patterns & alarms → P.8.
1

Round every 6 h — three buckets

improving · mixed · worsening
↑

Improving

concordant
  • ↑ CO & CPO, ↓ lactate at 12 & 24 h, ↑ UOP, pressors off, adequate ramp test.
  • Path recovery → wean (P.9), explant after a successful individualized reduction trial.
~

Mixed

discordant
  • Some params improve. Mixed CPO/lactate. Pressors lowered but not off. fails ramp.
  • Path continue support · assess escalation · if no recovery → durable VAD / Tx.
↓

Worsening

concordant
  • ↓ CO & CPO, ↑ lactate, ↓ UOP, inotrope-dependent, absent pulsatility.
  • Path diagnose the cause, then consider device escalation matched to LV/RV and oxygenation needs.
2

Hemodynamic trends that inform escalation

CPO & PAPi
CPO = MAP × CO ÷ 451 PAPi = (PASP − PADP) ÷ RAP
  • CPO ≤ 0.6 W is a high-risk signal in AMI shock. Reassess perfusion and support adequacy rather than using one number to assign a device.
  • Low PAPi (e.g. < 0.9 after AMI) raises concern for RV failure. Interpret with RAP/PCWP, echo, TR/PR and trajectory. A single threshold is not a universal RV-support gate.
  • Measurement use total CO from a documented method, not pump flow alone. Controller CO/CPO depends on an entered reference CO. Re-enter per IFU, including at 8 hours or when compliance changes, and verify independently.
Read the direction of travel
Serial patternNext assessment
CPO falls, lactate risesUrgent shock-team reassessment of cause and support adequacy.
CPO improves, lactate remains highCheck ongoing ischemia, oxygen delivery, clearance and noncardiac causes.
CPO remains low, lactate clearsVerify CO measurement, vasoactive support and organ perfusion.
Both improveContinue surveillance. Weaning still requires a supervised trial.
3

Targets & the daily bundle

individualize and trend
TargetGoal
MAP65–75 mmHg
CPO> 0.6 W
PAPiTrend with RAP, PCWP and RV echo
Lactate< 2, clearing
UOP> 0.5 mL/kg/h
SvO₂> 60%
  • Console P-level · flow (max/min) · waveform trend · purge P & flow · CO / CPO / LVEDP.
  • Position chart the cm mark at the lock unit daily. Suture/anchor secure each shift. Echo if any change.
  • Labs CBC · LDH · haptoglobin · plasma-free Hb · plt · fibrinogen · Cr/lytes · lactate · ABG · ACT/anti-Xa (P.7, P.10).
  • RV & preload interpret filling pressures and RV echo together. Give fluid only for demonstrated depletion.
  • Mobility 5.5 (axillary) can ambulate — confirm lock unit secure + echo first. Femoral CP → leg immobilizer.
4

The unloading point — PV loops

Impella unloads · ECMO loads
Qualitative LV pressure-volume shiftsCurve 1 shows leftward and downward unloading with Impella. Curve 2 is the reference shock loop. Curve 3 shows increased loading with VA-ECMO. These are schematic tendencies, not patient-specific predictions. LV pressure LV volume 3 2 1
  • 1 · Impella: lower LV pressure and volume with unloading.
  • 2 · Shock: reference loop.
  • 3 · VA-ECMO: greater LV pressure and volume if afterload causes distension.
Qualitative schematic. Actual pressure-volume changes depend on loading, native function and support. Loop area ≈ stroke work. Right edge ≈ LVEDV.
Lines, labs & nursing bundle
  • q4–6 h ACT / anti-Xa · console params · suction watch.
  • q6–12 h CBC · LDH · haptoglobin · plasma-free Hb · plt · fibrinogen.
  • Trend renal function, electrolytes, lactate and hemolysis to acuity. ABG/CXR for a clinical question. Echo for position or circulatory change.
  • Each shift chart the cm mark. Confirm suture/anchor. Access-limb pulse · Doppler · NIRS. Urine color.
  • Sidearm no alcohol on the purge sidearm. Keep the catheter straight, angle of entry preserved.
  • Sedation enough to protect groin precautions (femoral). 5.5 axillary → mobilize when stable.
Escalate, don't drift: reassess frequently and immediately with deterioration. Falling CPO despite increased support, low PAPi or rising lactate should prompt urgent shock-team reassessment of perfusion, device function and ventricular phenotype. Choose escalation for the cause and trajectory. No isolated threshold mandates RV support or ECMO.
Two separate tasks: purge pressure protects the motor from blood ingress. Systemic anticoagulation protects the patient and blood-contacting device. A heparin-free purge does not provide systemic anticoagulation.
1

Know the solution and the delivered dose

verify device IFU
ComponentPractical approach
Heparin purgeSCAI recommends D5W with heparin 25 units/mL for ongoing support. Follow the current model-specific IFU and pharmacy preparation.
Bicarbonate purge25 mEq sodium bicarbonate in 1 L D5W is the SCAI formulation when a heparin purge is unsuitable. The February 2026 FDA labeling change allows bicarbonate when heparin should not be used per physician judgment.
What not to addNo bivalirudin or argatroban in the purge. A systemic direct thrombin inhibitor can be used when indicated, with dose/assay adjustment for organ function.
Count purge heparinUnits/hour = units/mL × purge mL/hour. Example: 25 × 10 = 250 units/hour. Include this changing contribution when titrating IV UFH.
2

Choose one explicit anticoagulation protocol

targets are not interchangeable
  • During placement procedural ACT follows the IFU, procedure and concomitant antithrombotic therapy. Do not transfer a maintenance target to insertion.
  • During support IFU ACT targets commonly use 160–180 s. SCAI suggests anti-Xa 0.2–0.4 IU/mL or locally calibrated aPTT for ongoing UFH.
  • Sampling recheck after dose, purge or clinical changes according to the selected protocol. Track platelets, bleeding and hemolysis alongside the assay.
  • Discordance factor abnormalities can distort aPTT. Hemolysis, bilirubin and assay method can affect anti-Xa. Investigate unexpected results with the laboratory.
  • Apparent resistance check dose delivery, purge contribution, sampling and assay interference before escalating. Consider antithrombin assessment with specialist input.
  • No automatic escalation a high purge pressure or low anti-Xa alone is not a mandate for a higher systemic target, thrombolysis or pump exchange.
3

Bleeding and HIT are different problems

patient + pump
Clinically significant bleeding
Find and control the source, including retroperitoneal bleeding. SCAI's stepwise approach first stops IV heparin, then removes purge heparin and substitutes bicarbonate if bleeding persists. Severe bleeding requires urgent individualized decisions about all anticoagulants and antiplatelets.
Suspected / confirmed HIT
Assess clinical probability and test appropriately. When HIT requires heparin cessation, remove all heparin sources, including the purge. Select a nonheparin systemic anticoagulant with hematology/pharmacy and use a compatible heparin-free purge.
4

Purge fault → check the circuit before changing chemistry

FindingFirst assessment
High pressure / low flowInspect kinks, clamps, tubing and cassette. Assess motor current, hemolysis and possible obstruction. If a higher-dextrose solution is used, lowering to D5W may reduce resistance. Do not increase dextrose to treat high pressure.
Low pressure / leakInspect bag, connections, cassette and sidearm urgently. Use the current alarm sequence and replace defective components. A persistent leak risks blood ingress and pump failure.
Disc not detectedCheck the 2026 controller correction: reinsert the purge disc per IFU, then use a backup controller if the alarm persists. Plan the brief interruption of support.
2026 inventory check: Generation 1 purge cassettes and selected pump/controller units have specific field actions. Follow the applicable notice, including its continuity-of-care provisions (P.16).
1

On the console — correct vs the two migrations

echo detail → P.5
✓
Correct
Inlet at the labeled depth (≈3.5 cm CP · 5 cm 5.5), free in the LV cavity. Outlet above the valve. Waveforms can support this assessment but may be nonpulsatile during full support. Confirm & measure by echo (P.5).
↓
Too deep (in ventricle)
Outlet at/below the valve can recirculate blood into the LV. A ventricular signal or position alarm raises concern. Confirm by echo before imaging-guided correction (P.5).
↑
Too shallow (across)
Inlet near/in the aorta can cause ineffective LV unloading despite apparent pump flow. Confirm the inlet and outlet by imaging. Trained operator corrects position per IFU.
2

Alarm cheat-sheet — meaning → first action

patient first
AlarmWhat it meansFirst action
SuctionInlet under-filling — hypovolemia, over-aggressive P-level, RV failure, or wall apposition.↓ P-level, image and assess filling/RV. Fluids only for demonstrated depletion.
Impella Position UnknownLoss of pulsatility — the controller can't read a pulsatile signal (profound shock, low native output, full support, AF / arrhythmia). Does NOT mean it migrated into the aorta.Look at the patient first — MAP, the A-line, flow. Review signals and echo. A supervised brief P-level reduction may reveal pulsatility if tolerated. Don't reflexively reposition.
Impella Position WrongSuspected malposition or unreliable positioning signals. Confirm the actual catheter position.Verify with echo. Advance / reposition per SmartAssist (P.5).
Impella Position in VentricleSignal suggests deep position. Confirm outlet and inlet location by imaging.Pull back to the labeled depth under echo (P.5).
Purge Pressure HighKink, purge-path resistance, cassette problem or possible obstruction.Inspect circuit, flow and solution. Follow the model IFU (P.7). Pressure alone does not diagnose thrombus.
Purge Pressure Low / OpenLeak / disconnect → blood ingress risk.Inspect cassette & connections. Restore urgently.
ControllerController / connection / hardware fault.Check connections & power. On-screen steps. backup controller ready.
Low flowInadequate output — suction, malposition, afterload, device.Patient first. ↓ P-level if suctioning. Echo. Treat cause → tree below.
"Position Unknown" ≠ migrated into the aorta. Loss of pulsatility can prevent the positioning algorithm from resolving location. Migration and sensor failure still require assessment. Look at the patient: MAP, the arterial-line waveform, and flow. A supervised brief reduction may reveal pulsatility if tolerated. Obtain echo before adjusting catheter depth.
3

Low-flow / suction — work it down

don't reflexively turn it up

1 · Filling and perfusion

If suctioning, lower P-level as tolerated. Assess bleeding, LV filling and RV delivery.

Also look for tamponade. Elevated filling pressures do not prove adequate transmural filling. Give volume only for demonstrated depletion.

2 · Position and injury

Image the whole inlet-to-outlet route. Look for wall or mitral contact, valve injury and pericardial fluid.

Trained operator adjusts under imaging. A normal console does not exclude a mechanical problem.

3 · Load and device

Check pressure load, rhythm, purge circuit, motor current and hemolysis.

High purge pressure alone is not thrombus. Persistent low flow or deterioration needs urgent support-team reassessment.

4

Console & power emergencies

don't leave the pump stopped
  • Controller alarm check the white cable & connections (lay flat, no torque). If the AIC fails → swap to a charged backup controller — keep one at the bedside.
  • Power the AIC runs on internal battery (duration depends on controller and battery status) — keep it plugged in. On transport confirm charge + purge-bag volume + a compatible charged backup controller.
  • Pump stopped a stationary impeller risks thrombosis and retrograde flow (aorta → LV) — urgently follow the device-specific restart sequence. Suspected thrombus or obstruction requires expert assessment before repeated restart attempts.
  • Restart after any stop, re-confirm position by echo and the placement/motor-current waveforms before trusting the flow.
Readiness is physiologic. There is no universally validated Impella weaning schedule, mandatory 48-hour minimum, or single echo cutoff that proves readiness. A short PCI-support case and prolonged shock support require different plans.
1

Start with an exit strategy

recovery · bridge · goals
Recovery
  • Cause treated, adequate perfusion, improving organ function and manageable filling pressures.
  • Minimal or decreasing vasoactive support and a sustainable rhythm.
Bridge to therapy
  • If recovery is insufficient, assess durable LVAD, transplant or another temporary strategy early.
  • Reassess neurologic prognosis, RV reserve, organ injury and rehabilitation potential.
Goal-concordant limit
  • Clarify what additional support can achieve and the patient's goals.
  • A failing wean prompts reassessment, not indefinite escalation without a destination.
2

A supervised reduction trial

write the plan before changing speed
1 baselineRecord P-level, MAP, rhythm, vasoactive doses, lactate/urine trend, filling pressures and echo. Confirm the device is correctly positioned.
2 reduceReduce support in steps, with dwell time chosen by the shock team and response. Reassess before the next step. Avoid prolonged idle or stopped transvalvular support because of stasis and reverse flow.
3 challengeAt low support, assess whether native forward flow and perfusion remain adequate without rising filling pressures, pulmonary congestion or major vasoactive escalation.
4 decideIf intolerance develops, return promptly to the last tolerated level and investigate the cause. If stable, plan removal with a defined rescue strategy.
TIDE is an institutional framework, not a validated universal rule. It combines echo at full support, stepwise speed reduction with low-support reassessment, and selective stress echo/hemodynamics when recovery is uncertain.
3

Interpret three domains together

DomainEvidence of toleranceReason to stop the trial
PerfusionStable mentation, lactate, urine output and skin perfusion on minimal vasoactive support.Hypotension, rising lactate, oliguria, ischemia or new arrhythmia.
HemodynamicsAdequate native/total output with acceptable filling pressures. Interpret CPO, CI and venous oxygen saturation as trends.Falling output or rising RA/PCWP with congestion. A single CPO or PAPi threshold cannot certify success.
EchoLV size and systolic function, LVOT VTI, aortic opening, MR/AR and RV function assessed at the same recorded support level.LV distension, worsening MR, RV failure or a new mechanical complication. ECMO-derived numeric thresholds are not validated Impella explant criteria.
4

Removal is device- and access-specific

ConfigurationPlan
Femoral CPOperator-led withdrawal and stopping sequence per IFU, arterial closure strategy, anticoagulation plan and immediate vascular backup.
Axillary 5.5Surgical team manages device extraction and graft ligation/repair. Consider thrombus, embolic risk and graft infection.
RP / RP FlexDemonstrate RV tolerance of reduced support, then remove under the device-specific procedure with venous hemostasis and continued RV surveillance.
ECMO + ImpellaIf RV and pulmonary function recover, ECMO may be removed first while LV support continues. Severe respiratory or RV failure changes the sequence. Titrate unloading to echo and filling, not a fixed P2 rule.
After removal: watch for recurrent shock, access or retroperitoneal bleeding, limb ischemia, pseudoaneurysm and new valve dysfunction. Continue scheduled hemodynamic, access and hemoglobin reassessment. Link the next step to the MCS Weaning & Decannulation guide.
1

Hemolysis — the signature complication

look for a mechanical cause
Confirm hemolysis, then find its cause
  • Plasma-free Hb confirm and trend intravascular hemolysis. A value >40 mg/dL is used in some definitions, not a universal normal limit or an automatic exchange threshold.
  • Dark urine heme with few/no RBCs suggests pigment. Hematuria has urinary RBCs. Check microscopy and sample quality.
  • Supporting tests falling hemoglobin/haptoglobin and rising LDH/indirect bilirubin support the picture. LDH is also elevated by infarction and other tissue injury.
  • Mechanism suction, inlet/outlet obstruction, malposition or pump thrombus can produce shear. Check filling and the entire catheter route.
Treat the cause while maintaining perfusion
1 preloadAssess filling, bleeding and RV function. Replace volume only when depleted.
2 lower shearIf suctioning, reduce support as tolerated while maintaining perfusion. Correct the cause.
3 positionEcho/TEE: assess inlet, outlet, MR, RV and thrombus. Reposition only for an identified problem.
4 reassessTrend pf-Hb, hemoglobin and renal function after correction. Persistent severe hemolysis → urgent expert assessment for exchange/removal and alternative support.
2

Bleeding & the other complications

the harm signal is real
Access-site ooze — run the checklist
  • ACT in range (160–180)? heparin or bicarb in the purge?
  • peel-away sheath removed? forward suture used?
  • natural angle of entry preserved? leg immobilizer on?
  • arterial vs skin-tract ooze? catheter traction or movement?
  • Fixation / anticoagulation use approved securement and review all antithrombotic exposure. Control the bleeding source (P.7).
  • Limb ischemia large-bore arterial access — pulses · Doppler · NIRS. Vascular STAT.
  • Bleeding the dominant driver of harm — balance against thrombosis.
  • Stroke embolic — never cross a known LV thrombus. Neuro checks.
  • Aortic valve / AI catheter sits across the valve — watch for new/worsening AI.
  • RV failure unmasked LV unloading exposes a failing RV (suction, ↑CVP, ↓PAPi) → cause-directed RV therapy and support reassessment (P.15).
  • Suspected thrombosis assess purge, motor current, imaging and hemolysis together. Expert team decides exchange/removal.
3

ECpella — unloading the LV on VA-ECMO

vent the loaded ventricle
  • Why VA-ECMO raises LV afterload → distension, pulmonary edema, stasis. An Impella actively vents the LV (alternative to IABP / surgical vent).
  • Wean order if RV and pulmonary function recover, ECMO may come off first while Impella continues. Follow perfusion, filling and echo during reduction (P.9).
  • Evidence mixed meta-analysis shows no clear early-mortality benefit overall (borderline in matched cohorts), with more bleeding, hemolysis, limb ischemia, RRT.
  • So reserve venting for a clear indication (distension / pulmonary edema / AV not opening), not reflexively.
4

Complication quick-reference

rate · watch · act
ComplicationRisk contextWatchAct
Hemolysisdefinition-dependentpf-Hb trend, hemoglobin, dark urineassess filling · ↓P if suction · image · treat cause
Major bleedingdefinition-dependentHgb, access & mucosal sitessource control and the stepwise anticoagulation plan (P.7)
Limb / vascularaccess-dependentpulses · Doppler · NIRS (large-bore arterial)vascular STAT. Distal perfusion
Strokeembolicneuro examnever cross LV thrombus. Imaging
AKI / RRTcommon in shockCr, UOP, volume balancerenal support. RRT if needed
Device thrombosis—↑ purge pressure, ↓ flow, hemolysisexpert assessment and alternative support plan
Keep selection honest: the AMI-shock survival benefit came in a selected, LV-dominant population and was bought with more bleeding, limb ischemia, and RRT. registries link unselected use to higher complications & cost. Right patient, right pump, meticulous access & position.
◆

Side-by-side — verify against the current IFU

adult · current device family
 Impella CP (SmartAssist)Impella 5.5 (SmartAssist)Impella RP / RP Flex
SupportsLeft ventricleLeft ventricleRight ventricle
Flow capacity3.3–3.7 L/min mean at P9, peak up to 4.3up to 5.5 L/min> 4 L/min
AccessPercutaneous femoral (or axillary), retrograde across AoVSurgical cutdown — axillary artery graft (or direct aortic)Femoral vein (RP) / IJ or femoral (RP Flex) → RA → PA
Sheath / introducer14 Fr peel-away23 Fr × 6 cm via graft~23 Fr (RP). Single-access (RP Flex)
Motor / catheter14 Fr motor · 9 Fr shaft19 Fr motor · 21 Fr cannula · 9 Fr shaft22 Fr motor/cannula · 11 Fr shaft
TipFlexible pigtailNo pigtail — soft atraumatic tipDistal pigtail in PA
Position sensorOptical pressure (SmartAssist)Optical pressure (no differential sensor)Differential-pressure + fiber-optic (RP Flex)
Inlet depth (echo)≈ 3.5 cm below annulus≈ 5 cm below annulusOutlet in main PA
Speedup to ~46,000 rpm0–33,000 rpm—
US labeled duration≤4 days shock · ≤6 h HR-PCIup to 14 daysup to 14 days
Signature useAMI/HF shock · high-risk PCIFull LV support · bridge to recovery/LVAD/TxAcute RV failure within US labeling (P.15)
Dimensions refer to different parts (motor, cannula, shaft or introducer). Flow is load-dependent and is not guaranteed cardiac output. Verify the exact model and current device IFU.
P

P-level → flow · 5.5 accessory kit

console estimate · titrate
  • CP P9 mean flow 3.3–3.7 L/min, systolic peak up to 4.3. The mean and peak are different measurements.
  • 5.5 P9 mean flow 5.0–5.5 L/min in the IFU table. Delivered flow depends on loading and position.
  • P0 / < P2 P0 = off. Below P2 blood may flow retrograde — use only in the model-specific controlled removal sequence.
  • Reminder displayed flow is a calculated estimate — verify with MAP, lactate, CPO.
Impella 5.5 axillary kit
  • Graft 10 mm × 20 cm vascular graft. One graft lock for this graft, plus a supplied spare.
  • Sheath 23 Fr × 6 cm peel-away with hemostatic valve.
  • Dilator 8 Fr silicone-coated lubrication dilator.
  • Wire 0.018″ × 260 cm placement guidewire. Modular purge cassette.
↳

Picking the device — the 30-second version

detail → P.2
LV shock, percutaneous, fast Impella CP — femoral, no surgeon. Up to ~4 days.
LV shock, more flow / longer Impella 5.5 — surgical axillary, full support, ambulatory bridge.
RV-dominant failure Impella RP / RP Flex — RA → PA. RP Flex via IJ or femoral access.
Biventricular / respiratory failure select combined support. BiPella does not oxygenate. Significant hypoxemia may require an oxygenated circuit.
C

The Automated Impella Controller (AIC)

drives · monitors · purges
  • Drives the pump sets the P-level. Auto-regulates the purge. One console runs CP, 5.5, or RP.
  • Displays placement signal · motor current · flow (max/min/mean) · purge P & flow · SmartAssist CO / CPO / LVEDP / MAP.
  • Power AC + internal battery (duration depends on controller and battery status) — keep plugged in. Charge before transport.
  • Transport confirm battery + purge-bag volume + a backup controller. Lay the white cable flat (remove torque).
▸

The rest of the family

RP vs RP Flex · legacy
RP vs RP Flex
  • RP 23 Fr femoral vein. Effective but bed-bound.
  • RP Flex repositionable, IJ or femoral venous access. The IJ route can permit mobilization. Confirm inlet position for the chosen route.
Legacy / related
  • Impella 2.5 ~2.5 L/min, 12–13 Fr — classic high-risk PCI pump (PROTECT II).
  • Impella 5.0 / LD surgical predecessors of the 5.5. LD = direct-aortic.
Each Impella is a different operation — access, support level, position depth, the feel of anticoagulation, mobility, and removal all differ. Read down the column for the device you have. The generic workflow is on pp 3–10. This page is the per-device cheat-sheet.
◆

Management — side by side

read down your device's column
 Impella CPImpella 5.5Impella RP / RP Flex
RoleLV · AMI/HF shock · high-risk PCILV · full support · bridge to recovery/LVAD/TxRV · eligible post-LVAD, MI, transplant, surgery (P.15)
AccessPercutaneous femoral (US-guided, pre-close) across AoVSurgical axillary 10 mm graft (or direct aortic)Femoral vein (RP) / IJ or femoral (RP Flex) → RA → PA
Flow capacity3.3–3.7 L/min mean at P9, peak up to 4.3up to 5.5 L/min> 4 L/min
Support levelTitrate to perfusion, filling and suctionTitrate to unloading/perfusion, including on ECMOTitrate to independent pressures, perfusion and echo (P.15)
Echo positioninlet 3.5 cm below annulus · pigtail in LVinlet ~5 cm below annulus · no pigtailoutlet in main PA · femoral inlet IVC/RA or IJ inlet SVC/RA
AnticoagulationPurge (D5W + heparin 25 U/mL, or bicarbonate when heparin is unsuitable) + systemic ACT 160–180 / institutional anti-Xa/aPTT target. Insertion per IFU (P.7)Same targets & purgeDevice-specific protocol, count purge + systemic exposure
HemolysisPosition-sensitive. Trend pf-HbStill monitor for suction, malposition and hemolysisMonitor position, hemolysis and inlet/outlet obstruction
MobilityBed-bound (femoral → leg immobilizer)Ambulatory — rehab on support (axillary)RP bed-bound · RP Flex ambulatory (RIJ)
Max duration≤4 days shock · ≤6 h HR-PCIup to 14 days by US labelup to 14 days
WeaningSupervised stepwise trial, reassess at each levelIndividualized reduction with perfusion + echo (P.9)Supervised reduction with perfusion, filling pressures and RV echo
RemovalOperator-led IFU withdrawal/stopping sequence, closure plan and vascular backupOR — ligate / repair the axillary graftVenous — manual pressure / figure-of-8 / closure
Signature pitfallPosition-sensitive hemolysis & suctionRV failure unmasked on full LV unloadCannula across pulmonic / tricuspid
▸

Tips & tricks — by device

bedside pearls
CP

Impella CP

percutaneous LV
  • Cross it adjust only under imaging by a trained operator. Avoid mitral apparatus contact and force.
  • Suction-prone run the lowest P that perfuses. Assess filling and position before ↑ P.
  • Hemolysis image in multiple views. Persistent hemolysis → expert exchange/removal assessment.
  • Limb pulses · Doppler · NIRS q1–2h (14 Fr arterial).
5.5

Impella 5.5

surgical · ambulatory
  • Mobilize the headline advantage — confirm lock unit + echo before ambulation. PT early.
  • Watch the RV full LV unload unmasks RV failure — track PAPi, CVP and echo, then reassess support.
  • Graft approved fixation and graft care, with surgical removal planning.
  • Bridge document destination — ambulatory waitlist.
RP

Impella RP / Flex

right heart
  • Position confirm outlet in the main PA, inlet at IVC/RA (femoral) or SVC/RA (IJ). Cannula crosses TV & PV.
  • Mobility RP Flex via RIJ for ambulation. Dual sensors.
  • Wean with perfusion, filling pressures and RV echo at reduced support. No single TAPSE/PAPi value proves recovery.
  • Watch hemolysis if the cannula abuts the PA wall.
One-liner: CP = percutaneous LV support, hemolysis-/suction-prone, ≤ 4 days, bed-bound. 5.5 = surgical full LV support, ambulatory, the bridge — but it unmasks the RV. RP / RP Flex = the right-heart pump, RA → PA, RP Flex ambulatory via the RIJ.
▸

Device and surgical insertion

Impella 5.5 · verify current IFU
Impella 5.5: confirm the optical sensor, pump head, purge sidearm, graft route, and fixation steps against the current device IFU and surgical plan.
▤

The evidence base — read before you believe the flow number

shock · high-risk PCI · RV
TrialPopulationResultTakeaway
DanGer Shock2024 · RCT · 355 analyzedSTEMI shock, LV-dominant (severe RV failure / persistent OHCA coma excluded)180-day death 45.8% vs 58.5%, HR 0.74, NNT≈8. Composite safety 24% vs 6%, RRT 42% vs 27%.First RCT mortality win for Impella CP — in a selected phenotype, at a real safety cost.
IMPRESS2017 · RCT · n=48Severe AMI shock, ventilated (CP vs IABP)No significant difference: 30-day 46% vs 50%. 6-mo 50% both.Small, underpowered trial. Does not establish benefit or futility for an individual.
Schrage2019 · matched · 237×2AMI-CS, Impella vs IABP-SHOCK II30-day mortality 48.5% vs 46.4%. More severe bleeding (8.5% vs 3.0%) & vascular complications.Unselected use ≠ benefit. Complications are real.
PROTECT II2012 · RCT · n=452High-risk PCI, Impella 2.5 vs IABP30-day MAE ns. 90-day per-protocol 40% vs 51% (P=0.023).Primary end point neutral. Secondary/per-protocol findings do not establish a mortality benefit.
PROTECT III2022 · registry504 PROTECT II-like patients vs 216 historic Impella recipients90-day MACCE 15.1% vs 21.9%. Transfusion-bleeding 1.8% vs 9.3%.Historical comparison, not randomized proof of device benefit.
RECOVER RIGHT2015 · n=30Refractory RV failure (Impella RP)CI 1.8 → 3.3, CVP 19 → 13. 30-day survival 73%.Hemodynamic basis for Impella RP.
NCSI2019 · protocol · n=171AMI-CS, protocolized early MCSSurvival to discharge 72%. Death ∝ CPO < 0.6, lactate > 4.Single-arm association, without randomized proof of the protocol or insertion timing.
S

Four scenarios the console will throw at you

Recognize · Stop · Think · Do
01Suction + low flowFilling
Flow2.0
P-levelP8
AlarmSuction
CVP3
pfHb↑
MAP58
Stop
↓ P-level first to refill the inlet. Don't turn it up.
Think
Hypovolemia/bleeding · RV failure · malposition · over-pumping.
Do
Assess bleeding/filling · echo position & RV · treat cause · re-titrate.
02"Position in Ventricle"Migration
Signalventric
Motor Iflat
Flow3.0
pfHb↑
Echodeep
Depthdeep
Stop
Don't ignore — migration causes hemolysis & lost support.
Think
Echo shows the device too deep, with inlet and outlet in the LV. The waveform alone is insufficient.
Do
Imaging-guided correction by a trained operator, then re-secure.
03Cola urine / ↑ LDHHemolysis
Urinecola
LDH2200
pfHb>40
P-levelP9
Hgb↓
CVP8
Stop
Check position, filling and obstruction urgently.
Think
Inflow/outflow obstruction → shear. Preload-dependent.
Do
Assess preload · lowest tolerable P · image before repositioning · trend pf-Hb.
04RV failure unmaskedRight heart
Flow2.4
CVP18
PAPi0.8
Suctioncycling
LVunloaded
MAP60
Stop
This pattern raises concern for poor RV delivery. Confirm by hemodynamics and echo.
Think
RV failure is possible with high CVP and low PAPi. Also exclude tamponade and malposition.
Do
Optimize RV loading/contractility and select support for the full phenotype (P.15).
Always
comes
first
1 · Patient
Look at the patient before the console — MAP · perfusion · rhythm · urine. Displayed flow is an estimate. The patient is the truth.
2 · P-level down
For suction, reduce P-level while treating its cause. Low flow without suction needs diagnosis.
3 · Echo & call
Confirm position by echo. Loop in shock team / perfusion / CT surgery early. Use the current manufacturer support route in the current device labeling or official directory.
1

DanGer Shock: a survival benefit with a substantial harm burden

Trial outcomeImpella CP + standard careStandard care
Death at 180 days45.8% (82/179)58.5% (103/176)
Composite safety end point24.0%6.2%
Renal replacement therapy41.9%26.7%
Mortality HR 0.74 (95% CI 0.55–0.99). Absolute death reduction 12.7 percentage points, approximately 8 treated per death prevented. Safety events combined severe bleeding, limb ischemia, hemolysis, device failure and worsening aortic regurgitation. These end points overlap and cannot be subtracted to calculate a single “net benefit.”
The population that supports the result
  • 360 randomized, 355 analyzed: STEMI with recent shock, hypotension/vasopressor need, hypoperfusion and LVEF <45%.
  • Important exclusions included severe RV failure, mechanical MI complications and persistent coma after out-of-hospital arrest.
  • CP was studied in experienced centers. This is not a randomized survival claim for 5.5, RP, every shock cause or all arrest patients.
What changed after the initial report
  • 2025 US ACS guideline: microaxial support is reasonable for selected patients with STEMI and severe or refractory shock, Class 2a, B-R, with explicit attention to bleeding, ischemia and renal risk.
  • 2025 long-term follow-up: the survival advantage persisted during follow-up extending to ten years. It remains follow-up of the same selected cohort, not evidence for broader indications.
2

Keep shock, stable STEMI and planned support separate

Clinical settingWhat can be concluded
Anterior STEMI without shockSTEMI-DTU, 2026: 527 randomized patients. Unloading with a 30-minute delay before PCI did not reduce infarct size versus immediate PCI and increased bleeding. Do not delay reperfusion routinely to unload a stable STEMI.
High-risk PCIHeart-team selection considers anatomy, ischemic territory, LV function, surgical options and access risk. The US CP/2.5 PCI label is temporary support ≤6 hours. DanGer Shock is not a high-risk PCI trial.
Preemptive cardiac surgery supportIMPACT, 2026: a 100-patient single-arm 5.5 study showed feasibility in selected surgical patients with poor LV function. Without a randomized comparator, favorable event rates do not prove a survival benefit.
HF shock / bridgePhysiology and observational experience inform 5.5 use. State the intended bridge, likelihood of recovery and duration-label boundary. Do not import a STEMI-specific treatment effect.
3

Before escalating support, answer four questions

Device choice follows the phenotype. A higher P-level cannot correct RV failure, tamponade, severe hypoxemia or vasoplegia. Escalating lactate despite apparently adequate pump flow requires a new diagnosis and shock-team reassessment.
1

Same purpose, different venous route

FeatureRP / RP with SmartAssistRP Flex with SmartAssist
AccessFemoral venous route, inlet near IVC/RAIJ or femoral venous route. IJ inlet: SVC/superior atrial junction or RA. Femoral inlet: IVC.
Flow pathCaval/right atrial drainage → pump across the right heart → pulmonary artery. Confirm outlet and inlet by imaging.
OxygenationNone. The device increases pulmonary blood flow. It does not oxygenate blood or bypass pulmonary vascular obstruction.
MobilityFemoral precautions limit mobilizationIJ access can support rehabilitation when stable and securely fixed. Femoral access requires femoral movement precautions
2

Use the current indication, not “any RV shock”

US labeling · checked Oct 17, 2026
Current US labeling covers temporary RV support up to 14 days, BSA ≥1.5 m², for acute right-heart failure/decompensation of <48 hours after LVAD implantation, MI, heart transplant or open-heart surgery, without profound shock, end-organ failure or acute neurologic injury.
Anatomic checks
  • Mechanical or severely dysfunctional tricuspid/pulmonic valve, PA wall disease, RA/caval thrombus, or an unsuitable insertion route may preclude use.
  • A caval filter is relevant to the intended route. Verify unobstructed access and the exact model IFU.
  • Massive PE and chronic pulmonary vascular disease are not equivalent to the labeled postoperative/MI population.
Evidence boundary
  • RECOVER RIGHT was a small single-arm study demonstrating hemodynamic improvement and short-term survival in selected patients.
  • It does not establish a randomized survival benefit in refractory arrest, prolonged RV shock, severe organ failure or PE.
  • If LV dysfunction or respiratory failure is substantial, reconsider the whole support configuration.
3

2026 sensor correction: do not treat a display in isolation

RP with SmartAssist and RP Flex: differential-pressure sensor drift can make displayed flow, PA/CV placement signals and PAPi inaccurate. The sensor fault itself does not prevent the pump from supporting circulation. Use independent hemodynamic monitoring and imaging before intervention.
4

Reassess the circulation after each change

PatternInterpretation and next check
RA falls, systemic perfusion improvesSupports a useful RV bypass effect. Continue evaluating congestion, organ recovery and device complications.
Pulmonary edema or PCWP risesIncreased pulmonary return may exceed LV capacity. Reassess LV function, MR, afterload and need for left-sided support.
Low flow or suctionAssess drainage, volume losses, position, obstruction and the pulmonary pressure load. Treat the cause instead of chasing a display.
For configuration selection, oxygenated RVAD support and biventricular management, use the RVAD & BiVAD guide. Reassess native RV function during a supervised reduction trial rather than relying on a device-derived PAPi alone.
Checked October 17, 2026. A correction updates use instructions, while a removal targets inventory or servicing. Match the exact model, product code, serial/lot and current notice. This selected bedside summary is not a complete recall inventory.
1

Current actions to reconcile with the device at the bedside

FDA actionProblemAction that changes care
Left-sided pumps
2024 correction
Catheter manipulation can cause ventricular perforation/free-wall injury.Advance or torque only under imaging. Consider fragile infarcted tissue, small cavity or complex anatomy. New collapse → urgent echo for tamponade, device position and valve injury.
RP / RP Flex
2025 correction
Guidewire or other intravascular-device contact with the inlet can damage the pump/device.Coordinate other line/device procedures with the support team and follow the current imaging and handling instructions.
RP / RP Flex
April 3, 2026
Sensor drift can corrupt displayed flow and pressure-derived metrics.Use independent hemodynamics, imaging and model-specific IFU flow ranges. See P.15.
Generation 1 purge cassettes
April 3, 2026
Leak → low purge pressure → blood ingress and pump-stop risk.Quarantine affected inventory and use Generation 2. The notice permits necessary Generation 1 use only when Generation 2 is unavailable, with increased purge monitoring.
Selected CP sets
July 2, 2026
Specified units outside design specifications can develop low purge pressure.Check the listed serial numbers. Do not use affected sets, quarantine and return per notice.
AIC purge flag
September 24, 2026
Failed purge flag/retainer can prevent cassette recognition.All AIC units are in the phased service/removal scope. Inventory may continue supporting care while awaiting service. For a disc alarm, reinsert per IFU, then use backup AIC if unresolved.
Separate AIC early alert
September 23, 2026
Specified consoles need hardware, firmware and/or software updates for recognition, button or startup problems.Check serial list and coordinate service. Notice permits continued inventory use while awaiting service. This is distinct from the purge-flag action.
2

A deteriorating patient needs two simultaneous assessments

Patient team
  • Activate trained shock/resuscitation responders. Assess consciousness, arterial pressure, rhythm, oxygenation and perfusion.
  • A weak/absent pulse alone does not prove arrest during continuous flow. Follow the institutional device-specific resuscitation pathway.
  • Echo urgently for tamponade, catheter position, new MR/AR, LV distension, RV failure and thrombus. Obtain TEE when TTE cannot answer the question.
Device team
  • Read the exact alarm, P-level, flow and motor-current trend. Check power, cables, purge bag, pressure, flow and recent manipulation.
  • Keep a compatible charged backup controller and trained exchange operator available. Prepare for the brief support interruption.
  • Do not blindly reposition or repeatedly restart a pump with suspected obstruction. Follow the model-specific alarm and emergency instructions.
3

Transfer and shift handoff

make the current state reproducible