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8/10/2019 Pathogenesis and Management of Cardiogenic Shock and Postoperative Shock. Introduction. Chest 1992
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* From the Research and Congestive H eart Failure Divisions,
M inneapolis H eart Institute Foundation, M inneapolis.Reprint requests: D r.Goldenberg, M inneapolis H eart Institute, 92 0East 28th Street, M inneapolis 55407
596S M anagem ent of Cardiac Arrest and C ardiogenic S hock Irvin F G o ld e nb e rg
N on pharm aco lo g ic M anag em ent o f C ard iac A rres t an dC ardiogenic Shock*Irvin F . G oldenberg, M.D. F.C.C.P
P harm acologic m anagem ent of patients w ith cardiacarrest or cardiogenic shock m ay be insuIcient in
restoring adequate circulatory support. This has led
physicians to investigate and develop m ore aggressive
interventions for these problem s. Cardiogenic shock
m ost frequently occurs in the follow ing clinical set-
tings: (1) acute m yocardial infarction; (2) postcardiot-
om y; (3) an acute exacerbation in som eone w ith chronic
cardiac dysfunction and congestive heart failure; (4)
cardiac arrest secondary to an arrhythm ia; (5) cardiac
dysfunction secondary to a com plication from a per-
cutaneous interventional cardiac procedure,eg , coro-
nary angioplasty; and (6) less often as other acute
illnesses, eg , m yocarditis. A lthough initia l m anage-
m ent often requires im m ediate intervention to restore
circulatory support, even prior to know ing the defini-
tive cause of the patients shock,it is im portant that
an extensive diagnostic evaluation, particularly pur-
suing reversible causes of shock, be undertaken at the
earliest possible tim e. D uring this evaluation,it is
im portant to determ ine the degree of both left and
right ventricular dysfunction, as interventions m ay
differ particularly w hen m echanical circulatory assist
devices are being considered.
D espite recent pharm acologic advances, w hich have
led to the developm ent of newer inotropic agents (eg,
am rinone) and to throm bolytic therapy, recent studies
have dem onstrated that the incidence and m ortality
of cardiogenic shock in patients w ith an acute m yocar-
dial infarction, treated predom inantly w ith m edical
therapy, have not changed significantly over a recent
13-year period. The inhospita l m ortality rate in
patients with acute m yocardial infarction and cardio-
genic shock, treated predom inantly w ith pharm aco-
logic agents , has been reported to be between 70 and
1 00 p erc ent. - Even w hen pharm acologic therapy is
able to provide adequate circulatory support, m any
patients m ay still need a nonphannacologic interven-
tion eg , coronary artery bypass surgery to reverse
ischem ia) to restore adequate cardiac function andtherefore allow one to be weaned from pharm acologic
therapy.
Nonpharm acologic treatm ent for cardiogenic shock
and cardiac arrest consis t of (1) interventions eg ,
m echanical circulatory assist devices, cardiac trans-
plantation) that provide circulatory support to the
patient no m atter what the underlying cause of thecirculatory deterioration, and to (2) interventions eg ,
percutaneous interventional or surgical corrective pro-
cedures) that correct or reverse the specific cause of
the underlying shock (Table 1). This artic le will discuss
the nonpharm acologic interventions that have been
helpful in restoring circulatory support and reversing
underlying causes of cardiogenic shock and cardiac
arrest. These nonpharm acologic interventions have
had a significant im pact on the survival of these
patients. Tables 1 and 2 list the various m echanical
circulatory assist devices and cardiac procedures that
have been used in patients w ith cardiogenic shock.
Patients with cardiogenic shock or cardiac arrest
w ho require nonpharm acologic intervention generally
fall into three categories:
1.Patients Requiring Tem porary M echanical
C irculatory Support Only
These patients have cardiac dysfunction that is
expected to im prove w hile their circulation is sup-
ported by nonpharm acologic interventions (eg, m e-
chanical circulatory assist devices). Som e patients w ith
postcardiotom y cardiogenic shock would fall in this
category. These patients are often believed to have
stunned m yocardium that w ill recover with tim e.
2. Patients Requiring Tem porary C ircula tory Support
and a Circula tory or Cardiac Corrective P rocedure
Patients w ho require em ergent circulatory support
(,pharm acologic and/or m echanical circulatory assist
devices) and also have a circulatory or cardiac disorder
requiring a nonpharm acologic intervention eg , per-
cutaneous interventional or surgical procedure) to
restore cardiac function fall in this category. Even
after the nonpharm acologic intervention eg , coronary
angioplasty, coronary artery bypass surgery) has been
perform ed, these patients m ay require prolonged
circulatory support while their underlying cardiacfunction m ore fully recovers. Patients with acute
m yocardial infarction and cardiogenic shock requiring
percutaneous or surgical revascularization would fall
in this category.
3. Patients W ith Irreversible Cardiac D ysfunction
who Require Cardiac Transplantation or aPermanent
Im plantation of a M echanical Assist D evice
Patients w ho are in cardiogenic shock and w hose
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8/10/2019 Pathogenesis and Management of Cardiogenic Shock and Postoperative Shock. Introduction. Chest 1992
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C H E S T I 10 2 I 5 I N O V E M B E R 1992 I S upplem ent 2 597$
Table -Nonpharsnacologic Managemen* of
Cardiogenic Shock
M anagem ent of Shock
M echanical ventila tion
Mechanical circulatory a ss is t d ev ic es
Intra-aortic balloon p u m p
Pulm onary artery balloon counterpulsation
Extracorporeal membrane oxygenation*
Percutaneous left atria l to femoral artery bypassH e m o p u m p t
Left ventricular assist device or system
Right ventricular assist device
B iventricular assist devices
D irect m echanical ventricular actuation
Total a rt if ic ia l h ea rtPercutaneous interventional procedures and nonsurgical treatment
of cardiogenic shock or cardiac arrest
Percutaneous m echanical revascularization (coronary angioplasty,
directional an d rotational atherectomy, coronary laser angio-
plast coronary stunting, an d other m echanical percutaneous
interventions tha t attem pt to perm anently restore coronary
blood f low)
Augm entation of distal coronary blood flow (tem porary augm en-
tation)
augm entation of antegrade coronary perfusion by passive or
active antegrade coronary perfusion methods e g perfusion
or bailout catheters)
Synchronized coronary sinus retroperfusion
Valvuloplasty
Percutaneous transcatheter closure of ventricular septaldefect
Pacemaker for optim al h ear t ra te and atrioventricular delay
control
C atheter or ch em ical ablation ofarrhythmias
Pericardiocentesis
M echan ical circulatory ass ist d evices
Intra-aortic balloon p u m p
Percutaneous cardiopulm onary support*
H e m o p u m p t
Percutaneous left a tria l to femoral artery bypass
C ardioversion or defibrillationS urgic al p roc edu res
Coronary artery bypass grafting
Valve repa ir o r r ep l ac e m en t
Cardiac rupture repair (ventricular septal defect, free wall)
Pericardiectomy
Aneurysm ectom y for aneurysm responsible for intractable ar-
rhythm ias and/or card iogenic sh ock
P ulm onary em bolectom y
Pericardial w indow
Rem oval of intracardiac or extrinsic cardiac m ass contributing to
cardiogenic shock (eg, atria l myxoma)
Surgical treatm ent of arrhythmias e g ablation, subendocardial
resection)
Pacemaker for optimal heart rate and atrioventricular delay
controlM echanical circulatory assist devices (see above)
C oronary s inu s retroperfusion
Cardiac transplantation (orthotopic, heterotopic, and xenograft)
*May be p lac ed pe rcu tan eou sly or by surg ica l c utd ow n.
tPercutaneous device being developed.
cardiac function is believed to be irreversibly dam aged
fall into this category. These patients are initia lly
supported w ith pharm acologic agents and/or m echan-
ical circulatory assist devices. Cardiac transplantation
is usually the treatm ent of choice in acceptable
candidates. H ow ever, in patients not considered can-
didates for cardiac transplantation, perm anent im plan-
tation of a m echanical assis t device has been tried.5
W ith the developm ent of newer, im proved perm anent
m echanical circulatory assis t devices, the num ber of
patients falling into this la tter category hopefully w ill
increase in the near future.
It is not alw ays possible to determ ine which categorya patient m ay fall into because it is often difficult to
determ ine whether cardiac dysfunction is perm anent
or reversible. O ne patient was supported for 70 days
w ith a left ventricular assist device (LVA D ) w ith the
intent to perform cardiac transplantation.6 H ow ever,
the patients left ventricular function im proved signif-
icantly, m aking transplantation unnecessary.16
M EC H A N IC A L V E N T IL A T IO N
Initia tion of m echanical ventila tory support m ay
signfficantly im prove a patients system ic hem odynam -
ics by elim inating the w ork of ventila tion. T his can
provide as m uch as a 1-L increase in effective cardiac
output in som e patients, thus elim inating the need for
m echanical circulatory support in the occasional pa-
tient.
M E C H A N IC A L C IR C U L A T O R Y SU PP O R T D EV IC ES
The prim ary functions of m echanical circulatory
assist devices are (1) to provide circulatory support
and (2) to assist in m yocardial recovery.1 The prin-
cipal purpose in m ost patients is usually to provide
adequate circulatory support that is suffic ient to per-
fuse the vita l organs and prevent irreversible dam age.
To assist in m yocardial function recovery, m any of
these devices produce ventricular unloading, dim inish
m yocardial w ork, and favorably alter the ratio of
m yocardial oxygen supply and dem and. W hen consid-
ering w hich device to use in an individual patient,it
is im portant to understand the degree of circulatory
support (partia l or com plete) and the level of m yocar-
dial protection each device can provide.
H em odynam ic indications for m echanical circula-
tory support beyond the use of the intra-aortic balloon
pum p (IA BP) for patients with cardiogenic shock have
often been based on the suggestions of N orm an and
associates.as These suggestions, show n in Table 3, w ere
initially supported by m any investigators; how ever,
they are now believed to perhaps be too stringent and
probably harm ful if followed too rigidly.89 It has been
reported that the earlier the intervention w ith circu-
latory support devices, the better the outcom e.
Although prolonged use of high-dose inotropic therapy
m ay be able to provide borderline hem odynam ics and
m arginal circulatory support, prolonged use of these
agents m ay lead to increased m yocardial w ork and
potentia lly irreversible m yocardial dysfunction. In
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8/10/2019 Pathogenesis and Management of Cardiogenic Shock and Postoperative Shock. Introduction. Chest 1992
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on th e w ork of N orm an et ale and rep rin ted w it h p erm iss io n
from P en nin gton D G , Swartz M T.8
Table 2-Guidel ines fo r A pp ro pr ia te Selection of Mechanical Circu latory Support Devices
598S Management of C ardiac Arres t and C ardlogenic S hock Irvin F Goldenberg)
I)evice
Investi-
gational Pusition Support
Anticoagulation
Required
Preferred
Application Duration
Pulsalile
F low M echanism
Flow,
Umin
U su al M od e
Insertion
U su al S ite
Insertion
tA RP N o Internal L M oderate K , F B-Tx Short-inter Y esPN Pulsatile 0.5-0.8 Per, S FA
PARC N o Internal K Low P Short-inter Y es PN Pulsatile - St PA
Sarns& obe No ExtracorporealRt , L, B Full P , B-Tx S hort-in ter N o R O L L 6.0 S R APA, L AA o,LVA o
R ol le r P um p
Electrocatheter Y es Extracorporeal L Full K , P Short No CEN T,R O L L 1.5-4.5 Per F FA
Bin M edicus N o ExtracorporealRt , L, B Low -m oderate P ,B-Tx S hort-in ter No CEN T 5 S RA PA , LAA oLVAo
Centrim ed/Sarns No Extracorporeal Rt, L , B Low -m oderate P B-Tx Short-inter NoCEN T 5 S RA PA , LA Ao,
LVAo
ECM O N o Extracorporeal B Full K Short No CEN T, ROLL5 Per, S FsFA
H em opump Y es Internal L M oderate B, P Short No Rotary 3.5 St FA
Abiom ed BVS Y es Extracorporeal R t, L , B M oderate F, B-Tx Short-interYes PN Pulsatile 6.5 5 RA PA , LA Ao
Pierce-Donachy Y es Faracorporeal R t, L , B Low P B-TI Short-long Yes PN P ulsatile 6 S RA PA , LAA
VA D(Fhoratec)P ierce-Donachy Y es F aracorp oreal R I, L, B L ow F B-Tx Short-long Yes PN Pulsatile 6 5 RA PA , LA Ao,
VA D(Saran) LVA oSym bio n AVA D Yes Pararorporeal R t, L, B M oderate F, B-Tx Short-long Yes PN Pulsatile 7 5 RA PA , L A AoNovaror LVAs Yes Internal L Low B-Tx Short-long Yes EL Pulsatile 10 S LV AoThermedics VA D Yes Interim ] L N one B-Tx Short-long Yes PN P ulsatile 10 S LVAo(I -Heartmate)
S ym bio n TA ll Ye s Internal B M oderate B-Tx Short-long Y es P N Pu lsa tile 10 5 R AP A, L AA o
D M VA Ye s Internal B N one B,B -T x, P Shor t Yes PN Pulsatile 80-110%
of control
5
n vestiga ti.o na l de sic e exe mp tion requ ired fro m F ood and D rug A dm inistra tion . B VS =biv entricu lar sup po rt system ; E CM O =e xtra co rpo real m em brane o xy gen ation;LVAS=lef t ventricular
L =l ef t; B= bi ve nt ri ru la r; R =r es us ci ta hv, P=postcardiotomy;
B -Tx=bridge-to-transplantation; JA BP=intra-aortic balloon pum p; P AB Cpalm onary artery balloon counterpulsation; E lectsocatheter= percutaneous left atrium
bypass. P er=percutaneous; S =surgjcal procedure; RA PA = right atrial and pulm onary artery; L& Ao=left a trium and aortic ;LVAo= le ft ven tricle a nd a orta ; P A= pulm onary artery ;
F A= fem oral a rtery; F V= fem ora l ve in; ln ter= in term edia te; P N= pn eum atic;EL ele ctrical; C EN T= ce ntrifug al; R OL L= roller pu mp .
tP erc uta neo us ap pro ach being de velope d. M odified an d printed w ith pe rm issio n h umrefurenoes 18,20, and 21.
addition, prolonged m arginal circulatory support,
even if it m eets the criteria in Table 3, m ay lead to
irreversible dysfunction of other organs. Therefore ,
consideration for device im plantation should be m ade
prior to prolonged support w ith high doses of inotropic
agents. The hem odynam ic indications for circulatory
support devices outlined in Table 3, therefore , w hile
helpful, should be considered only guidelines.
W hen selecting a device,it is im portant to evaluate
the follow ing: (1) the potential reversibility of the
cardiac dysfunction; (2) the cause of the cardiac
dysfunction; (3) the degree of right and left ventricular
dysfunction; (4) the degree of circulatory support
Table 3-Hemodynamic Guidelines fo r M ec ha nic alCirculatory Support5
Guidelines
Cardiac in dex
8/10/2019 Pathogenesis and Management of Cardiogenic Shock and Postoperative Shock. Introduction. Chest 1992
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C H E S T I 10 2 I 5 I N O V E M B E R 1992 I S upplem ent 2 599S
Table 4-C riteria for tlniventricular and
R iventricular Support5
Criteria
Bight ven tr icu lar fa ilu re: R V A Dan d IABP
LA P 20 m m H g
Few or no arrhythmias
Near norm al left ventricular function by echo, cath, or M U GA
Left ventricular failure: LVA D onlyLA P >20 mm Hg
RA P 20 mm Hg
V entricular tachycardia or fibrilla tion
Severely im paired left and right ventricular function by echo,
cath, or M U G A
5 RVA D = right ventricular assist device; IA BP= intra-aortic balloon
p u m p ; RA P=right atrial pressure; LA P1eft atria l pressure;
LVA D = left ventricular assist device; echo= echocardiography;
B VA D s = b iventr icu lar assist devices; cath= catheterization;
M U G A = m ultigated acqu isition scan.Printed w ith perm issionfrom Penn ington , e tal.25
ventricular failure , an LV A D only; for right ventricular
failure a right ventricular assist device (RV A D) and an
IA BP If both ventric les w ere contracting poorly and
both right and left a tria l pressures w ere greater than
20 m m Hg, both an LV A D and an RVA D w ere
im planted. W hen arrhythm ias producing significant
hem odynam ic com prom ise w ere present, support
w ith biventncular assist device (BV A D) was favored.as
M echanical circulatory support devices m ay be
classified by m any different m ethods, and at present,
there is no universally accepted classffication. D evices
have been classified by the following: (1) their intended
use, ie , resuscitation or long-term support; (2) the
m echanism by w hich they provide circulatory support:
centrifugal, rotary, pneum atic pulsatile , and electric
pulsatile ; and (3) their position: extracorporeal, para-
corporeal, heterotopic (internal or external), or ortho-
topic .ss.sa Only a few of the presently used m echanical
assis t devices are universally available w ith m ost being
investigational and requiring Food and D rug Adm in-
is tra tion (FD A) approval. Table 2 lists the various
approved and investigational m echanical circulatory
assis t devices and provides the various characteristics
of the individual devices .1 For this review , I haveelected to classify devices in a m anner slightly differ-
ent from but sim ilar to that reported by Pennington
and Sw artz .8 D evices are classified as resuscita tive,
external centrifugal and roller pum ps, external pulsa-
tile assist devices, im plantable LVA D s, pulm onary
artery balloon counterpulsation, orthotopic biventric-
ular replacem ent prosthesis (total artific ial heart), and
perm anent devices. 18
The clinical results provided in this artic le are from
m ultiple sources, and include the volunteer regis try
for m echanical assist devices and artific ia l hearts at
Penn State University under the auspices of the
A m erican Society of Artific ia l O rgans (A SAIO ) and
the International Society for H eart Transplantation
(ISHT), the Total A rtific ia l H eart Registry at the
M inneapolis H eart Institute , the N ational R egistry for
Em ergent Percutaneous C ardiopulm onary Bypass , de-
vice m anufacturers , investigators, and literature re-view
Resuscitative Devices
Resuscita tive devices are m echanical circulatory
support devices that can be placed rapidly and do not
require an operating room for insertion. These devices
are often inserted in the em ergency departm ent,
intensive care unit, and cardiac catheterization labo-
ratory.8 The resuscita tive devices include the IAB P,
extracorporeal m em brane oxygenation (ECM O ), a
percutaneous left a tria l fem oral artery bypass system ,
a continuous axial blood flow pum p (Hem opum p), and
direct m echanical ventricular actuation (D M V A ). M ost
of these devices are usually placed for short-term use,
and if prolonged circulatory support is needed, the
patient usually is sw itched to one of the devices m ore
suitable for long-term support (Table 2).
The IAB P is the sim plest, m ost com m only used
m echanical circulatory assist device. A pproxim ately
75,000 to 80,000 IA BPs are inserted each year in the
U nited States (personal com m unications, DataScope
Corporation, M ontvale, N J). The exact num ber being
placed because of cardiogenic shock and cardiac arrest
is not known, how ever. The IA BP is usually inserted
percutaneously, and less often by cut-dow n, into the
fem oral artery and advanced into the descending
thoracic aorta just distal to the left subclavian artery.
W hen fem oral artery access is not possible , the balloon
catheter m ay be advanced into the descending thoracic
aorta from the iliac artery, axillary artery, subclavian
artery, abdom inal aorta , and ascending aorta .an In
addition, w hen long-term support with this device is
planned, it has been suggested that the patient can
be m obilized easier if the catheter is inserted in the
(1) axillary artery, (2) subclavian artery,sa or (3) iliac
artery.4 W hen placed in the iliac artery as a perm a-
nent device, the extravascular portion of the balloon
pneum atic tubing was stabilized by routingit
throughthe iliac crest.4
The IA BP is a pulsatile , pneum atic device that
infla tes with gas during diastole and deflates during
systole.#{176} The balloon catheter produces a reduction
in left ventricular afterload and an increase in coronary
perfusion pressure along w ith a decrease in m yocardial
oxygen consum ption, w hich favorably alters the ratio
of m yocardial oxygen supply and dem and.# {1 76 } A lt ho ug h
the device increases coronary diastolic perfusion pres-
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600S Management of Cardiac A rres t and Cardiogenk S hock Irvin F Gokienberg)
Table 5-H em odynam ic Effectsof Intra-aort icBalloon Pump
Effects % Change
Peak systolic arterial pressure 5 -1 5 d ec re ase
P resystolic (end -diastolic) aortic 2 0-3 0 d ecr ea se
pressure
Diastolic aortic pressure 70 increase
M ean aortic pressure N o significant change
Left ven tricular en d-d ias tolic pressure 10-20 d ecreasePulm onary artery w edge pressure 1 0- 20 d ec re ase
P eak d is/c lt 1 0- 20 d ec re as e
Heart rate 5-10 decrease
V m ax 25 decrease
Cardiac output 10-41) increase
sure, the ability of this device to increase coronary
blood flow in patients w ith severe flow-lim iting coro-
nary disease has been questioned. How ever, it does
appear to often increase coronary blood flow in
patients w ith m oderate to severe hypotension and
cardiogenic shock. {149}
The hem odynam ic effects of this device are variable
and depend som ewhat on the underlying cardiacfunction,29 The cardiac output m ay typically increase
from 10 to 40 percent (usually 10 to 20 percent).829
A lthough augm entation of cardiac output by 500 to
800 m I/m m has been reported to be the average
patient response, som e patients m ay have very m ini-
m al response w hile others m ay have significant
increases in cardiac output ie , >1.5 L/m in in-
crease). 19.29.33,34 The left ventricular end-diastolic pres-
sure and pulm onary artery w edge pressure usually
decrease 10 to 20 percent, but decreases >30 percent
have been seen in som e studies.29-33 The typical
hem odynam ic changes that occur w ith IA BP insertion
are show n in Table5,29
A lthough the IA BP is usually inserted for a short-
to interm ediate-term duration, the device has been
used for long-term support. O ne patient w as sup-
ported for 327 days.33 The IA BP has been used for
cardiogenic shock and cardiac arrest. W hen used for
cardiogenic shock secondary to a m yocardial infarc-
tion, this device has produced conflicting reports
regarding its ability to affect m ortality when used
without revascularization procedures.133 3.b 0 A c lo se
review of the data , how ever, does suggest the IA BP
has a m odest effect on decreasing m nhospita l m ortality
from cardiogenic shock in acute m yocardial infarction,
but long-term m ortality and m orbidity continue to be
poor. W hen this device is used alone (w ithout
revascularization) in patients w ith m yocardial infarc-
tion and cardiogenic shock, short-term (inhospital or
30-day) m ortality is betw een 47 percent and 83
percent.3340 M any of these patients m ay becom e
balloon dependent, w hile other patients m ay require
prolonged circulatory support eg , >14 days) before
they are able to be w eaned from the device.333740-
H ow ever, when the IA BP w as used in conjunction
w ith surgical revascularization for patients w ith acute
m yocardial infarction and cardiogenic shock, inhos-
pita l m ortality and long-term survival w ere im proved
when com pared w ith treatm ent w ith an IA BP
alone
W hen used early, an IA BP can potentia lly assis t in
m yocardial recovery. This device is very effective in
patients w ith acute m yocardial infarction and severem itral regurgitation or ventricular septal defect.30- It
also has been effective in treating hem odynam ically
unstable refractory ventricular arrhythm ias presum a-
bly by favorably im proving the ratio of m yocardial
oxygen supply and dem and and by im proving system ic
hemodynamics.#{176}-47
The IA BP has been used successfully as the sole
nonpharm acologic intervention in postcardiotom y
cardiogenic shock, w ith m ortality rates between 37
percent and 73 percent.8-33-5 In addition, the IAB P
was am ong the first m echanical assist devices used
successfully as a bridge to transplantation.52 Posttrans-
plant survival in patients who receive an IAB P as a
bridge to transplant is sim ilar to patients w ho w ere
supported w ith pharm acologic agents alone prior to
transplantation. A lthough the IA BP is capable of
supporting the circulation in som e patients, the m ajor
disadvantages are its relatively m inor effect on hem o-
dynam ics com pared w ith other m echanical assist de-
vices and its inability to have a significant effect in
m any patients w ith severe right ventricular dysfunc-
tion. Patients with the m ost severe cardiogenic shock
and patients in cardiac arrest will, in general, need
devices capable of providing a greater degree of
circulatory support. Low to m oderate to full dose
heparinization is usually used w ith the IABP C om pli-
cations occur in up to 30 percent of patients with
IAB E Com plications are prim arily vascular, but also
include infection, hem olysis, throm bocytopenia , em -
bolization, and gas leak. Contraindications include
significant aortic insufficiency and a significant aortic
aneurysm . The device m ay have difficulty functioning
adequately w hen cardiac arrhythm ias are present.
Fem oral artery-fem oral vein ECM O provides rapid
cardiopulm onary bypass for patients w ith cardiogenic
shock and/or cardiac arrest.8 A lthough original
placem ent of fem oral-fem oral ECM O required surgi-
cal cut-dow n, it now is frequently placed percutane-
ously.M The percutaneous technique w as initia lly
described by Phillips et al in 1983. Because of
advances in catheter design and favorable results from
the N ational R egistry of E lective Supported Angio-
plasty, use of this technique has led to rapid acceptance
of this approach for em ergency circulatory support.
Fem oral-fem oral ECM O has also been referred to as
peripheral cardiopulm onary bypass and when placed
percutaneously, percutaneous cardiopulm onary by-
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C HE S T 1102 I 5 I N O V E M B E R 1992 I Supplem ent 2 601S
pass. The system consists of a venous and arterial
cannula , a m em brane oxygenator, a blood pum p, and
a heat exchanger.34 The venous cannula is inserted
into the fem oral vein and advanced to the inferior
vena cava or right atrium . The arterial cannula is
inserted in the fem oral artery and m ay be advanced
into the iliac artery or aorta . B lood is withdraw n from
the right atrium or inferior vena cava through the
venous cannula and into the blood pum p (m ost oftena centrifugal blood pum p), where the blood is then
pum ped to the m em brane oxygenator and the blood
becom es oxygenated. The oxygenated blood then
returns through the arteria l cannula to the patient.
A lthough ECM O has been used to support patients
for up to 18 days,33 it is presently recom m ended that
patients who require continuous support for m ore
than 48 h have alternative m echanical circulatory
devices pursued for im plantation.18 A t experienced
centers, percutaneous cardiopulm onary support can
often be established w ithin 15 m m . The Volunteer
National Registry of Supported A ngioplasty Partic i-
pants is also collecting data on em ergency peripheral
cardiopulm onary bypass.57 The registry presently has
data on 234 patients w ho w ere treated w ith em ergency
peripheral cardiopulm onary bypass due to cardiac
arrest (N= 168) or cardiogenic shock (N= 66). There
w ere 82 patients (35 percent) w ho survived and were
im proved at the tim e of hospita l discharge. Patients
w ho had cardiopulm onary bypass established in less
than 20 m m had a 50 percent inhospita l survival. Flow
rates w ith this device are usually betw een 3.5 and 5
L/m in in m ost patients.34 Patients require full hepa-
rinization.8 How ever, there has been a report of safely
using ECM O without heparin in four patients w ho
had severe hem orrhage.29 D espite this report, full
heparinization is recom m ended. Com plications from
this device include bleeding, biventricular failure ,
infection, neurologic deficits, throm boem bolic events,
and lim b ischem ia. 33 Com pared with other m echan-
ical circulatory devices, patients on ECM O are less
m obile than the paracorporeal pneum atic devices, and
have longer and m ore severe hem olysis than the
noncentrifugal V A D.33 Its m ajor advantages are its
rapid insertion and its com plete cardiopulm onary
support even in patients w ith arrhythm ias, such asasystole or ventricular fibrilla tion. A lthough this de-
vice has been dem onstrated to provide excellent
system ic perfusion and hem odynam ic support, its
ability to provide m yocardial protection is un-
clear.18,60,65 In fact, there are data to suggest that
percutaneous cardiopulm onary support can induce
cardiac anaerobic m etabolism resulting in a detrim en-
tal effect on m yocardial protection.6 A dditional stud-
ies have dem onstrated regional wall m otion abnor-
m alities w ith w orsening w all m otion scores during
cardiopulm onary-supported coronary angioplasty.6#{176}
A percutaneous left a tria l fem oral artery circulatory
support system that obtains access to the left a trium
with a transseptal puncture has been used to success-
fully resuscitate patients in cardiogenic shock.as This
percutaneous partia l left heart bypass system uses a
14 to 20 French specifically designed venous cannula
(Electrocatheter Corporation, Rahw ay, N J, or Schnei-
der U SA , M inneapolis, M inn), w hich is inserted into
the fem oral vein and advanced across the intra-atria l
septum after a transseptal puncture is perform ed.62
Blood is then w ithdraw n using a roller pum p from the
left a trium and returned through a 14 to 20 French
cannula that has been inserted into a fem oral artery
and often advanced into the iliac artery or aorta . Since
a transseptal puncture is perform ed, this procedure
m ust be done under fluoroscopy. Flow rates of 1.5 to
Ficure 1. The Hem opum p is inserted into the com mon
fem oral artery vi a side arm graft an d is advanced acrossth e aortic valve into th e left ven tricle (reprodu ced w ith
perm ission from E m ery andJoyce).
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F I G U R E 2. The A rchim edean screw is approximately the size of a
pencil (reproduced w ith perm ission from Emery and Joyce).
SUS TA INE D NEG ATIVE
PR ESSU R E SYSTE M
VACU U M SO U R CE
D AM PER VALVE
F I G U R E 3. The schematic diagram of the direct m echanical ventricular actuation drive system and cup.The cup is show n actuating the ventric les into both the systolic right) a nd d ia sto lic left) configurations
(reproduced w ith perm ission from Low e et al .
602S M anagem ent of Cardiac A rrest and C ardiogenic S hock Irvin F Goldenberg)
4.5 L/m in have been obtained.62 Patients have been
supported w ith this device for up to 10 days.62 O nly a
sm all num ber of patients w ith cardiogenic shock have
received this device.627 C ontinuous and full hepa-
rinization is recom mended.8
The H em opum p (Johnson & Johnson, W arren, N J)
is a new , continuous axial blood flow pum p (Fig 1) that
propels blood from the left ventric le to the descending
aorta.672 It is an intravascular pum p that uses an
A rchim edean screw principle (Fig 2) and rotates at
15,000 to 25,000 rpm to provide unidirectional, non-
pulsatile flow at rates of 2 to 3.5 Lfm in. The 21 French
size pum p and inflow cannula of the Hem opum p is
advanced through a surgical cut-dow n in a fem oral
artery. The flexible 7-m m inflow cannula of the cable-
driven pum p is then advanced under fluoroscopic
exam ination into the ascending aorta and then across
the aortic valve into the left ventric le . The cable drive
shaft of the Hem opum p is 11 French and rem ains the
only obstruction to com m on fem oral artery flow
O ccasionally, insertion is m ade through the aorta . A
shorter H em opum p for direct insertion via the as-cending aorta is under developm ent. The H em opum p
is useful only for left ventricular support. A recent
s tudy of the H em opum p in patients w ith cardiogenic
shock w as com pleted (Johnson & Johnson sum m ary
report on m ulticenter trial w ith H em opum p in cardi-
ogenic shock: unpublished data). O ne hundred tw enty-
three patients w ho w ere supported for up to 14 days
w ere entered into this study. N inety-seven patients
(79 percent) underwent successful insertion of the
H em opum p while 26 patients (21 percent) were unable
to have the H em opum p inserted. N ine patients w ho
received the H em opum p were excluded from analysis
because they also had received other cardiac assist
devices. In the 88 patients still analyzed, 24 (27
percent) survived. In the 26 patients in w hom the
H em opum p could not be inserted, there were 5 (19
percent) survivors. The lack of a statistically significant
im proved survival in the patients w ho received the
H em opum p w as believed by the m anufacturer to be
due possibly to inadequate sam ple size or to the fact
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F I G U R E 4. Biventricular support w ith a centrifugal pump (courtesy of Bio M edicus, Eden Prairie , M inn).
CH ES T 1102 I 5 I N O V E M B E R 1992 I S upplem ent 2 603S
the patients entered into the study were too ill and
already had irreversible shock. A new study evaluating
patients w ith less severe and hopefully potentia lly
reversible cardiogenic shock is being considered.
Com plications included blood loss at the tim e of
insertion, vascular and throm boem bolic . C linically
significant hem olysis did not occur. M oderate antico-
agulation is necessary. A 14 French percutaneous
device is under developm ent.29 Som e initial s tudiesw ith this 14 French percutaneous device dem onstrated
significant hem olysis unlike the 21 French device.29
Direct m echanical ventricular actuation is a biven-
tricular circulatory support device that can be rapidly
applied (Fig 3).7 Although it requires a surgical
procedure, it is technically sim ple. This circulatory
support device has been described as an im proved
m ethod of internal cardiac m assage. The device can
be positioned through a sm all left anterior sixth
intercostal space thoracotom y. A recent feasibility
study in patients w ith cardiac arrest dem onstrated the
average application took less than 2 m m from the tim e
of skin incision, and resulted in im m ediate hem ody-
nam ic im provem ent.74 A nstadt et al74 provided the
follow ing description of how the device w orks.The device em ploys a contoured cup w hich is pneum atically driven
to actuate the ventricular myocardium . The drive system regulates
the cups actuation (cycle rate, systolic duration, actuating forces,
and rate of force delivery) and supplies a continuous vacuum to
maintain the cups attachm ent. This vacuum creates a constant seal
between t he v en tr ic ul ar myocardium an d the actu ating d iaphragm
of the cup. D uring actuation, the ventricular m yocardium is pushed
into systole and pulled into diastole configurations creating an
action w ith remarkable effectiveness. .
A lthough D M V A w as initia lly described in the m id-
1960s, only a few studies in hum ans have been
perform ed using this device. O ne report w as a clinical
feasibility tria l dem onstrating that in patients w ith
prolonged cardiac arrest, unresponsive to traditional
m edical interventions, D M VA could be applied rap-idly.74 In fact, in 22 patients in cardiac arrest for m ore
than 40 m m , the application of the device took less
than 2 m m from the tim e of skin incision. Four patients
w ere successfully defibrilla ted; how ever, a ll subse-
quently died. Application of the device resulted in
im m ediate hem odynam ic im provem ent. D uring this
s tudy, there w as no com plication related to the device
itself how ever, a cardiac laceration occurred during
the pericardiotom y in one patient. Another evaluation
in two patients w ith cardiogenic shock dem onstrated
the device could be applied in 3 to 5 m m and could
support the circulation in both these patients .75 O ne
subsequently underwent successful cardiac transplan-tation, and the other had support discontinued because
of irreversible neurologic injury w hich occurred prior
to device insertion.
The device is capable of producing cardiac outputs
of 80 to 110 percent of control. At present,it is
believed it should be used for relatively short-term
support w ith eventual replacem ent with a m ore stan-
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604S Managemen t o f C a rd ia c A rre st an d C ard iog en ic S hock Irv in F Goldenberg)
dard VA D .33 A s m ore data are obtained with this
device, its proper role w ill becom e m ore evident. This
device does have the advantage of rapid application
and does not require anticoagulation therapy.
External Centrifugal and Roller Pumps
A fter the IA BP, the centrifugal and roller pum ps
are the next m ost used m echanical assis t device. 7
This is prim arily due to their com m ercial availability,low cost, and sim plicity These devices are not inves-
tigational and can be obtained by all centers requesting
them . The devices can provide univentricular or
biventricular support (Fig4).18.59 Cannulas from the
devices (1) w ithdraw blood from the right atrium and
return it to the pulm onary artery for right ventricular
assistance, and (2) w ithdraw blood from the left atrium
or left ventricular apex and returnit to the ascending
aorta for left ventricular assistance.8 These devices
can pum p 5 to 6 11m m and can com pletely support
the circulation functioning in paralle l w ith the support
ventric le .19 Both roller and/or centrifugal pum ps are
readily available at institutions doing coronary artery
bypass surgery, as they are an integral part of the
cardiopulm onary bypass circuit used during cardiac
surgery.29 O ne could consider this one of the m ost
com m on form s of short-term m echanical circulatory
support. There are three m anufacturers w ho produce
the centrifugal pum ps (Bio M edicus, B io M edicus m c,
Eden Prairie , M inn; Sans, Sarns/3M , A nn Arbor,
M ich; and A ires M edical, W oodbury, M ass).9 The
centrifugal devices propel blood through the pum p
head w ith centrifugal force.u These pum ps are usually
nontraum atic and have good blood-handling proper-
ties.29 The Bio M edicus device generates flow by
utiliz ing a restrained vortex created by rapidly rotating
sm ooth plastic cones.29 A rapidly rotating im pella
generates flow w ith the Sarns device.29 The Sans
pum p has also been referred to as the Centrim ed
Table 6-Results of P atients Supported Postcardiotom y*
Patients
Supported W eaned Survived
Centr i fugal 72 2 356 (49)t 194 (27)
Thoratec 95 35 (37) 20 (21)
N ovacor LV A S 10 1 (10) 1 (10)
T CJ H eartm ate NA N A NA
Sym bion AV AD NA N A NA
A biom ed BVS System 5000 145 79 (54) 34 (23)Total 97 2 471 (48) 249 (25)
1. A SA IO -L SH T V olun tary R egis try3/1192, p erso na l co mm un ica -
tion ; 2 . Thoratec Clinical U pdate 1131192;3. N ovacor LV A S C linical
Update 5/3/92; 4. A biom ed, personal com m u nication , N ovem ber
1991. Modified an d p rin ted w ith perm ission from E m ery an d
Joyce.
tN um bers in parentheses indicate percent of total supported.
pum p.29 The centrifugal and roller pum ps produce
nonpulsatile flow . A lthough these devices are often
used in conjunction w ith an IA BP to produce pulsatile
flow , there are no definitive data available dem onstrat-
ing the necessity of using pulsatile flow w hen treating
patients w ith cardm ogenic 8 7929 Roller pum ps
are often the blood pum ps used w ith percutaneous
left a tria l-fem oral artery bypass,6229 w hile centrifugal
pum ps are the predom inant blood pum ps being used
w ith ECM O.M These devices are usually used for
short-term duration (less than 1 w eek), a lthough a
centrifugal device has been used for 31 days in a
patient w ho w as bridged to transplantation. Recom -
m endations on anticoagulation in patients w ith cen-
trifugal devices vary am ong the different investiga-
tors .8#{176}788283 W hile som e have recom m ended
m oderate continuous heparm n infusion throughout de-
vice im plantation, others have used little or no hepa-
rinization.89788229 A t our center, patients with cen-
trifugal pum ps are not required to receive heparin if
V AD flow is greater than 2 L. W hen VA D flow is less
than 1.5 to 2 L/m in, the patient receives continuous
Table 7-Result of VAD Support inPatients B ridg ed to T ran spla ntatio n5
Patients
Supported
Transplanted,
No . (% )
Supported Survived,
N o. (% )
T ransp lan ted S urvived,
No. (% )
Dayst
Supported
Centrifugal 99 59 (60) 35 (35) 35 (59) (1-31) 6
Thoratec 165 103 (63) 86 (52) 86 (83) (1-226) 18
N ovacor LV AS 113 67 (59) 62 (54) 62 (92) (1-370) 43
T C I-H eartm ate 56 31 (55) 27 (48) 27 (87) (1-324) 10 2
S ym bion A V A D 131t 27(N A ) 22(N A ) 22 (81) (1-164) 48A B IO M ED B V S S ystem 5000 58 42 (84) 23 (40) 23 (54) (1-30) 5
Total 491 302 (61) 233 (47) 233 (77)
1. A b iom ed A SA IO -IS H T Voluntary Registry 3/1192, personal com m unication; 2. Thoratec C linical Update 1131192; 3. Novacor LV AS
Update 5/3/92; 4.TC I personal com munication 1/1192;5. Sym b ion C linical Update 5/1191; 6. Abiom ed, personal com munication, N ovem ber
1991. M odified and printed with perm ission from references 19 and 86.
tRange and m ean days.
tln clu des all patien ts w h o received the S ym bion A V A Ddevice for any reason (b rid ge to tran splantation, postcardiotom y sh ock ,etc). N u m b e rw ho received it only as bridge to transplant is not available . The total number of patients who received the device and the nu
p atients transp lanted an d the n um ber of patien ts w h o su bsequ en tly survived after transplanta tion is available , h ow ever.
Excludes Symbion AV AD because data available areno t s im ila i to o th er d ev ic es,
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F,cuas 5. Biventricular supportwith th e Pierce-D onach y T horatecventricular assist system (reproduced w ith perm ission fromPen-
nington an d Termuhlen .
CH E ST 1102 / 5 / N O V EM B E R 1992 I S upplem ent 2 605S
heparinization. For patients on a roller pum p, contin-
uous heparm n is adm inistered throughout device im -
plantation.
The advantages of the centrifugal and roller pum ps
include the following: (1) availability; (2) low cost; (3)
ability to provide biventricular support; and (4) allow s
for cannulation of either left a trium or left ventric le.
The disadvantages of these devices include the follow -
ing: (1) poor patient m obility during device im planta-
tion; (2) lack of evidence that devices can be used for
prolonged periods of tim e; (3) need for at least lim ited
heparmnization; (4 ) tendency tow ard m ore frequent
and m ore severe hem olysis;as and (5) nonpulsatile flow .
The results from using centrifugal devices in pa-
tients w ith postcardiotom y shock and as a bridge to
transplantation are show n in Tables 6 and 7.
External Pulsatile Ventricular Assist Devices
The external pulsatile V A Ds are all investigational
devices requiring FD A approval. They include the
Pierce- D onachy Thoratec V AD (Fig 5) (Thoratec Lab-
oratories Corporation, Berldey, Calif), the Pierce-
D onachy Sans Pulsatile VA D (Sans/3M , Ann A rbor,
M ich), the Sym bion A V A D (Sym bion Inc, Salt Lake
City, Utah), and the Abiom ed BV S (Biventricular
Support System 1-5000) device (A biom ed m c, Dan-
vers, M ass).8 All these are pneum atic pulsatile devices
that can provide univentricular or biventricular sup-
port. For right ventricular support, blood is w ithdraw n
from the right atrium and pum ped to the pulm onary
artery w ith all four devices . For left ventricular support
w ith the Thoratec VA D or Sans Pulsatile VA D , blood
is w ithdraw n from the left a trium or left ventric le and
pum ped to the ascending aorta. D uring left ventricularassistance w ith the Sym bion AV A D or A biom ed device,
however, blood can only be withdraw n from the left
a trium (and not the left ventricle) and pum ped to the
ascending aorta . These devices can provide full c ir-
culatory support and flows of 6 to 7 IJm in.29 The
A biom ed is extracorporeal, while the other three
devices are paracorporeal in location. The extracor-
poreal location of the Abiom ed device signfficantly
im pairs patient m obility com pared w ith the other
devices w ithin this class. Therefore, the Abiom ed has
been used only for short to interm ediate duration,
w hile the other devices have been used for short to
lo ng d ura tio n. 8 The A biom ed device has polyurethane
valves, while the other devices all have m echanical
prosthetic valves. M oderate anticoagulation is needed
w ith Sym bion AV A D and A biom ed device. Pennington
and Sw artzra.es have stated that because of the high
shear rate of blood across the valves in the Thoratec
device, anticoagulation with heparin is not required
as long as the device has been im planted for less than
1 week and flow rates are greater than 3 IJm in. Since
1990, the FD A has prohibited investigational use of
the Sym bion A VA D .
The advantages of these devices include the follow -
ing: (1) greater patient m obility for the paracorporeal
devices; (2) substantial evidence for short- and long-
term support w ith the paracorporeal devices; (3)
heparin anticoagulation requirem ents are less for the
Thoratec device; and (4) provides pulsatile flow . D is-
advantages include the follow ing: (1) the devices are
investigational and m ore difficult to obtain; (2) the cost
is increased; (3) they are m ore difficult to insert; and
(4) they require m ore sophisticated support staff.
The clinical results w hen these devices were used
for postcardiotom y shock and as a bridge for trans-
plantation are show n in Tables 6 and 7. In addition,
the duration of support (m ean and range) w ith each of
the devices w hen used as a bridge to transplant is
provided in Table 7.
Implantable Left Ventricular Assist System s
There are two im plantable left ventricular assist
system s, both of w hich are investigational and can be
used only for left ventricular support.8-#{176} The devices
are the N ovacor (Novacor LV A S, Division of Baxter,
D eerfie ld, Ill), Left V entricular Assist System (LV AS),81
and the Therm o Cardiosystem s Inc (TCI) H eartm ate
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606S Managemen t of C ard iac Arrest andCardlogenic Shock Irv in F G old en be rg )
D evice29 (W oodburn, M ass). The latter device has also
been referred to as the Therm edics V AD . Both devices
provide pulsatile flow . The TC I H eartm ate is a pneu-
m atic pulsatile device,29 w hile the N ovacor is an
electrical pulsatile device. Both devices are im -
planted in the left upper quadrant of the abdom en.
The left ventricular apex is cannulated by both devices,
and blood is w ithdraw n from the left ventric le and
pum ped into the ascending aorta. Since neither deviceallow s for left atrial cannulation, these devices require
a portion of the left ventricle be rem oved w hen they
are in use.8 Therefore , these devices are less desirable
in patients w ho are likely to have recovery of their left
ventricular dysfunction e g, postcardiotom y shock).
The N ovacor pum p has a sm ooth, blood-contacting
surface, and uses pericardial tissue valves , w hile the
TCI Heartm ate uses porcine xenograft valves and has
a unique blood contacting surface that is textured to
provide for the form ation of a biologic lm ning.8 The
TCI Heartm ate does not require any anticoagulation
except for aspirin and dipyridam ole (Persantine).29
W hile som e investigators have used continuous low -
dose heparin in patients with the N ovacor LV AS,
others have suggested that heparm n anticoagulation
m ay be needed only when V AD flow rates are low ,
when the patient is being w eaned from the device, or
after postoperative day729.87
B ecause these devices supply only left ventricular
support, patients who require biventricular m echani-
cal support will either need to (1) be evaluated for a
totally different system (eg, total artific ial heart or tw o
pneum atic or centrifugal devices), or (2) receive a
hybrid system e g, treatm ent w ith im plantable LV AD
for left ventricular support and a centrifugal or exter-
nal pneum atic device for right ventricular support).
U nfortunately, the developm ent of right ventricular
failure is som etim es not identified until after one of
these im plantable devices is already in place, thus
leading to a subsequent placem ent of an RV A D at a
later tim e.87
Pulm onary Artery Balloon C ounterpulsa tion
Pulm onary artery balloon counterpulsation has
been used in postcardiotom y patients for the treat-
m ent of severe heart failure or shock secondary to
severe right ventricular dysfunction.8 Since 1980,
there have been reports of using a standard IA BP in a
graft sew n to the pulm onary artery to perform pul-
m onary artery balloon counterpulsation. The graft
sewn to the pulm onary artery acts as a reservoir for
blood and the balloon. Several reports have show n
definitive hem odynam ic im provem ent in postcardiot-
om y patients with significant right or biventricular
dysfunction. M ost reports , how ever, have included,
at m ost, a few patients. B ecause of the technical
com plexity of the procedure and the availability of
other assist devices, there has not been significant
application of this procedure in patients w ith postcar-
diotom y right ventricular dysfunction. A pulm onary
artery balloon that can be positioned into the pulm o-
nary artery percutaneously has been developed and
evaluated in anim als.29 U ntil a percutaneous pulm o-
nary artery balloon catheter is available clinically , I
suspect this procedure w ill receive only rare applica-
tion, especially at centers that have experience inplacing other RVA D s. It should, how ever, be consid-
ered as an option, particularly at centers that do not
have access to other RV AD s.
O rthotopic B iventricular Replacem ent Prosthesis
ArtJicia l H eart)
Since 1969, 11 different m odels of the total artificia l
heart have been used for tem porary or perm anent
circulatory support in 226 patients.5 Two hundred
thirty total artificia l hearts w ere placed in 226 pa-
tients.5 The total artific ia l heart w as used as a per-
m anent circulatory support device in five patients,
while the rem aining 221 patients (225 im plants) had
the total artific ia l heart placed as a bridge to trans-
plantation.5 O nly lim ited data are available on the 18
recipients of the Poisk and C zech total artific ia l heart.
The data on the 207 rem aining im plants (182 patients)
are sum m arized.5 Of the 207 im plants, 186 were w ith
a Sym bion total artificia l hearts (previously called the
Jarvik 7-70 and Jarvik 7 total artific ial hearts). Of the
207 im plants, 135 (65 percent) subsequently under-
w ent orthotopic cardiac transplantation. A t 1 year
postcardiac transplantation, 67 patients (50 percent)
w ere alive. O f the 39 non-Sym bion total artific ial heart
im plants, there w as only one (3 percent) long-term
survivor. The one non-Sym bion total artific ial heart
long-term survivor had a sm all Vienna heart placed.
H ow ever, in the patients w ho received a Sym bion total
artific ial heart, 40 percent survived 1 year, while 56
percent of the patients in this group w ho subsequently
underw ent transplantation survived 1 year.5
A description of all 11 m odels of the total artific ia l
heart is beyond the scope of this review. H ow ever,
because the m ajority of the im plantations w ere from
the Sym bion total artific ia l heart, a description of that
device w ill follow.
The Sym bion total artific ial heart is a pneum atic
device that consists of tw o separate ventric les (Fig 6).
A ll four valves are M edtronic-H all m echanical pros-
thetic valves. The artificia l right and left ventric les are
secured to the native right and left a trium , pulm onary
artery, and aorta . There are two versions of the
Sym bion total artificia l heart-the Sym bion 7 and
Sym bion 7-70, with the stroke volum e being 100 m l
and 70 m l, respectively. The tim e spent supporting
the circulation with the Sym bion total artific ial heart
as a bridge to transplant ranges from 1 to 603 days
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C HE ST / 102 I 5 I N O V E M B E R 1992 I S upplem ent 2 607S
F I G U R E 6. S ym bion t ot al a rt if ic ia l heart.
w ith a m ean tim e of 26 days and the m edian w as 8
days.5 Infection, bleeding, and renal failure were them ost com m on side effects from the total artffic ia l
heart. N eurologic events occurred in only 5 percent
of the patients who received the total artific ia l heart
as a bridge to transplantation.
A ll five patients w ho received the Sym bion total
artificia l heart as a perm anent device died.5 Range of
im plantation in these patients ranged from 10 to 620
days w ith 80 percent of the patients living m ore than
30 days.5 D eath in the five patients occurred from
sepsis in four and from surgical bleeding in one.15
Since January 1990, the FD A has prohibited the sale
of Sym bion total artificia l hearts in the U nited States.
Perm anent Devices
Five patients had the Sym bion total artificia l heart
im planted as a perm anent device before the FD A
prohibited further im plants. These patients were
described in the previous section of this report. In
addition, tw o patients had received an IA BP w ith the
intent on using it as a perm anent device.4 One of
these patients had the device rem oved after 8 w eeks
because of a fever of unknown origin. The other
patient died of renal failure 38 days after device
im plantation. A t present, investigational w ork in clin-ical studies are beginning in regard to im plantation of
a perm anent prototype of the Novacor LVA S. W hile
no other device is presently undergoing clinical eval-
uation, s ignificant w ork is being done in developing
other im plantable V AD s and total artific ia l heats for
perm anent use. Since the num ber of patients aw aiting
cardiac transplantation, presently and in the fore-
seeable future , far outw eigh the num ber of donor
hearts available , there are a substantial num ber of
patients w ho could obviously benefit from the devel-
opm ent of perm anent ventricular assist or replace-
m ent devices.
C om plications in Patients W ith M echanical Assist
Devices
The m ost com m on com plications in patients with
m echanical assist devices include bleeding, renal
failure , infection, and throm boem bolic events.829 In
devices that are im planted percutaneously, vascular
com prom ise is also another significant problem .18 In
patients on a m echanical assist device w ho are being
bridged to cardiac transplantation, their survival is
significantly lower if they have significant bleeding,
renal failure , or infection.8 In patients with postcar-
diotom y shock, the developm ent of renal failure orperioperative m yocardial infarction is associated with
a poorer prognosis.8 Rarely, hypoxia secondary to
Table 8-C oronary Angioplasty fo r C ardiogenic Shock Com plicating Acute M yocardial Infarction5
Reperfusion
M ortality Rate
{149}
Study N o. Rate Total + Reperfusion - Reperfusion
ONeill et al 27 24/27 [88] 8/27 [30] 6124 [25] 2/3 [67]
Shani et al 9 6/9 [67] 3/9 [33] N/A N /A N /A N/A
Heuser et al#{176} 10 6/10 [60] 4/10 [30] 1/6 [17] 3/4 [75]
Brow n et aln 28 17/28 [61] 16/28 [57] 7/17 [42] 9/11 [82]
Laram ee et al 39 33/39 [86] 16/39 [41] N/A N /A N /A N/A
Lee et al 24 13/24 [54] 12/24 [50] 3/13 [23] 9/11 [82]
Lee et aP 69 49/69 [71] 31169 [45] 15/49 [31] 16/20 [80]GaciochandTopol 25 18/25 [72] 11/25 [44] 4/18 [22] 7/7 [100]
Disler et al#{176} 7 5/7 [71] 417 [57] 2/5 [40] 2/2 [100]
Vernaetalbo6 7 7/7 [100] 1/7 [14] 1/7 [14] 0/0 [0]
M eyer et al#{176} 25 22./25 [88] 12/25 [47] 9/22 [41] 3/3 [100]
Hibbard et al 45 28/45 [62] 20/45 [44] 8/28 [29] 12/17 [71]
M oosvi et al 38 29/38 [76] 18/38 [47] 11/29 [38] 7/9 [78]
Eltchaninoffet al 33 25/33 [76] 12/33 [36] 6/25 [24] 6/8 [75]
Total 386 282/386 [73] 168/386 [44] 73/243 [30] 76/95 [80]
*D ata represent patient num bers. Numbers in brackets represent percents. N /A= not available; plus sign= w ith; m in us sign = without.
Printed w ith perm ission from Bates and Topol.L2
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608S M anagem ent of C ardiac Arrest and Cardiogenlc S hock Irv in F O oId en be i
right-to-left shunting across a patent foram en ovale
occurs in patients w ith an LV AD .29
Skeletal M uscle-Powered Cardiac Assistance
At present, em ergent use of skeletal m uscle-pow -
ered cardiac assistance is not possible for the treatm ent
of cardiogenic shock or cardiac arrest. D ynam ic car-
diom yoplasty, however, has been used clinically for
the treatm ent of patients with severe congestive heartfailure .29 It is, however, conceivable that with signifi-
cant further advances in cardiom yoplasty, atriom yo-
plasty, dynam ic aortom yoplasty, or skeletal m uscle-
pow ered cardiac assist devices , these interventions
could potentia lly be used for the long-term treatm ent
in patients w ith cardiogenic shock w hose circulation
had been initially stabilized and supported w ith m e-
chanical circulatory support devices.29 Further inves-
tigation in this area, how ever, is needed.29
PERCU TA NEOU S INTERVEN TIO NA L PRO CEDU RES
Percutaneous M echanical Revascularization
Coronary angioplasty, directional or rotational athe-
rectom y, coronary laser angioplasty, and coronary
stenting are percutaneous interventional procedures
that im prove coronary artery patency and can poten-
tia lly reverse m yocardial ischem ia and im prove he-
m odynam ics in patients with cardiogenic shock.12.912 9
A n evaluation of 14 studies that assessed the efficacy
of em ergency coronary angioplasty for cadiogenic
shock due to a m yocardial infarction w as recently
reviewed by Bates and Topol (Table 8).12 A sum mary
of the 14 studies dem onstrated that patency rates for
em ergency angioplasty in acute m yocardial infarction
and cadiogenic shock are low er than in other patients
w ith acute infarction.2 Successful reperfusion in those
studies ranged from 62 percent to 100 percent,
averaging 73 percent. The m ortality rate in the 14
studies ranged from 14 percent to 57 percent, aver-
aging 44 percent. This w as a significant reduction in
m ortality when com pared with m ortality rates for
m edical therapy alone in his torical controls. In the 73
percent of patients w ho had successful reperfusion
from coronary angioplasty, the m ortality rate w as 30
percent, while in the patients w ho did not have
successful reperfusion, the m ortality rate w as 80
percent.2 The latter m ortality rate was not signifi-
cantly different from w hat one would expect from
m edical intervention alone. The authors of this m eta-
analysis convincingly showed coronary angioplasty
im proves survival in patients w ith cadiogenic shock
and an acute m yocardial infarction. They also pre-
sented data to suggest throm bolytic agents have a very
low reperfusion rate in these patients and provide no
evidence that these agents are effective in reducing
m ortality in acute m yocardial infarction and cardio-
genic shock.12,110.hhl In fact, the data w ould suggest
that throm bolytic agents do not favorably affect m or-
ta lity in patients w ith cardiogenic shock.#{176}
In addition to coronary angioplasty, there are other
percutaneous interventional procedures eg , coronary
atherectom y,h12 laser angioplasty, and coronary stent-
ing) that should be helpful in producing coronary
reperfusion in the setting of an acute m yocardial
infarction w ith cardiogenic shock. A lthough these
latter procedures are likely to be helpful in the settingof acute m yocardial infarction and cardiogenic shock,
either when used alone or in conjunction with coro-
nary angioplasty, there are few data presently available
with these devices in this clinical situation.
In addition to the above procedures, w hich are
generally used with the hope of perm anently im prov-
ing coronary blood flow and cardiac function, there
are additional percutaneous interventional procedures
that can be used to tem porarily im prove m yocardial
oxygenation andfunction.683 A ugm entation of dista l
coronary artery perfusion m ay be accom plished (1)
passively through autoperfusion catheters eg , bailout
or perfusion balloon catheters), and (2) actively by
pum ping oxygenated blood or fluorocarbons through
the central lum en of an angioplasty catheter.29 In
addition, im proved m yocardial oxygenation and func-
tion can be accom plished by synchronized coronary
sinus retroperfusion w ith arterial blood6 1 Percuta-
neous synchronized coronary sinus retroperfusion
delivers pulsatile blood retrogradely through the car-
diac veins to the coronary bed dista l to a coronary
stenosis .293 A ll three of these latter interventions
im prove m yocardial oxygenation and m yocardial func-
tion and can im prove hem odynainics in som e patients
w ith acute m yocardial infarction or acute coronary
closure and cardiogenic shock while m ore definitive
interventions are being im plem ented. R ecently, these
interventions w ere extensively review ed by Lincoff et
al29 and w ill be only briefly discussed herein. By
im proving m yocardial oxygenation and function and
im proving hem odynam ics, these interventions stabi-
lize the patients condition and decrease m yocardial
necrosis w hile the patient undergoes percutaneous or
surgical reperfusion or revascularization. For synchro-
nized coronary sinus retroperfusion, an infla table
balloon-tipped coronary sinus catheter is placed per-
cutaneously through a 9 French sheath that has usually
been placed in the right internal jugular vein.3 It isthen advanced into the coronary sinus and preferably
into the great cardiac vein.3 A rteria l blood usually
obtained from a fem oral artery is infused into the
coronary sinus during ventricular diastole. A n advan-
tage to synchronized coronary sinus retroperfusion is
the catheter does not have to be placed across an
occluded or stenotic coronary artery, w hich at tim es
m ay not be possible . D isadvantages to coronary sinus
retroperfusion are (1)it m ay, on occasion, not be
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CH ES T / 102 / 5 / NO VE M B ER 1992 I Supplement2 609S
possible to cannulate the coronary sinus, and (2) in
som e patients , incom plete m yocardial protection m ay
be provided with this device. In addition, coronary
sinus retroperfusion has been perform ed predom i-
nantly in patients who had m yocardial ischem ia in-
duced from left anterior descending artery stenosis or
obstruction. It is unclear how well coronary sinus
retroperfusion w ould protect against ischem ia from
the circum flex or right coronary artery because theright coronary artery, and to a lesser extent the
circum flex, often drain directly into the right atrium ,
right ventric le, or an area of the coronary sinus that
w ould not be perfused by a coronary sinus catheter
advanced into the great cardiac vein.29
K ar and cow orkers3 reported the reversal of severe
chest pain, hypotension, cardiogenic shock, com plete
heart block, and global hypokinesis w ithin m inutes of
initia ting percutaneous synchronous coronary sinus
retroperfusion in a patient with acute closure of the
left anterior descending artery. This allow ed stabili-
zation of the patients condition while further attem pts
at angioplasty w ere m ade to open the coronary artery.
W hen this failed, the patient w ent to coronary bypass
surgery hem odynam ically stable .
Transcatheter C losure of Ventricular Septa l D efects
Lock et al described their initia l results with
attem pted transcatheter closure of ventricular septal
defects. Three of the six patients had a recent m yocar-
dial infarction and w ere in cardiogenic shock. The
conditions of two of the patients initia lly im proved,
but subsequently deteriorated. This initia l study
w ould not suggest this procedure could be used as
definitive treatm ent for a ventricular septal defectassociated with cardiogenic shock secondary to a
m yocardial infarction. H ow ever,it m ay be helpful in
initial stabilization of som e patients conditions prior
to subsequent em ergent surgery. H opefully, w ith
further im provem ent and advances in the procedure,
long-term results m ay im prove.
Percutaneous Aortic Valvuloplasty
Patients w ith critical aortic stenosis w ill rarely
present in cardiogenic shock. W hile som e physicians
have favored em ergency valve replacem ent w hen this
occurs, others have believed that operative risk is
prohibitive. A t other tim es, patients m ay refuse cardiac
surgery. There have been a lim ited num ber of reports
dem onstrating that em ergency balloon aortic valvu-
loplasty can significantly im prove hem odynam ics.56
A fter the patients hem odynam ics have stabilized,
m ore elective aortic valve replacem ent can be sched-
In one study w here surgery w as delayed and
catheterization w as repeated approxim ately 6 m onths
after initial valvuloplasty, patients dem onstrated a
significant sustained im provem ent in their hem ody-
nam ics over initia l presentation, including a significant
increase in their ejection fraction.5 Thus, in this
group of patients, not only was aortic valvuloplasty a
life-saving treatm ent for their aortic stenosis and
cardiogenic shock, it also significantly im proved their
ejection fraction prior to subsequent surgery for aortic
valve replacem ent, leading to a decrease in their risk
o f s ur ge ry .
Other Percutaneous P rocedures U sed to Treat
Cardiogenic Shock
Additional percutaneous interventional procedures
helpful in the treatm ent of cardiogenic shock include
(1) pacem aker placem ent to optim ally control heart
rate and atrioventricular (A V ) delay, (2) catheter or
chem ical ablation of arrhythm ias, and (3) pericardio-
centesis.
CA RD IA C SU RG ERY
Coronary Artery Bypass G raft Surgery
Coronary artery bypass graft surgery has been used
as an effective treatm ent for cardiogenic shock sec-
ondary to an acute m yocardial
B ates and Topol2 recently perform ed a m eta-analysis
on the m ortality of patients w ho underwent coronary
artery bypass surgery for cardiogenic shock com pli-
cating an acute m yocadial infarction (Table 9). Sixteen
studies w ere review ed during the period from 1973 to
1989. 12,43.t17429 There were 216 patients w ho under-
w ent coronary artery bypass graft surgery with a
m ortality rate of 40 percent (87 of the 216 patients).
In the eight studies published since 1980, there w ere
15 0 patients w ith only a 31 percent m ortality (47 of
Table 9-Coronary Artery Bypass Graft Surgery forCardiogenic Shock Complicating Acute M yocardial
lnfarction*
Study Year No. Mortality
M undth et al 1973 33 20 [61]
M iller et a 1974 12 7 [58]W illerson et al 1975 3 2 [67]
Johnson et al#{176} 1977 5 3 [60]
Ehrich et aP 1977 3 2 [67]
Bardet et al 1977 4 2 [50]
O Rourke et al 1979 6 4 [67]
Subramanian et al 1980 20 9 [45]M erav et al (cited in 1980 7 2 [29]
DeW ood et al 1980 19 8 [42]
Kirklin et ale' 1985 4 0 [0]
Phillips et al 1986 34 8 [24]
Laks et al' 1986 50 15 [30]
G uyton et a ' 1987 9 2 [22]
Bolooki 1989 7 3 [43]
Total 21 6 87 [40)
8D ata represent patient num bers. Numbers in brackets represent
percents. Printed w ith perm ission from Bates and Topol.
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610S M anagem ent of C ardiac A rrest and C ardiogenic S hock I rv in F G old en be rg )
1 50 p atie nts ). I2,43. 4-129 W hen coronary artery bypass
surgery is perform ed in the setting of an acute
m yocardial infarction and cardiogenic shock,it should
be perform ed as early as possible. D eW ood and
cow orkers43 reported that patients who underwent
bypass surgery less than 16 h after the onset of their
infarction had only a 25 percent m ortality, w hile
patients w ho underw ent coronary artery bypass sur-
gery m ore than 18 h after the onset of their sym ptom shad a 71 percent m ortality . Presently available data
would suggest that patients with acute m yocardial
infarction and cardiogenic shock, even without a
m echanical defect, should undergo either percutane-
ous m echanical or surgical revascularization if they
present early in their infarction or have evidence for
ongoing ischem ia. 12.43,96-1o9.117-129
O ther Cardiac Surgical Procedures
O ther cardiac surgical procedures that have been
helpful in the treatm ent of cardiogenic shock include
the following: (1) repair of ventricular septal defect29
or free w all rupture secondary to a m yocardial infarc-
tion or traum a; (2) valve repair or replacem ent in
patients w ith acute valvular obstruction or regurgi-
tation29 (from m ultiple causes , including m yocardial
infarction, endocarditis, traum a, atrial m yxom a, etc);
(3) pericardial w indow to rem ove pericardial fluid or
rem oval of an extrinsic cardiac m ass causing cardiac
tam ponade; (4) pulm onary em bolectom y in patients
with acute m assive pulm onary em bolism ; (5) aneurys-
m ectom y for aneurysm contributing to refractory
arrhythm ias or cardiogenic shock; and (6) surgical
treatm ent of refractory arrhythm ias eg , ablation or
resection). In addition, pericardiectom y has been
suggested for som e patients w ho have right ventricular
infarction and cardiogenic shock.130.132
C ardia c T ransp lanta tion
Patients w ho have cardiogenic shock and irreversi-
ble cardiac dysfunction need cardiac transplantation
or im plantation of a perm anent m echanical assis t
device for survival. Since protocols for perm anent
VA D s are just beginning, m ost of these patients, if
they are to survive, w ill undergo cardiac transplanta-
tion. Since 1967, there have been approxim ately
13,000 cardiac transplantations perform ed at 230
transplant centers.lu Presently 97.5 percent of thepatients have undergone orthotopic cardiac transplan-
tation, while 2.5 percent have undergone heterotopic
cardiac transplantation.1x1 A ccording to the Registry
for the ISH T, the 1- and 5-year actuaria l survival is 83
percent and 75 percent, respectively. However,
som e experienced program s do have 1-year survivals
of 90 to 95 percent. Because of the severe donor
shortage, approxim ately 30 percent of patients aw ait-
ing cardiac transplantation die prior to receiving a
transplant. In patients w hose conditions deteriorate
prior to transplantation, a m echanical circulatory assist
device can be used to support them until transplan-
tation.
CLIN ICA L SITU ATION S
Acute M yocardia l Infarction and C ardiogenic Shock
Optim al treatm ent for patients w ith acute m yocar-
dial infarction and cardiogenic shock consists of thefollow ing: (1) early restoration of coronary blood flow
to the infarct-related artery; (2) correction of any
m echanical com plications associated w ith an acute
infarction eg , ventricular septal defect, papillary
m uscle rupture w ith m itral regurgita tion, cardiac
rupture, infarct expansion w ith aneurysm al form ation)
that m ay be contributing to the cardiogenic shock;
and (3) providing adequate circulatory supportY 3 In
the m ajority of patients presenting early after an acute
m yocardial infarction and in cadiogenic shock, rapid
and early restoration of coronary blood flow with
throm bolytic therapy, percutaneous m echanical revas-
culanzation (percutaneous translum inal coronary an-
gioplasty, directional and rotational atherectom y, laser
angioplasty, etc), or surgical revascularization is likely
to have the greatest im pact on im proving ventricular
function and survival.3 The success of these inter-
ventions depends heavily on the tim e betw een the
onset of coronary artery closure and the restoration of
effective coronary blood flow. A lthough present data
w ith intravenous throm bolytic therapy for the treat-
m ent of patients with acute m yocardial infarction and
cardiogenic shock do not dem onstrate any significant
im provem ent insurvival,1b0lhI these agents should
probably be adm inistered if there is to be any delay in
perform ing em ergent cardiac catheterization and re-
vascularization. Patients should undergo em ergency
coronary angiography, and if anatom y is appropriate ,
acute percutaneous m echanical revasculariza-
tion.296-109 Patients w ho present early in their infarc-
tion and/or w ho have evidence for ongoing ischem ia
should have surgical revascularization perform ed if (1
percutaneous m echanical revascularization is unsuc-
cessful or unfeasible , and (2) if they have appropriate
coronary anatom y. I2,43.1I7 9 N onrandom ized trials have
show n significant im provem ent in survival in patients
w ith acute m yocardial infarction and cardiogenic
shock when treated w ith coronary angioplasty or
coronary artery bypass surgery com pared w ith histor-
ical control subjects treated m edically .34396-109729 T
im prove m yocardial oxygenation during percutaneous
m echanical revascularization or surgical revasculari-
zation, one should consider interventions that are
tem porarily helpful at increasing dista lcoronary artery
perfusion (eg, perfusion catheter, percutaneous syn-
chronized coronary sinus retroperfusion).293 These
latter interventions are not appropriate for all patients,
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C HE S T 1102 I 5 I N O V E M B E R 1992 / S upplem ent 2 611S
and their use w ill need to be individualized. Som e
patients w ho present with m ultivessel disease and
have adequate perfusion w ith coronary angioplasty
still do poorly and should be considered for coronary
artery bypass surgery.
A ll patients should also be evaluated by Doppler
echocardiography and heart catheterization for m e-
chanical com plications of acute m yocardial infarction
that m ay be contributing to the cardiogenic shock. Ifm echanical com plications are present, these patients
should receive appropriate surgical therapy. A l-
though patients with acute m yocardial infarction who
present w ith a ventricular septal defect and cardio-
genic shock w ill require surgical intervention, a rare
patient w ith this problem has had his or her condition
transiently stabilized w ith percutaneous transcatheter
closure of their ventricular septal defects .4 Initia l
w ork, how ever, does not suggest this procedure can
be used as definitive treatm ent for ventricular septal
defects associated w ith an acute m yocardial infarc-
tion.4 This procedure m ay be helpful in initial
stabilization of som e patients conditions prior to
subsequent urgent cardiac surgery. An exact role for
this treatm ent in patients with acute m yocardial
infarction w ill need to aw ait further trials.
Patients w ith right ventricular infarction and car-
diogenic shock m ay have special problem s that require
additional interventions. Intrapericardial pressure has
been show n to be elevated in anim als w ith right
ventricular infarction.3 Pericardiectom y in these an-
im als has been show n to im prove hem odynam ics. This
has led som e authors to recom m end pericardiectom y
as treatm ent in som e patients w ith right ventricular
infarction. {176}In addition, severe tricuspid regurgita-
tion secondary to acute right ventricular papillary
m uscle infarction treated w ith tricuspid valve replace-
m ent has been helpful in treating cardiogenic shock
in a rare patient with right ventricular infarction.37
A lthough A V sequentia l pacing m ay be im portant for
any patient w ith heart block in cardiogenic shock,
patients w ith right ventricular infarction appear to be
particularly dependent on their atria l contribution to
cardiac output, and therefore , these patients w ho
have evidence for AV dissociation, which could be
contributing to cardiogenic shock, w ill need to be
treated with urgent AV sequentia l pacing.
W hile attem pts are being m ade to restore coronary
perfusion and to perform a diagnostic evaluation,
interventions to provide circulatory support should
also proceed. In patients with hem odynam ic instabil-
ity not responsive to pharm acologic treatm ent, m e-
chanical circulatory assist devices m ay be needed to
provide tem porary support for (1) patients w ith re-
versible cardiac ischem ia and/or m echanical com pli-
cations of an acute m yocardial infarction until correc-
tive cardiac procedures can be perform ed ie , coronary
artery bypass surgery, ventricular septal defect repair),
or (2) patients with irreversible cardiac dam age as a
bridge to cardiac transplantation. In addition, som e
patients who are not candidates for corrective cardiac
surgery or cardiac transplantation w ill require tem -
porary circulatory support. Because stunned m yocar-
dium m ay take days to weeks to recover, prolonged
use of m echanical circulatory assist devices m ay be
needed in som e patients before they can be w eaned.In patients with cardiogenic shock not responsive
to pharm acologic therapy, placem ent of an IA BP w ill
tem porarily resolve the shock in 75 percent of the
patients.39 If shock persists despite an IA BP or if m ore
com plete circulatory support is obviously needed,
other resuscitative devices (fem oral-fem oral percuta-
neous cardiopulm onary bypass, Hem opum p,43 per-
cutaneous left a trial fem oral arterybypass62) should
be placed. Percutaneous cardiopulm onary bypass sup-
port is available at m any centers and can usually be
com pleted w ithin 15 m m . The H em opum p has been
inserted in 29 patients with m yocardial infarction w ith
15 patients (52 percent) being w eaned and 10 patients
(35 percent) being discharged (Johnson and Johnson
sum m ary report of m ulticenter clinical tria l of He-
m opum p in patients w ith cardiogenic shock: unpub-
lished data). In the ten patients w ith m yocardial
infarction in whom the H em opum p insertion w as
attem pted but unsuccessful, only tw o (20 percent)
patients survived (Johnson and Johnson sum m ary
report of m ulticenter clinical tria l of H em opum p in
patients w ith cardiogenic shock: unpublished data).
Pneum atic and centrifugal V A Ds and the total artific ia l
hearts have also been used to provide circulatory
support when (1) som e of the other devices m entioned
above w ere not available, (2) greater circulatory sup-
port was needed, (3) prolonged circulatory support
w as needed, (4) cardiac corrective surgery w as being
perform ed, or (5) the patient w as being bridged to
transplant. W illerson and Fraziers