UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`Abiomed, Inc. and Abiomed R&D, Inc.,
`Petitioners
`
`v.
`
`Maquet Cardiovascular, LLC
`Patent Owner
`____________
`Case IPR2017-01205
`U.S. Patent No. 9,561,314
`____________
`
`PATENT OWNER’S EXHIBIT 2002
`
`

`

`Clinical research
`
`Intervention
`
`First experience with the Impella Recover® LP 2.5 micro
`axial pump in patients with cardiogenic shock
`or undergoing high-risk revascularisation
`
`J. Dens'*, B. Meyns?2, R-D. Hilgers?, J. Maessend*, V. van Ommen5, U. Gerckens®, E. Grube®
`
`1. Department of Cardiology, UH Leuven, Belgium; 2. Department of Cardiac Surgery, UH Leuven, Belgium; 3. Department
`of Medical Statistics, RWTH-Aachen, Germany; 4. Department of Cardiac Surgery, UH Maastricht, The Netherlands;
`5. Department of Cardiology, UH Maastricht, The Netherlands; 6. Department of Cardiology, Heart Center, Siegburg, Germany.
`
`Noneof the authors have a conflict of interest to declare.
`
`KEYWORDS
`Recover® LP 2.5,
`micro axial pump,
`coronary
`revascularisation.
`
`Abstract
`.
`oo
`.
`.
`—
`.
`Aim:To study the feasibility, safety and efficacy of the Recover® LP 2.5 assist device in patients scheduled
`for high risk off-pump coronary bypass surgery, percutaneous coronary intervention or patients in cardio-
`genic shock.
`Methods and results: 40 patients presenting with cardiogenic shock (n=13) or scheduled for a high risk
`revascularisation (n=27) were included.
`36 were selected for safety and feasibility analysis. In 3 patients the pump could not be placed in an ade-
`quate position. 5 patients had access related complications. In 9 patients free Hb rose above 80 mg/dl.
`3 malfunctions and early device-removal occurred. After device modifications these problems did not
`recur. CO in the shockgroup increasedsignificantly: 4.4 /min+1.9 to 4.8 /min+1.2 (p=0.0178).
`The left ventricular filling pressures decreased in both groups (22 mmHg=/7.5 to 16 mmHg=6 in the
`shock group, [p=0.0008] and over6 hours from 14.3 mmHg+5.8 to 10 mmHg=+2.9 in the high-risk revas-
`cularisation group,[p=0.0327)).
`Conclusions: The Recover® LP 2.5 micro axial pump allows, via percutaneous approach, partial unloading
`of the left ventricle. The techniqueis, after design modifications, feasible and safe and results in haemo-
`dynamic improvement.
`
`* Corresponding author: Department of Cardiology, Gasthuisberg University Hospital, Herestraat 49, B-3000 Leuven, Belgium
`E-mail: joseph.dens@uz.kuleuven.ac. be
`
`© Europa Edition 2006. All rights reserved.
`
`£
`
`EURO PGR
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`Eurolnterv.2006;2:84-90
`Nbrvfu, Fy. 2002-1
`Maquet, Ex. 2002-1
`JQS2017-01205
`IPR2017-01205
`
`

`

`Introduction
`Since the introduction of off-pump coronary artery bypass surgery
`(OPCAB) and percutaneouscoronary interventions (PCI) in patients
`considered to be at high-risk for haemodynamic collapse or high
`likelihood of haemodynamic collapse, the need for an easy to place
`left ventricle assist device has emerged. The device most common-
`ly used in this setting is the intra-aortic balloon pump (IABP).
`Haemodynamic support with unloading of the left ventricle results
`in reduced filling pressures, decreased wall stress and oxygen
`demand. This lowers the risk for ischaemia and prevents subse-
`quent haemodynamicinstability!4.
`However, the IABP provides, by afterload reduction, only a limited
`increase in cardiac output and becomes less effective in patients
`with tachyarrhythmias and full-blown left ventricular dysfunction.
`Meanwhile substantial experience has been gained with more
`forceful assist devices!*!8,
`In patients with cardiogenic shock,
`haemodynamic support results in improved organ perfusion, and
`when combined with interventions for reperfusion or revascularisa-
`tion, it can result in increased survival rates!9?7,
`The Hemopump® (Medtronic®, Minneapolis, USA) and the
`Recover® (Impella®, Aachen, Germany) were thefirst axial pumps
`clinically used peri-operatively and for patients in cardiogenic
`shock230,
`
`Based on the experience with Recover® 5.0, a smaller percuta-
`neous transvalvular assist device, Recover® LP 2.5 (Figure 1) was
`developed. It is a miniaturised pump, providing load depending flow
`unloading the left ventricle. The pump incorporates an impeller with
`2 vanes driven byan electrical motor and has a 4 mm inflow can-
`nula (12F). The pump is placed through the aortic valve and aspi-
`rates blood from the left ventricle cavity and expels it
`into the
`ascending aorta. The pump can beintroduced via a femoral percu-
`taneous approach using a 13 F sheath. The driving console allows
`9 gradations in speed. At maximum speed (51.000 rotations per
`
`minute) a flow of 2.5 l/min is provided.
`
`Figure 1. Recover® LP 2.5, initial study (left) and market design (right).
`
`EURO PGR
`
`In this first trial in humans we studied the safety and efficacy of the
`Recover® LP 2.5 pump in patients scheduled for high-risk revascu-
`larisation (PCI or OPCAB)as well as in patients presenting with car-
`diogenic shock.
`
`Methods
`
`The study was a multicentre (3 centres) non-randomised prospec-
`tive trial to assess the safety, feasibility and the haemodynamic
`effects of the Recover® LP 2.5 in patients presenting with cardio-
`genic shock (group |) and in patients scheduled for a high-risk
`revascularisation (group II).
`Haemodynamiccriteria for cardiogenic shock were a mean arterial
`pressure (MAP) < 70 mmHg,a cardiac index (Cl) <2.0 l/min and
`a pulmonary capillary wedge pressure (PCWP) >18 mmHg or
`patients had to be on inotropes to maintain the MAP =>70 mmHg,
`a Cl =2.0 Vmin with a PCWP > 18 mmHg™.Patients could be on
`balloon pump support before Impella implantation.
`The revascularisation procedure was considered to be high-risk, if
`at least left ventricular function was impaired. Based on the patients
`characteristics, the EuroSCORE was calculated*!.
`Device-related exclusion criteria were: anticipated femoral access
`problems, the presence of a known mural intracardiac thrombus, a
`ventricular septal defect, hypertrophic obstructive cardiomyopathy,
`aortic valve disease (stenosis and/or regurgitation or an artificial valve).
`Exclusion criteria were: a body mass index (BMI) higher than
`37 kg/m2, participation in another clinical investigation during the
`last 60 days, age less than 18 years of age, pregnancy, refusal of
`blood transfusion, shock due to volume depletion.
`The Ethical Committees approved the study protocol. Patients gave
`written informed consentif their mental status permitted. Otherwise
`consentof a relative was obtained.
`
`Femoral percutaneous access was obtained by Seldinger tech-
`nique.
`In one centre prior to the introduction of a 13 F sheath,
`a Prostar XL closure device (Abbott®, Redwood City, USA) was
`placed, in order to obtain quick haemostasis at the time of pump
`removal. During the trial, a dedicated 13 F sheath was developed
`(Figure 2),
`it is a peal away sheath, with a separable valve. This
`valve is kept together by a clasp. After introduction of the 13 F
`sheath, a second 7 F sheathis introduced in the larger sheath,
`a Judkins Right (JR,) catheter is advanced over a J-tip wire. The
`aortic valve is crossed and a 0.014” wire advanced through the JR,
`in the left ventricle. The use of a pigtail is avoided since the 0.014”
`wire can get trapped in the side holes. The 7 F sheath and JR4
`catheter are removed, leaving the 0.014”wire in theleft ventricle.
`After purging the pump with a heparinised glucose 30% (20-40%)
`solution and a test run, the pump is advanced through the aorta,
`over the 0.014”wire into theleft ventricle.
`
`This enables a forceless crossing of the aortic valve, preventing
`kinking of the cannula or catheter during placement which could
`lead to pump malfunction.
`
`Nbrvfu, Fy. 2002-2
`Maquet, Ex. 2002-2
`JQS2017-01205
`IPR2017-01205
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`

`

`First experience with the Impella Recover® LP 2.5 micro axial pump
`
`implantation and later, once an hour. Continuous cardiac output
`(Vigilance Baxter®, Deerfield, USA), mean arterial pressure, mean
`pulmonary arterial pressure, mean capillary wedge pressure were
`measured each hour, and up to 6 hours after pump removal.
`
` purge pressure (mmHg), were registered every 10 minutes during
`
`Figure 2. The peal away sheath with valve and clasp.
`
`After wire removal, pump rotation is started. Speed is gradually
`increased underfluoroscopic guided positioning, in order to obtain
`a stable position without suction on theleft ventricular wall or pump
`displacementin the aorta. During thetrial, pump design modifica-
`tions were performedto obtain a morestable position in the left ven-
`tricle cavity and to reduce the shear forces. The main adaptations
`were: 1. stiffening of the cannula, 2. adding a pigtail at the tip of the
`cannula, 3. increasing the gap between the impeller vanes and the
`pump housing. At maximal speed (51,000 rotations per minute) the
`pump provides 2.5 |/min blood flow.
`For those patients in need of longer support times, the peal away
`sheath is removed and a tapered “access-closure” sheath (10-13 F),
`present on the shaft (Figure 3), advanced in the artery, until the
`bleeding stops. This tapered sheath, togetherwith arterial recoil can
`result in a smaller device remaining at the access site, reducing the
`risk of limb ischaemia.
`
`Repositioning of the cannula can be performed without compromis-
`ing sterility at the access site.
`All patients received heparin via the lubrification system of the
`pump (glucose 30%). All patients received 40 IU/kg of heparin to
`achieve an ACT > 250 secondsprior to pump implantation. Heparin
`administration was dosed to achieve an activated PTT between 50
`and 80 seconds.
`
`Biochemical markers
`
`Blood count, renal function,liver function, lactate and free haemoglo-
`bin were measured at baseline, 1 hour after pump start and at 6, 12,
`18, 24, 36 hours, 2, 3, 4, 5 days after arrival in the intensive care unit.
`
`Haemodynamics
`Monitoring of pump data i.e. performance level, pressure signal
`(mmHg), motor current (amperes), purge flow rate (ml/h) and
`
`
`
`Figure 3. The tapered sheath on the shaft.
`
`EURO PGR
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`Endpoints
`
`Predefined endpoints for safety were the absenceof device-related
`limb ischaemia, neurological deficits and a free haemoglobin level
`exceeding 80 mg/dl.
`Predefined endpoints for feasibility were ease of insertion, position-
`ing and explantation (graded).
`Efficacy end-points were a significant decreasein filling pressures,
`increase in cardiac output and increase in mean blood pressure.
`Follow-up for clinical events extended to one year after pump
`explantation.
`
`Sample size and statistical analysis
`
`To achieve first experience and information about safety and fea-
`sibility in application of the Recover® LP 2.5 device, the total
`numberof patients treated was limited to 40. The safety popula-
`tion consists of those patients fulfilling the major inclusion crite-
`ria, i.e. patients whereit wasinitiated to apply the Recover® LP
`2.5 device. This population was considered with respect to feasi-
`bility and safety questions. The efficacy questions (haemody-
`namic output) were only investigated in these patients where the
`pump did run.
`Categorical variables are described by numbers and percentages.
`Further, 95% confidence intervals of the estimated percentages
`(Clopper and Pearson, 1934) were given. The measurements of the
`haemodynamic parameters (cardiac output and index, mean arte-
`rial pressure and pulmonary capillary wedge pressure) were not
`time-synchronized. To evaluate the time effect of measurements,a
`repeated measurement analysis of variance model wasfitted to the
`data (SAS® software). The time effect was modelled as a linear
`regression variable. To describe the mean effect at certain time
`points, we used averaged measurements of the repeated observa-
`tion within the time intervals and computed means and standard
`deviations (SD) represented as the value + SD or standard errors
`(SE) of the resulting averages.
`
`Results
`
`From 02/2003 to 10/2004, 40 patients were screened in three cen-
`tres, Leuven (n=23), Siegburg (n=7) and Maastricht
`(n=10).
`Cardiogenic shock patients were only included in Leuven (n=8) and
`Siegburg (n=3). Of these 40 patients, 1 patient withdrew consent
`andin 3 patients the surgeon decided not to place the device and
`to perform off-pump revascularization without mechanical support
`after the patient had been included in the study. 36 patients were
`included for the safety and feasibility analysis.
`In 3 of these
`36 patients the pump wasneveractivated, in 2 patients the pump
`did not cross the aortic valve, and in 1 patient the pump wasdis-
`placedinto the aorta and recross was impossible. Of the 33 remain-
`ing patients (included in the efficacy analysis) 11 were in cardio-
`
`Nbrvfu, Fy. 2002-3
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`

`

`genic shock (group |) and 22 underwent a high-risk revascularisa-
`tion procedure (group II). Of the shock patients, 9 had an IABP
`before Impella implantation.
`Demographics of the studied population are presented in table 1.
`
`The mean support time in group | was 21.5+17.4 hours (range 1.9
`to 53.5 hours) and in group Il 2.1 hours+1.6 (range 0.5 to
`5.3 hours), indicating that none of these patients required further
`support after the PCI or OPCAB procedure.
`
`Table 1. Demographics
`
`Clinical research
`
`High risk
`Shock
`Only 1 patient experienced limb ischaemia, 1 patient (2.8%, 95% Cl:
`aevascularisation
`0.07%, 15%) suffered from a nervus femoralis injury and 3 patients
`N
`11
`22
`(8.3%, 95% Cl: 1.8%, 22%) had bleeding complications (Table 3).
`67.1410.9
`61.1410.9
`Age
`With the initial design a high numberof patients hadarise of free
`Gender
`haemoglobin of more than 80 mg/dl (n=9) (Table 4).
`Male
`Female
`BMI«
`
`Table 3. Safety and feasibility endpoints (N=36)
`Shock
`High risk
`revascularisation
`23
`
`N
`
`13
`
`Insufficient haemodynamic support
`Technical pump failure
`Free HG > 80 mg/dl
`Bleeding
`Nervus femoralis damage
`Leg ischaemia
`Aortic valve not crossable
`
`2
`3
`4
`0
`0
`1
`2
`
`8
`3
`27.845.2
`
`19
`3
`28.144.5
`
`EuroSCORE: points
`Support hours
`Relevantrisk factors
`Hypercholesterolemia
`Peripheral vascular disease
`Diabetes
`Pulmonary disease
`Neurological deficit (TIA®, CVA-)
`Tobacco (active or former)
`Coronary angiogram
`LM- disease
`LM + one vessel > 50%
`LM + two vessels > 50%
`LM + three vessels >50%
`
`10.444.3
`21.5417.4
`
`5.944.1
`2.141.6
`
`3
`1
`1
`1
`0
`8
`
`0
`1
`0
`1
`
`9
`3
`7
`1
`2
`11
`
`1
`2
`2
`2
`
`3 vessels without LM
`2 vessels without LM
`1 vessel without LM
`congestive
`EF- %
`
`2
`3
`3
`1
`29.424+11.16
`
`8
`5
`2
`0
`36.39415.01
`
`% Body Mass Index, ® transient ischaemic attack, -cerebrovascularacci-
`dent, —left main, -ejection fraction.
`
`The indication for revascularisation is presented in table 2. Overall
`these patients had left main or multiple vessel disease with poorleft
`ventricle function. For group | the expected in-hospital mortality,
`based on shocktrial registries is more than 50%. On the other
`hand, based on the EuroSCORE, the predicted mortality for the
`shock group is 9.78%,which might be an underestimation. For the
`elective revascularisation population (group Il) based on the
`EuroSCORE, the predicted mortality is 3.89%.
`
`Table 2.
`
`Indication for revascularisation in non-shock patients
`CABG:
`Multivessel disease with LM involvement
`Multivessel disease without LM involvement
`Single vessel disease without LM involvement
`
`PCI:
`
`Left main intervention
`Left main intervention + other target lesion
`Multivessel PCI without left main intervention
`Single remaining vessel intervention
`
`N = 22
`
`1
`N™~
`
`noon
`
`EURO
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`Total
`
`36
`
`wWwrPPrPWwW©WN
`
`PFoFWWNS&
`
`Table 4. Free Plasma Haemoglobin (mg/dl): patients treated with
`initial design/patients treated with market design
`Cardiogenic shock
`
`Number
`Mean free Hb (mg/dl)
`Standard error
`
`High risk intervention
`
`Number
`Mean free Hb (mg/dl)
`Standard error
`
`Pre pump
`6/2
`19/25
`9/20
`
`Pre pump
`16/3
`16/8
`5/2
`
`12h
`8/1
`189/8
`102/-
`
`6h
`17/2
`66/5
`18/0
`
`24h
`3/1
`102/7
`63/-
`
`12h
`9/3
`25/5
`10/0
`
`36h
`6/1
`134/5
`72/-
`
`24h
`9/0
`6
`1
`
`For this reason thestiffness of the cannula was increased to avoid
`
`kinking (kinking results in less performance and more haemolysis)
`and the distance between the impeller vanes and the pump hous-
`ing was increased 0.04 mm thus reducing shear-stress by
`100 N/m2. With this final design used in the last 5 patients no
`haemolysis above 80 mg/dl was observed (maximum = 46 mg/dl).
`Shock patients were at higher risk to develop haemolysis, 4 of
`13 patients > 80 mg/dl versus 5 of 23 patients in the elective group.
`The free plasma haemoglobin increases quickly during the first
`6 hours, thereafter a decline is observed.
`
`In the first two patients the pump could not be placed overthe aor-
`tic valve. As a consequence, a 0.014” wire was placed in theleft
`ventricle and the pump was advanced in an over-the-wire tech-
`nique. Since then this problem has not recurred. In one patient the
`
`-87-
`
`Nbrvfu, Fy. 2002-4
`Maquet, Ex. 2002-4
`JQS2017-01205
`IPR2017-01205
`
`

`

`First experience with the Impella Recover® LP 2.5 micro axial pump
`
`pump wasejected early and could not be repositioned. The implan-
`tation procedure was graded easy in 23, suitable in 6, difficult in 3
`and failed in 3 (non-reported in 1).
`In total 5 technical pump failures occurred: in 3 patients the explan-
`tation was complicated by a fracture of the cannula with the pump
`housing remaining at the accesssite; in one patient the remaining
`part was retrieved surgically.
`In 2 patients malfunction and early removal of the device occurred:
`in 1 patient this was due to a leak in the seal resulting in blood
`entering the electronic part of the pump; in the other it was due to
`a blockage of the impeller caused by atheromic plaque.
`The pump remained in a stable position in most of the patients, and
`only small repositioning corrections were performed during follow-up.
`
`The pump gave sufficient support in most of the patients. It should
`be mentioned, however,
`that in cardiogenic shock patients the
`pump was combined with an IABP (9/11). Even with both devices
`in place, due to haemodynamic instability, 2 patients crossed over
`to a device with more force (Recover® LP 5.0 and Medos®).
`The haemodynamic data are presented in table 5.
`A small but
`significant
`increase,
`from 4.441.9L/min to
`4.8+1.2 L/min,
`in cardiac output was seen in the shock group
`(p=0.0178).
`The major effect was, however, the decreasein filling pressures,
`most obvious in the cardiogenic shock group (PCW from
`22.547.5 mmHg to 17.4+7.5 mmHg, p=0.00008), butstill signif-
`icant
`in the high-risk revascularisation group (PCW from
`14.345.8 mmHg to 1042.9 mmHg, p=0.0327). The mean arteri-
`al pressure did not changesignificantly (p=0.3772) in the shock
`group andslightly decreasedin the high risk revascularisation group
`(—2.1 mmHg, p=0.0701). However, the decrease in pulsatility illus-
`trates the relative importance of the pump flow®2. Figure 4 shows
`the increase in motor current and decrease in pulsatility with a sta-
`
`Table 5. Cardiac output (CO), Pulmonary capillary wedge (PCW)
`and meanarterial pressure (AP) during Recover® LP 2.5 support
`Shock
`First hour
`6 hours
`24 hours
`
`4.441.9
`CO (I/min)
`22.547.5
`PCW (mmHg)
`87.4425.3
`MAP (mmHg)
`High risk revascularisation First hour
`CO (I/min)
`5,341.2
`PCW (mmHg)
`14.345.8
`MAP (mmHg)
`88.9415.9
`
`4.81.2
`17.447.5
`79.4415.5
`6 hours
`4.341.2
`10+2.9
`86.8220.8
`
`4.440.8
`16+6
`73.1414.7
`
`ble mean aortic blood pressure during a high-risk intervention (bal-
`loon inflation in the unprotected left main coronary artery).
`At 6 months follow-up in the high-risk intervention group
`4/22 patients died, of which one patient was 5 days post implanta-
`tion due to an acute myocardial infarction. During the PCI proce-
`dure no major adverse cardiac events occurred. The other
`3 patients died at a mean of 114 days post-procedure (range 82-
`159 days) indicative of the poor shapeof the patients treated. Of the
`shock patients 6/11 supported patients died, 2 during support, and
`all within the first 30 days.
`
`Discussion
`We performed a phase| non-randomised multicentre trial to assess
`the safety, feasibility and efficacy of a new percutaneousleft ventri-
`cle assist device. Previously the Recover® LP 2.5 wastested in ani-
`mals via the carotid artery. Infarct size reduction, even with partial
`support, could be demonstrated*2.
`In this clinical trial, using the femoral approach, several issues had
`to be addressed andsolved.
`
`Firstly, during the trial a dedicated 13F peal away sheath and tapered
`access closure sheet was developed. As a consequence the
`cathetersize in the femoral artery is reduced to 9F, reducing the risk
`of limb ischaemia and bleeding.
`
`Placement
`Signal
`[mmHg]
`
`75°
`
`200
`150
`
`100
`
`50
`
`ANAMiartviantnnsccacannanhARALAAARAARAAAANRINANANUANANAL
`
`Motor
`Current
`[A]
`
`0
`1.00
`
`0.80 -
`
`0.60
`
`0.40
`
`0.20
`
`0.00
`
`Figure 4. Amplitude of the motor current signal. Aortic pressure amplitude decreases during PCI.
`
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`Nbrvfu, Fy. 2002-5
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`

`

`Initially,
`technique was introduced.
`Secondly, an ‘over-the-wire’
`investigators, trying to advance the cannula across the aortic valve
`directly, encountered problemsof kinking of the cannula. This kink-
`ing resulted in failure of crossing the aortic valve (in 2 patients).
`Since the introduction of this over-the-wire technique, no morefail-
`ures were encountered.
`
`The third important modification was the extension of the cannula
`with a pigtail which allows more aligned positioning of the cannula
`in the left ventricle and reduces the risk of cannula displacement.
`In the application of high speed rotary blood pumps, haemolysis is
`an important concern. Haemolysis depends on the applied shear
`stress, which is assumed to be high, and the contact time, which
`assumed to be low. It is also known that shock patients have a
`reduced free haemoglobin clearance due to poorliver function®>.
`This explains why in the series haemolysis was more pronouncedin
`the shock group. We observed an early peak in free haemoglobin at
`6 hours with a sharp decline afterwards. We assumethat this phe-
`nomenonis explained by the rapid haemolysis in pre-damaged and
`fragile cells. During the study the distance between the 2 vanes of
`the impeller and the pump housing was increased to reduce the
`shear forces. Due to the previously described (monorail technique,
`pigtail, increase space between vanes and pump housing) madifi-
`cations, the last design, used in 5 patients, did not cause haemolysis.
`Free haemoglobin remained below 80 mg/dl. However, especially in
`patients with multiple organ failure, one should carefully monitor the
`free haemoglobin levels. A larger population needs to be studied
`with the final design to confirm the data.
`In general, activation of the pump results in a decrease of the sys-
`tolic-diastolic amplitude and an increase in the mean arterial pres-
`sure. Filling pressures are reduced substantially. The indication for
`usage of the Recover® LP 2.5 pump will remain high-risk revascu-
`larisations and patients presenting with haemodynamicinstability,
`even though randomised data supporting the use of an assist device
`during high-risk interventions are scarce.
`One should note that none of our patients died during the high-risk
`revascularisation procedure. The mortality rate at six months is
`indicative of the type of patients included in the protocol.
`The effect on cardiac output in both groups waslimited butsignifi-
`cant. Patients in the cardiogenic shock group were on inotropes,
`and had a balloon pump ontop, factors confounding the effect on
`cardiac output measurements.
`It should be stated, however, that in patients with very low output, the
`small Recover® LP 2.5 pump will not provide full support and
`haemodynamicstability, therefore IABP was combinedwith Impella.
`In these patients more forceful assist devices should be used.
`Although in shock patients, the use of IABP has become common,
`data of randomised trials are lacking and the effect on mortality of
`the IABP as a stand-alone procedureis not clear!9-20.22.23.25, Qn more
`advanced assist devices evenless data is available2?°,
`
`The most obvious effect of the pump was a clear reduction in pre-
`load of the left ventricle, as well in shock patients where the effect
`was most pronounced, as in patients who were haemodynamically
`stable but with increased LV-pressures secondary to their compro-
`mised LV-function. This unloading of the left ventricle might be ben-
`
`EURO
`
`PGR
`
`Clinical research
`
`eficial in patients presenting with large acute myocardial infarction,
`resulting in infarct size reduction. Although animal data are promis-
`ing283.35.36 data in humansare lacking at present.
`
`Conclusions
`Modifications of theinitially designed pump ledto a final new design
`whichis a fairly easy to use and successful percutaneousleft ven-
`tricle assist device with low rates of haemolysis. During high-risk
`revascularisation procedures haemodynamic stability was obtained.
`For cardiogenic shock patients it can be used as a toolforinitial sta-
`bilisation, mainly reducingfilling pressures and followed, if needed,
`by more aggressive treatment modalities.
`
`Acknowledgements
`We thank Mrs. H. Bollen for the excellent preparation of the article.
`
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