BULKY DOCUMENTS
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`(exceeds 300 pages)
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`Proceeding] Serial No: 9 / / g 92/ C3
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`Filed: 8’31*" Of»
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`-0-— LV Epicard Anterior
`LV Endocard Anterior
`
`Fig. 1 A to D Anterior wall myocardial blood
`flow in pigs before. during 60 minutes sur-
`gery. one and four hours after operative
`myocardial revascularisation performed by
`(A) cardiopulmonary bypass with cardiople-
`gic arrest (group ECC). (B) off-pump coro-
`nary artery bypass grafting (group OPCAB).
`(C) lmpella° elect 100 supported beating
`heart surgery (group tmpella). (D) sham op-
`eration (group Sham}: -0- left ventricular
`anterior wall epicardial blood flow. "0" left
`ventricular anterior wall endocardial blood
`flow. Values are means i standard error of
`mean. N gives numbers of animals per
`group. ‘ Signifies p < 0.05 versus pre surgery
`myocardial blood flow and ' signifies p < 0.05
`between groups.
`
`0. Sham, n-=8
`
`Intervention
`7//IIIII1
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`
`
`Pro
`
`60
`40
`120
`Time {min}
`
`300
`
`400
`
`300
`
`200
`
`100
`
`
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`
`
`regionalbloodflow{mIi‘100gxmln]
`
`8 regional
`
`bloodflow[m|i'100gm1in] NI
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`120
`60
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`300
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`= [H 0,05 statistically significant different from baseline
`fl : p< 0.05 statistically significant different between groups
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`Time [min]
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`o
`
`6% (Braun. Melsungen, Germany) were infused before pump in-
`sertion. The correct position was checked by diastolic pressure
`difference between the aortic and the left ventricular diastolic
`pressure [It]. Rotation speed was adjusted so that maximum
`ventricular unloading could be achieved. The lmpella pump ran
`for 60 minutes and as in group it the stabilisator was in place for
`60 minutes. The anastomosis was sutured in the same way as in
`group II and after completion the bulldog Clamp also stayed on
`the graft until the 40th minute.
`
`I-Iernodynamic parameters and myocardial contractility
`Heart rate, left and right atrial pressure. left ventricular pressure.
`mean arterial and mean pulmonary arterial pressure were re-
`corded on a Sirecust 1280 (Siemens. Nilrnberg. Germany) at dif-
`ferent time points (see Fig.1). Cardiac output was continuously
`determined and displayed on a Vigilance Monitor (Edwards Life-
`sciences, Unterschleissheirn. Germany). Left ventricular pressure
`first derivative over time was calculated and displayed on a Sys-
`tem 6+ hemodynamic module (Triton Technology. San Diego,
`USA). Heart rate. left and right atrial pressure. left ventricular
`pressure. and mean pulmonary arterial pressure were not re-
`corded during extracorporeal circulation.
`
`Craft patency
`Verification of graft patency was assessed by a CM 1005 transit
`time flow meter with a 3-mm probe (Cardio Med Gmbfl. Tau!‘-
`kirchen. Germany). The probe was placed 15 to 25 mm proximal
`to the anastomosis.
`
`Myocardial perfusion measurement
`Myocardial blood flow (MBF) was examined at baseline. twice
`during the surgical procedure (40 and 60 minutes) and 1 hour
`(I20 minutes) and 4 hours (300 minutes) after bypass by fluores-
`cence labelled microspheres (Molecular probes. Leiden. Nether-
`lands) as previously described [12]. Two million spheres per col-
`our were injected in a randomised manner into the left atrium
`over 30 seconds via the left atrial catheter. A reference blood
`sample of 10 ml was withdrawn from theabdominal aorta over
`a 3-minute period starting 30 seconds before microsphere's in-
`jection with a syringe pump ('l‘SE model 540210. Bad Homburg.
`Germany}. At the end of the experiment the heart was removed
`from the chest and rinsed with sterile saline and immersed in
`
`4% paraformaldehyde. After 7 to 10 days immersion three 5- to
`7-mm sections were cut at the height of the anastomosis. above.
`and underneath. Per section the left ventricular part was divided
`into 4 sectors (anterior. lateral. posterior. and septal) and every
`sector was separated into an endo- and an epicardial aspect. The
`right ventricular part was divided into an anterior and a posteri-
`or sector and both sectors were separated into an endo- and an
`epicardial aspect. Every specimen was finally divided in two
`parts. So. in total, 72 areas resulted. For digestion and dye extrac-
`tion we used a previously published protocol H2]. Myocardial
`blood flow values below 20 mllmin x 100 g were assumed as crit-
`ical low flow areas resulting in reduced myocardial function [13].
`
`Statistics
`
`Data are presented as mean 1 SEM. Statistical analysis was per-
`formed with Sigma Stat 3.0 (jandel Scientific Corp.. San Rafael,
`USA). The statistical significance of changes from baseline values
`
`Bierbadt B et al. Effect of Different
`
`Thorac Cardiov Surg 2005: 53: 103- I09
`
`EDWARDS 004832
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`

`
`within each group was tested with repeated measures ANOVA.
`Differences between groups were statistically analysed by one-
`way ANOVA comparing several groups. 11 values did not show a
`normal distribution. ANOVA for nonparametric values (Kruskal
`Wallis test) with multiple comparison method (Student-New-
`man-Keul's test) was used. Statistical significance was accepted
`at an error probability ofps0.05.
`
`Results
`
`All animals survived surgery and the post interventional 4-hour
`period. All constructed anastomoses showed acceptable flow
`without significant differences between groups. The observed
`flow patterns revealed no signs of bypass obstruction. in group 1
`norepinephrine had to be administered to maintain an adequate
`perfusion pressure. Maximum close was 18.75 iigfkg x h.
`
`Hemodynamic parameters
`The hemodynamic changes during and after myocardial revascu-
`larisation are summarized in Table 1. During surgery only the
`timepoint at 30 minutes is displayed. For immediate reactions
`after surgery the timepoint 70 minutes is shown. as is timepoint
`300 minutes for early changes after surgery.
`
`Hemodynamic impairment in response to extracorporeal circu-
`lation with cardioplegic arrest was observed regularly with de-
`creased MAP. tachycardia. and the need for vasopressor applica-
`tion(911 3 to6813 and 71 13mmHgaswell as6314Io 12017
`and 10418 beatsfmin). Cardiac output was slightly elevated
`immediately after aortic cross-clamp opening and returned to
`baseline values at the end ofthe observation period. Left ventric-
`ular contractility was significantly increased early after separa-
`tion from cardiopulmonary bypass. even before vasopressors
`were administered and normalised to starting point values
`(23591157_ 35741409. and 22961105 mmHg[s). Filling pres-
`sures, left ventricular and mean pulmonary artery pressure re-
`mained unchanged.
`
`During off-pump bypass grafting hemodynamic deterioration
`occurred with statistically significant decreases in cardiac out-
`put, mean arterial pressure. left ventricular pressure. and left
`ventricular contractility (4.8 1 0.3 to 3.410.2 llmin. 92 1 5 to
`79 14mmHg. 12616 to 10015 mmHg. and 25191296 to
`1666 1 147 mm Hgls. respectively). Cardiac output. mean arterial
`and left ventricular pressure as well as left ventricular contractil-
`ity did not recover baseline values. In opposition filling and mean
`pulmonary artery pressure remained within physiological
`ranges. However, no conversion to bypass grafting with extracur-
`poreal circulation due to the observed hemodynamic deteriora-
`tion was necessary.
`
`The impel|a° elect 100 assisted bypass grafting showed milder
`hemodynarnic impainnent compared to the off-pump proce-
`dure. Pump flow ranged from 1.9 to 3.51/min. Initiation of me-
`chanical unloading resulted in a decrease in left atrial pressure.
`a significant reduction of ventricular pressure. and LV pressure
`first derivative. Additionally. the left ventricular contractility re-
`covered completely after four hours. Cardiac output and mean
`arterial pressure drop off could be reduced compared to OPCAB
`
`Blerbach B et al. Effect of Different ... ‘Elnora: Cardiov Surg 2005: 5]: ‘I03 - I09
`
`(4.710.4 to 4.0102 and 9113 to 841 3 mmHg). but still re-
`mained statistically significant although it returned to control
`levels at
`the end of
`the experiment
`(4.3 1 0.2 |,lmin and
`80 1 2 mm Hg). In contrast to off-pump bypass grafting tachycar-
`dia was noticed postoperative1y(95 1 7 beatsfmin). Mean pulmo-
`nary artery pressure was slightly elevated in this group through-
`out the whole experiment due to preoperative volume loading.
`All groups showed a mild increase in MPAP immediately after
`termination ofsurgery at the time of protamine administration.
`
`Regional myocardial perfusion
`Left ventricular epi- and endocardial myocardial blood flow of
`the anterior wall at the level ofthe anastomosis is shown in Fig. 1.
`The other areas studied displayed similar flow courses.
`
`All baseline values in the 72 specimens from both ventricles re-
`vealed no statistical difference between the studied groups (epi-
`cardial blood flow: 107 1 8. range: 50 to 220 rnlfmin x100 g: en-
`docardial blood flow: 118 1 11. range: 46 to 302 mllmin x 100g).
`
`As expected during aortic cross clamping and cardioplegic arrest
`no myocardial perfusion in any observed specimen could be
`found. Reactive hyperemia occured during early reperfusion uni-
`formly without regional hypoperfusion (epicardial blood flow:
`214 119. range: 81 to 402 mlfmin x 100g and endocardial blood
`flow: 235123. range: 104 to 454 mlfminx 100g). 80 minutes
`(t= 120 min) after cross-clamp opening increased myocardial
`blood flow was still present (Fig.1 A}. Even at the end ofthe ex-
`periment myocardial blood flow exceeded baseline values. Low
`flow was detected only in four specimens in one animal but ofa
`total of 576 specimens at the end (Fig.2).
`
`Off-pump surgery with shunt insertion created only a mild and
`not significant decrease in myocardial perfusion in both ven-
`tricles during stabilisator placement (epicardial blood flow:
`8618, range: 19 to 158 mljminx 100g and endocardial blood
`flow: 9617. range: 25 to 146 mllmin x 100 g} (Fig. I B). After sur-
`gery myocardial blood flow reached baseline values. Two ani-
`mals presented with sporadic myocardial low flow during sur-
`gery (t-40 minutes 1 area and t=60 minutes 4 and 5 areas)
`(Fig.2).
`
`During microaxial blood pump support myocardial blood flow
`also decreased mildly in all areas (epicardial blood flow: 8418.
`range:
`11
`to 193 ml,lminx100g and endocardial blood flow:
`9117, range: 21 to168 ml]minx100g) (Fig.1C). After surgery
`myocardial blood flow returned to baseline values. Six animals
`had myocardial low flow during surgery in 1 to 18 areas. One
`specimen was hypoperfused immediately after surgery, while
`four hours after surgery in three animals I to 16 specimens again
`showed myocardial low perfusion (Fig. 2).
`
`There were no significant changes in myocardial blood flow in
`the control group (Fig.1D). Myocardial low flow occurred in
`eleven specimens in two animals at 60 minutes and in one ani-
`mal in three areas at 120 and 300 minutes (Fig. 2).
`
`EDWARDS 004833
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`Table 1 Hemodynamic variables in pigs before. during. 10 minutes. and four hours alter operative myocardial revascularisation performed by
`cardiopulmonary bypass with cardioplegic arrest (group 1 KC). olf-pump coronary artery bypass grafting (group 2 OPCAB). Impeller”
`elect I00 supported beating heart surgery (group 3 lrnpella), sham operation (group 4 Sham}; CVP: central venous pressure, dpldt:
`left ventricular pressure first derivative over time. LAP: left atrial pressure. LVP: left ventricuiar pressure. MAP: mean arterial pressure
`and MPAP: mean pulmonary artery pressure. Vaiues are means : standard error of mean. N gives numbers of animals per group
`
`Baseline
`Surgery
`70 min
`300 min
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`25 :16:
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`7415
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`65:3
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`Heart rate (min")
`Groupll.'CC(n-8)
`Group2OPCAB(n-8)
`Group 3l'mpella{n-8)
`Group4Sho,m(n=8)
`
`Cardiac output (l/min)
`Group I ECC (n = 8)
`Group20PCAB(n-8)
`Group 3 lmpella (:1 -8)
`Group 4 Sham (n = 8)
`MAP(mmHg}
`Groupl.ECC(n=3)
`Group2OPCAB{n-8)
`Group3lmpello(n-8}
`Group4Sham 01-8)
`MPAP(mrriH'gJ
`CmuptECC(n=8}
`Group2OPCAB{n=8)
`Group 3 impeila (n = 8)
`Group4$ham[n-8)
`
`l'.i-l.P‘(minHg)'
`GrouplECC(n-8)
`Cruup20FCAB(n-E]
`Group3lmpello (n=8)
`Group4Sham(n-3)
`
`cvP.ri_rrrn{49J
`Group1ECC(n-8)
`Group20PCABfn-8)
`Group3i'mpello{n-8)
`Group 4 Sham (n- 8)
`
`. .
`Group I ECC (n -8}
`Group2OPCAB(n-8)
`Group3rmpello(n-3)
`Group
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`12616
`11313
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`I00:5'#
`98:4'#
`118:4
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`2359 1157
`Group I ECC tn - 8)
`21311185’
`17501174’
`16661147?!
`25191296
`Group2OFCA8[n-8)
`22361162
`2173 1154
`1773 : 75'!
`2433 1117
`Group 3 impeIla(n - 8)
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`Group 4 Sham (n =8) 1937: 69‘ 26771 93 2341188’ 2264: 105‘
`
`' p < 0.05 versus pre surgery myocardial blood flow: it p < 0.05 between groups
`
`Discussion
`
`In our study. we observed hemodynamic impairment in all treat-
`ed groups. Most markedly it was seen in the ECC group with the
`need for vasopressor administration. Hypotension occurred
`
`although increased cardiac output and global left ventricular
`contractility was present as already described [1]. This observa-
`tion is related to the well~described inflammatory triggered post
`perfusion syndrome I 14]. In addition. released N0. which is stim-
`ulated by the surgical inflammatory response. contributes to the
`
`Bierbacb B et al. Effect of Different
`
`fliorac Cardiov Surg 2005; 53: 103- ‘I09
`
`EDWARDS 004834
`
`

`
`——&«---—~ HLM,n=8
`
`Off_pump_|-‘=3
`
`—v— ImpeI|a.n=8
`._._0.._.
`Sham, n=8
`
`‘ = p< 0,05 statistically significant
`different from baseline
`# = p< 0.05 statistically significant
`
`Fig. 2 Number of myocardial low flow areas
`in pigs before. during 60 minutes surgery,
`one and four hours after operative myocar-
`dial revascularisation performed by cardio-
`pulmonary bypass with cardioplegic arrest
`(group ECC — —A——l, oil-pump coronary ar-
`tery bypass grafting (group OPCAB - - I- -).
`lrnpella" elect 100 supported beating heart
`surgery (group lmpella —V—), sham opera-
`tion (group Sham — -0- —); values are means
`i standard error of mean. N gives numbers
`of animals per group. ‘ Signilies p < 0.05
`versus pre surgery myocardial blood flow
`and ' signifies p < 0.05 between groups.
`
`different between groups
`
`Intervention
`
`J
`. ‘no I uafl-'£.'."‘
`
`
`
`
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`Numbersofmyocardiallow-flowareas
`
`O2
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`40
`
`60
`
`300
`
`Time [min]
`
`increase in cardiac output that accompanies the reduced sys-
`temic vascular resistance after cardiovascular surgery [15]. Fur-
`thermore. hypotension is caused by extracorporeal circulation
`through generation of serotonin from pump-activated platelets
`triggered by nitric oxide release 116]. One simple aspect of the
`negative influence on peripheral resistance could be the cardio-
`plegic solution which is drained into systemic circulation using a
`two-stage venous cannula |l7.l8|. Normothermic body temper-
`ature during coronary bypass grafting with cardiopulmonary by-
`pass and hypothermic crystalloid cardioplegia is one major fac-
`tor reducing systemic vascular resistance I18}. In opposition to
`our findings reduced ventricular contractility was observed in a
`porcine model of cardiopulmonary bypass without cardioplegia
`and in a canine model with blood cardioplegia due to myocardial
`edema |l9.20].
`
`During off-pump bypass grafting hemodynamic instability was
`still tolerated in all animals without inotropic support. Cardiac
`output altered significantly during revascularisation more mark-
`edly than reported previously |3]. In contrast to earlier findings
`significant but not critical changes in MAP, LVP, LAP, and global
`left ventricular contractility occurred during surgery [3]. This
`might be related to the extended duration (60 minutes) of me-
`chanical anterior wall stabilisation. Additionally approximately
`half of the left ventricle‘s free anterior was compressed by the
`stabilisator used. This could be the reason for incomplete and de-
`layed hemodynamic recovery. Previous publications without he-
`modynamic impairment caused by OPCAB surgery employed
`much shorter interventions [21 I. The idea of a 60-minute inter-
`ventional period in our model was used to simulate a multivessel
`procedure and for the concordance ofthe surgical period in each
`experimental group.
`
`The use of the lmpella’ microaxial blood pump for left ventric-
`ular support during beating heart myocardial revascularisation
`achieved ventricular unloading as indicated by the fall in LAP. Re-
`
`Blerbach B at at. Effect of Different
`
`Thorac Cardlov Surg 2005; 53: 103 — 109
`
`cently similar findings were observed in an ovine model for mi-
`croaxial pump support reducing infarct size I ll ].
`
`In addition, augmented cardiac output and preserved global left
`ventricular contractility during and after surgery compared to
`the OPCAB group in our study were present.
`
`The major finding in our study were the results of regional myo-
`cardial perfusion. ECC with cardioplegia in contrast to earlier
`studies revealed uniform reperfusion after 40 minutes‘ cardio-
`plegic arrest without signs of microvascular obstruction 122]. As
`described by other groups transient rnicrovascular obstruction as
`well as malperfusion after cold crystalloid cardioplegic arrest
`were not found [22,23].
`
`There was no negative effect on regional myocardial perfusion
`although hemodynamic alteration occured during OPCAB sur-
`gery. The major reason was the shunt insertion into the U\D's ar»
`teriotomy |6|. Reduced ventricular contractility during surgery
`due to hypoperfusion could therefore be excluded. Surgical trau-
`ma results in an inflammatory response contributing to media-
`tor release and myocardial depression after cardiovascular sur-
`gery [15]. In support of this conclusion control animals showed
`decreases in MAP, cardiac output and global left ventricular con-
`tractility at the end of the observation period.
`
`Although the microaxial blood pump mitigates hemodynamic
`alterations, no improvement in regional myocardial perfusion is
`observed. Even worse. sporadic myocardial low flow was seen.
`This might be due to microembolies generated by the intracar-
`diac pump. A high pump speed might be able to produce gaseous
`microembolies by cavitation. In addition the pump caused suc-
`tion to the ventricular wall during external ventricular compres-
`sion. thereby also creating cavitation. lnflammatory response to
`intracardiac pump operation creating cellular rnicroaggregates
`seems to be less probable. because a reduced inflammatory re-
`
`EDWARDS 004335
`
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`sponse during and after pump run compared to cardiopulmo-
`nary bypass has been reported as indicated by a postoperative
`release of granulocyte elastase and complement C3a elevation
`[10]. Embolisation of plaque material can be excluded as an ex-
`planation. because no animal showed signs ofatherosclerosis at
`organ removal. Further clinical examinations should be per-
`formed to test the hypothesis of the clinical relevance of hetero-
`geneous microvascular obstruction l24l. One clinical limitation
`could be the lack of coronary artery disease in our model.
`
`In conclusion, the intracardiac microaxial support device aug-
`ments cardiac output during beating heart myocardial revascu-
`larisation in a porcine model but leads to microvascular low flow
`areas. In contrast. conventional techniques led to mild hemody-
`namic impairment but did not aggravate microvascular perfu-
`sion.
`
`Acknowledgments
`
`This study was supported by the German Heart Foundation
`(project number F,l13,lD1 ). The disposals for cardiopulmonary by-
`pass were donated by Edwards PAS, Wiirrstadt. Germany. The
`lmpella elect 100” microaxial blood pumps were donated by lm-
`pella Cardiosystems. Aachen, Germany. We thank Mr. Mitch Mal-
`Zahfl. Mr. Laszlo Kopacz. and Mrs. Andrea Schollrnaier for their
`excellent technical support.
`
`References
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`‘ Estafanous FG. Urzua J. Yared JP. Zuriclt AM. Loop FD. Tarazi RC. Pat-
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`]Thorac Cardiovasc Surg 1984: 872 175 -132
`1 Mishra M. Malhotra R. Mishra A. Meharwal ZS. Trehan N. Hemody-
`namic changes during displacement ofthe beating heart using epicar-
`dial stabilization for off-pump coronary artery bypass graft surgery.]
`Cardiothorac Vasc Anesth 2002; 16: 635-690
`3 Burfeind WR.jr. Duhaylongsod FG. Samuelson D. Leone B}.The effects
`of mechanical cardiac stabilization on left ventricular performance.
`Eur] Cardiothorac Surg 1993: 14: 285 - 289
`" Edgerton_lR. Dewey TM. Magee M]. Herbert MA. Prince SL Jones KK.
`Mack M]. Conversion in off-pump coronary artery bypass grafting:
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`Thorac Cardlov Surg 2005: 53: 103 -109
`
`EDWARDS 004836
`
`

`
`European Heart Journal Supplements 12004} 6 (Supplement F), Fl51—l-‘G7
`
`
`
`EUROPEAN
`SOCIETY OF
`CA.R[lC'I.1Y
`
`The evaluation of right ventricular performance
`in different clinical models of heart failure
`
`Carlo Campana*, Michele Pasotti, Lorenzo Monti, Miriam Revera,
`Alessandra Serio, Luisa Nespoli, Giulia Magrini, Laura Scelsi, Stefano Ghio,
`Luigi Tavazzi
`
`Department of Cardiology, IRCCS Policlinico Son Matteo, Piozzale Golgi 2, Pavia 27100, Italy
`
`KEYWORDS
`Right ventricular function:
`
`E"d'5ta89*'E3'1fa“""?:
`::';"'°“a"1' "YP9"°'“i°"3
`
`Aim To evaluate the role of right ventricular function in different clinical models of
`heart failure_
`
`in WHO class III and IV
`Methods 22 patients with pulmonary hypertension (PH)
`(group A) were evaluated by echocardiography, brain natriuretic peptide (BNP)
`measurements and right heart catheterization at baseline and after a mean fol-
`low-up of 15 s 4 months. 63 patients with chronic heart failure of different etiol-
`ogy, NYHA class liIb—iV,
`followed-up for 18 1 3 months (group B), underwent
`echocardiography, BNP measurements, right heart catheterization at study entry
`and follow—up.
`Results In group A patients, among hemodynamic parameters consistent with
`severe PH, right atrial pressure significantly increased (from 6114.8 to 101 6.5
`mmHg, p < 0.01); BNP showed a negative correlation with right ventricular ejection
`fraction (r"'=0.46).
`In group B, mean left and right ventricular (therrnodilution)
`ejection fraction (RVEF) were 21 1 7% and 18 1 9%; BNP showed significant correla-
`tions with pulmonary wedge pressure (r = 0.48, p = 0.02) and right ventricular func-
`tion indices (RVEF and tricuspidal annular plane systolic excursion}.
`Conclusions A multiparametric right ventricular evaluation is useful even if several
`diagnostic and prognostic variables which were investigated in this study are not
`likely to show the same prognostic role in right and biventricular models of heart
`failure.
`
`0 2004 Published by Elsevier Ltd on behalf of The European Society of Cardiology.
`
`Introduction
`
`Right ventricular function has not been extensively stud—
`ied until recenfly, because the right ven[ric[e was con.
`
`"Correspondence Carlo Carnpana MD Department of Cardiology
`facts Policlinico San Matteo, Piazzale Golgi 2, 27100 Pavia, Italy. Tel.:
`.39 3331 503459; fax: 399331 501271
`E-mail address: unita.sc@smatteo.pv.il cc. Campana).
`
`sidered to have a secondary role in the prognostic
`evaluation of several cardiac diseases, including chronic
`heart fa1'lUI'e-
`in addition. the 6ValU3li0n Of fight Ven-
`tricular fL|l'IC[iOl'I was diffiCU[t, because some diagnostic
`techniques were not efficient or easily reproducible.‘
`Radionuclide angiography is currently considered a useful
`diagnostic method; echocardiography depends on the
`accmacy °f ""a"V §55'f”‘F‘ti°"5 "_b°“t "e"m"-"tar 9e°""°'
`NY;
`the thermodilution technique, able t0 evaluate
`stroke volume and ejection fraction by catheter with a
`
`1520-765X/S - see front matter © 2004 Published by Elsevier Ltd on behalf of The European Society of Cardiology.
`doi:10.1016lj.ehjsup.2004.09.012
`
`EDWARDS 004837
`
`

`
`F62
`
`fast response thermistor, shows good reproducibility in
`monitoring right ventricular function, but is an invasive
`technique.’
`The aim of this study was to evaluate the evolution
`of right ventricular performance in two different clinical
`models of right ventricular dysfunction:
`the right ven-
`tricular impairment observed in patients with end-stage
`heart failure (HF) and the right ventricular dysfunction
`seen in patients affected by pulmonary hypertension
`(PH). The principal objectives were to evaluate the evo-
`lution of echocardiographic, Doppler and haemodynamic
`patterns related to right ventricular impairment and to
`identify possible correlations with neurohormonal sta-
`tus, as determined by brain natriuretic peptide (BNP)
`levels.
`
`Methods
`
`Study population
`
`The study population consisted of 85 consecutive patients re-
`ferred to the Cardiac Failure Unit of the Department of Cardiol-
`ogy, IRCCS Policlinico San Matteo, Pavia from September 2000.
`The patients were divided into two groups according to the pres-
`ence of different diagnoses, defining a specific pathophysiologi-
`cal role of the right ventricle.
`Group A was formed of 22 patients with a diagnosis of pre-
`capillary pulmonary hypertension (PH) and a model of isolated
`right ventricular failure.
`Group B was formed of 63 patients with severe chronic HF
`and a clinical pattern suggesting biventricular dysfunction.
`At entry into the study patients underwent a diagnostic eval-
`uation including haemodynamic measurements with right ven-
`tricular
`thermodilution_ determination
`and
`a Doppler
`echocardiographic study to assess left and right ventricular
`anatomy and function and to determine the haemodynamic pro-
`file in terms of pulmonary pressure and ventricular filling pres-
`sures. Functional status was assessed by the (:-min walking
`test (6MWT) in group A and by cardiopulmonary exercise testing
`(CPT) in group B.
`The study protocol established that baseline cardiac cathe-
`terlsation and echocardiographic and Doppler evaluations were
`performed within a few hours of each other. Right heart cathe-
`terisation controls were scheduled yearly; echocardiographic,
`Doppler, neurohormonal and functional status studies were to
`be carried out every 6 months.
`
`Cardiac catheterisation
`
`Cardiac catheterisation was achieved via the femoral or internal
`jugular vein, using a 7F modified Swan-Ganz catheter in
`conjunction with a computerised detection system of cardiac
`output and right ventricular ejection fraction (RVEF), model
`REF-1‘ or Vigilance"'° {Edwards-Lifescierices, Santa Ana, CA,
`USA). The following measures were recorded or derived during
`the procedure: pulmonary artery pressure, pulmonary wedge
`pressure, right atrial pressure, pulmonary vascular and arterio-
`iar resistances, systemic vascular resistances, cardiac output,
`right ventricular ejection fraction, stroke volume, left and right
`ventricular stroke work.
`
`C. Campana et al.
`
`Echocardiographic and Doppler studies
`
`Doppler-colour echocardiography was perfomied with the GE-
`Vingmed System Five (GE-Vingrned Ultrasound, Horten, Norway)
`using a multifrequency 2.5-3.5 MHz probe.
`In group A the following echocardiographic and Doppler var-
`iables were analysed:
`. Right and left ventricular end-diastolic and end-systolic
`areas, measured in the apical four-chamber view.
`a The ratio of ventricular areas (RV to LV areas ratio), calcu-
`lated as the ratio of the right ventricular end-diastolic area
`to the left ventricular end-diastolic area.
`a Right ventricular percent change in area, calculated from the
`right ventricular end-diastolic and end-systolic area (apical
`four—chamber view) as: RV % change in area = 100 X (RV
`end-diastolic area RV end-systolic area)IRV en