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Eur J Cardiothorac Surg 2008;33:418-423. doi:10.1016/j.ejcts.2007.11.022
Copyright © 2008, European Association for Cardio-thoracic Surgery. Published by Elsevier. All rights reserved.

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Kinetic assisted venous drainage for orthotopic heart transplantation in patients under mechanical circulatory support: a double-edged sword

Matthias E.W. Kirsch*, Zannis Kostantinos, Firas Ali, Emmanuelle Vermes, Gérard Bajan, Daniel Y. Loisance

Service de Chirurgie Thoracique et Cardiovasculaire, AP-HP, Hôpital Henri Mondor, Créteil, France

Received 23 May 2007; received in revised form 31 August 2007; accepted 26 November 2007.

* Corresponding author. Address: 51 Avenue du Maréchal de Lattre de Tassigny, 94 000 Créteil Cédex, France. Tel.: +33 1 49 81 21 72; fax: + 33 149 81 21 52. (Email: matthias.kirsch{at}hmn.aphp.fr).


    Abstract
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 References
 
Background: Heart transplantation in patients supported with ventricular assist devices (VADs) entails a high risk of injury at resternotomy. Prior femorofemoral bypass is the preferred approach in these patients, but poor venous drainage may restrict arterial flow rate. Patients and methods: We compared bypass parameters, transfusion requirements and postoperative outcome in 33 consecutive patients (40.4 ± 12.2 years old, 28 men) assisted with the Thoratec® paracorporeal VAD (mean duration, 3.0 ± 2.96 months) undergoing transplantation using either gravity siphon drainage (GSD, n = 16) or kinetic assisted venous drainage (KAVD, n = 17). Results: Cannulation technique, perfusion pressure, temperature and duration were similar between groups. There were no significant differences in arterial re-infusion flow rates (GSD, 3.6 ± 0.7 vs KAVD, 3.8 ± 0.6 l/min, p = 0.5). KAVD patients had a lower mean SvO2 and a higher desaturation index than GSD patients (69.5 ± 4.6 vs 76.1 ± 5.4 mmHg, p = 0.004; and 0.63 ± 0.23 vs 0.25 ± 0.63, p = 0.0001, respectively). Perioperative requirements in fresh frozen plasma and platelet transfusions were significantly higher in KAVD patients. However, there were no differences in postoperative patient outcome. Conclusion: Perceived benefits on venous return associated with KAVD do not necessarily translate into improved arterial re-infusion flow rates and should be weighed against the hazards of increased venous air aspiration and blood product requirements.

Key Words: Cardiopulmonary bypass • Assisted venous drainage • Heart assist devices • Heart transplantation


    1. Introduction
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 References
 
Ventricular assist devices (VADs) are commonly used to bridge selected patients with end-stage heart failure to cardiac transplantation. Survival after transplantation in patients under mechanical circulatory support has been reported to be similar to that of unsupported patients [1]. However, re-sternotomy and recipient heart and device explantation can be extremely challenging owing to device-related-adhesions, which expose to injury vital mediastinal structures or the VAD itself.

In patients deemed at high risk of injury, cardiopulmonary bypass is usually initiated peripherally, using femoral vein and artery cannulation [2]. This technique is usually effective for partial circulatory support, but full rate cardiopulmonary bypass is usually not possible due to inadequate venous drainage. Moreover, low venous pressure secondary to blood shedding and air aspiration from injury to the walls of the right atrium or the great veins can impede adequate drainage.

Venous drainage can be increased by the use of kinetic or vacuum assistance [3]. However, although these methods augment venous return, they also expose to additional blood trauma and increase the risk and amount of air aspiration during mediastinal dissection with potential subsequent arterial line emboli [4]. In the present retrospective study, we have compared cardiopulmonary bypass parameters, blood transfusion requirements and early postoperative outcome in patients assisted with the Thoratec® paracorporeal VAD and undergoing orthotopic heart transplantation using either gravity siphon or kinetic assisted venous drainage.


    2. Patients and methods
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 References
 
2.1 Patients
Between October 23, 1996 and February 2, 2004, 33 consecutive patients under mechanical circulatory support using the paracorporeal Thoratec® VAD (Thoratec Corporation, Pleasanton, CA) underwent orthotopic cardiac transplantation at Henri Mondor University Hospital. Patients undergoing transplantation after support with another type of assist device were excluded.

The series comprised 28 men and five women, aged 40.4 ± 12.2 years (range, from 17 to 59 years). Primary causes for heart failure are listed in Table 1 . Patients were assisted for a mean duration of 3.02 ± 2.96 months (range, from 0.0 to 11.8 months). Five patients (15.2%) were assisted using a left ventricular device only, while 28 patients required biventricular support (84.8%).


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Table 1 Causes of heart failure
 
2.2 Anaesthetic protocol
The anaesthetic protocol always associated continuous infusions of hypnotic (propofol), opioid (sufentanil) and neuromuscular blocking (tracrium) agents.

Aprotinin was used in 20 (61%) patients, depending on the risk of anaphylaxis estimated by the anaesthesiologist [5]. When administered, an intravenous loading dose of 2 x 106 KIU was followed by continuous infusion of 5 x 105 KIU/ h. An additional 2 x 106 KIU were added to the bypass pump prime.

2.3 CPB cannulation technique
In 26 patients (n = 78.8%), arterial cannulation was performed through the right or left femoral artery. In these patients, venous drainage was achieved through cannulation of a femoral vein with subsequent cannulation of the superior vena cava as soon as it was dissected free (n = 23), or through direct bi-caval cannulation (n = 3). In one patient a high pressure developed in the arterial line and required conversion to aortic cannulation during the course of CPB.

In the remaining seven patients (21.2%), arterial cannulation was performed directly in the distal ascending aorta or the proximal aortic arch. This approach was adopted in patients considered to be at low risk of mediastinal re-entry accident, which was left to the appreciation of the operating surgeon on the basis of the type (biventricular vs left ventricular support) and duration of support. In these patients, venous drainage was obtained through bicaval cannulation (n = 5) or separate cannulation of a femoral vein and the superior vena cava (n = 2).

Femoral vein cannulation was performed using Fem-FlexTM (Research Medical Inc., Midvale, Utah) and DLP® (Medtronic, Inc. Minneapolis, MN) femoral venous cannulae sized from 28 to 32 French (mean size 29.0 ± 1.4 French).

2.4 Perfusion strategy
In 20 patients (60.6%), femorofemoral bypass was established prior to resternotomy in order to achieve decompression of the right cavities of the heart and reduce their risk of injury, and was completed as soon as the superior vena cava could be cannulated. In the remaining patients (n = 13, 39.4%), CPB was established as late as possible during mediastinal dissection in order to reduce the duration of bypass.

2.5 Cardiopulmonary bypass circuit
In all patients the cardiopulmonary bypass circuit consisted of the following basic elements: (1) a soft shell venous reservoir bag (Affinity®, Medtronic) with a blood collection reservoir (EL Cardiotomy Reservoir, Medtronic); (2) a centrifugal arterial blood pump (Bio-Pump® Plus, Medtronic); (3) a hollow fibre membrane oxygenator (Affinity NT, Medtronic); and (4) a 40 µm arterial line filter (Jostra Quart, Maquet Cardiopulmonary AG, Germany). Perfusion flow rate was measured on line using the Medtronic Bio-Probe® flow transducer. Perfusion adequacy was monitored by continuous measurement of haemoglobin oxygen saturation in the venous blood (SvO2) using the BioTrend® oxygen saturation monitor (Medtronic).

2.6 Management of venous drainage
During the study period, two methods of venous drainage were used. With the first method (n = 16, from 1996 to 2004), venous drainage relied solely on the gravity siphon (gravity siphon drainage, GSD).

With the second method (n = 17, from 2000 to 2004), venous return was augmented using a centrifugal pump (kinetic assisted venous drainage, KAVD). Briefly, a centrifugal Biomedicus pumphead (Bio-Pump® BPX-80, Medtronic) driven by a Biomedicus 550 pump was incorporated into the venous line between the venous cannulae and the soft shell reservoir. A pressure monitoring line was connected to the venous line approximately 10 cm before the inlet of the venous pump. Bypass commenced with gravity drainage. Once stable, KAVD was initiated and progressively increased. During bypass, the negative pressure did not exceed –80 mmHg.

Although KAVD was introduced at a later time point, there remained an overlap of both techniques during the second half of the study period (Fig. 1 ).


Figure 1
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Fig. 1. Annual number of transplantations performed in patients assisted with the Thoratec® paracorporeal VAD using gravity siphon drainage (open bars) and kinetic assisted venous drainage (filled bars).

 
2.7 Data collection
Data were gathered retrospectively from patient files and perfusion records. Perfusion parameters were recorded sequentially at 1.5, 3.5, 5 and 10 min and then every 10 min throughout the duration of CPB. Each perfusion chart was divided in two periods. The first period was devised to reflect the most critical perfusion period during which venous return might be problematic. This period comprised the initiation of bypass (either peripherally or centrally) and the mobilisation and subsequent explantation of the native heart. The end of this period was identified on the perfusion records by the notification of cardioplegia re-infusion into the donor heart upon arrival in the operating room. The second period, considered less critical for venous drainage, comprised allograft implantation and the progressive weaning from CPB with its eventual period of assistance. For each patient, perfusion parameters were analysed for the whole duration of CPB, and for the first CPB period by averaging sequential recordings over the respective time frames.

Perfusion adequacy was estimated using mean SvO2 calculated over the whole duration of CPB, and a de-saturation index, defined as the ratio of the number of SvO2 recordings ≤70 mmHg by the total number of recordings.

Transfusion (red blood cells (RBC), fresh frozen plasma (FFP) and platelets) and crystalloid requirements were recorded for the perioperative period and the first 24 h in ICU. Hospital death was defined as death of any cause occurring during the hospitalisation in which the transplantation was performed. Those deaths occurring after discharge from the hospital but within 30 days of the procedure were also considered as hospital deaths.

2.8 Statistical analysis
Statistical analysis was performed using SPSS Base 12.0.1 for Windows statistical software (SPSS Inc, Chicago, IL). Continuous variables were expressed as the mean ± 1 standard deviation and compared using Student's t-test. Categorical variables were expressed as percentages and compared using the Chi-square or Fisher's exact tests, as appropriate. A p value of less than 0.05 was considered significant.


    3. Results
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 References
 
3.1 Patients
There were no significant differences in preoperative patient demographic and morphological data between both groups (Table 2 ). Importantly, the type (LVAD vs BiVAD) and the duration of support before transplantation were similar between both patient groups (Table 2).


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Table 2 Preoperative data
 
3.2 Perfusion parameters
Arterial cannulation techniques (femoral vs aortic) did not differ significantly between groups. Cannulation of a femoral vein was performed more frequently in the KAVD group (KAVD, 16 (94.1%); GSD, n = 9 (56.3%); p = 0.017). However, initiation of peripheral femorofemoral bypass prior to sternotomy was performed in a similar number of patients in both groups (GSD, 8 (50.0%); KAVD 12 (70.6%); p = 0.30).

Perfusion parameters such as CPB duration, mean arterial perfusion pressure, lowest perfusion temperature and lowest haemoglobin values were similar between both patients groups (Table 3 ). Arterial re-infusion flow rates were similar between both patient groups whether the whole duration of CPB or only the first period of CPB (results not shown) was considered (Table 3).


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Table 3 Cardiopulmonary bypass data
 
3.3 Perfusion adequacy
Sequential SvO2 measurements were recorded for 26 patients (GSD, 15 (93.8%); KAVD, 11 (64.7%); p = 0.09). In the KAVD group, mean SvO2 was significantly lower than in the GSD group (Table 3). Furthermore, the KAVD group had a significantly higher desaturation index, reflecting a higher number of desaturation episodes.

3.4 Blood product use
Aprotinin therapy was given in a similar proportion in both patient groups (KAVD, 11 (68.8%), GSD 6 (53.3%); p = 0.48). Perioperative requirements in FFP and platelet transfusions were significantly higher in the KAVD group (Table 4 ). In contrast, perioperative RBC transfusion and crystalloid infusion was similar in both patient groups.


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Table 4 Blood and crystalloid transfusion requirements
 
During the first 24 h in ICU, no significant differences were noted in blood product transfusion or crystalloid infusion between both groups (Table 4).

3.5 Outcomes
No significant differences were detected in duration of mechanical ventilation (GSD, 2.7 ± 3.7; KAVD, 4.5 ± 7.5; p = 0.42), ICU stay (GSD, 10.5 ± 6.3 days; KAVD, 16 ± 29.2 days; p = 0.47) and hospital mortality (GSD, 3 (18.8%); KAVD, 1 (5.9%); p = 0.34) between both patient groups.


    4. Discussion
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 References
 
In the present study we have compared perfusion parameters, transfusion requirements and clinical outcome after heart transplantation in patients under MCS using GSD or KAVD during CPB. Our main findings were: (1) arterial blood re-infusion rates were not significantly different between both groups; (2) haemoglobin oxygen saturation in the venous blood (mean SvO2, desaturation index) was significantly lower in the KAVD group; and (3) FFP and platelet transfusion requirements were significantly higher in the KAVD group.

Heart transplantation in patients implanted with Thoratec® VAD can be extremely challenging owing to the development of dense, device-related, mediastinal adhesions which expose patients to the injury of vital structures or the inflow and outflow cannulae.

Early transplantation would obviously alleviate these difficulties. However, actual donor organ shortage renders early transplantation less probable. Furthermore, survival after cardiac transplantation is influenced by the time interval from ventricular assist device insertion to transplantation [6,7]. Thus, survival has been shown to be significantly reduced when transplantation is performed within 2–4 weeks of VAD implantation, probably as a consequence of insufficient end-organ function restoration and patient rehabilitation [7].

Several strategies have been developed in order to reduce mediastinal adhesion formation. Thus, efforts should be made at the time of device implantation to limit dissection and tissue injury as much as possible. Furthermore, postoperative bleeding should also be prevented by careful surgical haemostasis and administration of antifibrinolytic agents. Some groups advocate placement of expanded polytetrafluoroethylene membranes over the right ventricle or the device at the end of the implantation procedure [8,9]. This strategy has been shown to reduce adhesions between tissues and device surfaces without increasing the risk of infection [9].

However, none of these procedures completely obviates the risk of injury at the time of re-operation, and femorofemoral bypass prior to re-sternotomy is a cautious option in some of these patients. Unfortunately, venous drainage is often insufficient in this setting, owing to the longer and smaller venous cannula, a frequently low central venous pressure related to blood spoliation, and the frequent aspiration of air through holes in the walls of the right atrium, right ventricle or the great veins. Thus, bypass flow is often critically reduced until the superior vena cava is dissected free and another venous cannula can be inserted in order to separately drain blood from the upper part of the body and allow complete exclusion of the heart. Improved venous drainage might be obtained in this setting with newer generation venous cannulae such as the self-expandable Smart canulaTM (Cardiosmart Ltd., Fribourg, Switzerland) [10]. Alternatively, we have tried additional percutaneous cannulation of the right internal jugular vein using a 14 Fr arterial cannula in two patients. However, time constraints, full dose anticoagulation and antiaggregation and frequent history of previous jugular catheterisations in these critically ill patients render this approach unpractical.

Kinetic or vacuum assisted venous drainage has been proved useful in the setting of minimally invasive surgery [11,12] and conventional re-operations after cardiac surgery [13] by allowing higher arterial re-infusion flows [13] and reduced blood product use [14]. In the present study, we found no significant difference in arterial re-infusion rates between GSD and KAVD. Moreover, patients with KAVD appeared to have less adequate tissue oxygenation as suggested by a lower mean SvO2 and a higher desaturation index. We believe that in our specific setting of extremely difficult mediastinal dissection in patients under mechanical circulatory support, the benefit of KAVD on venous return was probably offset by an increase of the risk and amount of air aspiration. Indeed, the venous centrifugal pump and the venous reservoir bag required constant clearing of air, and CPB was frequently hampered by air-locks as has been reported in an in-vitro setting [15]. We recently improved on this limitation by adding an arterial filter on the venous line, immediately above the venous centrifugal pump.

Patients under MCS undergoing heart transplantation are at increased risk of preoperative bleeding due to mediastinal re-entry injuries but also to device related chronic activation of fibrinolytic and inflammatory pathways and anti-thrombotic treatment [16]. We have observed a nearly two-fold increase in FFP and platelet transfusion in patients undergoing KAVD. One contributing factor might be increased blood trauma due to venous line vacuum or more intense blood activation by the contact with air, although experimental [17] and clinical [14] data using vacuum assisted venous drainage do not support this hypothesis.

The findings of the present study are limited by its retrospective nature, the small number of patients in each group and the long time-span over which these patients were included. Furthermore, transplantation in patients under MCS is an extremely complex procedure and we cannot exclude the possibility that severe unmeasured bias against KAVD were present and accounted for the differences observed between both groups. However, our results suggest that the perceived benefits on venous return associated with KAVD do not necessarily translate into higher arterial re-infusion flow rates and should be carefully weighed against possible hazards such as increased air aspiration and increased blood product requirements.


    References
 Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 References
 

  1. Drakos SG, Kfoury AG, Long JW, Stringham JC, Gilbert EM, Moore SA, Campbell BK, Nelson KE, Horne BD, Renlund DG. Effect of mechanical circulatory support on outcomes after heart transplantation. J Heart Lung Transpl 2006;25:22-28.[CrossRef][Medline]
  2. Merin O, Silberman S, Brauner R, Munk Y, Shapira N, Falkowski G, Dzigivker I, Bitran D. Femoro-femoral bypass for repeat open-heart surgery. Perfusion 1998;13:455-459.[Abstract/Free Full Text]
  3. Corno AF. Systemic venous drainage: can we help Newton?. Eur J Cardiothorac Surg 2007;31:1044-1051.[Abstract/Free Full Text]
  4. Willcox TW. Vacuum-assisted venous drainage: to air or not to air, that is the question. Has the bubble burst?. JECT 2002;34:24-28.
  5. Milano CA, Patel VS, Smith PK, Smith MS. Risk of anaphylaxis from aprotinin re-exposure during LVAD removal and heart transplantation. J Heart Lung Transpl 2002;21:1127-1130.[CrossRef][Medline]
  6. Ashton RC, Goldstein DJ, Rose EA, Weinberg AD, Levin HR, Oz MC. Duration of left ventricular assist device support affects transplant survival. J Heart Lung Transpl 1996;15:1151-1157.[Medline]
  7. Gammie JS, Edwards LB, Pierson III RN, Tsao L. Optimal timing of cardiac transplantation after ventricular assist device implantation. J Thorac Cardiovasc Surg 2003;127:1789-1799.[CrossRef]
  8. Oz MC, Levin HR, Rose EA. Technique for removal of left ventricular assist devices. Ann Thorac Surg 1994;58:257-258.[Abstract]
  9. Leprince P, Rahmati M, Bonnet N, Bors V, Rama A, Léger P, Gandjbakhch I, Pavie A. Expanded polytetrafluoroethylene membranes to wrap surfaces of circulatory support devices in patients undergoing bridge to heart transplantation. Eur J Cardiothorac Surg 2001;19:302-306.[Abstract/Free Full Text]
  10. Mueller XM, Tevaearai HT, Jegger D, Horisberger J, Mucciolo G, von Segesser LK. A new expandable venous cannula for minimal access heart surgery. Ann Thorac Surg 2002;74:S1330-S1333.[Abstract/Free Full Text]
  11. Jegger D, Tevaearai HT, Horisberger J, Mueller XM, Boone Y, Pierrel N, Seigneul I, von Segesser LK. Augmented venous return for minimally invasive open heart surgery with selective caval cannulation. Eur J Cardiothorac Surg 1999;16:312-316.[Abstract/Free Full Text]
  12. Colangelo N, Torracca L, Lapenna E, Moriggia S, Crescenzi G, Alfieri O. Vacuum-assisted venous drainage in extrathoracic cardiopulmonary bypass management during minimally invasive cardiac surgery. Perfusion 2006;21:361-365.[Abstract/Free Full Text]
  13. Toomasian JM, McCarthy JP. Total extrathoracic cardiopulmonary support with kinetic assisted venous drainage: experience in 50 patients. Perfusion 1998;13:137-143.[Abstract/Free Full Text]
  14. Banbury MK, White JA, Blackstone EH, Cosgrove DM. Vacuum-assisted venous return reduces blood usage. J Thorac Cardiovasc Surg 2003;126:680-687.[Abstract/Free Full Text]
  15. LaPietra A, Grossi EA, Pua BB, Esposito RA, Galloway AC, Derivaux CC, Glassman LR, Culliford AT, Ribakove GH, Colvin SB. Assisted venous drainage presents the risk of undetected air microembolism. J Thorac Cardiovasc Surg 2000;120:856-863.[Abstract/Free Full Text]
  16. Wegner JA, DiNardo JA, Arabia FA, Copeland JG. Blood loss and transfusion requirements in patients implanted with a mechanical circulatory support device undergoing cardiac transplantation. J Heart Lung Transpl 2000;19:504-506.[CrossRef][Medline]
  17. Mueller XM, Tevaearai HT, Horisberger J, Augstburger M, Burki M, von Segesser LK. Vacuum assisted venous drainage does not increase trauma to blood cells. ASAIO J 2001;47:651-654.[CrossRef][Medline]



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