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Right arrow Mechanical Circulatory Assistance

Ann Thorac Surg 2001;71:205-209
© 2001 The Society of Thoracic Surgeons

Original article: cardiovascular

Improved outcomes with an implantable left ventricular assist system: a multicenter study

Peer M. Portner, PhDa, Piet G. M. Jansen, MDb, Philip E. Oyer, MDa, Dereck R. Wheeldon, PhDa, Narayanan Ramasamy, PhDb

a Stanford University School of Medicine, Stanford, USA
b Baxter Novacor Division, Oakland, California, USA

Address reprint requests to Dr Portner, Department of Cardiothoracic Surgery, Falk Research Center, Stanford University School of Medicine, Stanford, California 94305-5407

Presented at the Thirty-Sixth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 31–Feb 2, 2000.


   Abstract
Top
 Footnotes
 Abstract
Introduction
 Material and methods
 Results
 Comment
 Appendix. Contributing centers
 Discussion
 References
 
Background. Cumulative experience with the Novacor wearable electric left ventricular assist system (LVAS) now exceeds 850 recipients. The pump inflow conduit (IFC) has been implicated in embolic complications.

Methods. Clinical outcomes were compared for two IFC designs in a retrospective, nonrandomized, multicenter study. The original IFC (woven, unsupported, crimped polyester: control group) and an alternative IFC (knitted, gelatin-sealed, integrally supported, uncrimped polyester: test group) were utilized upon availability in North American and European centers. Differences in cerebral embolism to 180 days postimplant were analyzed.

Results. Four hundred ninety patients implanted between August 1996 and August 1999, were studied. Two hundred eighty-eight received the control IFC and 202 received the test IFC. The groups (control, test) were well matched for age (48, 49 years), etiology (idiopathic 53%[152 of 288], 55% [112 of 202]; ischemic 34% [97 of 288], 33% [66 of 202]) and mean observation time (97, 91 days). The incidence of embolic cerebrovascular accidents (CVA) was 21% (60 of 288) in the control and 12% (24 of 202) in the test group (p = 0.010). Independent risk factors for embolic CVA were found to be preimplant acute myocardial infarction (odds ratio 4.3), age above 50 years (odds ratio 2.1), and ischemic etiology (odds ratio 1.7). There was no difference in survival between the groups (71% [205 of 288], 68% [137 of 202]).

Conclusions. The alternative (test) IFC has significantly reduced the incidence of embolic CVA. This improvement is likely due to increased resistance to deformation at implant, improved neointimal adhesion, and more favorable blood flow characteristics within the conduit.


   Introduction
Top
 Footnotes
 Abstract
 Introduction
Material and methods
 Results
 Comment
 Appendix. Contributing centers
 Discussion
 References
 
The Novacor electrically powered implantable left ventricular assist system (LVAS) was designed to provide definitive therapy for patients with terminal heart failure. A fully autonomous system, it can support the entire systemic circulation, while substantially decompressing the left ventricle. Originally designed to be totally implantable, current systems employ percutaneously connected wearable controller and battery packs, allowing full rehabilitation and a return to normal activities [1, 2]. Cumulative experience with the wearable system now exceeds 850 recipients worldwide. Currently, more than 60% of these recipients spend more than 80% of their support time outside the hospital. Support durations have increased progressively as patients are added to growing transplant waiting lists. As of January 2000, 63 Novacor recipients had been supported for more than 1 year, the longest over 4 years. High system reliability has been demonstrated in this outpatient setting, with minimal patient surveillance [3–9].

The current device configuration incorporates a dual pusher-plate blood pump with modular porcine xenograft valved conduits. Polyester inflow conduit (IFC) and outflow graft connect the pump between the left ventricular apex and ascending aorta. Early conduits were fabricated from low-porosity, woven, crimped polyester graft manufactured by Meadox (Cooley; Meadox Medical, Oakland, NJ). While exploring alternate graft materials for the IFC, careful examination of explanted conduits often revealed signs of longitudinal creases and other distortions, likely introduced during implantation. Additionally, the neointimal lining was typically poorly attached to the conduit wall (Fig 1) and often disrupted [10]. These findings influenced the selection of a gelatin-sealed, knitted polyester graft, with integral wall reinforcement, manufactured by Vascutek (Sulzer Vascutek Ltd, Renfrewshire, Scotland, UK), as an alternative IFC. This material has been extensively used as a vascular prosthesis [11–13]. Clinical outcomes were compared for the two IFC designs in a retrospective, nonrandomized, multicenter study.



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  		Fig 1. Inflow conduits at explant. Gross photography of longitudinally sectioned Cooley (A) and Vascutek (B) conduits, from a 17 year old supported for 61 days and an 18 year old supported for 99 days, respectively, both male with idiopathic cardiomyopathy and both successfully transplanted. Note the retracted, nonadherent pannus on the explanted Cooley conduit and the smooth adherent pannus lining the Vascutek conduit.

 

   Material and methods
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
Results
 Comment
 Appendix. Contributing centers
 Discussion
 References
 
The original Cooley IFC (woven, unsupported, crimped polyester: control group) and the alternative Vascutek IFC (knitted, gelatin-sealed, integrally supported, uncrimped polyester: test group) were utilized, upon availability, in 19 North American and 22 European centers. Because the alternative conduit was considerably less flexible, the implant technique had to be slightly modified. A 6-cm Vascutek IFC was made available, in addition to the original 9-cm length. The incidence of cerebral embolic rates (to 180 days postimplant for ongoing patients) was analyzed. A previous report on the Novacor European experience documented that 97% of cerebral embolic complications occurred within 180 days of implant [5]. An embolic cerebrovascular accident (CVA) was defined as a cerebral deficit, which was sudden in onset, clinically relevant, and persistent for more than 24 hours. The embolic origin of the deficit was confirmed by conventional diagnostic methods (eg, computed tomography scan) or by demonstration at autopsy.

The recommended anticoagulation and antiaggregation regimen was unfractionated heparin intravenously to 1.5x baseline activated prothrombin time, early postoperatively; replaced, when oral medications were tolerated, by Coumadin to an international normalized ratio (INR) of 2.5 to 3.0 and aspirin (80 to 350 mg/day).

Data were analyzed with SPSS (SPSS for Windows Release 9.0.0; SPSS Inc, Chicago, IL). Continuous variables were expressed as means ± standard error of the mean. Binary variables were described by frequency distributions. Univariate analysis (Fisher’s exact test) and multivariate analysis (Cox’s proportional hazards regression analysis) were used to identify preimplant risk factors for cerebral embolism. Kaplan-Meier analysis was used to estimate the freedom from embolic CVA over time; the log-rank statistic was used for group comparison. Patients were analyzed only while on LVAS support. A two-tailed p value less than 0.05 level was regarded as statistically significant.


   Results
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
Comment
 Appendix. Contributing centers
 Discussion
 References
 
Four hundred ninety patients implanted between August 1996 and August 1999, from 41 centers worldwide, were included in this retrospective, nonrandomized, multicenter study. There were 288 patients with the original IFC who constituted the control group and 202 with the alternative IFC who made up the test group. The groups were well matched. The control, test mean ages were 48.1 ± 0.8 and 48.7 ± 0.9 years, and body surface area 1.94 ± 0.01 and 1.94 ± 0.02 m2. The male:female ratio was 82%/12% in both groups. Diagnosis and preimplant status are summarized in Table 1. The mean observation time was 97 ± 4 and 91 ± 4 days, respectively.


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  		Table 1. Patient Characteristics at Implant

 
The incidence of embolic CVA was 21% (60/288) in the control and 12% (24/202) in the test group (p = 0.010). Freedom from embolic CVA to 180 days postimplant was 76.4% (±2.9%) in the control group and 84.3% (±3.1%) in the test group; log-rank = 0.0222 (Fig 2). The time course of cerebral complications was similar for control and test groups: median time of embolic events was 21 and 29 days with 87% and 95% of events, respectively, occurring within the first 3 months after implantation. In the test group, 58% (177 of 202) received the 6-cm IFC and 42% (85/202) received the 9-cm IFC. There was a trend towards a lower incidence of embolic CVAs with the 6-cm IFC (11.1% vs 12.9%, p = NS). Multivariate analysis (Cox’s proportional hazards regression analysis) revealed independent preimplant risk factors for cerebral embolism (Table 2): acute myocardial infarction (odds ratio 4.3), age over 50 years (odds ratio 2.1), and ischemic etiology (odds ratio 1.7).



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  		Fig 2. Freedom from embolic CVA. Freedom from embolic CVA was computed using the Kaplan-Meier algorithm. During the observation period (180 days post-LVAS implantation), the risk of embolic CVA was significantly lower in the test group (p = 0.022, log-rank statistic). The number of patients at risk (control, test) were 204, 139 at 1 month; 157, 106 at 2 months; 95, 79 at 4 months; and 64, 36 at 6 months.

 

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  		Table 2. Multivariate Analysis

 
The incidence of other clinical complications (bleeding, transient ischemic attack, renal dysfunction, right heart failure, infection) was similar between the two groups (Table 3). Surgical bleeding was defined as bleeding related to the surgical procedure and requiring reoperation. Nonsurgical bleeding includes digestive tract bleeding, late pump pocket bleeding, dental bleeding, or cerebral hemorrhage. A transient ischemic attack was defined as a central nervous system deficit, which is sudden in onset, and resolves within 24 hours. Renal dysfunction was defined as abnormal kidney function requiring multiple diuretics or replacement therapy (hemodialysis or filtration). Right heart failure was defined as a cardiac index less than 2.0 L/min/m2 with central venous pressure greater than 18 mm Hg and with normovolemia, requiring intravenous inotropes more than 10 µg/kg/min or right ventricular assist device support. Infection was defined as any positive culture for pathogenic organisms requiring antimicrobial therapy (positive blood culture for systemic infection). Survival, while supported, during the observation period was 71% in the control group and 68% in the test group (p = NS).


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  		Table 3. Other Clinical Complications

 

   Comment
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
Appendix. Contributing centers
 Discussion
 References
 
The incidence of cerebral complication rates in LVAS patients has been reported to be between 3% and 47% [14–17]. Most of these reports have been from limited, usually single institution, series. Thrombogenicity is multifactorial and complex, involving material "thromboresistance," flow and the coagulation state. Due to the interactive nature of patient-related characteristics, management factors, and device-related issues, it is usually difficult to determine which factor(s) play the dominant role in a given case. That management factors can significantly impact outcome, is illustrated by a single institution’s reported [15, 16] decrease from 47% to 11% in (Novacor) embolic complication rates after the introduction of platelet antiaggregants. Some authors have attributed low embolic rates to the use of a textured blood-contacting surface and the consequent development of a "compensated coagulopathy" [14, 18]. However, low (3%) embolic rates with this textured-surface design are not universal, with a recently reported series documenting a 16% rate [17]. There is also evidence [19] of adverse immune response (T-cell defect, B-cell hyper-reactivity) to this surface, contributing to an increased risk of device infection and patient sensitization. Substantial intercenter differences have been reported in the incidence of all major LVAS complications [5]. It is also generally assumed that the majority of embolic complications are thrombotic in origin [15].

Explants of the original Cooley IFCs have revealed evidence of conduit distortion at implant, resulting in disturbance of the luminal geometry and subsequent irregular neointimal lining. Histologic examination of this lining has been characterized by a loose array of collagen fibers with thrombin and fibrin inclusions, random orientation of smooth muscle cells, and only sparse filaments of fibrin anchoring the neointima to the polyester surface [10]. In contrast, there was no evidence in the reinforced Vascutek IFCs of distortion at implant. The intimal fibrin lining of the Vascutec IFC was characterized by collagen layers firmly anchored to the polyester, resulting in a smooth, thin, and adherent pannus (Fig 1).

Computer modeling of flow dynamics revealed important differences between the two conduits. The original Cooley IFC, designed with maximum crimp to facilitate implantation, produced large variations in mural shear rates of 0 to 85 dynes/cm2. This compares with the lower (and less variable) rate of 8 to 32 dynes/cm2 in the Vascutek IFC. These findings were subsequently confirmed in animal studies [20]. An ultrasonic color-flow Doppler mapping system was used to visualize and analyze flow behavior in the inflow conduit. Blood velocity profiles were reconstituted using a multigate Doppler velocimeter. Wall shear stresses were calculated from linear fitting of the velocity profiles, accounting for blood viscosity.

This retrospective study of a large multicenter LVAS population has demonstrated that changes to the inflow conduit, addressing the previously friable pannus by limiting flexibility, increasing mural flow, and improving neointimal adhesion, have resulted in a reduction of more than 50% in embolic CVAs. Furthermore, the evidence suggests a primary mechanism of particulate-, rather than thrombo-embolism. Recipients were observed for up to 180 days postimplant, because this provided a means of delineating the study, and the vast majority of complications took place well within this timeframe. All other aspects of patient selection and management remained essentially the same. Attention is now focused on further refinements in IFC design, recognizing that the inflow conduit has characteristics (flow and pressure) that are more venous than arterial. (Appendix)


   Footnotes
Top
 Footnotes
Abstract
 Introduction
 Material and methods
 Results
 Comment
 Appendix. Contributing centers
 Discussion
 References
 
Drs Portner and Oyer are consultants and Drs Jansen and Wheeldon are employees of World Heart Inc, manufacturer of the Novacor assist system. World Heart recently acquired the assets of the Novacor Division of Edwards Lifesciences (spin-out company from Baxter Healthcare Corp). Drs Portner and Ramasamy were previously employees of Baxter Novacor.


   Appendix. Contributing centers
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Appendix. Contributing centers
Discussion
 References
 
North America: Royal Victoria Hospital, Montreal, Quebec, Canada; Barnes Jewish Hospital, St. Louis, MO; Baylor College of Medicine, Houston, TX; Bowman Gray School of Medicine, Winston-Salem, NC; Cleveland Clinic Foundation, Cleveland, OH; Jewish Hospital Heart & Lung Institute, Louisville, KY; Methodist Hospital of Indiana, Indianapolis, IN; Mount Sinai Medical Center, New York, NY; Sentara Norfolk General Hospital, Norfolk, VA; St. Louis University Medical Center, St. Louis, MO; St. Luke’s Medical Center, Milwaukee, WI; Stanford University Medical Center, Stanford CA; Tampa General Hospital, Tampa, FL; The Johns Hopkins Hospital, Baltimore, MD; University of California San Diego Medical Center, San Diego, CA; University of Arizona Medical Center, Tucson, AZ; University of Pittsburgh Medical Center, Pittsburgh, PA; Vanderbilt University Medical Center, Nashville, TN; Yale University School of Medicine, New Haven, CT.

Europe: University of Vienna, Vienna, Austria; Cliniques Universtaires Saint Luc, Brussels, Belgium; Helsinki University Hospital, Helsinki, Finland; Hôpital La Pitié Salpétrière, Paris, France; Hôpital Henri Mondor, Créteil, France; Hôpital Trousseau, Chambray les Tours, France; Hôpital de Rangueil, Toulouse, France; Hôpital Broussais, Paris, France; Hôpital Laennec, Nantes, France; CHU de Brabois, Nancy, France; Hôpital La Timone, Marseille, France; Deutsches Herzzentrum Berlin, Germany; Herzzentrum Nordrhein Westfalen, Bad Oeynhausen, Germany; Westfällische Wilhelms-Universität Münster, Germany; Klinikum Grosshadern, Munich, Germany; Ruprecht-Karls-Universität, Heidelberg, Germany; Chirurgische Universitätsklinik, Freiburg, Germany; IRCCS Policlinico San Matteo Pavia, Italy; Ospedale Niguarda Ca Granda Milan, Milan, Italy; Universita di Padova, Padova, Italy; Akademiska Sjukhuset Uppsala, Sweden; Papworth Hospital, Cambridge, UK.


   Discussion
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Appendix. Contributing centers
 Discussion
References
 
DR W. RANDOLPH CHITWOOD, JR (Greenville, NC): Is this type conduit applied with any other device besides the Novacor pump or just strictly the Novacor?

DR PORTNER: Strictly to the Novacor. All the other devices have different conduits.

DR CHITWOOD: Have they found other conduit-related things that reduce thromboembolism besides anticoagulants?

DR PORTNER: It is such a complex issue in terms of the potential risk factors, that it is hard to separate the different mechanisms. The main point of this presentation was to elucidate the observation that particulate, rather than thromboembolism, was and probably still is the most significant source of Novacor embolic complications.

DR CHITWOOD: In the patients who advance with devices longer, is the same relation still held, that there was a marked reduction in emboli?

DR PORTNER: Yes, that is correct. There were no obvious differences between patient cohorts other than significant intercenter differences, presumably reflecting patient selection and patient management.

DR GUS J. VLAHAKES (Boston, MA): Doctor Portner, where do you think the remaining 12% of emboli comes from? Do you think there is still a small subpopulation of patients that will embolize off of the conduit or do you think that there is another area in the VAD where this may be occurring?

DR PORTNER: Well, as you know, we have spent considerable time investigating potential sources of embolism; initially, thrombotic deposits were found on the valves, and the valve design modified to improve local flow. It is likely that the inflow conduit is still the primary source and further conduit refinement is underway. All the usual suspects for embolic complications, such as atrial fibrillation, remain. The ideal level of anticoagulation and platelet antiaggregation is unknown and may, in fact, be less than current practice, with the source of particulate emboli eliminated.

DR VLAHAKES: How often is the shorter conduit used, and do you have any comparative data about possible reduction in embolic event rate with the shorter conduit?

DR PORTNER: In approximately 60% of the recipients. And interestingly, the majority of centers choose one size or the other. The conduits do not appear to be selected for patient habitus or patient size. And although there is currently no statistical difference, there is a trend towards a lower rate with the shorter conduit.


   References
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Appendix. Contributing centers
 Discussion
 References
 

  1. Portner P.M., Oyer P.E., Jassawalla J.S., et al. A totally implantable ventricular assist system for terminal heart failure. In: Kantrowitz A., ed. ASAIO primers in artificial organs: left ventricular assist devices. Philadelphia: JB Lippincott, 1988:57-76.
  2. Miller P.J., Billich T.J., LaForge D.H., et al. Initial clinical experience with a wearable controller for the Novacor left ventricular assist system. ASAIO J 1994;40:M464-M470.
  3. Portner P.M., Oyer P.E., McGregor C.G.A., et al. First human use of an electrically powered implantable ventricular assist system. Artif Organs 1985;9:36.
  4. Kormos R.L., Murali S., Dew M.A., et al. Chronic mechanical circulatory support: Rehabilitation, low morbidity and superior survival. Ann Thorac Surg 1994;57:51-58.[Abstract]
  5. El-Banayosy A., Deng M., Loisance D.Y., et al. The European experience of Novacor left ventricular assist (LVAS) therapy as a bridge to transplant: a retrospective multi-centre study. Eur J Cardiothorac Surg 1999;15:835-841.[Abstract/Free Full Text]
  6. Robbins R.C., Oyer P.E. Bridge to transplant with the Novacor left ventricular assist system. Ann Thorac Surg 1999;68:695-697.[Abstract/Free Full Text]
  7. Loisance D., Tixier D., Mazzucotelli J.P., et al. Mechanical circulatory support towards the permanent implantation. Eur J Cardiothorac Surg 1997;12(Suppl):25-28.[Abstract]
  8. Vigano M., Scuri S., Cobelli F., et al. Staged discharge out of hospital of the Novacor left ventricular assist system (LVAS) recipients. Eur J Cardiothorac Surg 1997;12(Suppl):45-50.
  9. Fey O., El-Banayosy A., Arosuglu L., et al. Out-of-hospital experience in patients with implantable mechanical circulatory support: present and future trends. Eur J Cardiothorac Surg 1997;12(Suppl):51-53.
  10. Moczar M, Houel R, Ginat M, et al. Evolution of pseudoneointimal growth in LVAS graft conduits. Artif Organs 1999;23:Abstract 34.
  11. Reid D.B., Pollock J.G. A prospective study of 100 gelatin-sealed aortic grafts. Ann Vasc Surg 1991;5:320-324.[Medline]
  12. Drury J.K., Ashton T.A., Cunningham J.D., et al. Experimental and clinical experience with gelatin impreganated Dacron prosthesis. Ann Vasc Surg 1987;1:542-547.[Medline]
  13. Vohra R., Drury J.K., Shapiro D., et al. Sealed vs unsealed knitted Dacron prostheses: a comparison of the acute phase protein response. Ann Vasc Surg 1987;1:548-551.[Medline]
  14. Slater J.P., Rose E.A., Levin H.R., et al. Low thromboembolic risk without anticoagulation using advanced-design left ventricular assist devices. Ann Thorac Surg 1996;62:1321-1328.[Abstract/Free Full Text]
  15. Schmid C., Weyand M., Nabavi G., et al. Cerebral and systemic embolisation during left ventricular support with the Novacor N100 device. Ann Thorac Surg 1998;65:1703-1710.[Abstract/Free Full Text]
  16. Schmid C., Weyand M., Hammel D., et al. Effect of platelet inhibitors on thromboembolism after implantation of a Novacor 100: preliminary results. Thorac Cardiovasc Surg 1998;46:260-262.[Medline]
  17. Mehta S., Souza D., Boehmer J., et al. Comparison of Pierce-Donachy (PD) and TCI left ventricular assist systems as bridge to clinical transplant: an institutional experience. ASAIO J 1999;45:148.
  18. Spanier T.B., Chen J.M., Oz M.C., et al. Time-dependent cellular population of textured-surface left ventricular assist devices contributes to the development of a biphasic systemic pro-coagulant response. J Thorac Cardiovasc Surg 1999;118:404-413.[Abstract/Free Full Text]
  19. Ankersmit H.J., Tugulea S., Spanier T.B., et al. Activation-induced T-cell death and immune dysfunction after implantation of left-ventricular assist device. Lancet 1999;354:550-555.[Medline]
  20. Clerin V., Houel R., Radier C., Loisance D.Y. Blood flow dynamics in the inflow and outflow conduits of the Novacor left ventricular system: an experimental in vivo study. ASAIO J 1999;45:170.



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S. Kono, K. Nishimura, T. Nishina, S. Yuasa, K. Ueyama, C. Hamada, T. Akamatsu, and M. Komeda
Autosynchronized systolic unloading during left ventricular assist with a centrifugal pump
J. Thorac. Cardiovasc. Surg., February 1, 2003; 125(2): 353 - 360.
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 J. Thorac. Cardiovasc. Surg.Home page
M. K. Pasque and J. G. Rogers
Adverse events in the use of HeartMate vented electric and Novacor left ventricular assist devices: Comparing apples and oranges
J. Thorac. Cardiovasc. Surg., December 1, 2002; 124(6): 1063 - 1067.
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 Ann. Thorac. Surg.Home page
R. C. Robbins, M. H. Kown, P. M. Portner, and P. E. Oyer
The totally implantable Novacor Left Ventricular Assist System
Ann. Thorac. Surg., March 1, 2001; 71 (2007): S162 - S165.
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