HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Fabrizio Gazzoli Davide Ricci Mauro Rinaldi Mario Viganò Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Gazzoli, F. Articles by Viganò, M. Search for Related Content PubMed PubMed Citation Articles by Gazzoli, F. Articles by Viganò, M. Related Collections Mechanical Circulatory Assistance Related Article

Ann Thorac Surg 2007;83:279-282
© 2007 The Society of Thoracic Surgeons

---

New Technology

Arrow CorAide Left Ventricular Assist System: Initial Experience of the Cardio-Thoracic Surgery Center in Pavia

^a Department of Cardiac Surgery, IRCCS Policlinico San Matteo, University of Pavia, Pavia
^b Department of Cardiac Surgery, Le Molinette Hospital, Turin, Italy

Accepted for publication May 8, 2006.

^_* Address correspondence to Dr Gazzoli, Department of Cardiac Surgery, IRCCS Policlinico San Matteo, Piazza Golgi 2, Pavia 27100, Italy (Email: f.gazzoli{at}smatteo.pv.it).

	Abstract

Top Abstract Introduction Technology Technique Clinical Experience Comment Disclosures and Freedom of... Footnotes References

 
PURPOSE: The aim of the present study is to describe our preliminary experience with the Arrow CorAide left ventricular assist system (LVAS).

DESCRIPTION: The Arrow CorAide LVAS is a small implantable, continuous flow centrifugal pump, with a fully suspended rotating assembly, intended as a bridge to transplant device, bridge to recovery, and for long-term use.

EVALUATION: Since April 2005 we have implanted the CorAide LVAS in 2 male patients, with a patient follow-up of more than 6 months. Surgical procedures were uneventful, and both patients had an uneventful postoperative course, with fast weaning from mechanical ventilation and inotropic support. No thromboembolic events, infective complication, hemolysis, or mechanical failure occurred. To date, both patients are in New York Heart Association class I.

CONCLUSIONS: In our initial experience the CorAide LVAS blood pump is nonthrombogenic, nonhemolytic, and easy to implant. Both patients have improved their functional status. Further follow-up is needed to assess long-term results.

	Introduction

Top Abstract Introduction Technology Technique Clinical Experience Comment Disclosures and Freedom of... Footnotes References

 
The CorAide is a left ventricular assist system (LVAS) for end-stage heart failure patients, developed by Arrow International in collaboration with the Cleveland Clinic Foundation [1–5]. The CorAide LVAS pump is a third-generation, implantable, centrifugal pump: the pulsatility, even though very low, is provided by the residual function of the native heart. The CorAide LVAS is intended as a bridge-to-transplant device, a bridge to recovery, and for long-term use to support the function of the left ventricle in patients whose native heart is unable to supply sufficient cardiac output. The aim of the present study is to describe our preliminary experience with this device.

	Technology

Top Abstract Introduction Technology Technique Clinical Experience Comment Disclosures and Freedom of... Footnotes References

 
Device Description
The Arrow International CorAide LVAS (LVD-4000; Arrow International, Reading, Pennsylvania) was originally designed and developed at the Cleveland Clinic Foundation [1–7]. The pump consists of only three subassemblies: a pump housing, a stator assembly, and a rotating assembly. The only moving part (the rotor) spins while it is suspended and stabilized within the pump housing using a combination of hydrodynamic and magnetic forces, and is sustained by a blood-lubricated fluid film bearing, which radially supports the rotating assembly with a stable, hydrodynamic fluid film. This unique feature results in no mechanical contact or wear, and the prevention of any blood stagnation within the pump, contributing to the durability and nonthrombogenicity of the pump.

The dimensions of the implantable components are significantly smaller (volume 154 mL, weight 364 g) than currently available pulsatile devices, thus enabling the device to also be fitted in physically small patients (Fig 1).

View larger version (79K): [in this window] [in a new window]   Fig 1. Left ventricular assist system CorAide.

The pump is designed to deliver an average flow of between 2 and 8 L per minute, and the range of variable pump speeds is from 2,080 to 3,000 revolutions per minute. It is very important to set the device with the patient’s correct hematocrit, as the estimation of the pump output is a function of the blood viscosity, centrifugal pump speed, and pressure across the pump. The pump’s control algorithm is able to successfully avoid suction of the left ventricle by reducing pump speed as needed to maintain a minimum degree of pulsatility in the pump flow waveform. That ensures that the ventricle is not completely empty and depulsed. A laptop computer, able to record the pump parameters, to modify the pump settings, and control the system performance, is connected to the device controller.

To improve device comfort, the external components have been reduced in size: the total weight of the portable power supplies (two batteries, whose autonomy is as long as approximately 6 hours) and the wearable controller is 1,350 g. The pump operates by simultaneously draining the energy supplied by both batteries, and the system is totally silent.

	Technique

Top Abstract Introduction Technology Technique Clinical Experience Comment Disclosures and Freedom of... Footnotes References

 
The implantable components consist of the pump, which constitutes a unique body with the inflow cannula, and the outflow graft, which is positioned at right angles to the inlet pathway, unlike axial flow pumps, where the blood flow goes through the pump in a straight line.

The implant is totally intrathoracic and is performed through a median longitudinal sternotomy, by extending the incision 4 cm below the xiphoid process. Subsequently, an inverted-T pericardiotomy is performed followed by the creation of a left supradiaphragmatic recess to allow the positioning of the pump, which may require a partial resection of the anterior part of the diaphragm.

Device assembly is performed after an accurate deairing and flushing of the pump with a 100 cc albumin solution. After that, cardiopulmonary bypass is started, and the procedure is performed with fibrillating heart. Then, the pump is put in place, and the percutaneous cable is tunnelled and externalized through the right side of the abdomen. After the apical coring of the left ventricle by means of a dedicated coring tool, the apical cuff is positioned with the help of two Teflon (Impra, subsidiary of L. R. Baird, Tempe, Arizona) strips, fixed with U stitches made of 0 nonreabsorbable woven thread: 4 sutures positioned at the cardinal points of the circumference and 2 additional interposed sutures for every quadrant. The sutures are reinforced with a 3-0 polypropylene thread. The inlet cannula is then inserted, parallel to the interventricular septum, under the guidance of transesophageal echocardiography and locked to the apical cuff by means of a cuff clamp. After that, the terminolateral anastomosis of the ouflow graft on the ascending aorta is performed with 4-0 polypropylene thread. Finally, the patient is weaned off the cardiopulmonary bypass, while simultaneously starting the device in fixed-speed mode.

	Clinical Experience

Top Abstract Introduction Technology Technique Clinical Experience Comment Disclosures and Freedom of... Footnotes References

 
Since April 2005, 2 patients have been implanted with the CorAide LVAS at our center. Institutional Ethical Committee approval was required, and a thorough informed consent was obtained from each patient.

The first cases were performed in Germany, at the Department of Thoracic and Cardiovascular Surgery of Bad Oeynhausen; then we had the initial experience in Italy. Summaries of the 2 patients are recorded below; both were on the transplant waiting list.

Patient 1 was a 62-year-old man affected by idiopathic dilated cardiomyopathy and type II diabetes mellitus, New York Heart Association (NYHA) functional class IV in the last 6 months and at the time of hospital admission, treated with intravenous inotropic (5 µg · kg^–1 · min^–1 dobutamine) and vasodilating (nitroprusside) therapy, with chronic atrial fibrillation treated by oral anticoagulant therapy. Left ventricular ejection fraction has been measured as 25% by echocardiography, right-side heart catheterization showing a cardiac output of 2.55 L/min, a cardiac index of 1.45 L · min^–1 · m^–2, a pulmonary capillary wedge pressure of 23 mm Hg, a right ventricular ejection fraction of 9%, and a right ventricular stroke work index of 7.3 mm Hg x mL/m² (Table 1). Laboratory studies show only a mild degree of renal failure (blood creatinine 1.7 mg/dL). On April 27, the patient underwent the surgical implant of a CorAide LVAS. Mechanical ventilation was maintained for 1 day only, and after 4 days of intensive care, the patient was transferred to the ward. Inotropic support, with a low dosage of adrenaline for the first 48 hours and dobutamine (maximum dosage 7 µg · kg^–1 · min^–1), was discontinued after 7 days. Since postoperative day 10, the patient has been able to mobilize independently. After a total hospital stay of 40 days, the patient was transferred to a rehabilitation center.

Both patients had a postoperative course free of complications, with a rapid weaning from mechanical ventilation and inotropic support, and we were able to discharge them on the device after 40 and 47 days of hospital stay. During the 6 months after the operation, we registered no thromboembolic or infective complications nor device failure. Our anticoagulation protocol included heparin infusion 12 to 36 hours after surgery, followed by oral warfarin and ticlopidine. No thromboembolic events occurred, even while maintaining a low level of anticoagulation therapy, with an international normalized ratio value around 2.5—that is considering that both patients are affected by AF. The absence of thrombogenicity of the device had already been shown before during the animal testing [4].

Moreover, no infective complications occurred: the antibiotic protocol was based on vancomycin, norfloxacin, and amphothericin. An important protective factor is the reduced dimensions of the percutaneous driveline (4-mm diameter), which limits the access pathways of the external pathogens. Accurate fixation of the driveline to the skin, through a dedicated adhesive securement device, protects percutaneous cable from inappropriate tractions and stresses at the exit site, thus minimizing the cutaneous trauma.

No significant hemolysis was observed in either patient (plasma free hemoglobin, 9.9 mg/dL maximum level and 3.0 mg/dL medium level).

The system has shown itself to be easy to implant, requiring minimal dissection to fit in the chest. Both patients are at home, they are in NYHA functional class I, with 4.5 to 5 L device output at rest (running in automatic mode). There has been no significant device alarm. Reoperation has not been necessary.

	Comment

Top Abstract Introduction Technology Technique Clinical Experience Comment Disclosures and Freedom of... Footnotes References

 
During our 6 months of follow-up, the CorAide LVAS appears to be highly reliable from a technical point of view, not having shown any malfunctions and being easy to handle and manage for the patient.

We were able to discharge both patients on the device: the first was transferred to a rehabilitation center owing to the distance from the hospital to his residence, whereas the second was discharged directly home. Both are asymptomatic for dyspnea (NYHA functional class I), and their hemodynamic conditions appear normal. They report a remarkable improvement in their quality of life and do not present any symptoms of end-organ dysfunction or psychological disturbance.

	Disclosures and Freedom of Investigation

Top Abstract Introduction Technology Technique Clinical Experience Comment Disclosures and Freedom of... Footnotes References

 
The authors had full control of the design of the study, methods used, outcome measurements, analysis of data, and production of the written report.

	Footnotes

Top Abstract Introduction Technology Technique Clinical Experience Comment Disclosures and Freedom of... Footnotes References

 
^Disclaimer The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.

	References

Top Abstract Introduction Technology Technique Clinical Experience Comment Disclosures and Freedom of... Footnotes References

 

1. Doi K, Golding LAR, Massiello AL, et al. Preclinical readiness testing of the Arrow International CorAide left ventricular assist system Ann Thorac Surg 2004;77:2103-2110.[Abstract/Free Full Text]
2. Gerhart RL, Horvath DJ, Ochiai Y, Krogulecki AY, Golding LAR. The effects of impact on the CorAide ventricular assist device ASAIO J 2002;48:449-452.[Medline]
3. Fukamachi K, Ochiai Y, Doi K, et al. Chronic evaluation of the Cleveland Clinic CorAide left ventricular assist system in calves Artif Organs 2002;26:529-533.[Medline]
4. Ochiai Y, Golding LAR, Massiello AL, et al. Cleveland Clinic CorAide blood pump circulatory support without anticoagulation ASAIO J 2002;48:249-252.[Medline]
5. Ochiai Y, Golding LAR, Massiello AL, et al. In vivo hemodynamic performance of the Cleveland Clinic CorAide blood pump in calves Ann Thorac Surg 2001;72:747-752.[Abstract/Free Full Text]
6. Golding LAR, Smith WA. Cleveland Clinic rotodynamic pump Ann Thorac Surg 1996;61:457-462.[Abstract/Free Full Text]
7. Horvath DJ, Golding LAR, Massiello A, et al. The CorAide blood pump Ann Thorac Surg 2001;71(Suppl):191.

This article has been cited by other articles:

				S. Large Invited commentary Ann. Thorac. Surg., January 1, 2007; 83(1): 282 - 282. [Full Text] [PDF]

This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Fabrizio Gazzoli Davide Ricci Mauro Rinaldi Mario Viganò Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Gazzoli, F. Articles by Viganò, M. Search for Related Content PubMed PubMed Citation Articles by Gazzoli, F. Articles by Viganò, M. Related Collections Mechanical Circulatory Assistance Related Article