Human Clinical Fitting Study of the DexAide Right Ventricular Assist Device

Ootaki, Yoshio; Ootaki, Chiyo; Massiello, Alex; Horvath, David J.; Chen, Ji Feng; Mihaljević, Tomislav; Navia, José L.; Smedira, Nicholas G.; Golding, Leonard A.R.; Fukamachi, Kiyotaka

doi:10.1111/j.1525-1594.2009.00741.x

Cited by 6 publications

(5 citation statements)

References 10 publications

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“…Our DexAide CFRVAD human cadaver and intra-operative fitting studies suggested that the optimum placement of the CFRVAD pump is in the right chest cavity (Figure 2B) when implanted in conjunction with an LVAD (22–23). This placement will require a right-angled inlet cannula that runs parallel to the diaphragm on the ventral side of the inferior vena cava and angles cranially to cannulate the diaphragmatic surface of the RV.…”

Section: Lesson Learned In Design and Animal Testing Of A Permanent Imentioning

confidence: 94%

Implantable Continuous-Flow Right Ventricular Assist Device: Lessons Learned in the Development of a Cleveland Clinic Device

Fukamachi

Shiose

Massiello

et al. 2012

The Annals of Thoracic Surgery

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Although the need for right ventricular assist device (RVAD) support for right ventricular failure after the implantation of a continuous-flow left ventricular assist device (CFLVAD) has decreased, right ventricular failure still occurs in up to 44% of patients after CFLVAD insertion. Cleveland Clinic’s DexAide continuous-flow RVAD was implanted in 34 calves during the course of its development. This review discusses lessons learned in the design and development of an implantable continuous-flow RVAD that are drawn from the results of these in vivo studies our clinical experience with RVAD support and a review of previously published reports on clinical RVAD use.

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Section: Lesson Learned In Design and Animal Testing Of A Permanent Imentioning

confidence: 94%

Implantable Continuous-Flow Right Ventricular Assist Device: Lessons Learned in the Development of a Cleveland Clinic Device

Fukamachi

Shiose

Massiello

et al. 2012

The Annals of Thoracic Surgery

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“…18 The DexAide RVAD was developed by modifying the CorAide device and has a diameter, length, weight, and device displacement volume of 44 mm, 48 mm, 280 g, and 69 mL, respectively. 51 The implantable centrifugal RVAD was developed by reducing the size of each primary vane, decreasing the number of primary vanes from seven to five and redesigning the volute. The DexAide can pump at speeds ranging from 1800 to 3600 RPM to provide over 5 L min 21 cardiac output to the pulmonary circulation.…”

Section: Coraide/dexaidementioning

confidence: 99%

Biventricular Assist Devices: A Technical Review

et al. 2011

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The optimal treatment option for end stage heart failure is transplantation; however, the shortage of donor organs necessitates alternative treatment strategies such as mechanical circulatory assistance. Ventricular assist devices (VADs) are employed to support these cases while awaiting cardiac recovery or transplantation, or in some cases as destination therapy. While left ventricular assist device (LVAD) therapy alone is effective in many instances, up to 50% of LVAD recipients demonstrate clinically significant postoperative right ventricular failure and potentially need a biventricular assist device (BiVAD). In these cases, the BiVAD can effectively support both sides of the failing heart. This article presents a technical review of BiVADs, both clinically applied and under development. The BiVADs which have been used clinically are predominantly first generation, pulsatile, and paracorporeal systems that are bulky and prone to device failure, thrombus formation, and infection. While they have saved many lives, they generally necessitate a large external pneumatic driver which inhibits normal movement and quality of life for many patients. In an attempt to alleviate these issues, several smaller, implantable second and third generation devices that use either immersed mechanical blood bearings or hydrodynamic/magnetic levitation systems to support a rotating impeller are under development or in the early stages of clinical use. Although these rotary devices may offer a longer term, completely implantable option for patients with biventricular failure, their control strategies need to be refined to compete with the inherent volume balancing ability of the first generation devices. The BiVAD systems potentially offer an improved quality of life to patients with total heart failure, and thus a viable alternative to heart transplantation is anticipated with continued development.

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“…Outflow graft luminal thickening was eliminated by switching to Gortex polytetrafluoroethylene (PTFE) graft (57)(58)(59). The anatomical fitting studies have confirmed the DexAide (Cleveland Clinic) can fit well in conjunction with an implanted LVAD in the right thoracic cavity (60,61). Potential issues caused by the adhesion between the DexAide pump (Cleveland Clinic) and the surrounding organs could be solved with proper wrapping technologies (61).…”

Section: Dexaide Rvad (Cleveland Clinic)mentioning

confidence: 99%

Mechanical Circulatory Support for Right Heart Failure: Current Technology and Future Outlook

Hsu¹,

Parker

Egger³

et al. 2011

Artificial Organs

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The increasing global prevalence of congestive heart failure is a major healthcare concern, accounting for a high morbidity rate worldwide. In particular, isolated right heart dysfunction after cardiotomy has a poor prognosis and is associated with a high mortality rate. The occurrence of postoperative right heart failure may develop in more than 40% of patients undergoing implantation of a left ventricular assist device (LVAD) and cardiac transplantation. To date, mechanical cardiac assistance in the form of VADs has become accepted as a therapeutic solution for end-stage patients when a donor heart is not available. However, right ventricular (RV) assistance is still in the early phase of development when compared with LVAD technology. State-of-the-art RVADs, both in clinical use and under development, are reviewed in this manuscript. Clinical RVADs include the extracorporeal pulsatile Abiomed BVS 5000 and AB5000, Thoratec PVAD, MEDOS VAD, BerlinHeart Excor, the percutaneous continuous flow CentriMag and TandemHeart systems, and the implantable Thoratec IVAD. Devices on the horizon, including the wear-free implantable DexAide and the minimally invasive Impella RD, are additionally reviewed. In addition to the current status of RV assistance, as well as the device categorization, the outlook and considerations for successful development of future RVADs were discussed.

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Human Clinical Fitting Study of the DexAide Right Ventricular Assist Device

Cited by 6 publications

References 10 publications

Implantable Continuous-Flow Right Ventricular Assist Device: Lessons Learned in the Development of a Cleveland Clinic Device

Implantable Continuous-Flow Right Ventricular Assist Device: Lessons Learned in the Development of a Cleveland Clinic Device

Biventricular Assist Devices: A Technical Review

Mechanical Circulatory Support for Right Heart Failure: Current Technology and Future Outlook

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