The drive-line to power contemporary ventricular assist devices exiting the skin is associated with infection, and requires a holstered performance of the cardiac pump, which reduces overall quality of life. Attempts to eliminate the drive-line using transcutaneous energy transfer systems have been explored but have not succeeded in viable widespread application. The unique engineering of the coplanar energy transfer system is characterized by 2 large rings utilizing a coil-within-the-coil topology, ensuring robust resonance energy transfer while allowing for a substantial (>6 hours) unholstered circulatory support powered by an implantable battery source. Herein we report the first known human experience with this novel technology, coupled with a continuous-flow assist left ventricular assist device, in 2 consecutive patients evaluated with the primary end-point of system performance at 30 days post-implantation. ispartof: JOURNAL OF HEART AND LUNG TRANSPLANTATION vol:38 issue:4 pages:339-343 ispartof: location:United States status: publishe

Bekbossynova, Mahabbat

Kassif, Yigal

Maly, Jiri

Massetti, Massimo

Meyns, Bart

Netuka, Ivan

Pya, Yuryi

Salov, Roman

Schueler, Stephan

Zilbershlag, Michael

English

Open Access Repository

http://www.jhltonline.orgINNOVATIONFirst human use of a wireless coplanar energytransfer coupled with a continuous-flow leftventricular assist deviceYuryi Pya, MD,a Jiri Maly, MD, PhD,b Mahabbat Bekbossynova, MD,aRoman Salov, MBA,a Stephan Schueler, MD, PhD, FRCS,cBart Meyns, MD, PhD,d Yigal Kassif, MD,e Massimo Massetti, MD, PhD,fMichael Zilbershlag, BSc,g and Ivan Netuka, MD, PhDbFrom the aNational Research Cardiac Surgery Center, Astana, Kazakhstan; bDepartment of Cardiovascular Surgery, Insti-tute for Clinical and Experimental Medicine, Prague, Czech Republic; cDepartment of Cardiovascular Surgery, FreemanHospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK; dCardiac Surgery Department, TheUniversity Hospitals Leuven, Leuven, Belgium; eCardiac Surgery Department, Sheba Medical Center, Tel Aviv, Israel;fCardio Vascular Department, Catholic University of the Sacred Heart Rome, Policlinico A. Gemelli Foundation, Rome,Italy; and the gLeviticusCardio, Ltd., Petach Tikva, Israel.Reprint requests: Ivan Netuka, MD,lar Surgery, Institute for Clinical and E1958/9, Prague 4, Czech Republic. TelepFax: +420261365015.E-mail address: ivan.netuka@ikem.c1053-2498/$ - see front matter  2019 Tis an open access article under the CC BYhttps://doi.org/10.1016/j.healun.2019.01.The drive-line to power contemporary ventricular assist devices exiting the skin is associated withinfection, and requires a holstered performance of the cardiac pump, which reduces overall quality oflife. Attempts to eliminate the drive-line using transcutaneous energy transfer systems have beenexplored but have not succeeded in viable widespread application. The unique engineering of thecoplanar energy transfer system is characterized by 2 large rings utilizing a coil-within-the-coil topol-ogy, ensuring robust resonance energy transfer while allowing for a substantial (>6 hours) unholsteredcirculatory support powered by an implantable battery source. Herein we report the first known humanexperience with this novel technology, coupled with a continuous-flow assist left ventricular assistdevice, in 2 consecutive patients evaluated with the primary end-point of system performance at30 days post-implantation.J Heart Lung Transplant 2019;38:339−343 2019 The Author(s). Published by Elsevier Inc. on behalf of International Society for Heart and LungTransplantation. This is an open access article under the CC BY-NC-ND license.(http://creativecommons.org/licenses/by-nc-nd/4.0/)KEY WORDS:ventricular assistdevice;drive-line, wireless;coplanar energytransfer;fully implantableHemocompatibility-related adverse events with continu-ous-flow left ventricular assist devices (CF-LVADs) havebeen reduced with newly engineered pumps,1,2 but ratesof infection remain high. Global registry data (IMACS)PhD, Department of Cardiovascu-xperimental Medicine, Vıdenskahone: +420261365015.zhe Author(s). Published by Elsevier Inc.-NC-ND license. (http://creativecommo1316suggest freedom from infection in only half of the patientsat 2 years.3 Principally, a drive-line infection is reported inone fifth of patients by 2 years, representing substantialmorbidity, mortality, readmissions, and cost of care.4−7The need for a permanent holstered mode of operation withthe drive-line components connected to an external control-ler and batteries represents a substantial limitation to mobil-ity and quality of life.Attempts to eliminate the drive-line using transcutane-ous energy transfer systems (TETS) have been explored inon behalf of International Society for Heart and Lung Transplantation. Thisns.org/licenses/by-nc-nd/4.0/)340 The Journal of Heart and Lung Transplantation, Vol 38, No 4, April 2019pulsatile LVADs8 and the total artificial heart.9 The needfor close alignment of coils in TETS led to a loss of effi-ciency with unholstered operation of the device capable forless than 30 minutes. Efforts to investigate alternative tech-nological solutions to develop a wireless device operationare challenging. Several in vitro and animal studies havesuggested possible solutions,10 including use of a coplanarenergy transfer (CET) system. Unlike TETS, the uniquearchitecture of the CET system is characterized by 2 largerings utilizing coil-within-the-coil topology, ensuring highand robust resonance energy powering. Moreover, an inte-grated internal battery can provide >6 hours of full-freedomwireless LVAD operation.To the best of our knowledge, our report is the first-in-human experience with a wireless energy transfer technol-ogy using a CET coupled with a CF-LVAD.MethodsTwo patients (51 and 24 years old), with advanced-stage heart fail-ure, refractory to medical therapy and dependent on inotropic sup-port, were considered candidates for LVAD implantation with abridge-to-transplant designation (Table 1). Neither patient waswilling to accept implantation with a conventional LVAD due tomobility concerns. Because ambulatory freedom from refractorysymptoms was important to the patients and waiting times forheart transplant were predicted to be long due to donor scarcitywithin national health-care program, the patients were offered thealternative of a wireless LVAD implantation based on anexpanded access protocol regulation. All legal requirements werefulfilled and ethics review board approval as well as fullyinformed patient consent were obtained before the procedures. Aprimary end-point for success was defined as 30-day survival freeof wireless energy transfer device malfunction necessitating a bail-out pump supply with an alternative power source.Investigational deviceA proprietary CET system (LeviticusCardio, Ltd., Petach Tikva,Israel) designed for wireless control and powering of LVADs hasTable 1 Baseline CharacteristicsPatient A Patient BAge (years) 51 24Gender Male MaleEthnicity Caucasian KazakhBSA (m2) 2.02 1.89Etiology of cardiomyopathy Ischemic Non-ischemicLV EF (%) 11 22LVEDd (mm) 93 71CI (l/min/m2) 1.9 2.2PCWP (mmHg) 24 20PAPs (mmHg) 33 40PAPm (mmHg) 20 30CVP (mm Hg) 6 5GFR - MDRD (ml/min per 1.73 m2) 67 116NYHA Class IV IVINTERMACS Profile 3 3Intended goal of support BTT BTTbeen validated in multiple long-term animal experiments (over 6months). The CET system replaces the original LVAD controller,battery, and monitor and eliminates the need for a drive-line con-nection. The system consists of an internal integrated controllerand battery coupled with an internal thoracic coil ring designedfor energy harvesting. External equipment includes a power trans-mission belt coupled with an external controller, battery, andwristwatch monitor (Figure 1).Although in unholstered mode, the patient, pump, and CEToperation are monitored by the proprietary wristwatch, which pro-vides alerts to any device malfunction. A second-line ancillaryinternal vibration alarm embedded within the controller is trig-gered during a major hazard, such as low internal battery power(Figure 2).To maximize safety in this early clinical experience, the systemwas pragmatically integrated with the Jarvik 2000 LVAS (JarvikHeart, Inc., New York, NY). This pump is implanted with a retro-auricular pedestal that connects to an external power source,which would be used as a back-up in case of component failure ofthe CET system (Figure 1). Automated data collection, reporting,and configuration systems utilize the standard MedRadio 402‒405-MHz communication protocol, which is also coupled with thewristwatch.Implantation procedureAfter exposing the heart via a median sternotomy, the internaldrive-line of the retroauricular pedestal power connector was tun-neled and affixed to the skull.11 After heparinization, and once thelung is deflated, an appropriate internal thoracic cavity coil size isascertained by sizers and the coil is positioned horizontally aroundthe circumference of the lower portion of a pleural cavity(Figure 1A). To ensure its stability, straps of the coil are attachedto adjacent structures at anatomically amenable locations. Sequen-tially, a pocket for the integrated controller-battery is createdbetween the musculus serratus and musculus latissimus dorsialong the lateral thoracic wall similar to the technique used in sub-cutaneous defibrillator placement. While on cardiopulmonarybypass (CPB), the pump is implanted in regular fashion and a par-allel V-shaped drive-line from the pump as well as internal coildrive-line are tunneled through an intercostal space to the control-ler. Once both connectors are secured, the pump is started using awireless operation and surgery completed after CPB wean.ResultsPatient outcomesSurgical implants were uneventful and a fully wireless LVADoperation was initiated successfully followed by primary chestclosure. One patient (Patient A) had a peri-operative ischemicstroke (modified Rankin Scale [mRS] score >3) and a neuro-logic condition necessitated prolonged ventilatory supportwith tracheostomy. At 30 days, the patient was discharged tostep-down to undergo intensive rehabilitation due to a residualleft lower extremity motor compromise.Further along the clinical course, contrast computerizedtomography confirmed pump thrombosis with subtotalobstruction of the outflow graft, while the CET system dataanalysis corroborated consistent pump rotor speed and awireless energy transfer ensured efficient supply despiteFigure 1 (A) Chest X-ray depicting implantable components topography. (B) Implantable components. (C) External components.Figure 2 Daily maximum continuous unholstered discharge intervals depicted as daily mean per week of support (individual bar graphsof both patients).Pya et al. Wireless Energy Transfer in CF-VAD 341increased power consumption requirements. On Day 35post-operatively, given the complex clinical scenario, amultidisciplinary team decided to terminate pump opera-tion, with consequent retirement of need for the CET sys-tem and inotropic support was resumed. At this writing, thepatient is in a stable condition on inotropes with satisfactoryend-organ function while listed for heart transplant in high-urgency status. (Patient A’s detailed narrative is presentedin the Supplementary Material available online at www.jhltonline.org/.).The second patient had an uneventful post-operativecourse and reached full ambulation within the first week ofsurgery. No major adverse events were encountered andthe patient was discharged from the hospital at 30 dayspost-implantation. (Exercise and lifestyle activities are pre-sented in Video S1 in the Supplementary Material online.)System performanceIn the early post-operative phase, CET system operation wasaccomplished as expected in both patients. The system pow-ered the pump and kept the battery charged to allow for medi-cal and nursing procedures. CET energy transfer efficiencyfurther improved after removing intensive care equipment anddrains, enabling optimal sizing of the external belt andenhancing coil alignment (see Figure S1 in the SupplementaryMaterial online).Figure 3 Discharge unholstered performance: (A/1) Patient A and (B/1) Patient B showing daily discharge intervals as a decrease involtage curve. Maximum discharge test: (A/2) Patient A and (B/2) Patient B showing 8.5 hours until the alarm alert followed by full batteryrecharging requiring approximately 6.5 hours. Arrow indicates start of recharge.342 The Journal of Heart and Lung Transplantation, Vol 38, No 4, April 2019Subsequently, a stepwise protocol-based extended daily“discharge-simulation” cycles were conducted Figure 2 and(Figure 3 Panels A/1, B/1). Maximum time on unholsteredsupport (Figure 3A/2 and B/2) was attained for 8.5 hoursuntil the first alarm triggered an internal controller vibrationand watch buzzer. Such a battery level ensures at least1 hour of pump operation before a low-capacity, high-alertalarm ensues. Both alarms were actionable as appropriatelyrecognized by both patients and allowed for return to charg-ing safely.DiscussionIn this study we have described 2 cases of a CET tech-nology that ameliorates infection risk by drive-line elimi-nation while providing successful energy transmissionand allowing for substantial (8.5 hours) unholstered sup-port while on the LVAD. The unique system architecturemeets maximum allowable temperature deviation ofimplanted components, as consistently validated in long-term animal studies. Using this power configuration, weproject that the controller exchange would requirereplacement in 3 years, permitting an appropriate first-use cycle. The current dimensions of the internal batteryand controller will require future modifications to reducetheir size while retaining charge capacity. The right-sidedinternal coil placement appears to be optimal based onour cadaver studies, suggesting a more circular pleuralcavity geometry that allows for coil upsizing. In animaltrials up to 6 months, we found favorable results of lungvs internal coil interaction, but this interface interactionwill require further focused attention. Our early experi-ence in these implants has indicated an absence of overtcompromise of the lung (atelectasis, external compres-sion, or chronic effusion) and this has been substantiatedby serial chest X-rays and computerized tomographyscans. Importantly, optimal management of the internalcoil at a time of transplantation will need to be defined.Ensuring patient safety remains central to these innova-tions and constitutes an ethical conundrum. A hybrid designutilizing the externalized retroauricular bailout connector pro-vided a pragmatic solution to balance safety and efficacy vali-dation in this early investigational experience. Furthermore,we selected patients with an intended goal of a bridge to trans-plant in case a rescue bailout for the entire system were tobecome necessary. Importantly, the CET system as configuredis capable of successful integration with most commerciallyavailable LVADs, a factor that has been tested by our groupin long-term animal trials. This promise allows the technologyto be paired with the most optimal device available to patientsand offers the potential for scalable widespread application.This important first-in-human clinical experience of the CETsystem will need to be further validated by longer term safetyand efficacy demonstration in larger numbers of patients.Pya et al. Wireless Energy Transfer in CF-VAD 343The durability and impact seen on patient outcomes calls forlarge-scale trials using this technology.Disclosure statementY.P. is a medical advisory board member of LeviticusCar-dio, Ltd.; J.M. is a medical advisory board member, boardmember, and stockholder of LeviticusCardio, Ltd.; S.S. is amedical advisory board member and stockholder of Leviti-cusCardio, Ltd., B.M. has an institutional research contractwith LeviticusCardio, Ltd.; Y.K. is a chief medical officerand stockholder of LeviticusCardio, Ltd.; M.Z. is a chiefexecutive officer and stockholder of LeviticusCardio, Ltd.;I.N. is a medical advisory board member, board member,and stockholder of LeviticusCardio, Ltd. The remainingauthors have no conflicts of interest to disclose.CET system development, integration with prevalentcommercially available LVADs, animal experiments, andthe first human clinical trial were sponsored by Leviticus-Cardio, Ltd. This project was supported in part by theOffice of the Chief Scientist of the Ministry of Industry,Israel (Grants 49639, 55065, 38675, 56638, and 63319).Supplementary dataSupplementary data associated with this article can befound in the online version at www.jhltonline.org/.Supplementary materialsSupplementary material associated with this article canbe found in the online version at https://doi.org/10.1016/j.healun.2019.01.1316.References1. Mehra MR, Goldstein DJ, Uriel N, et al. Two-year outcomes with amagnetically levitated cardiac pump in heart failure. N Engl J Med2018;378:1386-95.2. Schmitto JD, Pya Y, Zimpfer D, et al. Long-term evaluation of a fullymagnetically levitated circulatory support device for advanced heartfailure-two-year results from the HeartMate 3CE Mark Study. Eur JHeart Fail 2019;21:90-7.3. Kirklin JK, Xie R, Cowger J, et al. Second annual report from theISHLT Mechanically Assisted Circulatory Support Registry. J HeartLung Transplant 2018;37:685-91.4. Goldstein DJ, Naftel D, Holman W, et al. Continuous-flow devices andpercutaneous site infections: clinical outcomes. J Heart Lung Trans-plant 2012;31:1151-7.5. Hasin T, Marmor Y, Kremers W, et al. Readmissions after implanta-tion of axial flow left ventricular assist device. J Am Coll Cardiol2013;61:153-63.6. Baras Shreibati J, Goldhaber-Fiebert JD, Banerjee D, Owens DK,Hlatky MA. Cost-effectiveness of left ventricular assist devices inambulatory patients with advanced heart failure. JACC Heart Fail2017;5:110-9.7. Mehra MR, Salerno C, Cleveland JC, et al. Healthcare Resource useand cost implications in the MOMENTUM 3 long-term outcomestudy. Circulation 2018;138:1923-34.8. Mehta SM, Pae Jr WE, Rosenberg G, et al. The LionHeart LVD-2000: a completely implanted left ventricular assist device forchronic circulatory support. Ann Thorac Surg 2001;71(suppl):S156-61.9. Dowling RD, Gray Jr LA, Etoch SW, et al. Initial experience with theAbioCor implantable replacement heart system. J Thorac CardiovascSurg 2004;127:131-41.10. Waters BH, Park J, Bouwmeester JC, et al. Electrical power to runventricular assist devices using the free-range resonant electricalenergy delivery system. J Heart Lung Transplant 2018;37:1467-74.11. Westaby S, Jarvik R, Freeland A, et al. Postauricular percutaneouspower delivery for permanent mechanical circulatory support.J Thorac Cardiovasc Surg 2002;123:977-83.

First human use of a wireless coplanar energy transfer coupled with a continuous-flow left ventricular assist device

https://www.openaccessrepository.it/record/36132/files/fulltext.pdf

First human use of a wireless coplanar energy transfer coupled with a continuous-flow left ventricular assist device

Abstract

Similar works

Full text

Available Versions

Open Access Repository