key: cord-0049479-brwcpre3
authors: Sivathasan, Cumaraswamy; Hayward, Christopher; Jansz, Paul; Sibal, Amul Kumar; Chen, Chen; Cally, Ho Ka Lai; Balakrishnan, Komarakshi Rajagopalan; Cho, Yang Hyun; Nordin, Mohd.Nazeri; Barril, Joseph B.; Khaliel, Feras; Mehra, Mandeep R.
title: Durable Mechanical Circulatory Support Across the Asia Pacific Region
date: 2020-09-03
journal: J Heart Lung Transplant
DOI: 10.1016/j.healun.2020.08.022
sha: 1412e478d4f942b6d8377725eed1fbd53535fb59
doc_id: 49479
cord_uid: brwcpre3

nan

The Asia region consists of 48 countries with a population of 3.8 billion, extends from Saudi Arabia and Turkey in the west to the most eastern part of Russia. Asia-Pacific includes East Asia, South Asia, Southeast Asia, and Oceania. It extends from Pakistan in the west to Japan, Australia and New Zealand in the east 1 . Accurate data from Asia on heart transplantation is lacking as not all centers report their data to ISHLT registry. According to the Global Observatory on Donation and Transplantation (GODT), less than 0.4 heart transplants per million population are performed yearly compared to more than 7.5 per million in USA 2 . Availability of durable continuous flow left ventricular assist device (LVAD) technology has made mechanical circulatory support (MCS) an attractive alternative for the treatment of advanced HF permitting bridge to transplant (BTT) therapy or as long-term therapy 3 . (Table 1) MCS is emerging as a viable alternative to transplantation in Asia, but limitations in embracing this concept exist including discrepant practices in reimbursement of costly MCS therapy across the region.

The Asia Pacific community has been conducted biannual educational gatherings in Singapore, supported by the ISHLT since 2015 to advance understanding in this modality of therapy. This editorial is based on the third biannual meeting endorsed by ISHLT and held in Singapore on November 1 st -2 nd 2019 and includes a distillation of the current state of MCS, their principal outcomes and region-specific challenges by selected countries of origin. This is not meant to be an exhaustive review of the status but to provide a lens into the growing MCS activity in this unique region. The Japanese Mechanical cardiac support is not included in this report as this data is available in the Japanese registry for Mechanically Assisted Circulatory Support: First report. 4

Current status. MCS support started soon after heart transplantation in Australia, in 1994. Since then, the program is funded with a specific indication of bridge to transplantation. With ongoing donor shortages, MCS is accepted as integral to a successful heart transplant program, funded by individual state governments. At present, approximately 30-40% of transplants are supported with mechanical devices.

Destination therapy with a durable mechanical device is approved by the Therapeutic Goods Administration but is not funded, hence this occurs infrequently. As the number of transplants has increased over the last 5 years, with increased donor rates, and introduction of donation after circulatory death in one center (St Vincent's, Sydney), the number of LVAD implants has not increased over the last 3-4 years. 5 Budgetary restraint has limited the introduction of newer short-term circulatory devices, with most centers relying on extra-corporeal membrane oxygenation for systemic circulatory support in cardiogenic shock.

Short term extracorporeal support may also be used to bridge to transplantation. As with many jurisdictions, patient referrals remain late, with marked deconditioning in decompensated patients.

Unique Challenges. Specific challenges apparent across Australasia are the small number of MCS/transplant units compared to the geographically distances. Many patients live more than 500 miles from an implanting center. Patients are usually returned to the implanting center for major medical events, despite the distance. Adelaide, in South Australia, is the only non-implanting city with dedicated MCS cardiovascular and nurse coordinator services, supported by Melbourne and Sydney. Patient isolation is managed through education and maintenance of close contact with the implanting team.

Most units submitted data to the IMACS centralized Registry, until the current recruitment pause. 6 Post LVAD implantation, survival rates remain strong with a one-year survival of approximately 80%. Current efforts to increase the implantation rate include dedicated funding applications for alternate indicationssuch as destination therapy, as well as information and education events. Efforts to increase earlier referral are ongoing, and the mnemonic I-NEED-HELP was developed to highlight patients at the need for advanced heart failure team review. 7

Current Status. The Greenlane Cardiothoracic surgical unit at Auckland City Hospital is the referral center for Cardiothoracic transplants, ECMO and mechanical support and is a public funded health care system in New Zealand (NZ). The program is funded to implant up to 4 LVADs per year, but additional devices can be selectively funded. There is no funding for destination therapy. Reimbursement under the national health insurance was introduced to cover LVAD operations. Since then, more than 100 LVAD operations have been performed. Korean National Insurance system requires institutional approval which needs heart transplantation experience of more than 3 over the last 24 months. Either a bridge to transplant or destination therapy indication are reimbursable. The early mortality is about 5% and the longest survival is 8 years in a HMII patient. Short term MCS is widely used as a bridge to transplantation and most such patients wait only a few weeks for heart transplantation.

Although centers and patients have previously avoid use of implantable LVADs as a bridge to transplantation due to high cost and relatively short waiting times (unlike Japan or North America), there is greater acceptance recently due to a worsening donor availability and better insurance coverage.

Unique Challenges. Awareness of heart failure is still low amongst patients and amongst physicians leading to long referral times. HeartMate 3, Impella (Abiomed, Inc. MA) and Centrimag are not yet approved by the Korean FDA and remain under review. to a combination of device limitations, patient compliance, patient acceptance to therapy, and lack of a structured heart team. In the second Era of 2013-2019 with deployment of a multi-disciplinary heart team survival improved to 70% at 1-year. The HM 3 LVAD is associated with an improved survival rate at one year of 75% compared with 67% using other LVAD platforms, and morbidity like that reported in the clinical trials. 10 Unique Challenges. The major barrier is the lack of awareness of the benefits of LVADs, fear of device management at home and sub-optimal compliance in concert with poor lifestyle related habits such as smoking.

In summary, the Asia-pacific region is represented by MCS programs in variable stages of maturity with the principle challenges that tie each other together through the vine of a need for awareness of advanced heart failure therapy. Consistent themes appear to be of late referrals, cost and reimbursement challenges and unavailability of structured multi-disciplinary team support. Advocacy and educational efforts that seek to focus and overcome these key deficiencies will be necessary to advance the availability and outcomes of MCS in the Asia-pacific region.

Disclosures: Dr. Sivathasan reports personal fees and non-financial support from Abbot South East Asia, non-financial from Transmedic Singapore Private Limited. Dr. Hayward reports grants, personal fees and non-financial support from Medtronic, personal fees from Abbott, personal fees from Novartis. Dr. Jansz reports grants and personal fees from Medtronic. Dr. Chen is an employee of CH Biomedical, Inc. Dr.

Mehra reports receiving travel support and consulting fees, paid to Brigham and Women's Hospital, from Abbott, fees for serving on a steering committee from Medtronic and Janssen (Johnson & Johnson), fees for serving on a data and safety monitoring board from Mesoblast, consulting fees from Baim Institute of Clinical Research, Portola, Bayer and Triple Gene, and fees for serving as a scientific board member from Leviticus, NuPulseCV and FineHeart. Dr. Mehra is also editor of the JHLT but this editorial does not represent the official stance of the journal or the society that it represents. The other authors have indicated that they have nothing to disclose.

Mechanical circulatory support and heart transplantation in the Asia Pacific region

Japanese registry for Mechanically Assisted Circulatory Support: First report

Outcomes of Donation After Circulatory Death Heart Transplantation in Australia

Third Annual Report From the ISHLT Mechanically Assisted Circulatory Support Registry: A comparison of centrifugal and axial continuous-flow left ventricular assist devices

I Need Help"-A mnemonic to aid timely referral in advanced heart failure

Evaluation of in vitro hemolysis and platelet activation of a newly developed maglev LVAD and two clinically used LVADs with human blood

Evolving trends in mechanical circulatory support: Clinical development of a fully magnetically levitated durable ventricular assist device