The second official report from Japanese registry for mechanical assisted circulatory support (J-MACS): first results of bridge to bridge strategy

General Thoracic and Cardiovascular Surgery https://doi.org/10.1007/s11748-019-01227-y ORIGINAL ARTICLE The second official report from Japanese registry for mechanical assisted circulatory support (J‑MACS): first results of bridge to bridge strategy Koichiro Kinugawa1 · Takashi Nishimura2 · Koichi Toda3 · Yoshikatsu Saiki4 · Hiroshi Niinami5 · Shinichi Nunoda6 · Goro Matsumiya7 · Motonobu Nishimura8 · Hirokuni Arai9 · Shigeki Morita10 · Masanobu Yanase11 · Norihide Fukushima11 · Takeshi Nakatani12 · Yasushi Sakata13 · Minoru Ono14 on behalf of the J-MACS investigators Received: 26 August 2019 / Accepted: 10 October 2019 © The Author(s) 2019 Abstract Background The Japanese registry for mechanical assisted circulatory support (J-MACS) is a prospective registry to collect all data of implantable left ventricular assist device (LVAD) (and part of paracorporeal VAD) established in 2010. The first analytical report was published in 2017. The organization running J-MACS was used to be the pharmaceuticals and medical devices agency (PMDA), but has been changed to the council for clinical use of ventricular assist device related academic societies in 2017. Methods Since 2018, we changed the analytical methods as follows: first, we eliminated paracorporeal VAD from the analysis. Second, we included not only primary implantation but bridge to bridge (BTB) implantation of LVAD. Third, we added the analyses of adverse events that were not included in the previous analysis. Results As of Oct 2018, 711 primary LVAD implants and 168 BTB implants were enrolled. Survival rate of primary LVAD was 93% at 360 days and 91% at 720 days, and that of BTB was 86% at 360 days and 82% at 720 days. Conclusion We first reported the results of BTB in the second official report of J-MACS. The prognosis after LVAD implantation has been kept good in Japanese circumstances. Keywords Ventricular assist device · Implantable · Paracorporeal · Heart failure · Heart transplantation Introduction Like interagency registry of mechanically assisted circulatory support (INTERMACS) in North America or the European registry for patients with mechanical circulatory support (EUROMACS), the Japanese registry for mechanical assisted circulatory support (J-MACS) is a prospective registry for implantable left ventricular assist device (LVAD). These registries have now merged as the international society for heart and lung transplantation (ISHLT) mechanically Electronic supplementary material The online version of this article (https://doi.org/10.1007/s11748-019-01227-y) contains supplementary material, which is available to authorized users. * Minoru Ono ono‑[email protected]‑tokyo.ac.jp assisted circulatory support (IMACS) since 2016. J-MACS was established in 2010, and the first analytical report of J-MACS appeared in 2017 [1], and the details of organizing system for J-MACS were described in it. In 2017, the organization of J-MACS has been changed to the council for clinical use of ventricular assist device related academic societies that consists of members elected from ten societies. Analyzed J-MACS data have been uploaded on the biannual basis on the home page of the Japanese Association for Thoracic Surgery (https://www.jpats.org/) since Oct 2018. Similar to INTERMACS [2] and IMACS [3], we have decided to publish annual report of J-MACS, and this is the second official report of J-MACS, which includes data as of Oct 30, 2018. The cut-off date for data collection of this report was Dec 31, 2018. Extended author information available on the last page of the article 13 Vol.:(0123456789) General Thoracic and Cardiovascular Surgery Methods We have changed the analytical methods for J-MACS data. First, we eliminated paracorporeal VAD data from the analysis. The second alteration is to add the data of bridge to bridge (BTB) implants in the new analysis. BTB means conversion from paracorporeal VAD (or centrifugal pumps for extracorporeal circulation) to implantable LVAD. Bridging from percutaneous VAD (IMPELLA, Abiomed, Danvers, MA, USA) or percutaneous/central extracorporeal membrane oxygenation (ECMO) are included in primary LVAD group. BTB neither includes bridging from implantable LVAD, i.e. pump exchange. J-MACS used to assign a different number for the exchanged pump, which was necessary to track each pump performance in view of post-marketing surveillance. However, to focus patients’ prognosis after LVAD implantation, data of 2 (or more) pumps in a single patient are merged when overall survival (including stratification by age) is analyzed. In other words, overall survival curve is not censored at the time of pump exchange. We still censor at the time of transplantation, pump removal including exchange, and the last observation when comparing between primary LVAD and BTB or stratifying by J-MACS profile levels in primary LVAD group. We need primary LVAD data censored as such to compare INTERMACS or previous J-MACS data that were all from primary LVAD. Definition of profile has yet to be discussed in detail among BTB cases, and we did not include stratified data by preoperative profiles from BTB patients in this study. The third alteration is to draw Kaplan–Meier curves for specific adverse events. Previously, J-MACS only reported the incidence rate of adverse events [1]. However, the timing of first occurrence of adverse events may also be important to prevent them. Recent INTERMACS analyses also reported Kaplan–Meier curves for specific adverse events [2]. Kaplan–Meier curves for adverse events are censored at the time of first occurrence of the events in addition to at the time of transplantation, pump removal including exchange, and the last observation. With a limited space for publication, many of the analyses for adverse events appear as supplementary figures. For comparison between primary LVAD and BT groups, unpaired t test was used for numerical data, and Chi-square test or Fisher’s exact test was used for categorical data. Kaplan–Meier curves were compared with log-rank test. Results Device types The implantable VADs included in this report were EVEHEART (Sun Medical, Nagano, Japan), DuraHeart 13 (Terumo, Tokyo, Japan), HeartMate II (Thoratec, Pleasanton, CA, USA, now merged to Abbott, Abbott park, IL, USA), and Jarvik 2000 (Jarvik, New York, NY, USA) (supplementary table 1). HVAD (Medtronic, Mineapolis, MN, USA) and HeartMate 3 (Abbott, Abbott park, IL, USA) were also approved in Dec 2018 and Apr 2019 respectively, but this report did not include any of them. We excluded paracorporeal Nipro VAD (Nipro, Osaka, Japan) from this report, but otherwise the same as the first report [1]. Patient population Patient inclusion criteria for J-MACS are previously described [1]. From Apr 1, 2011 to Oct 30, 2018, 1130 implants from 49 participating hospitals were enrolled. Among them, we analyzed 879 patients after the exclusion of paracoporeal VAD cases (139), pump exchange cases (105), insufficient data cas (...truncated)