A recent partial regulatory device approval made fenestrated and branched endovascular aneurysm repair (F/BEVAR) a key topic at this year’s Japanese Society for Cardiovascular Surgery (JSCVS) annual meeting (20–22 February, Shimonoseki and Moji City, Japan), writes Hiroshi Mitsuoka (Shizuoka, Japan).
The modernisation of cardiovascular surgery in Japan began after World War II, leading to the establishment of the JSCVS in 1972. Since then, the society has played a pivotal role in education, specialty board certification, database management, and medical ethics.
The 55th annual meeting took place earlier this year, amid nationwide working practice reform that began in 2023 and the advancement of endovascular technologies. In Japan, the adoption of commercial F/BEVAR devices has been significantly delayed. However, the recent partial regulatory approval of the first thoracoabdominal aortic aneurysm (TAAA) device by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) made F/BEVAR a key topic at the conference.
Key lectures and debates
Tilo Kölbel (University of Hamburg, Hamburg, Germany) delivered an invited lecture on the evolution of F/BEVAR in TAAA treatment, sparking debates on the future role of endovascular approaches. The discussions extended across multiple sessions, culminating in a debate session led by four domestic speakers, titled ‘Open vs. endo: Treatment of TAAA’.
Two keynote lectures provided critical perspectives. Yutaka Okita (Takatsuki Hospital, Kobe, Japan) discussed challenges in open procedures despite technical advancements and Satoshi Nakatani (Osaka University, Osaka, Japan) introduced endovascular strategies for TAAA, including hybrid procedures (open branch reconstruction with thoracic endovascular aortic repair [TEVAR]/EVAR), chimney EVAR, and F/BEVAR, emphasising early postoperative benefits and lower mortality rates.
Mid-term results of F/BEVAR with PMEG
I presented mid-term results of F/BEVAR with physician-modified endografting (PMEG) for high-surgical-risk TAAA cases, based on 58 of 120 total PMEG procedures. In this short surveillance scenario, where patient morbidity limits long-term survival, PMEG demonstrated durability comparable to commercial devices when precisely designed with 3D model-assisted planning and deployed using intraoperative 3D imaging.
Findings showed low mortality (0% in extent I–III, V TAAA; 4% in extent IV and paravisceral AAA; 3.4% overall) and low complication rates (2% spinal ischaemia; 0% new permanent haemodialysis). While commercial F/BEVAR devices may improve outcomes, PMEG demand is likely to persist if accessibility and treatment indications remain challenging.
Comparing open surgery and endovascular approaches
Soichiro Henmi (Kobe University, Kobe, Japan) highlighted the benefits of open surgery in younger patients (<60 years old), demonstrating a 1% procedural mortality rate and a 77% five-year survival rate, significantly higher than those of older patients. He suggested that F/BEVAR may be more suitable for high-risk cases, particularly elderly (>70 years old), provided procedural success and safe secondary interventions can be ensured.
The future of F/BEVAR in Japan
Despite the partial approval, commercial F/BEVAR devices remain inaccessible in Japan due to pending reimbursement and procedural coding. However, the global trend continues favouring minimally invasive endovascular approaches. Open surgery and endovascular techniques should be regarded as complementary, as already discussed in countries where both approaches have long been available.
Although this session was held without PMDA-approved access to commercial F/BEVAR devices in Japan, it provided valuable insights into which TAAA cases would benefit most from both endovascular and open treatments, making it a highly meaningful discussion.
Hiroshi Mitsuoka is director of the Vascular & Endovascular Center at Shizuoka City Shizuoka Hospital in Shizuoka, Japan.
