
31
MEDISTIM ANNUAL REPORT - FISCAL YEAR 2023
Circulation – the official journal of the American
Heart Association – and one of the highest ranked
journals in cardiology and cardiovascular medicine,
published a consensus paper by 19 of the world’s
highest renowned specialists in coronary artery
bypass surgery (CABG) on October 5th. The
study describes a systematic review to identify
best practice evidence for guideline development
published the last 20 years. Over 2,200 articles
identified, more than 1,550 of them screened, and
38 of them included in this review paper. The expert
consensus process resulted in a new flowchart for
decision making guidance to cardiac surgeons on
how to utilize TTFM during surgery. The first of
the 10 consensus statements and justifications
states “TTFM should be used in every CABG case”.
The panelists agree “that quality assurance in
CABG procedures should be established as a key
component to improve patient outcomes”.
This is a pivotal paper for Medistim that clearly
graces all the initiatives to position MiraQ™
technology for routine use during CABG surgery.
Having the technology in focus in one of the world’s
most renowned cardiovascular journals indicate
that Medistim is moving in the right direction with
its strategy. Medistim’s REQUEST study published in
2020 was one of the key papers that was assessed
to underpin the importance of routine use of
quality assessment. This strong advocacy will not
only exert peer influence within the community of
cardiac surgeons, but it may pave the way for new
and enhanced clinical guidelines worldwide.
In 2022, Mojgan Laali et al. published the study
“Impact of transit-time flow measurement on
early postoperative outcomes in total arterial
coronary revascularization with internal thoracic
arteries: a propensity score analysis on 910 patients”.
Outcome in 430 CABG patients where TTFM was used
was compared with outcome from 480 CABG patients
where the surgeons were unwilling to perform TTFM.
The key finding is a significant reduction in Major
Adverse Cardiovascular Events (MACE) from 6.9 % to
3.3 % - a 50 % reduction by adding 3 extra minutes on
TTFM. This result was so convincing that the previous
non-believers at the hospital have adopted TTFM for
graft evaluation. This set of data is included in a large
multi-center study in France that Medistim believe
might ease the adaptation of TTFM in France.
In 2023 Medistim announced its partnership
with ROMA-Women, a groundbreaking cardiac
surgery trial that is specifically focused on women.
Historically, cardiovascular research and treatment
protocols have primarily focused on men, leaving
women underrepresented in clinical studies and
potentially receiving suboptimal care. Recognizing
this disparity, Medistim has joined forces with
the trial to champion gender-specific healthcare
advancements.
The multicenter randomized clinical trial, ROMA-
Women, will enroll about 2,000 women, studying
the use of single versus multiple arterial grafts in
coronary artery bypass (CABG) surgery. The trial
is spearheaded by renowned experts in the field
of cardiac surgery, including principal investigators
Mario Gaudino, Professor at Weill Cornell Medicine,
USA, and Stephen Fremes, Professor at Sunnybrook
Health Sciences, Canada. More than 100 centers
across the world are expected to participate. The
trial is an extension of the ongoing ROMA trial and
has already enrolled about 700 women.
ROMA-Women aims to address the unique
cardiovascular needs and challenges faced by
women. Compared to men, women are referred
for CABG at an older age and have more frequently
diabetes, hypertension, and dyslipidemia. From a
surgical perspective, the CABG operation is generally
more complex in women because of smaller and
more spastic coronary arteries than men. Hence,
it is believed that graft assessment may be even
more important in women, and in this trial, graft
patency will be assessed with Medistim’s Transit
Time Flow Measurement (TTFM) and High Frequency
Ultrasound (HFUS) technologies.
Guidelines recommend intraoperative ultrasound
after Carotid Endarterectomy (CEA) in 2022:
The European Society of Vascular Surgery (ESVS)
revised their Clinical Practice Guidelines in 2022
on the management of atherosclerotic carotid and
vertebral artery disease by among others, adding
a recommendation of the use of intra-operative
completion control with ultrasound imaging, to
reduce risk of peri-operative stroke for patients
undergoing carotid endarterectomy.
The Guidelines are set to identify luminal thrombus
after flow restoration, diagnose intimal flaps and
diagnose residual stenoses during surgery. The new
recommendation is based on a meta-analysis by
Knappich et al. 2021 that shows that both ultrasound
imaging and angiography are associated with a
reduced risk of death and stroke after CEA.
Professor Eckstein, University Hospital Rechts der Isar,
Munich, Germany, states that “This new guideline
recommendation clarifies that intraoperative