Thoraflex Hybrid Prosthesis (THP): the profile

ABSTRACT

Introduction

With the incidence of thoracic aortic disease on the rise, total arch replacement (TAR) with frozen elephant trunk (FET) remains the gold-standard management strategy due to optimal results. Several FET devices exist commercially on the global market. However, the mainstay and most commonly used and reported device is the Thoraflex Hybrid Prosthesis (THP), with several recent reports suggesting its superiority.

Areas covered

This review aims to collate and summarize the evidence in the literature on the clinical outcomes of TAR with FET using THP, with a focus on mortality, neurological complications, endoleak, distal stent-induced new entry (dSINE), aortic remodeling, coagulopathy, and graft kinking. In addition, the design features of THP is discussed, and an overview of market competitors is also highlighted.

Expert opinion

THP consistently demonstrates its effectiveness in treating complex thoracic aortic pathology through favorable clinical outcomes, which can be attributed to its unique and innovative design. Rates of early mortality ranged 0.6–14.2%, neurological complications 0–25%, endoleak 0–8.4% and dSINE 0–14.5%, with minimal incidence of graft kinking and coagulopathy. Aortic remodeling is favorable and comparable to competitors. All this evidence solidifies THP as the leading FET device, particularly when combined with appropriate patient selection and surgical planning.

KEYWORDS:

• Total arch replacement (TAR)
• Frozen Elephant Trunk (FET)
• Thoraflex hybrid
• THP
• aortic dissection
• thoracic aortic aneurysm

Article highlights

• The FET technique has become the gold-standard for TAR due to optimal clinical outcomes.

• FET relies on the use of a hybrid aortic prosthesis, also known as FET device, to replace the aortic arch and stent the descending thoracic aorta (DTA) in an antegrade fashion in a single procedure.

• Several FET devices have been developed and compete within the literature.

• The Thoraflex Hybird Prosthesis (THP) features unique and innovative design characteristics.

• THP can be considered the overall superior device in terms of clinical outcomes including mortality and long-term survival, neurological complications, endoleak, distal stent-graft induced new entry (dSINE), graft kinking, and coagulopathy.

• Aortic remodeling with THP is comparable to competitor devices.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Data availability statement

The evidence used to support this review are publicly available in electronic databases such as PubMed, Google Scholar, Ovid, Scopus and Embase.

Authors’ contributions

All authors substantially contributed to the conception and design of the review article and interpreting the relevant literature and were involved in writing the review article or revised it for intellectual content.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.