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Original research
Personalised external aortic root support for elective treatment of aortic root dilation in 200 patients
  1. Lucas Van Hoof1,
  2. Filip Rega1,
  3. Tal Golesworthy2,
  4. Peter Verbrugghe1,
  5. Conal Austin3,
  6. Johanna J M Takkenberg4,
  7. John R Pepper5,6,
  8. Tom Treasure7
  1. 1Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium
  2. 2Exstent Ltd, Tewkesbury, UK
  3. 3Department of Paediatric Cardiology and Cardiothoracic Surgery, St Thomas' Hospital, London, UK
  4. 4Department of Cardio-Thoracic Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands
  5. 5Cardiothoracic Surgery, Royal Brompton and Harefield NHS Foundation Trust, London, UK
  6. 6National Heart and Lung Institute, Imperial College London, London, UK
  7. 7Clinical Operational Research Unit, University College London, London, UK
  1. Correspondence to Dr Lucas Van Hoof, Cardiac Surgery, KU Leuven University Hospitals Leuven, Leuven 3000, Belgium; lucas.vanhoof{at}kuleuven.be

Abstract

Background and objectives In personalised external aortic root support (PEARS), a custom-made, macroporous mesh is used to stabilise a dilated aortic root and prevent dissection, primarily in patients with genetically driven aortopathies. Data are needed on the safety and postoperative incidence of aortic events.

Methods We present a multicentre cohort study evaluating the first 200 consecutive patients (median age 33 years) undergoing surgery with an intention to perform PEARS for aortic root dilatation in 23 centres between 2004 and 2019. Perioperative outcomes were collected prospectively while clinical follow-up was retrieved retrospectively. Median follow-up was 21.2 months.

Results The main indication was Marfan syndrome (73.5%) and the most frequent concomitant procedure was mitral valve repair (10%). An intervention for myocardial ischaemia or coronary injury was needed in 11 patients, 1 case resulting in perioperative death. No ascending aortic dissections were observed in 596 documented postoperative patient years. Late reoperation was performed in 3 patients for operator failure to achieve complete mesh coverage. Among patients with at least mild aortic regurgitation (AR) preoperatively, 68% had no or trivial AR at follow-up.

Conclusions This study represents the clinical history of the first 200 patients to undergo PEARS. To date, aortic dissection has not been observed in the restrained part of the aorta, yet long-term follow-up is needed to confirm the potential of PEARS to prevent dissection. While operative mortality is low, the reported coronary complications reflect the learning curve of aortic root surgery in patients with connective tissue disease. PEARS may stabilise or reduce aortic regurgitation.

  • aortic aneurysm
  • Marfan syndrome
  • aneurysm
  • dissecting

Data availability statement

The data underlying this article will be shared on reasonable request to the corresponding author.

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Data availability statement

The data underlying this article will be shared on reasonable request to the corresponding author.

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Footnotes

  • Contributors TG invented the procedure, developed the implant and was the first patient to undergo personalised external aortic root support (PEARS) surgery. JRP performed the first 26 operations. CA is the lead surgeon and performed 45 of the operations described in this study. This study was designed by LVH, TT, JRP, TG and FR. Perioperative data were collected prospectively by TG as standard protocol for the reporting of device-related issues. Detailed in-hospital outcomes and follow-up data were collected retrospectively by LVH, TT, JRP, CA and TG. Data analysis was performed by LVH, FR, PV and JJMT with input from all coauthors. The first draft of the manuscript was prepared by LVH, FR, PV and TT. All authors approved the final version to be published.

  • Funding LVH is supported by a Doctoral Grant Strategic Basic Research (SB 1S70220N) from the Research Foundation Flanders (FWO).

  • Competing interests The only author with a potential conflict of interest is TG, the inventor of the ExoVasc device. He was the first patient to undergo personalised external aortic root support (PEARS) surgery in 2004 and is a shareholder in Exstent Ltd, the company that manufactures the PEARS ExoVasc device. Exstent Ltd holds a family of Patents and Registered Trademarks covering the ExoVasc PEARS implant.

  • Provenance and peer review Not commissioned; internally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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