CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.

Overview

The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique used. The study involves patients undergoing elective surgical aortic valve replacement with a bioprosthesis. Participants enrolled will undergo a CT scan before and after surgery (at least 90 days after surgery) to analyze coronary ostia height.

Detailed description

Aortic valve stenosis is the most frequent heart valve disease in the adult population. The development of biological prostheses with slower valve degeneration and easier antithrombotic management and changes in the indications for the treatment of this valve disease, have allowed a reduction in the age in which such prostheses are implanted thus leading to a greater use of biological prostheses rather than mechanical ones. In the next few years this will cause a higher rate of structural valve degeneration resulting in stenosis and/or insufficiency. In patients considered to be at high surgical risk, the transcatheter implantation of a valve-in-valve (VIV) represents a valid alternative to standard surgery, except for coronary obstruction which appears more frequent in VIV procedures, especially in patients receiving VIV after surgical aortic valve replacement. The risk factors mainly associated with this complication are represented by the type of implanted prostheses and the anatomical relationship between the coronary ostia and the expected final position of the cusps of the bioprostheses transcatheter-implanted.Recent studies have demonstrated how coronary height seems to be significantly reduced in case of surgical aortic valve replacement with a supra-annular technique, as occurs in our center.

Aim of this interventional, single-center study is to demonstrate whether there is a change in the coronary ostia height after surgical aortic valve replacement and whether it possibly depends on the type of prosthesis.

All patients undergoing elective aortic valve replacement surgery at our institution who meet the inclusion criteria for the study will be contacted to perform a postoperative CT scan at least 90 days after surgery.

Interventions

• Radiation CT scan with contrast medium
  Multi-detector CT scan (if possible with prospective-ECG gated sequential scan) with contrast medium injection of nonionic contrast agent. All CT datasets will be analysed for the qualitative and quantitative assessment of the aortic root. The coronary height will be assessed at baseline in relation to the aortic annulus and in relation to the stent of the bioprostheses after aortic valve replacement.

Primary outcome measures

• Coronary ostia height differences. [Time frame: At least 90 days after surgery]

Secondary outcome measures (1)

• Coronary ostia height differences between different bioprostheses. [Time frame: At least 90 days after surgery]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years;
• Aortic valve stenosis or insufficiency with indication for elective aortic valve replacement with a bioprosthesis;
• Possible concomitant coronary artery disease with indication for surgical or percutaneous revascularization;
• CT imaging of the thorax with iodinated contrast agent carried out before surgery;
• Signed informed consent, inclusive of release of medical information.

Exclusion criteria

• Aortic valve replacement in bicuspid valve or endocarditis;
• Aortic valve replacement associated with surgery of ascending aorta/aortic root;
• Aortic valve replacement associated with other cardiac valve surgery;
• Previous cardiac surgery of any kind;
• Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgment of the investigator;
• Participation in another clinical trial that could interfere with the endpoints of this study;
• Pregnant at time of screening;
• Allergy or hypersensitivity to iodinated contrast agent;
• End-stage renal disease on dialysis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

Italy · 1 center

• Policlinico Agostino Gemelli — Roma

Publications

• Stewart BF, Siscovick D, Lind BK, Gardin JM, Gottdiener JS, Smith VE, Kitzman DW, Otto CM. Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study. J Am Coll Cardiol. 1997 Mar 1;29(3):630-4. doi: 10.1016/s0735-1097(96)00563-3. PMID 9060903
• Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632 PMID 34453165
• Dunning J, Gao H, Chambers J, Moat N, Murphy G, Pagano D, Ray S, Roxburgh J, Bridgewater B. Aortic valve surgery: marked increases in volume and significant decreases in mechanical valve use--an analysis of 41,227 patients over 5 years from the Society for Cardiothoracic Surgery in Great Britain and Ireland National database. J Thorac Cardiovasc Surg. 2011 Oct;142(4):776-782.e3. doi: 10.1016/j.jtc PMID 21924147
• Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T, Lancellotti P, Sondergaard L, Ludman PF, Tamburino C, Piazza N, Hancock J, Mehilli J, Byrne RA, Baumbach A, Kappetein AP, Windecker S, Bax J, Haude M. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a cons PMID 28874031
• Giordana F, Bruno F, Conrotto F, Saglietto A, D'Ascenzo F, Grosso Marra W, Dvir D, Webb J, D'Onofrio A, Camboni D, Grubitzsch H, Duncan A, Kaneko T, Toggweiler S, Latib A, Nerla R, Salizzoni S, La Torre M, Trompeo A, D'Amico M, Rinaldi M, De Ferrari G. Incidence, predictors and outcomes of valve-in-valve TAVI: A systematic review and meta-analysis. Int J Cardiol. 2020 Oct 1;316:64-69. doi: 10.1016 PMID 32470529
• Bernardi FLM, Dvir D, Rodes-Cabau J, Ribeiro HB. Valve-in-Valve Challenges: How to Avoid Coronary Obstruction. Front Cardiovasc Med. 2019 Aug 23;6:120. doi: 10.3389/fcvm.2019.00120. eCollection 2019. PMID 31508426
• Coti I, Maierhofer U, Rath C, Werner P, Loewe C, Kocher A, Laufer G, Andreas M. Effect of conventional and rapid-deployment aortic valve replacement on the distance from the aortic annulus to coronary arteries. Interact Cardiovasc Thorac Surg. 2021 Jan 22;32(2):196-203. doi: 10.1093/icvts/ivaa247. PMID 33236042
• Bruno P, Cammertoni F, Rosenhek R, Mazza A, Pavone N, Iafrancesco M, Nesta M, Chiariello GA, Spalletta C, Graziano G, Sanesi V, D'Errico D, Massetti M. Improved Patient Recovery With Minimally Invasive Aortic Valve Surgery: A Propensity-Matched Study. Innovations (Phila). 2019 Oct;14(5):419-427. doi: 10.1177/1556984519868715. Epub 2019 Aug 21. PMID 31431105

Identifiers

NCT: NCT05714293 · 5316

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗