Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.

NCT05708118 | Unknown

• 1 other identifier: 5239
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients who underwent elective aortic valve replacement or TAVR for stenotic bicuspid aortic valve (BAV) at our institution from 2015 to June 2022. Participants will undergo both a CT and an echocardiographic assessment at least 90 days after surgery.

Conditions

Bicuspid Aortic Valve; Aortic Valve Stenosis; Aortic Aneurysm; Heart Diseases; Valvular Heart Disease; Valvular Aortic Stenosis; Ascending Aorta Aneurysm

Keywords

Heart valves; Transcatheter aortic valve implantation; Surgical aortic valve replacement; Ascending aorta aneurysm; Bicuspid aortic valve; Bicuspid aortopathy; Transfemoral TAVR

Outcome Measures

Primary Outcomes (1)

• Ascending aorta diameters changes.

  Evaluation of ascending aorta diameters after transcatheter or surgical aortic valve replacement highlighted by both CT and echocardiographic assessment.

  At least 90 days after intervention.

Study Arms (2)

Surgical Aortic Valve Replacement (SAVR)

Patients who undergo surgical aortic valve replacement through median longitudinal sternotomy.

Diagnostic Test: Echocardiographic assessment.; Diagnostic Test: Computed-tomography assessment

Transcatheter Aortic Valve Replacement (TAVR)

Patients who undergo transcatheter aortic valve replacement through a transfemoral access.

Diagnostic Test: Echocardiographic assessment.; Diagnostic Test: Computed-tomography assessment

Interventions

Echocardiographic assessment. DIAGNOSTIC_TEST

Patients will be contacted to carry out an echocardiography at least 90 days after surgery. Measurements will be taken for aortic annulus, sinuses of Valsalva, sino-tubular junction, tubular ascending aorta. Aortic valve will be assessed as well.

Surgical Aortic Valve Replacement (SAVR); Transcatheter Aortic Valve Replacement (TAVR)

Computed-tomography assessment DIAGNOSTIC_TEST

All enrolled patients will undergo a multislice CT scan (retrospectively ECG-gated, whenever possible) with standard contrast medium injection protocol of nonionic contrast agent. All post-surgery controls will be performed at least 90 days after surgery. All CT datasets will be analysed on a dedicated workstation for the qualitative and quantitative assessment of the aortic root including measurements for aortic annulus, sinuses of Valsalva, sino-tubular junction, tubular ascending aorta.

Also known as: CT scan

Surgical Aortic Valve Replacement (SAVR); Transcatheter Aortic Valve Replacement (TAVR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with bicuspid aortic valve stenosis treated with surgical or transcatheter aortic valve replacement and concomitant ascending aorta aneurysm, with no indication to surgical treatment at the time of intervention.

You may qualify if:

• Age ≥ 18 years
• Bicuspid aortic valve stenosis treated with surgical or transcatheter aortic valve replacement;
• Concomitant ascending aorta aneurysm, with no indication to surgical treatment at the time of intervention;
• Patients with indication to follow-up Chest CT angiography Scan.
• Signed informed consent, inclusive of release of medical information.

You may not qualify if:

• Aortic valve replacement in tricuspid valves or bicuspid insufficient valves 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 or breastfeeding at time of screening.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Agostino Gemelli

Roma, 00168, Italy

RECRUITING

Related Publications (15)

• Verma S, Siu SC. Aortic dilatation in patients with bicuspid aortic valve. N Engl J Med. 2014 May 15;370(20):1920-9. doi: 10.1056/NEJMra1207059. No abstract available.

  PMID: 24827036 BACKGROUND

• Michelena HI, Desjardins VA, Avierinos JF, Russo A, Nkomo VT, Sundt TM, Pellikka PA, Tajik AJ, Enriquez-Sarano M. Natural history of asymptomatic patients with normally functioning or minimally dysfunctional bicuspid aortic valve in the community. Circulation. 2008 May 27;117(21):2776-84. doi: 10.1161/CIRCULATIONAHA.107.740878.

  PMID: 18506017 BACKGROUND

• Tzemos N, Therrien J, Yip J, Thanassoulis G, Tremblay S, Jamorski MT, Webb GD, Siu SC. Outcomes in adults with bicuspid aortic valves. JAMA. 2008 Sep 17;300(11):1317-25. doi: 10.1001/jama.300.11.1317.

  PMID: 18799444 BACKGROUND

• Kim YG, Sun BJ, Park GM, Han S, Kim DH, Song JM, Kang DH, Song JK. Aortopathy and bicuspid aortic valve: haemodynamic burden is main contributor to aortic dilatation. Heart. 2012 Dec;98(24):1822-7. doi: 10.1136/heartjnl-2012-302828.

  PMID: 23204534 BACKGROUND

• Fedak PW, Verma S, David TE, Leask RL, Weisel RD, Butany J. Clinical and pathophysiological implications of a bicuspid aortic valve. Circulation. 2002 Aug 20;106(8):900-4. doi: 10.1161/01.cir.0000027905.26586.e8. No abstract available.

  PMID: 12186790 BACKGROUND

• Girdauskas E, Borger MA, Secknus MA, Girdauskas G, Kuntze T. Is aortopathy in bicuspid aortic valve disease a congenital defect or a result of abnormal hemodynamics? A critical reappraisal of a one-sided argument. Eur J Cardiothorac Surg. 2011 Jun;39(6):809-14. doi: 10.1016/j.ejcts.2011.01.001. Epub 2011 Feb 20.

  PMID: 21342769 BACKGROUND

• Michelena HI, Khanna AD, Mahoney D, Margaryan E, Topilsky Y, Suri RM, Eidem B, Edwards WD, Sundt TM 3rd, Enriquez-Sarano M. Incidence of aortic complications in patients with bicuspid aortic valves. JAMA. 2011 Sep 14;306(10):1104-12. doi: 10.1001/jama.2011.1286.

  PMID: 21917581 BACKGROUND

• Roberts WC, Janning KG, Ko JM, Filardo G, Matter GJ. Frequency of congenitally bicuspid aortic valves in patients >/=80 years of age undergoing aortic valve replacement for aortic stenosis (with or without aortic regurgitation) and implications for transcatheter aortic valve implantation. Am J Cardiol. 2012 Jun 1;109(11):1632-6. doi: 10.1016/j.amjcard.2012.01.390. Epub 2012 Mar 27.

  PMID: 22459301 BACKGROUND

• Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

  PMID: 21639811 BACKGROUND

• Vincent F, Ternacle J, Denimal T, Shen M, Redfors B, Delhaye C, Simonato M, Debry N, Verdier B, Shahim B, Pamart T, Spillemaeker H, Schurtz G, Pontana F, Thourani VH, Pibarot P, Van Belle E. Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Stenosis. Circulation. 2021 Mar 9;143(10):1043-1061. doi: 10.1161/CIRCULATIONAHA.120.048048. Epub 2021 Mar 8.

  PMID: 33683945 BACKGROUND

• 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. doi: 10.1093/eurheartj/ehab395. No abstract available.

  PMID: 34453165 BACKGROUND

• Yasuda H, Nakatani S, Stugaard M, Tsujita-Kuroda Y, Bando K, Kobayashi J, Yamagishi M, Kitakaze M, Kitamura S, Miyatake K. Failure to prevent progressive dilation of ascending aorta by aortic valve replacement in patients with bicuspid aortic valve: comparison with tricuspid aortic valve. Circulation. 2003 Sep 9;108 Suppl 1:II291-4. doi: 10.1161/01.cir.0000087449.03964.fb.

  PMID: 12970248 BACKGROUND

• Girdauskas E, Rouman M, Disha K, Espinoza A, Misfeld M, Borger MA, Kuntze T. Aortic Dissection After Previous Aortic Valve Replacement for Bicuspid Aortic Valve Disease. J Am Coll Cardiol. 2015 Sep 22;66(12):1409-11. doi: 10.1016/j.jacc.2015.07.022. No abstract available.

  PMID: 26383730 BACKGROUND

• Burzotta F, Aurigemma C, Romagnoli E, Shoeib O, Russo G, Zambrano A, Verdirosi D, Leone AM, Bruno P, Trani C. A less-invasive totally-endovascular (LITE) technique for trans-femoral transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2020 Aug;96(2):459-470. doi: 10.1002/ccd.28697. Epub 2020 Jan 11.

  PMID: 31925991 BACKGROUND

• Burzotta F, Shoeib O, Aurigemma C, Trani C. Angio-Guidewire-Ultrasound (AGU) Guidance for Femoral Access in Procedures Requiring Large Sheaths. J Invasive Cardiol. 2019 Feb;31(2):E37-E39. doi: 10.25270/jic/18.00173.

  PMID: 30700629 BACKGROUND

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease; Aortic Valve Stenosis; Aortic Aneurysm; Heart Diseases; Heart Valve Diseases; Aneurysm, Ascending Aorta

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Aortic Valve Disease; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ventricular Outflow Obstruction; Aneurysm; Vascular Diseases; Aortic Diseases; Aortic Aneurysm, Thoracic

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Giovanni A Chiariello, MD

  Policlinico Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marialisa Nesta, MD

CONTACT

+39 3495667812; marialisa.nesta@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: January 20, 2023
• Primary Completion: January 21, 2024
• Study Completion: January 21, 2024
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

IT (1)