Bicuspid Aortic Valve (BAV)
Conditions
Keywords
LIRA method, Bicuspid aortic Valve, TAVR
Brief summary
Transcatheter aortic valve replacement (TAVR) outcomes in patients with raphe-type bicuspid aortic valve (BAV) are still suboptimal for the non negligible rate of stroke and permanent pacemaker implantation. There is still lack of consensus on the optimal sizing method for prosthesis selection in BAV patients. The objective of the present study is to evaluate the efficacy and safety of the LIRA sizing method in raphe-type BAV patients undergoing TAVR.
Detailed description
Bicuspid aortic valve (BAV) still represents a challenge for percutaneous treatment due to the peculiar anatomy. BAV patients have been historically excluded from major randomized controlled trials. Observational data have showed a high rate of paravalvular leak (PVL) with the use of self-expanding prostheses and a non-negligible rate of annular rupture with the use of balloon expandable valves. More recent data have shown better outcomes with current generation prostheses although the rate of stroke and permanent pacemaker implantation remains high. These suboptimal results, possibly related to BAV different anatomy, have advocated the use of different sizing method for prosthesis selection in this setting. Recent evidence has shown that transcatheter heart valve (THV) anchoring in BAV patients might occur at the raphe-level, defined as the LIRA (Level of Implantation at the RAphe) plane. Thus, a novel supra-annular sizing method based on the measurement of the perimeter at the raphe-level, the LIRA-method, has been developed in our center and validated in small cohorts of patients. The aim of our study is to evaluate the efficacy and safety of the LIRA method in raphe-type bicuspid patients undergoing TAVR.
Interventions
None listed
Sponsors
IRCCS San Raffaele
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients over 18 years old with severe aortic stenosis and type 1 or 2 BAV according to Sievers classification) undergone TAVR with self-expanding supra-annular prostheses sized according to the LIRA method between September 2018 and June 2024
Exclusion criteria
* Redo-TAVR * TAVR performed in emergency setting * TAVR performed for severe aortic regurgitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device success | Up to 30 days after TAVI procedure | Device success as defined by VARC 3 criteria : presence of technical success, freedom from mortality, freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complications, intended performance of the valve (less than moderate aortic regurgitation, mean gradient \< 20 mmHg, peak velocity \<3 m/s, doppler velocity index \>0.25). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of partecipants with TAVI-related Adverse Events as assessed by VARC 3 criteria. | Up to 30 days after TAVI procedure | * All-cause mortality * All stroke * VARC type 2-4 bleeding * Major vascular, access-related, or cardiac structural complication * Acute kidney injury stage 3 or 4 * New permanent pacemaker due to procedure- related conduction abnormalities * Surgery or intervention related to the device |
| Clinical efficacy | Up to 1 year after TAVI procedure | Freedom from all-cause mortality, freedom from all stroke, freedom from hospitalization for procedure -or-valve-related causes, freedom from KCCQ Overall Summary score \<45 or decline from baseline \>10 point |
| Technical success | At exit from procedure room | Freedom from mortality; successful access, delivery and retrieval of the delivery system; correct positioning of a single prosthetic heart valve into the proper anatomical location; freedom from surgey or intervention related to the device or to a major vascular or access-related, or cardiac structural. |
| Intended performance of the valve | Up to 30 days after TAVI procedure | Less than moderate aortic regurgitation, mean gradient \< 20 mmHg, peak velocity \<3 m/s, doppler velocity index \>0.25 |
Countries
Italy, Switzerland
Contacts
Primary ContactProf. Matteo Montorfano, MD
Backup ContactBarbara Bellini, MD
Outcome results
None listed