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The Use of BASILICA Technique to Prevent Coronary Obstruction in a TAVI-TAVI Procedure.

ABSTRACT: Transcatheter aortic valve implantation (TAVI) to manage structural bioprosthetic valve deterioration has been successful in mitigating the risk of a redo cardiac surgery. However, TAVI-in-TAVI is a complex intervention, potentially associated with feared complications such as coronary artery obstruction. Coronary obstruction risk is especially high when the previously implanted prosthesis had supra-annular leaflets and/or the distance between the prosthesis and the coronary ostia is short. The BASILICA technique (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) was developed to prevent coronary obstruction during native or valve-in-valve interventions but has now also been considered for TAVI-in-TAVI interventions. Despite its utility, the technique requires a not so widely available toolbox. Herein, we discuss the TAVI-in-TAVI BASILICA technique and how to perform it using more widely available tools, which could spread its use.

SUBMITTER: Tagliari AP

PROVIDER: S-EPMC8658292 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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The Use of BASILICA Technique to Prevent Coronary Obstruction in a TAVI-TAVI Procedure.

Tagliari Ana Paula AP Petersen Saadi Rodrigo R Medronha Eduardo Ferreira EF Keller Saadi Eduardo E

Journal of clinical medicine 20211126 23

Transcatheter aortic valve implantation (TAVI) to manage structural bioprosthetic valve deterioration has been successful in mitigating the risk of a redo cardiac surgery. However, TAVI-in-TAVI is a complex intervention, potentially associated with feared complications such as coronary artery obstruction. Coronary obstruction risk is especially high when the previously implanted prosthesis had supra-annular leaflets and/or the distance between the prosthesis and the coronary ostia is short. The ...[more]

PMID: 34884239

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Project description:BackgroundCoronary artery obstruction is a rare, devastating complication of transcatheter aortic valve replacement. Transcatheter electrosurgical aortic leaflet laceration (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction [BASILICA]) is a novel technique to prevent coronary artery obstruction. We report the 1-year outcomes of the BASILICA trial. Primary end points of 30-day success and safety have been reported previously.MethodsThe BASILICA trial was a prospective, multicenter, single-arm safety and feasibility study. Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and high risk of coronary artery obstruction, were included. End points at 1 year included death, stroke, and myocardial infarction. Source data was independently verified and end points independently adjudicated.ResultsThirty subjects were enrolled between February 2018 and July 2018. At 30 days, BASILICA was successful in 28 subjects (93.3%), there were 3 strokes (10%), including 1 disabling stroke (3.3%), 1 death (3.3%), and 1 periprocedural myocardial infarction (3.3%). Between 30 days and 1 year, there were no additional strokes, no myocardial infarction, and 2 deaths (10% 1-year mortality). No subject needed repeat intervention for aortic valve or coronary disease. Two subjects had infective endocarditis (6.7%), but neither was isolated to the aortic valve. There were no hospital admissions for heart failure. Fourteen (46.7%) subjects required repeat hospital admission for other causes. Aortic valve gradients on echocardiography, New York Heart Association functional class, and Kansas City Cardiomyopathy Questionnaire scores improved from baseline to 30 days and were maintained at 1 year.ConclusionsIn these subjects with multiple comorbidities and restrictive anatomy that underwent transcatheter aortic valve replacement, there was no late stroke, myocardial infarction, or death related to BASILICA. Mitigation of coronary obstruction remained intact at 1 year and was not related to recurrent readmission. These results are reassuring for patients and physicians who wish to avoid the long-term complications related to snorkel stenting.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT03381989.

Project description:ObjectivesThe BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR) investigational device exemption trial was a prospective, multicenter, single-arm safety and feasibility study.BackgroundCoronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement (TAVR). Current stent-based preventative strategies are suboptimal. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction.MethodsSubjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and at high risk of coronary artery obstruction, were included. The primary success endpoint was successful BASILICA and TAVR without coronary obstruction or reintervention. The primary safety endpoint was freedom from major adverse cardiovascular events. Data were independently monitored. Endpoints were independently adjudicated. A core laboratory analyzed computed tomography images.ResultsBetween February 2018 and July 2018, 30 subjects were enrolled. Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from coronary obstruction and reintervention. Primary safety was met in 21 (70%), driven by 6 (20%) major vascular complications related to TAVR but not BASILICA. There was 1 death at 30 days. There was 1 (3%) disabling stroke and 2 (7%) nondisabling strokes. Transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR.ConclusionsBASILICA was feasible in both native and bioprosthetic valves. Hemodynamic compromise was uncommon. Safety was acceptable and needs confirmation in larger studies. BASILICA appears effective in preventing coronary artery obstruction from TAVR in subjects at high risk.

Dataset Information

The Use of BASILICA Technique to Prevent Coronary Obstruction in a TAVI-TAVI Procedure.

Publications

The Use of BASILICA Technique to Prevent Coronary Obstruction in a TAVI-TAVI Procedure.

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