Abstract

Coronary obstruction is a rare but life-threatening complication following transcatheter aortic valve replacement (TAVR). Comparative analysis between snorkel stenting and BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction) remain limited. We analyzed 122 patients from the COBRA registry, including 68 who underwent BASILICA and 54 who received snorkel stents. In-hospital survival was numerically higher in the BASILICA group compared to the snorkel stent group (97% vs. 89%). BASILICA was also associated with lower rates of life-threatening bleeding (0.0% vs. 10%) and major vascular complications (1.5% vs. 12%). In patients at risk, a preemptive BASILICA strategy may offer an attractive approach for primary prevention of coronary obstruction in patients undergoing TAVR.

Competing Interest Statement

ABG and VCB have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, JenaValve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; have received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have an equity interest in Transmural Systems. IB and PTG have institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. CMD receives compensation for the following roles: Medtronic: Consultant; Edwards Lifesciences: Proctor; ReCor Medical: Consultant; and Shockwave Medical: Consultant. NK has served as a proctor for Edwards Lifesciences. TR has served as a proctor and consultant for Boston Scientific, Edwards Lifesciences, and Medtronic; has served on the advisory board for Medtronic; and holds equity interest in Transmural Systems Inc. GP has institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific; and is a proctor for Edwards Lifesciences. RJL is coinventor on patents assigned to the National Institutes of Health (NIH), for electrosurgical devices. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Funding Statement

Supported by Emory Division of Cardiology intramural funds and by NIH Z01-HL006040.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Emory University Institutional Review Board approved this study, and the participating sites either obtained local IRB approval or accepted the Emory IRB exemption

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Footnotes

Funding: Supported by Emory Division of Cardiology intramural funds and by NIH Z01-HL006040.

Conflict of Interest/Financial Disclosures: ABG and VCB have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, JenaValve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; have received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have an equity interest in Transmural Systems. IB and PTG have institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. CMD receives compensation for the following roles: Medtronic: Consultant; Edwards Lifesciences: Proctor; ReCor Medical: Consultant; and Shockwave Medical: Consultant. NK has served as a proctor for Edwards Lifesciences. TR has served as a proctor and consultant for Boston Scientific, Edwards Lifesciences, and Medtronic; has served on the advisory board for Medtronic; and holds equity interest in Transmural Systems Inc. GP has institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific; and is a proctor for Edwards Lifesciences. RJL is coinventor on patents assigned to the National Institutes of Health (NIH), for electrosurgical devices. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Data Availability

All data produced in the present study are available upon reasonable request to the authors

AbbreviationsBASILICABioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstructionSTS-PROMSociety of Thoracic Surgeons Predicted Risk of MortalityTAVRtranscatheter aortic valve replacement