Prevention of coronary obstruction in patients at risk undergoing transcatheter aortic valve implantation: the Hamburg BASILICA experience

Dirk Westermann, Sebastian Ludwig, Daniel Kalbacher, Clemens Spink, Matthias Linder, Oliver D Bhadra, Julius Nikorowitsch, Lara Waldschmidt, Till Demal, Lisa Voigtländer, Andreas Schaefer, Moritz Seiffert, Simon Pecha, Niklas Schofer, Adam B Greenbaum, Hermann Reichenspurner, Stefan Blankenberg, Lenard Conradi, Johannes Schirmer, Dirk Westermann, Sebastian Ludwig, Daniel Kalbacher, Clemens Spink, Matthias Linder, Oliver D Bhadra, Julius Nikorowitsch, Lara Waldschmidt, Till Demal, Lisa Voigtländer, Andreas Schaefer, Moritz Seiffert, Simon Pecha, Niklas Schofer, Adam B Greenbaum, Hermann Reichenspurner, Stefan Blankenberg, Lenard Conradi, Johannes Schirmer

Abstract

Objectives: This study aimed to assess the clinical outcome of the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary obstruction (BASILICA) technique in a single-center patient cohort considered at high or prohibitive risk of transcatheter aortic valve implantation (TAVI)-induced coronary obstruction.

Methods: Between October 2019 and January 2021, a total of 15 consecutive patients (age 81.0 [78.1, 84.4] years; 53.3% female; EuroSCORE II 10.6 [6.3, 14.8] %) underwent BASILICA procedure prior to TAVI at our institution. Indications for TAVI were degeneration of stented (n = 12, 80.0%) or stentless (n = 1, 6.7%) bioprosthetic aortic valves, or calcific stenosis of native aortic valves (n = 2, 13.3%), respectively. Individual risk of TAVI-induced coronary obstruction was assessed by pre-procedural computed tomography analysis. Procedural and 30-day outcomes were documented in accordance with Valve Academic Research Consortium (VARC)-2 criteria.

Results: BASILICA was attempted for single left coronary cusp in 12 patients (80.0%), for single right coronary cusp in 2 patients (13.3%), and for both cusps in 1 patient (6.7%), respectively. The procedure was feasible in 13 patients (86.7%) resulting in effective prevention of coronary obstruction, whilst TAVI was performed without prior successful bioprosthetic leaflet laceration in two patients (13.3%). In one of these patients (6.7%), additional chimney stenting immediately after TAVI was performed. No all-cause deaths or strokes were documented after 30 days.

Conclusion: The BASILICA technique appears to be a feasible, safe and effective concept to avoid iatrogenic coronary artery obstruction during TAVI in both native and bioprosthetic valves of patients at high or prohibitive risk. ClinicalTrials.gov Identifier: NCT04227002 (Hamburg AoRtic Valve cOhoRt).

Keywords: BASILICA; Coronary obstruction; Transcatheter aortic valve implantation.

Conflict of interest statement

DW reports personal fees from AstraZeneca, Bayer, Berlin-Chemie and Novartis. SL reports non-financial support from Edwards Lifesciences. DK has received lecture fees and travel support from Abbott and lecture as well as proctor fees and travel support from Edwards Lifesciences. MS reports non-financial support from Abbott, Biotronik, Boehringer Ingelheim, Boston Scientific, Edwards Lifesciences, Nicolai Medizintechnik, OrbusNeich Medical, personal fees from Abiomed, Amgen, AstraZeneca, Bayer Healthcare, Bristol-Myers Squibb, Boston Scientific, Medtronic, Philips and Shockwave Medical and grants from Philips. NS reports personal fees from Boston Scientific and non-financial support from Abbott and Edwards Lifesciences. SB reports grants and personal fees from Abbott, Bayer and Thermo Fisher, grants from SIEMENS and Singulex, personal fees from Abbott, Astra Zeneca AMGEN, Medtronic, Pfizer, Roche, Novartis and Siemens Diagnostics. LC is proctor and consultant for Edwards Lifesciences and Boston Scientific and consultant for Medtronic and Abbott Vascular. JS reports lecture fees from Edwards Lifesciences, travel compensation from Boston Scientific and Edwards Lifesciences and is a proctor for Symetis SA and JenaValve. All other authors report no conflicts of interest.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study flowchart. AR aortic regurgitation, AS aortic stenosis, BASILICA bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction, CO coronary obstruction, SAVR surgical aortic valve replacement, SHV surgical heart valve, TAVI transcatheter aortic valve implantation, THV transcatheter heart valve, ViV valve-in-valve
Fig. 2
Fig. 2
Deficient Sinus. 3mensio Structural Heart V9.1, Pie Medical Imaging, Maastricht, Netherlands. A Deficient Sinus (pre-procedural CT). Deficient Sinus is defined by low coronary height and narrow sinus of Valsalva. Measurement (3.1 mm) indicates low left coronary artery height. Surgical valve leaflets have been drawn retrospectively. B Coronary obstruction in a patient with Deficient Sinus [pre-procedural CT with a virtually implanted THV (Evolut R, Medtronic)]. Following THV implantation, the surgical valve leaflet directly obstructs the complete sinus of Valsalva, including the LCA, inhibiting coronary blood flow. C Valve-to-coronary (VTC) distance (3D CT reconstruction). CT computed tomography, LCA left coronary artery, THV transcatheter heart valve, VTC valve-to-coronary distance
Fig. 3
Fig. 3
Sequestered Sinus. A Sequestered Sinus (pre-procedural CT). Sequestered Sinus is defined by low STJ height (indicated measurement, 10.5 mm) and narrow STJ diameter. Surgical valve leaflets have been drawn in retrospectively. B Coronary obstruction in a patient with Sequestered Sinus [pre-procedural CT with a virtually implanted THV (Evolut R, Medtronic)]. Following THV implantation the surgical valve leaflet indirectly inhibits blood flow to SOV and LCA by obstruction at the STJ. C Valve-to-sinotubular junction (VTSTJ) distance (3D CT reconstruction). CT computed tomography, LCA left coronary artery, SOV sinus of Valsalva, STJ sinotubular junction, THV transcatheter heart valve, VTSTJ valve-to-sinotubular junction
Fig. 4
Fig. 4
BASILICA (fluoroscopic images). A Catheter and wire setup before BASILICA. B Leaflet traversal into the snare. C Flying V configuration. D Result after successful leaflet laceration and THV implantation. BASILICA bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction, THV transcatheter heart valve
Fig. 5
Fig. 5
BASILICA failure. A Impenetrable calcified leaflet (Sorin Mitroflow surgical valve). B Wire-interference with a THV in mitral position (Sapien-in-MAC), Sorin Mitroflow aortic valve, pre-TAVI three-dimensional CT reconstruction. C pre-TAVI CT (see B). BASILICA bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction, CT computed tomography, MAC mitral annulus calcification, TAVI transcatheter aortic valve implantation, THV transcatheter heart valve
Fig. 6
Fig. 6
Chimney stenting. A Chimney stent implantation in left coronary artery after BASILICA failure (CoreValve Evolut R in Sorin Mitroflow), post-TAVI CT. B post-TAVI three-dimensional CT reconstruction (see A). BASILICA bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction, CT computed tomography, TAVI transcatheter aortic valve implantation
Fig. 7
Fig. 7
Successful BASILICA. A Confirmation of successful leaflet laceration by peri-procedural transesophageal echocardiography. B Lacerated leaflet (x) in a patient with Sequestered Sinus, post-TAVI CT. C Confirmation of lacerated leaflet (dashed line), post-TAVI three-dimensional CT reconstruction. D Post-TAVI CT in a patient with Sequestered Sinus (CoreValve Evolut R in Sorin Mitroflow) after BASILICA. BASILICA bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction, CT computed tomography, TAVI transcatheter aortic valve implantation

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