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      Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement

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          <div class="section"> <a class="named-anchor" id="S1"> <!-- named anchor --> </a> <h5 class="section-title" id="d5693994e257">Background:</h5> <p id="P1">Coronary artery obstruction is a rare but fatal complication of transcatheter aortic valve replacement (TAVR). </p> </div><div class="section"> <a class="named-anchor" id="S2"> <!-- named anchor --> </a> <h5 class="section-title" id="d5693994e262">Objectives:</h5> <p id="P2">We developed a novel technique called BASILICA ( <span style="text-decoration: underline">B</span>ioprosthetic or native <span style="text-decoration: underline">A</span>ortic <span style="text-decoration: underline">S</span>callop <span style="text-decoration: underline">I</span>ntentional <span style="text-decoration: underline">L</span>aceration to prevent <span style="text-decoration: underline">C</span>oronary <span style="text-decoration: underline">A</span>rtery obstruction). </p> </div><div class="section"> <a class="named-anchor" id="S3"> <!-- named anchor --> </a> <h5 class="section-title" id="d5693994e289">Methods:</h5> <p id="P3">We lacerated pericardial leaflets <i>in vitro</i> using catheter electrosurgery, and tested leaflet splaying after benchtop TAVR. The procedure was tested in swine. BASILICA was then offered to patients at high risk of coronary obstruction from TAVR and ineligible for surgical aortic valve replacement. BASILICA used marketed devices. Catheters directed an electrified guidewire to traverse and lacerate the aortic leaflet down the centreline. TAVR was performed as usual. </p> </div><div class="section"> <a class="named-anchor" id="S4"> <!-- named anchor --> </a> <h5 class="section-title" id="d5693994e297">Results:</h5> <p id="P4">TAVR splayed lacerated bovine pericardial leaflets.</p> <p id="P5">BASILICA was successful in pigs, both to left and right cusps. Necropsy revealed full length lacerations with no collateral thermal injury. Seven patients underwent BASILICA on a compassionate basis. Six had failed bioprosthetic valves, both stented and stent-less. Two had severe aortic stenosis, including one patient with native disease, three had severe aortic regurgitation, and two had mixed aortic valve disease. One patient required laceration of both left and right coronary cusps. There was no hemodynamic compromise in any patient following BASILICA. All patients had successful TAVR, with no coronary obstruction, stroke, or any major complications. All patients survived to 30 days. </p> </div><div class="section"> <a class="named-anchor" id="S5"> <!-- named anchor --> </a> <h5 class="section-title" id="d5693994e304">Conclusions:</h5> <p id="P6">BASILICA may durably prevent coronary obstruction from TAVR. The procedure was successful across a range of presentations, and requires further evaluation in a prospective trial. Its role in treatment of degenerated TAVR devices remains untested. </p> </div><p id="P7"> <div class="figure-container so-text-align-c"> <img alt="" class="figure" src="/document_file/10c00220-7ebd-4507-a644-9da835883c84/PubMedCentral/image/nihms-949385-f0010.jpg"/> </div> </p><p id="P8">Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) is a technique to prevent coronary artery obstruction complicating transcatheter aortic valve replacement (TAVR). BASILICA uses catheter electrosurgery to split aortic valve leaflets lengthwise immediately prior to TAVR. We describe the technique on the benchtop and in animals. We also report the first-in-human application in seven patients, including both aortic stenosis and regurgitation, in both bioprosthetic and native aortic valves. All patients had high predicted risk of coronary artery obstruction. All patients had successful BASILICA and TAVR, with no coronary obstruction, stroke or 30-day mortality. </p>

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          Author and article information

          JACC: Cardiovascular Interventions
          JACC: Cardiovascular Interventions
          Elsevier BV
          April 2018
          April 2018
          : 11
          : 7
          : 677-689
          © 2018


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