Dataset Information

Intentional Percutaneous Laceration of the Anterior Mitral Leaflet to Prevent Outflow Obstruction During Transcatheter Mitral Valve Replacement: First-in-Human Experience.

ABSTRACT: OBJECTIVES:This study sought to use a new catheter technique to split the anterior mitral valve leaflet (AML) and prevent iatrogenic left ventricular outflow tract (LVOT) obstruction immediately before transcatheter mitral valve replacement (TMVR). BACKGROUND:LVOT obstruction is a life-threatening complication of TMVR, caused by septal displacement of the AML. METHODS:The procedure was used in patients with severe mitral valve disease and prohibitive surgical risk. Patients either had prior surgical mitral valve ring (n = 3) or band annuloplasty (n = 1) or mitral annular calcification with stenosis (n = 1). Iatrogenic LVOT obstruction or transcatheter heart valve dysfunction was predicted in all based on echocardiography and computed tomography. Transfemoral coronary guiding catheters directed an electrified guidewire across the center and base of the AML toward a snare in the left atrium. The externalized guidewire loop was then electrified to lacerate the AML along the centerline from base to tip, sparing chordae, immediately before transseptal TMVR. RESULTS:Five patients with prohibitive risk of LVOT obstruction or transcatheter heart valve dysfunction from TMVR successfully underwent LAMPOON, with longitudinal splitting of the A2 scallop of the AML, before valve implantation. Multiplane computed tomography modeling predicted hemodynamic collapse from TMVR assuming an intact AML. However, critical LVOT gradients were not seen following LAMPOON and TMVR. Doppler blood flow was seen across transcatheter heart valve struts that encroached the LVOT, because the AML was split. Transcatheter heart valve function was unimpeded. CONCLUSIONS:This novel catheter technique, which resembles surgical chord-sparing AML resection, may enable TMVR in patients with prohibitive risk of LVOT obstruction or transcatheter heart valve dysfunction.

SUBMITTER: Babaliaros VC

PROVIDER: S-EPMC5579329 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Intentional Percutaneous Laceration of the Anterior Mitral Leaflet to Prevent Outflow Obstruction During Transcatheter Mitral Valve Replacement: First-in-Human Experience.

Babaliaros Vasilis C VC Greenbaum Adam B AB Khan Jaffar M JM Rogers Toby T Wang Dee Dee DD Eng Marvin H MH O'Neill William W WW Paone Gaetano G Thourani Vinod H VH Lerakis Stamatios S Kim Dennis W DW Chen Marcus Y MY Lederman Robert J RJ

JACC. Cardiovascular interventions 20170401 8

<h4>Objectives</h4>This study sought to use a new catheter technique to split the anterior mitral valve leaflet (AML) and prevent iatrogenic left ventricular outflow tract (LVOT) obstruction immediately before transcatheter mitral valve replacement (TMVR).<h4>Background</h4>LVOT obstruction is a life-threatening complication of TMVR, caused by septal displacement of the AML.<h4>Methods</h4>The procedure was used in patients with severe mitral valve disease and prohibitive surgical risk. Patients ...[more]

PMID: 28427597

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Project description:BackgroundLeft ventricular outflow tract (LVOT) obstruction is a leading cause of mortality and exclusion from transcatheter mitral valve replacement (TMVR). Intentional laceration of the anterior mitral valve leaflet to prevent LVOT obstruction (LAMPOON) is a transcatheter mimic of surgical chord-sparing leaflet resection.ObjectivesThe purpose of this prospective multicenter trial was to study LAMPOON with transseptal (Edwards Lifesciences, Irvine, California) TMVR in annuloplasty rings or native mitral annular calcification (MAC).MethodsSubjects at high or extreme surgical risk and prohibitive risk of LVOT obstruction from TMVR were included. Eligibility was modified midtrial to exclude subjects with threatened LVOT obstruction from a Sapien 3 valve fabric skirt. The primary endpoint was procedure survival with successful LAMPOON, with successful TMVR, without reintervention, and with LVOT gradient <30 mm Hg ("optimal") or <50 mm Hg ("acceptable"). Secondary endpoints included 30-day mortality and major adverse cardiovascular events. There was universal source-data verification and independent monitoring. All endpoints were independently adjudicated. Central laboratories analyzed echocardiogram and CT images.ResultsBetween June 2017 and June 2018, 30 subjects were enrolled equally between the MAC and ring arms. LAMPOON traversal and midline laceration was successful in 100%. Procedure survival was 100%, and 30-day survival was 93%. Primary success was achieved in 73%, driven by additional procedures for paravalvular leak (10%) and high-skirt neo-LVOT gradients observed before a protocol amendment. There were no strokes.ConclusionsLAMPOON was feasible in native and annuloplasty ring anatomies in patients who were otherwise ineligible for treatment, with acceptable safety. LAMPOON was effective in preventing LVOT obstruction from TMVR. Despite LAMPOON, TMVR using Sapien 3 in annuloplasty rings and MAC still exhibits important limitations. (NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation; NCT03015194).

Project description:ObjectivesThe aim of this study was to test the hypothesis that transcatheter electrosurgery might allow intentional detachment of previously placed MitraClip(s) from the anterior leaflet to recreate a single mitral orifice for transcatheter mitral valve implantation (TMVI), leaving the retained MitraClip(s) securely fastened to the posterior leaflet and without interfering with the mitral bioprosthesis.BackgroundPatients with severe mitral regurgitation or stenosis despite edge-to-edge mitral repair with the MitraClip typically have few therapeutic options because the resultant double orifice precludes TMVI. Transcatheter electrosurgery may allow detachment of failed MitraClip(s) from the anterior leaflet to recreate a single orifice for TMVI.MethodsThis was a single-center, 5-patient, consecutive, retrospective observational cohort. Patients underwent transcatheter electrosurgical laceration and stabilization of failed MitraClip(s) to recreate a single orifice, leaving the MitraClip(s) securely fastened to the posterior leaflet. Subsequently, patients underwent TMVI with an investigational device, the Tendyne mitral bioprosthesis, on a compassionate basis. Patients were followed up to 30 days.ResultsMitraClip detachment from the anterior leaflet and Tendyne implantation were successful in all patients. All patients survived to discharge. All patients were discharged with grade 0 central mitral regurgitation. Two patients had moderate perivalvular mitral regurgitation that did not require reintervention. During the follow-up period of 30 days, there were no deaths, cases of valve dysfunction, or reintervention. There was no evidence of erosion or bioprosthetic valve dysfunction attributable to the retained MitraClip(s) still attached to the posterior leaflet.ConclusionsTranscatheter electrosurgical detachment of failed MitraClips from the anterior leaflet followed by TMVI is technically feasible and safe at 30 days. Longer term study is needed to determine the clinical benefit of this approach and new algorithms for TMVI sizing following electrosurgical laceration and stabilization of a failed MitraClip to avoid perivalvular leak.

Dataset Information

Intentional Percutaneous Laceration of the Anterior Mitral Leaflet to Prevent Outflow Obstruction During Transcatheter Mitral Valve Replacement: First-in-Human Experience.

Publications

Intentional Percutaneous Laceration of the Anterior Mitral Leaflet to Prevent Outflow Obstruction During Transcatheter Mitral Valve Replacement: First-in-Human Experience.

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