Background Clinical trials have demonstrated that second-generation cobalt-chromium everolimus-eluting stent (CoCr-EES) is superior to first-generation paclitaxel-eluting stent (PES) and is non-inferior or superior to sirolimus-eluting stent (SES) in terms of safety and efficacy. It remains unclear whether vascular responses to CoCr-EES are different from SES and PES, since the pathology of CoCr-EES has not been described in humans. Methods and Results A total of 204 lesions (SES=73, PES=85, CoCr-EES=46) from 149 autopsy cases with duration of implant >30 days and ≤3 years were pathologically analyzed, where comparison of vascular responses was corrected for duration of implant. The observed frequency of late and very late stent thrombosis (LST/VLST) was less in CoCr-EES (4%) versus SES (21%, p=0.029) and PES (26%, p=0.008). Neointimal thickness was comparable among the groups, while the percent uncovered struts was strikingly lower in CoCr-EES (median=2.6%) versus SES (18.0%, p≤0.0005) and PES (18.7%, p<0.0005). CoCr-EES showed less inflammation score (with no hypersensitivity) and less fibrin deposition versus SES and PES. The observed frequency of neoatherosclerosis, however, did not differ significantly among the groups (CoCr-EES=29%, SES=35%, PES=19%). CoCr-EES had the least frequency of stent fracture (CoCr-EES=13%, SES=40%, PES=19%; p=0.007 for CoCr-EES versus SES), whereas fracture-related restenosis or thrombosis was comparable among the groups (CoCr-EES=6.5%, SES=5.5%, PES=1.2%). Conclusions CoCr-EES demonstrated greater strut coverage with less inflammation, less fibrin deposition, and less LST/VLST as compared to SES and PES in human autopsy analysis. Nevertheless, the observed frequencies of neoatherosclerosis and fracture-related adverse pathologic events were comparable in these devices, indicating that careful long-term follow-up remains important even after CoCr-EES placement.
BACKGROUND Left 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. OBJECTIVES The 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). METHODS Subjects 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. RESULTS Between 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. CONCLUSIONS LAMPOON 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)
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