Ischemic septal rupture producing an acquired ventricular septal defect (VSD) is a catastrophic complication of acute myocardial infarction. Acute therapeutic options are often futile because the tear in the septum is complex with surrounding edematous and necrotic tissue that evolves over several weeks following infarction. Concomitant left ventricular (LV) and/or right ventricular (RV) dysfunction limit effective surgical repair mostly to survivors of natural selection. “Dedicated” endovascular devices are best suited for the minority of patients with thin septums and small, circular defects during the chronic phase of post-infarct VSD1. In other VSD anatomies, commercially available devices are too rigid to deliver, have an outward force that expands already necrotic defects and are highly permeable, failing to occlude high-flow defects. There is a need for better therapy.
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Matthew C. L. Keith;
Xian-Liang Tang;
Yukichi Tokita;
Qian-hong Li;
Shahab Ghafghazi;
Joseph Moore;
Kyung U. Hong;
Brandon Elmore;
Alok Amraotkar;
Brian L. Ganzel;
Kendra Grubb;
Michael P. Flaherty;
Gregory Hunt;
Bathri Vajravelu;
Marcin Wysoczynski;
Roberto Bolli
Background: There is mounting interest in using c-kit positive human cardiac stem cells (c-kit<sup>pos</sup> hCSCs) to repair infarcted myocardium in patients with ischemic cardiomyopathy. A recent phase I clinical trial (SCIPIO) has shown that intracoronary infusion of 1 million hCSCs is safe. Higher doses of CSCs may provide superior reparative ability; however, it is unknown if doses >1 million cells are safe. To address this issue, we examined the effects of 20 million hCSCs in pigs. Methods: Right atrial appendage samples were obtained from patients undergoing cardiac surgery. The tissue was processed by an established protocol with eventual immunomagnetic sorting to obtain in vitro expanded hCSCs. A cumulative dose of 20 million cells was given intracoronarily to pigs without stop flow. Safety was assessed by measurement of serial biomarkers (cardiac: troponin I and CK-MB, renal: creatinine and BUN, and hepatic: AST, ALT, and alkaline phosphatase) and echocardiography pre- and post-infusion. hCSC retention 30 days after infusion was quantified by PCR for human genomic DNA. All personnel were blinded as to group assignment. Results: Compared with vehicle-treated controls (n=5), pigs that received 20 million hCSCs (n=9) showed no significant change in cardiac function or end organ damage (assessed by organ specific biomarkers) that could be attributed to hCSCs (P>0.05 in all cases). No hCSCs could be detected in left ventricular samples 30 days after infusion. Conclusions: Intracoronary infusion of 20 million c-kit positive hCSCs in pigs (equivalent to ∼40 million hCSCs in humans) does not cause acute cardiac injury, impairment of cardiac function, or liver and renal injury. These results have immediate translational value and lay the groundwork for using doses of CSCs >1 million in future clinical trials. Further studies are needed to ascertain whether administration of >1 million hCSCs is associated with greater efficacy in patients with ischemic cardiomyopathy.
Background: Myxomas account for approximately half of all primary cardiac neoplasms. Most occur in the left atrium and only rarely are attached to the mitral valve, with just over 30 such cases reported in the literature. These neoplasms can manifest with a combination of obstruction of blood flow, systemic embolization, and constitutional symptoms. Case Description: We present a case of a 32-year-old African American man presenting at an emergency department with symptoms of a transient ischemic attack. Transesophageal echocardiography identified a mass originating from the posterior leaflet of the mitral valve. The mass was surgically resected and histologically classified as a myxoma. He remained asymptomatic during the course of 5-year surveillance. Conclusions: Few similar cases have been described in the literature. Here we present a review of the diagnosis and surgical management of this rare presentation for mitral valve myxoma.
Coronary obstruction remains a pernicious complication of transcatheter aortic valve replacement (TAVR). It is caused by outward displacement of a valve leaflet, directly blocking the coronary ostium or sealing the coronary sinus. Bioprosthetic or native aortic leaflet intentional laceration to prevent coronary artery obstruction (BASILICA) creates a slit lesion along the midline of the aortic leaflet, which splays after TAVR, allowing coronary perfusion. Despite successful BASILICA, a small fraction of patients experience some degree of obstruction, such as from a prolapsing leaflet. We developed a leaflet removal technique (CATHeter Electrosurgical Debulking and RemovAL [CATHEDRAL]; Video 1) to treat such patients and herein report the first application.
BACKGROUND: Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) and laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON) reduce the risk of coronary and left ventricular outflow obstruction obstruction during transcatheter aortic valve replacement and transcatheter mitral valve replacement. Despite successful laceration, BASILICA or LAMPOON may fail to prevent obstruction caused by inadequate leaflet splay in patients having challenging anatomy such as very small valve-to-coronary distance, diffusely calcified, rigid leaflets, or undergoing transcatheter aortic valve replacement inside existing transcatheter aortic valve replacement. We describe a novel technique of balloon-augmented (BA) leaflet laceration to enhance leaflet splay. METHODS: We measured the incremental leaflet splay from BA-BASILICA in vitro. From November 2019 to March 2021, 16 patients underwent BA-BASILICA and 4 BA-LAMPOON at 3 centers. RESULTS: BA-BASILICA increased benchtop leaflet tip splay 17%, maximum splay angle 30%, and splay area 23%, resulting in a more rounded apex and larger effective area. Sixteen patients at risk for inadequate BASILICA leaflet splay, including 4 transcatheter aortic valve replacement inside existing transcatheter aortic valve replacement, underwent BA-BASILICA. All had successful leaflet laceration. One had coronary obstruction requiring immediate orthotopic stenting. Two underwent elective orthotopic coronary stenting through the transcatheter valve cells for leaflet prolapse without coronary ischemia. There were no deaths during the procedure or at 30 days. Four patients at risk for inadequate anterior mitral leaflet splay underwent BA-LAMPOON. All had successful target leaflet laceration without left ventricular outflow obstruction obstruction or procedural death. One died within 30 days. CONCLUSIONS: BA leaflet laceration enhances leaflet splay in vitro and may allow transcatheter aortic valve replacement and transcatheter mitral valve replacement in patients otherwise ineligible for traditional BASILICA or LAMPOON due to challenging anatomy. Graphic Abstract: A graphic abstract is available for this article.
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John C Lisko;
Vasilis Babaliaros;
Jaffar M Khan;
Norihiko Kamioka;
Patrick Gleason;
Gaetano Paone;
Isida Byku;
Jasleen Tiwana;
James M McCabe;
Krishna Cherukuri;
Ramzi Khalil;
David Lasorda;
Sachin S Goel;
Neal S Kleiman;
Michael J Reardon;
David V Daniels;
Christian Spies;
Paul Mahoney;
Brian C Case;
Brian K Whisenant;
Pradeep K Yadav;
Jose F Condado;
Rachel Koch;
Kendra Grubb;
Christopher G Bruce;
Toby Rogers;
Robert Lederman;
Adam Greenbaum
Objectives: The purpose of this study was to evaluate tip-to-base intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) in patients undergoing transcatheter mitral valve replacement (TMVR) in annuloplasty rings or surgical mitral valves. Background: LAMPOON is an effective adjunct to TMVR that prevents left ventricular outflow tract obstruction (LVOTO). Laceration is typically performed from the base to the tip of the anterior mitral leaflet. A modified laceration technique from leaflet tip to base may be effective in patients with a prosthesis that protects the aortomitral curtain. Methods: This is a multicenter, 21-patient, consecutive retrospective observational cohort. Patients underwent tip-to-base LAMPOON to prevent LVOTO and leaflet overhang, or therapeutically to lacerate a long anterior mitral leaflet risking or causing LVOTO. Outcomes were compared with findings from patients in the LAMPOON investigational device exemption trial with a prior mitral annuloplasty. Results: Twenty-one patients with a annuloplasty or valve prosthesis–protected mitral annulus underwent tip-to-base LAMPOON (19 preventive, 2 rescue). Leaflet laceration was successful in all and successfully prevented or treated LVOTO in all patients. No patients had significant LVOTO upon discharge. There were 2 cases of unintentional aortic valve injury (1 patient underwent emergency transcatheter aortic valve replacement and 1 patient underwent urgent surgical aortic valve replacement). In both cases, the patients had a supra-annular ring annuloplasty, and the retrograde aortic guiding catheter failed to insulate the guidewire lacerating surface from the aortic root. All patients survived to 30 days. Compared with classic retrograde LAMPOON, there was a trend toward shorter procedure time. Conclusions: Tip-to-base laceration is a simple, effective, and safe LAMPOON variant applicable to patients with an appropriately positioned mitral annular ring or bioprosthetic valve. Operators should take care to insulate the lacerating surface from adjacent structures.
The use of bioprosthetic prostheses during surgical aortic valve replacements has increased dramatically over the last two decades, accounting for over 85% of surgical implantations. Given limited long-term durability, there has been an increase in aortic valve reoperations and reinterventions. With the advent of new technologies, multiple treatment strategies are available to treat bioprosthetic valve failure, including valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR). However, ViV TAVR has an increased risk of higher gradients and patient prosthesis mismatch (PPM) secondary to placing the new valve within the rigid frame of the prior valve, especially in patients with a small surgical bioprosthesis in situ. Bioprosthetic valve fracture allows for placement of a larger transcatheter valve, as well as a fully expanded transcatheter valve, decreasing postoperative gradients and the risk of PPM.
Background: Intentional laceration of the anterior mitral leaflet (LAMPOON) is an effective adjunct to transcatheter mitral valve replacement that prevents left ventricular outflow tract (LVOT) obstruction. To date, LAMPOON has been performed in over 150 patients using a retrograde approach that can be technically challenging. A modified antegrade transseptal technique may simplify the procedure. Methods: Antegrade LAMPOON was developed and tested in nonsurvival pig experiments. Thereafter, antegrade LAMPOON was performed in patients at prohibitive risk of LVOT obstruction. Clinical, procedural, and angiographic details were abstracted from medical records of their index procedure, and were compared with findings in comparable patients at risk of fixed-LVOT obstruction in the LAMPOON investigational device exemption trial. Results: Eight patients at risk of fixed LVOT obstruction underwent antegrade LAMPOON. Leaflet traversal and laceration were technically successful in all. There were no cases of clinically significant LVOT obstruction (mean LVOT gradient at discharge: 5.4±1.4 mm Hg). One patient suffered a ventricular wire perforation, unrelated to the antegrade LAMPOON technique, and did not survive to discharge. At the time of discharge, no patients had an increase of >10 mm Hg in LVOT gradient compared with baseline. Procedure times (from traversal to transcatheter mitral valve replacement) were shorter, compared with the retrograde technique in the LAMPOON investigational device exemption trial (39±09 versus 65±35 minutes). All patients survived (8/8, 100%) the procedure, and 7/8 (88%) survived to 30 days, similar to subjects in the LAMPOON investigational device exemption trial. Conclusions: Antegrade LAMPOON is an effective, reproducible, and simplified strategy to lacerate the anterior leaflet before transcatheter mitral valve replacement. The authors recommend the technique as the new standard for LAMPOON.
OBJECTIVES
The 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.
BACKGROUND
Patients 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.
METHODS
This 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.
RESULTS
MitraClip 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.
CONCLUSIONS
Transcatheter 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.
Paravalvular leak (PVL) remains a key limitation of transseptal transcatheter mitral valve replacement (TMVR) using the SAPIEN 3 valve (Edwards Lifesciences, Irvine, California), especially in prior surgical rings (VIR) or mitral annular calcification (VIM) (1,2). PVL often results from valve malalignment and imperfect implantation depth that allow leakage around the fabric skirt. Valve alignment is determined mainly by the position of the rigid delivery guidewire in the left ventricular (LV) apex.