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All bioprosthetic valves, both surgical and transcatheter, have a finite lifespan before their leaflets inevitably degenerate, leading to stenosis or regurgitation. As younger, low-risk patients receive a transcatheter aortic valve, it is expected that they will most likely outlive their bioprosthetic valve. The heterogeneity of studies regarding surgical valve durability makes the interpretation of the data challenging. Leaflet thickening is seen in transcatheter heart valves but currently there is no evidence that it leads to premature valve deterioration or clinical events. Standardized definitions of structural valve deterioration should allow for comparisons between future clinical trials to assess the durability of different transcatheter heart valves.

The SAPIEN 3 is the only transcatheter heart valve commercially available for compassionate transcatheter mitral valve replacement in patients with previous mitral surgical rings and mitral annular calcification (valve in ring [VIR] and valve in mitral annular calcification [VIM]). Reported outcomes have been inconsistent or poor. The review provides an overview of the authors' approach to achieve largely consistent results despite the intrinsic limitations of SAPIEN 3 VIM and VIR. The approach includes bedside modifications of the valve implant, the delivery system, and of the cardiac substrate itself. Until purpose-built devices are readily available, VIR and VIM procedures will require aggressive multidisciplinary cooperation, meticulous planning and execution, and postprocedure management by experienced, high-volume operators.

Coronary artery obstruction is a devastating complication of transcatheter aortic valve replacement (TAVR). Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery Obstruction (BASILICA) is a transcatheter, electrosurgical technique that was developed to prevent obstruction due to sinus effacement or sinus sequestration. BASILICA creates a midline laceration of one (solo) or both (doppio) offending aortic leaflets and has been performed in over 1,000 patients at high risk for obstruction. The procedure has been studied in the prospective BASILICA IDE Trial and data from the International BASILICA Registry of 214 patients supports efficacy and safety; procedural success was achieved in 94.4% and at thirty days 95.3% were free from culprit coronary artery obstruction, all-cause mortality was 2.8% and disabling stroke was reported in only 0.5%. In this review we discuss screening for patients at high risk for coronary artery obstruction, technical details related to performing the BASILICA procedure and how to troubleshoot a BASILICA procedure.

Transcatheter aortic valve replacement (TAVR) is approved for all patient risk profiles and is an option for all patients irrespective of age. However, patients enrolled in the low- and intermediate-risk trials were in their 70s, and those in the high-risk trials were in their 80s. TAVR has never been systematically tested in young (

Background/purpose The MANTA vascular closure device (VCD) is the first commercially available dedicated closure device for large-bore femoral arterial access-site closure and was approved by the United States Food and Drug Administration (FDA) in February 2019. Real-world data on the most commonly reported complications and modes of failure associated with the MANTA closure device are limited. We analyzed post-marketing surveillance data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database for the MANTA VCD (Teleflex, Wayne, Pennsylvania). Methods/materials Post-marketing surveillance data from the FDA MAUDE database from February 2019 through March 2020 were analyzed, yielding 170 reports. Results Of the 170 reports of major complications involving MANTA devices, 141 reports involved either injury (136) or death (5) related to the device. Of the 141 reports, bleeding was the most common adverse outcome described (45), followed by vessel occlusion (30) and vessel dissection (21). Device malfunction incidents (29 reports) were reported in 4 main categories: failed deployment (16 reports), malposition of the collagen (9), insufficient information (3), and device dislocation (1). Conclusions Our analysis of the MAUDE database demonstrates that in real-world practice, the MANTA VCD was found to be associated with complications, including death, vascular injury , and difficulties with the device itself. Ongoing user education, proctoring, and pre-procedural patient selection are important to minimize risks associated with the MANTA VCD.

Objectives This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure. Background Transcatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking. Methods The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events. Results Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection. Conclusions BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction.

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 distinguishing proof of online networking networks has as of late been of significant worry, since clients taking an interest in such networks can add to viral showcasing efforts. Right now center around clients' correspondence considering character as a key trademark for recognizing informative systems for example systems with high data streams. We portray the Twitter Personality based Communicative Communities Extraction (T-PCCE) framework that recognizes the most informative networks in a Twitter organize chart thinking about clients' character. We at that point grow existing methodologies as a part of client’s character extraction by collecting information that speak to a few parts of client conduct utilizing AI strategies. We utilize a current measured quality based network discovery calculation and we expand it by embeddings a post-preparing step that dispenses with diagram edges dependent on clients' character. The adequacy of our methodology is exhibited by testing the Twitter diagram and looking at the correspondence quality of the removed networks with and without considering the character factor. We characterize a few measurements to tally the quality of correspondence inside every network. Our algorithmic system and the resulting usage utilize the cloud foundation and utilize the MapReduce Programming Environment. Our outcomes show that the T-PCCE framework makes the most informative networks.

Transcatheter mitral valve replacement (TMVR) is an emerging therapy for patients with severe mitral valve disease considered unsuitable for conventional surgery. Pre-procedural planning is paramou...

BASILICA (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction) is an emerging technique to avoid coronary obstruction during transcatheter aortic valve replacement (TAVR) ([1][1]). Although fluoroscopic visualization during BASILICA is

Patients undergoing percutaneous coronary intervention (PCI) often have high-bleeding-risk (HBR) factors. Dual antiplatelet therapy (DAPT) further increases this risk of bleeding. We sought to compare clinical outcomes according to presence or absence of HBR factors in patients with elevated ischemic risk (DAPT score ≥ 2) undergoing PCI. We evaluated all patients undergoing PCI at MedStar Washington Hospital Center (January 2009 to July 2018) with DAPT score ≥2, which is associated with elevated risk of ischemic events. Patients were categorized as HBR group (HBR score ≥1) or low-bleeding-risk (LBR) group (HBR score = 0). Outcomes included major adverse cardiac events such as target vessel revascularization, stent thrombosis, death, and bleeding events at 30 days, 6 months, 1 year, and 2 years. The final cohort consisted of 7,499 patients: 3,949 patients had LBR features, and 3,550 patients had HBR features. The 2 groups were different at baseline, with HBR patients being older and having a higher prevalence of congestive heart failure and renal dysfunction than the LBR group. The mean DAPT score was 2.96±1.1 for the LBR group and 3.7±1.4 for the HBR group (p0.001). During follow-up at 30 days, 6 months, and 1 and 2 years, the rates of target vessel revascularization and stent thrombosis were not significantly different between the 2 groups. Bleeding events and all-cause mortality were significantly more frequent in the HBR group than in the LBR group. In conclusion, patients undergoing PCI often have pre-existing risk factors that predispose them to ischemic and bleeding complications. Prolonged duration of DAPT to mitigate ischemic events could lead to a disproportionate increase in bleeding events, especially in HBR patients.

Transcatheter electrosurgery refers to a family of procedures using radiofrequency energy to vaporize and traverse or lacerate tissue despite flowing blood. The authors review theory, simulations, and benchtop demonstrations of how guidewires, insulation, adjunctive catheters, and dielectric medium interact. For tissue traversal, all but the tip of traversing guidewires is insulated to concentrate current. For leaflet laceration, the "Flying V" configuration concentrates current at the inner lacerating surface of a kinked guidewire. Flooding the field with non-ionic dextrose eliminates alternative current paths. Clinical applications include traversing occlusions (pulmonary atresia, arterial and venous occlusion, and iatrogenic graft occlusion), traversing tissue planes (atrial and ventricular septal puncture, radiofrequency valve repair, transcaval access, Potts and Glenn shunts), and leaflet laceration (BASILICA, LAMPOON, ELASTA-Clip, and others). Tips are provided for optimizing these techniques. Transcatheter electrosurgery already enables a range of novel therapeutic procedures for structural heart disease, and represents a promising advance toward transcatheter surgery.

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.

An 84-year-old woman with a history of a 29-mm bioprosthetic Mosaic (Medtronic, Minneapolis, Minnesota) mitral valve replacement presented with heart failure. Transesophageal echocardiography (TEE) demonstrated severe regurgitation ([Figure 1A][1]) from torn prosthetic leaflets ([Figure 1B][1]).

Coronary artery obstruction complicates transcatheter aortic valve replacement (TAVR), with an incidence lower than 1% but higher in certain subgroups ([1][1]). Patients requiring TAVR for failing transcatheter aortic valves (TAVR-in-TAVR) may be at the highest risk because of the reduced neosinus

Objectives This study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD). Background Transcaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol cardiac occluders has been shown to be safe, but persistent aortocaval fistulae at exit from the catheterization lab and bleeding complications were common in a prospective study. Methods Preclinical testing of the TCD was performed in 24 Yorkshire swine, including 10 under good laboratory practice conditions. Subsequently, subjects undergoing transcatheter aortic valve replacement for symptomatic severe aortic stenosis, ineligible for transfemoral arterial access, were enrolled in a U.S. Food and Drug Administration–approved early feasibility study of the TCD (Transmural Systems, Andover, Massachusetts). Independently adjudicated endpoints included technical, device, and procedural success, incorporating in-hospital and 30-day clinical and imaging follow-up. Results Transcaval access and closure in swine confirmed that at 30 days, TCDs were almost entirely endothelialized. Subsequently, 12 subjects were enrolled in the early feasibility study. Transcaval access, transcatheter aortic valve replacement, and aortocaval fistula closure was successful in all 12 subjects. The primary endpoint of technical success was met in 100% of subjects. Complete closure of the transcaval access tract was achieved in 75% of subjects at exit from the catheterization lab and in 100% of subjects at 30 days. There were zero modified Valve Academic Research Consortium-2 major vascular complications and zero Valve Academic Research Consortium-2 life-threatening or major bleeding complications related to transcaval access or the TCD. Conclusions The TCD achieved complete closure of the transcaval access tract in most subjects at exit from the catheterization lab and essentially eliminated transcaval-related bleeding. Dedicated devices for transcaval access and closure could enable more widespread adoption of transcaval techniques without fear of bleeding complications. (Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement; NCT03432494).

Percutaneous coronary intervention (PCI) has evolved dramatically, along with patient complexity. We studied trends in in-hospital mortality with changes in patient complexity over the last decade stratified by clinical presentation. The study population included all patients presenting to the cardiac catheterization lab between January 2009 and July 2018. Expected in-hospital mortality was calculated using the National Cardiovascular Data Registry CathPCI risk scoring system. Yearly mean in-hospital mortality rates (%) were plotted and smoothed by weighted least squares regression for each presentation: ST-elevation myocardial infarction (STEMI), non-ST-elevation acute coronary syndrome (NSTE-ACS), and stable ischemic coronary artery disease (SI CAD). The overall cohort included 13,732 patients who underwent PCI during the study period, of whom 2,142 were for STEMI, 2,836 for NSTE-ACS, and 8,754 for SI CAD. Indications for PCI have changed over time, with more PCIs being performed for NSTE-ACS and STEMI than for SI CAD. NSTE-ACS and STEMI patients had a steady decrease in in-hospital mortality over time compared with SI CAD patients. Overall observed mortality continues to decrease in NSTE-ACS patients, with reduction in the observed mortality rate within the STEMI population to below expected since 2013. Patient complexity has not changed significantly. These results may be attributed to improved patient selection coupled with optimal pharmacotherapy with more robust therapies during procedure and hospitalization.

OBJECTIVES: To test custom-shape guiding catheter curves intended to simplify aortic valve leaflet laceration. BACKGROUND: Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) is an adjunct to transcatheter aortic valve replacement. It can be technically demanding using popular coronary guiding catheters and catheter-in-guide coaxial systems. New elephant-trunk shaped Pachyderm Left (PAL1,PAL2,PAL3, Launcher, Medtronic) and Right (PJR4) guiding catheters match the geometric requirements to engage aortic cusp hinge points. We evaluate whether these catheters ease BASILICA compared with conventional-shape coronary guiding catheters used in the BASILICA IDE trial. METHODS: This is a single-center, consecutive, retrospective observational cohort of patients who underwent BASILICA for risk of TAVR-induced coronary obstruction defined as virtual valve-to-coronary distance < 4mm, immediately upon commercial availability of the new Pachyderm shaped catheters. Clinical, procedural, and angiographic details were abstracted from medical records of their index procedure, and were compared to adjudicated findings in the BASILICA IDE trial. RESULTS: Nine leaflets in 6 patients were traversed and lacerated using BASILICA and Pachyderm curve guiding catheters for traversal, including three solo left and three doppio left and right leaflets. Leaflet traversal was universally successful. Leaflet time-to-leaflet traversal was shorter using Pachyderm catheters compared with the BASILICA IDE trial (8.3 min (5.6 – 15) vs 45 min (20, 61), p=0.016). There were no deaths, strokes, or vascular complications. CONCLUSIONS: The new Pachyderm shaped guiding catheters significantly hastened the leaflet time-to-traversal during BASILICA TAVR. We recommend they be used instead of conventional coronary-shaped guiding catheters.

An increasing number of surgically implanted bioprostheses will require re-intervention for structural valve deterioration. Valve-in-valve transcatheter aortic valve replacement (ViV TAVR) has become an alternative to reoperative surgery, currently approved for high-risk and inoperable patients. Challenges to the technique include higher rates of prosthesis–patient mismatch and coronary obstruction, compared to native valve TAVR. Herein, we review results of ViV TAVR and novel techniques to overcome the aforementioned challenges.

Highlights •CT is sensitive but nonspecific to identify risk for TAVR-induced coronary obstruction. •BASILICA may prevent coronary obstruction in cases of native and valve-in-valve TAVR. •BASILICA is applicable to sinus sequestration and deficient-sinus mechanisms. •BASILICA is complex with available equipment, but dedicated equipment may simplify it.

Transcatheter mitral valve replacement (TMVR) is a promising strategy for patients with mitral valve disease and no surgical options. Left ventricular outflow tract (LVOT) obstruction is a life-threatening complication of TMVR. Although there are no commercially available devices to prevent LVOT obstruction, the risk of it can be reduced by careful preprocedure planning and the use of novel modifications to commercially available devices. This article summarizes current techniques to prevent LVOT obstruction with an emphasis on electrosurgical strategies.

Background/purpose Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality used to assess coronary arteries and as an adjunctive tool for optimization of percutaneous coronary interventions. Overall, the rate of complications and adverse events related to intravascular imaging is low. Limited data exist on the most commonly reported complications and modes of failure related to the use of OCT. Therefore, we analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess the reported complications and failure modes for OCT and reviewed techniques to optimize device use. Methods/materials The MAUDE database was queried for all event reports involving coronary OCT devices. Two independent reviewers identified 49 device reports included in the final analysis. Modes of failure and device-related patient complications were assessed. Results Of the 49 cases with reported device-related issues, 6.1% involved malfunction prior to insertion of the OCT catheter, and 30.6% of reported events did not result in an associated patient-related adverse event. The most commonly reported adverse events included coronary dissection and difficulty removing the catheter within a previously stented segment. No events of contrast-induced nephropathy were reported. Conclusions Findings from the MAUDE database highlight the modes of device-related events associated with OCT. Device issues are uncommon, and as a result, users should be aware of optimal techniques to prevent and minimize adverse events related to device use.

Background/purpose Right ventricular (RV) mechanical circulatory support remains an important adjunctive therapy for RV failure refractory to medical therapy. Impella RP (Abiomed, Danvers, MA) is approved for providing temporary RV support for patients with acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Robust data on the most commonly reported complications and failure modes for the Impella RP are lacking. We analyzed the post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to assess these endpoints. Materials/methods The MAUDE database was queried for the time period January 1, 2009, through December 31, 2018, for Impella devices by Searching for the following event types: “injury”, “malfunction”, “death”, and “other”. The search yielded 436 device reports. Impella RP medical device reports were screened, and 35 reports were included for the final analysis. Results In cases of reported complications, Impella RP was placed most commonly for right ventricular failure (RVF) developing in postcardiotomy patients (20%). The most commonly reported complications included bleeding (42.9%) and vascular complications (22.8%). The modes of failure included damage or fracture of the device elements (34.2%); thrombus, or clot in the system (17.1%); and device detachment (8.6%). Conclusions Findings from the MAUDE database highlight the failure modes of the Impella RP device that should be addressed in order to improve the device performance and obtain improved clinical outcomes when utilized for RVF.

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

Objectives The authors investigated 1-year outcomes after transcaval access and closure for transcatheter aortic valve replacement (TAVR), using commercially available nitinol cardiac occluders off-label. Background Transcaval access is a fully percutaneous nonfemoral artery route for TAVR. The intermediate-term fate of transcaval access tracts is not known. Methods The authors performed a prospective, multicenter, independently adjudicated trial of transcaval access, using Amplatzer nitinol cardiac occluders (Abbott Vascular, Minneapolis, Minnesota), among subjects without traditional transthoracic (transapical or transaortic) access options. One-year clinical follow-up included core laboratory analysis of serial abdominal computed tomography (CT). Results 100 subjects were enrolled. Twelve-month mortality was 29%. After discharge, there were no vascular complications of transcaval access. Among 83 evaluable CT scans after 12 months, 77 of fistulas (93%) were proven occluded, and only 1 was proven patent. Fistula patency was not associated with overall survival (p = 0.37), nor with heart failure admissions (15% if patent vs. 23% if occluded; p = 0.30). There were no cases of occluder fracture or migration or visceral injury. Conclusions Results are reassuring 1 year after transcaval TAVR and closure using permeable nitinol occluders off-label. There were no late major vascular complications. CT demonstrated spontaneous closure of almost all fistulas. Results may be different in a lower-risk cohort, with increased operator experience, and using a dedicated transcaval closure device. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824)

Aims To characterize the dynamic nature of the left ventricular outflow tract (LVOT) geometry and flow rate in patients following transcatheter mitral valve replacement (TMVR) with anterior leaflet laceration (LAMPOON) and derive insights to help guide future patient selection. Methods and results Time-resolved LVOT geometry and haemodynamics were analysed with post-procedure computed tomography and echocardiography in subjects (N = 19) from the LAMPOON investigational device exemption trial. A novel post hoc definition for LVOT obstruction was employed to account for systolic flow rate and quality of life improvement [obstruction was defined as LVOT gradient >30 mmHg or LVOT effective orifice area (EOA) ≤1.15 cm2]. The neo-LVOT and skirt neo-LVOT were observed to vary substantially in area throughout systole (64 ± 27% and 25 ± 14% change in area, respectively). The peak systolic flow rate occurred most commonly just prior to mid-systole, while minimum neo-LVOT (and skirt neo-LVOT) area occurred most commonly in early-diastole. Subjects with LVOT obstruction (n = 5) had smaller skirt neo-LVOT values across systole. Optimal thresholds for skirt neo-LVOT area were phase-specific (260, 210, 200, and 180 mm2 for early-systole, peak flow, mid-systole, and end-systole, respectively). Conclusion The LVOT geometry and flow rate exhibit dynamic characteristics following TMVR with LAMPOON. Subjects with LVOT obstruction had smaller skirt neo-LVOT areas across systole. The authors recommend the use of phase-specific threshold values for skirt neo-LVOT area to guide future patient selection for this procedure. LVOT EOA is a ‘flow-independent’ metric which has the potential to aid in characterizing LVOT obstruction severity.

Background: Coronary artery obstruction is a rare, devastating complication of transcatheter aortic valve replacement. Transcatheter electrosurgical aortic leaflet laceration (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction [BASILICA]) is a novel technique to prevent coronary artery obstruction. We report the 1-year outcomes of the BASILICA trial. Primary end points of 30-day success and safety have been reported previously. Methods: The BASILICA trial was a prospective, multicenter, single-arm safety and feasibility study. Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and high risk of coronary artery obstruction, were included. End points at 1 year included death, stroke, and myocardial infarction. Source data was independently verified and end points independently adjudicated. Results: Thirty subjects were enrolled between February 2018 and July 2018. At 30 days, BASILICA was successful in 28 subjects (93.3%), there were 3 strokes (10%), including 1 disabling stroke (3.3%), 1 death (3.3%), and 1 periprocedural myocardial infarction (3.3%). Between 30 days and 1 year, there were no additional strokes, no myocardial infarction, and 2 deaths (10% 1-year mortality). No subject needed repeat intervention for aortic valve or coronary disease. Two subjects had infective endocarditis (6.7%), but neither was isolated to the aortic valve. There were no hospital admissions for heart failure. Fourteen (46.7%) subjects required repeat hospital admission for other causes. Aortic valve gradients on echocardiography, New York Heart Association functional class, and Kansas City Cardiomyopathy Questionnaire scores improved from baseline to 30 days and were maintained at 1 year. Conclusions: In these subjects with multiple comorbidities and restrictive anatomy that underwent transcatheter aortic valve replacement, there was no late stroke, myocardial infarction, or death related to BASILICA. Mitigation of coronary obstruction remained intact at 1 year and was not related to recurrent readmission. These results are reassuring for patients and physicians who wish to avoid the long-term complications related to snorkel stenting. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03381989.

Delivery of electrosurgery energy through catheters and guidewires enables interventionists to ‘cut’ through obstructive intravascular lesions or across cardiac chambers. A novel application of transcatheter electrosurgery is to make controlled lacerations in heart valve leaflets. This review describes three applications of transcatheter electrosurgery of aortic and mitral valve leaflets to enable transcatheter heart valve implantation. Intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow obstruction splits and splays the anterior mitral valve and enables transcatheter mitral valve replacement without left ventricular outflow tract obstruction. Technique modifications and novel applications are described. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction enables transcatheter aortic valve replacement without coronary artery obstruction. The technique is described and novel uses, especially in the setting of repeat transcatheter aortic valve replacement, are discussed. Finally, electrosurgical laceration and stabilization of mitral valve clip devices (ELASTA-Clip) enables transcatheter mitral valve replacement after MitraClip implantation. In conclusion, transcatheter electrosurgery is an important and versatile new tool in structural heart intervention.

The prognosis of left circumflex (LC) versus non-LC in-stent restenosis (ISR) ostial lesions following treatment has not been assessed. We aimed to assess this prognosis. Anecdotally, treatment of ostial LC ISR has been associated with high recurrence rates. We performed a retrospective analysis of patients from our institution who underwent coronary intervention of an ostial ISR lesion between 2003 and 2018. The primary endpoint was target lesion revascularization (TLR) and major adverse cardiovascular events (MACE). Overall, 563 patients underwent ostial ISR lesion intervention, 144 for an ostial LC ISR lesion. Compared to patients with ostial ISR in non-LC lesions, patients with ostial LC ISR were older, had higher rates of diabetes mellitus and previous coronary bypass surgery. At 1-year follow-up, TLR-MACE rates were 26.6% in the LC group versus 18.4% in the non-LC group (p = 0.036). The TLR rate was also higher in the LC group compared to the non-LC group (p = 0.0498). Univariate and multivariate analyses demonstrated a higher TLR-MACE rate for LC versus non-LC ostial ISR lesions. In conclusion, our study shows increased event rates after treatment of LC versus non-LC ISR lesions. Further studies should be done to assess the optimal treatment approach for ostial LC ISR.

Transcatheter mitral valve replacement (TMVR) is a therapeutic option for patients with severe mitral disease who are deemed inoperable due to their overall surgical risk. The close relationships between the left ventricular outflow tract (LVOT) and the anterior mitral valve leaflet can lead to LVOT obstruction, a common complication with high mortality. Predicting and preventing LVOT obstruction is therefore essential, prior to TMVR. Laceration of the Anterior Mitral leaflet to Prevent Outflow ObtructioN (LAMPOON) is a transcatheter electrosurgical technique to split the anterior mitral valve leaflet immediately prior to TMVR. The technique has been studied in a prospective clinical trial and has evolved with many iterations for specific anatomies. In this review, we discuss the different LAMPOON techniques to prevent and treat LVOT obstruction.

Background: The supra-annular leaflet position and tall stent frame of the self-expanding Evolut PRO or Evolut PRO+ transcatheter heart valves (THVs) may cause coronary occlusion during transcatheter aortic valve replacement (TAVR)-in-TAVR and present challenges for future coronary access. We sought to evaluate the risk of TAVR-in-TAVR with Evolut PRO or Evolut PRO+ THVs and the feasibility of future coronary access. Methods: The CoreValve Evolut PRO Prospective Registry (EPROMPT; NCT03423459) prospectively enrolled patients with symptomatic severe aortic stenosis to undergo TAVR using a commercially available latest generation self-expanding THV at 2 centers in the United States. Computed tomography was performed 30 days after TAVR, which we used to simulate TAVR-in-TAVR with a second Evolut PRO or Evolut PRO+ THV and evaluate for risk of coronary obstruction and feasibility of future coronary access. Results: Eighty-one patients enrolled with interpretable computed tomography are reported herein. Computed tomography simulation predicted sinus of Valsalva sequestration and resultant coronary obstruction during future TAVR-in-TAVR in up to 23% of patients. Computed tomography simulation predicted that the position of the pinned THV leaflets would hinder future coronary access in up to 78% of patients after TAVR-in-TAVR. Conclusions: Further THV design improvements and leaflet modification strategies are needed to mitigate the risk of coronary obstruction during TAVR-in-TAVR with self-expanding THVs and to facilitate future coronary access. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03423459.

Objectives Assess the impact on fluoroscopy time and contrast use in patients with tortuous brachiocephalic/thoracic aortas undergoing right transradial coronary angiography (RTCA) and provide strategies to manage. Background Unfavorable anatomy with severe brachiocephalic/thoracic tortuosity, referred to as an "elephant head," remains a significant obstacle for RTCA. Methods We reviewed the coronary angiograms of patients who underwent RTCA and had tortuous aortas. Angiography was attempted first using a universal catheter (Tiger) and switched to a left coronary specific catheter (Judkins Left [JL]) if challenging. Fluoroscopy time, contrast volume, and greatest distance from the patient's midline to the catheter in the aorta were recorded. Results Forty-nine patients (62.6 ± 12.0 years, 69.4% male) were included. Fifteen (30.6%) patients underwent successful angiography with a Tiger catheter; 34 (69.4%) patients required switching to JL catheter. The average distance of Tiger catheters to the midline of the spine was 0.78 ± 0.41 cm versus 1.28 ± 0.44 cm (p = .001) in JL catheters. Tiger catheter use resulted in less fluoroscopy time (6.48 ± 4.73 min) and contrast use (58.87 ± 43.53 ml) than in cases switched to JL (13.26 ± 10.76 min [p = .026]; 86.5 ± 69.95 ml [(p = .017]). Conclusions For patients undergoing RTCA with significant brachiocephalic/thoracic aorta tortuosity, "elephant head," a Tiger catheter can be used efficiently for curvatures 1 cm, operators should consider immediately switching to a JL catheter.

Background: Despite an expanding armamentarium of devices, many patients with mitral regurgitation referred for transcatheter mitral valve repair or replacement are not eligible to participate in the clinical trials or receive a commercially available device. We sought to understand the reasons why patients were excluded from receiving therapy. Methods: We retrospectively analyzed the medical charts, and correspondence related to patients referred to our tertiary valve center for transcatheter mitral valve replacement (TMVR) or transcatheter mitral valve repair (TMVr) between June 2016 to September 2019. Patients were screened for eligibility by our structural Heart Team for either TMVR or TMVr. If TMVR or TMVr was not offered the reason for screen failure was recorded and categorized. Results: Over the 3-year period, 564 patients were referred for TMVR/TMVr. Of these, 15.9% were determined to be eligible for and underwent surgical repair or replacement. 440 patients (78.0%) were considered for TMVR/TMVr. 92 patients (16.3%) underwent TMVR/TMVr. The majority of patients (348/564, 61.7%) ultimately did not undergo intervention (Panel A). The reasons for exclusion were clinical in 78%, issues related to patient preference of care delivery in 49% of patients, anatomical in 37% and futility in 25% of patients (Panel B). Conclusions: The majority of patients with mitral regurgitation referred for transcatheter mitral therapy are excluded for a variety of reasons. Clinical trials testing new transcatheter mitral valve devices should be encouraged to follow patients who are excluded to better understand optimal timing of intervention, address challenging anatomies, and ultimately improve penetrance of these novel therapies.

Despite an expanding armamentarium of devices, many patients with mitral regurgitation referred for transcatheter mitral valve repair (TMVr) or replacement (TMVR) do not meet strict clinical trial inclusion and exclusion criteria. We sought to understand the rates that patients were excluded from transcatheter mitral valve therapies and reasons why. We retrospectively analyzed the medical charts and correspondence related to patients referred to our tertiary valve center for TMVr or TMVR between June 2016 and September 2019. Patients were screened for eligibility by our structural Heart Team for either TMVr or TMVR. If TMVr or TMVR was not offered, the reason for screen failure was recorded and categorized. Over the 3-year period, 564 patients were referred for TMVr and orTMVR. Out of these, 15.9% were determined to be eligible for, and underwent, surgical repair or replacement. Ninety-two patients (16.3%) underwent TMVr or TMVR. The majority of patients (343 of 564, 60.8%) ultimately did not undergo intervention. The primary reason for exclusion was clinical in 38.5%, issues related to patient preference of care delivery in 38.8%, anatomical in 13.7%, and futility in 9.0%. In contemporary real-world practice, the majority of patients with mitral regurgitation referred for transcatheter therapies are excluded. Clinical trials testing new transcatheter devices should be encouraged to record and report reasons for screen failure and follow these patients to better understand optimal timing of intervention, address challenging anatomies, and, ultimately, improve penetrance of these novel therapies.

Background/Purpose This sub-analysis of the prospective Low Risk TAVR (LRT) trial determined anatomical characteristics associated with hypoattenuated leaflet thickening (HALT), which may contribute to early transcatheter heart valve (THV) degeneration. Methods/Materials The LRT trial enrolled 200 low-risk patients between February 2016 and February 2018. All subjects underwent baseline and 30-day CT studies, analyzed by an independent core laboratory. Additional measurements, namely THV expansion, eccentricity, depth, and commissural alignment, were made by consensus of three independent readers. HALT was observed only in the Sapien 3 THV, so Evolut valves were excluded from this analysis. Results In the LRT trial, 177 subjects received Sapien 3 THVs, of whom 167 (94.3%) had interpretable 30-day CTs and were eligible for this analysis. Twenty-six subjects had HALT (15.6%). Baseline characteristics were similar between groups. There was no difference in THV size implanted and baseline aortic-root geometry between groups. In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6±1.1 mm HALT versus 3.3±1.8 mm no-HALT, p=0.03). There were more patients in the HALT group with commissural malalignment (40% vs. 28%; p=0.25), but this did not reach statistical significance. In a univariable regression model, no predetermined variable were shown to independently predict the development of HALT. Conclusions This study did not find anatomical or THV implantation characteristics that predicted the development of HALT at 30 days. This study cannot exclude subtle effects or interaction between factors because of the small number of events. Summary This sub-analysis of the prospective Low Risk TAVR trial found that hypoattenuated leaflet thickening (HALT) was associated with shallower transcatheter heart valve implantation. No predictors of HALT were found in a univariable regression analysis.

Objectives We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). Background Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. Methods Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports. Results Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group. Conclusions Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.

International medical graduates (IMGs), individuals who graduated from medical school outside of the United States or Canada, constitute 31.3% of active neurologists and one-third of current neurology trainees. Although three-fourths of IMG neurology trainees are not US citizens, they are an integral part of our trainee and practice workforce. IMGs play a vital role in providing greater access to health care for millions of patients, particularly in traditionally underserved regions and in the face of a current global health care crisis. With this article, we outline some of the unique challenges faced by immigrant, US-trained neurologists as they seek to provide neurologic care across the country, including preparing and applying for residency, securing authorization to remain in the United States to practice, and positioning themselves for successful careers in academic and private practice. We also call for advocacy and legislation to help reduce these barriers as a means to address the increasing physician workforce gap.

Ostial coronary artery lesions can be challenging during percutaneous coronary intervention (PCI) because of elastic fiber content, calcium burden, and angulation. We assessed procedural and clinical major adverse cardiac events (MACE) associated with PCI for ostial lesions, focusing on ostial left circumflex (LC) lesions compared with ostial left anterior descending artery (LAD) and right coronary artery lesions. All patients with ostial or very proximal coronary artery lesions treated with PCI at MedStar Washington Hospital Center (Washington, DC) from 2003 to 2018 were included. The primary end point was target lesion revascularization (TLR)-MACE, defined as the composite of all-cause mortality, Q-wave myocardial infarction (MI), and TLR at 1 year. A total of 4,759 patients with available 1-year follow-up were included: 2,236 ostial/very proximal LAD, 980 ostial/very proximal LC, and 1,543 ostial/very proximal right. The presenting clinical syndrome for the LC group was mainly stable or unstable angina, whereas MI was more common in the LAD. At 1 year, the TLR-MACE rate was 16.7% in the LC group versus 12.5% in the LAD and 11.8% in the right group (p = 0.001). Mortality rates were 11.2% in the LC group versus 8.4% in the LAD and 6% in the right group (p0.001). A Cox model showed that dialysis had the highest impact on TLR-MACE. In conclusion, compared with PCI of ostial or very proximal LAD or right lesions, PCI of ostial or very proximal LC lesions was associated with higher rates of TLR-MACE.

Background/purpose Coronary artery calcification is a marker of advanced atherosclerosis and a predictor of adverse clinical outcomes. Rotational atherectomy (RA) can effectively modify calcified lesions, optimizing procedural outcomes. We interrogated the most commonly reported adverse events involving rotational atherectomy systems (Rotablator and Rotapro) by analyzing post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. Methods/materials We queried MAUDE from September 1, 2016, through December 31, 2019. After excluding duplicate reports, we included 363 reports for Rotablator and 63 reports for Rotapro in the final analysis. Results Percentages represent the proportion of total submitted MAUDE reports. The most commonly reported complications for Rotablator and Rotapro included dissection (2.7% and 6.3%, respectively) and perforation (4.1% and 19%, respectively). The most commonly reported device-related issues included detachment or structural damage, or both, for Rotablator (39.1%) and entrapment of the device component for Rotapro (47.6%). The most commonly damaged device component was the Rotawire, whereas the most commonly entrapped device component was the Rotaburr for both device configurations. Rotablator and Rotapro device-related complications were most commonly reported for the left anterior descending artery. Conclusion An analysis of the MAUDE database demonstrates that in real-world practice, RA devices are associated with important complications. Ongoing surveillance of safety profiles, patient outcomes, and failure modes of RA devices is warranted. Our analysis provides important insights into the mechanisms of failure of RA devices and associated complications but cannot verify causality. Summary We interrogated the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to summarize the most commonly reported adverse events and device-related issues associated with the rotational atherectomy systems (Rotablator and the newer iteration, Rotapro). The MAUDE database serves as an important tool for improved collaboration between clinicians, device manufacturers, and regulatory bodies to optimize device safety and patient outcomes.

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 We report the first pledget-assisted suture tricuspid annuloplasty (PASTA) in a patient with torrential tricuspid regurgitation (TR). Background Tricuspid valve regurgitation is a common malignant disease with no commercially available transcatheter therapy. PASTA is a "percutaneous surgical" procedure using pledgeted sutures to create a double-orifice tricuspid valve. Methods An 83-year-old man had end-stage TR caused by a defibrillator lead. He consented to undergo PASTA on a compassionate basis. A double-orifice valve was created with pledgeted sutures from percutaneous right ventricular apical access. Results TR was reduced from torrential to trace. The vena contracta reduced to from 23 to 1 mm and annular area reduced from 1817 to 782 mm2 . However, the annulus dehisced and required closure with a percutaneous nitinol plug. The patient was discharged home and was alive 6 months later but with persistent symptoms. Conclusions The anatomy of a double-orifice valve can eliminate TR but a better solution is required to avoid excessive suture tension on annular tissue.

During the novel coronavirus disease 2019 (COVID-19) pandemic, many hospitals have been asked to postpone elective and surgical cases. This begs the question, “What is elective in structural heart disease intervention?” The recently proposed Society for Cardiovascular Angiography and Interventions/American College of Cardiology consensus statement is, unfortunately, non-specific and insufficient in its scope and scale of response to the COVID-19 pandemic. We propose guidelines that are practical, multidisciplinary, implementable, and urgent. We believe that this will provide a helpful framework for our colleagues to manage their practice during the surge and peak phases of the pandemic. General principles that apply across structural heart disease interventions include tracking and reporting cardiovascular outcomes, “healthcare distancing,” preserving vital resources and personnel, shared decision-making between the heart team and hospital administration on resource-intensive cases, and considering delaying research cases. Specific guidance for transcatheter aortic valve replacement and MitraClip procedures varies according to pandemic phase. During the surge phase, treatment should broadly be limited to those at increased risk of complications in the near term. During the peak phase, treatment should be limited to inpatients for whom it may facilitate discharge. Keeping our patients and ourselves safe is paramount, as well as justly rationing resources., Highlights • Many elective and surgical cases have been postponed during the COVID-19 pandemic. • We propose guidelines for managing structural heart disease during the pandemic. • General principles include preserving vital resources and personnel. • Specific guidance for TAVR and mitral valve repair changes with pandemic phase. • Keeping our patients and ourselves safe and justly rationing resources is paramount.

Highlights • ACC Scientific Sessions 2020 shared the latest research in cardiology. • We highlight results from 14 late-breaking trials. • Areas covered include TAVR, coronary, and peripheral artery disease.