Background: Impella RP and RP Flex can provide right ventricular (RV) support in numerous clinical situations. Notably, the redesigned RP Flex allows for an internal jugular approach compared to the femoral venous approach with RP.
Aims: We investigated the type and frequency of device-related complications as reported in the US Food and Drug Administration (FDA) Manufacturer and User Facility Experience (MAUDE) for both Impella RP and RP Flex to see if there are any differences.
Background: Among patients with aortic stenosis, ventricular remodeling by hypertrophy can limit the augmentation of flow with exertion, even after valve intervention. However, the effect of hypertrophy on quality of life (QoL) improvement has not been studied. We aimed to determine the effect of ventricular hypertrophy on QoL outcomes after transcatheter aortic valve replacement (TAVR).
View Article and Find Full Text PDFJACC Cardiovasc Interv
September 2024
Background: Left ventricular outflow tract (LVOT) obstruction is a common, often fatal complication of transcatheter mitral valve replacement (TMVR). Laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON) was safe and effective at preventing LVOT obstruction at 30 days in the National Heart, Lung, and Blood Institute LAMPOON trial.
Objectives: The authors report the 5-year outcomes of intentional anterior mitral leaflet laceration before SAPIEN 3 TMVR, in patients at risk of LVOT obstruction.
Background: Conduction disturbances have uncertain implications for long-term left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR). We aimed to examine LVEF changes in patients up to two years post-TAVR.
Methods: We examined patients who underwent TAVR between 2012 and 2020 and underwent echocardiography follow-up.
Background: In 2019, the US Food and Drug Administration (FDA) approved transcatheter aortic valve replacement (TAVR) for low-risk patients with symptomatic severe tricuspid aortic stenosis. However, bicuspid aortic valve (BAV) patients were included only in single-arm registries of pivotal low-risk TAVR trials, resulting in limited data for this subgroup.
Methods: The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and the first FDA-approved investigational device exemption trial to evaluate the feasibility of TAVR with balloon-expandable or self-expanding valves in low-risk patients with symptomatic severe BAV stenosis.
Background: PROTECT IV is a current enrolling randomized controlled trial evaluating high-risk percutaneous coronary intervention (HR-PCI) with prophylactic Impella versus no Impella to reduce the composite primary endpoint of all-cause death, stroke, myocardial infarction (MI), or cardiovascular hospitalization. In a PROTECT IV-like cohort of patients who underwent HR-PCI without Impella, we aimed to report the rate of major adverse events to determine whether the trial is adequately powered.
Methods And Results: A total of 700 patients meeting similar inclusion/exclusion criteria of PROTECT IV who underwent HR-PCI without Impella at a single tertiary center from 2008 to 2022 were included in the analysis.
Periprocedural stroke after transcatheter aortic valve implantation (TAVI) remains a significant issue, which is associated with high morbidity, and is increasingly important as intervention shifts to younger and lower-risk populations. Over the last decade of clinical experience with TAVI, the incidence of periprocedural stroke has stayed largely unchanged, although it is prone to underreporting due to variation in ascertainment methods. The aetiology of stroke in TAVI patients is multifactorial, and changing risk profiles, differing study populations, and frequent device iterations have made it difficult to discern consistent risk factors.
View Article and Find Full Text PDFShark meat consumption may pose a significant risk to human health as high levels of toxic pollutants bioaccumulate in muscular tissue. Commercial harvest of Carcharhinus brachyurus meat in South Africa is estimated at 100-300 filleted tons per annum. Muscle tissue samples from 41 sharks were collected from the southern and eastern coastlines of South Africa in 2022 and analysed for 10 trace elements and 8 polychlorinated biphenyl congeners.
View Article and Find Full Text PDFThe benefit of mechanical circulatory support with Impella (Abiomed, Inc., Danvers, Massachusetts) for high-risk percutaneous coronary intervention (HR-PCI) is uncertain. PROTECT III registry data showed improved outcomes with Impella compared with historical data (PROTECT II) but lack a direct comparison with the HR-PCI cohort without Impella support.
View Article and Find Full Text PDFBioprosthetic aortic valve thrombosis is frequently detected after transcatheter and surgical aortic valve replacement due to advances in cardiac computed tomography angiography technology and standardized surveillance protocols in low-surgical-risk transcatheter aortic valve replacement trials. However, evidence is limited concerning whether subclinical leaflet thrombosis leads to clinical adverse events or premature structural valve deterioration. Furthermore, there may be net harm in the form of bleeding from aggressive antithrombotic treatment in patients with subclinical leaflet thrombosis.
View Article and Find Full Text PDFBackground: Hemoglobin (Hgb) drop without bleeding is common among patients undergoing transcatheter aortic valve replacement; however, the clinical implications of significant Hgb drop have not been fully evaluated.
Methods And Results: Consecutive patients undergoing transcatheter aortic valve replacement at our institution from 2011 to 2021 were retrospectively reviewed. Three groups were assessed: no Hgb drop and no bleed (NoD-NoB [reference group]), Hgb drop with bleed, and Hgb drop and no bleed (D-NoB).
Background: Deep intramural ventricular tachycardia substrate targets are difficult to access, map, and ablate from endocardial and epicardial surfaces, resulting in high recurrence rates.
Objectives: In this study, the authors introduce a novel approach called ventricular intramyocardial navigation for tachycardia ablation guided by electrograms (VINTAGE) to access and ablate anatomically challenging ventricular tachycardia from within the myocardium.
Methods: Guidewire/microcatheter combinations were navigated deep throughout the extravascular myocardium, accessed directly from the right ventricle cavity, in Yorkshire swine (6 naive, 1 infarcted).
Background: Outflow graft obstruction (OGO) is an uncommon yet life-threatening complication in patients with left ventricular assist devices (LVADs). In this retrospective, single-center case series, we identify the baseline demographics and presenting features of patients who develop LVAD OGO and the procedural details and outcomes surrounding percutaneous endovascular intervention (PEI).
Methods: We conducted a retrospective review of patients with LVADs at our institution between January 2010 and February 2023 who developed OGO and were treated with PEI.
Background: The Evolut self-expanding valve (SEV) systems (Medtronic), were designed to accommodate varying valve sizes and reduce paravalvular leak (PVL) while maintaining a low delivery profile. These systems have evolved between product generations, alongside valve deployment techniques changing over time.
Aims: This study aimed to examine whether these changes impacted clinical outcomes.
Background: High-sensitivity troponin (hsTnI) is correlated with cardiac mortality; however, studies on the relationship of markedly elevated hsTnI with in-hospital mortality after cardiac surgery are sparse. Therefore, we aimed to define this relationship in order to help guide in-hospital, acute management of post-surgical patients.
Methods: We retrospectively analyzed all cardiac surgeries completed at our institution between January 2020 and June 2022 in which a peak hsTnI was noted to be >35× upper limit of normal (ULN = 34 ng/L).
Background: Next-day discharge (NDD) outcomes following uncomplicated self-expanding transcatheter aortic valve replacement have not been studied. Here, we compare readmission rates and clinical outcomes in NDD versus non-NDD transcatheter aortic valve replacement with Evolut.
Methods And Results: Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry patients (n=29 597) undergoing elective transcatheter aortic valve replacement with self-expanding supra-annular valves (Evolut R, PRO, and PRO+) from July 2019 to June 2021 were stratified by postprocedure length of stay: ≤1 day (NDD) versus >1 day (non-NDD).
The advent of excimer laser coronary atherectomy (ELCA) nearly four decades ago heralded a novel way to treat complex lesions, both coronary and peripheral, which were previously untraversable and thus untreatable. These complex lesions include heavily calcified lesions, ostial lesions, bifurcation lesions, chronic total occlusions, in-stent restenosis (including stent underexpansion), and degenerative saphenous vein grafts. We discuss the technology of ELCA, its indications, applications, and complications, and suggest the "MAXCon ELCA" technique for better outcomes without increased risk.
View Article and Find Full Text PDFBackground: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR).
Methods: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority).
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