Publications by authors named "James M McCabe"

Article Synopsis
  • This study investigated the effect of mitral stenosis (MS) on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) with modern balloon-expandable valves, using data from over 327,000 patients across multiple centers.
  • It was found that while patients with severe MS initially had worse outcomes, when matched for similar characteristics, their 30-day outcomes were similar to those with mild or less MS, except for a higher rate of pacemaker implantation.
  • However, by three years post-TAVR, patients with severe MS showed a significantly higher mortality rate compared to those with mild or less MS, suggesting long-term risks associated with severe MS.
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Background: We aimed to develop a transcatheter aortic valve replacement (TAVR) sizing algorithm and implantation method to facilitate safe and effective TAVR without contrast use in patients with severe chronic kidney disease (CKD) who do not yet require renal replacement therapy. Patients with CKD are a challenging patient subset to treat using standard TAVR care pathways which most usually require the use of iodinated contrast media both during gated computed tomography (CT) angiography sizing, and valve deployment. Iodinated contrast exposure may worsen kidney function in a dose-dependent fashion, and may result in a need for renal replacement therapy.

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Background: Mitral annular calcification with valve dysfunction remains a challenging syndrome. Operative risk is high, and available transcatheter therapies are limited.

Methods: This study describes our initial experience with a novel procedure to address large mitral annuli when no surgical or trial-based transcatheter mitral valve replacement device is available.

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Purpose Of Review: To describe the emerging role of transcatheter septal myotomy in the treatment of hypertrophic obstructive cardiomyopathy.

Recent Findings: Transcatheter septal myotomy was developed to address risk of LVOT obstruction during TMVR, however it has been performed in patients with LVOT obstruction related to hypertrophic cardiomyopathy, in whom it improves symptoms, reduces LVOT gradients, and is associated with low incidence of procedural complications. Transcatheter myotomy is a novel approach to address LVOT obstruction related to hypertrophic cardiomyopathy in patients who are not favorable surgical candidates.

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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.

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Article Synopsis
  • Surgical mitral valve repairs may not hold up over time, leading to potential repeat surgeries; transcatheter mitral valve-in-ring (MViR) offers a new option for high-risk patients.
  • A study analyzed outcomes of MViR involving 820 patients, with most in poor heart function classes and significant mitral regurgitation; initial results showed a 30-day mortality rate of 8.3% and a 1-year rate of 22.4%.
  • At one year, MViR patients experienced improvements in heart function and reduced mitral regurgitation, but there were concerns about elevated pressure gradients and a 9.1% reintervention rate, affirming MViR as a viable
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Article Synopsis
  • The study investigates the Trilogy transcatheter heart valve as a treatment for patients with native aortic regurgitation who are at high risk for surgery-related complications and mortality.
  • Conducted as the ALIGN-AR trial, it enrolled 180 symptomatic patients across 20 US sites, assessing both safety and efficacy of the heart valve over a one-year period.
  • Results showed a high technical success rate (95%), with low incidences of 30-day complications, including deaths and strokes, indicating potential benefits of this non-surgical intervention for high-risk patients.
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•Degenerative common AVC defect can mimic rheumatic MV stenosis.•Closure of primum ASD can be achieved percutaneously.•Live 3D multiplanar TEE is crucial for procedural guidance.

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Background: Left ventricular outflow tract (LVOT) obstruction is a source of morbidity in hypertrophic cardiomyopathy (HCM) and a life-threatening complication of transcatheter mitral valve replacement (TMVR) and transcatheter aortic valve replacement (TAVR). Available surgical and transcatheter approaches are limited by high surgical risk, unsuitable septal perforators, and heart block requiring permanent pacemakers.

Objectives: The authors report the initial experience of a novel transcatheter electrosurgical procedure developed to mimic surgical myotomy.

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Background: The fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported.

Objectives: The aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR).

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Background: Favorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy.

Objectives: The authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry.

Methods: Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively.

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Article Synopsis
  • The MITRAL trial is a prospective study that assesses the safety and effectiveness of using transcatheter heart valves to replace failed surgical mitral valves in patients with severe mitral annular calcification.
  • The study followed 91 high-risk patients over five years, focusing on three treatment types: mitral valve-in-valve (MViV), valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC).
  • Results showed that MViV patients had the lowest mortality rate (21.4%) and significant improvements in heart failure symptoms, while MViR and ViMAC groups had higher mortality rates (65.5% and 67.9%, respectively) despite stable heart function
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Background: Ocedurenone (KBP-5074), a nonsteroidal mineralocorticoid receptor antagonist, is documented to lower blood pressure in patients with stage 3b/4 chronic kidney disease (CKD) with uncontrolled or resistant hypertension (BLOCK-CKD study). However, the efficacy and safety of Ocedurenone in subgroups such as Hispanic patients or those with stage 4 CKD, diabetes, or very high albuminuria have not been reported.

Methods: A total of 162 patients were enrolled in the BLOCK-CKD study.

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Article Synopsis
  • * Results showed that patients with severe AR had larger annulus areas and anatomical features compared to those with AS, leading to a higher rate of exclusion from TAVR based on specific anatomical criteria.
  • * Additionally, patients with severe AS were more likely to have high-risk anatomy for coronary occlusion, highlighting important differences between the two conditions in the context of TAVR interventions.
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Access to the arterial circulation and full anticoagulation carries a risk of serious bleeding during and after percutaneous coronary intervention. Important sources of bleeding include the arterial access site and coronary artery perforation. Prompt and effective management of hemorrhagic complications is an essential interventional skill.

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The prevalence of concurrent cancer and severe aortic stenosis (AS) is increasing due to an ageing population. In addition to shared traditional risk factors for AS and cancer, patients with cancer may be at increased risk for AS due to off-target effects of cancer-related therapy, such as mediastinal radiation therapy (XRT), as well as shared non-traditional pathophysiological mechanisms. Compared with surgical aortic valve replacement, major adverse events are generally lower in patients with cancer undergoing transcatheter aortic valve intervention (TAVI), especially in those with history of mediastinal XRT.

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The removal of intramyocardial masses has long been thought of as a surgical procedure and is generally reserved for patients with obstructive symptoms when the mass is thought to be benign. Thus, many patients who are incidentally diagnosed with intracardiac masses are either subjected to protracted follow-up with serial imaging awaiting tumor growth before surgical excision is ultimately offered. We report a novel procedure in which a 54-year-old man with an atrial myxoma underwent successful percutaneous resection using electrosurgery followed by removal with a novel endovascular retrieval system.

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