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Patient Preferences for Features Associated With Leadless Versus Conventional Transvenous Cardiac Pacemakers.

Circ Cardiovasc Qual Outcomes

December 2024

Duke Clinical Research Institute (S.D.R., J.-C.Y., M.J.W., J.S., F.R.J., S.O., S.M.A.-K.), Duke University School of Medicine, Durham, NC.

Article Synopsis
  • A study examined patient preferences for different types of pacemakers, including new dual-chamber leadless options and traditional transvenous ones, to identify which features are most important to them.
  • Surveying 117 patients, researchers found that half preferred leadless pacemakers while the other half favored conventional ones, highlighting a significant division in choices.
  • Key factors influencing patient decisions included preferred pacemaker type, acceptance of complication and infection risks, and the time since regulatory approval, with many willing to accept higher risks for their preferred options.
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Context: This is a follow-up to the original published article, Effects of the Strong Hearts Program after a Major Cardiovascular Event in Patients with Cardiovascular Disease.

Objectives: This study evaluated the long-term efficacy of the Strong Hearts program up to 2 years after program completion.

Methods: All study participants who initially completed the Strong Hearts program between 2020 and 2021 (n=128) were contacted at 12 months and 24 months following the date of program completion.

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Article Synopsis
  • Left atrial appendage closure (LAAC) is used as an alternative stroke prevention method for patients who cannot take blood thinners, but pulmonary artery injury (PAI) is a rare and serious complication associated with it.
  • A review of previous PAI cases and data from the FDA's MAUDE database identified 36 cases, predominantly involving older patients, and highlighted that PAI often presents soon after the procedure, with a significant percentage requiring surgery.
  • The study emphasizes the need for heightened awareness of PAI symptoms post-LAAC, especially concerning rapid fluid accumulation around the heart, even without clear predictive signs from imaging or clinical details.
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Article Synopsis
  • Intravenous enoxaparin is compared with unfractionated heparin (UFH) as a safer, more effective anticoagulant for percutaneous coronary intervention (PCI) in a study of 1019 patients from January 2015 to December 2019.
  • The study found high procedural success (98.2%) with very low rates of complications, including 0 deaths and minimal bleeding events.
  • Results suggest that enoxaparin is a viable alternative anticoagulant for low-risk and elective PCI cases accessed via the radial artery.
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Background: The Food and Drug Administration approved the Amulet occluder (Abbott) after demonstrating safety and effectiveness in the Amulet IDE (AMPLATZER Amulet LAA Occluder) trial.

Objectives: The aim of the EMERGE Left Atrial Appendage study is to evaluate early postapproval outcomes of the Amulet occluder in the United States using data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry.

Methods: Patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022, were included.

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Background: Coronary pseudoaneurysm is a rare, potentially fatal, complication of coronary intervention. A challenging management case of a giant right coronary pseudoaneurysm is presented.

Case Summary: A 56-year-old man presented with an atypical presentation for ST-elevation myocardial infarction.

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Background: The fourth-generation mitral transcatheter edge-to-edge repair (M-TEER) device introduced an improved clip deployment sequence, independent leaflet grasping, and 2 wider clip sizes to tailor the treatment of patients with mitral regurgitation (MR) for a broad range of anatomies. The 30-day safety and effectiveness of the fourth-generation M-TEER device were previously demonstrated.

Objectives: The aim of this study was to evaluate 1-year outcomes in a contemporary, real-world cohort of subjects treated with the MitraClip G4 system.

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Background: Anatomical and clinical criteria to define mitral transcatheter edge-to-edge repair (TEER) "unsuitability" have been proposed on the basis of a Heart Valve Collaboratory consensus opinion from physician experience with early-generation TEER devices but lacked an evidence-based approach.

Objectives: The aim of this study was to explore the spectrum of TEER suitability using echocardiographic and clinical outcomes from the EXPAND G4 real-world postapproval study.

Methods: EXPAND G4 is a global, prospective, multicenter, single-arm study that enrolled 1,164 subjects with mitral regurgitation (MR) treated with the MitraClip G4 System.

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Background: The fourth-generation MitraClip G4 System builds on the previous NTR/XTR system with additional wider clip sizes (NTW and XTW), an independent grasping feature, and an improved clip deployment sequence.

Objectives: The primary objective of this study was to assess the safety and performance of the MitraClip G4 System within a contemporary real-world setting.

Methods: EXPAND G4 is a prospective, multicenter, international, single-arm, postapproval study that enrolled patients with primary (degenerative) mitral regurgitation (MR) and secondary (functional) MR at 60 centers.

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Context: Cardiac rehabilitation (CR) and intensive cardiac rehabilitation (ICR) are secondary prevention interventions for cardiovascular disease (CVD) with a class 1a indication yet suboptimal utilization. To date, there are only three approved ICR programs. Alternative programing should be explored to increase enrollment and adherence in these interventions.

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Introduction: Use of a novel magnetic sensor enabled optical contact force ablation catheter has been established to be safe and effective for treatment of symptomatic drug-refractory paroxysmal atrial fibrillation (AF) but has yet to be demonstrated in the persistent AF (PersAF) population.

Methods: PERSIST-END was a multicenter, prospective, nonrandomized, investigational study designed to demonstrate the safety and effectiveness of TactiCath™ Ablation Catheter, Sensor Enabled™(SE) (TactiCath SE) for use in the treatment of subjects with documented PersAF refractory or intolerant to at least one Class I/III AAD. The ablation strategy included pulmonary vein isolation and additional targets at physician discretion.

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Background: Current endovascular treatments of below the knee (BTK) popliteal or tibial/peroneal arteries including investigational drug-coated balloons have limited long-term efficacy.

Objectives: This Phase 2 trial assessed the feasibility of adventitial deposition of temsirolimus to reduce neointimal hyperplasia and clinically relevant target lesion failure (CR-TLF) 6 months after BTK arterial revascularization.

Methods: This prospective, multicenter, double-blinded, comparative, dose-escalation trial enrolled 61 patients with Rutherford 3 to 5 symptoms undergoing endovascular revascularization of ≥1 angiographically significant BTK lesions.

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Article Synopsis
  • * A meta-analysis of 10 studies with 1,462 patients found no increase in stroke or mortality risk associated with HALT, although it was linked to a higher post-TAVR aortic valve gradient.
  • * The study also hinted at trends showing a higher risk of HALT in men and a lower risk in patients with chronic kidney disease (CKD), but these findings weren't statistically significant, indicating a need for further research.
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Objectives: To demonstrate the feasibility and safety of performing elective percutaneous coronary intervention (PCI) during contrast reaction producing severe hypotension.

Background: The development of profound hypotension due to a contrast reaction requires emergency treatment and usually signals procedure termination.

Methods And Results: We report successful completion of planned PCI with blood pressure support with vasopressors during contrast-induced hypotension in nine procedures in three patients with previously known contrast reaction causing hypotension.

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Atherosclerosis of the aorta is a well-known risk factor for peri-operative complications in patients undergoing cardiac surgery. Coronary and peripheral artery bypass procedures can be challenging when the native aorta is not amenable to bypass grafting due to severe calcification. We describe the successful management of a patient who underwent ascending aorta replacement with concomitant three-vessel coronary artery bypass, bilateral aorto-axillary bypass and left axillary-to-carotid bypass.

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Background Although beta-blockers are recommended following myocardial infarction (MI), the benefits of long-term treatment have not been established. The study's aim was to evaluate beta-blocker efficacy by dose in 1-year post-MI survivors. Methods and Results The OBTAIN (Outcomes of Beta-Blocker Therapy After Myocardial Infarction) registry included 7057 patients with acute MI, with 6077 one-year survivors.

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Background/purpose: The transradial approach has been proposed as an alternative to traditional transfemoral access for diagnostic and therapeutic purposes in several catheterization procedures. Historically, extended length devices for lower limb endovascular interventions have been limited. The aim of this study was to investigate the acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for the treatment of lower extremity peripheral artery disease (PAD).

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Objectives: The objective of this clinical trial was to evaluate the safety and effectiveness of the TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) (Abbott, Abbott Park, Illinois) for the treatment of drug-refractory, symptomatic paroxysmal atrial fibrillation (PAF).

Background: Catheter ablation of atrial fibrillation (AF) is an established therapy for the treatment of PAF. Ablation technology is evolving with the primary goals of improving efficacy and safety of the procedure.

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Introduction: Previous studies have suggested that women with chroniclimb-threatening ischemia (CLTI) may have worse outcomes than men. The aim of this study was to determine whether there are sex-related differences in outcomes of patients with CLTI undergoing endovascular treatment with current endovascular technologies.

Patients And Methods: Data were derived from the LIBERTY 360 study (NCT01855412).

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Coronary artery fistulas are rare anomalies that often become symptomatic with age. They are typically diagnosed incidentally during coronary angiography. The chief nonsurgical treatment is transcatheter coil embolization.

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Background: The growing prevalence of childhood obesity has resulted in an increased number of children and adolescents who undergo bariatric surgery. The safety of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) remains controversial in the pediatric population.

Objective: To assess the safety of LSG compared with LRYGB in patients aged ≤21 years.

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Background: Randomized trials demonstrated that the rate of access to the center of the CFA was low and not different with fluoroscopy vs. anatomic landmarks. We investigated the role a novel fluoroscopic-guided technique with the micropuncture needle (MPN) for the common femoral artery (CFA) access.

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Cardiac Interventional Procedures in Cardio-Oncology Patients.

Cardiol Clin

November 2019

Department of Cardiology, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit 1451, Houston, TX 77030, USA. Electronic address:

Comorbidities specific to the cardio-oncology population contribute to the challenges in the interventional management of patients with cancer and cardiovascular disease (CVD). Patients with cancer have generally been excluded from cardiovascular randomized clinical trials. Endovascular procedures may represent a valid option in patients with cancer with a range of CVDs because of their minimally invasive nature.

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