Evaluation of a second-generation intercostal extravascular implantable cardioverter defibrillator lead with a pectoral pulse generator for sensing, defibrillation, and anti-tachycardia pacing.

Aims: Intercostal extravascular implantable cardioverter defibrillator (EV-ICD) leads may work better in contact with the pericardium thereby directing pacing and defibrillation energy towards excitable myocytes. We report 3-month safety and performance outcomes with a second-generation intercostal EV-ICD lead paired with standard, commercially available ICD pulse generators (PGs).

Methods And Results: Subjects undergoing a transvenous ICD (TV-ICD) procedure received a concomitant intercostal EV-ICD lead system.

Centrally inserted central catheter placement using a novel, handheld, image-guided, robotic device: Results of initial feasibility trial in patients.

Background: Central venous access devices (CVADs) are an essential and widely used tool for the treatment of the critically ill, patients undergoing major surgery, and for many patients requiring hemodialysis. Automation of centrally inserted central catheters (CICCs) could potentially make CVAD placement safer, more effective, and more accessible. A new device that uses ultrasound image-guided, robotic needle placement, in addition to traditional Seldinger technique, to place a CICC is described.

Lymphatic Drainage in Patients with Heart Failure: A Feasibility Study.

Lymphatic dysfunction contributes to congestion and end-organ damage in heart failure (HF), yet current therapies do not directly target lymphatic congestion. Thoracic duct (TD) drainage offers a novel approach to address this gap. This multicenter feasibility study evaluated the safety and feasibility of minimally invasive TD drainage in patients with HF.

One-year patency of a novel biorestorative polymeric coronary artery bypass conduit.

Coronary artery bypass graft (CABG) surgery remains the gold standard in the treatment of complex coronary artery disease. Saphenous vein grafts (SVG) are commonly used for the non-left anterior descending artery. However, SVG failure rates in CABG surgery have been reported to be as high as 30% at 1 year and ∼50% at 10 years.

Clinical Experience of a Novel Optical Coherence Tomography-Guided Coronary Chronic Total Occlusion Re-Entry Device.

We demonstrated a first-in-human case of successful antegrade dissection and re-entry using an image-guided re-entry catheter that enables real-time high-resolution visualization with graphical augmentation, and precision steering and advancement of a guidewire. The total time from over-the-wire deployment in the proximity of the distal cap to successful re-entry was <20 minutes. ().

Initial Experience With Intercostal Insertion of an Extravascular ICD Lead Compatible With Existing Pulse Generators.

Background: This study assessed safety and feasibility of a novel extravascular implantable cardioverter defibrillator (ICD) lead when inserted anteriorly through a rib space and connected to various commercially available ICD pulse generators (PGs) placed in either a left mid-axillary or left pectoral pocket. Currently available or investigational, extravascular-ICDs include a subcutaneous or subxiphoid lead connected to customized extravascular-ICD PGs.

Methods: This novel extravascular-ICD (AtaCor Medical Inc, San Clemente, CA) employs a unique intercostal implant technique and is designed to function with commercial DF-4 ICD PGs.

First-in-Human Experience With the ModulHeart Device for Mechanical Circulatory Support and Renal Perfusion.

Background: ModulHeart (Puzzle Medical Devices Inc) is a modular device providing hemodynamic support through 3 endovascular pumps inserted in series and assembled in parallel into a self-expandable anchor implanted in the descending aorta. The current study evaluates the feasibility and safety of cardiorenal support with ModulHeart among patients undergoing high-risk percutaneous coronary intervention (PCI).

Methods: This study was a prospective, single-center, first-in-human study.

A Novel Visually Guided Radiofrequency Balloon Ablation Catheter for Pulmonary Vein Isolation: One-Year Outcomes of the Multicenter AF-FICIENT I Trial.

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Multicenter Experience with the Surfacer Inside-Out Access Catheter System in Patients with Thoracic Venous Obstruction: Results from the SAVE Registry.

Purpose: To report the device performance and safety for the Surfacer Inside-Out access catheter system in patients with thoracic central venous obstruction (TCVO) requiring central venous access (CVA).

Materials And Methods: Five sites prospectively enrolled 30 patients requiring a tunneled dialysis catheter between February 2017 and September 2018 in the SAVE (Surfacer System to Facilitate Access in Venous Obstructions) registry. Patient demographics, medical history, and type of TCVO were documented at enrollment.

The Surfacer Inside-Out Access System for right-sided catheter placement in dialysis patients with thoracic venous obstruction.

Purpose: Thoracic central venous obstruction is a common clinical complication in dialysis patients utilizing hemodialysis catheters. Thoracic central venous obstruction can lead to inability to utilize affected veins for catheter placement and sequential use of less preferred alternative venous access sites. The latter can affect the ability to create and/or mature permanent arteriovenous access and contribute to the future loss of thoracic veins for venous access.

Feasibility of An Entirely Extracardiac, Minimally Invasive,Temporary Pacing System.

Background: A completely extracardiac pacing system provides the potential for clinical advantages over existing device alternatives that require intravascular, endocardial, or epicardial contact. Preliminary studies evaluating the feasibility of cardiac pacing with a lead in the anterior mediastinum, outside the pericardium and circulatory system have been completed. These studies examined (1) the anatomic access route, (2) the usability of a delivery tool to facilitate lead placement, and (3) the pacing performance of the extracardiac lead.

Endovascular Creation of Arteriovenous Fistulae for Hemodialysis Access with a 4 Fr Device: Clinical Experience from the EASE Study.

Background: The use of arteriovenous fistula (AVF) is hampered by long surgical wait times, slow maturation, and upwards of 60% that do not mature. We describe our clinical experience in using a system with a 4F catheter profile for endovascular AVF creation in patients on hemodialysis.

Methods: This was a multioperator, single-center, single-arm, prospective study intended to evaluate safety and efficacy of a 4 Fr endovascular AVF (endoAVF) system for the creation of vascular access in hemodialysis patients.

First-in-human experience with Aortix intraaortic pump.

Background: There are limited options for percutaneous mechanical circulatory support (pMCS) in patients requiring high-risk percutaneous coronary intervention.

Objectives: This first-in-human, single-center study aimed to evaluate the safety and feasibility of a novel pMCS device in high-risk percutaneous coronary intervention patients.

Methods: Aortix (Procyrion, Houston, Texas) is a pMCS device deployed in the descending aorta via the femoral artery that uses axial flow to provide cardiac unloading and augment renal and systemic perfusion.

Efficacy and Safety of the HeartMate Percutaneous Heart Pump During High-Risk Percutaneous Coronary Intervention (from the SHIELD I Trial).

This study aimed to evaluate the use of the HeartMate percutaneous heart pump, a catheter-based axial flow pump designed to provide partial left ventricular support, in patients who underwent high-risk percutaneous coronary intervention (PCI). Patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing PCI may require mechanical circulatory support. Fifty high-risk patients were enrolled in a prospective, nonrandomized, multicenter, open-label trial.

Diaphragm Activation in Ventilated Patients Using a Novel Transvenous Phrenic Nerve Pacing Catheter.

Objectives: Over 30% of critically ill patients on positive-pressure mechanical ventilation have difficulty weaning from the ventilator, many of whom acquire ventilator-induced diaphragm dysfunction. Temporary transvenous phrenic nerve pacing using a novel electrode-bearing catheter may provide a means to prevent diaphragm atrophy, to strengthen an atrophied diaphragm, and mitigate the harms of mechanical ventilation. We tested the initial safety, feasibility, and impact on ventilation of this novel approach.

Treatment of Chronic Functional Mitral Valve Regurgitation With a Percutaneous Annuloplasty System.

Background: Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited and additional interventional approaches are required.

Objectives: This study sought to report the safety and performance data from the feasibility study with a novel direct annuloplasty system.

Methods: Seventy-one patients with moderate to severe FMR (mean 67.

Transcatheter Alcohol-Mediated Perivascular Renal Denervation With the Peregrine System: First-in-Human Experience.

Objectives: This study evaluated the first clinical use of a new endovascular approach to renal denervation, using chemical neurolysis, via periadventitial infusion of dehydrated alcohol (ethanol) to perform "perivascular" renal artery sympathetic denervation.

Background: Renal denervation remains a promising technology for the treatment of hypertension and other disorders.

Methods: A novel 3-needle delivery device (Peregrine System Infusion Catheter, Ablative Solutions, Inc.

First-in-Man Transcervical Surgical Aortic Valve Replacement Using the CoreVista System.

Objective: This study aimed to evaluate a novel device system for surgical aortic valve replacement (SAVR) using a unique new less invasive access approach. The hypothesis is that SAVR can be performed through a short transverse incision in the neck, similar to that used for transcervical thymectomy avoiding chest disruption.

Methods: A new device system was developed to provide retraction, step-by-step illumination, and on-screen visualization for the new approach.

Transcatheter anastomosis connector system for vascular access graft placement: results from a first-in-human pilot study.

Purpose: A lengthy healing and maturation period follows standard surgical preparation of a permanent arteriovenous access, often requiring or extending use of a venous catheter (VC) for hemodialysis. The InterGraft™ Anastomotic Connector System was developed for minimally invasive anastomosis of an arteriovenous graft (AVG). The venous and arterial InterGraft™ connectors are designed to provide optimized flow dynamics and may result in reduction of AVG stenosis.

Next generation renal denervation: chemical "perivascular" renal denervation with alcohol using a novel drug infusion catheter.

Background/purpose: We update the pre-clinical and early clinical results using a novel endovascular approach, to perform chemical renal denervation, via peri-adventitial injection of micro-doses of dehydrated alcohol (ethanol-EtOH).

Methods/materials: A novel, three-needle delivery device (Peregrine™) was used to denervate the renal arteries of adult swine (n = 17) and in a first-in-man feasibility study (n = 18). In the pre-clinical testing EtOH was infused bilaterally with one infusion per renal artery into to the perivascular space, using EtOH doses of 0.

Percutaneous creation of an arteriovenous fistula for hemodialysis access.

Purpose: Arteriovenous fistulae (AVFs) created by conventional surgical techniques are associated with suboptimal short- and long-term patency. This study investigated the feasibility of creating fistulae with a percutaneous system and evaluated the utility of percutaneous AVFs (pAVFs) in providing hemodialysis access.

Materials And Methods: From August 2012 to September 2013, a percutaneous system was used to attempt pAVF creation between the proximal ulnar artery and a closely associated ulnar vein in 33 patients.