nitinol and Heart-Failure

Functional mitral regurgitation in heart failure limits survival in a severity-graded fashion. Even mild mitral regurgitation doubles mortality risk. We report the use of a non-stented coronary sinus device to reduce mitral annulus dimension in order to re-establish mitral valve competence. The device (PTMA, Viacor, Inc., Wilmington, MA, USA) consists of a multi-lumen PTFE (Teflon) PTMA catheter in which Nitinol (nickel-titanium alloy) treatment rods are advanced. For individual use up to three rods of different length and stiffness can be used. Therefore dimension reduction can be performed in an incremental fashion. Fluoroscopy and 3 D echocardiography are performed throughout the procedure to visiualize the positioning and confirm maximum treatment effect. The case describes the use and the effect of PTMA treatment. Safety and efficacy of the PTMA device will be investigated in the upcoming PTOLEMY 2 trial.

Topics: Aged; Aged, 80 and over; Alloys; Cardiac Catheterization; Coronary Sinus; Echocardiography, Three-Dimensional; Female; Fluoroscopy; Follow-Up Studies; Heart Failure; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Male; Middle Aged; Mitral Valve Insufficiency; Prosthesis Design; Treatment Outcome

Mechanical right ventricular (RV) support offers a treatment option for critically ill patients with RV failure (RVF). We developed an assist device for rapid percutaneous implantation. The aim of the present study was to investigate the implantation procedure, haemodynamic performance and possible side effects of the novel right ventricular assist device - PERKAT RV - in an animal model.. The PERkutane KATheterpumptechnologie RV (PERKAT RV) device consists of a nitinol chamber covered by foil containing inflow valves. An outlet tube is attached to its distal part. The system is designed for 18 Fr percutaneous implantation. The chamber is unfolded in the inferior vena cava while the outlet tube bypasses the right heart with the tip in the pulmonary trunk. An IABP balloon is placed inside. Balloon deflation generates blood flow into the chamber; during inflation, blood is guided into the pulmonary arteries. Acute RVF was induced by venous injection of Sephadex in seven sheep for evaluation of the device. The PERKAT RV was able to improve haemodynamics immediately generating a median increase in cardiac output of 59%. Longer pump support was evaluated in a second study. Four sheep were supported for eight hours without any problems.. The percutaneous implantation and explantation of the PERKAT RV device was possible in the designed way. The sheep studies proved beneficial haemodynamic effects in acute RVF. The system offers easy and safe treatment in acute RVF.

Topics: Alloys; Animals; Device Removal; Disease Models, Animal; Female; Heart Failure; Heart-Assist Devices; Hemodynamics; Intra-Aortic Balloon Pumping; Prosthesis Design; Prosthesis Implantation; Pulmonary Embolism; Sheep, Domestic; Stents; Time Factors; Ventricular Function, Right

The development of de novo aortic insufficiency (AI) is a significant complication of long-term LVAD support, which can lead to ineffective support, decreased device durability, end organ malperfusion, and increased mortality. Surgical aortic valve (AV) closure has been the standard treatment for symptomatic patients, but is associated with high mortality and recurrence of AI. Percutaneous AV closure using the Amplatzer cribriform device is a feasible and may be the preferable option to treat LVAD-associated severe AI in high-surgical risk patients. Certain technical issues with this procedure should be taken into consideration to achieve optimal results. © 2015 Wiley Periodicals, Inc.

Topics: Aged, 80 and over; Alloys; Aortic Valve; Aortic Valve Insufficiency; Cardiac Catheterization; Echocardiography, Doppler, Color; Echocardiography, Transesophageal; Heart Failure; Heart-Assist Devices; Humans; Male; Porosity; Prosthesis Design; Radiography, Interventional; Septal Occluder Device; Treatment Outcome; Ventricular Function, Left

We sought to evaluate the pathologic findings of the percutaneous Parachute device implanted in patients with severe heart failure (HF).. Currently, most treatments of HF rest on optimal medical therapy with adjunctive interventional or surgical palliative treatments. One such treatment is the Parachute device, which partitions the left ventricle excluding the scarred myocardium from functioning myocardium, and has shown promise in clinical studies.. We have examined histopathologically seven cases [six males (age range 43–74 years; mean 56 years) and one female (55 years)] of Parachute device that were either retrieved at autopsy (n = 4) or during transplantation (n = 3); implant duration, 15-1,533 days.. Three patients died of cardiac causes and none died from complications. Histologic early changes (<30 days, n = 1) included adherent thrombus, with focal neutrophil infiltration and degenerating inflammatory cells. Over time (31–300 days, n = 4), there was organized thrombus and development of neoendocardial thickening especially at the free-edge of the device and its contact with the adjacent endocardium while the base of the device showed varying degrees of fibrin thrombus. The greatest organization of thrombus was observed in devices removed at >300 days (680 and 1533 days); both had fractures of the foot along with strut fracture and one had tearing of the expanded polytetrafluoroethylene.. The percutaneous Parachute device appears as a promising adjunctive treatment for patients suffering from severe HF. The pathologic changes are those of organizing thrombus with and without inflammation with minor complications of foot and strut fracture.

Topics: Adult; Aged; Alloys; Autopsy; Coronary Artery Disease; Device Removal; Equipment Design; Female; Heart Failure; Heart Transplantation; Heart-Assist Devices; Humans; Male; Middle Aged; Myocarditis; Myocardium; Severity of Illness Index; Thrombosis; Time Factors; Wound Healing