Showing posts with label Innovations. Show all posts
Showing posts with label Innovations. Show all posts

Tuesday, May 3, 2011

Cath: Novelties. Fusing MRI with X-ray

Published ahead of print. Accessed on 5/2/2011
Circulation: Cardiovascular Imaging

X-ray Magnetic Resonance Fusion to Internal Markers and Utility in Congenital Heart Disease Catheterization

Yoav Dori1*, et al.
The Children's Hospital of Philadelphia, Philadelphia, PA & Siemens Healthcare, Malvern, PA
Corresponding author; email: doriy@email.chop.edu

Abstract
Background—X-ray magnetic resonance fusion (XMRF) allows for utilization of 3D data during cardiac catheterization. However, to date, technical requirements have limited the use of this modality in clinical practice. Here we report on a new internal marker XMRF method that we have developed and describe how we used XMRF during cardiac catheterization in congenital heart disease.

Methods and Results—XMRF was performed in a phantom and in 23 patients presenting for cardiac catheterization who also needed cardiac MRI for clinical reasons. The registration process was performed in less than 5 minutes per patient with minimal radiation (0.004 - 0.024 mSv) and without contrast. Registration error was calculated in a phantom and in 8 patients using the maximum distance between angiographic and 3D model boundaries. In the phantom the measured error in the AP projection had a mean of 1.15 mm (standard deviation 0.73). The measured error in patients had a median of 2.15 mm (IQR 1.65 - 2.56 mm). Internal markers included bones, airway, image artifact, calcifications, and the heart and vessel borders. The MRI data was used for road mapping in 17/23 (74%) cases and camera angle selection in 11/23 (48%) cases.

Conclusions—Internal markers based registration can be performed quickly, with minimal radiation, without the need for contrast, and with clinically acceptable accuracy using commercially available software. We have also demonstrated several potential uses for XMRF in routine clinical practice. This modality has the potential to reduce radiation exposure and improve catheterization outcomes.

Two video links:
http://circimaging.ahajournals.org/content/suppl/2011/04/29/CIRCIMAGING.111.963868.DC1/Video1.mov

Video showing MRI fusion with fluoro guiding cath procedure:
http://circimaging.ahajournals.org/content/suppl/2011/04/29/CIRCIMAGING.111.963868.DC1/Video2.mov

Tuesday, April 26, 2011

Innovation: Robotic Coronary Angioplasty

































J Am Coll Cardiol Intv, 2011; 4:460-465,

First-in-Human Evaluation of a Novel Robotic-Assisted Coronary Angioplasty System

Juan F. Granada, MD*,,*, Juan A. Delgado, MD, Maria Paola Uribe, MSCE, Andres Fernandez, MD, Guillermo Blanco, MD, Martin B. Leon, MD, Giora Weisz, MD
* Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, New York, New York Corbic Research Institute, Envigado, Colombia Corbic Medical Center, Envigado, Columbia New York Presbyterian Hospital, Columbia University Medical Center, New York, New York (Email: jgranada@crf.org)

Background: A remote-control, robotic-assisted angioplasty system is under development to address some of the procedural challenges and occupational hazards associated with traditional PCI.

Methods:

CorPath 200 robotic system (Corindus, Inc., Natick, Massachusetts) consists of a remote cockpit & a multicomponent bedside unit that enables the operator to advance, retract, and rotate guidewires and rapid exchange catheters. The primary endpoint was device clinical success (30% residual stenosis) without in-hospital major adverse cardiac events.


Technical success was defined as the ability of the system to complete all the planned angioplasty steps on the basis of procedural segments. Patients were followed up to 30 days after angioplasty procedure.

Results: A total of 8 patients were enrolled in the study. The primary endpoint was achieved in all patients (100%). The technical success of the robotic system was 97.9% in completing 47 of 48 planned steps. There were no device- or procedure-related complications and no in-hospital or 30-day major adverse cardiac events. The operators rated the robotic system performances as equal to or better than manual procedures in 97.5% of the cases. The operator radiation exposure was 97% lower than the levels found at the standard table position.

Conclusions: Early clinical experience with a robotic-assisted angioplasty system demonstrated feasibility, safety, and procedural effectiveness comparable to manual operation. In addition, the total operator exposure to radiation was significantly low. A larger study is warranted to verify the safety and effectiveness of robotic-assisted percutaneous coronary intervention.

Tuesday, September 21, 2010

Stroke & PFO - New devices

J Am Coll Cardiol Intv, 2010; 3:963-967
Patent Foramen Ovale Closure With the SeptRx Device. Initial Experience With the First "In-Tunnel" Device.
Wibke J. Zimmermann, MD, Corinna Heinisch, MD, Nicolas Majunke, MD, Stephan Staubach, MD, Scott Russell, Nina Wunderlich, MD, Horst Sievert, MD*
CardioVascular Center, Sankt Katharinen, Frankfurt, Germany

Objectives: The purpose of this study was to evaluate the safety and effectiveness of the SeptRx patent foramen ovale (PFO) closure device (SeptRx, Inc., Fremont, California).

Background: A PFO is a relatively common remnant of the fetal circulation that can be associated with cryptogenic stroke, transient ischemic attack, migraine, or decompression sickness. Percutaneous PFO closure with different devices has been performed for many years. However, most of the common devices leave a relatively large amount of material in the left and right atria. The SeptRx PFO device (SeptRx, Inc.) is the first PFO closure device designed to fit directly into the pocket of the PFO.

Methods: From July 2006 to May 2007, 13 patients between 18 and 65 years of age with a history of cryptogenic stroke or transient ischemic attack were included into this first-in-man trial. All patients received 100 mg aspirin and 75 mg clopidogrel for 6 months. Follow-up was done at 1 and 6 months after procedure with transesophageal echocardiography and transcranial Doppler.

Results: In 11 of 13 patients, PFO closure with the SeptRx device was successfully performed. In 2 patients, PFO closure with this device was not possible due to the anatomy of the PFO; 1 device was retrieved before release, and the other was recaptured with a snare. After 30 days, 6 of the 11 PFOs were closed; after 6 months, all were closed. No adverse events occurred.

Conclusions: The SeptRx PFO closure device appears to be safe and effective. The advantage of this occluder is that there is only minimal foreign material on the left and right sides of the interatrial septum. This is the first such "in-tunnel" PFO closure device.



The longer anchors are on the left atrial side and are designed to uncoil to accommodate a range of patent foramen ovale (PFO) tunnel lengths. The interior of the device contains a fine-wire braided Nitinol mesh, which provides an immediate barrier to the conduction of emboli and is intended to stimulate the body‘s natural adhesion response for permanent closure of the PFO.




J Am Coll Cardiol Intv, 2010; 3:968-973
Patent Foramen Ovale Closure Using a Bioabsorbable Closure Device
Safety and Efficacy at 6-Month Follow-Up
Ben J. Van den Branden, MD*, Martijn C. Post, MD, PhD, Herbert W. Plokker, MD, PhD, Jurriƫn M. ten Berg, MD, PhD, Maarten J. Suttorp, MD, PhD
Department of Interventional Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands

Objectives: The aim of this study was to assess the mid-term safety and efficacy of percutaneous patent foramen ovale (PFO) closure using a bioabsorbable device (BioSTAR, NMT Medical, Boston, Massachusetts).

Background: Closure of PFO in patients with cryptogenic stroke has proven to be safe and effective using different types of permanent devices.

Methods: All consecutive patients who underwent percutaneous PFO closure with the bioabsorbable closure device between November 2007 and January 2009 were included. Residual shunt was assessed using contrast transthoracic echocardiography.

Results: Sixty-two patients (55% women, mean age 47.7 ± 11.8 years) underwent PFO closure. The in-hospital complications were a surgical device retrieval in 2 patients (3.2%), device reposition in 1 (1.6%), and a minimal groin hematoma in 6 patients (9.7%). The short-term complications at 1-month follow-up (n = 60) were a transient ischemic attack in the presence of a residual shunt in 1 patient and new supraventricular tachycardia in 7 patients (11.3%). At 6-month follow-up (n = 60), 1 patient without residual shunt developed a transient ischemic attack and 1 developed atrial fibrillation. A mild or moderate residual shunt was noted in 51.7%, 33.9%, and 23.7% after 1-day, 1-month, and 6-month follow-up, respectively. A large shunt was present in 8.3%, 3.4%, and 0% after 1-day, 1-month, and 6-month follow-up.

Conclusions: Closure of PFO using the bioabsorbable device is associated with a low complication rate and a low recurrence rate of embolic events. However, a relatively high percentage of mild or moderate residual shunting is still present at 6-month follow-up.

The biodegradable matrix is mounted on the MP35N STARFlex "double-umbrella" framework. The left and right atrial umbrellas are connected by microsprings, serving as a self-centering mechanism.




Sunday, September 19, 2010

Innovation: Parental Use of External Defibrillator for Infant with LQTS

Pediatrics 2006:118:e526-e529
Abhay Divekar and Reeni Soni


Congenital long-QT syndrome with 2:1 atrioventricular block presenting in the perinatal period is rare, has a poor prognosis, and leads to high risk for lethal ventricular arrhythmic events. An implantable cardioverter-defibrillator seems to be the most effective treatment in the prevention of arrhythmic sudden cardiac death in patients with long-QT syndrome. Technical limitations and risks associated with implantable cardioverter-defibrillators in asymptomatic infants is considered too great to justify use for primary prophylaxis against sudden cardiac death. In this case report we describe the first successful parental use of an automated external defibrillator prescribed for primary prophylaxis against sudden cardiac death in an infant with long-QT syndrome.


Additional Reading:
T wave morphology in LQTS
Circulation 2000;102:2849-2855

Very useful article to identify genotype based on EKG findings.

Saturday, September 11, 2010