Advertisement

Topics

TCD Detection of Gas and Solid Micro-Emboli in Patients Undergoing Coronary Artery Bypass Grafting (CABG): The Influence of Proximal Anastomosis Technique

2014-07-24 14:25:35 | BioPortfolio

Summary

The purpose of this study is to test the hypothesis that using three different techniques to anastomose coronary grafts to the aorta: partial occlusion, single cross clamp, or using the Heartstring anastomotic device, will change the amount of gas and solid microemboli as detected by the EmbodopR transcranial Doppler (TCD) system and consequently the neurocognitive performance of patients after coronary bypass operation.

Description

It is not uncommon for a cardiac surgical patient to have his heart fixed but his brain damaged. Sometimes the damage is overt and manifests itself as a major neurological deficiency. The frequency of stroke, the so called type 1 damage, is reported to be between 1 and 4 percent. This may increase mortality from 1.4% to 22% and hospitalization from 6.6 days to 17.5 days. Diffuse encephalopathy, presenting as delirium, confusion, coma and seizures, so called type 2 damage, is reported to appear in a much higher frequency of 3% to 7%, depending on timing and methods of evaluation. This type of damage will increase mortality from 1.4% to 7.5% and hospitalization from 6.6% to 15.2%. Sometimes it is more subtle and appears as neurocognitive decline. This type of damage may be found in 53% of the patients at discharge, in 24% after six months and the frequency rises again to 42% at five years. The impact on the patient and his family might be devastating and the burden on the medical system and society enormous. Long term, moderate to severe disability may affect 69% of the stroke patients and survival may decline to 67% after one year.

After years of research efforts it became evident that inadequate global blood flow to the brain is relatively uncommon and cerebral hemorrhage is a rare cause of brain damage during cardiac operations. It also became evident that one of the most important damage mechanisms is embolization to the brain and the inflammatory response which amplifies the ischemic embolic damage. Looking for possible embolic sources by monitoring embolic signals (HITS) on the transcranial doppler (TCD) tracings, researchers found that manipulation of the aorta during cardiac surgery, like cannulation and especially clamping is a major source of emboli. Using the side biting clamp while performing proximal anastomosis has the potential to crush the aortic wall and release macro and micro emboli especially when the aorta is atherosclerotic. Using a single cross clamp technique might eliminate the aortic wall solid debris but introduce air emboli instead.

Dealing with the same problem, a few proximal anastomotic devices have been introduced and most of them withdrawn from the market because of inferior patency rate. The Heartstring proximal anastomotic device is one of the recently introduced devices for which early good patency rate has been demonstrated. The advantages, in terms of less brain embolization or improved neurologic outcome, have never been demonstrated for the Heartstring or any other anastomotic device.

A recent potential breakthrough in this field of emboli research and prevention in order to improve neurologic outcome after cardiac surgery is the introduction of the EmbodopR system by DWL. This is a high quality TCD system which has been further developed to monitor cerebral emboli. It contains a module which automatically screens every event suspected as embolic, eliminates those recognized as artifacts according to four different criteria and records only real embolic events. Another module can differentiate every event as gas or solid emboli by simultaneously insonating the middle cerebral artery blood with tow ultrasound beams, each of different frequency. The result is a new ability for real time monitoring and characterization of embolic events during cardiac operations.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Intracranial Embolism and Thrombosis

Intervention

Proximal anastomosis using Heartstring anastomotic device

Location

Dr Zvi Adler
Haifa.
Israel
31096

Status

Recruiting

Source

Rambam Health Care Campus

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:25:35-0400

Clinical Trials [1104 Associated Clinical Trials listed on BioPortfolio]

Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis

The HDH device is intended for creating sutureless vascular anastomosis in various blood vessels. The HDH device consists of four parts: an elastic tube (graft), docking head (anastomotic ...

Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease

Kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for Crohn's disease (CD). This tecnique implies a hand-sewn ileocolic ...

Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer

Anastomotic leak (AL) is a breakdown of a suture line in a surgical anastomosis with a subsequent leakage of the luminal content. Anastomotic leakage occurs commonly in rectal and esophage...

NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In additio...

Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy

The study involves adult subject requiring colonic anastomosis following laparoscopic intra-corporeal surgery. The anastomosis will be performed by using nitinilclip by the LapCAC device i...

PubMed Articles [4101 Associated PubMed Articles listed on BioPortfolio]

Stapled side-to-side anastomosis might be benefit in intestinal resection for Crohn's disease: A systematic review and network meta-analysis.

Intestinal anastomosis is an essential step in the intestinal resection in patients with Crohn's disease (CD). Anastomotic configuration such as handsewn end-to-end anastomosis (HEEA), stapled side-to...

Endoscopic Treatment of the Coloanal Anastomotic Dehiscence and Stricture: Stenting Via Rendezvous Technique.

An anastomotic leak is a serious complication of colorectal surgery. Leak management is often grueling, and a definitive stoma is often mandatory for rescue therapy. Herein, we present a patient who e...

Endoluminal vacuum-assisted therapy as treatment for anastomotic leak after ileal pouch-anal anastomosis: a pilot study.

Anastomotic leak after ileal pouch-anal anastomosis (IPAA) could lead to poor functional results and failure of the pouch. The aim of the present study was to analyze the outcomes of the vacuum-assist...

A novel technique for cervical gastro-oesophageal anastomosis during minimally invasive oesophagectomy.

Anastomotic leakage, fibrous stricture and gastro-oesophageal reflux are three major complications of gastro-oesophageal anastomosis, particularly in cervical anastomosis. Our aim was to evaluate the ...

Anastomotic leakage after side-to-end anastomosis for rectal cancer: does leakage location matter?

To assess outcome according to location of anastomotic leakage (AL) after side-to-end stapler or manual low colorectal or coloanal anastomosis following laparoscopic total mesorectal excision (TME) fo...

Medical and Biotech [MESH] Definitions

Embolism or thrombosis involving blood vessels which supply intracranial structures. Emboli may originate from extracranial or intracranial sources. Thrombosis may occur in arterial or venous structures.

Breakdown of the connection and subsequent leakage of digestive system fluid from a SURGICAL ANASTOMOSIS of digestive system structures. Most common leakages are from breakdown of the sutured lines in gastrointestinal or bowel anastomosis.

Microsurgical revascularization to improve intracranial circulation. It usually involves joining the extracranial circulation to the intracranial circulation but may include extracranial revascularization (e.g., subclavian-vertebral artery bypass, subclavian-external carotid artery bypass). It is performed by joining two arteries (direct anastomosis or use of graft) or by free autologous transplantation of highly vascularized tissue to the surface of the brain.

A Y-shaped surgical anastomosis of any part of the digestive system which includes the small intestine as the eventual drainage site.

A procedure consisting of the SURGICAL ANASTOMOSIS of the proximal part of the JEJUNUM to the distal portion of the ILEUM, so as to bypass the nutrient-absorptive segment of the SMALL INTESTINE. Due to the severe malnutrition and life-threatening metabolic complications, this method is no longer used to treat MORBID OBESITY.

More From BioPortfolio on "TCD Detection of Gas and Solid Micro-Emboli in Patients Undergoing Coronary Artery Bypass Grafting (CABG): The Influence of Proximal Anastomosis Technique"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Cardiology
Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...


Searches Linking to this Trial