IMPELLA INTERACTION WITH FIBERS OF STERILE GAUZES (+)

 

Impella devices are typically implanted in the hemodynamics laboratory or the operating room, where sterile gauzes made of interwoven fibers are commonly used. 

These sterile gauzes are absorbent pads made of cotton or synthetic materials. 

 

Typically, the gauzes used in the cath lab or operating room are X-ray detectable, as they contain a radiopaque thread or strip to make them visible on X-rays, helping prevent retention of gauze inside the patient.

 

Often, surgical gauzes are designed to be lint-free to avoid leaving these fibers in the surgical site.

But there is always the possibility that a fiber may come loose and end up in the surgical field or in the sterile saline containers. 

 

Abiomed identified that in the analysis of some cases of low flow or pump thrombosis the clot may form around a matrix of white or blue fibers.

 More information in this video: 

 

 

 

 Fig: Sterile Gauze

Fig: Sterile saline basin. 

 

 

Fig: Abiomed Field Safety Notice: Impella Risk of fiber ingestion. 

Fig: Prevent Impella contact with fibers. 

Fig: Avoid rinsing Impella in the sterile saline basin. 

Fig: Keep Impella i the packaging until the insertion. 

Tags: impella, fibers, interaction, sterile, gauze, cath lab, operating room, OR, Cotton, synthetic, X-ray, detectable, opaque, loose, low flow, pump stop, hemolysis, matrix, white fiber, blue fiber, clot, ingestion, recommendations, packaging, rinse, basin, fluid, bath, saline, floating, IFU, instructions, safety, alert.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

IMPELLA RISK OF VENTRICLE PERFORATION (+)

 

The Impella CP and 5.5 devices are cardiac assist systems used for hemodynamic support in cases of high risk PCI or cardiogenic shock.

They are advanced over a guidewire and placed inside the left ventricle.

One of the reported complications is left ventricular perforation due to catheter manipulation during insertion or repositioning.

In February 2024, The FDA issued a recall regarding Impella left sided blood pumps due to perforation risks.

The company Abiomed, due to reported cases, announced an update to the instructions for use of the Impella CP and Impella 5 point 5 devices to include the possibility of cardiac perforation and the measures to take to prevent it.

Complete and detailed information in the next video:

Fig: Impella CP positioning.

Fig: Impella Tuohy Borst Valve

Fig: Repositioning unit.

Fig: Impella 5.5 position.

Fig: Impella 5.5 repositioning unit.

Tags: impella, iatrogenic, perforation, risk, high risk PCI, HRPCI, shock, cardiogenic shock, complication, FDA, FDA recall, IFU, pacing electrode, pulmonary artery catheter, TAVR, TAVI, ablation catheter, Amplazter closure device, position, Tuohy-Borst valve, sheath, repositioning unit, echocardiogram, impella cp, impella 5.5, fixation, CPR, aneurism.

IMPELLA ECP, DESCRIPTION AND OPERATION, AFTER TCT 2024 PIVOTAL TRIAL PRESENTATION. (+)

 

n 2024, at the TCT congress, the Impella ECP pivotal trial results were presented.

At that time, the only Impella catheter approved for High Risk PCI was the Impella CP, a device with a maximum diameter of 14 French.

The Impella ECP was designed to provide hemodynamic support during high-risk PCI, allowing for a reduction in arterial sheath access size to 9 French, as It incorporates a compressible 21 French pump.

Complete information in the next video:

 

FIGURE: IMPELLA ECP CATHETER.

FIGURE: IMPELLA ECP PIGTAIL, INFLOW, OUTFLOW. 

FIGURE: IMPELLA ECP SCREEN.

FIGURE: IMPELLA ECP: PIGTAIL, INFLOW. 

TAGS: impella, impella ECP, impella CP, high risk PCI, HRPCI, 6h, Expandable cardiac output, expandable, compresible, 21F, 9F, sheath, retrieve, pigtail, impeller, inflow, outflow, cannula, shaft, motor, red handle, hemopump, history, wireless, delivery, insertion, mean flow, average flow, expected flow, screen, optical sensor, removal, resheath, re-sheath, angioseal, angioseal 8F, FDA, submitted, aproval.