Category: News


Lantry – Complications of ECMO from maryland.ccproject.com on Vimeo.

In 1901 Jokichi Takamine (1854-1922) isolated the pure form of adrenaline, also known as epinephrine.

In 1893, George Oliver (1841– 1915), using his own instruments, studied the impact of glycerol extracts on arteries.

Routine use of adrenaline for cardiac arrest was first proposed in the 1960’s. Its inclusion within cardiac arrest management was based upon an understanding of the physiological role of adrenaline, and experimental data from animal research which showed that ROSC was more likely when the drug was used. It was not included on the basis of evidence of benefit in humans, but has remained, since today, a significant component of advanced life support despite minimal human data indicating beneficial effect .

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The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

Recalled Product:

  • HeartWare Ventricular Assist Device (HVAD)
  • Serial Numbers: All HVADs with serial numbers lower than HW25838
  • Product Codes: 1103, 1104
  • Manufacturing Dates: March 17, 2006 to June 27, 2016
  • Devices Recalled in the U.S.:105 units distributed nationwide

Device Use

The HVAD helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant. The system includes a pump implanted in the space around the heart (pericardium) and a controller that controls the speed and function of the pump.

The HVAD is designed for use both in and out of hospital settings, including during patient transport.

Reason for Recall

HeartWare Inc. is recalling the HVAD pumps due to a design problem with the driveline connector. The driveline is a tube that connects the HVAD’s pump to the external controller and power source. Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.

Who May be Affected

  • Patients receiving cardiac support using the HVAD system
  • Health care providers and caregivers monitoring patients with a HVAD system

What to Do

On August 17, 2016, HeartWare Inc. sent an “Urgent Medical Device Recall Letter” to affected customers. The letter instructed consumers to:

  • Identify affected HVADs in hospital inventory
  • Complete and return the “Acknowledgement Form” attached to the letter
  • Return affected products to HeartWare Inc.
  • After returning the affected products, complete and return the “Completion Form” to a HeartWare representative no later than 2 months from the date on the letter
  • Remind their patients about the safe use of the HVAD System, particularly with regard to moisture and proper connection to power and data sources.

Contact Information

Health care providers who have questions should contact their HeartWare representative or contact HeartWare Inc. at cs@heartware.com or 1-877-367-4823 with any questions related to this recall.

Date Recall Initiated:

July 29, 2016

Additional Resources:

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

Abstract
BACKGROUND:
This clinical practice guideline addresses six questions related to liberation from mechanical ventilation in critically ill adults. It is the result of a collaborative effort between the American Thoracic Society (ATS) and American College of Chest Physicians (CHEST).
METHODS:
A multi-disciplinary panel posed six clinical questions in a Population, Intervention, Comparator and Outcomes (PICO) format. A comprehensive literature search and evidence synthesis was performed for each question, which included appraising the certainty in the evidence (i.e., the quality of evidence) using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach. The Evidence-to-Decision Framework was applied to each question, requiring the panel to evaluate and weigh the: importance of the problem, confidence in the evidence, certainty about how much the public value the main outcomes, magnitude and balance of desirable and undesirable outcomes, resources and costs associated with the intervention, impact on health disparities, and acceptability and feasibility of the intervention.
RESULTS:
Evidence-based recommendations were formulated and graded, initially by subcommittees and then modified following full panel discussions. The recommendations were confirmed by confidential electronic voting; approval required that at least 80% of the panel members agree with the recommendation.
CONCLUSION:
The panel provides recommendations regarding liberation from mechanical ventilation. The details regarding the evidence and rationale for each recommendation are presented in the American Journal of Respiratory and Critical Care Medicine and CHEST.

Please join us for this year’s Annual General Meeting (AGM) at 15:30 on Saturday, October 22, 2016 in the Ville Marie room at the Westin Montreal.
This meeting will highlight the activities and accomplishments of the Society and its members as well as help determine the upcoming CANCARE initiatives.

CANCARE Annual General Meeting
Saturday, October 22, 2016
17:30 – 18:30
Westin, Room Ville Marie

On behalf of the Conference Planning Committee of the American Delirium Society, I cordially invite you to submit   proposals for presentation at ADS’ 7th Annual Meeting, June 4 – June 6, 2017, in Nashville, TN.

Key to-be-completed-by dates to bear in mind:

09/15/2016:  Submission of Proposals for Symposia, Workshops and Roundtable Discussions
12/15/2016:  Submission of Oral Presentation Abstracts
01/16/2017:  Submission of Poster Abstracts
03/31/2017:  Early Registration Closes (Presenters must register by this date)

Rakesh Arora
President – The CANCARE Society
Past President – The American Delirium Society

ECMO DAY

Multidisciplinary discussion including Perfusion, Cardiovascular Surgeons, Intensivists, Emergency Physicians, and Cardiologists involved in ECMO.

www.icm-mhi.org/fr/jour-ecmo-day

 

A study in the American Journal of Critical Care (AJCC) found a remarkably high prevalence of delirium in a small cohort of critically ill patients treated with therapeutic hypothermia after cardiac arrest.

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People with sleep disorders may have a higher risk of death, heart failure and stroke after having a procedure to open blocked heart arteries, according to new research in the Journal of the American Heart Association.

Acute coronary syndrome is an umbrella term for conditions in which blood supplied to the heart is suddenly blocked. Doctors reopen blocked arteries by threading a catheter through the femoral artery in the groin or the radial artery in the wrist through percutaneous coronary intervention, or PCI, a procedure also known as angioplasty. Go the AHA news

Abstract
OBJECTIVE:
The objective of this article is to provide a summary of the perceptions of healthcare providers and family members toward their role in active patient care in the ICU and compare the views of healthcare providers with those of relatives of critically ill patients.

DATA SOURCES:
The search was conducted using PubMed as the primary search engine and EMBASE as a secondary search engine.

STUDY SELECTION:
Studies were included if they were conducted in the ICU, had an adult patient population, and contained a discussion of active patient care, including perspective or actions of family members or healthcare providers about the active participation.

DATA EXTRACTION:
Titles and abstracts of articles identified through PubMed and EMBASE were assessed for relevancy of family involvement. The full article was reviewed of titles and abstracts involving family involvement of care in the ICU to assess if the topic was active care and if the article involved perceptions of healthcare providers or family members. The references of all selected articles were then evaluated for the inclusion of additional studies.

DATA SYNTHESIS:
Articles including perceptions of healthcare providers were grouped separately from articles including attitudes of family members. Articles that contained the perceptions of both healthcare providers and family members were considered in both groups but were evaluated with each perspective separately. Examples of specific patient care tasks that were mentioned in each article were identified.

CONCLUSIONS:
A positive attitude exists among both family members and providers toward the involvement of family members in active care tasks. Providers and family members share the attitude that a partnership is necessary and that encouragement for family members to participate is essential. The findings in this review support the need for more objective research regarding how families are caring for their loved ones and how family involvement in care is affecting patient and family outcomes.