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Journal and News Scan
May 17, 2019
Submitted by: Claire Vernon
Patient Care and General Interest
The British Heart Foundation reports that the number of premature deaths related to cardiovascular disease has risen in the UK for the first time in 50 years.
A federal judge in the US ruled against the Food and Drug Administration’s (FDA) 2017 decision to allow e-cigarettes to remain on the commercial market prior to obtaining FDA approval, a move that was applauded by the associations that brought the suit.
Drugs and Devices
The US FDA has expanded the approved duration of support for 2 Impella heart pumps from 6 to 14 days.
Xvivo Perfusion, Inc, was granted premarket approval by the US FDA for its ex vivo lung perfusion system, a move that expands the device’s previous humanitarian device exemption authorization.
The US FDA has approved dalteparin sodium for treating venous thromboembolism in children as young as 1 month old.
Research, Trials, and Funding
The antiplatelet agent ticagrelor showed antibacterial activity against Staphylococcus and Enterococcus strains that was not seen with other antiplatelet agents, say researchers from Liege, Belgium.
Researchers in China compared the levels of circulating tumor cells after either a vein-first or artery-first approach to lobectomy for lung cancer.
An iron boost on the day before cardiac surgery reduced the need for blood transfusion in patients with anemia or iron deficiency, say researchers from Zurich, Switzerland.
Researchers in Durham, North Carolina, USA, grew human acellular vessels that were implanted in dialysis patients, and they speculate about potential future applications for these vessels, such as use during heart surgery.
May 16, 2019
Submitted by: Claire Vernon
Zhang and colleagues retrospectively compared outcomes for 27 patients who underwent lung transplantation either with or without ex vivo lung perfusion at their center. The ex vivo lung perfusion group consisted of recipients who received initially-discarded donor lungs that were reconditioned using ex vivo perfusion. Similar outcomes were observed between the two groups, including primary graft dysfunction, pulmonary function, chronic lung allograft dysfunction, and survival.
May 16, 2019
Submitted by: Joel Dunning
I believe that this is the world's first randomized controlled trial of mini aortic valve replacement (AVR) versus full sternotomy AVR.
It is a very well-conducted study where the surgeon was randomly assigned to perform an AVR by sterntomy or by manubrium-only. The same consultant surgeon performed either operation after randomization. No trainee performed any operations as operating surgeon. The protocol was very tightly adhered to.
The primary outcome was red cell transfusion at 7 days, and there were many secondary outcomes including length of stay, complications, etc, as might be expected.
The mean age was 69 and the mean EuroSCORE was 5.2 and the groups were perfectly matched.
The bypass time was 82 minutes in the ministernotomy group and 59 minutes in the sternotomy group.
The major outcome results might surprise you! Click on the link to find out!
May 15, 2019
Submitted by: Aristotle Protopapas
An interesting metanalysis, especially:
- The ad hoc results of off-pump surgery.
- The mean number of silent brain infarcts per patient was significantly higher in the transcatheter aortic valve implantation group (4.58 ± 2.09) compared with the aortic valve replacement group (2.16 ± 1.62, P=0.03).
May 14, 2019
Submitted by: Tom C. Nguyen
The manuscript summarizes evidenced-based perioperative guidelines for enhanced recovery after surgery (ERAS).
May 14, 2019
Submitted by: Arie Blitz
Ticagrelor (Brilinta), an oral P2Y12 inhibitor, is an agent used in combination with aspirin for dual antiplatelet therapy after coronary interventions. It's antiplatelet function cannot be reversed by platelet transfusion. The authors evaluated the efficacy of IV PB2452, a monoclonal antibody, in reversing ticagrelor's antiplatelet effect in a randomized, double-blind, placebo-controlled, phase 1 trial in healthy volunteers. The administration of PB2452 resulted in reversal of ticagrelor's antiplatelet effect within 5 minutes of infusion of the former, and this effect was sustained. There were minimal adverse events associated with this reversal agent.
May 10, 2019
Submitted by: Claire Vernon
Patient Care and General Interest
As state-specific regulations around marijuana change in the US, physicians and surgeons express concern about the dearth of information about the potential long-term harmful effects of smoking the drug.
A teenage heart transplant recipient has partnered with a chef to create a heart-healthy cookbook.
A genetically-engineered bacteriophage infusion is used to treat a lung transplant recipient’s drug-resistant infection in London, UK.
Patients don’t understand their implanted pacing devices as well as they think they do, and they also want to know more about their devices.
Australian professional golfer Jason Day has partnered with AstraZeneca to raise awareness of biomarker testing for lung cancer, following his mother’s diagnosis of late stage cancer.
Drugs and Devices
A medical device alternative summary reporting program from the US Food and Drug Administration (FDA) will be shut down, and past records will be made publicly available.
The US FDA has issued a safety communication, alerting providers that the batteries in certain pacemakers or cardiac resynchronization therapy pacemakers from Medtronic can fail early.
Research, Trials, and Funding
Research presented at the recent Annual Meeting of the American Association for Thoracic Surgery in Toronto, Canada, evaluated the use of an ultrasonic vessel-sealing device in minimally invasive lobectomy.
Healthy novice runners who trained for their first marathon showed a reduction in aortic stiffness, say researchers from University College London.
Researchers from London report in Nature the usage of microRNA to induce cardiac regeneration after heart attack in pigs.
May 10, 2019
Submitted by: Wei-Guo Ma
Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labeling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS–STS–AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO), and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions.
The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labeling of SHV size, in vivo and in vitro testing, and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard-setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS–STS–AATS Valve Labelling Task Force summarizes the background of SHV sizing and labeling and identifies the most important elements where further standardization is necessary.
May 9, 2019
Submitted by: Claire Vernon
Fuhrman and colleagues investigated the occurrence of acute kidney injury (AKI) in young adults with congenital heart disease undergoing a surgical procedure, a group of patients that is increasing in number. They retrospectively analyzed data for 699 patients between 18 and 40 years of age who were admitted to a children’s hospital's cardiac intensive care unit over an 11 year time period. AKI occurred in 13.2% of these patients. Suspected sepsis, exposure to calcineurin inhibitors, vancomycin, and piperacillin-tazobactam increased the odds of injury, even after controlling for several factors including repeat cardiopulmonary bypass.
The authors conclude that postoperative AKI is common in young adults with congenital heart disease and is associated with adverse outcomes. They also suggest that care be taken in the use of potentially nephrotoxic medications.
May 9, 2019
Submitted by: Claire Vernon
Ostrowski and colleagues report on the results of two lung cancer computed tomography screening programs that, when combined, included more than 14,000 smokers older than 50 years. The incidence of lung cancer was 1-2%. A total of 4% of patients were referred for further invasive diagnostic follow-up. Surgical resection was necessary in 1.5%. The authors found that modified inclusion criteria in one of the screening programs lead to a different detection rate of non–small cell lung cancer.