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Journal and News Scan

Source: The New England Journal of Medicine
Author(s): Gregg W. Stone, JoAnn Lindenfeld, William T. Abraham, Saibal Kar, D. Scott Lim, Jacob M. Mishell, Brian Whisenant, Paul A. Grayburn, Michael Rinaldi, Samir R. Kapadia, Vivek Rajagopal, Ian J. Sarembock, Andreas Brieke, Steven O. Marx, David J. Cohen, Neil J. Weissman, and Michael J. Mack for the COAPT Investigators

This multicenter study evaluated the efficacy of medical therapy plus transcatheter valve repair (MitraClip) to medical therapy alone for heart failure accompanied by secondary moderate to severe mitral regurgitation. The device group experienced significantly fewer hospitalizations and lower mortality at 24 months follow-up. 

Source: The New England Journal of Medicine
Author(s): Scott J. Antonia, Augusto Villegas, Davey Daniel, David Vicente, Shuji Murakami, Rina Hui, Takayasu Kurata, Alberto Chiappori, Ki H. Lee, Maike de Wit, Byoung C. Cho, Maryam Bourhaba, Xavier Quantin, Takaaki Tokito, Tarek Mekhail, David Planchard, Young-Chul Kim, Christos S. Karapetis, Sandrine Hiret, Gyula Ostoros, Kaoru Kubota, Jhanelle E. Gray, Luis Paz-Ares, Javier de Castro Carpeño, Corinne Faivre-Finn, Martin Reck, Johan Vansteenkiste, David R. Spigel, Catherine Wadsworth, Giovanni Melillo, Maria Taboada, Phillip A. Dennis, Mustafa Özgüroğlu for the PACIFIC Investigators

This comprises the eagerly anticipated summary of the second primary endpoint of the PACIFIC trial of Durvalumab vs placebo in patients who completed CT/RT without progression for unresectable stage III NSCLC. Durvalumab significantly improved overall survival, progression free survival, and time to distant metastasis or death. No new safety concerns were raised.

Source: News from around the web.
Author(s): Emily Robinson

Patient Care and General Interest

A man who received quintuple bypass surgery in Little Rock, Arkansas, USA, plans to cycle a 50-mile race only two months later.

A woman in Denver, Colorado, USA, was told she had 6-9 months to live after being diagnosed with Stage 3 lung cancer; however, after participating in clinical trials for lung cancer treatment, she is doing well 10 years later.

 

Drugs and Devices

A hospital in New Jersey, USA, is testing an artificial intelligence device designed to detect bleeding during endovascular procedures.

The US Food and Drug Administration has approved the PK Papyrus covered coronary stent system for the treatment of acute coronary artery perforations during PCI, the first device to be approved for this indication in 17 years.

A study by the New York University School of Medicine in New York City suggests that an artificial intelligence tool can diagnose non-small cell lung cancer types with 97 percent accuracy.

 

Research, Trials, and Funding

A paper published in the Irish Journal of Medical Science indicates that undetected cases of high cholesterol are adding to the incidence of cardiovascular disease, which is the greatest cause of death in Ireland.

A Journal of the American College of Cardiology study of off-pump versus on-pump CABG suggests that the on-pump approach provides superior long-term survival.  

Source: European Journal of Cardio-Thoracic Surgery
Author(s): Chin L Poh, Edward Buratto, Marco Larobina, Rochelle Wynne, Michael O’Keefe, John Goldblatt, James Tatoulis, Peter D Skillington

Poh and colleagues analyzed the results of the Ross procedure in 129 patients with bicuspid aortic valve and pure aortic regurgitation. The mean age at surgery was 34.7 ± 10.6 years and mean length of follow-up was 9.6 ± 6.8 years. Late survival at 10 and 20 years after surgery were 99% and 95%, respectively, and aortic valve redo surgery was necessary in 11 patients. Longer aortic cross-clamp and cardiopulmonary bypass times and larger preoperative sinotubular junction diameter were predictors of having redo aortic valve surgery.

Source: Annals of Cardiothoracic Surgery
Author(s): Cristiano Spadaccio, Umberto Benedetto

This comphrensive review by Spadaccio and Benedetto try to address the unanswered question: to stent or not to stent?

The conclusions underline that the higher cerebrovascular risks associated with surgery are still overcome by long term outcome.

Source: The Annals of Thoracic Surgery
Author(s): Adam N. Protos, Jaimin R. Trivedi, William M. Whited, Michael P. Rogers, Ugochukwu Owolabi, Kendra J. Grubb, Kristen Sell-Dottin, Mark S. Slaughter

Management of tricuspid endocarditis in this single institution study of 63 patients included repair, replacement, and excision. Repair patients were older and sicker. Acute outcomes were similar among the groups. Valvectomy patients had a lower rate of readmission during the first postoperative year, highlighting this approach as a useful strategy for identifying eventual candidates for valve replacement.

Source: The New York Times
Author(s): Denise Grady

A New York Times journalist travels with Team Heart, a nonprofit organization providing humanitarian heart surgery for rheumatic disease in Rwanda. In addition to highlighting the overwhelming need, her perspective illuminates some harsh realities of these efforts in resource-poor countries. Examples include the cultural repercussions of mechanical valves in females of childbearing age and the challenging surgical judgment required when operating on patients who are sick enough to warrant surgery, yet not too sick to survive in the context of limited perioperative support. Dr. Ralph Bolman III, Dr. Thoralf Sundt, and Dr. Bruce Leavitt are among the physicians participating in the effort and featured story.

Source: World Journal for Pediatric and Congenital Heart Surgery
Author(s): Karthik V. Ramakrishnan, David Zurakowski, William Pastor, Richard A. Jonas, Pranava Sinha

This study compares the early outcomes and hospital charges associated with early primary repair vs systemic-to-pulmonary artery shunt for neonates and young infants. The Pediatric Health Information System database was queried for patients <90 days of age with primary diagnosis of tetralogy of Fallot who underwent nonelective surgical repair or palliation between January 2008 and December 2014. The initial cohort of 821 patients (group 1 early primary repair, N = 554; group 2 systemic-to-pulmonary artery shunt, N = 267) was propensity score matched (248 patients in each group) to account for baseline imbalances in age and prostaglandin use. The analysis suggests that the two approaches are comparable with regard to morbidity, mortality and hospital resource utilization. The article is accompanied by separate Invited Commentaries, by Emile Bacha, MD and by Yves D’Udekem, MD, PhD.

Source: Journal of the American College of Cardiology
Author(s): Ron Waksman, Toby Rogers, Rebecca Torguson, Paul Gordon, Afshin Ehsan, Sean R. Wilson, John Goncalves, Robert Levitt, Chiwon Hahn, Puja Parikh, Thomas Bilfinger, David Butzel, Scott Buchanan, Nicholas Hanna, Robert Garrett, Federico Asch, Gaby Weissman, Itsik Ben-Dor, Christian Shults, Roshni Bastian, Paige E. Craig, Hector M. Garcia-Garcia, Paul Kolm, Quan Zou, Lowell F. Satler, Paul J. Corso

Results of a clinical trial using transcatheter aortic valve replacement provided a "strong signal" that it is safe for patients with low surgical risk, potentially helping to open the way for broader use of the minimally invasive procedure, also known as TAVR.

The Low-Risk TAVR trial results, presented this week at the European Society of Cardiology Congress 2018 showed no deaths or disabling strokes within 30 days of undergoing the procedure for 200 patients with low surgical risk who participated in the study, led by MedStar Heart & Vascular Institute at MedStar Washington Hospital Center.

The results of the trial, the first of its kind, approved by the Food and Drug Administration, were published online in the Journal of the American College of Cardiology.

Source: Nordic Cochrane Centre
Author(s): Peter Gøtzsche, Tom Jefferson

The highly respected Cochrane Collaboration is in crisis today at its 25th annual meeting in Edinburgh as one board member is expelled and six more resign. There are more links below but it seems to have been over a dispute regarding the independence of authors and members with regards to links to industry and pharmaceutical companies. Here is a statement from the rump governing board, released yesterday:
https://www.cochrane.org/news/message-governing-board

Peter Gøtzsche's statement: "I regret to inform you that I have been expelled from membership in the Cochrane Collaboration by the favourable vote of six of the 13 members of the governing board."
https://nordic.cochrane.org/sites/nordic.cochrane.org/files/public/uploads/moral_crisis_in_cochrane.pdf 

Four other members of the board have resigned: Gerald Gartlehner, David Hammerstein, Joerg Meerpohl, and Nancy Santesso.
https://austria.cochrane.org/news/why-we-resigned

Two other members of the governing bord (Rae Lamb and Catherine Marshall) resigned because of governance issues.
https://www.cochrane.org/news/message-governing-board

This dispute has been going on for some time but the trigger may have been the critique of the Cochrane reivew of HPV vaccines (not of the vaccines themselves, but of the methods used):
https://ebm.bmj.com/content/early/2018/07/27/bmjebm-2018-111012

Here is the Cochrane editor in chief's response to the critique:
https://www.cochrane.org/news/cochranes-editor-chief-responds-bmj-ebm-article-criticizing-hpv-review

Responses to this will be published in BMJ-EBM. Earlier coverage is published in BMJ and The Lancet. There is a lot more but these are all the public facts up to now. 

Cochrane HPV vaccine review: BMJ journal defends "inconvenient criticisms."
https://www.bmj.com/content/362/bmj.k3927.full

Details provided by professor Tom Jefferson, senior associate tutor.

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