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Journal and News Scan

Source: Cook Medical Newsroom
Author(s): Cook Medical

Cook Medical announced that Dr Joseph Lombardi in New Jersey treated the first patient in the US using the newly approved Zenith® Dissection Endovascular System as part of the device's commercial launch. The system consists of a proximal stent-graft component and a distal bare stent component. “The value in this dissection stent is that it’s pathology-specific, designed just for this disease," said Dr Lombardi, the Global Principal Investigator of the STABLE I and STABLE II clinical trials.

Source: News from around the web.
Author(s): Claire Vernon

Patient Care and General Interest

The US Centers for Medicare and Medicaid Services have released their proposed update to the national coverage policy for transcatheter aortic valve replacement, in which they did not increase volume requirements.

An updated guideline for lung cancer diagnosis and management from the UK National Institute for Health and Care Excellence was published in the British Medical Journal.

 

Research, Trials, and Funding

A randomized trial conducted in 18 countries and published in the Canadian Medical Association Journal suggests that steroid administration during coronary artery bypass grafting (CABG) does not reduce the risk of acute kidney injury.

Researchers in Pennsylvania, USA, have applied a machine learning algorithm to low-dose computed tomography scans try to reduce false positives in lung cancer screening.

Motion-correcting software combined with fetal magnetic resonance imaging was used to generate improved 3D images for diagnosing congenital heart disease, report researchers from London, UK, in the Lancet.

Researchers in Milan, Italy, report results from the randomized MYRIAD trial, finding that patients undergoing CABG have equivalent survival whether they receive intravenous or inhaled anesthesia.

A population-based prospective study of more than 50,000 individuals in northeastern Iran found an association between the preference for drinking one’s tea “very hot” and esophageal cancer risk, say researchers in the International Journal of Cancer.

Source: European Journal of Cardio-Thoracic Surgery
Author(s): Changbo Sun, Masaki Anraku, Takahiro Karasak,i Hideki Kuwano, Kazuhiro Nagayama, Jun-Ichi Nitadori, Masaaki Sato, Jun Nakajima

Sun and colleagues investigated the relationship between low skeletal muscle mass and the prognosis of early-stage non–small cell lung cancer (NSCLC). In more than 300 patients with early-stage NSCLC, the truncal muscle index at the first lumbar vertebral level correlated with lower rates of recurrence-free and overall survival five years after resection. The authors conclude that the truncal muscle index could be useful to include in the preoperative assessment of patients for whom curative resection of NSCLC is planned.

Source: The Journal of Thoracic and Cardiovascular Surgery
Author(s): Hatem Hosny, Yasser Sedky, Soha Romeih, Walid Simry, Ahmed Afifi, Amr Elsawy, Mohamed Abdul Khalek, Ramy Doss, Ahmed Elguindy, Heba Aguib, Magdi Yacoub

Professor Yacoub and his team reported their experience with the use of the Mustard operation, in its original form and in a new modification designed to enhance the atrial functions and filling of the left ventricle.

In 5 years, 101 patients with transposition of the great arteries (TGA) underwent the Mustard operation, 86 with the new modification. The median age at operation was 16 months (6 months - 27 years), 75 patients were male (74.3%), and median preoperative oxygen saturation was 71%. There were no early deaths. Three patients died during a median follow-up of 24.2 months, all with large VSD and established pulmonary vascular disease. At latest follow up, all patients were in stable sinus rhythm. There were no baffle leaks. Seven patients had asymptomatic narrowing of the superior baffle, and one required balloon dilation. The authors report that follow-up is 100% complete and includes CT and MRI at regular intervals (75 patients to date). Analysis of representative subsets showed enhanced rate and pattern of left ventricle filling in the modified operation compared to the classic Mustard operation.

The authors conclude that the Mustard operation, particularly the modified technique, should play an important role in treating late-presenting patients with TGA. Improving the pattern of filling of the left ventricle could enhance the long-term results of the Mustard operation.

Source: The Thoracic and Cardiovascular Surgeon
Author(s): Jan Heimeshoff, Constanze Merz, Marcel Ricklefs, Felix Kirchhoff, Axel Haverich, Christoph Bara, Christian Kühn

Heimeshoff and colleagues retrospectively analyzed the function of wearable cardioverter-defibrillators (WCDs) provided for 100 patients after cardiac surgery. Patients received a WCD if their left ventricular ejection fraction was 35% or lower, or if their implantable cardioverter-defibrillator (ICD) had been explanted. Left ventricular ejection fraction was improved from 28.9 ± 8% after surgery to 36.7 ± 11% at follow-up (p < 0.001). Ventricular arrhythmias occurred in 13% of patients. Three patients were successfully defibrillated, and WCDs did not give any inappropriate shocks. After the wearing period for the WCD was complete, 25 patients had an ICD implanted. The authors conclude that WCDs were effective in protecting patients against postoperative ventricular tachyarrhythmias.

Source: The New England Journal of Medicine
Author(s): Mandeep R. Mehra, Nir Uriel, Yoshifumi Naka, Joseph C. Cleveland, Jr., Melana Yuzefpolskaya, Christopher T. Salerno, Mary N. Walsh, Carmelo A. Milano, Chetan B. Patel, Steven W. Hutchins, John Ransom, Gregory A. Ewald, Akinobu Itoh, Nirav Y. Raval, Scott C. Silvestry, Rebecca Cogswell, Ranjit John, Arvind Bhimaraj, Brian A. Bruckner, Brian D. Lowes, John Y. Um, Valluvan Jeevanandam, Gabriel Sayer, Abeel A. Mangi, Ezequiel J. Molina, Farooq Sheikh, Keith Aaronson, Francis D. Pagani, William G. Cotts, Antone J. Tatooles, Ashok Babu, Don Chomsky, Jason N. Katz, Paul B. Tessmann, David Dean, Arun Krishnamoorthy, Joyce Chuang, Ia Topuria, Poornima Sood, Daniel J. Goldstein, for the MOMENTUM 3 Investigators

The investigators published the final analysis of the MOMENTUM 3 trial comparing the fully magnetically levitated centrifugal continuous-flow HeartMate 3 pump to the mechanical-bearing axial continuous-flow HeartMate II pump. The composite primary end point was survival at two years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at two years.

HeartMate 3 and HeartMate II were implanted in 516 and 512 patients, respectively. In the analysis of the primary end point, 397 patients (76.9%) with HeartMate 3, as compared with 332 (64.8%) with HeartMate II, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at two years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the HeartMate 3 group than in the HeartMate II group (12 patients [2.3%] versus 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The number of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in patients with HeatMate 3 comparted to patients with HeartMate II.

These data show that among patients with advanced heart failure, the fully magnetically levitated centrifugal-flow HeartMate 3 was associated with less frequent need for pump replacement and superior survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.

Source: The Annals of Thoracic Surgery
Author(s): Siva Raja, Dean P. Schraufnagel, Eugene H. Blackstone, Sudish C. Murthy, Prashanthi N. Thota, Lucy Thuita, Rocio Lopez, Scott L. Gabbard, Monica N. Ray, Neha Wadhwa, Madhu R. Sanaka, Andrea Zanoni, Thomas W. Rice

Raja and colleagues evaluated the return of symptoms and rate of reintervention following Heller myotomy for achalasia. Over a seven-year period, 248 patients underwent Heller myotomy. The majority of patients, 69%, experienced the return of at least one symptom during the follow-up period (median follow-up of 36 months), and 50 patients underwent 85 reinterventions. The majority of reinterventions were done endoscopically, and five-year freedom from reintervention was lowest for patients with type I achalasia. The authors conclude that it is important for patients to understand that Heller myotomy will likely only palliate achalasia symptoms, and they recommend lifelong postprocedural surveillance.

Source: European Journal of Cardio-Thoracic Surgery
Author(s): Martin Andreas, Iuliana Coti, Raphael Rosenhek, Shiva Shabanian, Stephane Mahr, Keziban Uyanik-Uenal, Dominik Wiedemann, Thomas Binder, Alfred Kocher, Guenther Laufer

Andreas and colleagues report their experience of aortic valve replacement with rapid-deployment surgical aortic valves prostheses in 500 patients over seven years. The authors found a 0.8% 30-day mortality, and the valves showed excellent hemodynamic performance, durability, and safety with a median follow-up time of 12 months. Minimally invasive access was achieved in 47% of patients.

Source: The Annals of Thoracic Surgery
Author(s): Takashi Yamauchi, Hiroshi Takano, Toshiki Takahashi, Takafumi Masai, Masayuki Sakaki, Yukitoshi Shirakawa, Katsukiyo Kitabayashi, Naoki Asano, Koichi Toda, Yoshiki Sawa, for the Osaka Cardiovascular Surgery Research Group (OSCAR)

To date, there has been no unianimous method to calculate the diameter of the aorta prior to the occurence of type A aortic dissection. In this study, reseachers from Osaka, Japan, reported the efforts in developing equations for estimating the predissection diameters of the ascending aorta and the arch based on postdissection measurements. These equations have the potential of determining the size of stent grafts in the management of patients with type A dissection.

Source: Vascular News
Author(s): Vascular News

Endospan announced that it has received European CE Mark approval for its Nexus stent graft system for the endovascular repair of aortic arch disease comprising both aneurysms and dissections.

Nexus is a low-profile branched stent-graft designed and engineered specifically for the aortic arch to allow ease of deployment while achieving a durable effective repair and importantly minimizing the risk of stroke and other cardiovascular complications. It represents a major milestone, being the first low-profile branched endovascular stent-graft to be available off-the-shelf in Europe for endovascular repair of the aortic arch, especially for high-risk partients with complex arch pathologies.

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