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Journal and News Scan

Source: US Food and Drug Administration
Author(s): US FDA

In a letter to healthcare providers, the US FDA summarized a recent evaluation of a postapproval study of the Abiomed Impella RP system. In clinical trials, 73% of patients survived 30 days after device explant, hospital discharge, or to definitive intervention. In the postapproval study, just over 17% of patients met this goal. There is some evidence to suggest that patients in the postapproval study were suboptimal candidates for the system.

Source: Journal of Vascular Surgery
Author(s): Marie Elisabeth Stelzmueller, Richard Nolz, Stephane Mahr, Dietrich Beitzke, Florian Wolf, Martin Funovics, Guenther Laufer, Christian Loewe, Doris Hutschala, Marek P. Ehrlich

In this retrospective cohort study, Dr Ehrlich and his colleagues reported excellent early and long-term results of thoracic endovascular aortic repair (TEVAR) for 55 high-risk patients with life-threatening acute complicated type B aortic dissection. The mean age of patients was 52 ± 13 years. The indications for TEVAR included malperfusion (58%), aortic rupture (18%), or persistent untreatable pain with true lumen reduction or rapid aortic diameter enlargement (24%). The technical success was 91% and overall in-hospital mortality rate was 9%. At 5 years, survival was 75%, with 77% freedom from aorta-related death and 63% freedom from reintervention.

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

Patient Care and General Interest

Former Indian Prime Minister Manmohan Singh chimes in to the #10YearChallenge with a focus on his heart surgery.

A New England Journal of Medicine case report on trachealization of the esophagus made headlines, describing a patient who had sought care after getting a pizza roll stuck in his throat.

An update to the 2014 US guidelines on managing patients with atrial fibrillation was issued by the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society.

 

Research, Trials, and Funding

Cell-free DNA might be useful to monitor patients with transplanted lungs for transplant rejection, say researchers from the US National Heart, Lung, and Blood Institute.

A partnership between space technology company Techshot and NASA aims to study cardiac tissue growth in zero gravity.

Research presented at the recent Society of Thoracic Surgeons’ Annual Meeting in San Diego, California, suggests that cardiac surgery outcomes in the US are similar at the beginning and the end of the academic training year.

Source: World Journal for Pediatric and Congenital Heart Surgery
Author(s): Gerard R. Martin, Jeffrey B. Anderson, Robert N. Vincent

Martin and colleagues describe two efforts to improve outcomes within the congenital heart disease field: the Improving Pediatric and Adult Congenital Treatments (IMPACT) Registry and the National Pediatric Cardiology-Quality Improvement Collaborative (NPC-QIC). The authors discuss some of the insights that have been gained using data from the IMPACT Registry and outcome improvements that have resulted from the collaborative structure of the NPC-QIC. They emphasize the importance of both registries and learning collaboratives to ensure that best practices are both identified and implemented.

Source: The Thoracic and Cardiovascular Surgeon
Author(s): Keti Vitanova, Cornelius Leopold, Jelena Pabst von Ohain, Cordula Wolf, Elisabeth Beran, Rüdiger Lange, Julie Cleuziou

Vitanova and colleagues reviewed outcomes of systemic-to-pulmonary artery shunt surgery to identify potential risk factors for negative outcomes in neonates. Between 2000 and 2016, 305 shunts were implanted in 280 newborns, with a median age of 9 days old. Shunt failure occurred in 8% of patients, and shunt-related mortality was 4%. Univariate analysis determined perioperative platelet transfusion, central shunt, shunt size of 3 mm, and postoperative extra corporeal membrane oxygenation to be risk factors for shunt failure.

Source: Interactive Cardiovascular and Thoracic Surgery
Author(s): Masatoshi Hata, Armin Zittermann, Kavous Hakim-Meibodi, Jochen Börgermann, Jan Gummert

Hata and colleagues performed a propensity score-matched analysis comparing 85 pairs of patients who underwent either minimally invasive mitral valve repair or chordal-sparing replacement for degenerative mitral valve regurgitation. Freedom from major adverse cardiac and cerebrovascular events after seven years was similar between the groups. There was no difference in mortality and no difference in freedom from valve reintervention.

Source: The Annals of Thoracic Surgery
Author(s): Jens Garbade, Finn Gustafsson, Steven Shaw, Jacob Lavee, Diyar Saeed, Yuriy Pya, Thomas Krabatsch, Jan D. Schmitto, Michiel Morshuis, Joyce Chuang, Daniel Zimpfer

Garbade and colleagues compared outcomes reported during the European Conformity (CE) Mark clinical trial of the HeartMate 3 left ventricular assist device (LVAD)  to outcomes for patients treated since the device came to market. Patients treated after device approval, from the ELEVATE registry, were more severely ill, were older, and underwent more concomitant valve procedures than those treated in the CE Mark trial. After adjusting for baseline differences between the groups, the authors found comparable 30-day survival. Rates of bleeding, infection, and stroke were also similar between the two groups, and no instances of pump thrombosis were recorded.

Source: Annals of Cardiothoracic Surgery
Author(s): Pietro Giorgio Malvindi, Vito Margari, Florinda Mastro, Giuseppe Visicchio, Georgios Kounakis, Antonella Favale, Pierpaolo Dambruoso, Cataldo Labriola, Carmine Carbone, Domenico Paparella

Malvindi and colleagues assessed the outcomes of aortic clamping strategies, either transthoracic cross-clamp (TTC, n = 165) or endoaortic balloon occlusion (EAO, n = 93) for patients undergoing minimally invasive mitral valve surgery. Endoaortic balloon occlusion was more commonly used for redo surgery (2% of TTC cases versus 12% of EAO cases). Cerebral stroke was more prevalent in EAO cases than TTC cases (0% versus 4.3%, p = 0.03), although after multivariate adjustment this difference was not significant. There was no difference in aortic dissection rates. The authors determined EAO to be a safe method of cross-clamping, and it is their preferred method for redo procedures.

Source: The Journal of Thoracic and Cardiovascular Surgery
Author(s): Mathieu Vergnat, Boulos Asfour, Claudia Arenz, Philipp Suchowerskyj, Benjamin Bierbach, Ehrenfried Schindler, Martin Schneider, Viktor Hraska

Vergnat and colleagues retrospectively evaluated long-term outcomes for neonates who underwent either balloon valvotomy or open valvoplasty between 1989 and 2015 (51 and 52 patients, respectively). Although both methods offer good survival benefits, open valvoplasty was associated with a higher freedom from operation during the follow-up period.

Source: The Annals of Thoracic Surgery
Author(s): Brendon M. Stiles, Mohamed K. Kamel, Sebron W. Harrison, Mohamed Rahouma, Benjamin Lee, Abu Nasar, Jeffrey L. Port, Nasser K. Altorki

Stiles and colleagues evaluated outcomes for patients with esophageal cancer undergoing surgical resection after either neoadjuvant chemoradiation or preoperative chemotherapy without radiation. The authors evaluated disease-free and cancer-specific survival from prospective data collected from 338 patients, 112 who underwent neoadjuvant chemoradiation and 226 receiving chemotherapy. Nearly all patients underwent transthoracic esophagectomy for their surgical procedure. Patients with adenocarcinoma showed an increased local tumor response but no difference in survival with neoadjuvant chemoradiation, whereas patient with squamous cell carcinoma had improved cancer-specific survival.

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