Research Spotlight

Chadi, S. A., A. Fingerhut, M. Berho, S. R. DeMeester, J. W. Fleshman, N. H. Hyman, D. A. Margolin, J. E. Martz, E. C. McLemore, D. Molena, M. I. Newman, J. F. Rafferty, B. Safar, A. J. Senagore, O. Zmora and S. D. Wexner (2016). “Emerging trends in the etiology, prevention, and treatment of gastrointestinal anastomotic leakage.” J Gastrointest Surg: 2016 Sep [Epub ahead of print].

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Anastomotic leaks represent one of the most alarming complications following any gastrointestinal anastomosis due to the substantial effects on post-operative morbidity and mortality of the patient with long-lasting effects on the functional and oncologic outcomes. There is a lack of consensus related to the definition of an anastomotic leak, with a variety of options for prevention and management. A number of patient-related and technical risk factors have been found to be associated with the development of an anastomotic leak and have inspired the development of various preventative measures and technologies. The International Multispecialty Anastomotic Leak Global Improvement Exchange group was convened to establish a consensus on the definition of an anastomotic leak as well as to discuss the various diagnostic, preventative, and management measures currently available.

Cox, C. E., S. Russell, V. Prowler, E. Carter, A. Beard, A. Mehindru, P. Blumencranz, K. Allen, M. Portillo, P. Whitworth, K. Funk, J. Barone, D. Norton, J. Schroeder, A. Police, E. Lin, F. Combs, F. Schnabel, H. Toth, J. Lee, B. Anglin, M. Nguyen, L. Canavan, A. Laidley, M. J. Warden, R. Prati, J. King and S. C. Shivers (2016). “A prospective, single arm, multi-site, clinical evaluation of a nonradioactive surgical guidance technology for the location of nonpalpable breast lesions during excision.” Ann Surg Oncol 23(10): 3168-3174.

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OBJECTIVES: This study was a multicenter evaluation of the SAVI SCOUT((R)) breast localization and surgical guidance system using micro-impulse radar technology for the removal of nonpalpable breast lesions. The study was designed to validate the results of a recent 50-patient pilot study in a larger multi-institution trial. The primary endpoints were the rates of successful reflector placement, localization, and removal. METHODS: This multicenter, prospective trial enrolled patients scheduled to have excisional biopsy or breast-conserving surgery of a nonpalpable breast lesion. From March to November 2015, 154 patients were consented and evaluated by 20 radiologists and 16 surgeons at 11 participating centers. Patients had SCOUT((R)) reflectors placed up to 7 days before surgery, and placement was confirmed by mammography or ultrasonography. Implanted reflectors were detected by the SCOUT((R)) handpiece and console. Presence of the reflector in the excised surgical specimen was confirmed radiographically, and specimens were sent for routine pathology. RESULTS: SCOUT((R)) reflectors were successfully placed in 153 of 154 patients. In one case, the reflector was placed at a distance from the target that required a wire to be placed. All 154 lesions and reflectors were successfully removed during surgery. For 101 patients with a preoperative diagnosis of cancer, 86 (85.1 %) had clear margins, and 17 (16.8 %) patients required margin reexcision. CONCLUSIONS: SCOUT((R)) provides a reliable and effective alternative method for the localization and surgical excision of nonpalpable breast lesions using no wires or radioactive materials, with excellent patient, radiologist, and surgeon acceptance.

Soni, P. D., F. Y. Moraes, W. C. Jackson, R. Gadia, R. T. Dess, J. Y. Lee, G. Palapattu, S. A. Tomlins, R. Mera, T. Morgan, J. W. Hearn, H. M. Sandler, D. A. Hamstra, E. T. Leite, Z. S. Zumsteg, F. Y. Feng and D. E. Spratt (2016). “Multicenter independent validation of the zumsteg-spratt risk classification system of intermediate- and high-risk men treated with dose-escalated radiation therapy without androgen deprivation therapy.” Int J Radiat Oncol Biol Phys 96(2s): E233.

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Previously we proposed a novel risk classification schema to separate intermediate risk patients into favorable and unfavorable risk groups that has been incorporated into NCCN guidelines. However, these analyses were performed in a cohort of patients where androgen deprivation therapy (ADT) was utilized heterogeneously. Herein, we report an independent validation of the Zumsteg-Spratt risk classification schema in a large cohort of intermediate and high risk patients who did not receive ADT.

Solomon, S. D., B. Claggett, M. Packer, A. Desai, M. R. Zile, K. Swedberg, J. Rouleau, V. Shi, M. Lefkowitz and J. J. McMurray (2016). “Efficacy of sacubitril/valsartan relative to a prior decompensation: The paradigm-hf trial.” JACC Heart Fail 4(10): 816-822.

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OBJECTIVES: This study assessed whether the benefit of sacubtril/valsartan therapy varied with clinical stability. BACKGROUND: Despite the benefit of sacubitril/valsartan therapy shown in the PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial, it has been suggested that switching from an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker should be delayed until occurrence of clinical decompensation. METHODS: Outcomes were compared among patients who had prior hospitalization within 3 months of screening (n = 1,611 [19%]), between 3 and 6 months (n = 1,009 [12%]), between 6 and 12 months (n = 886 [11%]), >12 months (n = 1,746 [21%]), or who had never been hospitalized (n = 3,125 [37%]). RESULTS: Twenty percent of patients without prior HF hospitalization experienced a primary endpoint of cardiovascular death or heart failure (HF) hospitalization during the course of the trial. Despite the increased risk associated with more recent hospitalization, the efficacy of sacubitril/valsartan therapy did not differ from that of enalapril according to the occurrence of or time from hospitalization for HF before screening, with respect to the primary endpoint or with respect to cardiovascular or all-cause mortality. CONCLUSIONS: Patients with recent HF decompensation requiring hospitalization were more likely to experience cardiovascular death or HF hospitalization than those who had never been hospitalized. Patients who were clinically stable, as shown by a remote HF hospitalization (>3 months prior to screening) or by lack of any prior HF hospitalization, were as likely to benefit from sacubitril/valsartan therapy as more recently hospitalized patients.

Mack, M. and D. Holmes (2016). “Bioprosthetic valve thrombosis: The harder one looks, the more one finds.” J Thorac Cardiovasc Surg 152(4): 952-953.

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The desire to avoid anticoagulation after surgical aortic valve replacement (SAVR) has been one of the major drivers toward the greater use of bioprosthetic valves and less use of mechanical valves so that more than 90% of surgical valves now implanted are tissue. Recently concerns have been raised about the occurrence of bioprosthetic valve thrombosis (BPVT) and its possible relationship to subsequent structural valve deterioration.1 Recent studies done with sophisticated imaging techniques, including 4-dimensional computed tomography (4D CT) with high-speed scanners have clearly documented leaflet immobility, thickness, and thrombosis both early and late after both SAVR and transcatheter aortic valve replacement (TAVR) procedures (Figure 1).2 Although the true incidence and clinical relevance of these different findings are as yet unknown, it is clear that the phenomenon is more common than was previously appreciated.3