Baylor Heart and Vascular Institute

Packer, M. (2017). “The absence of an ideal observer: Why some clinical trials may not be what we think they are.” Circulation 136(12): 1085-1086.

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A large clinical trial typically involves a leadership committee, a sponsor, numerous geographically dispersed investigators, and a group responsible for operational functions. The leadership committee helps to define the trial hypotheses and the methods by which they are tested; however, its members personally make no observations and may not know exactly how observations are made. The sponsor invests substantial sums of money, without assurance that the hypothesis is valid and generally without direct involvement in the collection of data. The investigators are paid to recruit patients, but they may have little vested in the overall results of the trial. The operations group ensures that patients are recruited rapidly, knowing that it will be difficult to confirm whether patients were recruited appropriately or trial procedures were followed faithfully. Among these trial components, who is the ideal, fully informed and impartial observer? Could the parties (each acting in self-interest but within regulatory standards) collectively yield a flawed product? Here are a few hypothetical possibilities.

Podgaetz, E., G. S. Schwartz and D. P. Mason (2017). “Minimally invasive posterior basilar segmentectomy by a posterior approach: Should we start flipping?” J Thorac Cardiovasc Surg 154(4): 1440-1441.

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Multiple studies have demonstrated that sublobar resection is an acceptable treatment modality for small peripheral tumors without suggestive lymphadenopathy. 1 Although wedge resection can be achieved thoracoscopically for peripheral lesions, lesions located deep in the lung parenchyma often require a segmentectomy or lobectomy to be certain to fully encompass the tumor. Segmentectomies are far less common than lobectomy and are significantly more technically demanding, even when performed via thoracotomy.

Parsa, P., K. Cantu, J. Eidt, D. Gable and G. Pearl (2017). “Case report: A durable open repair of a rare profunda aneurysm.” Ann Vasc Surg 44: 424.e427-424.e410.

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Profunda femoris artery aneurysms (PFAAs) are rare and difficult to diagnose in the early stages of development due to location and encasement in the deep thigh musculature. We report the case of a 74-year-old male who was discovered to have a right PFAA during evaluation for progressively worsening short distance claudication. He had undergone an angioplasty of the left iliofemoral system several months ago with no improvement of his symptoms. The PFAA was diagnosed through computed tomography angiography and repaired via syndactylization of profunda femoris branches and interposition grafting with a polytetrafluoroethylene stretch graft. The imaging features are described in the article. Although PFAAs are rare clinical presentations, their development should be considered, in particular when symptoms such as progressive or unchanging claudication are present in a patient following an angioplasty of the affected iliofemoral system.

Gottlieb, R. L., T. Sam, S. Y. Wada, J. F. Trotter, S. K. Asrani, B. Lima, S. M. Joseph, G. V. Gonzalez-Stawinski and S. A. Hall (2017). “Rational heart transplant from a hepatitis c donor: New antiviral weapons conquer the trojan horse.” J Card Fail 23(10): 765-767.

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BACKGROUND: Donors with hepatitis C (HCV) viremia are rarely used for orthotopic heart transplantation (HT) owing to post-transplantation risks. New highly effective HCV antivirals may alter the landscape. METHODS: An adult patient unsuitable for bridging mechanical support therapy accepted a heart transplant offer from a donor with HCV viremia. On daily logarithmic rise in HCV viral load and adequate titers to ensure successful genotyping, once daily sofosbuvir (400 mg)-velpatasvir (100 mg) (Epclusa; Gilead) was initiated empirically pending HCV genotype (genotype 3a confirmed after initiation of therapy). RESULTS: We report the kinetics of acute hepatitis C viremia and therapeutic response to treatment with a new pangenotypic antiviral agent after donor-derived acute HCV infection transmitted incidentally with successful cardiac transplantation to an HCV-negative recipient. Prompt resolution of viremia was noted by the 1st week of a 12 week course of antiviral therapy. Sustained virologic remission continued beyond 12 weeks after completion of HCV therapy (SVR-12). CONCLUSIONS: The availability of effective pangenotypic therapy for HCV may expand donor availability. The feasibility of early versus late treatment of HCV remains to be determined through formalized protocols. We hypothesize pharmacoeconomics to be the greatest limitation to widespread availability of this promising tool.

Shutze, W., B. Richardson, R. Shutze, K. Tran, A. Dao, G. O. Ogola, A. Young and G. Pearl (2017). “Midterm and long-term follow-up in competitive athletes undergoing thoracic outlet decompression for neurogenic thoracic outlet syndrome.” J Vasc Surg: 2017 Sep [Epub ahead of print].

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BACKGROUND: Neurogenic thoracic outlet syndrome (NTOS) results from compression of the brachial plexus by the clavicle, first rib, and scalene muscles and may develop secondary to repetitive motion of the upper extremity. Athletes routinely perform repetitive motions, and sports requiring significant arm and shoulder use may put the participant at increased risk for NTOS. Competitive athletes who develop NTOS may require first rib resection and scalenectomy (FRRS) for symptomatic relief. However, the effectiveness of FRRS has not previously been studied in this vulnerable population. METHODS: This is a cross-sectional study of competitive athletes with NTOS who received FRRS by the senior author between 2009 and 2014. Eligible patients were contacted by phone and invited to complete a nine-item survey assessing the long-term effects of FRRS on pain medication use, postoperative physical therapy duration, patient satisfaction, symptom relief, activities of daily living, athletic performance, time to return of athletic performance, and need for other operations. Multivariate analyses of the following risk factors were performed: age, pectoralis minor release, preoperative narcotic use, athletic shutdown, and involvement in a throwing sport. RESULTS: There were 232 competitive athletes who met the inclusion criteria, and 67 of these (age, 14-48 years; 35 male; 99% white) responded to the survey. The average time between surgery and survey completion was 3.9 years (range, 2.2-7.0 years). The most frequent sports conducted by this group were baseball and softball (n = 44 [66%]), volleyball (n = 7 [10%]), and cheerleading and gymnastics (n = 5 [7%]), ranging from high-school to professional levels. The survey results revealed that 96% were improved in pain medication use, 75% would undergo FRRS on the contralateral side if needed, 82% had resolution of symptoms, and 94% were able to perform activities of daily living without limitation; 70% returned to the same or better level of athletic activity after FRRS, and this occurred within 1 year in 50%. Multivariate regression analysis identified younger age as a predictor of the length of physical therapy and preoperative narcotics use as a predictor of symptom resolution. CONCLUSIONS: At our center, >40% of patients requiring FRRS for NTOS are competitive athletes. The results of this study show that the majority of them are able to return to their precompetitive state after FRRS, and few experience limitations in their daily living activities. Half can return to competition at or exceeding their premorbid ability level within 6 months of surgery. The majority are pleased with their decision to undergo FRRS. Further investigation is needed to identify predictive factors for successful return to competitive athletics.