Perceptions and Attitudes Regarding Medical Device Development in Canada Among Canadian Innovators: A Qualitative Study.

OBJECTIVES: The Canadian medical device industry presents unique challenges to innovators. However, little attention has been paid to exploring the distinct experience of Canadian medical device innovators in the literature. The objective of this study is to explore the experience of Canadian innovators in navigating this industry, with a focus on their perceptions and attitudes towards the use of health economic evaluation. METHODS: Semi-structured interviews were conducted using virtual conferencing technology. All participants were C-level employees of small- and medium-sized enterprises (SMEs) with adequate knowledge of their company's overall strategy. Qualitative data were analyzed to reveal emerging themes. RESULTS: Interviews were performed with ten participants. Forty percent of participants rated themselves as having either minimal or basic knowledge of health economics. Thirty percent of participants had not pursued early economic evaluation of their device, while 90% rated health economics as being either "Quite important" or "Very important" to their company. The perception of increased barriers to successful device adoption in Canada relative to the USA was a prominent sentiment among participants, with 50% expressing discontentment with either the device approval process or health technology assessment process in Canada. Twenty percent stated that their primary target market involved the USA and/or other international jurisdictions. CONCLUSION: Canadian medical device innovators appear to understand the importance of health economic evaluation in the innovation process. However, they report difficulty with device approval and adoption, with some innovators focusing their efforts outside of Canada altogether. Further research should be directed toward understanding how to better support SMEs, given that they are a tremendous source of growth for the Canadian medical device industry.

Exploring the approach to parameter uncertainty in early economic evaluations of surgical technology - a systematic review.

INTRODUCTION: The role of early economic evaluation (EEE) in the development of medical technology has been increasingly recognized; however, data on the use of EEE in surgical technology are sparse. The objective of this review was to explore the use of EEE in the development of surgical technologies, with emphasis on how uncertainty has been addressed. AREAS COVERED: A systematic review was conducted, and original articles employing any form of EEE of surgical technology were selected for review, with 10 studies included in the analysis. These studies demonstrated significant variation in the approach to managing parameter uncertainty, specifically regarding the type of analysis used and the inclusion of effectiveness parameters in sensitivity analysis. The conclusions drawn did not appear to factor in uncertainty in the models. EXPERT OPINION: Approaches to handling parameter uncertainty in previous EEEs of surgical technology have been limited, with some studies failing to address parameter uncertainty. In addition, EEEs do not appear to follow established guidelines with respect to the use of sensitivity analyses. It is important that EEEs of surgical technology address parameter uncertainty in order to draw more robust conclusions from the analysis and allow investors to consider this uncertainty when making investment decisions.

Spontaneous perforation of pyometra-is hysterectomy required in the emergent setting? A case report and literature review.

Spontaneous perforation of pyometra is a rare event associated with significant morbidity and mortality when diffuse peritonitis is present. While malignant lesions of the cervical tract are the most common cause of pyometra, several benign conditions can contribute to this diagnosis. Traditionally hysterectomy has been the surgical approach of choice for this clinical entity; however, in the setting of septic shock, temporizing techniques may offer the opportunity to stabilize patients and complete a thorough work up before committing to definitive resection. This report explores a case of septic shock secondary to spontaneous perforation of pyometra that was definitively managed with peritoneal lavage and wide drainage. Intraoperative hysteroscopy and uterine biopsy were performed, and no malignancy was identified on final pathology. Intraoperative hysteroscopy along with peritoneal lavage and wide drainage may reduce the morbidity and mortality associated with sepsis from spontaneous perforation of pyometra and potentially avoid unnecessary hysterectomy.

Self-Expanding Metal Stents Do Not Adversely Affect Long-term Outcomes in Acute Malignant Large-Bowel Obstruction: A Retrospective Analysis.

BACKGROUND: Self-expanding metal stents as a bridge to surgery in acute malignant large-bowel obstruction has gained popularity. However, long-term oncologic outcomes have not been well established. OBJECTIVE: To investigate long-term oncologic outcomes of patients undergoing curative resection after the placement of a colonic stent compared with emergency surgery for acute malignant large-bowel obstruction. DESIGN: This is a retrospective study. SETTING: All patients presenting at 3 tertiary care centers between April 2002 and December 2012 with a diagnosis of complete malignant large-bowel obstruction were reviewed. Patients with disease distal to the hepatic flexure were selected for analysis. PATIENTS: One hundred twenty-two patients who underwent either emergency surgery or placement of a colonic stent with curative intent were included. INTERVENTIONS: Patients receiving emergency surgery within 24 hours of presenting with obstructive symptoms, including those with failed stents, were included in the emergency surgery group. All patients with clinically successful stent deployment before surgery were included in the stent group. MAIN OUTCOME MEASURES: Overall survival and disease-free survival were calculated using the Kaplan-Meier method. RESULTS: Sixty-four patients underwent emergency surgery, and 58 patients underwent placement of a self-expanding metal stent. Groups were similar in terms of sex, tumor stage and grade, and Charlson and Charlson-Age Comorbidity Index scores. Patients in the surgery group were older than patients in the stent group. There were no differences in the number of lymph nodes harvested, positive nodes, rates of vascular and perineural invasion, or utilization of chemotherapy. Thirty-day mortality after resection was similar between groups (7.41% vs 4.41%; p > 0.05). Patients who underwent colonic stenting as a bridge to surgery had similar 10-year overall survival (40.5% vs 32.7%; p = 0.13) and 10-year disease-free survival (40.2% vs 33.8%; p = 0.26) compared with those who underwent emergency surgery. Similar results were seen on intention-to-treat analysis. LIMITATIONS: This was a small retrospective study. CONCLUSIONS: Stent insertion followed by oncologic resection is associated with similar overall survival and disease-free survival compared with emergency resection. Stent insertion as a bridge to surgery should be considered in patients presenting with malignant colorectal obstruction. See Video Abstract at http://links.lww.com/DCR/B714Los Stents Metálicos Autoexpandibles No Afectan Negativamente Los Resultados A Largo Plazo En La Obstrucción Maligna Aguda Del Colon: Un Análisis Retrospectivo. ANTECEDENTES: Los stents metálicos autoexpandibles como puente a una cirugía en la obstrucción maligna aguda del colon han ganado popularidad. Sin embargo, no se han establecido bien los resultados oncológicos a largo plazo. OBJETIVO: Investigar los resultados oncológicos a largo plazo de los pacientes sometidos a resección curativa después de la colocación de un stent colónico en comparación con la cirugía de urgencia para la obstrucción maligna aguda del colon. DISEO: Estudio retrospectivo. MBITO: Entre abril de 2002 y diciembre de 2012, se revisaron todos los pacientes que acudieron a tres centros de tercer nivel con un diagnóstico de obstrucción maligna completa del colon. Se seleccionaron para el análisis los pacientes con enfermedad distal al ángulo hepático. PACIENTES: Se incluyeron 122 pacientes que fueron operados de urgencia o a una colocación de un stent colónico con intención curativa. PROCEDIMIENTOS: Los pacientes que se sometieron a cirugía de urgencia dentro de las 24 horas posteriores a la presentación de síntomas obstructivos; se incluyeron aquellos con stents fallidos en el grupo de cirugía de urgencia. Todos los pacientes con colocación clínicamente exitosa del stent antes de la cirugía se incluyeron en el grupo de stent. PRINCIPALES VARIABLES ANALIZADAS: La sobrevida global y la sobrevida libre de enfermedad se calcularon mediante el método de Kaplan-Meier. RESULTADOS: Sesenta y cuatro pacientes fueron llevados a cirugía urgente y en 58 pacientes se colocó de un stent metálico autoexpandible. Los grupos fueron similares en relación a sexo, estadio y grado del tumor, puntuación de comorbilidad de Charlson y Charlson-Age. Los pacientes del grupo de cirugía eran mayores que los del grupo de stents. No hubo diferencias en el número de ganglios linfáticos recolectados, ganglios positivos, tasas de invasión vascular y perineural o utilización de quimioterapia. La mortalidad a los 30 días después de la resección fue similar entre los grupos (7,41% frente a 4,41%; p> 0,05). Los pacientes que se sometieron a la colocación de un stent colónico como puente a la cirugía tuvieron una sobrevida general a diez años similar (40,5% vs 32,7%; p = 0,13) y una sobrevida libre de enfermedad a diez años (40,2% vs 33,8%, respectivamente; p = 0,26) en comparación a los operados de urgencia. Se observaron resultados similares en el análisis por intención de tratamiento. LIMITACIONES: Estudio retrospectivo reducido. CONCLUSIONES: La utilización de un stent y posteriormente la resección oncológica se asocia a una sobrevida general y una sobrevida libre de enfermedad similar en comparación con la resección de urgencia. La utilización de un stent como puente a la cirugía debe considerarse en pacientes que presentan obstrucción colorrectal maligna. Consulte Video Resumen en http://links.lww.com/DCR/B714. (Traducción-Dr. Lisbeth Alarcon-Bernes).

Selective retrograde cerebral cooling in complete cerebral circulatory arrest.

BACKGROUND AND PURPOSE: Cerebral hypothermia is a known neuroprotectant with promising applications in the treatment of ischemic events. Although systemic cooling is standard in post-cardiac arrest care, the deleterious effects of whole-body cooling have precluded it from translation into a viable treatment option for acute ischemic stroke (AIS). Selective cerebral cooling has been proposed as a method to minimize these risks while granting the neuroprotection of therapeutic hypothermia in AIS. METHODS: In a porcine model (n = 3), the efficacy of selective retrograde cerebral cooling through the internal jugular vein was evaluated in the setting of complete cerebral circulatory arrest. Furthermore, a novel endovascular device and cooling system enabling selective retrograde cerebral cooling were studied in a normothermic perfused cadaver. RESULTS AND CONCLUSION: Neurologic assessment of animals receiving this therapy reflected substantial neuroprotection in animals undergoing both 15 min and 30 min of otherwise catastrophic complete cerebral circulatory arrest. The novel endovascular device and cooling system were validated in human anatomy, demonstrating successful cerebral cooling, and feasibility of this mechanism of selective retrograde cerebral cooling.

Delayed jejunal perforation after laparoscopic cholecystectomy.

Bowel perforation is a rare complication of laparoscopic cholecystectomy, which if left undiagnosed can have fatal consequences. In addition, isolated small bowel perforation is extremely rare and should be considered in patients presenting with sudden onset abdominal pain in the postoperative period. A 57-year-old male with symptomatic gallstones underwent urgent laparoscopic cholecystectomy and was discharged home on postoperative day (POD) 1 without complications. He presented to the emergency department on POD 11 complaining of sudden onset abdominal pain. A CT scan did not confirm a diagnosis and he was admitted for observation. On post admission day 2, he became significantly peritonitic and laparotomy revealed jejunal perforation. Bowel resection with hand-sewn anastomosis was completed and he was discharged on POD 10. Follow-up at 6 weeks revealed no further issues. We review the literature on small bowel perforation post laparoscopic cholecystectomy.