Research Spotlight

Juengst, S. B., V. Silva, Y. Goldin, K. Cicerone, J. Lengenfelder, N. Chiaravalloti, S. Driver, D. Mellick, G. Dart, C. L. Kew, A. Nabasny and K. R. Bell (2019). “Care partner problem solving training (CP-PST) for care partners of adults with traumatic brain injury during inpatient rehabilitation: Study protocol for a multisite, randomized, single-blind clinical feasibility trial.” Contemp Clin Trials 80: 9-15 [Epub ahead of print].

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Traumatic brain injury (TBI) often leads to immediate and chronic functional impairments that affect care partners, or those providing physical and/or emotional support to individuals with TBI. The many challenges associated with being a care partner often lead to caregiver burden and can compromise the well-being and quality of life of care partners and individuals with TBI under their care. Equipping care partners with problem-solving skills could facilitate and sustain their transition into this supportive role. Problem-solving training (PST) has demonstrated efficacy for providing such skills to care partners of individuals with TBI after discharge from inpatient rehabilitation. We propose that PST delivered to care partners during inpatient rehabilitation of individuals with TBI will provide care partners with the skills to manage their caregiving roles across the transition from hospital to home. Herein, we describe the methodology of a current randomized controlled trial that examines the feasibility and efficacy of PST plus TBI education compared to TBI education alone to improve care partner burden, emotional distress, and adaptive coping when delivered during the inpatient rehabilitation stay of individuals with moderate-severe TBI.

Jacob, S., B. Lima, G. V. Gonzalez-Stawinski, M. M. El-Sayed Ahmed, P. C. Patel, E. V. Belli, I. A. Makey, M. Thomas, K. Landolfo, C. Landolfo, J. C. Leoni Moreno, D. S. Yip and S. M. Pham (2019). “Extracorporeal Membrane Oxygenation as a Salvage Therapy for Patients With Severe Primary Graft Dysfunction After Heart Transplant.” Clin Transplant Mar 14: e13538. doi: 10.1111/ctr.13538. [Epub ahead of print].

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BACKGROUND: Severe primary graft dysfunction (PGD) is the leading cause of early death after heart transplant. AIM: To examine the outcomes of heart transplant recipients who received venoarterial extracorporeal membrane oxygenation (VA-ECMO) for severe PGD. METHODS: We reviewed electronic health records of adult patients who underwent heart transplant from November 2005 through June 2015. We defined severe PGD according to International Society for Heart and Lung Transplantation consensus statements. RESULTS: Of 1,030 heart transplant patients, 31 (3%) had severe PGD and required VA-ECMO. The mean (range) age was 59 (43-69) years. Fifteen patients (48%) underwent prior sternotomy and 10 (32%) received a left ventricular assist device as a bridge to transplant. Severe PGD manifested as failure to wean from cardiopulmonary bypass in 20 patients (65%) and as severe hemodynamic instability in the immediate postoperative period in 10 (32%), including cardiac arrest in 3 (10%). Twenty-five patients (81%) were successfully weaned from VA-ECMO, and 19 (61%) were discharged; the other 12 (39%) died. CONCLUSIONS: Although VA-ECMO is a common method for providing mechanical circulatory support to patients with PGD, multicenter studies are needed to assess factors associated with successful outcomes and improved survival of these patients.

Hughes, D. A., K. Nicholls, G. Sunder-Plassmann, A. Jovanovic, U. Feldt-Rasmussen, R. Schiffmann, R. Giugliani, V. Jain, C. Viereck, J. P. Castelli, N. Skuban, J. A. Barth and D. G. Bichet (2019). “Safety of switching to Migalastat from enzyme replacement therapy in Fabry disease: Experience from the Phase 3 ATTRACT study.” Am J Med Genet A Mar 28. [Epub ahead of print].

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Migalastat is the only oral treatment for Fabry disease, which provides a suitable alternative to once‐every‐2‐weeks intravenous enzyme replacement therapy (ERT) in patients with amenable mutations who are ERT‐experienced and can also be utilized as a first‐line therapy in ERT‐naive patients. Although there has not yet been a consensus among physicians who treat patients with Fabry disease on when to choose migalastat over ERT, we have developed some criteria in our clinical practices, which include: age 16 years and older (18 years and older in the United States and Canada), a confirmed amenable mutation, an eGFR > 30 mL/min/1.73 m2, compliance with every‐other‐day oral administration, and no intention by female patients to become pregnant. Patients’ preference and hypersensitivity to ERT are also factors in considering the best treatment option for patients. We suggest having a comprehensive counseling session with the patient to discuss the mechanism of action, clinical data, and approved indication for migalastat, as well as schedule of administration. For patients switching from ERT, migalastat is commonly initiated ~2 weeks after the last dose of ERT based on the infusion interval; however, other practical considerations may influence the exact duration between the last ERT infusion and first dose of migalastat. Migalastat may be safely initiated within days of the last ERT infusion. In conclusion, patients with amenable mutations who have been receiving ERT infusions can be safely switched to migalastat 150 mg QOD, and no special procedure is needed for the switch. (Excerpt from text, p. 3-4; no abstract available.)

Hassan, T. M., E. Ontiveros, D. Davis and S. G. Leeds (2019). “Endoscopic Removal of Noneroded Nonadjustable Gastric Bands Using Induced Mucosal Erosion With a Stent, and Review of the Literature.” Surg Innov 26(2): 162-167.

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BACKGROUND: Laparoscopic removal of noneroded nonadjustable gastric bands (NAGBs) may lead to major life-threatening complications. A minimally invasive approach involving endoscopic removal by induced mucosal erosion with a stent (IMES) has been used in a few publications to remove NAGBs. OBJECTIVE: To examine a minimally invasive endoscopic approach to removal of a NAGB. SETTING: A large tertiary/quaternary referral hospital. METHODS: We report 4 patients that underwent IMES at our institution and present a literature review of published cases. The procedure includes using an endoscopically placed fully covered stent through the NAGB stricture to cause erosion of the mucosa where the stent is putting direct pressure. After a predetermined length of time, the stent is removed with the NAGB and without a laparoscopic or open procedure. Primary endpoint for our cohort was successful removal to the NAGB with IMES. Secondary endpoints included interval of time to retrieval of the stent, complications from IMES, presenting symptoms, and type of NAGB. These endpoints were then compared with previous publications indicating the use of IMES. RESULTS: Three of 4 patients were female with a mean age of 64.5 years. All patients had the NAGB successfully removed with IMES. The mean time for NAGB and stent removal after insertion was 17.5 days. No major complications were noted. Two patients had post-IMES strictures and were managed by balloon dilation. CONCLUSION: Endoscopic removal of NAGBs is a safe and feasible procedure for NAGB removal and can be used in place of laparoscopic surgery.

Hamandi, M., R. L. Smith, W. H. Ryan, P. A. Grayburn, A. Vasudevan, T. J. George, J. M. DiMaio, K. A. Hutcheson, W. Brinkman, M. Szerlip, D. O. Moore and M. J. Mack (2019). “Outcomes of Isolated Tricuspid Valve Surgery Have Improved in the Modern Era.” Ann Thorac Surg Apr 2. [Epub ahead of print].

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BACKGROUND: Surgery for isolated tricuspid valve (TV) disease remains relatively infrequent due to significant patient comorbidities and poor surgical outcomes. We reviewed our experience with isolated TV surgery in the current era to determine if outcomes have improved. METHODS: From 2007 through 2017, 685 TV operations were performed in a single institution of which 95 (13.9%) were isolated TV surgery. Patients were analyzed for disease etiology, risk factors, operative mortality and morbidity and long term survival. RESULTS: 95 patients underwent isolated TV surgery, an average of 9 patients/year increasing from an average of 5/year to 15/year during the study period. Surgery was reoperative in 41% (38/95), including 11.6% (11/95) with prior CABG and 29.4% (28/95) with prior valve surgery (9 tricuspid, 11 mitral, 2 aortic, 5 mitral/aortic and 1 mitral/tricuspid).Repair was performed in 71.6% (68/95) and replacement in 28.4% (27/95). Operative mortality was 3.2% (3/95) with no mortality in the most recent 73 patients over the last 6 years. Stroke occurred in 2.1% (2/95), acute kidney injury requiring dialysis in 5.3% (5/95) and need for new permanent pacemaker in 16.8% (16/95). CONCLUSIONS: In the current era with careful patient selection and periprocedural management, isolated TV surgery can be performed with lower morbidity and mortality than has traditionally been reported with good long term survival. These outcomes can also serve as a benchmark for catheter-based tricuspid valve intervention outcomes.