Positive Impact of an Aortic Center Designation.

BACKGROUND: In January 2015, we created a multidisciplinary Aortic Center with the collaboration of Vascular Surgery, Cardiac Surgery, Interventional Radiology, Anesthesia and Hospital Administration. We report the initial success of creating a Comprehensive Aortic Center. METHODS: All aortic procedures performed from January 1, 2015 until December 31, 2016 were entered into a prospectively collected database and compared with available data for 2014. Primary outcomes included the number of all aortic related procedures, transfer acceptance rate, transfer time, and proportion of elective/emergent referrals. RESULTS: The Aortic Center included 5 vascular surgeons, 2 cardiac surgeons, and 2 interventional radiologists. Workflow processes were implemented to streamline patient transfers as well as physician and operating room notification. Total aortic volume increased significantly from 162 to 261 patients. This reflected an overall 59% (P = 0.0167) increase in all aorta-related procedures. We had a 65% overall increase in transfer requests with 156% increase in acceptance of referrals and 136% drop in transfer denials (P < 0.0001). Emergent abdominal aortic cases accounted for 17% (n = 45) of our total aortic volume in 2015. The average transfer time from request to arrival decreased from 515 to 352 min, although this change was not statistically significant. We did see a significant increase in the use of air-transfers for aortic patients (P = 0.0041). Factorial analysis showed that time for transfer was affected only by air-transfer use, regardless of the year the patient was transferred. Transfer volume and volume of aortic related procedures remained stable in 2016. CONCLUSIONS: Designation as a comprehensive Aortic Center with implementation of strategic workflow systems and a culture of "no refusal of transfers" resulted in a significant increase in aortic volume for both emergent and elective aortic cases. Case volumes increased for all specialties involved in the center. Improvements in transfer center and emergency medical services communication demonstrated a trend toward more efficient transfer times. These increases and improvements were sustainable for 2 years after this designation.

Outcomes of a Clinical Pathway for Borderline Resectable Pancreatic Cancer.

BACKGROUND: Without prospective data establishing a consensus multimodality approach to borderline resectable pancreatic adenocarcinoma, institutional treatment regimens vary. This study investigated the outcomes of the clinical pathway at the author's institution, which consists of neoadjuvant gemcitabine, docetaxel, capecitabine, and stereotactic radiotherapy followed by surgery. METHODS: The study reviewed all cases that met the National Comprehensive Cancer Network (NCCN) diagnostic criteria for borderline resectable pancreatic adenocarcinoma from 1 January 2006, to 31 December 2013. Pancreatectomy rates, margin status, pathologic response, disease-free survival (DFS), disease-specific survival (DSS), and overall survival (OS) were retrospectively examined. Standard statistical methods and Kaplan-Meier survival analysis were used for statistical comparisons. RESULTS: Of 121 patients who met criteria, 101 entered the clinical pathway, and 94 (93.1 %) completed neoadjuvant chemotherapy and radiation therapy. Of the 101 patients, 55 (54.5 %) underwent pancreatectomy, with 53 patients (96.4 %) having microscopically negative margins (R0) and 2 patients (3.6 %) having microscopically positive margins (R1). Vascular resection was required for 22 patients (40 %), with rates of 95.5 % for R0 (n = 21) and 4.5 % for R1 (n = 1). A pathologic response to treatment was demonstrated by 45 patients (81.8 %) and a complete response by 10 patients (14.5 %). Pancreatectomy resulted in a median DFS of 23 months (95 % conflidence interval [CI] 14.5-31.5), a median DSS of 43 months (95 % CI, 25.7-60.3), and a median OS of 33 months (95 % CI, 25.0-41.0) versus a median DSS and OS of 14 months (95 % CI, 10.9-17.1) for patients without pancreatectomy (DSS: P = 3.5 × 10(-13); OS: P = 4.7 × 10(-10)). CONCLUSIONS: The study demonstrated high rates for neoajduvant therapy completion (93.1 %) and pancreatectomy (54.5 %). After pancreatectomy, DSS was significantly improved (43 months), with a pathologic response demonstrated by 81.8 % and a complete response by 14.5 % of the patients. The results support further study of this borderline resectable pancreatic adenocarcinoma clinical pathway.

Implantable carotid sinus stimulator for the treatment of resistant hypertension: local effects on carotid artery morphology.

BACKGROUND: The Rheos System is a chronically implanted carotid sinus baroreflex activating system with a pulse generator and bilateral perivascular carotid sinus leads (CSLs) that is being evaluated in prospective clinical trials for the treatment of drug-resistant hypertension. We evaluated carotid artery structural integrity after implantation of the CSLs. METHODS: To assess the effect of chronic CSL attachment, 29 CSLs were implanted on the common carotid arteries of eight sheep. The studies were terminated at 3 and 6 months postimplantation to assess anatomic and histologic changes. Additionally, 10 patients with resistant hypertension were enrolled in the Rheos Multicenter Feasibility Trial. Duplex ultrasound (DUS) was performed before device implantation and at 1 and 4 months postimplantation in this patient cohort. An independent core laboratory assessed all DUSs. RESULTS: Ovine carotid angiography revealed no significant stenoses, while anatomic and histologic evaluations demonstrated electrode encapsulation in a thin layer of connective tissue with no evidence of stenosis, erosion, or inflammation. DUS evaluation revealed no significant increase in peak systolic velocities of the common and internal carotid arteries 1 and 4 months after initial implantation, indicating a lack of injury, remodeling, or stenosis. CONCLUSION: The current data suggest that the CSLs used with the Rheos System are not associated with the development of carotid stenosis or injury. These short-term data support the concept of CSL placement and merit long-term investigation in a larger multicenter prospective trial.

Cost-effectiveness of treating resistant hypertension with an implantable carotid body stimulator.

The purposes of this study are to investigate the cost-effectiveness of an implantable carotid body stimulator (Rheos; CVRx, Inc, Minneapolis, MN) for treating resistant hypertension and determine the range of starting systolic blood pressure (SBP) values where the device remains cost-effective. A Markov model compared a 20-mm Hg drop in SBP from an initial level of 180 mm Hg with Rheos to failed medical management in a hypothetical 50-year-old cohort. Direct costs (2007$), utilities, and event rates for future myocardial infarction, stroke, heart failure, and end-stage renal disease were modeled. Sensitivity analyses tested the assumptions in the model. The incremental cost-effectiveness ratio (ICER) for Rheos was $64,400 per quality-adjusted life-years (QALYs) using Framingham-derived event probabilities. The ICER was <$100,000 per QALYs for SBPs > or =142 mm Hg. A probability of device removal of <1% per year or SBP reductions of > or =24 mm Hg were variables that decreased the ICER below $50,000 per QALY. For cohort characteristics similar to Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure-Lowering Arm (ASCOT-BPLA) participants, the ICER became $26,700 per QALY. Two-way sensitivity analyses demonstrated that lowering SBP 12 mm Hg from 220 mm Hg or 21 mm Hg from 140 mm Hg were required. Rheos may be cost-effective, with an ICER between $50,000 and $100,000 per QALYs. Cohort characteristics and efficacy are key to the cost-effectiveness of new therapies for resistant hypertension .

An implantable carotid sinus stimulator for drug-resistant hypertension: surgical technique and short-term outcome from the multicenter phase II Rheos feasibility trial.

BACKGROUND: A large number of patients have hypertension that is resistant to currently available pharmacologic therapy. Electrical stimulation of the carotid sinus baroreflex system has been shown to produce significant chronic blood pressure decreases in animals. The phase II Rheos Feasibility Trial was performed to assess the response of patients with multidrug-resistant hypertension to such stimulation. METHODS: The system consists of an implantable pulse generator with bilateral perivascular carotid sinus leads. Implantation is performed bilaterally with patients under narcotic anesthesia (to preserve the reflex for assessment of optimal lead placement). Dose-response testing at 0 to 6 V is assessed before discharge and at monthly intervals thereafter; the device is activated after 1 month's recovery time. This was a Food and Drug Administration-monitored phase II trial performed at five centers in the United States. RESULTS: Ten patients with resistant hypertension (taking a median of six antihypertensive medications) underwent implantation. All 10 were successful, with no significant morbidity. The mean procedure time was 198 minutes. There were no adverse events attributable to the device. Predischarge dose-response testing revealed consistent (r = .88) reductions in systolic blood pressure of 41 mm Hg (mean fall is from 180-139 mm Hg), with a peak response at 4.8 V (P < .001) and without significant bradycardia or bothersome symptoms. CONCLUSIONS: A surgically implantable device for electrical stimulation of the carotid baroreflex system can be placed safely and produces a significant acute decrease in blood pressure without significant side effects.

Electrical stimulation of the carotid sinus for the treatment of resistant hypertension.

Hypertension is a major cause of morbidity and mortality worldwide. Despite a myriad of oral agents, many patients fail to reach their target blood pressure. Electrical stimulation of the carotid sinus, an old therapeutic concept, lowers blood pressure by initiating the baroreflex and reducing sympathetic tone. Recent evidence suggests that the baroreflex is more important in the setting of chronic hypertension than originally believed. The carotid stimulator may be a safe and effective therapeutic option for patients with resistant hypertension.