Assessment of novel surgical procedures using decellularised muscle and bioactive ceramic: a histological analysis.

Tissue regeneration and neovascularisation in cases of major bone loss is a challenge in maxillofacial surgery. The hypothesis of the present study is that the addition of resorbable bioactive ceramic Silica Calcium Phosphate Cement (SCPC) to Declluraized Muscle Scaffold (DSM) can expedite bone formation and maturation. Two surgical defect models were created in 18 nude transgenic mice. Group 1(n = 6), with a 2-mm decortication calvarial defect, was treated with a DSM/SCPC sheet over the corticated bone as an onlay then seeded with human Mesenchymal Stromal Cells hMSC in situ. In Group 2 (n = 6), a critical size (4 mm) calvarial defect was made and grafted with DSM/SCPC/in situ human bone marrow stromal cells (hMSCs). The control groups included Group 3 (n = 3) animals, with a 2-mm decortication defect treated with an onlay DSM sheet, and Group 4 (n = 3) animals, treated with critical size defect grafted with plain DSM. After 8 weeks, bone regeneration in various groups was evaluated using histology, immunohistochemistry and histomorphometry. New bone formation and maturation was superior in groups treated with DSM/SCPC/hMSC. The DMS/SCPC scaffold has the ability to augment and induce bone regeneration and neovascularisation in cases of major bone resorption and critical size defects.

Costs and complications of hospital admissions for inferior vena cava filter malfunction.

OBJECTIVE: Inferior vena cava filter (IVCF) malfunction can result from penetration, fracture, or migration of the device necessitating retrieval. Endovascular and open retrieval of IVCF have been described in institutional series without comparison. This study examines national hospital admissions for IVCF malfunction and compares the outcomes of open and endovascular retrieval. METHODS: The National Inpatient Sample database (2016-2017) was reviewed for admissions with International Classification of Diseases, Tenth Revision (ICD-10) codes specific for IVCF malfunction. All ICD-10 procedural codes were reviewed, and patients were divided based on open or endovascular IVCF retrieval. Patient characteristics, outcomes, and costs of hospitalization were compared between the two groups. RESULTS: There were 665 patients admitted with a diagnosis of IVCF malfunction. Open IVCF retrieval was performed in 100 patients and endovascular removal in 90 patients. Of those undergoing open surgery, 45 patients (45%) required median sternotomy and 55 (55%) required abdominal surgeries. Most patients were white females with a mean age of 54.4 years (range, 49.3-59.6 years) with a history of deep venous thrombosis (55.3%) or pulmonary embolism (31.6%). Most patients with IVCF malfunction were treated in large (81.6%) or urban teaching (94.7%) hospitals situated most commonly in the South (42.1%) and Northeast (29.0%) with no difference in characteristics of the patients or the centers between the two groups. Patients undergoing open IVCF retrieval were more likely to undergo surgery on an elective basis compared with endovascular IVCF retrieval (75.0% vs 11.1%; P < .001). Open IVCF retrieval was associated with a higher likelihood of thromboembolic complication compared with endovascular retrieval (20% vs 0%; P = .04). There was a trend toward higher infectious complications and overall complications with endovascular removal, but this difference did not reach statistical significance. Open retrieval was associated with a mortality of 5.0% compared with no inpatient mortality with endovascular retrieval (P = .33). The mean hospital length of stay was no difference between the two groups. Open retrieval was associated with significantly higher hospital costs than endovascular retrieval ($34,276 vs $19,758; P = .05). CONCLUSIONS: Filter removal for patients with IVCF malfunction is associated with significant morbidity and cost, regardless of modality of retrieval. The introduction of specific ICD-10 codes for IVCF malfunction allows researchers to study these events. The development of effective tools for outpatient retrieval of malfunctioning IVCF could decrease related hospitalization and have potential savings for the healthcare system.

Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.

BACKGROUND: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system. METHODS: A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature. RESULTS: The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost. CONCLUSIONS: The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.

Disparities and Impact of Medicaid Expansion on Left Ventricular Assist Device Implantation and Outcomes.

BACKGROUND: Left ventricular assist device (LVAD) therapy is an increasingly viable alternative for patients who are not candidates for heart transplantation or who are waiting for a suitable donor. We aimed to determine whether there is an association between sex, race/ethnicity, insurance coverage, and neighborhood income and access to/outcomes of LVAD implantation. We further analyzed whether access to LVAD improved in states that did versus did not expand Medicaid. METHODS AND RESULTS: Retrospective cohort study using State Inpatient Databases to identify patients 18 to 85 years of age admitted for heart failure, cardiogenic shock, or LVAD implantation from 2012 to 2015. Logistic regression analyses adjusting for age, all the sociodemographic factors above, medical comorbidities, and a hospital random effect were used to quantify odds of receipt of LVADs, as well as outcomes conditional on receiving an LVAD, for the sociodemographic groups of interest. A total of 925 770 patients were included; 3972 (0.43%) received LVADs. After adjusting for age, comorbidities, and hospital effects, women (adjusted odds ratio [aOR], 0.45 [0.41-0.49]), black patients (aOR, 0.83 [0.74-0.92]), and Hispanic patients (aOR, 0.74 [0.64-0.87]) were less likely to receive LVADs than whites. Medicare (aOR, 0.79 [0.72-0.86]), Medicaid (aOR, 0.52 [0.46-0.58]), and uninsured patients (aOR, 0.17 [0.11-0.25]) were less likely to receive LVADs than the privately insured, and patients in low-income ZIP codes were less likely than those in higher income areas (aOR, 0.71 [0.65-0.77]). Among those who received LVADs, women (aOR, 1.78 [1.38-2.30]), patients of unknown race or race other than white, black, or Hispanic (aOR, 1.97 [1.42-2.74]), and uninsured patients (aOR, 4.86 [1.92-12.28]) had higher rates of in-hospital mortality. Medicaid expansion was not associated with an increase in LVAD implantation. CONCLUSIONS: There are meaningful sociodemographic disparities in access and outcomes for LVAD implantation. Medicaid expansion was not associated with an increase in LVAD rates.

Is the Affordable Care Act Medicaid Expansion Linked to Change in Rate of Ventricular Assist Device Implantation for Blacks and Whites?

BACKGROUND: The Affordable Care Act (ACA) has been associated with increased heart transplant listings among blacks, who are disproportionately uninsured. It is unclear whether the ACA is also associated with increased ventricular assist device implantation in blacks. METHODS: Using Healthcare Cost and Utilization Project Data State Inpatient Databases from 19 states and Washington DC, we analyzed 1157 patients from early-adopter states (ACA Medicaid expansion by January 2014) and 785 patients from nonadopter states (no implementation from 2013 to 2014). Piecewise Poisson regression with a discontinuity was used to estimate change in census-adjusted rates of ventricular assist device implants by race and ACA adopter status 1 year before and after January 2014. RESULTS: Following the ACA Medicaid expansion, the proportional change in rate increased significantly among blacks from early adopter (1.40 [95% CI, 1.12-1.75], pre 0.57/100 000 to post-ACA 0.80/100 000) but not nonadopter states (1.25 [95% CI, 0.98-1.58], pre 0.40/100 000 to post-ACA 0.50/100 000). However, the early and nonadopter changes in implantation rates were not statistically different from each other (P=0.50). There were no immediate changes in whites in either state group following the ACA Medicaid expansion (early adopter, 1.12 [95% CI, 0.98-1.29], pre 0.27/100 000 to post-ACA 0.30/100 000; nonadopter, 0.98 [95% CI, 0.82-1.16], pre 0.27/100 000 to post-ACA 0.26/100 000). CONCLUSIONS: Among eligible states participating in Healthcare Cost and Utilization Project Data State Inpatient Databases, the ACA was not associated with immediate changes in ventricular assist device implantation rates by race. Although a significant increase in implantation rate was observed among blacks from early-adopter states, the change was not statistically different from the change seen in nonadopter states.

Better With Time: An Economic Assessment of Long-Term Mechanical Circulatory Support in a Population Surviving at Least 1 Year with a Left Ventricular Assist Device.

This study aims to identify the major components of left ventricular assist device (LVAD)-related costs in a population on long-term mechanical circulatory support to gain insight into opportunities for improvements in quality, safety, and efficiency of care for end-stage heart failure patients. This was a single institution, retrospective cost analysis of patients who received a Heartmate II or HeartWare LVAD between November 2005 and October 2015. Payments for hospitalization for device implantation and subsequent readmissions were represented as the institution's 2015 Medicare reimbursement rate. The incidence, average Medicare reimbursement, and length of stay of readmissions were analyzed for the first year postimplant. A full year of LVAD-related hospitalizations in patients surviving ≥12 months, has a median Medicare reimbursement of $247,208. The most common complications related to ventricular assist devices were gastrointestinal bleeding, driveline infection, stroke, and pump thrombosis. Over 90% of total costs were incurred during the initial hospitalization. Seventy-five percent of first-time readmissions occurred within the first 4 months post discharge. Intensive care unit costs accounted for the single largest cost category during readmissions for all of the 4 most common complications. The trends demonstrated suggest that longer lengths of LVAD support in appropriately selected patients results in progressively decreasing cost-per-month up to 12 months, given the large upfront cost of device implantation and relatively modest additional costs of readmissions. This analysis emphasizes the importance of devices with improved complication profiles and clinical protocols to reduce unnecessary intensive care unit stays to increase the cost effectiveness of long-term ventricular assist device therapy.

Vascular complications associated with percutaneous left ventricular assist device placement: A 10-year US perspective.

BACKGROUND: Over the last decade, there has been a significant increase in the use of percutaneous left ventricular assist devices(p-LVADs). p-LVADs are being increasingly used during complex coronary interventions and for acute cardiogenic shock. These large bore percutaneous devices have a higher risk of vascular complications. We examined the vascular complication rates from the use of p-LVAD in a national database. METHODS: We conducted a secondary analysis of the National In-patient Sample (NIS) dataset from 2005 till 2015. We used the ICD-9-CM procedure codes 37.68 and 37.62 for p-LVAD placement regardless of indications. We investigated common vascular complications, defining them by the validated ICD 9 CM codes. χ2 test and t test were used for categorical and continuous variables, respectively for comparison. RESULTS: A total of 31,263 p-LVAD placements were identified during the period studied. A majority of patients were male (72.68%) and 64.44% were white. The overall incidence of vascular complications was 13.53%, out of which 56% required surgical treatment. Acute limb thromboembolism and bleeding requiring transfusion accounted for 27.6% and 21.8% of all vascular complications. Occurrence of a vascular complication was associated with significantly higher in-hospital mortality (37.77% vs. 29.95%, p < .001), length of stay (22.7 vs. 12.2 days, p < .001) and cost of hospitalization ($ 161,923 vs. $ 95,547, p < .001). CONCLUSIONS: There is a high incidence of vascular complications with p-LVAD placement including need for vascular surgery. These complications are associated with a higher in-hospital, LOS and hospitalization costs. These findings should be factored into the decision-making for p-LVAD placement.

Pre- and intraoperative acoustic and functional assessment of the novel APrevent® VOIS implant during routine medialization thyroplasty.

PURPOSE: Persistent unilateral vocal fold paralysis (UFVP) with glottal insufficiency often requires type I medialization thyroplasty (MT). Previous implants cannot be adjusted postoperatively if necessary. The newly developed APrevent® VOIS implant (VOIS) can provide postoperative re-adjustment to avoid revision MT. The objective of this pilot study is to evaluate the VOIS intraoperatively concerning voice improvement, surgical feasibility and device handling. METHODS: During routine MT, VOIS was applied short time in eight patients before the regular implantation of the Titanium Vocal Fold Medialization Implant (TVFMI™). In all patients, perceptual voice sound analysis using R(oughness)-B(reathiness)-H(oarseness)-scale, measurement of M(aximum)-P(honation)-T(ime) and glottal closure in videolaryngoscopy were performed before and after implanting VOIS/TVFMI™. Acoustic analyses of voice recordings were performed using freeware praat. Surgical feasibility, operative handling and device fitting of VOIS and TVFMI™ were assessed by the surgeon using V(isual)-A(nalog)-S(cale). Data were statistically analyzed with paired t test. RESULT: All patients showed significant improvement of voice sound parameters after VOIS/TVFMI™ implantation. The mean RBH-scale improved from preoperative R = 2.1, B = 2.3, H = 2.5 to R = 0.6, B = 0.3, H = 0.8 after VOIS and R = 0.5, B = 0.3, H = 0.8 after TVFMI™ implantation. The mean MPT increased from preoperative 7.9 to 14.6 s after VOIS and 13.8 s after TVFMI™ implantation. VOIS/TVFMI™ achieved complete glottal closure in 7/8 patients. The satisfaction with intraoperative device fitting and device handling of VOIS was as good as that of TVFMI™. CONCLUSION: The novel APrevent® VOIS implant showed similar intraoperative voice improvement compared to routinely used TVFMI™ without adverse device events and with safe device fitting.

Assessment of the healing process after percutaneous implantation of a cardiovascular device: a systematic review.

The healing process, occurring after intra-cardiac and intra-vascular device implantation, starts with fibrin condensation and attraction of inflammatory cells, followed by the formation of fibrous tissue that slowly covers the device. The duration of this process is variable and may be incomplete, which can lead to thrombus formation, dislodgement of the device or stenosis. To better understand this process and the neotissue formation, animal models were developed: small (rats and rabbits) and large (sheep, pigs, dogs and baboons) animal models for intra-vascular device implantation; sheep and pigs for intra-cardiac device implantation. After intra-vascular and intra-cardiac device implantation in these animal models, in vitro techniques, i.e. histology, which is the gold standard and scanning electron microscopy, were used to assess the device coverage, characterize the cell constitution and detect complications such as thrombosis. In humans, optical coherence tomography and intra-vascular ultrasounds are both invasive modalities used after stent implantation to assess the structure of the vessels, atheroma plaque and complications. Non-invasive techniques (computed tomography and magnetic resonance imaging) are in development in humans and animal models for tissue characterization (fibrosis), device remodeling evaluation and device implantation complications (thrombosis and stenosis). This review aims to (1) present the experimental models used to study this process on cardiac devices; (2) focus on the in vitro techniques and invasive modalities used currently in humans for intra-vascular and intra-cardiac devices and (3) assess the future developments of non-invasive techniques in animal models and humans for intra-cardiac devices.

Magnification Spot Radiographs Improve Assessment for Inferior Vena Cava Filter Fractures prior to Removal Compared to CT.

PURPOSE: To determine if magnification spot radiographs acquired before attempting inferior vena cava (IVC) filter removal have value in the assessment for filter fractures. MATERIALS AND METHODS: A retrospective review of complex IVC filter removals performed at a tertiary referral center from October 2015 to May 2017 was performed. Magnification spot radiographs (frontal and at least 2 oblique views) were obtained with the fluoroscopic unit in the procedure suite prior to venous access for filter removal. Patients were included in the study if a computed tomography (CT) scan of the abdomen/pelvis before filter removal was available. Ninety-six patients (47 women and 49 men) were included. Most removed filters were the Recovery/G2/G2X/Eclipse/Meridian (n = 28), the Günther Tulip (n = 26), and the Celect/Celect Platinum (n = 22). Blinded review of the pre-procedural CT scans and spot radiographs for the presence of filter fractures was performed by 2 interventional radiologists. Accuracy of each modality was assessed using the status of the explanted filter as the gold standard. Agreement between the 2 readers was assessed with the kappa statistic. RESULTS: Fractures were present in 27 explanted filters (28%). Accuracy of CT was 88% and 68% for readers 1 and 2, respectively, which increased to 98% and 97% with magnification spot radiographs. The kappa statistic was 0.12 for CT and 0.97 for spot radiographs. CONCLUSIONS: Magnification spot radiographs acquired before attempting IVC filter removal improve detection of filter fractures and agreement among interventional radiologists. Therefore, these should be performed routinely to allow for optimal treatment planning.

Landscape of Cardiovascular Device Registries in the United States.

Background Regulators increasingly rely on registries for decision making related to high-risk medical devices in the United States. However, the limited uniform standards for registries may create substantial variability in registry implementation and utility to regulators. We surveyed the current landscape of US cardiovascular device registries and chart the extent of inconsistency in goals, administration, enrollment procedures, and approach to data access. Methods and Results A systematic review using Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines identified studies (1995-2017) referencing cardiovascular device registries with a US-based institution. Registries were then evaluated by reviewing associated articles and websites. Extracted data included device type, primary scientific aim(s), funding, stewardship (eg, administration of registry procedures), enrollment procedures, informed consent process, and mechanisms to access data for research. The 138 cardiovascular device registries in the cohort covered devices addressing interventional cardiology (65.9%), arrhythmias (15.2%), heart failure (10.1%), and valvular disease (10.1%). While the majority (55.8%) were industry-funded, stewardship was predominantly overseen by academic centers (74.0%). Most registry participation was voluntary (77.5%), but a substantial minority (19.7%) were required as a condition of device implantation. Informed consent requirements varied widely, with written consent required in only 55.1% of registries. Registry data were primarily accessible only to stewards (84.1%), with 13.8% providing pathways for external applications. Conclusions The majority of cardiovascular device registries were funded privately under the auspices of academic institutions, which set the rules for data access. The substantial variation between cardiovascular device registries suggests a role for regulators to further strengthen guidelines to improve quality, consistency, and ethical standards.

Costs and complications of endovascular inferior vena cava filter retrieval.

OBJECTIVE: Advanced endovascular techniques are frequently used for challenging inferior vena cava (IVC) filter retrieval. However, the costs of IVC filter retrieval have not been studied. This study compares IVC filter retrieval techniques and estimates procedural costs. METHODS: Consecutive IVC filter retrievals performed at a tertiary center between 2009 and 2014 were retrospectively reviewed. Procedures were classified as standard retrieval (SR) if they required only a vascular sheath and a snare device and as advanced endovascular retrieval (AER) if additional endovascular techniques were used for retrieval. Cost data were based on hospital bills for the procedures. Patients' characteristics, filter dwell time, retrieval procedure details, complications, and costs were compared between the groups. All statistical comparisons were performed using SAS 9.3 software. RESULTS: There were 191 IVC filter retrievals (SR, 157; AER, 34) in 183 patients (mean age, 55 years; 51% male). Fifteen filters (7.9%) were placed at an outside hospital. The indications for placement were mostly therapeutic (76% vs 24% for prophylaxis). All IVC filters were retrievable, with Bard Eclipse (Bard Peripheral Vascular, Tempe, Ariz; 34%) and Cook Günther Tulip (Cook Medical, Bloomington, Ind; 24%) the most common. Venous ultrasound examination of the lower extremities of 133 patients (70%) was performed before retrieval, whereas only 5 patients (2.6%) received a computed tomography scan of the abdomen. There was no difference in the mean filter dwell time in the two groups (SR, 147.9 ± 146.1 days; AER, 161.4 ± 91.3 days; P = .49). AERs were more likely to have had prior attempts at retrieval (23.5%) compared with SRs (1.9%; P < .001). The most common AER techniques used were the wire loop and snare sling (47.1%) and the stiff wire displacement (44.1%). Bronchoscopy forceps was used in four cases (11.8%); this was the only off-label device used. AERs were more likely to require more than one venous access site for the retrieval procedure (23.5% vs 0%; P < .001). AERs were significantly more likely to have longer fluoroscopy time (34.4 ± 18.3 vs 8.1 ± 7.9 minutes; P < .001) and longer total procedural time (102.8 ± 59.9 vs 41.1 ± 25.0 minutes; P < .001) compared with SRs. The complication rate was higher with AER (20.6%) than with SR (5.2%; P = .006). Most complications were abnormal radiologic findings that did not require additional intervention. The procedural cost of AER was significantly higher (AER, $14,565 ± $6354; SR, $7644 ± $2810; P < .001) than that of SR. This translated to an average increase in cost of $6921 ± $3544 per retrieval procedure for AER. CONCLUSIONS: Advanced endovascular techniques provide a feasible alternative when standard IVC filter retrieval techniques do not succeed. However, these procedures come with a higher cost and higher rate of complications.

Prophylactic Inferior Vena Cava Filters Prior to Bariatric Surgery: Insights From the National Inpatient Sample.

OBJECTIVES: The aim of this study was to determine in-hospital mortality, post-surgical thromboembolic events, and health care costs associated with the placement of prophylactic inferior vena cava filters (IVCFs) prior to bariatric surgery. BACKGROUND: The role of prophylactic IVCFs prior to bariatric surgery is controversial, and the nationwide clinical outcomes associated with this practice are unknown. METHODS: This observational study used the National Inpatient Sample database to identify obese patients who underwent bariatric surgery from January 2005 to September 2015. Using propensity score matching, outcomes associated with patients receiving prophylactic IVCFs prior to their bariatric surgery were compared with those among patients who did not receive IVCFs. RESULTS: A total of 258,480 patients underwent bariatric surgery, of whom 1,047 (0.41%) had prophylactic IVCFs implanted. Patients with prophylactic IVCFs compared with those without IVCFs had a significantly higher rate of the combined endpoint of in-hospital mortality or pulmonary embolism (1.4% vs. 0.4%; odds ratio: 3.75; 95% confidence interval [CI]: 1.25 to 11.30; p = 0.019). Additionally, prophylactic IVCFs were associated with higher rates of lower extremity or caval deep vein thrombosis (1.8% vs. 0.3%; odds ratio: 6.33; 95% CI: 1.87 to 21.4; p < 0.01), length of stay (median 3 days vs. 2 days; p < 0.01), and hospital charges (median $63,000 vs. $37,000; p < 0.01). CONCLUSIONS: In this nationwide observational study, prophylactic IVCF implantation prior to bariatric surgery was associated with worse clinical outcomes and increased health care resource utilization.

Intra-Scleral Ciliary Sulcus Suprachoroidal Microtube: Making Supraciliary Glaucoma Surgery Affordable.

PURPOSE: The suprachoroidal space (SCS) has been a successful target to lower intraocular pressure (IOP) in glaucoma patients. We present the results of 4 patients who underwent a novel glaucoma surgical procedure to lower IOP: Intrascleral Ciliary Sulcus-Suprachoroidal Microtube. METHODS: A sterile medical grade silicone microtube (Tube extender, New World Medical) was surgically placed to drain aqueous from the posterior chamber ciliary sulcus of the eye to the SCS. The internal diameter of the tube was 300 um and the length varied from 8-10mm. After informed consent was obtained and witnessed, this procedure was performed in glaucoma patients with pseudophakia. The tube was placed intrasclerally beneath an inferotemporal sclera flap (50% thickness approximately 4mm x 4mm). The anterior end of the tube was inserted into the ciliary sulcus approximately 2mm from the limbus and the posterior end was placed into the SCS approximately 4mm from the limbus. The microtube was sutured to the sclera with a 10-0 nylon suture. 8-0 vicryl sutures were used to close the sclera flap and the conjunctiva inferotemporally. RESULTS: All 4 patients had lower IOP. The average reduction of IOP was 36% at 3 months. The amount of glaucoma medications per patient at 3 months dropped from an average of 3 to 0.25. The risks are similar to traditional glaucoma incisional surgery. CONCLUSION: This new technique of Intrascleral Ciliary Sulcus-Suprachoroidal Microtube in all four patients with mild, moderate, and advanced glaucoma demonstrated a significant lowering of IOP and a decrease in the number of medications. Further research is required to assess long term efficacy and safety.

Preparedness and Mutuality Affect Quality of Life for Patients With Mechanical Circulatory Support and Their Caregivers.

BACKGROUND: Clinical and US regulatory guidelines for patients with mechanical circulatory support (MCS) require the identification of a caregiver to assist with MCS care. There is limited understanding of the impact of MCS caregiving on patients and caregivers. The purpose of this study was to examine how living with MCS affects the quality of life (QoL) of patients and their caregivers through the lens of preparedness and mutuality. METHODS AND RESULTS: The sample included 30 MCS patients and their caregivers. Semistructured qualitative interviews about factors contributing to QoL were conducted with patients and caregivers and analyzed using a 2-phase thematic process. Caregiving impacts QoL of MCS patients and their caregivers long term. When there was limited time to engage in decision-making about MCS implantation, people entered MCS caregiving relationships naive to its full demands. Although most people adjusted to the task demands, MCS caregiving had a significant impact, both positive and negative, on interpersonal relationships. We applied the concepts of preparedness and mutuality to help frame the understanding of the emergent themes of forced choice, adjustment, gratitude, relationship change, strain, and burden (both caregiver and patient perceived). Availability of networks of support was identified as a crucial resource. CONCLUSIONS: MCS caregiving affects QoL for both patients and caregivers. Specifically, preparedness, mutuality, and availability of supportive networks influence QoL of MCS patients and their caregivers. Caregiving relationships change over time. Long-term support by the MCS clinical team can help ensure that physical and emotional needs of MCS patients and caregivers are identified and addressed.

Standardized Psychosocial Assessment Before Left Ventricular Assist Device Implantation.

BACKGROUND: Before consideration of advanced cardiac therapies, guidelines recommend a comprehensive multidisciplinary examination, including psychosocial assessment. The Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) has emerged as a highly reproducible tool to assess for psychosocial impairment and is associated with negative medical and psychosocial outcomes after transplantation. We sought to assess the association between SIPAT and outcomes after left ventricular assist device. METHODS AND RESULTS: We evaluated 128 patients implanted with a first left ventricular assist device at the Cleveland Clinic from 2013 to 2017 who underwent a prospectively collected quantitative psychosocial assessment using SIPAT. Several survival analyses were performed testing the association between SIPAT score and mortality, first adverse event (defined as hospitalization, device exchange, or death), and recurring adverse events after multivariable adjustment. Median SIPAT score was 14 (interquartile range, 9.5-22.5), with higher values (representing more impairment) seen in patients implanted as destination therapy. After a median follow-up of 349 (interquartile range, 178-684) days, there were 319 adverse events (18 deaths, 10 device exchanges, and 291 readmissions) with 2.5±2.4 events per patient. Higher preimplant SIPAT scores were not associated with mortality ( P=0.764) or time to a first adverse event ( P=0.589) but were associated with cumulative adverse events (hazard ratio, 1.31; 95% CI, 1.09-1.58; P=0.005 per Δ10 in score). In addition, SIPAT was associated with days alive outside of the hospital ( P=0.016). CONCLUSIONS: A standardized assessment of psychosocial impairment after left ventricular assist device using the SIPAT score was not associated with mortality or time to first adverse event but was associated with cumulative adverse cardiac events. This score may provide insight when structuring mitigation strategies for high-risk patients and should be further tested in a prospective multicenter study.

Noninvasive Assessment of Hemodynamic Status in HeartWare Left Ventricular Assist Device Patients: Validation of an Echocardiographic Approach.

OBJECTIVES: The aim of this prospective study was to validate an echocardiographic protocol derived from 5 HeartWare left ventricular assist device (HVAD) patients for the noninvasive evaluation of right atrial pressure (RAP) and left atrial pressure (LAP) in HVAD patients. BACKGROUND: Echocardiography is an invaluable tool to optimize medical treatment and pump settings and also for troubleshooting residual heart failure. Little is known about the echocardiographic evaluation of hemodynamic status in HVAD patients. METHODS: Right heart catheterization and Doppler echocardiography were performed in 35 HVAD patients. Echocardiography-estimated RAP (eRAP) was assessed using inferior vena cava diameter, hepatic venous flow analysis, and tricuspid E/e' ratio. Echocardiography-estimated LAP was assessed using E/A ratio, mitral E/e' ratio, and deceleration time. RESULTS: eRAP and estimated LAP significantly correlated with invasive RAP and LAP (respectively, r = 0.839, p < 0.001, and r = 0.889, p < 0.001) and accurately detected high RAP and high LAP (respectively, area under the curve 0.94, p < 0.001, and area under the curve 0.91, p < 0.001). High eRAP was associated with high LAP (area under the curve 0.92, p < 0.001) and correlated with death or hospitalization at 180 days (odds ratio: 8.2; 95% confidence interval: 1.1 to 21.0; p = 0.04). According to estimated LAP and eRAP, patients were categorized into 4 hemodynamic profiles. Fifteen patients (43%) showed the optimal unloading profile (normal eRAP and normal wedge pressure). This profile showed a trend toward a lower risk for adverse cardiac events at follow-up (odds ratio: 0.2; 95% confidence interval: 0.1 to 1.0; p = 0.05) compared with other hemodynamic profiles. CONCLUSIONS: Doppler echocardiography accurately estimated hemodynamic status in HVAD patients. This algorithm reliably detected high RAP and LAP. Notably, high RAP was associated with high wedge pressure and adverse outcome. The benefit of noninvasive estimation of hemodynamic status in the clinical management of patients with left ventricular assist devices needs further evaluation.

Persistently low inferior vena cava filter retrieval rates in a population-based cohort.

BACKGROUND: Practice patterns associated with inferior vena cava (IVC) filter placement have seen considerable variation in the last decade. We used a statewide administrative database to examine trends in IVC filter placement and retrieval in the general population. METHODS: We reviewed Florida state inpatient and ambulatory surgery databases from 2004 to 2014. International Classification of Diseases, Ninth Revision diagnosis and procedure codes and Current Procedural Terminology codes were searched for patients undergoing inpatient or outpatient IVC filter placement, and each patient was longitudinally tracked to the time of inpatient or outpatient filter retrieval. For inpatient filter placements, associated diagnoses were reviewed to identify indications for placement. Univariate and multivariate logistic regression models were constructed to identify factors associated with improved retrieval rates. RESULTS: During the 11-year period, 131,791 IVC filter placements were identified, with a 50% increase from 2004 to 2010 and a 24% decline from 2010 to 2014. Median age at filter placement was 71 years (interquartile range, 57-81 years). Mean follow-up after filter placement was 17.3 ± 25.5 months. Only 8637 filters (6.6%) were retrieved. The annual retrieval rate trended upward, from 3.4% in 2004 to 8.5% in 2013 (P < .001). Median filter dwell time was 96.5 days (interquartile range, 44-178 days). Diagnoses associated with filter placement included venous thromboembolism (75.9%), trauma (35.0%), hemorrhage (29.9%), malignant disease (29.4%), and stroke (5.1%). Retrieval rates were highest in younger patients (34.0% in patients younger than 20 years) and lowest in Medicare patients (2.5%). In a multivariate logistic regression model, Medicare was associated with decreased retrieval rates (odds ratio, 0.33; 95% confidence interval, 0.31-0.35; P < .001) after adjusting for age and associated diagnoses. Weaker risk factors included increased age, white race, and diagnoses of deep venous thrombosis, pulmonary embolism, and malignant disease. A trauma diagnosis was associated with improved retrieval. To further investigate the Medicare effect, a propensity score-matched model was created to better account for confounding effects. In this model, Medicare persisted as a risk factor for decreased filter retrieval (odds ratio, 0.43; 95% confidence interval, 0.40-0.46; P < .001). CONCLUSIONS: IVC filter placements, after a substantial increase between 2004 and 2010, have been declining since 2010. Retrieval rates in the general population are steadily improving but continue to lag behind those described in center-specific literature. Increased age and Medicare as the primary payer are the strongest risk factors for lack of filter retrieval. Widespread improvements on a national scale are needed to improve the appropriateness of filter placements and to enhance filter retrieval rates.

Early cost-utility estimation of the surgical correction of pectus excavatum with the Nuss bar.

OBJECTIVES: The surgical correction of pectus excavatum (PE) with a Nuss bar provides satisfactory outcomes, but its cost-effectiveness is yet unproven. We prospectively analysed early outcomes and costs for Nuss bar placement. METHODS: Fifty-four patients aged 16 years or older (6 females and 48 males; mean age, 17.9 years; range 16.0-29.4 years) with a PE filled out a Short Form-36 Health Survey (SF-6D) preoperatively and 1 year after a Nuss procedure. Costs included professional fees and fees for the operating room, materials and hospital care. Changes in the responses to the SF-36 or its domains were compared using the Wilcoxon signed rank test and the utility test results were calculated preoperatively and postoperatively from the SF-6D. The quality-adjusted life years (QALYs) were calculated from the results of these tests. RESULTS: Significant improvements in physical functioning, social functioning, mental health and health transition (all P < 0.05) were noted. The other SF-36 subgroups showed improvement; however, the improvement was not significant. The SF-6D utility showed improvement from 0.76 preoperatively to 0.79 at the 1-year follow-up (P = 0.096). The mean direct costs were €8805. The 1-year discounted QALY gain was 0.03. The estimated cost-utility ratio was €293 500 per QALY gained. CONCLUSIONS: Despite a significant improvement in many domains of the SF-36, the results of the SF-6D cost-utility analysis showed only a small improvement in cost-effectiveness (> €80 000/QALY) for patients with PE 1 year after Nuss bar placement. Based on this discrepancy, general health outcome measurements as the basis for cost-utility analysis in patients with PE may not be the best way forward.