Device Instructions For Use Research Articles

Endovascular Aortic Repair With the E-Tegra Device: Preliminary Outcomes From a Multicenter National Registry.

Endovascular aortic repair (EVAR) is currently expanding its feasibility thanks to design innovations, but hostile proximal necks and narrow iliac arteries are still a constraint, as expressed by the Instructions for Use (IFU) of most devices. Our aim is to report the preliminary results of the E-Tegra endograft in infrarenal abdominal aortic aneurysms (AAAs) performed in 15 high-volume centers. The e-Tegra Italian endoGraft REgistry (TIGRE) is a prospectively maintained database of consecutive EVAR with the E-Tegra stent-graft across 15 participating centers between March 2021 and March 2023. The registry records baseline clinical data, anatomic measurements of the abdominal aorta, perioperative and postoperative outcomes, with a scheduled follow-up period of 3 years for all patients. This is a preliminary analysis of the first results updated to January 2024. The primary endpoints are technical and clinical success, perioperative mortality, freedom from endograft rupture, and aortic-related mortality. The secondary endpoints are freedom from reintervention, and any type of endoleak (EL). The results were analyzed in relation with the anatomic characteristics of the AAAs, namely, iliac axes tortuosity and proximal neck hostility. The registry included 147 consecutive EVAR (138 elective and 9 in emergent setting), 7 of which were associated with an iliac branch implantation. Ninety patients had at least 1 criterion of anatomical hostility, and 25 were treated outside the device IFU. Primary technical success was achieved in 146 cases (99.3%) and assisted success in 147 (100%), with no perioperative mortality. After a median follow-up period of 20 months, no aneurysm-related mortality occurred. Reinterventions were 5: 2 for type IB EL and 3 for type II ELs with aneurysm sac increase. Five more type II ELs with aneurysm sac stability are under observation. No differences in terms of reinterventions were noted between aneurysms with standard and hostile anatomy. The E-Tegra endograft is safe and effective in treating AAAs with standard and hostile anatomy, with a low rate of complications and reinterventions, although longer-term outcomes and larger numbers are needed to compare its performances related to specific anatomic criteria. This multi-center nationwide Registry reports a real-world experience of EVAR performed with the E-Tegra abdominal endograft across 15 high-volume Centers, providing early- and mid-term device-specific results, which will help vascular surgeons in endograft selection. In particular, this study focuses on clinical results obtained in treating aneurysms with hostile anatomy, analyzing the performances of the E-Tegra endograft in cases of hostile proximal necks and narrow or tortuous iliac axes.

Novel Thermoreversible Reverse-Phase-Shift Foam With Deployment System for Treatment of Penetrating Globe Trauma in a Newly Described Porcine Model.

The initial management of penetrating ocular injuries is a major sight-threatening problem for both civilian and military medicine. A novel device (Eye-Aid) temporarily tamponades leakage from such injuries while being easy to remove upon arrival to specialized ophthalmologic care. Eye-Aid consists of a protective eye shield with an adhesive backing that connects to a portable canister containing rapidly deployable thermoresponsive foam. The aim of this study was to compare the use of the novel Eye-Aid device to control in a new live swine ocular injury model. Bilateral penetrating ocular injuries were created on 14 male Yorkshire swine in a standardized manner using a 16-gauge needle device to puncture the central cornea and cause a full-thickness wound. Researchers randomized eye intervention side, with the contralateral eye used as paired control. Two minutes after the injury, the eye shield components of the Eye-Aid system, which has a sticky pad for attachment to the skin and a luer-lock for foam deployment, were placed bilaterally. Eight minutes after the injury, foam was deployed for the intervention eye according to the device instructions for use. For the control eye, no additional procedures were performed. Six hours post-injury, end A-scan and intraocular pressure (IOP) were measured. Primary study outcome was change in axial length of the globe. Secondary outcomes were as follows: (1) Presence of full anterior chamber collapse, defined as a lack of measurable anterior lens capsule-reflex (ALC-reflex) on A-scan and (2) change in IOP. Outcomes were analyzed as paired intra-animal data, with intervention and control data for each animal. A paired t-test was used to analyze the difference in axial length change and IOP change between treatment groups, whereas a conditional logistic regression was used to analyze dichotomous ALC-reflex outcome and estimate the odds ratio associated with the Eye-Aid device. A significant difference (P < .0001) in mean change in axial length between intervention (-210 μm) and control (-1,202 μm) groups was found. There was a significant difference in ALC-reflex presence, with 79% of eyes having an ALC-reflex in the intervention group, compared to 14% in the control (P = .008). IOP remained higher in the intervention group, with a mean change of -1.5 mmHg for the intervention group compared to -4.0 mmHg in the control (P = .0001). This study describes the first development of an in vivo large animal ocular injury model that realistically approximates the emergent time course and pathophysiology of patients with full-thickness corneal open globe injuries. It also gives the first description of using thermoreversible hydrogel foam for such injuries. Eye-Aid was found to be significantly better than control for treatment of such injuries, based on measurements of both structure and pressure. Assuming that the absence of an ALC-reflex demonstrates complete anterior chamber collapse, the Eye-Aid group demonstrated a 79% eye "save" rate compared to only 14% in the control group, as described earlier. This results in a Number Needed to Treat of 3 for this finding. Eye-Aid additionally demonstrated several characteristics that would be beneficial in a device targeted for emergent deployment by non-ophthalmologists.

Is There Really No Kit for Kids? Quantification of Manufacturer Recommendations Regarding Paediatric Use For High-Volume IR Devices.

The development of paediatric specific devices appears to lag behind advancements in our specialty. Children could therefore be limited in the number of procedures available to them unless we continue to use and modify adult devices 'off-label'. This study quantifies the proportion of IR devices in which paediatric use is indicated by the manufacturer. Cross-sectional analysis of device instructions for use (IFU), assessing inclusion of children was performed. Vascular access, biopsy, drainage, and enteral feeding devices, from 28 companies who sponsored BSIR, CIRSE and SIR (2019-2020) as determined by the meeting websites, were included. Devices for which the IFU was not available were excluded. 190 (106 vascular access, 40 biopsy, 39 drainage and 5 feeding) devices with IFU's from 18 medical device manufacturers were assessed. 49/190 (26%) IFU's referenced children. 6/190 (3%) explicitly stated the device could be used in children and 1/190 (0.5%) explicitly stated the device was not for use in children. 55/190 (29%) implied they could be used in children through caution notes. The most common caution was a reference to the size of the device that could be accommodated in a child (26/190, 14%). This data identifies an unmet need for paediatric IR devices and could be used to support the future development of devices intended for the children we treat. There is potentially a larger proportion (29%) of devices suitable for paediatric use, but which lack manufacturer explicit support. Level 2c, Cross-Sectional study.

The association between device instructions for use adherence and outcomes after elective endovascular aortic abdominal aneurysm repair

ObjectiveAortic neck anatomy has a significant impact on the complexity of endovascular aortic aneurysm repair (EVAR), with concern that neck characteristics outside of the instructions for use (IFU) may result in worse outcomes. Therefore, this study determined the impact of neck characteristics outside of the IFU on perioperative and 1-year outcomes and mid-term survival after EVAR. MethodsWe identified all patients undergoing elective infrarenal EVAR from December 2014 to May 2020 in the Vascular Quality Initiative database. Neck characteristics outside of the IFU were determined based the specific device IFU neck characteristics (neck diameter, length, and angulation). Patients without 1-year follow-up were excluded for the 1-year outcomes analyses (n = 6138 [40%]). We used multivariable adjusted logistic regression and Cox proportional hazard models to identify the independent associations between neck characteristics outside of the IFU and our outcomes. ResultsOf the 15,448 patients identified, 22.1% had neck characteristics outside of the IFU, including 6.6% with a infrarenal angle, 6.8% with a neck length, 10.4% with a neck diameter, and 1.1% with a suprarenal angulation outside of the IFU. Of these, 2.4% had more than one neck characteristic outside of the IFU. Patients with neck characteristics outside of the IFU were more often female (27.9% vs 15.0%; P < .001) and were older (median age, 75 years vs 73 years; P < .001). EVAR patients with neck characteristics outside of the IFU had higher rates of type Ia endoleaks at completion (4.8% vs 2.5%; P < .001), perioperative mortality (1.2% vs 0.6%; P < .001), 1-year sac expansion (7.1% vs 5.3%; P = .017), and 1-year reinterventions (4.4% vs 3.2%; P = .03). In multivariable adjusted analyses, neck characteristics outside of the IFU were independently associated with type Ia completion endoleaks (OR, 1.6; 95% CI, 1.3-2.0; P < .001), perioperative mortality (OR, 1.8; 95% CI, 1.2-2.7; P = .005), 1-year sac expansion (OR, 1.4; 95% CI, 1.0-1.8; P = .025), and 1-year reinterventions (OR, 1.4; 95% CI, 1.0-1.9; P = .039). The unadjusted midterm survival was lower for patients with neck characteristics outside of the IFU than for patients without (5-year survival 84.0% vs 86.7%; log-rank P < .001). However, after adjustment, survival was similar for patients with neck characteristics outside of the IFU to those within (hazard ratio, 1.1; 95% CI, 1.0-1.3; P = .22). ConclusionsNeck characteristics outside of the IFU are independently associated with completion type Ia endoleaks, perioperative mortality, 1-year sac expansion, and 1-year reinterventions among patients undergoing elective EVAR. These results indicate that continued effort is needed to improve the proximal seal in patients with neck characteristics outside of the IFU undergoing EVAR. Also, in patients with severe hostile neck characteristics, alternative approaches such as open repair, use of a fenestrated or branched device, or endoanchors should be considered.

540 Progressive temporal reduction of complications after TAVI

Abstract Aims The TAVI registry represents a single-centre observational retrospective study that consecutively collected symptomatic patients with severe aortic stenosis between September 2009 and February 2021 at the Magna Graecia University (Catanzaro, Italy). Our aim was to evaluate the rate of complications which can occur after Transcatheter aortic valve replacement (TAVR) and its possible predictors. Methods We included a total of 346 consecutive patients, admitted to our institution between September 2009 and February 2021. Inclusion criteria were: severe aortic stenosis in high-risk patients unsuitable for surgery after cardiac team consent, valve anatomy adjusted according to device instructions for use, life expectancy&amp;gt; 1 year. Clinical, echocardiographic and procedural data were collected and reported in an electronic database. Surgical risk was prospectively assessed using the European Cardiac Operational Risk Assessment System (EuroSCORE II, https://www.euros core.org/calc.html). The mean age of the population was 80.3 ± 5.4 years; 144 patients (41.6%) were male. The average EuroSCORE II was 6.3 ± 5.7. All reported P-values are two-sided and P-values &amp;lt;0.05 were considered significant. STATA (StataCorp, USA) was used for data analysis. Results Out of the total population analysed, the number of patients who underwent a vascular complication was 23 or 6.6%. Female sex was an independent predictor of vascular complication (P 0.015) regardless of the presence of peripheral vascular disease (OR 3.73; 95% CI 1.20–11.5), while no correlation was found with BSA. The number of patients experiencing severe bleeding and/or need for transfusion was 85 or 24.6% of the total. Mean baseline haemoglobin values were 12.1 g/dL ± 1.7 with lower mean values reported during hospitalization of 9.2 g/dL ± 1.4 (P &amp;lt;0.001), while predicted values at discharge were 9.8 g/dL ± 1.2. The pre and post procedural PR interval value was 171.1 ± 33.6 ms vs. 193.3 ± 35.7 ms (P &amp;lt;0.001) (Figure 2). The pre-procedural QRS interval value was 95.0 ± 21.7, the post-procedural mean value was 115.4 ± 26.5 (P &amp;lt;0.001). The number of patients with QRS&amp;gt; 120 ms after the procedure was 92 (26.5%). Out of the total number of patients analysed, the number of subjects who required PM implantation was 77 patients, i.e. 22.3% of the total. Of these, 25 patients (32.4%), Evolut R 45 patients (58.6%) and Sapien 7 patients (9.0%) had received implants. The need for pacemaker implantation did not affect the average length of stay (P 0.5). Conclusions Since its advent, the transfemoral aortic valve prosthesis implant has experienced impressive and continuous growth, radically revolutionizing the treatment of symptomatic severe aortic stenosis. Furthermore, the clear improvement of the procedural safety and efficacy profiles, due on the one hand to the technological evolution of the devices, of the introduction and release systems and of the experience of the operators, has reduced the number of complications related to the implant and improved the management of the same.

Comparison of treatment options for aortic necks outside standard endovascular aneurysm repair instructions for use

Objective/BackgroundEndovascular aneurysm repair (EVAR) is associated with worse outcomes in patients whose anatomy does not meet the device instructions for use (IFU). However, whether open surgical repair (OSR) and commercially available fenestrated EVAR (Zenith Fenestrated [ZFEN]) represent better options for these patients is unknown. MethodsWe identified all patients without prior aortic surgery undergoing elective repair of abdominal aortic aneurysms with neck length ≥4 mm at a single institution with EVAR, OSR, and ZFEN. We applied device-specific aneurysm neck-related IFU to EVAR patients, and a generic EVAR IFU to ZFEN and OSR patients. Long-term outcomes were studied using propensity scores with inverse probability weighting. We compared outcomes in patients undergoing EVAR by adherence to IFU and outcomes by repair types in the subset of patients not meeting IFU. ResultsOf 652 patients (474 EVAR, 34 ZFEN, 143 OSR), 211 had measurements outside of standard EVAR IFU (109 EVAR [23%], 27 ZFEN [80%], and 74 OSR [52%]). Perioperative mortality was 0.5% overall. For EVAR, treatment outside the IFU was associated with significantly higher adjusted rates of long-term type IA endoleak (22% at 5 years compared to 2% within IFU, hazard ratio [HR]: 5.8 [3.1-10.9], P < .001), and lower survival (5- and 10-year survival: 56% and 34% vs 81% and 53%, HR: 2.3 [1.2-4.3], P = .01). There was no difference in reinterventions or open conversion. In patients not meeting IFU, ZFEN was associated with higher adjusted rates of reinterventions (EVAR as referent: HR: 2.6 [1.5-4.4, P < .001), whereas OSR and EVAR patients experienced similar reintervention rates (HR: 0.7 [0.4-1.1], P = .13). Patients outside the IFU experienced lower mortality with OSR compared with either EVAR (HR: 0.4 [0.2-0.9], P = .005) or ZFEN (HR: 0.3 [0.1-0.7], P = .002). When restricted to patients outside the IFU deemed fit for open repair, OSR patients remained associated with lower adjusted mortality compared with ZFEN (HR: 0.2 [0.1-0.5], P < .001), but statistical significance was lost in the comparison to EVAR (HR: 0.6 [0.3-1.1], P = .1). ConclusionsTreatment outside device-specific IFU is associated with adverse long-term outcomes. Open surgical repair is associated with higher long-term survival in patients who fall outside of the EVAR IFU and should be favored over EVAR or ZFEN in suitable patients. A three-vessel-based fenestrated strategy may not be a durable solution for difficult aortic necks, but more data are needed to evaluate the performance of newer, four-vessel devices.

An update on the improvement of patient eligibility with the use of new generation endografts for the treatment of abdominal aortic aneurysms

ABSTRACT Purpose Endovascular aneurysm repair (EVAR), performed within device instructions for use (IFU), offers improved outcomes. New endograft designs attempt to increase eligibility rates of abdominal aortic aneurysm (AAA) patients treated within device IFU. We aim to examine the anatomic suitability of the Ovation endograft in our AAA patients and compare it with the other contemporary devices. Research design and methods Three-hundred and seven consecutive elective AAA patients treated during a 5-year period were included. Patient-specific anatomic characteristics were based on endograft IFUs to determine eligibility rates of each system. Results Two-hundred-twenty-five patients underwent EVAR and 82 open surgery. Ineligibility for device implantation was significantly lower for the Ovation iX system (32%) compared to other devices (AFX-2:49%, Altura:49%, Anaconda:54%, Endurant II:46%, Excluder:52%, Excluder Conformable:39%, Incraft:43%, E-Tegra:52%, Zenith-Alpha:52%; P-Value<0.001). The Alto system (next-generation Ovation) achieved an even lower ineligibility rate of 30% (P = 0.008). Short proximal aortic neck length followed by access vessel inadequacy were the primary reasons for ineligibility. Conclusion The Ovation-iX included more patients with anatomic characteristics within device IFUs resulting in improved eligibility rates compared with the rest of contemporary devices. Its evolution, the Alto system, further improves patient eligibility due to the inclusion of shorter aortic necks. Expert Opinion The Ovation iX system presented a significantly better performance and was eligible for use in a greater number of patients in our series of elective AAA repairs, accommodating patient-specific aortic anatomies. Of course, performing EVAR within the endograft’s IFU is important to achieve optimal and durable outcomes. The proximal neck length followed by the size of the access vessels are the two more common factors resulting in loss of eligibility. Except for overall eligibility rates, a case by case decision must be made on which is the most suitable device for each patient, based on the specific characteristics of its unique anatomy.

Comparison of midterm results of endovascular aneurysm repair for ruptured and elective abdominal aortic aneurysms

ObjectiveEndovascular aneurysm repair (EVAR) became an increasingly preferred modality for abdominal aortic aneurysm (AAA) repair both in elective AAA repair (el-EVAR) and EVAR of a ruptured AAA (r-EVAR) setting. Ruptured AAAs usually have more hostile anatomies and less time for planning. Consequently, more complications may arise after r-EVAR. The purpose of this study was to compare mi-term outcomes between r-EVAR and el-EVAR. MethodsA retrospective cohort analysis of patients undergoing EVAR from 2000 to 2015 at a tertiary institution was performed. Patients with previous aortic surgery, nonatherosclerotic AAA and isolated iliac aneurysms were excluded. In-hospital casualties or patients who were intraoperatively converted to open repair were also excluded. For the midterm outcome analysis, only patients with at least two postoperative examinations (a 30-day computed tomography scan and a second postoperative examination performed 6 months or later) were considered. The primary end point was freedom from aneurysm-related complications (a composite of type I or III endoleak, aneurysm sac growth, migration of more than 5 mm, device integrity failure, AAA-related death, late postimplant rupture, or AAA-related secondary intervention). Freedom from secondary interventions, neck-related events (defined as a composite of type IA endoleak, migration of more than 5 mm, or preemptive neck-related secondary intervention) and late survival were secondary end points. The impact of device instructions for use (IFU) compliance on neck events was also assessed. ResultsThe study included 565 patients (65 r-EVAR and 500 el-EVAR). Eighty-two patients were treated outside proximal neck IFU, 13 in the r-EVAR group (21.3%) and 69 (14.5%) in the el-EVAR (P = .16). During the index hospitalization, there were more complications (12.3% vs 3.2%; P = .001) and reinterventions (12.3% vs 2.8%; P < .001) in the r-EVAR group. After discharge, median clinical follow-up time was 4.3 years (interquartile range, 2.1-7.0 years) without differences between both groups. Five-year freedom from AAA-related complications was 53.9% in the r-EVAR group and 65.4% in the el-EVAR (P = .21). In multivariable analysis the r-EVAR group was not at increased risk for late complications (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.54-1.61; P = .81). Five-year freedom from neck-related events was 74% in r-EVAR and 82% in the el-EVAR group (P = .345). Patients treated outside neck IFU were at greater risk for neck-related events both in r-EVAR (HR, 6.5; 95% CI, 1.8-22.9; P = .004) and el-EVAR group (HR, 2.6; 95% CI, 1.5-4.5; P < .001). Freedom from secondary interventions at 5 years was 63.0% for r-EVAR and 76.9% for el-EVAR (P = .16). Survival at 5 years was 68.8% in the r-EVAR group and 73.3% in the el-EVAR group (P = .30). ConclusionsDurable and sustainable midterm outcomes were found for both r-EVAR and el-EVAR patients who survived the postoperative period. Patients treated outside the IFU are at greater risk for late complications. Surveillance protocols may be tailored according to individual anatomy and IFU compliance rather than timing of repair.

Human Factors and Medical Device Instructions for Use: It’s Not Just Good Business and Good Science, It’s the Law

The stated purpose of this panel was to discuss how the application of human factors science to the design, evaluation and development of medical device labeling and instructions for use is both good business and consistent with the law. Specific examples of the law were briefly discussed in the panel and are described in more detail in this paper. Questions posed by the audience quickly made it apparent that a higher-level conversation around risk was desired. One of the main topics addressed was that of unintended misuse; a summary of that discussion is also included in the paper. The overarching theme of the panel was as follows: The best we can do as human factors professionals is perform good science, document the work that we’ve done and the reasons for decisions that were made. We should also always strive to create the best product which requires balancing numerous constraints and competing goals.

Female sex is associated with comparable 5-year outcomes after contemporary endovascular aneurysm repair despite more challenging anatomy

BackgroundWomen with abdominal aortic aneurysms less often meet anatomic criteria for endovascular repair and experience worse perioperative and long-term survival. MethodsWe compared long-term survival, aneurysm-related mortality, and rates of endoleaks and reinterventions between male and female patients in the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) using 2:1 propensity score matching. ResultsThere were 1130 male patients and 133 female patients, yielding 399 patients after matching (266 male patients, 133 female patients). Female patients were older, with smaller aneurysms, smaller iliac arteries, and shorter, more angulated necks, and they were more often treated outside the device instructions for use (all P < .001). Through 5 years, female patients experienced overall mortality comparable to that of well-matched male patients (34% vs 38%, respectively; hazard ratio, 0.89 [0.61-1.29]; P = .54) and lower aneurysm-related mortality (0% vs 3%; P = .047). Female patients experienced higher rates of any postoperative type IA endoleak through 5 years (10% vs 1%; P < .001) but comparable rates of secondary endovascular procedures (14% vs 16%; P = .40). Female sex was independently associated with significantly higher risk of long-term type IA endoleaks (hazard ratio, 4.8 [1.2-20.8]; P = .04), even after accounting for anatomic factors. No female patient experienced aneurysm rupture during follow-up, and only one female patient underwent conversion to open repair. ConclusionsDespite more challenging anatomy, female patients in the ENGAGE registry had long-term outcomes comparable to those of male patients. However, female patients experienced higher rates of type IA endoleaks. Although standard endovascular aneurysm repair remains a viable solution for most women, whether high-risk patients may be better served with open surgery, custom-made devices, EndoAnchors (Aptus Endosystems, Sunnyvale, Calif), or chimneys is worthy of further study.

Long-term results after standard endovascular aneurysm repair with the Endurant and Excluder stent grafts

ObjectiveMany endografts are currently available for standard endovascular repair of infrarenal abdominal aortic aneurysms. Comparison of long-term outcomes between devices might aid in this decision process, but comparative data are scarce. The purpose of this study was to report long-term clinical outcomes of two commercially available endoprosthesis, the Endurant (Medtronic Vascular, Inc, Minneapolis, Minn) and the Excluder (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts. MethodsPatients undergoing standard endovascular repair from July 2004 to December 2011 in a single institution with the Endurant or the Low-Porosity Excluder endografts were eligible. Only patients treated for intact degenerative abdominal infrarenal aneurysms were included. All measurements were performed on center-lumen line reconstructions obtained on dedicated software. The primary end point was primary clinical success, defined as clinical success without the need for an additional or secondary surgical or endovascular procedure. Neck-related events (a composite of type IA endoleak, neck-related secondary intervention, or migration of >5 mm), neck morphology changes, renal function, and overall survival were secondary end points. ResultsThe study included 277 patients (156 Endurants; 121 Excluders). The median follow-up was 5.8 years (range, 0.1-12.4 years) and did not differ between groups (P = .18). Patients treated with the Endurant stent graft had wider (neck diameter of >28 mm, 27.3% vs 1.7% [P < .001]; neck diameter of 27 mm, [interquartile range (IQR), 24-29 mm] for Endurant and 24 mm [IQR, 22-25 mm] for Excluder; P < .001) and more angulated necks (β-angle of >60°, 26.7% vs 12.5%; P = .004). Oversizing was greater in the Endurant group (16% [IQR, 12%-22%] vs 13% [IQR, 8%-17%], respectively; P < .001). Patients were treated outside device instructions for use regarding proximal neck: 16.7% in the Endurant and 17.3% in the Excluder group (P = .720). The 7-year primary clinical success was 54.7% for the Endurant and 58.1% for the Excluder groups (P = .53). Freedom from neck-related events at 7 years was 76.7% for the Endurant and 78.8% for Excluder group (P = .94). The Endurant stent graft (hazard ratio [HR], 2.7; 95% confidence interval [CI], 1.3-5.8; P = .009) was an independent predictor of significant renal function decline. Neck dilatation was greater in Endurant-implanted patients (13% [95% CI, 2%-22%] vs 4% [95% CI, 0%-10%]; P < .001). Overall survival at 7 years was 61.4% in the Endurant and 50.3% (n = 50; standard error, 0.047) in the Excluder group (P = .39). ConclusionsThis study reveals that durable and sustainable results can be obtained with either of these late generation devices. This finding suggests that careful planning and a tailored device selection taking into account the patient's anatomy are more relevant determinants than the graft model itself to obtain clinical success. The Endurant endoprosthesis seems to be associated with a higher rate of neck dilatation and faster decrease in the estimated glomerular filtration rate, but further studies with longer follow-up are necessary to determine the clinical relevance of these findings.

Patient preferences and health state utilities associated with dulaglutide and semaglutide injection devices among patients with type 2 diabetes in Italy

Aims: Several glucagon like peptide-1 (GLP-1) receptor agonists are available as weekly injections for treatment of type 2 diabetes. These medications vary in their injection devices, and these differences could impact quality-of-life and patient preference. The purpose of this study was to examine patient preferences and estimate health state utilities associated with injection devices for two weekly GLP-1 therapies. Materials and methods: Participants with type 2 diabetes in Italy (Milan, Rome) valued three health state vignettes in time trade-off interviews. The health states had identical descriptions of type 2 diabetes, but differed in description of the treatment process: (1) oral treatment regimen, (2) oral plus weekly dulaglutide injection, and (3) oral plus weekly semaglutide injection. Results: A total of 216 participants completed interviews (57.9% male; mean age = 60.5). Almost all patients (99.5%) preferred the oral health state over either injection health state. Comparing between the two injections, 88.4% preferred the dulaglutide health state, while 11.6% preferred the semaglutide state. Mean (SD) utilities were 0.907 (0.076) for oral, 0.894 (0.085) for dulaglutide, and 0.887 (0.087) for semaglutide. The mean (SD) utility difference between the injection device health states was 0.007 (0.019). Limitations: Although the health states were designed to match the injection device instructions for use as closely as possible, vignette-based methods are inherently limited because results are based on perceptions of the health states rather than actual patient experience with the devices. Conclusions: Results provide insight into patient preferences associated with injection devices for weekly GLP-1 receptor agonists. The majority of patients preferred the dulaglutide device over the semaglutide device, and for some patients, this difference had an impact on utility valuations. Patient preferences for injection devices could be an important factor to consider when selecting treatments for type 2 diabetes.

There Is Limited Value in the One Month Post Endovascular Aortic Aneurysm Repair Surveillance Computed Tomography Scan

Endovascular aortic aneurysm repair (EVAR) is the preferred first-line treatment for abdominal aortic aneurysms. Current postprocedure surveillance recommendations by manufacturers are a 1-month computed tomography angiography (CTA) followed by a 12-month CTA in most circumstances. The objective of this study is to determine the utility of the 1-month CTA following elective EVAR and determine if initial surveillance at 6-month CTA is appropriate. A single-center retrospective chart review of all elective EVARs at a tertiary medical center over a 12-year period was conducted. Patients were excluded if postoperative surveillance imaging was not available. Data analysis encompassed demographics, chart review, and imaging including angiogram and cross-sectional imaging to asses for endoleaks and other findings. There were 363 patients who underwent elective EVAR and had available postoperative imaging during the study period. Within the 1-month follow-up, a CTA group of 316 patients was detected with 98 (31%) endoleaks. Of these, 5 (1.5%) required intervention: 1 for infolding of an iliac limb and 4 for type I endoleak which was present on completion angiogram-3 in patients treated outside of instructions for use and 1 with a type Ib endoleak on intraoperative completion imaging. In the 158 patients with 1 and 3-month CTAs, there were 47 persistent endoleaks, 9 previously undetected endoleaks not seen in 1-month CTA, and 13 resolved endoleaks. Three patients (1.2%) underwent intervention for type II endoleak and aneurysm expansion. In 47 patients with only a 6-month CTA, there were 16 endoleaks not seen on completion angiography and 2 of which were treated with reintervention-1 for a type I endoleak and 1 for a type II endoleak. There is limited utility to 1-month surveillance CTA in patients undergoing elective EVAR within the device instructions for use that has no evidence of type I endoleak on completion angiography. It is safe to start routine EVAR surveillance at 6 months in this patient population. This has implications when considering bundled and value-based payments in the longitudinal care of abdominal aortic aneurysm patients.

Health state utilities associated with attributes of weekly injection devices for treatment of type 2 diabetes

BackgroundGlucagon-like peptide-1 (GLP-1) receptor agonists are often recommended as part of combination therapy for type 2 diabetes when oral medication does not result in sufficient glycemic control. Several GLP-1 receptor agonists are available as weekly injections. These medications vary in their injection delivery systems, and these differences could impact quality of life and treatment preference. The purpose of this study was to estimate utilities associated with attributes of injection delivery systems for weekly GLP-1 therapies.MethodsParticipants with type 2 diabetes in the UK valued health states in time trade-off interviews. The health states (drafted based on literature, device instructions for use, and clinician interviews) had identical descriptions of type 2 diabetes, but differed in description of the treatment process. One health state described oral treatment, while six others described oral treatment plus a weekly injection. The injection health states varied in three aspects of the treatment administration process: requirements for reconstituting the medication (i.e., mixing the medication prior to the injection), waiting during medication preparation, and needle handling. Every participant valued all seven health states.ResultsA total of 209 participants completed interviews (57.4% male; mean age = 60.4y). The mean utility of the oral treatment health state was 0.89. All injection health states had significantly (p < 0.01) lower utilities ranging from 0.86 to 0.88. Differences among health state utilities suggest that each administration requirement had a small but measureable disutility: -0.004 (reconstitution), -0.004 (needle handling), -0.010 (reconstitution, needle handling), and -0.020 (reconstitution, waiting, needle handling).ConclusionsFindings suggest it is feasible to use the TTO method to quantify preferences among injection treatment processes. It may be useful to incorporate these utility differences into cost-utility models comparing weekly injectable treatments for patients with type 2 diabetes.

Optimizing surgical placement of the HeartWare ventricular assist device in children and adolescents by virtual implantation

BackgroundIn order to safely place adult-size intracorporeal devices into small patients, innovative techniques such as virtual implantation are necessary to assess proper fit. We assessed the hypothesis that virtual implantation of the HeartWare ventricular assist device will facilitate safe placement in patients at or below industry size guidelines. MethodsFive patients (ages 3–17years; BSA 0.67–1.5m2) with a body surface area at or below the minimum body surface area of ≤1.5m2 as stated in the device instructions for use were identified as potential candidates for HeartWare device underwent virtual implantation. ResultsThree patients went on to have successful HeartWare device placement based on virtual implantation techniques despite not meeting standard device criteria or standard apical position. Each case description demonstrates the individual benefit of utilizing virtual implantation for HeartWare device placement. ConclusionPre-operative assessment with virtual implantation successfully predicted and optimized device placement in the pediatric population despite not meeting standard device fit criteria or standard apical position.

Long-term results of endovascular repair for descending thoracic aortic aneurysms

ObjectiveSince thoracic endovascular aortic repair (TEVAR) received U.S. Food and Drug Administration approval for the treatment of descending thoracic aneurysms in March 2005, excellent 30-day and midterm outcomes have been described. However, data on long-term outcomes are lacking with Medicare data suggesting that TEVAR has worse late survival compared with open descending repair. As such, the purpose of this study was to examine the long-term outcomes for on-label use of TEVAR for repair of descending thoracic aneurysms. MethodsOf 579 patients undergoing TEVAR between March 2005 and April 2016 at a single referral center for aortic surgery, 192 (33.2%) were performed for a descending thoracic aneurysm indication in accordance with the device instructions for use, including 106 fusiform (55.2%), 80 saccular (41.7%), and 6 with both saccular and fusiform (3.1%) aneurysms. All aneurysms were located distal to the left subclavian artery and proximal to the celiac axis, and hybrid procedures including arch or visceral debranching were excluded with the exception of left carotid-subclavian artery bypass. Aortic dissection and intramural hematoma as indications for TEVAR were also excluded. Primary 30-day and in-hospital outcomes included mortality, stroke, need for new permanent dialysis, and permanent paraparesis or paraplegia. Primary long-term outcomes included survival and rate of reintervention secondary to endoleak. The Kaplan-Meier method was used to estimate long-term overall and aorta-specific survivals. ResultsThe mean age was 71.1 ± 10.4 years. All aneurysms in this series were degenerative in nature and no patients with a connective tissue disorder were included. The mean aortic diameter was 5.9 ± 1.5 cm at time of intervention. Rates of 30-day and in-hospital mortality, stroke, permanent dialysis, and permanent paraparesis and paraplegia were 4.7%, 2.1%, 0.5%, and 0.5%, respectively. At a mean follow-up of 69 ± 44 months (range, 3-141 months), there were 68 late deaths (35.4%), two of which were due to aortic rupture. Overall and aorta-specific survivals at 141 months (11.8 years) were 45.7% and 96.2%, respectively. Endovascular reintervention was required in 14 patients (7.3%) owing to type I (n = 10), type II (n = 2), and type III (n = 2) endoleak, all of which subsequently resolved. No patient required open reintervention for any cause. ConclusionsLong-term (12-year) aorta-specific survival after on-label endovascular repair of degenerative descending thoracic aneurysms in nonsyndromic patients is excellent (96%) with sustained protection from rupture, and a low rate of reintervention owing to endoleak (7%). Endovascular repair should be considered the treatment of choice for this pathology.

Aortic endografting failure due to deviation from device instructions for use

Aortic endografting failure due to deviation from device instructions for use

Endovascular repair of ruptured abdominal aortic aneurysms with the endurant stent-graft: a combined experience from three centers.

Endovascular repair of ruptured abdominal aortic aneurysms (RAAAs) has been previously reported to reduce mortality rates compared to open repair. Newer stent-grafts may provide even better results with applicability in a larger number of patients. We present our experience with the Medtronic Endurant endograft over a three-year period. Consecutive cases of RAAAs which have been managed with the Endurant stent-graft were recruited from three centers and were analyzed retrospectively. Twenty-three patients (22 males; mean age 74±9 years) were treated between June 2010 and May 2013. The technical success rate was 100% with no intraoperative endoleaks. Thirty-day mortality was 13% (3/23 patients). Two patients required prolonged hospitalization and mechanical ventilation. For the remaining 18 patients, the average hospitalization length was 5.5 days. Two major risk factors were found to be significantly associated with increased mortality: low systolic blood pressure on arrival at the hospital (63±6 vs. 99±22; P=0.01), and post-operative development of an abdominal compartment syndrome (Relative Risk - RR=13.3, 95% confidence interval - CI: 1.6-106; P=0.03). Other important clinical variables which did not significantly affect mortality included age (mean age 83±9 years in those who died vs. 73±9 years in the survivors; P=0.09), type of graft (bifurcated vs. aorto-uni-iliac; RR=2.2, 95% CI: 0.3-15; P=0.4), aneurysm diameter (11±4 cm vs. 9±2 cm; P=0.28), and proximal neck angulation (68±14 vs. 57±26 degrees; P=0.5). A proximal neck angulation >75° was not associated with a higher mortality rate (RR=1.33, 95% CI: 0.22-7.8; P=1). Endovascular repair of RAAAs resulted in high technical success and low mortality rates in this series of patients treated with the Endurant stent graft. Hypotension on arrival to the hospital and development of an abdominal compartment syndrome were predictive of increased risk of death. Patient age, aneurysm diameter and graft configuration did not negatively impact survival. Non-compliance with the device instructions for use (IFU) did not adversely affect results in this small patient series. Larger studies are needed to confirm our results.

Adherence to EVAR Device Instructions for Use (IFU) Guidelines Has No Impact on Long-Term Outcomes

Adherence to EVAR Device Instructions for Use (IFU) Guidelines Has No Impact on Long-Term Outcomes

Disease-specific guidelines for reporting adverse events for peripheral vascular medical devices

Disease-specific guidelines for reporting adverse events for peripheral vascular medical devices