Investigational Device Exemption Clinical Trial Research Articles

Three-Year Outcomes of a US Pivotal Trial Substudy for Conformable Endoprosthesis in >=10 mm Non-Angulated Neck Anatomy

To report the midterm clinical outcomes from the GORE® EXCLUDER® Conformable AAA Endoprosthesis system (EXCC) pivotal regulatory trial in the United States (U.S.). This is a prospective, multicenter, investigational device exemption clinical trial at 31 US. sites with Core Laboratory assessment of imaging and independent adjudication of safety. The study enrolled patients with abdominal aortic aneurysms (AAA) with a minimum proximal landing zone ≥10mm and proximal neck angulation of ≤60 degrees between December 2017 and February 2019 as part of a larger study to gain indications of the EXCC device. Endpoints included patient survival, freedom from secondary interventions, and stent-graft related outcomes. There were 80 patients enrolled (88.8% male, mean 73.5± 8.14 years-old). Mean maximum aortic diameter was 57.7±8.0mm (range, 42.5-82.7). There was 100% freedom from type I and III endoleak and aneurysm-related mortality at 36-months. Freedom from secondary intervention was 91.9± (0.83, 0.96, 95% C.I.) at 36-months. There were no device fractures, migrations (≥10mm), or aneurysm ruptures. At 36months, thirteen patients (26.5%) had type 2 endoleak, 32 patients (58.2%) had AAA sac regression, 17 (30.9%) had no change in diameter, and 6 (10.9%) had sac enlargement. Seven patients (8.8%) through 36months underwent reintervention. The 3-year outcomes have continued to show an adequate safety and efficacy profile of the EXCC device with no aneurysm related mortality or Type I/III endoleak. These results demonstrate durability for an EVAR device in US regulatory trials.

Long-Term Results of Physician-Modified Endografts for the Treatment of Elective, Symptomatic, and Ruptured Juxtarenal Abdominal Aortic Aneurysms.

The objective of this study was to report long-term results of an ongoing physician-sponsored, investigational device exemption (IDE) pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for the treatment of patients with juxtarenal aortic aneurysms. Data from a nonrandomized, prospective, consecutively enrolling IDE clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on January 2, 2024, with outcomes analysis through December 31, 2023. Primary safety and effectiveness end points were used to measure treatment success. The safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The effectiveness end point was the proportion of subjects who achieved treatment success. Treatment success required the following at 12 months: technical success, defined as successful delivery and deployment of a PMEG with preservation of intended branch vessels; and freedom from: type I and III endoleak, stent graft migration >10mm, aortic aneurysm sack enlargement >5mm, and aortic aneurysm rupture or open conversion. Over the 12-year study period, 228 patients were enrolled; 205 began the implant procedure, and 203 received PMEG. Thirteen patients withdrew prior to PMEG. Two withdrew (<1.0%) after failure to deploy due to tortuous iliac anatomy and are tracked as intent to treat, and a total of 24 withdrew after receiving the PMEG implant. Forty-four patients died during the study period. A total of 14 were deemed lost to follow-up. Fifty-nine completed the 5-year follow-up period, and 62 remain active in follow-up visits.Aneurysm anatomy, operative details, and lengths of stay were recorded and included: aneurysm diameter (mean, 67.5mm; range, 49-124mm), proximal seal zone length (mean, 41.6mm; range, 18.9-92.9mm), graft modification time (mean, 48.7min), procedure time (mean, 137.7min), fluoroscopy time (mean, 33.8min), contrast material use (mean, 93.0mL), estimated blood loss (mean, 118.8mL), length of hospital stay (mean, 3.7d), and intensive care unit length of stay (mean, 1.6d).A total of 575 fenestrations were created for 387 renal arteries, 181 superior mesenteric arteries (SMAs), and 7 celiac arteries. Renal arteries were in 96% of patients and included 410 renal artery stents in 203 patients. The SMA was stented as needed and included one patient with an SMA stent placed before the procedure, 19 during the procedure, and 2 patients who underwent stent placement after the procedure. There were no open conversions or device migrations and 1 partial explant due to late distal graft occlusion. Three ruptures (1.4%) were recorded on days 830, 1346, and 1460. There was 1 presumed graft infection at 750 days (<0.5%) treated with? Thirty-day all-cause mortality was 2.9% (6/204). One type Ia, 1 type Ib, and 7 type III endoleaks were identified during follow-up and treated with successful reintervention at the 1-year period. The overall rate of major adverse events at 30 days was 15% (29/194). Technical success was 93.7%, and overall treatment success was 82.6%. PMEG can be performed with low rates of long-term morbidity and mortality, confirming our early and midterm reports that endovascular repair with PMEG is safe, durable, and effective for managing patients with juxtarenal aortic aneurysms. While historically considered experimental, these results suggest that PMEG is a safe and durable option and should be considered for patients where off-the-shelf devices are not available.

Paired Comparison Survey Analysis Utilizing Rasch Methodology of the Relative Difficulty and Estimated Work Relative Value Units of CPT Code 0202T.

In anticipation of Food and Drug Administration (FDA) approval of the Total Posterior Spine (TOPS) system, the International Society for the Advancement of Spine Surgery (ISASS) conducted a study to estimate the work relative value units (RVUs) for facet arthroplasty. The purpose of this study was to establish a valuation of work RVU for Current Procedural Terminology (CPT) Code 0202T in the interim until the Relative Value Scale Update Committee (RUC) can determine an appropriate value. The valuation established from this survey will assist surgeons to establish appropriate procedure reimbursement from third-party payers. A survey was created and sent to 52 surgeons who had experience implanting the TOPS system during the investigational device exemption clinical trial. The survey included a patient vignette, a description of CPT Code 0202T along with a video of the TOPS system, and a confirmation question about the illustration's effectiveness. Respondents were asked to compare the work involved in CPT Code 0202T to 8 lumbar spine procedures. A Rasch analysis was performed to estimate the relative difficulty of CPT 0202T using the work RVUs of the comparable procedures. Forty-one surgeons responded to the survey. Of all the procedures, CPT Code 0202T received the most responses for equal work compared with posterior osteotomy (46%) followed by transforaminal lumbar interbody fusion (41%). The results of the regression analysis indicate a work RVU for CPT 0202T of 39.47. The study found an estimated work RVU of 39.47 for CPT Code 0202T using Rasch analysis. As an alternative to this Rasch methodology, one may consider a crosswalk methodology to the work RVUs for transforaminal lumbar interbody fusion procedurally, not as an alternative code. These recommendations are not a substitute for RUC methodology but serve as a reference for physicians and third-party payers to understand work RVU similarities for charge and payment purposes temporarily until RUC methodology provides accurate RVUs for the procedure.

Prospective, multicenter clinical trial comparing the M6-C compressible cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 5-year results of an FDA investigational device exemption study

BACKGROUND CONTEXTVarious total disc replacement (TDR) designs have been compared to anterior cervical discectomy and fusion (ACDF) with favorable short and long-term outcomes in FDA-approved investigational device exemption (IDE) trials. The unique design of M6-C, with a compressible viscoelastic nuclear core and an annular structure, has previously demonstrated favorable clinical outcomes through 24 months. PURPOSETo evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. STUDY DESIGNProspective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. PATIENT SAMPLESubjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and received M6-C (n=160) or ACDF (n=189) treatment as part of the IDE study. Safety outcomes were evaluated at 5 years for all subjects. The primary effectiveness endpoint was available at 5 years for 113 M6-C subjects and 106 ACDF controls. OUTCOME MEASURESThe primary endpoint of this analysis was composite clinical success (CCS) at 60 months. Secondary endpoints were function and pain (neck disability index, VAS), physical quality of life (SF-36, SF-12), safety, neurologic, and radiographic assessments. METHODSPropensity score subclassification was used to control for selection bias and match baseline covariates of the control group to the M6-C subjects. Sixty-month CCS rates were estimated for each treatment group using a generalized linear model controlling for propensity score. RESULTSAt 5 years postoperatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p=.013). Secondary endpoints indicated that significantly more M6-C subjects achieved VAS neck and arm pain improvements and showed maintained or improved physical functioning on quality-of-life measures compared to baseline assessments. The M6-C group-maintained flexion-extension motion, with significantly greater increases from baseline disc height and disc angle than observed in the control group. The rates of M6-C subsequent surgical interventions (SSI; 3.1%) and definitely device- or procedure-related serious adverse events (SAE failure; 3.1%) were similar to ACDF rates (SSI=5.3%, SAE failure=4.8%; p>.05 for both). CONCLUSIONSSubjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in reoperation rates or safety outcomes.

Characterization and management of type II and complex endoleaks after fenestrated/branched endovascular aneurysm repair

IntroductionEndoleaks are more common after fenestrated/branched endovascular aneurysm repair (F/B-EVAR) than infrarenal EVAR secondary to the length of aortic coverage and number of component junctions. Although reports have focused on type I and III endoleaks, less is known regarding type II endoleaks after F/B-EVAR. We hypothesized that type II endoleaks would be common and often complex (associated with additional endoleak types), given the potential for multiple inflow and outflow sources. We sought to describe the incidence and complexity of type II endoleaks after F/B-EVAR. MethodsF/B-EVAR data prospectively collected at a single institution in an investigational device exemption clinical trial (G130210) were retrospectively analyzed (2014-2021). Endoleaks were characterized by type, time to detection, and management. Primary endoleaks were defined as those present on completion imaging or at first postoperative imaging, and secondary were those on subsequent imaging. Recurrent endoleaks were those that developed after a successfully resolved endoleak. Reinterventions were considered for type I or III endoleaks or any endoleak associated with sac growth >5 mm. Technical success defined as the absence of flow in the aneurysm sac at procedure conclusion and methods of intervention were captured. ResultsAmong 335 consecutive F/B-EVARs (mean ± standard deviation follow-up: 2.5 ± 1.5 years), 125 patients (37%) experienced 166 endoleaks (81 primary, 72 secondary, and 13 recurrent). Of these 125 patients, 50 (40% of patients) underwent 71 interventions for 60 endoleaks. Type II endoleaks were the most frequent (n = 100, 60%), with 20 identified during the index procedure, 12 (60%) of which resolved before 30-day follow-up. Of the 100 type II endoleaks, 20 (20%; 12 primary, 5 secondary, and 3 recurrent) were associated with sac growth; 15 (75%) of those with associated sac growth underwent intervention. At intervention, 6 (40%) were reclassified as complex, with a concomitant type I or type III endoleak. Initial technical success for endoleak treatment was 96% (68 of 71). There were 13 recurrences, all of which were associated with complex endoleaks. ConclusionsNearly half of the patients who underwent F/B-EVAR experienced an endoleak. The majority were classified as type II, with nearly a fifth associated with sac expansion. Interventions for a type II endoleak frequently led to reclassification as complex, with a concomitant type I or III endoleak not appreciated on computed tomography angiography and/or duplex. Further study is needed to determine if the primary treatment goal for complex aneurysm repair is sac stability or sac regression, as this would inform both the importance of properly classifying endoleaks noninvasively and the intervention threshold for managing type II endoleaks.

Cervical Disk Arthroplasty and Range of Motion at 7 Years: Impact on Adjacent Level Degeneration.

Secondary analysis of data collected in a prospective, randomized, noninferiority Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trial. The objective of this study was to evaluate the impact of range of motion (ROM) following single-level cervical disk arthroplasty (CDA) on the development of radiographic adjacent level degeneration (ALD). The rationale for CDA is that maintenance of index-level ROM will decrease adjacent level stresses and ultimately reduce the development of ALD compared with anterior cervical discectomy and fusion. However, little information is available on the impact of hypermobility on the development of ALD after CDA. Radiographic assessments were evaluated for index-level flexion-extension ROM and ALD. Continuous data was assessed using 1-way analysis of variance. The relationship between ALD progression and ROM was evaluated using χ 2 tests. The α was set at 0.05. More ALD progression was observed after anterior cervical discectomy and fusion than CDA ( P =0.002 at the superior and P =0.049 at the inferior level). Furthermore, there was an association between ALD progression and ROM ( P =0.014 at the superior level and P =0.050 at the inferior level) where patients with mid-ROM after CDA experienced the lowest frequency of ALD progression at the superior and inferior levels. Patients with the lowest and highest ROM after CDA experienced a greater increase in ALD score at the inferior level ( P =0.046). Sex and age were associated with ROM groups ( P =0.001 and 0.023, respectively). While maintenance of index-level ROM is protective after CDA, patients with the highest ROM after CDA have similar rates of ALD progression to the lowest ROM and greater increases in ALD compared with mid-ROM after CDA. High ROM after CDA may contribute to ALD progression.

Reinterventions after physician-modified endovascular grafts for treatment of juxtarenal aortic aneurysms are non-detrimental to long-term survival

ObjectiveReintervention after endovascular aortic aneurysm repair is common. However, their frequency and impact on mortality after physician-modified endografts (PMEGs) is unknown. This study aims to describe reinterventions after PMEG for treatment of juxtarenal aneurysms and their effect on survival. MethodsData from a prospective investigational device exemption clinical trial (Identifier #NCT01538056) from 2011 to 2022 were used. Reinterventions after PMEG were categorized as open or percutaneous and major or minor by Society for Vascular Surgery reporting standards and as high or low magnitude based on physiologic impact. Reinterventions were also categorized by timing, based on whether they occurred within 30 days of PMEG as well as within 1 week of PMEG. Survival was compared between patients who did and did not undergo reintervention and between reintervention subcategories. ResultsA total of 170 patients underwent PMEG, 50 (29%) of whom underwent a total of 91 reinterventions (mean reinterventions/patient, 1.8). Freedom from reintervention was 84% at 1 year and 60% at 5 years. Reinterventions were most often percutaneous (80%), minor (55%), and low magnitude (77%), and the most common reintervention was renal stenting (26%). There were 10 early reinterventions within 1 week of PMEG. Two aortic-related mortalities occurred after reintervention.There were no differences in survival between patients who underwent reintervention and those who did not. However, survival differed based on the timing of reintervention. After adjusted analysis, reintervention within one week of PMEG was associated with an increased risk of mortality both compared with late reintervention (hazard ratio, 11.1; 95% confidence interval, 2.7-46.5) and no reintervention (hazard ratio, 5.2; 95% confidence interval, 1.6-16.8). ConclusionsReinterventions after PMEG were most commonly percutaneous, minor, and low magnitude procedures, and non-detrimental to long-term survival. However, early reinterventions were associated with increased mortality risk. These data suggest that a modest frequency of reinterventions should be expected after PMEG, emphasizing the critical importance of lifelong surveillance.

Using the Evaluating Devices Using Claims and RegisTry Data (EDUCATe) Plan within the Vascular Implant Surveillance and Interventional Outcomes Network (VISION) to Analyze the Long-Term Outcomes following Endovascular Aortic Aneurysm Repair

Implanted devices undergo clinical trials to assess their safety and effectiveness. However, pivotal device trials are limited in their follow-up while postmarket surveillance may incompletely capture late failure. Linking clinical trials to Medicare claims can address these limitations. This study matched patients from investigational device exemption (IDE) clinical trials for endovascular aortic aneurysm repair (EVAR) to Medicare claims-based registry data to compare long-term device outcomes between the 2 sources. Patient-level data from 2 industry-sponsored IDE trials of EVAR devices was provided by a single industry partner. Trial data were matched at the patient level to data from the Vascular Implant Surveillance and Interventional Outcomes Network (VISION), a registry that is a part of the Society for Vascular Surgery Patient Safety Organization. The primary outcomes analyzed were survival and freedom from aneurysm-related reintervention. Of 159 clinical trial patients, 134 were eligible for claims-based matching and 115 (85.5%) were successfully matched to VISION registry data. For the matched cohort, the Kaplan-Meier estimated survival was 94.8% at 1year, 82.6% at 3years, and 68.1% at 5years. Estimates for freedom from reintervention were 90% at 1year, 82.4% at 3years, and 78.1% at 5years. The estimates for survival were nearly identical between the clinical trial data and that found in the VISION data (log-rank P=0.89). Freedom from reintervention was similar between the groups, with IDE trial reported freedom from reintervention of 87.3% and 73.3%, compared to VISION of 92.6% and 83% at 1 and 5years, respectively (log-rank P=0.13). Clinical trial patients who undergo EVAR can be successfully matched to claims-based registry data to improve long-term device surveillance and outcomes reporting. Claims-based results agreed well with IDE trial results for patients through 5years, supporting the accuracy of claims-based data for longer-term surveillance. Linking clinical trial and claims-based registry data can lead to robust device monitoring.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study.

Prospective randomized Food and Drug Administration investigational device exemption clinical trial. The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device. Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty. Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient. At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points ( P >0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening. Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate.

One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial

ObjectiveTo report the 1-year clinical outcomes from the GORE EXCLUDER Conformable AAA Endoprosthesis system in the US regulatory trial. MethodsThe study is a prospective, multicenter, investigational device exemption clinical trial at 31 US sites with core laboratory assessment of imaging and independent event adjudication. The primary safety (incidence of major adverse events at 30 days) and effectiveness end points (successful aneurysm treatment at 1 year) were assessed in a cohort of patients with abdominal aortic aneurysms (AAAs). ResultsWe enrolled 80 patients between December 19, 2017, and February, 27, 2019. The mean maximum aortic diameter was 57.7 ± 7.95 mm (range, 42.5-82.7 mm) with an average patient age of 73.5 ± 8.14 years (range, 56-96 years). Overall technical success was 100% (80/80). The mean hospital length stay was 1.2 ± 0.6 days (range, 1-4 days). No primary safety end point events were observed, including no death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, procedural blood loss of more than 1000 mL, or thromboembolic events including limb occlusion or distal emboli. There were no type I or III endoleaks detected on the 1-, 6-, or 12-month follow-up computed tomography scans. There were no stent fractures, device migrations (≥10 mm), AAA ruptures, or conversions to open surgical repair observed. Two patients had AAA sac growth of more than 5 mm at 1 year owing to type II endoleaks. There were no aneurysm-related deaths within the 12-month follow-up, and freedom from aneurysm-related mortality was 100% through 1 year. ConclusionsThe safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis system has been demonstrated with 98.5% freedom from primary effectiveness end point events at 1 year and 100% freedom from primary safety end point events assessed through 30 days.

Ten-Year Outcomes of 1- and 2-Level Cervical Disc Arthroplasty From the Mobi-C Investigational Device Exemption Clinical Trial

Kim, Kee MD; Hoffman, Greg MD; Bae, Hyun MD; Redmond, Andy MD; Hisey, Michael MD; Nunley, Pierce MD; Jackson, Robert MD; Tahernia, David MD; Araghi, Ali DO

Impact of Race on Clinical Outcomes After Implantation With a Fully Magnetically Levitated Left Ventricular Assist Device: An Analysis From the MOMENTUM 3 Trial.

Heart failure disproportionately affects Black patients. Whether differences among race influence outcomes in advanced heart failure with use of a fully magnetically levitated continuous-flow left ventricular assist device remains uncertain. We included 515 IDE (Investigational Device Exemption) clinical trial patients and 500 Continued Access Protocol patients implanted with the HeartMate 3 left ventricular assist device in the MOMENTUM 3 study (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3). Outcomes were compared between Black and White left ventricular assist device recipients for the primary end point of survival free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years, overall survival, adverse events, 6-minute walk distance, and quality of life scores. Of 1015 HeartMate 3 patients, 675 were self-identified as White and 285 as Black individuals. The Black patient cohort was younger, more obese and with a history of hypertension, and more nonischemic cause of heart failure, relative to the White patient group. Black and White patients did not experience a difference in the primary end point (81.1% versus 77.9%; hazard ratio, 1.08 [95% CI, 0.76-1.54], P=0.6568). Black patients were at higher risk of adverse events (calculated as events per 100 patient-years), including bleeding (75.4 versus 63.5; P<0.0001), stroke (9.5 versus 7.2; P=0.0183), and hypertension (10.1 versus 3.2; P<0.0001). The 6-minute walk distance was not different at baseline and 6 months between the groups, however, the absolute change from baseline was greater for White patients (median: +183.0 [interquartile range, 42.0-335.3] versus +163.8 [interquartile range, 42.3-315.0] meters, P=0.01). The absolute quality of life measurement (EuroQoL group, 5-dimension, 5-level instrument visual analog scale) at baseline and 6 months was better in the Black patient group, but relative improvement from baseline to 6 months was greater in White patients (median: +20.0 [interquartile range, 5.0-40.0] versus +25.0 [interquartile range, 10.0-45.0]; P=0.0298). Although the survival free of disabling stroke or reoperation to replace/remove a malfunctioning device at 2 years with the HM 3 left ventricular assist device did not differ by race, Black HeartMate 3 patients experienced a higher morbidity burden and smaller gains in functional capacity and quality of life when compared with White patients. These findings require efforts designed to better understand and overcome these gaps through systematic identification and tackling of putative factors. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02224755 and NCT02892955.

Significant aortic neck dilation occurs after repair of juxtarenal aneurysms with fenestrated endovascular aneurysm repair

ObjectiveAortic neck dilation is a reported mode of failure and can be associated with aneurysm sac expansion after standard endovascular abdominal aortic aneurysm repair (EVAR). Fenestrated EVAR (FEVAR) of the juxtarenal segment increases the seal zone length and is often used to treat this disease progression. However, the frequency and risk factors for neck dilation after FEVAR is unknown. MethodsWe evaluated 124 consecutive FEVARs performed under an investigational device exemption clinical trial for juxtarenal aneurysms (ClinicalTrials.gov identifier, NCT01538056). The aortic diameter at the level of the superior mesenteric artery (SMA; highest fenestration) and lowest renal artery (lowest fenestration) was assessed from computed tomography angiography preoperatively, at 30 days, and annually thereafter. A subgroup analysis was performed to assess aortic neck dilation by the graft type used, degree of oversizing, infrarenal neck length, effective seal zone length, and aortic diameter at the level of the lowest and highest fenestration. Multivariable analysis was then performed to evaluate for predictors of aortic neck dilation. ResultsOf the 124 patients, 56 had complete anatomic detail and follow-up data available for ≥3 years. Those without preoperative or follow-up data available were excluded. The aortic diameter had increased significantly by 3 years at the level of both the SMA (2.4 mm; P < .01) and the lowest renal artery (3.2 mm; P < .01). When those with and without aortic dilation (>3 mm) were compared, only oversizing differed at the level of the SMA (14% vs 19%; P < .01). At the level of the lowest renal artery, the graft diameter differed (30 mm vs 28 mm; P = .02). However, after adjusted analysis, these differences were not significant. Finally, a subgroup analysis was performed to evaluate aortic dilation over time stratified by anatomic factors and should that aortic dilation occurred across differing aneurysm diameters, percentage of oversizing, graft types, and seal zone lengths. ConclusionsAortic neck dilation in the visceral segment can occur after endovascular repair of juxtarenal aneurysms using FEVAR. Further research is warranted to determine how these changes might affect the long-term outcomes.

Commentary: Ten-Year Outcomes of 1- and 2-Level Cervical Disc Arthroplasty From the Mobi-C Investigational Device Exemption Clinical Trial.

Correspondence: Rodney John Charles Laing, MD, FRCS(SN), Department of Neurosurgery, Cambridge University Hospitals NHS Trust, Hills Road, Cambridge CB2 0QQ, United Kingdom. Email: [email protected]

Initial experience with the Terumo aortic Treo device for fenestrated endovascular aneurysm repair

ObjectiveThe Terumo aortic (TA) Treo device (Terumo, Somerset, NJ) is an endograft with unique features that lends itself to fenestrated endovascular aneurysm repair (FEVAR), including a low device profile, a wide amplitude stent design, and an increased interstent distance. We have described our initial experience with the Treo device for FEVAR to treat short neck and juxtarenal abdominal aortic aneurysms. MethodsAs part of an ongoing physician-sponsored investigational device exemption clinical trial (ClinicalTrials.gov identifier, NCT01538056), subjects were prospectively enrolled and underwent elective FEVAR using a variety of devices. Demographic and procedural details were collected. The data from subjects treated specifically with the Treo device from November 3, 2016 to May 2, 2019 were collected and analyzed. ResultsOf a cohort of 161 patients who had undergone elective FEVAR, 46 had been treated with the TA Treo device. Most patients were men (70%), with a mean age of 75 years and high rates of hypertension (74%), hyperlipidemia (83%), coronary artery disease (33%), and chronic obstructive pulmonary disease (33%). The mean aneurysm size was 66 mm, the mean preoperative infrarenal neck length was 5 mm, and the mean final seal zone length was 45 mm. The average hospital and intensive care unit lengths of stay were 2.4 and 1.5 days, respectively. A total of 129 fenestrations were created for 44 superior mesenteric and 85 renal arteries (2.8 fenestrations per patient). Technical success, defined as successful implantation of the device with all target vessels preserved, was 98% (45 of 46), with only one renal artery not successfully preserved. The mean follow-up period was 598 days. During the study period, 18 endoleaks were detected (17 type II and 1 type III), with one patient with a type III endoleak requiring reintervention. Three subjects had died within 30 days, one of intracranial hemorrhage, one of respiratory failure, and one of ischemic colitis. The graft modification times for the TA Treo were significantly shorter (43 minutes) than those for other commercially available devices (Cook Zenith, 55 minutes; Medtronic Endurant, 54 minutes; P < .0001). ConclusionsOur institution has reported exclusive worldwide experience using the TA Treo device for FEVAR. This device provides for a highly efficient and technically successful procedure for most patients. The procedural and fluoroscopy times were low even in the setting of high complexity. The technical success rates and simplification of the FEVAR procedure have made this approach a preferred technique for most patients at our institution.

Management of arch aneurysms with a single-branch thoracic endograft in zone 0.

BackgroundWe present preliminary data from a patient cohort undergoing thoracic endovascular aortic repair for Ishimaru zone 0 and 1 using a novel branched arch endograft.MethodsThis US multicenter early feasibility investigational device exemption clinical trial treated 9 patients with a mean age 72.8 ± 8.0 years (77.8% male). The endograft was designed with a single side branch designed to facilitate aortic coverage proximal to the innominate or left carotid artery while maintaining branch vessel patency. Pathology treated included fusiform (n = 2) or saccular (n = 7) aneurysm, with a maximum aortic diameter of 6.3 ± 0.7 cm. Treatment was into zone 0 in 8 patients, and zone 1 in 1 patient.ResultsAll patients underwent initial successful first-stage supra-aortic trunk revascularization using a variety of techniques, without the occurrence of stroke. For the second thoracic endovascular aortic repair stage, median total treatment length was 20 cm. The primary end point of device delivery and branch vessel patency was achieved in 100% of patients, without 30-day mortality or spinal cord ischemia. Cerebrovascular events were observed in 2 patients through 30 days. No type I or III endoleaks were reported and all side branches were patent at 12-month imaging follow-up.ConclusionsEndovascular repair of Ishimaru zone 0 or 1 arch aortic aneurysms can be achieved with a novel branched arch endograft. Future studies will evaluate the mid-term outcomes with this device in other pathologies and further define the occurrence of postoperative neurologic events.

Safety and effectiveness of the TREO stent graft for the endovascular treatment of abdominal aortic aneurysms

ObjectiveThe short- and mid-term outcomes of endovascular aortic aneurysm repair have made it a standard treatment of abdominal aortic aneurysms. However, newer generation devices have yet to demonstrate improved long-term rates for complications, reinterventions, and survival. The TREO stent graft is a latest generation device and was evaluated for approval in the United States. MethodsIn a multicenter, nonrandomized, investigational device exemption clinical trial, we assessed the safety and effectiveness of the TREO device, with core laboratory assessment of the imaging studies and an independent adjudication of safety. The primary effectiveness endpoint was successful aneurysm treatment at 1 year. The primary safety endpoint was the incidence of major adverse events (MAE) at 30 days. ResultsA total of 150 patients (132 men; 88.0%) with infrarenal abdominal aortic (87.3%) or aortoiliac (12.7%) aneurysms were enrolled. The data were normally distributed. The mean age was 71.7 ± 7.4 years. The MAE incidence at 30 days was 0.7%. One subject experienced two MAE: myocardial infarction and procedural blood loss of 1000 mL. The proportion of successful aneurysm treatment at 1 year was 93.1%. Longer term follow-up continues, with no aneurysm-related mortality at the latest follow-up. At 3 years, the cumulative all-cause mortality and incidence of type I and type III endoleaks was 10.7% (n = 16), 2.7% (n = 4), and 0% (n = 0), respectively. In addition, aneurysm sac shrinkage >5 mm at 3 years had occurred in 54.3% of patients, and 9.3% had required a secondary intervention (n = 14). ConclusionsThe safety and effectiveness of endovascular repair of abdominal aneurysms with TREO were demonstrated, with 93.1% successful aneurysm treatment at 1 year and aneurysm sac shrinkage >5 mm at 3 years in 54.3% of patients. Long-term follow-up continues to determine whether these favorable outcomes will be sustained.

Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study

BACKGROUND CONTEXTVarious designs of total disc replacement (TDR) devices have been compared to anterior cervical discectomy and fusion (ACDF) with favorable outcomes in FDA-approved investigational device exemption trials. The design of M6-C with a compressible viscoelastic nuclear core and an annular structure is substantially different than prior designs and has previously demonstrated favorable kinematics and clinical outcomes in small case series. PURPOSETo evaluate the safety and effectiveness of the novel M6-C compressible artificial cervical disc compared with ACDF for subjects with single-level degenerative cervical radiculopathy. STUDY DESIGN/SETTINGProspective, multicenter, concurrently and historically controlled, FDA-approved investigational device exemption clinical trial. PATIENT SAMPLESubjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and assigned to receive M6-C or ACDF. OUTCOME MEASURESPain and function (Neck Disability Index, VAS), quality of life (SF-36), safety, neurologic, and radiographic assessments of motion (both flexion extension and lateral bending) were performed. The primary clinical endpoint was composite clinical success (CCS) at 24 months. METHODSUsing propensity score subclassification to control for selection bias, 160 M6-C subjects were compared to a matched subset of 189 ACDF controls (46 concurrent and 143 historical controls). RESULTSBoth ACDF and M6-C subjects reported significant improvements in patient-reported outcomes at all time points over baseline. Overall SF-36 Physical Component Score and neck and arm pain scores were significantly improved for M6-C as compared to ACDF treatment. CCS and mean Neck Disability Index improvements were similar between M6-C and ACDF. Correspondingly, there were significantly fewer subjects that utilized pain medication or opioids following M6-C treatment at 24 months relative to baseline. Range of motion was maintained in subjects treated with M6-C. Subsequent surgical interventions, dysphagia rates, and serious adverse events were comparable between groups. CONCLUSIONSM6-C treatment demonstrated both safety and effectiveness for the treatment of degenerative cervical radiculopathy. Treatment with M6-C demonstrated noninferiority for the primary endpoint, indicating a similar ability to achieve CCS at 24 months. However, for the secondary endpoints, M6-C subjects demonstrated significantly improved pain and function compared to ACDF subjects, while maintaining range of motion, improving quality of life, and decreasing analgesic and opioid usage at 2 years postoperatively relative to baseline.

Two-Level Anterior Cervical Discectomy and Fusion Versus Cervical Disc Arthroplasty-Long-Term Evidence Update.

Multiple studies have highlighted the motion-sparing benefits of single-level cervical disc arthroplasty (CDA) compared with anterior cervical discectomy and fusion (ACDF). However, few studies have reviewed multilevel ACDF versus CDA. Several recent studies have midterm and even long-term data available comparing 2-level ACDF versus CDA. We reviewed 3 reports from 2 large randomized, prospective Food and Drug Administration investigational drug exemption trials looking at 2-level CDA versus ACDF, which provide the bulk of the available midterm to long-term, high-level evidence for the topic. We also present several smaller and/or shorter-term studies. One 5-year study showed that, while both CDA and ACDF showed significant improvement in patient-reported outcome scores, CDA demonstrated greater improvement in Neck Disability Index (NDI) scores than ACDF (mean = -37 versus mean = -28, P = .0003), were more likely to be satisfied (96.4% versus 89.5%, P = .04), had fewer secondary surgeries (4% versus 16.2%, P = .0003), had fewer adjacent level reoperations (3.1% versus 11.4%), and developed less adjacent segment degeneration (50.7% versus 90.5%, P < .0001). Adverse events occurred more frequently with ACDF (8.6% versus 4.4%).Similarly, Lanman et al [Lanman TH, Burkus JK, Dryer RG, Gornet MF, McConnell J, Hodges SD. Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial. J Neurosurg Spine. 2017;27(1):7-19] showed that, at 7 years, while both groups demonstrated improvement in patient-reported outcomes, CDA had greater improvement in regard to NDI, neck pain, and Short Form (36) Physical Component Summary scores (each P < .001), had higher rates of satisfaction (94.8% versus 92.6%), had lower rate of secondary surgery at treated levels (4.2% versus 14.7%), and had a lower, albeit not statistically significant, rate of secondary surgeries at adjacent levels (6.5% versus 12.5%). Adverse events were more common with ACDF (7.2% versus 3.2%).More recently, Gornet et al [Gornet MF, Lanman TH, Burkus JK, et al. Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial. J Neurosurg Spine. 2019;31:508-518.] in 2019 reported 10-year data from the same clinical trial as the Lanman et al report comparing 2-level CDA (209 patients) versus ACDF (188 patients). With >84% follow-up for both groups at 10 years, they found that CDA demonstrated a statistically significantly improved rate of overall success (84% versus 62%) as compared with ACDF. Greater improvements were seen in several other outcome measures for CDA, including NDI, neurological success, and neck pain scores. The CDA group had a lower rate of serious implant-related adverse events and demonstrated a lower rate of needing a secondary surgery at an adjacent level, 9% versus 18% in the ACDF group. Results of 2 large randomized trials suggest similar-to-improved patient reported outcomes for multilevel CDA versus ACDF maintained out to midterm to long-term follow-up of 5-10 years, with lower rates of revision surgery at index and adjacent levels and lower rates of serious adverse device-related events. 5. Comparison of the safety and efficacy of multi-level cervical disc arthroplasty and cervical discectomy and fusion.

Procedure-Associated Costs and Midterm Outcomes of Endovascular Zone 0 and Zone 1 Aortic Arch Repair

Thoracic endovascular aortic repair (TEVAR) of proximal aortic arch disease provides a less invasive treatment option for high-risk patients who are not candidates for open arch reconstruction. However, the fiscal impact of these techniques remains unclear. Therefore, our objective was to characterize the midterm outcomes after zone 0 and zone 1 TEVAR and to describe the associated technical costs, technical revenues, and net technical margins at a single tertiary medical center. We examined all patients who underwent TEVAR between April 2011 and August 2019 by retrospective chart review at a single tertiary medical center. Patients were categorized by proximal thoracic endograft extent to identify those with zone 0 or zone 1 landing zones. Procedural characteristics and outcomes were described. Total technical costs, technical revenues, and net technical margins were obtained from the hospital finance department. We identified 10 patients (6 zone 0, 4 zone 1) who had been turned down for open surgical arch reconstruction. Patients were predominantly female (n = 8 [80%]), and the mean age was 72.8 ± 5.5 years. Repair was performed in five asymptomatic patients, urgently in three symptomatic patients and emergently in two ruptured patients. Aortic disease and procedural details are described in the Table. Great vessel debranching with chimney stent grafting was performed in four patients, debranching with branched thoracic endografting in one patient (investigational device exemption clinical trial), and traditional surgical debranching alone in four patients. In situ fenestration was performed in one patient. Within the 30-day postoperative period, one patient experienced a stroke and one patient died. Bypass and branch vessel patency were 100% through the duration of follow-up (mean, 19.3 months). Mean total technical cost associated with all procedures or stages of repair was $105,164 ± $59,338, whereas mean net technical margin was −$25,055 ± $18,746. The net technical margin was negative in the treatment of nine patients. Endovascular repair of the proximal aortic arch is associated with good midterm outcomes in patients considered too high risk for open repair. However, reimbursement does not adequately cover the cost of treatment, with net technical margins being negative in nearly all cases. To remain financially sustainable, efforts should be made to optimize aortic arch TEVAR delivery as well as to advocate for reimbursement commensurate with associated costs.TableProcedural details, outcome measures, and associated technical costs and net technical margins for Zone 0 (n = 6) and Zone 1 (n = 4) TEVARPatientIndication for repairProximal extent of coverageGreat vessel reconstructionNumber of procedures/stagesStroke or deathBypass/Branch patencySurvivalTechnical cost (USD)Net technical margin (USD)1Ruptured aneurysmZone 1Carotid-carotid bypass, LSA embolization1No100%Alive at 31 months; follow-up ongoingN/AN/A2Asymptomatic aneurysmZone 0Carotid-carotid bypass, LSA to L carotid transposition, Gore TSSB branched device to innominate artery3No100%Died of MI 15 months after repair$141,688-$29,5493Type IA endoleak after Zone 2 TEVAR for acute type B dissectionZone 0Carotid-carotid bypass, carotid-LSA transposition, innominate chimney2Death-Died in hospital 4 days after TEVAR$153,668-$45,5984Asymptomatic aneurysmZone 1LSA to carotid transposition, L CCA chimney2No100%Alive at 37 months; follow-up ongoing$115,223-$31,7485Symptomatic aneurysmZone 0Carotid-carotid-LSA bypass, innominate chimney, LSA embolization2Stroke100%Died 18 months after repair$101,317-$20,9286Ruptured dissectionZone 0Carotid-carotid bypass, chimney to innominate, snorkel to LSA2No100%Alive at 34 months; follow-up ongoing$185,613-$54,6227Asymptomatic aneurysmZone 0L carotid to R carotid transposition, L carotid to LSA bypass, LSA embolization2No100%Alive at 23 months; follow-up ongoing$97,579-$18,8878Chronic type B dissection with asymptomatic aneurysmZone 1Carotid-carotid-LSA bypass2No100%Alive at 2 months; follow-up ongoing$48,068-$26,2809Penetrating aortic ulcerZone 0Carotid-carotid-LSA bypass at OSH2 (debranching at OSH)No100%Died 6 months after repair of unknown causes$42,813$4,90210Chronic type B dissection with asymptomatic aneurysmZone 1Left carotid and LSA in situ branched fenestrations1No100%Alive at 8 months; follow-up ongoing$60,505-$2,784CCA, Common carotid artery; LSA, left subclavian artery; MI, myocardial infarction; OSH, outside hospital; TSSB, thoracic single side branch; USD, United States dollars. Open table in a new tab