Investigational Device Exemption Study Research Articles

The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study

IntroductionThe Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment...

Design and Clinical Evaluation of the Interoperable Artificial Pancreas System (iAPS) Smartphone App: Interoperable Components with Modular Design for Progressive Artificial Pancreas Research and Development.

There is an unmet need for a modular artificial pancreas (AP) system for clinical trials within the existing regulatory framework to further AP research projects from both academia and industry. We designed, developed, and tested the interoperable artificial pancreas system (iAPS) smartphone app that can interface wirelessly with leading continuous glucose monitors (CGM), insulin pump devices, and decision-making algorithms while running on an unlocked smartphone. After algorithm verification, hazard and mitigation analysis, and complete system verification of iAPS, six adults with type 1 diabetes completed 1 week of sensor-augmented pump (SAP) use followed by 48 h of AP use with the iAPS, a Dexcom G5 CGM, and either a Tandem or Insulet insulin pump in an investigational device exemption study. The AP system was challenged by participants performing extensive walking without exercise announcement to the controller, multiple large meals eaten out at restaurants, two overnight periods, and multiple intentional connectivity interruptions. Even with these intentional challenges, comparison of the SAP phase with the AP study showed a trend toward improved time in target glucose range 70-180 mg/dL (78.8% vs. 83.1%; P = 0.31), and a statistically significant reduction in time below 70 mg/dL (6.1% vs. 2.2%; P = 0.03). The iAPS system performed reliably and showed robust connectivity with the peripheral devices (99.8% time connected to CGM and 94.3% time in closed loop) while requiring limited user intervention. The iAPS system was safe and effective in regulating glucose levels under challenging conditions and is suitable for use in unconstrained environments.

I-Factor™ Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study.

i-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. To report 2-yr follow-up. Subjects randomly received either autograft (n =154) or i-Factor™ (n =165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes. At 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively (P= .2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft; P= .7869). Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft; P= .1448); Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p = .2763); Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft; P= .1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft; P= .4507), and SF36v2 Mental Component Score improved 7.88 (i-FactorTM) and 7.53 (autograft; P= .9872). The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P= .0302). Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation (P= .3411). There were no allergic reactions associated with i-Factor™. Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery.

Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control

Early results of the Micra Investigational Device Exemption (IDE) study and Micra Post-Approval Registry (PAR) demonstrated excellent safety and efficacy performance; however, intermediate-term results across a large patient population in the real-world setting have not been evaluated. We report updated performance of the Micra transcatheter pacemaker from a worldwide PAR and compare it with the IDE study as well as a transvenous historical control. The safety objective of the analysis was system- or procedure-related major complications through 12 months postimplantation. We compared the major complication rate with that of the 726 patients from the IDE and with a reference data set of 2667 patients with transvenous pacemakers by using a Fine-Gray competing risk model. The Micra device was successfully implanted in 1801 of 1817 patients (99.1%). The mean follow-up period was 6.8 ± 6.9 months. Through 12 months, the major complication rate was 2.7% (95% confidence interval [CI] 2.0%-3.7%). The risk of major complications for Micra PAR patients was 63% lower than that for patients with transvenous pacemakers through 12 months postimplantation (hazard ratio 0.37; 95% CI 0.27-0.52; P < .001). The major complication rate trended lower in the PAR than in the IDE study (hazard ratio 0.71; 95% CI 0.44-1.1; P = .160), driven by the lower pericardial effusion rate in the PAR. There were 3 cases of infection associated with the procedure, but none required device removal and there were no battery or telemetry issues. Pacing thresholds were low and stable through 12 months postimplantation. Performance of the Micra transcatheter pacemaker in international clinical practice remains consistent with previously reported data. Major complications were infrequent and occurred 63% less often compared to transvenous systems. Micra Transcatheter Pacing System Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873.

Outcomes of the GORE Iliac Branch Endoprosthesis in clinical trial and real-world registry settings

BackgroundWe report midterm outcomes with the GORE Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) in the U.S. investigational device exemption (IDE) trial and comparatively assess outcomes in the IDE trial with outcomes in a real-world population of patients treated in the Gore Global Registry for Endovascular Aortic Treatment (GREAT). MethodsFrom 2013 to 2016, the IDE trial enrolled 99 patients treated with the IBE for common iliac artery (CIA) aneurysms or aortoiliac aneurysms. Bilateral IBE treatment was allowed only in the continued access phase. From 2013 to 2016, there were 92 patients treated with the IBE in the GREAT registry. Baseline characteristics, procedural variables, and reinterventions through 6 months were compared in the IDE trial and GREAT registry. Clinical and core laboratory-assessed imaging outcomes were assessed in the IDE trial through 2 years. ResultsGREAT patients were significantly older (P = .01) and of shorter height (P < .001) and lower weight (P < .001). There were also significantly more women treated in GREAT vs the IDE trial (8% vs 1%; P = .02). Thirteen GREAT patients (14%) and 4 of 35 continued access IDE patients (11%) had bilateral IBE placement (P = .70). IDE patients were more likely to be treated with percutaneous access methods (55% vs 40%; P = .04). Three IDE patients and three GREAT patients underwent 1-month reintervention, with two IDE reinterventions (2.1%) and one GREAT reintervention (1.6%) for thrombotic events. Five additional patients in each study underwent reintervention through 6 months (5% vs 5%; P = .92), all for nonthrombotic events. Internal iliac limb patency was 93.6% (95% confidence interval, 86.4%-97.1%) at 12 and 24 months in the IDE study. Subset analyses of the 10 IDE and GREAT patients with ≤6-month reintervention vs 181 intervention-free patients found that acute myocardial infarction (P = .01), nonpercutaneous access (P = .01), and surgical conduit use (P < .001) were associated with reintervention through 6 months. In the IDE trial, 3.4% and 4.1% of patients underwent reintervention at 12 months and 24 months, respectively, all for treatment of type II endoleaks. At 24 months, 8.7% of IDE patients exhibited abdominal aortic aneurysm sac expansion; 21.7% exhibited abdominal aortic aneurysm sac regression. No patients exhibited CIA aneurysm sac expansion; 45% exhibited CIA aneurysm sac regression. ConclusionsMidterm IDE outcomes and 6-month outcomes in the worldwide GREAT registry suggest that endovascular aortic aneurysm repair with concomitant CIA aneurysm repair with the IBE device is safe and effective. Thrombotic events are uncommon and are concentrated in the first month after the index procedure, and they typically can be resolved with endovascular reintervention.

Prostate Artery Embolization for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Results From a Prospective FDA-Approved Investigational Device Exemption Study

ObjectiveTo evaluate the safety and efficacy of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). MethodsA prospective, single-center, open-label FDA-approved study was conducted to evaluate the safety and efficacy of PAE for LUTS secondary to BPH. We enrolled men ≥ 45, prostate volume > 40 g, International prostate symptom score (IPSS) > 13, peak flow rate (Qmax) ≤ 12 mL/s, and voided volume ≥ 125 mL. Patients were evaluated with questionnaires (IPSS, quality-of-life [QoL], International index of erectile function, and male sexual health questionnaire for ejaculatory dysfunction) and clinical measures (postvoid residual volume and Qmax at baseline 1, 3, and 12 months) after PAE. Baseline and 6-month total prostate (TV) and central gland (CG) volumes were obtained. Results45 patients (mean volume: 99 cc, range: 30-214 g) were treated over the course of the 3-year study. At 1 month, there were improvements in IPSS (23.6 ± 6.1 to 12.0 ± 5.9, P < .0001), QoL (4.8 ± 0.9 to 2.6 ± 1.6, P < .0001), Qmax (5.8 ± 1.0 to 12.4 ± 6.8,P < .0001). At 3 months, there were improvements in IPSS (10.2 ± 6.0, P < .0001), QoL (2.4 ± 1.6, P < .0001) and Qmax (15.3 ± 12.3, P < .0001). At 6 months, there were improvements in IPSS (11.0 ± 7.6, P < .0001) and QoL (2.3 ± 1.7, P < .0001). At 1 year, there were improvements in IPSS (12.4 ± 8.4,P < .0001) and QoL (2.6 ± 1.6, P < .0001). There were reductions in postvoid volume residues: baseline 157 ± 45, 1 month 123 ± 47, P = .057, 3 months 127 ± 114, P = .34, 6 months 112±116, P = .002 and 1 year 109±116 P = .025. Median decreases in TV and CG were 18% (CI: 13-27) (P = 0.0001) and 27% (CI: 20-36)(P = 0.0001), respectively. Self-limited adverse events included dysuria (n = 13), hematuria (n = 6), hematospermia (n = 2), urinary frequency (n = 3) and retention (n = 2). No severe adverse events, nontarget embolization, or adverse effects on erectile function or sexual health. ConclusionThis prospective clinical trial demonstrates that PAE is safe and efficacious for BPH, with significant improvement in LUTS and reduction in TV and CG volumes.

Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150cc).

To present short-term safety and efficacy data of men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) treated with Aquablation. Men with LUTs secondary to BPH (60-150cc) underwent Aquablation treatment from February 2016 to December 2017 across 17 investigational sites in the USA from two contemporary investigational device exemption (IDE) studies called WATER (NCT02505919) and WATER II (NCT03123250). One hundred seven males with mean age of 67.3 ± 6.5 years were treated with Aquablation; mean prostate volume was 99.4 ± 24.1cc. The pooled results show that large prostates have an average procedure time of less than 36min and discharge on average 1.6 ± 1days. The IPSS decreased by 16.7 ± 8.1 points at 3months and Qmax increased by 11.2 ± 12.4ml/s. The Clavien-Dindo (CD) grade 2 or higher event rate at 3months was 29%. A non-hierarchical breakdown for CD events yielded 18% grade 2 and 19% grade 3 or higher. Men with LUTS secondary to BPH (60-150cc) in a pooled analysis were treated safely and effectively with Aquablation up to 3months postoperatively. ClinicalTrials.gov identifiers, NCT02505919 and NCT03123250. PROCEPT BioRobotics.

Is Two-level Cervical Disc Replacement More Cost-effective Than Anterior Cervical Discectomy and Fusion at 7 Years?

Cost-effectiveness analysis. To investigate 7-years cost-effectiveness of two-level cervical disc replacement (CDR) and anterior cervical discectomy and fusion (ACDF). CDR and ACDF are both effective treatment strategies for managing degenerative conditions of the cervical spine. CDR has been shown to be a more-cost effective intervention in the short term, but the long-term cost-effectiveness has not been established. We analyzed 7-years follow-up data from the two-level Medtronic Prestige LP investigational device exemption study. Short-form 36 (SF-36) data were converted into health utility scores using the SF-6D algorithm. Costs were based on direct costs from the payer perspective, and effectiveness was measured as quality-adjusted life years (QALYs). The willingness-to-pay (WTP) threshold was set to $50,000/QALY. A probabilistic sensitivity analysis was conducted via Monte Carlo simulation. Two-level CDR had a 7-year cost of $176,654.19, generated 4.65 QALYs, and had a cost-effectiveness ratio of $37,993.53/QALY. Two-level ACDF had a 7-year cost of $158,373.48, generated 4.44 QALYs, and had a cost-effectiveness ratio of $35,635.72. CDR was associated with an incremental cost of $18,280.71 and an incremental effectiveness of 0.21 QALYs, resulting in an incremental cost-effectiveness ratio (ICER) of $89,021.04, above the WTP threshold. Our Monte Carlo simulation demonstrated CDR would be chosen 46% of the time based on 10,000 simulations. Two-level CDR and ACDF are both cost-effective procedures at 7-year follow up for treating degenerative conditions of the cervical spine. Based on an ICER of $89,021.04/QALY, we cannot conclude which treatment is the more cost-effective option at 7-years. CDR would be chosen 46% of the time based on 10,000 iterations of our Monte Carlo probabilistic sensitivity analysis. 3.

Venous Stents: Current Status and Future Directions

Venous outflow obstruction is a dominant contributor to chronic venous disease. Treatment of venous disease has historically been limited by available vascular stent technology not specifically designed for the venous system. The ideal venous stent must provide requisite flexibility, strength, and accurate deployment for the anatomical and pathophysiological conditions of chronic venous disease. Venous stent technology is advancing with multiple dedicated venous stents currently available in Europe and with investigational device exemption studies ongoing in the United States. These technological advancements are promising for patients suffering from chronic venous disease. This article discusses the current status and future directions of venous stents.

4:20 PM Abstract No. 432 Prospective single-center investigational device exemption study of prostate artery embolization for lower urinary tract symptoms

4:20 PM Abstract No. 432 Prospective single-center investigational device exemption study of prostate artery embolization for lower urinary tract symptoms

Pulsed electromagnetic field stimulation may improve fusion rates in cervical arthrodesis in high-risk populations.

ObjectivesPulsed electromagnetic field (PEMF) stimulation was evaluated after anterior cervical discectomy and fusion (ACDF) procedures in a randomized, controlled clinical study performed for United States Food and Drug Administration (FDA) approval. PEMF significantly increased fusion rates at six months, but 12-month fusion outcomes for subjects at elevated risk for pseudoarthrosis were not thoroughly reported. The objective of the current study was to evaluate the effect of PEMF treatment on subjects at increased risk for pseudoarthrosis after ACDF procedures.MethodsTwo evaluations were performed that compared fusion rates between PEMF stimulation and a historical control (160 subjects) from the FDA investigational device exemption (IDE) study: a post hoc (PH) analysis of high-risk subjects from the FDA study (PH PEMF); and a multicentre, open-label (OL) study consisting of 274 subjects treated with PEMF (OL PEMF). Fisher’s exact test and multivariate logistic regression was used to compare fusion rates between PEMF-treated subjects and historical controls.ResultsIn separate comparisons of PH PEMF and OL PEMF groups to the historical control group, PEMF treatment significantly (p < 0.05, Fisher’s exact test) increased the fusion rate at six and 12 months for certain high-risk subjects who had at least one clinical risk factor of being elderly, a nicotine user, osteoporotic, or diabetic; and for those with at least one clinical risk factor and who received at least a two- or three-level arthrodesis.ConclusionAdjunctive PEMF treatment can be recommended for patients who are at high risk for pseudoarthrosis.Cite this article: D. Coric, D. E. Bullard, V. V. Patel, J. T. Ryaby, B. L. Atkinson, D. He, R. D. Guyer. Pulsed electromagnetic field stimulation may improve fusion rates in cervical arthrodesis in high-risk populations. Bone Joint Res 2018;7:124–130. DOI: 10.1302/2046-3758.72.BJR-2017-0221.R1.

Long-Term Clinical Experience with Selectively Constrained SECURE-C Cervical Artificial Disc for 1-Level Cervical Disc Disease: Results from Seven-Year Follow-Up of a Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial.

This research was initiated to compare the long-term clinical safety and effectiveness of the selectively constrained SECURE-C (Globus Medical, Audubon, Pennsylvania) Cervical Artificial Disc to anterior cervical discectomy and fusion (ACDF). To preserve segmental motion, cervical total disc replacement (CTDR) was developed as an alternative to ACDF. Current CTDR designs incorporate constrained and unconstrained metal-on-metal or metal-on-polymer articulation with various means of fixation. Eighteen investigational sites participated in this prospective clinical trial; 380 patients were enrolled and treated in the investigational device exemption study. The first 5 patients treated at each site were nonrandomized and received the investigational SECURE-C device. Patients were randomized, treated surgically, and evaluated postoperatively at 6 weeks, 3 months, 6 months, 12 months, 24 months, and annually thereafter through 84 months postoperative. Overall results for the randomized cohorts demonstrated statistical superiority of the investigational SECURE-C group over the control ACDF group at 84 months postoperative. SECURE-C showed clinically significant improvement in pain and function in terms of neck disability index and visual analog scale scores, and superiority in patient satisfaction was also achieved for patients treated with SECURE-C. Clinical study results indicated that the selectively constrained SECURE-C Cervical Artificial Disc is as safe and effective as ACDF. Long-term results from the Post Approval Study demonstrated that SECURE-C is statistically superior to ACDF in terms of overall success and patient satisfaction. Lower rates of subsequent index-level surgeries and device-related adverse events were observed in the SECURE-C group than in the ACDF group. The long-term, level 1 clinical evidence presented here is consistent with other reports supporting the safety and efficacy of cervical arthroplasty, and furthers advocacy for motion preservation as a viable alternative to fusion.

Spinal Stenosis in the Absence of Spondylolisthesis: Can Interlaminar Stabilization at Single and Multi-levels Provide Sustainable Relief?

In the absence of spondylolisthesis, fusion procedures are generally not recommended. However, decompression alone often does not provide long-term clinical success of intractable leg and back pain. Decompression with interlaminar stabilization (ILS) offers a new option within the clinical continuum of care by providing a nonfusion surgical alternative. The objective of this study is to examine the sustainability of decompression with ILS and to understand the clinical success at either 1 or 2 levels as a surgical treatment for nonspondylolisthesis patients with spinal stenosis. Under an FDA-regulated investigational device exemption (IDE) study, a total of 322 patients were enrolled in the prospective, randomized trial. This investigation focuses only on the subset of patients (116 total) from this overall cohort who were treated with decompression plus ILS at 1 or 2 levels and who did not present with spondylolisthesis preoperatively. The patients were assessed before and after surgery up to 60 months. At 60-month follow up, there was no statistically significant difference in ODI ≥ 15 point improvement between patient populations (81.6% of 1 level, 90.3% of 2 level). At 60 months, 83.1% of 1 level and 86.3% of 2 level patients did not require a secondary surgical procedure. At 60 months, 94.7% of 1 level and 100% of 2 level reported ≥20 mm improvement in Visual Analogue Scale leg pain. Patients reported improvement in their physical state according to Short Form-12 scores (89.3% of 1 level, 88.9% of 2 level). Patient satisfaction at 60 months was 97.4% for 1 level and 93.3% for 2 level. The therapeutic sustainability for the treatment of spinal stenosis without spondylolisthesis with ILS at 1 or 2 levels in the lumbar region has been shown to be safe and efficacious for patients who have failed conservative treatment. Decompression with ILS offers a nonterminal surgical option for the treatment of the symptomology of spinal stenosis, a progressive degenerative condition, that potentially can provide longer durability and stability than decompression alone.

Defining the Ideal Lumbar Total Disc Replacement Patient and Standard of Care.

: Lumbar total disc replacement, now in use since 2004, was determined by the panel to be a standard of care for the treatment of symptomatic single-level lumbar degenerative disc disease in the active patient subpopulation as outlined by the investigational device exemption study criteria. The large body of evidence supporting this statement, including surgeons' experiences, was presented and discussed. Consensus statements focusing on decision-making criteria reflected that efficacy, long-term safety, clinical outcomes with validated measures, and cost-effectiveness should form the basis of decision-making by payers. Diagnostic challenges with lumbar degenerative disc disease patients were discussed among the panel, and it was concluded that although variably used among surgeons, reliable tools exist to appropriately diagnose discogenic back pain.

Investigating the 7-Year Cost-Effectiveness of Single-Level Cervical Disc Replacement Compared to Anterior Cervical Discectomy and Fusion.

Study Design:Cost-effectiveness analysis.Objectives:To determine the 7-year cost-effectiveness of cervical disc replacement (CDR) and anterior cervical discectomy and fusion (ACDF).Methods:We analyzed 7-year Short Form-36 Health Survey data collected from the Prestige Cervical Disc investigational device exemption study (IDE). The SF-6D algorithm was used to convert this data into health state utilities. Costs were calculated from the payer perspective, and quality adjusted life years (QALYs) were used to represent effectiveness. A Markov transition-state model was used to evaluate the cost-effectiveness of single-level CDR versus ACDF, and a Monte Carlo simulation was performed to assess the probabilistic sensitivity of the model.Results:CDR generated a 7-year cost of $172 989 compared to a 7-year cost of $143 714 for ACDF. CDR generated 4.53 QALYs compared to 3.85 QALYs generated by ACDF. The cost-effectiveness ratio of CDR was $38 247/QALY, while the cost-effectiveness ratio of ACDF was $37 325/QALY. The incremental cost-effectiveness ratio of CDR was $43 522/QALY, under the willingness to pay threshold of $50 000/QALY. Our probabilistic sensitivity analysis demonstrated CDR would be chosen 56% of the time based on 10 000 simulations.Conclusions:Single-level CDR and ACDF were both cost-effective strategies at 7 years for treating degenerative conditions of the cervical spine. Both the Markov simulation and the Monte Carlo simulation demonstrate CDR to be the more cost-effective strategy at 7 years. Continued analysis of IDE data should be performed to validate long-term cost-effectiveness of these treatment strategies.

Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) study

IntroductionThe WEB Intra-saccular Therapy (WEB-IT) trial is an investigational device exemption study to demonstrate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. The...

Stemless Shoulder Arthroplasty: Review of Early Clinical and Radiographic Results.

➢ Stemless anatomic and reverse shoulder arthroplasty designs have been shown to have equivalent short-term clinical outcomes compared with stemmed designs; however, to our knowledge, there have been no published long-term follow-up studies.➢ Radiographic results in the short-term follow-up period show a low prevalence of component loosening, stress shielding, or osteolysis.➢ Stemless arthroplasty requires an accurate humeral-head osteotomy to properly restore humeral anatomy because of the lack of a stem as a guide.➢ There is only 1 design approved by the U.S. Food and Drug Administration (FDA) currently available, to our knowledge, but there are several ongoing Investigational Device Exemption (IDE) studies.

Comparing the 5-Year Health State Utility Value of Cervical Disc Replacement and Anterior Cervical Discectomy and Fusion.

Study Design:Health utility analysis.Objectives:To determine the health state utility (HSU) of 1- and 2-level anterior cervical discectomy and fusion (ACDF) and cervical disc replacement (CDR).Methods:Data from the Medtronic Prestige Cervical Disc investigational device exemption studies was used. Four groups were defined: 1-level ACDF, 1-level CDR, 2-level ACDF, and 2-level CDR. The 36-item Short Form Health Survey (SF-36) was collected at baseline, 12 months, 24 months, 36 months, and 60 months postoperatively and converted into utility scores for each time point. A repeated-measures 1-way analysis of variance (ANOVA) was used to detect differences among groups. Tukey’s method for multiple comparisons was used to determine which means within the groups were statistically different (P < .05).Results:We found a statistically significant difference in HSU among groups as determined by repeated-measures 1-way ANOVA (P = .0008). Post hoc analysis indicated that 1-level ACDF had a statistically lower utility score compared with 1- and 2-level CDR (P = .04 and P = .02, respectively). Similarly, 2-level ACDF had lower utility values compared with 2-level CDR (P = .010). One-level ACDF utility values were not different from 2-level ACDF values (P = .55). Similarly, 1-level CDR and 2-level CDR did not have different utility values (P = .67).Conclusions:Overall, CDR had higher health state utility scores for 1- and 2-level procedures at every time point. This study indicates that CDR results in a higher postoperative health utility state than ACDF, and may therefore be an effective alternative to ACDF for treating degenerative conditions of the cervical spine.

The 5-year cost-effectiveness of two-level anterior cervical discectomy and fusion or cervical disc replacement: a Markov analysis

Background ContextAnterior cervical discectomy and fusion (ACDF) and cervical disc replacement (CDR) are both acceptable surgical options for the treatment of cervical myelopathy and radiculopathy. To date, there are limited economic analyses assessing the relative cost-effectiveness of two-level ACDF versus CDR. PurposeThe purpose of this study was to determine the 5-year cost-effectiveness of two-level ACDF versus CDR. Study DesignThe study design is a secondary analysis of prospectively collected data. Patient SamplePatients in the Prestige cervical disc investigational device exemption (IDE) study who underwent either a two-level CDR or a two-level ACDF were included in the study. Outcome MeasuresThe outcome measures were cost and quality-adjusted life years (QALYs). Materials and MethodsA Markov state-transition model was used to evaluate data from the two-level Prestige cervical disc IDE study. Data from the 36-item Short Form Health Survey were converted into utilities using the short form (SF)-6D algorithm. Costs were calculated from the payer perspective. QALYs were used to represent effectiveness. A probabilistic sensitivity analysis (PSA) was performed using a Monte Carlo simulation. ResultsThe base-case analysis, assuming a 40-year-old person who failed appropriate conservative care, generated a 5-year cost of $130,417 for CDR and $116,717 for ACDF. Cervical disc replacement and ACDF generated 3.45 and 3.23 QALYs, respectively. The incremental cost-effectiveness ratio (ICER) was calculated to be $62,337/QALY for CDR. The Monte Carlo simulation validated the base-case scenario. Cervical disc replacement had an average cost of $130,445 (confidence interval [CI]: $108,395–$152,761) with an average effectiveness of 3.46 (CI: 3.05–3.83). Anterior cervical discectomy and fusion had an average cost of $116,595 (CI: $95,439–$137,937) and an average effectiveness of 3.23 (CI: 2.84–3.59). The ICER was calculated at $62,133/QALY with respect to CDR. Using a $100,000/QALY willingness to pay (WTP), CDR is the more cost-effective strategy and would be selected 61.5% of the time by the simulation. ConclusionsTwo-level CDR and ACDF are both cost-effective strategies at 5 years. Neither strategy was found to be more cost-effective with an ICER greater than the $50,000/QALY WTP threshold. The assumptions used in the analysis were strongly validated with the results of the PSA.

Endovascular Repair in Acute Complicated Type B Aortic Dissection: 3-Year Results from the Valiant US Investigational Device Exemption Study.

Acute complicated type B aortic dissection (TBAD) is a potentially catastrophic, life-threatening condition. If left untreated, there is a high risk of aortic rupture, irreversible organ or limb damage, or death. Several risk factors have been associated with acute complicated TBAD, including age and refractory hypertension. In the acute phase, even uncomplicated patients are more prone to develop complications if hypertension and pain are left medically untreated. Innovations in stent graft technologies have incrementally improved outcomes since their first use for this condition in 1999, though improvement is needed in mitigating periprocedural complications, adverse events, and mortality. In the past decade, endovascular repair has become the preferred treatment because of its superior outcomes to open repair and medical therapy. The Valiant Captivia Thoracic Stent Graft System is a third-generation endovascular stent graft with advancements in minimally invasive delivery, conformability to the anatomy, and the minimization of adverse sequelae. Herein, this stent graft is briefly reviewed and its 3-year outcomes are presented. Freedom from all-cause and dissection-related mortality was 79.1% and 90.0%, respectively. The Valiant Captivia Stent Graft represents a safe, effective intervention for acute complicated TBAD. Continued surveillance is needed to verify its longer-term durability.