Investigational Device Exemption Trial Research Articles

Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design.

There is growing evidence in support of pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) for the treatment of patients with symptomatic persistent atrial fibrillation (persAF). However, there is limited data on the safety and efficacy of this approach using the cryoballoon. The aim of this multicenter, investigational device exemption trial (G190171) is to prospectively evaluate the acute and long-term outcomes of PVI versus PVI+PWI using the cryoballoon in patients with symptomatic persAF. The PIVoTAL is a prospective, randomized controlled study ( ClinicalTrials.gov : NCT04505163) in which patients with symptomatic persAF refractory/intolerant to ≥ 1 class I-IV antiarrhythmic drug, undergoing first-time catheter ablation, will be randomized to PVI (n = 183) versus PVI+PWI (n = 183) using the cryoballoon in a 1:1 fashion. The design will be double-blind until randomization immediately after PVI, beyond which the design will transform into a single-blind. PVI using cryoballoon will be standardized using a pre-specified dosing algorithm. Other empiric ablations aside from documented arrhythmias/arrhythmias spontaneously induced during the procedure will not be permitted. The primary efficacy endpoint is defined as AF recurrence at 12months, after a single procedure and a 90-day blanking period. Arrhythmia outcomes will be assessed by routine electrocardiograms and 7-14day ambulatory electrocardiographic monitoring at 3, 6, and 12months post-ablation. The PIVoTAL is a prospective, randomized controlled trial designed to evaluate the outcomes of PVI alone versus PVI+PWI using the cryoballoon, in patients with symptomatic persAF. We hypothesize that PVI+PWI will prove to be superior to PVI alone for prevention of AF recurrence.

162. Two-level cervical disc replacement using a PEEK-on-ceramic device: prospective outcome data from an FDA IDE trial

BACKGROUND CONTEXT While there have been several large-scale FDA investigational device exemption (IDE) studies on single-level cervical total disc replacement (TDR) such information is available for only two devices used for two-level disc replacement. One of these devices has metallic endplates and a plastic core, the other is a two-piece device machined from a titanium-ceramic composite. A TDR designed with titanium-coated PEEK endplates and a biconvex zirconia toughened alumina ceramic core is being evaluated in an IDE trial for two-level implantation. PURPOSE The purpose of this study was to investigate preliminary outcomes of the PEEK-on-ceramic TDR based on three sites participating in the two-level trial. STUDY DESIGN/SETTING This was a prospective study based on data from three of 18 centers participating in the TDR arm of a prospective study evaluating two-level cervical TDR using a nonconcurrent historical control. PATIENT SAMPLE These preliminary outcomes were based on 62 patients at 12 months postoperative following two-level cervical TDR. OUTCOME MEASURES Patient reported outcome measures included the neck disability index (NDI) and numerical rating scores (NRS) separately assessing neck and arm pain intensity. Radiographic measures made at the index levels included disc height and flexion/extension range of motion (ROM). METHODS Patients enrolled in the trial received the Simplify® PEEK-on-ceramic TDR. Evaluations were conducted prior to surgery and at 6 weeks, and 3, 6 and 12 months after surgery. All radiographs were analyzed by an independent lab specializing in image assessment. RESULTS The mean NDI score decreased significantly (p CONCLUSIONS Preliminary results of this IDE study found that two-level cervical TDR using the PEEK-on-ceramic implant was associated with significant decreases in pain and function scores, which were maintained during 12-month follow-up. Disc height of the operated segments were increased after surgery and remained increased through 12-month follow-up. ROM was increased, significantly at the superior level and nonsignificantly at the inferior level. These early results suggest that the device may be a future consideration for the treatment of symptoms arising from two-level degenerative conditions of the cervical spine. Patients from all centers continue to be followed annually. FDA DEVICE/DRUG STATUS Simplify disc (Investigational/Not approved)

161. Cervical disc replacement using a PEEK-on-ceramic implant: prospective data from seven sites participating in an FDA IDE trial for single-level surgery

BACKGROUND CONTEXT The first cervical total disc replacements (TDRs) used on a large-scale basis, produced motion through a ball-and-socket action, with metal endplates articulating with a plastic core. Various designs followed: metal-on-metal devices, a titanium-ceramic composite device, as well as a compressible disc with metal endplates. The use of PEEK material for spinal implants continues to increase, primarily due to its mechanical and positive imaging properties (ie, no metallic artifact on MRI or CT). A TDR was designed with titanium-coated PEEK endplates and a biconvex zirconia toughened alumina ceramic core. PURPOSE The purpose of this study was to evaluate preliminary results of seven sites participating in the single-level Investigational Device Exemption (IDE) study for a PEEK-on-ceramic TDR. STUDY DESIGN/SETTING This is a prospective study evaluating the cervical TDR using a non-concurrent historical control. Data from 7 of 16 sites participating in the investigational arm are provided. PATIENT SAMPLE The device was implanted into 123 patients at 7 of 16 sites participating in the FDA IDE trial for single-level cervical degenerative radiculopathy with or without spinal cord compression from C3 to C7. Twelve-month data were available for 120 patients and 24-month data were available for 87 patients. OUTCOME MEASURES Outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS) assessing neck and arm pain, and the Dysphagia Handicap Index (DHI). Radiographic assessment of the operated level included disc height, flexion/extension range of motion, and lordosis. METHODS Patients enrolled in the trial received the Simplify PEEK-on-ceramic TDR. Evaluations were conducted prior to surgery and within 2 weeks, 6 weeks, and 3, 6, 12 and 24 months after surgery. Radiographs were analyzed by an independent lab specializing in image assessment. RESULTS Mean NDI scores decreased significantly (p CONCLUSIONS Preliminary results of this study found the PEEK-on-ceramic disc replacement produced significant decreases in pain and function scores, which were maintained through the 12- and 24-month follow-up. Range of motion, disc height, and lordosis of the operated segment were significantly increased after surgery and maintained during follow-up. The values were similar to those reported in other FDA IDE trials for cervical TDR. FDA DEVICE/DRUG STATUS Simplify (Investigational/Not approved)

Nerve Root Sedimentation Sign: Can It Predict the Success for Surgical Intervention in Patients With Symptomatic Lumbar Spinal Stenosis?

Introduction: The use of interspinous process devices are less invasive surgical methods designed to manage mild to moderate lumbar spinal stenosis symptoms. Symptomatic relief may not be seen in all patients undergoing this procedure. Magnetic resonance imaging (MRI) parameters have been used to predict the success of clinical outcomes in patients with symptomatic lumbar spinal stenosis for decompressive surgeries. The purpose of this study was to determine the feasibility of using nerve root sedimentation sign to predict mid- to long-term clinical outcomes of patients treated with interspinous spacers for lumbar spinal stenosis.Methods: This was a retrospective study using prospective multicenter Food and Drug Administration Investigational Device Exemption (FDA IDE) trial (Superion™ and X-STOP®) data. Inclusion criteria were patients treated with interspinous spacers, aged 45 or older with lumbar spinal stenosis at one or more contiguous levels from L1 to L5 and symptoms of neurogenic claudication. Preoperative axial T2 weighted MRI images were used to determine nerve root sedimentation sign. Preoperative, six-week, one- and two-year postoperative clinical outcomes were measured using Oswestry Disability Index (ODI) scores. Clinical outcomes were compared between positive and negative nerve root sedimentation sign groups; p ≤0.05 was considered significant.Results: This study included n=374 patients; 40 excluded; 334 included (113=positive nerve root sedimentation sign (NRSS) (34%) and 221=negative NRSS (66%)). At six weeks, significant postoperative ODI correction was noted in both groups (p<0.001). No significant differences in ODI scores were identified between groups. A subgroup analysis with MRI image quality grade 3 and certainty determination grade 5, six-week postoperative ODI correction was significant in both groups. Six-week, one- and two-year postoperative ODI scores were greater by 6 points in the positive nerve root sedimentation sign group compared to the negative nerve root sedimentation sign group.Conclusions: Although satisfactory postoperative improvement occurred in both groups, there were statistically significant differences noted in certain sub-categories. The subgroup analysis indicated MRI image quality and nerve root sedimentation sign certainty of determination may be factors that may aid with planning the surgical management of lumbar spinal stenosis.

Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK)

Purpose: To report the 12-month safety and efficacy outcomes of the investigational device exemption trial evaluating an implantable below-the-knee (BTK) dissection repair device. Materials and Methods: The prospective, multicenter, single-arm Tack-Optimized Balloon Angioplasty (TOBA) II BTK study (ClinicalTrials.gov identifier NCT02942966) evaluated the Tack Endovascular System in the BTK arteries vs objective performance goals derived from a systematic review of BTK angioplasty literature. Patients presenting with Rutherford category 3–5 ischemia were eligible and were enrolled during the procedure if angioplasty resulted in dissection(s) of the BTK arteries. Between February 2017 and December 2018, the study enrolled 233 patients (mean age 74.4±10.0 years; 157 men). Most lesions (93.8%) were de novo; almost half (118/248, 47.6%) were total occlusions. Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions. The 30-day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary efficacy endpoint was a composite of MALE at 6 months and 30-day POD. These safety and efficacy endpoints were assessed at 12 months as observational endpoints along with amputation-free survival (AFS), freedom from clinically-driven target lesion revascularization (CD-TLR), vessel patency, and changes from baseline in clinical and quality of life measures. Results: All patients had post-PTA dissection and received at least 1 Tack implant (range 1 to 16). The angiographic core laboratory noted successful resolution of 100% of the 341 treated dissections. At 12 months, 93.4% (170/182) of patients remained free of the composite endpoint of MALE + POD. Tacked segment patency was 81.3% and limb salvage was 96.8% at 12 months; freedom from CD-TLR and AFS were 83.1% and 89.3%, respectively. Sustained Rutherford category improvement was reported in 82.4% of evaluated patients, with 62.4% improving ≥3 categories (p<0.001). Ninety of 124 index wounds (72.5%) healed or improved. Conclusion: The Tack Endovascular System is safe and effective in the treatment of post-angioplasty BTK dissections. Twelve-month outcome data from the TOBA II BTK study demonstrate high rates of patency, limb salvage, and wound healing.

Impact of bridging stent design and configuration on branch vessel durability after fenestrated endovascular repair of complex aortic aneurysms

ObjectiveThe ideal mating stent for target vessel revascularization in fenestrated endovascular aneurysm repair (FEVAR) of juxtarenal and thoracoabdominal aortic aneurysms remains unknown. The objective of this study was to assess the outcomes associated with use of different stent types and configurations mated with reinforced fenestrations during FEVAR. MethodsClinical data from patients undergoing FEVAR for juxtarenal and thoracoabdominal aortic aneurysms in a prospective physician-sponsored investigational device exemption trial were analyzed. Outcomes for two different balloon-expandable covered stents (BECSs) mated with reinforced fenestrations were assessed along with the impact of distal extension with a self-expanding stent (SES). Primary patency, branch-related endoleak, and reintervention rates were determined. Cox proportional hazards model was used for time-to-event analysis. ResultsFrom 2001 to 2016, there were 918 patients who underwent fenestrated or branched endograft repair of complex aortic aneurysms; 1604 renal arteries (RAs), 714 superior mesenteric arteries (SMAs), and 333 celiac arteries (CAs) were mated with reinforced fenestrations using JOMED (n = 2014; Abbott Vascular, Santa Clara, Calif) or iCAST (n = 637; Atrium Medical, Hudson, NH) BECSs. The type of BECS did not affect short-term or long-term patency, branch-related endoleaks, or reintervention rates in the RA, SMA, or CA. Twenty-five percent (402/1604) of RAs, 84% (598/714) of SMAs, and 8% (27/333) of CAs underwent distal SES extension at the index operation. RAs with a distal SES in addition to the BECS had a higher likelihood of an occlusion event (hazard ratio, 2.791; 95% confidence interval, 1.42-5.48; P = .003) and reinterventions (P = .036) compared with those without an SES. Addition of a distal SES to the BECS in the SMA or CA did not have an impact on patency or reintervention rates. ConclusionsBECS choice does not appear to have an impact on branch durability after FEVAR. Selective distal SES placement in RAs with high-risk anatomy does not appear to significantly protect against an occlusion event or to prevent secondary interventions. Routine addition of a distal SES does not improve SMA fenestration durability.

Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial

Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs. In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing. Between May 30 and Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52·7%) patients were female. For the primary safety endpoint at 30 days, the event rate was higher in the Portico valve group than in the commercial valve group (52 [13·8%] vs 35 [9·6%]; absolute difference 4·2, 95% CI -0·4 to 8·8 [upper confidence bound {UCB} 8·1%]; pnon-inferiority=0·034, psuperiority=0·071). At 1 year, the rates of the primary efficacy endpoint were similar between the groups (55 [14·8%] in the Portico group vs 48 [13·4%] in the commercial valve group; difference 1·5%, 95% CI -3·6 to 6·5 [UCB 5·7%]; pnon-inferiority=0·0058, psuperiority=0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups. The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves. Abbott.

Preoperative Functional Status Predicts 2-year Mortality in Patients Undergoing Fenestrated/branched Endovascular Aneurysm Repair

Fenestrated/branched endovascular aneurysm repair (F/BEVAR) is a minimally invasive alternative for patients at high risk for open repair of complex aortic aneurysms. Nearly all investigative study protocols evaluating F/BEVAR require a predicted life expectancy >2 years for study inclusion. However, accurate risk models for predicting 2-year survival in this patient population are lacking. We sought to identify preoperative predictors of 2-year survival in patients undergoing F/BEVAR. Prospectively collected data on all consecutive F/BEVAR procedures, performed in an institutional review board-approved registry and/or physician-sponsored investigational device exemption trial (IDE# G130210), were reviewed (November 2010 to February 2019). Forty-four preoperative patient characteristics, including comorbidities, preoperative functional status, and aneurysm/repair characteristics, were assessed. Preoperative functional status was defined as totally dependent (any impairment in activities of daily living (ADLs) or residence in a skilled nursing facility), partially dependent (any impairment in instrumental ADLs), or independent (no impairment of ADLs/instrumental ADLs). Based on a univariate screen (P < .2), a Cox proportional hazards model was constructed to identify independent predictors of 2-year all-cause mortality. Among 256 consecutive F/BEVARs (six [2.3%] common iliac, 94 [41%] juxtarenal, 35 [14%] pararenal, 119 [47%] thoracoabdominal, and 2 [0.8%] arch aneurysms), the 2-year mortality was 18%. On Cox modeling, the only independent preoperative predictor of 2-year mortality was functional status (totally dependent, hazard ratio [HR], 5.4 [95% CI, 1.8-16; P < .01]; partially dependent, HR, 4.7 [95% CI, 2.5-8.7; P < .01]). A history of coronary revascularization was protective (HR, 0.5, 95% CI, 0.2-0.9; P = .03). Factors such as age, congestive heart failure, chronic kidney disease, diabetes, chronic obstructive pulmonary disease, aneurysm extent, and prior aortic surgery were not significant. The 2-year mortality for the independent (n = 176 [69%]), partially dependent (n = 69 [27%]), and totally dependent groups (n = 10 [3.9%]), was 11%, 33%, and 40%, respectively (Fig). In patients undergoing F/BEVAR, decreased preoperative functional status is the strongest predictor of 2-year mortality, with totally dependent patients experiencing poor survival. Traditional risk factors were not independently significant, perhaps reflecting a high prevalence of severe chronic illness in these high-risk patients participating in an investigational device exemption trial. Given that 2-year survival in the independent group of this high-risk cohort is 89%, which mirrors that of infrarenal EVAR, expanding the indication for F/BEVAR to patients who are independent is reasonable for low-risk patients as well.

Adjacent Segment Pathology After Treatment With Cervical Disc Arthroplasty or Anterior Cervical Discectomy and Fusion, Part 2: Clinical Results at 7-Year Follow-Up.

Adjacent segment pathology (ASP) following cervical disc arthroplasty (CDA) or anterior cervical discectomy and fusion (ACDF) is identified by imaging (RASP) or clinical symptoms (CASP). Clinical symptoms of CASP have been broadly defined, but subsequent adjacent-level surgeries are clear indicators of CASP. Current literature remains inconsistent in the incidence and potential predictors of CASP. Here, we will evaluate a robust data set for the incidence of CASP resulting in subsequent surgery, attempt to identify factors that might affect CASP, and analyze the association of CASP with patient-reported outcomes (PROS) and RASP. Data were prospectively collected during a US Food and Drug Administration randomized, multicenter, investigational device exemption trial comparing CDA (Mobi-C, Zimmer Biomet, Westminster, CO) with ACDF. CASP was defined as any adjacent-level subsequent surgical intervention. Post hoc analyses were conducted on the incidence, time to CASP diagnosis, and relationship of CASP with patient demographics. Longitudinal retrospective case-control analysis was used to assess the correlation of CASP to PROs and radiographic adjacent segment pathology (RASP). Kaplan-Meier estimates indicated significantly lower probability of CASP over time for 1-level (P = .002) and 2-level (P = .008) CDA patients. Treatment with ACDF and younger age were associated with higher CASP risk. CDA was more effective than ACDF (70.5%; 95% CI = 45.1, 84.2; P < .0001) at preventing CASP. Case-control analysis indicated increased probability of CASP for patients with grade 3/4 RASP, but the difference was not statistically significant. When we pooled CASP patients, the median grade of RASP at the visit prior to surgery was 1, with only 6 patients presenting with grade 3/4 RASP. Patients treated with CDA have a lower incidence of CASP than do patients treated with ACDF, although the mechanism remains unclear. CASP and RASP remain uncorrelated in this large data set, but other predictive variables such as treatment, age, and number of levels should be further investigated.

Antegrade Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction: A Simplified Technique From Bench to Bedside.

Intentional laceration of the anterior mitral leaflet (LAMPOON) is an effective adjunct to transcatheter mitral valve replacement that prevents left ventricular outflow tract (LVOT) obstruction. To date, LAMPOON has been performed in over 150 patients using a retrograde approach that can be technically challenging. A modified antegrade transseptal technique may simplify the procedure. Antegrade LAMPOON was developed and tested in nonsurvival pig experiments. Thereafter, antegrade LAMPOON was performed in patients at prohibitive risk of LVOT obstruction. Clinical, procedural, and angiographic details were abstracted from medical records of their index procedure, and were compared with findings in comparable patients at risk of fixed-LVOT obstruction in the LAMPOON investigational device exemption trial. Eight patients at risk of fixed LVOT obstruction underwent antegrade LAMPOON. Leaflet traversal and laceration were technically successful in all. There were no cases of clinically significant LVOT obstruction (mean LVOT gradient at discharge: 5.4±1.4 mm Hg). One patient suffered a ventricular wire perforation, unrelated to the antegrade LAMPOON technique, and did not survive to discharge. At the time of discharge, no patients had an increase of >10 mm Hg in LVOT gradient compared with baseline. Procedure times (from traversal to transcatheter mitral valve replacement) were shorter, compared with the retrograde technique in the LAMPOON investigational device exemption trial (39±09 versus 65±35 minutes). All patients survived (8/8, 100%) the procedure, and 7/8 (88%) survived to 30 days, similar to subjects in the LAMPOON investigational device exemption trial. Antegrade LAMPOON is an effective, reproducible, and simplified strategy to lacerate the anterior leaflet before transcatheter mitral valve replacement. The authors recommend the technique as the new standard for LAMPOON.

Adjacent Segment Pathology After Treatment With Cervical Disc Arthroplasty or Anterior Cervical Discectomy and Fusion, Part 1: Radiographic Results at 7-Year Follow-Up.

Adjacent segment pathology (ASP) remains a concern following treatment with cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF). Radiographic ASP (RASP) is ASP identified on imaging, which may or may not include clinical symptoms. The risk factors for development of RASP and its clinical effects remain controversial. In part 1 of a 2-part publication we evaluate the incidence and predictors of RASP as well as determine whether any association exists between RASP and patient-reported outcomes (PROs). Data were prospectively collected during a US Food and Drug Administration randomized, multicenter, investigational device exemption trial comparing CDA (Mobi-C; Zimmer Biomet, Westminster, CO) with ACDF. Multiple post hoc analyses were conducted on RASP as it related to demographics and patient outcomes. Kaplan-Meier estimates of time to Kellgren-Lawrence (K-L) grade 3/4 were calculated separately for all groups. Multivariate Cox proportional hazard models were used analyze whether RASP was associated with patient preoperative demographic characteristics and preoperative and postoperative radiographic characteristics. The association of RASP with PROs was analyzed using generalized estimating equations and matched, retrospective cohort analysis. The incidence of grade 3/4 RASP was lower for patients treated with CDA when initial treatment was at 1 level (27% vs 47%, P < .0001) and at 2 levels (14% vs 49%, P < .0001). Kaplan-Meier estimates indicated significantly lower probability of grade 3/4 RASP over time for patients receiving CDA (P < .001). Treatment with ACDF, treatment of 1 level, higher age, body mass index, higher preoperative physical components score, and a lower Cobb angle were associated with elevated risk of grade 3/4 RASP. CDA was shown to be more effective than ACDF (64.4%; 95% CI = 50.9, 74.2; P < .0001) at preventing RASP. The incidence and risk of RASP is decreased when patients are treated with CDA compared with ACDF. Although the mechanism of CDA that generates this protective effect is not understood, PROs remain unaffected through 7 years despite changes in RASP.

Performance of Viabahn balloon-expandable stent compared with self-expandable covered stents for branched endovascular aortic repair

ObjectiveThe objective of this study was to compare the performance between the Viabahn balloon-expandable stent (VBX; Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) and a covered self-expandable stent (SES; Fluency [Bard Peripheral Vascular, Tempe, Ariz]) used as bridging stents for directional branches during fenestrated or branched endovascular aneurysm repair of complex aortic aneurysms. MethodsPatients with thoracoabdominal aortic aneurysms (type I-IV) or pararenal aortic aneurysms either at high risk for open repair or unsuitable for endovascular repair with commercially available devices were prospectively enrolled in a physician-sponsored investigational device exemption trial. Descriptive statistics of the cohort included demographics, risk factors, and anatomic and device characteristics. Individual branches were grouped as either VBX or SES and had data analyzed for primary patency, branch-related type I or type III endoleaks, branch instability, branch-related secondary intervention, and branch-related aortic rupture or death. Categorical variables were expressed as total and percentage, and continuous variables were expressed as median (interquartile range). Kaplan-Meier curves were used to estimate long-term results. Groups were compared with the log-rank test. P value <.05 was considered statistically significant. ResultsDuring the period from July 2012 through June 2019, there were 263 patients treated for complex aortic aneurysm (thoracoabdominal aortic aneurysm) with fenestrated or branched endografts. The devices used were either custom-manufactured devices or off-the-shelf p-Branch or t-Branch (Cook Medical, Bloomington, Ind) devices. The median age was 71 years (interquartile range, 66-79 years); 70% were male, and 81% were white. The most common cardiac risk factors were smoking (92%), hypertension (91%), hyperlipidemia (78%), and chronic obstructive pulmonary disease (52%). The total number of vessels incorporated into the repair was 977, with branches representing 18.4% (179 branches). Among these 179 branches, the celiac artery, superior mesenteric artery, right renal artery, and left renal artery received 54 (30%), 56 (31%), 38 (21%), and 31 (18%) branches, respectively. VBX and SES groups represented 96 (54%) and 81 (46%) of the branches implanted. The celiac artery, superior mesenteric artery, right renal artery, and left renal artery received VBX as a bridging stent in 40%, 46.7%, 33.8%, and 32.2% respectively. The overall cohort survival rate was 78.5% at 24 months. There was no branch-related rupture or mortality. Primary patency at 24 months (VBX, 98.1%; SES, 98.6%; log-rank, P = .95), freedom from endoleak (VBX, 95.6%; SES, 98.6%; log-rank, P = .66), freedom from secondary intervention (VBX, 94.7%; SES, 98.1%; log-rank, P = .33), and freedom from branch instability (VBX, 95.6%; SES, 97.2%; log-rank, P = .77) were similar between groups. ConclusionsThis initial experience with VBX stents demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death. Our results demonstrate that in a high-volume, experienced aortic center, the VBX stent is a safe and effective bridging stent option during branched endovascular aortic repair. Multicenter studies with a larger cohort and longer follow-up are necessary to validate these findings.

Long-term outcomes of the Ovation Stent Graft System investigational device exemption trial for endovascular abdominal aortic aneurysm repair

ObjectiveThe objective of this study was to report the 5-year outcomes of the Food and Drug Administration investigational device exemption clinical trial of endovascular aneurysm repair (EVAR) with the Ovation stent graft (Endologix, Irvine, Calif) for elective treatment of abdominal aortic aneurysm (AAA). MethodsThe study comprised 161 patients who underwent EVAR as part of the prospective, international, multicenter pivotal Ovation stent graft trial. The main inclusion criteria were AAA diameter ≥5 cm, proximal neck length ≥7 mm, neck angulation ≤60 degrees, and bilateral iliac fixation length ≥10 mm. The primary end point was a composite outcome of primary clinical success at 5 years. Primary clinical success was defined in accordance with the Society for Vascular Surgery guidelines as successful aneurysm exclusion without aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion, aneurysm rupture, graft migration, or conversion to open repair. Secondary end points included freedom from reintervention, all-cause mortality, and aneurysm-related mortality. ResultsPatients were predominantly male (87.6%) and elderly with a mean age of 73 ± 7.7 years; 66 patients (41%) had challenging anatomy and would be considered outside the instructions for use with other stent grafts, 26 (16.2%) had a proximal neck length <10 mm, and 53 (33%) had a minimum access vessel diameter <6 mm. Technical success was 100%. Of 126 surviving patients, 84 (66.7%) completed 5-year follow-up. The 5-year primary clinical success rate was 78%, aneurysm-related mortality was 1% (one patient), and all-cause mortality was 25%. The AAA-related death resulted from AAA post-EVAR rupture at 49 months in a patient who refused treatment for a type IB endoleak. Freedom from type I or type III endoleak was 95.1%. Freedom from secondary interventions was 80.2%. Most of the reinterventions were performed for type II endoleak (24 [63.1%]) or for limb thrombosis or stenosis (7 [18.4%]). There was no graft migration. None of the patients required open conversion. ConclusionsFive-year results from the Ovation pivotal and continued access investigational device exemption trials demonstrate excellent long-term durability of this endograft despite that 41% of patients had anatomy unfit for other stent grafts. There were no migrations or conversions to open repair and 99% freedom from aneurysm-related mortality. These results suggest a less invasive on-label endovascular option for patients with challenging anatomy who may otherwise require hybrid or open repair.

Incidence and management of iliac artery aneurysms associated with endovascular treatment of juxtarenal and thoracoabdominal aortic aneurysms

BackgroundThis study reports the clinical impact of iliac artery aneurysms (IAAs) in a population of patients with juxtarenal and thoracoabdominal aortic aneurysms being treated with fenestrated or branched aortic endografts. MethodsData from 364 patients with IAA (33%) were extracted from the 1118 patients treated for juxtarenal or thoracoabdominal aortic aneurysms with a fenestrated or branched aortic endograft in a physician-sponsored investigational device exemption trial (2001-2016). IAAs were defined as ≥21 mm in diameter, as measured by an imaging core laboratory. Outcomes were assessed by univariate and multivariable analysis. ResultsIAAs were unilateral in 219 (60%) and bilateral in 145 (40%) of the 364 patients. Treatment was iliac leg endoprosthesis without coverage of the hypogastric artery (seal distal to the IAA in the common iliac artery), placement of a hypogastric branched endograft in 105 (21%), and hypogastric artery coverage with extension into the external iliac artery in 103 (20%); 67 (13%) were untreated. Procedure duration was longer for those with IAA (5.3 ± 1.79 hours vs 4.6 ± 1.74 hours; P < .001), although hospital stay was not. There was no difference in aneurysm-related mortality and all-cause mortality for patients with unilateral and bilateral IAAs compared with those without an IAA. Treatment of patients with a hypogastric branched endograft had similar all-cause mortality compared with treatment of patients without a hypogastric branched endograft but also with an IAA. Reintervention rates were significantly higher in those with bilateral IAAs compared with no IAA (hazard ratio, 1.886; P < .001). Spinal cord ischemia trended higher in patients with bilateral IAA. ConclusionsIAA management at the time of fenestrated or branched endovascular aneurysm repair increases procedure time without increasing hospitalization. The reintervention rate and spinal cord ischemia rate are higher in patients with bilateral IAA compared with those with no IAA.

Functional Outcomes Associated With Adjacent-level Ossification Disease 10 Years After Cervical Disc Arthroplasty or ACDF.

A retrospective review of a prospective, randomized control Food and Drug Administration (FDA) investigational device exemption trial comparing anterior cervical discectomy and fusion (ACDF) with Bryan cervical disc arthroplasty. Determine the clinical significance of adjacent-level ossification disease (ALOD) on long-term functional outcomes after ACDF or arthroplasty. ALOD occurs when the anterior longitudinal ligament and annulus adjacent to the index surgical level calcifies. As previously reported, ALOD happens more commonly after an arthrodesis than an arthroplasty. No investigation has previously examined 10-year clinical outcomes associated with ALOD. Forty patients were included in the 10-year follow-up. The index level was radiographically blinded and the cephalad-adjacent level was evaluated for ALOD. These scores underwent statistical analysis to compare the 2 surgical groups (ACDF and arthroplasty) for differences in the development of ALOD at a decade follow-up. Two investigational groups, on the basis of a high or low ALOD score, then proceeded through statistical analysis to compare the functional outcomes of patients in each group. Statistical evaluation of ALOD findings in patients from each surgical group found a significantly higher rate of high-grade ALOD in patients who underwent cervical arthrodesis with plate fixation compared with cervical arthroplasty (68.2% vs. 11.1%, P=0.0003). Functional outcomes of patients were also assessed at the 10-year mark and outcomes in patients with either high-grade or low-grade ALOD were compared. When stratified by high versus low-grade ALOD, no significant difference was found for Neck Disability Index (NDI) (P=0.6431), VAS-arm (P=0.4497), or VAS-neck (P=0.8700) scores between groups. The present study suggests that there are no significant long-term functional outcome differences between patients with and without significant ALOD. Our findings suggest ALOD may be a radiographic finding that does not alter patient-reported outcomes. Level III-therapeutic.

Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis

ObjectivesThe aim of this study was to evaluate clinical outcomes and transcatheter heart valve hemodynamic parameters after transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic stenosis (AS). BackgroundTAVR is approved for low-risk patients in the United States. However, patients with bicuspid AS were excluded from the randomized cohorts of the pivotal low-risk trials. MethodsThe LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and was the first and only U.S. Food and Drug Administration–approved investigational device exemption trial to evaluate the feasibility of TAVR with either balloon-expandable or self-expanding valves in low-risk patients with bicuspid AS. The primary endpoint was all-cause mortality at 30 days. Baseline and follow-up echocardiography and computed tomography to detect leaflet thickening were analyzed in an independent core laboratory. ResultsSixty-one low-risk patients with symptomatic, severe AS and bicuspid aortic valves (78.3% Sievers type 1 morphology) underwent TAVR at 6 centers from 2016 to 2019. The mean age was 68.6 years, and 42.6% were men. At 30 days, there was zero mortality and no disabling strokes. The rate of new permanent pacemaker implantation was 13.1%; just 1 patient had a moderate paravalvular leak at 30 days. Hypoattenuated leaflet thickening was observed in 10% of patients at 30 days. ConclusionsTAVR appears to be safe in patients with bicuspid AS, with short length of hospital stay, zero mortality, and no disabling strokes at 30 days. Subclinical leaflet thrombosis was observed in a minority of patients at 30 days but did not appear to be associated with clinical events.

Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue

ObjectivesThe COMMENCE trial was conducted to evaluate the safety and effectiveness of an aortic bioprosthesis with novel RESILIA tissue (Edwards Lifesciences, Irvine, Calif). Reports of early noncalcific valve failure resulting from thrombosis or leaflet tears in other valves warrant careful evaluation of early valve performance. MethodsPatients underwent clinically indicated surgical aortic valve replacement with the Edwards Pericardial Aortic Bioprosthesis, Model 11000A (Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), single-arm, Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee; echocardiograms were analyzed by an independent core laboratory. ResultsBetween January 2013 and March 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years. Mean Society of Thoracic Surgeons predicted risk of mortality was 2.0% ± 1.8%. Follow-up duration was 3.7 ± 1.2 years, with a total of 2533 patient years of follow-up and a median follow-up of 4 years. Early all-cause mortality was 1.2%, thromboembolism 2.3%, all bleeding 1.0%, and major paravalvular leak 0.1%. One- and 4-year actuarial freedom from all-cause mortality was 97.7% (95% confidence interval, 96.5%-98.8%) and 91.9% (95% confidence interval, 89.7%-94.1%), respectively. At 4 years, New York Heart Association functional class improved compared with baseline in 63.0%, effective orifice area was 1.5 ± 0.5 cm2, and mean gradient was 11.0 ± 5.6 mm Hg. Freedom from moderate or greater transvalvular insufficiency was 99.7%. There were no events of structural valve deterioration. ConclusionsSafety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue at 4 years are favorable. This novel tissue does not appear to result in unexpected early thrombosis events or noncalcific structural valve deterioration.

4:12 PM Abstract No. 11 Prospective investigational device exemption trial of genicular artery embolization for the treatment of knee osteoarthritis: Interim safety results

4:12 PM Abstract No. 11 Prospective investigational device exemption trial of genicular artery embolization for the treatment of knee osteoarthritis: Interim safety results

Asymptomatic ACDF Nonunions Underestimate the True Prevalence of Radiographic Pseudarthrosis.

Secondary analysis of subjects in the control anterior cervical discectomy and fusion (ACDF) arm of Medtronic Investigational Device Exemption (IDE) trials for cervical disc arthroplasty (CDA). To compare patient-reported outcomes (PROs) in patients with radiographic nonunion to patients with a solid fusion. The true prevalence of nonunion after ACDF is unknown. Nonunion may be under-reported, as some patients are not symptomatic enough to justify radiographic evaluation. Three hundred forty-five subjects enrolled in the control arm of IDE trials for CDA who had single-level ACDF with allograft and plate with 24 month data formed the study cohort. Using the 24-month postop evaluation, subjects were divided into those who had radiographic fusion and those who did not using strict study criteria. SF-36, NDI, Neck and Arm pain NRS scores were reported at 12, 24, 36, 60, and 84 months postop. For subjects who had secondary surgery failures, the last observations before the secondary surgery were carried forward to future visits for the analysis. Forty-four (13%) patients had radiographic nonunion and 301 (87%) were fused at 24 months postop. At 24 months, PROs were similar between the two groups. Seven patients in the Nonunion group (16%) and 10 (3%) in the Fused group had additional surgery at the index level prior to the 24 follow-up (P = 0.003). Over the 84-month follow-up a total of 9 patients in the Nonunion group (21%) and 22 (7%) in the Fused group had additional surgery at the index level (P = 0.009). While the radiographic nonunion rate at 24 months was 13%, PROs show that many of the radiographic nonunions were asymptomatic. Although the majority of patients with radiographic nonunion did not undergo additional surgery, the rate of secondary surgeries at the index level was significantly higher in the radiographic nonunion group. 2.

Proper technical procedures improved outcomes in a retrospective analysis of EVAS FORWARD IDE trial 3-year results

ObjectiveAdverse outcomes observed late in the Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix, Inc, Irvine, Calif) investigational device exemption trial prompted refinement of the anatomic instructions for use (IFU). This study aimed to investigate the association of procedural factors during Nellix endograft deployment and patient outcomes. MethodsWe retrospectively reviewed 1-month imaging of 333 patients enrolled in the prospective, multicenter EVAS investigational device exemption trial between January 2014 and September 2016. Initial observations of those patients who met revised anatomic IFU yet still experienced late adverse events suggested that inadequate seal and low graft placement were common among these patients. Key procedural variables identified from a univariate analysis were applied to construct four cohorts stratified by procedural technical performance (technically adequate [P+] or technically inadequate [P−]) and the revised anatomic indications for use (anatomically within IFU [A+] or anatomically outside of IFU [A−]) and to compare them for aneurysm-related outcomes. A logistic regression analysis was performed to identify significant predictors of sac expansion or migration. ResultsProximal and distal seal zones and low graft placement were identified by logistic regression analysis as significant predictors of sac expansion or migration. Accordingly, acquisition of ≥10-mm proximal and distal seal zones and the position of the lowest stent within 10 mm of the lowest renal artery were clinically justified as thresholds for a technically adequate procedure. Patients who did not achieve these parameters were deemed to have a technically inadequate procedure. By use of the proposed procedural adequacy criteria and established anatomic criteria, patients were stratified into four cohorts: A+/P+ (n = 77), A+/P− (n = 54), A−/P+ (n = 71), and A−/P− (n = 131). Three-year estimates of freedom from migration of 10 mm were 98.6% in A+/P+, 95.9% in A+/P−, 85.8% in A−/P+, and 80.1% in A−/P−; freedom from type IA endoleak estimates were 98.6% in A+/P+, 100% in A+/P−, 96.4% in A−/ P+, and 90.3% in A−/P− cohorts. Freedom from sac expansion and secondary intervention were 96.9% and 90.6% in A+/P+, 86.0% and 93.6% in A+/P−, 87.1% and 83.1% in A−/P+, and 80.5% and 79.8% in A−/P− groups, respectively. Two early deaths (aneurysm-related mortality) on days 4 and 12 postoperatively were reported within the A+/P− group. Kaplan-Meier estimates of freedom from all-cause mortality and aneurysm-related mortality at 3 years were similar between cohorts. ConclusionsThis post hoc analysis suggests that achieving a 10-mm proximal and distal seal with adequate positioning of the endograft with respect to the renal arteries is associated with improved patient outcomes.