Implant-related Adverse Events Research Articles

Impact of omitting the intravenous heparin bolus on outcomes of leadless pacemaker implantation.

Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear. We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion. Among 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow-up after LP implant was 14.3 (interquartile range [IQR]: 8.4-27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p = .15). Implant-related adverse events were also similar between heparin bolus and no bolus groups: access-site hematoma requiring intervention (7 vs. 5, p = .99), pseudoaneurysm (1 vs. 1, p = .99), cardiac perforation (1 vs. 1, p = .99), intraprocedural device thrombus formation (2 vs. 4, p = .41), 30-day rehospitalization (21 vs. 15, p = .98), and 30-day all-cause mortality (16 vs. 14, p = .70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p = .10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p = .52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p = .34). Long-term device performance was also similar between groups. Omission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications.

Long-term Follow-up of a Phase 1/2a Clinical Trial of a Stem Cell-Derived Bioengineered Retinal Pigment Epithelium Implant for Geographic Atrophy

PurposeTo report long-term results from a Phase 1/2a clinical trial assessment of a scaffold-based human embryonic stem cell-derived retinal pigmented epithelium (RPE) implant in subjects with advanced geographic atrophy (GA). DesignThe study was a US Food and Drug Administration (FDA)-approved single-arm, open-label Phase 1/2a clinical trial. SubjectsSubjects were between the ages of 69 and 85 at the time of enrollment and were legally blind in the treated eye (best corrected visual acuity (BCVA) of ≤ 20/200) as a result of GA involving the fovea. InterventionThe clinical trial enrolled 16 subjects, 15 of whom were successfully implanted. The implant was administered to the worse-seeing eye with the use of a custom subretinal insertion device. The companion non-implanted eye served as the control. The primary endpoint was at 1 year; thereafter subjects were followed at least yearly. Main Outcome MeasuresSafety was the primary endpoint of the study. The occurrence and frequency of adverse events were determined by scheduled eye exams, including measurement of BCVA, intraocular pressure, and multimodal imaging (fundus photography, optical coherence tomography, and fluorescein angiography). In addition, serum antibody titers were collected to monitor systemic humoral immune responses to the implant cells. ResultsAt a median follow-up of three years, fundus photography revealed no migration of the implant. There were no unanticipated, severe, implant-related adverse events throughout the follow-up period, and the most common anticipated severe adverse event (severe retinal hemorrhage) was eliminated in the second cohort (9 subjects) through the use of improved intraoperative hemostasis. Non-severe, transient retinal hemorrhages were noted either intra-op or post-op in all subjects as anticipated for a subretinal surgical procedure. Throughout the median 3-year follow-up, the results show that implanted eyes were more likely to improve by >5 letters BCVA, and less likely to decrease by >5 letters compared to non-implanted eyes. ConclusionsThis report details the long-term follow-up of the largest study of subjects with GA to receive a scaffold-based stem cell-derived bioengineered RPE implant. Results show that the implant, at a median 3-year follow-up, is safe and well-tolerated in subjects with advanced dry AMD. The safety profile, along with the early indication of efficacy, warrants further clinical evaluation of this novel approach for the treatment of GA.

Early Outcomes of an Artificial Endothelial Replacement Membrane Implantation After Failed Repeat Endothelial Keratoplasty.

The purpose of this study was to report the outcomes of a novel artificial endothelial replacement membrane implant for treating corneal edema after failed repeat endothelial keratoplasty (EK). This was a retrospective interventional case series. Patients with chronic corneal edema underwent removal of the EK graft and implantation of an artificial endothelial replacement membrane (EndoArt, EyeYon Medical, Israel) several months after 2 or more Descemet stripping endothelial keratoplasty procedures. The implant was secured to the posterior corneal surface using an air-gas bubble. Outcome measures included corrected distance visual acuity (logMAR), central corneal thickness, device-related complications, and ocular discomfort. Five eyes of 5 patients underwent EndoArt implantation. Six months after surgery, the synthetic endothelial replacement membrane was well-centered and adherent to the posterior corneal surface, with improvement in central corneal transparency in all patients. Corrected distance visual acuity increased from mean 1.26 ± 0.25 (logMAR) preoperatively to 0.74 ± 0.44 (logMAR) postoperatively (P = 0.06). Central corneal thickness significantly decreased from a mean of 805 ± 135 μm (excluding the EK graft) preoperatively to 588 ± 60 μm (excluding the EndoArt) postoperatively (P = 0.015). No severe device-related complications developed after surgery, although most patients required more than 1 air-gas bubble injection to achieve complete implant adhesion. All patients experienced preoperative reduction in subjective ocular pain. Synthetic endothelial replacement membrane implantation improves central corneal transparency and visual acuity in patients with failed EK and guarded prognosis for repeat keratoplasty. No significant implant-related adverse events occurred after surgery.

Abstract 14849: Impact of Intravenous Heparin Bolus on Outcomes of Leadless Pacemaker Implantation

Background: During Micra leadless pacemaker (LP) implantation, continuous heparin is infused to prevent thrombus within the sheath and on the device. Early guidance from the manufacturer (Medtronic) recommended an initial systemic heparin bolus to further prevent thrombus formation. However, systemic heparin may increase the risk of implant complications. Thus, many operators have moved away from routine boluses. However, there is a paucity of data on the impact of heparin bolus on outcomes. Methods: We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at the operator discretion. Results: Among 621 LP implants, 326 received a heparin bolus, 243 did not, and 52 patients had unknown bolus status. In the cohort, 50.4% were men. Mean age at implant was 76.8 ± 14.9 years. Mean follow up was 1.7 ± 1.4 years. There were no significant differences in device electrical parameters (R wave sensing, impedance, and capture thresholds), right ventricular pacing burden (RVP), or left ventricular ejection fraction (LVEF) comparing heparin bolus vs. no bolus at both initial interrogation and long-term follow up (Figure). There was no difference between groups in the number of attempted device deployments per implant procedure (1.42 ± 0.81 vs 1.31 ± 0.66, p=0.15). Implant-related adverse events were also similar between bolus and no-bolus groups: access-site hematoma (5 vs 7, p=0.99), pseudoaneurysm (1 vs 1, p=0.99), cardiac perforation (1 vs 1, p=0.99), 30-day re-hospitalization (15 vs 21, p=0.98) and 30-day all-cause mortality (14 vs 16, p=0.57). There was 1 additional non-fatal cardiac perforation in a patient with unknown bolus status. Conclusion: Routine systemic bolus of heparin can be safely omitted in appropriately selected patients undergoing LP implant. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients with high risk for thrombotic complications.

Comparing 200,000 Breast Implants and 85,000 Patients over Four National Breast Implant Registries.

Growing awareness about breast implant-related adverse events has stimulated the demand for large, independent data resources. For this, data from breast implant registries could be combined. However, that has never been achieved yet. Real-world data from four currently active national breast implant registries were used. All permanent breast implants from the Australian, Dutch, Swedish, and American registries were included. A subpopulation present across all registries between 2015 and 2018 was subsequently selected, including only permanent breast implants inserted during primary surgery for breast reconstruction or augmentation in patients without previous breast device surgery. Nationwide coverage, patient and implant characteristics, infection control measures, and revision incidences were analyzed. A total of 207,189 breast implants were registered. Nationwide coverage varied between 3% and 98%. The subpopulation included 111,590 implants (7% reconstruction, 93% augmentation). Across the registries, mean patient age varied between 41 and 49 years ( P < 0.001) for reconstruction and 31 and 36 years ( P < 0.001) for augmentation. Variation was observed in implant preferences across the countries and over the years. Infection control measures were most frequently registered in Australia. Cumulative revision incidence at 2 years ranged from 6% to 16% after reconstruction and from 1% to 4% after augmentation. For the first time, independent, national, registry-based data from four breast implant registries were combined. This is a powerful step forward in optimizing international breast implant monitoring, evidence-based decision-making, and patient safety.

Absorbable Electrospun Poly-4-hydroxybutyrate Scaffolds as a Potential Solution for Pelvic Organ Prolapse Surgery.

Women with pelvic organ prolapse (POP) have bothersome complaints that significantly affect their quality of life. While native tissue repair is associated with high recurrence rates, polypropylene knitted implants have caused specific implant-related adverse events that have detrimental, often irreversible, effects. We hypothesize that surgical outcome can be improved with a tissue-engineered solution using an absorbable implant that mimics the natural extracellular matrix (ECM) structure, releases estrogen, and activates collagen metabolism by fibroblasts as the main regulators of wound healing. To this aim, we produced electrospun poly-4-hydroxybutyrate (P4HB) scaffolds and biofunctionalized them with estradiol (E2). The cell-implant interactions relevant for POP repair were assessed by seeding primary POP vaginal fibroblasts isolated from patients on electrospun P4HB scaffolds with 1%, 2%, or 5% E2 and without E2. To test our hypothesis on whether ECM mimicking structures should improve regeneration, electrospun P4HB was compared to knitted P4HB implants. We evaluated vaginal fibroblast proliferation, ECM deposition, and metabolism by quantification of collagen, elastin, and matrix metalloproteinases and by gene expression analysis for 28 days. We established effective E2 drug loading with a steady release over time. Significantly higher cell proliferation, collagen-, and elastin deposition were observed on electrospun P4HB scaffolds as compared to knitted P4HB. For this study, physical properties of the scaffolds were more determinant on the cell response than the release of E2. These results indicate that making these electrospun P4HB scaffolds E2-releasing appears to be technically feasible. In addition, electrospun P4HB scaffolds promote the cellular response of vaginal fibroblasts and further studies are merited to assess if their use results in improved surgical outcomes in case of POP repair.

Breast Implant-Related Adverse Events During Mammography: An Assessment of the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

Adverse events arising in patients with breast implants during mammography reported by the Food and Drug Administration include implant rupture, pain, and impaired visualization. However, data supporting these claims were collected in 2004, and since, newer implant generations have been developed with overall rate of implantation increasing by 48%. This article aims to determine the current incidence of implant-related adverse events arising during mammography. We analyzed reports regarding silicone and saline breast implants published in the Food and Drug Administration Manufacturer and User Facility Device Experience database between 2008 and November 2018. Search terms included "mammogram," "mammography," "radiograph," "breast cancer screening," "breast cancer test," and "x-ray." Of the 20 539 implant-related adverse events available in the Manufacturer and User Facility Device Experience database, 427 were retrieved using our search strategy and 41 were related to mammography. Thirty-five of identified cases (85.4%) reported implant rupture, of which 19 (54.3%) were confirmed by a healthcare professional, 9 (25.7%) were clinically confirmed by saline implant deflation, and 7 (20.0%) were unverified reports by patients. Sixteen ruptures (45.7%) occurred with silicone implants, whereas 19 ruptures (54.3%) occurred with saline. Other adverse events included pain (29.3%), change in implant appearance (14.6%), and swelling (7.3%). Although implant rupture, pain, change in implant appearance, and swelling may occur, minimal implant-related adverse events arise during mammography. Given the extremely low reported risk of implant rupture, this should neither prevent patients from adhering to breast cancer screening programs nor deter patients from seeking breast implants. Patients should be aware of these reported risks and discuss screening options with their breast cancer screening team.

What Factors Affect Whether Patients Return to the Same Surgeon to Replace the Contralateral Joint? A Study of Over 200,000 Patients.

Patients with hip and knee arthritis often undergo bilateral total hip arthroplasty (THA) and total knee arthroplasty (TKA) in a staged or simultaneous fashion. However, when staged, the incidence and factors associated with having both procedures performed by the same surgeon or different surgeon are not well studied. All patients undergoing nonsimultaneous bilateral THA or TKA for osteoarthritis were abstracted from the 2010 to 2020 PearlDiver Mariner administrative database. The National Provider Identifier number was used to determine whether the same surgeon performed both surgeries. Demographics, comorbidities, and 90-day complications after the first joint replacement were assessed as possible independent predictors of utilizing a different surgeon for the contralateral joint. Of 87,593 staged bilateral THAs, the same surgeon performed 40,707 (46.5%) arthroplasties. Of 147,938 staged bilateral TKAs, the same surgeon performed 77,072 (52.1%) arthroplasties. Notably, older cohorts of patients had independent, stepwise, and significantly greater odds of changing surgeons for the contralateral THA and TKA. Those patients who were insured by Medicare and Medicaid had significantly lower odds of changing surgeons. For both THA and TKA, surgical and implant-related adverse events (surgical site infection/periprosthetic joint infection, periprosthetic fracture, dislocation, manipulation) carried the greatest odds of undergoing the contralateral replacement with a different surgeon. Patients covered by Medicaid and sicker patients were significancy less likely to switch surgeons for their contralateral THA or TKA. Additionally, patients experiencing a surgery-related adverse event within 90 days of their first THA or TKA had significantly, increased odds of switching surgeons for their subsequent TJA.

Achieving stomal continence with an ileal pouch and a percutaneous implant

In this study, a soft-tissue-anchored, percutaneous port used as a mechanical continence-preserving valve in reservoir ileo- and urostomies was functionally and morphologically evaluated in eight dogs. During follow-up, the skin failed to attach to the implant, but the intestine inside the stoma port appeared to be attached to the mesh. After reaching adequate reservoir volume, the urostomies were rendered continent by attaching a lid to the implant. The experiments were ended at different time intervals due to implant-related adverse events. In only one case did the histological evaluation reveal integration at both the implant-intestine and implant-skin interfaces, with a low degree of inflammation and the absence of bacterial colonisation. In the remaining cases, integration was not obtained and instead mucosal downgrowth and biofilm formation were observed. The skin-implant junction was characterised by the absence of direct contact between the epidermis and the implant. Varying degrees of epidermal downgrowth, granulation tissue formation, inflammatory cell infiltration and bacterial growth and biofilm formation were prominent findings. In contrast, the subcutaneously located anchor part of the titanium port was well integrated and encapsulated by fibrous tissue. These results demonstrate the opportunity to achieve integration between a soft-tissue-anchored titanium port, skin and intestine. However, predictable long-term function could not be achieved in these animal models due to implant- and non-implant-related adverse events. Unless barriers at both the implant-skin and implant-intestine junctions are created, epidermal and mucosal downward migration and biofilm formation will jeopardise implant performance.

Evaluation of Same-Day versus Next-Day Implantation of Intracanalicular Dexamethasone for the Control of Postoperative Inflammation and Pain Following Cataract Surgery.

PurposeTo evaluate the safety and efficacy of a sustained-release intracanalicular dexamethasone insert for postoperative inflammation and pain implanted in a clinical setting preoperatively or on postoperative day 1.MethodsSingle-site, retrospective, contralateral eye study of patients undergoing cataract surgery. Included were subjects with a dexamethasone intracanalicular insert implanted in the clinic immediately prior to surgery in one eye (same-day) and on postoperative day 1 (POD1) in the contralateral eye. The primary outcome measure was the resolution of anterior chamber inflammation at 1 week postoperative. Secondary outcome measures included proportion of eyes requiring additional therapy for pain and inflammation through 1 month as well as the number of eyes with IOP spikes above baseline. Safety measures included adverse events through 1 month postoperative.ResultsSixty-two eyes of 31 subjects were included in the case series. At 1 week postoperative, 52% of the eyes (n = 16) achieved complete resolution of inflammation in the same-day group and 58% (n = 18) met this endpoint at 1 week in the POD1 group. One subject in the same-day group required additional therapy for rebound inflammation and no eyes required additional therapy in the POD1 group. There were no reports of pain at 1 week or 1 month in either group. There were no implant-related adverse events in either group.ConclusionThe favorable results of this study indicate that the sustained-release dexamethasone insert can be safely implanted in the clinic either preoperatively on the day of surgery or on postoperative day 1 for the control of pain and inflammation following cataract surgery.

Improving the Management of Patients with Osteoporosis Undergoing Spinal Fusion: The Need for a Bone Mineral Density-Matched Interbody Cage

With an increasingly aging population globally, a confluence has emerged between the rising prevalence of degenerative spinal disease and osteoporosis. Fusion of the anterior spinal column remains the mainstay surgical intervention for many spinal degenerative disorders. However, decreased vertebral bone mineral density (BMD), quantitatively measured by dual x-ray absorptiometry (DXA), complicates treatment with surgical interbody fusion as weak underlying bone stock increases the risk of post-operative implant-related adverse events, including cage subsidence. There is a necessity for developing cages with advanced structural designs that incorporate bioengineering and architectural principles to tailor the interbody fusion device directly to the patient’s BMD status. Specifically, lattice-designed cages that mimic the web-like structure of native cancellous bone have demonstrated excellent resistance to post-operative subsidence. This article provides an introductory profile of a spinal interbody implant designed intentionally to simulate the lattice structure of human cancellous bone, with a similar modulus of elasticity, and specialized to match a patient’s bone status across the BMD continuum. The implant incorporates an open pore design where the degree of pore compactness directly corresponds to the patient’s DXA-defined BMD status, including patients with osteoporosis.

Fracture-related outcome study for operatively treated tibia shaft fractures (F.R.O.S.T.): registry rationale and design

BackgroundTibial shaft fractures (TSFs) are among the most common long bone injuries often resulting from high-energy trauma. To date, musculoskeletal complications such as fracture-related infection (FRI) and compromised fracture healing following fracture fixation of these injuries are still prevalent. The relatively high complication rates prove that, despite advances in modern fracture care, the management of TSFs remains a challenge even in the hands of experienced surgeons. Therefore, the Fracture-Related Outcome Study for operatively treated Tibia shaft fractures (F.R.O.S.T.) aims at creating a registry that enables data mining to gather detailed information to support future clinical decision-making regarding the management of TSF’s.MethodsThis prospective, international, multicenter, observational registry for TSFs was recently developed. Recruitment started in 2019 and is planned to take 36 months, seeking to enroll a minimum of 1000 patients. The study protocol does not influence the clinical decision-making procedure, implant choice, or surgical/imaging techniques; these are being performed as per local hospital standard of care. Data collected in this registry include injury specifics, treatment details, clinical outcomes (e.g., FRI), patient-reported outcomes, and procedure- or implant-related adverse events. The minimum follow up is 12 months.DiscussionAlthough over the past decades, multiple high-quality studies have addressed individual research questions related to the outcome of TSFs, knowledge gaps remain. The scarcity of data calls for an international high-quality, population-based registry. Creating such a database could optimize strategies intended to prevent severe musculoskeletal complications. The main purpose of the F.R.O.S.T registry is to evaluate the association between different treatment strategies and patient outcomes. It will address not only operative techniques and implant materials but also perioperative preventive measures. For the first time, data concerning systemic perioperative antibiotic prophylaxis, the influence of local antimicrobials, and timing of soft-tissue coverage will be collected at an international level and correlated with standardized outcome measures in a large prospective, multicenter, observational registry for global accessibility.Trial registrationClinicalTrials.gov: NCT03598530.

Adverse Events Involving Hallux Metatarsophalangeal Joint Implants: Comprehensive Analysis of US Food and Drug Administration Data from 2010 to 2018

Category:Midfoot/Forefoot; OtherIntroduction/Purpose:The prevalence of osteoarthritis of the hallux metatarsophalangeal joint (MTPJ) is estimated to affect 1 in 40 people over the age of 50. Surgical treatment options for MTPJ arthritis include joint preservation, joint resurfacing, and salvage arthrodesis. Arthroplasty of the great toe MTPJ has evolved over the past several decades. The aims of this study were to examine the MAUDE database to determine reported adverse events for hallux MTPJ arthroplasty.Methods:The US Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2010-2018 to determine reported adverse events for approved implants. We recorded and categorized the type of adverse event and excluded duplicate reports and those extracted from already published literature.Results:Among 64 unique hallux MTPJ implant adverse events, the most common modes of failure were component loosening (34%), component fracture (9.4%), inflammation (9.4%), infection (14.1%), and allergic reaction (7.8%). In regards to implant type, synthetic implants (Cartiva) had the highest percentage of adverse events (23.4%), followed by Arthrosurface ToeMotion (20.3%), Ascension MGT (12.5%), Arthrosurface HemiCAP (10.9%), Futura primus (9.4%), and Osteomed Reflexion (6.3%). The number of adverse events reported increased substantially after 2016.Conclusion:Our study of the MAUDE database demonstrated that component loosening and infection are the most common modes of adverse events for hallux MTPJ implants. Cartiva accounted for one-fourth of the implant-related adverse events during our study period, followed by ToeMotion and Ascension MGT implants. Given that the adverse events for hallux MTPJ implants are underreported, improved reporting mechanisms should be utilized to improve our understanding on long-term effects of various hallux MTPJ implants.

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.

Treating Symptomatic Midvault Soft Tissue Collapse in Revision Rhinoplasty with a Nasal Wall Implant.

Summary:Persistent nasal airway obstruction (NAO) due to midvault soft tissue collapse in patients following rhinoplasty or nasal surgery is a clinical challenge for surgeons. An absorbable lateral nasal wall implant is one option available to help treat midvault soft tissue collapse and to improve NAO symptoms. Previous studies have not investigated its use in complex revision functional rhinoplasty with respect to patient-reported outcomes. Data were collected on all patients with a history of previous nasal procedures who underwent Latera implant placement in conjunction with functional rhinoplasty from January to December 2018. The Nasal Obstructive Symptom Evaluation and Visual Analogue Scale were used to evaluate functional outcomes. Eight implants were placed in 6 revision functional rhinoplasty patients with midvault collapse. All patients responded to the survey. Mean follow-up was 16 ± 4 months. There were no implant-related adverse events. Mean Nasal Obstructive Symptom Evaluation score was 33 ± 33, and mean Visual Analogue Scale score was 20 ± 9. In total, 1 patient reported complete resolution of NAO, whereas 2 patients reported mild, 1 reported moderate, 1 reported severe, and 1 reported extreme symptoms. Four of the 6 patients reported nasal obstruction improvement, with all reporting improvement in midvault soft tissue collapse. Apart from being used in nasal valve collapse treatment, a lateral nasal wall implant is a potentially useful solution that may help surgeons improve patients’ NAO symptoms in complex functional rhinoplasty cases. However, in certain cases, a patient’s nasal obstructive symptoms may continue to be multifactorial.

Adverse events involving hallux metatarsophalangeal joint implants: Analysis of the United States Food and Drug Administration data from 2010 to 2018

BackgroundThe prevalence of osteoarthritis of the hallux metatarsophalangeal joint (MTPJ) is 1 in 40 people over the age of 50. Surgical treatment options for MTPJ arthritis include joint preservation, joint resurfacing, and arthrodesis. Hallux MTPJ implants have evolved over the past several decades, but are associated with various complications. The aim of this study was to examine the MAUDE database to determine reported adverse events for hallux MTPJ implants. Materials and methodsThe US Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2010 to 2018 to review voluntary reported adverse event reports for approved implants within the United States. We recorded the type of adverse event and excluded duplicate reports and those extracted from already published literature. ResultsAmong 64 reported hallux MTPJ implant adverse events, the most common modes of adverse events were component loosening (34%), infection (14.1%), component fracture (9.4%), inflammation (9.4%), and allergic reaction (7.8%). Regarding implant type, Cartiva SCI had the highest percentage of adverse events (23.4%), followed by Arthrosurface ToeMotion (20.3%), Ascension MGT (12.5%), Arthrosurface HemiCAP® (10.9%), Futura primus (9.4%), and Osteomed Reflexion (6.3%). There was an increase in reported adverse events after 2016. The MAUDE database does not report the total incidence of implant insertion. ConclusionOur study of the MAUDE database demonstrated that component loosening and infection are the most common modes of adverse events for hallux MTPJ implants. Cartiva accounted for one-fourth of the implant-related adverse events during our study period, followed by ToeMotion, and Ascension MGT implants. Continued reporting of adverse events will improve our understanding on short and long-term complications of various hallux MTPJ implants. Level of evidenceLevel IV; Case Series from Large Database Analysis; Treatment Study.

Occurrence and clinical implications of heterotopic ossification after cervical disc arthroplasty with the Prestige LP Cervical Disc at 2 contiguous levels.

The authors sought to assess the impact of heterotopic ossification (HO) on clinical outcomes and angular range of motion (ROM) after cervical disc arthroplasty (CDA) performed with the Prestige LP Cervical Disc (Prestige LP disc) at 2 levels. HO was assessed and graded from 0 to IV for increasing severity on lateral neutral radiographs at each visit in 209 patients who underwent implantation of Prestige LP discs at 2 cervical levels in a clinical trial with extended 10-year follow-up. ROM was compared by using HO grade, and clinical outcomes were compared between HO subgroups (grade 0-II vs III/IV) based on HO severity at 2 and 10 years after surgery. The grade III/IV HO incidence at either or both index levels was 24.2% (48/198) at 2 years and 39.0% (57/146) at 10 years. No statistical difference was found in overall success; neurological success; or Neck Disability Index (NDI), neck pain, arm pain, or SF-36 Physical Component Summary (PCS) scores between the HO subgroups (grade 0-II vs III/IV) at either 2 or 10 years. The cumulative rate of possible implant-related adverse events (AEs) was higher in patients having grade III/IV HO at 2 years (56.3%) and 10 years (47.8%) compared with those having grade 0-II HO at 2 years (24.4%) and 10 years (17.9%), specifically in 2 subcategories: spinal events and HOs reported by the investigators. No statistical difference was found between the HO subgroups in possible implant-related serious AEs or secondary surgeries at the index or adjacent levels. The average angular ROMs at index levels were lower in subjects with higher-grade HO at 2 and 10 years. The average ROMs at the superior level were 8.8°, 6.6°, 3.2°, and 0.3°, respectively, for the HO grade 0/I, II, III, and IV groups at 10 years, and 7.9°, 6.2°, 3.7°, and 0.6°, respectively, at the inferior level. Radiographically severe (grade III or IV) HO after CDA with the Prestige LP disc at 2 levels did not significantly affect efficacy or safety outcomes (severe AEs or secondary surgeries). However, severe HO, particularly grade IV HO, significantly limited ROM, as expected.

Intramedullary nailing as a safe and efficient treatment option for all types of displaced proximal humeral fractures in geriatric patients: A retrospective evaluation of 49 patients treated with the new Targon PH+ nail.

Implant specific complications and outcome for the use of proximal humeral nails in different fracture types are not well described. Evaluation of adverse effects and outcome of patients treated with the new Targon PH+ implant for proximal humeral fractures in a geriatric population. A consecutive series of patients from a single institution was retrospectively evaluated. Adverse events (AE) were assessed from patients' files and during follow-up examination. Current pain level was evaluated using the Visual Analogue Scale (VAS). The disability score of arm, shoulder and hand (DASH) as well as the Constant-Murley score were assessed. Patient satisfaction was evaluated by questionnaire. Forty-nine patients with a mean age of 72.0 ± 10.0 years were included with a follow-up of 2.2 years. Five patients showed twopart fractures (10%), 24 threepart fractures (50%) and 20 fourpart fractures (40%). Additional shaft fracture occurred in twelve cases (24%). Implant-related AE were recorded in six cases (12%). Pain under strain was moderate with a mean of 27.6 ± 27.1 mm. DASH score showed a mean of 25.9 ± 24.9. Constant score of the affected shoulder was 57 ± 23.8 with a mean difference of 16 points compared to reference shoulder. No significant differences in AE, VAS, DASH or Constant score could be found according to fracture groups. Most patients were satisfied with the surgical outcome (84%). The Targon PH+ nail demonstrated good functional results and low adverse events in geriatric patients. Additional studies including less experienced centres are required to further evaluate the possible benefits of this implant.

One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: Outcomes Up to 7 Years.

Anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) have been used to treat degenerative disc disease at single as well as multiple cervical levels. This study compares the safety and efficacy of 1-level versus 2-level CDA and ACDF. In total, 545 and 397 patients with degenerative disc disease were studied in 1-level and 2-level Food and Drug Administration (FDA)-approved clinical trials, respectively: CDA (n = 280 and 209), ACDF (n = 265 and 188). Data from these studies were used to compare 1- versus 2-level procedures: the propensity score method was used to adjust for potential confounding effects, and adjusted mean outcome safety and efficacy scores at 2 and 7 years postsurgery were compared between 1-level and 2-level procedures within treatment type. One-level and 2-level procedures had similar rates of improvement in overall success and patient-reported outcomes scores for both CDA and ACDF. There were no statistical differences in rates of implant-related adverse events (AEs) or serious implant-related AEs between 1-level and 2-level CDA. The 7-year rate of implant-related AEs was higher for 2-level than 1-level ACDF (27.7% vs 18.9%, P ≤ .036), though the rates of serious implant-related AEs between ACDF groups did not differ significantly. Secondary surgery rates were not statistically different between 1-level and 2-level procedures (CDA or ACDF) at the index or adjacent levels at 2 or 7 years. Grade IV heterotopic ossification at 7 years was reported in 4.6% of 1-level CDA patients and 8.6%/7.3% at the superior/inferior levels, respectively, of 2-level CDA patients. One- and 2-level CDA appear equally safe and effective in the treatment of cervical degenerative disc disease. Two-level ACDF appears to be as effective as 1-level ACDF but with a higher rate of some AEs at long-term follow-up. 2. clinicaltrials.gov: NCT00667459, NCT00642876, and NCT00637156.

Bioresorbable Scaffold-Based Controlled Drug Delivery for Restenosis.

Bioresorbable scaffolds have emerged as a potential alternative to non-erodible metal implants to alleviate the long-term risk of permanent device vascular implant-related adverse events. Bioresorbable scaffolds provide a temporary mechanical support function until the vessel reaches complete healing, and the implant progressively disappears and vasomotion resumes. A polymer matrix with embedded drugs coated onto the scaffold surface degrades slowly, reducing the size from the exterior toward the interior, and this allows controlled drug release to a local vascular segment. Drug elution from a bioresorbable scaffold system is characterized by a rapid initial release that achieves high concentration along the intimal surface, which is designed to prevail vascular dilation-induced injury and formation of neointimal hyperplasia. This review highlights diverse types of bioresorbable biomaterials as vascular scaffolds, drug release kinetics, adaptive arterial wall remodeling, and complexities in the advancement of vascular scaffolds to treat restenosis.