Search

Objective: Owing to the ageing population the implantation rate of total knee arthroplasty (TKA) continues to rise. Aseptic revisions in primary TKA are one of the main causes of revision. The aim of the following study was to determine the incidence of and reasons for aseptic revision in constrained and unconstrained TKA and in unicondylar knee arthroplasty (UKA)., Methods: The data collection was carried out with the help of the German Arthroplasty Register (EPRD). The reasons for aseptic revision surgery were worked out using this. The incidence and the comparison of aseptic revisions were analysed with the aid of Kaplan-Meier estimates. A multiple Chi-squared test with the Holm method was used to identify group differences in collateral ligament deficiencies., Results: In total, 300,998 cases of knee arthroplasties were analysed, of which 254,144 (84.4%) were unconstrained TKA, 9993 (3.3%) were constrained TKA and 36,861 (12.3%) were UKA. The rate of aseptic revisions was significantly increased compared with unconstrained and constrained TKA (p < 0.0001). In constrained TKA, a revision rate of 2.0% for aseptic reasons was reported, whereas in unconstrained TKA 1.1% and in UKA 2.7% revision surgeries were identified. After 7 years the rates of aseptic revisions amounted to 3.3% for constrained TKA, 2.8% for unconstrained TKA and 7.8% for UKA. Ligament instability was the most common cause of aseptic revisions and accounted for 13.7% of unconstrained TKA. In constrained TKA ligament instability led to a revision in 2.8% of cases. In UKA, tibial loosening was identified to be the most common cause of revisions at 14.6%, whereas the progression of osteoarthritis was responsible for 7.9% of revisions. Ligament instability was observed in 14.1% of men compared with 15.9% of women in unconstrained TKA and in UKA in 4.6% of cases for both sexes., Conclusion: In patients with UKA the rates of aseptic revision are significantly higher than in unconstrained and constrained TKA. Ligament instability was the most common cause of aseptic revision in unconstrained TKA. In UKA, tibial loosening was the most common cause of revision surgery, whereas the progression of osteoarthritis was the second most common cause. Comparable levels of ligament instability were observed in both sexes., Level of Evidence:  III, cohort study., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Purpose: Due to ageing population, the implantation rate of total knee arthroplasties (TKAs) is continuously growing. Aseptic revisions in primary knee arthroplasty are a major cause of revision. The aim of the following study was to determinate the incidence and reasons of aseptic revisions in constrained and unconstrained TKA, as well as in unicondylar knee arthroplasties (UKAs)., Methods: Data collection was performed using the German Arthroplasty Registry. Reasons for aseptic revisions were calculated. Incidence and comparison of aseptic revisions were analysed using Kaplan-Meier estimates. A multiple χ 2 test with Holm's method was used to detect group differences in ligament ruptures., Results: Overall, 300,998 cases of knee arthroplasty with 254,144 (84.4%) unconstrained TKA, 9993 (3.3%) constrained TKA and 36,861 (12.3%) UKA were analysed. Aseptic revision rate in UKA was significantly increased compared to unconstrained and constrained TKA (p < 0.0001). In constrained TKA, a 2.0% revision rate for aseptic reasons were reported after 1 year, while in unconstrained TKA 1.1% and in UKA, 2.7% of revisions were identified. After 7 years in constrained TKA 3.3%, in unconstrained TKA 2.8%, and in UKA 7.8% sustained aseptic revision. Ligament instability was the leading cause of aseptic revision accounting for 13.7% in unconstrained TKA. In constrained TKA, 2.8% resulted in a revision due to ligament instability. In the UKA, the most frequent cause of revisions was tibial loosening, accounting for 14.6% of cases, while progression of osteoarthritis accounted for 7.9% of revisions. Ligament instability was observed in 14.1% of males compared to 15.9% of females in unconstrained TKA and in 4.6% in both genders in UKA., Conclusion: In patients with UKA, aseptic revision rates are significantly higher compared to unconstrained and constrained TKA. Ligament instability was the leading cause of aseptic revision in unconstrained TKA. In UKA, the most frequent cause of revisions was tibial loosening, while progression of osteoarthritis was the second most frequent cause of revisions. Comparable levels of ligament instability were observed in both sexes., Level of Evidence: Level III, cohort study., (© 2024 The Authors. Knee Surgery, Sports Traumatology, Arthroscopy published by John Wiley & Sons Ltd on behalf of European Society of Sports Traumatology, Knee Surgery and Arthroscopy.)

Introduction: The rate of revision TKA and thus the use of hinged implants (HI) steadily rises. Aseptic loosening lies on the top of the failure patterns. However, no evidence exists until now based on national scale high-caseloads that analyzes the impact of cemented HI stem-design on aseptic survival rates., Methods: Data on aseptic HI-revisions with full-cemented tibia-stems were conducted from the German Arthroplasty Registry. Cases were divided in primary HI (PHI) and HI used in revision operations (RHI). Endpoint was a new revision following either a PHI or an RHI. The impact of stem conicity (conical vs. cylindrical), diameter (≤ 13 mm vs. > 13 mm), length (≤ 90 mm vs. > 90 mm) and offset on the 6-Year-Cumulative-Aseptic-Revision-Rate (6Y-CARR) was estimated via Kaplan-Meier curve and compared between groups via Log-Rank-Tests., Results: 3953 PHI and 2032 RHI fulfilled inclusion-criteria. Stem conicity had no impact on 6Y-CARR (p = 0.08 and p = 0.8). Diameter > 13 mm hat an impact on PHI (p = 0.05) with lower 6Y-CARR but not on RHI (p = 0.2). Length > 90 mm showed significantly worst 6Y-CARR in PHI (p = 0.0001) but not in RHI (p = 0.3). Offset-stems showed significantly better 6Y-CARR in PHI (p = 0.04), but not in RHI (p = 0.7)., Conclusion: There was no significant impact of the cemented tibia-stem conicity on 6Y-CARR, neither in PHI nor in RHI. The effect of length, diameter and offset on the 6Y-CARR observed in the PHI, was not detectable in the more complex RHI-cases reflecting its limited clinical relevance by itself in more multifactorial backgrounds. Therefore, results must be interpreted with caution due to considerable system-effects and different utilization-scenarios., (© 2024. The Author(s).)

Background: Hip arthroplasties and revision procedures will continue to rise over the next decades. In 2020 in Germany, 75% of all revision surgeries involved an exchange of at least one component; exchanges of all components were carried out in 27.5% of the revisions. The most common failure modes were aseptic loosening, infections, periprosthetic fractures, instabilities, and metal-related pathologies., Indications: Aseptic loosening remains the most common reason for revision. However, the indications for hip arthroplasty revisions have changed over time, with a decrease in revisions due to aseptic loosening and an increase in revisions due to infection and periprosthetic fracture. The rate of dislocations remained approximately constant over the past decade, with international differences. Metal-associated pathologies will continue to play a significant role in revision hip arthroplasty., (© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: Proximal aortic neck dilatation (PND) affects a considerable proportion of patients undergoing endovascular aneurysm repair (EVAR) and is associated with increased rates of type I endoleak (EL1), migration, and reinterventions. Although there are numerous studies investigating PND following the placement of endografts that utilize self-expanding stent (SES) technology, there are few reports for patients treated with endografts that utilize polymer-filled rings. The purpose of this study is to examine PND and graft migration after EVAR with the Ovation stent graft., Methods: The study comprised patients who underwent EVAR as part of the prospective, international, multicenter Ovation stent graft trial. A clinical events committee adjudicated adverse events through 1 year, an independent imaging core laboratory analyzed imaging through 5 years, and a data safety and monitoring board provided study oversight. Neck diameter was measured at the level of the lowest renal artery. PND was defined as neck enlargement of 3 mm or more. Graft migration was defined as distal movement >10 mm or movement ≤10 mm when resulting in secondary intervention., Results: A total of 238 patients received this device during the study period. Patients were predominantly male (81%), with a mean age of 73 ± 8 years. Median follow-up was 58 months (IQR 36-60). Almost half the patients (110 patients, 46%) had challenging anatomy; defined as outside the instructions for use (IFU) with other commercially available stent grafts. 41 patients (17.2%) had a proximal neck length <10 mm and 93 (39%) had a minimum access vessel diameter <6 mm. The technical success rate was 100%. The 1-, 3- and 5-year overall survival rates were 96.6%, 86.2% and 74.9%, respectively. The immediate postoperative proximal neck diameter ranged from 16 mm to 31 mm with a mean of 22.4 ± 3 mm. During follow-up, ten patients (4.2%) developed PND. Freedom from PND estimates at 1, 3 and 5 years were 97.7%, 96%, and 93.6%, respectively. None of the patients developed endograft migration., Conclusions: The use of the Ovation stent graft was associated with low rates of PND despite challenging neck anatomy in 17% of patients. No graft migration was observed. The design of this endograft may explain its superiority to SES in preventing neck dilatation and migration even in patients with challenging neck anatomy. This is important, as we continue to see significant late failures of EVAR due to proximal neck degeneration., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: We have reported the short-term outcomes regarding the safety of the off-the-shelf Zenith t-Branch multibranched thoracoabdominal stent-graft (William Cook Europe ApS, Bjaeverskov, Denmark) in a postmarket, multicenter study., Methods: Patients who had been treated with the t-Branch device from September 2012 to November 2017 at three European centers were either prospectively or retrospectively enrolled in the present study. Device implantation and postprocedural follow-up were performed according to the standard of care at each center. The primary objectives of the present study were to assess the procedure-related mortality and morbidity at 30 days and 1 year and to assess the presence of endoleaks, device integrity, and stent-graft and branch vessel patency., Results: A total of 80 patients were included in the present study (mean age, 71.0 ± 7.4 years; 70.0% male). Most (n = 77) had been treated for thoracoabdominal aortic aneurysms (TAAAs) and the rest for dissection (n = 3). Most TAAAs were stable (72.7%; 56 of 77). The remaining TAAAs were symptomatic (7.8%; 6 of 77) or had a contained rupture (19.5%; 15 of 77). The t-Branch device was successfully deployed in 79 patients. In one patient, the delivery system of the device could not be advanced through the iliac artery. Within 30 days, one patient had died (1.3%). At 1 year, seven patients had died (8.8%), and no aortic rupture or conversion to open surgery had been reported. The 30-day neurologic events included stroke in three patients (3.8%), paraplegia in one (1.3%), and paraparesis in six patients (7.5%). Secondary interventions were required in nine patients (11.3%) during follow-up. Postoperative endoleaks were observed in 37 of 72 patients (51.4%), including type II endoleak in 30, type Ia in 4, and type III endoleak in 6 patients. At 1 year, endoleaks had been reported in 20 patients (16 with type II and 4 with type III). The t-Branch main body graft patency was 100% throughout the 1-year follow-up period. At 30 days after the procedure, all celiac and superior mesenteric artery branches were patent and one left renal and one right renal branch were occluded. At 1 year, occlusion had developed in three bridging stent-grafts for the celiac artery, one for the left renal artery, and two for the right renal artery., Conclusions: The t-Branch device appears safe, with good 30-day and 1-year mortality and morbidity in the present study, including both stable and symptomatic cases., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Short-stemmed total hip arthroplasty (THA) is well established and gaining popularity in Germany. The perception that short stems may predispose to primary instability in the femur has resulted in a more thorough follow-up of younger patient cohorts than the typical uncemented THA population. To address this issue, an evidence-based approach is presented for a retrospective mid-term survival analysis of a large registry-based cohort in primary cementless THA comparing short stems with a matched group of conventional stems., Material and Methods: Propensity score matching (PSM, see Infobox 1) was used on 131,580 primary cementless THAs fulfilling the inclusion criteria performed between November 2012 and September 2019 and the cumulative probability of revision (CPR) of short and conventional stems for any reason, for reasons excluding prosthetic joint infection (PJI), and due to PJI were compared., Results: After PSM at 1:1 balanced groups of 17,526 short stems and of 17,526 conventional stems were achieved demonstrating no significant difference for CPR for any reason and for reasons excluding PJI. Matched CPR for any reason was 2.9% (95% confidence interval, CI, 2.4-3.5%) 5 years after primary THA in the short stem and 3.1% (95% CI 2.7-3.4%) in the conventional stem group. The CPR excluding PJI was 2.2% (95% CI 1.7-2.7%) vs. 2.1% (95% CI 1.8-2.4%). In contrast, the incidence of PJI was statistically significant lower for short stems., Conclusion: For the considered period, there was no statistically significant survival difference in uncemented THA between comparison groups but a lower incidence for PJI in short-stem THA. Further analyses of registry data are required to rule out range of indications and late mechanical failure of short stems.

Introduction: Articular surface replacement (ASR) XL implants exhibit higher-than-expected revision rates, blood ion concentrations and soft tissue lesions, making revisions troublesome and potentially unsatisfying. Appropriate techniques and outcomes in ASR XL revisions are rarely documented. The aims of this study were the assessments of pre-revision data, post-revision clinical and radiographic outcomes and ion levels in isolated acetabular ASR XL revisions performed using highly porous titanium cups and Delta ceramic articulations., Methods: 18 isolated acetabular ASR XL revisions in 16 patients were performed using Ti-Por cups (Adler Ortho, Milan, Italy) and Delta bearings (CeramTec, Plochingen, Germany). Pre-revision demographic, clinical, radiological and implant-related features were assessed. Clinical and radiographic parameters (cup positioning, osseointegration) after revisions were evaluated at a minimum follow-up of 5 years. Ion concentrations in blood and urine were collected in pre-revision setting and 1 year after revision., Results: 4 complications occurred in 3 different revisions (16.7%), 1 dislocation, 2 infections, 1 psoas impingement. No re-revision was performed at 5 years (1 scheduled arthroscopy). Good clinical outcomes were achieved (HHS score: 88.3 ± 9.2). All the cups showed reassuring signs of osseointegration (>3 parameters). Blood ion concentrations significantly decreased: patients with Co blood ion concentration over the threshold (7 μg/l) decreased from 76.5% to 0%. No pre-revision or intraoperative data influenced the revision outcomes., Conclusions: Highly porous titanium cups and Delta ceramic articulations provided reliable mid-term clinical and radiographic outcomes in isolated acetabular ASR XL revisions. Ion concentrations significantly decreased. Multicentre prospective controlled studies are required to confirm these preliminary outcomes.

Background: Dual-mobility cups have been shown to reduce the dislocation risk after THA. Although dual-mobility cups can be a useful strategy to mitigate against recurrent dislocation after revision surgery, few clinical studies have focused on the results of complex revision THAs with extensive bone and soft-tissue loss or in patients who have undergone more than one previous surgical procedure., Questions/purposes: (1) What is the survival free from revision for dislocation of dual-mobility cups used in complex revision THAs? (2) What is the survival free from any dislocation?, Methods: Between January 1, 2009 and December 31, 2013, 327 patients underwent a complex revision THA that included an acetabular revision, defined as preexisting massive bone loss in the acetabulum (at least Paprosky Type 2B) and/or proximal femur (at least Paprosky Type 3), substantial gluteal soft-tissue involvement, at least two previous surgical procedures or a one-stage septic revision, or history of dislocation. All 327 complex revision patients received a dual-mobility cup. Of those, 34% (111) were lost to follow-up before 5 years and were not known to have reached a study endpoint (revision for dislocation, and any dislocation) before then, leaving 216 patients for analysis. For patients with bilateral hip surgeries only the first operated hip was included for analysis. The median (range) follow-up duration was 69 months (60 to 110). The primary endpoint was dislocation or re-revision for dislocation. Fifty-six percent (120 of 216) of the patients were women and 44% (96 of 216) were men. The mean age of the patients was 69 ± 9 years. The patients underwent a median of four surgical procedures (1 to 4) before the index procedure (the revision evaluated in this study). A survival analysis was performed using the Kaplan-Meier method; any dislocation or revision for dislocation was determined as the endpoint., Results: The dislocation-free survival rates were 96% (95% confidence interval 92 to 98) at 5 years and 82% (95% CI 72 to 89) at 9 years. The overall dislocation rate was 11% (24 of 216 patients) at the final follow-up interval. Survival free of revision for dislocation was 99% (95% CI 96 to 100) at 5 years and 85% (95% CI 75 to 92) at 9 years., Conclusions: Dual-mobility cups used in complex revision THA in this series had a higher rate of dislocation and revision than expected, based on earlier studies of dislocations of these components. Although we believe dual-mobility cups are still the first choice of implant if the patient has instability, these cups should be used cautiously if severe bone loss or soft-tissue involvement is present., Level of Evidence: Level III, therapeutic study., Competing Interests: All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2020 by the Association of Bone and Joint Surgeons.)

Background: Progressive oxidation of highly cross-linked ultra-high molecular weight (UHMPWE-X) liners is considered to be a risk factor for material failure in THA. Antioxidants such as vitamin E (alpha-tocopherol) (UHMWPE-XE) were supplemented into the latest generation of polyethylene liners. To prevent inhomogenous vitamin E distribution within the polymer, blending was established as an alternative manufacturing process to diffusion. The purpose of the present study was to investigate the in vivo wear behavior of UHMWPE-XE in comparison with conventional UHMWPE-X liners using virtual CAD-based radiographs., Methods: Until now, 94 patients from a prospective, randomized, controlled, multicenter study were reviewed at 5-year follow-up. Of these, 51 (54%) received UHMWPE-XE and 43 (46%) UHMWPE-X liners. Anteroposterior pelvic radiographs were made immediately after surgery and at 1 and 5 years postoperatively. The radiographs were analyzed using the observer-independent analysis software RayMatch ® (Raylytic GmbH, Leipzig, Germany)., Results: The mean wear rate was measured to be 23.6 μm/year (SD 13.7; range 0.7-71.8 μm). There were no significant differences between the two cohorts (UHMWPE-X: 23.2 μm/year vs. UHMWPE-XE: 24.0 μm/year, p = 0.73). Cup anteversion significantly changed within the 1st year after implantation independent from the type of polyethylene liner [UHMWPE-X: 18.2-23.9° (p = 0.0001); UHMWPE-XE: 21.0-25.5° (p = 0.002)]. No further significant changes of cup anteversion in both groups were found between year 1 and 5 after implantation [UHMWPE-X (p = 0.46); UHMWPE-XE (p = 0.56)]., Conclusion: The present study demonstrates that the addition of vitamin E does not adversely affect the midterm wear behavior of UHMWPE-X. The antioxidative benefit of vitamin E is expected to become evident in long-term follow-up. Cup anteversion increment by 5° within the 1st year is likely a result of the released hip flexion contracture resulting in an enhanced posterior pelvic tilt. Therefore, a reassessment of target values in acetabular cup placement might be considered.

Background: Instability and dislocation after total hip arthroplasty (THA) is a common reason for revision surgery. THA head-neck adapters promise the reconstruction of optimal femoral offset and leg length in revision THA (rTHA) while retaining stable implants. The aim of this retrospective multi-centre study is to report on the results achieved with the use of head adapters in partial rTHA, to avoid the instability of the implant., Methods: 55 cases of partial rTHA performed between February 2015 and April 2017 in 3 different hospitals using the Bioball Head Adapter (BHA) (Bioball Merete, Medical GmbH, Berlin, Germany) were retrospectively recorded. All patients were evaluated from a radiological point of view at an average follow-up of 3.5 years. Failure was defined as re-revision surgery for any cause as well as a subjective feeling of instability of the joint., Results: One failure was registered in an extreme case and radiological findings show no suggestive signs of radiolucencies or loosening and therefore all implants have been considered stable., Conclusions: Despite some limitations of this retrospective study and according to the relevant literature, our data confirms that BHA is a safe system that allows the flexibility to restore femoral offset and version, to adjust leg length, to minimise instability, to avoid unnecessary removal of otherwise well-fixed components thus improving tribology and reducing the risk of taper junction issues without major complications in partial rTHA.

Background As transcatheter aortic valve replacement (TAVR) is expected to progress into younger patient populations, valve-in-TAVR (ViTAVR) may become a frequent consideration. Data on ViTAVR, however, are limited. This study investigated the outcome of ViTAVR in comparison to valve in surgical aortic valve replacement (ViSAVR), because ViSAVR is an established procedure for higher-risk patients requiring repeated aortic valve intervention. Methods and Results Clinical and procedural data of patients who underwent ViTAVR at 3 sites in the United States and Germany were retrospectively compared with data of patients who underwent ViSAVR at Cedars-Sinai Medical Center, according to Valve Academic Research Consortium-2 criteria. A total of 99 consecutive patients, 52.5% women, with a median Society of Thoracic Surgeons score of 7.2 were identified. Seventy-four patients (74.7%) underwent ViSAVR, and 25 patients (25.3%) underwent ViTAVR. Balloon-expandable devices were used in 72.7%. ViSAVR patients presented with smaller index devices (21.0 versus 26.0 mm median true internal diameter; P <0.001). Significantly better postprocedural hemodynamics (median prosthesis mean gradient, 12.5 [interquartile range, 8.8-16.2] versus 16.0 [interquartile range, 13.0-20.5] mm Hg; P =0.045) were observed for ViTAVR compared with the ViSAVR. Device success, however, was not different (79.2% and 66.2% for ViTAVR and ViSAVR, respectively; P =0.35), as were rates of permanent pacemaker implantation (16.7% versus 5.4%; P =0.1). One-year-mortality was 9.4% and 13.4% for ViTAVR and ViSAVR, respectively (log-rank P =0.38). Conclusions Compared with ViSAVR, ViTAVR provides acceptable outcomes, with slightly better hemodynamics, similar device success rates, and similar 1-year mortality.

Background: Percutaneous pulmonary valve implantation (PPVI) has become an important treatment of right ventricular outflow tract dysfunction. Studies directly comparing the long-term outcome of PPVI with the Melody valve to surgical pulmonary valve replacement (SPVR) are lacking., Methods: All patients treated with PPVI with the Melody valve and SPVR between January 2006 and December 2018 in our center were enrolled into a database and investigated with a standard follow-up protocol. The current study compares the outcomes in means of survival, reinterventions, infectious endocarditis, and performance of the valves., Results: The study included 452 patients, of whom 241 were treated with PPVI with the Melody valve and 211 patients with SPVR with different types of valves. Median follow-up time was 5.4 years (3 months to 12.5 years), and the total observation was 2449 patient-years. Estimated survival after 10 years was 94% in the Melody group and 92% in the SPVR group ( P =0.47). There was no difference in the estimated survival free of surgery on the implanted valve at 10 years (Melody, 87%, versus SPVR, 87%; P =0.54) or in the survival with the originally implanted pulmonary valve (Melody group, 80%; SPVR group, 73%; P =0.46) between both groups. The annualized incidence of infective endocarditis was 1.6% in the Melody group and 0.5% in the SPVR group, and the estimated survival free of endocarditis did not differ significantly between groups (Melody group, 82%; SPVR group, 86%; P =0.082). Survival free of valve replacement because of infective endocarditis was comparable between both groups (Melody, 88%; SPVR, 88%; P =0.35)., Conclusions: PPVI with the Melody valve and SPVR provides similar survival, freedom of reinterventions, and infective endocarditis with or without the need of replacement of the pulmonary valve. Being less invasive, PPVI should be considered a method for treatment for patients with dysfunctional right ventricular outflow tracts.

Objectives: The purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years., Background: The CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV., Methods: The CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability., Results: After 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cm 2 vs. 1.9 ± 0.5 cm 2 ; p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in 7 BE patients (7.3%) and 1 SE patient (0.8%; p = 0.06), and moderate or severe structural valve deterioration in 6 BE patients (6.6%) and no SE patient (0%; p = 0.018). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%; p = 0.63)., Conclusions: Five-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: We evaluated a large database with mechanical failure of a single uncemented modular femoral component, used in revision hip arthroplasty, as the end point and compared them to a control group treated with the same implant. Patient- and implant-specific risk factors for implant failure were analyzed., Methods: All cases of a fractured uncemented modular revision femoral component from one manufacturer until April 2017 were identified and the total number of implants sold until April 2017 was used to calculate the fracture rate. The manufacturer provided data on patient demographics, time to failure, and implant details for all notified fractured devices. Patient- and implant-specific risk factors were evaluated using a logistic regression model with multiple imputations and compared to data from a previously published reference group, where no fractures had been observed. The results of a retrieval analysis of the fractured implants, performed by the manufacturer, were available for evaluation., Results: There were 113 recorded cases with fracture at the modular junction, resulting in a calculated fracture rate of 0.30% (113/37,600). The fracture rate of the implant without signs of improper use was 0.11% (41/37,600). In 79% (89/113) of cases with a failed implant, either a lateralized (high offset) neck segment, an extralong head, or the combination of both were used. Logistic regression analysis revealed male sex, high body mass index (BMI), straight component design, and small neck segments were significant risk factors for failure. Investigation of the implants (76/113) showed at least one sign of improper use in 72 cases., Conclusion: Implant failure at the modular junction is associated with patient- and implant-specific risk factors as well as technical errors during implantation. Whenever possible, the use of short and lateralized neck segments should be avoided with this revision system. Implantation instructions and contraindications need to be adhered to and respected. Cite this article: Bone Joint J 2020;102-B(5):573-579.

This study aimed to investigate the rate of severe structural valve deterioration (SVD) and long-term outcomes of patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). Propensity score matched analysis of patients who underwent TAVI (n = 216) and SAVR (n = 216) between 2008 and 2012. Long-term echocardiographic parameters and clinical outcomes were assessed after more than 6 years after TAVI/SAVR. Rate of severe SVD was 10.5% versus 4.5% in the TAVI and SAVR groups, respectively, but the difference was not statistically significant (hazard ratio [HR] 2.5; 95% confidence interval [CI] 0.7 to 8.3; p = 0.159). This was largely driven by higher rates of mean transprosthetic gradient ≥40 mm Hg (7.0 vs 3.4%; p = 0.327) and aortic regurgitation (4.7% vs 0%; p = 0.058). TAVI patients had lower survival rates at 6 years than SAVR patients (40.7% vs 59.6%, respectively, p <0.001, HR 2.15; 95% CI 1.45 to 3.20). Rate of cardiovascular events (14.4% TAVI vs 18.2% SAVR, HR 0.8; 95% CI 0.4 to 1.3; p = 0.347) and permanent pacemaker implantation (PPI; 16.0% TAVI vs 9.2% SAVR, p = 0.234) was similar between the 2 groups. In conclusion, incidence of moderate and severe SVD was not statistically different between TAVI and SAVR. Rate of moderate or severe aortic regurgitation was significantly higher in the TAVI group with predominant use of first-generation valves. Reintervention rate was low in both groups. Survival rate was lower after TAVI, probably because of higher frailty index, but incidence of cardiovascular events, PPI, and SVD was similar in both groups., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Introduction: Patients with diabetes mellitus are known to carry an increased risk for surgical site infections and perioperative complications. The subcutaneous implantable cardioverter defibrillator is an established treatment option in patients at risk for sudden cardiac death especially with an increased risk for infection over time., Methods and Results: Forty-eight patients (mean age = 55.0 ± 21.3 years, 31.3% patients with diabetes mellitus, 75% male) who underwent consecutive subcutaneous implantable cardioverter defibrillator surgery between February 2016 and May 2019 were retrospectively analysed. Overall adverse events including relevant bleeding complications, any surgical wound problems and infections requiring reoperation or device malfunction were evaluated as primary combined safety endpoint. Patients with diabetes mellitus tended to be older with a higher body mass index compared to non-diabetes mellitus. Procedure duration and postsurgery hospital days were not different in diabetes mellitus versus non-diabetes mellitus patients. Analysis of the primary combined endpoint showed no significant difference but a trend towards higher event rates in the diabetes mellitus group (diabetes mellitus vs non-diabetes mellitus: 20% vs 12.1%, p  = 0.119)., Conclusion: Diabetes mellitus is a frequent and relevant variable in patients undergoing subcutaneous implantable cardioverter defibrillator implantation represented by 31.3% in this consecutive cohort. Our results suggest that diabetes mellitus is not associated with a prolonged hospital stay or increased rate of periprocedural adverse events.

Background: To investigate the impact of left ventricular outflow tract (LVOT) calcification on the incidence of device failure and mortality in patients undergoing transcatheter aortic valve implantation (TAVI)., Methods: Of 690 consecutive patients undergoing transfemoral TAVI in our center from January 2013 to December 2015, 600 presented with non-severe (NSCA LVOT ) and 90 (13.0%) with severe (SCA LVOT ) LVOT calcification. Primary outcome of interest was device failure defined as a composite of procedural death, prosthesis dislocation, annulus rupture or significant para-valvular leakage (PVL). Secondary outcome of interest was 30-day and one-year all-cause mortality., Results: Mean age of the population was 80.8 ± 7.2 years, mean STS score was 5.7 ± 4.6% and 50.6% of the patients were women. Patients with SCA LVOT more frequently experienced device failure (10.0% vs. 3.8%, p = 0.009) and were at higher risk of 30 day (10.0% vs. 2.8%, p < 0.001) all cause mortality as compared to those with NSCA LVOT . Furthermore, patients with SCA LVOT were more frequently in need of post-dilation (15.6% vs. 8.5%, p = 0.032) and showed higher incidence of significant PVL (7.8% vs. 2.5%, p = 0.007). In multivariate analysis, SCA LVOT (hazard ratio 2.87; 95% CI 1.20 to 6.34) and use of balloon-expandable prosthesis (hazard ratio 0.32; 95% CI 0.15 to 0.73) were identified as independent predictors of device failure., Conclusion: Presence of severe LVOT calcification in patients undergoing transfemoral TAVI is associated with a higher risk of device failure and short-term mortality., (Copyright © 2020 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Background: Endoprosthetic reconstruction of massive bone defects has become the reconstruction method of choice after limb-sparing resection of primary malignant tumors of the long bones. Given the improved survival rates of patients with extremity bone sarcomas, an increasing number of patients survive but have prosthetic complications over time. Several studies have reported on the outcome of first endoprosthetic complications. However, no comprehensive data, to our knowledge, are available on the likelihood of an additional complication and the associated risk factors, despite the impact of this issue on the affected patients., Questions/purposes: (1) What are the types and timing of complications and the implant survivorship free from revision after the first complication? (2) Does survivorship free from repeat revision for a second complication differ by anatomic sites? (3) Is the type of first complication associated with the risk or the type of a second complication? (4) Are patient-, tumor-, and treatment-related factors associated with a higher likelihood of repeat revision?, Methods: Between 1993 and 2015, 817 patients underwent megaprosthetic reconstruction after resection of a tumor in the long bones with a single design of a megaprosthetic system. No other prosthetic system was used during the study period. Of those, 75% (616 of 817) had a bone sarcoma. Seventeen patients (3%) had a follow-up of less than 6 months, 4.5% (27 of 599) died with the implant intact before 6 months and 43% (260 of 599 patients) underwent revision. Forty-three percent of patients (260 of 599) experienced a first prosthetic complication during the follow-up period. Ten percent of patients (26 of 260) underwent amputation after the first complication and were excluded from further analysis. Second complications were classified using the classification of Henderson et al. to categorize surgical results. Briefly, this system categorizes complications as wound dehiscence (Type 1); aseptic loosening (Type 2); implant fractures or breakage and periprosthetic fracture (Type 3); infection (Type 4); and tumor progression (Type 5). Implant survival curves were calculated with the Kaplan-Meier method and compared using the log-rank test. Hazard ratios (HR) were estimated with their respective 95% CIs in multivariate Cox regression models., Results: A second complication occurred in 49% of patients (115 of 234) after a median of 17 months (interquartile range [IQR] 5 to 48) after the surgery for the first complication. The time to complication did not differ between the first (median 16 months; IQR 5 to 57) and second complication (median 17 months; IQR 5 to 48; p = 0.976). The implant survivorship free from revision surgery for a second complication was 69% (95% CI 63 to 76) at 2 years and 46% (95% CI 38 to 53) at 5 years. The most common mode of second complication was infection 39% (45 of 115), followed by structural complications with 35% (40 of 115). Total bone and total knee reconstructions had a reduced survivorship free from revision surgery for a second complication at 5 years (HR 2.072 [95% CI 1.066 to 3.856]; p = 0.031) compared with single joint replacements. With the numbers we had, we could not show a difference between the survivorship free of revision for a second complication based on the type of the first complication (HR 0.74 [95% CI 0.215 to 2.546]; p = 0.535). We did not detect an association between total reconstruction length, patient BMI, and patient age and survivorship free from revision for a second complication. Patients had a higher risk of second complications after postoperative radiotherapy (HR 1.849 [95% CI 1.092 to 3.132]; p = 0.022) but not after preoperative radiotherapy (HR 1.174 [95% CI 0.505 to 2.728]; p = 0.709). Patients with diabetes at the time of initial surgery had a reduced survivorship free from revision for a second complication (HR 4.868 [95% CI 1.497 to 15.823]; p = 0.009)., Conclusions: Patients who undergo revision to treat a first megaprosthetic complication must be counseled regarding the high risk of future complications. With second complications occurring relatively soon after the first revision, regular orthopaedic follow-up visits are advised. Preoperative rather than postoperative radiotherapy should be performed when possible. Future studies should evaluate the effectiveness of different approaches in treating complications considering implant survivorship free of revision for a second complication., Level of Evidence: Level III, therapeutic study.

Introduction: Data on long-term durability of St Jude Medical Durata defibrillation leads compared to its previous model, the St Jude Medical Riata leads in clinical practice are missing. Aim of the study was to analyze the long-term performance of the Durata defibrillation leads compared to the Riata leads in clinical practice., Methods and Results: A total of 1407 consecutive patients of a prospective single-centre implantable cardioverter defibrillator (ICD)-registry were analyzed who underwent ICD implantation with a Durata (n = 913) or Riata (n = 494) ICD lead between 2002 and 2017. Most of the leads were implanted via a subclavian vein access. The estimated lead defect rates after 5 and 10 years were not different between the Durata (11% and 36%) and Riata leads (13% and 38%). Among Durata leads single coil and DF-4 connector ICD leads had a lower incidence of lead failure. Major causes of lead failure were compression of the lead in the clavicular region, generator to lead friction and distal fatigue fracture whereas lead defect due to externalization was a rare cause of lead defect in Riata leads (3%)., Conclusion: Among ICD leads implanted via the subclavian vein access the lead defect rate of Durata leads after 10 years is similar to that of Riata leads. Single coil and DF-4 ICD leads are associated with a lower lead failure rate. Mechanical stress represents a major cause of lead failure mechanism whereas externalization might only play a minor role in clinical practice., (© 2019 Wiley Periodicals, Inc.)

Objectives: This study sought to evaluate the impact of the ACURATE neo (NEO) (Boston Scientific, Marlborough, Massachusetts) versus SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) on permanent pacemaker implantation (PPI) in patients with pre-existing right bundle branch block (RBBB) after transcatheter aortic valve replacement., Background: Pre-existing RBBB is the strongest patient-related predictor for PPI after transcatheter aortic valve replacement. No comparison of newer-generation transcatheter heart valves with regard to PPI in these patients exists., Methods: This multicenter registry includes 4,305 patients; 296 (6.9%) had pre-existent RBBB and no pacemaker at baseline and formed the study population. The primary endpoint was new PPI at 30 days. The association of NEO versus S3 with PPI was assessed using binary logistic regression analyses and inverse probability treatment weighting in a propensity-matched population., Results: The 30-day PPI rate was 39.2%. The S3 and NEO were used in 66.9% and 33.1%, respectively. The NEO was associated with lower rates of PPI compared with the S3 (29.6% vs. 43.9%; p = 0.025; odds ratio [OR]: 0.54; 95% confidence interval [CI]: 0.32 to 0.89; p = 0.018), after multivariable adjustment (OR: 0.48; 95% CI: 0.26 to 0.86; p = 0.014), and in the inverse probability treatment weighting analysis (OR: 0.37; 95% CI: 0.25 to 0.55; p < 0.001). There was no difference in device failure (8.2% vs. 6.6%; p = 0.792) or in-hospital course. In the propensity-matched population, PPI rate was also lower in the NEO versus S3 (23.1% vs. 44.6%; p = 0.016; OR: 0.37; 95% CI: 0.17 to 0.78; p = 0.010), with no difference in device failure (9.2% vs. 6.2%; p = 0.742)., Conclusions: In patients with RBBB, risk of PPI was significantly lower with the NEO compared with the S3, suggesting the possibility of a patient tailored transcatheter heart valve therapy., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Non-transvenous implantable cardioverter-defibrillators (ICDs) as used in small patients and in patients with congenital heart disease (CHD) have not been compared with transvenous systems with respect to safety and efficacy yet. Aim of the present study was to describe the prevalence of and to identify contributing factors for appropriate and inappropriate ICD discharges in patients with non-transvenous and transvenous ICD., Methods and Results: Single centre analysis of all paediatric and CHD patients who had received an ICD since 1995. One hundred and ninety-five patients were included. A transvenous system had been implanted in 153 (78%) subjects, the remaining 42 (22%) individuals received an extracardiac (EC)-ICD system. During mean follow-up of 4.5 years appropriate ICD shocks were noted in 32 (16%) individuals, whereas inappropriate shocks occurred in 22 (11%) patients. Appropriate shocks were more frequent in patients with an EC-ICD than in individuals with transvenous systems (29% vs. 13%, P = 0.02). Rapidly conducted atrial tachycardia (AT) was the most common reason for inappropriate shocks (76%). Rate of inappropriate shocks was not different between EC and transvenous systems (12% vs. 11%, P = 0.26). Lead failure was more prevalent in subjects with an EC-ICD (29% vs. 7%, P = 0.001)., Conclusion: Individuals with EC-ICD systems were particularly prone to experience appropriate shocks. As rapidly conducted AT was the most common reason for inappropriate ICD shocks, rigorous treatment of these arrhythmias and proper ICD programming are mandatory. Though lead failure was of concern in EC-ICD patients, EC-ICD systems were not inferior with respect to inappropriate shocks.

Background: Reported survival rates of unicondylar knee arthroplasty (UKA) vary considerably. The influences of patient characteristics and the type of implant have already been examined. This analysis investigated the influence of hospital volume on 5-year-survival rate, using administrative claims data of Germany's largest health insurance provider., Methods: We analysed administrative claims data for 20,946 UKAs covered by the German local healthcare funds (Allgemeine Ortskrankenkasse, AOK) between 2006 and 2012. Survival rates were estimated using Kaplan-Meier analysis. The influence of hospital case numbers on 5-year survival was analysed by means of multivariable Cox regression adjusted for patient characteristics. We estimated hazard ratios (HR) with 95% confidence intervals for five hospital volume categories: < 12 cases, 13 - 24 cases, 25 - 52 cases, 53 - 104 cases, > 104 cases (per hospital and year)., Results: The overall 5-year Kaplan-Meier survival rate was 87.8% (95%-CI: 87.3 - 88.3%). This increased with hospital volume (< 12 cases: 84.1% vs. > 104 cases: 93.2%). The analysis identified low hospital volume as an independent risk factor for surgical revision (< 12 cases: HR = 2.13 [95%-CI 1.83 - 2.48]; 13 - 24 cases: HR = 1.94 [95%-CI: 1.67 - 2.25]; 25 - 52 cases: HR = 1.66 [95%-CI: 1.41 - 1.96]; 53 - 104 cases: HR = 1.51 [95%-CI: 1.28 - 1.77]; > 104 cases: reference category)., Discussion: Our analysis revealed a significant relationship between hospital case numbers and 5-year survival rate, which increases with hospital volume. The risk of surgical revision within 5 years in hospitals with fewer than 25 UKAs per year is approximately twice as high as in hospitals with more than 104 cases., Competing Interests: Die Autoren geben an, dass kein Interessenkonflikt besteht., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: Anatomic shoulder arthroplasty in osteoarthritis with biconcave glenoid wear results in decreased functional results and a higher rate of early glenoid loosening., Aim: The aim of the data analysis of the German shoulder arthroplasty register was to clarify whether reverse shoulder arthroplasty can provide better functional results and a lower complication rate than anatomic arthroplasty in osteoarthritis with biconcave glenoid wear., Methods: The analysis included 1052 completely documented primary implanted arthroplasties with a minimum follow-up of 2 years. In 119 cases, a B2-type glenoid was present. Out of these cases, 86 were treated with an anatomic shoulder arthroplasty, and in 33 cases a reverse shoulder arthroplasty was implanted. The mean follow-up was 47.6 months., Results: The Constant score with its subcategories, as well as the active range of movement improved significantly after anatomic and after reverse shoulder arthroplasty., Discussion: We observed no difference in functional results between both types of arthroplasty; however, reverse arthroplasty showed a significant higher revision rate (21.2%) (3% glenoid loosening, 6% prosthetic instability) than anatomic shoulder arthroplasty (12.8%) (11.6% glenoid loosening, 1.2% prosthetic instability), whereas anatomic shoulder arthroplasty showed a higher rate of glenoid loosening. Functional and radiographic results of both types of arthroplasty are comparable with the results reported in the literature, although our analysis represents results from an implant registry (data pertaining to medical care quality).

Background: Following a Europe-wide scandal, substandard breast implants containing silicone for industry purposes produced by Poly Implant Prothèse (PIP&Rofil) were explanted due to its potential health risks., Objective: We investigated whether these implants actually imposed a threat to patients' health., Methods: In this retrospective single-centre case-control study, we compared patients with breast augmentation receiving implant explantation (01/2011-01/2015). Data were collected retrospectively from the patients' records. Patients were split into two groups: PIP&Rofil and implants of other manufacturers., Results: A total of 307 patients with 495 breast implants met the inclusion criteria, 64 patients with 115 PIP&Rofil implants and 243 patients with 380 implants of other manufacturers. Comparison of descriptive statistics between the two groups revealed that for a variety of indicators (e.g. patient age, breast cancer, aesthetic vs. reconstructive indication, implant volume, submuscular vs. subglandular implant position) PIP implants differ from non-PIP implant patients. Raw mean comparison showed higher rupture rates for non-PIP implants, 28.42 % (PIP 23.48 %). However, when controlling for implant indwelling time, PIP implants had shown higher rupture rates. Both groups had similar rates of capsular contracture (PIP: 71.30 %, Others: 72.63 %) with different distribution of Baker Scores (Baker 2/3/4: PIP 5/8/13 and non-PIP 3/24/135)., Conclusion: Concerning patient symptoms, we did not find any objective reason to justify implant explantation of PIP&Rofil implants as a solely precautionary measure. As PIP&Rofil implants showed shorter retention periods until rupture and ruptured implants can cause symptoms or health problems, PIP&Rofil implants should be regularly monitored and explanted if there is evidence of rupture., Level of Evidence Iii: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Background: The objective of this study was to analyze the results of open heart mitral valve operations for survival prediction in patients with previously unsuccessful MitraClip procedures., Methods: Thirty-three consecutive patients who underwent mitral valve surgery in our institution were studied. At a median of 41 days, they had previously undergone one to five futile MitraClip implantations. At the time of their operations, patients were 72.6 ± 10.3 years old, and the calculated risk, using the European System for Cardiac Operative Risk Evaluation (EuroSCORE) II, was a median of 26.5%. Individual outcomes were recorded, and all patients were monitored postoperatively., Results: Thirty-day mortality was 9.1%, and the overall survival at 2.2 years was 60.6%. Seven cardiac-related and six noncardiac deaths occurred. Univariate survival regression models demonstrated a significant influence of the following variables on survival: EuroSCORE II (p = 0.0022), preoperative left ventricular end-diastolic dimension (p = 0.0052), left ventricular ejection fraction (p = 0.0249), coronary artery disease (p = 0.0385), and severe pulmonary hypertension (p = 0.0431). Survivors showed considerable improvements in their New York Heart Association class (p < 0.0001), left ventricular ejection fraction (p = 0.0080), grade of mitral regurgitation (p = 0.0350), and mitral valve area (p = 0.0486). Survival after mitral repair was not superior to survival after replacement., Conclusions: Indications for surgery after failed MitraClip procedures must be considered with the greatest of care. Variables predicting postoperative survival should be taken into account regarding the difficult decision as to whether to operate or not. Our data suggest that replacement of the pretreated mitral valve is probably the more reasonable concept rather than complex repairs. When the EuroSCORE II at the time of surgery exceeds 30%, conservative therapy is advisable., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: There are few long term studies to show the safety and efficacy of iliac artery aneurysm exclusion, especially in regards to the straight iliac branched device. The objective of our study was to add our data with a mean follow-up of 32 months to the existing data available., Methods: Patients undergoing iliac bifurcation procedure either as standalone or in combination with abdominal aortic aneurysm exclusion at two vascular centers had data prospectively gathered between 2004 and 2014. Collected data was analyzed for baseline characteristics, procedural events, and clinical follow-up; variables included endoleaks, reinterventions, and internal iliac artery (IIA) closure., Results: A total of 45 iliac vessels in 41 patients (36 male) with a mean age of 70.4 years were treated with the iliac branched device. Procedural success was achieved in 85% (35/41) of patients and 87% (39/45) vessels with no intraoperative death. Of the six technical failures, three occurred due to failure to place the straight iliac branched device or stent properly. Two occurred because of endoleaks at the end of the procedure, and one occurred because the IIA side-branch occluded and could not be reopened. The mean patient follow-up was 32.0 ± 27.3 months (range, 0-109 months). During this time period, the IIA patency rate on an intention-to-treat basis was 81%, and the freedom from endoleak rate on an intention-to-treat basis was 76% per patient. The freedom from reintervention per patient was 75%. No patient reported symptoms of pelvic ischemia and permanent buttock claudication., Conclusions: In this study with mean follow-up of 32 months, treatment with iliac bifurcated devices is a safe and durable option in a carefully selected population of patients with iliac artery bifurcation aneurysms., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Patent foramen ovale (PFO) is associated with cryptogenic strokes and transient ischemic attacks (TIAs). This study examined the initial experience with a new PFO occluder, the Nit-Occlud® PFO Occlusion Device., Methods: Sixty-three patients with history of cryptogenic stroke or TIA and PFO underwent percutaneous closure of the defect with the Nit-Occlud® PFO Occlusion Device. The primary endpoint was successful implantation without recurrent event, device malfunction, embolization, or the need for a replacement device over 6 ± 2 weeks. All patients underwent transesophageal echocardiography (TEE) at 6-weeks, and 42 patients had repeat TEE at 6-months. Clinical follow-up at 18.7 ± 7.4 months was also performed., Results: The device was successfully implanted in 62 (98.4%) patients with no relevant procedural complications. At 6-week follow-up, 60 (95.2%) patients met the primary endpoint. A residual shunt at rest and with Valsalva was noted in 8 (12.7%) and 31 (49.2%) patients respectively at 6-week TEE. At 6-months, 1 of 42 (2.4%) and 9 of 42 (21.4%) patients had a residual shunt at rest and with Valsava, respectively. At 18 months, 5/63 patients had recurrent events (3 TIAs, 2 strokes). No device-related complications occurred. One patient developed atrial fibrillation., Conclusion: In patients with cryptogenic stroke or TIA and a PFO, the Nit-Occlud® PFO Occlusion Device appears to be both a safe and effective means to occlude the PFO. It is associated with high procedural success and favorable rates of complete closure., (© 2015 Wiley Periodicals, Inc.)

Background: There is accumulating evidence that up to 20% of the implanted devices after TAVI are associated with a significant degree of paravalvular leaks, which appear to be associated with a negative clinical outcome., Methods: A total of 355 patients with severe aortic valvular stenosis (AVS) were treated by TAVI (Corevalve n = 222, Edwards Sapien n = 133). Survival, NT-proBNP and the grade of PVL were quantified up to 12 months after implantation., Results: Technical success rate was 97.8%. Thirty-day mortality was 9.6%. Post-procedural transvalvular aortic regurgitation was seen only in a minority of cases (5%), whereas PVL were frequently observed (grade: <1+ in 58.2%, ≥1-<2 in 33.9%, and ≥2 in 7.9%). There was a clear relation-ship between PVL and adverse outcome (P < 0.001). After a transient increase, NT-proBNP showed a significant decline. Interestingly, a PVL ≥2+ was associated with a much higher rise in NT-proBNP compared to the other groups (P < 0.01), and a post-procedural increase in NT-proBNP by more than 1640 ng L(-1) within 5 days was associated with a significant increase in rate of death (P < 0.01)., Conclusions: TAVI is an efficient treatment option for high-risk patients with severe AVS. The incidence of PVL is an inacceptable clinical problem. Serial measurement of NT-proBNP can be used for risk-stratification in patients with a significant PVL. In general, PVL graded ≥2+ is associated with a dramatically increased 6-month mortality. Therefore, any action to reduce paraprosthetical regurgitation is highly recommended., (© 2013 Wiley Periodicals, Inc.)

There has previously been no structured long-term documentation of the results of hip and knee prosthesis operations in Germany. This article presents the objectives, structure and data flow of the newly established German arthroplasty registry (EPRD). The EPRD is run as a subdivision of the German Society for Orthopedics and Orthopedic Surgery (Deutsche Gesellschaft für Orthopädie und orthopädische Chirurgie, DGOOC). It is dedicated to scientific principles and guarantees independency and immediate feedback to surgeons. The cooperation between insurance funds, hospitals, industry and scientific society is the key to success. Additional data acquisition and bureaucratic formalities are limited to a minimum and in particular there is no use of paper. Involving the health insurance funds provides access to relevant routine data. The implant documentation is facilitated by means of an implant library and barcode scanning in the operating room. The EPRD documents the survival of implants including the reasons for revision. Although the highest level of patient data protection is guaranteed, individual patients can be identified in case of implant recalls.

Purpose: To report a subgroup analysis comparing safety and effectiveness outcomes in Japanese and non-Japanese patients as part of a prospective, multinational, randomized controlled trial (ClinicalTrials.gov identifier NCT00120406) evaluating a paclitaxel-coated drug-eluting stent (DES) compared to percutaneous transluminal angioplasty (PTA) for treating peripheral artery disease., Methods: Patients were randomly assigned to primary DES or PTA. In the Japanese cohort, 27 patients (21 men; mean age 71.2±9.6 years) were randomized to PTA and 25 patients (19 men; mean age 69.8±10.2 years) to primary DES. In the non-Japanese cohort, 211 patients (131 men; mean age 67.3±10.6 years) were randomized to PTA and 211 patients (136 men; mean age 67.6±9.5 years) to primary DES. Outcome measures included event-free survival (EFS), freedom from target lesion revascularization (TLR), patency, stent fracture, and sustained clinical benefit through 2 years., Results: Safety and effectiveness outcomes were similar in the Japanese and non-Japanese cohorts, although the outcomes in the Japanese cohort treated with primary DES were numerically better. In the DES group, the 2-year EFS was 92.0% vs. 85.0% (p=0.61), freedom from TLR was 96.0% vs. 85.5% (p=0.55), primary patency was 80.0% vs. 74.3% (p=0.61), and clinical benefit was sustained in 88.5% vs. 80.5% of patients (p=0.31) in the Japanese and non-Japanese cohorts, respectively. Stent fractures were seen in 4 of 457 stents at 12 months: 3 in the Japanese cohort and 1 in the non-Japanese cohort., Conclusion: The subgroup analysis comparing Japanese and non-Japanese patients supports the safety and effectiveness of the paclitaxel-coated DES in Japanese patients with stenotic lesions in the femoropopliteal arteries. The lack of major differences associated with ethnicity in these 2-year outcomes supports the validity and value of multinational clinical trials.

Background: Complications in Children and Adults with Cochlear Implant Background: Cochlear Implants (CI) are developed in the last 20 years to a regular therapy in congenital deaf children/newborns and deafened teens and adults. The success of speech understanding with the CI in adults is so extraordinary that meanwhile also unilateral deaf, contralateral normal hearing persons are implanted. In case of early implanted children a nearly normal speech development is possible in most of the cases. MATERIAL UND METHODS: Nevertheless the surgical procedures is a challenge concerning the potential complications combined with a foreign body, the CI, in a non-steril part of the ear., Results: This paper reports on the complications in a patients collective, implanted within 21 years. Separated within the severity of the complications and their therapeutic consequences (conservative and surgical) it could be shown that the incidence of severe perioperative complications within the second decade could be reduced from 3.92% (first decade) to 1.8%. Also the companies have learned to construct the products more save., Conclusion: In summary the reliable and complete postoperative control and the modification of therapy concepts leads to a constant reduction of complications., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: The burden of revision of the 210,000 total hip and the 146,000 total knee arthroplasties performed in Germany every year is 10.9% and 7.9%, respectively. Since the probability of revisions could be cut in half by the implementation of a national joint registry in Sweden, several other countries have also established national joint registries. Nevertheless, these registries were not able to detect the failure of some implant systems, which resulted in thousands of patients who had received implants being recalled later on., Objectives: We aimed to identify the methods that are currently used for statistical analyses in joint registries and which could be used to implement an early warning system., Materials and Methods: We analyzed the available reports of national joint registries regarding the methods used for the early detection of implants that perform less efficiently than expected. The methods identified are described and evaluated if they are suitable for being used in a national joint registry., Results: While most of the identified national joint registries use the Kaplan-Meier method for analyzing implant survival, there was little agreement regarding the methods used for the early detection of implants that perform less efficiently than expected. Methods identified included revision rate per 100 component years, variants of statistical process control (SPC), cumulative sums (CUSUM) and funnel plots., Conclusion: Currently, there are no standardized methods for the early detection of inferior implants that are used by the established national joint registries. Most of the statistical methods that could be identified were either not used at all or only in a very limited number of registries. The value of these methods still needs to be established. It appears probable that the statistical methods for early detection have to be developed further in order to identify a possible inferior performance of implants at an earlier point in time. This is necessary in order to avoid that thousands of patients are again treated with implants which are associated with an increased revision rate.

Background: Implant safety is a topic gaining more and more public interest. Implants are safety relevant medical devices which in the case of failure can lead to life-threatening situations., Objectives: A well-founded failure analysis requires expert knowledge not only of materials and implant design but also a qualified explantation procedure and storage conditions., Methods: A selective literature search was carried out putting the main emphasis on implant failure analysis supplemented with own investigations., Results: The reasons for implant breakdown are mostly failures of materials and in the manufacturing process. In some cases false material combinations can lead to tribocorrosion effects under cyclic loading., Conclusion: The increased level of knowledge gained from complex analyses of failed implants produces valuable evidence for better quality management.

Objectives: The purpose of this "first-in-man" study was to investigate the safety of a novel vascular polyester prosthesis coated with a resorbable polymer and free of any animal-based coating agents such as gelatin or collagen., Methods: In a nonrandomized first-in-man multicenter safety study, the frequency of perigraft seroma (PGS) as the primary endpoint was studied in consecutive patients undergoing aortic reconstructions. The follow-up control to study the primary endpoint was intended at 3 months under routine clinical conditions. Pre- and postoperative white blood cell counts (WBC), C-reactive protein (CRP), and liver enzyme levels to characterize the systemic inflammation response and possible metabolic consequences were determined at different postoperative time points (secondary endpoints). Additionally, the primary unassisted patency rate, perioperative complications and serious adverse events, as well as intraoperative handling properties of the graft based on a semiquantitative scale were assessed. Magnetic resonance angiography (MRA) follow-up investigations were scheduled postoperatively at 3 months to determine graft tissue integration and the presence of PGS., Results: A total of 24 patients with comorbidities such as coronary artery disease (8.3 %, 2/24), chronic occlusive pulmonary disease (COPD, 8.3 %, 2/24), Fontaine III/IV (20.8 %, 5/24), and diabetes (20.8 %, 5/24) were enrolled from June 2011 to September 2012. Due to two early nongraft-related deaths, there were 22 patients that had a follow-up. In these 22 patients, the freedom from PGS was 90.9 % (20/22) suggesting that the graft/tissue integration was comparable to other vascular grafts described in the relevant literature. WBC counts were not significantly different (pre (8.67 ± 2.98 1/nl) vs. follow-up (7.97 ± 2.24 1/nlI, p = 0.203). Likewise, preoperative CRP serum levels (6.47 ± 11.59 mg/l) were not different from those at follow-up (7.87 ± 12.81 mg/l, p = 0.769). There were two patients with a documented coagulation disorder and two premature deaths (cardiac failure, cerebral bleeding). The primary unassisted patency at follow-up was 77.3 % (17/22) in all patients who reached the follow-up (85.0 % or 17/20 if two cases with documented coagulation disorders are excluded). The reasons for occlusions were technical/surgical difficulties (2/5) and documented coagulation disorders (2/5). In one occlusion, the cause was unknown. There were no graft infections. Intraoperative graft handling properties were evaluated less favorable as compared to the routinely used gelatin- or collagen-coated polyester grafts in each investigator's clinical practice., Conclusions: Our results suggest that Uni-Graft® Synthetic is a promising prosthetic vascular graft to reduce PGS. Our findings should be interpreted with caution noting the limitation of the lack of a control group.

Background: Drug-eluting stents (DES) have substantially reduced target vessel revascularization (TVR) after percutaneous coronary interventions. Risk factors for clinical events need to be redefined with this treatment option., Methods and Results: In the prospective DES.DE registry, baseline clinical and angiographic characteristics as well as in-hospital and follow-up events were recorded for all enrolled patients. Between October 2005 and May 2009, 21,774 patients receiving DES were enrolled at 98 DES.DE sites. The composite of death, myocardial infarction (MI) and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and TVR were predefined as primary endpoints. At 1-year follow-up rates for overall death, MI, stroke, MACCE, TVR and definite stent thrombosis were 2.7, 3.1, 1.4, 7.1, 11.5 and 0.6 %, respectively. Aside from well-known risk factors like age, diabetes mellitus and triple-vessel disease, stratification in patients with or without MACCE revealed atrial fibrillation, non-ST-segment elevation myocardial infarction, renal failure, impaired ejection fraction and peripheral vascular disease as strong predictors of MACCE at 1 year., Conclusion: Data collected in the DES.DE registry, reflecting the clinical practice in Germany, revealed favorable clinical outcomes after DES implantation in a real world setting but also identifying several high-risk populations.

Aims: To evaluate passive-fixation lead failure rates and long-term patient survival in subjects implanted with Sprint Fidelis electrodes., Methods and Results: We identified 748 subjects who received a Sprint Fidelis (n = 429; Medtronic models 6948: 94.8%, 6949: 2.6%, 6930: 1.9%, 6931: 0.7%) or a Sprint 'non-Fidelis' implantable cardioverter defibrillator lead (n = 319, Medtronic models 6944: 68.6%, 6947: 17.9%, 6942: 7.8%, 6943: 3.4%, 6945: 2.2%) at our centre between 1998 and 2008. Kaplan-Meier patient survival was lower in the Fidelis group than in the Control cohort (68.4 vs. 77.0% at 5 years, P = 0.0061), but multivariate analyses revealed no significant association between mortality and implanted lead type. Passive-fixation lead failure rate at 5 years was 14.4% (95% confidence interval (CI) [9.2, 19.3]) in the Fidelis (n = 414) group and 1.8% (95% CI [0.0-3.8]) in the Control (n = 241) cohort (P < 0.001 upon multivariate comparison)., Conclusion: Failure rates of passive-fixation Sprint Fidelis leads are increased and similar to those previously reported for active-fixation Fidelis electrodes. Despite the elevated risk for lead failure and its potential sequelae, the Sprint Fidelis has no obvious impact on long-term mortality.

Background: The purpose of this study is to examine the influence of the prosthesis type on early mortality and long-term survival after re-replacement of aortic valve prosthesis, especially in patients over 60 years old., Methods: Late outcome of 223 patients who underwent a reoperation on the aortic valve and received a mechanical (mechanical group) or biological (biological group) heart valve prosthesis at a single institution were analyzed for survival and major valve-related complications, including structural valve deterioration, thromboembolism, hemorrhage, further reoperation, and valve-related mortality., Results: Preoperative New York Heart Association class IV (P = 0.001), emergency procedure (P = 0.002), and endocarditis (P = 0.025) were significant risk factors for 30-day mortality rates, which were 8.4 % and 12.5 %, respectively (mechanical versus biological group, P = 0.361). A subanalysis of elective patients revealed a low risk of 30-day mortality of 2.4 % and 1.8 %, respectively. Event-free survival was comparable at 5 years (73.9% ± 3.6% versus 70.5% ± 6.5%, mechanical versus biological group) and 10 year (49.7% ± 5.0% versus 35.3% ± 9.8%, mechanical versus biological group). In a propensity-matched subanalysis, survival and event-free survival were comparable at 5 and 10 years in both groups., Conclusion: The type of aortic valve prosthesis did not affect early outcome and late survival in patients who underwent valve replacement, and therefore, the current strategy favoring a biological aortic valve prosthesis for patients aged over 60 years in first-time operations could also be applied in re-replacement.

Background: Hemiarthroplasty is a common procedure for treating femoral neck fractures in orthogeriatrics. For training purposes the operation may also be performed by supervised residents. Our study aims at evaluating the rates of early surgical complications after hemiarthroplasty in different age groups, comparing operations performed by consultants and residents., Methods: All patients treated with hemiarthroplasty between December 2006 and July 2011 at our municipal, maximum-care-providing hospital were included in a retrospective cohort. The Excia® stem with a self-centering bipolar head (Aesculap, Tuttlingen) was used in all patients. Educational level of the operator (consultant vs. resident) and operation time were noted as well as early complications including luxation, infection, haematoma, seroma, and early periprosthetic fractures (e.g., intraoperative lesions of the greater trochanter). The complication rates were evaluated and compared by the chi-square test., Results: 241 of 729 hemiarthroplasties were performed by supervised residents. Neither the overall complication rate nor the rates of specific complications differed significantly between the patients operated by consultants and those operated by residents. The result was still true if comparing the different age groups. On average operation time was 8 minutes longer in teaching operations., Conclusions: Focusing on early surgical complications, the teaching of hemiarthroplasty does not seem to increase the risk to patients of any age. We conclude that the hemiarthroplasty procedure is suitable for teaching younger colleagues in orthogeriatrics. As age is just one of several potential risk factors, additional studies on this topic should be undertaken., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: Revision total knee arthroplasties (TKA) have been performed with increasing frequency over the last 25 years., Methods: In this study, we retrospectively analyzed 78 patients who underwent 78 revision TKAs during the years 2003–2007 with an average follow-up of 81 months (range 60–108 months). All patients were treated with a standard rotating hinge prosthesis (TC3, DePuy, Warsaw, IN, USA) due to significant instability. We evaluated the postoperative results using the Knee Society clinical rating system and the WOMAC rating system., Results: Clinical results revealed significant improvements in both scores. Complications occurred in almost one-third of the cases, with a reoperation rate of 26 %., Conclusion: Our mid-term findings show that revision TKAs lead to an improvement in patient-perceived outcomes of physical variables. While revision TKA is a useful option for patients, procedure-associated complications should not be neglected. During the course of the procedure, it is important to collect patient-oriented data and focus on responsive and valid scores.

Infection of vascular prostheses, particularly in the central aortic position, is a growing challenge in vascular surgery. Beside the use of extra-anatomic prosthetic bypasses the need for anatomic reconstruction with infection-resistant materials is growing. The use of arterial allografts is an established method in many centres for in situ reconstruction. Used historically as the only option for vessel replacement, allografts were seldom used once the development of synthetic prostheses started. Use as a vascular graft in infected regions began in the 1990s. Discussions about the use of "fresh" allografts without preservation were terminated by order of the European Union in 2003 (although the long-term benefits have been foreseen). Currently, because of the German Tissue Act, only "cryopreserved" allografts can be used. Larger, partially controlled studies about the outcome after cryopreserved allograft transplantation have shown similar results to the use of silver prostheses, with a significantly lower prevalence of re-infection. Questions remain about the use of immunosuppression after human allograft transplantation. Immunological interactions are mainly involved in allograft degeneration. Aneurysmal changes (most commonly late degeneration of allografts) can be treated with endovascular procedures and therefore have no direct impact on long-term results. The availability of allografts in Europe tends to be restricted, but companies based outside the EU permit a good supply. The use of allografts in non-university institutions shows the wide acceptance of the material and its suitability for routine use in vascular surgery, even if the treatment of infected vascular prostheses in the central position remains associated with high morbidity and mortality., (Georg Thieme Verlag KG Stuttgart · New York.)

Background and Aim of the Study: The study aim was to investigate the incidence of patient-prosthesis mismatch (PPM) with new catheter valves, and its influence on the patients' clinical state. At present, few echocardiographic data are available on the incidence and impact of PPM with the CoreValve and Sapien prostheses for transcatheter aortic valve implantation (TAVI)., Methods: The reliability of effective orifice area (EOA) measurements was assured by awaiting an interval of six months after TAVI. Of 256 survivors after TAVI, 149 complete echocardiographic data sets were available for the assessment of the indexed EOA (iEOA). In total, 106 CoreValve prostheses and 43 Sapien prostheses were implanted in this high-risk cohort (mean age 81 +/- 6 years, mean logistic EuroSCORE 20 +/- 13%)., Results: The overall incidence of PPM (iEOA < 0.85 cm2/m2) was 61%. Patients with a larger body surface area were more likely to develop PPM (p = 0.001), while the prosthesis type, native annulus diameter, preoperative EOA, gender and prosthesis size had no influence. The mean aortic gradient was significantly higher in patients with PPM. A reduction in the left ventricular end-diastolic diameter was seen in all patients, without significant differences between groups. There were no differences in postoperative NYHA class or self-assessed health state between patients with or without PPM., Conclusion: PPM was common after TAVI in the presented cohort, presumably because the native calcium masses narrow the outflow area available for blood flow. As expected for low gradients, there was no impairment of left ventricular dimension regression or clinical state of the patients, even if severe PPM was present. Based on the presented data, it is assumed that PPM might be less relevant in TAVI patients.

Background: Little information is available regarding the clinical and long-term results of patients with complex prosthetic valve endocarditis (PVE) involving the aortic root who undergo root replacement based on the Cabrol or Bentall procedures., Methods: Between January 2007 and December 2011, 148 patients underwent cardiac operations for PVE. The analysis included 31 patients with complex PVE and concomitant destruction of the aortic root. Of these, 13 patients were treated by the Cabrol procedure and 18 patients by the Bentall procedure. The mean EuroSCORE for mortality was 50.7%±3.8%. Mean follow-up was 3.8±0.4 years (range, ≤8.0 years), with a total of 97 patient-years., Results: The observed 30-day mortality was 12.9% and 5-year survival was 75.3%. The most common cause of death was septic multiple organ failure (42.9%). Independent predictors of mortality in multivariate analyses were terminal renal failure (odds ratio [OR], 4.8; p<0.01), type 2 diabetes mellitus (OR, 4.6; p<0.01), postoperative renal failure (OR, 4.0; p<0.01), and staphylococcal infection (OR, 2.1; p=0.01). The prevalence of freedom from reinfection was 100.0% and that from valve-related events was 93.5%., Conclusions: Complex PVE is associated with quite high mortality and morbidity. Composite aortic root replacement provided good clinical and long-term outcomes as well as a low prevalence of reinfection and valve-related events. These results seem not to be inferior to those reported for noncomplex PVE. If the Bentall "button" technique was not feasible, the Cabrol procedure also provided excellent results., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Aims: A considerable number of lead defects occurs during long-term cardioverter defibrillator therapy. Evidence-based strategies for the handling of chronically implanted, non-functional high-voltage (HV) leads are mandatory., Methods and Results: Patient outcome after abandonment of HV leads was retrospectively compared with patient outcome following other lead revision strategies and following primary implantation. A total of 903 consecutive patients undergoing 997 implantable cardioverter defibrillator (ICD) implantations or lead revisions were followed for a mean period of 48.8 ± 37.8 months. One or more additional HV leads were placed in 60 patients. An additional pace/sense lead was implanted in 13 patients. Extraction and replacement of a dysfunctional HV lead was performed in 21 patients. The overall rate of complications including artefact sensing, ineffective defibrillation, symptomatic subclavian vein thrombosis, and other lead defects did not differ between patients with and without an additional HV lead (10.0 vs. 8.9%, P = 0.32). Survival without lead associated complications did not differ between groups. Results remained unchanged after correction for covariates., Conclusions: Abandoned HV leads did not increase the risk of ICD system-related complications in the majority of patients. Thus, a general lead extraction policy of dysfunctional HV leads cannot be advised in an average ICD population. Recommendations may not apply for young and physically active patients, in whom HV lead extraction must be considered.

The growing number of revisions in orthopaedic surgery as well as the multifactorial reasons for implant failure give cause for taking a closer look at the clinical documentation of adverse events. Based on our long-term experience it is our goal to present recommendations for an adequate documentation and filing. In the framework of the introduction of a quality management system (ISO 9001:2008) in our hospital, a process was developed for reportable incidents with medical devices regulating adequate documentation. Therefore, specific forms were developed. The retrievals are stored for subsequent damage analyses and are available for possible legal claims and tracking. A file should be opened for each reportable incident containing information about the event, a copy of the obligatory BfArM report, surgery report, medical device labels, radiographs and photographs. Declarations of agreement as well as handover certificates should be maintained in order to keep record of the retrievals. In order to assure consistent documentation, we recommend use of specific forms as presented in this paper. Identification of risk factors for implant failure and a long-term reduction of damage cases will only be possible under consequent incident reporting and responsible documentation of adverse events. Processing of cases of damage is accelerated and simplified by the presented recommendations and forms. Together with the newly established joint replacement registry, a higher quality of patient treatment and implant safety should be obtained., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: The statutory health insurance system embodies a large amount of data on the treatments of their members. Depending on joint, prosthesis type, patient activity and comorbidity, knee and hip replacements can last up to 20 years. Based on statutory health insurance data the main object of this analysis was to investigate how high the early revision rate of replacements actually is., Methods: The number of replacements in the years 2005 and 2006 has been extracted from the TK database for hip (OPS-Code 5-820, n = 20,875), knee (OPS 5-822, n = 13,466), upper limbs (OPS 5-824, n = 901), and lower limbs (OPS 5-826) replacements. This data has then been related to each consecutive operation (i. e. change or excision of joint endoprosthesis) over a joint-specific observation period of two years., Results: In 3.7% of the cases joint replacements stood for less than 2 years (hip 3.5%, knee 3.8%, upper limbs 6.5%, and lower limbs 5.5%). There is a significantly positive correlation between the treatment data of the hospitals and the outcome as to low rates of reoperations at early stages. The main reason for short lifetime (76 - 81%) is mechanical failure., Conclusion: The percentage of joint endoprostheses with significantly short lifetimes has been unexpectedly high. The de facto lifetimes of joint endoprostheses thus often do not match the manufacturers' information. The authors strongly support the idea of a national endoprosthesis register as such a register could give detailed information on firstly whether these deficits are due to material defects, osteolysis or dislocation and secondly which products are mainly affected.

Background: To identify insertion procedure and force application related complications in Jet Screw (JS) type mini-implants when inserted in the palatal slope., Setting and Sample Population: The Department of Orthodontics, the University Hospital Münster. Forty-one consecutively started patients treated using mini-implants in the palatal slope. In this retrospective study, 66 JS were evaluated. Patient records were used to obtain data on the mode of utilization and complications. Standardized photographs overlayed with a virtual grid served to test the hypothesis that deviations from the recommended insertion site or the type of mechanics applied might be related to complications regarding bleeding, gingival overgrowth or implant failure., Results: Two implants (3%) were lost, and two implants (3%), both loaded with a laterally directed force, exhibited loosening while still serving for anchorage. Complications that required treatment did not occur, the most severe problem observed being gingival proliferation which was attributable neither to patients' age nor to applied mechanics or deviations from the ideal implant position., Conclusions: The JS mini-implant is reliable for sagittal and vertical movements or anchorage purposes. Laterally directed forces might be unfavorable. The selection of implant length as well as the insertion procedure should account for the possibility of gingival overgrowth.

Recently, moderate and severe postprocedure aortic regurgitations (ARs) have been identified as independent risk factors for short- and midterm mortality after transcatheter aortic valve implantation (TAVI). However, very few data exist on the long-term outcome of postprocedure AR. From 2008 to 2011, 198 consecutive patients with severe aortic stenosis successfully underwent TAVI with the CoreValve prosthesis (Medtronic CV, Minneapolis, Minnesota). After the procedure, patients were subdivided into groups depending on the presence of moderate/severe AR. The primary study end point was death from any cause after TAVI. The secondary end point was defined as cardiovascular death. In study patients (80 ± 6 years old, logistic European System for Cardiac Operative Risk Evaluation 22 ± 16%, left ventricular ejection fraction 53 ± 13%), moderate/severe AR occurred in 28 patients (14%). Despite similar baseline characteristics, patients with moderate/severe AR had higher 30-day and 1-year mortality rates than patients with none/mild AR (21% vs 6%, p = 0.019; 57% vs 16%, p <0.001, respectively). During a mean follow-up of 535 ± 333 days, the primary end point was reached in 54 and the secondary end point in 33 patients. Moderate/severe AR was the strongest independent risk factor of all-cause-mortality (hazard ratio 4.89, 95% confidence interval 2.78 to 8.56, p <0.001) and the strongest independent risk factor of cardiovascular mortality (hazard ratio 7.90, 95% confidence interval 3.95 to 15.81, p <0.001). In conclusion, moderate and severe postprocedure ARs are not uncommon complications after TAVI. Although long-term outcome of patients with none/mild AR is favorable, outcome of patients with moderate/severe AR is dismal., (Copyright © 2012 Elsevier Inc. All rights reserved.)