Single-Incision Mini-Slings for Stress Urinary Incontinence in Women.

BACKGROUND: Until recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. Data comparing the effectiveness and safety of newer single-incision mini-slings with those of standard midurethral slings are limited. METHODS: We performed a pragmatic, noninferiority, randomized trial comparing mini-slings with midurethral slings among women at 21 U.K. hospitals during 36 months of follow-up. The primary outcome was patient-reported success (defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire) at 15 months after randomization (approximately 1 year after surgery). The noninferiority margin was 10 percentage points. RESULTS: A total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<0.001 for noninferiority). At the 36-month follow-up, success was reported by 177 of 246 patients (72.0%) and by 157 of 235 patients (66.8%) in the respective groups (adjusted risk difference, 5.7 percentage points; 95% CI, -1.3 to 12.8). At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings. Over the 36-month follow-up period, the percentage of patients with tape or mesh exposure was 3.3% with mini-slings and 1.9% with midurethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively. Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group. CONCLUSIONS: Single-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months, and the percentage of patients reporting success remained similar in the two groups at the 36-month follow-up. (Funded by the National Institute for Health Research.).

First-in-man report of transsubclavian venous implantation of the Aveir leadless cardiac pacing system.

INTRODUCTION: Transsubclavian venous implantation of the Aveir leadless cardiac pacemaker (LCP) has not been previously reported. METHODS AND RESULTS: Three cases of transsubclavian implantation of the Aveir LCP are reported. Two cases were postbilateral orthotopic lung transplant, without appropriate femoral or jugular access due to recent ECMO cannulation and jugular central venous catheters. In one case, there was strong patient preference for same-day discharge. Stability testing confirmed adequate fixation and electrical testing confirmed stable parameters in all cases. All patients tolerated the procedure well without significant immediate complications. CONCLUSIONS: We demonstrate the feasibility of transsubclavian implantation of the Aveir LCP.

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

BACKGROUND: 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. 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 operator discretion. RESULTS: 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. CONCLUSION: 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.

Electrical storm after left ventricular assist device (LVAD) implantation.

INTRODUCTION: Ventricular tachycardia storm or electrical storm (ES) is a common complication following left ventricular assist device (LVAD) implantation. The factors contributing to ES and outcomes are less studied. The study aimed to determine the factors associated with ES and the probability of survival in patients undergoing LVAD in three tertiary centers over a span of 15 years. METHODS: We performed a retrospective cohort study on all patients who underwent LVAD implantation at the Mayo Clinic (Rochester, Phoenix, and Jacksonville) from January 1, 2006 to December 31, 2020. ES was defined as ≥3 episodes of sustained ventricular tachycardia over a period of 24 h with no identifiable reversible cause. Detailed chart reviews of the electronic health records within the Mayo Clinic and outside medical records were performed. RESULTS: A total of 883 patients who underwent LVAD implantation were included in our study. ES occurred in 7% (n = 61) of patients with a median of 13 days (interquartile range [IQR]: 5-297 days) following surgery. We found 57% of patients (n = 35) developed ES within 30 days, while 43% (n = 26) patients developed ES at a median of 545  (IQR 152-1032) days after surgery. Following ES, 26% of patients died within 1 year. Patients with ES had a significant association with a history of ventricular arrhythmias and implantable cardioverter defibrillator (ICD) shocks before the procedure. ES was significantly associated with reduced survival compared to patients without ES (hazards ratio [HR]: 1.92, 95% CI: 1.39-2.64, p < .001). CONCLUSION: Following LVAD implantation, the rate of ES was 7% with majority of ES occurring within 30 days of LVAD. Risk factors for ES included pre-implant history of ventricular arrhythmias and ICD shock. ES was significantly associated with reduced survival compared to patients without ES.

Use of percutaneous mechanical circulatory support for right ventricular failure.

BACKGROUND: Utilization of right ventricular mechanical circulatory support (RV-MCS) devices has been limited by a lack of recognition of RV failure as well as a lack of availability and experience with RV-MCS. AIMS: We report a single-center experience with the use of percutaneous RV-MCS and report predictors of adverse outcomes. METHODS: This was a single-center retrospective cohort study. Data from consecutive patients who received RV-MCS for any indication between June 2015 and January 2022 were included. Data on baseline comorbidities, hemodynamics, and laboratory values were collected. The primary outcome was in-hospital mortality analyzed as a logistic outcome in a multivariable model. These variables were further ranked by their predictive value. RESULTS: Among 58 consecutive patients enrolled, the median age was 66 years, 31% were female and 53% were white. The majority of the patients (48%) were hospitalized for acute on chronic heart failure. The majority of the patients were SCAI SHOCK Stage D (67%) and 34 (64%) patients had MCS placed within 24 h of the onset of shock. Before placement of RV-MCS, median central venous pressure (CVP) and RV stroke work index were 20 mmHg and 8.9 g m/m2, respectively. Median serum lactate was 3.5 (1.6, 6.2) mmol/L. Impella RP was implanted in 50% and ProtekDuo in the remaining 50%. Left ventricular MCS was concomitantly used in 66% of patients. Twenty-eight patients (48.3%) died. In these patients, median serum lactate was significantly higher (4.1 [2.3, 13.0] vs. 2.2 [1.4, 4.0] mmol/L, p = 0.007) and a trend toward higher median CVP (24 [18, 31] vs. 19 [14, 24] mmHg, p = 0.052). In the multivariable logistic model, both serum lactate and CVP before RV-MCS placement were independent predictors of in-hospital mortality. Serum lactate had the highest predictive value. CONCLUSION: In our real-world cohort, 52% of patients treated with RV-MCS survived their index hospitalization. Serum lactate at presentation and CVP were the strongest predictors of in-hospital mortality.

Independent association between IVC filter placement and VTE risk in patients with upper gastrointestinal bleeding and isolated distal DVT: A retrospective cohort study.

BACKGROUND: The placement of inferior vena cava (IVC) filters often emerges as an alternative preventative measure against pulmonary embolism in patients with upper gastrointestinal (GI) bleeding and isolated distal deep vein thrombosis (DVT). We aimed to investigate the association of IVC filter placement and the incidence of venous thromboembolism (VTE) recurrence in this patient population. METHODS: We performed a retrospective cohort study including 450 patients with upper GI bleeding and isolated distal DVT. Propensity score matching using logistic regression was conducted to mitigate potential selection bias. Logistic regression models and additional sensitivity analyses were conducted to estimate the association between IVC filter implantation and VTE recurrence. Interaction and stratified analyses were also performed according to the background covariates. RESULTS: Patients who underwent IVC filter placement were significantly younger than patients in the surveillance group (55.8 ± 9.0 vs 58.4 ± 11.2 years, p = 0.034). Patients in the IVC filter group demonstrated a higher distal thrombus burden. The VTE recurrence composite was significantly higher in patients who underwent IVC filter placement (44.1% [45/102] vs 25% [87/348], p < 0.001). Unmatched crude logistic regression analysis identified a significant association between IVC filter placement and VTE recurrence composite (OR = 2.37; 95% CI, 1.50-3.75). Sensitivity analyses yielded congruent outcomes. CONCLUSION: This study revealed an increased risk of VTE recurrence among patients receiving IVC filter placement, suggesting that IVC filter placement may not be suitable as a primary treatment for patients with upper GI bleeding and isolated distal DVT.

Subcutaneous air entrapment after subcutaneous implantable cardioverter defibrillator implantation evaluated by computed tomography.

BACKGROUND: Inappropriate shock (IAS) caused by subcutaneous air entrapment (AE) in an early period after subcutaneous implantable cardioverter defibrillator (S-ICD) implantation has been reported, however, no detailed data on air volume are available. We evaluated the subcutaneous air volume after implantation and its absorption rate one week after implantation. METHODS: Patients who underwent S-ICD implantation in our hospital received chest CT scans immediately after implantation and followed up 1 week later. The total subcutaneous air volume, air around the generator, the distal electrode, and the proximal electrode within 3 cm were calculated using a three-dimensional workstation. Fat areas at the level of the lower edge of the generator were also analyzed. RESULT: Fifteen patients received CT immediately after implantation. The mean age was 45.6 ± 17.9 (66.7% of men), and the mean body mass index was 24.3 ± 3.3. The three-incision technique was applied in seven patients and two-incision technique was in the latter eight patients. The mean total subcutaneous air volume was 18.54 ± 7.50 mL. Air volume around the generator, the distal electrode, and the proximal electrode were 11.05 ± 5.12, 0.72 ± 0.72, and 0.88 ± 0.87 mL, respectively. Twelve patients received a follow-up CT 1 week later. The mean total subcutaneous air was 0.25 ± 0.45 mL, showing a 98.7% absorption rate. CONCLUSION: Although subcutaneous air was observed in all patients after S-ICD implantation, most of the air was absorbed within 1 week, suggesting a low occurrence of AE-related IAS after a week postoperation.

Single center outcomes after temporary mechanical circulatory assist device prior to Heartmate 3 implantation - a retrospective cohort study.

Objectives. Temporary mechanical circulatory support (TMCS) has become a component in the therapeutic strategy for treatment of cardiogenic shock as a bridge-to-decision. TMCS can facilitate recovery of cardiopulmonary function, end-organ function, and potentially reduce the surgical risk of left ventricular assist device (LVAD) implantation. Despite the improvements of hemodynamics and end-organ function, post-LVAD operative morbidity might be increased in these high-risk patients. The aim of the study was to compare outcomes after Heartmate 3 (HM3) implantation in patients with and without TMCS prior to HM3 implant. Methods. In this retrospective cohort study of all HM3 patients in the period between November 2015 and October 2021, patients with and without prior TMCS were compared. Patients' demographics, baseline clinical characteristics, laboratory tests, intraoperative variables, postoperative outcomes, and adverse events were collected from patient records. Results. The TMCS group showed an improvement in hemodynamics prior to LVAD implantation. Median TMCS duration was 19.5 (14-26) days. However, the TMCS group were more coagulopathic, had more wound infections, neurological complications, and more patients were on dialysis compared with patient without TMCS prior to HM3 implantation. Survival four years after HM3 implantation was 80 and 82% in the TMCS (N = 22) and non-TMCS group (N = 41), respectively. Conclusion. Patients on TMCS had an acceptable short and long-term survival and comparable to patients receiving HM3 without prior TMCS. However, they had a more complicated postoperative course.

The Inferior Vena Cava Filter Placement Parameters May Predict Filter Retrieval Outcomes.

BACKGROUND: We aimed to investigate the potential correlation between the placement factors of various retrievable inferior vena cava filters and retrieval outcomes. Additionally, we aimed to identify the factors affecting the placement tilt of the filter. METHODS: This retrospective study was conducted at a tertiary care center to investigate patients who had previously undergone retrievable filter placement at our center and who subsequently had their filters removed between January 2020 and December 2021. Patient characteristics and filter-related factors were recorded. Complex filter retrieval was defined as cases that required a minimum of 8 minutes of fluoroscopy or that involved advanced techniques. Regression models were used to explore patient- and placement procedure-related factors that could influence retrieval outcomes and the placement tilt angle. RESULTS: The study included 163 patients, and all filters were successfully retrieved. Thirty-seven (22.7%) retrievals were classified as complex retrievals. The mean diameter of the inferior vena cava in the preplacement position for the entire cohort was 16 ± 1.8 mm. The median filter tilt angles at placement and retrieval were 5.0° (IQR, 1.8°-9°) and 4.6° (IQR, 2.1°-8.0°), respectively. The placement tilt angle was not significantly associated with complex retrieval (P = 0.59). The filter hook abutment to the vena cava wall (OR, 10.76, P = 0.003), dwell time (OR, 1.02, P = 0.029), and diameter of the vena cava (OR, 10.21, P < 0.001) were associated with complex retrieval. The diameter (P = 0.049), age (P = 0.049), and filter brand (P = 0.001) were found to be significantly associated with placement tilt. CONCLUSIONS: The inferior vena cava diameter at the time of placement predicts difficulty in filter retrieval. In addition, the filter hook abutting the inferior vena cava wall and long indwelling time may complicate retrieval. The vena cava diameter is also closely related to the degree of filter tilt.

Intracorporeal LVAD implantation in pediatric patients: A single-center 10 years' experience.

BACKGROUND: Mechanical cardiac support is currently an effective strategy to reduce morbidity and mortality in pediatric patients. However, solid evidence regarding the feasibility of intracorporeal devices in children still needs to be provided. We report our 10-year experience with intracorporeal left ventricular assist devices (LVAD) in children. MATERIALS AND METHODS: We included all patients undergoing intracorporeal, continuous-flow LVAD implantation between 2012 and 2022. Baseline and postoperative data were collected from the institutional database. RESULTS: Seven HeartWare and 4 HeartMate3 were implanted in 11 patients (median age 13.9 years, median body surface area - BSA - 1.42 m2, IQR 1.06-1.68). The most frequent indication to LVAD implant was dilated cardiomyopathy (72.7%). All candidates underwent a thorough preoperative advanced imaging. Three-dimensional reconstructions and implant fit simulation were performed when BSA was <1.2 m2, weight <30 kg, or internal transverse thoracic diameter <20 cm. There was no operative death. The most common postoperative complication was surgical re-exploration due to bleeding (27.3%). One patient died of severe neurological complications after about 3 months of hospitalization. No late deaths or unplanned re-hospitalizations occurred in the remaining 10, 6 of whom were discharged home. There were no major complications at the follow-up. All survivors underwent successful heart transplantation. CONCLUSIONS: Intracorporeal LVAD implantation proved to be a potentially feasible and safe option in young teenagers and children whose BSA was >1.0 m2. In borderline cases, the 3D reconstruction with implant fit simulation can effectively help to identify those patients who can safely undergo intrathoracic LVAD implantation.

The Degree of Inferior Vena Cava Filter Tilt Associated with Challenging Retrieval.

BACKGROUND: Inferior vena cava (IVC) filter tilt is associated with technical difficulties at the time of retrieval. However, the degree of tilt that predisposes patients to undergo complex or failed retrieval has not been defined. METHODS: The electronic charts of patients undergoing IVC filter removal between 2010 and 2019 at a single tertiary center were reviewed. Patient and procedural characteristics were recorded. Venograms of placement and retrieval procedures were reviewed, and IVC filter tilt was determined based on its deviation from the IVC axis. IVC diameter and the distance from the lowest renal vein were measured using corresponding filter's length for calibration. All measurements were performed by 3 reviewers and confirmed by 2 reviewers. Patients were divided into 2 groups: those who underwent successful removal procedures requiring standard retrieval methods ("simple retrieval group") and those who required advanced endovascular techniques or had failed completely IVC filter retrievals ("challenging retrieval group"). A regression analysis was performed to determine factors associated with challenging retrieval. RESULTS: There were 365 patients who underwent IVC filter retrieval (n = 294 (80.6%) and n = 71 (19.4%) in the simple and challenging groups, respectively) with no difference in age, sex, comorbidities, or indication between the 2 groups. Failed retrieval occurred in 21 patients (5.8%) and was more common among patients requiring advanced endovascular techniques compared to standard techniques (18.0% vs. 3.2%, P < 0.001). In the overall cohort, the mean filter tilt at the time of retrieval was 4.9° ± 4.4° [0c27°], and 145 patients (39.7%) had a filter tilt ≥5.0°. Compared to the simple retrieval group, patients in the challenging group had significantly longer dwell time, greater tilt of IVC filter during placement and retrieval, as well as higher tilt change between the 2 venograms. There was no correlation between the access site during placement and challenging retrieval. However, patients undergoing filter placement via right jugular vein had lower filter tilt as compared to femoral access. Patients with filter tilt ≥5.0° were more likely to have a challenging filter retrieval compared to patients with ˂5.0° tilt (29.7% vs. 12.7%, P < 0.001). Regression analysis showed that tilt ≥5.0° (odds ratio [OR] = 1.18 [1.11-1.25]), dwell time (OR = 1.04 [1.01-1.07]), and age (OR = 0.97 [0.95-0.99]) were independently associated with challenging retrieval. CONCLUSIONS: IVC filter tilt ≥5.0°, dwell time and age are associated with challenging retrieval. Right jugular vein access, multiple imaging projections, and careful filter manipulation during deployment should be considered to maintain tilt at ˂ 5.0° and decrease the likelihood of challenging retrieval.

HeartMate 3 implantation with an emphasis on the biventricular configuration.

OBJECTIVES: Right ventricular failure following implantation of a durable left ventricular assist device (LVAD) is a major driver of mortality. Reported survival following biventricular (BiVAD) or total artificial heart (TAH) implantation remains substantially inferior to LVAD alone. We report our outcomes with LVAD and BiVAD HeartMate 3 (HM3). METHODS: Consecutive patients undergoing implantation of an HM3 LVAD between November 2014 and December 2021, at The Alfred, Australia were included in the study. Comparison was made between the BiVAD and LVAD alone groups. RESULTS: A total of 86 patients, 65 patients with LVAD alone and 21 in a BiVAD configuration underwent implantation. The median age of the LVAD and BiVAD groups was 56 years (Interquartile range 46-62) and 49 years (Interquartile range 37-55), respectively. By 4 years after implantation, 54% of LVAD patients and 43% of BiVAD patients had undergone cardiac transplantation. The incidence of stroke in the entire experience was 3.5% and pump thrombosis 5% (all in the RVAD). There were 14 deaths in the LVAD group and 1 in the BiVAD group. The actuarial survival for LVAD patients at 1 year was 85% and BiVAD patients at 1 year was 95%. CONCLUSIONS: The application of HM 3 BiVAD support in selected patients appears to offer a satisfactory solution to patients requiring biventricular support.

Mobility Rates After Lower-Limb Amputation for Patients Treated with Physician-Led Collaborative Care Model.

BACKGROUND: Clinical outcomes after major lower-limb amputation have been historically poor. The current care provided to most amputees is often disorganized and without physician supervision. The primary purpose of this study is to examine rates of postamputation mobility achieved with a prosthesis by patients with chronic limb-threatening ischemia and/or diabetes who required major lower-limb amputation and were treated under an established physician-led collaborative care pathway. The secondary purpose is to describe the structure and utilization of the care pathway by multiple independent vascular surgery practices in the United States to enable future exploration of its impact on key clinical outcomes within this patient population. METHODS: Clinical records of 2,475 patients from 6 vascular practices that adopted this collaborative care pathway between 2017 and 2020 were retrospectively reviewed. Only records with sufficient documented histories of amputation surgeries, prosthetic services, and mobility status were included. RESULTS: Of 2,475 patient records reviewed, 1,787 patients (2,157 major amputations) were eligible for analysis. Sixty-two-point 2 percent (n = 1,111) of patients achieved mobility with the collaborative care pathway. Mobility rate varied by amputation level in the study. Prosthetic mobility was achieved in 73.5% of transtibial amputations, 40.4% of transfemoral amputations, and 35.7% of through-knee amputations, regardless of patient laterality, which is superior or equivalent to the best published rates of mobility. CONCLUSIONS: The study describes the structure and utilization of a physician-led collaborative care pathway for treating patients who require lower-limb amputation that meets 5 of the 7 recommendations from the 2019 Global Vascular Guidelines on the Management of Chronic Limb Threatening Ischemia. Internal data analysis results suggest that patients treated via this care pathway can potentially achieve improved mobility rates with a prosthesis following amputation. This collaborative care pathway should be further evaluated for its ability to directly improve mobility and other clinically relevant amputation outcomes.

A rare case of bilateral malignant glaucoma after cataract surgery with capsular tension ring implantation: a case report.

BACKGROUND: Bilateral malignant glaucoma induced by a capsular tension ring associated with ring-shaped cysts of the ciliary body post-cataract surgery is rare. Herein, we present a case to highlight the possibility of capsular tension ring-induced malignant glaucoma. CASE PRESENTATION: A 59-year-old woman underwent phacoemulsification combined with capsular tension ring implantation for cataracts and zonular fibre laxity in both eyes. Upon admission, annular ciliary masses were detected in both eyes using ultrasound biomicroscopy. Two months post-surgery, the patient experienced vision deterioration, high intraocular pressure, and an axial shallowing anterior chamber in the right eye, and responded poorly to traditional anti-glaucoma medication. Ten days later, similar symptoms appeared in the left eye. Ultrasound biomicroscopy detected contact between the ciliary body and the capsular tension ring. Subsequently, malignant glaucoma was diagnosed. Anterior and posterior capsulotomies performed peripheral to intraocular lens optics using neodymium: YAG laser restored communication and alleviated the symptoms. A one-year follow-up revealed stable intraocular pressure and anterior chamber in both eyes. CONCLUSIONS: This is the first case report of bilateral malignant glaucoma after cataract surgery induced by capsular tension ring, which is associated with bilateral ring-shaped cysts of the ciliary body. Blockage between the ciliary body and capsular tension ring was confirmed using ultrasound biomicroscopy.

Temporal Analysis in Outcomes of Long-Term Mechanical Circulatory Support: Retrospective Study.

BACKGROUND: Mechanical assist device indications have changed in recent years. Reduced incidence of complications, better survival, and the third generation of mechanical support devices contributed to this change. In this single-center study, we focused on two time periods that are characterized by the use of different types of mechanical support devices, different patient characteristics, and change in the indications. METHODS: The data were processed from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). We retrospectively defined two time intervals to reflect changes in ventricular assist device technology (period 1: 2007-2015; period 2: 2016-20222). A total of 181 patients underwent left ventricular assist device implantation. Device utilization was the following: HeartMate II = 52 (76.4%) and HeartWare = 16 (23.6%) in period 1 and HeartMate II = 2 (1.8%), HeartMate 3 = 70 (61:9%), HeartWare = 29 (25.7%), SynCardia TAH = 10 (8.8%), and BerlinHeart EXCOR = 2 (1.8%) in period 2. The outcomes of the time intervals were analyzed and evaluated. RESULTS: Survival was significantly higher during the second time period. Multivariate analysis revealed that age and bypass pump time are independent predictors of mortality. Idiopathic cardiomyopathy, bypass time, and the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) score are independent predictors of adverse events. Furthermore, the first period was noted to be at an increased risk of the following adverse events: pump thrombosis, gastrointestinal bleeding, and bleeding events. CONCLUSION: Despite the higher risk profile of the patients and persistent challenges, during the second period, there was a significant decrease in mortality and morbidity. The use of the HeartMate 3 device may have contributed to this result.

3D-printed titanium porous prosthesis combined with the Masquelet technique for the management of large femoral bone defect caused by osteomyelitis.

BACKGROUND: The treatment of infected bone defects remains a clinical challenge. With the development of three-dimensional printing technology, three-dimensional printed implants have been used for defect reconstruction. The aim of this study was to investigate the clinical outcomes of three-dimensional printed porous prosthesis in the treatment of femoral defects caused by osteomyelitis. METHODS: Eleven patients with femoral bone defects following osteomyelitis who were treated with 3D-printed porous prosthesis at our institution between May 2017 and July 2021, were included. Eight patients were diagnosed with critical-sized defects, and the other three patients were diagnosed with shape-structural defects. A two-stage procedure was performed for all patients, and the infection was eradicated and bone defects were occupied by polymethylmethacrylate spacer during the first stage. The 3D-printed prosthesis was designed and used for the reconstruction of femoral defects in the second stage. Position of the reconstructed prostheses and bone growth were measured using radiography. The union rate, complications, and functional outcomes at the final follow-up were assessed. RESULTS: The mean length of the bone defect was 14.0 cm, union was achieved in 10 (91%) patients. All patients showed good functional performance at the most recent follow-up. In the critical-sized defect group, one patient developed a deep infection that required additional procedures. Two patients had prosthetic dislocations. Radiography demonstrated good osseous integration of the implant-bone interface in 10 patients. CONCLUSION: The 3D printed prostheses enable rapid anatomical and mechanically stable reconstruction of extreme femur bone defects, effectively shortens treatment time, and achieves satisfactory clinical outcomes.

Radiological evaluation before and after treatment with an osseointegrated bone-anchor following major limb amputation-a guide for radiologists.

Osseointegrated implants have been developed to allow direct skeletal fixation of a prosthesis as an alternative to traditional socket-fitted prostheses for patients who have suffered from a major limb amputation. The implants contribute to improvements in functional outcome and quality of life and radiological evaluation plays a crucial role in pre- and post-operative assessment. This article acts as a guide for radiologists who may be tasked with providing the radiological information required by surgeons and prosthetists. We also look at the radiological appearances of complications that may arise in patients treated with an osseointegrated implant. Plain X-rays are used to screen patients who wish to undergo treatment. Limb-length X-rays are then used to measure the length of any residual bone, and comparisons can be made with the normal side (if present). From this, decisions about the likely size of the implant and the need for further amputation can be made. CT scans enable accurate assessment of the medullary cavity and cortical thickness. Post-operatively, plain X-rays form the mainstay of the routine monitoring of the bone-implant interface. Potential complications include infection, aseptic loosening, mechanical fracture of the implant and periprosthetic fracture. Infection and aseptic loosening can be seen as a lucency at the bone-implant interface which (if left untreated) can lead to loss of the implant. Implant and periprosthetic fractures are radiographically obvious. Radiologists involved in the care of patients undergoing treatment with an osseointegrated implant should become familiar with the imaging requirements so they can contribute to optimal patient outcomes.

Staged implantation of active transcutaneous bone conduction hearing devices (BCHD) after explantation of older generation bone anchored hearing aids (BAHAs): Surgical outcomes and approach to management.

PURPOSE: To evaluate outcomes following explantation of percutaneous or transcutaneous bone conduction implants (pBCIs or tBCIs) and subsequent implantation of transcutaneous active bone conduction hearing devices (BCHDs); to provide guidance regarding staging of surgery and adjunctive procedures. MATERIALS AND METHODS: Retrospective chart review of eight adult subjects (ten ears) with pBCIs or tBCIs who underwent explantation of their device and subsequent implantation with a BCHD [MED-EL BONEBRIDGE™ (n = 7, 70 %) or Cochlear™ Osia® (n = 3, 30 %)]. RESULTS: Reasons for pBCI or tBCI explantation were pain (60 %, 6/10), infection (60 %, 6/10), skin overgrowth (50 %, 5/10), and inability to obtain new processors (20 %, 2/10). Median time between pBCI or tBCI removal and BCHD staged implant was 4.7 (IQR 2.2-8.1) months. Two subjects developed complications following BCHD implantation. One had a persistent wound overlying the osseointegrated screw after removal of the pBCI abutment, requiring removal and temporalis rotational flap. Staged Osia® implantation was performed, but ultimately wound dehiscence developed over the device. The second subject experienced an infection after BONEBRIDGE™ implantation (32 days after pBCI explant), necessitating washout and treatment with intravenous antibiotics. There was subsequent device failure. CONCLUSION: The transition from a pBCI or tBCI to a novel transcutaneous device is nuanced. Staged pBCI or tBCI explantation and novel BCHD implantation with sufficient time for wound healing is vital. Adjunctive procedures to augment soft tissue in cases of prior attenuation may be required to avoid complications with larger internal devices.

Intraoperative prophylactic right ventricular assist device in prevention of postcardiotomy failure.

OBJECTIVES: In patients at risk of developing right ventricular failure after cardiac surgery, right ventricular support with a ventricular assist device may be a promising strategy to reduce mortality. We present our experience with intraoperative right ventricular assist device implantation as a prevention strategy of right ventricular failure after cardiac surgery. METHODS: Between 2016 and 2022, we implanted four right ventricular assist devices prophylactically in a series of patients with surgical indication for valvular heart disease and high risk of postoperative right ventricular failure. Indications for the right ventricular assist device were suprasystemic pulmonary hypertension or severe right ventricular dysfunction. RESULTS: Externalization of the device cannulas through intercostal spaces was performed in three patients, allowing early mobilization and withdrawal without resternotomy. Removal of the device ocurred on the eighth postoperative day. ICU and hospital length of stay was 12 (±1.6) and 23 days (±4.2) respectively. Hospital mortality was null. No patient died during follow-up, mean follow-up was 32.5 months [1-72]. Patients improved their NYHA functional class up to grade II during follow-up. CONCLUSIONS: Acute right ventricular failure after cardiac surgery remains a significant cause of morbidity and mortality. Prophylactic strategies to prevent postoperative right ventricular dysfunction may decrease the incidence of refractory postoperative right ventricular failure. We propose a novel approach to prevent right failure after cardiac surgery with prophylactic intraoperative ventricular assist device implantation.

Clinical outcomes and complications of a new high-density polyethylene-based spherical integrated porous orbital implant.

PURPOSE: To describe our experience over 6 years using a new high-density polyethylene-based spherical integrated porous orbital implants (Oculfit). METHODS: This is an observational retrospective case series study analyzing all cases requiring Oculfit implants between February 2015 and September 2021. Clinical information regarding the population included, the characteristics of the implant, and the outcomes and complications during the follow-up were noted. The success of the implant was defined according to anatomical and functional parameters. RESULTS: The study analyzed 90 cases of anophthalmic patients. The main causes for enucleation or evisceration were ocular decompensations (36.7%) and neoplasms (27.8% uveal melanoma and 7.8% retinoblastoma). Anatomical success was identified in 63 (70.0%) cases, functional success in 79 (87.8%) and complete success (anatomical + functional) in 61 (67.7%) cases. Factors associated with the functional success were age and exposure of the primary orbital implant. Complications appeared in 11 (12.2%) cases, which were completely resolved without sequelae in 4 (4.4%). Orbital explant was required in 5 (5.6%) cases. CONCLUSION: In our experience, Oculfit can be considered a useful alternative among the currently available options for orbital implants and has a good efficacy/safety profile.