Long-term single-centre large volume experience with transseptal endocardial left ventricular lead implantation.

AIMS: The aim of our study was to investigate the long-term efficacy and safety of transseptal endocardial left ventricular lead implantation (TELVLI). METHODS AND RESULTS: Transseptal endocardial left ventricular lead implantation was performed in 54 patients (44 men, median age 69, New York Heart Association III-IV stage) between 2007 and 2017 in a single centre. In 36 cases, the transseptal puncture (TP) was performed via the femoral vein, and in 18 cases, the TP and also the left ventricular (LV) lead placement were performed via the subclavian vein. An electrophysiological deflectable catheter was used to reach the LV wall through the dilated TP hole. The LV lead implantation was successful in all patients. A total of 54 patients were followed up for a median of 29 months [interquartile range (IQR) 8-40 months], the maximum follow-up time was 94 months. Significant improvement in the LV ejection fraction was observed at the 3-month visit, from the median of 27% (IQR 25-34%) to 33% (IQR 32-44%), P < 0.05. Early lead dislocation was observed in three cases (5%), reposition was performed using the original puncture site in all. The patients were maintained on anticoagulation therapy with a target international normalized ratio between 2.5 and 3.5. Four thromboembolic events were noticed during follow-up. A total of 27 patients died, with a median survival of 15 months (IQR 6-40). CONCLUSION: The TELVLI is an effective approach for cardiac resynchronization therapy (CRT) however it is associated with a substantial thromboembolic risk (7%).

Long-term Visual Outcomes and Complications of Boston Keratoprosthesis Type II Implantation.

PURPOSE: To report the long-term visual outcomes and complications after Boston keratoprosthesis type II implantation in the largest single-center case series with the longest average follow-up. DESIGN: Retrospective review of consecutive clinical case series. PARTICIPANTS: Between January 1992 and April 2015 at the Massachusetts Eye and Ear Infirmary, 48 eyes of 44 patients had keratoprosthesis type II implanted by 2 surgeons (C.H.D. and J.C.). METHODS: For each eye, data were collected and analyzed on the preoperative characteristics, intraoperative procedures, and postoperative course. MAIN OUTCOME MEASURES: Visual acuity outcomes, postoperative complications, and device retention. RESULTS: The most common indications for surgery were Stevens-Johnson syndrome in 41.7% (20 of 48 eyes) and mucous membrane pemphigoid in 41.7% (20 of 48 eyes). Mean follow-up duration was 70.2 months (standard deviation, 61.8 months; median, 52 months; range, 6 months to 19.8 years). Almost all patients (95.8%, 46 of 48 eyes) had a preoperative visual acuity of 20/200 or worse. Postoperative visual acuity improved to 20/200 or better in 37.5% (18 of 48 eyes) and to 20/100 or better in 33.3% (16 of 48 eyes) at the last follow-up visit. The most common postoperative complication was retroprosthetic membrane formation in over half (60.4%, 29 of 48 eyes). The most pressing postoperative complication was glaucoma onset or progression in about a third. Preexisting glaucoma was present in 72.9% (35 of 48 eyes). Glaucoma progressed in 27.1% (13 of 48 eyes) and was newly diagnosed in 8.3% (4 of 48 eyes) after surgery. Other postoperative complications were tarsorrhaphy revision in 52.1% (25 of 48 eyes), retinal detachment in 18.8% (9 of 48 eyes), infectious endophthalmitis in 6.3% (3 of 48 eyes), and choroidal detachment or hemorrhage in 8.3% (4 of 48 eyes). Half of eyes retained their initial keratoprosthesis at the last follow-up (50.0%, 24 of 48 eyes). CONCLUSIONS: The Boston keratoprosthesis type II is a viable option to salvage vision in patients with poor prognosis for other corneal procedures. Retroprosthetic membranes, keratoprosthesis retention, and glaucoma are major challenges in the postoperative period; however, the keratoprosthesis can still provide improved vision in a select group of patients.

Boston Keratoprosthesis Type 1: A Randomized Controlled Trial of Fresh versus Frozen Corneal Donor Carriers with Long-Term Follow-up.

PURPOSE: To compare the long-term clinical outcomes of fresh versus frozen corneal graft carriers for the Boston Keratoprosthesis type 1 (B-KPro). DESIGN: Prospective, single-center, nonblinded, randomized controlled trial. All participants were followed through the initial study protocol of 24 months and were approached to enter an extension phase, with continuing follow-up visits to 60 months. PARTICIPANTS: All patients undergoing B-KPro surgery between October 2008 and December 2009 by a single experienced surgeon at the Centre Hospitalier de l'Université de Montréal using an allograft carrier were considered. Patients were excluded if they had previously undergone B-KPro implantation. METHODS: Participants were randomized individually to receive a B-KPro using a frozen or a fresh corneal graft carrier on the basis of tissue availability on the day of surgery, as determined by the local eye bank. MAIN OUTCOME MEASURES: The primary outcome measure was device retention at 24 and 60 months. Secondary outcome measures included surgical feasibility, visual acuity (VA), and complications. RESULTS: Thirty-seven eyes of 37 patients were enrolled in the initial study protocol, with 19 eyes randomized to fresh and 18 to frozen carrier grafts. Thirty-six eyes were followed through to 24 months, with 1 lost to follow-up. Of these, 26 were enrolled in the extension (11 eyes with a frozen and 15 eyes with a fresh carrier graft). There were no differences in the baseline characteristics of patients enrolled in the extension phase versus those who were not. At 60 months, median corrected distance VA) in the fresh group had improved to 20/150 from a baseline of counting fingers, whereas the frozen group improved to 20/400 from a baseline of hand motions. Device retention was 100% at 24 months and 96% at 60 months. There were no significant differences in the rate of complications between groups. CONCLUSIONS: Fresh and frozen corneal donors offer similar clinical outcomes when used as carriers for the B-KPro, with no significant differences in device retention, visual rehabilitation, or rates of complications at 24 or 60 months.

Retention rates and benefits of Painless Punctal Plug F(TM) in dry eye patients.

In this article, the authors attempt to determine the retention rate and benefits of Painless Punctal Plug F(TM) placed in patients diagnosed with dry eye. This is a prospective, observational cohort study. Forty patients diagnosed with dry eye underwent Painless Punctal Plug F placement in the inferior puncta (80 puncta) in a private clinic from January 2010 to July 2012. Patients were then followed up monthly for seven months taking note of plug retention, spontaneous plug loss, and complications. Retention rates of patients with mean age of 58.6 years were 100% after one month, 98.75% after two months, 96.25% after three months, 95% after four months, 93.75% after five months, and 92.5% after seven months. In the 80 plugs, three plugs underwent spontaneous punctal plug loss and three plugs were removed due to local discomfort. In total, 74 out of 80 plugs remained intact after seven months of follow-up. Kaplan-Meier analysis showed that there was propensity for spontaneous punctal plug loss or plug removal in the Sjogren group as compared to the non-Sjogren group. No complications were noted such as epiphora, local inflammatory reaction, nor canalicular pyogenic granuloma except for local discomfort. This study showed that Painless Punctal Plug F has a high retention rate with the following benefits, it has one-size, fitted for small to medium puncta; extended round end which made prior dilation unnecessary and once inserted, the soft round bulb fits snugly inside the punctum preventing plug loss.

Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes.

BACKGROUND AND PURPOSE: There have recently been highly publicized examples of suboptimal outcomes with some newer implant designs used for total hip replacement. This has led to calls for tighter regulation. However, surgeons do not always adhere to the regulations already in place and often use implants from different manufacturers together to replace a hip, which is against the recommendations of the Medicines and Healthcare Products Regulatory Agency (MHRA) and the directions of the manufacturers. PATIENTS AND METHODS: We used data from the National Joint Registry of England and Wales (NJR) to investigate this practice. RESULTS: Mixing of components was common, and we identified over 90,000 cases recorded between 2003 and 2013. In the majority of these cases (48,156), stems and heads from one manufacturer were mixed with polyethylene cemented cups from another manufacturer. When using a cemented stem and a polyethylene cup, mixing of stems from one manufacturer with cups from another was associated with a lower revision rate. At 8 years, the cumulative percentage of revisions was 1.9% (95% CI: 1.7-2.1) in the mixed group as compared to 2.4% (2.3-2.5) in the matched group (p = 0.001). Mixing of heads from one manufacturer with stems from another was associated with a higher revision rate (p < 0.001). In hip replacements with ceramic-on-ceramic or metal-on-metal bearings, mixing of stems, heads, and cups from different manufacturers was associated with similar revision rates (p > 0.05). INTERPRETATION: Mixing of components from different manufacturers is a common practice, despite the fact that it goes against regulatory guidance. However, it is not associated with increased revision rates unless heads and stems from different manufacturers are used together.

Experience with Minimally Invasive Ponto Surgery and Linear Incision Approach for Pediatric and Adult Bone Anchored Hearing Implants.

PURPOSE: To compare intra- and postoperative outcomes between the standard linear incision with tissue preservation and the Minimally Invasive Ponto Surgery (MIPS). STUDY DESIGN: A non-randomized retrospective cohort series. METHODS: Medical files were reviewed of adult and pediatric bone anchored hearing implant recipients. Extracted outcomes included patient characteristics, implant survival, operative time, anesthesia use, intra and postoperative complications, soft tissue tolerability assessed by the Holger's classification, and implant stability assessed by the Resonance Frequency Analysis (RFA). Outcomes were compared between two surgeries. RESULTS: A total of 59 implants were placed (21 MIPS; 38 linear). Conductive hearing loss was the most common etiology for implantation. Surgery was conducted under local anesthesia in 67% of MIPS patients and 16% of linear patients. No intraoperative complications were reported for both surgical approaches and no implants were lost. Patients undergoing implantation via the MIPS approach displayed less skin reaction postoperatively, however this was not significant (P = .2848). The most common Holgers score for both groups was grade 1. The median and mean surgical duration for the MIPS group was statistically lower than the linear group (P = .0001). Implant stability measured by the RFA implant stability quotient was greater in the MIPS cohort. CONCLUSION: The MIPS approach seems either similar or superior to the linear approach in all perioperative outcomes evaluated. Outcomes such as surgical duration, anesthesia choice and implant stability measurements support implantation through the MIPS approach for patients meeting eligibility criteria.

Clinical outcome and risk factors for failure in late acute prosthetic joint infections treated with debridement and implant retention.

OBJECTIVES: Debridement, antibiotics and implant retention (DAIR) is the recommended treatment for all acute prosthetic joint infections (PJI), but its efficacy in patients with late acute (LA) PJI is not well described. METHODS: Patients diagnosed with LA PJI between 2005 and 2015 were retrospectively evaluated. LA PJI was defined as the development of acute symptoms (≤ 3 weeks) occurring ≥ 3 months after arthroplasty. Failure was defined as: (i) the need for implant removal, (ii) infection related death, (iii) the need for suppressive antibiotic therapy and/or (iv) relapse or reinfection during follow-up. RESULTS: 340 patients from 27 centers were included. The overall failure rate was 45.0% (153/340). Failure was dominated by Staphylococcus aureus PJI (54.7%, 76/139). Significant independent preoperative risk factors for failure according to the multivariate analysis were: fracture as indication for the prosthesis (odds ratio (OR) 5.4), rheumatoid arthritis (OR 5.1), age above 80 years (OR 2.6), male gender (OR 2.0) and C-reactive protein > 150 mg/L (OR 2.0). Exchanging the mobile components during DAIR was the strongest predictor for treatment success (OR 0.35). CONCLUSION: LA PJIs have a high failure rate. Treatment strategies should be individualized according to patients' age, comorbidity, clinical presentation and microorganism causing the infection.

Comparative Outcomes of Boston Keratoprosthesis Type 1 Implantation Based on Vision in the Contralateral Eye.

PURPOSE: To compare the outcomes of Boston keratoprosthesis type 1 implantation after failed keratoplasty in patients who are blind or sighted in the contralateral eye. METHODS: Retrospective comparative case series of Boston keratoprosthesis type I recipients performed for failed keratoplasty, between January 1, 2008, and June 30, 2016, at a single center. Patients were divided based on the best-corrected visual acuity in the contralateral eye at the time of surgery: group I, ≤20/200, and Group II, >20/200. Preoperative diagnoses, postoperative visual acuity, device retention, and postoperative complications were compared. RESULTS: Group I (37 eyes) and group II (36 eyes) had similar demographics, median preoperative best-corrected visual acuity (count fingers) in the operated eye, and median duration of postoperative follow-up (37.4 vs. 45.2 months, respectively). Keratoprosthesis retention after the first year postimplantation was significantly better in group I versus group II (P = 0.038). Sterile vitritis and sterile keratolysis occurred more frequently in group II compared with group I (P = 0.013 and P = 0.056, respectively). At final examination, visual outcomes were not significantly different between the 2 groups. CONCLUSIONS: Most patients with failed keratoplasty who were implanted with a Boston keratoprosthesis type I experienced improved vision, and visual acuity of the contralateral eye did not seem to influence the visual outcome of surgery. However, patients with good vision in the contralateral eye were more likely to experience complications, possibly because of reduced vigilance when the other eye has ambulatory vision.

Comparative study of morphological and histological changes between differently structured expanded polytetrafluoroethylene implants in an animal model.

BACKGROUND: Expanded polytetrafluoroethylene (e-PTFE) is a popular graft material used in augmentation rhinoplasty. New e-PTFE has thicker fibrils and is more compact than first developed e-PTFE. This study aimed to compare morphological and histological changes between differently structured e-PTFE implants in a rat model. METHODS: Two types of e-PTFE were implanted in the cranial region of 30 adult male rats. En bloc specimens containing the implants and surrounding soft tissues were sampled 1, 3, and 6 months after implantation. We measured the three-dimensional size of the implants over time and evaluated histological changes using light and electron microscopy. RESULTS: Grossly, no implants were extruded, and there was no evidence of wound infection. All first developed e-PTFE samples were fixed to surrounding tissues after 1 month, whereas new e-PTFE samples tended to migrate and were easily separated from surrounding tissues until 3 months after implantation. The first developed e-PTFE height diminution rate was 14.7% of the initial value after 6 months; however, new e-PTFE size was not changed. Diameter and height diminution rates for first developed e-PTFE were significantly greater than those for new e-PTFE after 6 months. Histologically, connective tissue in growth was observed in first developed e-PTFE after 1 month, and the internodal space decreased over time; however, connective tissue did not infiltrate into new e-PTFE until 6 months and the internodal space was not significantly changed. CONCLUSION: First developed e-PTFE should be carefully trimmed in augmentation because of its potential to decrease in size over time, whereas new e-PTFE is more likely to show migration and instability.