Problems, complications, and reinterventions in 4893 onlay humeral lateralized reverse shoulder arthroplasties, a systematic review: part II-problems and reinterventions.

BACKGROUND: Several modifications to the original Grammont reverse shoulder arthroplasty (RSA) design have been proposed to prevent distinctive issues, such as both glenoid and humeral lateralization. The aim of this systematic review was to determine rates of problems, complications, reoperations, and revisions after onlay lateralized humeral stem RSA, hypothesizing that these are design related. METHODS: This systematic review was performed in accordance with the PRISMA statement guidelines. A literature search was conducted (1 January 2000 to 14 April 2020) using PubMed, Cochrane Reviews, Scopus, and Google Scholar, employing several combinations of keywords: "reverse shoulder arthroplasty," "reverse shoulder prosthesis," "inverse shoulder arthroplasty," "inverse shoulder prosthesis," "problems," "complications," "results," "outcomes," "reoperation," and "revision." RESULTS: Thirty-one studies with 4893 RSA met inclusion criteria. The 892 postoperative problems and 296 postoperative complications represented overall problem and complication rates of 22.7% and 7.5%, respectively. Forty-one reoperations and 63 revisions resulted, with overall reoperation and revision rates of 1.7% and 2.6%, respectively. CONCLUSIONS: Problem, complication, and reintervention rates proved acceptable when implanting a high humeral lateralization stem RSA. The most frequent problem was scapular notching (12.6%), and the most common postoperative complication was scapular stress fracture (1.8%). An overall humeral complication rate of 1.9% was identified, whereas no humeral fractures or stem loosening were reported with short stems. Infections (1.3%) were the most common reason for component revision, followed by instability (0.8%). LEVEL OF EVIDENCE: Systematic review IV.

Problems, complications, and reinterventions in 4893 onlay humeral lateralized reverse shoulder arthroplasties: a systematic review (part I-complications).

BACKGROUND: Several modifications to the original Grammont reverse shoulder arthroplasty (RSA) design have been proposed to prevent distinctive issues, such as both glenoid and humeral lateralization. The aim of this systematic review was to determine rates of problems, complications, reoperations, and revisions after onlay lateralized humeral stem RSA, hypothesizing that these are design related. METHODS: This systematic review was performed in accordance with the PRISMA statement guidelines. A literature search was conducted (01.01.2000-14.04.2020) using PubMed, Cochrane Reviews, Scopus, and Google Scholar employing several combinations of keywords: "reverse shoulder arthroplasty," "reverse shoulder prosthesis," "inverse shoulder arthroplasty," "inverse shoulder prosthesis," "problems," "complications," "results," "outcomes," "reoperation," "revision." RESULTS: Thirty-one studies with 4893 RSA met inclusion criteria. The 892 postoperative problems and 296 postoperative complications represented overall problem and complication rates of 22.7% and 7.5%, respectively. Forty-one reoperations and 63 revisions resulted, with an overall reoperation rate of 1.7% and overall revision rate of 2.6%. CONCLUSIONS: Problem, complication, and reintervention rates proved acceptable when implanting a high humeral lateralization stem in RSA. The most frequent problem was scapular notching (12.6%), and the most common postoperative complication was scapular stress fracture (1.8%). An overall humeral complication rate of 1.9% was identified, whereas short stems reported no humeral fractures or stem loosening. Infections (1.3%) proved to be the most common reason for component revision, and instability had a complication rate of 0.8%. LEVEL OF EVIDENCE: Systematic review IV.

One-stage exchange with antibacterial hydrogel coated implants provides similar results to two-stage revision, without the coating, for the treatment of peri-prosthetic infection.

PURPOSE: Aim of this study was to verify the hypothesis that a one-stage exchange procedure, performed with an antibiotic-loaded, fast-resorbable hydrogel coating, provides similar infection recurrence rate than a two-stage procedure without the coating, in patients affected by peri-prosthetic joint infection (PJI). METHODS: In this two-center case-control, study, 22 patients, treated with a one-stage procedure, using implants coated with an antibiotic-loaded hydrogel [defensive antibacterial coating (DAC)], were compared with 22 retrospective matched controls, treated with a two-stage revision procedure, without the coating. RESULTS: At a mean follow-up of 29.3 ± 5.0 months, two patients (9.1%) in the DAC group showed an infection recurrence, compared to three patients (13.6%) in the two-stage group. Clinical scores were similar between groups, while average hospital stay and antibiotic treatment duration were significantly reduced after one-stage, compared to two-stage (18.9 ± 2.9 versus 35.8 ± 3.4 and 23.5 ± 3.3 versus 53.7 ± 5.6 days, respectively). CONCLUSIONS: Although in a relatively limited series of patients, our data shows similar infection recurrence rate after one-stage exchange with DAC-coated implants, compared to two-stage revision without coating, with reduced overall hospitalization time and antibiotic treatment duration. These findings warrant further studies in the possible applications of antibacterial coating technologies to treat implant-related infections. LEVEL OF EVIDENCE: III.

Total hip arthroplasty performed with a tissue-preserving technique using superior capsulotomy.

PURPOSE: We present a minimally invasive tissue-sparing posterior superior (TSPS) approach that intends to protect the abductor muscles during total hip arthroplasty, prevents the release of the short rotator muscles, and provides the surgeon with the option to repair the posterior capsule. We hypothesized that the TSPS technique would produce a better clinical outcome, faster recovery, and lower complication rates, and that it would not jeopardize acetabular component position. METHODS: A retrospective, observational study was conducted in a consecutive series of patients. A cohort of 130 patients (130 hips) operated with a standard posterolateral approach were compared with a cohort of 132 patients (132 hips) operated with a TSPS approach. Patients were assessed with the Harris hip score (HHS) and Western Ontario and McMaster Universities index (WOMAC), which were carried out preoperatively, one month (HHS only), three months, one year, and at four years post-operatively. RESULTS: Compared with the standard group, patients in the TSPS group showed a faster return to ambulation as reflected in better post-operative HHS and WOMAC scores up until one year (p < 0.05). No significant differences in HHS (p = 0.564) and WOMAC (p = 0.796) scores were found at the four-year follow-up. No major adverse events were observed in either group. CONCLUSION: The TSPS approach yielded better early clinical outcomes and appears to be a safe and reliable technique. However, these early differences do not appear to be sustained over time, as comparable mid-term clinical outcomes with similar complications rates were observed.

Fast-resorbable antibiotic-loaded hydrogel coating to reduce post-surgical infection after internal osteosynthesis: a multicenter randomized controlled trial.

BACKGROUND: Infection is one of the main reasons for failure of orthopedic implants. Antibacterial coatings may prevent bacterial adhesion and biofilm formation, according to various preclinical studies. The aim of the present study is to report the first clinical trial on an antibiotic-loaded fast-resorbable hydrogel coating (Defensive Antibacterial Coating, DAC®) to prevent surgical site infection, in patients undergoing internal osteosynthesis for closed fractures. MATERIALS AND METHODS: In this multicenter randomized controlled prospective study, a total of 256 patients in five European orthopedic centers who were scheduled to receive osteosynthesis for a closed fracture, were randomly assigned to receive antibiotic-loaded DAC or to a control group (without coating). Pre- and postoperative assessment of laboratory tests, wound healing, clinical scores and X-rays were performed at fixed time intervals. RESULTS: Overall, 253 patients were available with a mean follow-up of 18.1 ± 4.5 months (range 12-30). On average, wound healing, clinical scores, laboratory tests and radiographic findings did not show any significant difference between the two groups. Six surgical site infections (4.6%) were observed in the control group compared to none in the treated group (P < 0.03). No local or systemic side-effects related to the DAC hydrogel product were observed and no detectable interference with bone healing was noted. CONCLUSIONS: The use of a fast-resorbable antibiotic-loaded hydrogel implant coating provides a reduced rate of post-surgical site infections after internal osteosynthesis for closed fractures, without any detectable adverse event or side-effects. LEVEL OF EVIDENCE: 2.

Exercise training effects on elderly and middle-age patients with chronic heart failure after acute decompensation: A randomized, controlled trial.

BACKGROUND: The aim of this study was to evaluate the effect of exercise training on cardiac function in heart failure (HF) patients recently suffering from acute decompensation. Radionuclide ambulatory ventricular function monitoring (VEST) was used to detect variations in cardiac hemodynamics during training period. METHODS: This was a monocentric, randomized, controlled trial. We enrolled 72 HF patients [left ventricle ejection fraction (LVEF) <40%] within two weeks after acute cardiogenic pulmonary edema: 40 in the elderly group, 32 in the middle-aged group. Trained patients underwent a specific four-weeks exercise program (closed-chain resistive activities and abdominal exercises) which was supervised by a therapist in agreement with patients' characteristics. Catecholamines at rest, echocardiography, right-heart catheterization, and bicycle ergometer were performed. VEST was performed at the end of the 4weeks-training in all patients in order to assess patients' cardiac hemodynamics [LVEF, cardiac output (CO), stroke volume]. RESULTS: Exercise training significantly improved exercise duration, peak oxygen consumption, and ventilatory threshold both in elderly and middle-aged patients (p<0.0001) after the 4-week controlled training. Despite age (F=35.086, p<0.0001; F=16.967, p<0.0001; F=42.574, p=0.03, respectively), training reliably influence previous cardiopulmonary parameters (F=29.402, F=16.421, F=26.80, p<0.0001, respectively). Norepinephrine and epinephrine were significantly reduced in both trained groups. Peak LVEF (37.3±4.7% vs 34±6.2%, p=0.002), peak stroke volume (43.3±3.9% vs 37.5±4.3%, p=0.001), and peak CO (63.4±6.1% vs 48.2±4.7%, p<0.0001) increased in middle-aged patients after 4-week training. CONCLUSIONS: Exercise training improves cardiac performance indexes and pulmonary function in both middle-aged and elderly HF patients early after an acute episode of cardiac decompensation.

Does an Antibiotic-Loaded Hydrogel Coating Reduce Early Post-Surgical Infection After Joint Arthroplasty?

Background: Infection remains among the main reasons for joint prosthesis failure. Preclinical reports have suggested that antibacterial coatings of implants may prevent bacterial adhesion and biofilm formation. This study presents the results of the first clinical trial on an antibiotic-loaded fast-resorbable hydrogel coating (Defensive Antibacterial Coating, DAC®) in patients undergoing hip or knee prosthesis. Methods: In this multicenter, randomized prospective study, a total of 380 patients, scheduled to undergo primary (n=270) or revision (n=110) total hip (N=298) or knee (N=82) joint replacement with a cementless or a hybrid implant, were randomly assigned, in six European orthopedic centers, to receive an implant either with the antibiotic-loaded DAC coating (treatment group) or without coating (control group). Pre- and postoperative assessment of clinical scores, wound healing, laboratory tests, and x-ray exams were performed at fixed time intervals. Results: Overall, 373 patients were available at a mean follow-up of 14.5 ± 5.5 months (range 6 to 24). On average, wound healing, laboratory and radiographic findings showed no significant difference between the two groups. Eleven early surgical site infections were observed in the control group and only one in the treatment group (6% vs. 0.6%; p=0.003). No local or systemic side effects related to the DAC hydrogel coating were observed, and no detectable interference with implant osteointegration was noted. Conclusions: The use of a fast-resorbable, antibiotic-loaded hydrogel implant coating can reduce the rate of early surgical site infections, without any detectable adverse events or side effects after hip or knee joint replacement with a cementless or hybrid implant.

Ivabradine and Bisoprolol on Doppler-derived Coronary Flow Velocity Reserve in Patients with Stable Coronary Artery Disease: Beyond the Heart Rate.

INTRODUCTION: Coronary flow velocity reserve (CFVR) is an important prognostic marker in patients with stable coronary artery disease (CAD). Beta-blockers and ivabradine have been shown to improve CFVR in patients with stable CAD, but their effects were never compared. The aim of the current study was to compare the effects of bisoprolol and ivabradine on CFVR in patients with stable CAD. METHODS: Patients in sinus rhythm with stable CAD were enrolled in this prospective, randomized, double-blind trial. Patients had to be in a stable condition for at least 15 days before enrollment, on their usual therapy. Patients who were receiving beta-blockers or ivabradine entered a 2-week washout period from these drugs before randomization. Transthoracic Doppler-derived CFVR was assessed in left anterior descending coronary artery, and was calculated as the ratio of hyperemic to baseline diastolic coronary flow velocity (CFV). Hyperemic CFV was obtained using dipyridamole administration using standard protocols. After CFVR assessment, patients were randomized to ivabradine or bisoprolol and entered an up-titration phase, and CFVR was assessed again 1 month after the end of the up-titration phase. RESULTS: Fifty-nine patients (38 male, 21 female; mean age 69 ± 9 years) were enrolled. Transthoracic Doppler-derived assessment of CFV and CFVR was successfully performed in all patients. Baseline characteristics were similar between the bisoprolol and ivabradine groups. No patient dropped out during the study. At baseline, rest and hyperemic peak CFV as well as CFVR was not significantly different in the ivabradine and bisoprolol groups. After the therapy, resting peak CFV significantly decreased in both the ivabradine and bisoprolol groups, but there was no significant difference between the groups (ivabradine group 20.7 ± 4.6 vs. 22.8 ± 5.2, P < 0.001; bisoprolol group 20.1 ± 4.1 vs. 22.1 ± 4.3, P < 0.001). However, hyperemic peak CFV significantly increased in both groups, but to a greater extent in patients treated with ivabradine (ivabradine: 70.7 ± 9.4 vs. 58.8 ± 9.2, P < 0.001; bisoprolol: 65 ± 8.3 vs. 58.7 ± 8.2, P < 0.001). Accordingly, CFVR significantly increased in both groups (ivabradine 3.52 ± 0.64 vs. 2.67 ± 0.55, P < 0.001; bisoprolol 3.35 ± 0.70 vs. 2.72 ± 0.55, P < 0.001), but it was significantly higher in ivabradine group, despite a similar decrease in heart rate (63 ± 7 vs. 61 ± 6; P not significant). CONCLUSION: Ivabradine improves hyperemic peak CFV and CFVR to a greater extent than bisoprolol in patients with stable CAD, despite a similar decrease in heart rate. These data demonstrate that the benefits from ivabradine therapy go beyond the heart rate. This could be due to a different mechanism such as diastolic perfusion time, isovolumic ventricular relaxation, end-diastolic pressure, and collaterals. FUNDING: Servier.

Effects of ranolazine on noninvasive coronary flow reserve in patients with myocardial ischemia but without obstructive coronary artery disease.

INTRODUCTION: Ranolazine reduces the Na-dependent calcium overload via inhibition of the late sodium current, improving diastolic tone and oxygen handling during myocardial ischemia. In patients with angina, evidence of myocardial ischemia, but no obstructive coronary artery disease (CAD), abnormal coronary autoregulation plays a key role. Transthoracic Doppler-derived coronary flow reserve (CFR) is an index of coronary arterial reactivity and decreases in both microvascular dysfunction and coronary artery stenosis. The aim of this study was to assess the effect of ranolazine on CFR in this group of patient. METHODS: Fifty-eight (39M, 19F) patients with angina and evidence of myocardial ischemia, but no obstructive CAD, were enrolled in a double-blind, placebo-controlled trial. Participants were assigned to ranolazine (29) or placebo (29) for 8 weeks (up to 500 mg twice a day). CFR was determined as the ratio of hyperemic, induced by intravenous dypiridamole administration, to baseline diastolic coronary flow velocity. CFR was assessed before and after 8-week therapy. RESULTS: CFR was successfully performed in all patients. There were no significant differences in baseline characteristics and CFR between ranolazine and placebo group. After 8 weeks CFR significantly increased in ranolazine group (2.54 ± 0.44 vs. 1.91 ± 0.31; P = 0.005) but not in placebo group (1.99 ± 0.32 vs. 1.94 ± 0.29; P = ns). No patient dropped out during 8 weeks therapy. Side effects were similar in both groups. CONCLUSIONS: Ranolazine is able to improve CFR in these patients. This is probably due to improvement in abnormal coronary autoregulation, both reducing baseline diastolic coronary flow velocity and increasing hyperemic diastolic coronary flow velocity.

Idiopathic pulmonary fibrosis and coronary artery disease.

Idiopathic pulmonary fibrosis (IPF) is defined as a chronic fibrosing interstitial disease of unknown cause, limited to the lungs, and associated with the histopathologic and/or radiologic pattern of usual interstitial pneumonia (UIP); it generally progresses into respiratory failure and death. Although progression of the disease is the most common cause of death, there are increasing reports of its association with other pathologies has been reported: e.g., IPF patients seem more susceptible to cardiovascular diseases. Therefore, other pathologies might also influence the natural course. In this paper, we describe a case of IPF and coronary artery disease (CAD). We emphasize the importance of cardiopulmonary exercise test (CPET) as a useful procedure to monitor disease progression in IPF patients. We also stress the importance of a careful analysis of variables measured for an accurate interpretation of the clinical picture and an improvement of the clinical management of patients. Moreover, we suggest that a careful assessment of CPET parameters may additionally help in the early detection of high cardiovascular ischemic risk.

Expandable intramedullary nailing and platelet rich plasma to treat long bone non-unions.

BACKGROUND: Roentgenographic and functional outcomes of expandable self locking intramedullary nailing and platelet rich plasma (PRP) gel in the treatment of long bone non-unions are reported. MATERIALS AND METHODS: Twenty-two patients suffering from atrophic diaphyseal long bone non-unions were enrolled in the study. Patients were treated with removal of pre-existing hardware, decortication of non-union fragments, and fixation of pseudoarthrosis with expandable intramedullary nailing (Fixion, Disc'O Tech, Tel Aviv, Israel). At surgery, PRP was placed in the pseudoarthrosis rim. RESULTS: The thirteen-month follow-up showed 91% (20/22 patients) of patients attaining bony union. The average time to union was 21.5 weeks. No infection, neurovascular complication, rotational malalignment, or limb shortening >4 mm were observed. The healing rate of non-unions was comparable to that observed in previous studies but with a lower complication frequency. CONCLUSIONS: The combined use of self locking intramedullary nailing and PRP in the management of atrophic diaphyseal long bone non-unions seems to produce comparable results with less complications than previously reported. Further data are warranted to investigate the single contribution of PRP gel and Fixion nail.

[Splenic abscesses: 6 cases in 15 years]. / Gli ascessi splenici: 6 casi in 15 anni.

Splenic abscesses are a rare type of disease, owing to the quite exceptional primary forms, but the prevalence of the disease is rising as a result of the increase in the population at risk. The authors report on their experience based on 6 observations of such cases over a period of 15 years. The diagnosis was obtained by ultrasonography in all 6 cases. Only one case was successfully treated by percutaneous drainage, the other 5 all requiring splenectomy. Only one patient, suffering from Chédiak-Higashi disease, died of bronchopneumonia 6 months postoperatively. Nowadays the disease is diagnosed earlier than it was in the past owing to the increasingly widespread use and refinement of diagnostic methods, but even today identification of splenic abscess may still be late due to the presence of predisposing diseases which mask the clinical picture, and also because, since the condition is so rare, one very often fails to think of it in the early stages. An analysis of the recent literature indicates that percutaneous drainage is a reliable technique which presents a high therapeutic success rate and low cost compared to surgery. Though we believe that the ongoing progress in the fields of ultrasonography and CT-guided intervention may allow us to treat increasing numbers of patients with splenic abscesses in future, we feel, also in the light of our own experience, that splenectomy still remains the reference treatment, in that ideal conditions for successful percutaneous drainage do not often present themselves.