Dimensional analysis of the upper airway in obstructive sleep apnoea syndrome patients treated with mandibular advancement device: A bi- and three-dimensional evaluation.

BACKGROUND: The efficiency of the mandibular advancement device (MAD) in patients with obstructive sleep apnoea syndrome (OSAS) has been demonstrated. Nevertheless, the behaviour of the upper airway once MAD is placed and titrated, and its correlation with the apnoea-hypopnoea index (AHI) is still under discussion. OBJECTIVES: To analyse the morphological changes of the upper airway through a bi- and three-dimensional study and correlate it with the polysomnographic variable, AHI. METHODS: Patients were recruited from two different hospitals for the treatment of OSAS with a custom-made MAD. A cone-beam computer tomography and a polysomnography were performed at baseline and once the MAD was titrated. RESULTS: A total of 41 patients completed the study. Treatment with MAD reduced the AHI from 22.5 ± 16.8 to 9.2 ± 11.6 (p ≤ .05). There was a significant increase of the total airway volume with MAD from 21.83 ± 7.05 cm3 to 24.19 ± 8.19 cm3 , at the expense of the oropharynx. Moreover, the correlation between the improvement of the AHI and the augmentation of the volume of the upper airway was not statistically significant. CONCLUSIONS: The oral device used in this prospective study increased the mean upper pharyngeal airway volume and significantly reduced the AHI. Future studies that measure the muscular tone are needed to completely understand the association between the AHI and the physiological and anatomical response of the upper airway.

Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial.

BACKGROUND: The use of poly-l-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients. METHODS: This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment-elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69). RESULTS: Between June 2017 and June 2018, 150 ST-segment-elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P<0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm; P<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], P=0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P=1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% versus -2.4±1.3% in the SES group, P=0.003). CONCLUSIONS: When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348.

Effectiveness of a mandibular advancement device in obstructive sleep apnea patients: a prospective clinical trial.

PURPOSE: This study aimed to determine the effectiveness of a mandibular advancement device in a sample of obstructive sleep apnea syndrome patients by the evaluation of respiratory and neurophysiologic parameters and clinical symptoms. Second, the influence of certain predictor factors related with the patient and the intraoral device, were considered in the final response with this treatment option. METHODS: Forty-one patients constituted the final sample. Outcomes were measured using polysomnography, Epworth sleepiness scale and an analogue visual snoring scale, before treatment and once the device was properly titrated. RESULTS: Mean apnea-hypopnea index decreased from 22.5 ± 16.8 to 9.1 ± 11.6 (p ≤ 0.05), influencing only gender and Fujita index as predictor factors. The oxygen saturation, arousal index, percentages of sleep stages and sleep efficiency significantly improved with the mandibular advancement device (MAD) placement. The snoring index improved in absolute terms in 6.1 units and the excessive daytime sleepiness was reduced from 12.2 ± 4.7 to 8.5 ± 3.8 (p ≤ 0.00). CONCLUSIONS: The successful treatment rate with the MAD was 65.8%. The placement and posterior regulation of the intraoral appliance efficiently reduced the apnea-hypopnea index, improved the sleep quality and the clinical symptomatology associated. Obstructive sleep apnea syndrome is a highly prevalent disease. and dentists should be aware of the benefits enhanced by this prosthetic device, considered the first treatment option by certain physicians.

Correlation between Polysomnographic Parameters and Tridimensional Changes in the Upper Airway of Obstructive Sleep Apnea Patients Treated with Mandibular Advancement Devices.

BACKGROUND: The effectiveness of mandibular advancement devices has been solidly demonstrated in the past. They are considered a valid alternative treatment to continuous positive airway pressure for patients with obstructive sleep apnea. Nevertheless, the relationship between polysomnographic parameters and the increase in the volume of the upper airway in patients with obstructive sleep apnea syndrome has not been clearly established so far. This study aimed to determine the impact of these oral appliances upon the volume of the airway after the device titration phase and correlate it with the degree of mandibular advancement and the improvement of polysomnographic parameters. METHODS: All patients were diagnosed by polysomnography and were treated with a customized, titratable mandibular advancement device. Three-dimensional volumetric measurements were performed using cone beam computed tomography. RESULTS: The present study included 45 patients diagnosed with obstructive sleep apnea hypopnea syndrome (mild in 23 patients, moderate in 11 and severe in 11). Forty-four percent of the patients presented with an apnea hypopnea index <5/h at the end of treatment. The volume of the upper airway increased an average of 4.3 ± 5.9 cm3, this represents a percentage increase of 20.9%, which was significantly correlated with an apnea hypopnea index and a minimum oxygen saturation improvement. CONCLUSIONS: The mandibular advancement device used was found to be effective in improving polysomnographic parameters. Moreover, the oral appliance was able to significantly increase the tridimensional dimensions of the upper airway. Moreover, this finding was correlated with a reduction in the apnea hypopnea index (p = 0.007) and an increase on minimum oxygen saturation (p = 0.033).

Clinical and Angiographic Outcomes With Drug-Coated Balloons for De Novo Coronary Lesions: A Meta-Analysis of Randomized Clinical Trials.

Background The role of drug-coated balloons (DCBs) in the treatment of de novo coronary lesions is not well established. Methods and Results Electronic databases and major conference proceedings were searched for randomized controlled trials that compared DCBs with stents or angioplasty for de novo coronary lesions. The primary outcome was target lesion revascularization. Summary estimates were conducted using random-effects analysis complemented by several subgroup and sensitivity analyses. A total of 14 randomized controlled trials with 2483 patients were included. At a mean follow up of 12 months, DCBs were associated with no difference in the incidence of target lesion revascularization as compared with alternative strategies (risk ratio [RR], 0.79; 95% CI, 0.35-1.76). There was no difference in treatment effect based on the indication (ie, small-vessel disease, myocardial infarction, bifurcation, or high bleeding risk) (Pinteraction=0.22). DCBs were associated with lower target lesion revascularization compared with bare metal stents and similar target lesion revascularization compared with drug-eluting stents (Pinteraction=0.03). There was no difference between DCBs and control in terms of major adverse cardiac events, vessel thrombosis, or cardiovascular mortality. However, DCBs were associated with a lower incidence of myocardial infarction (RR, 0.48; 95% CI, 0.25-0.90) and all-cause mortality (RR, 0.45; 95% CI, 0.22-0.94). Conclusions In patients with de novo coronary lesions, use of DCBs was associated with comparable clinical outcomes irrespective of the indication or comparator device. DCBs had a similar rate of target lesion revascularization compared with drug-eluting stents. A randomized trial powered for clinical outcomes and evaluating the role of DCBs for all-comers is warranted.

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

OBJECTIVES: This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). BACKGROUND: Treatment of patients with DES-ISR remains a challenge. METHODS: The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. RESULTS: A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for "late" (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. CONCLUSIONS: The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940).

Treatment options for stent restenosis: insights from intracoronary imaging, clinical trials, and registries.

Although drug-eluting stents (DES) have markedly reduced the incidence of stent restenosis (SR), the increased number and complexity of percutaneous coronary interventions performed worldwide explain the sustained prevalence of SR. Intracoronary imaging techniques remain essential tools to unravel the underlying mechanical causes potentially leading to SR. Current clinical trial data suggest that DES are the most effective therapy for the management of both bare-metal stents SR and DES-SR. In this setting, however, drug-eluting balloons represent a valid therapeutic alternative with the attractive advantage of not requiring the implantation of an additional metallic layer. In this review, we will discuss trial data on the historical evolution and the evidence supporting currently available therapeutic modalities for patients with bare-metal stents SR or DES-SR.

Coronary artery aneurysm formation following implantation of a bioresorbable vascular scaffold for in-stent restenosis.

Coronary artery aneurysm (CAA) formation is a rare complication of coronary intervention that may develop after implantation of bare-metal or drug-eluting stents. The etiology of this entity appears to be multifactorial and its prognosis is poorly understood, but it has been associated with an increased risk of stent thrombosis. To date few cases of CAAs related to bioresorbable vascular scaffold (BVS) implantation have been reported, and the development of CAA after BVS implantation for the treatment of in-stent restenosis (ISR) has not been previously described. Here we present two cases of CAA formation after BVS, which represent the first demonstration of CAA formation after the use of BVS for ISR.

Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

OBJECTIVES: The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR). BACKGROUND: The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown. METHODS: The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire. RESULTS: A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p < 0.001). At 3 years, the rates of cardiac death (2% vs. 1%), myocardial infarction (4% vs. 5%) and target vessel revascularization (9% vs. 5%) were similar in the DEB and EES arms. Importantly, however, at 3 years, the rate of target lesion revascularization was significantly lower in the EES arm (2% vs. 8%; p = 0.04; hazard ratio: 0.23; 95% confidence interval: 0.06 to 0.93). The need for "late" (>1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms. CONCLUSIONS: The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953).

[Transvaginal mesh perineal repair of the rectovaginal septum in the treatment of rectocele and enterocele. Outcomes in 77 patients]. / La perineoplastia protésica del tabique rectovaginal, vía transvaginal, en el tratamiento del rectocele y enterocele. Resultados de 77 casos.

OBJECTIVE: Anatomical and functional outcomes after transvaginal perineoplasty of the vaginal septum using polypropylene mesh in 77 patients with rectocele, enterocele, or both were studied. The frequency of other associated pelvic floor defects was also analyzed. PATIENTS AND METHOD: Between 1997 and May 2005, 77 patients underwent surgery (30 for enterocele, 33 for rectocele and 14 for both defects). In all patients, complete dissection of the rectovaginal space, resection of the redundant vaginal wall tissue, suturing of the polypropylene mesh to the lateral bundles of the puborectal muscle, and posterior colporrhaphy were performed. In enteroceles, Douglas' pouch was resected before the mesh was placed. RESULTS: During follow-up, there were 3 minimal vaginal dehiscences requiring partial extirpation of the mesh in 2 (12.1%), and 1 (1.2%) rectocele recurrence. No subsequent mesh extrusions or recurrences were detected during follow-up. The frequency of associated pelvic floor disorders was 92%. CONCLUSIONS: In our experience, placement of polypropylene mesh in the rectovaginal septum with lateral suturing to puborectal muscle bundles provides excellent results compared with other approaches and meshes that are not sutured and fixed in the rectovaginal space, leading to mesh infection, extrusion or complete removal.

Specific immunotherapy with a standardized latex extract in allergic workers: a double-blind, placebo-controlled study.

BACKGROUND: Preventive measures have been proposed to reduce the risk of sensitization to natural rubber latex (NRL), but this is not always feasible. OBJECTIVE: The aim of this study was to determine the efficacy and safety of specific immunotherapy with a standardized latex extract in sensitized workers. METHODS: Twenty-four patients allergic to NRL with contact urticaria (n = 8) and rhinitis or asthma (n = 16) were included (16 in the active group and 8 in the placebo group). Treatment started in a cluster immunotherapy protocol, with injections every week for 3 months and then every other week for another 3 months. RESULTS: Patients in the active group had significantly lower values than patients in the placebo group in skin terms of reactivity to NRL (P <.01), rubbing test results (P =.047), and latex glove use test results (P =.046) after 6 months of treatment. There were no significant differences between the active and placebo groups in symptom scores, use of medication, self-assessment, or methacholine test results either before or after treatment. Differences in nasal and bronchial symptoms during specific inhalation challenges (P = not significant and P =.05, respectively) were observed in favor of the active group. In the active group 32 systemic reactions were observed (8% of doses), mostly during the build-up period, being more frequent in patients with respiratory symptoms (P =.004). All reactions responded promptly to treatment. CONCLUSION: Clinical efficacy was shown mainly on cutaneous symptoms, although an improvement in rhinitis and asthma symptoms was also observed during specific inhalation challenges. Latex-specific immunotherapy might be a useful approach for the treatment of latex allergy in sensitized workers.