Long-term outcome (5-10 years) after non absorbable mesh insertion compared to partially absorbable mesh insertion for anterior vaginal wall prolapse repair.

OBJECTIVE: To evaluate long-term (5-10 years) outcomes of Minimally Invasive Surgical (MIS) kit insertion with Prolift® (non-absorbable) mesh compared to the use of Prolift M® (partially absorbable), for anterior vaginal wall prolapse repair. STUDY DESIGN: In this retrospective study we compared women undergoing MIS kit Prolift ® insertion (n=90) vs. Prolift M® insertion (n=79) for anterior vaginal wall prolapse repair between 2006 and 2012 at our Institution. A number of 169 women fulfilled the inclusion criteria and were included in the study. RESULTS: During the study period 128 women (76%) completed full follow-up; of them 58 (73%) following MIS kit Prolift® insertion, and 70 (88%) following MIS kit ProliftM® insertion. There was no signifi cant difference between the Prolift® and Prolift M® regarding parity (3.04 vs. 2.88, p=0.506), presence of hypertension (24.1% vs. 39.1%, p=0.088), diabetes mellitus (3.4% vs. 11.6%, p=0.109), or urinary stress incontinence (39.7% vs. 47.1%, p=0.475). All participants had been diagnosed with POP grade 3 or 4 before the procedure. No significant complications during the procedure or postoperative period were identified in the study groups. The follow-up period was at least five years in duration for both groups. Both groups were comparable according to questionnaires focused on function and satisfaction. CONCLUSION: Patients undergoing MIS kit Prolift® and Prolift M® insertion for anterior vaginal wall prolapse repair had comparable early and late postoperative outcomes. No differences in patient's function and satisfaction between the two groups were identified. According to our fi ndings, there is no superiority to either of the two studied mesh devices.

Long-term outcome (5-10 years) after non absorbable mesh insertion compared to partially absorbable mesh insertion for anterior vaginal wall prolapse repair

ABSTRACT Objective: To evaluate long-term (5-10 years) outcomes of Minimally Invasive Surgical (MIS) kit insertion with Prolift® (non-absorbable) mesh compared to the use of Prolift M® (partially absorbable), for anterior vaginal wall prolapse repair. Study design: In this retrospective study we compared women undergoing MIS kit Prolift® insertion (n=90) vs. Prolift M® insertion (n=79) for anterior vaginal wall prolapse repair between 2006 and 2012 at our Institution. A number of 169 women fulfilled the inclusion criteria and were included in the study. Results: During the study period 128 women (76%) completed full follow-up; of them 58 (73%) following MIS kit Prolift® insertion, and 70 (88%) following MIS kit ProliftM® insertion. There was no significant difference between the Prolift® and Prolift M® regarding parity (3.04 vs. 2.88, p=0.506), presence of hypertension (24.1% vs. 39.1%, p=0.088), diabetes mellitus (3.4% vs. 11.6%, p=0.109), or urinary stress incontinence (39.7% vs. 47.1%, p=0.475). All participants had been diagnosed with POP grade 3 or 4 before the procedure. No significant complications during the procedure or postoperative period were identified in the study groups. The follow-up period was at least five years in duration for both groups. Both groups were comparable according to questionnaires focused on function and satisfaction. Conclusion: Patients undergoing MIS kit Prolift® and Prolift M® insertion for anterior vaginal wall prolapse repair had comparable early and late postoperative outcomes. No differences in patient's function and satisfaction between the two groups were identified. According to our findings, there is no superiority to either of the two studied mesh devices.

Predictors of long-term adverse events after Absorb bioresorbable vascular scaffold implantation: a 1,933-patient pooled analysis from international registries.

AIMS: The aim of this study was to investigate the predictors of long-term adverse clinical events after implantation of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS). METHODS AND RESULTS: We pooled patient-level databases derived from the large-scale ABSORB EXTEND study and five high-volume international centres. Between November 2011 and November 2015, 1,933 patients underwent PCI with a total of 2,372 Absorb BVS implanted. The median age was 61.0 (IQR 53.0 to 68.6) years, 24% had diabetes, and 68.2% presented with stable coronary artery disease. At a median follow-up of 616 days, MACE occurred in 93 (4.9%) patients, all-cause death in 36 (1.9%) patients, myocardial infarction in 47 (2.5%) patients, and target vessel revascularisation in 72 (3.8%) patients. Definite or probable scaffold thrombosis occurred in 26 (1.3%) patients. On multivariable logistic regression analysis, acute coronary syndromes (hazard ratio [HR] 2.79, 95% confidence interval [CI]: 1.47 to 5.29; p=0.002), dyslipidaemia (HR 1.43, 95% CI: 1.23 to 1.79; p=0.007), scaffold/reference diameter ratio >1.25 (HR 1.49, 95% CI: 1.18 to 1.88; p=0.001), and residual stenosis >15% (HR 1.67, 95% CI: 1.34 to 2.07; p<0.001) were independent predictors of MACE, whereas the use of intravascular imaging was independently associated with a reduction in MACE (HR 0.13, 95% CI: 0.06 to 0.28; p<0.001). CONCLUSIONS: Optimal Absorb BVS implantation and the use of intravascular imaging guidance are associated with lower rates of adverse events at long-term follow-up.

Ruptura de tornillo tibial interferencial biodegradable posterior a reconstrucción de ligamento cruzado anterior / Broken bioabsorbable interference tibial screw of anterior cruciate ligament reconstruction

Se presenta un reporte un caso con una ruptura de tornillo interferencial biodegradable tibial luego de la reconstrucción de ligamento cruzado anterior (LCA) con injerto cuádruple autólogo de semitendinoso y recto interno. Doce meses postoperatorios luego de una recuperación satisfactoria inicia con síntomas de bloqueo y dolor de rodilla. La Resonancia magnética (RM) mostró ruptura del tornillo tibial sin pérdida de la ubicación ni continuidad de la plástica de LCA. Se realizó extracción de la parte rota del tornillo por vía artroscópica. La paciente tuvo una recuperación completa de su rodilla. Éste caso describe posibles causas de ruptura del tornillo biodegradable y se sugiere tomar en cuenta los cuidados necesarios para evitar dicho problema.

We report a case of broken screw from the tibial site of anterior cruciate ligament reconstruction using an autologous ipsilateral semitendinosus-gracilis quadruple graft. Twelve months after initially successful ACL surgery the patient felt locking symptoms and knee pain. MRI showed a broken bioabsorbable interference tibial screw without loss of location or continuity of the ACL graft. At revision arthroscopy the broken part was removed. The patient had full recovery. This case describes possible causes of bioscrew rupture in ACL surgery and we suggest the necessary precautions to avoid this problem.

Foreign-Body Reaction and Osteolysis in Dorsal Lunate Dislocation Repair With Bioabsorbable Suture Anchor.

Background: In recent years the use of biodegradable suture anchors for treating tendon and ligament pathology in hand surgery became popular. These materials are biocompatible, radiolucent, and load sharing, as they incrementally transfer load to surrounding bone during the resorption process. Despite these numerous advantages, polyglycolic (PGA) and poly-L-lactic acid (PLLA) have become a problem because of the potential risk for foreign body reactions. Methods: This article presents a case of an intraosseous foreign body reaction and massive osteolysis of the proximal carpal after dorsal lunate dislocation repair with bioabsorbable suture anchors. Results: Because of the persistent pain and the decreased strength, a proximal row carpectomy was performed 12-months after the initial trauma. Conclusions: Hand surgeons should be aware of the possibility of a late foreign body reaction, that could be especially severe in carpal bones.

Impact of post-dilation on the acute and one-year clinical outcomes of a large cohort of patients treated solely with the Absorb Bioresorbable Vascular Scaffold.

AIMS: We sought to determine the impact of post-dilation (PD) on clinical outcomes in a large cohort of patients treated only with the Absorb Bioresorbable Vascular Scaffold (BVS). METHODS AND RESULTS: We evaluated all consecutive patients enrolled in the multicentre, single-arm ABSORB EXTEND study up to June 2013. The study allowed treatment of up to two coronaries (diameter 2.0 to 3.8 mm) and the use of overlapping (lesion length ≤28 mm). Patients with severe lesion calcification/tortuosity were excluded. Aggressive lesion predilation (balloon to artery ratio of 0.9-1.0) was mandatory, and PD was left to the operator's discretion. Patients were grouped according to whether PD was performed or not, and the one-year incidences of MACE and scaffold thrombosis were compared. A total of 768 patients were enrolled in the study; PD was performed in 526 (68.4%). There were no significant differences between the PD group and non-PD group in the majority of baseline characteristics, including the presence of moderate calcification and of B2/C lesions. Lesion length was similar (12.3±5.1 mm vs. 12.1±5.3 mm, p=0.6), as was RVD (2.6 mm for both groups, p=0.2). Residual in-scaffold stenosis (15.5±6.4% with PD, 15.0±6% without PD, p=0.3) and the need for bail-out scaffold/stent (4.2% with PD, 4.6% without PD, p=0.8) were comparable. Acute gain was higher in the non-PD group (1.14±0.3 mm vs. 1.21±0.4 mm, p=0.02). Clinical device success was 98.9% in both groups. At one year, there was no difference in MACE (5.4% in the PD group vs. 2.5% in the non-PD group, p=0.1). All individual components of TLR, death, and MI were similar as well as definite/probable scaffold thrombosis between the two groups. CONCLUSIONS: These results reflect very similar final angiographic and clinical results achieved with or without post-dilation in the treatment of low to moderately complex coronary lesions. Therefore, post-dilation should be performed whenever needed to optimise acute results.

Inflammatory reaction and tensile strength of the abdominal wall after an implant of polypropylene mesh and polypropylene/poliglecaprone mesh for abdominal wall defect treatment in rats.

PURPOSE: To compare the inflammatory reaction and the growing resistance of the abdominal wall with the use of poliglecaprone meshes and polypropylene meshes associated with poliglecaprone in the correction of abdominal defects. METHODS: Seventy-seven Wistar rats were divided into three groups: CG (non-operated animals: EG (polypropylene mesh) and UG (polypropylene and poliglecaprone mesh). A muscular and aponeurotic defect was formed and treated according to the group. Evaluations were made after 4, 7, 14, 28 and 56 days. The resistance and inflammatory pattern were studied. RESULTS: There was a gradual and significant gain in resistance, regularly in the EG and irregularly in the UG, which was lower on the 14th day (p=0.008). The inflammatory reaction was acute and more intense in the UG on the fourth day. At all other times, the inflammatory pattern was acute to chronic, similar in both groups, with minimum intensity on the 56th day. CONCLUSION: The greater resistance offered by the polypropylene mesh was regular and ascending, stabilizing on the 28th day, while that of the polypropylene/poliglecaprone was not even. In the end, the resistances were similar. The inflammatory response was greater in the UG on the fourth day and similar at all other times.

Adverse events associated with biodegradable lactide-containing suture anchors.

PURPOSE: To evaluate the occurrence of adverse events and inflammatory reactions related to the use of biodegradable anchors. METHODS: A retrospective review of a consecutive series of arthroscopic shoulder procedures using biodegradable suture anchors performed by a single surgeon was undertaken. The database was purged of patient identifiers. The blinded data were analyzed for procedure type, anchor type and composition, associated procedures, and general demographic data. Anchor composition and number were recorded. A shoulder procedure after the index operation was considered an adverse event. The nature of these procedures was evaluated using medical records, operative images, and video, looking specifically for inflammatory reactions. Any anchor-related issues were documented. RESULTS: Three hundred sixty cases met the inclusion criteria. The procedure was a tendon repair (rotator cuff or biceps) in 265 cases and a labral repair (instability or SLAP) in 97, 2 of which were combined instability and tendon repairs. Nine different biodegradable anchors were identified, possessing 4 different polymer combinations. Adverse events (reoperations) were identified in 18 of 360 patients (5%): 13 tendon repairs and 5 labral/instability repairs. Only 2 were anchor related. In 1 tendon repair case, the anchor broke and an anchor fragment required removal. In 1 labral repair case, the anchor eyelet (a suture) loosened from the anchor body and eroded the humeral head. No cases of inflammatory synovitis were observed. No statistical difference in adverse event rates existed between tendon and labral repairs (P > .05). CONCLUSIONS: Anchor-specific adverse events occurred in 2 of 360 procedures (0.5%). One was anchor design related (the prominent head containing the suture eyelet broke off) in a poly-L-lactic acid (PLLA) anchor. One was anchor material related and occurred when the poly-levo (70%)/dextro (30%)-lactide anchor body reabsorbed, loosening the encased eyelet suture and allowing this suture to migrate into the joint. No inflammatory reactions were documented in the slowly degrading pure PLLA or more rapidly degrading biocomposite PLLA/ß-tricalcium phosphate-based anchors. LEVEL OF EVIDENCE: Level IV, retrospective review, therapeutic study.

Inflammatory reaction and tensile strength of the abdominal wall after an implant of polypropylene mesh and polypropylene/poliglecaprone mesh for abdominal wall defect treatment in rats

PURPOSE: To compare the inflammatory reaction and the growing resistance of the abdominal wall with the use of poliglecaprone meshes and polypropylene meshes associated with poliglecaprone in the correction of abdominal defects. METHODS: Seventy-seven Wistar rats were divided into three groups: CG (non-operated animals: EG (polypropylene mesh) and UG (polypropylene and poliglecaprone mesh). A muscular and aponeurotic defect was formed and treated according to the group. Evaluations were made after 4, 7, 14, 28 and 56 days. The resistance and inflammatory pattern were studied. RESULTS: There was a gradual and significant gain in resistance, regularly in the EG and irregularly in the UG, which was lower on the 14th day (p=0.008). The inflammatory reaction was acute and more intense in the UG on the fourth day. At all other times, the inflammatory pattern was acute to chronic, similar in both groups, with minimum intensity on the 56th day. CONCLUSION: The greater resistance offered by the polypropylene mesh was regular and ascending, stabilizing on the 28th day, while that of the polypropylene/poliglecaprone was not even. In the end, the resistances were similar. The inflammatory response was greater in the UG on the fourth day and similar at all other times. .

Safety and efficacy of biolimus-eluting stent with biodegradable polymer: insights from EINSTEIN (Evaluation of Next-generation drug-eluting STEnt IN patients with coronary artery disease) Registry.

OBJECTIVE: To evaluate the incidence of major adverse cardiac events (cardiac death, or acute myocardial infarct, or target vessel revascularization) at one year in "real world" patients. METHODS: The EINSTEIN registry is an observational, prospective, single center study that consecutively included 103 patients (152 lesions) treated with the BiomatrixTM stent, a biolimus A9-eluting stent with biodegradable polymer. RESULTS: The mean age was 65.0±12.4 years; male gender represented 83.5% of the patients; and 37.9% of them were diabetic. At one-year, major adverse cardiac events occurred in 11.7% of the patients, including 2.9% of cardiac death, 4.9% of with non ST- segment elevation acute myocardial infarction, and 3.9% of target vessel revascularization. Stent thrombosis occurred in only 1% (1 patient) at one-yearfollow-up. CONCLUSION: The present Registry suggests that new generation biolimus A9 drug-eluting stents are safe and effective in a "real world", all-comers patients, showing low rates of major cardiac adverse events on long-term follow-up.

Comparison between unidirectional barbed and polyglactin 910 suture in vaginal cuff closure in patients undergoing total laparoscopic hysterectomy.

The aim of the study was to compare the efficacy and safety of barbed unidirectional vs. polyglactin 910 suture in vaginal cuff closure on patients submitted to total laparoscopic hysterectomy. From November 2011 until March 2012, a prolective, comparative, longitudinal, non-randomized study was performed on patients submitted to total laparoscopic hysterectomy (TLH). On entry, patients were assigned to two different groups, Group 1: Vaginal cuff closure with unidirectional #00 (n = 25) barbed suture, and Group 2: Vaginal cuff closure with polyglactin 910 #1 suture. The length of closure time and the frequency of dehiscence in vaginal vault were measured on the 14th postoperative day. We did not find significant differences between the groups on the general characteristic analysis. However, significant differences were found (P = .029) in the average vaginal cuff closure time (12.7 ± 3.1 min. for barbed suture group vs. 20.4 ± 7.1 min. for polyglactin 910 group). No dehiscence case was found in any group. Based on the results of this study, we can conclude that unidirectional barbed suture reduces the surgical time for vaginal cuff closure during total laparoscopic hysterectomy and doesn't increase the vaginal cuff dehiscence risk.

Stent selection in patients with myocardial infarction: drug eluting, biodegradable polymers or bare metal stents?

Percutaneous coronary intervention (PCI) has been increasingly used in the last years during interventional procedures in patients with acute coronary syndromes (ACS) including ST elevation myocardial infarction (STEMI) and non-ST elevation myocardial infarction (NSTEMI). In patients with either STEMI, NSTEMI, high risk ACS with EKG changes or cardiac enzymes rises; PCI with bare metal stent (BMS) implantation has been associated with a significant improvement in clinical outcome. Therefore, BMS implantation during primary PCI in STEMI has become a standard of practice. With the introduction of drug eluting stents (DESs) in this decade, the use of these new devices instead of BMSs in patients with STEMI has emerged as a rational PCI alternative in this particular subgroup of patients. In spite of the unquestionable benefits of DESs in terms of reduction of restenosis and TVR, specific concerns have arisen with regard to their long-term safety. High incidence of very late stent thrombosis has been described with these devices, and special attention should be paid in patients with unstable coronary lesions, in which plaque composition and remodeling may play a main role in their safety and long-term outcome. Intraluminal thrombus caused by plaque rupture is the most frequent mechanism of STEMI, in which the necrotic core and thin fibrous cap play a major role. In this context, the use of first DESs designs may be futile or even unsafe because delayed healing may further contribute to plaque instability. Adjunctive invasive imaging tools can improve stent deployment and safety outcome in these lesions with intravascular findings of plaque instability. Recently, other players such as new dedicated antithrombotic BMS designs, including selfexpanding stents or drug-eluting coated balloons, are exploring their potential indications in patients with ACS and myocardial infarction. This paper reports and discusses new stent devices and adjunctive pharmacologic agents. It also mentions and describes the recent patents of devices invented to use in these complex lesions subsets.

[Foreign body reaction to biodegradable esophageal prosthesis. A case report]. / Reacción a cuerpo extraño de una prótesis esofágica biodegradable. Informe de un caso.

Although benign esophageal stricture induced by various factors can often be managed with dilatations using hydrostatic balloons or different dilators, some patients have esophageal stenosis that is refractory to such treatment. Endoprothesis have facilitated the palliation of malignant esophageal strictures. However, the indications for permanent esophageal stenting in patients with benign esophageal strictures have not been established. Everyday, the use of plastic self-expanding endoprosthesis is more common in esophageal strictures because of their advantages over metallic stents, ease of placement and retrieval, and limited local tissue reaction. More recently, biodegradable stents have been used to manage benign esophageal stenosis. We report a case of a 72 years woman who was attended because of the presence of esophageal stenosis secondary to caustic ingestion refractory to dilatation, was placed a biodegradable stent and developed a foreign body reaction.

Evaluación de la respuesta hística del beta fosfato tricálcico (Biograft-G) como implante óseo / Histological evaluation of tricalcium beta phosphate (Biograft-G) as bone implant

Con el objetivo de determinar la histocompatiblidad y las propiedades de osteoconducción y biodegradación del Biograft-G (beta fosfato tricálcico sintético) obtenido por el Centro de Biomateriales de la Universidad de La Habana, se usaron para esta experiencia, 10 perros Beagle, a los cuales se les realizaron implantes de Biograft-G en fémur y mandíbula, con sus correspondientes controles. Estos animales fueron sacrificados en los siguientes periodos: a los tres y seis meses; y al año y dos años de implantados. Se obtuvo muestras de tejido en bloque del hueso implantado las cuales se fijaron en formol neutro y posteriormente procesadas, previa descalcificación, por el método de inclusión en parafina y coloreadas con Hematoxilina y Eosina. El estudio se realizó con microscopio óptico. Los resultados permitieron determinar que el Biograft-G resultó ser un material histocompatible, osteoconductor y biodegradable(AU)

With the aim to determine the histocompatibility, osteoconduction properties and biodegradation of synthetic tricalcium beta phosphate (Biograft-G) obtained in the Biomaterials Centre of Havana University we developed an experimental study using 10 Beagle dogs in which were placed Biograft-G implants in femur and jaw bones with their corresponding controls. The animals were sacrificed in three different periods: 3, 6 months, one and two years time of implantation. Block bone samples were obtained, fixed in 10 percent neutral formalin, decalcified and processed with the paraffin inclusion method and stained with Haematoxylin and Eosin. The study was carried out with optical microscope. We conclude that, according to the results obtained, Biograft-G is a histocompatible, osteoconductor and biodegradable material(AU)

Root resorption and ankylosis associated with guided tissue regeneration.

BACKGROUND: Root resorption and ankylosis have been reported rarely as sequelae to guided tissue regeneration (GTR). The authors describe a clinical case of root resorption following GTR that involved the use of a bioabsorbable membrane. CASE DESCRIPTION: Two years after GTR was performed on a Class II furcation defect, the clinical examination revealed root resorption reaching the pulp chamber. The furcation defect was filled with epithelium and connective tissue, which contained inflammatory infiltrate and fragments of the membrane. The authors also observed areas of the tooth that exhibited points of ankylosis and root resorption. CLINICAL IMPLICATIONS: Clinical trials have reported favorable clinical and histologic results with GTR. However, this case report, along with other case reports and studies in animals, suggests a high risk of root resorption and ankylosis after GTR, which could limit the indications for this technique.

Tissue response to poly-L-lactide acid-polyglycolic acid absorbable screws in autogenous bone grafts: a histologic morphological analysis.

OBJECTIVES: To evaluate the local bone condition of autogenous chin grafts in contact with resorbable polymers fixation devices. MATERIAL AND METHODS: Seven patients presenting severe maxillary and mandibular atrophy underwent alveolar ridge reconstruction with autogenous chin grafts fixed with conventional metallic screws, who received poly L-lactide acid-polyglycolic acid and titanium test screws for histological evaluation after 4 months of implantation. RESULTS: Viable bone tissue could be seen in the specimens related to titanium test screws, with no signs of bone resorption or inflammation. A thick layer of fibrous connective tissue was observed between the resorbable test screws and bone tissue, which presented a few areas of resorption. CONCLUSION: There are no contraindications of both materials for use as fixation devices in autogenous bone grafts. However, care must be taken when using absorbable screws in a period of 4 months, which can interfere with the sequence of the treatment with endosseous dental implants.