12-month Follow-up Results Research Articles

First-in-human feasibility study of the aXess graft (aXess-FIH): 6-Month results.

The creation of an arteriovenous fistula (AVF) is considered the most effective hemodialysis (HD) vascular access. For patients who are not suitable for AVF, arteriovenous grafts (AVGs) are the best access option for chronic HD. However, conventional AVGs are prone to intimal hyperplasia, stenosis, thrombosis, and infection. Xeltis has developed an AVG as a potential alternative to currently available AVGs based on the concept of endogenous tissue restoration. The results of the first 6-month follow-up are presented here. The aXess first-in-human (FIH) study [NCT04898153] is a prospective, single-arm, multicenter feasibility study that evaluates the early safety and performance of the aXess Hemodialysis Graft. A total of 20 patients with end-stage renal disease were enrolled across six European investigational sites. At 6-months follow-up, all grafts were patent with primary and secondary patency rates were 80% and 100%, respectively. Three patients required a re-intervention to maintain graft patency, while one re-intervention was required to restore patency. One graft thrombosis and zero infections were reported. The expected advantages of the novel aXess Hemodialysis Graft over conventional AVGs would be evaluated by the analysis on long-term safety and effectiveness during the 5-year follow-up of the currently ongoing trial.

Prognosis for Patients after Pulmonary Embolism and its Determining Factors (Results of 12-Month Follow-Up)

INTRODUCTION: Pulmonary embolism (PE) is a cardiovascular disease with high mortality: according to autopsy data, PE is the cause of death in every tenth deceased person. Despite a relatively long history of studying PE, the literature data on this problem are scattered, incomplete and often do not represent the Russian population.
 AIM: To evaluate 12-month survival rate of patients after a past episode of PE and to establish predictors of fatal outcome.
 MATERIALS AND METHODS: The work was carried out within the Russian SIRENA register. The study included 107 patients (age median and interquartile range 63 (5274) years), who underwent inpatient treatment in Regional Clinical Cardiologic Dispensary of Ryazan (hospitalization from 01.05.2018 to 31.05.2019; inclusion period 13 months). In the period of hospitalization, the information was taken from the data of medical records and objective examinations, and after the discharge through telephone control. Follow-up period from the moment of hospitalization was 12 months; response 84.5%.
 RESULTS: The 12-month survival rate of patients with PE was 77.1%; recurrence of venous thromboembolism developed in 6.5% of patients, bleeding in 22.4% of patients. The only statistically significant predictor of the development of a fatal outcome after discharge from hospital was the presence of cancer, including that in history (relative risk (RR) 4.4; 95% confidence interval (CI) 1.414.5; p = 0.014). The leading predictors of death from the moment of hospitalization within 12 months were high risk based on the integral assessment of severity and of early death risk (RR 9.9; 95% CI 1.279.5; p = 0.031), age 65 years (RR 5.1; 95% CI 1.715.2; p = 0.003), hospitalization with other than PE primary diagnosis (RR 4.5; 95% CI 1.910.8; p = 0.001), impaired filtration function of kidneys (RR 4.3; 95% CI 1.711.1; p = 0.003). Besides, a statistically significant increase in the risk of death during this period was associated with history of atherosclerotic diseases, stroke, heart failure, oncology, hemodynamic instability in the acute period, the need for loop diuretics during hospitalization and the presence of S1Q3 syndrome.
 CONCLUSION: The mortality rate of patients with PE in one of the regional vascular centers of Ryazan in 20182019 generally agrees with the data of the previous international studies. The leading predictors of fatal outcome within 12 months from the moment of hospitalization include a severe condition of a patient at the time of hospitalization, age 65 years, untimely diagnosis of PE and reduction of filtration function of kidneys.

Observation of Visual Quality after Femtosecond Laser-Assisted Cataract Surgery Combined with Trifocal Intraocular Lens Implantation.

Objective This study is the first observation of Alcon's PanOptix trifocal intraocular lens (IOL) implanted in 55 cataract patients with femtosecond laser-assisted cataract surgery. Methods Fifty-five patients (63 eyes) with cataract were treated with femtosecond laser-assisted cataract surgery combined with trifocal IOL implantation. Visual acuity, defocus curve, higher order aberration (HOA), refractive stability, eyeglass removal rate, and satisfaction were evaluated and analyzed. Results We found that the visual acuity of patients with near, intermediate, and distance vision was better than 0.1 LogMAR at 1, 3, and 6 months after the completion of surgery. The uncorrected near visual acuity (UCNVA), uncorrected intermediate visual acuity (UCIVA), and uncorrected distance visual acuity (UCDVA) of patients at 1, 3, and 6 months after surgery were compared with those before operation, showing statistical significance. Six months after the operation, all patients' surgical eyes had a smooth transition in the defocus range from +0D to -2.5D, and the visual acuity of the surgical eyes reached a level better than 0.1 LogMAR. The statistical results of 6-month follow-up showed that the eyeglass removal rate at near, intermediate, and far distances was 100%. At 6 months postoperatively, only 1 case had nocturnal glare, which affected life; 3 cases developed glare and halo but did not affect life. The patient satisfaction rate was 98.18%. Conclusions Femtosecond laser-assisted cataract surgery with trifocal IOL implantation can remove the lens from the patient with satisfactory visual quality and significantly improve the postoperative satisfaction of the patient.

Experience of using scleroobliteration in venous angiodysplasia (results of 12-month follow-up)

AIM: To evaluate the results of using the minimally-invasive technique of scleroobliteration in patients with venous malformations.
 MATERIALS AND METHODS: From 2006 to 2020, 41 interventions were performed for venous-cavernous angiomatosis of various localization through scleroobliteration. Nineteen patients (46.3%) underwent complex treatment, which included a combination of this minimally-invasive technique with other surgical interventions (resection of angiomatous tissues, laser coagulation, and radiofrequency obliteration).
 RESULTS: Clinical improvement was achieved in 38 (92.7%) patients. According to the data of ultrasound control, 25 patients (61%) experienced no blood flow in the obliteration zone, and there was regression of the initial symptoms within 1 year of observation following intervention. The results of treatment were better due to the local spread of the angiomatous process. With diffuse forms, it was not possible to achieve a positive effect in 3 patients (11.1%).
 CONCLUSION: Scleroobliteration can provide a positive result in the treatment of patients with venous-cavernous angiodysplasia, both as an independent method and in combination with other minimally-invasive techniques.

CRYOABLATION IN ATRIAL FIBRILLATION: RATIONALE OF THE NATIONAL PROSPECTIVE REGISTRY AND PRELIMINARY RESULTS

Aim. Current registry is the continued national study on cryoablation in atrial fibrillation (AF). The aim of the project is assessment of safety and efficacy of cryoballoon ablation of pulmonary veins from AF treatment in real clinical practice prospective observation.Material and methods. The project has been developed for prospective inclusion of the data to guarded automatic informational system, on clinical data of patients, ablation parameters, repeat ablation and results of 12-month follow-up. To participate in the project in January of 2017, the representatives of 33 in-patient facilities were invited, that routinely perform the procedure.Results. Twenty five institutions confirmed their participation, and by December of 2017, the database was completed by specialists from 13 clinics: information on the ablation procedure and outcomes is included for 451 patient. The enrollment is ongoing with estimated end by January 2019; prospective follow-up to be completed by January 2020.Conclusion. Prospective registry of AF cryoablation is important for gathering of experience and common analysis of the procedures throughout the country. Detailed analysis will make it to reveal predictors of efficacy and methods for procedural risk decrease.

Brain white matter integrity in heroin addicts during methadone maintenance treatment is related to relapse propensity.

IntroductionCognitive deficits caused by heroin‐induced white matter (WM) impairments hinder addicts' engagement in and benefit from treatment. The predictive value of WM integrity in heroin addicts during methadone maintenance treatment (MMT) for future relapse is unclear.MethodsForty‐eight MMT patients were given baseline diffusion tensor imaging scans and divided into heroin relapsers (HR, 25 cases) and abstainers (HA, 23 cases) according to the results of 6‐month follow‐up. Intergroup comparisons were performed for fractional anisotropy (FA), radial diffusivity (RD), and axial diffusivity (AD). The correlation between diffusion tensor imaging indices and the degree of heroin relapse was analyzed.ResultsCompared with HA group, HR group had reduced FA in the right retrolenticular part, left anterior and posterior limb of internal capsule, bilateral anterior corona radiata, and right external capsule. Three out of the six regions showed increased RD, with no changes in AD. The FA and AD values in the left posterior limb of internal capsule correlated negatively with the heroin‐positive urinalysis rate within follow‐up.ConclusionsLower WM integrity in MMT patients may add to neurobiological factors associated with relapse to heroin use. Strategies for improving WM integrity provide a new perspective to prevent future relapse to heroin abuse.

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry.

Data from clinical trials suggested that biodegradable-polymer-based drug-eluting stents (DES) might improve long-term clinical outcomes. PROLIM (Balton, Warsaw, Poland) DES is based on a stainless steel platform with a closed cell design releasing sirolimus from biodegradable copolymer (lactic and glycolic acid) in eight weeks. In the present study the safety and the efficacy of a PROLIM stent was assessed in patients with de novo coronary lesions in 12-month clinical follow-up. It was a single-centre, observational, prospective registry to assess the safety and efficacy of a PROLIM stent implantation in all consecutive patients with de novo coronary artery lesions treated with percutaneous coronary intervention (PCI). The primary study endpoint was a composite safety (cardiac death, non-fatal myocardial infarction), and the second study endpoint was the efficacy of PROLIM implantation-clinically driven target vessel revascularisation (TVR) assessed at 12-month follow-up. One hundred patients were enrolled into the study and 118 PROLIM stents were implanted. Thirty-two (32%) patients had diabetes, 46 (46%) patients were prior PCI, and 17 (17%) patients had coronary artery bypass grafting. 67% of stented lesions were complex ones (B2/C) and 17% were bifurcations. During the 12-month follow-up primary study endpoints occurred in five (5%) patients. Two (2%) cardiac deaths were reported and three (3%) TVRs were performed, of which one was related to in-PROLIM stent restenosis. PCI with biodegradable-polymer PROLIM DES seems to be safe and effective in 12-month follow-up. A larger trial is warranted to assess clinical outcomes post PROLIM stent implantation.

Vitamin K antagonists vs. heparin for the treatment of splanchnic vein thrombosis in the isth registry : results of 12-month follow-up and a propensity score analysis

Objectives: Splanchnic vein thrombosis [SVT] is a challenging disease, because of the concurrent increased risk of bleeding and potentially life-threatening complications. We aimed to explore the actual management of SVT in a large prospective cohort and to report clinical outcomes during follow-up. Methods: Consecutive SVT patients were enrolled in a multicenter international registry, from 2008 to 2012. Clinical outcomes (major bleeding; vascular events, defined as venous or arterial thrombosis; mortality) were collected. A propensity score (PS), created from baseline characteristics of patients receiving the two main treatments (different dosages of parenteral anticoagulants vs. vitamin K antagonists [VKAs]), was used to estimate the effect of therapeutic strategies. We here report the results of the 12-month follow-up. Results: There were 613 patients enrolled: mean age 53.1 ± 14.8 years; 62.6% males. Initially, 143 patients were not anticoagulated; 175 received parenteral anticoagulants only (mean duration 6.28 ± 4.21 months) and 295 started VKAs (9.67 ± 3.53 months). Major bleeding occurred in 25 patients, 16 on treatment (4.53/100 patient-years [pt-y]) and 9 off treatment (5.45/100 pt-y); vascular events in 47 patients, 27 and 20 (7.93/100 pt-y vs. 11.85/100 pt-y); death in 79 patients, 44 and 35 (12.35/100 pt-y vs. 20.30/100 pt-y). Solid cancer, ascites, anemia, and thrombocytopenia were inversely associated with the prescription of VKAs in a binary logistic regression. Using PS based on these variables, we matched 102 patients treated with VKAs with 102 patients treated with parenteral anticoagulants. Major bleeding occurred in 5.88% vs. 0.98% for VKAs and heparin, respectively; vascular events in 2.94% vs. 8.82%; and mortality in 5.88% vs. 18.63%. Conclusion: In our cohort of SVT patients, the incidence of vascular and bleeding events at 1-year follow-up was relevant. Although the PS matching did not allow for a complete balance of heterogeneity, in designated patients VKA treatment appeared to be sufficiently safe.

ASSA14-12-11 Modified mini-crush versus Cullotte techniques in bifurcation lesions of left anterior descending artery: clinical and angiographic long-term outcome after implantation of drug-eluting stents

Background The best option on the treatment of coronary bifurcation lesions is a subject of considerable debate. However, recent evidence suggests that bifurcation lesions might be treated by drug-eluting stent on both branches using the mini-crush (MMC) with a low rate of major adverse cardiac event and restenosis. This retrospective study sought to assess the clinical and angiographic long-term outcome after implanting drug-eluting stents in the bifurcation lesions of left anterior descending artery (LAD) with the Cullotte and MMC technique. Methods From April 2003 to January 2013, 445 patients were consecutively treated with either MMC (MMC group, n = 141) or Cullotte (Cullotte group, n = 304). The results of in-hospital and 12-month clinical follow-up were analysed. The indexes of in-hospital, angiographic restenosis at 12-months and major adverse cardiac events (MACE) including death, myocardial infarction or any target lesion revascularisation were evaluated. Results The mean 12-month angiographic follow-up was completed in 63 patients (44.7%) of MMC group and in 118 patients (38.8%) of Cullotte group. The MMC group compared with the Cullotte group had significantly shorter operative time and lower main or side branches restenosis (hazard ratio [HR]: 0.41, 95% confidence interval [CI]: 0.20 to 0.85; p = 0.016; and HR 0.52, 95% CI 0.27–0.99; P = 0 .047, respectively). So, the MMC group compared with the Cullotte group had significantly lower revascularisation (HR 0.57, 95% CI 0.31–0.97; p = 0.023). After a propensity score adjustment, 2-year cumulative major adverse cardiac events were similar between groups (p = 0.16). Conclusions The modified mini-crush technique with DES can be safely performed giving complete coverage of the ostium of side branches and optimising side branch access. Both techniques of bifurcation treatment met high procedural success with low complication rates and similar major adverse cardiac event long-term outcome. However, the MMC minimised the stent structs in main branch, yields a lower restenosis rate at main or side branches.

Corticosteroid avoidance in adult kidney transplant recipients under rabbit anti-T-lymphocyte globulin, mycophenolate mofetil and delayed cyclosporine microemulsion introduction

We conducted the first prospective, randomized, open-label multicenter study in low-immunologic risk adult recipients of primary cadaver kidney transplants receiving rabbit anti-T-lymphocyte globulin, mycophenolate mofetil, cyclosporine microemulsion introduced on day 5, with and without corticosteroids. Patients were randomly assigned according to age and cold ischemia time to receive corticosteroids for at least 6 months or no corticosteroids at all. The main efficacy evaluation criterion was acute rejection (including all treated episodes and those biopsy-confirmed) during the first year following transplantation. For this purpose, this report includes the actual results of the whole 12-month follow-up of all randomized patients. For efficacy analysis, 98 patients were evaluated in the Steroid avoidance group and 99 in the Steroid maintenance group. Taken as a whole, 81% of the patients (n = 159) never received anti-rejection treatment. From the 38 patients who received anti-rejection treatment, 25 (25.5%) were in the Steroid avoidance group and 13 (13.1%) in the Steroid maintenance group (P < 0.031), experiencing respectively 17 (17.3%) and 7 (7.1%) biopsy-proven first episodes of acute rejection (P < 0.031). Borderline changes (6 vs. 3) were not considered as biopsy-proven acute rejections. Onset of first rejection was significantly shorter in the Steroid avoidance group (P < 0.027). First-line anti-rejection treatment response, need for any rescue therapy, as well as histologic severity of rejection episodes did not statistically differ between the groups. One-year post-transplantation analysis showed no differences in delayed graft function, serum creatinine, creatinine clearance, 24-h proteinuria, as well as serious adverse events between the groups. De novo diabetes (P < 0.07) or dyslipidemia (P < 0.01) as well as newly diagnosed malignancies (P < 0.059) were however more frequently observed in the Steroid maintenance group. At the end of the first post-transplant year, 99% of patients in the Steroid avoidance group and 97% of patients in the Steroid maintenance group were respectively alive (P = 0.34), with respectively 95% and 93.2% of functioning kidney grafts (P = 0.62). Our results showed that total avoidance of corticosteroids from the day of transplantation was associated with a significantly increased number of clinically diagnosed and treated, and biopsy-proven acute rejections during the first year of transplantation. Nevertheless, overall outcome, 1-year patient and graft survival as well as renal function were similar, and the patients in the Steroid avoidance group exhibited a lower incidence of de novo dyslipidemia, diabetes mellitus and malignancies often associated with steroid treatment.

Bone Marrow–Derived Aldehyde Dehydrogenase–Bright Stem and Progenitor Cells for Ischemic Repair

Adult stem cell populations selected for use in cardiovascular clinical trials typically are mononuclear cell fractions of bone marrow and peripheral blood or cells of specific cell lineages selected by surface markers such as CD34 or CD133. This article describes a potent stem and progenitor cell population identified by an intracellular marker of "stemness" that crosses multiple lineages. Aldehyde dehydrogenase (ALDH)-bright (ALDH(br)) populations isolated from bone marrow contain potent stem and progenitor cells representing all cell types thought to be needed for ischemic repair and include hematopoietic, endothelial, mesenchymal, and neural progenitor cells. An animal model of hindlimb ischemia demonstrated that the ALDH(br) population was highly effective in restoring blood flow to ischemic limbs. Based upon the accumulating evidence for a potential therapeutic effect of bone marrow-derived cells in ischemic disease in humans and the vascular regenerative potential of ALDH(br) cells in the hindlimb model, clinical trials to investigate the use of autologous bone marrow-derived ALDH(br) cells in patients with ischemic heart failure and critical limb ischemia were initiated. Study designs are described. Results of the completed study in patients with critical limb ischemia (CLI) are encouraging and are summarized. Results of 6-month follow-up for the study in ischemic heart failure are pending.

Comparison of safety and sensitivity in diagnosis of liver lesion between ultrasound-guided 16 gauges and 18 gauges core needle biopsy

To compare safety and sensitivity in diagnosis of liver lesion between ultrasound-guided 16 gauges (G) and 18 G core needle biopsy. Ultrasound-guided 16 G needle biopsy was performed in 141 patients, 77 males and 64e females, aged 51.2, and ultrasound-guided 18 G needle biopsy was performed in 105 patients, 54 males and 51 females, aged 60.1. The final diagnosis was based on the post-operative pathological examination and/or the results of 6-month follow-up. In the In the ultrasound-guided 16 G needle biopsy, 171 passes were performed with an average of 1.21 pass, a sensitivity rate of 95.9%, and a specificity rate of 100%, and abdominal pain occurred in 51 cases, and bleeding occurred in 3 cases. In the ultrasound-guided 18 G needle biopsy, 161 passes were performed with an average of 1.53 passes, a sensitivity rate of 83.8%, and a specificity rate of 100%, and abdominal pain occurred in 37 cases, and bleeding occurred in 2 cases. The number of pass of the 16 G was significantly less then that of the 128 G group (P = 0.000). The sensitivity rate of the 16 G needle biopsy was significantly higher than that of the 18 G group (P = 0.46). Ultrasound-guided 16 gauges core needle biopsy is safe for the diagnosis of hepatic disease and more sensitive than the 18 G biopsy.

287 Does intracoronary infusion of autologous bone marrow stem cells improve left ventrical function in patients with acute myocardial infarction? Results of 6-month follow-up

287 Does intracoronary infusion of autologous bone marrow stem cells improve left ventrical function in patients with acute myocardial infarction? Results of 6-month follow-up

A multicenter, partially blinded, randomised study of the efficacy of photodynamic therapy (PDT) using porfimer sodium (POR) for the ablation of high-grade dysplasia (HGD) in Barrett's esophagus (BE): Results of 6-month follow-up

A multicenter, partially blinded, randomised study of the efficacy of photodynamic therapy (PDT) using porfimer sodium (POR) for the ablation of high-grade dysplasia (HGD) in Barrett's esophagus (BE): Results of 6-month follow-up

A multicenter, partially blinded, randomised study of the efficacy of photodynamic therapy (PDT) using porfimer sodium (POR) for the ablation of high-grade dysplasia (HGD) in Barrett's esophagus (BE): Results of 6-month follow-up

A multicenter, partially blinded, randomised study of the efficacy of photodynamic therapy (PDT) using porfimer sodium (POR) for the ablation of high-grade dysplasia (HGD) in Barrett's esophagus (BE): Results of 6-month follow-up

AIDS Vaccination Studies Using an Ex Vivo Feline Immunodeficiency Virus Model: Homologous Erythrocytes as a Delivery System for Preferential Immunization with Putative Protective Antigens

Feline immunodeficiency virus (FIV) is a useful model for testing of criteria for AIDS vaccine development. In the protocol we adopted, we used a primary isolate of FIV as a source of antigen and, for challenge, plasma from cats infected with the homologous virus never passaged in vitro. Cat erythrocytes (RBC) were coated with the surface components of freshly harvested and purified FIV by means of biotin-avidin-biotin bridges and used to immunize specific-pathogen-free cats (four doses at monthly intervals; total amount of FIV antigen administered per cat, approximately 14 microg). Immunized cats developed moderate levels of antibodies directed mainly to surface components of the virion and clearly evident lymphoproliferative responses. Four months after the last dose of immunogen, FIV-immunized cats and control cats immunized with bovine serum albumin-coated RBC were challenged. Judged from the results of the subsequent 12-month follow-up, FIV-immunized cats exhibited at least some degree of protection. However, following rechallenge, most of the FIV-immunized animals became virus positive in spite of a booster immunogen dose given 2 months before the second challenge.

Nifedipine and Mortality

When an approved treatment is considered for an unapproved indication, the physician must evaluate the safety of the medication, its value in related conditions, and the individual patient. What is asked is that he make a prudent decision based upon full knowledge of the available evidence.”1 Furberg and his colleagues2 entitle their article “Nifedipine: Dose-Related Increase in Mortality in Patients With Coronary Heart Disease.” They provide a valuable service by making us think more carefully about the benefit/risk ratio of the calcium antagonists as a group. However, by touting calcium antagonists as being unsafe and possibly lethal, they also create a great deal of uncertainty and anxiety among physicians and patients. We feel that they overstate their case. The following is an attempt to show that (1) the allegations focus on short-acting nifedipine, so that even if correct, they cannot be applied to other calcium antagonists; (2) the accusation of a dose-related increase in mortality rests on a biased selection of data chosen for the meta-analysis; and (3) several of the mechanisms suggested for the proposed adverse effects are unlikely. Finally, we shall argue that pharmaceutical companies have been remiss in not obtaining outcome studies for short-acting nifedipine and for other calcium antagonists, especially in the case of ischemic heart disease. Several aspects of the Furberg paper suggest that calcium antagonists in general are accused; for example, the statement that “the literature reviews strongly suggest that the problem may go beyond short-acting nifedipine. Troubling and major adverse cardiovascular events have been linked to other calcium antagonists, primarily dihydropyridines.” It should be clearly and unequivocally stated that Furberg et al2 provide no evidence whatsoever for any adverse effect on mortality or morbidity for any other agent, with one important exception. That exception is nimodipine, approved for use in …

Regenerating hyaline cartilage in articular defects of old chickens using implants of embryonal chick chondrocytes embedded in a new natural delivery substance

Partial and full thickness defects were created mechanically in articular cartilage and subchondral bone of the tibiotarsal joint condyles of 3-year-old chickens. The wounds were then repaired using embryonal chick chondrocytes embedded in a new biocompatible, hyaluronic acid-based delivery substance. Controls were similarly operated on but received either no treatment or implants of the delivery substance only. Animals were killed from 1 week to 6 months postoperatively. Sections from the two groups were examined and compared macroscopically, histologically, and histochemically. Results of 6-month follow-up showed that only the defects of the experimental chickens were completely filled with reparative hyaline cartilage tissue, with no signs of inflammation or immunologic rejection. Initially the entire defect cavity, whether partial thickness or full thickness up to the deep regions in the subchondral bone, was filled with cartilaginous reparative tissue. Relatively rapid maturation occurred under the tidemark; chondrocytes hypertrophied, were invaded with vascular elements and ossified. In the superficial areas, the reparative tissue remained cartilaginous and matured as typical hyaline cartilage tissue. These results indicate that aged chicken cartilage and its accompanying thin and spongy osteoporotic bone offer a favorable host environment for embryonal cell implants.