Safety and efficacy of a device to narrow the coronary sinus for the treatment of refractory angina: A single-centre real-world experience

Objective

The coronary sinus Reducer is a recently introduced device to treat patients with severe angina symptoms refractory to optimal medical therapy and not amenable for conventional revascularisation. We aimed to assess the safety and efficacy of the Reducer in a real-world cohort of patients with refractory angina.

Methods

This is a single-centre retrospective registry. Patients with severe angina symptoms, objective evidence of myocardial ischaemia using any adequate non-invasive modality and without options for conventional revascularisation were regarded eligible for Reducer implantation.

Results

Twenty-three patients (74?% male, mean age 70?±?8 years, 91.3?% previous bypass surgery, 82.6?% previous percutaneous intervention, 47.8?% previous myocardial infarction, 52.2?% diabetes mellitus) underwent Reducer implantation. The safety endpoint (successful implantation of the first device without device-related adverse events) was met in all patients. After a median follow-up of 9 (8–14) months the efficacy (any reduction in Canadian Cardiovascular Society (CCS) class and revascularisation-free survival) was reached in 17 patients (74?%): 8 patients (34.8?%) improved by 1 CCS class, 7 (30.4?%) by 2 CCS classes and 2 (8.7?%) by 3 CCS classes. One patient died 4 months after implantation because of progressive heart failure (not associated with Reducer implantation).

Conclusion

In this single-centre real-world experience, Reducer implantation was safe and demonstrated excellent clinical efficacy in the treatment of refractory angina at mid-term follow-up.

     

Everolimus-eluting bioresorbable vascular scaffold in daily clinical practice: A single-centre experience

Background

Recent evidence has raised concerns regarding the safety of the everolimus-eluting bioresorbable vascular scaffold (E-BVS) (Absorb, Abbott Vascular, Santa Clara, CA, USA). Following these data, the use of this device has diminished in the Netherlands; however, daily practice data are limited. Therefore we studied the incidence of safety and efficacy outcomes with this device in daily clinical practice in a single large tertiary centre in the Netherlands.

Methods

All E?BVS treated patients were included in this analysis. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel non-fatal myocardial infarction (TV-MI) and clinically-driven target lesion revascularisation (TLR). The secondary endpoint was the incidence of definite scaffold thrombosis.

Results

Between October 2013 and January 2017, 105 patients were treated with 147 E?BVS. This population contained 42 (40%) patients with diabetes mellitus and 43 (40.9%) undergoing treatment for acute coronary syndrome, and thus represents a high-risk patient cohort. Mean follow-up was 19.8 months. Intravascular imaging guidance during scaffold implantation was used in 64/105 (43.5%) patients. The primary endpoint (TLF) occurred in 3 (2.9%) patients. All-cause mortality and cardiac mortality occurred in 2 (2%) and 0 (0%) patients respectively. TV-MI occurred in 2 patients (1.9%): both were periprocedural and not related to the BVS implantation. TLR occurred in 1 patient (1.0%) during follow-up. No definite scaffold thrombosis occurred during follow-up.

Conclusion

This single-centre study examining the real-world experience of E?BVS implantation in a high-risk population shows excellent procedural safety and long-term clinical outcomes.

     

Off-site primary percutaneous coronary intervention in a new centre is safe: comparing clinical outcomes with a hospital with surgical backup

Objectives

To evaluate the procedural and clinical outcomes of a new primary percutaneous coronary intervention (PPCI) centre without surgical back-up (off-site PCI) and to investigate whether these results are comparable with a high volume on-site PCI centre in the Netherlands.

Background

Controversy remains about the safety and efficacy of PPCI in off-site PCI centres.

Methods

We retrospectively analysed clinical and procedural data as well as 6?month follow-up of 226 patients diagnosed with ST-elevated myocardial infarction (STEMI) who underwent PPCI at VieCuri Medical Centre Venlo and 115 STEMI patients who underwent PPCI at Catharina Hospital Eindhoven.

Results

PPCI patients in VieCuri Medical Centre had similar procedural and clinical outcomes to those in Catharina Hospital. Overall there were no significant differences. The occurrence of procedural complications was low in both groups (8.4?% VieCuri vs. 12.3?% Catharina Hospital). In the VieCuri group there was one procedural-related death. No patients in either group needed emergency surgery. At 30 days, 17 (7.9?%) patients in the VieCuri group and 9 (8.1?%) in the Catharina Hospital group had a major adverse cardiac event.

Conclusion

Performing PPCI in an off-site PCI centre is safe and effective. The study results show that the procedural and clinical outcomes of an off-site PPCI centre are comparable with an on-site high-volume PPCI centre.

     

Trends in service time of pacemakers in the Netherlands: a long-term nationwide follow-up study

Aims

After decades of experience and strongly improved technology, service time of pacemaker generators is expected to increase. To test this hypothesis, we conducted a retrospective review of a large cohort of patients with a pacemaker.

Methods

We reviewed data collected between 1984 and 2006 in the first national Dutch pacemaker registry. This registry covered 96% of all generators implanted. We analysed the time of and reason for explantation of pacemaker generators. A 7-year follow-up interval after first implantation and following replacements was used to analyse changes over time.

Results

During 22 years of data collection, nearly 97,000 first pacemaker generators were implanted. A total of 27,937 (22.4%) generators were explanted within a mean of 6.3 (standard deviation 3.3) years. Reasons for approximately 60% of these explantations were ‘end of life’ of the pacemaker generator or elective system change. Complications or failures such as infections and recalls accounted for approximately 20% of the explantations. For the remaining 20%, the reasons for explantation had not been registered.

Conclusion

Despite progress in technology, a substantial proportion of pacemaker generators is explanted before its expected service time, with one in five generators being replaced due to technical failures, infections or other complications. Furthermore, the time interval between pacemaker implantation and explantation due to normal ‘end of life’ (battery EOL) decreased. Infections continue to rank highly as a cause for pacing system replacement, despite all current preventive measures.

     

Simulation of a balloon expandable stent in a realistic coronary artery—Determination of the optimum modelling strategy

Computational models of stent deployment in arteries have been widely used to shed light on various aspects of stent design and optimisation. In this context, modelling of balloon expandable stents has proved challenging due to the complex mechanics of balloon–stent interaction and the difficulties involved in creating folded balloon geometries. In this study, a method to create a folded balloon model is presented and utilised to numerically model the accurate deployment of a stent in a realistic geometry of an atherosclerotic human coronary artery. Stent deployment is, however, commonly modelled by applying an increasing pressure to the stent, thereby neglecting the balloon. This method is compared to the realistic balloon expansion simulation to fully elucidate the limitations of this procedure. The results illustrate that inclusion of a realistic balloon model is essential for accurate modelling of stent deformation and stent stresses. An alternative balloon simulation procedure is presented however, which overcomes many of the limitations of the applied pressure approach by using elements which restrain the stent as the desired diameter is achieved. This study shows that direct application of pressure to the stent inner surface may be used as an optimal modelling strategy to estimate the stresses in the vessel wall using these restraining elements and hence offer a very efficient alternative approach to numerically modelling stent deployment within complex arterial geometries. The method is limited however, in that it can only predict final stresses in the stented vessel and not those occurring during stent expansion, in which case the balloon expansion model is required.     

Gastric duplication cyst in an adult with autoimmune hemolytic anemia: a case report and review of the literature

Background

Gastric duplication cysts are uncommon congenital anomalies found primarily in children and rarely seen in the adult population. Accurate diagnosis of cysts before resection is difficult even using the most advanced imaging techniques.

Case presentation

In this report, we describe a 28-year-old Moroccan patient with a history of autoimmune hemolytic anemia who presented with an asymptomatic abdominal cystic mass detected during abdominal computed tomography performed before splenectomy. Magnetic resonance imaging performed for accurate characterization showed a high-signal-intensity cystic mass on T2-weighted images, located between the patient’s stomach and spleen. The patient underwent a complete cyst resection during exploratory laparotomy. The histological examination showed a cyst lined by three different epithelia with bundles of smooth muscle, which suggested a gastric duplication cyst.

Conclusions

We report a case of gastric cyst duplication in an adult with autoimmune hemolytic anemia, and we discuss this rare association, radiological findings, and the unique histological findings of this case.

     

Breast metastasis from squamous cell carcinoma of the oropharynx: a case report

Background

Breast metastases from extramammary tumors are extremely rare, the most common primary tumors being contralateral breast carcinoma, followed by lung, gynecological, gastrointestinal, melanoma, and hematological cancers. Only a few cases deriving from head and neck squamous cell carcinoma have been reported in the literature to date.

Case presentation

We report a case of a 47-year-old Caucasian woman who presented to our hospital with a solitary breast lesion in the right upper external quadrant associated with multiple bone and visceral metastases. Two years before, she had undergone radical resection of a squamous cell carcinoma of the oropharynx (stage pT2, pN1), which was followed by adjuvant radiotherapy. Breast ultrasound showed a hypoechogenic tumor lesion of 4 cm in the right upper external quadrant that was associated with multiple axillary and infra-/supraclavicular adenopathies. A positron emission tomographic scan documented multiple visceral and bone metastases with a single hypermetabolic lesion of the right breast. The results of histology and immunohistochemistry were consistent with a metastasis from a squamous cell carcinoma. The patient died of acute respiratory insufficiency 1 month after her breast metastasis diagnosis and before starting any systemic antitumoral treatment.

Conclusions

Although breast metastases are extremely rare, they should be considered in any patient with a history of cancer and confirmed by histology and immunohistochemistry because they are very difficult to distinguish from other primary breast tumors based only on clinical and radiological features. There are no standardized treatment guidelines for breast metastasis management. Surgery and radiotherapy can play a role in symptom palliation, but they do not have any relevant impact on survival, the prognosis being poor, with an estimated overall survival less than 1 year from diagnosis.

     

Müllerian adenosarcoma of the uterus: report of a case with imprint cytology

BACKGROUND: Müllerian adenosarcoma is a rare morphologic variant of uterine sarcoma that, although well described histologically, is scarcely mentioned in the cytologic literature. CASE: A 75-year-old female was suspected of having atypical endometrial hyperplasia on an endometrial smear. However, subsequent imaging techniques revealed the presence of a bulky, polypoid mass filling the uterine cavity. On pathologic examination of the hysterectomy specimen, the polypoid tumor was diagnosed as mullerian adenosarcoma, homologous, with sarcomatous overgrowth, in which the sarcomatous component was compatible with high grade endometrial stromal sarcoma. Imprint smears of the tumor consisted of two morphologic patterns, sarcomatous and glandular. The sarcomatous tumor cells, with coarse chromatin and relatively scant cytoplasm, formed small aggregates or appeared alone. These cells were semiround or oval and had conspicuous nucleoli. In addition to these observations, small and large clusters of glandular cells with mild atypism were interspersed with the sarcomatous cells. CONCLUSION: Cytologic examination of müllerian adenosarcoma well reflects its pathologic features.     

Design of commissioning process for Halcyon™ linac with a new rigid board: A clinical experience

PurposeThis study performed the accurate measurements of beam profiles with a new rigid board, which was consistent with the supplied reference beam profiles (RBPs) for clinical Halcyon model.MethodsPercentage depth doses (PDDs), lateral and diagonal dose profiles were measured and compared with RBPs. A water tank was set on the rigid board bridged Halcyon bore without sagging and source-to-surface distance was 90.0 cm. Field sizes were from 2.0 to 28.0 cm squares and depths of lateral and diagonal dose profiles were 1.3, 5.0, 10.0, and 20.0 cm. For the PDD, the depth of maximum dose (d_max), PDD value at depth of 10.0 cm (PDD₁₀), and absolute dose difference (DD) between RBP and measured beam profiles (MBP) were evaluated. For lateral and diagonal dose profiles, DDs for the whole and divided areas (central, shoulder, and extended areas) defined by third derivative, and distance-to-agreement (DTA) in the penumbra area were evaluated.ResultsFor PDDs, the differences of d_max and PDD₁₀ and DD beyond the d_max were within 1.0 mm, 0.3%, and 1.0%, respectively. For lateral and diagonal dose profiles, the DDs reached approximately 5.0% in the whole area because of penumbra area, while the DDs in the central, shoulder, and extended areas were within 1.0%, 2.0%, and 1.0%, respectively. The DTAs in the penumbra area were within 0.8 mm.ConclusionsThe supplied RBPs can be used clinically owing to the good agreement with the accurate MBPs with rigid board.     

Inheritance of the replication complex: a unique or common phenomenon in the control of DNA replication?

Early models of the regulation of initiation of DNA replication by protein complexes predicted that binding of a replication initiator protein to a replicator region is required for initiation of each DNA replication round, since after the initiation event the replication initiator should dissociate from DNA. It was, therefore, assumed that binding of the replication initiator is a signal for triggering DNA replication. However, more recent investigations have revealed that in many replicons this is not the case. Studies on the regulation of the replication of plasmids derived from bacteriophage lambda demonstrated that, once assembled, the replication complex can be inherited by one of the two daughter plasmid copies after each replication round and may function in subsequent replication rounds. Since this DNA-bound protein complex bears information about specific initiation of DNA replication, this phenomenon has been called "protein inheritance." A similar phenomenon has recently been reported for oriJ-based plasmids. Moreover, the current model of the initiation of DNA replication in the yeast Saccharomyces cerevisiae proposes that the origin recognition complex (ORC) remains bound to one copy of the ori sequence (the ARS region) after initiation of DNA replication. Thus, it seems plausible that protein inheritance is not unique for lambda plasmids, but may be a common phenomenon in the control of DNA replication, at least in microbes.     

Reconstitution of the water-oxidizing complex in manganese-depleted photosystem II preparations using synthetic Mn complexes: a fluorine-19 NMR study of the reconstitution process

Reconstitution of Mn-depleted photosystem II (PSII) particles was examined with synthetic trinuclear Mn complexes of newly developed tripod ligands. Rates of the electron transfer and oxygen evolution were up to 74-86 and 52-56% of those measured in native PSII. These values are higher than those for the PSII reconstituted by MnCl(2). The role of the tripod ligands during the reconstitution process was examined by (19)F NMR. Due to the high NMR sensitivity of the (19)F nucleus and the low abundance of fluorine atoms in natural PSII, it was possible to selectively observe the fluorine atoms on the tripod ligand. It was shown that the tripod ligands were released from the Mn complex after the reconstitution. We propose that the primary step in the reconstitution process is the prebinding of the Mn complex to the hydrophobic part of the PSII particle.     

Lz-0 × Berkeley: a new Arabidopsis recombinant inbred line population for the mapping of complex traits

This study describes the generation and test of a genetic resource suited to identify determinants of cell biological traits in plants. The use of quantitative trait loci (QTL) mapping for a better genetic understanding of cell biological traits is still at an early stage, even for biotechnologically important cell properties, such as the dimensions of fiber cells. A common strategy, the mapping of QTLs in recombinant inbred line (RIL) populations, is limited by the fact that the existing RIL populations exploit only a small fraction of the existing natural variation. Here, we report the mapping of QTLs impacting on the length of fiber cells in Arabidopsis inflorescence stems in a newly generated RIL population derived from a cross between the accessions Berkeley and the little known Lz-0. Through inbreeding of individual F₂ plants, a total of 159 new F₈ lines were produced and genotyped with a set of 49 single nucleotide polymorphism markers. The population was successfully used not only for the mapping of three QTLs controlling fiber length, but also to map five QTL controlling flowering time under short and long-day conditions. Our study demonstrates the usefulness of this new genetic resource by mapping in it QTLs underlying a poorly explored cellular trait as well as an already better explored regulatory pathway. The new RIL population and an online platform for the continuous supplementation of genetic markers will be generally available to substantially broaden the genetic diversity through which loci with impact on plant quantitative traits can be identified.     

Expansion of the Multi-Link Frontier™ coronary bifurcation stent: micro-computed tomographic assessment in human autopsy and porcine heart samples

Background

Treatment of coronary bifurcation lesions remains challenging, beyond the introduction of drug eluting stents. Dedicated stent systems are available to improve the technical approach to the treatment of these lesions. However dedicated stent systems have so far not reduced the incidence of stent restenosis. The aim of this study was to assess the expansion of the Multi-Link (ML) Frontier™ stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection.

Methodology/Principal Findings

Nine ML Frontier™ stents were implanted in seven human autopsy heart samples with known coronary artery disease and five ML Frontier™ stents were implanted in five porcine hearts. Proximal, distal and side branch diameters (PD, DD, SBD, respectively), corresponding opening areas (PA, DA, SBA) and the mean stent length (L) were assessed by micro-computed tomography (micro-CT). PD and PA were significantly smaller in human autopsy heart samples than in porcine heart samples (3.54±0.47 mm vs. 4.04±0.22 mm, p = 0.048; 10.00±2.42 mm² vs. 12.84±1.38 mm², p = 0.034, respectively) and than those given by the manufacturer (3.54±0.47 mm vs. 4.03 mm, p = 0.014). L was smaller in human autopsy heart samples than in porcine heart samples, although data did not reach significance (16.66±1.30 mm vs. 17.30±0.51 mm, p = 0.32), and significantly smaller than that given by the manufacturer (16.66±1.30 mm vs. 18 mm, p = 0.015).

Conclusions/Significance

Micro-CT is a feasible tool for exact surveying of dedicated stent systems and could make a contribution to the development of these devices. The proximal diameter and proximal area of the stent system were considerably smaller in human autopsy heart samples than in porcine heart samples and than those given by the manufacturer. Special consideration should be given to the stent deployment procedure (and to the follow-up) of dedicated stent systems, considering final intravascular ultrasound or optical coherence tomography to visualize (and if necessary optimize) stent expansion.     

Registers and follow-up methods of populations in a public health survey: the example of the village Glanlé in Ivory Coast

Demography has a fundamental place in a public health survey, and it is essential to provide the population follow-up. A population exhaustive census is the first compulsory phase. It turns out that this phase is necessary if we want to know with precision the size of the population studied and its main demographic characteristics (sex, age ...). The census allows us to provide a real population follow-up, in order to measure the evolution of the different disorders and to estimate the effects of a prophylaxis on each individual in a precise time. This follow-up requires a computerized population register which contains all the information concerning every individual. This data file is updated with new data collected by next surveys. The realization of the nominal population pyramid, is a complementary tool to the population follow-up. Each individual, characterized by sex and age, is allocated a position in the pyramid by his identification number. The figurative contrasts show several cases noticed according to the studied events. The reconstruction of the genealogy represents another form of the population follow-up, by reconstructing biological kinship relationships between the inhabitants.