Interventional Technologies Research Articles

A fast and stable vascular deformation scheme for interventional surgery training system.

BackgroundThe emergence and development of robot assistant interventional vascular surgery technologies have benefited many patients with cardiovascular or cerebrovascular diseases. Due to the absence of effective training measures, these new advanced technologies have not been fully utilized and only few experienced surgeons can perform such complicated surgeries so far. In order to solve such problems, virtual reality based vascular interventional surgery training system, a promising way to train young surgeons or assist experienced surgeons to perform surgery, has been widely studied.MethodsIn this paper, we mainly conduct a thorough study on both reliable deformation and high real-time performance of an interactive surgery training system. An efficient hybrid geometric blood vessel model which handles the collision detection query and vascular deformation calculation separately is employed to enhance the real-time performance of our surgery training system. In addition, a position-based dynamic approach with volume conservation constraint is used to improve the vascular deformation result. Finally, a hash table based spatial adaptive acceleration algorithm which makes the training system much more efficient and reliable is described.ResultsSeveral necessary experiments are conducted to validate the vascular deformation scheme presented in this paper. From the results we can see that the position-based dynamic modeling method with volume conservation constraint can prevent the vascular deformation from the issue of penetration. In addition, the deformation calculation with spatial acceleration algorithm has enhanced the real-time performance significantly.ConclusionThe corresponding experimental results indicate that both the hybrid geometric blood vessel model and the hash table based spatial adaptive acceleration algorithm can enhance the performance of our surgery training system greatly without losing the deformation accuracy.

Hepatocellular Carcinoma: Surgical Management and Evolving Therapies.

HCC is the second leading cause of cancer death worldwide. The majority of cases arise within the background of liver cirrhosis and are most commonly related to chronic hepatitis B and C viral infection. Surgical resection, liver transplantation, and tumour ablation are potentially curative modalities in cases of localized, non-metastatic, hepatocellular carcinoma. Systemic sorafenib has been shown to be marginally effective in slow disease progression in patients whose cirrhosis is so severe that they are not candidates for liver directed therapy and in those with metastatic disease. Several large prospective and retrospective studies have demonstrated transplantation to provide better long term outcomes than resection in patients with small volume carcinoma. Other small retrospective series have demonstrated similar outcomes for patients with well matched tumour characteristics and compensated cirrhosis. There is not even level one evidence to guide the choice of modality to be used in individual cases and treatment algorithms vary widely among high volume centres. Newer and emerging techniques and approaches such as laparoscopic liver resection and living donor transplantation continue to evolve and impact choice of treatment in absence of well-controlled comparative trials. For locally advanced disease and in patients with significant cirrhosis, interventional technologies such as transarterial chemoembolization or transarterial radioembolization can provide disease control or result in tumour regression and hypertrophy in the future liver remnant and may allow interval resection or down-staging to liver transplantation. Improving transarterial, surgical, and transplant techniques continue to expand the surgical and interventional options for managing localized HCC and are driving a shift towards aggressive multimodality therapy in patients with localized hepatoma.

DEVELOPMENT OF TECHNOLOGIES FOR HEALTHY AGING: SEARCHING FOR THE RIGHT WAY

Background: Medical imaging (e.g. PET-scan) and interventional (e.g. robotic surgery) technologies seem- to better fit the actual technological progress than do technologies for aging. The commercial market of aging care remains subdued since the introduction of low-technology devices decades ago (e.g. walker). Revisiting the evaluation and development methods of technologies to support healthy aging could help spread innovative technologies in this field. Methods and findings: In literature, a number of publications have been identified that addresses issues about technological devices that target the different needs of the older person. Nevertheless, a successful evaluation and development often remains unmet. This deficiency arises to a large extent from the confrontation of two worlds: that of technology which is not yet well versed in the field of healthy aging intervention, and the medical world which mainly uses the linear pharmaceutical drug development model. Many methods propose to tackle the global multidimensional evaluation of health technologies. However, they do not address the sequencing of the whole development and evaluation processes. In the present paper, we present a framework to help tackle the complexity of healthy aging technologies assessment and development. Conclusion: The evaluation and development methods usually adopted for healthy aging technologies are not appropriate and that all the collaborative multidisciplinary processes have to be revised.

Adjunctive intra-coronary imaging for the assessment of coronary artery disease.

Atherosclerotic coronary artery disease remains a leading cause of worldwide morbidity and mortality. Invasive angiography currently remains the gold standard method of diagnosing and treating coronary disease; however, more sophisticated adjunctive interventional technologies have been developed to combat the inter and intra-observer variability frequently encountered in the assessment of lesion severity. Intravascular imaging now plays a key role in optimising percutaneous coronary interventions and provides invaluable information as part of the interventional cardiologist’s diagnostic arsenal. The principles, technical aspects and uses of two modalities of intracoronary imaging, intravascular ultrasound and optical coherence tomography, are discussed. We additionally provide examples of cases where the adjunctive intracoronary imaging was superior to angiography alone in successfully identifying and treating acute coronary syndromes.

Surgical innovation and safety: femoroacetabular impingement and the IDEAL collaborative framework.

Operative treatment of femoroacetabular impingement (FAI) is a relatively new, yet rapidly expanding surgical innovation. Although the practice of surgery is inherently innovative, there is no clear distinction between minor technical variation and true modification that warrants testing. This raises important questions about how new procedures should be evaluated before being broadly disseminated. The IDEAL Collaborative is a consortium that promotes safe and responsible translation of research into clinical practice. The collaborative has delineated the typical stages of evolution of new interventional technologies, and the type of study designs appropriate for each stage. This report examines the surgical treatment of FAI as a case study of the IDEAL framework and discusses both missed and future opportunities for critical assessment.

Paclitaxel-Coated Balloons: Review of a Promising Interventional Approach to Preventing Restenosis in Femoropopliteal Arteries.

Peripheral arterial disease (PAD), a major cause of morbidity and mortality worldwide, is characterized by intermittent claudication and is associated with chronic diseases such as diabetes and hypertension. The goal of treatment is to address the underlying cause and to modify risk factors. Although medical management is the first-line treatment of PAD, some individuals may have severe symptoms and require revascularization with percutaneous transluminal angioplasty with or without stent placement or surgery. Interventional approaches may, however, be associated with high prevalence of restenosis and subsequent complications such as critical limb ischemia and amputation. Drug-eluting balloons (DEBs) are a new interventional technology with the primary goal of preventing restenosis. We review the clinical trials and studies that assessed the efficacy and safety profile of DEB and will focus on the restenosis rate in femoropopliteal arteries including target lesion revascularization (TLR) and late lumen lesion (LLL) using different modalities of intervention such as stents and DEB. Average data collected from the trials reported included restenosis rate of 25%, 0.3 mm LLL, and 14% reduction in TLR with DEB versus uncoated balloons. Below the knee (BTK) only intervention studies were excluded from this review as endovascular approach is usually reserved for critical limb ischemia for BTK disease. Interventional approach to treat PAD with DEB appears to be a promising technology. Additional larger studies are needed to further define safety, efficacy, and longer term outcome with this novel technology.

Luminescence-based Imaging Approaches in the Field of Interventional Molecular Imaging.

Luminescence imaging-based guidance technologies are increasingly gaining interest within surgical and radiologic disciplines. Their promise to help visualize molecular features of disease in real time and with microscopic detail is considered desirable. Integrating luminescence imaging with three-dimensional radiologic- and/or nuclear medicine-based preinterventional imaging may overcome limitations such as the limited tissue penetration of luminescence signals. At the same time, the beneficial features of luminescence imaging may be used to complement the routinely used radiologic- and nuclear medicine-based modalities. To fully exploit this integrated concept, and to relate the largely experimental luminesce-based guidance approaches into perspective with routine imaging approaches, it is essential to understand the advantages and limitations of this relatively new modality. By providing an overview of the available luminescence technologies and the various clinically evaluated exogenous luminescent tracers (fluorescent, hybrid, and theranostic tracers), this review attempts to place luminescence-based interventional molecular imaging technologies into perspective to the available radiologic- and/or nuclear medicine-based imaging technologies. At the same time, the transition from anatomic to physiologic and even molecular interventional luminescence imaging is illustrated.

Status and prospects of percutaneous vertebroplasty combined with ¹²⁵I seed implantation for the treatment of spinal metastases.

Metastatic spinal tumours are the most common type of bone metastasis. Various methods have been used to treat metastatic spinal lesions, including radiotherapy, chemotherapy, isotope therapy, bisphosphonate therapy, analgesics, and surgery. Conservative treatments such as radiotherapy and chemotherapy are not appropriate and usually are ineffective in patients with vertebral fractures and/or spinal instability. Minimally invasive surgical treatments using non-vascular interventional technology, such as percutaneous vertebroplasty (PVP), have been successfully performed in the clinical setting. PVP is a non-invasive procedure that creates small wounds and is usually associated with only minor complications. In the present study, we will review the clinical status and prospects for the use PVP combined with 125I seed implantation (PVPI) to treat spinal metastases. The scientific evidence for this treatment, including safety, efficacy, and outcome measures, as well as comparisons with other therapies, was analysed in detail. PVPI effectively alleviates pain in metastatic spinal tumour patients, and the use of interstitial 125I seed implants can enhance the clinical outcomes. In conclusion, PVPI is a safe, reliable, effective, and minimally invasive treatment. The techniques of PVP and 125I seed implantation complement each other and strengthen the treatment’s effect, presenting a new alternative treatment for spinal metastases with potentially wide application.

Transcatherter Aortic Valve Implantation (TAVI), the evolution, the 2nd. Generation, the directions & the criterias of the future generations

Transcatheter valve intervention are more advanced and also successful evolution of conventional cardiac surgery. The first step in cardiac surgery was performed on the beating hearts in the case of digital or instrumental mitral commisurotomy. Although open heart surgery stays always the “Gold Standard” procedure, because it is crucial in understanding via direct “Visus” the valve diseases. Transcatheter technologies takes advantages from the open heart technique using catheter based instruments for elderly and high risk patients. Transcatheter mitral valve commisurotomy was the first surgical therapy converted to transcatheter one in the 1980. Today with a new art of transcatheter technology, with more clinical efficacy and safety is this “The Procedure of Choice” with a faster recovery and less peri-operative pain. But although it seems the TAVI procedure is more effective at elderly high risk or non-operable patients. The German TAVR registry shows that at low risk population, the observed mortality & morbidity is higher than that population by the EUROSCORE. The key and the crucial point at the introduction a new clinical technology is the optimal “TRANSLATION” to the daily human practice. The new interventional technology have to be supported – after previous excellent results of animal and all clinical phase studies - by “Clinical Evidence!!!”. In this technology imaging is the crucial factor in the selection & in the screening process, to guide patients to the right size and art of device selection, as well as in playing a fundamental role during procedures to guide the implant safely and effectively. In the future the best imagination with a real touch will be probably holographic by an almost “REAL “ 3D or 4D anatomical peri-operative representation.

Eptifibatide in Coronary Intervention

> You can observe a lot just by watching. > > —Yogi Berra A combination of anticoagulant and antiplatelet therapies is foundational to the safe conduct of percutaneous coronary intervention (PCI).1 This reflects the obligate disruption of coronary vessel integrity and the consequent potential for thrombosis related to PCI. Beginning over 2 decades ago, eptifibatide, an agent that blocks the glycoprotein IIb/IIIa receptor, has been evaluated in clinical trials to ameliorate the potential for PCI-related thrombosis and for improving procedural and clinical outcomes.2–7 Although the glycoprotein IIb/IIIa inhibitors have been proven to reduce thrombotic events complicating PCI (death, myocardial infarction, abrupt vessel closure, and stent thrombosis), treatment is accompanied by an increase in the incidence of bleeding events that are in turn associated with worsened cardiovascular outcomes.8–10 See Article by Gurm et al The ideal PCI antithrombotic regimen eliminates the potential for catheter and device thrombosis, maximizes the clinical efficacy of the procedure, and minimizes the risk of bleeding. The dramatic evolution in interventional device technologies of the past several decades, coupled with the availability of new antithrombotic agents, has remarkably improved procedure …

Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial

New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent. This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion (more than 50% stenosis) from March, 2011, to August, 2012, were assessed for eligibility. Patients were randomly assigned in a 1:1 ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat. The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0·025. This trial is registered with ClinicalTrials.gov, number NCT01956448. Of 7103 screened, 1502 patients with 1883 lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and 1497 patients with 1791 lesions to receive the biodegradable-polymer biolimus-eluting stent. 79 (5·3%) and 75 (5·0%) patients, respectively, met the primary endpoint (absolute risk difference 0·0025, upper limit of one-sided 95% CI 0·016%; p=0·004). The individual components of the primary endpoint did not differ significantly between stent types at 12 months. The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients. Medtronic Cardiovascular and Biosensors Interventional Technologies.

Capsule endoscopy of the future: What's on the horizon?

Capsule endoscopes have evolved from passively moving diagnostic devices to actively moving systems with potential therapeutic capability. In this review, we will discuss the state of the art, define the current shortcomings of capsule endoscopy, and address research areas that aim to overcome said shortcomings. Developments in capsule mobility schemes are emphasized in this text, with magnetic actuation being the most promising endeavor. Research groups are working to integrate sensor data and fuse it with robotic control to outperform today's standard invasive procedures, but in a less intrusive manner. With recent advances in areas such as mobility, drug delivery, and therapeutics, we foresee a translation of interventional capsule technology from the bench-top to the clinical setting within the next 10 years.

Biodegradable Polymer-Based Sirolimus Coating Stent in a Porcine Coronary Restenosis Model

Durable polymer-based first-generation sirolimus-eluting stents (SES) reduce the risks of in-stent restenosis (ISR) and revascularization compared to bare metal stents (BMS). Therefore, drug eluting stents (DES), such as those using sirolimus and paclitaxel, have increasingly become available and used for the treatment of atherosclerotic coronary artery stenosis lesions. However, the permanent polymer in these DES can cause chronic inflammation and hypersensitive reactions in the stented artery after drug release. This may lead to delayed re-endothelialization, delayed arterial healing, and late stent thrombosis. In order to overcome the shortcomings of durable polymers, new DES using biodegradable polymers have been developed. DES with biodegradable polymers have been shown to be safe and effective in clinical trials. For example, biolimus A9-eluting stents (BES, Biomatrix, Biosensors Interventional Technologies Pte Ltd., Singapore) were developed as a third-generation drug eluting stent containing a bioabsorbadable polymer (PLA, poly-L-lactic acid) with the highly lipophilic sirolimus derivative biolimus A9. The objective of the present study was to evaluate a biodegradable polymer-based sirolimus coating on a novel bare-metal stent in a porcine coronary restenosis model.

Histopathology of vascular response to drug-eluting stents: an insight from human autopsy into daily practice.

Drug-eluting stents (DES) were developed with the primary purpose of inhibiting neointimal overgrowth following percutaneous coronary intervention (PCI). While DES have significantly reduced the rates of restenosis compared with bare metal stent (BMS), they have not completely eliminated it. Moreover, late stent thrombosis (LST), attributed to delayed arterial healing or abnormal vessel responses to DES, have emerged as a major safety concern. Although newer DES or other novel devices are expected to show promising results, the problems in interventional technologies have not been completely resolved. In this review, we will consider the current status of DES in clinical practice and discuss the strengths and limitations of recent advances from the view of histopathology.

The Application of Medical Robotics in the MRI-Guided Invention

This proposal focuses on the interventional MRI technology and the MRI compatible robots which are used to overcome some limitation of the MRI. In the introduction part, the development and the limitation of the current MRI interventions are introduced and a possible solution, MRI compatible robotic assistance, is proposed. In the design part, the specification of the MRI robot is discussed, including the MRI compatible material, the motor and encoder, the control unit and the combination of haptic sensor. Finally, the possible future application of the MRI compatible interventional robots is introduced.

Brief history of interventional radiology

In 1923, angiography was first successively used for the human body. In 1953, a Swedish doctor Sven-Ivar Seldinger pioneered the Seldinger technique, which laid down the foundation of interventional radiology. In 1963, Charles Dotter first proposed the idea of interventional radiology. In 1964, Charles Dotter opened a new era of percutaneous angioplasty through accidental operation, marking the formation of interventional radiology. On this basis, the techniques of balloon catheter dilation and metal stent implantation was developed. Endovascular stent was proposed in 1969. In 1973, the percutaneous angioplasty has been a breakthrough with the emergence of soft double-lumen balloon catheter. Percutaneous coronary angioplasty is applied in 1977. Since the 1990s, balloon angioplasty relegated to secondary status with the emergence of metal stent. Currently, endovascular stent have entered a new stage with the emergence of temporary stent and stent grafts and biological stent. Transcatheter arterial embolization had been one of the most important basic techniques for interventional radiology since 1965, it had also been a corresponding development with the improvement of embolic agents and catheter technology for the treatment of diseases now. Transjugular intrahepatic portosystemic stent-shunt is a comprehensive interventional radiology technology since 1967, in which the biliary system can be reached through a jugular vein, and the improvement appeared with balloon expandable stent in 1986.Since 1972, non-vascular interventional techniques was another important branch of interventional radiology. Currently, it is applied in the diagnosis and treatment of many diseases of the internal organs like the pancreas, liver, kidney, spinal cord, Fallopian tubes, esophagus and other organs. In 1973, Chinese radiologist first conducted the angiography test. Interventional radiology was introduced into China in the 1980s, it was readily developed through the sponsoring of training class (1981) and academic conferences (1986). Along with the return of the overseas scholars, the gap in the interventional diagnosis and treatment technology between China and the world has been narrowing since the 1990s.

Pädiatrische Radiologie in der Hals-Nasen-Ohren-Heilkunde

Head and neck diseases in children and adolescents pose special diagnostic and differential diagnostic challenges to ENT surgeons as well as to radiologists. Both disciplines have to adapt the latest radiological and interventional technologies to the needs of the paediatric patient in order to enable a minimally invasive but successful diagnostic procedure. High quality sonography by an experienced examiner often is the only imaging technique that is required in children and adolescents. Radiographs are rarely indicated in paediatric head and neck diseases. MRI, compared to computed tomography, has the advantage of the lack of radiation exposure. Additionally, because of current advances in high resolution techniques to delineate very small details or in visualization of different tissue characteristics it has become an integral part of the pre-and post-operative imaging. However, children should not be denied an adequate diagnostic procedure even if it includes a sedation, an intervention or an exposure to radiation. The responsible use of the diagnostic options under consideration of the therapeutic consequences is essential. It is most likely to be successful in a close interdisciplinary cooperation of paediatric ENT specialists and radiologists as well as paediatric anaesthesiologists in selected cases. Although benign diseases predominate in children and adolescents, the possibility of a malignancy has to be considered in case of atypical clinical and radiological findings. In many of these young patients the outcome and the probability of survival are directly connected to the initial diagnostic and therapeutic strategies, which should therefore be in accordance with the current guidelines in oncological therapy studies. Our collection of clinical cases consists of representative examples of useful diagnostic approaches in common and age specific diagnoses as well as in rare diseases and malformations. It shows the significance of a special knowledge in embryology and normal postnatal development for the differentiation of normal variants from pathological findings. Only in considering the results of imaging studies in their clinical context, we may succeed in detecting a syndrome behind a single malformation or in adequately caring for a patient with a chronic disease such as cystic fibrosis.

Early experience with stent retrievers and comparison with previous-generation mechanical thrombectomy devices for acute ischemic stroke

OBJECT.: There is limited information regarding patient outcomes following interventions for stroke during the window for endovascular therapy. Studies have suggested that recently approved stent retrievers are safer and more effective than earlier-generation thrombectomy devices. The authors compared cases in which the Solitaire-FR device was used to those in which a MERCI or Penumbra device was used. This study is a single-center retrospective review of 102 consecutive cases of acute stroke in which patients were treated with mechanical thrombectomy devices between 2007 and 2013. Multivariate models, adjusted for confounding factors, were used to investigate functional independence (modified Rankin Scale [mRS] score ≤ 2, and successful reperfusion (thrombolysis in cerebral infarction [TICI] score ≥ 2b). Thrombectomy device had a significant impact on functional independence (mRS score ≤ 2) at discharge from the hospital (p = 0.040). Solitaire-FR treatment resulted in significantly more patients being discharged as functionally independent in comparison with MERCI treatment (p = 0.016). A multivariate model found the use of Solitaire-FR to improve the odds of good clinical outcome in comparison with prior-generation devices (OR 6.283, 95% CI 1.785-22.119, p = 0.004). Additionally, the use of Solitaire-FR significantly increased the odds of successful reperfusion (OR 3.247, 95% CI 1.160-9.090, p = 0.025). The stent retriever Solitaire-FR significantly improved the odds of functional independence and successful revascularization of the arterial tree. New interventional technology for stroke continues to mature, but randomized trials are needed to establish the actual benefit to specific patient populations.

Incidence of Abnormal Offspring from Cloning and Other Assisted Reproductive Technologies

In animals produced by assisted reproductive technologies, two abnormal phenotypes have been characterized. Large offspring syndrome (LOS) occurs in offspring derived from in vitro cultured embryos, and the abnormal clone phenotype includes placental and fetal changes. LOS is readily apparent in ruminants, where a large calf or lamb derived from in vitro embryo production or cloning may weigh up to twice the expected body weight. The incidence of LOS varies widely between species. When similar embryo culture conditions are applied to nonruminant species, LOS either is not as dramatic or may even be unapparent. Coculture with serum and somatic cells was identified in the 1990s as a risk factor for abnormal development of ruminant pregnancies. Animals cloned from somatic cells may display a combination of fetal and placental abnormalities that are manifested at different stages of pregnancy and postnatally. In highly interventional technologies, such as nuclear transfer (cloning), the incidence of abnormal offspring continues to be a limiting factor to broader application of the technique. This review details the breadth of phenotypes found in nonviable pregnancies, together with the phenotypes of animals that survive the transition to extrauterine life. The focus is on animals produced using in vitro embryo culture and nuclear transfer in comparison to naturally occurring phenotypes.

NICE embracing digital technology

Since the beginning of the existence of NICE in April 1999, there has been almost constant change. We were originally set up to ensure that the most clinically and cost effective drugs and treatments were made widely available on the NHS in England and Wales, and to help clinicians by injecting scientific rigour into the complex and crowded business of clinical guideline production. From a small organisation producing a handful of technology appraisals and clinical guidelines, our remit has expanded to include recommendations for the public health community, guidance on interventional procedures, diagnostics assessments and medical technologies. More recently, we have started to provide information on new medicines and other prescribing advice. April 2013 saw the introduction of a programme to produce guidance and quality standards in social care – as such, the Health and Social Care Act 2012 has re-established NICE as the National Institute for Health and Care Excellence. Our role, responsibilities and organisational status are not the only things to have changed at NICE. In recent years we have embraced digital technology to present and promote our products, and better reflect the way we know healthcare professionals increasingly want to access this information – quickly and easily.