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6.
J Interv Card Electrophysiol ; 54(2): 161-170, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30471050

RESUMO

PURPOSE: To compare lead failure manifestation and lead performance of the Biotronik Linox/Sorin Vigila defibrillator lead (Linox group) with the St. Jude Medical Riata/Riata ST (Riata group) and Medtronic Sprint Fidelis defibrillator leads (Fidelis group). METHODS: We assessed the performance of all aforementioned leads implanted at our center and investigated the manifestation of lead failures. RESULTS: Of 93 Linox, 86 Riata, and 81 Fidelis leads implanted at our center, 11 (12%), 22 (26%), and 25 (31%) leads failed during a median follow-up of 46, 61, and 84 months, respectively. Inappropriate shocks were delivered in 64% (Linox), 5% (Riata), and 32% (Fidelis) of lead failures; a device alert was noted in none (Linox), 5% (Riata), and 52% (Fidelis); and lead failure was a coincidental finding in 36% (Linox), 91% (Riata), and 16% (Fidelis) of cases (p < 0.001). Non-physiological high rate signals were observed in 73% (Linox), 27% (Riata), and 80% (Fidelis) of lead failures (p = 0.001) and damaged lead integrity was found in 36% (Linox), 73% (Riata), and 24% (Fidelis) of cases (p = 0.064). Lead survival at 5 years was 88%, 92%, and 71% for Linox, Riata, and Fidelis group, respectively. CONCLUSIONS: The most frequent clinical manifestation of lead failure was inappropriate shocks for Linox, coincidental finding for Riata and device alert for Fidelis leads. Non-physiological high rate signals were frequently observed in Linox and Fidelis lead failures whereas in Riata lead failures, a damaged lead integrity was the predominant finding.


Assuntos
Desfibriladores Implantáveis/efeitos adversos , Eletrodos Implantados/efeitos adversos , Desenho de Equipamento/métodos , Análise de Falha de Equipamento , Segurança de Equipamentos/estatística & dados numéricos , Adulto , Fatores Etários , Idoso , Terapia de Ressincronização Cardíaca/efeitos adversos , Terapia de Ressincronização Cardíaca/métodos , Cardiomiopatia Dilatada/terapia , Estudos de Coortes , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/terapia , Estudos Retrospectivos , Medição de Risco , Fatores Sexuais , Estados Unidos
7.
Laryngoscope ; 129(2): 482-489, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30412276

RESUMO

OBJECTIVE: Our objective is to evaluate the safety in patients with cochlear implants (CIs) and auditory brainstem implants (ABI) undergoing 1.5 Tesla (T) magnetic resonance imaging (MRI). Secondly, we want to raise awareness on CI and MRI safety, and advocate for continued improvement and advancement to minimize morbidity for our CI patients. METHODS: Retrospective case series from 2006 to 2018 at a single tertiary academic center. Data was collected on patients with CI or auditory brainstem implants undergoing MRI. Outcomes collected include demographic data, age at time of MRI, MRI characteristics, complications, CI manufacturer, and image quality. RESULTS: Eighteen patients with CI or ABI collectively underwent a total of 62 MRI scans. Five of 15 (33%) CI patients with magnet had complications: five total of 24 MRI scans (21%). Two patients had magnet removal prior to 29 MRI scans without complications. Four of five MRI-related complications were equipped with a U.S. Food and Drug Administration-approved head wrap. Three of five required a trip to the operating room to explore and reposition the CI magnet; two could not complete MRI secondary to pain. Of the complications, two were Cochlear (Sydney, Australia), two Advanced Bionics (Valencia, CA), and one MED-EL (Innsbruck, Austria). Synchrony model (MED-EL) had 0 of seven complications, with a total of 19 MRI scans, which features a freely rotating and self-aligning magnet. CONCLUSION: Our series offers a diverse number of CI manufacturers and is in accordance with other literature that CI MRI-related adverse events are occurring at an unacceptable frequency. We can promote CI MRI safety through our institutions' MRI CI patient protocols, raise awareness that diagnostic MRI benefits must outweigh CI-related complications, and advocate for continued industry technological innovation. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:482-489, 2019.


Assuntos
Implantes Auditivos de Tronco Encefálico/efeitos adversos , Implantes Cocleares/efeitos adversos , Segurança de Equipamentos/estatística & dados numéricos , Imagem por Ressonância Magnética/efeitos adversos , Imãs/efeitos adversos , Adulto , Idoso , Pré-Escolar , Feminino , Humanos , Imagem por Ressonância Magnética/instrumentação , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
8.
Br Dent J ; 225(5): 391-394, 2018 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-30140045

RESUMO

All members of the clinical dental team face a daily risk of a personal sharp injury. A wide range of sharp instruments are used, some of which are specifically designed to easily pierce the skin and mucosa. The instruments are placed, moved, passed between colleagues, used for treatment, replaced and cleaned, all in relatively confined areas. The clinical dental workplace and the decontamination unit are both therefore sharp-risk environments. There is a clear risk of a sharp injury and the potential consequences of occupational exposure to blood-borne pathogens are at least inconvenient and at worst, career and even life threatening. However, good sharp safety is not universally understood and practised throughout the dental profession. This paper considers the risk of sharp injury in dentistry and discusses some of the methods used to improve sharp safety.


Assuntos
Instrumentos Odontológicos/efeitos adversos , Odontologia , Segurança de Equipamentos/estatística & dados numéricos , Local de Trabalho/normas , Patógenos Transmitidos pelo Sangue , Descontaminação , Recursos Humanos em Odontologia , Humanos , Incidência , Ferimentos Penetrantes Produzidos por Agulha/epidemiologia , Ferimentos Penetrantes Produzidos por Agulha/etiologia , Ferimentos Penetrantes Produzidos por Agulha/prevenção & controle , Doenças Profissionais/epidemiologia , Doenças Profissionais/etiologia , Doenças Profissionais/prevenção & controle , Exposição Ocupacional/estatística & dados numéricos , Medição de Risco , Fatores de Risco , Reino Unido/epidemiologia
9.
PLoS One ; 13(6): e0197883, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29920525

RESUMO

BACKGROUND: All surgical meshes entering the U.S. market have been cleared for clinical use by the 510(k) process of the Food and Drug Administration (FDA), in which devices simply require proof of "substantial equivalence" to predicate devices, without the need for clinical trials. However, recalled meshes associated with adverse effects may, indirectly, continue to serve as predicates for new devices raising concerns over the safety of the 510(k) route. METHODOLOGY: Here we assess the potential magnitude of this problem by determining the ancestral network of equivalence claims linking recently cleared surgical meshes. Using the FDA website we identified all surgical meshes cleared by the 510(k) route between January 2013 and December 2015 along with all listed predicates for these devices. Using a network approach, we trace the ancestry of predicates across multiple generations of equivalence claims and identify those meshes connected to devices that have since recalled from the market along with the reason for their recall. CONCLUSIONS: We find that the 77 surgical meshes cleared between 2013 and 2015 are based on 771 interconnected predicate claims of equivalence from 400 other devices. The vast majority of these devices (97%) are descended from only six surgical meshes that were present on the market prior to 1976. One of these ancestral meshes alone, provided the basis of 183 subsequent devices. Furthermore, we show that 16% of recently cleared devices are connected through equivalence claims to the 3 predicate meshes that have been recalled for design and material related flaws causing serious adverse events. Taken together, our results show that surgical meshes are connected through a tangled web of equivalency claims and many meshes recently cleared by the FDA have connections through chains of equivalency to devices which have been recalled from the market due to concerns over clinical safety. These findings raise concerns over the efficacy of the 510(k) route in ensuring patient safety.


Assuntos
Regulamentação Governamental , Telas Cirúrgicas , United States Food and Drug Administration/legislação & jurisprudência , Aprovação de Equipamentos/legislação & jurisprudência , Segurança de Equipamentos/estatística & dados numéricos , Humanos , Estados Unidos
10.
BMC Health Serv Res ; 18(1): 402, 2018 06 04.
Artigo em Inglês | MEDLINE | ID: mdl-29866152

RESUMO

BACKGROUND: Post-market surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Few studies have examined factors that influence whether and how physicians report AMDEs, an essential step in the development of behaviour change interventions. This study was a secondary analysis comparing application of the Theoretical Domains Framework (TDF) and the Tailored Implementation for Chronic Diseases (TICD) framework to identify potential behaviour change interventions that correspond to determinants of AMDE reporting. METHODS: A previous study involving qualitative interviews with Canadian physicians that implant medical devices identified themes reflecting AMDE reporting determinants. In this secondary analysis, themes that emerged from the primary analysis were independently mapped to the TDF and TICD. Determinants and corresponding intervention options arising from both frameworks (and both mappers) were compared. RESULTS: Both theoretical frameworks were useful for identifying interventions corresponding to behavioural determinants of AMDE reporting. Information or education strategies that provide evidence about AMDEs, and audit and feedback of AMDE data were identified as interventions to target the theme of physician beliefs; improving information systems, and reminder cues, prompts and awards were identified as interventions to address determinants arising from the organization or systems themes; and modifying financial/non-financial incentives and sharing data on outcomes associated with AMDEs were identified as interventions to target device market themes. Numerous operational challenges were encountered in the application of both frameworks including a lack of clarity about how directly relevant to themes the domains/determinants should be, how many domains/determinants to select, if and how to resolve discrepancies across multiple mappers, and how to choose interventions from among the large number associated with selected domains/determinants. CONCLUSIONS: Given discrepancies in mapping themes to determinants/domains and the resulting interventions offered by the two frameworks, uncertainty remains about how to choose interventions that best match behavioural determinants in a given context. Further research is needed to provide more nuanced guidance on the application of TDF and TICD for a broader audience, which is likely to increase the utility and uptake of these frameworks in practice.


Assuntos
Segurança de Equipamentos/estatística & dados numéricos , Vigilância de Produtos Comercializados , Gestão da Segurança/normas , Confiabilidade dos Dados , Segurança de Equipamentos/normas , Humanos , Padrões de Prática Médica , Pesquisa Qualitativa
11.
Scand J Clin Lab Invest ; 78(5): 417-420, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29888620

RESUMO

Tourniquets are widely used to make the vein more visible prior to blood collection. Venepuncture tourniquets are however a non-sterile and potentially reusable equipment. Several studies have shown that they are colonised by a variety of pathogenic bacteria and consecutively use of the same tourniquet on multiple patients will increase the risk of a nosocomial infection. This matter is however only scarcely studied. The objective of this study was to investigate the nationwide use of disposable and non-disposable venepuncture tourniquets and the standardised procedures for cleaning the tourniquets. A questionnaire concerning use and cleaning of tourniquets was therefore sent to all major Danish clinical biochemistry laboratories (n = 12). All but one laboratory had a local procedure for usage and handling of tourniquets, including structured procedures for cleaning. Despite this, only 75% of laboratories had a guideline for cleaning the tourniquets and only 50% had a specified cleaning program. At the hospitals using non-disposable tourniquets the handling differed considerably and at two hospitals the tourniquets were only cleaned once a week, while one laboratory did not clean the tourniquet before it was visibly stained. Of note, five of the eight hospitals using disposable tourniquets only disposed the tourniquets on a daily basis. In conclusion, there is a lack of guidelines for handling tourniquets in 25-33% of the hospitals and a number of hospitals used both types (disposable and non-disposable), which could confuse the handling of the tourniquets. A national guideline for usage and cleaning of venepuncture tourniquets is therefore strongly recommended.


Assuntos
Infecção Hospitalar/prevenção & controle , Reutilização de Equipamento/estatística & dados numéricos , Flebotomia/ética , Torniquetes , Dinamarca , Segurança de Equipamentos/ética , Segurança de Equipamentos/estatística & dados numéricos , Humanos , Higiene/educação , Guias de Prática Clínica como Assunto , Inquéritos e Questionários
12.
Investig Clin Urol ; 59(2): 126-132, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29520389

RESUMO

Purpose: To assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States. Materials and Methods: We reviewed 1,103 individual medical device reports submitted to the MAUDE database that inspired the United States (US) Food and Drug Administration's 2008 Public Health Notification. Entries were compiled into a categorical database that reported manufacturer, brand, reporter type, report source, and type of adverse event. Results: There were numerous examples of missing, duplicated, and non-standardized entries. Analysis revealed 64 reports with duplicated information, and six reports representing multiple patients. Forty-seven percent of medical device reports did not identify a reporter source. At least 28% of reported devices are no longer on the US market. There was wide variability in the quality and completeness of submitted reports and true adverse event rates could not be accurately calculated because the number of total cases was unknown. Conclusions: The MAUDE database was limited in its ability to collect, quantify, and standardize real-life adverse events related to transvaginal mesh. While it functions to collect information related to isolated adverse events, systematic limitations of the MAUDE database, that no doubt extend to other medical devices, necessitate the development of new reporting systems. Alternatives are under development, which may allow regulators to more accurately scrutinize the safety profiles of specific medical devices.


Assuntos
Segurança de Equipamentos , Procedimentos Cirúrgicos em Ginecologia/instrumentação , Telas Cirúrgicas , Confiabilidade dos Dados , Coleta de Dados/estatística & dados numéricos , Bases de Dados Factuais , Segurança de Equipamentos/métodos , Segurança de Equipamentos/estatística & dados numéricos , Feminino , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Prolapso de Órgão Pélvico/cirurgia , Telas Cirúrgicas/efeitos adversos , Telas Cirúrgicas/normas , Estados Unidos , United States Food and Drug Administration , Incontinência Urinária por Estresse/cirurgia
13.
Expert Opin Drug Saf ; 17(4): 347-357, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29463158

RESUMO

BACKGROUND: The aim of this study is to determine the characteristics, magnitude, and the quality of reporting of mandated events involving intravenous patient-controlled analgesia (IV-PCA) devices in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database; a postmarket surveillance system. METHODS: We utilized a mixed-methods approach to systematically characterize structured data and text narratives associated with IV-PCA events submitted to MAUDE between 1 January 2011 and 12 September 2016. RESULTS: Of 1,430 IV-PCA events reported during the study period, 6.4% were adverse events (AEs) as identified via structured data fields in the MEDWATCH forms. Upon qualitative review of the narrative texts, 11.0% of events were associated with an unfavorable clinical outcome, which was 71% higher than the incidence of the adverse outcomes reported using the structured data fields. Device-related issues, which were mostly preventable, accounted for 86.9% of events. Of 65 reportable events submitted by manufacturers, 18.5% did not comply with reporting requirements as mandated by law. CONCLUSION: Patients on IV-PCA continue to experience serious complications as a result of preventable errors. Multi-modal interventions including educational training and the development and adoption of PCA devices with improved safety features are needed to improve safety.


Assuntos
Analgesia Controlada pelo Paciente/efeitos adversos , Segurança de Equipamentos/estatística & dados numéricos , Equipamentos e Provisões/efeitos adversos , Vigilância de Produtos Comercializados/estatística & dados numéricos , Analgesia Controlada pelo Paciente/instrumentação , Bases de Dados Factuais , Humanos , Incidência , Erros de Medicação/estatística & dados numéricos , Estados Unidos , United States Food and Drug Administration
14.
Am J Obstet Gynecol ; 217(1): 42-46.e1, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-28500861

RESUMO

The field of women's health has endured numerous recent controversies involving medical devices such as pelvic meshes, laparoscopic morcellators, and a hysteroscopic sterilization device. With the recent passage of the 21st Century Cures Act, new legislation will change how the Food and Drug Administration regulates medical devices. Given these controversies and new changes, we investigated high-risk, class I recalls in women's health from 2002 through 2016. Class I recalls for medical devices are defined by the Food and Drug Administration as the most serious recall events and are designated for situations when there is a reasonable probability of serious adverse health consequences or death. We defined a recall event as a group of unique Food and Drug Administration recalls that share a similar reason for recall and occurred within a 1-month time frame. In total, 7 class I recall events were identified encompassing 83 unique recalls affecting >88,000 medical devices in distribution. Recalls involved a broad range of devices used in women's health including diagnostic assays for chlamydia and gonorrhea, a laparoscopic tissue morcellator, and obstetrical/gynecological surgical kits. Four of 7 (57%) recall events were due to postmarketing problems such as improper packaging and labeling while the remaining 3 (43%) recalls were due to premarketing problems (eg, software issues). Additionally, 3 of 7 (43%) recall events were cleared via the 510(k) pathway, while the remaining were essentially exempt from any form of premarket approval. Two recall events involved sterility concerns of 71 surgical kits used in obstetrics and gynecological surgeries representing the majority of affected devices (78,423) in distribution. Class I medical device recalls are rare but serious events. Most recalled devices in women's health had minimal preapproval regulation and were recalled due to both premarketing and postmarketing reasons. Future regulatory efforts to improve postmarketing surveillance may mitigate the potential impact and frequency of class I recalls, but do not replace the need for a higher burden of proof for both safety and efficacy prior to medical device approval.


Assuntos
Segurança de Equipamentos/estatística & dados numéricos , Ginecologia/instrumentação , Recall de Dispositivo Médico , Obstetrícia/instrumentação , Equipamentos e Provisões/classificação , Feminino , Humanos , Vigilância de Produtos Comercializados/normas , Fatores de Risco , Estados Unidos , United States Food and Drug Administration , Saúde da Mulher
15.
Pacing Clin Electrophysiol ; 40(6): 624-628, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28294359

RESUMO

BACKGROUND: Medical technology has made significant advances over the last few decades with smaller and more dynamic pacemakers. However, technical failures leading to premature replacement is a cause of concern. We present a series of Medtronic EnRhythm devices that reached premature elective replacement indicator (ERI). METHODS: The database of Centre of Heart Rhythm Disorders was searched for EnRhythm device implantation from 2006 to 2011. Battery depletion <8.5 years was considered premature considering the projected average longevity to be 8.5-10.5 years. An unexpected premature ERI was defined when it was reached within 3 months of last normal check. Device follow-up was conducted every 3 months after advisory. RESULTS: A total of 88 EnRhythm pacemakers were implanted. Over a median follow-up of 6.2 years (range: 0.3-9.2), 39 (44.3%) EnRhythm devices reached premature ERI. In 11 (28%), ERI was not recognized and patients were being investigated for other causes of unsteadiness or dyspnea prior to device check. Notably, three (7%) patients had premature ERI < 3.5 years. Ten (25.6%) had sudden and unexpected premature ERI. While asynchronous pacing was observed, there were no cases of absence of pacing. CONCLUSIONS: The rate of premature ERI for EnRhythm devices was 44.3%, significantly higher than reported by the manufacturer. Of concern, a sizeable proportion occurred unexpectedly, warranting more frequent reviews and empirical replacement in some patients. With the experience of the EnRhythm, appropriate monitoring strategies are recommended for future advisories.


Assuntos
Remoção de Dispositivo/estatística & dados numéricos , Fontes de Energia Elétrica/estatística & dados numéricos , Análise de Falha de Equipamento/estatística & dados numéricos , Falha de Equipamento/estatística & dados numéricos , Segurança de Equipamentos/estatística & dados numéricos , Recall de Dispositivo Médico , Marca-Passo Artificial/estatística & dados numéricos , Idoso , Desenho de Equipamento , Feminino , Humanos , Masculino , Segurança do Paciente/estatística & dados numéricos , Austrália do Sul/epidemiologia
16.
Pacing Clin Electrophysiol ; 40(5): 476-481, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28169434

RESUMO

BACKGROUND: Magnetic resonance imaging (MRI) in patients with non-MRI-conditional cardiac implantable electronic devices (CIEDs) has been shown to be safe when performed under closely monitored protocols. However, the safety of MRI in patients with devices with a nearly depleted battery has not been reported. METHODS: Prospective data were collected between January 2008 and May 2015 in patients with non-MRI-conditional CIEDs undergoing clinically indicated MRI under institutional protocol. Patients who were pacemaker dependent were excluded. Patients whose devices were at elective replacement indicator (ERI) at the time of MRI or close to ERI (ERI or replacement for battery depletion within 3 months of scan) were identified through database review and analyzed for clinical events. RESULTS: MRI scans (n = 569) were performed in 442 patients. Of these, we identified 13 scans performed with a nearly depleted battery in nine patients. All scans with implantable cardioverter defibrillators (ICDs, n = 9) were uneventful. However, two scans with pacemakers close to ERI resulted in a power-on-reset (PoR) event. One scan with a pacemaker close to ERI that was programmed to DOO mode reached ERI during MRI and automatically changed to VVI mode. Additionally, one scan with a pacemaker at ERI did not allow programming. All pacemakers with events were implanted before 2005. CONCLUSION: Patients with pacemakers and ICDs with a nearly depleted battery can safely undergo MRI when patients are not pacemaker dependent. Attention should be paid because old devices can result in PoR or ERI during MRI, which may lead to oversensing and inhibition of pacing.


Assuntos
Desfibriladores Implantáveis/estatística & dados numéricos , Fontes de Energia Elétrica , Falha de Equipamento/estatística & dados numéricos , Segurança de Equipamentos/estatística & dados numéricos , Imagem por Ressonância Magnética/estatística & dados numéricos , Marca-Passo Artificial/estatística & dados numéricos , Idoso , Causalidade , Contraindicações , Desenho de Equipamento , Análise de Falha de Equipamento , Humanos , Imagem por Ressonância Magnética/instrumentação , Masculino , Minnesota/epidemiologia , Prevalência , Fatores de Risco
17.
Pacing Clin Electrophysiol ; 40(5): 467-475, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28224629

RESUMO

OBJECTIVES: This study compared risks associated with magnetic resonance imaging (MRI) in patients with non-MRI conditional and MRI conditional pacing and defibrillator systems with particular attention to clinically actionable outcomes. BACKGROUND: While recipients of new MRI conditional pacemaker and defibrillator systems may undergo MRI scanning with very low risk, safety and regulatory concerns persist regarding such scanning in recipients of non-MRI conditional systems. METHODS: Patients with any cardiac device who were referred for MRI were prospectively enrolled at a single center and underwent scanning at 1.5 Tesla. Pre- and postscan lead characteristic changes, system integrity, and symptoms were analyzed. A comparison was made between non-MRI conditional and MRI conditional devices. RESULTS: 105 patients were evaluated allowing for comparison of 97 scans with non-MRI conditional devices and 16 scans with MRI conditional devices. The cohort included those with pacemaker dependency, defibrillator, and cardiac resynchronization devices. Small, nonsignificant changes were observed in lead characteristics following scanning, and there was no significant difference when comparing non-MRI and MRI conditional devices. Lead parameter changes did not require lead revision or programming changes. No device reset, failures, or premature scan termination was observed. CONCLUSIONS: 1.5 T MRI scanning in patients with MRI conditional and non-MRI conditional cardiac devices was performed with similar, low clinical risk.


Assuntos
Desfibriladores Implantáveis/estatística & dados numéricos , Traumatismos por Eletricidade/epidemiologia , Falha de Equipamento/estatística & dados numéricos , Segurança de Equipamentos/estatística & dados numéricos , Imagem por Ressonância Magnética/instrumentação , Imagem por Ressonância Magnética/estatística & dados numéricos , Marca-Passo Artificial/estatística & dados numéricos , Idoso , Causalidade , Contraindicações , Desenho de Equipamento , Análise de Falha de Equipamento , Feminino , Georgia/epidemiologia , Humanos , Masculino , Prevalência , Fatores de Risco
18.
Pacing Clin Electrophysiol ; 40(5): 488-493, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28240382

RESUMO

BACKGROUND: Treatment of left ventricular electrode dislocation and phrenic nerve stimulation remains an issue in the era of new electrode designs. METHODS: Safety and efficacy of minimal invasive lead repositioning and pocket opening reposition procedures were evaluated between December 2005 and December 2012 at our center. Minimal invasive method was developed and widely utilized at our center to treat phrenic nerve stimulation. The distally positioned left ventricular lead is looped around by a deflectable catheter in the right atrium introduced from the femoral vein access and then pulled back. Coronary stent implantation was used afterwards for lead stabilization in some patients. RESULTS: 42 minimal invasive and 48 electrode repositions with pacemaker pocket opening were performed at 77 patients for left ventricular lead problems. Minimal invasive reposition could be carried out successfully in 69% of (29 patients) cases. Note that in 14.3% of the cases (six patients) minimal invasive procedures were acutely unsuccessful and crossover was necessary. In 16.6% of the cases (seven patients) lead issues were noted later during follow-up. Opening of the pocket could be carried out successfully in 81.2% (39 patients) and was unsuccessful acutely in 6.25% (three patients). Repeated dislocation was noticed, 12.5%, in this group (six patients). Complication during minimal invasive procedures was electrode injury in one case. Pocket openings were associated with several complications: atrial fibrillation, pericardial effusion, fever, hematoma, and right ventricular electrode dislodgement. CONCLUSION: Minimal invasive procedure-as the first line approach-is safe and feasible for left ventricular electrode repositioning in selected cases.


Assuntos
Procedimentos Cirúrgicos Cardíacos/estatística & dados numéricos , Eletrodos Implantados/estatística & dados numéricos , Ventrículos do Coração/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos/estatística & dados numéricos , Marca-Passo Artificial/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Implantação de Prótese/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Remoção de Dispositivo/estatística & dados numéricos , Segurança de Equipamentos/estatística & dados numéricos , Feminino , Humanos , Hungria/epidemiologia , Incidência , Masculino , Complicações Pós-Operatórias/prevenção & controle , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
19.
Mil Med ; 182(1): e1653-e1657, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-28051989

RESUMO

Knowledge of transport ventilator performance impacts patient safety. This study compared minute ventilation (VE) of the MOVES and Uni-Vent 731 when ventilating the VentAid Training Test Lung with compliance (C) ranging from 0.02 to 0.10 L/cm H2O and three different airway resistances (R) (none, Rp5, or Rp20). Tidal volume (VT) was 800 ± 25 mL. Respiratory rate was increased to ventilator's maximum or until auto-PEEP > 5 cm H2O. Respiratory parameters were recorded with the RSS 100HR Research Pneumotach. Data were reported as median (interquartile range). Peak inspiratory pressure (PIP) of the Uni-Vent and MOVES ranged from 22.3 (22.2-22.5) to 82.6 (82.2-83.2) and 20.8 (20.6-20.9) to 50.6 (50.2-50.9) cm H2O, respectively. VE of the Uni-Vent and MOVES ranged from 17.7 (17.7-17.7) to 31.5 (31.5-31.5) and 11.3 (10.5-11.3) to 20.2 (19.7-20.5) L/min, respectively. Linear regression demonstrated strong, negative correlation of VE with PIP for the MOVES (VE [L/min] = 26 - 0.31 × PIP [cm H2O], r = -0.97) but weak, positive correlation for the Uni-Vent (r = 0.05). Uni-Vent VE exceeded MOVES VE under each test condition (p = 0.0002). If patient VE requirements exceed those predicted by the MOVES regression equation, then using the Uni-Vent should be considered.


Assuntos
Desenho de Equipamento/normas , Ventiladores Mecânicos/normas , Desenho de Equipamento/estatística & dados numéricos , Segurança de Equipamentos/normas , Segurança de Equipamentos/estatística & dados numéricos , Humanos , Segurança do Paciente , Respiração com Pressão Positiva/estatística & dados numéricos , Estatísticas não Paramétricas , Volume de Ventilação Pulmonar , Ventiladores Mecânicos/estatística & dados numéricos
20.
N Engl J Med ; 376(6): 526-535, 2017 02 09.
Artigo em Inglês | MEDLINE | ID: mdl-28121489

RESUMO

BACKGROUND: The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI). METHODS: We used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. Secondary safety end points were access-site bleeding requiring treatment and postprocedural blood transfusion. RESULTS: We analyzed data from 73,124 patients who had received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. The Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular-closure devices (absolute risk, 1.2% vs. 0.8%; relative risk, 1.59; 95% confidence interval [CI], 1.42 to 1.78; P<0.001); there was also a significantly greater risk of access-site bleeding (absolute risk, 0.4% vs. 0.3%; relative risk, 1.34; 95% CI, 1.10 to 1.62; P=0.001) and transfusion (absolute risk, 1.8% vs. 1.5%; relative risk, 1.23; 95% CI, 1.13 to 1.34; P<0.001). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater in three prespecified high-risk subgroups: patients with diabetes, those 70 years of age or older, and women. All safety alerts were confirmed in an independent sample of 48,992 patients from April 1, 2014, to September 30, 2015. CONCLUSIONS: A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first 12 months of monitoring. (Funded by the Food and Drug Administration and others.).


Assuntos
Segurança de Equipamentos , Intervenção Coronária Percutânea/instrumentação , Dispositivos de Oclusão Vascular/efeitos adversos , Idoso , Desenho de Equipamento , Segurança de Equipamentos/estatística & dados numéricos , Feminino , Hemorragia/epidemiologia , Hemorragia/etiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Vigilância da População , Estudos Prospectivos , Sistema de Registros , Risco , Medição de Risco/métodos
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