Implantation of a novel insertable cardiac monitor: preliminary multicenter experience in Europe.

BACKGROUND: The LUX-Dx™ is a novel insertable cardiac monitor (ICM) introduced into the European market since October 2022. PURPOSE: The aim of this investigation was to provide a comprehensive description of the ICM implantation experience in Europe during its initial year of commercial use. METHODS: The system comprises an incision tool and a single-piece insertion tool pre-loaded with the small ICM. The implantation procedure involves incision, creation of a device pocket, insertion of the ICM, verification of sensing, and incision closure. Patients receive a mobile device with a preloaded App, connecting to their ICM and transmitting data to the management system. Data collected at European centers were analyzed at the time of implantation and before patient discharge. RESULTS: A total of 368 implantation procedures were conducted across 23 centers. Syncope (235, 64%) and cryptogenic stroke (34, 9%) were the most frequent indications for ICM. Most procedures (338, 92%) were performed in electrophysiology laboratories. All ICMs were successfully implanted in the left parasternal region, oriented at 45° in 323 (88%) patients. Repositioning was necessary after sensing verification in 9 (2%) patients. No procedural complications were reported, with a median time from skin incision to suture of 4 min (25th-75th percentiles 2-7). At implantation, the mean R-wave amplitude was 0.39 ± 0.30 mV and the P-wave visibility was 91 ± 20%. Sensing parameters remained stable until pre-discharge and were not influenced by patient characteristics or indications. Procedural times were fast, exhibited consistency across patient groups, and improved after an initial experience with the system. Operator Operator feedback on the system was positive. Patients reported very good ease of use of the App and low levels of discomfort after implantation. CONCLUSIONS: LUX-Dx™ implantation appears efficient and straightforward, with favorable post-implantation sensing values and associated with positive feedback from operators and patients.

Trauma care in Italy: evidence of in-hospital preventable deaths.

The quality of a trauma system can be assessed by the rate of preventable deaths. A random selected sample of 110 trauma patients was examined using both clinical and autopsy data. The assessors were asked the following question: If this patient had sustained the accident in front of the hospital in a normal working day, might death have been prevented? Death was found to be unavoidable in 61 cases, in 25 cases death was classified potentially preventable; 11 cases were classified as clearly preventable death. The main failures of treatment were identified as errors and delays during the first phases of in-hospital assessment and care. An improvement in the pre-hospital phase will be almost useless if the quality of the definitive in-hospital management is not addressed.

[Immune response to plasma-derived hepatitis B vaccine in hospital health personnel of Parma]. / Risposta immune ai vaccini plasma-derivati anti epatite B nel personale sanitario ospedaliero di Parma.

In January 1984 a hepatitis B vaccination campaign was started in health care workers of Hospital of Parma. Within 3 years, of the 953 subjects submitted to serologic screening, 446 were eligible and 409, serum negative for HBV, completed the vaccination. 202 received HB-VAX vaccine (M.S.D.) intramusculary into the buttock at 0.1 and 6 months, and 208 received HEVAC-B vaccine (Pasteur) into deltoid region at 0, 1, 2 and 12 months. After the booster injection, percent of seroconversion (anti-HBs greater than 10 UI/l) and anti-HBs antibody titres were significantly (p less than 0.01) higher in HEVAC-B recipients (95.6%, mean anti-HBs titres = 6400 UI/l), than in the subjects vaccined with HB-VAX (77.1%, mean anti-HBs titres = 2703 UI/l). There was no significative difference in immune response in both groups with respect to age, sex or occupational category. Three hepatitis B infections were identified in HB-VAX recipients, but no one in individuals vaccined with HEVAC-B. No participants had serious adverse effects, minor side effects occurred with equal frequency in both groups. In general, both plasma-derived vaccines have proved to be highly immunogenic, safe and well tolerated in health care workers, however HEVAC-B vaccine, since contains S and pre-S ag, has shown a more satisfactory immunogenic effect.

[Immune response to hepatitis B vaccine and duration of protection in a dialysis unit]. / Risposta immune al vaccino anti epatite B e durata della protezione in un centro dialisi.

Thirty members of the staff and fifty-one patients of Parma hemodialysis unit, serum negative for HBV markers, having completed the vaccination (HB-vax vaccine) against hepatitis B, were followed for two years after booster dose. After the third injection, the response to HB vaccine was significantly higher (p less than .0005) in staff members, than in patients. In the staff group, 83.3% were responders at mean titers of anti-HBs of 2703 mUI/ml; only 51% of patients developed anti-HBs at mean titres of 287 mUI/ml. As to either sex or age, no significant differences were observed in the two groups. Among hemodialysis patients the higher response (71.4%) was noted in the less than 40 aged individuals in comparison with those 40-60 (56.9%) or greater than 60 aged (38%). The persistence of the immunisation in both groups appeared to be statistically correlated to the anti-HBs titres after booster injection. At the end of the follow-up, 63.3% of the staff vaccinated members, but only 15.6% of the patients still had protective titre. No ill-effects induced by vaccine developed. Hepatitis B infection was only observed in one non responder member of the staff. The study demonstrates a low response to HB-vaccine and a rapid decrease of anti-HBs titre in the hemodialysis patients, thus leading to the need of frequent revaccination.

[Acquired immunodeficiency syndrome: epidemiological, clinical and immunological findings in risk groups in Parma]. / Sindrome da immunodeficienza acquisita: rilievi epidemiologici, clinici e sieroimmunologici in gruppi a rischio a Parma.

Between August 1985 and June 1987, 809 subjects at risk for AIDS have been studied. 231 (28.5%) were seropositive for human immunodeficiency virus (HIV) antibodies. The seropositivity rate was 41% among drug addicts, 20.5% among homosexual/bisexual males, 19.7% among sexual partners of seropositive individuals. None of 62 subjects belonging to the health care personnel who interacted with seropositive patients and none of the 26 relatives of HIV-infected subject, have been found to be seropositive. Moreover the HIV seropositivity in the population of Parma was only 0.01%. Among the seropositive subjects, 155 (67.1%) were asymptomatic; 2 (0.8%) showed acute infection (a mononucleosis-like syndrome in both, associated with aseptic meningitis in one); 57 (24.6%) had PLG, 7 (3.4%) ARC, 9 (3.8%) full-blown AIDS (8 of these latter are dead).

[Hepatitis B virus infection in a hospital population in Parma: implementation of a vaccination program]. / L'infezione da HBV nella popolazione ospedaliera di Parma: impostazione di un programma di vaccinazione.

An epidemiological survey of hepatitis B virus infection has been carried out in medical and paramedical employees of the Hospital of Parma, in order to identify high-risk groups and to estimate how many of subjects might be immunized with newly available but expansive vaccine. Radioimmunoassay procedures were used to detect the hepatitis B surface antigen (HBsAg) and the corresponding antibody (anti-HBs) in serum samples from 1682 hospital workers. Among these person tested, HBsAg was present in 57 (3.4%) and anti-HBs in 438 (26.3%); at least one of the two markers was found in 495 (29.4%). The prevalence of HBsAg and anti-HBs was related more closely to age, years and kind of occupation, than to clinical service (i.e. renal dialysis or medical services) and title (physician, nurse, laboratory technician, support staff.

[An outbreak type A hepatitis in a family group living in a village near Parma. Epidemiologic evaluation and prophylaxis (author's transl)]. / Analisi di un focolaio epidemico familiare di epatite A nella provincia di Parma. Considerazioni di epidemiologia e profilassi.

The most recent data concerning the characteristics of hepatitis A virus, as well as epidemiology and prophylaxis of type A hepatitis are described. An epidemic of hepatitis A which occurred in a village near Parma is analysed. The diagnosis was based on the detection, by radioimmunoassay, of specific antibody to hepatitis A antigen (anti-HAV) at the beginning of the infection and during the convalescence. In addition the occurrence of high levels of specific immunoglobulins type M anti HAV, during the acute phase, was a further evidence of the diagnosis. The presence of other agents responsible for acute hepatitis, such as Cytomegalovirus and Epstein-Barr virus, has been excluded by laboratory examination.

[Automatic teleprocessing of ECG problems and prospectives of a service center (author's transl)]. / La lettura automatica a distanza degli elettrocardiogrammi. Problemi e prospettive di un Centro Servizi

The different alternative for an ECG's computer interpretative service are described and analyzed. The important factors which can be used as measures of effectiveness for each alternative are identified as: 1) waiting time before sending ECG; 2) waiting time before receiving the report; 3) capability of satisfying emergency calls; 4) cost per ECG. Three major alternatives are compared on the basis of these measures of effectiveness. The utility of a computer center serving more hospitals is evaluated against the utility of having an in-house computer in the hospital, on the basis of cost and convenience of service considerations.