Influence of monitoring and atrial arrhythmia burden on quality of life and health care utilization in patients undergoing pulsed field ablation: A secondary analysis of the PULSED AF trial.

BACKGROUND: Freedom from atrial arrhythmia (AA) recurrence ≥30 seconds after pulsed field ablation (PFA) in patients with atrial fibrillation (AF) was reported in PULSED AF (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF; ClinialTrials.gov Identifier: NCT04198701). AA burden may be a more clinically meaningful endpoint. OBJECTIVE: The purpose of this study was to determine the influence of monitoring strategies on AA detection and AA burden association with quality of life (QoL) and health care utilization (HCU) after PFA. METHODS: Patients underwent 24-hour Holter monitoring at 6 and 12 months and weekly, and symptomatic transtelephonic monitoring (TTM). AA burden post-blanking was calculated as the greater of (1) percentage of AA on total Holter time; or (2) percentage of weeks with ≥1 TTM with AA out of all weeks with ≥1 TTM. RESULTS: Freedom from all AAs varied by >20% when differing monitoring strategies were used. PFA resulted in zero burden in 69.4% of paroxysmal atrial fibrillation (PAF) and 62.2% of persistent atrial fibrillation (PsAF) patients. Median burden was low (<9%). Most PAF and PsAF patients had ≤1 week of AA detection on TTM (82.6% and 75.4%) and <30 minutes of AA per day of Holter monitoring (96.5% and 89.6%), respectively. Only PAF patients with <10% AA burden averaged a clinically meaningful (>19 point) QoL improvement. PsAF patients experienced clinically meaningful QoL improvements irrespective of burden. Repeat ablations and cardioversions significantly increased with higher AA burden (P <.01). CONCLUSION: The ≥30-second AA endpoint is dependent on the monitoring protocol used. PFA resulted in low AA burden for most patients, which was associated with clinically relevant improvement in QoL and reduced AA-related HCU.

The WATCHMAN left atrial appendage closure device for patients with atrial fibrillation: current status and future perspectives.

INTRODUCTION: Atrial fibrillation (AF) is associated with an increased risk of stroke. Stroke prevention with oral anticoagulation (OAC) is recommended in AF patients at increased risk of stroke. The left atrial appendage (LAA) is the main source of thrombus formation in AF patients. The WATCHMAN percutaneous LAA closure (LAAC) device may serve as an alternative to OAC overcoming disadvantages including the risk of (major) bleeding. AREAS COVERED: This review will focus on LAAC with the Watchman device for stroke prevention in AF patients. Current status, available literature, clinical safety and efficacy will be summarized. Furthermore, the future perspectives of Watchman will be discussed. EXPERT OPINION: LAAC with Watchman appears a promising, safe, and effective alternative to OAC. Ongoing and future studies to consolidate the position of Watchman should focus on comparative safety and efficacy of different LAAC devices, patient selection, various post-procedural antithrombotic regimens, head-to-head comparisons with NOAC, better understanding of device-related thrombus, and the role of the LAA in the propagation of non-valvular AF. This research may attribute to a paradigm shift in which LAAC no longer serves as a 'last resort' treatment for AF patients ineligible for OAC but may serve as a second-line or even first-line treatment option for AF patients.

Curative-Intent Surgery for Pancreatic Tumors: A Review of Procedures From the Brazilian National Health System.

PURPOSE: In Brazil, a country with major health access disparities, resource limitations make management of pancreatic cancer (PC) challenging. This study evaluated curative-intent surgery for PC in the Brazilian public health care system. METHODS: We collected data for PC surgical procedures with curative intent in Brazil's public health care system (DATASUS) and from the demographic database. Costs, lengths of stay, number of perioperative deaths, and PC deaths were analyzed for each state and then associated with population, gross domestic product (GDP) per capita, and number of procedures. RESULTS: A total of 37,142 patients died as a result of PC in Brazil between 2008 and 2012. The number of deaths (per 100,000 person-years) was highest in the south and southeast regions. Mortality from PC had a positive association with the number of procedures and GDP per capita. Between January 2008 and July 2014, 3,386 procedures were performed, the majority (51.2%) in the southeast region. Four hundred ninety-three patients died, which translates to an inpatient mortality rate of 14.6%. The northern states had the highest perioperative mortality (mean, 25%). The number of procedures per 100,000 residents was higher in the southeast and south. Overall, cost tended to increase as the number of procedures or population increased. For fixed GDP per capita and population, cost tended to increase as the number of procedures increased, whereas for a fixed number of procedures and GDP per capita, cost tended to decrease as population increased. The mean length of hospital stay was 16.9 days, which was higher than in major international centers. CONCLUSION: This study is the first to our knowledge to evaluate regional disparities in PC care in Brazil. Perioperative mortality was high in the public health care system. Regionalized policies that improve care are needed.

Inappropriate shocks in the subcutaneous ICD: Incidence, predictors and management.

BACKGROUND: The entirely subcutaneous implantable cardioverter-defibrillator (S-ICD) eliminates the need for transvenous leads, and therefore has the potential to improve lead-longevity and reduce lead-related complications. The S-ICD has a morphology-based sensing algorithm of which inappropriate shocks have been reported. METHODS: We analyzed the incidence, predictors and management of inappropriate shocks in the EFFORTLESS S-ICD Registry, which collects S-ICD implantation information and follow-up data from clinical centers in Europe and New Zealand. RESULTS: During a follow-up of 21 ± 13 months, 48 out of 581 S-ICD patients (71% male, age 49 ± 18 years) experienced 101 inappropriate shocks (8.3%). The most common cause was cardiac signal oversensing (73%), such as T-wave oversensing. Eighteen shocks (18%) were due to supraventricular tachycardias (SVT), of which 15 occurred in the shock-only zone. Cox-proportional hazard modeling using time-dependent covariates demonstrated that patients with a history of atrial fibrillation (HR 2.4) and patients with hypertrophic cardiomyopathy (HR 4.6) had an increased risk for inappropriate shocks, while programming the primary vector for sensing (from xyphoid to V6) reduced the risk. Reprogramming or optimization of SVT treatment after the first clinical event of inappropriate shock was successful in preventing further inappropriate shocks for cardiac oversensing and SVT events. CONCLUSIONS: Inappropriate shocks, mainly due to cardiac oversensing, occurred in 8.3% of the S-ICD patients. Patients with hypertrophic cardiomyopathy or a history of atrial fibrillation were at increased risk, warranting specific attention for sensing and programming in this population.

Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD: design and rationale of the EFFORTLESS S-ICD Registry.

BACKGROUND: Leads in and on the heart of the transvenous implantable cardioverter defibrillator (ICD) form the Achilles' heel of this system due to potential for peri- and postimplant complications. The S-ICD is a newer generation of the ICD that does not require leads on the heart or in the vasculature. We present the rationale and study design of the Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (EFFORTLESS S-ICD) Registry which was designed to evaluate the long-term performance of the S-ICD including patient quality of life and long-term resource utilization. METHODS: The Registry is an observational, nonrandomized, standard of care evaluation to be conducted at approximately 50 investigational centers in Europe and New Zealand where the S-ICD is approved for use and distribution. Clinical Registry endpoints include perioperative (30 days postimplant) complication-free rate, 360-day complication-free rate, and percentage of inappropriate shocks for atrial fibrillation and supraventricular ventricular tachyarrhythmia. Other endpoints include patient-reported outcomes (e.g., quality of life) and hospital personnel implant and follow-up experience with the S-ICD system. CONCLUSIONS: Results from EFFORTLESS will build on and expand the initial published experience with the S-ICD, which demonstrated that the device successfully and consistently detects and treats episodes of sustained ventricular tachyarrhythmias. The Registry will also evaluate the patients' perspective of how it is to live with an S-ICD as compared to a contemporary transvenous system and track the experience of implanting physicians and personnel performing patient follow-up with a completely subcutaneous system.

Dental age assessment (DAA): a simple method for children and emerging adults.

INTRODUCTION: Methods of dental age assessment (DAA) give a wide margin of error and, because third molars are usually excluded, prevent estimation around the age of 18 years. This study extends the use of defined tooth development stages (TDSs) to include third molars. SUBJECTS AND METHODS: Re-use of dental panoramic tomographs (DPTs) and other X-rays taken for clinical use comprised the sample of 1,547 subjects. The radiographic images were then captured in digital format. The TDSs were assessed and the estimated mean age and its standard error were calculated for each TDS. The mathematical technique of meta-analysis was used to provide an estimate of the mean age, with 99% confidence interval, of a new 'test' subject. To assess the accuracy of the method, each of these mean values was then compared with the gold standard of chronological age. RESULTS: On average, estimated dental age (DA) over-estimated chronological age (CA) by 0.29 years, approximately 3(1/2) months. The maximum likely difference between the estimated DA and CA was 1.65 years. CONCLUSION: Estimation of dental age using well defined TDSs, extended to include third molars and combined with the statistical technique of meta-analysis, provides investigators with a rapid and accurate estimation of age.

Desperately seeking synergy: the journey to systems integration of women's health services.

Providing women's health services can be a profitable enterprise. With 70% of health care purchases being made by women for themselves and their families, focusing on women as health care consumers strengthens the entire system. However, shrinking reimbursement and market pressures are creating an atmosphere of financial instability in health care. Is system integration the answer? The four presenters-each an executive champion for the women's service line in their systems-agree that integration can potentially reduce costs, improve quality of care, and increase patient and stakeholder satisfaction. Benefits can only be realized, however, if clinicians are engaged as partners early in the process, the organization is prepared to respond quickly to market changes, and competitive forces and culture differences across the system are acknowledged and addressed. "Women's Services" must also continually demonstrate its value to the system and find creative ways to differentiate itself in the marketplace.

A comparison of fetal echocardiography in university and health maintenance organization settings.

Fetal echocardiographic findings, and decisions to continue or to terminate affected pregnancies, may differ between university (UNIV) and health maintenance organization (HMO) settings. The aim of this study was to review the fetal echocardiographic experience at a combined university/health maintenance organization program over a 4-year period. Imaging and counseling for affected pregnancies were provided by the same, single investigator at both sites. Out of a total of 1382 studies (940 UNIV, 442 HMO), 127 abnormals were identified (94 UNIV, 33 HMO). Among the 127 pregnancies with fetal heart disease, 24 (19%) underwent elective termination, 16% at UNIV and 27% at HMO (p = 0.2). Mean gestational age at the time of diagnosis was 25.2 weeks at UNIV compared with 22.3 weeks at HMO (p = 0.002). At UNIV, only 51% of diagnoses were made before 24 weeks compared with 79% at HMO (p = 0.003). Screening fetal sonograms, performed between 18 and 20 weeks on every pregnancy at HMO but not at UNIV, enabled earlier detection of congenital heart disease (CHD) and allowed more women with severely affected pregnancies the option to terminate. In both settings, indications with the highest yields for CHD included a right-sided stomach, abnormal four-chamber view, sustained bradycardia, abnormal fetal karyotype, fetal omphalocele, and maternal indomethacin. An echogenic reflector was identified in 86 pregnancies (7%) and did not represent a risk factor for CHD. No major differences in CHD were found between UNIV and HMO. In summary, this study found a significantly earlier diagnosis of CHD at HMO than at UNIV. This discrepancy between programs may explain, at least in part, the trend toward a higher frequency of decisions to terminate affected pregnancies at HMO than at UNIV, despite similar fetal findings.

The pattern of change in salivary immunoglobulins and antibodies to S. mitis and S. oralis in children undergoing bone marrow transplantation: use of an indirect method of assessment.

The objective of this study was to assess the pattern of change in salivary immunoglobulins and antibodies to S. mitis and S. oralis in 23 children following allogeneic bone marrow transplantation and their matched controls. To overcome the difficulty of obtaining a sufficient quantity of whole saliva from very young, sick children saliva was collected in a 5-ml oral rinse of sterile normal saline. It was not possible to measure the volume of whole saliva in each rinse and the concentration of the salivary immunoglobulins and bacterial antibodies were estimated from 1 ml of oral rinse. Despite these shortcomings a pattern of change in the mean concentrations of total salivary IgA, secretory IgA, antibodies to S. mitis and S. oralis and total IgG at specific event- related times during the transplantation period has been demonstrated. There was a significant increase in the concentration of salivary IgG 7 days post-transplantation, followed by significant decreases in total salivary IgA, secretory IgA and antibodies to S. mitis after recovery of the peripheral neutrophil count above 0.5 x 10(9). The concentrations of total IgA and antibodies to S. oralis was significantly greater in the transplant group 119 days post-transplantation.

[Periodontal treatment needs in a Spanish school population]. / Necesidad de tratamiento periodontal de la población escolar Espanõla.

The aim of this study was to assess the periodontal treatment needs of the population under 20 years of age in Spain. 1469 young people, aged 7, 12 and 15-19 years, and representing the urban (60%) and rural (40%) population from Spain were evaluated using the Community Periodontal Index of Treatment Needs (C.P.I.T.N.). In the first age group (7 years), 12% presented calculus or overhanging restorations, and 45% had bleeding upon probing only. In the age group of 12 years the proportion of individuals with calculus, overthanging restorations or moderate pocket depths was 39%, while 38% had gingivitis as their highest treatment need. In the oldest group (15-19 years) the number of subjects with bleeding upon probing decreased to 17%, while the percentage of individuals having moderate pockets, calculus or overhanging restorations increased to 67%. 1% of this youngsters had pockets of 6 mm. or over. At age 7, only 30% had "acceptable gingival health", and no more than 15% of the 18 year-olds reached this condition.

[Periodontal treatment needs in a Spanish school population. 2. Intraoral distribution of different signs]. / Necesidad de tratamiento periodontal de la población escolar Española. II. Distribución intrabucal de los diferentes signos.

The aim of this study was to assess the prevalence of the different periodontal disease indicators used in the C.P.I.T.N. per sextant in the Spaniard population under 20 years of age. We have examined a randomly chosen sample of 1450 school-aged individuals, 7, 12 and 15 to 19 years old. We have observed a healthy periodontium more frequently in the upper anterior region, calculus predominates in the lower incisors close followed by molars, and periodontal pockets of 4 mm or deeper were commonly found in the molar regions. We could'nt detect important deviations from this distribution pattern in the different age groups or between males and females.

[Caries prevalence and periodontal treatment needs in the same individuals]. / Prevalencia de caries y necesidad de tratamiento periodontal en los mismos individuos.

The aim of this study was to determine whether dental caries and periodontal disease occur frequently in the same subjects 1469 young people, aged 7, 12 and 15-19 years, and representing the urban (60%) and rural (40%) population from Spain were evaluated. Dental caries and periodontal treatment needs were registered according to the index D.M.F.T. and C.P.I.T.N., following the criteria of WHO. We have found a highly significant relation between both variables, average D.M.F.T. scores increased as periodontal treatment needs were more advanced. Those subjects with lower codes of C.P.I.T.N. presented also lower D.M.F.T. scores, while these individuals with higher D.M.F.T. scores, based on a great number of open carious lesions, were more affected for periodontal disease. It does not support either a directly synergistic or antagonistic correlation in the prevalence of these two diseases in the same subjects. Dental health status is at a certain time an end result of years of varying dental health behaviour. In industrialized countries a variety of factors seems to determine the prevalence of dental caries and/or periodontal disease: dietary habits, access to fluorides, efficacy of oral hygiene measures, utilization of dental health care services. These data and ideas supported the strategy of preventing the dental caries and periodontal disease simultaneously.

[Relationship of dental treatment and oral hygiene to caries prevalence and need for periodontal treatment]. / Relación entre el tratamiento dental y la higiene oral con la prevalencia de caries y necesidad de tratamiento periodontal.

The aim of this study was to examine the relationship between differences in dental attendance and oral hygiene patterns and dental caries and periodontal treatment needs. 1469 young people, aged 7, 12 and 15-19 years, and representing the urban (60%) and rural (40%) population from Spain were evaluated. Dental caries and periodontal treatment needs were registered according to the index D.M.F.T. and C.P.I.T.N., following the criteria of W.H.O. Regular dental attendance was observed in 16.6% of subjects examined, and only 9.4 saw a dentist regularly for dental prophylaxis. Statistical analyses showed that while the more frequent the dental visits, the lower the rate of caries, and periodontal treatment needs, the higher, however, the average number of fillings and the D.M.F.T. scores. These individuals had the higher number of functioning teeth, restored or sound, but they also had the disadvantage of having higher levels of disease experience. By the other way the individuals who saw the dentist regularly for dental prophylaxis presented the lower caries rate and periodontal treatment needs, the fewer tooth loss, and also an important reduction in the D.M.F.T. scores. Similar observations had been made in the individuals who brush their teeth frequently or with a correct technique. The results suggested that while frequent dental visits do not apparently help to prevent the onset of further dental disease, we can achieve this goal with regular preventive oriented dental therapy.