Change in the use of remote monitoring of cardiac implantable electronic devices in Italian clinical practice over a 5-year period: results of two surveys promoted by the AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

AIMS: The aim of this study was to evaluate the use of remote monitoring in Italian clinical practice and its trend over the last 5 years. METHODS: In 2012 and 2017, two surveys were conducted. Both were open to all Italian implanting centres and consisted of 25 questions on the characteristics of the centre, their actual use of remote monitoring, applied organizational models and administrative and legal aspects. RESULTS: The questionnaires were completed by 132 and 108 centres in 2012 and 2017, respectively (30.6 and 24.7% of all Italian implanting centres). In 2017, significantly fewer centres followed up fewer than 200 patients by remote monitoring than in 2012, while more followed up more than 500 patients (all P < 0.005). In most of the centres (77.6%) that responded to both surveys, the number of patients remotely monitored significantly increased from 2012 to 2017.In both surveys, remote monitoring was usually managed by physicians and nurses. Over the period, primary review of transmissions by physicians declined, while it was increasingly performed by nurses; the involvement of technicians rose, while that of manufacturers' technical personnel decreased. The percentage of centres in which transmissions were submitted to the physician only in critical cases rose (from 28.3 to 64.3%; P < 0.001). In 86.7% of centres, the lack of a reimbursement system was deemed the main barrier to implementing remote monitoring. CONCLUSION: In the last 5 years, the number of patients followed up by remote monitoring has increased markedly. In most Italian centres, remote monitoring has increasingly been managed through a primary nursing model. The lack of a specific reimbursement system is perceived as the main barrier to implementing remote monitoring .

Clinical and organizational management of cardiac implantable electronic device replacements: an Italian Survey promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

AIMS: The aim of this survey was to assess the management and organization of cardiac implantable electronic device (CIED) replacement in Italy. METHODS: A questionnaire consisting of 24 questions on organizational aspects and on the peri-procedural management of anticoagulant therapies and antibiotic prophylaxis was sent via the Internet to 154 Italian arrhythmia centers. RESULTS: A total of 103 out of 154 centers completed the questionnaire (67% response rate). In 43% of the centers, the procedures were performed under day-case admission, in 40% under ordinary admission, and in 17% under either day-case or ordinary admission. The most frequent reason (66%) for choosing ordinary admission rather than day-case admission was to obtain full reimbursement. Although warfarin therapy was continued in 73% of the centers, nonvitamin K oral anticoagulants were discontinued, without bridging, 24 h or less prior to replacement procedures in 88%. Prophylactic antibiotic therapy was systematically administered in all centers; in 97%, the first antibiotic dose was administered 1-2 h prior to procedures. Local antibacterial envelopes were also used in 43% of the centers in patients with a higher risk of device infection. CONCLUSION: This survey provides a representative picture of how CIED replacements are organized and managed in current Italian clinical practice. The choice of the type of hospitalization (short versus ordinary) was more often motivated by economic reasons (reimbursement of the procedure) than by clinical and organizational factors. Peri-procedural management of anticoagulation and prophylactic antibiotic therapy was consistent with current scientific evidence.

Facility-Level Variation and Clinical Outcomes in Use of Cardiac Resynchronization Therapy With and Without an Implantable Cardioverter-Defibrillator.

BACKGROUND: Little is known about real-world facility-level preferences for cardiac resynchronization therapy devices with (CRT-D) and without (CRT-P) defibrillator backup. We quantify this variation at the facility level and exploit this variation to compare outcomes of patients receiving these 2 devices. METHODS AND RESULTS: Claims data from fee-for-service Medicare beneficiaries were used to identify new CRT-P and CRT-D implants, 2006 to 2012. We modeled factors associated with receipt of each device, and compared mortality, hospitalizations, and reoperations for patients receiving each using both logistic regression and instrumental variable analysis to account for confounding. Among 71 459 device recipients (CRT-P, 11 925; CRT-D, 59 534; 31% women), CRT-P recipients were older, more likely to be women, and had more comorbidities. Variation in device selection among facilities was substantial: After adjustment for patient characteristics, the odds of receiving a CRT-P (versus CRT-D) device were 7.6× higher for a patient treated at a facility in the highest CRT-P use quartile versus a facility in the lowest CRT-P use quartile. Logistic modeling suggested a survival advantage for CRT-D devices but with falsification end points indicating residual confounding. By contrast, in the instrumental variable analysis using facility variability as the proposed instrument, clinical characteristics and falsification end points were well balanced, and 1-year mortality in patients who received CRT-P versus CRT-D implants did not differ, while CRT-P patients had a lower probability of hospitalizations and reoperations in the year following implant. CONCLUSIONS: CRT-P versus CRT-D selection varies substantially among facilities, adjusted for clinical factors. After instrumental variable adjustment for clinical covariates and facility preference, survival was no different between the devices. Therefore, CRT-P may be preferred for Medicare beneficiaries considering new CRT implantation.

Hospitalization Trends and Health Resource Use for Adult Congenital Heart Disease-Related Heart Failure.

Background This study assessed trends in heart failure ( HF) hospitalizations and health resource use in patients with adult congenital heart disease ( ACHD ). Methods and Results The Nationwide Inpatient Sample was used to compare ACHD with non- ACHD HF hospitalization and health resource trends. Health resource use was assessed using total hospital charges, hospital length of stay, and procedural burden. A total of 87 175±2676 ACHD -related HF hospitalizations occurred between 1998 and 2011. During this time, ACHD HF hospitalizations increased 91% (4620±438-8809±740, P<0.0001) versus a 21% increase in non- ACHD HF hospitalizations ( P=0.003). ACHD HF hospitalization was associated with longer length of stay ( ACHD HF versus non- ACHD HF, 7.2±0.09 versus 6.8±0.02 days; P<0.0001), greater procedural burden, and higher charges ($81 332±$1650 versus $52 050±$379; P<0.0001). ACHD HF hospitalization charges increased 258% during the study period ($26 533±$1816 in 1998 versus $94 887±$8310 in 2011; P=0.0002), more than double that for non- ACHD HF ( P=0.04). Patients with ACHD HF hospitalized in high-volume ACHD centers versus others were more likely to undergo invasive hemodynamic testing (30.2±0.6% versus 20.7±0.5%; P<0.0001) and to receive cardiac resynchronization/defibrillator devices (4.7±0.3% versus 1.8±0.2%; P<0.0001) and mechanical circulatory support (3.9±0.2% versus 2.4±0.2%; P<0.0001). Conclusions ACHD -related HF hospitalizations have increased dramatically in recent years and are associated with disproportionately higher costs, procedural burden, and health resource use.

Frequency of in-hospital adverse outcomes and cost utilization associated with cardiac resynchronization therapy defibrillator implantation in the United States.

BACKGROUND: The utilization of cardiac resynchronization therapy defibrillator (CRT-D) has increased significantly, since its initial approval for use in selected patients with heart failure. Limited data exist as for current trends in implant-related in-hospital complications and cost utilization. The aim of our study was to examine in-hospital complication rates associated with CRT-D and their trends over the last decade. METHODS AND RESULTS: Using the Nationwide Inpatient Sample, we estimated 378 248 CRT-D procedures from 2003 to 2012. We investigated common complications, including mechanical, cardiovascular, pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with CRT-D, defining them by the validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. Mechanical complications (5.9%) were the commonest, followed by cardiovascular (3.6%), respiratory failure (2.4%), and pneumothorax (1.5%). Age (≥65 years), female gender (OR, 95% CI; P value) (1.08, 1.03-1.13; 0.001), and the Charlson score ≥3 (1.52, 1.45-1.60; <0.001) were significantly associated with increased mortality/complications. CONCLUSIONS: The overall complication rate in patients undergoing CRT-D has been increasing in the last decade. Age (≥65), female sex, and the Charlson score ≥3 were associated with higher complications. In patients who underwent CRT-D implantation, postoperative complications were associated with significant increases in cost.

Association of the US Department of Justice Investigation of Implantable Cardioverter-Defibrillators and Devices Not Meeting the Medicare National Coverage Determination, 2007-2015.

Importance: The US Department of Justice (DOJ) conducted an investigation into implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria. Objective: To examine changes in the proportion of initial primary prevention ICDs that did not meet NCD criteria following the announcement of the DOJ investigation at hospitals that reached settlements (settlement hospitals) and those that did not (nonsettlement hospitals). Design, Setting, and Participants: Multicenter, longitudinal, serial cross-sectional analysis of 300 151 initial primary prevention ICDs among Medicare beneficiaries from January 1, 2007, through December 31, 2015, at 1809 US hospitals in the National Cardiovascular Data Registry (NCDR) ICD Registry, of which 452 hospitals (with 99 591 primary prevention ICDs) reached settlements with the DOJ. Exposures: The DOJ investigation announcement in 2010. Main Outcomes and Measures: Proportion of initial primary prevention ICDs not meeting NCD criteria. Results: In January 2007, the proportion of initial ICDs not meeting NCD criteria was 25.8% (95% CI, 24.7% to 26.8%) at settlement hospitals and 22.8% (95% CI, 22.1% to 23.5%) at nonsettlement hospitals (P < .001). Over the study period, there was a 62.7% (95% CI, 59.2% to 66.1%) relative decrease and 16.1% (95% CI, 14.8% to 17.5%) absolute decrease in the proportion of ICDs not meeting NCD criteria at settlement hospitals compared with a 53.2% (95% CI, 50.4% to 56.0%) relative decrease and 12.1% (95% CI, 11.2% to 13.0%) absolute decrease in proportion at nonsettlement hospitals (P < .001 for both; P for interaction < .001). Trends significantly differed between hospital groups only in the period following the announcement of the DOJ investigation (January 2010-June 2011) [corrected], with larger and more rapid decreases at settlement hospitals (P for interaction = .01). Over the study period, there was a 32.8% (95% CI, 29.9% to 35.7%) relative decrease and a 1703 ICDs (95% CI, 1520 to 1886) absolute decrease in the volume of primary prevention ICDs implanted at settlement hospitals compared with a 17.4% (95% CI, 14.8% to 20.0%) relative decrease and a 1495 ICDs (95% CI, 1249 to 1741) absolute decrease in volume at nonsettlement hospitals (P < .001 for both; P for interaction < .001), with more modest decreases or slight increases in secondary prevention ICD volume. These patterns were similar when examining ICD utilization among non-Medicare beneficiaries. Conclusions and Relevance: From 2007 through 2015, the volume of primary prevention implantable cardioverter-defibrillators and the proportion of devices not meeting the Centers for Medicare & Medicaid Services National Coverage Determination criteria decreased at all hospitals with substantially larger decreases at hospitals that reached settlements in the US Department of Justice investigation. These patterns extended to implantable cardioverter-defibrillators placed in non-Medicare beneficiaries, which were not the focus of the US Department of Justice investigation.

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads.

BACKGROUND: The transvenous implantable cardioverter-defibrillator (ICD) lead is the most common source of complications in a traditional ICD system. This investigation aims to determine the incidence, predictors, and costs associated with these complications using a large insurance database. METHODS AND RESULTS: Data from the OptumLabs™ Data Warehouse, which include diagnosis, physician and procedure codes, and claims from patient hospitalizations, were analyzed. Patients with a de novo ICD or cardiac resynchronization therapy defibrillator implanted from January 1, 2003, through June 30, 2015, were included; those who did not have continuous coverage beginning 1 year before implantation were excluded, resulting in 40 837 patients followed up over an average of 2.3±2.1 years. Patients were followed up until they had the procedure or their last active date in the database. Of 20 580 device procedures, 2165 (5.3%) and 771 (1.9%) had mechanical and infectious complications, respectively. The 5-year rate of freedom from mechanical complication was 92.0% and 89.3% for ICDs and cardiac resynchronization therapy defibrillators, respectively. Infectious complications were more likely in patients with a history of atrial fibrillation, diabetes mellitus, and renal disease, and the risk increased with subsequent device procedures. Younger age, female sex, lack of comorbidities, and implantations between 2003 and 2008 were associated with more mechanical complications. CONCLUSIONS: Incidence of mechanical and infectious complications of transvenous ICD leads over long-term follow-up is much higher in the real world than in clinical studies. In our study cohort, 1 of 4 transvenous ICD leads had mechanical complications when followed up to 10 years. The high rate of reintervention leads to additional complications.

Five year trends (2008-2012) in cardiac implantable electrical device utilization in five European nations: a case study in cross-country comparisons using administrative databases.

Aims: Common methodologies for analysis of analogous data sets are needed for international comparisons of treatment and outcomes. This study tests using administrative hospital discharge (HD) databases in five European countries to investigate variation/trends in pacemaker (PM) and implantable cardioverter defibrillator (ICD) implant rates in terms of patient characteristics/management, device subtype, and initial implantation vs. replacement, and compares findings with existing literature and European Heart Rhythm Association (EHRA) reports. Methods and results: HD databases from 2008 to 2012 in Austria, England, Germany, Italy and Slovenia were interrogated to extract admissions (without patient identification) associated with PM and ICD implants and replacements, using direct cross-referencing of procedure codes and common methodology to compare aggregate data. 1 338 199 records revealed 212 952 PM and 62 567 ICD procedures/year on average for a 204.4 million combined population, a crude implant rate of about 104/100 000 inhabitants for PMs and 30.6 for ICDs. The first implant/replacement rate ratios were 81/24 (PMs) and 25/7 (ICDs). Rates have increased, with cardiac resynchronization therapy (CRT) subtypes for both devices rising dramatically. Significant between- and within-country variation persists in lengths of stay and rates (Germany highest, Slovenia lowest). Adjusting for age lessened differences for PM rates, scarcely affected ICDs. Male/female ratios remained stable at 56/44% (PMs) and 79/21% (ICDs). About 90% of patients were discharged to home; 85-100% were inpatient admissions. Conclusion: To aid in policymaking and track outcomes, HD administrative data provides a reliable, relatively cheap, methodology for tracking implant rates for PMs and ICDs across countries, as comparisons to EHRA data and the literature indicated.

A Decade of Information on the Use of Cardiac Implantable Electronic Devices and Interventional Electrophysiological Procedures in the European Society of Cardiology Countries: 2017 Report from the European Heart Rhythm Association.

AIMS: The aim of this analysis was to provide comprehensive information on invasive cardiac arrhythmia therapies in the European Society of Cardiology (ESC) area over the past 10 years. METHODS AND RESULTS: The European Heart Rhythm Association (EHRA) has collected data on invasive arrhythmia therapies since 2008. This year 53 of the 56 ESC member countries provided data for the EHRA White Book. Here we present updated data on procedure rates together with information on demographics, economy, vital statistics, local healthcare systems and training activities. Considerable heterogeneity in the access to invasive arrhythmia therapies still exists across the five geographical ESC regions. In 2016, the device implantation rates per million population were 3-6 times higher in the Western region than in the non-European and Eastern ESC member countries. Catheter ablation activity was highest in the Western countries followed by the Northern and Southern areas. In the non-European countries, atrial fibrillation ablation rate was more than tenfold lower than in the European countries. On the other hand, the growth rate over the past ten years was highest in the non-European and Eastern countries. In some Eastern European countries with relative low gross domestic product the procedure rates exceeded the average values. CONCLUSION: It was encouraging to note that during the past decade the growth in invasive arrhythmia therapies was greatest in the areas historically with relatively low activity. Nevertheless, there is substantial disparity and continued efforts are needed to improve harmonization of cardiac arrhythmia therapies in the ESC area.

Cardiac Implantable Electronic Device-Related Infection and Extraction Trends in the U.S.

BACKGROUND: Implantation of cardiac implanted electronic device (CIED) has surged lately. This resulted in a rise in cardiac device-related infections (CDI) and inevitably, lead extractions. We examined the recent national trend in the incidence of CIED infections and lead extractions in hospitalized patients and associated mortality. METHODS: Using the Nationwide Inpatient Sample for the years 2003-2011 we identified patients diagnosed with a CDI-associated infection as determined by discharge ICD-9 diagnostic codes. We examined the trend of device-related infections overall and in different subgroups. We studied mortality associated with device infections, lead extractions, associated costs, and length of stay. RESULTS: There is a significant increase in the number of hospitalizations due to CDI from 5,308 in the year 2003 to 9,948 in 2011. Males (68%), Caucasians (77%), and age group 65-84 years (56.4%) accounted for majority of CDI. The mortality associated with CDI was 4.5 %, and was worse in higher age groups (2.5% in 18-44 years compared to 5.3% in 85+ years, P < 0.001). Average length of stay was unchanged over the years remaining at 13.6 days; however, mean hospitalization charges increased from $91,348 in 2003 to $173,211 in 2011 (P < 0.001). Among all lead extraction procedures, the percentage of patients undergoing lead extraction secondary to CDI also increased from 2003 (59.1%) to 2011 (76.7%), P-value < 0.001. CONCLUSIONS: Healthcare burden associated with CDI infections and associated lead extractions has significantly increased in the recent years. Despite an increase in cost associated with CIED infections, mortality remains the same, and is higher in older patients.

Implantation of subcutaneous implantable cardioverter defibrillators in Europe: results of the European Heart Rhythm Association survey.

AIMS: The purpose of this European Heart Rhythm Association (EHRA) survey is to provide an overview of the current use of subcutaneous cardioverter defibrillators (S-ICDs) across a broad range of European centres. METHODS AND RESULTS: A questionnaire was sent via the internet to centres participating in the EHRA electrophysiology research network. Questions included standards of care and policies used for patient management, indications, and techniques of implantation of the S-ICDs. In total, 52 centres replied to the questionnaire. More than one-fourth of the responding centres does not implant the S-ICD (n = 14, 27%). The majority reported to have implanted <10 (50%) or 10-29 (23%) S-ICDs during the last 12 months. Lack of reimbursement (25%), non-availability (19%), and cost of the device (25%) seem to limit the use of the S-ICD. The most commonly reported indications for S-ICD implantation are a difficult vascular access (82%), a history of previous complicated transvenous ICD (8O%), young age (69%), or an anticipated higher risk of infection (63%). Inappropriate therapies were the most frequently reported major problems (38%), but the majority of respondents (51%) never encountered any issue after an S-ICD implantation. Most of the respondents (83%) anticipate significant increase of S-ICD use within the next 2 years. CONCLUSION: This survey provides a contemporary insight into S-ICD implantation and management in the European electrophysiology centres, showing different approaches, depending on local policies. Cost issues or lack of reimbursement strongly influence the dissemination of the device. However, most respondents retain that S-ICD use will significantly increase in a very short time.

[ANMCO/SIC/SIT Consensus document: The future of telemedicine in heart failure]. / Documento di consenso ANMCO/SIC/SIT: Il futuro della telemedicina nello scompenso cardiaco.

Telemedicine applied to heart failure patients is a tool for recording, remote transmission, storage and interpretation of cardiocirculatory parameters and/or diagnostic images, useful, as emphasized by the latest guidelines, to allow for intensive home monitoring in patients with advanced heart failure or during the vulnerable post-acute phase to improve the prognosis and quality of life for patients.Recently, several meta-analyses have shown that the patterns of care supported by telemedicine are not only effective, but also economically advantageous. The benefit is unquestionable with a 30-35% reduction in mortality and a 15-20% reduction in hospitalizations. Patients implanted with cardiac devices can also benefit from an integrated remote clinical management as all modern devices can transmit technical and diagnostic data. However, telemedicine can bring benefits to the patient with heart failure only if it is part of a shared and integrated, multidisciplinary and multiprofessional "Chronic Care Model". Moreover, the future development of remote telemonitoring programs in our country goes through the primary use of products certified as medical device, field validation of organizational solutions proposed, a legislative and administrative adaptation to new care methods and the widespread growth of competence in clinical care to remotely manage the complexity of chronicity.With this consensus document the Italian Cardiology reaffirms its willingness to contribute to the government of the tumultuous and fragmented technological development, proposing a new phase of qualitative assessment, standardization of processes and testing the application of telemedicine to heart failure.

Multi-Center, Community-Based Cardiac Implantable Electronic Devices Registry: Population, Device Utilization, and Outcomes.

BACKGROUND: The purpose of this study is to describe key elements, clinical outcomes, and potential uses of the Kaiser Permanente-Cardiac Device Registry. METHODS AND RESULTS: This is a cohort study of implantable cardioverter defibrillators (ICD), pacemakers (PM), and cardiac resynchronization therapy (CRT) devices implanted between January 1, 2007 and December 31, 2013 by ≈400 physicians in 6 US geographical regions. Registry data variables, including patient characteristics, comorbidities, indication for procedures, complications, and revisions, were captured using the healthcare system's electronic medical record. Outcomes were identified using electronic screening algorithms and adjudicated via chart review. There were 11 924 ICDs, 33 519 PMs, 4472 CRTs, and 66 067 leads registered. A higher proportion of devices were implanted in males: 75.1% (ICD), 55.0% (PM), and 66.7% (CRT), with mean patient age 63.2 years (ICD), 75.2 (PM), and 67.2 (CRT). The 30-day postoperative incidence of tamponade, hematoma, and pneumothorax were ≤0.3% (ICD), ≤0.6% (PM), and ≤0.4% (CRT). Device failures requiring revision occurred at a rate of 2.17% for ICDs, 0.85% for PMs, and 4.93% for CRTs, per 100 patient observation years. Superficial infection rates were <0.03% for all devices; deep infection rates were 0.6% (ICD), 0.5% (PM), and 1.0% (CRT). Results were used to monitor vendor-specific variations and were systematically shared with individual regions to address potential variations in outcomes, utilization, and to assist with the management of device recalls. CONCLUSIONS: The Kaiser Permanente-Cardiac Device Registry is a robust tool to monitor postprocedural patient outcomes and postmarket surveillance of implants and potentially change practice patterns.

Gender, Racial, and Health Insurance Differences in the Trend of Implantable Cardioverter-Defibrillator (ICD) Utilization: A United States Experience Over the Last Decade.

Prior studies have highlighted disparities in cardiac lifesaving procedure utilization, particularly among women and in minorities. Although there has been a significant increase in implantable cardioverter-defibrillator (ICD) insertion, socioeconomic disparities still exist in the trend of ICD utilization. With the use of the Nationwide Inpatient Sample from 2003 through 2011, we identified subjects with ICD insertion (procedure code 37.94) and cardiac resynchronization defibrillator (procedure code 00.50, 00.51) as codified by the International Classification of Diseases, Ninth Revision, Clinical Modification. Overall, 1 020 076 ICDs were implanted in the United States from 2003 to 2011. We observed an initial increase in ICD utilization by 51%, from 95 062 in 2003 to 143 262 in 2006, followed by a more recent decline. The majority of ICDs were implanted in men age ≥65 years. Implantation of ICDs was 2.5× more common in men than in women (402 per million vs 163 per million). Approximately 95% of the ICDs were implanted in insured patients, and 5% were used in the uninsured population. There has been a significant increase in ICD implantation in blacks, from 162 per million in 2003 to 291 per million in 2011. We found a significant difference in the volume of ICD implants between the insured and the uninsured patient populations. Racial disparities have narrowed significantly in comparison with those noted in earlier studies and are now more reflective of the population demographics at large. On the other hand, significant gender disparities continue to exist.

Manpower and outpatient clinic workload for remote monitoring of patients with cardiac implantable electronic devices: data from the HomeGuide Registry.

BACKGROUND: This study aimed to assess manpower and resource consumption of the HomeGuide workflow model for remote monitoring (Biotronik Home Monitoring [HM], Biotronik SE & Co. KG, Berlin, Germany) of cardiac implantable electronic devices in daily clinical practice. METHODS: The model established a cooperative interaction between a reference nurse (RN) for ordinary management, and a responsible physician (RP) for medical decisions in each outpatient clinic. RN reviewed remote transmissions and alerts, addressing critical cases to the RP. RESULTS: A total of 1,650 patients were enrolled in 75 sites: 25% pacemakers (PM), 22% dual-, 27% single-chamber implantable defibrillators (ICD), 2% PM with cardiac resynchronization therapy (CRT), and 24% ICD-CRT. During a median follow-up of 18 (10-31) months, 3,364 HM sessions were performed (74% by the RN, 26% by the RP) to complete 18,478 remote follow-ups. Median duration of remote follow-ups was 1.2 (0.6-2.0) minutes, corresponding to a manpower of 43.3 (4.2-94.8) minutes/month every 100 patients for nurses and 10.2 (0.1-31.1) for physicians (P < 0.0001). RN submitted 15% of remote transmissions to RP, who decided unscheduled follow-ups in 12% of the cases. The median manpower for phone calls was 1.9 (0.8-16.5) minutes/month every 100 contacted patients. There were 2.84 in-hospital visits/patient, 0.46 of which triggered by HM findings. A cumulative per-patient HM follow-up time of 15.4 minutes (20% of total follow-up time) allowed remote detection of 73% of actionable events. CONCLUSIONS: HM implemented in the HomeGuide workflow model required <1 hour/month every 100 patients to detect the majority of actionable events with limited administrative workload.

Development of an entirely subcutaneous implantable cardioverter-defibrillator.

The recent advent of an entirely subcutaneous implantable defibrillator (ICD) has provided a relevant contribution to the debate concerning the use of ICD therapy in patients at high risk for death. Although conventional transvenous ICDs have proven very effective during the past 23 years, they still appear to be limited by nontrivial acute and long-term complications. This study delineates some of the historical and current issues characterizing the advent of the subcutaneous ICD system in daily clinical practice. Subcutaneous ICDs have proven effective in more than 1100 patients worldwide and appear to be competitive with transvenous ICD in all clinical conditions not requiring antibradycardia, antitachycardia, or cardiac resynchronization pacing.

[Current perspectives in telemonitoring and devices in chronic heart failure patients: lights and shadows]. / Prospettive della telemedicina e del monitoraggio mediante dispositivi nel paziente con scompenso cardiaco cronico: luci e ombre.

The complexity of an integrated approach, mandatory for chronic diseases such as heart failure, might be simplified by the availability of new technologies for remote data transmission at relatively low costs. Home telemonitoring for complex patients opens new perspectives for the safe discharge of chronically severe patients and intensive surveillance for unstable subjects, and shows potential benefits on patients' quality of life and cost containment. Systematic reviews and meta-analyses document a 30-35% decrease in mortality and a 15-20% reduction in hospital admissions. Critical issues remain the presence of health facilities and professionals both in hospital and in the community adequately prepared for patient management through the telemonitoring tool, the selection of patients who may benefit most from it, and financial reimbursement of remote monitoring. The main indication to telemonitoring is the patient at high risk of short-term hemodynamic deterioration, but psychosocial issues should also be considered. New perspectives for tailored management of heart failure patients come from the recent availability of implantable devices able to record hemodynamic parameters. Current evidence is, however, insufficient to affirm their reliability, efficacy, cost-effectiveness, and management changes that may derive from their use.

Implantation trends and patient profiles for pacemakers and implantable cardioverter defibrillators in the United States: 1993-2006.

BACKGROUND: Prior studies of cardiac rhythm management devices (pacemakers [PM] and implantable cardioverter defibrillators [ICD]) utilization in the United States have been limited to the Medicare population. We evaluated the national trends for the implantation of PMs and ICDs including the burden of device replacement. METHODS: The Nationwide Inpatient Sample was queried to identify PM and ICD patients between 1993 and 2006 using ICD-9-CM codes, including demographics, health profile, and economic data. The Charlson Comorbidity Index (CCI) and replacement burden were calculated, and changes over time studied. RESULTS: From 1993 to 2006, 2.4 million patients received a primary PM and 0.8 million received an ICD, while there were 369,000 PM replacements and 74,000 ICD replacements. Women comprised 49% of PM and 24% of ICD patients. The mean ICD replacement burden was 8.4% (range 5-22%) and decreased significantly over time (P < 0.0001) while the replacement burden for PMs was constant (mean = 13.4%, range 11-16%). ICD patients had more comorbidities than PM patients (CCI: 0.8 vs 1.1, P < 0.0001). CONCLUSIONS: The replacement burden for PMs has remained constant, while the replacement burden for ICDs has decreased. This is likely due to the stability of the patient population receiving PMs and technology maturity. Alternatively, the indications for ICD implantation have broadened, resulting in an increased number of primary ICD implantations. The age and comorbidities are increasing in those patients receiving ICDs while the PM population is stable. These data suggest that monitoring of replacement burden is warranted, given the changing populations, their disparate clinical outcomes, and economic implications to the health care system.

Trend in implantable cardioverter defibrillators and relation to need.

BACKGROUND: Rates of implantation of implantable cardioverter defibrillators (ICD) have increased continuously ever since they were first introduced. Notwithstanding guidelines endorsed by international scientific organizations, their use varies greatly across industrialized countries. The aim of this study was to assess whether variations in temporal trends and geographical distribution in the use of ICD devices across Piedmont, Northern Italy, are related to variations in need. METHODS: We calculated ICD implantation rates in the 19 local health units of Piedmont from 1999 to 2006, and correlated their temporal trend with four proxy indicators of need: coronary heart disease (CHD) mortality, CHD hospital discharge rates, cardiac heart failure discharge rates and bisoprolol or carvedilol prescription rates. RESULTS: The ICD implantation rate increased five-fold between 1999-2000 and 2005-2006, mainly among the elderly. Implantation rates were five-fold higher in men compared to women for the entire duration of the study. There were significant differences between local health units, which increased over time. Among men there was only a statistically significant correlation with coronary heart disease mortality (r = 0.66) in the period from 2005 to 2006, and with the use of bisoprolol and carvedilol starting from 2001 to 2002. No significant correlation with need indicators was found in women. CONCLUSION: The use of ICD devices increased in apparent response to new research evidence, and, at least in part, in response to need. However, this process only involved men; ICD devices are largely underused in women and without apparent relation to need.