Assessment of the 2017 AHA/ACC/HRS Guideline Recommendations for Implantable Cardioverter-Defibrillator Implantation in Cardiac Sarcoidosis.

BACKGROUND: Implantable cardioverter-defibrillators are used to prevent sudden cardiac death in patients with cardiac sarcoidosis. The most recent recommendations for implantable cardioverter-defibrillator implantation in these patients are in the 2017 American Heart Association/American College of Cardiology/Heart Rhythm Society Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. These recommendations, based on observational studies or expert opinion, have not been assessed. We aimed to assess them. METHODS: We performed a large retrospective cohort study of patients with biopsy-proven sarcoidosis and known or suspected cardiac sarcoidosis that underwent cardiovascular magnetic resonance imaging. Patients were followed for a composite end point of significant ventricular arrhythmia or sudden cardiac death. The discriminatory performance of the Guideline recommendations was tested using time-dependent receiver operating characteristic analyses. The optimal cutoff for the extent of late gadolinium enhancement predictive of the composite end point was determined using the Youden index. RESULTS: In 290 patients, the class I and IIa recommendations identified all patients who experienced the composite end point during a median follow-up of 3.0 years. Patients meeting class I recommendations had a significantly higher incidence of the composite end point than those meeting class IIa recommendations. Left ventricular ejection fraction (LVEF) >35% with >5.7% late gadolinium enhancement on cardiovascular magnetic resonance imaging was as sensitive as and significantly more specific than LVEF >35% with any late gadolinium enhancement. Patients meeting 2 class IIa recommendations, LVEF >35% with the need for a permanent pacemaker and LVEF >35% with late gadolinium enhancement >5.7%, had high annualized event rates. Excluding 2 class IIa recommendations, LVEF >35% with syncope and LVEF >35% with inducible ventricular arrhythmia, resulted in improved discrimination for the composite end point. CONCLUSIONS: We assessed the Guideline recommendations for implantable cardioverter-defibrillator implantation in patients with known or suspected cardiac sarcoidosis and identified topics for future research.

Management of cardiac implantable devices in patients undergoing radiotherapy.

The delivery of radiotherapy to patients with a cardiac implantable electronic device (CIED) is not an infrequent event. Consideration of the potential issues for patients is an important part of their care. An overview of CIEDs is provided, including the potential problems encountered and the steps that can be taken to mitigate this risk.

Predicted longevity of contemporary cardiac implantable electronic devices: A call for industry-wide "standardized" reporting.

BACKGROUND: Battery longevity is an important factor that may influence the selection of cardiac implantable electronic devices (CIEDs). However, there remains a lack of industry-wide standardized reporting of predicted CIED longevity to facilitate informed decision-making for implanting physicians and payers. OBJECTIVE: The purpose of this study was to compare the predicted longevity of current generation CIEDs using best-matched CIEDs settings to assess differences between brands and models. METHODS: Data were extracted for current model pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy-defibrillators (CRT-Ds) from product manuals and, where absent, by communication with the manufacturers. Pacemaker longevity estimations were based on standardized pacing outputs (2.5V, 0.40-ms pulse width, 500-Ω impedance) and pacing loads of 50% or 100% at 60 bpm. ICD and CRT-D longevity were estimated at 0% pacing and 15% atrial plus 100% biventricular pacing, with essential capacitor reforms and zero clinical shocks. RESULTS: Mean maximum predicted longevity of single- and dual-chamber pacemakers was 12.0 ± 2.1 and 9.8 ± 1.9 years, respectively. Use of advanced features such as remote monitoring, prearrhythmia electrogram storage, and rate response can result in ∼1.4 years of reduction in longevity. Mean maximum predicted longevity of ICDs and CRT-Ds was 12.4 ± 3.0 and 8.8 ± 2.1 years, respectively. Of note, there were significant variations in predicted CIED longevity according to device manufacturers, with up to 44%, 42%, and 44% difference for pacemakers, ICDs, and CRT-Ds, respectively. CONCLUSION: Contemporary CIEDs demonstrate highly variable predicted longevity according to device manufacturers. This may impact on health care costs and long-term clinical outcomes.

Prospective Assessment of Linox Implantable Cardioverter Defibrillator Leads for Structural or Electrical Abnormalities.

INTRODUCTION: Insulation failure leading to conductor externalization (CE) of a Linox (Biotronik, Berlin, Germany) implantable cardioverter defibrillator (ICD) lead has recently been reported. The aim of this study was to assess prospectively all Linox family ICD leads implanted at our center for evidence of CE or an electrical abnormality. METHODS: All patients with a Linox family ICD lead implanted at our center, between November 2007 and March 2015, were identified and all living patients were invited to attend for fluoroscopic screening and electrical assessment of the lead. RESULTS: A total of 183 patients had a Linox family ICD lead implanted at our center. Of these, 5 patients (2.7%) had the lead extracted because of electrical failure and 2 of these leads had evidence of CE. Out of 158 living patients with a Linox family ICD lead, 111 patients attended for screening (mean age 63.1 years, 22.5% female). In this group of patients, no cases of CE or electrical abnormalities of the lead were identified. CONCLUSION: In this study evaluating 183 patients with a Linox family ICD lead implanted at a single center, 5 leads (2.7%) were explanted because of electrical failure and 2 of these leads had evidence of CE. Prospective fluoroscopic assessment of 111 Linox family ICD leads, with a mean dwell time of 31.5 months, revealed no further cases of CE.

Active implantable medical device EMI assessment for wireless power transfer operating in LF and HF bands.

The electromagnetic interference (EMI) imposed on active implantable medical devices by wireless power transfer systems (WPTSs) is discussed based upon results of in vitro experiments. The purpose of this study is to present comprehensive EMI test results gathered from implantable-cardiac pacemakers and implantable cardioverter defibrillators exposed to the electromagnetic field generated by several WPTSs operating in low-frequency (70 kHz-460 kHz) and high-frequency (6.78 MHz) bands. The constructed in vitro experimental test system based upon an Irnich's flat torso phantom was applied. EMI test experiments are conducted on 14 types of WPTSs including Qi-compliant system and EV-charging WPT system mounted on current production EVs. In addition, a numerical simulation model for active implantable medical device (AIMD) EMI estimation based on the experimental test system is newly proposed. The experimental results demonstrate the risk of WPTSs emitting intermittent signal to affect the correct behavior of AIMDs when operating at very short distances. The proposed numerical simulation model is applicable to obtain basically the EMI characteristics of various types of WPTSs.

Cost-Effectiveness Analysis of Iodine-123 Meta-Iodobenzylguanidine Imaging for Screening Heart Failure Patients Eligible for an Implantable Cardioverter Defibrillator in the USA.

BACKGROUND: Many guideline-eligible heart failure (HF) patients do not receive a survival benefit from implantable cardioverter defibrillators (ICDs). Improved risk stratification may help to reduce costs and improve the cost effectiveness of ICDs. OBJECTIVE: To estimate the potential outcomes, costs, and cost effectiveness of using iodine-123 meta-iodobenzylguanidine (I-mIBG) to screen HF patients eligible for an ICD. METHODS: A decision-analytic model was developed to compare screening with I-mIBG imaging and no screening over 2-year and 10-year time horizons from a US payer perspective. Data on I-mIBG imaging and risk stratification were obtained from the ADMIRE-HF/HFX (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) trial. Data on ICD effectiveness for prevention of sudden cardiac death (SCD) were obtained from a meta-analysis. Costs of ICDs and costs of generator and lead procedures were obtained from the Agency for Healthcare Research and Quality National Inpatient Sample. Age-specific mortality was modeled using US life tables and data from the ACT (Advancements in ICD Therapy) Registry on risks of SCD and non-SCD mortality. Sensitivity analyses were conducted. RESULTS: In the analysis, screening with I-mIBG imaging was associated with a reduction in ICD utilization of 21 %, resulting in a number needed to screen to prevent 1 ICD implantation of 5. Screening reduced the costs per patient by US$5500 and US$13,431 (in 2013 dollars) over 2 and 10 years, respectively, in comparison with no screening and resulted in losses of 0.001 and 0.040 life-years, respectively, over 2 and 10 years. Screening was decrementally cost effective, with savings of US$5,248,404 and US$513,036 per quality-adjusted life-year lost over 2 and 10 years, respectively. In subgroup analyses, cost savings were greater for patients with an ejection fraction (EF) of 25-35 % than for those with an EF <25 %. CONCLUSIONS: According to the model, screening of guideline-eligible patients selected for ICDs with I-mIBG imaging may be cost effective and may help reduce costs associated with implantation of ICDs, with a minimal impact on survival.

Longevity of implantable cardioverter defibrillators: a comparison among manufacturers and over time.

AIMS: Longevity of implantable cardioverter defibrillators (ICDs) is crucial for patients and healthcare systems as replacements impact on infection rates and cost-effectiveness. Aim was to determine longevity using very large databases of two teaching hospitals with a high number of replacements and a rather homogeneous distribution among manufacturers. METHODS AND RESULTS: The study population consists of all patients in whom an ICD was inserted in. All ICD manufacturers operating in Switzerland and the Netherlands and all implanted ICDs were included. Implantable cardioverter defibrillator replacements due to normal battery depletion were considered events, and other replacements were censored. Longevity was assessed depending on manufacturers, pacing mode, implant before/after 2006, and all parameters combined. We analysed data from 3436 patients in whom 4881 ICDs [44.2% VVI-ICDs, 27.4% DDD-ICDs, 26.3% cardiac resynchronization therapy (CRT)-ICDs, 2.0% subcutaneous ICDs] were implanted. The four major manufacturers had implant shares between 18.4 and 31.5%. Replacement due to battery depletion (27.4%) was performed for 1339 ICDs. Patient survival at 5 years was 80.1%. Longevity at 5 years improved in contemporary compared with elderly ICDs [63.9-80.6% across all ICDs, of 73.7-92.1% in VVIs, 58.2-76.1% in DDDs, and of 47.1-66.3% in CRT defibrillators, all P value < 0.05]. Remarkable differences were seen among manufacturers, and those with better performance in elderly ICDs were not those with better performance in contemporary ones. CONCLUSION: Implantable cardioverter defibrillator longevity increased in contemporary models independent of manufacturer and pacing mode. Still, significant differences exist among manufacturers. These results might impact on device selection.

Assessment of Efficacy and Necessity of Routine Defibrillation Threshold Testing in Patients Undergoing Implantable Cardioverter-Defibrillator (ICD) Implantation.

Defibrillation threshold (DFT) testing is performed routinely in patients undergoing implantable cardioverter-defibrillator (ICD) implantation to verify the ability of the ICD to terminate ventricular fibrillation (VF). However, neither the efficacy nor the safety of DFT testing has been proven; thus, the necessity of such testing is controversial. We conducted a retrospective study of the efficacy of DFT testing, particularly with respect to long-term outcomes of ICD implantation.The study included 150 patients (125 men, 25 women, aged 59.0 ± 17.6 years) who underwent ICD or cardiac resynchronization therapy defibrillator implantation, with (n = 73) or without (n = 77) intraoperative DFT testing, between June 1996 and September 2007. VF was induced by delivery of a T-wave shock, and a 20-25-J shock was then delivered. If the 20-25-J shock failed to terminate VF, 30 J was delivered. We assessed whether undersensed VF events occurred during DFT testing and/or during patient follow-up and checked for any association between undersensing and delayed shock delivery. During DFT testing, fine VF was sensed, and shocks were delivered in a timely manner. Nevertheless, 2 patients in the DFT testing group died from VF within 3 years after device implantation.DFT testing, in comparison to non-DFT testing, appeared to have no influence on the long-term outcomes of our patients, suggesting that DFT testing at the time of ICD implantation is limited.

Initial Experience of an Anesthesiology-based Service for Perioperative Management of Pacemakers and Implantable Cardioverter Defibrillators.

BACKGROUND: Management of cardiovascular implantable electronic devices (CIEDs), including pacemakers and implantable cardioverter defibrillators, for surgical procedures is challenging due to the increasing number of patients with CIEDs and limited availability of trained providers. At the authors' institution, a small group of anesthesiologists were trained to interrogate CIEDs, devise a management plan, and perform preoperative and postoperative programming and device testing whenever necessary. METHODS: Patients undergoing surgery between October 1, 2009 and June 30, 2013 at the University of Washington Medical Center were included in a retrospective chart review to determine the number of devices actively managed by the Electrophysiology/Cardiology Service (EPCS) versus the Anesthesiology Device Service (ADS), changes in workload over time, surgical case delays due to device management, and errors and problems encountered in device programming. RESULTS: The EPCS managed 254 CIEDs, the ADS managed 548, and 227 by neither service. Over time, the ADS providers managed an increasing percentage of devices with decreasing supervision from the EPCS. Only two CIEDs managed by the ADS required immediate assistance from the EPCS. Patients who were unstable postoperatively were referred to the EPCS. Although numerous issues in programming were encountered, primarily when restoring demand pacing after programming asynchronous pacing for surgery, no patient harm resulted from ADS or EPCS management of CIEDs. CONCLUSIONS: An ADS can provide safe CIED management for surgery, but it requires specialized provider training and strong support from the EPCS. Due to the complexity of CIED management, an ADS will likely only be feasible in high-volume settings.

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.

The use of imaging for electrophysiological and devices procedures: a report from the first European Heart Rhythm Association Policy Conference, jointly organized with the European Association of Cardiovascular Imaging (EACVI), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology.

Implantations of cardiac devices therapies and ablation procedures frequently depend on accurate and reliable imaging modalities for pre-procedural assessments, intra-procedural guidance, detection of complications, and the follow-up of patients. An understanding of echocardiography, cardiovascular magnetic resonance imaging, nuclear cardiology, X-ray computed tomography, positron emission tomography, and vascular ultrasound is indispensable for cardiologists, electrophysiologists as well as radiologists, and it is currently recommended that physicians should be trained in several imaging modalities. There are, however, no current guidelines or recommendations by electrophysiologists, cardiac imaging specialists, and radiologists, on the appropriate use of cardiovascular imaging for selected patient indications, which needs to be addressed. A Policy Conference on the use of imaging in electrophysiology and device management, with representatives from different expert areas of radiology and electrophysiology and commercial developers of imaging and device technologies, was therefore jointly organized by European Heart Rhythm Association (EHRA), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology (ESCR). The objectives were to assess the state of the level of evidence and a first step towards a consensus document for currently employed imaging techniques to guide future clinical use, to elucidate the issue of reimbursement structures and health economy, and finally to define the need for appropriate educational programmes to ensure clinical competence for electrophysiologists, imaging specialists, and radiologists.

Lack of current implantable cardioverter defibrillator guidelines application for primary prevention of sudden cardiac death in Latin American patients with heart failure: a cross-sectional study.

AIMS: This cross-sectional study evaluated the application of accepted international implantable cardioverter defibrillator (ICD) guidelines for primary prevention of sudden cardiac death in patients with heart failure. METHODS AND RESULTS: The PLASMA (Probabilidad de Sufrir Muerte Arritmica) study was designed to characterize management of cardiac patients in Latin America. Twelve centres included 1958 consecutively admitted patients in cardiology units in 2008 and 2009. Discharged patients were evaluated for primary prevention, ICD indication and prescription by general cardiologists. Of 1711 discharged patients, 1525 (89%) had data available for evaluating indication status. Class I indications for ICD therapy were met for 153 (10%) patients based on collected data. Only 20 (13%, 95% confidence interval: 7.7-18.4%) patients with indication were prescribed an ICD. Patients prescribed an ICD were younger than patients who were not prescribed an ICD (62 vs. 68 years, P < 0.01). The reasons given by cardiologists for not prescribing an ICD for 133 patients with an indication were: indication criteria not met (75%), life expectancy <1 year (9.7%), rejection by the patient (5.2%), no medical coverage paying for the device (3.7%), psychiatric patient (2.2%), and other reasons (4.2%). CONCLUSIONS: In Latin America, international guidelines for primary prevention ICD implantation are not well followed. The main reason is that cardiologists believe that patients do not meet indication criteria, even though study data confirm that criteria are met. This poses a significant challenge and underlines the importance of continuous and improved medical education.

An analysis of implantable cardiac device reliability. The case for improved postmarketing risk assessment and surveillance.

Implantable cardiac devices have become the mainstay of the treatment of patients with heart disease. However, data regarding their reliability and, inferentially, safety have been called into question. We reviewed annual reports submitted to the Food and Drug Administration Office of Device Evaluation by device manufacturers from 2003 to 2007. The annual number of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillator (CRT-D) implants, explants, and returned devices were tabulated along with the cumulative (Cum) number of implants for each device. We derived an annual explantation rate (AER) defined as the ratio of the annual number of explants less the number of normal battery depletions/Cum (×1000). From 2003 to 2007, 256,392 CRT-D and 459,300 ICD devices were implanted in the United States. The overall mean (±SD) AERs for ICD and CRT-D devices were, respectively, 49.5 (15.6) per 1000 ICD devices and 82.6 (35.5) per 1000 CRT-D devices. The AER for each device type significantly decreased over the study period (P for trend <0.001) although the AER for CRT-D devices was 38% higher than that for ICD devices (P < 0.001). On average, 20.3% of CRT-D devices and 22.6% of ICD devices were returned to the manufacturer for analysis after explantation. The rates of explanted CRT-D and ICD devices decreased from 2003 to 2007. Notwithstanding this favorable trend, the AER for CRT-D devices was higher than that for ICD devices. Improved methods for tracking individual device histories are needed for more precise estimates of the risk of device explantation for suspected malfunction. The proportion of devices returned to the manufacturer is suboptimal and needs to be improved to better understand the mechanisms of device malfunction.

How to truly value implantable cardioverter-defibrillators technology: up-front cost or daily cost?

BACKGROUND: We calculated the daily cost of implantable cardioverter-defibrillators (ICDs) based on their actual longevity to prove whether the up-front cost is a reliable parameter for the ICD purchasing-process. METHODS. Longevity of single chamber (SC), double chamber (DC), and biventricular (BiV) ICDs from Medtronic (MDT), Guidant (GDT), and St. Jude Medical (SJM) was measured in all the patients implanted in years 2000, 2001, 2002 who reached device replacement within December 31, 2009. The cost of each ICD (device + lead/s) was normalized for its own longevity. Data are expressed as median (25th-75th percentile). RESULTS: A total of 123/153 patients completed the study, 70 percent being alive 8 years after implantation. MDT devices had a superior longevity compared with GDT and SJM (p < .001). Fifty-eight percent of replaced ICDs had a service life at least 1 year shorter than the manufacturers' prediction. Longer-lasting devices had a significantly lower daily cost: €4.8 (4.6-5.7) versus €6.8 (6.2-9.2) and €6.9 (6.2-7.6) for SC (p < .001); €6.9 (6.8-7.7) versus €12.6 (11.8-13.3) and €13.4 (10.3-16.1) for DC; €8.5 (8.3-10.3) versus €15.4 (15.1-15.8) and €14.6 (14.1-14.9) for BiV (p < .005). CONCLUSIONS: The true cost of ICD treatment is strictly dependent on device longevity, whereas device up-front cost is unreliable. This aspect should be valued in the technology purchasing process, and could set the basis for an outcome-based reimbursement system. Our observations may be the benchmark respectively for ICD longevity and daily ICD cost in future comparisons. Independent observations in the real-life scenario are needed to properly value newer technologic improvements.

Actions elicited during scheduled and unscheduled in-hospital follow-up of cardiac devices: results of the ATHENS multicentre registry.

AIM: The number of cardiac implantable electronic devices (CIEDs) is continuously growing and this translates into a high number of in-hospital follow-ups. This workload justifies the increasing popularity of remote monitoring systems for the follow-up of CIEDs. The ATHENS registry was designed to find out what actions are taken during in-hospital follow-up of CIEDs at 10 different centres in Northern Italy. METHODS AND RESULTS: Between 1 March 2010 and 30 June 2010, all patients who came to our centres for a follow-up of their CIEDs were enrolled in the registry. We defined as visit with an action (VWA) a follow-up that elicited an action in that patient. The primary endpoint was the prevalence of VWA on the whole population. The secondary endpoints were: prevalence of VWA on the pacemaker (PM) population; prevalence of VWA on the implantable cardioverter defibrillator (ICD) population; prevalence of VWA on the cardiac resynchronization therapy (CRT) population; predictors of VWA in univariate and multivariate analyses. A total of 3362 patients were recruited. The primary endpoint was reached in 762 patients, 22.8% of patients (95% CI 21.4-24.3). The prevalence of action was highest for CRT (29.8%), followed by PM (22.8%) and ICD (18.6%). In a multivariate model, the prevalence of action was higher for CRT, than for PM and was lowest for ICD and it was higher for unscheduled visits and first visits than for scheduled visits. CONCLUSIONS: Our registry demonstrates that 'some actions' are taken during about 20% of scheduled in-hospital follow-up of CIEDs. These data should encourage the use of remote follow-up systems.

Characterization and financial impact of implantable cardioverter-defibrillator patients without interventions 5 years after implantation.

BACKGROUND: Implantable cardioverter defibrillators (ICD's) are increasingly used for primary and secondary prevention of sudden cardiac death. However, data on how many ICD patients indeed receive appropriate ICD therapy during long-term follow-up is scarce. AIM: The aim of our study was to determine the number of patients without appropriate ICD therapy 5 years after ICD implantation, to identify predicting factors, to assess the occurrence of late first ICD therapy and to quantify the financial impact of ICD therapy in a real-world setting. DESIGN: Prospective observational study. METHODS: We prospectively enrolled 322 consecutive ICD patients. Baseline data were collected at implantation and patients were followed for a median of 7.3 years (IQR 5.8-9.2 years). Time to first appropriate ICD therapy (either antitachycardia pacing or cardioversion) was documented. RESULTS: Five years after implantation, 139 patients (43%) had not received appropriate ICD therapy. In multivariable analysis, a primary prevention indication and negative electrophysiological studies prior to ICD implantation were independent predictors of freedom from ICD therapy. Of the patients without ICD therapy, 5 years after implantation, 25% had experienced inappropriate ICD shocks. Two hundred and seven devices (1.5 devices per patient) were needed for the 139 patients without ICD intervention within 5 years, accounting for € 31,784 per patient. During an additional follow-up of 3 years, 12% of the patients with unused ICD received a late first appropriate ICD therapy. CONCLUSION: About half of the ICD patients receive appropriate ICD therapy within 5 years after implantation. Furthermore, there is a significant proportion of patients receiving late first shocks after five initially uneventful years.

Proportion of patients needing an implantable cardioverter defibrillator on the basis of current guidelines: impact on healthcare resources in Italy and the USA. Data from the ALPHA study registry.

AIMS: Implantable cardioverter defibrillators (ICD) improve survival in selected patients with left ventricular dysfunction or heart failure (HF). The objective is to estimate the number of ICD candidates and to assess the potential impact on public health expenditure in Italy and the USA. METHODS AND RESULTS: Data from 3513 consecutive patients (ALPHA study registry) were screened. A model based on international guidelines inclusion criteria and epidemiological data was used to estimate the number of eligible patients. A comparison with current ICD implant rate was done to estimate the necessary incremental rate to treat eligible patients within 5 years. Up to 54% of HF patients are estimated to be eligible for ICD implantation. An implantation policy based on guidelines would significantly increase the ICD number to 2671 implants per million inhabitants in Italy and to 4261 in the USA. An annual increment of prophylactic ICD implants of 20% in the USA and 68% in Italy would be necessary to treat all indicated patients in a 5-year timeframe. CONCLUSION: Implantable cardioverter defibrillator implantation policy based on current evidence may have significant impact on public health expenditure. Effective risk stratification may be useful in order to maximize benefit of ICD therapy and its cost-effectiveness in primary prevention.

New Zealand primary implantable cardioverter defibrillator implantation and biventricular pacing guidelines.

Primary implantation of an implantable Cardioverter Defibrillator (ICD) is recommended for patients with ischaemic or non-ischaemic cardiomyopathy present for at least 3 months, with ejection fraction (EF) = or <30% measured = or >3 months after optimal heart failure treatment. Patients should be on maximal heart failure treatment as tolerated for = or >3 and preferably 6 months, and in New York Heart Association (NYHA) Class II or III. They should be = or >3 months remote from any revascularisation procedure or have no clinical symptoms or findings that would make them a candidate for revascularisation. There should be no associated disease reducing survival <18 months. Biventricular pacing is recommended for patients with an EF = or <35% after = or >6 weeks of optimal heart failure treatment, whose QRS duration is >149 ms or is 120-149 ms with two additional criteria for dyssynchrony (aortic pre-ejection delay >140 ms, interventricular mechanical delay >40 ms or delayed activation of the posterolateral left ventricular wall). They should be NYHA Class III, have had no major cardiovascular event in the prior 6 weeks and be in sinus rhythm. There should be no major comorbidity reducing survival <18 months or seriously impairing quality of life.