Intraprocedural PRAETORIAN score for early assessment of S-ICD implantation: A proof-of-concept study.

INTRODUCTION: The PRAETORIAN score (PS) was developed to assess the implant position and predict defibrillation success of the subcutaneous implantable cardioverter defibrillators (S-ICD). The main critique moved to the routine use of PS has been its postprocedural timing, that limits its usefulness on procedure guidance. The aim of this proof-of-concept study was to assess the feasibility of an intraprocedural use of PS. METHODS: Forty consecutive patients undergoing S-ICD implantation were enrolled. Intraprocedural PS (IP-PS) obtained with fluoroscopy before closure of the pocket and postprocedural PS (PP-PS) obtained with two-views chest X-ray were compared. Intraprocedural data and PS were compared with the historic cohorts of the involved institutions. RESULTS: When assessing IP-PS and PP-PS, a complete overall agreement was observed (100%, 1.00-κ; p < .001). When assessing a per-step agreement, a very high-degree of concordance in evaluating Step 1 of the PS was observed (95%, 0.81-κ; p < .001). A complete agreement in Step 2-3 (100%, 1.00-κ; p < .001) of the PS was reported. In comparison with our historical cohort, procedural time in the IP-PS cohort did not increase (45 [41-52] vs. 45 [39-49] min; p = .351) while the expected increase in fluoroscopy time resulted scarce (15 [10-15] s). CONCLUSION: An IP-PS can be reliably obtained using fluoroscopy guidance during S-ICD implantation, without a significant increase in procedural duration and may serve as guidance for implanting physicians, to avoid postprocedural S-ICD repositioning, leading to patient discomfort and significantly enhancing infective risks. IP-PS showed a very high agreement with the PP-PS obtained from two-views chest X-ray.

Heart failure hospitalizations and costs in ICD/CRT-D recipients following replacement or upgrade: the DECODE registry.

AIMS: The aim of this study is to report heart failure hospitalization (HFH) rates and associated costs within 12 months following implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) device replacement or upgrade from ICD to CRT-D. METHODS AND RESULTS: The DEtect long-term COmplications after icD rEplacement (DECODE) was a prospective, single-arm, multicentre cohort study that explored complications in ICD/CRT-D recipients. All clinical and survival data at 12 months were prospectively analysed. For each adjudicated HFH, admission and discharge dates and ICD-9-CM diagnosis and procedure codes were recorded. The reimbursement for each HFH was calculated for each diagnosis-related group code. Between 2013 and 2015, 983 patients (mean age 71 years, male 76%, mean left ventricular ejection fraction 35%, and New York Heart Association Class I/II 75.6%) were enrolled. Patients underwent device replacement (900; 91.6%, 446 ICD/454 CRT-D) or ICD upgrade to CRT-D (83; 8.4%). Post-replacement hospitalizations occurred in 220 patients, with the primary discharge diagnosis identifying cardiovascular causes in 175 patients (80%). Fifty-five (5.6%) patients experienced at least one HFH. Overall, 91 HFH events occurred (9.6% event rate, 95% confidence interval: 7.7-11.7) in 70 patients; 66 (6.7%) patients died, 40 (60.6%) of cardiovascular causes. The HFH rate was significantly higher following upgrades, and the occurrence of HFH was associated with an 11-fold increased mortality risk (95% confidence interval: 5.9-20.5, P < 0.0001). Medical diagnosis-related group accounted for 91.2% of HFH; the mean cost per HFH was €5662 ± 9497, and the mean cost per patient was €9369 ± 12 687. On multivariate analysis, predictors of HFH were atrial fibrillation, chronic kidney disease, and all-cause hospitalization within 30 days prior to the procedure. CONCLUSIONS: In the DECODE registry, HFH and mortality rates in the year following ICD/CRT-D replacement or upgrade were low. In this particular subset, underlying cardiac disease was the main driver of HFH, mortality, and higher healthcare expenditures.

Driving restriction in patients with cardiac implantable electronic devices: an overview of worldwide regulations.

Introduction: It is common belief that driving with an implantable cardioverter defibrillator (ICD)/pacemaker (PM) might be associated with sudden cardiac incapacitation, road traffic accidents, and chance to harm to self and others. On the other hand, the ability to drive is highly valuable in the modern era, representing a cornerstone of daily living and employment. National regulations try to balance the right to drive of ICD/PM patients and the risk they pose to public safety, but rules for granting them a driving license are considerably different worldwide. For the same subset of patients driving restrictions may vary between 1 week and 1 year depending on the local law.Areas covered: In this article we systematically review driving restrictions in ICD/PM patients in 16 countries all over the world, highlighting their differences and analyzing data from the literature that underlie their formulation.Expert opinion: Current regulations are mainly based on historical data that do not take into account improvements in ICD/PM technologies and driving environment, which have made driving with an ICD/PM is substantially safe. Newer studies and updated regulatory documents are warranted to set the best driving restrictions and reach homogeneity worldwide.

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.

Cost-effectiveness of implantable cardioverter-defibrillator in today's world.

The implantable cardioverter-defibrillator (ICD) is an example of an effective intervention with high up-front costs and delayed benefits. It has become a proven and well-accepted therapy not only for secondary but also for primary prevention of sudden cardiac death in patients with ischemic and non-ischemic heart disease. In recent years, the international guidelines have extended the indications to the prophylactic ICD, increasing the number of eligible patients and, together, the financial challenges of a widespread implementation. In this article, we review the available economic tools that can help address the ICD cost issue. We think that the awareness of such knowledge may facilitate dialogues between physicians, administrators and policy-makers, and help foster rational decision making.

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.

Is cardiac resynchronization therapy cost-effective?

Cardiac resynchronization therapy (CRT) is a treatment of proven efficacy for selected patients with heart failure and associated conduction disturbances. The increasing financial burden that healthcare systems face has increased the interest in cost-effectiveness and cost-utility estimates, focused on devices with defibrillation capabilities (CRT-D), with a high upfront cost, as well as on simpler devices providing only biventricular pacing (CRT-P). Available economic estimates are largely dependent on data source, assumptions, modelling technique, time horizon, and perspective, leading to some variability in cost-effectiveness and cost-utility estimates. As a whole, cost-effectiveness and cost-utility estimates of both CRT-P and CRT-D improve as the time horizon examined is lengthened and appear to be below US$50,000 per quality-adjusted life-year, a threshold value commonly adopted for coverage of healthcare interventions in the USA and quite comparable with similar thresholds used within Europe. Limited data are available on the comparative cost-effectiveness or cost-utility of CRT-P and CRT-D devices. Moreover, more data on the effectiveness and long-term benefits of CRT-D and CRT-P are needed in order to estimate better the value of these treatments in the 'real world, as well as for attempts to improve cost-effectiveness through improved patient selection.

Longevity of implantable cardioverter-defibrillators: implications for clinical practice and health care systems.

AIMS: Comparative studies on the longevity of implantable cardioverter-defibrillators (ICDs) among different manufacturers have never been reported. Longevity of ICD devices implanted from 1 January 2000 to 31 December 2002 was prospectively investigated according to their type and manufacturer. METHODS AND RESULTS: Longevity of single-chamber (SC), double-chamber (DC), and biventricular (CRT-D) ICDs from Medtronic (MDT), Guidant (GDT), and St Jude Medical (SJM) was measured in all the patients who required device replacement. The observation follow-up ended on 31 December 2007; patients who died prematurely or were transplanted before battery exhaustion were excluded from the analysis. Factors associated with longevity (number of delivered shocks, pacing activity) were researched. One hundred and fifty-three patients received an ICD in the abovementioned period. Six underwent heart transplantation, and 23 died before device replacement; 80 had an SC device, 59 had DC device, and 14 had CRT-D device. Longevity of MDT was superior to GDT and SJM, replacement rates being, respectively, 42%, 95.3%, and 97.2%. Only MDT manufacturers and SC type were associated with greater ICD longevity. Longevity had an impact on the cost/month of treatment of replaced ICDs. CONCLUSION: Battery longevity is significantly different among manufacturers. ICD cost is strictly dependent on device longevity, whereas device up-front cost is of limited clinical meaning. Appropriate assessment of cost-effectiveness should be based on ICD longevity in the real-life scenario.