Implantable Cardioverter-defibrillator Procedures Research Articles

Reduced incidence of CIED infections with peri- and post-operative antibiotic use in CRT-P/D and ICD procedures.

Higher cardiac implantable electronic device (CIED) infection incidence has been observed with cardiac resynchronization therapy pacemaker/defibrillator (CRT-P/D) and implantable cardioverter defibrillator (ICD) devices compared to traditional pacemakers with a 1.2% rate reported at 1 year. CIED infection management has high morbidity/mortality. A previous study from this institution demonstrated significantly reduced CIED infection rate when peri/post-operative antibiotics were given for traditional pacemaker procedures. The present study examines CIED infection incidence following peri/post-operative antibiotics during CRT-P/D and ICD procedures. All patients who underwent CRT-P/D and ICD procedures from 1996 to 2015 received IV cephalexin/clindamycin pre- and 8-hours post-procedure followed by 5 days of oral therapy. There were 427 procedures (CRT-P = 146 (34.2%); CRT-D = 142 (33.3%); ICD = 139 (32.6%)). Mean age at time of procedure was 61.6 years. Mean follow-up duration was 4.26 years. CIED infection occurred in 6 patients (ICD = 4, CRT-P = 1, CRT-D = 1), amounting to a rate of 4.96/1000 device-years in total. Times to CIED infection from procedure were: 1.7, 3.5, 6.7, 7.3, 7.9 and 9.2 years. Five out of 6 infections occurred in patients with repeat procedures. This study demonstrates that administration of peri- followed by post-operative antibiotics during CRT-P/D and ICD procedures is associated with a very low rate of CIED infection. This rate of 4.96 infections per 1000 device-years compares favorably to contemporary rates of 8.9 infections per 1000 device-years. Most CIED infections occur late and well-beyond the 1-year follow-up of the Prevention of Arrhythmia Device Infection Trial, the largest trial on this question. This approach should be considered pending a definitive trial

Prevalence of One-Year Mortality after Implantable Cardioverter Defibrillator Placement: An Opportunity for Palliative Care?

Background: Current guidelines recommend against placement of implantable cardioverter defibrillators in patients with a life expectancy less than one year. These patients may benefit from early palliative care services; however, identifying this population is challenging. Objective: Determine whether a validated prognostic tool, based on patient factors and health care utilization from electronic medical records, accurately predicts one-year mortality at the time of implantable cardioverter defibrillator placement. Design: We used the United States (U.S.) Veterans Administration's "Care Assessment Needs" one-Year Mortality Score to identify patients at high risk of mortality (score ≥95) before their procedure. Data were extracted from the Corporate Data Warehouse. Logistic regression was used to assess the odds of mortality at different score levels. Setting/Subjects: Patients undergoing a new implantable cardioverter defibrillator procedure between October 1, 2015 and September 30, 2017 in the U.S. Veterans Administration. Results: Of 3194 patients with a new implantable cardioverter defibrillator placed, 657 (21.8%) had a score ≥95. The mortality rate among these patients was 151/657 (22.9%) compared with 281/3194 (8.8%) for all patients undergoing a new implantable cardioverter defibrillator procedure. Patients with a score ≥95 had 14.0 (95% confidence interval 8.0-24.4) higher odds of death within one year of the procedure compared with those with a score ≤60. Conclusions: The "Care Assessment Needs" Score is a valid predictor of one-year mortality following implantable cardioverter defibrillator procedures. Integrating its use into the management of Veterans Administration (VA) patients considering implantable cardioverter defibrillators may improve shared decision making and engagement with palliative care.

Abstract 12560: The Association of Social Risk Factors With Hypertrophic Cardiomyopathy Treatments and Mortality: US National Inpatient Sample, 2012-2018

Introduction: Hypertrophic cardiomyopathy (HCM) is the most common heritable cardiac disease. In small studies race has been associated with disparities in septal reduction therapy (SRT) but little is known about the association of social risk factors with HCM treatments and outcomes. Methods: A retrospective cohort of admissions for HCM in the National Inpatient Sample from 2012-2018 was identified using ICD-9-CM and ICD-10-CM diagnosis codes. SRT and implantable cardioverter-defibrillator (ICD) procedures were identified using ICD-9-CM and ICD-10-CM procedure codes. Logistic regression controlling for social risk factors, Elixhauser comorbidities, pre-existing ICD, and clustering by hospital-year was used to determine the association of social risk factors with HCM procedures and in-hospital mortality. Results: We identified 60,227 patients with HCM; 45.82% with obstructive HCM (oHCM). Among them, 57.25% were female, 18.65% were Black, 26.75% were in the lowest ZIP income quartile, and 14.89% lived in rural areas. ICD procedures were done on 3.07% of patients with HCM. Septal myectomy and alcohol septal ablation were received by 6.89% and 2.21% of patients with oHCM, respectively. The in-hospital mortality rate was 3.32% for HCM admissions. Compared to White patients, Black patients were less likely to receive septal myectomy (odds ratio [OR] 0.56, 95% confidence interval [0.45-0.70], p<0.001) and more likely to receive ICD procedures (OR 1.17 [1.01-1.36], p=0.03). Patients in the lowest income quartile were less likely to receive septal myectomy (OR 0.81 [0.68-0.98], p=0.03) and ICD procedures (OR 0.83 [0.71-0.98], p=0.02). Rural patients were more likely than urban patients to receive septal myectomy (OR 1.39 [1.17-1.64], p<0.001) and to die during hospitalization (OR 1.38 [1.19-1.59], p<0.001). Female patients were less likely to receive ICD procedures (OR 0.69 [0.62-0.76], p<0.001) but more likely to die during hospitalization (OR 1.19 [1.07-1.31], p<0.001). Conclusions: Among 60,227 patients with HCM, social risk factors were associated with significant disparities in in-hospital mortality and in receiving septal myectomy and ICD treatment. Further research is required to identify and address the sources of these disparities.

Ischemic and non-ischemic patterns of late gadolinium enhancement in heart failure with reduced ejection fraction.

Late gadolinium enhancement (LGE) by cardiac magnetic resonance (CMR) may reveal myocardial fibrosis which is associated with adverse clinical outcomes in patients undergoing implantable cardioverter-defibrillator (ICD) placement. At the same time, transmural LGE in the posterolateral wall is related to nonresponse to conventional cardiac resynchronization therapy (CRT). Herein, the aim was to assess the presence and determinants of LGE in CMR in heart failure (HF) with reduced ejection fraction. Sixty-seven patients were included (17.9% female, aged 45 [29-60] years), who underwent LGE-CMR and had left ventricular ejection fraction (LVEF) as determined by echocardiography. In HF patients with LVEF ≤ 35% (n = 29), ischemic and non-ischemic patterns of LGE were observed in 51.7% and 34.5% of patients, respectively. In controls (n = 38), these patterns were noted in 23.7% and 42.1% of patients, respectively. HF patients with LVEF ≤ 35% and transmural LGE in the posterolateral wall (31.0%) were characterized by older age, coronary artery disease (CAD) and previous myocardial infarction (MI) (61 ± 6 vs. 49 ± 16 years, p = 0.008, 100% vs. 40%, p = 0.003 and 78% vs. 25%, p = 0.014, respectively). In patients with LVEF ≤ 35%, LGE of any type, diagnosed in 86.2% of patients, was associated with CAD (68% vs. 0%, p = 0.02), while only trends were observed for its association with older age and previous MI (p = 0.08 and p = 0.12, respectively). Among HF patients with LVEF ≤ 35%, clinical factors including older age, CAD, and previous MI are associated with transmural LGE in the posterolateral wall, while CAD is associated with LGE. This data may have potential implications for planning ICD and CRT placement procedures.

Impact of diabetes on clinical outcome of patients with heart failure undergoing ICD and CRT procedures: results from the German Device Registry.

AimsDiabetes mellitus (DM) has a negative impact on prognosis in patients with heart failure (HF). The role impact of DM in HF patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices might differ and remains unclear. The aim of our study was to investigate the impact of DM on periprocedural complications and clinical outcome in HF patients undergoing ICD or CRT implantation.Methods and resultsWithin the German Device Registry, data from 50 German centres were collected between January 2007 and February 2014. A retrospective analysis of n = 5329 patients undergoing ICD implantation was conducted. Patients' characteristics, procedural data, periprocedural complications, and post‐procedural clinical outcome, including a composite clinical endpoint of all‐cause mortality, stroke, and myocardial infarction (MACCE), were analysed. Subgroup analysis were performed for ICD and CRT implantations. Median follow‐up was 15.7 (12.9; 20.0) and 16.2 (12.8; 21.2) months in DM and non‐DM patients. Of 5329 patients enrolled, n = 1448 (27.2%) had a diagnosis of DM. Within the cohort, 94% of DM and 90% of non‐DM patients had a diagnosis of HF. Patients with DM were older, had higher body mass index, and higher rate of cardiovascular comorbidities compared with non‐DM patients. Unadjusted and adjusted analyses revealed similar all‐over intrahospital periprocedural complication rates in both groups (4.1% vs 3.9%). Unadjusted Kaplan–Meier survival analysis showed higher all‐cause mortality after 1 year (9.0% vs 6.3%; log‐rank P = 0.001) with higher MACCE rates (10.0% vs 7.3%; P < 0.001) in the DM group versus non‐DM patients. After multivariable adjustment for relevant covariates, the association of DM to MACCE disappeared [HR 1.11 (0.89‐1.38)]. Because chronic kidney disease (CKD) was clearly associated with increased 1 year MACCE after multivariate adjustment [odds ratio (OR) 2.11 (1.68–2.64)], a subgroup analysis was performed showing a strong trend towards more perioperative complications in DM patients with CKD [OR 2.16 (0.9–5.21)], while no effect of DM was observed in patients without CKD [OR 0.73 (0.42–1.28)].ConclusionsThe overall risk of periprocedural complications and short‐term (1 year) clinical outcome in patients with DM and HF undergoing ICD or CRT defibrillator (CRT‐D) implantation was not increased. In contrast, CKD was associated with an increased risk of 1 year MACCE in HF patients undergoing ICD/CRT‐D implantation.

Economic impact of introducing TYRX amongst patients with heart failure and reduced ejection fraction undergoing implanted cardiac device procedures: a retrospective model based cost analysis

Background and aims: Infection is a serious and expensive complication of Cardiac Implantable Electronic Device (CIED) procedures. A retrospective based cost analysis was performed to estimate Trust level savings of using the TYRX antibacterial envelope as a primary prevention measure against infection in a tertiary referral centre in South London, UK.Methods: A retrospective cohort of heart failure patients with reduced ejection fraction undergoing Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) procedures were evaluated. Decision-analytic modelling was performed to determine economic savings of using the envelope during CIED procedure vs CIED procedure alone.Results: Over a 12 month follow-up period following CIED procedure, the observed infection rate was 3.14% (n = 5/159). The average cost of a CIED infection inpatient admission was £41,820 and, further to economic analysis, the additional costs attributable to infection was calculated at £62,213.94. A cost saving of £624 per patient by using TYRX during CIED procedure as a primary preventative measure against infection was estimated.Conclusions: TYRX would be a cost-saving treatment option amongst heart failure patients undergoing ICD and CRT device procedures based on analysis in the local geographical area of South London. If upscaled to the UK population, we estimate potential cost savings for the National Health Service (NHS).

A Population-Based Study of Adherence to Guideline Recommendations and Appropriate-Use Criteria for Implantable Cardioverter Defibrillators

Studies evaluating physician adherence to guideline recommendations for implantable cardioverter defibrillator (ICD) therapy are sparse, and none exist for the application of appropriate-use criteria (AUC) in clinical practice. As part of a quality improvement initiative, a review of all ICD procedures was performed from January 1, 2015 to December 31, 2016 in Alberta, Canada, to evaluate the proportion of patients receiving appropriate ICD therapy and to identify reasons for nonadherence. Our device-implant process involves an electrophysiologist or implanting cardiologist evaluation, reminders of ICD eligibility criteria on the device requisition, and peer-review consensus. Implants were classified according to the 2008 American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) ICD guidelines, 2013 Canadian Cardiovascular Society (CCS) Cardiac Resynchronization Therapy (CRT) guidelines, and 2013 AUC. There were 1,300 ICD procedures performed, and the mean age was 63.8 ± 12.9 years; 79% were male; the mean ejection fraction was 0.32 ± 0.13, and 69% were for primary prevention. Among all implants, < 1% were discordant with American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) recommendations. Among CRT implants, 10% were inconsistent with Canadian Cardiovascular Society (CCS) recommendations. According to AUC, 92% of implants were appropriate. Reasons for nonadherence to ACC/AHA/HRS recommendations included QRS width < 120 msec (n = 3), LVEF > 0.35 (n = 2) and recent myocardial infarction (MI) (n = 1). The most common reason for nonadherence to AUC was the absence of criteria for classification (n = 57, 4%). In this population-based study, we found that a process of specialist evaluation, eligibility reminders on device forms, and peer-review consensus may improve adherence to guideline recommendations and AUC for ICD therapy.

Implantable cardioverter-defibrillator therapy in Australia, 2002-2015.

To quantify the number of implantable cardioverter-defibrillator (ICD) procedures in Australia by year, patient age and sex, and to estimate age group-specific population rates and the associated costs. Design, setting: Retrospective observational study; analysis of Australian National Hospital Morbidity Database hospital procedures data. Patients with an ICD insertion, replacement, adjustment, or removal procedure code, July 2002 - June 2015. Number of ICD procedures by procedure year, patient age (0-34, 35-69, 70 years or more) and sex; age group-specific population procedure rates; number of procedures associated with complications. The number of ICD procedures increased from 1844 in 2002-03 to 6504 in 2014-15; more than 75% of procedures were in men. In 2014-15, the ICD insertion rate for people aged 70 years or more was 78.1 per 100 000 population, 22 per 100 000 for those aged 35-69 years, and 1.40 per 100 000 people under 35. The reported complication rate decreased from 45% in 2002-03 to 19% in 2014-15, partly because of a change in the coding of complications. The number of removals corresponded to at least 4% of the number of insertions each year. The aggregate cost of hospitalisations with an ICD procedure during 2011-14 was $445 644 566. ICD procedures are becoming more frequent in Australia, particularly in people aged 70 or more. Patterns of care associated with ICD therapy, particularly patient- and hospital-related factors associated with adverse events, should be investigated to better understand and improve patient outcomes.

Safety of continuing warfarin therapy in patients undergoing cardiac resynchronization therapy device implantation

Background: Continuing warfarin therapy is considered safe for patient undergoing pacemaker or implantable cardioverter defibrillator procedures, but less evidence exists for patients undergoing cardiac resynchronization therapy (CRT) device implantation. Subjects and Methods: We retrospectively evaluated 136 consecutive patients who received a CRT device. Three periprocedural anticoagulation strategies were utilized: Group 1, continuation of therapeutic warfarin; Group 2, cessation of warfarin with heparin bridging; and Group 3, cessation of anticoagulation temporarily. Groups were compared on the incidence of complications. Results: Of the 136 patients, 87 (64%) were in Group 1, 18 (13%) were in Group 2, and 31 (23%) were in Group 3. Group 1 patients had an international normalized ratio of 2.3 ± 0.5, which was significantly higher than the other two groups. Coronary sinus dissection occurred in four patients: Three in Group 1 and one in Group 2, but no patient experienced pericardial effusion or tamponade. Group 2 experienced a higher incidence of pocket hematoma (P = 0.0065) and a longer length of hospital stay (P = 0.0069) than Group 1. Transient ischemic attack occurred in one patient in Group 3. Conclusion: Continuing warfarin with therapeutic international normalized ratio seems to be safe in individuals undergoing CRT device implantation.

Current use of implantable electrical devices in Sweden: data from the Swedish pacemaker and implantable cardioverter-defibrillator registry.

The National Swedish Pacemaker and Implantable Cardioverter-Defibrillator (ICD) Registry collects prospective data on all pacemaker and ICD implants in Sweden. We aimed to report the 2012 findings of the Registry concerning electrical devices implantation rates and changes over time, 1 year complications, long-term device longevity and patient survival. Forty-four Swedish implanting centres continuously contribute implantation of pacemakers and ICDs to the Registry by direct data entry on a specific website. Clinical and technical information on 2012 first implants and postoperative complications were analysed and compared with previous years. Patient survival data were obtained from the Swedish population register database. In 2012, the mean pacemaker and ICD first implantation rates were 697 and 136 per million inhabitants, respectively. The number of cardiac resynchronization therapy (CRT) first implantations/million capita was 41 (CRT pacemakers) and 55 (CRT defibrillators), with only a slight increase in CRT-ICD rate compared with 2011. Most device implantations were performed in men. Complication rates for pacemaker and ICD procedures were 5.3 and 10.1% at 1 year, respectively. Device and lead longevity differed among manufacturers. Pacemaker patients were older at the time of first implant and had generally worse survival rate than ICD patients (63 vs. 82% after 5 years). Pacemaker and ICD implantation rates seem to have reached a level phase in Sweden. Implantable cardioverter-defibrillator and CRT implantation rates are very low and do not reflect guideline indications. Gender differences in CRT and ICD implantations are pronounced. Device and patient survival rates are variable, and should be considered when deciding device type.

The impact of changing antiseptic skin preparation agent used for cardiac implantable electronic device (CIED) procedures on the risk of infection.

Cardiac implantable electronic device (CIED) infection is a major complication that is associated with increased morbidity and mortality. Recent data suggested a relationship between the antiseptic agent used for skin preparation at time of CIED procedure and risk for infection. On April 30, 2011, we changed the antiseptic agent used for skin preparation at our tertiary care facility from chlorhexidine-alcohol to povidone-iodine for all CIED procedures. We retrospectively reviewed records of all patients who underwent CIED procedure 1 year before and after the change. CIED infection was defined as pocket or endovascular systemic infection that required removal within 1 year of the index procedure. We examined if the change affected the risk of CIED infection. A total of 2,792 patients underwent 2,840 CIED procedures; 1,748 (61.5%) had implantable cardioverter defibrillator procedures and 1,092 (38.4%) had permanent pacemaker procedures. Chlorhexidine-alcohol agent was used in 1,450 (51.1%) procedures, and povidone-iodine agent was used in 1,390 (48.9%). After 1 year of follow-up, 31 patients (1.09%) developed CIED infection that required system removal. The 1-year infection rate was 1.1% among both antiseptic agent groups and there were no significant differences in the infection presentations among both groups (P = 0.950). Multivariate Cox proportional hazards regression model showed that risk factors for infection within 1 year included age, diabetes, and African American race. In one large cohort of patients undergoing CIED procedures, the antiseptic agent used for skin preparation (chlorhexidine-alcohol vs povidone-iodine) was not associated with increased risk of developing CIED infection.

In-Hospital Complications Associated With Reoperations of Implantable Cardioverter Defibrillators

Repeat implantable cardioverter defibrillator (ICD) procedures are increasing and may be associated with higher risks for complications. To provide more information for clinical decision making, especially in light of recent defibrillator advisories, we examined a large national cohort to characterize repeat ICD procedural outcomes. Using data from the National Cardiovascular Data Registry (ICD Registry), we compared patient characteristics, reasons for ICD implantation, and associated in-hospital adverse events among 92,751 patients receiving their first device and 81,748 patients who underwent repeat procedures with (n= 31,057) and without (n= 50,691) lead involvement. Hierarchical multivariable logistic regression was used to determine the predictors of in-hospital complications. Complication rates were higher in those who underwent repeat ICD procedures with lead involvement (lead implantation or revision), compared with patients who underwent initial implants (3.2% vs 2.6%, p <0.001) or versus those with pocket-only (e.g., generator change only) procedures (3.2% vs 0.6%, p <0.001). There were significantly more in-hospital deaths, lead dislodgements, and infections requiring antibiotics in the lead involvement cohort. Compared with those who had a pocket-only procedure, the multivariable adjusted odds ratio of any complication were increased at 4.20 (95% confidence interval: 3.66 to 4.82, p <0.001) in patients who underwent repeat procedures with lead involvement excluding lead extraction or 7.11 (95% confidence interval: 5.96 to 8.48, p <0.001) in procedures involving lead extractions. Inconclusion, repeat ICD procedures, when involving the addition or revision of a lead with or without concurrent lead extraction, are associated with higher complication ratescompared with initial implants and with those who underwent pocket-only procedures.

Greater Mortality Risk Among Patients With Delayed Follow-up After Implantable Cardioverter Defibrillator Procedures

BackgroundSubstantial numbers of deaths occur among implantable cardioverter defibrillator (ICD) recipients. Timely follow-up after ICD implantation might improve patient outcomes. Our objective was to examine follow-up care and outcomes among patients undergoing ICD implantation. MethodsWe compared patient characteristics and outcomes of those with late (> 12 weeks) vs early defibrillator clinic follow-up after ICD implantation in the Ontario ICD Database from 2007 to 2011. We examined the effect of ICD clinic follow-up visits after implant compared with primary care physician tracer on mortality outcomes using time-varying covariate analyses. ResultsAmong 8096 ICD recipients (age 64.6 ± 12.6 years), 1145 (14%) received delayed follow-up. Patients with early ICD clinic follow-up experienced reduced risk of all-cause mortality, with a hazard ratio [HR] of 0.69 (95% confidence interval [CI], 0.50-0.95; P = 0.023) adjusted for clinical factors, primary care visits after discharge, and distance to follow-up centre. Early ICD clinic follow-up was associated with a reduction in out-of-hospital death with adjusted HR of 0.52 (95% CI, 0.36-0.76; P = 0.001) but not with a significant change in cardiovascular hospitalizations. In a tracer analysis, early primary care physician follow-up was associated with a nonsignificant trend toward increased mortality with an adjusted HR of 1.48 (95% CI, 0.97-2.25; P = 0.072). Reduced estimated glomerular filtration rate, secondary prevention or replacement devices, myocardial ischemia, smoking, and greater geographic distance to the implanting centre increased the odds of delayed follow-up. ConclusionsAfter device implantation, early defibrillator clinic follow-up was associated with reduced risk of all-cause and out-of-hospital death compared with those experiencing delayed follow-up.

A retrospective analysis of proceduralist-directed, nurse-administered propofol sedation for implantable cardioverter-defibrillator procedures

There is controversy whether proceduralist-directed, nurse-administered propofol sedation (PDNAPS) is safe. To assess the frequency of adverse events when PDNAPS is used for implantable cardioverter-defibrillator (ICD)-related procedures and to determine the patient and procedural characteristics associated with adverse events. Consecutive ICD-related procedures using PDNAPS from May 2006 to July 2009 at a tertiary-care hospital were evaluated. Serious adverse events were defined as procedural death, unexpected transfer to an intensive care unit, respiratory failure requiring intubation/bag-mask ventilation, or hypotension requiring vasoconstrictor/inotrope support. Nonserious adverse events were defined as hypotension requiring fluid resuscitation or hypoxemia requiring augmented respiratory support with non-rebreather mask, oral airway, or jaw lift. Of 582 patients (age 64 ± 14 years, 72.3% males) undergoing ICD-related procedures using PDNAPS, 58 (10.0%) patients had serious adverse events with no procedural death and 225 (38.7%) had nonserious adverse events. Longer procedure duration (relative risk [RR] = 2.1 per hour; 95% confidence interval [CI] = 1.6-2.8; P < .001) and biventricular implant (RR = 2.7; CI = 1.4-5.3; P = .003) were independent predictors of serious adverse events. A longer procedure duration (RR = 1.4 per hour; CI = 1.1-1.7; P = .001), heart failure class (RR = 1.4 per 1 class; CI = 1.1-1.7; P = .002), and use of propofol infusion (RR = 3.5; CI = 2.2-5.7; P < .001) were independent predictors of nonserious adverse events. PDNAPS for shorter ICD procedures including single- and dual-chamber implants, generator changes, and defibrillation threshold testing have acceptable rates of serious adverse events and manageable nonserious adverse events and should be considered for further study. Biventricular implants and other complex procedures should be done with an anesthesiologist.

Complications of ICD Generator Change and Implantations

Although implantable cardioverter-defibrillator (ICD) therapy can be lifesaving, complications are a possibility with implantation and during longterm follow-up. Though early ICDs, placed via open thoracotomy, were associated with a significant risk, the modern era of transvenous ICD implantation has reduced the surgical risk substantially. The conclusion of several decades of randomized clinical trials supporting the use of ICDs and cardiac resynchronization therapy (CRT) in patients with moderate-to-advanced heart failure highlights an important paradox. Whereas nonthoracotomy ICD implantation can be performedwith fewercomplications thanearlydevices, the patients now considered for this therapy are generally more ill and often with advanced heart failure. The impact of significant cardiac disease and associated comorbid medical illness on complication rates must also be considered. This article reviews the available data reporting complications associated with ICD procedures. Adverse events associated with both the acute procedural risk as well as those events that occur later are examined.

ICD therapy in women: Are men from Mars and women from Venus?

Heart failure affects approximately 5.8 million people in the United States, with women composing nearly half that population. 1 Lloyd-Jones D. Adams R.J. Brown T.M. et al. Heart disease and stroke statistics—2010 update: a report from the American Heart Association. Circulation. 2010; 121: e46-e215 Crossref PubMed Scopus (1385) Google Scholar The annual incidence of heart failure is approximately 670,000 in patients ages 45 years and older, with men and women affected in equal numbers. 1 Lloyd-Jones D. Adams R.J. Brown T.M. et al. Heart disease and stroke statistics—2010 update: a report from the American Heart Association. Circulation. 2010; 121: e46-e215 Crossref PubMed Scopus (1385) Google Scholar Treatment of heart failure patients with severe systolic dysfunction includes optimization of medical therapy in addition to primary prevention of sudden cardiac death (SCD) with implantation of an implantable cardioverter-defibrillator (ICD). 2 Hunt S.A. Abraham W.T. Chin M.H. et al. 2009 focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation. 2009; 119: e391-e479 Crossref PubMed Scopus (1400) Google Scholar , 3 Hunt S.A. Abraham W.T. Chin M.H. et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005; 112: e154-e235 Crossref PubMed Google Scholar This approach to the primary prevention of SCD in patients with heart failure is the result of multiple clinical trials that have evaluated the efficacy of ICDs in this population. 4 Moss A.J. Zareba W. Hall W.J. et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002; 346: 877-883 Crossref PubMed Scopus (5576) Google Scholar , 5 Bardy G.H. Lee K.L. Mark D.B. et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005; 352: 225-237 Crossref PubMed Scopus (5257) Google Scholar The integration of these results into practice guidelines has led to a significant increase in the rate of ICD implantation in the United States. 6 Hammill S.C. Kremers M.S. Kadish A.H. et al. Review of the ICD Registry's third year, expansion to include lead data and pediatric ICD procedures, and role for measuring performance. Heart Rhythm. 2009; 6: 1397-1401 Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar Gender differences in clinical outcome and primary prevention defibrillator benefit in patients with severe left ventricular dysfunction: A systematic review and meta-analysisHeart RhythmVol. 7Issue 7PreviewWomen are underrepresented in primary prevention implantable cardioverter-defibrillator (ICD) trials, and data on the benefit of ICD therapy in this subgroup are controversial. Full-Text PDF

Publicly Reporting Implantable Cardioverter Defibrillator Outcomes

The past decade has seen a dramatic increase in efforts by both payors and governmental agencies to measure and publicly report patient outcomes to ensure that patients receive appropriate, high-quality care. As a result, terms such as outcomes, quality, report cards, and benchmarking have entered the lexicon of clinical medicine, and both physicians and hospitals are increasingly being held accountable for the outcomes of their patients. This movement shows no sign of slowing down. In May 2008, the Centers for Medicare and Medicaid Services proposed increasing the total number of inpatient hospital measures from 40 to 73,1 and numerous physician measures are in various phases of development. In the current environment, it is likely that implantable cardioverter defibrillators (ICDs), which reduce the risk of sudden cardiac death,2 will soon emerge as a high-priority target for the development of performance measures, given that the procedure is expensive, performed on severely ill patients, and associated with significant risk of complications. Article see p 240 Accordingly, the findings published by Al-Khatib et al3 in this issue of Circulation: Arrhythmia and Electrophysiology warrant consideration in the context of current efforts to publicly report patient outcomes using Medicare claims data. In this excellent article, the authors used data from Centers for Medicare and Medicaid Services standard analytic files to determine the 90-day postprocedure complication rates and 1-year mortality rates of 8581 Medicare beneficiaries who had an ICD implanted by one of 1959 implanting physicians. The authors note that the complication rate declined from 18.8% in 2002 to 14.2% in 2005 and further identified specific factors associated with an increased risk of complication such as chronic lung disease, dementia, and renal disease. Of interest, physician experience as measured by procedure volume was not significantly associated with the risk of complication, although an earlier …

Case-Control Study of Surgical Site Infections Associated With Pacemakers and Implantable Cardioverter-Defibrillators

In 2000, the rate of surgical site infections (SSIs) associated with pacemaker and implantable cardioverter-defibrillator (ICD) procedures performed in the cardiothoracic operating rooms of hospital A was 16% (19 of 116 procedures resulted in infections). This study investigates risks for SSI associated with these procedures in the cardiothoracic operating room. Unmatched 1 : 3 case-control study performed over a 12-month period among patients who had undergone implantation of a pacemaker and/or ICD. A standardized observation scrutinized infection control practices in the area where the procedures were performed. The cardiothoracic operating rooms of hospital A, which belongs to a hospital consortium in the midwestern United States. Patients with SSI were identified as case patients. Control patients were chosen from the group of uninfected patients who had procedures performed during the same period as case patients. A total of 19 SSIs associated with pacemaker and ICD procedures were retrospectively identified among the patients who underwent procedures in these cardiothoracic operating rooms. Culture samples were obtained from 7 patients; 2 yielded coagulase-negative Staphylococcus on culture, 2 yielded Staphylococcus aureus, 1 yielded Serratia marcescens, and 2 showed no growth. In the case-control study, age, race, sex, diabetes mellitus, smoking history, timing of antibiotic therapy, and hair removal did not differ significantly between case patients and control patients. Case patients were more likely to have an abdominal device in place (odds ratio [OR], 5.5 [95% confidence interval {CI}, 1.6-19.3]; P=.006) and less likely to have received a new implant (OR 0.3 [95% CI, 0.1-0.8]; P=.02) or to have had new leads placed (OR, 0.2 [95% CI, 0.1-0.6]; P=.003). Abdominal placement of implanted devices was associated with occurrence of an SSI after pacemaker and/or ICD procedures.

Management of ventricular arrhythmias in diverse populations in California

Background The use of coronary angiography and revascularization is lower than expected among black patients. It is uncertain whether use of other cardiac procedures also varies according to race and ethnicity and whether outcomes are affected. Methods We analyzed discharge abstracts from all nonfederal hospitals in California of patients hospitalized for a primary diagnosis of ventricular tachycardia or ventricular fibrillation between 1992 and 1994. We compared mortality rates and use of electrophysiologic study (EPS) and implantable cardioverter-defibrillator (ICD) procedures according to the race and ethnicity of the patient. Results Among 8713 patients admitted with ventricular tachycardia or ventricular fibrillation, 29% (n = 2508) had a subsequent EPS procedure, and 9% (n = 818) had an ICD implanted. After controlling for potential confounding factors, we found that black patients were significantly less likely than white patients to undergo EPS (odds ratio 0.72, CI 0.56-0.92) or ICD implantation (odds ratio 0.39, CI 0.25-0.60). Blacks discharged alive from the initial hospital admission had higher mortality rates over the next year than white patients, even after controlling for multiple confounding risk factors (risk ratio 1.18, CI 1.03-1.36). The use of EPS and ICD procedures was also significantly affected by several other factors, most notably by on-site procedure availability but also by age, sex, and insurance status. Conclusions In a large population of patients hospitalized for ventricular arrhythmia, blacks had significantly lower rates of utilization for EPS and ICD procedures and higher subsequent mortality rates. (Am Heart J 2002;144:431-9.)