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.

Incidence, predictors and outcomes of hematoma after ICD implantation: An analysis of a nationwide database of 85,276 patients.

BACKGROUND: Pocket hematoma is one of the most common complications following cardiac device implantation. This study examined the impact of this complication on in-hospital outcomes following Implantable Cardioverter Defibrillator (ICD) implantation. METHODS: Data from Nationwide Inpatient Sample (NIS) 2010 was queried to identify all primary implantations of ICDs and Cardiac Resynchronization Therapy Defibrillators (CRT-D) during the year 2010 using ICD-9 codes. We then identified the patients who experienced a procedure related hematoma during the hospital stay. We compared the outcomes of the patients with and without a hematoma complication. All analyses were performed using SPSS 20 complex samples using appropriate weights to adjust for the complex sampling design of the national database. RESULTS: Out of a total of 85,276 primary ICD implantations in the year 2010, 2233 (2.6% of the implantations) were complicated by a hematoma. Increased age (p < 0.001), and comorbidities such as congestive heart failure (odds ratio (OR) - 1.86, p < 0.001), coagulopathy (OR - 2.3, p < 0.001) and renal failure (OR - 1.52, p < 0.001) were associated with an increased risk of pocket hematoma formation. Patients who developed a hematoma had a longer hospitalization (9.1 days versus 5.5 days, p < 0.001) and higher in-hospital costs ($56,545 versus $47,015, p < 0.001) compared to patients who did not have a hematoma. Overall mortality associated with ICD implantation was low (0.6%), and hematoma formation did not adversely affect mortality (0.6% versus 0.4%, p = 0.63). CONCLUSION: Hematoma occurs infrequently after ICD implantation, however, it adversely impacts the cost of procedure and length of stay.

Impact of haematoma after pacemaker and CRT device implantation on hospitalization costs, length of stay, and mortality: a population-based study.

AIMS: Pocket haematoma is a common complication following pacemaker implantation. Impact of this complication on post-procedural outcomes has previously not been systematically studied. We sought to identify the incidence of pocket haematoma after a de novo pacemaker and cardiac resynchronization therapy (CRT) device implantation and evaluate its impact on the hospital outcomes using a large all-payer national inpatient database. METHODS AND RESULTS: Data from Nationwide Inpatient Sample 2010 was queried to identify all primary implantations of single chamber, dual chamber pacemakers, and biventricular devices during the year 2010 using the appropriate ICD-9 codes. Patients who experienced a procedure-related haematoma during the hospital stay were identified. Of a total of 78,751 primary pacemaker implantations in the year 2010, 1677 (2.1%) of the implantations were complicated by a pocket haematoma. Higher age groups, more complex pacemaker types (BiV > dual chamber > single chamber), and comorbidities such as congestive heart failure and coagulopathy were associated with an increased risk of pocket haematoma formation post-pacemaker implantation. Patients who developed a pocket haematoma had a longer length of stay (8.7 vs. 4.8 days, P < 0.001), higher hospitalization costs ($48,815 vs. $34,324, P < 0.001) and higher in-hospital mortality (2.0 vs. 0.7%, P < 0.001) compared with patients who did not develop a haematoma. CONCLUSIONS: Haematoma is a relatively common complication associated with pacemaker implantation; however, it adversely impacts in-hospital outcomes.

Comparison of Computed Tomography derived Fractional Flow Reserve to invasive Fractional Flow Reserve in Diagnosis of Functional Coronary Stenosis: A Meta-Analysis.

Computed Tomography derived Fractional Flow Reserve (CTFFR) is an emerging non-invasive imaging modality to assess functional significance of coronary stenosis. We performed a meta-analysis to compare the diagnostic performance of CTFFR to invasive Fractional Flow reserve (FFR). Electronic search was performed to identify relevant articles. Pooled Estimates of sensitivity, specificity, positive likelihood ratio (LR+), negative likelihood ratio (LR-) and diagnostic odds ratio (DOR) with corresponding 95% confidence intervals (CI) were calculated at the patient level as well as the individual vessel level using hierarchical logistic regression, summary receiver operating characteristic (SROC) curve and area under the curve were estimated. Our search yielded 559 articles and of these 17 studies was included in the analysis. A total of 2,191 vessels in 1294 patients were analyzed. Pooled estimates of sensitivity, specificity, LR+, LR- and DOR with corresponding 95% CI at per-patient level were 83% (79-87), 72% (68-76), 3.0 (2.6-3.5), 0.23 (0.18-0.29) and 13 (9-18) respectively. Pooled estimates of sensitivity, specificity, LR+, LR- and DOR with corresponding 95% CI at per-vessel level were 85% (83-88), 76% (74-79), 3.6 (3.3-4.0), 0.19 (0.16-0.22) and 19 (15-24). The area under the SROC curve was 0.89 for both per patient level and at the per vessel level. In our meta-analysis, CTFFR demonstrated good diagnostic performance in identifying functionally significant coronary artery stenosis compared to the FFR.

Cardiac Resynchronization Therapy: US Trends and Disparities in Utilization and Outcomes.

BACKGROUND: The use of cardiac resynchronization therapy (CRT) has increased significantly since its initial approval in 2001 for use in patients with advanced heart failure. However, trends in utilization of CRT have not been systematically characterized. METHODS AND RESULTS: We used the Nationwide Inpatient Sample database to identify all patients with CRT implantation during 2002 to 2010. The overall trends in CRT device implantation, patient characteristics, and outcomes were examined in detail and compared among demographic subgroups. During 2002 to 2010, a total of 374,202 CRT procedures were recorded. Significant and persistent gender and racial disparities favoring men (71.4%) and white (79.6%), respectively, were noted in all years. The highest number of CRT devices were implanted in the 65- to 84-year age group (64.6%), with significant increase in number of CRT implants in older patients ≥ 85 years over the years (P = 0.02). The CRT-associated in-hospital mortality improved from 1.08% in 2003 to 0.70% in 2010 (P = 0.03). The correlates of higher mortality included males (0.93% versus 0.71% in females; P = 0.04) and older age (age ≥ 85 years had 1.5% mortality versus 0.8% for age < 85 year; P < 0.001). The mean hospital length of stay for CRT decreased, while mean CRT-associated hospital charges increased progressively over the years. Factors associated with higher charges were gender (males > females), older age, and greater comorbidities. CONCLUSIONS: CRT implantation is a relatively safe procedure that has become safer in higher risk patients. However, significant disparities in CRT utilization exist in certain demographic subgroups, and these disparities have persisted across the years.

Meta-analysis of 21- versus 22-G aspiration needle during endobronchial ultrasound-guided transbronchial needle aspiration.

BACKGROUND: Two different needle gauges (21 and 22 G) are currently used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Few studies have compared the diagnostic utility of EBUS-TB107NA using 21 versus 22 G needles. We aimed to systematically analyze all existing literature comparing the diagnostic benefit of these 2 needles. METHODS: A systematic search for the identification of all relevant studies comparing 21 and 22 G needles in EBUS-TBNA was performed using the MEDLINE, EMBASE, SCOPUS databases up to September 21, 2014. All the extracted data underwent meta-analysis using Review Manager 5.3 and Comprehensive Meta-analysis 3.3. Study-specific odds ratios (OR) were calculated and combined using random-effects model. Between study heterogeneity was assessed using the I statistic. RESULTS: A total of 5 studies involving 1720 patients were identified. The sample adequacy rate was 89.1% in the 21 G group and 90.0% in the 22 G group and this difference was not statistically significant [OR, 0.94; 95% confidence interval (CI), 0.56-1.59; P=0.82]. Similarly, there was no significant difference in the diagnostic yield (73.7% vs. 58.5%; OR, 1.04; 95% CI, 0.80-1.35; P=0.80) or the mean number of needle passes (mean difference -0.31; 95% CI, -1.1 to 0.47; P=0.44). There were no major complications reported in any of these studies. CONCLUSIONS: There were no differences in the diagnostic yield, sample adequacy, or the mean number of needle passes between the 21 and 22 G groups during EBUS-TBNA. Similarly, the complication rates were low and similar between the 2 groups.

Electrolyte and hemodynamic changes following percutaneous left atrial appendage ligation with the LARIAT device.

PURPOSE: The left atrial appendage (LAA) is a well-known source of atrial natriuretic peptide (ANP) and therefore plays an important role in homeostasis. The neurohormonal impact of epicardial exclusion of the LAA with the LARIAT procedure is unknown. In this proof-of-concept study, we postulated that LAA exclusion would impact homeostasis as evidenced by changes in electrolytes and blood pressure (BP). METHODS: A total of 76 patients who underwent successful LAA exclusion were enrolled in this retrospective observational study utilizing a prospective registry. Electrolytes, BP, and heart rate (HR) were monitored before LARIAT and post-LARIAT (24 and 72 h and 6 months). RESULTS: There was a significant reduction of systolic BP (mmHg) at 24 h (113.3 ± 16.0; p < 0.0001) and 72 h (119.0 ± 18.4 mmHg; p < 0.0001) post-LARIAT when compared with pre-LARIAT BP (138.2 ± 21.3). The reduction in systolic BP persisted at 6-month follow-up (128.8 ± 17.3; p = 0.0005). There was significant reduction in serum sodium (mmol/L) at 24 h (135.4 ± 3.6; p < 0.0001) and 72 h (136.3 ± 3.7; p < 0.001) post-LARIAT when compared to pre-LARIAT (138.7 ± 3.2). The reduction in sodium was not persistent at 6-month follow-up (138.4 ± 3.3; p = 0.453). CONCLUSIONS: LAA exclusion results in an early and persistent decrease in systolic BP. Additionally, there is an early decline in serum sodium, which normalizes at long-term follow-up. The underlying mechanism leading to these changes is not entirely clear; however, it is likely related to neurohormonal changes post LAA exclusion.