Nirav Dalal

Hospitalization rates and associated cost analysis of cardiac resynchronization therapy with an implantable defibrillator and quadripolar vs. bipolar left ventricular leads: a comparative effectiveness study.

Aims This study compares, from a prospective, observational, non-randomized registry, the post-implant hospitalization rates and associated healthcare resource utilization of cardiac resynchronization therapy-defibrillator (CRT-D) patients with quadripolar (QUAD) vs. bipolar (BIP) left ventricular (LV) leads. Methods and results Between January 2009 and December 2012, 193 consecutive patients receiving de novo CRT-D implants with either a QUAD (n = 116) or a BIP (n = 77) LV lead were enrolled at implant and followed until July 2013 at a single-centre, university hospital. Post-implant hospitalizations related to heart failure (HF) or LV lead surgical revision and associated payer costs were identified using ICD-9-CM diagnosis and procedure codes. Italian national reimbursement rates were determined. Propensity scores were estimated using a logistic regression model based upon 11 pre-implant baseline characteristics and were used to derive a 1 : 1 matched cohort of QUAD (n = 77) and BIP (n = 77) patients. Hospitalization rates for the two groups were compared using negative binomial regression and associated payer costs were compared using non-parametric bootstrapping (×10 000) and one-sided hypothesis test. Hospitalization rates of the QUAD group [0.15/ patient (pt)-year] were lower than those of the BIP group (0.32/ pt-year); the incidence rate ratio was 0.46, P = 0.04. The hospitalization costs for the QUAD group (434 ± 128 €/pt-year) were lower than those for the BIP group (1136 ± 362 €/pt-year). The average difference was 718 €/pt-year, P = 0.016. Conclusions In this comparative effectiveness assessment of well-matched groups of CRT-D patients with quadripolar and bipolar LV leads, QUAD patients experienced a lower rate of hospitalizations for HF and LV lead surgical revision, and a lower cost burden. This has important implications for LV pacing lead choice.

Impact of remote monitoring on clinical events and associated health care utilization: A nationwide assessment

BACKGROUND Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) improves patient survival. However, whether RM reduces health care utilization is unknown. OBJECTIVE The purpose of this study was to determine whether RM was associated with reduced hospitalization and costs in clinical practice. METHODS We conducted a nationwide cohort study using the Truven Health Analytics MarketScan database. Patients implanted with a CIED between March 31, 2009, and April 1, 2012, were included. All-cause hospitalization events were compared between those using RM and those not using RM by using Cox proportional hazards methods with Andersen-Gill extension and propensity scoring. We also compared health care costs (payments >30 days after CIED implantation). RESULTS Overall, there were 92,566 patients (mean age 72 ± 13 years; 58,140 [63%] men) with a mean follow-up of 19 ± 12 months, including 54,520 (59%) pacemaker, 27,816 (30%) implantable cardioverter-defibrillator, and 10,230 (11%) cardiac resynchronization therapy patients. Only 37% of patients (34,259) used RM. Patients with RM had Charlson Comorbidity Index values similar to those not using RM but had lower adjusted risk of all-cause hospitalization (adjusted hazard ratio 0.82; 95% confidence interval 0.80-0.84; P < .001) and shorter mean length of hospitalization (5.3 days vs 8.1 days; P < .001) during follow-up. RM was associated with a 30% reduction in hospitalization costs (

Longer Delay From Chronic Pain to Spinal Cord Stimulation Results in Higher Healthcare Resource Utilization.

8720 mean cost per patient-year vs

Pulmonary artery pressure-guided heart failure management: US cost-effectiveness analyses using the results of the CHAMPION clinical trial

12,423 mean cost per patient-year). For every 100,000 patient-years of follow-up, RM was associated with 9810 fewer hospitalizations, 119,000 fewer days in hospital, and

Survival in Women Versus Men Following Implantation of Pacemakers, Defibrillators, and Cardiac Resynchronization Therapy Devices in a Large, Nationwide Cohort

370,270,000 lower hospital payments. CONCLUSION RM is associated with reductions in hospitalization and health care utilization. Since only about a third of patients with CIEDs routinely use RM, this represents a major opportunity for quality improvement.

Association of Opioid Usage with Spinal Cord Stimulation Outcomes

A shorter delay time from chronic pain diagnosis to spinal cord stimulation (SCS) implantation may make it more likely to achieve lasting therapeutic efficacy with SCS. The objective of this analysis was to determine the impact of pain‐to‐SCS time on patients’ post‐implant healthcare resource utilization (HCRU).

Impact of ventricular tachycardia ablation on health care utilization

Haemodynamic‐guided heart failure (HF) management effectively reduces decompensation events and need for hospitalizations. The economic benefit of clinical improvement requires further study.

The Relationship Between Level of Adherence to Automatic Wireless Remote Monitoring and Survival in Pacemaker and Defibrillator Patients.

Background Whether outcomes differ between sexes following treatment with pacemakers (PM), implantable cardioverter defibrillators, and cardiac resynchronization therapy (CRT) devices is unclear. Methods and Results Consecutive US patients with newly implanted PM, implantable cardioverter defibrillators, and CRT devices from a large remote monitoring database between 2008 and 2011 were included in this observational cohort study. Sex‐specific all‐cause survival postimplant was compared within each device type using a multivariable Cox proportional hazards model, stratified on age and adjusted for remote monitoring utilization and ZIP‐based socioeconomic variables. A total of 269 471 patients were assessed over a median 2.9 [interquartile range, 2.2, 3.6] years. Unadjusted mortality rates (MR; deaths/100 000 patient‐years) were similar between women versus men receiving PMs (n=115 076, 55% male; MR 4193 versus MR 4256, respectively; adjusted hazard ratio, 0.87; 95% CI, 0.84–0.90; P<0.001) and implantable cardioverter defibrillators (n=85 014, 74% male; MR 4417 versus MR 4479, respectively; adjusted hazard ratio, 0.98; 95% CI, 0.93–1.02; P=0.244). In contrast, survival was superior in women receiving CRT defibrillators (n=61 475, 72% male; MR 5270 versus male MR 7175; adjusted hazard ratio, 0.73; 95% CI, 0.70–0.76; P<0.001) and also CRT pacemakers (n=7906, 57% male; MR 5383 versus male MR 7625, adjusted hazard ratio, 0.69; 95% CI, 0.61–0.78; P<0.001). This relative difference increased with time. These results were unaffected by age or remote monitoring utilization. Conclusions Women accounted for less than 30% of high‐voltage implants and fewer than half of low‐voltage implants in a large, nation‐wide cohort. Survival for women and men receiving implantable cardioverter defibrillators and PMs was similar, but dramatically greater for women receiving both defibrillator‐ and PM‐based CRT.

System and method for responding to pulsed gradient magnetic fields using an implantable medical device

Study Design Observational study using insurance claims. Objective To quantify opioid usage leading up to spinal cord stimulation (SCS) and the potential impact on outcomes of SCS. Setting SCS is an interventional therapy that often follows opioid usage in the care continuum for chronic pain. Methods This study identified SCS patients using the Truven Health MarketScan databases from January 2010 to December 2014. The index event was the first occurrence of a permanent SCS implant. Indicators of opioid usage at implant were daily morphine equivalent dose (MED), number of unique pain drug classes, and diagnosis code for opioid abuse. System explant was used as a measure of ineffective SCS therapy. Multivariate logistic regression was used to analyze the effect of pre-implant medications on explants. Results A total of 5,476 patients (56 ± 14 years; 60% female) were included. SCS system removal occurred in 390 patients (7.1%) in the year after implant. Number of drug classes (odds ratio [OR] = 1.11, P = 0.007) and MED level (5-90 vs < 5 mg/d: OR = 1.32, P = 0.043; ≥90 vs < 5 mg/d: OR = 1.57, P = 0.005) were independently predictive of system explant. Over the year before implant, MED increased in 54% (stayed the same in 21%, decreased in 25%) of patients who continued with SCS and increased in 53% (stayed the same in 20%, decreased in 27%) of explant patients (P = 0.772). Over the year after implant, significantly more patients with continued SCS had an MED decrease (47%) or stayed the same (23%) than before (P < 0.001). Conclusions Chronic pain patients receive escalating opioid dosage prior to SCS implant, and high-dose opioid usage is associated with an increased risk of explant. Neuromodulation can stabilize or decrease opioid usage. Earlier consideration of SCS before escalated opioid usage has the potential to improve outcomes in complex chronic pain.

Single chamber leadless intra-cardiac medical device with dual-chamber functionality

BACKGROUND Catheter ablation of ventricular tachycardia (VT) has been shown to reduce the number of recurrent shocks in patients with an implantable cardioverter-defibrillator (ICD). However, how VT ablation affects postprocedural medical and pharmaceutical usage remains unclear. OBJECTIVE The purpose of this study was to investigate changes in health care resource utilization (HCRU) after VT ablation. METHODS This large-scale, real-world, retrospective study used the MarketScan databases to identify patients in the United States with an ICD or cardiac resynchronization therapy-defibrillator (CRT-D) undergoing VT ablation. We calculated cumulative medical and pharmaceutical expenditures, office visits, hospitalizations, and emergency room (ER) visits in the 1-year periods before and after ablation. RESULTS A total of 523 patients met the study inclusion criteria. After VT ablation, median annual cardiac rhythm-related medical expenditures decreased by