title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Department of Cardiology, University of Rome 'Tor Vergata', Viale Oxford, 81, Rome 00133, Italy forleo@me.com.
authors.forename: Giovanni B
authors.initials: GB
authors.lastname: Forleo
authors.affiliation: Albert Einstein College of Medicine at Montefiore Hospital, New York, USA Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, TX, USA Department of Cardiology, University of Foggia, Foggia, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Biase
authors.affiliation: St Jude Medical, Sylmar, CA, USA.
authors.forename: Rupinder
authors.initials: R
authors.lastname: Bharmi
authors.affiliation: St Jude Medical, Sylmar, CA, USA.
authors.forename: Nirav
authors.initials: N
authors.lastname: Dalal
authors.affiliation: Department of Cardiology, University of Rome 'Tor Vergata', Viale Oxford, 81, Rome 00133, Italy.
authors.forename: Germana
authors.initials: G
authors.lastname: Panattoni
authors.affiliation: St Jude Medical Italia, Agate Brianza, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Pollastrelli
authors.affiliation: Department of Cardiology, University of Rome 'Tor Vergata', Viale Oxford, 81, Rome 00133, Italy.
authors.forename: Manfredi
authors.initials: M
authors.lastname: Tesauro
authors.affiliation: Department of Cardiology, University of Rome 'Tor Vergata', Viale Oxford, 81, Rome 00133, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Santini
authors.affiliation: Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, TX, USA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
authors.affiliation: Department of Cardiology, University of Rome 'Tor Vergata', Viale Oxford, 81, Rome 00133, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Romeo
mesh_terms: D000368:Aged; D058406:Cardiac Resynchronization Therapy / Q000191:economics*; D017147:Defibrillators, Implantable / Q000191:economics* / Q000706:statistics & numerical data; D004567:Electrodes, Implanted / Q000191:economics; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006333:Heart Failure / Q000191:economics* / Q000453:epidemiology / Q000517:prevention & control; D006760:Hospitalization / Q000191:economics* / Q000706:statistics & numerical data*; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D016896:Treatment Outcome; D014600:Utilization Review
keywords: Cardiac resynchronization therapy; Cost-effectiveness; Health economics; Hospitalizations; Left ventricular lead; Quadripolar lead