Reduced Mortality Associated With Quadripolar Compared to Bipolar Left Ventricular Leads in Cardiac Resynchronization Therapy.

OBJECTIVES The study sought to compare survival, lead deactivation, and lead replacement with quadripolar versus bipolar leads using a retrospective cohort of patients with newly implanted cardiac resynchronization therapy (CRT) systems. BACKGROUND In CRT, quadripolar left ventricular (LV) leads offer alternative pacing sites and vectors not available with bipolar LV leads, which may improve the effectiveness of the therapy. METHODS Using nationwide data from device implant registration records of a single manufacturer, we identified patients with a de novo cardiac resynchronization therapy with defibrillation (CRT-D) implanted between November 30, 2011, and May 31, 2013. Patients were followed for up to 24 months. The primary predictor was LV lead type (quadripolar Quartet [St. Jude Medical, St. Paul, Minnesota] LV lead or bipolar LV lead). The primary outcome was death and the secondary outcomes were LV lead replacement and deactivation. RESULTS Among 23,570 patients (69.5 ± 11.1 years of age; 28% female; median follow-up time 1.14 years), 18,406 had quadripolar and 5,164 had bipolar LV leads. The quadripolar and bipolar groups had 5.04 and 6.45 deaths per 100 patient-years, respectively (p < 0.001). After multivariate adjustment, the quadripolar lead was associated with a lower risk of deactivation (hazard ratio [HR]: 0.62; 95% confidence interval [CI]: 0.46 to 0.84; p = 0.002), replacement (HR: 0.67; 95% CI: 0.55 to 0.83; p < 0.001), and death (HR: 0.77; 95% CI: 0.69 to 0.86; p < 0.001). CONCLUSIONS In this observational study of CRT-D devices, use of a quadripolar, compared to a bipolar LV lead, was associated with a reduction in LV lead deactivation, replacement, and mortality.

[1]  Daniel B. Vatterott,et al.  Cardiac resynchronization therapy in the real world: comparison with the COMPANION study. , 2012, Journal of cardiac failure.

[2]  J. Baker,et al.  Postoperative Performance of the Quartet® Left Ventricular Heart Lead , 2013, Journal of cardiovascular electrophysiology.

[3]  K. Anstrom,et al.  Linking the National Cardiovascular Data Registry CathPCI Registry With Medicare Claims Data: Validation of a Longitudinal Cohort of Elderly Patients Undergoing Cardiac Catheterization , 2012, Circulation. Cardiovascular quality and outcomes.

[4]  G. Boriani,et al.  Acute changes in electromechanical parameters during different pacing configurations using a quadripolar left ventricular lead , 2013, Journal of Interventional Cardiac Electrophysiology.

[5]  P. Doevendans,et al.  Quadripolar Leads in Cardiac Resynchronization Therapy. , 2015, JACC. Clinical electrophysiology.

[6]  Sean M. O'Brien,et al.  Comparative effectiveness of revascularization strategies. , 2012, The New England journal of medicine.

[7]  F. Romeo,et al.  Without a quadripolar left ventricular lead you don't succeed: a challenging case of phrenic nerve stimulation. , 2012, International journal of cardiology.

[8]  J. Daubert,et al.  The effect of cardiac resynchronization on morbidity and mortality in heart failure. , 2005, The New England journal of medicine.

[9]  Erwan Donal,et al.  Sites of left and right ventricular lead implantation and response to cardiac resynchronization therapy observations from the REVERSE trial. , 2012, European heart journal.

[10]  J. Daubert,et al.  Effect of QRS Duration and Morphology on Cardiac Resynchronization Therapy Outcomes in Mild Heart Failure: Results From the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) Study , 2012, Circulation.

[11]  C. Rinaldi,et al.  Cardiac Resynchronization Therapy Delivered Via a Multipolar Left Ventricular Lead is Associated with Reduced Mortality and Elimination of Phrenic Nerve Stimulation: Long‐Term Follow‐Up from a Multicenter Registry , 2015, Journal of cardiovascular electrophysiology.

[12]  S. A. Christman,et al.  Heart failure decompensation and all-cause mortality in relation to percent biventricular pacing in patients with heart failure: is a goal of 100% biventricular pacing necessary? , 2009, Journal of the American College of Cardiology.

[13]  M. Chung,et al.  Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures: Results From the REPLACE Registry , 2010, Circulation.

[14]  A. Natale,et al.  Clinical and procedural outcome of patients implanted with a quadripolar left ventricular lead: early results of a prospective multicenter study. , 2012, Heart rhythm.

[15]  Wojciech Zareba,et al.  Left Ventricular Lead Position and Clinical Outcome in the Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy (MADIT-CRT) Trial , 2011, Circulation.

[16]  Robert Gray,et al.  A Proportional Hazards Model for the Subdistribution of a Competing Risk , 1999 .

[17]  D. Delurgio,et al.  Cardiac resynchronization in chronic heart failure. , 2002, The New England journal of medicine.

[18]  Laura G. Qualls,et al.  QRS duration, bundle-branch block morphology, and outcomes among older patients with heart failure receiving cardiac resynchronization therapy. , 2013, JAMA.

[19]  William T. Abraham,et al.  An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure , 2013, European heart journal.

[20]  L. Tavazzi,et al.  Improving cardiac resynchronization therapy response with multipoint left ventricular pacing: Twelve-month follow-up study. , 2015, Heart rhythm.

[21]  S. Solomon,et al.  Predictors of Response to Cardiac Resynchronization Therapy in the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy (MADIT-CRT) , 2011, Circulation.

[22]  Wojciech Zareba,et al.  Cardiac-resynchronization therapy for the prevention of heart-failure events. , 2009, The New England journal of medicine.

[23]  P. Heidenreich,et al.  Long-Term Outcome After ICD and CRT Implantation and Influence of Remote Device Follow-Up: The ALTITUDE Survival Study , 2010, Circulation.

[24]  S. Solomon,et al.  Cardiac resynchronization therapy is more effective in women than in men: the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) trial. , 2011, Journal of the American College of Cardiology.

[25]  M. Bloomston,et al.  The Social Security Death Index (SSDI) most accurately reflects true survival for older oncology patients. , 2013, American journal of cancer research.

[26]  Paul J. Wang,et al.  Effectiveness of Cardiac Resynchronization Therapy by QRS Morphology in the Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy (MADIT-CRT) , 2011, Circulation.