Cardiac Resynchronization Therapy in the Real World: Comparison With the COMPANION Study

doi:10.1016/j.cardfail.2011.10.014

Journal of Cardiac Failure

Volume 18, Issue 2, February 2012, Pages 153-158

https://doi.org/10.1016/j.cardfail.2011.10.014 Get rights and content

Abstract

Background

Several clinical trials have confirmed that cardiac resynchronization therapy (CRT) improves outcomes in well defined patient populations. It is uncertain, however, whether outcomes are similar in real-world clinical settings. This study compared outcomes after CRT with defibrillator (CRT-D) in a large real-world private-practice cardiology setting with those in the COMPANION multicenter trial.

Methods and Results

A total of 429 consecutive patients who received CRT-D for standard indications (group 1) were retrospectively compared with the 595 patients (group 3) in the COMPANION CRT-D cohort regarding survival and survival free of cardiovascular (CV) hospitalization. A subgroup of the group 1 patients who met the COMPANION entrance criteria (group 2) was also compared with the COMPANION cohort (group 3) both with and without propensity-matching statistical analysis. Survival and survival free of CV hospitalization was better in group 1 than in group 3. Survival in group 2 with and without propensity matching was similar to group 3. However, survival free of CV hospitalization was better in the real-world patients (group 2) even after adjustment for differences in baseline characteristics.

Conclusions

Survival and CV hospitalization outcomes in a real-world clinical setting are as good as, or better than, those demonstrated in the COMPANION research trial.

Section snippets

Study Population

All patients who met standard criteria for CRT (QRS ≥120 ms, EF ≤35%, NYHA functional class III/IV HF) and received a first CRT-D device between January 1, 2003, and December 31, 2008, at St Paul Heart Clinic (SPHC) were included in this study (group 1). A subset of these patients who met the additional COMPANION entrance criteria of no previous pacemaker implantation and a history of hospitalization for decompensated HF in the year before randomization were analyzed separately (group 2). Both

Baseline Characteristics

Baseline patient characteristics for the 2 groups of SPHC patients (groups 1 and 2) and the COMPANION study patients (group 3) are shown in Table 1. Compared with group 3 patients, group 1 patients were older and more likely to have ischemic etiology, atrial fibrillation history, lower heart rate, higher beta-blocker use, lower ACEI/ARB use, higher EF, and smaller LV dimensions. Compared with group 3 patients, group 2 patients were also older and more likely to have ischemic etiology, higher

Discussion

The results of the present analysis demonstrate that CRT-D patients meeting standard criteria for implantation and treated in a large private-practice cardiology group experience survival and survival free of CV hospitalization rates significantly higher than those reported in the COMPANION study. After adjustment for the more stringent entrance criteria in COMPANION and for baseline differences in study populations, survival benefits were similar in the 2 studies, but survival free of CV

Conclusion

In a large private-practice clinical setting, CRT-D patients meeting standard criteria for implantation demonstrated mortality rates better than those found in the COMPANION multicenter research trial. Mortality rates in this real-world setting are similar to COMPANION once adjustments are made for differences in baseline characteristics. However, survival free of CV hospitalization is high and better than that demonstrated in COMPANION, even after adjusting for differences in baseline

Acknowledgments

The authors thank Craig Aamlie for his assistance in creating and maintaining the SPHC CRT database.

Disclosures

Drs Bank and Anand are consultants for Boston Scientific Corp and Medtronic. Mr Yong and Mr Seth are employees of Boston Scientific Corp. All of the other authors report no potential conflicts of interest.

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2016, JACC: Clinical Electrophysiology
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.
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.
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.
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).
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.
On the underutilization of Cardiac resynchronization therapy
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Citation Excerpt :
There is increasing evidence that CRT in the real world provides benefit similar to, or better than, that in clinical trials. We analyzed data from 429 consecutive patients receiving CRT-D for standard indications in our clinic.23 Survival was similar to the CRT-D arm of COMPANION, and survival free of cardiovascular hospitalization exceeded that of COMPANION without as well as with propensity matching.
Cardiac resynchronization therapy (CRT) is an exciting therapy that can treat patients with systolic heart failure and left ventricular dysfunction who have a wide QRS complex. Indications for its use have been refined and expanded based on recent clinical data and guidelines, yet the rate of new CRT implants in the United States has not changed much over the past 8 years. Many patients receiving implantable cardioverter-defibrillators can benefit from, but are not receiving, appropriately-indicated CRT devices. We summarize data on CRT use, discuss reasons for probable underutilization, and provide recommendations for augmenting proper and effective use of this highly beneficial therapy.
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Combined electrical and global markers of dyssynchrony predict clinical response to Cardiac Resynchronization Therapy
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2013, Journal of International Medical Research
Pacemaker optimization in nonresponders to cardiac resynchronization therapy: Left ventricular pacing as an available option
2012, PACE - Pacing and Clinical Electrophysiology

: All decisions regarding this manuscript were made by a guest editor.

: Funding: Boston Scientific Corp, St Paul, Minnesota.

: See page 158 for disclosure information.

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Review ArticleCardiac Resynchronization Therapy in the Real World: Comparison With the COMPANION Study

Abstract

Background

Methods and Results

Conclusions

Section snippets

Study Population

Baseline Characteristics

Discussion

Conclusion

Acknowledgments

Disclosures

J Card Fail

J Card Fail

ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline)

Circulation

Cardiac resynchronization in chronic heart failure

N Engl J Med

Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure

N Engl J Med

Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay

N Engl J Med

The effect of cardiac resynchronization on morbidity and mortality in heart failure

N Engl J Med

Beyond the randomized clinical trial: the role of effectiveness studies in evaluating cardiovascular therapies

Circulation

Echocardiographic improvements with pacemaker optimization in the chronic post cardiac resynchronization therapy setting

Clin Med Card

Review Article
Cardiac Resynchronization Therapy in the Real World: Comparison With the COMPANION Study