Applicability of the iterative technique for cardiac resynchronization therapy optimization: full-disclosure, 50-sequential-patient dataset of transmitral Doppler traces, with implications for future research design and guidelines

Europace. 2014 Apr;16(4):541-50. doi: 10.1093/europace/eut257. Epub 2013 Sep 25.

Abstract

Aims: Full-disclosure study describing Doppler patterns during iterative atrioventricular delay (AVD) optimization of biventricular pacemakers (cardiac resynchronization therapy, CRT).

Method and results: Doppler traces of the first 50 eligible patients undergoing iterative Doppler AVD optimization in the BRAVO trial were examined. Three experienced observers classified conformity to guideline-described patterns. Each observer then selected the optimum AVD on two separate occasions: blinded and unblinded to AVD. Four Doppler E-A patterns occurred: A (always merged, 18% of patients), B (incrementally less fusion at short AVDs, 12%), C (full separation at short AVDs, as described by the guidelines, 28%), and D (always separated, 42%). In Groups A and D (60%), the iterative guidelines therefore cannot specify one single AVD. On the kappa scale (0 = chance alone; 1 = perfect agreement), observer agreement for the ideal AVD in Classes B and C was poor (0.32) and appeared worse in Groups A and D (0.22). Blinding caused the scattering of the AVD selected as optimal to widen (standard deviation rising from 37 to 49 ms, P < 0.001). By blinding 28% of the selected optimum AVDs were ≤60 or ≥200 ms. All 50 Doppler datasets are presented, to support future methodological testing.

Conclusion: In most patients, the iterative method does not clearly specify one AVD. In all the patients, agreement on the ideal AVD between skilled observers viewing identical images is poor. The iterative protocol may successfully exclude some extremely unsuitable AVDs, but so might simply accepting factory default. Irreproducibility of the gold standard also prevents alternative physiological optimization methods from being validated honestly.

Trial registration: ClinicalTrials.gov NCT01258829.

Keywords: Atrioventricular delay (AVD); Doppler echocardiography; Optimization.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Aged
  • Cardiac Resynchronization Therapy Devices*
  • Cardiac Resynchronization Therapy*
  • Echocardiography, Doppler*
  • Equipment Design
  • Female
  • Heart Conduction System / diagnostic imaging*
  • Heart Conduction System / physiopathology
  • Heart Failure / diagnostic imaging*
  • Heart Failure / physiopathology
  • Heart Failure / therapy*
  • Humans
  • Male
  • Middle Aged
  • Mitral Valve / diagnostic imaging*
  • Mitral Valve / physiopathology
  • Observer Variation
  • Predictive Value of Tests
  • Randomized Controlled Trials as Topic
  • Reproducibility of Results
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01258829