What is the clinical evidence from this study?

Study design: Observational. Population: Sinus node disease, chronotropic incompetence, and recurrent paroxysmal atrial fibrillation (n=26). Intervention: Medtronic Thera DR pacemaker with new automatic mode switching algorithm. Primary outcome: Safety and efficacy of automatic mode switching (AMS episodes and Holter recordings).

November 1, 1996

Reliability of a New Algorithm for Automatic Mode Switching from DDDR to DDIR Pacing Mode in Sinus Node Disease Patients with Chronotropic Incompetence and Recurrent Paroxysmal Atrial Fibrillation

Key Result

The new automatic mode switching algorithm in the Medtronic Thera DR pacemaker reliably detected paroxysmal atrial fibrillation, with simultaneous activation in all 22 recorded episodes.

Study Design

Type

Observational (n=26)

Structured PICO

Does a new automatic mode switching algorithm reliably detect and respond to paroxysmal atrial fibrillation in patients with sinus node disease and chronotropic incompetence?

Population

26 patients (mean age 73, 61.5% female) with sinus node disease, chronotropic incompetence, and recurrent paroxysmal atrial fibrillation followed for 1 year after pacemaker implantation.

Exposure

Medtronic Thera DR pacemaker featuring a new algorithm for automatic mode switching (AMS) from DDD-DDDR to DDIR based on running average of intrinsic atrial rate.

Outcome

Safety and efficacy of the new AMS algorithm (evaluated via clinical evaluation, 12-lead ECG, Holter monitoring, and exercise testing compared with pacemaker memory data).surrogate

The evaluated automatic mode switching algorithm is highly reliable, sensitive, and specific for managing paroxysmal atrial fibrillation in pacemaker patients.

Abstract

To evaluate the safety and efficacy of a new algorithm for automatic mode switching (AMS) from DDD-DDDR to DDIR, 26 patients, 16 females and 10 males, mean age 73 +/- 6 years of age, affected by sinus node disease, chronotropic incompetence, and recurrent paroxysmal atrial fibrillation (PAF) received the Medtronic Thera DR pacemaker. The device continuously calculates, in ms, the running average of the intrinsic atrial rate (MAR) and compares the current atrial interval (CAI) with the stored MAR. When the CAI is greater than the MAR it increases by 8 ms, and when the CAI is less than the MAR, it decreases by 23 ms. When MAR < or = 330 ms (182 beats/min), tachycardia is detected and AMS is activated. All patients had clinical evaluation, 12-lead ECG, Holter monitoring, and exercise testing after implantation and every 3 months for 1 year. The results were compared with the data stored in the pacemaker memory: AMS episodes number; the histogram of the last 14 episodes; and atrial electrogram recording. Twenty-two Holter recordings in 13 patients showed PAF and in all of them AMS occurred simultaneously. AMS lasted between 10 seconds and 20 hours, and MAR ranged from 195-400 beats/min. No episode of PAF and no AMS were recorded in 39 Holter recordings in 22 patients. Appropriate AMS was confirmed in five patients by stored atrial electrogram and in nine by 12-lead ECG and pacemaker event markers. Mean atrial sensing was 2.13 +/- 1.04 mV during PAF and 3.18 +/- 1.46 mV during sinus rhythm. No PAF episode and no AMS were recorded during exercise testing. In conclusion, this new algorithm was very reliable, sensitive, and specific.

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