| Literature DB >> 26949428 |
Rakesh Yadav1, Aparna Jaswal2, Sridevi Chennapragada3, Prakash Kamath4, Shirish M S Hiremath5, Dhiman Kahali6, Sumit Anand7, Naresh K Sood8, Anil Mishra6, Jitendra S Makkar9, Upendra Kaul10.
Abstract
BACKGROUND: Several past clinical studies have demonstrated that frequent and unnecessary right ventricular pacing in patients with sick sinus syndrome and compromised atrio-ventricular conduction (AVC) produces long-term adverse effects. The safety and efficacy of two pacemaker algorithms, Ventricular Intrinsic Preference™ (VIP) and Ventricular AutoCapture (VAC), were evaluated in a multi-center study in pacemaker patients.Entities:
Keywords: Atrio-ventricular conduction; DDDR; Right ventricular pacing
Year: 2015 PMID: 26949428 PMCID: PMC4759122 DOI: 10.1016/j.joa.2015.07.004
Source DB: PubMed Journal: J Arrhythm ISSN: 1880-4276
Baseline device programming.
| Mode | DDD(R) | |
| Base rate | ≤60 | |
| Max track rate | 220-Age*0.8 or 0.9 | |
| Paced AV delay | 180 ms | |
| Sensed AV delay | 150 ms | |
| Rate responsive AV/PV delay | OFF | |
| Atrial refractory (PVARP) | 275 ms | |
| RR PVARP | Medium | |
| Atrial sensitivity | 0.3 mV | |
| Auto mode switch | DDI (R) | |
| Atrial tachycardia detection rate | 20 bpm above max tracking rate or 180 bpm | |
| AF Supression™ | OFF | |
| Post Vent. Atrial Blanking | Optimized (Oversensing test) | |
| PMT options | Autodetect | |
| Sampling options | Continuous | |
| No. of stored EGMs | 8 | |
| Maximum duration | 6 s | |
| Channel | Dual | |
| Atrial EGM configuration | A.Bipolar | |
| Atrial dynamic range | ±3.0 mV | |
| Vent. EGM configuration | V.Bipolar | |
| Vent. dynamic range | ±15.0 mV | |
| PMT detection | ON | |
| High ventricular rate | ON (175 bpm) | |
| Number of consecutive cycles | 10 | |
| AT/AF detection | ON | |
| Prolongation | N/A | Open |
| Search cycles | N/A | 30 s |
| Search interval | N/A | 3 |
| Ventricular autocapture | OFF | ON |
AV – Atrio-ventricular, AF – atrial fibrillation, AT – atrial tachycardia, CG – Control group, EGM – Electrogram, N/A – Not applicable, PV – Paced delay, PMT – Pacemaker mediated tachycardia, VIP – Ventricular Intrinsic Preference algorithm, TG – Treatment Group.
Fig. 1Study flow chart. The figure depicts study flow chart. It illustrates the study design, according to which the patients based on their intrinsic Atrio-ventricular conduction were divided into either Compromised AV Conduction arm or Intact AV Conduction arm. In both arms patient were then randomized to VIP ON+VAC ON group (TG) and VIP OFF+VAC OFF group (CG).
Baseline demographic data.
| 7/31 | 6/24 | 0.55 | 7/46 | 5/31 | 0.38 | |
| 65±12 | 66±13 | 0.70 | 63±9 | 65±11 | 0.56 | |
| 162±8 | 163±8 | 162±13 | 162±9 | |||
| 65±16 | 61±10 | 66±16 | 57±9 | |||
| 129±17 | 123±16 | 0.23 | 125±17 | 121±17 | 0.47 | |
| 74.±7 | 72±11 | 0.48 | 74±11 | 74±8 | 0.92 | |
| 54±13 | 52±8 | 0.66 | 58±7 | 58±8 | 0.80 | |
| 25±5 | 30±5 | 0.07 | 27±6 | 29±5 | 0.29 | |
| 40±3 | 47±4 | 0.23 | 37±9 | 42±2 | 0.61 | |
| Sick sinus syndrome | 7/31 | 17/68 | 5/33 | 10/62 | ||
| Sinus bradycardia | 4/18 | 13/52 | 4/26 | 6/37 | ||
| SA block/sinus arrest | 3/13 | 5/20 | 1/6 | 5/31 | ||
| Intermittent AV-block | 14/63 | 6/24 | 8/53 | 6/37 | ||
| I | 13/59 | 14/56 | 8/53 | 12/75 | ||
| II | 9/40 | 6/24 | 6/40 | 2/12 | ||
| III | 0/0 | 3/12 | 1/6 | 2/12 | ||
| Unknown | 0/0 | 2/8 | 0.21 | 0/0 | 0/0 | 0.31 |
| None | 3/13 | 4/16 | 0/0 | 5/31 | ||
| Hypertension | 14/63 | 16/64 | 8/53 | 7/43 | ||
| CAD | 6/27 | 7/28 | 5/33 | 3/18 | ||
| HCM | 0/0 | 1/4 | 0/0 | 0/0 | ||
| TIA/RIND/CVA/stroke | 0/0 | 1/4 | 0/0 | 0/0 | ||
| MI | 1/4 | 1/4 | 2/13 | 1/6 | ||
| Diabetes mellitus | 7/31 | 9/36 | 7/46 | 3/18 | ||
| Renal insufficiency | 1/4 | 0/0 | 0/0 | 0/0 | ||
| Valve disease | 0/0 | 1/4 | 0/0 | 0/0 | ||
| Cardiac surgery | 3/13 | 5/20 | 2/13 | 2/12 | ||
| Other | 7/31 | 6/24 | 6/40 | 5/31 | ||
| ACE-inhibitors/ARB | 11 | 11 | 7 | 6 | ||
| Amiodarone | 0 | 1 | 1 | 3 | ||
| Anticoagulant | 3 | 6 | 3 | 1 | ||
| Anti-platelets | 5 | 9 | 3 | 5 | ||
| Beta-blocker | 3 | 6 | 3 | 5 | ||
AV – Atrio-ventricular, ACE – Angiotensin converting enzyme, ARB – Angiotensin receptor blocker, cAVC – Compromised Atrio-ventricular conduction, CAD – Coronary artery disease, CVA – Cerebrovascular accident, CG – Control group, HCM – Hypertrophic cardiomyopathy, iAVC – Intact Atrio-ventricular conduction, LVEF – Left ventricular ejection fraction, LVESD – Left ventricular end systolic diameter, LVEDD – Left ventricular end diastolic diameter, MI – Myocardial ischemia, N – Number, NYHA – New York Heart association, RIND – Reversible Ischemic Neurologic Deficit, SA – Sino-atrial, SD – Standard Deviation, TG – Treatment Group, TIA – Transient ischemic attack.
Age was calculated by subtracting the date of the baseline visit with the date of birth divided by 365.25 (because of the leap years).
Baseline data not available for 1 patient in the AVC VIP ON+VAC ON Group.
Echo data is not available for all patients as it was not mandatory protocol requirement.
Multiple choices may have been checked for each patient.
Fig. 2Mean±SD plot of percentage of RV pacing over study period. The figure depicts significant reduction of %RVp at 12-Month follow up when VIP algorithm was activated in both cAVC & iAVC arms. In the iAVC group, %RVp was reduced by VIP from 68+39% in CG to 15±25% in TG (p=0.0067). In the cAVC group, VIP reduced the %RVp from 97±3% in CG to 39±41% in TG (p=0.0004).
Fig. 3Box plot for percentage of RV pacing at 6-Month & 12-Month visit. the figure depicts box plot representation for significant reduction of %RVp at 12-Month follow up when VIP algorithm was activated in both cAVC & iAVC arms. In the iAVC group, %RVp was reduced by VIP from 68+39% in CG to 15±25% in TG (p=0.0067). In the cAVC group, VIP reduced the %RVp from 97±3% in CG to 39±41% in TG (p=0.0004).
Six-month and 12-month follow-up visit ventricular pacing for both groups.
| 21 | 92±21 | 21 | 97±3 | 0.0004 | ||
| 23 | 45±43 | 23 | 39±41 | |||
| 15 | 67±36 | 13 | 68±39 | 0.0067 | ||
| 12 | 9±22 | 14 | 15±25 | |||
cAVC – Compromised Atrio-ventricular conduction, CG – Control group, iAVC – Intact Atrio-ventricular conduction, N – Number, SD – Standard Deviation, TG – Treatment Group.
Data not available for one patient.
Secondary endpoint analysis.
| 25 | 49±34 | 15 | 53±38 | 25 | 0.38±0.71 | 0.13±0.71 | 14 | 0.25±0 | 0 | |
| 20 | 37±17 | 14 | 41±27 | 19 | 0.24±0.03 | −0.01±0.03 | 14 | 0.38±0.47 | 0.13±0.47 | |
| 22 | 32±13 | 12 | 30±7 | 22 | 0.25±0. | 0 | 11 | 0.25±0 | 0 | |
| 22 | 24±11 | 13 | 31±13 | 22 | 0.25±0.04 | 0±0.04 | 13 | 0.26±0.03 | 0.01±0.03 | |
AVD – Absolute value difference, cAVC – Compromised Atrio-ventricular conduction, iAVC – Intact Atrio-ventricular conduction, CG – Control group, N – Number, SD – Standard Deviation, TG – Treatment Group.
p<0.0001 within iAVC and cAVC group.