THERAPY ADVISOR IN PACEMAKERS: C-STAR INTERIM RESULT
A.Schuchert1,
R. Charles2 on behalf
of the C-STAR investigators
1University Hospital
Eppendorf, Hamburg, Germany
2The Cardiothoracic
Centre, Liverpool, UK
Introduction:
Digital pacemakers have the ability to store a large amount of clinically relevant
pacemaker and patient data. Analysis of this data in clinical practice may become
very time-consuming and burdensome. In addition many pacemaker settings are
left unchanged after implantation. Therefore an expert system, the Therapy Advisor
(TA) (Vitatron C-series), was developed, which automatically analyses all data
and indicates which diagnostics need attention. In addition it provides recommendations
for optimizing the pacemaker therapy.
C-STAR evaluates this TA system.
Methods: Prospective, multicentre,
observational registry. Inclusion: Class I/II pacing indication, Vitatron C60
DR/C50 D, Registry Consent Form. Interim analysis: 1st follow-up of 100 patients,
changes in pacemaker settings and medication, following advices, evaluation
of TA.
Results: 2-month follow-ups
of 100 patients: 60% male, age: 72.6 ± 10.2, indications: 47 SSS, 46
AV block, 4 drug induced bradycardia, 3 other. Changes in pacemaker settings
were mainly driven by the pacemaker diagnostics; drug therapy changes were equally
driven by diagnostics and symptoms. 79% of the programming recommendations were
followed. Main reason not to follow them was that it was not clinically necessary
in the individual patient.
The most common message was: “TA has nothing significant to report”
indicating
that no abnormalities were observed in the diagnostics.
The questions “Does the TA help assessing patients” and “TA
makes the follow- up more efficient” were evaluated by the investigator
in more than 80% of the cases as neutral to positive.
Conclusion The Therapy Advisor
provides clinically relevant information for
optimizing the pacemaker therapy and makes the follow-up more efficient.
IMPACT OF THE FULLY DIGITAL PACEMAKERS
ON THE DAILY FOLLOW-UP ACTIVITIES
P. Scipione, F. Capestro, P. Cecchetti, A. Misiani, M. Trombetti*
Division of Cardiology, Lancisi Hospital, Ancona, Italy
*Vitatron Medical Italia, Bologna, Italy
The pacemakers (PMs) based on fully digital technology may not
only improve the research activities but also the daily management of patients
(Pts) during a standard follow-up (FU). The most important features helping
the physicians in this context are the extremely high speed of telemetry, the
high
resolution EGM (800 Hz) and the automatic analysis of the stored diagnostic
information to speed-up the decisional process during each FU (Therapy Advisor
– TA). Aim of the study is to collect data about the time devoted to the
FU of such a devices.
Methods: Patients (Pts) with indication for permanent DDDR pacing and implanted with C-60 Vitatron PM were followed-up at 1 (FU1) and 3 months (FU2) after implantation. During FU1 we performed the complete telemetry, the EGM analysis, the TA consultation, the analysis of pacing and sensing parameters and the final programming of the device. During FU2 we only performed the telemetry, the EGM analysis and the TA consultation: reprogramming of the device was performed only in case of suspected malfunctions or indicated by the TA.
Results: Till now 35 Pts were enrolled. At FU1 34 Pts ended the technical FU in 3’20” ± 41”. In 22 Pts (63%) the TA suggested the activation of a specific algorithm to reduce ventricular pacing: they were Pts with preserved AV conduction or paroxysmal AV block. The output setting was adjusted in all patients. One patient needed further investigation (8 minutes) for suspected atrial oversensing as suggested by the TA: atrial blanking was reprogrammed at 175 ms. At FU2 the mean time of FU was 3’05” ± 21” without any need of further tailoring of the therapies.
Conclusion The TA, based on
the high quality sensing combined with a very
fast telemetry, represents an important improvement for standard management
of implanted Pts
XI International Symposium on Progress in Clinical Pacing, 2004, p. 52
HYBRID ABLATION AND PREVENTIVE
PACING THERAPY TO CONTROL PERSISTENT ATRIAL FIBRILLATION: HAPPi-AF PILOT STUDY
RESULTS
P. Neuzil2,
V.Y. Reddy1, M. Taborsky2,
P. Niederle2, J.N.
Ruskin1
1Massachusetts General
Hospital, Massachusetts, US
2Na Homolce Hospital,
Prague, Czech Republic
Introduction: Atrial fibrillation (AF) is the most common supra-ventricular tachyarrhythmia. In many patients (pts) with paroxysmal AF, foci located in the pulmonary veins initiate the arrhythmia and can be targeted for catheter ablation. However, evaluation of success has been largely limited to symptoms or infrequent 24-hour Holter recordings. Also, catheter ablation is generally of lower efficacy in pts with persistent or permanent AF. Preventive pacing algorithms (PPA) may be effective in reducing AF burden and recurrence of AF. The HAPPi-AF study aims to evaluate the effectiveness of the combination of PPA and ostial catheter ablation in pts with chronic AF. Pilot data is presented.
Methods: Prospective randomized-controlled study to 3 groups: Group A-PPA only (PPA), Group B-ablation only (Abl), Group C-PPA and ablation (PPA+Abl). Inclusion: Drug-resistant, symptomatic persistent or permanent AF. Device: Vitatron Selection 9000. Follow-up (FU): stratified into 3- and 6- month data. Outcome: Median AF burden and Mean AF burden and number of episodes.
Results: Data from 22 pts:
73% male, age: 57 ± 8 yrs, AF history: 63 ± 57.7 months.
Data per group (3 / 6 months FU):
Group A (PPA, n =7): Median (%): 0.9 / 1.2, Mean (%): 29.1 / 28.8, # episodes:
112.7 / 89.0
Group B (Abl, n =6): Median (%): 33.0 / 2.6, Mean (%): 32.6 / 5.9, # episodes:
1141.5 / 294.4
Group C (PPA+Abl, n =9): Median (%): 0.0 / 0.0, Mean (%): 3.0 / 1.1, # episodes:
34.0 / 185.3
Conclusions: This data suggests that the combination of PPA and ablation may be the preferred treatment for pts with persistent or permanent AF. The final data of the HAPPi-AF study including data from 150 pts will evaluate this.
LONG TERM FOLLOW-UP OF ATRIAL LEADS WITH
SHORT TIP-TO-RING SPACING: COMPARISON WITH STANDARD LEADS
A. Nash, P.A.R. Owen, T. Newberry, A.J. Marshall
The Southwest Cardiothoracic Centre, Plymouth, UK
Reliable atrial sensing is a prerequisite for accurate device
derived diagnostics and for the delivery of appropriate pacing therapies. Oversensing
of far-field R-waves (FFRW) or myopotentials produces artefact that can reduce
this reliability. Atrial electrodes with short tip-to-ring spacing reduce the
incidence of FFRW oversensing. We present a long term follow-up of patients
implanted with a pacing lead (Crystalline, Vitatron B.V., The Netherlands) with
this characteristic. Fifteen patients were included in a clinical evaluation
of this lead between March and August 2000. Satisfactory performance of the
lead both in general terms and in facilitating the rejection of artefact by
pacemaker diagnostic software was confirmed. Subsequently, two patients suffered
early atrial lead displacement requiring replacement with standard leads. Three
patients have died and two have refused further investigation. The remaining
eight patients have been followed up at a mean of 52 months after implant. FFRW
oversensing could be demonstrated at maximum sensitivity settings in two (25%)
of these patients, but not at normal pacemaker settings. Other lead parameters
(threshold, impedance and sensed P-wave
amplitude) were all satisfactory. In a control group with standard atrial leads,
FFRW oversensing occurred in 40% of patients at maximum sensitivity settings
and in a proportion of these at normal settings. Myopotential oversensing did
not occur in either group of patients.
Conclusions:
1. The Vitatron Crystalline lead continues to perform satisfactorily in the
long term
2. In this sample, a trend towards an advantage with short tip-to-ring spacing
has been demonstrated. A larger sample size is needed to confirm these findings
and to assess clinical relevance.
Pace prevention of atrial fibrillation:
Results from the VIP registry
Thorsten Lewalter@, Alexander Yang@, Friedhelm Saborowski#,
Dietrich Pfeiffer+, Tilmann
Markert*, J. Schrickel@, J.O. Schwab@, A. Bitzen@, M. Linhart@ B. Lüderitz@
@Dept. of Cardiology, Univ. of Bonn, Bonn, Germany + University Clinic Leipzig,
Department of
Cardiology *Heart Center Coswig #Hospital Cologne-Holweide, Department of Internal
Medicine
Pacemaker (PM) therapy is one the interventional techniques
to prevent recurrent atrial fibrillation (AF). So far, preventive pacing did
demonstrate only a moderate and clinically not convincing effect in non-selected
patients with recurrent AF. Therefore, the VIP (“Vorhofflimmer(Atrial
fibrillation)-prevention by Individualized pacemaker Programming)-registry was
initiated to
identify subgroups of patients being more likely responders to preventive pacing
algorithms
Method: The registry includes
624 pts. with recurrent AF and a conventional indication for PM therapy. Patients
received a dual chamber device with detailed AF diagnostics and 4 different
preventive algorithms (Selection series, Vitatron). Following implantation a
3 month diagnostic phase with conventional pacing identified pts. with “substrate-AF”
(>70% of AF episodes
with less than 2 premature atrial contractions (PACs) before AF onset) from
“trigger-AF” (<70% of AF episodes with less than 2 PACs before
AF onset). For a consecutive follow-up of 3 month pts. with trigger-AF were
programmed to PAC-initiated preventive pacing algorithms whereas pts. with “substrate-AF”
underwent continuous overdrive pacing.
Results: 161 patients (69.6±10.9
yrs.) completed so far diagnostic and preventive pacing phases: Comparing the
AF subgroups, pts. with trigger-AF and an AF burden of >1% exhibited an AF
burden reduction of 32.6% (Mean AF burden: 9.7% vs 6.5% with preventive pacing,
n.s.) whereas pts. with substrate- AF demonstrated an increase in the mean AF
burden of 14.9% while performing preventive pacing (Mean AF burden: 10.6%/diagnostic
phase vs
12.5%/preventive pacing).
Conclusion: Patients with trigger-AF demonstrate a relative reduction of 32.6% in AF burden with preventive pacing as compared to patients with substrate-AF who demonstrated an increase in AF burden while performing a continuous atrial overdrive pacing. The results of this pacemaker registry indicate that patients with trigger-AF are more likely responders to preventive pacing.
XI International Symposium on Progress in Clinical Pacing, 2004, p. 38
A PACEMAKER EXPERT SYSTEM FOR ATRIAL FIBRILLATION:
T-STAR INTERIM RESULTS
A. Schuchert on behalf of the T-STAR investigators University
hospital Eppendorf, Hamburg, Germany
Introduction: Digital pacemakers
have the ability to store a large amount of diagnostic data. Furthermore modern
pacemakers feature a wide array of algorithms for both rate and rhythm control
in Atrial Fibrillation (AF). Analysis of all AF related diagnostics and activating
the best algorithms in each individual patient might be time-consuming.
Therefore an expert-system, the Therapy Advisor (TA), was developed. During
initial Interrogation the TA automatically analyses all data, indicates which
diagnostics need attention by means of Main Observations (MOs), Detailed Information
Messages (DIMs) and provides Programming Advices (PAs) to optimise pacemaker
therapy.
T-STAR evaluates the AF related messages of the TA. These interim results include
an analysis of the messages given by a computer simulation program of the TA
in 38 patients
Methods: Prospective, multicentre, observational study. Inclusion: Class I/II pacing indication, Registry Consent. Interim analysis: follow-up of 38 patients, appropriateness and clinical relevance of TA messages. The investigators were asked to diagnose and treat patients prior to using the TA.
Results: Including data of
38 patients: 26% male, age: 72.3 ± 8.3, primary indication: SSS 61%.
Average time since implant: 24.5 ± 15.4 months. 6 patients were excluded
due to protocol deviations.
71 messages concerning AF were generated in 16 out of 32 patients.
83% of all messages were considered to be appropriate to the investigators.
In detail:
94% of MOs, 87% of DIMs and 63% of PAs.
In one case the TA gave a programming advice the investigator had not thought
of.
The feedback of the investigators will be used to refine future upgrades.
Conclusion: These results
confirm the clinical relevance of the Therapy
Advisor for optimising the pacemaker AF therapy.
XI International Symposium on Progress in Clinical Pacing, 2004, p. 20
Tolerability of pacing algorithms for
atrial fibrillation (af) prevention
D. Cervellati, N. Propato, M. Mambelli(1), F. Pignatti(2),
P. Fontana(3), S. Orazi (4), P. Pepi
(5), M. Trombetti (6)
U.O. Cardiologia, Osp. Civile, Imola; (1)U.O. Cardiologia, Osp. Civile, Cesena;
(2)U.O. Cardiologia, Osp. Civile, Carpi; (3)U.O. Cardiologia, Osp. Civile, Sassuolo;
(4)Serv. Cardiologia, Osp. Civile di Rieti; (5)Div. Cardiologia, Osp. Carlo
Poma, Mantova; (6)Vitatron Medical Italia, Bologna
Pacing algorithms designed to prevent AF may induce atrial overdrive and consequently a higher heart rate that could be not tolerated by the patient (Pt).
Aim of the study: The SEPT (Side Effects of Pacing Therapies) is a prospective, randomized, cross-over study to evaluate the tolerability of specific algorithms for AF prevention, with respect to conventional DDD(R) stimulation.
Methods: 32 Pts with
SSS brady-tachy were enrolled and implanted with Vitatron Prevent AF or Selection
9000 pacemaker (pm) equipped with specific AF algorithms and Holter functions.
Two weeks after implant Pts were randomised: DDD(R); DDD(R)+Pace Conditioning
(PC) to continuously overdrive the atrium, DDD(R)+ premature atrial contraction
related algorithms (Alg), 1
month each. The maximum pacing rate related to AF prevention algorithms was
limited to 100 bpm by programmation. Rate responsive function was activated
according to brady indication for pacing and kept constant for the whole study
period. At follow-up Pts were evaluated during exercise and through the Specific
Symptom Scale referring to the previous month.
Symptoms due to arrhythmias were excluded by comparing the diary of the Pt with
data stored by the pm.
Results: 24 Pts were symptoms free at each randomisation phase and during exercise. Soon after programmation 2 Pt requested an early cross-over, when atrial overdrive was programmed ON, without AF episodes. Six Pts did not perform the exercise stress test due to non cardiac reasons. The mean pacing % was 64% in DDD(R), 95% in DDD(R)+PC, 81% in DDD(R)+Alg.
Conclusions: all pacing
algorithms are well tolerated by Pts both during exercise
and in normal life, excepted continuous atrial overdrive in 2 cases.
XI International Symposium on Progress in Clinical Pacing, 2004, p. 39
CAN WE SELECT PATIENTS WITH SSS AND ATRIAL
FIBRILLATION RESPONDER TO PACING? THE RESULTS OF THE RANDOMIZED AND PROSPECTIVE
EPASS PILOT STUDY
R. Verlato, F. Zanon*, E. Bertaglia^, P. Turrini, M.S. Baccillieri, E. Baracca*,
P. Pascotto^, D.
Venturini§, G. Corbucci§.
Cardiology Department - General Hospital, Camposampiero, Italy, *Cardiology
Department
- General Hospital, Rovigo, Italy, Cardiology Department - ^General Hospital,
Mirano,
Italy, §Vitatron, Bologna, Italy
The selection of patients (Pts) responder to algorithms and specific sites of pacing for atrial fibrillation (AF) prevention is not clear yet.
Aim of the study is to compare pacing sites in Pts with SSS and history of AF, in relation with the electrophysiologic study (EP).
Methods: 36 Pts (72±7
years old, 11M, 25F) were submitted to EP before randomization of pacing site
and algorithms. The ERP from right atrial appendage (RAA) was measured at 600
ms cycle. A2 duration was measured at RAA 10 ms above the atrial ERP. The difference
between basal and incremental conduction times (CT) was measured between the
RAA and the coronary
sinus os (CSos)(delta-CTos): basal CT was the time between A1 at RAA and A1
at CSos, incremental CT was the time between A2 at RAA and A2 at CSos 10 ms
above the atrial ERP. Vulnerability index was calculated as ERP/A2. Pts with
A2>100ms, ERP/A2<2,2, P wave duration >110ms and delta-CTos>60ms
were group1 (severe conduction delay). The remaining Pts
were group2. The number of AF episodes lasting more than 7 minutes (AFEp) stored
by the pacemaker (Selection 9000, Vitatron), was collected at 2 follow-ups of
3 months each.
Results: 23 Pts (64%)
had A2>100 ms (147±39); 13 Pts (36%) had delta- CTos > 60 ms (79±10);
18 Pts (50%) had ERP/A2 ratio <2,2 (1,69±0,39).
Pts of group1 implanted in the IAS showed a trend of AF-Ep/day reduction when
continuously paced (p=0,06) with respect to standard DDD programming, while
Pts of group1 implanted in the RAA showed an increased AFEp/ day (p=0,046) when
continuously paced. Pts of group 2 did not show statistically significant differences
between DDD and continuous pacing.
Conclusion: The study supports the hypothesis that Pts with severe conduction delay may benefit of continuous pacing in the IAS, but not in the RAA.
XI International Symposium on Progress in Clinical Pacing, 2004, p. 38
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