1
7 ABSTRACTS – Oral JACC Febmary 1997 =41) and saphenous vein graft (N = 14) lesions using serial QCA methods (CMS-GFT). Reference segments just proximal and distal to the gamma proba margins were identified; the minimal lumen diameter (MLD) within the axial stent length (“within stent”) and between the reference segments (“within segment”) were uaed to determine residual and follow-up % stenoais. QCA results are summarized (Table).tP <0.0001 vs. stent. Reference, mm 2.83& 0.52 3.08+0.64 3.00+ 0.62 MLD,stentmm 1.o6+0.46 2.85& 0,73 2.12+ 0.88 segment 2.43+ 0.68t 1.72+ 0.69t Stenosis, stent“A 61.9+ 16.4 5.6+22.5 28.0+ 29,10 segment 21.114.5* 41,6+ 21.2t rhe “within stent” restenosis rate was 25% and the “within segment” restenosie rate was p We corrc/ude that the “within stent” restenoeis rate is substantially lower than the “within segment” rate; and 2) indices reflecting Iuminal changes within the entire coronaty segment may provide a better angiographic surrogate for clinical restenosis. u 720 Advances in Defibrillatiordlmplantable Antiarrhythmic Devices Monday,March17, 1997, 4:00 p.m.–5:3Op.m. AnaheimMarriott,SouthHall El 7201 ArrhythmiaClaaaificationwiththeFirat Dual-Chamber ImplantableCardiovefterDefibrillator W. Jung, B. Eemailzadeh 1, R. Nitzsche, C. Wolpert, B. Ludetftz for the Defender 9001 Investigator Group. DepaHrnerrtof Cardiology, Urfiversityof Bonn, Bonn, GermanH 1Department of Cardiovascular Surgery University of Bonn, Bonn, Germany Current implantable eerdioverter defibrillator (lCDs) usethetachycardia rate with or without additional detection criteria such as rate stability and sudden onaet for arrhythmia discrimination. The first dual-chamber ICD (Defender 9001, ELA Medical) uses a new arrhythmia detection algorithm based on following criteria: rate, RR interval stability, atrioventricular (AV) relation analyeis and atrial or ventricular acceleration in case of 1:1 AV relation. 42 patients with refractory ventricular tachyarrhyfhmias received the Defender syetem. Resuffa: During follow-up of 5.6 + 5.7 months (range of 1-16 months), 208 spontaneous arrhythmia episodes were recorded by the internal Helter function and classified by the device as ventricular tachycerdia (VT, n = 87), ventricular fibrillation (VF, n = 52), or supreventricular origin (SVT, n = 69). Helter data were reviewed by independent investigators who judged the classification appropriate in all but 4 episodes. These 4 episodes were classified by the device as VT, but were identified by the investigators as atrial flutter with two to one conduction and a stable ventricular rate of 150 bpm. All eustained VT/VF apisodes were successfully terminated either with antitechycerdia pacing or with the ficst shock therapy. Two non device related deaths occurred. At the end of follow-up, arrhythmia detection was programmed in a dual-chamber mode in 30 patients, in a monitor only mode without VT therapy in 9 patients, and in a ventricular mode in 1 patient due to an atrial lead dislodgement. Cone/uaiona:l. Dual-chamber ICDsprovideaquivalent efficaW and safety rates compared to single-chamber ICDS. 2. This new detection algorithm significantly improves arrhythmia diagnosis accuracy. In a dual-chamber ICD, this algorithm is highly effective in reducing the number of inappropriate shocks without sacrifying the delivey of appropriate shocks, 4:15 n 7202 ComparativeSurvivalofMADIT-Eligible but NoninduciblePatienta J.P. Daubed, S.L. Higgins, W. Zareba, D.J. Wilber. The University of Rocheater, RochesteL NY USA, University of Chicago, Chicago //, USA We evaluated the survival of pts screened for MADIT (Multicenter Automatic Defibrillator Implantation Trial) but found noninducible (Nl) at eledrophysiol- ogy study, and therefore excluded from randomization. This group of NI pts met all other MADIT eligibility criteria which included age 25-SO, prior Ml, ejection fraction <0.343,and asymptomatic nonaustained VT (NSVT). All pts screened at 3 MADITclinical centers who were NI (n =85) were followed until MADIT termination (4/1/96). The NI group was compared (see Table below) to the pts who were inducible, nonsuppressible and who were randomized to mnventional (CONV) treatment in MADIT (amiodarone 74%, Class 1Aagent 11%). GrOUD. N 8 1 9 N + + 0.035 F/Udays 592+ 399 755555 0.025 Totaldeaths 7 (8%) 39 (39”/.) <0.001 1yr K-Msurvival 98% 77% <0.001 By multivariate Cox model analysis risk of death was 4.24 times greater for inducible status (CONV group) (confidence intervals 1.75-10.26, p= 0.001). Cone/usiona.’ This study suggests that inducibiiity is associated with significantly higher risk of death in pts with ejection fraction <0.36, NSVT and prior ML 4:30 720-3 EmpiricVerauaTeatedAntitschycardiaPacing: ResultaFroma ProspectiveStudyIncluding2W Patienta A. Schaumann, F.von zur Muehlen, B.-D. Gonska, H. Kreuzer. University of Goettingen, Dept of Cardiolog& Goeftingen, Germany Antitachyeerdia pacing (ATP) is a programmable feature in impianteble car- diovetier defibrillator (lCD). It was evaluated if ATP is effective for the termination of ventricular tachycardias (VT) even if ATP could not be tested at the predischarge examination for the successful termination of induced VT. The results were compared to patients with tested ATP. Of 200 patients after ICD implantation only 54 pts were inducible for VT which could be terminated by ATP attempts at predischarge. In 146 patients ATP was programmed empirically although its efficacy could not be tested due to non-inducible VT. The underlying heart diaeaae and left ventricular function was comparable in both groups. ATP was programmed as an autodecremental ramp with 61% of the tachycardia cycle length and up to 3 sequences with 8 to 10 stimuli. Spontaneous VT during the follow-up of 20.4 (S-55 months) rnontha were analyzed by the stored eieefrograms and the therapy histoty recorded by the ICD. In the group of tested patients 95% of 34319spontaneous VT were terminated with ATP.ATP had no effect on the tachycerdia in 2.4% and an acceleration was noted in 2.4% with a ahock terminating the ventricular tachycerdia. Empirically programmed ATP terminated 90% of 1346 spontaneous VT. The acceleration rate was 5%. We conclude that empiric programmed ATP is highly effective (90%) in terminating spontaneous ventricular tachycardias. The risk of acceleration is still low (5%) even though it is higher when compared to tested ATP. ATP should be programmed to all patients empirically regardless of pre-discharge testing. 4:45 -l ~he~~TR,~Autom Atria, DefibrillationSystem:ThreaholdStabilityandShock Safety W. Jung, P.G. Kirchhoff 1,’C.-P. LSU2,H.-F.Tse2, B. Li.ideritzfor the Metrtx System Clinical Investigational Group. Dept. of Cardiology University of Bonn, Bonn, Germany,1Dept. of Cardiovascular Surgery University of Bonn, Bonn, GermanK 2 University of Hong Kong, Hong Kong Patients (pts) implanted with the Metrix 3000 Automatic Atrial Defibrillator System were evaluated for chronic lead stability and shock safety. All pts receivedthree leads at implant: an aetivefixation lead with a8cm defibrillation coil in the tight atrium, a passive 6 cm defibrillation coil in the diatal coronary sinus and a tined bipolar lead in the right ventricular apex. Lead stability was assessed at pre-discharge, l-month and 3-months poet-implant. EDw was measured using a modified up-down-up algorithm at implant and at the 3-month follow-up visit. At these visits ahock safety was evaluated by assessment of proarrhythmia post-shock and by telemetric marking of R- waves. 15 pts with a age of 59 + 10 years received the METRIX system. Results: The pts have been followed for a mean of 112 days (range of 20-297). All pts underwent pre-discharge testing, and 6 pte had the 3- month follow-up vieit. There was no early or late dielodgment of any lead. Implant ED50was meaeured to be 196 + 46 V (1.4 * 0.7 J). Chronic (3- month) EDWIwae measured to be 205 + 67 V (1.6 + 1.0 J). There was no statistical difference between the acute and chronic ED50meaaurements. No proarrhythmic events were obsetved from 1061 shocks (717 therapeutic and 384 induction) delivered to the pte. A total of 21,061 R-waveewere evaluated: 8,073 R-wavee were marked ae suitable for shock delivery of which 3,931

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Page 1: Abstract

7 ABSTRACTS – Oral JACC Febmary 1997

=41) and saphenous vein graft (N = 14) lesions using serial QCA methods(CMS-GFT). Reference segments just proximal and distal to the gammaproba margins were identified; the minimal lumen diameter (MLD) withinthe axial stent length (“within stent”) and between the reference segments(“within segment”) were uaed to determine residual and follow-up % stenoais.QCA results are summarized (Table). tP <0.0001 vs. stent.

Reference,mm 2.83& 0.52 3.08+0.64 3.00+ 0.62MLD,stentmm 1.o6+0.46 2.85& 0,73 2.12+ 0.88segment 2.43+ 0.68t 1.72+ 0.69tStenosis,stent“A 61.9+ 16.4 5.6+22.5 28.0+ 29,10segment 21.1● 14.5* 41,6+ 21.2t

rhe “within stent” restenosis rate was 25% and the “within segment”restenosie rate was p We corrc/ude that the “within stent”restenoeis rate is substantially lower than the “within segment” rate; and 2)indices reflecting Iuminal changes within the entire coronaty segment mayprovide a better angiographic surrogate for clinical restenosis.

u720 Advances in DefibrillatiordlmplantableAntiarrhythmic Devices

Monday,March 17, 1997, 4:00 p.m.–5:3Op.m.AnaheimMarriott,SouthHall

El7201 ArrhythmiaClaaaificationwiththe FiratDual-ChamberImplantableCardiovefterDefibrillator

W. Jung, B. Eemailzadeh 1, R. Nitzsche, C. Wolpert, B. Ludetftz for theDefender 9001 Investigator Group. DepaHrnerrtof Cardiology, UrfiversityofBonn, Bonn, GermanH 1Department of Cardiovascular Surgery Universityof Bonn, Bonn, Germany

Current implantable eerdioverter defibrillator (lCDs) usethetachycardia ratewith or without additional detection criteria such as rate stability and suddenonaet for arrhythmia discrimination. The first dual-chamber ICD (Defender9001, ELA Medical) uses a new arrhythmia detection algorithm based on

following criteria: rate, RR interval stability, atrioventricular (AV) relationanalyeis and atrial or ventricular acceleration in case of 1:1 AV relation. 42patients with refractory ventricular tachyarrhyfhmias received the Defendersyetem.

Resuffa: During follow-up of 5.6 + 5.7 months (range of 1-16 months),208 spontaneous arrhythmia episodes were recorded by the internal Helterfunction and classified by the device as ventricular tachycerdia (VT, n =87), ventricular fibrillation (VF, n = 52), or supreventricular origin (SVT, n= 69). Helter data were reviewed by independent investigators who judgedthe classification appropriate in all but 4 episodes. These 4 episodes wereclassified by the device as VT, but were identified by the investigators asatrial flutter with two to one conduction and a stable ventricular rate of150 bpm. All eustained VT/VF apisodes were successfully terminated eitherwith antitechycerdia pacing or with the ficst shock therapy. Two non devicerelated deaths occurred. At the end of follow-up, arrhythmia detection wasprogrammed in a dual-chamber mode in 30 patients, in a monitor only modewithout VT therapy in 9 patients, and in a ventricular mode in 1 patient dueto an atrial lead dislodgement.

Cone/uaiona:l. Dual-chamber ICDsprovideaquivalent efficaW and safetyrates compared to single-chamber ICDS. 2. This new detection algorithmsignificantly improves arrhythmia diagnosis accuracy. In a dual-chamberICD, this algorithm is highly effective in reducing the number of inappropriateshocks without sacrifying the delivey of appropriate shocks,

4:15

n7202 ComparativeSurvivalof MADIT-EligiblebutNoninduciblePatienta

J.P. Daubed, S.L. Higgins, W. Zareba, D.J. Wilber. The University ofRocheater, RochesteL NY USA, University of Chicago, Chicago //, USA

We evaluated the survival of pts screened for MADIT (Multicenter AutomaticDefibrillator Implantation Trial) but found noninducible (Nl) at eledrophysiol-ogy study, and therefore excluded from randomization. This group of NI ptsmet all other MADIT eligibility criteria which included age 25-SO, prior Ml,ejection fraction <0.343,and asymptomatic nonaustained VT (NSVT). All ptsscreened at 3 MADITclinical centers who were NI (n =85) were followed untilMADIT termination (4/1/96). The NI group was compared (see Table below)

to the pts who were inducible, nonsuppressible and who were randomized tomnventional (CONV) treatment in MADIT (amiodarone 74%, Class 1Aagent11%).

GrOUD. N

81 9 N

+ + 0.035F/Udays 592+ 399 755● 555 0.025Totaldeaths 7 (8%) 39 (39”/.) <0.0011yr K-Msurvival 98% 77% <0.001

By multivariate Cox model analysis risk of death was 4.24 times greaterfor inducible status (CONV group) (confidence intervals 1.75-10.26, p =0.001). Cone/usiona.’This study suggests that inducibiiity is associated withsignificantly higher risk of death in pts with ejection fraction <0.36, NSVTand prior ML

4:30

720-3 EmpiricVerauaTeatedAntitschycardiaPacing:ResultaFroma ProspectiveStudyIncluding2WPatienta

A. Schaumann, F.von zur Muehlen, B.-D. Gonska, H. Kreuzer. University ofGoettingen, Dept of Cardiolog& Goeftingen, Germany

Antitachyeerdia pacing (ATP) is a programmable feature in impianteble car-diovetier defibrillator (lCD). It was evaluated if ATP is effective for thetermination of ventricular tachycardias (VT) even if ATP could not be testedat the predischarge examination for the successful termination of inducedVT.The results were compared to patients with tested ATP.

Of 200 patients after ICD implantation only 54 pts were inducible forVT which could be terminated by ATP attempts at predischarge. In 146patients ATP was programmed empirically although its efficacy could notbe tested due to non-inducible VT. The underlying heart diaeaae and leftventricular function was comparable in both groups. ATP was programmedas an autodecremental ramp with 61% of the tachycardia cycle length andup to 3 sequences with 8 to 10 stimuli. Spontaneous VT during the follow-upof 20.4 (S-55 months) rnontha were analyzed by the stored eieefrogramsand the therapy histoty recorded by the ICD. In the group of tested patients95% of 34319spontaneous VT were terminated with ATP.ATP had no effecton the tachycerdia in 2.4% and an acceleration was noted in 2.4% witha ahock terminating the ventricular tachycerdia. Empirically programmedATP terminated 90% of 1346 spontaneous VT. The acceleration rate was5%.

We conclude that empiric programmed ATP is highly effective (90%) interminating spontaneous ventricular tachycardias. The risk of acceleration isstill low (5%) even though it is higher when compared to tested ATP. ATPshould be programmed to all patients empirically regardless of pre-dischargetesting.

4:45

-l ~he~~TR,~Automati~Atria,DefibrillationSystem:ThreaholdStabilityandShockSafety

W. Jung, P.G.Kirchhoff 1,’C.-P.LSU2,H.-F.Tse2, B. Li.ideritz for the MetrtxSystem Clinical Investigational Group. Dept. of Cardiology University ofBonn, Bonn, Germany,1Dept. of Cardiovascular Surgery University ofBonn, Bonn, GermanK 2 University of Hong Kong, Hong Kong

Patients (pts) implanted with the Metrix 3000 Automatic Atrial DefibrillatorSystem were evaluated for chronic lead stability and shock safety. All ptsreceivedthree leads at implant: an aetivefixation lead with a8cm defibrillationcoil in the tight atrium, a passive 6 cm defibrillation coil in the diatal coronarysinus and a tined bipolar lead in the right ventricular apex. Lead stabilitywas assessed at pre-discharge, l-month and 3-months poet-implant. EDwwas measured using a modified up-down-up algorithm at implant and atthe 3-month follow-up visit. At these visits ahock safety was evaluated byassessment of proarrhythmia post-shock and by telemetric marking of R-waves. 15 pts with a age of 59 + 10 years received the METRIX system.

Results: The pts have been followed for a mean of 112 days (rangeof 20-297). All pts underwent pre-discharge testing, and 6 pte had the 3-month follow-up vieit. There was no early or late dielodgment of any lead.Implant ED50was meaeured to be 196 + 46 V (1.4 * 0.7 J). Chronic (3-month) EDWIwae measured to be 205 + 67 V (1.6 + 1.0 J). There was nostatistical difference between the acute and chronic ED50meaaurements. Noproarrhythmic events were obsetved from 1061 shocks (717 therapeutic and384 induction) delivered to the pte.A total of 21,061 R-waveewere evaluated:8,073 R-wavee were marked ae suitable for shock delivery of which 3,931