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(Circulation. 1999;100:1203-1208.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Catheter Ablation of Paroxysmal Atrial Fibrillation Using a 3D Mapping System
From the Cardiology Department, Hospital S. Raffaele, Milan, Italy (C.P., F.L., G.V., M.L.L., M.R., A.C., S.C.); the Cardiology Department, University of Messina, Messina, Italy (G.O., M.P.C.); the Cardiovascular System Laboratory, Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel (S.S., S.A.B.-H.); and the Allgemeines Krankenhaus St Georg, II Medizinische Abteilung, Hamburg, Germany (R.C.).
Correspondence to Carlo Pappone, MD, Divisione di Cardiologia, Ospedale S Raffaele, Via Olgettina, 60, 20132 Milano, Italy.
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Abstract |
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 Top Abstract IntroductionMethodsResultsDiscussionReferences |
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Background—We treated paroxysmal recurrent atrial fibrillation (AF) with radiofrequency (RF) catheter ablation by creating long linear lesions in the atria. To achieve line continuity, a 3D electroanatomic nonfluoroscopic mapping system was used.
Methods and Results—In 27 patients with recurrent AF, a catheter incorporating a passive magnetic field sensor was navigated in both atria to construct a 3D activation map. RF energy was delivered to create continuous linear lesions: 3 lines (intercaval, isthmic, and anteroseptal) in the right atrium and a long line encircling the pulmonary veins in the left atrium. After RF application, the atria were remapped to validate completeness of the block lines, demonstrated by late activation of the areas circumscribed by the lines. The mean procedure duration was 312±103 minutes (range, 187 to 495), with mean fluoroscopy time of 107±44 minutes (range, 32 to 185 minutes). No acute complications occurred, but 1 patient experienced early prolonged sinus pauses and received a pacemaker. During the first day, 17 patients (63%) had AF episodes, but at discharge, 25 patients were in sinus rhythm. After a follow-up of 6.0 to 15.3 months (average, 10.5±3.0 months), 16 patients are asymptomatic, 3 have an almost complete disappearance of symptoms, 1 patient is improved, and 7 patients have their AF attacks unchanged.
Conclusions—Paroxysmal recurrent drug-refractory AF can be treated by RF catheter ablation. Creation of long continuous linear lesions necessary to compartmentalize the atria is facilitated by a nonfluoroscopic electroanatomic mapping system.
Key Words: catheter ablation • fibrillation • mapping
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Atrial fibrillation (AF) is the most common tachyarrhythmia,1 its prevalence being
5% in people >65 years old.2 Current therapeutic
strategies include antiarrhythmic drugs and electrical cardioversion.
More recently, alternative treatments, such as catheter ablation or
modulation of the atrioventricular (AV)
node,3 implantation of an atrial
defibrillator,4 and surgical procedures5 6
have been proposed. Very recently, the possibility of treating AF by means of radiofrequency (RF) catheter ablation has been reported.7 8 The nature of AF makes a transcatheter approach difficult, because lesions generated with this technique are small and apparently inadequate to modify the substrate of this arrhythmia
The present study was designed to test the hypothesis that a nonfluoroscopic electroanatomic mapping system might assist in the creation and verification of linear transcatheter RF lesions in patients with paroxysmal AF.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Patients
We studied 27 patients with symptomatic, recurrent, drug-refractory paroxysmal AF lasting for
1 year. There were 20 men
and 7 women, with a mean age of 45.8±11.6 years (range, 27 to 67
years). Only 2 patients had structural heart disease, 1 hypertrophic
cardiomyopathy, and 1 mitral valve prolapse.
Correctable causes of AF, such as thyroid disease, had been excluded,
and all patients were nonresponders to antiarrhythmic drugs (average of
3.6±1.5 drugs per patient). Amiodarone had been used in 9
patients but at the time of the study had been withdrawn in each
patient for at least 3 months. Before inclusion in the protocol, every
patient underwent extensive observation throughout 1 month. Two 24-hour
Holter recordings were performed to obtain documentation of
episodes of AF and to demonstrate the correspondence of the
arrhythmia with symptoms. Patients were also provided with an
event report to record every episode of AF with particular regard
to its duration. Inclusion in the study required, over 3 weeks, a
minimum of 3 episodes per week, with duration >1 hour
(Table
).
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Electrophysiological Study
The study protocol was approved by the ethics committee of the
San Raffaele Hospital; patients were informed about the experimental
nature of the procedure and its related risks and gave written informed
consent. Antiarrhythmic drugs were discontinued for 5 half-lives. The
electrophysiological study was performed in
accordance with the standard technique. Quadripolar 6F catheters were
placed in the coronary sinus (CS) and in the right
ventricular apex. A pigtail catheter was placed in the
ascending aorta to obtain continuous arterial pressure
monitoring. A reference catheter (Ref-Star, Cordis-Webster) was placed
on the back of the patient, and a deflectable-tip catheter (Navi-Star,
Cordis-Webster) was used for mapping and ablation. Left atrial (LA)
catheterization was obtained by a transseptal route
with a standard Brockenbrough needle and a long sheath.
Mapping System
The nonfluoroscopic navigation and mapping system has already
been described.9 10 11 The system is composed of a miniature
passive magnetic field sensor incorporated into a standard
electrophysiological catheter, an external
ultralow magnetic field emitter (location pad), and a processing unit
(Carto, Biosense). Ultralow magnetic fields are emitted from the
location pad; the spatial and temporal characteristics of the sensed
magnetic fields contain the information needed to solve a set of
overdetermined algebraic equations yielding the location (x,
y, and z) and orientation (roll, yaw, and pitch)
of the catheter tip. The resolution of the location capabilities of the
system was quantified previously and shown to be <1 mm for both
in vitro and in vivo studies.12 This information
allows tracking of the tip of the mapping catheter while it is deployed
within the heart.
Mapping Process
The mapping and ablation procedures were performed during
continuous CS pacing at a rate of 100 bpm. The mapping catheter was
introduced into the atria under fluoroscopic guidance, and its location
was recorded relative to the location of the fixed reference
catheter. By moving the catheter inside the heart, the mapping system
continuously analyzed its location and orientation and
presented it to the user on the monitor of a graphic
workstation, thereby allowing navigation without the use of
fluoroscopy.
The mapping procedure was based on dragging the catheter over the endocardium and sequentially acquiring the location of its tip together with its electrogram while in contact with the endocardium. 3D chamber geometry was reconstructed in real time by use of the set of location points sampled from the endocardium. The local activation time (LAT) at each site was determined as the time interval between the pacing artifact and the steepest negative intrinsic deflection in the unipolar electrogram recorded from the catheter tip. The stability of the catheter-to-endocardium contact was evaluated on the basis of (1) end-diastolic stability (the distance in millimeters between 2 successive endocardial locations) and (2) LAT stability (the interval in milliseconds between 2 successive LATs). A point was added to the map only if the end-diastolic stability was <2 mm and the LAT stability was <2 ms.10 12 For each atrial chamber, a number of points ranging from 50 to 110 was taken (average, 81±14).
On the basis of the various LATs, a map was constructed showing the
activation sequence resulting from the time of activation of different
zones in a cardiac chamber. The activation map was color-coded (red
indicating the earliest and purple the latest activation) and
superimposed on the 3D chamber geometry (Figure 1).
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RF Application
RF energy was delivered via the distal electrode of the
NAVI-STAR catheter. RF power was titrated to achieve a temperature of
65°C in the right atrium (RA) or 55°C in the LA. A maximum power of
60 W was used for 60 to 120 seconds, with the target of reducing the
amplitude of the local electrogram by 75% of the initial value. Any
linear lesion was composed of a series of focal lesions, whose location
was tagged on the map (Figures 2 through 4).
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In the RA, 3 linear lesions were designed: (1) posterior intercaval;
(2) medial isthmus, between the IVC and the tricuspid annulus; and (3)
septal, between the superior aspect of the intercaval line and the
posteroseptal tricuspid annulus. The anteroseptal line was
intentionally left incomplete in the upper part to avoid isolation of
the sinus node. In the LA, 1 long lesion was generated, encircling the
pulmonary veins and connected to the mitral annulus on 2
sides (Figure 2B
).
After the planned lines of block had been created, the atria were
remapped, and the preablation and postablation activation maps were
compared. The result was considered satisfactory whenever there was no
evident impulse propagation across the line of block but the
depolarization wave front reached the region beyond the block over a
different route. An incomplete block was revealed by impulse
propagation through the line, shown by an identical color in points
lying at the same level on the 2 sides of the line; in such a case,
further RF pulses were given to complete the line of block. We assumed
arbitrarily that a line of block was "complete" when there was a
difference in activation time by 60 ms between 2 points at the same
level at the 2 sides of a line separated from each other by a distance
of <1 cm.
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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The biatrial approach was used in 14 patients, isolated LA ablation in 5 patients, and isolated RA ablation in 8. The mean procedure duration (±SD) was 312±103 minutes (range, 187 to 495 minutes), with mean fluoroscopy time of 107±44 minutes (range, 32 to 185 minutes). In the last 13 cases, fluoroscopy time was significantly reduced compared with the earlier ones (70±24 versus 144±22 minutes, P<0.01; Student's t test for unpaired data). Fluoroscopy was used only to insert the catheters, to identify the anatomic landmarks, and to perform the transseptal approach, whereas the collection of location points was achieved mainly without fluoroscopy.
The average number of RF pulses was 98±21 for LA ablation and 61±15 for RA ablation. In 21 patients, postablation verification demonstrated the completeness of the lines of block, whereas in 6 patients, no such demonstration was obtained despite several additional RF applications in sites corresponding to possible "holes."
The post-RF changes in activation maps are evident from Figures 2, 3, and 4.
Figure 2A shows progressive
color transition throughout the atrial walls: points close to each
other reflect either the same color or a small color difference,
corresponding to activation 10 to 20 ms apart, whereas in Figure 2C, the lines of block, indicated by red tags, separate zones
with totally different colors, ie, activation >60 ms apart. This means
that the activation wave front does not cross the line. The
postablation remapping (Figure 2C) demonstrates that the area
encircled by the line of block has late activation colors (dark blue to
purple), the expression of late arrival of the activation wave front to
this area. The same phenomenon is evident in Figures 3 and 4. Figure 3 shows an inferomedial view of the RA; 3A
reflects the preablation map, 3B the designed line of block, and 3C the
postablation map. Again, the area circumscribed by the lines of block
has late activation colors, whereas it had mostly early activation
colors in the preablation map. This demonstrates that the lines of
block prevent a normal intra-atrial impulse conduction, resulting in
late activation of the RA free wall.
Figure 4 shows the results of linear lesions deployed in
an RA (the posterior intercaval line). Panel A depicts the preablation
map and B and C postablation maps. In the first post-RF map (B), the
line of block is incomplete, as suggested by the presence, in the lower
half of the line, of areas reflecting the same color (green) on the 2
sides of the line. The map shown in C, obtained after further RF
application to the critical site, suggests that the line of lesion is
complete (no indistinguishable colors at matched points on the 2 sides
of the line).
Effects of the Ablation Procedure on AF
Catheter ablation resulted in relevant reduction of AF attacks in
most patients. After a follow-up of 6.0 to 15.3 months (average,
10.5±3.0 months), 16 of 27 treated patients are
asymptomatic (4 on drugs), 3 have almost complete
disappearance of symptoms (all 3 on drugs), 1 patient is improved in
terms of number and duration of episodes, and the remaining 7 show no
change in their AF episodes (Table).
No complications occurred during the procedures, but 1 patient had complications in the early follow-up. Twenty-four hours after the procedure, transthoracic and transesophageal echocardiograms were unchanged in 24 patients, whereas in 3, a slight pericardial effusion was demonstrated. This was not associated with symptoms or signs of pericarditis and disappeared at the 1-week control without any treatment. Evaluation of mechanical atrial function by means of Doppler mitral and tricuspid flow analysis did not demonstrate any change after the ablation procedure: the E/A transmitral flow velocity ratio was 1.37±0.5 versus 1.37±0.47 before and after catheter ablation, respectively.
At the end of the ablation session, all patients were in sinus rhythm, as at the beginning of the procedure, but 17 patients (63%) suffered from AF during the 24 hours after the procedure, with episodes ranging from a few minutes to several hours. A 67-year-old woman experienced episodes of AF followed by sinus pauses as long as 6 seconds; she underwent implantation of a DDD pacemaker. After this patient, we started leaving the anteroseptal line in the RA incomplete, in an attempt to prevent sinus node dysfunction. Analysis of Holter recordings did not reveal any sign of sinus node disease in the last 24 patients.
Predischarge Holter recording showed atrial extrasystoles in all patients, paroxysmal atrial flutter with a duration of 30 minutes in 1 patient, and brief AF episodes in 7 patients.
At 1 week from discharge, 19 patients were free of AF (disappearance of symptoms, no Holter evidence of the arrhythmia). Seven of them had frequent atrial extrasystoles at Holter monitoring, and 1 patient experienced an ECG-documented episode of atrial tachycardia at a rate of 140 bpm. The remaining 8 patients had recurrent episodes of AF. One month after the procedure, 16 patients (4 on drugs) were asymptomatic and had no AF. Seven patients had isolated episodes of AF (no more than 2 episodes during 1 month), and the remaining 4 had no change in symptoms.
Three months after ablation, 16 patients were free of recurrence, whereas 3 patients had isolated episodes of AF. One patient had recurrence of AF but with fewer and shorter episodes than before. In 7 patients (26%), including 5 of 6 in whom no complete ablation lines had been obtained, AF episodes were unchanged. At 6 months, no change occurred in comparison with the 3-month follow-up.
The procedure was successful in eliminating or significantly reducing AF in 12 of 14 patients (85%) with the biatrial approach, in 3 of 5 patients (60%) who underwent isolated LA ablation, and in 4 of 8 patients (50%) in whom only RA ablation was performed.
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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RF catheter ablation appears promising in the treatment of paroxysmal AF. Our data reveal that 19 patients (70%) were treated successfully (16 totally asymptomatic, 3 with a dramatic reduction of symptoms) and 1 patient improved, whereas in 7 patients (21%), the arrhythmia was unchanged. Although the follow-up is limited and some recurrences could have been undetected by Holter recordings and/or unrecognized by the patients, all of them were so highly symptomatic that it is not difficult to assume that in the successful group the arrhythmia was either eliminated or significantly reduced.
Rationale for Ablation Techniques in AF
Ablation treatment for AF is based on the hypothesis that without
a relatively large atrial mass in which to operate, multiple reentrant
wavelets sufficient in number to perpetuate AF cannot coexist. If so,
AF may be cured by dividing the atria into several areas electrically
isolated from each other. This procedure was originally applied by Cox
et al,5 who introduced the maze operation. The favorable
results achieved by surgeons led to preliminary laboratory
investigation of RF catheter ablation of AF in animals and subsequent
application in humans.7 8 13 14 15
Target of Ablation in AF
The present study, as well as previous reports, suggests
that catheter ablation is suitable for the treatment of AF. The target
of ablation and the number of linear lesions to be created, however,
are still debatable. A biatrial approach appears preferable to either
isolated LA or RA ablation, because the success rate was 85% in
patients with biatrial ablation, whereas it was only 50% to 60% of
patients in whom 1 single atrium had been approached. The number of
patients in each group, however, is too small to permit statistical
analysis. In a study by Haïssaguerre,7
biatrial ablation was also associated with a higher success rate
than RA ablation alone.
A relevant technical problem in AF ablation concerns the
"completeness" of ablation lines, because incomplete electrical
separation between contiguous areas is likely to permit impulse
conduction sufficient for propagation of fibrillatory wave fronts. With
current ablation technology, creation of complete ablation lines is
difficult: it is hard to assess the continuity of a long linear lesion
just by looking at the movements of the catheter tip on the
fluoroscopic screen. In contrast, the technique based on 3D
electroanatomic mapping permits us to evaluate the completeness of the
linear lesion, because each lesional point is tagged on the map, so
that interruptions in line continuity may be easily identified, and
further RF applications in critical regions may succeed in completing
the lines (Figure 4).
It was not possible in every case, however, to achieve complete lines of block resulting in significant change of the activation map: in 6 patients, no complete lines were obtained despite additional RF applications. In these patients, the possible holes were filled with further lesions, and an uninterrupted series of tags was achieved, but no satisfactory change in activation resulted. Identification of line continuity relies on a critical change in activation rather than being expressed as an uninterrupted series of tags.
"Completeness" of the line of block, in our definition, means
a delay of conduction 60 ms between points close to each other,
whereas "incompleteness" of block indicates a lesser degree of
conduction delay or normal conduction. Completeness of the line judged
by change in activation map does not imply total absence of conduction
across the line of block but rather merely indicates that the route of
propagation of the impulse front is different with respect to the
previous condition. Theoretically, therefore, a circulating wave front
could still traverse the line of block, despite a significant
postablation change of the activation map, which might account for some
recurrences of the arrhythmia after achievement of
complete lines of block.
Postablation AF
The incidence of AF on the day after the ablation procedure
was very high in this study. It is difficult to assess the mechanism
leading to acute postablation AF, but we can assume that the phenomenon
is similar to that described after the maze operation. In 47% of
patients undergoing the maze surgical procedure, AF developed in the
early postoperative period, even though in the follow-up, 98% of
patients were free of recurrence, and 89% of them did not take
any antiarrhythmic medication. Cox et al6 explained such a
finding by assuming a postoperative shortening of the atrial refractory
period, allowing initiation and maintenance of AF despite the
absence of atrial areas large enough to permit the arrhythmia
under normal conditions. This is because shortening of the refractory
period significantly decreases the critical mass necessary for reentry.
It is possible that in our patients, the edema associated with the
large number of endocardial lesions shortened the atrial refractory
period in such a way that AF occurred in the early postprocedure time.
This is not the only possible explanation for postoperative AF;
enhancement of ectopic automaticity could also play a role.
Limitations of the Study
We treated only patients with paroxysmal AF and without
significant anatomic atrial involvement. The present results thus
cannot be extended to patients with chronic AF and diseased atria.
Moreover, the technique is based on mapping and RF delivery during
constant atrial pacing from the CS, which facilitates comparison of
preablation and postablation maps. Treatment of patients with chronic
AF requires a different approach, because atrial pacing is impossible,
so that preablation and postablation maps cannot be compared in the
manner described here.
The procedure is long because mapping and remapping of the atria require acquisition of a large number of points. Although in our limited series we had no complications related to transseptal catheterization and long-lasting catheter manipulation in the left heart, such an approach should be considered to carry some risk of thromboembolism. Finally, the long-term outcome of the procedure is unknown, and theoretically AF could recur if recovery of conduction in some areas again allows the coexistence of multiple reentrant wavelets.
Conclusions
Paroxysmal recurrent drug-refractory AF can be treated by RF
catheter. Creation of the long continuous linear lesions necessary to
compartmentalize the atria is facilitated by the use of a
nonfluoroscopic electroanatomic mapping system that permits accurate
selection of the target sites for RF application as well as evaluation
of the completeness of the lesion. The procedure described here is
time-consuming and carries some risks. Thus, such an approach should be
considered only for patients disabled by their arrhythmia.
Further investigation is needed to define the possibility of applying
the same procedure to patients with chronic AF.
Received July 27, 1998; revision received June 14, 1999; accepted June 17, 1999.
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