Europace (2001) 3, 4–9
doi:10.1053/eupc.2000.0137, available online at http://www.idealibrary.com on
SELECTED ORIGINAL ARTICLES
Safety and efficacy of low-energy cardioversion of
500 patients using two different techniques
A. Andraghetti and M. Scalese*
Medical PATH, Milan, Italy
Aim To present some safety and efficacy issues of lowenergy internal cardioversion of chronic atrial fibrillation
from 500 consecutive procedures performed with two different techniques, using either two single-coil catheters, or a
single twin-coil catheter.
Methods and Results Low-energy internal cardioversion
was carried out in 368 patients by means of two defibrillation catheters: the former was positioned in the right atrium
and the latter either in the left pulmonary artery (212
patients), or in the distal coronary sinus (156 patients). In
the remaining 132 patients, a single twin-coil catheter was
positioned with the distal coil either in the pulmonary
artery (75 patients) or in the coronary sinus (57 patients),
while the proximal coil was in the right atrium. The external
defibrillator delivered truncated biphasic shocks (6/6 ms, tilt
50%), with a voltage of 10–400 V. In 283 patients (57%)
external cardioversion had been unsuccessfully tried before
low-energy internal cardioversion. After a total of 1118
shocks, the overall success rate was 92·2% (91·3% with two
catheters and 94·7% with the single catheter); the success
rate was 93·4 and 91·3% with the coronary sinus and the
pulmonary artery approach, respectively. The mean energy
used was 6·53·4 J (voltage: 32045 V); no difference was
Introduction
Atrial fibrillation is the most common cardiac arrhythmia and is responsible for the most hospital admissions[1]. Since atrial fibrillation may induce troublesome
Manuscript submitted 14 April 2000, revised 24 October 2000, and
accepted 26 October 2000.
*For the VascoStim TC Investigators Group. The principal investigators and the institutions where this study was performed are
listed in the Appendix.
Correspondence: Medical PATH, Via IV Novembre, 42, 20080
Besate, Milan, Italy. E-mail: [email protected]
1099–5129/01/010004+06 $35.00/0
found between the twin catheter (6·33·1 J) and the single
catheter approach (6·93·7 J), while the coronary sinus
configuration required a significantly lower energy than the
pulmonary artery configuration (5·62·9 vs 7·23·8 J,
P<0·05). The duration of the current atrial fibrillation
episode was the only clinical characteristic statistically
different between the 461 successfully cardioverted patients
and the 39 failures (295 vs 727 days, P<0·01). No complication was recorded during or after the delivery of the
therapy; no procedure had to be terminated because of
patient’s intolerance.
Conclusions Low-energy internal cardioversion is a safe
and effective procedure for converting chronic atrial fibrillation, confirmed by this large multicentre experience. The
newly available twin-coil catheter seems to achieve a
slightly better success rate compared with the traditional
two-catheter technique, and is associated with the same
safety profile.
(Europace 2001; 3: 4–9)
2001 The European Society of Cardiology
Key Words: Atrial fibrillation, internal cardioversion.
symptoms, embolic complications[2] and deterioration
in cardiac function[3], sinus rhythm restoration should
be the main goal of treatment in most patients[4].
Pharmacological cardioversion may be attempted but
has limited efficacy, particularly in long-lasting chronic
arrhythmias, unforeseeable effects and may also be
associated with unwanted effects[5]. External electrical
cardioversion is still considered the best therapeutic
option with an expected success rate of 70–90%, according to the characteristics of the patients[6–8]). Unfortunately, external cardioversion requires brief general
anaesthesia, cannot be repeated immediately in case of
early recurrence of atrial fibrillation and frequently fails
2001 The European Society of Cardiology
Safety and efficacy of low-energy cardioversion
5
Figure 1 Positioning of the two single-coil defibrillation catheters, in the antero-posterior
view: the former is always placed against the right atrium lateral wall, the latter is positioned
either in the distal coronary sinus (left) or in the left branch of the pulmonary artery (right);
a third catheter is placed in the right ventricular apex.
in cases of atrial fibrillation of long duration and in
overweight patients.
Low-energy internal cardioversion has recently been
introduced in humans with very high success rates and
an excellent safety profile[6,7,9–19]. The best technique to
be used is still debated and wider indications, new
catheters, new shock waveforms and new procedures are
being tested.
The aim of this study is to present some safety
and efficacy features of this new therapeutic procedure,
carried out with different techniques in a very large
experience (500 patients), and to characterize patients
who are suitable and unsuitable for this procedure.
Methods
Patients
From March 1997 to November 1998, 500 consecutive
patients with chronic atrial fibrillation underwent lowenergy internal cardioversion at 70 centres in Italy. Each
centre enrolled a median of six patients (range 1–46).
Each procedure was supervised by one of the authors.
Patients were enrolled if the following inclusion
criteria were fulfilled: (a) persistent atrial fibrillation of
at least 2 weeks’ duration; (b) effective anticoagulation
for at least 3 weeks (INR: 2·5–3·5); and (c) absence of
left atrial or ventricular thrombi. Patients were excluded
from the study if there was evidence of hyperthyroidism,
digitalis toxicity, recent (<6 weeks) myocardial infarction or history of stroke or thromboembolism. All
patients received adequate anticoagulation treatment,
before and after the procedure, as suggested by the
American College of Chest Physicians’ guidelines[20].
Transoesophageal echocardiography was performed
when clinically indicated, in order to exclude the
presence of intracavitary thrombi.
The benefits and risks of the study were discussed with
the patients and written consent was obtained from all
patients before starting the procedure.
Protocols for internal cardioversion
Two different techniques were employed for the procedure, in a non-randomized sequence, according to the
physician’s preference and experience. The first, more
traditional technique (368 patients) involved two 7F
defibrillation catheters with an active coil and a surface
area >500 mm (VascoStim TC 3+1 DT and VascoStim
TC 2+1 CK, by VascoMed GmbH, Germany): the
former, usually inserted through the right femoral vein,
was positioned under fluoroscopic guidance in the right
atrium, so that the coil had firm contact with the lateral
free wall; the latter was preferentially positioned in the
distal coronary sinus (in this instance, the catheter
was inserted through the left subclavian, right internal
jugular or left basilic vein) or in the left branch of the
pulmonary artery (in this case, the catheter was usually
inserted via the right femoral vein). A third catheter
(usually a standard diagnostic 6F quadripolar catheter)
was advanced from the right femoral vein and placed in
the right ventricular apex to provide R-wave synchronization and deliver back-up ventricular demand pacing
(Fig. 1).
In the remaining 132 patients a single twin-coil
catheter was used (VascoStim TC 2+2 JO, by
VascoMed GmbH, Germany): this 7F catheter, usually
inserted via the right femoral vein, was positioned with
the tip and distal coil either in the left branch of the
pulmonary artery or in the coronary sinus; in both cases
the proximal coil, at 11 cm from the distal coil, was
situated against the right atrial floor or right lateral wall.
A second 6F electrode catheter was positioned in the
right ventricular apex for sensing and pacing (Fig. 2).
Europace, Vol. 3, January 2001
6
A. Andraghetti and M. Scalese
Figure 2 Positioning of the single two-coil defibrillation catheter: the tip and distal coil are
placed either in the distal coronary sinus (left) or in the left branch of the pulmonary artery
(right); in both cases, the proximal coil remains in the right atrium (either against the lateral
wall or the atrial floor); a second catheter is positioned in the right ventricular apex.
The defibrillation catheters were connected to an
external atrial defibrillator (DSA, InControl, Redmond,
CA, U.S.A.) able to deliver truncated biphasic shocks
(6/6 ms, tilt 50%) and with a leading-edge voltage programmable between 10 and 400 V; the shocks were
synchronized to a ventricular endocardial trigger signal
and could be delivered only after cycle lengths between
500 and 800 ms. The shock energy was chosen by the
investigators not in order to determine the defibrillation
threshold, but with the aim of restoring sinus rhythm
with the minimum number of shocks; the initial energy
and the successive steps were thus chosen on the basis
of clinical characteristics of the patients and the
investigator’s experience. Successful cardioversion was
defined as the restoration of sinus rhythm lasting longer
than 1 min. Criteria for abandoning the procedure were
patient’s request or delivery of three shocks at the
maximum energy level (10·5 J). In case of initial failure,
class Ic antiarrhythmic drugs could be administered i.v.
at any time during the procedure in order to achieve a
favourable outcome.
Patient sedation was obtained, when needed, with i.v.
diazepam (5–10 mg) or midazolam (2–10 mg), according
to the physician’s preference.
Statistical analysis
All variables are expressed as mean valuestandard
deviation (SD). Statistical comparison was performed
using the Student’s t-test for unpaired data and 2 and
multivariate analysis. (STATISTICA by Stat Soft ). A P
value <0·05 was considered statistically significant.
Results
Patient characteristics
Internal cardioversion was performed in 500 consecutive
patients (324 men, 176 women), with a mean age of
Europace, Vol. 3, January 2001
6210 years. The mean duration of atrial fibrillation,
exactly defined in all but 32 patients, was 1122
months; the mean left atrial size was 46·06·2 mm. In
283 patients (57%), external cardioversion had been
unsuccessfully tried before internal cardioversion. The
main patient characteristics are summarized in Table 1.
Internal cardioversion: efficacy
In 368 patients, internal cardioversion was performed
with two single-coil catheters: the former was always
positioned in the right atrium, the latter was positioned
Table 1
Clinical characteristics of the 500 patients
Age (years)
Male/female ratio
Body weight (kg)
Body mass index (kg/m2)
Left atrial diameter (mm)
Duration of atrial fibrillation (months)
Previous failed external CV
Patients on AAA
MeanSD
Range
6210
324/176
8417
42·74·2
46·06·2
1122
283 (57%)
291 (58%)
26–86
n.a.
30–138
33·2–60·5
30–68
0·5–176
n.a.
n.a.
n.a., not applicable; CV, cardioversion; AAA, antiarrhythmic
agents.
Table 2
version
Catheter configuration during internal cardio-
Two catheters (one+one coils)
RA–PA
RA–CS
368 pts
212 pts
156 pts
Single catheter (2 coils)
RA–PA
RA–CS
132 pts
75 pts
57 pts
RA, right atrium; PA, pulmonary artery; CS, coronary sinus.
Safety and efficacy of low-energy cardioversion
7
Table 3 Main internal cardioversion results according to the technique utilized and
catheter configuration
Success rate (%)
Effective energy (J)
Fluoroscopy time (min)
Two catheters
(one coil)
Single catheter
(two coils)
RA–PA
RA–CS
336/368
(91·3%)
6·33·1
9·67·5
125/132
(94·7%)
6·93·7
6·25·9
262/287
(91·3%)
7·23·8
8·36·7
199/213
(93·4%)
5·62·9*
9·27·6
*P<0·05 vs two catheters.
RA, right atrium; PA, pulmonary artery; CS, coronary sinus.
Table 4 Clinical characteristics and technical findings in patients with successful and
unsuccessful internal cardioversion
Number of patients
Age (years)
Male/female ratio
Body weight (kg)
Body mass index (kg/m2)
Left atrial diameter (mm)
Duration of atrial fibrillation (days)
Previous failed external CV
Patients on AAA
Maximum energy (J)
Shock impedance (Ohms)
Successful ICV
Unsuccessful ICV
P value
461 (92·2%)
6210
291/170
8316
42·64·3
46·26·3
295505
267 (58%)
270 (59%)
6·53·4
65·99·8
39 (7·8%)
5711
33/6
8915
43·33·3
43·73·9
7271204
16 (41%)
21 (54%)
10·11·3
64·49·5
—
n.s.
n.s.
n.s.
n.s.
n.s.
<0·01
n.s.
n.s.
<0·05
n.s.
ICV, internal cardioversion; n.s., not significant; CV, cardioversion; AAA, antiarrhythmic agents.
either in the left branch of the pulmonary artery (212
patients) or in the distal coronary sinus (156 patients). In
the remaining 132 patients, a single twin-coil catheter
was used: the distal coil was positioned in the left branch
of the pulmonary artery in 75 cases and in the distal
coronary sinus in 57 cases (Table 2).
The overall success rate was 92·2% (461/500 patients);
the success rate was slightly higher with the singlecatheter approach (94·7%) compared with the classical
two-catheter technique (91·3%), as well as in the
coronary sinus configuration (93·4%) compared with
the pulmonary artery configuration (91·3%). Early
recurrences of atrial fibrillation were recorded in 18
patients (3·6%). No difference among the subgroups was
statistically significant (Table 3).
The mean energy used to convert sinus rhythm in the
whole group (461 patients) was 6·53·4 J, corresponding to a mean voltage of 32045 V (mean impedance:
65·9 Ohms). No significant difference in the effective
energy was found between patients using two coils in
two catheters (6·33·1 J) or in a single catheter
(6·93·7 J). A slightly and significantly lower energy
was required to convert patients when the electrode was
positioned in the coronary sinus (5·62·9 J) compared with the pulmonary artery (7·23·8 J, P<0·05)
(Table 3).
The mean fluoroscopy time was shorter when the
single catheter was used (6·25·9 min), compared with
the twin-coil catheter (9·67·5 min), as well as when
the pulmonary artery configuration was chosen
(8·36·7 min) compared with the coronary sinus
configuration (9·27·6 min) (Table 3).
Table 4 compares some clinical characteristics of the
461 patients successfully converted to sinus rhythm
(92·2%) with the remaining 39 patients (7·8%) in whom
the procedure failed. The only statistically different
finding in the two groups was the duration of the current
atrial fibrillation episode, which was much longer in the
failure group (mean 727 days) compared with the success group (295 days, P< 0·01). The successfully converted patients were older, had a left atrium slightly
larger, a greater number of previous cardioversions and
were more frequently on antiarrhythmic agents, but
none of these variables was significantly different
between the two groups.
Internal cardioversion: safety
A total of 1118 consecutive shocks were delivered, with
an average of 2·2 shocks per procedure. No unwanted
effect was recorded during or after therapy; particularly,
no ventricular arrhythmia was induced, no synchronization failure was observed and no therapy was witheld
because of patient’s intolerance. Only in 12 patients
(2·4%) was back-up pacing transiently necessary for
initial bradycardia. In 54 patients (10·8%) a class Ic
antiarrhythmic drug was injected during the procedure
Europace, Vol. 3, January 2001
8
A. Andraghetti and M. Scalese
(propafenone in 36 cases and flecainide in 18 cases) due
to initial failure or immediate atrial fibrillation recurrence; in all cases, sinus rhythm was finally established,
without any complication.
Discussion
Efficacy
Previously reported trials on patients treated with
intracardiac application of low-energy shocks have
demonstrated that conversion of chronic atrial fibrillation to sinus rhythm is feasible and safe with this
technique[6,7,9–19]. The present study confirms the efficacy of this therapy (92·2% on the average) after application of internal cardioversion in the largest series of
consecutive patients ever published.
The success rate of the present series is higher than in
most reported groups of patients treated with traditional
external transthoracic cardioversion (70–90%)[6–8]. In a
recent trial comparing the two procedures in 187 consecutive patients with chronic atrial fibrillation, Alt
et al.[7] demonstrated that internal cardioversion was
more effective than external cardioversion (93 vs 79%,
P<0·01); the mean energy for successful cardioversion
was 5·8 J for the internal and 313 J for the external
cardioversion. It is noteworthy that in 22 of the 25
patients in whom external cardioversion failed, sinus
rhythm could subsequently be restored with internal
cardioversion. This observation, together with other
similar favourable findings[11–13,18] suggests that the indications for internal cardioversion may be extended to
patients resistant to external cardioversion.
Safety
The most remarkable finding of this study is the
demonstration of the absolute safety of internal cardioversion: no ventricular proarrhythmia, no prolonged
sinus bradycardia nor atrioventricular block, no complication secondary to shock or sedation of the patients
occurred after delivery of 1118 shocks. These data are
even more impressive taking into account that most
centres enrolled only a few patients each; moreover, they
were lacking in experience and were gaining practice in
this new technique. Some complications are reported in
the literature, all due to technical failures. In a series of
70 consecutive patients who underwent internal cardioversion, Alt et al.[7] had only one patient who suffered
ventricular fibrillation immediately after the shock discharge, due to loss of synchronization, and recovered
uneventfully after external defibrillation. Barold et al.[21]
had two shocks, out of a total of 148, leading to
ventricular fibrillation: in the first patient, this was due
to faulty sensing, resulting in an unsynchronized shock;
in the second patient, the shock was delivered after a
very short coupling interval during phenylephrine
infusion.
Europace, Vol. 3, January 2001
Technical features
No significant difference regarding efficacy and safety
issues was evident between the use of two single-coil
catheters or one twin-coil catheter. The only difference is
a longer fluoroscopy time needed, at least in the hands of
these practicing physicians, to place correctly two separate catheters. As expected[12], a slightly better outcome
was shown when the right atrium–coronary sinus
configuration was used (93·4% success rate) compared
with the pulmonary artery configuration (91·3%). The
difference seems not so remarkable as to justify timeconsuming repeat attempts to catheterize the coronary
sinus ostium.
The lack of experience of most involved centres and
the unavoidable ‘learning curve’ of several investigators
is also the reason for a generally prolonged fluoroscopy
time recorded in this co-operative study compared with
other studies carried out in single centres.
No judgement may be expressed in regard to the
effective voltage and energy, and no comparison can be
made with other previous trials, since in this study the
authors decided not to reach the so-called ‘defibrillation
threshold’ (which requires several shocks starting at a
low voltage and usually with 50 V increments), but to
restore sinus rhythm with the minimum number of
shocks: in each procedure, the investigator determined
the starting level of energy and the successive steps in
case of failure, on the basis of the clinical characteristics
of the patient and the arrhythmia itself; in most
instances, the starting voltage was 200–250 V, followed
by 300–350 V and finally by 400 V, which was the
maximum voltage delivered by the external defibrillator.
The authors believe that patients’ tolerance is better with
a few shocks at a relatively high voltage compared with
several consecutive shocks starting from low voltages,
since in many instances, the pain threshold may be low
and tolerance is poor even at low voltages[14,15].
The large number of patients in this series permitted,
for the first time, identification and characterization of a
group of patients who failed the procedure and comparison of them with the patients who converted to sinus
rhythm. The only clinical variable capable of differentiating successful cardioversions from failures was the
duration of the current episode of atrial fibrillation; that
was, on average, about 2 years in resistant patients in
this series. This finding is in agreement with previously
reported observations, in small groups of patients, where
greater energy was required to convert atrial fibrillation
of longer duration[7,19]. On the contrary, no significant
difference was found between left atrial diameters of the
two groups of patients (successes and failures).
Limitations of the study
The lack of randomization in the choice of the technique
to be used is the main limitation of this study; that is
why the authors do not draw any definite conclusion
about the differences between the two techniques and
merely report the data.
Safety and efficacy of low-energy cardioversion
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Appendix
VascoStim TC Investigators Group
P. A. Ravazzi, P. Diotallevi, S.S. Antonio e Biagio, Alessandria;
S. Barbieri, N.C.C. di Alessandria, Alessandria; P. Scipione,
Lancisi, Ancona; G. Saccomanno, M. Marini, I.N.R.C.A.,
Ancona; R. De Nardis, Civile, Arzignano (VI); F. Gaita, M. S.
Bocchiardo, F. Lamberti, M. Scaglione, R. Riccardi, Colla,
Colò, Civile, Asti; P. Rizzon, G. Luzzi, Policlinico, Bari; A.
Bridda, G. Cargnel, Civile, Belluno; A. Curnis, Civili, Brescia;
G. Benedini, A. Gardini, S. Anna, Brescia; R. Verlato, Turrini,
Baccilieri, Civile, Camposampiero (PD); M. Ivaldi, P G. De
Marchi, S. Spirito, Casale M.to (AL); G. L. Gonzi, Oglio Po,
Casalmaggiore (CR), L. Franceschetto, M. Albunni, P.
Maiolino, Civile, Cittadella (PD); W. Bonini, G. L. Botto,
S. Anna, Como; C. Pappone, S. Bianchi, Villa Maria Cecilia,
Cotignola (RA); G. Rossetti, A. Vado, C. Bruna, S. Croce,
Cuneo; M. D’Aulerio, S. Biagio, Domodossola (VB); D.
Cornacchia, Infermi, Faenza (RA); L. Corò, M. Fantinel, P.
Delise, S. Maria del Prato, Feltre (BL); G. E. Antonioli, T.
Toselli, S. Anna, Ferrara; L. Padeletti, A. Colella, Careggi,
Firenze; Petrucci, Filippini, S. Antonio Abate, Gallarate (VA);
A. Lucatti, S. Setti, Celesia, Genova; M. Zoni Berisso, Galliera,
Genova; B. Castaldi, Civile, Isernia; G. A. De Giorgi, V. Fazzi,
Lecce; M. Pagani, D. Spaziani, Civile, Legnano (MI); E.
Tampieri, Civile, Lugo (RA); G. Stabile, A. De Simone, Casa
di Cura S. Michele, Maddaloni (CE); G. Calculli, Riuniti,
Matera; G. Bignamini, Predabissi, Melegnano (MI); A.
Raviele, G. Gasparini, A. Bonso, Umberto I, Mestre (VE); S.
Bianchi, Madonnina, Milano; P. Della Bella, Monzino, Milano;
P. Terranova, Sacco, Milano; C. Pappone, C. D’Ascia, P.
Mazzone, A. Salvati, San Raffaele, Milano; E. Bertaglia, Civile,
Mirano (VE); G. R. Zennari, P. V. Moracchini, P. Baraldi, P.
Sabbatani, S. Agostino, Modena; M. Santomauro, Federico II,
Napoli; B. Musto, C. Cavallaro, Monaldi, Napoli; E. Occhetta,
G. Francalacci, Maggiore della Carità, Novara; P. Mazzone,
S. Rocco, Ome (BS); G. F. Buja, D. Corrado, R. Chioin,
Università, Padova; M. Landolina, S. Matteo, Pavia; E. Sgarbi,
P. Bocconcelli, M. Mariani, S. Salvatore, Pesaro; R. Luise,
S. Spirito, Pescara; A. Capucci, G. Q. Villani, Civile, Piacenza;
G. Gherarducci, A.O. Pisana, Pisa; F. Zardo, S. Maria degli
Angeli, Pordenone; F. Sisto, S. Carlo, Potenza; W. Serino, P.
Lisanti, R. Fiorilli, San Carlo, Potenza; A. Maresta, G. Spitali,
S. Maria delle Croci, Ravenna; E. Adornato, V. Pennisi,
Riuniti, Reggio Calabria; M. Santini, C. Pandozi, San Filippo,
Roma; A. Spampinato, Villa Tiberia, Roma; M. Gasparini,
M. Mantica, Humanitas, Rozzano (MI); M. Chimienti, O.
Clinicizzato, San Donato (MI); L. Marinelli, I. Sicurezza
Sociale, San Marino; A. Croce, S. Rossi, M. Galli, Gen.
Provinciale, Saronno (VA); W. Mariotti, N. Ciampani,
Senigallia (AN); P. Giani, G. Leoni, V. Giudici, Bolognini,
Seriate (BG); G. Speca, Civile, Teramo; V. Freggiaro, Riuniti,
Tortona (AL); D. Barbieri, S. Lombroso, Circolo, Tradate
(VA); M. Disertori, G. Inama, L. Gramegna, M. Del Greco,
S. Chiara, Trento; G. Bellotti, Treviglio (BG); R. Mantovan,
F. Marton, Cà Foncello, Treviso; S. De Blasi, G. Panico,
Tricase (LE); G. Binaghi, S. Caico, E. Verna, F. Forgione,
A. Limido, Circolo, Varese.
Europace, Vol. 3, January 2001