Gregory M. Ayers

Atrioverter: An Implantable Device for the Treatment of Atrial Fibrillation

BACKGROUND During atrial fibrillation, electrophysiological changes occur in atrial tissue that favor the maintenance of the arrhythmia and facilitate recurrence after conversion to sinus rhythm. An implantable defibrillator connected to right atrial and coronary sinus defibrillation leads allows prompt restoration of sinus rhythm by a low-energy shock. The safety and efficacy of this system, called the Atrioverter, were evaluated in a prospective, multicenter study. METHODS AND RESULTS The study included 51 patients with recurrent atrial fibrillation who had not responded to antiarrhythmic drugs, were in New York Heart Association Heart failure class I or II, and were at low risk for ventricular arrhythmias. The atrial defibrillation threshold had to be </=240 V during preimplant testing. Atrial fibrillation detection, R-wave shock synchronization, and defibrillation threshold were tested at implantation and during follow-up. Shock termination of spontaneous episodes of atrial fibrillation was performed under physician observation. Results are given after a minimum of 3 months of follow-up. During a follow-up of 72 to 613 days (mean, 259+/-138 days), 96% of 227 spontaneous episodes of atrial fibrillation in 41 patients were successfully converted to sinus rhythm by the Atrioverter. In 27% of episodes, several shocks were required because of early recurrence of atrial fibrillation. Shocks did not induce ventricular arrhythmias. Most patients received antiarrhythmic medication during follow-up. In 4 patients, the Atrioverter was removed: in 1 because of infection, in 1 because of cardiac tamponade, and in 1 because of frequent episodes of atrial fibrillation requiring His bundle ablation. CONCLUSIONS With the Atrioverter, prompt and safe restoration of sinus rhythm is possible in patients with recurrent atrial fibrillation.

Pulmonary vein isolation using transvenous catheter cryoablation for treatment of atrial fibrillation without risk of pulmonary vein stenosis.

OBJECTIVES We sought to evaluate the efficacy and safety of pulmonary vein (PV) isolation using transvenous cryoablation for the treatment of atrial fibrillation (AF). BACKGROUND Although electrical isolation of PVs with radiofrequency energy for the treatment of AF is feasible, it is associated with a significant risk of PV stenosis. Cryoablation is a new alternative therapy allowing ablation of tissue while preserving its underlying architecture. METHODS In 52 patients with paroxysmal (n = 45) or persistent (n = 7) AF, PV isolation using the CryoCor cryoablation system (CyroCor Inc., San Diego, California) with a 10F deflectable transvenous catheter was performed as guided by ostial PV potentials. Cryoablation was applied twice at each targeted site (2.5 to 5 min/application). Computed tomography (CT) of the thorax was performed at baseline and at 3 and 12 months to evaluate for PV stenosis. RESULTS All targeted PVs were completely isolated in 49 (94%) of 52 of patients. Of 152 PVs targeted, 147 (97%) were successfully isolated (mean 3.0 PVs isolated per patient). After a mean period of 12.4 +/- 5.5 months of follow-up, 37 (71%) of 52 patients had no recurrence of AF or were clinically improved, including 29 patients (56%) who had no recurrence of AF with (n = 11) or without the use of anti-arrhythmic drugs. At 3 and 12 months, the CT scan showed no evidence of PV stenosis associated with cryoablation in any patients. CONCLUSIONS Transvenous catheter cryoablation is an effective method to create PV electrical isolation for the treatment of AF. A clinically satisfactory result can be achieved in 71% of patients with AF, without the risk of PV stenosis.

Ventricular proarrhythmic effects of ventricular cycle length and shock strength in a sheep model of transvenous atrial defibrillation.

BACKGROUND Synchronized cardioversion is generally accepted as safe for the treatment of ventricular tachycardia and atrial fibrillation when shocks are synchronized to the R wave and delivered transthoracically. However, others have shown that during attempted transvenous cardioversion of rapid ventricular tachycardia, ventricular fibrillation (VF) may be induced. It was our objective to evaluate conditions (short and irregular cycle lengths [CL]) under which VF might be induced during synchronized electrical conversion of atrial fibrillation with transvenous electrodes. METHODS AND RESULTS In 16 sheep (weight, 62 +/- 7.8 kg), atrial defibrillation thresholds (ADFT) were determined for a 3-ms/3-ms biphasic shock delivered between two catheters each having 6-cm coil electrodes, one in the great cardiac vein under the left atrial appendage and one in the right atrial appendage along the anterolateral atrioventricular groove. A hexapolar mapping catheter was positioned in the right ventricular apex for shock synchronization. In 8 sheep (group A), a shock intensity 20 V less than the ADFT was used for testing, and in the remaining 8 sheep (group B), a shock intensity of twice ADFT was used. With a modified extrastimulus technique, a basic train of eight stimuli alone (part 1) and with single (part 2) and double (part 3) extrastimuli were applied to right ventricular plunge electrodes. Atrial defibrillation shocks were delivered synchronized to the last depolarization. In part 4, shocks were delivered during atrial fibrillation. The preceding CL was evaluated over a range of 150 to 1000 milliseconds. Shocks were also delayed 2, 20, 50, and 100 milliseconds after the last depolarization from the stimulus (parts 1 through 3) or intrinsic depolarization (part 4). The mean ADFT for group A was 127 +/- 48 V, 0.71 +/- 0.60 J and for group B, 136 +/- 37 V, 0.79 +/- 0.42 J (NS, P > .15). Of 1870 shocks delivered, 11 episodes of VF were induced. Group A had no episodes of VF in part 1, two episodes of VF in part 2 (CL, 240 and 230 milliseconds with 2-millisecond delay), and one episode each in parts 3 (CL, 280 milliseconds with 2-millisecond delay) and 4 (CL, 240 milliseconds with 100-millisecond delay). Group B had two episodes in part 1 (CL, 250 and 300 milliseconds with 20-millisecond delay), three episodes in part 2 (CL, 230, 230, and 250 milliseconds with 2-millisecond delay), and one episode each in parts 3 (CL, 260 milliseconds with 2-millisecond delay) and 4 (198 milliseconds with 100-millisecond delay). No episodes of VF were induced for shocks delivered after a CL > 300 milliseconds. CONCLUSIONS Synchronized transvenous atrial defibrillation shocks delivered on beats with a short preceding ventricular cycle length (< 300 milliseconds) are associated with a significantly increased risk of initiation of VF. To decrease the risk of ventricular proarrhythmia, short CLs should be avoided.

Randomized Study Comparing Radiofrequency Ablation With Cryoablation for the Treatment of Atrial Flutter With Emphasis on Pain Perception

Background—Radiofrequency ablation (RF) of atrial flutter (AFL) has a high procedural efficacy, a low recurrence rate, and reports of procedure-related pain. The aim of the present study was to compare RF with cryoablation (cryo) for the treatment of AFL, with emphasis on pain perception during application of energy. Methods and Results—Fourteen patients (55±11 years, 11 males) with AFL were randomized to receive ablation of the cavotricuspid isthmus (CTI) by either RF or cryo. Cryothermia was delivered with the CryoCor Cryoablation System (10F, 6-mm tip), and radiofrequency energy was delivered with the use of an 8-mm–tip catheter. Pain was evaluated according to a visual analogue scale (VAS; 0 to 100). All patients in the cryo group were successfully ablated with a mean of 18 applications (9 sites), and RF was successful in 6 of 7 patients (not significant) with 13 applications (not significant). The mean temperature was −82°C and 55°C for cryo and RF, respectively. One patient in the cryo group perceived pain, versus all 7 patients in the RF group (P <0.05). The proportion of painful applications averaged 75.3% in the RF group and 2.0% in the cryo group (P <0.05), whereas the corresponding VAS for pain was 38.3±25.3 and 0.32±0.86, respectively (P <0.05). At 6-month follow-up, there were no recurrences of atrial flutter. Conclusion—Cryo, as compared with RF, produces significantly less pain during application. Although in the present study there was no significant difference in efficacy, larger studies will be needed to definitively compare efficacy.

Clinical shock tolerability and effect of different right atrial electrode locations on efficacy of low energy human transvenous atrial defibrillation using an implantable lead system

OBJECTIVES The objectives of this study were 1) to evaluate the effect of different right atrial electrode locations on the efficacy of low energy transvenous defibrillation with an implantable lead system; and 2) to qualitate and quantify the discomfort from atrial defibrillation shocks delivered by a clinically relevant method. BACKGROUND Biatrial shocks result in the lowest thresholds for transvenous atrial defibrillation, but the optimal right atrial and coronary sinus electrode locations for defibrillation efficacy in humans have not been defined. METHODS Twenty-eight patients (17 men, 11 women) with chronic atrial fibrillation (AF) (lasting > or = 1 month) were studied. Transvenous atrial defibrillation was performed by delivering R wave-synchronized biphasic shocks with incremental shock levels (from 180 to 400 V in steps of 40 V). Different electrode location combinations were used and tested randomly: the anterolateral, inferomedial right atrium or high right atrial appendage to the distal coronary sinus. Defibrillation thresholds were defined in duplicate by using the step-up protocol. Pain perception of shock delivery was assessed by using a purpose-designed questionnaire; sedation was given when the shock level was unacceptable (tolerability threshold). RESULTS Sinus rhythm was restored in 26 of 28 patients by using at least one of the right atrial electrode locations tested. The conversion rate with the anterolateral right atrial location (21 [81%] of 26) was higher than that with the inferomedial right atrial location (8 [50%] of 16, p < 0.05) but similar to that with the high right atrial appendage location (16 [89%] of 18, p > 0.05). The mean defibrillation thresholds for the high right atrial appendage, anterolateral right atrium and inferomedial right atrium were all significantly different with respect to energy (3.9 +/- 1.8 J vs. 4.6 +/- 1.8 J vs. 6.0 +/- 1.7 J, respectively, p < 0.05) and voltage (317 +/- 77 V vs. 348 +/- 70 V vs. 396 +/- 66 V, respectively, p < 0.05). Patients tolerated a mean of 3.4 +/- 2 shocks with a tolerability threshold of 255 +/- 60 V, 2.5 +/- 1.3 J. CONCLUSIONS Low energy transvenous defibrillation with an implantable defibrillation lead system is an effective treatment for AF. Most patients can tolerate two to three shocks, and, when the starting shock level (180 V) is close to the defibrillation threshold, they can tolerate on average a shock level of 260 V without sedation. Electrodes should be positioned in the distal coronary sinus and in the high right atrial appendage to achieve the lowest defibrillation threshold, although other locations may be suitable for certain patients.

Initial Clinical Experience With Ambulatory Use of an Implantable Atrial Defibrillator for Conversion of Atrial Fibrillation

BackgroundA recent study has shown that the implantable atrial defibrillator can restore sinus rhythm in patients with recurrent atrial fibrillation when therapy was delivered under physician observation. The objective of this study was to evaluate the safety and efficacy of ambulatory use of the implantable atrial defibrillator. Methods and ResultsAn atrial defibrillator was implanted in 105 patients (75 men; mean age, 59±12 years) with recurrent, symptomatic, drug-refractory atrial fibrillation. After successful 3-month testing, patients could transition to ambulatory delivery of shock therapy. Patients completed questionnaires regarding shock therapy discomfort and therapy satisfaction using a 10-point visual-analog scale (1 represented “not at all,” 10 represented “extremely”) after each treated episode of atrial fibrillation. During a mean follow-up of 11.7 months, 48 of 105 patients satisfied criteria for transition and received therapy for 275 episodes of atrial fibrillation. Overall shock therapy efficacy was 90% with 1.6±1.2 shocks delivered per episode (median, 1). Patients rated shock discomfort as 5.2±2.4 for successful therapy and 4.2±2.2 for unsuccessful therapy (P >0.05). The satisfaction score was higher for successful versus unsuccessful therapy (3.4±3.3 versus 8.7±1.3, P <0.05). There was no ventricular proarrhythmia observed throughout the course of this study. ConclusionsAmbulatory use of an implantable atrial defibrillator can safely and successfully convert most episodes of atrial fibrillation, often requiring only a single shock. Successful therapy is associated with high satisfaction and only moderate discomfort.

Reversible impairment of left and right ventricular systolic and diastolic function during short-lasting atrial fibrillation in patients with an implantable atrial defibrillator: a tissue Doppler imaging study.

YU, C.‐M., et al.: Reversible Impairment of Left and Right Ventricular Systolic and Diastolic Function During Short‐Lasting Atrial Fibrillation in Patients with an Implantable Atrial Defibrillator: A Tissue Doppler Imaging Study. AF with a fast ventricular response may cause ventricular mechanical impairment, though whether short‐lasting AF with satisfactory rate control may affect ventricular function is unknown. This study investigated if prompt cardioversion by an implantable atrial defibrillator (IAD) may prevent left (LV) and right ventricular (RV) systolic and diastolic dysfunction. Ten patients (mean age 61 ± 9 years, 8 men) with paroxysmal AF without structural heart disease who received an IAD were studied by echocardiography and tissue Doppler imaging (TDI) for both ventricles. Measurements were made during baseline sinus rhythm and at 1‐minute, 20‐minute, 4‐hour, and 1‐week postcardioversion of an episode of spontaneous AF. The occurrence of AF and the ventricular rate were monitored at 2‐hour intervals by the device. There were 50 episodes of AF with a mean duration of 8.8 ± 8.9 days (2 hours to 37 days). There was no difference in M‐mode measured LV fractional shortening and ejection fraction between baseline sinus rhythm and after cardioversion. However, the TDI derived myocardial systolic velocity (TDI‐S) was significantly lower at 1‐ minute postcardioversion and was normalized at 1 week in both LVs (baseline: 5.7 ± 1.8, 1 minute: 4.2 ± 1.0, 20 minutes: 4.3 ± 0.9, 4 hours: 4.8 ± 1.0, 1 week: 5.5 ± 1.8 cm/s; P < 0.005 when comparing 1 minute and 20 minutes to baseline; P < 0.05 when comparing 4 hour to baseline) and RV (baseline: 10.4 ± 2.1, 1 minute: 7.8 ± 1.4, 20 minutes: 8.1 ± 1.2, 4 hours: 9.2 ± 1.5, 1 week: 10.0 ± 2.0 cm/s; P < 0.005 when comparing 1 minute, 20 minutes, and 4 hours to baseline). For diastolic function, transmitral Doppler study showed a decrease in early filling velocity at 1 minute (P < 0.05) and 20 minutes (P < 0.005), which was normalized at 4 hours. There was no change in transtricuspid Doppler flow. However, TDI derived myocardial early filling velocity was decreased in the LV (baseline: 6.0 ± 2.8, 1 minute: 5.4 ± 2.3, 20 minutes: 5.4 ± 2.1, 4 hours: 6.1 ± 2.2, 1 week: 5.8 ± 1.7 cm/s; P < 0.05 when comparing 1 minute and 20 minutes to baseline) and RV (baseline: 8.9 ± 3.5, 1 minute: 7.9 ± 3.3, 20 minutes: 8.1 ± 3.3, 4 hours: 8.5 ± 2.9, 1 week: 8.4 ± 3.5 cm/s; P < 0.05 when comparing 1 minute to baseline). AF of a longer duration (> 48 hours) resulted in a more depressed TDI‐S in LV (> 48 hours: 4.2 ± 1.0, ≤ 48 hours: 5.3 ± 1.3 cm/s; P < 0.01). Shocks in sinus rhythm did not affect any of the above echocardiographic parameters. Therefore, despite adequate rate control, short‐lasting AF impairs systolic and diastolic function in both ventricles, which improves gradually after cardioversion. Early restoration of sinus rhythm by an IAD minimizes ventricular dysfunction. TDI is a sensitive tool to assess early systolic and diastolic dysfunction.

Favorable effects of flecainide in transvenous Internal cardioversion of atrial fibrillation

OBJECTIVES The aim of the study was to evaluate the effects of intravenous (IV) flecainide on defibrillation energy requirements in patients treated with low-energy internal atrial cardioversion. BACKGROUND Internal cardioversion of atrial fibrillation is becoming a more widely accepted therapy for acute episode termination and for implantable atrial defibrillators. METHODS Twenty-four patients with atrial fibrillation (19 persistent, 5 paroxysmal) underwent elective transvenous cardioversion according to a step-up protocol. After successful conversion in a drug-free state, atrial fibrillation was induced by atrial pacing; IV flecainide (2 mg/kg) was administered and a second threshold was determined. In patients in whom cardioversion in a drug-free state failed notwithstanding a 400- to 550-V shock, a threshold determination was attempted after flecainide. RESULTS Chronic persistent atrial fibrillation was converted in 13/19 (68%) patients at baseline and in 16/19 (84%) patients after flecainide. Paroxysmal atrial fibrillation was successfully cardioverted in all the patients. A favorable effect of flecainide was observed either in chronic persistent atrial fibrillation (13 patients) or in paroxysmal atrial fibrillation (5 patients) with significant reductions in energy requirements for effective defibrillation (persistent atrial fibrillation: 4.42+/-1.37 to 3.50+/-1.51 J, p < 0.005; paroxysmal atrial fibrillation: 1.68+/-0.29 to 0.84+/-0.26 J, p < 0.01). In 14 patients not requiring sedation, the favorable effects of flecainide on defibrillation threshold resulted in a significant reduction in the scores of shock-induced discomfort (3.71+/-0.83 vs. 4.29+/-0.61, p < 0.005). No ventricular proarrhythmia was observed for any shock. CONCLUSIONS Intravenous flecainide reduces atrial defibrillation threshold in patients treated with low-energy internal atrial cardioversion. This reduction in threshold results in lower shock-induced discomfort. Additionally, flecainide may increase the procedure success rate in patients with chronic persistent atrial fibrillation.

Heterogeneous Changes in Electrophysiologic Properties in the Paroxysmal and Chronically Fibrillating Human Atrium

Heterogeneous Changes in Atrial Electrophysiologic Properties. Introduction: The regional changes in atrial elettrophysiologic properties related to atrial fibrillation (AF) in patients with paroxysmal AF (PAF) and chronic AF (CAF) remain unclear. The purpose of this study was to investigate the regional changes in atrial electrophysiology in patients with AF. Methods and Results: We evaluated the atrial electrophysiology at different sites (high right atrium, low right atrium [LRAJ, and distal coronary sinus [DCS]) in 11 patients with CAF, 8 patients with PAF, and 10 controls. Patients with CAF had significantly prolonged interatrial conduction and corrected sinus node recovery time, and shortened atrial effective refractory period (ERP) with loss of rate‐related adaptation in the DCS, hut had paradoxic prolongation of atrial ERP in the LRA, as compared with patients with PAF and the controls. As a result, the spatial distribution of atrial ERP that was observed in the controls and in patients with PAF was reversed in patients with CAF, without an increase in the dispersion of atrial refractoriness. Patients with PAF showed intermediate changes in atrial conduction times and atrial refractoriness as compared with patients with CAF and controls.

Spontaneous episodes of atrial fibrillation after implantation of the Metrix Atrioverter: observations on treated and nontreated episodes

OBJECTIVES We sought to evaluate the number and duration of device-treated and self-terminating, nontreated episodes of atrial fibrillation (AF) after implantation of the Metrix Atrioverter. BACKGROUND A recent study has shown that the Atrioverter can rapidly restore sinus rhythm in patients with AF; however, the effect of the device on the clinical course of the arrhythmia in these patients is unknown. METHODS The Atrioverter was implanted in 51 patients with symptomatic, recurrent, drug-refractory AF. The device was programmed to periodically monitor the cardiac rhythm. Defibrillation of AF episodes was performed under physician observation. RESULTS During a mean follow-up of 260 +/- 144 days, 1,161 episodes of AF were observed during valid monitoring periods in 45 of 51 patients. Forty-one patients experienced 231 episodes for which they sought defibrillation therapy. The average duration of the treated episodes during valid monitoring periods (190 of 231 episodes in 39 of 41 patients) was significantly longer than that of the nontreated episodes (38 +/- 44 vs. 10 +/- 8 h; p < 0.05). The time between episodes requiring Atrioverter therapy increased, and the risk of having an episode requiring treatment decreased. No changes were observed in the number and duration of the short-lasting, nontreated episodes as time since implantation of the device increased. CONCLUSIONS In patients with symptomatic, recurrent, drug-refractory AF, the frequency of long-lasting episodes, which were treated under observation with repeated defibrillation using the Atrioverter, decreased. The number and duration of short-lasting, nontreated episodes did not change during the 20-month study period. The effect of ambulatory use of the device on the recurrence of short-lasting episodes needs to be evaluated.