Visual Balloon-Guided Point-By-Point Ablation: Reliable...

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Visual Balloon-Guided Point-By-Point Ablation:Reliable, Reproducible, and Persistent Pulmonary Vein Isolation

Dukkipati et al.: Visually-Guided AF Ablation

Srinivas R. Dukkipati, MD1, Petr Neuzil MD, PhD2, Jan Skoda MD2, Jan Petru MD2, Andre

d’Avila, MD, PhD1, Shephal K. Doshi, MD3, Vivek Y. Reddy, MD1

1The Helmsley Electrophysiology Center, Mount Sinai School of Medicine, New York, New

York, 2Homolka Hospital, Prague, Czech Republic, 3Saint John’s Hospital, Santa Monica,

California

Address for correspondence:

Vivek Y. Reddy, MD

Mount Sinai Hospital

One Gustave L. Levy Place, Box 1030

New York, NY 10029

Phone: (212) 241-7114

Fax : (646) 537-9691

E-mail: [email protected]

Journal Subject Codes: [5] Arrhythmias, clinical electrophysiology, drugs; [22] Ablation/ICD/surgery

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ABSTRACT

Background — While conceptually straightforward, placing point-to-point contiguous

radiofrequency lesions to achieve pulmonary vein isolation (PVI) is technically challenging in

patients with paroxysmal atrial fibrillation (PAF). Furthermore, chronic efficacy is limited by

late PV reconnections. A novel compliant balloon ablation catheter (BAC) able to deliver

visually-guided short arcs/spots of laser energy was tested in initial pre-clinical and clinical cases

to determine if visual guidance could predict reliable and persistent PVI.

Methods and Results — This study consisted of i) an experimental porcine phase with both

acute (n=15 pigs) and 4-week chronic (n=10) data, and ii) a single-center clinical feasibility

phase (n=27 PAF patients), again with acute and 3-month chronic data. Under endoscopic

guidance, point-by-point peri-venous ablation was performed in a contiguous and overlapping

manner. Each porcine PV was longitudinally sectioned for detailed histological analysis. At 3-

months post-ablation, patients underwent a pre-specified remapping procedure regardless of

symptomotology. In the acute and chronic animals, 29/30 (97%) PVs were electrically isolated

after placing the initial circumferential lesion set. For the 4-week chronic animals, 80% of PVs

remained isolated; lesions were histologically circumferential in 120/120 (100%) PV sections,

and transmural in 116/120 (96.7%) PV sections (average transmurality = 99.0 5.5%). In

patients, 100% of the PVs were isolated after 1.3 attempts/PV – 84% of them (85/101) isolated

after the initial visually-guided lesion set. At 3 months, 61/68 (90%) PVs continued to be

electrically isolated.

Conclusions — Using a visually-guided, compliant balloon ablation catheter with point-by-point

ablative capability, PV isolation can be achieved in a reliable, reproducible, and persistent

manner.

Key words: Atrial Fibrillation, Catheter Ablation, Laser, Pulmonary Veins, Visual Guidance

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INTRODUCTION

Pulmonary vein (PV) isolation is the mainstay of catheter based therapy for atrial

fibrillation (AF).1-11 However, achieving electrical PV isolation with point-by-point ablation is

technically challenging. Recently, balloon catheters utilizing multiple energy sources have been

utilized to facilitate PV isolation.12-17 While many of these balloons share similar characteristics,

the laser balloon is unique in its ability to provide real-time endoscopic visualization and to

deliver laser energy at operator-determined locations around the PV-left atrial junction.17

Although clinically promising, the first generation laser balloon ablation catheter (BAC)

was limited in its ability to deliver optimal lesions due to balloon noncompliance and the large

90o – 120o ablative arc. This translated to suboptimal balloon contact and difficulty in delivering

sufficient energy along the large ablative arc due to risk of thrombus formation from ablation at

areas with overlapping blood. Accordingly, the rate of acute PV isolation in the clinical series

was only 91% with an AF recurrence rate of 60%.Because of these limitations, the balloon was

redesigned to 1) maximize balloon-tissue contact by making a balloon of adjustable diameter and

compliance, and 2) allow the delivery of spot laser lesions. This second generation balloon was

evaluated in a two-phase study. The pre-clinical phase involved electrophysiological and

histological assessment of the lesions delivered by the balloon in a series of acute and chronic

porcine experiments. The clinical phase involved a single center evaluation in patients

undergoing catheter ablation for paroxysmal atrial fibrillation with a prespecified PV remapping

procedure at ~3 months regardless of intervening symptomatology. Thus, in addition to the

acute procedural performance of this BAC, we are also able to report on the 3-month

permanency of electrical PV isolation.

METHODS

The pre-clinical experiments were approved by the Institutional Animal Care and Use

Committees. The clinical phase was approved by the human ethics committee at Homolka

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Hospital. The authors had full access to and take full responsibility for the integrity of the data.

All authors have read and agree to the manuscript as written.

Endoscopic Ablation System with Adaptive Contact (EASAC): The EASAC

(CardioFocus, Inc., Marlborough, Massachusetts) consists of the following major components:

(i) delivery sheath, (ii) balloon ablation catheter (BAC), (iii) endoscope, (iv) lesion generator,

and (v) cooling console. The delivery sheath is a deflectable 12-Fr ID sheath with the capability

of 180º deflection. The BAC (Figure 1) is a variable diameter, compliant balloon with a flexible

tip (to minimize the possibility of mechanical trauma). Contained within the balloon are

multiple lumens within the central shaft for the endoscope, lesion generator, and cooling

conduits. The balloon is constantly cooled with circulating D2O.

The BAC is positioned at the PV ostium and inflated (Figure 2A&B) to provide good

contact. A 2-Fr endoscope is located at the proximal portion of the balloon and provides real-

time visualization of the face of the balloon (Figure 2C). Regions of the balloon in contact with

blood appear red, and regions in contact with tissue blanch white. The field of view is partially

obscured in the area behind the central shaft. This partially obscured view is located 180o

opposite the radiopaque “L” marker on the balloon catheter shaft and allows positional

correlation between the fluoroscopic and the endoscopic images. The lesion generator consists

of an optical fiber within the central shaft that generates a 30o arc of light that is projected onto

regions of balloon contact. This arc serves as an aiming beam for laser delivery, and can be

easily advanced/retracted and rotated along the balloon face with endoscopic visualization. Once

an appropriate location is selected, laser energy (980 nm) is delivered through the same optical

fiber to ablate the target tissue. Multiple lesions are delivered in an overlapping manner to

achieve circumferential ablation (Figure 2D).

Pre-Clinical Phase – Ablation Procedure: After an overnight fast, 25 pigs (15 acute, 10

chronic) were induced with 1.4 mg/kg Telazol, 1.1 mg/kg acetylpromazine, and 0.05 mg/kg IM

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atropine. The animals were intubated and ventilated with oxygen and 1.5-2.5% Isoflurane.

Femoral venous access was obtained and transseptal puncture was performed using a

Brockenbrough needle under fluoroscopic guidance. The deflectable 12-Fr sheath was advanced

into the LA over a 0.035” or 0.038” guidewire. Intravenous heparin was given as a continuous

infusion and boluses to maintain an ACT>300 sec. The deflectable sheath was positioned at the

ostium of the target PV. Contrast was injected through the sheath to assess PV anatomy and

diameter. A circular mapping catheter (Biosense-Webster, Inc., Diamond Bar, California) was

placed in the PV to evaluate electrograms at baseline and post-ablation to assess for electrical

isolation.

The BAC was delivered through the deflectable sheath and inflated at the ostium of the

target PV. The right superior (RSPV), and sometimes the left superior (LSPV), were targeted for

ablation; the decision to target a PV was based on the presence of baseline PV electrograms. The

porcine right inferior (RIPV) and left inferior (LIPV) were not targeted as PV electrograms are

rarely, if ever, present. Additionally in pigs, the esophagus is located much more posteriorly to

the LA than seen in humans, and esophageal injury is never seen. However, the course of the

right phrenic nerve is similar to humans and injury is possible during ablation. Therefore, during

ablation around the RSPV, phrenic nerve pacing was performed with a catheter placed in the

superior vena cava. Using endoscopic visualization, the aiming beam was manipulated around

the PV and laser energy was delivered in a contiguous, overlapping, and circumferential manner

to achieve PV isolation.

The dose of laser energy available for use ranged between 5.5 – 16 Watts/cm at 20-30 sec

duration per lesion. When ablation in regions with overlapping blood was required, the lowest

energy of 5.5 Watts/cm for 30 sec per lesion was used (this is based upon pre-clinical data

indicating safety despite blood overlap at this dose). To ablate the tissue located at the partially

distorted region behind the central shaft, the BAC was partially deflated, rotated, and then

reinflated to allow full visualization of this obscured region. Following circumferential ablation

PV isolation was assessed with the circular mapping catheter. If electrical breakthrough was

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observed, the BAC was repositioned in the PV ostium to ablate in the region of breakthrough and

achieve PV isolation. At 30 min post-ablation, PV isolation was confirmed again and PV

angiography was repeated to again assess PV diameters.

The acute animals were sacrificed and pathological examination was performed. The

chronic animals were recovered and brought back for a repeat procedure at 4 weeks to assess

PV diameters and electrical isolation by the methods described above. For these chronic

experiments, at the time of the second procedure, the animals were sacrificed and pathological

examination was performed.

Pre-Clinical Phase – Pathological Examination: The explanted heart and surrounding

tissue, were subjected to gross examination. In all animals, the LA and PVs were examined to

assess location and circumferentiality of the lesions. The LA and PVs, as well as any abnormal

tissue were fixed with 10% formalin for histological examination. The PVs were opened

longitudinally at the superior-most aspect (12 o’clock position) and sectioned (8-15 slices/PV) in

a circumferentially longitudinal pattern parallel to blood flow. The sections underwent paraffin

processing and were stained with either hematoxylin-eosin (H&E), Movat pentachrome, or

Masson’s trichrome stains. The slides were examined by light microscopy and evaluated for

thermal injury and necrosis.

Clinical Phase – Study Design. The clinical phase was a prospective, open label, non-

randomized, single center study of patients with symptomatic, recurrent, paroxysmal AF. The

inclusion criteria were: age 18-75 years, and recurrent paroxysmal atrial fibrillation that was

refractory to at least one antiarrhythmic drug (Class I – IV). All patients were otherwise deemed

to be candidates for radiofrequency catheter ablation. Key exclusion criteria included: a prior

PV isolation procedure, presence of intracardiac thrombus or spontaneous echo contrast,

myocardial infarction or cardiac surgery in the prior 3 months, moderate to severe valvular

disease, left ventricular ejection fraction <30%, LA diameter >5 cm, PV diameter >30 mm (for

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oval PVs, the mean of the PV major and minor dimension was used), or stroke/transient ischemic

attack in previous 6 months. Pre-procedural CT scans were performed to assess LA and PV

anatomy and size.

A total of 27 patients underwent ablation with the BAC. Following the procedure, all

patients were discharged on warfarin, and at times, low molecular weight heparin until the

international normalized ratio was 2.0. Following the procedure, antiarrhythmic medications

were either discontinued or reduced in dosage for 1 month after which they were completely

discontinued. There was a 1 month blanking period following ablation. All patients were

discharged with an event monitor for weekly transmissions and for recurrence of AF symptoms.

Post-procedure clinic visits were performed at 1 and 3 months. A repeat CT scan was performed

at 3 months to assess for PV stenosis. At ~3 months after the index procedure, patients were

brought back for a repeat procedure to assess for the permanency of PV isolation. This second

procedure was performed regardless of the intervening symptomatology.

Clinical Phase – Ablation and Remapping Procedures: The ablation and remapping

procedures were performed in a modified manner to the methods described for the preclinical

experiments. All procedures were performed under conscious sedation. Two transseptal

punctures were performed; one for the deflectable sheath and BAC, and the second for the

circular mapping catheter. Intracardiac echocardiography was used during the procedures to

facilitate transseptal puncture and BAC positioning. During ablation of the RSPV, pacing from

the superior vena cava was performed to minimize risk of phrenic nerve palsy. In all patients, an

esophageal temperature probe was placed to monitor esophageal heating and ablation was

stopped when the temperature reached 38.5oC. After inflation of the BAC, laser energy was

delivered around the PV ostium in a contiguous, overlapping, and circumferential manner. After

completion of a single circumferential lesion set, PV electrical isolation was assessed with the

circular mapping catheter. If breakthrough was present, further ablation with the BAC was

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performed at sites of electrical breakthrough. After PV isolation was achieved, it was reassessed

at 30 min post-ablation.

The remapping procedures were also performed under conscious sedation. After a

transseptal puncture, PV isolation was assessed with a circular mapping catheter. If electrical

breakthrough was identified, a second transseptal puncture was performed. Then ablation was

performed with a externally-irrigated radiofrequency ablation catheter (Celsius or Navistar

ThermoCool, Biosense-Webster, Inc., Diamond Bar, CA). All data are expressed as mean ±

standard deviation.

RESULTS

Pre-Clinical Phase – Acute Porcine Experiments: Among 15 pigs, a total of 20 PVs (15

RSPV, 5 LSPV) were targeted for ablation. The BAC conformed well to the PV ostia and antra

and provided adequate contact and visualization (Figure 2). With the initial visually-guided

placement of an overlapping circumferential ablation lesion set, 19/20 (95%) PVs were

electrically isolated. After identifying the area of electrical breakthrough using a circular

mapping catheter, the remaining PV was isolated with additional balloon laser lesions. The

mean number of ablation lesions needed to isolate each PV was 31.0±14.1 with a mean ablation

time of 24.7±11.9 min. All PVs (100%) remained electrically isolated after 30 minutes post-

ablation. The mean PV diameter change was -2.5±7.7% (limits -22.2 to +8.3%).

Gross pathological examination of the PVs revealed well-demarcated circumferential and

contiguous lesions. Interestingly, grossly visual gaps were identified in 7/20 (35%) PVs (Figure

3) despite the fact that all PVs were electrically isolated. Histological examination was

performed in 13/15 pigs (12 RSPV, 5 LSPV). The histological lesion characteristics observed

are shown in Table 1. On a per vein basis, histological acute lesion transmurality was

80.8±16.2% (limits 57.0-100%). When assessed by histological sections (n=187), the mean

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transmurality was 84.6±27.8% (limits 0.0-100%). Of the PV sections, 122/187 (65.2%) had

completely transmural lesions while only 8/187 (4.3%) had no lesion. The maximal lesion depth

observed was 12.7 mm which represented a completely transmural lesion. On histological

examination, all injury was confined to the PV antra without extension into the PVs. One animal

had a lung lesion in a location directly adjacent to the PV antrum. There was no phrenic nerve

injury or thrombi seen on either the BAC or atrial tissue.

Pre-Clinical Phase – Chronic Experiments: In 10 pigs, 10 PVs (all RSPV) were

targeted for ablation. All PVs (100%) were electrically isolated on first attempt and remained

isolated 30 minutes post-ablation. Based on the finding of visual gaps in the acute animal

experiments, more overlapping lesions (30-50% overlap) were delivered in the chronic series.

When remapped after 4 weeks, 8/10 PVs (80%) were still electrically isolated. On gross

pathological examination, the lesions appeared contiguous and circumferential although they

were more difficult to discern because they had a whiter, less intense appearance than those

observed acutely (Figure 4A). On a per vein basis, the chronic mean lesion transmurality was

98.8±2.1% (limits 94.6-100%). When analyzed by histological PV sections (n=120), the mean

lesion transmurality was 99.0±5.5% (limits 59.8-100%). Complete lesion transmurality was

present in 96.7% of PV sections with lesion depths of up to 12.0 mm. The lesions were

completely circumferential without any gaps by histology. In the two animals with recovered

electrical conduction, the circular mapping catheter identified breakthrough in the

anterior/inferior portion of the RSPV. One animal was ablated using low-dose energy (5.5 W/30

sec) in this region and had a 59.8% transmural lesion (total wall thickness = 10.5 mm) in this

region by histology. The second animal had showed 100% transmural lesions in the sampled PV

sections; presumably, the area of chronic conduction gap was between the sampled slices.

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In all 10 animals, ablation lesions extended beyond the atrial wall onto the adjacent

pulmonary artery (Figure 4B) and in 6 animals there was extension of thermal injury into the

PV. Lung injury was seen in 3 animalsand there was no phrenic injury seen. The mean change

in chronic PV diameters was -2.6±19.0% (limits -33.9 to +21.7%).

Clinical Phase – Patient Demographics: The baseline patient demographics are shown

in Table 2. The mean age of the cohort was 52.7±12.6 years (limits 25-66). All patients had

paroxysmal AF with a mean duration of symptoms of 6.7±7.1 years, and 77.8% (21/27 patients)

failed 1 class I or III antiarrhythmic drug. Nine patients (33.3%) were taking warfarin, 1

(3.7%) aspirin, and 6 (22.2%) low molecular weight heparin just prior to the procedure.

Clinical Phase – Visually-Guided Ablation: There were a total of 101 PVs in 27

patients – all PVs were targeted for ablation. The variable diameter and compliant nature of the

balloon provided adequate contact for visualization (Figure 5) and made it amenable for use

with diverse PV anatomies (Supplemental Table 1, Figures 6 & Supplemental Figure 1).

With visual guidance, 84.2% (85/101) PVs were isolated with the initial visually-guided

circumferential placement of contiguous point-by-point lesions. By using the circular mapping

catheter to identify the point of electrical breakthrough, the remaining PVs were isolated; thus,

100% of PVs were ultimately isolated. The average number of attempts to isolate each vein was

1.3. All PVs remained isolated after a minimum of 30 minutes post-ablation. The mean

fluoroscopy time per patient was 17.3 6.3 minutes, mean ablation time was 110.9 29.6 minutes,

and total laser energy delivery time was 65.9 14.9 minutes.

Nine patients had esophageal temperature rises >38.5oC prompting cessation of energy

delivery. The temperature rises occurred posterior to the: LIPV in 4 patients, LCV in 3, at the

junction of the LSPV/LIPV in 1, and LSPV and LIPV in 1. There were no significant

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temperature rises >38.5oC with ablation near the right sided PVs seen. There were no instances

of loss of phrenic nerve capture during ablation of the right sided veins. No major adverse

events were seen including cardiac tamponade, strokes or transient ischemic attacks, or bleeding.

Clinical Phase – PV Remapping and Follow-Up. Of the 27 patients, 23 were at least 3

months post-ablation. Of these 23, 18 agreed to undergo PV remapping at a mean of 11.1±0.9

weeks post-ablation. In these patients, persistent electrical isolation was present in 61/68 PVs

(89.7%). In toto, resumption of electrical conductivity was observed in 6 patients and 7 veins – 5

patients had one reconnection each, while the remaining patient had two PV reconnections

(Supplemental Table 2). All PVs were completely isolated in 12/18 (66.7%) patients. Each of

the reconnected PVs had a single area of focal reconnection. An analysis of the location of these

gaps is shown in Supplemental Figure 2. The distribution of reconnections observed on a per

vein basis was: 2 in the LSPV, 2 in the RSPV, and 3 in the RIPV. There were no reconnections

involving the LIPV, left or right common PVs. On a per vein basis, the success of chronic PV

isolation was 86.7% (13/15) for the LSPV, 100% (15/15) for the LIPV, 88.2% (15/17) for the

RSPV, and 82.4% (14/17) for the RIPV. There was 100% chronic PV isolation in the 3 left

common and 1 right common PVs.

At 3 months, 4/23 patients had recurrent AF symptoms with documentation of the

episodes in 3. All of the patients with recurrence were remapped and 2 of 4 had PV

reconnections (Supplemental Table 2). The remaining 2 patient had documented recurrence of

AF, however, all PVs were electrically isolated suggesting a non-PV trigger for the AF. These 2

were the only patients still on a Class I or III antiarrhythmic drug. There was no significant PV

stenosis >30% as assessed by CT scans at 3 months. There was also no evidence of other

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complications: including phrenic damage, atrial esophageal fistula, gastric dysmotility, and

thromboembolism/stroke.

DISCUSSION

In patients with paroxysmal AF, the goal of catheter based therapy is to achieve

permanent PV electrical isolation.1-11 Despite, a high rate of acute isolation, the incidence of

recurrent AF related to PV reconnections is substantial.18-20 In the present study, we have shown

that with visual-guidance, 100% of targeted PVs could be isolated using the variable diameter,

compliant balloon with the capability of real-time endoscopic visualization during point-by-point

ablation using laser energy. Furthermore, with adequate lesion overlap, a high degree of lesion

circumferentiality and transmurality could be achieved. In the chronic preclinical experiments,

lesions were 100% circumferential and 99% transmural in the sampled PV histological sections.

This likely translated to the high rate of chronic PV isolation seen at remapping (80% in the

preclinical experiments, 90% in patients). These favorable results were achieved safely without

any major adverse events.

Feasibility of PV Isolation. In patients with paroxysmal AF, visually-guided PV

isolation using a balloon ablation catheter utilizing laser energy delivery was previously shown

to be possible.17 Although clinically promising, acute PV isolation was feasible in only 91% of

PVs and there was a high rate of clinical recurrence, with only 60% of patients remaining free of

AF without antiarrhythmic drugs at 12 months. These results could be explained in-part by the

suboptimal area of balloon/tissue contact and a large 90o-120o ablative arc which often

necessitated low energy delivery due to overlapping blood and concern for thrombus formation.

In the present study, a compliant balloon with a variable diameter and a point-by-point ablative

capability was used. These changes translated in the ability to isolate 100% of targeted PVs

acutely in both the preclinical and clinical experiments.

With visual guidance alone, 97% of PVs in pigs and 84% of PVs in humans were isolated

after placement of the initial encircling lesion set. In pigs, acute lesions created with laser

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energy were more readily identifiable with endoscopic visualization, than in humans. The acute

lesions in humans appeared paler and less intense than in pigs, and were frequency difficult to

discern. Additionally, the area of balloon/tissue contact was also better in pigs. These factors

likely account for the observed difference.

Lesion Characteristics. Although all PVs were isolated, visual gaps in the ablation line

were observed in 35% of PVs in the acute preclinical series, highlighting the fact that isolation

can often be achieved in the absence of a completely circumferential lesion set. Whether these

PVs would have been chronically reconnected, or whether there might have been lesion

progression is unanswered in these experiments. Based on these observations, in the subsequent

chronic preclinical and clinical experiments, there was an attempt to achieve a 30-50% lesion

overlap. Thus in the chronic pigs, no gaps were identified either visually or by histology.

Complete lesion transmurality was seen in 65% of sampled PV sections in the acute pigs, and

97% of PV sections in the chronic pigs. While more lesion overlap may partially account for this

difference, it is more likely that the full extent of injury is more readily appreciated following

lesion maturation. The chronic pig experiments highlight that it is possible to achieve complete

lesion circumferentiality and tranmurality using the visually-guided BAC.

Efficacy & Safety. At ~3 months, 90% of PVs remained electrically isolated and 83% of

patients were free of AF. All PVs were isolated in 67% of remapped patients. These favorable

results are likely due to improved balloon characteristics as previously described. These findings

also compare favorably to the other available balloon ablation technologies, particularly the

cryoballoon.12,13Unlike with the visually-guided BAC, often more than one cryoballoon was used

in conjunction with another catheter for “spot ablation”, to achieve isolation of all the PVs. The

most common reported adverse event with the cryoballoon is reversible right phrenic nerve

palsy. In the present study, one balloon was often enough to isolate all PVs and there were no

major adverse events, including phrenic nerve injury.

Limitations. In animals, the ablation lesions are more readily visible and balloon/tissue

contact is better than in humans. Therefore, with visual-guidance alone, a high proportion of

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The chronic pig experiments highlight that it is possible to ac

nsmurality was seen in 65% of sampled PV sections in the ac

in the chronic pigs. While more lesion overlap may partially

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14

veins were isolated. While a similar trend was seen in humans, notable differences included

difficulty in visually discerning the lesion; thus overlap was often based more on overlap of each

laser spot with the subsequent laser spot. In patients, although the endpoint was persistent PV

isolation at ~3 month remapping, the procedures were done in a single center with 27 patients.

Therefore, more experience with this particular balloon ablation catheter in multiple centers is

needed to more accurately determine the long-term efficacy and safety. Also, the 3 month

timepoint was chosen as a reasonably late after the initial procedure; however, we cannot rule

out the possibility that more reconnections might be seen at later timepoints. Finally, while only

18, and not all, patients presented for the remapping study, it should be noted that any potential

bias is more likely to be against the device. That is, it is more likely that symptomatic patients

would show up for the second procedure; thereby artificially decreasing the true chronic isolation

rate on an intention-to-treat basis.

CONCLUSIONS

Using a compliant, variable diameter, visually-guided laser balloon with point-by-point

ablative capability, acute PV isolation can be safely achieved in all PVs. The properties of the

balloon make it amenable to address diverse PV sizes and anatomies. With visual-guidance and

placement of overlapping and contiguous lesions, circumferential and transmural lesions can be

reproducibly achieved which translates to persistent electrical isolation in ~90% of PVs.

FUNDING SOURCES

This study was supported by CardioFocus, Inc.

DISCLOSURES

Vivek Y. Reddy, Petr Neuzil, and Shephal K. Doshi: Research grant support from CardioFocus,

Inc.

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LLLLLLLavavererereeree gngngngngngngne e e eeee T,T,T,T,T,,, H HHHHHHocoooooco

athetetetetetetetererererererer a aa a aa ablblblblblblblatatatatatatatioioioioioioionn

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e afteeeeeeer r r r r rr cicicicicicicircrcrcrcrcrcrcumumumumumumumfefefefefeff r

e

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aroleieieieieieiei A A A A A A A, ,,, ,,, EsEsEsEsEsEsEspopopopopopoposississss t

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Table 1. Histological Lesion Characteristics in the Pre-Clinical Acute and Chronic Porcine Experiments.

Acute Chronic

Pulmonary Veins # of PVs 17 10 Mean Lesion Depth, mm 2.4±0.8 5.0±0.9 Mean Atrial Wall Thickness, mm 3.0±1.0 5.1±0.9 Mean Lesion Transmurality, % 80.8±16.2 98.8±2.1

Histological Sections # of Sections 187 120 Mean Lesion Depth, mm 2.4±2.0 5.0±2.6 Mean Atrial Wall Thickness, mm 3.1±2.5 5.1±2.7 Mean Lesion Transmurality, % 84.6±27.8 99.0±5.5 values are mean±standard deviation

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Table 2. Clinical Phase – Patient Demographics.

Patient Data (N = 27)

Age, mean ± SD (limits) 52.7 ± 12.6 (25 – 66) Gender, M/F 18 / 9 Duration of AF, mean ± SD yrs (limits) 6.7 ± 7.1 (0.3 – 30.0) Coronary Artery Disease, n (%) 1 (3.7%) Hypertension, n (%) 14 (51.9%) Congestive Heart Failure, n (%) 6 (22.2%) Diabetes Mellitus, n (%) 0 (0%) Stroke, n (%) 0 (0%) Structural Heart Disease, n (%) 0 (0%) Ejection Fraction, mean ± SD (limits) 67± 7% (45 – 80%)LA Diameter, mean ± SD (limits) 4.5 ± 0.7 (3.0 – 5.6)History of Atrial Flutter, n (%) 6 (22.2%) Antiarrhythmic Medications Class I 13 (48.1%) Class II 14 (51.9%) Class III 6 (22.2%) Class IV 4 (14.9%)

* LA diameter (N=20, ejection fraction (N=22). One patient had a LA diameter of 5.6 cm and represented a protocol deviation.

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FIGURE LEGENDS

Figure 1. The Visually-Guided Laser Balloon Ablation Catheter. A schematic representation

of the catheter is shown in (A). Within the central shaft are the 2F endoscope, lesion generator,

and cooling conduits for circulating D2O. The radiopaque “L” marker is located 180o opposite to

the partially obscured view location seen on endoscopic visualization. The balloon catheter is

shown in (B). The catheter also consists of a variable diameter and compliant balloon, and an

atraumatic and flexible tip. The adjustable aiming point is also shown in a view from the tip of

the catheter (C). This aiming point can be manipulated in a circumferential and longitudinal

manner to control the site of laser energy delivery.

Figure 2. Positioning of the Balloon Ablation Catheter and Endoscopic Views. (A) The

deflectable sheath and circular mapping catheter is situated at the ostium of the LSPV of a pig.

The anatomy of the PV is identified with injection of dye through the sheath. (B) The balloon

ablation catheter is shown situated at the ostium of the LSPV and conforms well to the shape of

the PV ostium and antrum (arrow). Endoscopic views from a different animal with the balloon

in the LSPV are shown in (C) and (D). The area of good balloon contact around the vein is pale

and the area with blood is red. The partially obscured view due to the central shaft is also shown

(white, dashed lines). The aiming point is manipulated around the ostium of the PV and

determines site of laser energy delivery. The ablation lesions are also visualized.

Figure 3. Gross Examination of the Pulmonary Veins Following Laser Ablation Using the

Balloon Ablation Catheter. The explanted left atrium of a pig following laser balloon ablation

of the RSPV and LSPV is shown in (A). The left atrium is inverted to display the endocardial

surface. The ablation lesions are seen around the PVs and appear to be contiguous and

circumferential. However, on closer examination a visual gap in the ablation line was identified

(B) and (C). While this was not fully appreciated during the procedure, careful retrospective

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review of the endoscopic films identified the gap which occurred due to insufficient lesion

overlap in the area. Interestingly, despite the visible gap, the PV was electrically isolated.

Figure 4. Gross and Histological Assessment of Chronic Lesions. (A) Circumferential and

contiguous lesions around the pulmonary vein (PV) of a pig are shown 4 weeks post-ablation.

The lesions are paler and less intense than those seen acutely. (B) A histological section

(Masson’s trichrome stain) showing a transmural lesion adjacent to the PV ostium is shown

(arrow). The lesion extends into the adjacent lung and pulmonary artery.

Figure 5. Balloon Contact and Visualization. A 3D CTA reconstruction of the left atrium of a

patient who underwent ablation is shown in the right anterior oblique (A) and posteroanterior (B)

projections. The RIPV of the patient has multiple proximal branches (1-4). The compliant

balloon catheter was placed in the RIPV and conformed well to the size and shape of the PV

ostium (C). An endoscopic view through the balloon catheter showed not only good contact

with the area around the PV ostium, but was also able to delineate the numerous branches of the

RIPV (D).

Figure 6. A Single Balloon Catheter Conforming to Multiple PVs. (A) The baseline 3D CTA

reconstruction of the left atrium of a patient who underwent ablation is shown in the

posteroanterior projection is shown. This patient had an LSPV (yellow dashed line), LIPV, and a

single RCV (white dashed line). The variable radius and compliant nature of the balloon was

able to conform to the different size and shapes of the LSPV (B) and RCV (C) allowing for

successful pulmonary vein isolation. (D) The post-ablation electroanatomical map in the

posteroanterior view of the left atrium of the same patient is shown. Superimposed on the 3D

CTA is a bipolar voltage map following electrical isolation of all veins. The color range of the

voltage map spans from 0.1mV (gray) to 1.0mV (purple) and delineates the level of electrical

isolation.

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Y. ReddySrinivas R. Dukkipati, Petr Neuzil, Jan Skoda, Jan Petru, Andre d'Avila, Shephal K. Doshi and Vivek

Pulmonary Vein IsolationVisual Balloon-Guided Point-By-Point Ablation: Reliable, Reproducible, and Persistent

Print ISSN: 1941-3149. Online ISSN: 1941-3084 Copyright © 2010 American Heart Association, Inc. All rights reserved.

Dallas, TX 75231is published by the American Heart Association, 7272 Greenville Avenue,Circulation: Arrhythmia and Electrophysiology

published online May 26, 2010;Circ Arrhythm Electrophysiol.

http://circep.ahajournals.org/content/early/2010/05/26/CIRCEP.109.933283World Wide Web at:

The online version of this article, along with updated information and services, is located on the

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is online at: Circulation: Arrhythmia and Electrophysiology Information about subscribing to Subscriptions:

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requested is located, click Request Permissions in the middle column of the Web page under Services. FurtherCenter, not the Editorial Office. Once the online version of the published article for which permission is being

can be obtained via RightsLink, a service of the Copyright ClearanceCirculation: Arrhythmia and Electrophysiology Requests for permissions to reproduce figures, tables, or portions of articles originally published inPermissions:



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SUPPLEMENTAL MATERIAL

Supplemental Table 1. Number and Type of PVs Targeted for Ablation

Number Treated

(N = 101)

LSPV 21

LIPV 21

LCPV 6

RSPV 25

RIPV 25

RCPV 2

LA Roof Vein 1

Supplemental Table 2. Chronic PV Isolation in Patients with Remapping Procedures.

LSPV LIPV LCV RSPV RIPV RCV AF

Symptoms Documented

1 + + + + No No

2 + + + No No

3 + + + – No No

4 + + + + No No

5 + + + + No No

6 + + – + No No

7 + + + + No No

8 + + + Yes Yes

9 + + + + No No

10 + + + + No No

11 + + – No No

12 + + + + No No

13 + + + + Yes Yes

14 – + + + Yes No

15 + + + No No

16 + + + + No No

17 – + + – No No

18 + + – + Yes Yes

Total 13/15 15/15 3/3 15/17 14/17 1/1

86.7% 100% 100% 88.2% 82.4% 100%

Supplemental Figure 1

Supplemental Figure 2

SUPPLEMENTAL FIGURE & VIDEO LEGENDS

Supplemental Figure 1. 3D CTA Reconstructions of the Left Atria Illustrating the

Different PV Anatomies that were Targeted. These posteroanterior views of the left atrium

show typical PV variants that were successfully targeted with the balloon ablation catheter.

There were patients with separate ostia for all 4 PVs (upper left), a right common vein (upper

right), a left common vein (bottom left), and a small left middle vein (arrow, bottom right).

Supplemental Figure 2. An Illustration Highlighting Areas of Chronic PV Reconnection.

An anteroposterior illustration of the left atrium and pulmonary veins showing the areas of

chronic PV reconnections that were seen in 6 of 18 patients during the remapping procedures.

There were no reconnections involving the right or left common veins, or the LIPV.

Movie 1. Endoscopic Visualization of PV Branches. The endoscopic view of the branches

of the right inferior PV described in Figure 5 are seen.

Movie 2. Endoscopic Visualization During Point-by-Point Ablation. The balloon catheter is

at the ostium of the right superior PV; shown are the fluoroscopic image (top left), an

intracardiac ultrasound image (bottom left), and the endoscopic view (right). The laser ablation

lesions are shown being created (from ~1 o’clock to ~5 o’clock); in the interests of time, the

video is shown at accelerated speed.

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