December Newsletter copy - Stereotaxis · DECEMBER 2015 VOLUME 1 ISSUE 4 ... French symposium attracted 860 participants, ... Ventricular Arrhythmias Using Contact Force

STEREOTAXIS NEWS VOLUME 1 ISSUE 4DECEMBER 2015

Questions? Contact [email protected]

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Remote Magnetic Navigation:Latest Clinical Research and Novel Techniques

Michael Porter, MD, FACC, FHRSSaint Joseph Hospital (Denver, CO)

Tamas Szili-Torok, MD, PhDErasmus MC (Rotterdam, Netherlands)

Luigi Di Biase, MD, PhD, FACC, FHRSMonte�ore Medical Center (Bronx, NY)

PresentersAndrea Natale, MD, FACC, FHRS, FESCExecutive Medical Director, Texas Cardiac Arrhythmia InstituteSt. David’s Medical Center (Austin, TX)

Moderator

DateJanuary 14-16, 201614

Thurs Booth Exhibit HoursThursday, January 14 9:00 am – 4:30 pmFriday, January 15 9:00 am – 4:30 pmSaturday, January 16 9:00 am – 2:00 pm

LocationBooth #324BHyatt Regency Orlando49801 International DriveOrlando, FL 32819

Join us for a scienti�c program featuring expert physicians on the use of the Stereotaxis robotic navigation platform.

Date: Thursday, January 14, 2016Time: 12:00 – 1:30 PM (complimentary lunch provided on a first come, first served basis)Location: Regency Ballroom – Product Theatre One (Hyatt Regency Orlando)

Season’s GreetingsWishing you a joyful holiday

Join Stereotaxis at the 21st AnnualInternational AF Symposium

Product Theatre Symposium

Dear valued customer,

As we approach the end of 2015, I would like to express my sincere gratitude to you, our valued customer, for making

Stereotaxis a part of your ever-advancing journey to make patients healthier.

All of us at Stereotaxis look forward to

continuing our collaboration with you in the years to come.

William C. Mills III

Chairman of the Board & Chief Executive Officer

Questions? Contact [email protected]

Desert Springs Hospitalin the News

France

Asia-Pacific

September 23-25 marked Stereotaxis’ fourth appearance at the French Arrhythmia Congress in Avignon, France. Hosted by the French Society of Cardiology, the biennial, entirely French symposium attracted 860 participants, up 13% from attendance in 2013. The event is held in the Palais des Papes, a one-time fortress, palace and papal residence during the 14th century.

In early December, Desert Springs Hospital (Las Vegas, NV) was featured on the local FOX station, KVVU. Desert Springs Hospital is the only institution in Nevada to offer Stereotaxis’ remote magnetic navigation system and installed the Niobe™ system in January 2015. The hospital has increased its electrophysiology program to include complex arrhythmia procedures and attracts physicians from three separate cardiology groups from the Las Vegas region.

In this news segment, Dr. Erik Sirulnick, described how the magnets guide the direction of the catheter, the softness and the safeness of the catheter. It also featured a patient testimonial – Pamella Blair. Pamella was treated by Dr. Sirulnick at Desert Springs Hospital with the Niobe system. She had suffered from a concealed AVRT and for over 20 years, was unsuccessfully treated with drugs and manual ablation. The illness rendered her inactive, short of breath and debilitated her quality of life drastically. The effects of her arrhythmia were so severe that she was even unable to pick up her granddaughter. The Stereotaxis technology, with its unprecedented safety profile, high efficiency and ability create durable lesions helped cure Pamella. Her quality of life has been restored.

In early November, University Medical Center (UMC) New Orleans (New Orleans, LA), the academic medical center of LCMC Health completed its first procedure performed using the Niobe™ remote magnetic navigation system on a patient with Wolff-Parkinson-White syndrome.

The Stereotaxis lab at UMC is led by expert EP practitioners and educators in the area, including Dr. Colleen Johnson, Director of Cardiac Electrophysiology at Tulane Heart and Vascular Institute, and Dr. Paul LeLorier, Director of Electrophysiology Services at LSU Health Sciences Center, both partners of UMC. The first procedure was performed by Dr. Jameel Ahmed.

The UMC lab is equipped with the Niobe remote magnetic navigation system, the Vdrive™ robotic navigation system and Odyssey™ information management solutions.

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“I was cured. It’s gone, no more, I won’t have to deal with it…It’s just been amazing.”

Watch the news segment here http://goo.gl/jBKLUT

Pamella Blair patient treated with Stereotaxis’ remote magnetic navigation system

In November, during the Asia Pacific Heart Rhythm Society (APHRS) scientific session in Melbourne, Australia, Stereotaxis hosted a Users Meeting Luncheon and Roundtable Discussion with Dr. Eric Prystowsky for our Asia Pacific magnetic navigation users. The luncheon brought together physicians from Australia, Singapore, and Japan.

Dr. Eric Prystowsky and Dr. Chi Keong Ching

First Patient Treated at University Medical Center New Orleans

Questions? Contact [email protected]

On November 3, 2015, Dr. Peter Weiss of Intermountain Medical Center(Salt Lake City, UT) presented a webinar presentation on

“The advantages of magnetic navigation in the growing area of ventricular tachycardia (VT) ablation”.

In it, Dr. Weiss described the following key points► the need for ablation in VT patients► the clinical proof remote magnetic navigation (RMN) has in treating VT ► the advantages of RMN technology in creating stable focal contact and treating fascicular VT ► how RMN makes treating VT more approachable► the benefits of working from a control room

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e-lectrophysiology Webinar Education Series

The recording can be viewed herehttp://goo.gl/U6zWR4

Live from Russia

In October, for the third consecutive year, a live remote magnetic navigation procedure was transmitted to the All-Russian Workshop of “Clinical Electrophysiology, Interventional and Surgical Arrhythmology” at the Bakulev Center in Moscow. This is a truly poignant education workshop as all physicians in Russia are required to complete this course in order to become EP specialists. This year, a complex left atrial procedure was performed using the Niobe™ remote magnetic navigation system by Dr. Vitaliy Shabanov and transmitted from Meshalkin Hospital in Novosibirsk.

Dr. Shabanov focused on the safety profile of the technology, automated features, and the low X-ray exposure to both patient and physicians.

The full text publications of two recently highlighted scientific peer-reviewed journal articles can be accessed on the Stereotaxis website. Use the links below to access a complimentary copy.

Full Text Scientific Publications Available

Magnetic guidance versus manual control: comparison of radiofrequency lesion dimensions and evaluation of the e�ect of heart wall motion in a myocardial phantom.

Bhaskaran A, Barry MA, I Al Raisi S, Chik W, Nguyen DT, Pouliopoulos J, Nalliah C, Hendricks R, Thomas S, L McEwan A, Kovoor P, Thiagalingam A.

J Interv Card Electrophysiol. 2015 Oct;44(1):1-8. doi: 10.1007/s10840-015-0023-3.Epub 2015 Jun 30.

Full text link http://goo.gl/r672Qx PMID 26123094

PMID 26200478

Safety and Clinical Outcome of Catheter Ablation of Ventricular Arrhythmias Using Contact Force Sensing:Consecutive Case Series.

Hendriks AA, Akca F, Dabiri Abkenari L, Khan M, Bhagwandien R, Yap SC, Wijchers S, Szili-Torok T.

J Cardiovasc Electrophysiol. 2015 Jul 20. doi: 10.1111/jce.12762. [Epub ahead of print]

Full text link http://goo.gl/qzu2NC

Questions? Contact [email protected]

Latest Scientific Publication

Compare procedural bene�t and outcomes of patients with ischemic cardiomyopathy (IC) undergoing ventricular tachycardia (VT) ablation with remote magnetic navigation (RMN) versus a manual approach.

Objective

Substrate mapping and ablation technique with scar homogenization were utilized for ablation with the end point of elimination of all abnormal electrograms within and or around the scar area.

Methods

Using RMN in patients with IC and a scar size greater than 60 cm2 increases success rate at follow up when compared to manual ablation.

With manual ablation these type of procedures are time consuming and the outcomes might be a�ected by fatigue.

Conclusion

A total of 218 consecutive patients with scar size > 60 cm2 underwent scar homogenization with either RMN (138 patients) or manual (80 patients) ablation. Mean scar size was 140±61 cm2. VT was inducible in 83% of patients with a cycle length of 352.1±70.7 msec.

60% higher substrate map density with RMN yet a lower mapping time (80.3 min with RMN vs. 96.1 with manual).

Higher RF time with RMN (74.4 min vs. 66.1 min with manual), leading to better outcome, according to the authors.

Acute ablation success was achieved in 217 (99.5%) of patients.

One pericardial tamponade occurred in the manual ablation group (1.25% of patients).

Mean follow-up was 15.4±6.8 months.

Results

Scar Homogenization Ablation in Patients with Ischemic Cardiomyopathy: Comparison Between Remote Magnetic Navigation and Manual Ablation

Circulation.2015; 132: A14384

Di Biase, et al. Publication includes authors from multiple centers including St David’s Medical Center, UCLA Health System, and University of Kansas. (See attached poster for participating authors and institutions details.)

81%

69%

60%

65%

70%

75%

80%

85%

RMN Manual

Chronic Success

p=0.037

After 15.4±6.8 months

- Dr. J. David Burkhardt

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Questions? Contact [email protected]

Luigi Di Biase1,2,3,4, MD, PhD; Roderick Tung5, MD; J. David Burkhardt1, MD; Jorge Romero5 ; Chintan Trivedi1, MD, MPH; Sanghamitra Mohanty1, MD; Carola Gianni1, MD; Pasquale Santangeli1,4, MD; Rong Bai1, MD; Rodney Horton1, MD; Javier E. Sanchez1, MD; G. Joseph Gallinghouse1, MD; Patrick Hranitzky1,MD; Amin Al-Ahmad1, MD; Dhanunjaya Lakkireddy6, MD; Yaruva Madhu Reddy6; MD; Salwa Beheiry7, RN; Richard Hongo7, MD Kalyanam Shivkumar5, MD; Andrea Natale1,3,7,8,9,10, MD.

Scar Scar HomogeneizationHomogeneization Ablation In Patients With Ischemic Cardiomyopathy: Comparison Between Remote Magnetic Ablation In Patients With Ischemic Cardiomyopathy: Comparison Between Remote Magnetic Navigation And Manual AblationNavigation And Manual Ablation

1) Texas Cardiac Arrhythmia Institute at St David Medical Center, Austin, Texas, USA; 2) Albert Einstein College of Medicine, at Montefiore Hospital, New York, USA; 3) University of Texas, Department of Biomedical Engineering, Austin, Texas, USA; 4) Department of Cardiology, University of Foggia, Foggia, Italy; 5) UCLA Cardiac Arrhythmia Ctr, UCLA Health System, Los Angeles, CA; 6) University of Kansas, Kansas City ;7) California Pacific Medical Center, San Francisco, California, USA; 8) Stanford University, CA, USA,; 9) Case Western University, Ohio, USA; 10) Scripps Clinic, CA, USA

• Remote magnetic navigation (RMN) and ablation with the magnetic irrigated tip catheter has been reported as a feasible and safe technique for the treatment of ventricular arrhythmias (VA).

• We compared the procedural benefit and the outcomes of patients with ischemic cardiomyopathy (IC) undergoing VAs ablation with the RMN versus the manual approach.

AbstractAbstract

IntroductionIntroduction

Introduction: Remote magnetic navigation (RMN) and ablation with the magnetic irrigated tip catheter has been reported as a feasible and safe technique for the treatment of ventricular arrhythmias (VA). We compared the procedural benefit and the outcomes of patients with ischemic cardiomyopathy (IC) undergoing VAs ablation with the RMN versus the manual approach. Methods: Consecutive pts with IC undergoing VAs ablation both with RMN and with manual ablation at different Institutions were enrolled. Substrate mapping and ablation technique with scar homogenization were utilized for ablation with the end point of elimination of all abnormal electrograms within and or around the scar area. Procedural data and outcomes were analyzed. Postablation pacing maneuvers and isoproterenol were used to verify Vas inducibility. Results: A total of 218 consecutive pts (85.3% male, 69.2±7.7 years, LVEF 30.6±8.2) with IC were included with 80 pts undergoing manual ablation while 138 pts underwent RMN ablation. Patients with a scar size < 60 cm2 at the 3D voltage mapping system were excluded. The mean scar size was 140 ± 61 cm2. VT was inducible in 83% pts with a cycle length of 352.1±70.7 msec. The density of the substrate map was higher in the RMN group when compared to the manual ablation group (553±118 vs 347±97, p<0.001). Acute ablation success was achieved in 217 (99.5%) of pts. The mean procedural duration and fluoroscopy time was 255.8±116.6 min and 34.8±22.9 min respectively. The mean mapping time was lower in the RMN group (80.3 ± 13.8 min) compared to the manual ablation group (96.1 ± 20.3 minutes, p < 0.001), while the radiofrequency time was lower in the manual ablation group(66.1 ± 27.3 min vs. 74.4 ± 20.7 min, p=0.02). At 15.4±6.8 months follow-up the success rate in the RMN group was 81.2% (112) while in the manual ablation group 55 (69%) pts were recurrence free (p=0.037). There was one pericardial tamponade which required pericardiocentesis in the manual ablation group. Conclusion: This study shows that VAs ablation using RMN in pts with IC and a scar size greater than 60 cm2 increases success rate at follow up when compared to manual ablation. The better outcome might be due to the higher amount of time dedicated to RF applications to achieve scar homogenization rather than mapping.

• Consecutive pts with IC undergoing VAs ablation both with RMN and with manual ablation at different Institutions were enrolled.

• Substrate mapping and ablation technique with scar homogenization were utilized for ablation with the end point of elimination of all abnormal electrograms within and or around the scar area.

• Procedural data and outcomes were analyzed. Postablation pacing maneuvers and isoproterenol were used to verify Vas inducibility.

MethodsMethods

ResultsResults • A total of 218 consecutive pts (85.3% male, 69.2±7.7 years, LVEF

30.6±8.2) with IC were included with 80 pts undergoing manual ablation while 138 pts underwent RMN ablation.

• Patients with a scar size < 60 cm2 at the 3D voltage mapping system were excluded.

• The mean scar size was 140 ± 61 cm2. VT was inducible in 83% pts with a cycle length of 352.1±70.7 msec. The density of the substrate map was higher in the RMN group when compared to the manual ablation group (553±118 vs 347±97, p<0.001).

• Acute ablation success was achieved in 217 (99.5%) of pts. The mean procedural duration and fluoroscopy time was 255.8±116.6 min and 34.8±22.9 min respectively.

• The mean mapping time was lower in the RMN group (80.3 ± 13.8 min) compared to the manual ablation group (96.1 ± 20.3 minutes, p < 0.001), while the radiofrequency time was lower in the manual ablation group(66.1 ± 27.3 min vs. 74.4 ± 20.7 min, p=0.02).

• At 15.4±6.8 months follow-up the success rate in the RMN group was 81.2% (112) while in the manual ablation group 55 (69%) pts were recurrence free (p=0.037).

• There was one pericardial tamponade which required pericardiocentesis in the manual ablation group.

• This study shows that VAs ablation using RMN in pts with IC and a scar size greater than 60 cm2 increases success rate at follow up when compared to manual ablation.

• The better outcome might be due to the higher amount of time dedicated to RF applications to achieve scar homogenization rather than mapping.

FigureFigure

ConclusionsConclusions

DisclosuresDisclosures Dr. Di Biase is a consultant for Hansen Medical Biosense Webster, St Jude Medical and received speaker honorarium/travel reimbursement from Biotronik, Atricure and Epi EP. Dr. Natale received speaker honorariums from Boston Scientific, Biosense Webster, Medtronic and St. Jude. All the remaining authors have no disclosures.

• Example of a patient undergoing manual sichemic VT ablation. Note the large size reconstructed with the three-dimensional mapping system.

• Substrate mapping and ablation technique with scar homogenization were utilized for ablation with the end point of elimination of all abnormal electrograms within and or around the scar area.

• With manual ablation these type of procedures are time consuming and the outcomes might be affected by ‘fatigue”.

Latest Scientific Publication - continued