Dr Vivek Reddy, Indian-origin doctor in the US, has developed the first wireless pacemaker, confirm results after its one-year trial.
The device, 10% the size of current traditional pacemaker, resembles a tiny, metal silver tube and smaller than a triple-A battery, measuring a few centimeters in length.
“This is the first time we’ve seen one-year follow-up data for this innovative, wireless cardiac pacing technology and our results show the leadless pacemaker is comparable to traditional pacemakers,” said Dr Vivek Reddy, Director of Arrhythmia Services at The Mount Sinai Hospital.
Every year, 7 lakh new patients receive the pacemaker and more than 4 million patients across the globe have a pacemaker, the hospital said.
The new leadless pacemaker eliminates the need for a surgical pocket and the visible pacemaker device on a patient’s chest, no wires or connectors or leads and keeps the patient free from all the restrictions usually imposed.
The device is useful as it’s less infections and develops no complications or dysfunction. “Our latest findings further support the promising performance and safety of this minimally-invasive, non-surgical pacing device. More long-term follow-up of these LEADLESS study patients will further our understanding of the potential advantages, benefits, and complication risks of leadless pacemaker technology, along with additional ongoing, larger trials,” Dr Reddy said.
The device was tested on 32 patients with a slowed heartbeat, bradycardia, at two hospitals in Prague and one in Amsterdam, the hospital said. The miniature, leadless cardiac pacemaker can be placed directly inside a patient’s heart without surgery during a catheter-guided procedure through the groin via the femoral vein, said a statement from the hospital.
It closely monitors the heart’s electrical rhythms and if the heart beat is too slow it provides electrical stimulation therapy to regulate it. The results of the trial show pacing thresholds (0.43 volts) and sensing (10.32 mV) of the leadless pacemaker device are as good as those in traditional pacemakers, said the statement.
Reddy presented the findings on May 9 at Heart Rhythm 2014, the Heart Rhythm Society’s 35th Annual Scientific Sessions in San Francisco. He was the first to implant the new pacemaker at the Mount Sinai Hospital launching the multicenter clinical trial LEADLESS II. The device will undergo further tests for safety and efficacy in 670 patients at 50 centers across the US and Canada.
Dr Reddy specializes in cardiology at Mount Sinai Hospital in New York City, where he is also a professor. He conducts complex ablative procedures, state-of-the-art Atrial Fibrillation ablation and epicardial and endocardial ablation of ventricular tachyaarhythmias. He is the prime operator for left atrial appendage occlusive devices for the prevention of strokes in atrial fibrillation and renal artery denervation for recalcitrant high blood pressure.
His pubished research papers focusing on the use of catheters and he has been featured in essays and scientific papers upwards of 10 times.
Dr Reddy hails from Andhra Pradesh and earned his Medical Doctorate from the University of Michigan Medical School, and pursued his residency in internal medicine at the Yale-New Haven Hospital.
He completed his fellowship in cardiovascular diseases at the University of Chicago Hospitals, and another fellowship in electrophysiology at Massachusetts General Hospital, before joining the Mount Sinai in 2009.
Prior to it, he was the Director of Cardiac Electrophysiology and Associate Professor of Medicine at the University of Miami, Miller School of Medicine.
Dr Reddy’s Publications:
Reddy VY, Neuzil P, Taborsky M, Ruskin JN. Short-term results of substrate mapping and radiofrequency ablation of ischemic ventricular tachycardia using a saline-irrigated catheter. J Am Coll Cardiol 2003 Jun; 41(12): 2228-2236.
D’Avila A, Scanavacca M, Sosa E, Ruskin JN, Reddy VY. Pericardial anatomy for the interventional electrophysiologist. J Cardiovasc Electrophysiol 2003 Apr; 14(4): 422-430.
Reddy VY, Malchano ZJ, Holmvang G, Schmidt EJ, d’Avila A, Houghtaling C, Chan RC, Ruskin JN. Integration of cardiac magnetic resonance imaging with three-dimensional electroanatomic mapping to guide left ventricular catheter manipulation: feasibility in a porcine model of healed myocardial infarction. J Am Coll Cardiol 2004 Dec 7; 44(11): 2202-2213.
Mikaelian BJ, Malchano ZJ, Neuzil P, Weichet J, Doshi SK, Ruskin JN, Reddy VY. Images in cardiovascular medicine. Integration of 3-dimensional cardiac computed tomography images with real-time electroanatomic mapping to guide catheter ablation of atrial fibrillation. Circulation 2005 Jul; 112(2): e35-36.
Obel OA, d’Avila A, Neuzil P, Saad EB, Ruskin JN, Reddy VY. Ablation of left ventricular epicardial outflow tract tachycardia from the distal great cardiac vein. J Am Coll Cardiol 2006 Nov 7; 48(9): 1813-1817.
Aryana A, d’Avila A, Heist EK, Mela T, Singh JP, Ruskin JN, Reddy VY. Remote magnetic navigation to guide endocardial and epicardial catheter mapping of scar-related ventricular tachycardia. Circulation 2007 Mar 13; 115(10): 1191-1200.
Reddy VY, Neuzil P, Malchano ZJ, Vijaykumar R, Cury R, Abbara S, Weichet J, McPherson CD, Ruskin JN. View-synchronized robotic image-guided therapy for atrial fibrillation ablation: experimental validation and clinical feasibility. Circulation 2007 May 29; 115(21): 2705-2714.
Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med 2007 Dec; 357(26): 2657-2665.
Dukkipati SR, Mallozzi R, Schmidt EJ, Holmvang G, d’Avila A, Guhde R, Darrow RD, Slavin G, Fung M, Malchano Z, Kampa G, Dando JD, McPherson C, Foo TK, Ruskin JN, Dumoulin CL, Reddy VY. Electroanatomic mapping of the left ventricle in a porcine model of chronic myocardial infarction with magnetic resonance-based catheter tracking. Circulation 2008 Aug 19; 118(8): 853-862.
Reddy VY. Atrial fibrillation: unanswered questions and future directions. Cardiol Clin 2009 Feb; 27(1): 201-216, x-xi.
Reddy VY, Neuzil P, Themistoclakis S, Danik SB, Bonso A, Rossillo A, Raviele A, Schweikert R, Ernst S, Kuck KH, Natale A. Visually-guided balloon catheter ablation of atrial fibrillation: experimental feasibility and first-in-human multicenter clinical outcome. Circulation 2009 Jul 7; 120(1): 12-20.
Ahmed H, Reddy VY. Technical advances in the ablation of atrial fibrillation. Heart Rhythm; In Press.
Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P, P. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet 2009 Aug 15; 374(9689): 534-542.