This technology is an improved, minimally invasive technique for biventricular heart pacing using ventricle leads that include an anatomically shaped stylet.
Unmet Need: Effective, fast technique for establishing biventricular pacing
Congestive heart failure is growing public health problem, with more than 550,000 new cases in the U.S. each year. Biventricular pacing is an established therapy for patients with congestive heart failure and left ventricular dyssynchrony, but electrode placement is technically difficult and fails in 10 percent of cases. Current methods of implanting left ventricular pacing are particularly problematic as coronary sinus lead insertion is both invasive and time consuming, leading to reduced effectiveness of cardiac resynchronization therapy.
The Technology: Device and methodology for improved biventricular pacing after heart failure
This technology describes a technique and embodiments for temporary or permanent post-surgical biventricular heart pacing, as well as new methodology to place leads employing open chest or less invasive parasternal lead insertion. This methodology utilizes a flexible coronary sinus lead guided via a routinely placed cannula and includes a rigid shaped stylet that conforms to the expected curves of the coronary sinus and branch vein. Transvenous pacing is particularly valuable as an alternative for returning patients, in which the left ventricle epicardium is inaccessible. It can also be implemented in patients when it is infeasible to obtain a stable pacing site. In some embodiments, the components allow for insertion under local anesthesia instead of during general anesthesia. Additionally, the modified cannula is useful for all lead insertions, especially when a transvenous approach is not possible, and can be combined with one or more sensors for guidance functions.
This technology has been validated in the coronary sinuses of pig hearts.
Applications:
- Temporary cardiac pacing after cardiac reoperation
- Temporary biventricular pacing in patients with an inaccessible left ventricle epicardium
- Epicardial pacing in patients resistant to intubation and/or general anesthesia
- Lead insertion by parasternal procedure
- Implantation of devices for permanent cardiac pacing
Advantages:
- Enables permanent or temporary biventricular pacing
- Successful cardiac pacing in patients undergoing repeat surgery
- Can be adapted into a number of configurations
- Enables a less invasive procedure without open chest surgery
- Can be modified for use during open chest surgery
- Placement is not restricted to left ventricle leads when insertion is obstructed
- Conforms to the expected curves of the coronary sinus and branch vein
- Incorporates sensors or transmitters to help guide lead placement
- Can be combined with an optional pressure-seal for insertion under local anesthesia
Lead Inventor:
Henry M. Spotnitz, M.D.
Patent Information:
Patent Status
Related Publications:
Spotnitz HM, Yeager KJ, Cabreriza SE, Vunjak-Novakovic G, Wang DY, Pearson GD “Introducer Development for Coronary Sinus Access From Parasternal Mediastinotomy” Innovations (Phila). 2015 May-Jun; 10(3): 202-8.
Wang DY, Gerrah R, Rusanov A, Yalamanchi V, Cabreriza SE, Spotnitz HM. “Left ventricular pacing lead insertion via the coronary sinus cardioplegia cannula: a novel method for temporary biventricular pacing during reoperative cardiac surgery” J Thorac Cardiovasc Surg. 2011 Jul; 142(1): 73-6.
Quinn TA, Cabreriza SE, Richmond ME, Weinberg AD, Holmes JW, Spotnitz HM. “Simultaneous variation of ventricular pacing site and timing with biventricular pacing in acute ventricular failure improves function by interventricular assist” Am J Physiol Heart Circ Physiol. 2009 Dec; 297(6): H2220-6.
Artrip JH, Sukerman D, Dickstein ML, Spotnitz HM. “Transesophageal echocardiography guided placement of a coronary sinus pacing lead” Ann Thorac Surg. 2002 Oct; 74(4): 1254-1256.
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