https://www.heartrhythmjournal.com/article/S1547-5271(09)00562-1/pdf

Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management: This document was endorsed by the American Heart Association (AHA)

MEMS devices are manufactured using similar microfabrication techniques as those used to create integrated circuits. They often, however, have moving components that allow physical or analytical functions to be performed by the device. Although MEMS can be aseptically fabricated and hermetically sealed, biocompatibility of the component materials is a key issue for MEMS used in vivo. Interest in MEMS for biological applications (BioMEMS) is growing rapidly, with opportunities in areas such as biosensors, pacemakers, immunoisolation capsules, and drug delivery. The key to many of these applications lies in the leveraging of features unique to MEMS (for example, analyte sensitivity, electrical responsiveness, temporal control, and feature sizes similar to cells and organelles) for maximum impact. In this paper, we focus on how the biological integration of MEMS and other implantable devices can be improved through the application of microfabrication technology and concepts. Innovative approaches for improved physical and chemical integration of systems with the body are reviewed. An untapped potential for MEMS may lie in the area of nervous and endocrine system actuation, whereby the ability of MEMS to deliver potent drugs or hormones, combined with their precise temporal control, may provide new treatments for disorders of these systems.

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A BioMEMS review: MEMS technology for physiologically integrated devices

A closed-loop variable frequency vagal stimulation apparatus for control of ventricular rate during atrial fibrillation. In one embodiment the apparatus includes a stimulator applied to the left vagus nerve and a proportional controller programmed to automatically and continuously adjust the vagal stimulation frequency proportionally as a function of the difference between actual and desired ventricular excitation rates. In a second embodiment the apparatus includes a vagal nerve stimulator and a controller which automatically adjusts the vagal stimulation frequency as a function of the difference between ventricular excitation rate and arterial pulse rate in order to eliminate or minimize pulse deficit.

Method and apparatus using vagal stimulation for control of ventricular rate during atrial fibrillation

A patient monitoring and/or therapy delivery system and method employing an implantable medical device for sensing absolute physiologic signal values within the body of a patient, e.g., absolute blood pressure, temperature, etc., and an external monitoring device for monitoring and conveying ambient signal values to the implantable medical device, wherein the absolute physiologic signal values and the ambient signal values are combined to derive relative physiologic signal values for storage and/or control of a therapy provided by the implantable medical device. In the context of an implantable physiologic monitor, the relative and optionally, the absolute and/or ambient physiologic signal values are stored in memory for telemetry out to an external programmer in an uplink RF telemetry transmission initiated by medical personnel operating the external programmer. In the context of an implantable therapy delivery device, the relative physiologic signal values are also employed in therapy delivery algorithms.

System and method for deriving relative physiologic signals

A rate-responsive pacemaker which includes a conventional programmable pulse generator, a physiological sensor, and a processor is disclosed which generates heart stimulation pulses on demand, or as otherwise programmed, as controlled by a rate control signal which is derived from the physiological sensor. The physiological sensor generates a raw signal which varies as a function of some physiological parameter, such as activity level to provide some indication of whether the heart rate should increase or decrease, and hence whether the pacemaker should change the rate at which pacing pulses are provided. The processor converts the raw signal to the sensor-indicated rate signal in accordance with a selectable transfer relationship which defines the sensor-indicated rate signal as a function of a set of discrete sensor level index signals. The sensor-indicated rate signal remains at a minimum value or base rate for all sensor level index signals below a prescribed rate response threshold, with this rate response threshold being set automatically by the processor as a function of a running average of the sensor level index signals monitored over a prescribed time period.

Microprocessor controlled rate-responsive pacemaker having automatic rate response threshold adjustment

From December 1988 to April 1994, the extraction of 2,195 intravascular pacing leads from 1,299 patients was attempted at 193 centers. Indications were: infection (54%, including 10% septicemia), pacemaker reoperation with removal of nonfunctional or incompatible leads (40%), and other causes (6%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, via the femoral vein using snares, retrieval baskets, and sheaths, or via both approaches. Leads had been implanted for 0.2 months to 24 years (mean 56 months). At the conclusion of the intravascular procedure, 86.8% of the leads were completely removed, 7.5% were partially removed, and 5.7% were not removed. For physicians performing their first case, 12% of leads were not removed; for physicians who had performed more than 10 cases, only 2% of leads were not removed. Of the 189 leads where extraction attempts had previously failed, 75.1% were completely removed, 14.8% were partially removed, and 10.1% were not removed. Scar tissue increased in severity with implant duration, was a complicating factor, and was the main cause of failure to remove leads. Use of the femoral approach increased with implant duration (5% of leads implanted 12 months or less, 11% of leads 13 months to 3 years, 20% of leads 4-7 years, and 31% of leads 8-24 years), primarily because of increasingly abundant scarring and prior lead damage. Fatal and near fatal complications occurred in 2.5%, including 8 (0.6%) deaths (3 hemopericardium/tamponade, 1 hemothorax, 3 pulmonary embolus, 1 stroke).(ABSTRACT TRUNCATED AT 250 WORDS)

Five-years experience with intravascular lead extraction. U.S. Lead Extraction Database.

Chronic lead extraction using intravascular countertraction techniques was studied in patients with over 65 different lead models including passive and active fixation devices. Indications for removal of 115 leads implanted 5 days to 264 months (mean 58 months) in 62 patients (mean 65 years) included septicemia, subcutaneous tissue infection, preerosion, free-floating lead, lead trapped in valve, too many leads, pain, and vein thrombosis. The superior vena cava (SVC) approach was attempted in 101 leads and was successful in 82 attempts (71% of total leads). The inferior vena cava (IVC) approach via the femoral vein was required to extract 14 (12%) leads inaccessible to the SVC approach and the 19 leads that failed the SVC approach (29% of total leads). The SVC procedure includes a sized stylet locked at the tip and telescoping sheaths advanced over the lead to the heart. An IVC procedure includes placement of a 16 F sheath workstation via a femoral vein into the right atrium. A deflection catheter and Dotter snare in an 11 F sheath were advanced through the workstation into the right atrium. The lead was maneuvered into position, snared, and pulled into the workstation. For both the SVC and IVC approaches, the leads were removed by applying traction on the lead and countertraction with the sheaths. In experienced hands, these techniques have proven safe and effective for removing chronic transvenous leads.

Intravascular Lead Extraction Using Locking Stylets and Sheaths

The heart has two properties: rhythmicity and contractility Rhythmic contractions are initiated by the heart's pacemaker, the sinoatrial node, which lies in the right atrium If the sino-atrial node fails, or if its electrical excitations are not propagated to the ventricles (the main pumping chambers), they wil still contract rhythmically but at a rate that is sometimes too slow to provide enough cardiac output to sustain consciousness It is for this reason that rhythmic electrical stimuli are delivered to the ventricles in order to increase cardiac output to a level adequate to permit the subject to perform routine daily tasks The technique of applying rhythmic electrical stimuli to the ventricles is called cardiac pacemaking; it can be achieved in several interesting ways, as this paper will describe

The Exercise-Responsive Cardiac Pacemaker

FEARNOT, N.E., ET AL.: Intravascular Lead Extraction Using Locking Stylets, Sheaths, and Other Techniques. Septicemia necessitates extraction of chronic pacemaker leads. Using locking stylets and sheaths to extract leads via the implantation vein (subclavian, cephalic, or jugular) and maneuvering devices, sheaths, and retrieval baskets via the femoral approach, extraction of 228 leads implanted 5 days to 240 months (mean 55 months) was attempted in 136 patients (mean 62 years) at 34 institutions. In addition to septicemia (9%) and infection (39Y0), total 48%, indications included prophylaxis/replacement (40%), and other (12%). Seventy-seven leads were atrial, 151 ventricular; 147 were unipolar, 81 bipolar; 96 had silicone insulation, 127 polyurethane, 1 poly/silicone, and 2 undetermined. Fixation included tines or fins (1601, screw (401, flange (12), and other (16). One hundred and ninety-four leads were completely extracted, 19 partly extracted, and 15 not extracted. Procedural complications were: torn atrium requiring open heart repair (1), hemothorax requiring a chest tube and blood transfusions (1), subacute hemothorax requiring drainage 18 days after discharge (1), thrombosis treated by drugs (1), and myocardial avulsion without sequela (1). Important observations included the significant training required due to the large number of possible clinical variables, and the need to be prepared for life-threatening cardiovascular complications. With training, procedures done at higher volume and lower volume institutions met with similar success. Conclusion: Intravascular lead extraction is a viable technique whose benefits outweigh the risks, given the proper intensive training and open heart surgical backup, and may obviate the need for open heart surgery for lead extraction.

Intravascular lead extraction using locking stylets, sheaths, and other techniques.

Extraction of chronic pacemaker leads has been recommended for infections, prevention of venous thrombosis, migration, and possible perforation. Success with constant traction techniques has been variable, and the cost and morbidity of open chest surgical procedures are prohibitive. Efficacy of a new system for lead extraction using intravascular techniques was analyzed. The system (Cook Pacemaker) uses a locking stylet, which is secured at the distal electrode by counterclockwise rotation to reinforce the lead and facilitate traction, and dilator sheaths that are used to free the lead from adhesions in the venous system. In a series of 56 patients (ages 19-88) who presented for lead extraction because of erosion (5), infection (14), lead replacement (35), or other (2), 86 leads were extracted. Thirty-two were atrial leads and 54 ventricular; 23 had active fixation and 63 passive. Average duration of implant was 58 +/- 42 months (range 1-264). Eighty-four leads were totally removed and two partially removed. For these two leads, the distal tip was not removed; in both cases the locking stylet was not secured at the distal electrode due to obstruction within the lead. Two patients developed arm edema following the procedure, which resolved with elevation. One patient developed a subclavian thrombosis, which resolved with warfarin anticoagulation. Four patients have expired due to unrelated causes. In conclusion, this intravascular approach for extraction of chronic leads is effective, and the procedure is safe when performed by experienced personnel.

Heidi J. Smith

Papers

Five-years experience with intravascular lead extraction. U.S. Lead Extraction Database.

Intravascular Lead Extraction Using Locking Stylets and Sheaths

The Exercise-Responsive Cardiac Pacemaker

Intravascular lead extraction using locking stylets, sheaths, and other techniques.

Intravascular extraction of chronic pacemaker leads: efficacy and follow-up.