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Ann Thorac Surg 1997;64:180
© 1997 The Society of Thoracic Surgeons

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Invited Commentary

Invited Commentary

Department of Medicine and Cardiothoracic Surgery, Montefiore Hospital, 111 E 210th St, Bronx, NY 10467

See also page 175.

About 42,000 Telectronics 330-801 bipolar atrial leads have been implanted over the past several years. The leads were relatively easy to use and, unlike some other atrial bipolar leads, the insulation was durable, so that many physicians used them when an active-fixation, bipolar atrial lead was selected. The same manufacturer provided passive-fixation bipolar atrial leads during the same time frame. In both instances the J shape was maintained by a flat wire embedded between the outer coaxial conductor and the outer polyurethane sheath. This wire is flexible and bends easily, and both leads are easily straightened by a guidewire placed within the lead lumen. The few failures of the 330-801 lead by fracture of the J wire, which might extrude from the lead and perforate the heart or an adjacent great vessel, has caused a problem unique in the history of pacemaker leads. The actual proportion of leads that have or can be expected to fail is unknown. Other recalled leads, perhaps 300,000 to 350,000 of them, have caused patient difficulty because of poor performance. Deteriorated insulation causes difficulty because pacing or sensing is inadequate. In the instance of the 330-801, even in the presence of normal pacing and sensing, the migration of the fractured J wire may actively cause serious patient difficulty. Even the 330-854, the passive-fixation lead version, is now being evaluated for potential wire fracture. It is not yet clear whether concern is warranted.

Nevertheless, the actual number of injuries and fatalities associated with this lead has been greater during removal of the leads than from the leads remaining in situ. Although the removal effort has been encouraged by the manufacturer on advice from its medical advisory board, the decision to remove all such leads may become so drastic an intervention that it, too, has its drawbacks. As of January 30, 1997, six deaths were deemed to result from the lead and 13 from an effort at lead removal; six of the 13 deaths were in class I (no fracture) (Personal communication, Accufix Research Institute, March 5, 1997). Physicians and surgeons involved in lead extraction should carefully assess (as in all of medicine) the individual indications for intervention and consider carefully the expertise of the operator.

Lead systems have been a serious problem over the entire history of pacemaker technology. In the earliest days, both pulse generators and lead systems failed frequently and were substantially equally unreliable. Later, with pulse generators having a consumable element (the battery), leads were deemed to be durable elements and pulse generators expendable. With the advent of dual-chamber pacemakers during the decade of the 1970s, it became clear that placing both an atrial and a ventricular lead in many patients would provide hardware bulk larger than could be accommodated. The polyurethane-insulated leads were much smaller and amenable to dual-chamber pacing. At present, leads are causing significant difficulty while pulse generators are quite reliable and, when depleted, fail in an orderly and predictable manner.

Telfer and associates are to be commended for their skill and avoidance of significant technical difficulty in this series of patients. Yet, optimism must be tempered because less experienced people continue to remove leads and patient injury can be assumed to continue over the next several years.

Related Article

Telectronics 330-801 Atrial Lead Extraction via the Subclavian Approach

Edward A. Telfer, Brian Olshansky, Christopher Cadman, Stephen P. Prater, Charles Lanzarotti, Ronald H. Miles, and Bradford P. Blakeman
Ann. Thorac. Surg. 1997 64: 175-180. [Abstract] [Full Text]

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This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Seymour Furman Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Furman, S. Search for Related Content PubMed Articles by Furman, S. Related Collections Related Article