Peer Review Report For: Case Report: A nine year follow-up for a pacemaker generator poly-tetra-fluoro-ethylene coating for allergic reactions to pacemaker compounds [version 1; peer review: 2 approved with reservations]

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Background: Allergic reaction to pacemaker compounds is a rare complication of cardiac pacing. Initial management is difficult because accurate diagnosis is often delayed. The tendency is to initially suspect a bacterial infection, rather than to quickly rule out an allergy to the pacemaker components. Management of this condition is difficult and not well established. Case presentation: A 75-year-old man underwent a dual chamber pacemaker implantation. The patient needed two generator re-implantations because of sterile skin necrosis. Pace maker allergic reaction was suspected despite non-conclusive skin patch testing. The patient underwent pacemaker system removal and re-implantation of poly-tetra-fluoro-ethylene sheet coated generator in a retropectoral position. Subsequently, there has been no externalization or recurrence in nine years of follow-up. Take-away lesson: Contact allergy to pacemakers is often unrecognized. Once infection has been excluded, allergy testing must be performed. The only valuable treatment is the removal of all the system components, followed by a replacement with hypoallergenic material. Polytetrafluoroethylene coated materials can be effective to prevent recurrence.

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