Dual Anchor Internal Pulse Generator Technique May Lower Risk of Twiddler’s Syndrome: A Case Series and Literature Review

Sobstyl, Michał; Ząbek, Mirosław; Brzuszkiewicz-Kuźmicka, Grażyna; Pasterski, Tomasz

doi:10.1111/ner.12581

Cited by 19 publications

(14 citation statements)

References 11 publications

(72 reference statements)

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“…After screening titles and abstracts, 479 potentially relevant articles were identified, and the full text was assessed against the inclusion criteria. Finally, 240 articles were chosen to be included in this meta‐analysis …”

Section: Resultsmentioning

confidence: 99%

Estimating Risk for Future Intracranial, Fully Implanted, Modular Neuroprosthetic Systems: A Systematic Review of Hardware Complications in Clinical Deep Brain Stimulation and Experimental Human Intracortical Arrays

Bullard

Hutchison

Lee

et al. 2020

Neuromodulation: Technology at the Neural Interface

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Objective A new age of neuromodulation is emerging: one of restorative neuroengineering and neuroprosthetics. As novel device systems move toward regulatory evaluation and clinical trials, a critical need arises for evidence‐based identification of potential sources of hardware‐related complications to assist in clinical trial design and mitigation of potential risk. Materials and Methods The objective of this systematic review is to provide a detailed safety analysis for future intracranial, fully implanted, modular neuroprosthetic systems. To achieve this aim, we conducted an evidence‐based analysis of hardware complications for the most established clinical intracranial modular system, deep brain stimulation (DBS), as well as the most widely used intracranial human experimental system, the silicon‐based (Utah) array. Results Of 2328 publications identified, 240 articles met the inclusion criteria and were reviewed for DBS hardware complications. The most reported adverse events were infection (4.57%), internal pulse generator malfunction (3.25%), hemorrhage (2.86%), lead migration (2.58%), lead fracture (2.56%), skin erosion (2.22%), and extension cable malfunction (1.63%). Of 433 publications identified, 76 articles met the inclusion criteria and were reviewed for Utah array complications. Of 48 human subjects implanted with the Utah array, 18 have chronic implants. Few specific complications are described in the literature; hence, implant duration served as a lower bound for complication‐free operation. The longest reported duration of a person with a Utah array implant is 1975 days (~5.4 years). Conclusions Through systematic review of the clinical and human‐trial literature, our study provides the most comprehensive safety review to date of DBS hardware and human neuroprosthetic research using the Utah array. The evidence‐based analysis serves as an important reference for investigators seeking to identify hardware‐related safety data, a necessity to meet regulatory requirements and to design clinical trials for future intracranial, fully implanted, modular neuroprosthetic systems.

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Section: Resultsmentioning

confidence: 99%

Estimating Risk for Future Intracranial, Fully Implanted, Modular Neuroprosthetic Systems: A Systematic Review of Hardware Complications in Clinical Deep Brain Stimulation and Experimental Human Intracortical Arrays

Bullard

Hutchison

Lee

et al. 2020

Neuromodulation: Technology at the Neural Interface

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“…Twiddler and Reel's syndromes have similar contributing factors, such as female gender, obesity, large pocket, old age, dementia, and deep brain stimulation [3-4]. The patient we described was neither obese nor had a diagnosis of dementia.…”

Section: Discussionmentioning

confidence: 92%

Reel Syndrome: An Atypical Cause for Inappropriate Shocks in a Patient with Automated Implantable Cardioverter Defibrillator (AICD)

Mohammad

Pervaiz

Mufti

et al. 2018

Cureus

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A 71-year-old woman, with the past medical history of heart failure with reduced ejection fraction (EF) and automated implantable cardioverter defibrillator (AICD) placement (for low EF 5-10%) in 2015, presented in February 2017 with the complaint of AICD shocks following an episode of vomiting. She denied any chest pain, abdominal pain, shortness of breath, palpitation, or dizziness. Electrocardiogram (EKG) on admission showed ectopic atrial rhythm with premature ventricular contractions in bigeminies, anterior fascicular block, and left axis deviation. On examination of the cardiovascular system, there was a normal S1 heart sound with a loud A2. There was no jugular venous distention on the neck or pitting edema on the legs. Laboratory studies showed no elevation of cardiac enzymes. Evaluation with chest x-ray showed the right ventricular lead had migrated to the right atrium and the defibrillator generator was flipped with leads coiled around it in transverse axis. AICD interrogation was performed which revealed inappropriate shocks were due to atrial fibrillation with rapid ventricular rate and loss of capture of the right ventricular lead. The diagnosis of Reel syndrome was made, and an electrophysiologist was consulted for replacement of the AICD. Reel syndrome is a variant of Twiddler’s syndrome, which is a rare complication of pacemaker implantation. It manifests with the rotation of generator on transverse axis with leads coiling around it. Twiddler’s syndrome, on the other hand, is the rotation of the generator on its long axis, which causes damage to the leads by twisting. Reel syndrome is usually observed within months from the placement of the generator compared to Twiddler, which takes years to occur. Twiddler and Reel's syndromes have similar contributing factors, such as female gender, obesity, large pocket, old age, dementia, and deep brain stimulation. Our patient only had two risk factors, namely, the sex and age. We propose that every patient with a pacemaker malfunction and AICD shocks should have a posterior-anterior (PA) chest x-ray and a lateral chest x-ray in addition to AICD interrogation. Twiddler’s syndrome is effortlessly observed because of the twisting of dual leads compared to Reel syndrome, which is not straightforward because of the lack tortuosity of the leads.

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“…When re-implantation of a device is necessary, the addition of antimicrobial therapy to the device pouch or envelope may reduce rates of infection [19]. Some have also suggested a dual anchoring technique, along with non-absorbable sutures [20].…”

Section: Discussionmentioning

confidence: 99%

Erosive Twiddler’s Syndrome: A Severe Case with Externalization of the Pacemaker

Stuart

Gilbert

Valencia

2020

Cureus

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Implantable pacemakers have been the mainstay of therapy for patients with severely decreased left ventricular ejection fractions and recurrent arrhythmias, among other cardiac pathology. Twiddler's syndrome (TS) is an uncommon but potentially life-threatening complication of pacemaker therapy, defined as pacemaker malfunction in the setting of device lead dislodgment due to physical manipulation. Traditionally, there are three distinct TS variants (reeling, ratchet and coiling). This case offers evidence of a unique and new variant of TS, severe recurrent erosive subtype with pacemaker externalization.

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Dual Anchor Internal Pulse Generator Technique May Lower Risk of Twiddler’s Syndrome: A Case Series and Literature Review

Cited by 19 publications

References 11 publications

Estimating Risk for Future Intracranial, Fully Implanted, Modular Neuroprosthetic Systems: A Systematic Review of Hardware Complications in Clinical Deep Brain Stimulation and Experimental Human Intracortical Arrays

Estimating Risk for Future Intracranial, Fully Implanted, Modular Neuroprosthetic Systems: A Systematic Review of Hardware Complications in Clinical Deep Brain Stimulation and Experimental Human Intracortical Arrays

Reel Syndrome: An Atypical Cause for Inappropriate Shocks in a Patient with Automated Implantable Cardioverter Defibrillator (AICD)

Erosive Twiddler’s Syndrome: A Severe Case with Externalization of the Pacemaker

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