Response to: Critical Analysis of the TYRX Absorbable Antibacterial Envelope's Impact on Device Pocket Healing
Bibliographic record
Abstract
While we agree to more studies on the topic, as acknowledged in our manuscript: “Larger, controlled studies are needed to confirm these findings and ensure their generalizability to a broader patient population,” their conclusions merit some additional precision. Our study is the first to describe the histology in patients with a previous TYRX implant, building on our previous animal studies [1]. Our conclusions are not that a thinner pocket is preferable, but that reducing the inflammatory response, calcification, and fibrosis around the leads may help prevent complications during generator replacement. The difference in capsule thickness—our biopsies were only performed on the anterior capsule, not the posterior capsule, as Massaro et al. also did, alongside the anterior biopsies—is significant histopathologically but not clinically in terms of erosion risk. Their analysis of the Massaro paper does not align with the conclusion of their manuscript, which describes the opposite. Reducing the inflammatory response and fibrosis through additional methods (including the TYRX pocket) may be beneficial for future replacements, as well as lowering infection risk. They do not address Twiddler syndrome in their manuscript. Regarding the calcification process, we described the histology using standard methods and acknowledged the differences with the Massoro series. The comment about standardized histopathologic definitions seems difficult to understand, given that our histopathology scoring was based on Annex E of the International Standards Organization (ISO) 10993-6:2016, with the study pathologist blinded to the patient data. Pathologists from both our group and theirs collaborated to ensure the most accurate comparison possible, taking into account the differences in methodologies. In reference to the Yang et al. paper, this comparison is not suitable, as their study involved prosthetic heart valves exposed to rheology with blood flow. In contrast, the TYRX pocket is a fully resorbable implant with a limited timeframe for a foreign body reaction. Most responses to biodegradable polymers are an M2 response that is associated with healing. They promote angiogenesis, accelerate skin cell proliferation and re-epithelialization, and regulate collagen remodeling that inhibits scar hyperplasia [2]. Furthermore, the immunomodulatory response to the TYRX pocket will be temporary due to the fully absorbable nature of the material. Adding Rifampicin to the mesh has also been proposed to reduce the immune response. Finally, Twiddler syndrome is well described in cases involving de novo implants. In our series, all patients had undergone previous surgeries, and no systematic pocket enlargement was performed; therefore, the risk of Twiddler syndrome would be minimal. Additionally, some studies have reported a possible benefit of the TYRX pocket in managing this syndrome, in addition to securing the device within the pocket [3-5]. The risk of Twiddler in de novo implants with a TYRX pocket is not known; in higher-risk patients, fixation of the device with nonabsorbable sutures remains a valuable option. A recent animal study also looked at migration and rotation of the device with a third-generation TYRX pocket and found no significant mobility [6]. Regarding their reference to the Yatomi et al. manuscript, this group described the natural pocket thickness measured from the surface echo, noting a thinner skin over the device in patients with a small BMI, as well as in those with other comorbidities, such as low hemoglobin, heart failure, and renal dysfunction. This aims to suggest pocket inspection during follow-up; however, it is essential to remember that no TYRX or other pocket device will completely prevent erosion. Good surgical technique, deep implantation over the pectoralis major fascia, or considering a subpectoral implant in high-risk patients to avoid erosion, remain the best preventive strategies. We thank the authors for their comments on our manuscript. Francois Philippon, MD, FRCPC, FHRS, FCCS, FCHRS Renu Virmani, MD Aloke V, Finn, MD
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.081 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.022 | 0.015 |
| Insufficient payload (model declined to judge) | 0.050 | 0.024 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".