9-04: Worldwide Clinical Experience of the Retrieval of Leadless Cardiac Pacemakers
Bibliographic record
Abstract
Introduction: Leadless cardiac pacemakers (LCPs) address certain device and lead related complications of transvenous pacemakers, but patients occasionally require device system upgrade, or require new devices for battery depletion. Retrievability is a desirable feature of implanted LCPs. We report the retrieval experience of the Nanostim LCP post-implantation in worldwide clinical studies. Methods: Patients receiving a right ventricular active-fixation LCP (Nanostim, St. Jude Medical, USA) within two multicenter clinical trials conducted in Europe, US, Canada and Australia, and required device retrieval were included in this analysis. The presence of any serious adverse device effects (SADEs) up to 30 days after retrieval was documented. Results: As of Nov 30, 2015, a total of 1006 patients were enrolled within two multicenter trials. Twelve patients (78.9 ± 12 yrs, 75% male) implanted with the LCP underwent retrieval attempts (9 centers, 9 operators). The reasons for retrieval were: elevated pacing thresholds (6 pts), worsening heart failure (5 pts), and elective explantation (1 pt). Five patients received new LCPs, 2 received conventional dual-chamber pacemakers, and 5 heart failure patients received CRT devices. The timing of LCP retrieval was 197 ± 190 days (median = 154 days; range = 1 to 506 days) with a Nanostim retrieval catheter without any SADEs (including no pericardial tamponade); four patients had received the LCP implant over 1 year prior to retrieval. Conclusion: The Nanostim LCP proved to be safely and successfully retrievable in patients up to ∼1.5 years post-implantation.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".