ABSTRACT
Objectives
To evaluate and compare the feasibility, safety, and efficacy of the classic and a novel, proximal implantation technique of the Adjustable Transobturator Male System (ATOMS) in patients with severe Post‐Prostatectomy‐Incontinence.
Patients and Methods
This retrospective cohort comprised 131 male patients who received ATOMS implants for severe PPI between November 2018 and May 2024. The classic, distal technique was applied up to July 2021, after which the proximal technique was exclusively adopted. Baseline data, intraoperative details, and postoperative results were documented. Follow‐up was obtained cross‐sectionally in November 2024, covering continence outcomes and patient satisfaction using validated questionnaires.
Results
Baseline characteristics were comparable between groups. The proximal technique required greater initial cushion‐filling volume but fewer postoperative adjustments. Early continence outcomes were similar, with both groups achieving a median of 1.0 pad/day and a full continence rate of 54.0%. At follow‐up, the proximal cohort demonstrated superior functional results, including higher complete continence rates (64.6% vs. 38.1%) and greater patient satisfaction. Patients in the proximal group reported lower ICIQ‐SF scores and a higher likelihood of recommending the procedure. Postoperative urgency was less frequent. Although residual urine occurred more often with proximal implantation, rates of urinary retention, surgical complications, and explantation did not differ.
Conclusion
The proximal technique offers good long‐term continence outcomes, higher patient satisfaction, and fewer urgency symptoms while maintaining a comparable complication profile. Short‐ and long‐term results seem superior to the classic method, though interpretation of long‐term data is limited by unequal follow‐up durations. Overall, our findings support the proximal approach as the preferred method for ATOMS implantation.
Keywords: ATOMS, distal, incontinence, LUTS, proximal, radical prostatectomy, SUI
1. Introduction
The gold standard for the surgical treatment of prostate cancer is radical prostatectomy (RP) with or without lymphadenectomy [1]. But while oncological outcomes have been proven to be excellent, even in high‐volume centers with experienced surgeons and independent of surgical technique, about 10% of patients develop post‐prostatectomy incontinence [2, 3, 4]. The underlying causes of this adverse event appear to be multifactorial and remain incompletely understood, with pelvic anatomy, surgical technique, and patient‐specific characteristics likely contributing [5, 6]. Affected patients may experience substantial limitations in daily activities and marked impairments in quality of life [7].
Different treatment regimens for PPI exist. While oftentimes conservative options like pelvic‐floor training suffice, multiple surgical treatment options have been established [8, 9]. One of which is the Adjustable Transobturator Male System (ATOMS). This implant has demonstrated long‐term efficacy in patients treated for stress urinary incontinence (SUI), particularly following radical prostatectomy or radiotherapy [10, 11, 12, 13].
The initial surgical approach for implantation of the ATOMS described by Seweryn et al. was the standard transobturator technique, involving an “outside‐in” transobturator tunneling, where the mesh arms are passed through the obturator foramen and anchored to the inferior pubic ramus, with the silicone cushion positioned ventrally to the bulbar urethra and the adjustment port placed subcutaneously in the scrotal or inguinal region [14, 15, 16].
With increasing experience using this device, a modified implantation technique emerged. Angulo et al. reported that patients with unsatisfactory outcomes after their initial ATOMS implant achieved improved continence following reimplantation, suggesting that treatment failure was largely attributable to suboptimal positioning rather than device malfunction [10]. These observations were a matter of debate in expert panels and prompted surgeons in high‐volume centers to search for a solution. This resulted in the development of a more proximal implantation approach that would also partially mimic the mode of action of fixed sling systems and would also reduce the risk of misplacement. This technique targets the urethral bulb by transecting the perineal central tendon, enabling partial retrobulbar positioning of the silicone pad and a more favorable location beneath the proximal bulbar urethra. Modified tunneling and fixation techniques facilitate a reliably proximal and anatomically optimized cushion placement. Initially adopted for revision surgery in persistent incontinence, the approach was later applied to primary implantation and formally described as a method for revision surgery by Queissert et al. in 2023 [17].
To our knowledge, this is the first study directly comparing the two different approaches for primary implantation. Therefore, we aimed to compare the classic method (CM) and new proximal method (PM) in terms of feasibility, safety, and efficacy in patients undergoing ATOMS surgery for PPI at our high‐volume tertiary referral center.
2. Materials and Methods
2.1. Patient Population
We included patients who underwent ATOMS (A.M.I. GmbH, Feldkirch, Austria) implantation for SUI after RP between November 2018 and May 2024. Surgical eligibility was determined by incontinence severity and pelvic floor function, evaluated via outpatient cystoscopy [8]. While full sphincter coaptation is a desirable prerequisite for ATOMS surgery, patients who refused an artificial urinary sphincter [18] or in cases where AUS was unsuitable, ATOMS was offered to patients with incomplete sphincter closure. Exclusion criteria were non–RP‐related incontinence and urgency or mixed incontinence. ATOMS was the only implanted device in all cases. From July 2021 onward, the proximal method, discussed in expert panels and later described by Queissert et al., was applied [17]. Prior to this, the classical method was used [16]. All procedures were performed exclusively by two experienced surgeons.
Baseline data included date and type of RP, tumor characteristics, and relevant comorbidities. Incontinence severity was assessed via daily pad usage pre‐ and post‐implantation, supplemented by 24‐h pad testing, cystoscopy, and evaluation of urgency symptoms. Perioperative parameters recorded were initial filling volume, operative time, and total number and volume of subsequent adjustments. Follow‐up outcomes included pad usage, complete continence (0 pads/day), and complications such as urinary retention, residual urine, wound‐healing disorders, port revision, and explantation. Early outcomes were assessed at the routine 4–6‐week postoperative visit. Standard postoperative care was identical for both procedures. Postoperative post‐void residual urine leading to early adjustment of the implant was defined as 100 ml or more.
2.2. Follow‐Up
Follow‐up was conducted as a cross‐sectional survey, with standardized correspondence mailed simultaneously to all participants in November 2024. The questionnaire addressed current continence status (defined as complete dryness), overall satisfaction, willingness to recommend the device, and any prior explantation. Patients were additionally asked to perform a 24‐h pad test and to complete validated instruments, including the Patient Global Impression (PGI) scale and the International Consultation on Incontinence Questionnaire–Urinary Incontinence (SF‐ICIQ‐UI) [19, 20]. Prepaid return envelopes were provided to facilitate the return of completed forms.
2.3. Statistical Analysis
Statistical analyses followed the Guidelines for Reporting of Statistics for Clinical Research in Urology [21]. Data were processed using SPSS Statistics 29 (IBM Corp., Armonk, NY, USA). Normality of continuous variables was assessed with the Shapiro–Wilk test. Continuous data are presented as mean ± SD or median (IQR), and categorical data as frequencies (%). Between‐group comparisons were performed using the independent‐samples t test or Mann–Whitney U test for continuous variables, and Chi‐square or Fisher's exact test for categorical variables. Statistical significance was set at a two‐sided p < 0.05.
3. Results
3.1. Cohort and Baseline Characteristics
Overall, 131 patients were included in the final analysis. 48 patients underwent ATOMS implantation with the CM (36.6%) and 83 patients with the PM (63.4%). Baseline characteristics are presented in Table 1. Also, both groups did not differ in comorbidities such as diabetes, previous oncologic disease history (p > 0.3) or ASA score (ASA > 3).
Table 1.
Patient characteristics.
| Baseline characteristics (n = 131) | |||
|---|---|---|---|
| Classic method (48/131 – 36.6%) | Proximal method (83/131 – 63.4%) | p‐value | |
| Age, (median ± IQR) | 73.5 (67.3–77.0) | 73.0 (68.0–78.0) | 0.739 |
| BMI, (median ± IQR) | 26.0 (24.0–29.0) | 25.0 (24.0–28.0) | 0.454 |
| Diabetes mellitus, n (%) | 4 (8.5) | 10 (12.0) | 0.532 |
| Hypertension n (%) | 28 (59.6) | 48 (57.8) | 0.846 |
| ASA > 3, n (%) | 24 (51.1) | 48 (42.2) | 0.328 |
| Oncological disease other than PCa n (%) | 6 (12.5) | 9 (10.8) | 0.774 |
| Tumor characteristics | |||
| Locally advanced n (%) | 25 (52.1) | 30 (37.5) | 0.143 |
| High‐risk Tumor (Gleason 8 or higher) n (%) | 13 (27.1) | 17 (20.5) | 0.386 |
| Resection status n (%) | 9 (18.8) | 13 (15.7) | 0.649 |
| ADT n (%) | 12 (25.0) | 8 (9.6) | 0.019 |
| Irradiation n (%) | 19 (39.6) | 28 (34.1) | 0.533 |
| Type of radical prostatectomy | |||
| Open, n (%) | 33 (68.8) | 45 (54.2) | 0.102 |
| Robot‐assisted, n (%) | 15 (31.3) | 38 (45.8) | |
| Daily pad usage (median ± IQR) | 5.0 (4.0–8.0) | 4.0 (3.0–6.0) | 0.009 |
| 24‐h pad test (mL, ± IQR) | 345.0 (200.0–425.0) | 320.0 (170.0–560.0) | 0.991 |
| Bladder capacity in ml, (median ± IQR) | 400.0 (350.0–500.0) | 350.0 (310.0–430.0) | 0.185 |
| Incontinence during night n (%) | 4 (8.3) | 4 (4.8) | 0.418 |
| Time to incontinence surgery (months, median ± IQR) | 28.5 (18.5–50.0) | 37.0 (24.0–79.0) | 0.040 |
| Previous incontinence surgery n (%) | 3 (6.3) | 4 (4.8) | 0.726 |
| Complete sphincter closure n (%) | 48 (100.0) | 82 (98.8) | 0.445 |
Resection status and prior irradiation were comparable between groups. Tumor characteristics, including locally advanced disease (52.1% vs. 37.5%) and high‐risk tumors (Gleason ≥ 8: 27.1% vs. 20.5%), did not differ significantly. However, ADT use was significantly more frequent in the classical method group (25.0% vs. 9.6%, p = 0.019). Open surgery predominated in both cohorts (68.8% vs. 54.2%), though without statistical significance (p = 0.102).
Median daily pad usage was significantly higher in the CM group (5.0 vs. 4.0 pads/day, p = 0.009), albeit with no observable difference between groups in preoperative 24‐h pad test and bladder capacity (p = 0.991 and p = 0.185). No difference was found in nightly incontinence with rates ranging from 5% to 8% of patients in both groups (p = 0.418). The median time from prostatectomy to incontinence surgery was shorter in the CM group (28.5 vs. 37.0 months, p = 0.040). Prior incontinence surgery was rare and evenly distributed (6.3% vs. 4.8%, p = 0.726). During preoperative cystoscopy, all patients with CM (100%) and nearly all in the PM group (98.8%) achieved complete sphincter closure (p = 0.445).
3.2. Perioperative Data, Continence Results and Complications After ATOMS Implantation
At first follow‐up, continence outcomes, displayed in Table 2, were comparable: median pad usage was 1.0 pad/day in both groups (p = 0.347), with complete continence achieved in 54.0% (p = 0.996). The proximal method required a greater initial filling volume (8.0 vs. 7.0 mL, p < 0.001), whereas the classical method needed more postoperative adjustments (3 vs. 2, p = 0.035). Final total volume did not differ (13.0 vs. 12.5 mL, p = 0.599). Surgery was marginally longer for the proximal approach (26 vs. 25 min, p = 0.005).
Table 2.
Perioperative data and early functional outcomes.
| Continence postoperatively | |||
|---|---|---|---|
| Classic (n = 48) | Proximal (n = 83) | p‐value | |
| Daily pad usage (median ± IQR) | 1.0 (0.0–2.3) | 1.0 (0.0–2.0) | 0.347 |
| Complete continence (0 pads per day), n (%) | 26 (54.0) | 45 (54.2) | 0.996 |
| Intraoperative data | |||
| Initial cushion volume in mL (median ± IQR) | 7.0 (6.0–7.0) | 8.0 (8.0‐9.0) | < 0.001 |
| Number of adjustments needed, n (%) | 3 (2.0–3.3) | 2 (1.0–3.0) | 0.035 |
| Total additional volume after last adjustment, (median ± IQR) | 13.0 (11.5–15.1) | 12.5 (11.0–15.3) | 0.599 |
| Surgery duration in minutes (median ± IQR) | 25 (18.0–28.8) | 26 (22.0–37.0) | 0.005 |
| Complications | |||
| Residual urine postoperatively, n (%) | 0 (0.0) | 7 (8.4) | 0.041 |
| Acute urinary retention, n (%) | 1 (2.1) | 5 (6.0) | 0.299 |
| Wound healing disorder, n (%) | 2 (4.2) | 6 (7.2) | 0.481 |
| Urge postOP, n (%) | 9 (18.8) | 5 (6.0) | 0.023 |
| Need for port revision, n (%) | 2 (4.2) | 1 (1.2) | 0.275 |
| Explanation, n (%) | 9 (18.8) | 7 (8.4) | 0.082 |
| Due to change to AUS, n (%) | 7 (77.8) | 4 (57.1) | — |
Significant postoperative post‐void residual urine, treated with subsequent adjustment, occurred more frequently after proximal implantation (8.4% vs. 0%, p = 0.041). Rates of urinary retention, wound complications, and port revision were similar (all p > 0.05). Urgency was significantly more common after the classical approach (18.8% vs. 6.0%, p = 0.023). Explantation tended to be higher in the classical group (18.8% vs. 8.4%, p = 0.082), mainly due to conversion to an AUS (77.8% vs. 57.1%). All other patients had to undergo explantation due to infection of the implant.
3.3. Cross‐Sectional Follow‐Up Data
Follow‐up data, shown in Table 3, were available for 69 patients (53%). 21 patients were treated with the CM and 48 patients with the PM. Median follow‐up for all patients was 27 months, while it varied between the two groups. It was at 52 months in CM and at 20 months in PM. Median daily pad usage showed no statistical difference (p = 0.088). Complete continence (0 pads/day) was achieved significantly more often in patients in the PM group (64.6% vs. 38.1%, p = 0.041). Similarly, the current 24‐h pad test showed a trend toward better outcomes after PM surgery (median 30.0 mL vs. 92.0 mL, p = 0.088). This trend also shows in the larger range of 24h‐pad‐test results (demonstrated in Figure 1), which is suggestive of a larger number of negative outliers in the CM.
Table 3.
Follow‐up data.
| Follow‐up data (median follow‐up time 27.0 months, n = 69) | |||
|---|---|---|---|
| Classic (n = 21) | Proximal (n = 48) | p‐value | |
| Median time of follow‐up (months) | 52 | 20 | |
| Age at follow‐up | 77.0 (71.5–81.0) | 74.0 (70.0–79.0) | 0.086 |
| Daily pad usage (median ± IQR) | 2 (1.0–3.0) | 1 (1.0–2.0) | 0.088 |
| Complete continence, n (%) | 8 (38.1) | 31 (64.6) | 0.041 |
| Current 24 h pad‐test (median ± IQR) | 92 (14.3–260.5) | 30.0 (4.0–87.0) | 0.088 |
| Patient satisfaction, n (%) | 8 (40.0) | 34 (75.6) | 0.006 |
| Would recommend, n (%) | 14 (73.7) | 42 (95.5) | 0.012 |
| ICIQ‐SF Score, (median ± IQR) | 13.0 (7.5–16.5) | 8.0 (4.0–11.0) | 0.004 |
| IPSS Score, (median ± IQR) | 10.0 (3.0–14.0) | 6.0 (3.0–10.0) | 0.070 |
| PGI Score, n (%) | 0.069 | ||
| Very much improved | 5 (25.0) | 22 (48.9) | |
| Much improved | 8 (40.0) | 14 (31.1) | |
| Minimally improved | 5 (25.0) | 6 (13.3) | |
| No change | 1 (5.0) | 3 (6.7) | |
| Minimally worse | 0 (0.0) | 0 (0.0) | |
| Much worse | 1 (5.0) | 0 (0.0) | |
| Very much worse | 0 (0.0) | 0 (0.0) | |
| I‐IQOL Score, (median ± IQR) | 70.5 (50.0–88.6) | 81.3 (58.2–92.3) | 0.356 |
Figure 1.
24 h Pad test at time of follow‐up.
Patient satisfaction was significantly higher after proximal implantation (75.6% vs. 40.0%, p = 0.006), and more patients would recommend the procedure (95.5% vs. 73.7%, p = 0.012). Proximal patients also showed lower median ICIQ‐SF scores (8.0 vs. 13.0, p = 0.004) and lower, though not significantly different, IPSS scores (6.0 vs. 10.0, p = 0.070). Most participants in both groups reported postoperative improvement: 48.9% versus 25.0% rated their condition as “very much improved,” while 31.1% versus 40.0% described it as “much improved.” Only one classic‐method patient reported no improvement, and none reported worsening (p = 0.227). Median I‐QOL scores were slightly higher in the proximal cohort (81.3 vs. 70.5, p = 0.356).
4. Discussion
The patient collectives in our study were well comparable in terms of age, BMI, and comorbidities, evenly distributed between collectives. High‐risk tumors, which may render nerve‐sparing surgery impossible and therefore worsen later functional outcomes, were also evenly distributed between groups [22, 23]. The higher percentage of patients operated using an open approach in the CM group showcases the overall switch from open to robotic prostatectomy [24]. Both groups showed no significant difference in the severity of PPI, with the statistically significant difference in daily pad usage not being reproducible in the more objective and less bias‐prone 24h‐pad‐test. Overall, the severity of incontinence in our cohort is in line with existing literature, where preoperative 24 h pad test results range from 350 cc to 747 cc [11, 16, 25, 26]. Interestingly, the PM patients had waited almost a year longer to undergo incontinence surgery. This might be attributable to evolving conservative treatment options such as pelvic floor‐exercise regimens, lifestyle intervention, pharmacologic or electrostimulation [6].
The shorter operative time observed with the distal approach likely reflects the more demanding dissection required proximally. Nevertheless, surgery times in our cohort were comparatively low. Previous studies reported mean durations of 47.1 min and 67 min [16, 25], underscoring improvements achievable in high‐volume centers. Although the 1‐min difference we found may reach statistical significance, its clinical relevance is negligible. Still, minimizing operative duration remains desirable given its impact on infectious complications in implant surgery [27].
Surprisingly, short‐term outcomes revealed no difference in daily pad usage or complete continence. Patients treated with the proximal method required a higher initial cushion volume, likely due to partial retrobulbar placement providing broader support to the bulbar urethra [17]. In the method used in our center, the cushion is filled with a 10 cc syringe that is fully injected into the cushion. Then the syringe cylinder is let loose, allowing for a passive backflow from the cushion now compressed by the tissue. The residual volume after said passive backflow stops defines the final cushion volume. Conversely, the classical method, where less pressure on the bulbus is applied, required more postoperative adjustments to achieve satisfactory results (p = 0.035), ultimately reaching a similar total filling volume. Our total filling volume aligns with that reported by Angulo et al. for the classical technique [25], although they observed fewer adjustments and a median final volume of 17.5 mL. A meta‐analysis of 20 studies similarly reported a mean of 2.4 fillings per patient [11]. Given that the proximal cohort showed more residual urine and nearly a three‐fold higher risk of acute urinary retention, surgeons must balance the potential benefit against risks such as infection or explantation associated with additional adjustments. However, increased retention may also reflect stronger continence effects. Notably, urgency symptoms were more common after distal implantation, which may indicate greater outlet obstruction with the classical technique, whereas the proximal approach may improve continence through partial repositioning of the bulbus, similar to fixed slings [6, 28].
Further, though not statistically significant, we found the need for secondary surgical interventions to be higher in the CM group, with double the rate of explantation and an almost four‐fold need of revision of the port. Almost three‐quarters of these patients had their ATOMS explanted to switch to an artificial urinary sphincter [18] due to unsatisfactory continence and not due to complications with their ATOMS implant. Yet, these higher explantation rates could be attributed to the aforementioned misplacement of the implant. Follow‐up in the proximal group is shorter, and complication‐rates therefore must be interpreted with caution, as they also reflect the surgical learning curve in our centre, with the very first cases being operated using the CM. Additionally, different locations for port positioning have been used over the years, partially due to patient preference and partially due to a switch from lateral to median scrotal placement of the port, further limiting comparability.
Lavigne et al. reported 10‐year outcomes for the first UK ATOMS cohort treated with the classic technique, showing a 24‐month device‐survival of 88.4% with 9% conversion to AUS and 9% explantation for infection [12]. Hoda et al. documented a 4% infection‐related explantation rate at 30 months, while Esquinas et al. found a pooled explantation rate of 5.75% at a mean follow‐up of 20.9 months and an overall complication rate of 16% [11, 16]. These figures are broadly in line with our long‐term survival estimates; however, interpretation is limited by our follow‐up rate of only ~50%, preventing robust comparison. Furthermore, the complete transition from CM to PM in 2021 resulted in markedly different follow‐up durations, and given the time‐dependent nature of ATOMS survival, this reduces direct comparability of complication rates between groups.
After cross‐sectional follow‐up, we found that functional outcomes improved with the PM, with the complete continence rate almost double that of the CM collective. Furthermore, PM patients displayed significantly better patient satisfaction, recommendation rates, and ICIQ‐SF scores. At first, it seems that the PM offers superior long‐term results. Yet, the time since surgery is important here, partially because of the aforementioned time‐dependent survival rate of the implant and partially because age, next to irradiation, has been established as an independent risk factor for decreased device survivability [12]. An additional possible explanation for worse functional outcomes in the CM cohort is the higher rate of patients receiving ADT, which has been shown to lead to bulbar atrophy and erosion in AUS patients, though a similar effect has not yet been demonstrated in ATOMS patients [29, 30]. In their meta‐analysis, Esquinas et al. reported an overall dryness rate of 67% at a mean follow‐up of 20.9 months with a wide range from 39% to 92% [11]. This heterogeneity is partially due to age differences in the observed collectives, as in aging men the urinary sphincter loses function which might contribute to the poorer results in older patient collectives [31]. The reported dryness rates in studies with comparable follow‐up timeframes seem comparable to our proximal group. The functional outcomes in our distal collective appear worse; however, our cohort has a longer follow‐up than any of the studies mentioned in the meta‐analysis. The heterogeneity of results showcases the variety of functional results met in different patient collectives, depending on pre‐existing conditions and age, which additionally gravely limits comparability. Of note, a 30‐month follow‐up conducted by Hoda et al. showed no substantial changes in functional outcomes between a 6‐and a 30‐month follow‐up [16]. Given that, one may assume that the difference in functional outcome in our study may persist. Although this existing data gives a solid comparison for the functional outcomes of our PM cohort with comparable follow‐up periods in the meta‐analysis, a comparison with the CM cohort can only be made indirectly and is gravely limited. Moreover, a longer‐term durability of the functional results in our PM cohort cannot be inferred and would have to be evaluated in a prospective and randomized cohort with standardized follow‐up.
The current study is not devoid of limitations. First, its retrospective, single‐center design and the cross‐sectional follow‐up with different median follow‐up in both groups due to the complete change to the PM at our center in 2021. Therefore, practical impossibility to provide standardized timeframes for long‐term follow‐up. This, as well as the individual learning curves of surgeons performing the implantation, influences the comparability of long‐term results, and therefore, they need to be interpreted with caution. In addition, potentially relevant factors such as prostate size or previous surgical history were not consistently available and could not be adjusted for. Also, follow‐up was only available for 53% of the patients, which leaves a substantial number of patients without any knowledge about their functional outcomes. A future larger, prospective, and possibly multicentric study will have to supply data with a standardized follow‐up comparing the two approaches.
Our study demonstrated similar short‐term continence for both methods, with fewer instances of urgency in the PM. Our long‐term data suggest favorable functional outcomes for the PM, data that need to be confirmed in further trials. This study represents the first and only analysis comparing outcomes of ATOMS surgery between the classic and proximal implantation techniques so far. Overall, especially in short‐term follow‐up, we demonstrate the PM as an efficacious and safe surgical approach that's promising to offer superior relief to patients suffering from PPI, thus adding valuable insights to the current body of literature demonstrating the advantages of the PM.
5. Conclusion
This study is the first to assess differences between the classic implantation method and the proximal implantation method for the ATOMS. Our data show promising long‐term functional outcomes in the proximal implantation method, but are limited by different timeframes of follow‐up. Short term‐results seem to favor the proximal method too. Our results demonstrate that the proximal approach is a safe and efficacious option for the treatment of post‐prostatectomy incontinence, making it a valuable addition to treatment options for male SUI. Long‐term outcomes appear promising, but a definite conclusion favoring one of the methods cannot yet be made. To avoid the inherent limitations of the retrospective study design, future prospective studies on larger patient collectives will have to assess long‐term results in a standardized manner to improve comparability.
Funding
The authors have nothing to report.
Ethics Statement
The work conducted is in accordance with the Declaration of Helsinki and has been reviewed by the ethics committee of LMU Munich as project number 23‐0409.
Consent
The patients/patients' legal guardian in this manuscript have given written informed consent to publication of the presented data where necessary.
Conflicts of Interest
Fabian Queissert, Yannic Volz, and Ricarda Bauer work in an advisory function for A.M.I. and Boston Scientific. All other authors have no conflict of interest to declare.
Acknowledgments
Conceptualization, Investigation: Leo F. Stadelmeier, Yannic Volz. Data curation: Marc Kidess, Troya Georgieva, Julian Hermans, Marina Hoffmann, Ricarda Bauer, Patrick Keller, Moritz Happe. Formal analysis: Elisa Lederer, Daniel Puhr‐Westerheide, Leo F. Stadelmeier. Writing – original draft: Leo F. Stadelmeier, Yannic Volz, Fabian Queissert, Ricarda Bauer. Writing – review and editing: Alexander Tamalunas, Christian G. Stief.
Data Availability Statement
The data that support the findings of this study are available on reasonable request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data that support the findings of this study are available on reasonable request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.