# Was Motorized Spiral Enteroscopy Too Risky? A Systematic Review and Meta‐Analysis Including German Registry Data

## TL;DR

A study found that motorized spiral enteroscopy had higher complication rates than balloon enteroscopy, raising concerns about its safety despite earlier benefits.

## Contribution

The study systematically compared adverse events of motorized spiral enteroscopy with balloon-based methods using registry and literature data.

## Key findings

- MSE had significantly higher adverse event and serious adverse event rates compared to balloon enteroscopy.
- Esophageal injury and intestinal perforation were more common with MSE than with balloon enteroscopy.
- AE reporting for MSE was detailed but lacked consistent follow-up and tracking.

## Abstract

Motorized spiral enteroscopy (MSE) was introduced as a major advancement in small‐bowel enteroscopy, enabling higher complete enteroscopy rates with shorter procedure times. However, after a fatal adverse event (AE) involving severe esophageal injury, the device was withdrawn from the market in July 2023. This raised questions about whether earlier safety signals were missed.

We conducted a systematic review and meta‐analysis comparing MSE with balloon‐based enteroscopy (double‐balloon [DBE] and single‐balloon enteroscopy [SBE], analyzed together). Outcomes included overall AEs, serious AEs (SAEs), and data collection quality. Results from the German PowerSpiral Registry were included, comprising 647 MSE procedures in 523 patients (January 2020–July 2023) before registry closure following device withdrawal.

Thirteen MSE studies (including the registry) and 55 DBE/SBE studies were analyzed, totaling 12,559 enteroscopies (2024 MSE; 10,535 DBE/SBE). MSE showed significantly higher rates of AEs (10.8% vs. 1.6%) and SAEs (1.5% vs. 0.4%). Procedure‐related SAEs were also more frequent with MSE (1.1% vs. 0.3%). Esophageal injury (0.10% vs. 0.009%) and intestinal perforation (0.5% vs. 0.1%) occurred more often with MSE, whereas acute pancreatitis (0.05% vs. 0.27%) and esophageal perforation (0% vs. 0.02%) were more common with DBE/SBE. AE reporting for MSE was detailed, but structured follow‐up and reliable case tracking were inconsistent.

MSE was associated with higher AE and SAE rates than balloon enteroscopy. These findings highlight the need for cautious adoption, rigorous safety monitoring, and more robust AE reporting when introducing innovative endoscopic technologies.

The prospective and retrospective cohort studies were registered in the German Registry of Clinical Studies (DRKS), namely DRKS00026990 and DRKS00028571

Summarize the established knowledge on this subject.◦Motorized PowerSpiral Enteroscopy (MSE) demonstrated shorter procedure times, deeper intestinal access, and higher complete enteroscopy rates than earlier enteroscopy techniques.◦Early safety studies reported AE rates within European guideline thresholds, suggesting that MSE was safe in clinical use.◦Despite these promising outcomes, the device was withdrawn from the market in July 2023 following safety concerns after a fatal esophageal perforation.What are the significant and/or new findings of this study?◦MSE was associated with higher adverse event rates, including serious events, compared with balloon enteroscopy.◦Cautious use and strengthened adverse event monitoring are essential when introducing new and innovative endoscopic technologies.

Summarize the established knowledge on this subject.

Motorized PowerSpiral Enteroscopy (MSE) demonstrated shorter procedure times, deeper intestinal access, and higher complete enteroscopy rates than earlier enteroscopy techniques.

Early safety studies reported AE rates within European guideline thresholds, suggesting that MSE was safe in clinical use.

Despite these promising outcomes, the device was withdrawn from the market in July 2023 following safety concerns after a fatal esophageal perforation.

What are the significant and/or new findings of this study?

MSE was associated with higher adverse event rates, including serious events, compared with balloon enteroscopy.

Cautious use and strengthened adverse event monitoring are essential when introducing new and innovative endoscopic technologies.