Comparative Analysis of Thulium Fiber and Holmium:YAG Lasers in Urology
Overview
This study analyzed adverse events (AEs) associated with thulium fiber lasers (TFL) and holmium:YAG (Ho:YAG) lasers in urology using the FDA MAUDE database. Findings revealed distinct AE profiles between the two laser types, with Ho:YAG lasers showing more device malfunctions and patient events, while TFLs had more fiber breaks. Post-2021 FDA recall, TFL-related patient harm and fiber breakages significantly decreased.
Background
Lasers have been integral to urological surgery since the 1970s, with Ho:YAG lasers widely used due to their effective water absorption at 2120 nm wavelength. The newer TFL, operating at 1940 nm, offers potentially superior stone ablation and higher stone-free rates. Despite their efficacy and safety, both laser types carry risks of device malfunction and adverse events, necessitating ongoing surveillance. The FDA MAUDE database provides a valuable resource for monitoring such device-related complications.
Data Highlights
Parameter
TFL
Ho:YAG
p-value
Total Events Analyzed
467
487
–
Device Issues Identified
98.5%
99.6%
–
Laser Device/Console Malfunction
Less frequent
More frequent
<0.001
Fiber Breaks
More frequent
Less frequent
<0.0001
Patient Events
13.5%
35.3%
<0.0001
Gupta Level I Events
85%
59.3%
–
Gupta Level II Events
Less frequent
More frequent
–
Gupta Level III Events
2.1%
Less frequent
–
Gupta Level IV Events
0
1 (bladder perforation with death)
–
TFL Events Pre-Recall (Patient Harm Free)
60.8%
–
–
TFL Events Post-Recall (Patient Harm Free)
90.3%
–
–
Key Findings
Ho:YAG lasers had significantly more device malfunctions, including console errors and overheating, compared to TFLs (p < 0.001).
TFLs exhibited significantly more fiber break incidents than Ho:YAG lasers (p < 0.0001), especially inside patients during procedures.
Patient adverse events were more frequent with Ho:YAG lasers (35.3%) than TFLs (13.5%) (p < 0.0001), with Ho:YAG showing more moderate (Level II) events.
Most adverse events were minor (Gupta Level I), with TFLs having a higher proportion of these, while Ho:YAG had more Level II events and one Level IV event involving patient death.
In non-prostate procedures, TFLs had more fiber breaks, whereas Ho:YAG lasers had more procedure cancellations and higher severity Level II events.
Following the 2021 FDA recall, TFL-related patient harm decreased significantly, with fewer fiber breaks inside patients and reduced Level II and III events.
Clinical Implications
Clinicians should be aware that Ho:YAG lasers are more prone to device malfunctions and patient adverse events, whereas TFLs carry a higher risk of fiber breakage. The 2021 FDA recall and subsequent safety updates for TFLs have improved patient safety outcomes. Careful device selection and adherence to updated safety protocols can mitigate risks and optimize procedural success.
Conclusion
This comparative analysis highlights distinct adverse event profiles for TFL and Ho:YAG lasers in urology, emphasizing the importance of ongoing surveillance and safety improvements. Post-recall enhancements have notably reduced TFL-associated patient harm, supporting safer clinical use.
References
Althunayan et al. 2014 -- Analysis of Ho:YAG laser adverse events in urology
FDA 2021 -- Class II recall of Soltive Premium and Soltive Pro Super Pulsed Laser Systems
