Device

Neuroendoscopic lavage for periventricular-intraventricular hemorrhage

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Neuroendoscopic lavage for periventricular-intraventricular hemorrhage

J.Sales-Llopis

Neurosurgery Department, General University Hospital Alicante, Spain

Neuroendoscopic lavage for periventricular-intraventricular hemorrhage (PIVH) is an emerging surgical approach aimed at improving the clearance of intraventricular blood clots, reducing hydrocephalus, and improving neurological outcomes in affected patients. Here’s an overview of the technique and its implications:

Indications

Neuroendoscopic lavage is typically indicated in cases of:

1. Severe intraventricular hemorrhage (IVH) associated with periventricular hemorrhage.

2. Obstructive hydrocephalus caused by blood clots in the ventricular system.

3. Cases where conservative management or external ventricular drainage (EVD) alone is insufficient for clot resolution.

Procedure

The procedure involves using a neuroendoscope to directly access the ventricular system. Key steps include:

1. Ventricular access: A burr hole is created to access the affected ventricle under neuronavigation guidance.

2. Neuroendoscopic insertion: A flexible or rigid endoscope is introduced into the ventricle.

3. Clot removal: Blood clots are aspirated or fragmented under direct visualization using specialized instruments or saline irrigation.

4. Irrigation: The ventricles are irrigated with warmed saline to ensure clearance of debris and residual clots.

5. EVD placement: Often, an external ventricular drain is left in place to monitor intracranial pressure (ICP) and facilitate further drainage of blood or cerebrospinal fluid (CSF).

Advantages

1. Enhanced clot clearance: Direct visualization allows for targeted and effective removal of clots, reducing clot burden and the associated risk of persistent hydrocephalus.

2. Reduced inflammation: By removing blood and its breakdown products, neuroendoscopic lavage may decrease the inflammatory response that contributes to ventricular scarring and hydrocephalus.

3. Minimally invasive: Compared to open surgical approaches, it involves smaller incisions and reduced disruption of brain tissue.

4. Potential for improved outcomes: Studies have suggested better neurological recovery and lower rates of shunt dependency in some cases.

Challenges and Limitations

1. Technical expertise: The procedure requires advanced neuroendoscopic skills and specialized equipment.

2. Risks: Complications include infection, hemorrhage, or damage to ventricular structures.

3. Not universally applicable: It is most effective in cases where clot consistency and location are suitable for endoscopic removal.

4. Limited evidence: While promising, robust clinical trials are needed to establish its efficacy compared to standard treatments.

Outcomes

– Early studies indicate that neuroendoscopic lavage can reduce mortality and improve functional outcomes in patients with PIVH and hydrocephalus.

– It may decrease the need for permanent CSF shunting and lower rates of complications related to prolonged EVD use.

Future Directions

1. Standardization: Developing standardized protocols for patient selection and procedural techniques.

2. Technological advances: Innovations in endoscopic tools and navigation systems to enhance safety and efficacy.

3. Long-term studies: Further research to evaluate the long-term benefits and cost-effectiveness of neuroendoscopic lavage.

The current neurosurgical procedure for periventricular-intraventricular hemorrhage resulting in posthemorrhagic hydrocephalus (PHH) seeks to reduce intracranial pressure with temporary and then Cerebrospinal fluid shunt. In contrast, neuroendoscopic lavage (NEL) directly addresses the intraventricular blood that is hypothesized to damage the ependyma and parenchyma, leading to ventricular dilation and hydrocephalus.

Systematic reviews

Wassef et al. conducted a systematic review of the literature on neuroendoscopic lavage in IVH of prematurity to examine data on the choice of neuroendoscope and outcomes regarding shunt rate. They then collected manufacturer data on neuroendoscopic devices, including inflow and outflow mechanisms, working channel specifications, and tools compatible with the working channel. We paired this information with the advantages and disadvantages reported in the literature and observations from the experiences of pediatric neurosurgeons from several institutions to provide a pragmatic evaluation of international clinical experience with each neuro endoscope in NEL.

Eight studies were identified; four neuroendoscopes have been used for NEL as reported in the literature. These include the Karl Storz Flexible Neuroendoscope, LOTTA® system, GAAB system, and Aesculap MINOP® system. The LOTTA® and MINOP® systems were similar in setup and instrument options. Positive neuroendoscope features for NEL include increased degrees of visualization, better visualization with the evolution of light and camera sources, the ability to sterilize with autoclave processes, balanced inflow and outflow mechanisms via separate channels, and a working channel. Neuroendoscope disadvantages for NEL may include special sterilization requirements, large outer diameter, and limitations in working channels.

A neuroendoscope integrating continuous irrigation, characterized by measured inflow and outflow via separate channels and multiple associated instruments, appears to be the most commonly used technology in the literature. As neuro endoscopes evolve, maximizing clear visualization, adequate inflow, measured outflow, and large enough working channels for paired instrumentation while minimizing the footprint of the outer diameter will be most advantageous when applied for NEL in premature infants 1).

Wassef et al.’s review provides an essential contribution to the understanding of neuroendoscopic technology in the context of NEL for IVH in premature infants. While the study outlines critical device features and evolving trends, its conclusions are constrained by limited data and a lack of quantitative analysis. Nevertheless, the work highlights key priorities for technological and clinical advancement, serving as a foundation for future research and innovation in this challenging yet promising area of pediatric neurosurgery.

Retrospective cohort studies

The records of patients with a diagnosis of grade III or IV IVH were reviewed between September 2022 and February 2024. The Papile-Burstein classification grade was determined on cranial ultrasonography. Demographic information collected included gestational age, birth weight, weight at the time of surgical intervention, infection confirmed with CSF, and hemorrhage. Standard local guidelines for temporary (CSF reservoir) and permanent (shunt or endoscopic third ventriculostomy (ETV) CSF diversion was implemented. Warmed Lactated Ringer’s was utilized for NEL. The primary outcome was the need for permanent CSF diversion (shunt or ETV).

Twenty consecutive patients with grade III or IV IVH complicated by PHH were identified. Twelve patients underwent CSF reservoir placement and NEL, 4 underwent CSF reservoir placement only, 1 underwent shunt placement only, and 3 did not require neurosurgical intervention. Of the 12 patients who underwent reservoir placement and NEL, 8 (67%) ultimately met the criteria for permanent CSF diversion compared with 2 of 4 (50%) who underwent CSF reservoir placement only. The mean gestational age at birth, birth weights, and age/weight at the time of temporary CSF diversion were similar across groups. The average time interval between temporary and permanent CSF diversion was longer in patients who underwent NEL (2.5 months for shunt and 6.5 months for ETV) compared with CSF reservoir placement only (1.1 months).

NEL is an innovative alternative for the treatment of PHH of prematurity. Flanders et al. from the New York University Grossman School of Medicine, Department of Pediatrics, Children’s Hospital of Philadelphia, Pennsylvania established an endoscopic lavage program at their institution and herein report the first published account in the United States of the feasibility of NEL for PHH 2).

Flanders et al. provide an intriguing glimpse into the potential of neuroendoscopic lavage for managing PHH of prematurity. While the approach is innovative and technically feasible, the study’s small sample size, lack of randomization, and limited long-term outcome data temper the enthusiasm for immediate adoption. Further research is essential to confirm the efficacy, safety, and cost-effectiveness of NEL, ensuring its role as a viable alternative or adjunct to existing treatment paradigms for PHH.

Comparative retrospective studies

Between August 2010 and December 2012 (29 months), 19 neonates with posthemorrhagic hydrocephalus underwent neuroendoscopic lavage for removal of intraventricular blood remnants. During a similar length of time (29 months) from March 2008 to July 2010, 10 neonates were treated conventionally, initially using temporary CSF diversion via lumbar punctures, a ventricular access device, or an external ventricular drain. Complications and shunt dependency rates were evaluated retrospectively. Results The patient groups did not differ regarding gestational age and birth weight. In the endoscopy group, no relevant procedure-related complications were observed. After the endoscopic lavage, 11 (58%) of 19 patients required a later shunt insertion, as compared with 100% of infants treated conventionally (p < 0.05). Endoscopic lavage was associated with fewer numbers of overall necessary procedures (median 2 vs 3.5 per patient, respectively; p = 0.08), significantly fewer infections (2 vs 5 patients, respectively; p < 0.05), and supratentorial multiloculated hydrocephalus (0 vs 4 patients, respectively; p < 0.01) [corrected]. Conclusions Within the presented setup the authors could demonstrate the feasibility and safety of neuro-endoscopic lavage for the treatment of posthemorrhagic hydrocephalus in neonates with IVH. The nominally improved results warrant further verification in a multicenter, prospective study 3).

The study provides a compelling case for the feasibility and safety of neuroendoscopic lavage in neonates with posthemorrhagic hydrocephalus. The lower rates of shunt dependency, infections, and multiloculated hydrocephalus are encouraging and suggest a potential benefit of NEL over conventional management.

However, the study’s limitations, particularly its retrospective design, small sample size, and lack of long-term outcomes, necessitate further investigation. A multicenter, prospective study is critical to validate these findings, optimize patient selection, and determine the technique’s broader applicability and impact on long-term neurodevelopment.

This study represents a promising step forward, but cautious interpretation is essential until more robust evidence emerges.

1)

Wassef CE, Thomale UW, LoPresti MA, DeCuypere MG, Raskin JS, Mukherjee S, Aquilina K, Lam SK. Experience in endoscope choice for neuroendoscopic lavage for intraventricular hemorrhage of prematurity: a systematic review. Childs Nerv Syst. 2024 Aug;40(8):2373-2384. doi: 10.1007/s00381-024-06408-6. Epub 2024 May 27. PMID: 38801444; PMCID: PMC11269422.
2)

Flanders TM, Hwang M, Julian NW, Sarris CE, Flibotte JJ, DeMauro SB, Munson DA, Heimall LM, Collins YC, Bamberski JM, Sturak MA, Storm PB, Lang SS, Heuer GG. Neuroendoscopic lavage for posthemorrhagic hydrocephalus of prematurity: preliminary results at a single institution in the United States. J Neurosurg Pediatr. 2025 Jan 24:1-8. doi: 10.3171/2024.10.PEDS24119. Epub ahead of print. PMID: 39854725.
3)

Schulz M, Bührer C, Pohl-Schickinger A, Haberl H, Thomale UW. Neuroendoscopic lavage for the treatment of intraventricular hemorrhage and hydrocephalus in neonates. J Neurosurg Pediatr. 2014 Jun;13(6):626-35. doi: 10.3171/2014.2.PEDS13397. Epub 2014 Apr 4. Erratum in: J Neurosurg Pediatr. 2014 Jun;13(6):706. PMID: 24702621.

DISC care

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DISC care

https://neosurgery.com/project/spine/

Prospective multicenter cohort clinical investigation

The aim of this prospective multicenter cohort clinical investigation was to evaluate the performance and safety of a new hernia blocking system (HBS), implanted after a limited discectomy, for recurrent lumbar disc herniation prevention.

Prospective, multicenter (6 sites), cohort clinical investigation. Thirty patients with a postero-lateral disc herniation between L4-S1 and large annular defects (> 6 mm wide), who underwent a limited discectomy and were treated with a new HBS (DISC care, NEOS Surgery S.L.), were included.

Godino et al. presents details about the investigational device, its surgical technique, intraoperative parameters, and up to 6 months follow-up outcomes. The primary endpoint of the study was to assess the incidence of early symptomatic reherniation. In addition, disc height, leg and back pain (NRS 0-10), Oswestry Disability Index (ODI), quality of life (EQ-5D-5L) and device safety, were evaluated.

Clinicaltrials: gov: NCT04188236; date: 27th November 2019.

Thirty patients (43.3% female, 41.7 ± 10.9 years) were implanted with the device under evaluation in a mean of 16 ± 9.6 min. Six months after surgery, no symptomatic reherniation was detected and disc height was maintained in all patients included. All patients had a significant reduction in leg pain (> 2 points in the NRS), 92.9% improved > 15 points in the ODI and 82.6% significantly improved their quality of life (≥ 12 points in EQ VAS score). No product-related serious adverse events nor reoperations occurred.

The implantation of an HBS is a feasible and safe procedure that prevents early disc herniation recurrence in patients at high risk of reherniation 1).

Strengths of the Study Innovative Focus: The study introduces a new hernia blocking system (HBS), addressing a critical need in spine surgery—preventing recurrent lumbar disc herniation in high-risk patients. This innovation holds promise for improving post-discectomy outcomes.

Study Design: The prospective, multicenter cohort design strengthens the reliability of the findings by incorporating diverse surgical teams and patient demographics across six institutions. Such an approach minimizes potential biases from single-center studies.

Clear Methodology: The inclusion criteria are well-defined, focusing on patients with large annular defects and specific levels of herniation (L4-S1). Additionally, the assessment endpoints are clinically relevant, including reherniation rates, pain (NRS), disability (ODI), and quality of life (EQ-5D-5L).

Safety and Efficacy: The absence of symptomatic reherniation and maintenance of disc height at six months are significant outcomes, especially given the known challenges of recurrent herniation in this patient cohort. The lack of product-related serious adverse events and reoperations further supports the safety of the HBS.

Quantitative Results: Improvements in leg pain (>2 points in NRS), disability (>15 points in ODI for 92.9% of patients), and quality of life (≥12 points in EQ VAS for 82.6% of patients) are clinically significant, offering robust support for the device’s efficacy.

Weaknesses and Limitations Short Follow-Up Period: While the six-month follow-up provides early insights into the device’s safety and efficacy, recurrent disc herniations often occur beyond this timeframe. Longer-term data are essential to confirm durability and sustained benefits.

Small Sample Size: The study includes only 30 patients, limiting the generalizability of its findings. A larger cohort would enhance statistical power and the reliability of conclusions.

Lack of Control Group: The absence of a control group undergoing standard discectomy without HBS implantation makes it challenging to attribute observed benefits solely to the device. Randomized controlled trials (RCTs) are necessary to establish causation.

Subjective Outcome Measures: While NRS, ODI, and EQ-5D-5L are validated tools, they are subjective and may be influenced by patient expectations or placebo effects. Objective functional outcomes or imaging-based metrics could supplement these measures.

Potential Conflicts of Interest: The involvement of NEOS Surgery S.L. in providing the device introduces a potential bias. Transparency about funding and potential conflicts is crucial, though not explicitly addressed in the abstract.

Future Directions Extended Follow-Up: Studies with follow-ups of 2–5 years are needed to evaluate the long-term efficacy and safety of the HBS, particularly in preventing delayed reherniations and preserving disc height.

Larger, Controlled Trials: Conducting RCTs comparing HBS implantation to standard discectomy or other augmentation methods (e.g., annular closure devices) will provide more definitive evidence of its benefits.

Economic Analysis: A cost-effectiveness analysis of the HBS compared to traditional methods would be valuable, given the potential implications for widespread adoption in clinical practice.

Broader Patient Inclusion: Expanding the study to include patients with different types of disc herniations or annular defect sizes may clarify the broader applicability of the device.

Conclusion This study offers promising early evidence supporting the safety and efficacy of the HBS in preventing early recurrent lumbar disc herniation. Despite its limitations, the research sets a strong foundation for further investigation and highlights the potential of this novel device to address a significant clinical challenge. However, longer follow-ups, larger sample sizes, and randomized controlled comparisons are imperative to confirm these findings and establish the HBS as a standard of care in spinal surgery.

1)

Godino O, Fernandez-Carballal C, Català I, Moreno Á, Rimbau JM, Alvarez-Galovich L, Roldan H. A new hernia blocking system to prevent recurrent lumbar disc herniation: surgical technique, intraoperative findings and six-months post-operative outcomes. Eur Spine J. 2024 Dec 8. doi: 10.1007/s00586-024-08595-x. Epub ahead of print. PMID: 39648196.

Hubly Surgical

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Hubly Surgical

https://hublysurgical.com/

The manual twist drill used for intracranial access represents an opportunity for potential improvement in efficiency, safety, and ease of use. A new generation of portable electrical drills with smart autostop mechanisms, such as the Hubly cranial drill (Hubly Surgical; Lisle, IL), aim to address these opportunities for improvement.

Two patients received EVDs using the portable electrical autostop drill (PEAD): A 54-year-old woman who suffered a postoperative hemorrhage and a 59-year-old woman who presented with early hydrocephalus secondary to hypertensive subarachnoid hemorrhage (SAH). Between both patients, a total of 9 and 2 access attempts were necessary to breach the inner table and visual dura. Access times in both cases, from skin incision to dural puncture, were less than 5 min. There were no apparent complications with the use of the PEAD in either case, and there was excellent placement of the EVD at the foramen of Monroe in both cases.

Oak et al. demonstrate the first successful use of a portable electrical drill with smart autostop in humans. The PEAD has potential to reduce procedure time and human error. Further development of the smart autostop drill may allow for more consistent and safer EVD placement 1).

A cadaveric study was conducted using both drills to perform several burr holes in the fronto-temporo-parietal region of the skull. An evaluation was performed on the number of dura plunges, and complete burr hole success rates were compared.

A total of 174 craniotomies using the HD and 36 burr holes using the ST perforator were performed. Despite significantly exceeding intended drill bit tolerance by multiple uses of a single-use disposable HD, autostop engaged in 100% of the 174 craniotomies and before violating dura in 99.4% of the 174 craniotomies, with the single dura penetration occurring on craniotomy no. 128 after the single-use drill bit had significantly dulled beyond its single-use tolerance. Autostop engaged before dura penetration for 100% of the 36 burr holes drilled with the ST perforator ( P = .610). All the perforations were complete using the HD after resuming drilling. An autostop mechanism in a cranial drill is not commonly available for portable bedside perforators. In the operating room, most use a mechanical method to stop the rotation after losing bone resistance. This new drill uses an electrical mechanism (smart autostop) to stop drilling, making it a single-use cranial drill with advanced features for safety and efficiency at the bedside.

There was no difference in the safety and efficacy of the new cordless electric drill with smart autostop when performing craniotomies compared with a traditional well-established electric cranial perforator with mechanical autostop on a cadaveric model 2)

1)

Oak A, Dardick J, Rusheen A, Materi J, Weingart J, Gonzalez LF, Anderson WS, Mukherjee D. First-in-human experience of a portable electrical drill with smart autostop for bedside external ventricular drain placement. J Clin Neurosci. 2024 Nov 27;131:110941. doi: 10.1016/j.jocn.2024.110941. Epub ahead of print. PMID: 39608055.
2)

Assumpcao de Monaco B, Benjamin CG, Doomi A, Taylor R, Stringfellow CE, Benveniste RJ, Jagid JR, Graciolli Cordeiro J. Safety Analysis of a New Portable Electrical Drill With a Smart Autostop Mechanism for Bedside Cranial Procedures. Oper Neurosurg (Hagerstown). 2023 Oct 1;25(4):311-314. doi: 10.1227/ons.0000000000000804. Epub 2023 Aug 4. PMID: 37543731; PMCID: PMC10468110.