A novel Lumbo-Peritoneal Shunt System Including a Gravitational Unit: First Experiences and Clinical Perspectives

doi:10.21203/rs.3.rs-5158582/v1

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A novel Lumbo-Peritoneal Shunt System Including a Gravitational Unit: First Experiences and Clinical Perspectives

https://doi.org/10.21203/rs.3.rs-5158582/v1

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In Europe and North America, hydrocephalus is commonly treated with ventriculo-peritoneal shunts (VPS), while in Japan and other Asian countries, lumboperitoneal shunts (LPS) are preferred. Despite the risk of overdrainage, no adaptable valve with an integrated gravitational unit was available for LPS until recently. We report on a novel modular valve system designed for LPS. We retrospectively analyzed 24 patients who underwent LPS implantation between March 2023 and July 2024. The median age was 64.5 years, with various etiologies including posthemorrhagic hydrocephalus (41.7%), idiopathic normal pressure hydrocephalus (37.5%), and idiopathic intracranial hypertension (8.3%). LPS was also used as salvage therapy in three cases with complex cranial wounds. Relevant complications requiring reoperation occurred in 16.7% of patients, with peritoneal catheter dislocation accounting for 75% of these cases. Overdrainage was observed in 20.8% of patients, but only one serious event necessitated LPS removal. Follow-up showed improvements in gait and vision for iNPH and IIH patients, respectively. This study is the first to use the novel LPS with an integrated gravitational unit, showing promising outcomes across various hydrocephalus etiologies and highlighting its potential as a salvage option for complex cases. Further research with larger cohorts is needed.

Health sciences/Neurology/Neurological disorders/Hydrocephalus

Health sciences/Medical research

Health sciences/Neurology

lumboperitoneal shunt

communicating hydrocephalus

idiopathic normal pressure hydrocephalus

idiopathic intracranial hypertension

ventriculoperitoneal shunt

overdrainage

Communicating hydrocephalus remains a primary indication for permanent surgical cerebral spinal fluid diversion. Primary causes, such as idiopathic normal pressure hydrocephalus (iNPH), as well as secondary causes, such as posthemorrhagic hydrocephalus (PHH), require individualized surgical decisions regarding the need for and type of shunt, the selection of specific valves, and the respective individual settings to meet the patient's needs. Idiopathic intracranial hypertension (IIH) without radiographic evidence of hydrocephalus also requires careful consideration.¹ When considering surgical treatment of communicating hydrocephalus, there are generally two main options: ventriculoperitoneal (VPS) and lumboperitoneal (LPS) shunts. Interestingly, although LPS offers a number of relevant advantages, such as no risk of intracerebral hemorrhage or seizures and, with respect to some countries, no driving prohibition in contrast to VPS surgery (e.g., Germany 3 months, UK 6 months, Denmark 1 month), VPS is the most common treatment for these conditions in Europe and the United States.² In contrast, in Japan, nearly half of iNPH patients recommended for surgery receive LPS. The SINPHONI-2 randomized clinical trial (RCT) demonstrated the benefits of this therapeutic option for patients with iNPH in terms of functional status and Hakim triad symptoms. However, overall complications such as overdrainage, revision rates due to malfunction and development of subdural hematoma (SDH) after LPS were more frequent.³ There are conflicting studies regarding these outcomes in IIH^4,5 In patients with PHH, LPS implantation appears to be associated with a lower risk of overall complications, infections, and VPS-related complications (such as epileptic seizures and parenchymal injury) compared to standard of care.⁶ Sun et al. are currently investigating the validity of these results in a non-randomized control trial.⁷

The randomized, multicenter SVASONA trial clearly demonstrated the importance of the gravity unit in preventing overdrainage in mobile iNPH patients treated with a VPS.⁸ Although overdrainage and related problems are a well-known and relevant complication after CSF shunting, there is no specific valve/gravitational valve system for LPS.

Recently, a new Valve Board system specifically designed for LPS has been introduced (Miethke ®, Potsdam, Germany). This silicone board is barium sulfate enriched and allows the integration of a wide range of differential pressure units (DPU) and nonadjustable gravitational units (nGU), including hybrid solutions such as the adjustable gravitational unit (aGU), as well as control reservoirs. This modular solution offers flexibility in board placement, such as paravertebral or thoracic locations. All valves are securely encased within the board to prevent dislodgement while allowing percutaneous readings, valve setting adjustments, and reservoir punctures. This novel system has not been previously studied.

Our study presents the first 24 cases of communicating hydrocephalus of various origins treated with this novel implant in our neurosurgical center.

Study Design

This is a retrospective study analyzing patients who received a novel lumbo-peritoneal shunt system at the Department of Neurosurgery, Goethe University Hospital, Frankfurt, Germany between March 2023 and July 2024.

Data Collection

Data were collected retrospectively from electronic medical records in accordance with the General Data Protection Regulation. Based on § 27 BDSG (Art. 9 GDPR, § 2 (j) https://gdpr-info.eu/art-9-gdpr/) considering the exceptions to GDPR regulations for scientific purposes, the obtainment of the informed consent was waived.

Parameters evaluated included age, sex, body mass index (BMI), indication, duration of surgery, length of hospital stay, initial shunt settings, clinical status at follow-up, and complications. Major complication was defined as a complication leading to reoperation under general anesthesia. Minor complication was defined as a complication requiring only an outpatient visit. This study was conducted in accordance with the tenets of the Declaration of Helsinki. Local ethics committee approval was obtained on March 14, 2024 (EAN: 2023 − 1610).

Statistical analysis

JASP was used for descriptive statistics. For categorical variables, counts were recorded with percentages. For continuous variables, medians were calculated with interquartile ranges (IQR), with the 25th and 75th percentiles noted. RAGraphs 2.0 was implemented for data visualization.

Surgical procedure

Our center follows a single-position approach, implementing lateral oblique positioning adapted from Goto et al.⁹ using a vacuum mattress to save time by avoiding intraoperative repositioning. Three incisions are made: paravertebral (Fig. 1b), lateral supracostal, and standard lateral laparotomy (Fig. 1a & b).

First, after a 2–3 cm paravertebral midline skin incision, a Thuohe needle is inserted into the L 3/4 or L 4/5 interspinal space. After visualization of CSF flow, a spinal catheter is placed subdurally in a cranial direction, approximately 15–20 cm from the subcutaneous layer. This is done under fluoroscopic guidance to avoid kinking or caudal dislocation of the catheter. The next step is to create a lateral supracostal subcutaneous pocket for placement of the LPS Valve Board (Fig. 2a). The distal end of the spinal catheter is then tunneled in an arcuate fashion to the subcostal subcutaneous pouch where it is connected to the Valve Board and secured with a ligature. The Valve Board is then anchored to the subcutaneous tissue with four silk sutures. Care should be taken not to place the Valve Board more than 1 cm below the subcutaneous tissue as this may prevent future transcutaneous valve adjustments. Lateral laparotomy is performed following the standard procedure.

The decision to place the valve board on the left or right side is based on the patient's preferred sleeping position. This should be determined preoperatively as the valve boards are preassembled for either the left or right side. Alternatively, the Valve Board can be placed paravertebrally.

Between March 2023 and July 2024, a total of 24 patients with various forms of communicating hydrocephalus were implanted with the novel LPS system. The median age of the patients was 64.5 years [54.5–72.3], with 54.2% female and 45.8% male patients. The median BMI was 26.6 [24.1–30.1]. (Table 1)

Wide spectrum of indications

Of the patients who received LPS, 10 (41.7%) had PHH. Of these, 5 (50.0%) had aneurysmal subarachnoid hemorrhage (aSAH), 2 (20.0%) had arterio-venous malformation (AVM), and 3 (30.0%) had intracerebral hemorrhage (ICH). Nine patients (37.5%) with iNPH and 3 patients (12.5%) with IIH were also implanted with LPS. In patients with iNPH and IIH, both VPS and LPS options were considered. In most cases, LPS was preferred by the patients due to the avoidance of a 3-month driving restriction after VPS in Germany. In addition, two miscellaneous indications for LPS (8.3%) were given: one patient with postoperative hydrocephalus after meningioma resection and one patient with postoperative CSF fistula after resection of a malignant brain tumor.

Of the above cases, three patients (2 miscellaneous, 1 PHH) were indicated for LPS as salvage therapy after experiencing severe wound healing complications following decompressive craniectomy and subsequent allogenic cranioplasty and VPS, including infection and dry wound necrosis. LPS was implanted to prevent further damage to the cranial wounds. (Table 1)

Intra- and postoperative aspects

The median operative time (from incision to suture) was 68 [59.8–82.0] minutes. Considering the total operating room time including positioning, the median time was 115.5 [93.0–130.0] minutes.

On the first postoperative day, all patients underwent abdominal radiography in AP and lateral projection (Fig. 2c). This also allows control of the upright position of the gravitational unit and allows radiographic reading of the valve setting determined by the smart phone application (Fig. 2b, d & a). Post-operative recovery was rapid in most patients, particularly those with iNPH and IIH. The median length of hospital stay after LPS implantation was 1.5 [1.0–4.0]. (Table 1)

Selection of gravitational units, differential pressure units and initial shunt setting

In the vast majority of patients (75.0%), a nGU with a pre-set pressure of 20 cmH₂O was selected. In the remaining cases, either an nGU with 30 cmH₂O was implanted (12.5% of cases) or an aGU with an initial setting of 24 cmH₂O in a single case. The reasons for implantation of a GU with initial settings higher than 20 cmH₂O were slit ventricles in one patient with postoperative CSF fistula and larger stature in three iNPH patients.

Considering the initial settings of the adjustable DPUs, there was variation in our cohort. In patients with PHH, the DPU was set to 5, 8, or 10 cmH₂O depending on the preoperative drainage rate by EVD or lumbar drain. In two patients with an initial setting of 5 and 10 cmH₂O, respectively, higher DPU pressures were later required due to the development of overdrainage.

In iNPH we also chose DPU with an initial setting of 5, 8 or 10 cmH₂O. Differential pressure adjustment was required in 3 cases. In two patients at follow-up, the DPU was set to a lower differential pressure than the initial setting of 10 and 5 cmH₂O, respectively. This was due to non-responsiveness of the gait disturbance. In one case with an initial DPU setting of 10 cmH₂O, adjustment to a higher differential pressure was necessary to treat symptoms of overdrainage.

In two patients with different indications for LPS, a DPU with initial settings of 5 cmH₂O and 10 cmH₂O combined with 20 and 30 cmH₂O nGU respectively was selected. In the first case, this was done to treat postoperative hydrocephalus. In the second case, the higher pressure was chosen to treat an otherwise therapy-resistant CSF fistula without a hydrocephalic component.

Major complications

The overall rate of major complications was 16.7%. Surgical revision was required in these 4 cases. In 3 (12.5%) of these patients, surgical revision was required due to dislocation of the peritoneal catheter with resulting pseudozyst formation. In one IIH patient (4.2%), the LPS system had to be removed due to LPS infection and problems finding optimal valve settings. After infection, the patient received a VPS with a telemetric ICP measurement reservoir. (Table 1)

Minor complications

Clinical overdrainage was noted in 5 patients (20.8%) who presented with either a sinking flap (PHH patients after decompressive craniectomy) or position-dependent headache. These symptoms resolved rapidly after the valve was adjusted to a higher pressure level. None of the patients with overdrainage developed a subsequent subdural hygroma or subdural hematoma, potentially requiring burr hole evacuation. (Table 1)

Outcomes on follow-up

At the time of this study, only 54.2% of the enrolled patients presented for outpatient follow-up. This was mainly due to the long inpatient rehabilitation stays of the PHH patients. In contrast, 77.8% of our iNPH patients presented for follow-up. The median follow-up in this group of patients was 13.0 weeks [9.0 -26.5]. All of these patients reported significant improvement in gait disturbances. Improvement in urinary incontinence and cognitive impairment was reported in 28.6% of cases.

All patients with IIH were followed up on an outpatient basis for a median of 15.0 weeks (10.0-22.5). Two out of three IIH patients (66.7%) reported significant improvement in visual acuity with regression of optic disc edema as objectively assessed by an ophthalmologist. The same proportion of patients reported relief of preoperative headache. One patient remained a non-responder for both symptoms.

Our PHH cohort had limited follow-up data as only a minority were seen in the outpatient setting by the end of our data analysis. Despite requiring multiple DPU adjustments due to overdrainage with a sinking flap, this aSAH patient showed significant improvement in mobilization and compliance with physical therapy in the rehabilitation clinic at the last follow-up.

This is the first study to report on the novel modular LPS solution that includes a DP unit as well as a gravitational valve and control reservoir. Our study includes a broad spectrum of hydrocephalus entities and demonstrates comparable outcomes associated with the novel LPS system in the treatment of communicating hydrocephalus in iNPH and IIH patients. The majority of comlications were minor and required only outpatient visits. In addition, the LPS System is a valuable option for patients with complex cranial wounds.

In Europe and North America, communicating hydrocephalus is commonly treated with a VPS, while interestingly, LPS is more commonly used in Japan. Although overdrainage and related complications are well known after CSF shunting, no specific LPS valve system including an adaptable valve unit and a gravitational unit exists. Recently, a novel valve system designed for LPS has been introduced.

Our results are consistent with most studies comparing the efficacy of LPS versus VPS in the treatment of communicating hydrocephalus. A comprehensive meta-analysis by Ho et al, which pooled data from 3,654 patients with communicating hydrocephalus, showed no significant difference in outcome as measured by mRS between LPS and VPS.¹ The most studied subgroup of patients with communicating hydrocephalus are those with idiopathic normal pressure hydrocephalus (iNPH). Two RCTs evaluated postoperative outcomes in iNPH patients after LPS³ and VPS procedures.¹⁰ A pooled analysis of these two studies showed no significant difference in postoperative iNPHGS scores between the LPS and VPS groups, with 89% and 86% of patients, respectively, responding to shunt treatment at 1-year follow-up.¹¹

A study on the treatment of IIH found that an LPS had a similar effect to standard therapy with VPS. The LPS was found to improve visual acuity and reduce headaches in 55–100% and 76–92% of cases, respectively.^12,13

In our cohort, patients with PHH represented the largest proportion of patients with communicating hydrocephalus. Unfortunately, only one patient had follow-up data at the end of this study, which showed a significant improvement in alertness and mobilization. To date, there are only a limited number of mostly retrospective studies comparing the efficacy and safety of LPS in PHH with VPS. The largest identified retrospective study showed no significant change in outcome between LPS and VPS. However, the overall complication rate was significantly lower in the LPS group.⁶ A non-randomized, monocentric prospective trial on this topic is currently pending.⁷

The controversy surrounding the complication rate after LPS implantation remains a frequently discussed topic in hydrocephalus research. The reported complication rates in the literature are very heterogeneous, probably due to the large heterogeneity of the LPS studies. Based on class I evidence from two large RCTs in iNPH (SINPHONI and SINPHONI 2), the overall complication rate in the LPS group was 49.6% compared to 35% in the VPS group.^3,10 In contrast, the meta-analysis by Ho et al. reported a significantly lower complication rate of 13% in the LPS group compared to 23.8% in the VPS group.¹ A study of complication rates after LPS found no significant difference in overall complication rates compared to VPS.⁴

Overdrainage is a common complication following LPS, with up to 35.5% of patients in the LPS group experiencing overdrainage symptoms in the SINPHONI 2 RCT. In contrast, the VPS group had a lower incidence of overdrainage, with only 22% of patients experiencing overdrainage and only 1% requiring surgery for subdural effusion/hematoma.³ In our cohort, 20.8% of patients presented with clinical symptoms of overdrainage. These were observed in every diagnosis group in our cohort. However, none of these patients required surgical intervention, as there was noch relevant subdural effusion or hematoma.The overdrainage occurred in all subgroups. In one case of IIH and one case of iNPH, overdrainage occurred with the initial DPU setting of 10 cmH₂O and nGU of 20 cmH₂O, which may necessitate a higher initial setting of the DPU and/or nGU selection with higher fixed pressure to prevent overdrainage in the future. Two patients with PHH presented with a sinking flap on early follow-up. This occurred as both patients had received decompressive craniectomy after aSAH and AVM rupture, respectively. The DPU was initially set to 5 and 10 cmH₂O, respectively, due to high preoperative drainage volumes through the external ventricle drain and the predominantly prone position of these two patients at the time of discharge from our institution.

In 3 cases (12.5%), the peritoneal catheter was found to have dislocated outside of the peritoneal cavity. In two of these patients, the BMI was over 26. Higher BMI values can lead to increased intrabdominal pressure, which is believed to increase the risk of peritoneal catheter dislocation.^14,15 All three patients underwent surgical catheter reinsertion.

In our cohort, only one patient was found to have LPS infection, representing 4.2% of all cases. Due to the small size of our cohort, we cannot make significant comparisons with other studies. However, the infection rate reported by Azad et al. for LPS (5.8%) was similar to that for VPS (5.2%).4 The SINPHONI RCT reported an infection rate of only 1%, also not significantly different from the VPS cohort.³ The meta-analysis by Ho et al. showed that infection rates were significantly lower in the LPS group (1.53%) compared to the VPS group (5.4%).¹ In our single case, this resulted in surgical removal of the LPS.

In our study, the revision rate was 16.7%, with most cases due to peritoneal catheter dislocation. The SINPHONI 2 RCT reported a significantly lower revision rate of 10.2% compared to 1% in the VPS cohort. In general, the revision rate after LPS seems to be higher compared to VPS. Similar revision rates to our study were reported in the LPS study of iNPH at 24%.¹⁶ In one of the largest retrospective cohort studies of IIH comparing LPS and VPS, the revision rate in the LPS group was as high as 52%, insignificantly favoring the standard procedure with VPS over LPS.⁵ In fact, this high revision rate in IIH may be due to the lack of a gravitational unit, as IIH patients often require high valve settings.

In three cases, an LPS was implanted instead of a VPS due to previous extensive disruption of cranial wound healing after VPS. These patients had previously developed infections following cranioplasty after decompressive craniectomy. Implantation of an LPS in these patients allowed removal of allogeneic VPS material in direct contact with the complicating cranial wound, allowing undisturbed healing and reducing further risk to the cranial wound in the event of potential shunt dysfunction. Following these three cases, we identified five additional PHH patients who underwent decompressive craniectomy and received an LPS because further cranial procedures (such as cranioplasty) were anticipated. This procedure may be the preferred option for patients who are expected to undergo multiple cranial surgeries, such as those with posthemorrhagic hydrocephalus after decompressive craniectomy, to reduce the risk of shunt infection.

The ability to implant the Valve Board in multiple locations also provides a unique opportunity to address basic patient needs, such as sleeping position preferences. For most of the patients who were able to consent, the main argument for choosing the LPS was the lack of need for intracranial surgery, the avoidance of brain manipulation and the risk of brain hemorrhage and in turn the absence of the prohibition to drive in Germany.

A number of limitations of this study should be noted: The retrospective design of the study was the most limiting factor. In addition, the small number of cases limits the ability to make comparisons with larger studies. Finally, the follow-up time is rather short as we report the first consecutive cases using the novel LPS valve plate system. Further studies with larger sample sizes and prospective designs are needed to thoroughly evaluate the efficacy and safety of LPS implantation compared to standard VPS procedures.

This is the first study applying the novel LPS integrating a gravitational unit. In our cohort we did not find relevant complications especially with respect to overdrainage. Our findings demonstrate promising results in all different etiologies of HC treated in our cohort. Furthermore we found the LPS system as a valuable rescue option for patients with complex cranial wound conditions. Further investigations involving larger cohorts and prospective designs are imperative to validate these outcomes and optimize treatment strategies.

Conflict of interest statement:

VP and TF have received lecture honoraria from BBraun - Aesculap AG company. All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.

Author Contribution

JO*: design, data collection, data analysis, figure creation, writing of the manuscriptPK: revision of the manuscriptLQ: revision of the manuscriptDJ: revision of the manuscriptTF: revision of the manuscriptMC: revision of the manuscript, supervisionVP: design, writing of the manuscript, revision of the manuscript, supervision

Acknowledgement

We thank to Elke Hattingen, MD; the chair of the Institute of Neuroradiology for providing postoperative radiographs.

Data Availability

The data supporting the findings of this study are not publicly available due to local GDPR regulations. However, access to this data can be granted upon reasonable request via email ([email protected]).

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Table 1

Basic chracteristics
	Overall, n = 24
Age	64.5 [54.5–72.3]^*
Sex
female	13 (54.2%)
male	11 (45.8%)
BMI	26.6 [24.1–30.1]^**
Indications
PHH	10 (41.7%)
aSAH	5 (50.0%)
AVM	2 (20.0%)
ICH	3 (30.0%)
iNPH	9 (37.5%)
IHH	3 (12.5%)
Miscellaneous	2 (8.3%)
Time in surgery [minutes]
incision to suture	68 [59.8–82.0]
positioning to suture	115.5 [93.0–130.0]
Length of stay [days]	1.5 [1–4]
Major complications	4 (16.7%)
peritoneal catheter dislocation	3 (12.5%)
infection	1 (4.2%)
subdural effusions/hematoma	0 (0.0%)
Minor complications	5 (20.8%)
overdrainage	5 (20.8%)

* n (%)

** median (25th and 75th quartile of IQR)

No competing interests reported.

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You are reading this latest preprint version

A novel Lumbo-Peritoneal Shunt System Including a Gravitational Unit: First Experiences and Clinical Perspectives

Status:

Version 1

Abstract

Figures

Introduction

Methods

Study Design

Data Collection

Statistical analysis

Surgical procedure

Results

Wide spectrum of indications

Intra- and postoperative aspects

Selection of gravitational units, differential pressure units and initial shunt setting

Major complications

Minor complications

Outcomes on follow-up

Discussion

Conclusions

Declarations

Conflict of interest statement:

Author Contribution

Acknowledgement

Data Availability

References

Tables

Additional Declarations

Status:

Version 1