Safety and Feasibility of Steerable Radiofrequency Ablation in Combination with Cementoplasty for the Treatment of Large Extraspinal Bone Metastases

Round 1

Reviewer 1 Report

 

A Steerable Radiofrequency ablation in combination with cementoplasty for the treatment of large, irregular and challanging extraspinal bone metastases: preliminary experience in a single center

 

Role of combined percutaneous radiofrequency ablation and cementoplasty for the treatment of extraspinal painful bone metastases have been well established in multiple prior studies. However, this is a novel study utilizing the articulating bipolar extensible electrode radiofrequency ablation technology marked by Merit for ablation and stabilization of extraspinal bony metastasis.

 

Title

Recommend to change the title to “Safety and feasibility of steerable radiofrequency ablation in combination with cementoplasty for the treatment of large extraspinal bone metastases”

 

Abstract

Background

·      Ok

 

Method

·      Please mention the study design, retrospective vs prospective, or…

·      Please mention which RF system was used.

 

Results

·      After RFA should be rephrased to RFA and cementoplasty

·      Leakage to “leakages”

 

Conclusion

·      Please start your conclusion with safety and feasibility since they were there reason for this study.

·      Avoid using seems

 

Introduction

 

·      Before aim, please discuss why RFA is preferred over cryoablation.

·      Also please provide advantages of steerable is preferred over fixed RF probes.

 

Materials and Methods

·      Please start this section with study design subsection and provide the date this study carried out and the center.

·      Provide an statement about IRB approval.

 

Results

Ok

 

Discussion

·      Please start the discussion with the main findings, that steerable RFA technique and cementoplasty was safe and feasible.

·      A lot of publications have shown safety, feasibility, and efficacy of RFA and cementoplasty. Please discussion advantage/benefit of steerable RFA technique over the traditional one. This should be the center of discussion.

 

Conclusions

·      The first statement of the conclusion should say :” RFA steerable device in combination with cementoplasty is safe and feasible for patients with painful bone metastases 275 challenging for morphology”. Since the safety and feasibility was the aim of the study.

·      Omit “seems”.

 

Figures

 

Figure 1

Please connect the mean pain on this figure to show linear changes in the pain.

 

Figure 2

Redundant. please omit

 

Figure 3

Ok

 

Figure 4

Ok

 

Figure 5

Redundant. please omit

 

Tables

 

Table 1

Ok

 

Table 2

Ok

Author Response

REVIEWER 1

 

A Steerable Radiofrequency ablation in combination with cementoplasty for the treatment of large, irregular and challanging extraspinal bone metastases: preliminary experience in a single center

 

Role of combined percutaneous radiofrequency ablation and cementoplasty for the treatment of extraspinal painful bone metastases have been well established in multiple prior studies. However, this is a novel study utilizing the articulating bipolar extensible electrode radiofrequency ablation technology marked by Merit for ablation and stabilization of extraspinal bony metastasis.

 

Title

Recommend to change the title to “Safety and feasibility of steerable radiofrequency ablation in combination with cementoplasty for the treatment of large extraspinal bone metastases”

Following this suggestion, the title has been modified.

 

Abstract

Background

• Ok

 

Method

• Please mention the study design, retrospective vs prospective, or… Thanks for the suggestion. This sentence has been added: “all data were retrospectively reviewed.”
• Please mention which RF system was used. The system used for treatment has been clarified using the sentence” All the ablation procedures were performed using a steerable RFA device (STAR, Merit Medical Systems, Inc., South Jordan, UT, USA )”

 

Results

• After RFA should be rephrased to RFA and cementoplasty.
• Leakage to “leakages”.
  Thanks for the suggestions. The changes have been made.

 

Conclusion

• Please start your conclusion with safety and feasibility since they were there reason for this study. Thanks to the reviewer for this specific comment. The whole sentence has been modified as following “The combined treatment of RFA, with a steerable device, and cementoplasty is a safe, feasible promising clinical option for the management of painful bone metastases challenging for morphology and location, resulting in an improvement of the quality of life of patients”.
• Avoid using seems The whole sentence has been modified as following “The combined treatment of RFA, with a steerable device, and cementoplasty is a safe, feasible promising clinical option for the management of painful bone metastases challenging for morphology and location, resulting in an improvement of the quality of life of patients”.

 

Introduction

 

• Before aim, please discuss why RFA is preferred over cryoablation. Please, read ahead
• Also please provide advantages of steerable is preferred over fixed RF probes. Following reviewer’ indications this sentence has been added: “Different thermal ablation modalities are actually available for the treatment of bone metastases; current percutaneous thermal ablation techniques used are primarily cryoablation (CRA) and radiofrequency ablation (RFA), both high effective and safe in selected patients (5). In most of cases RFA is technically performed with the insertion of only one electrode-needle with a crucial advantage when a challenging location should be reached. The choice of a steerable bipolar radiofrequency probe can result an essential tool for difficult to reach and large extraspinal bone metastases, when articulating the distal segment of the ablation probe into multiple portions of the tumor, can achieve a complete ablation area through a single osseous access channel. This is a technical aspect that impacts on the choice of a steerable needle with respect to a fixed one.”

 

 

Materials and Methods

• Please start this section with study design subsection and provide the date this study carried out and the center. We followed reviewer’ suggestions
• Provide an statement about IRB approval. A sentence about IRB approval has been added

 

Results

Ok

 

Discussion

• Please start the discussion with the main findings, that steerable RFA technique and cementoplasty was safe and feasible. Thanks to the reviewer for this specific comment.

This sentence has been added “ A steerable radiofrequency ablation device with an articulating bipolar extensible electrode in combination with cementoplasty is a feasible and safe option of for the treatment of challenging for location and morphology lytic metastatic bone lesions”.

 

• A lot of publications have shown safety, feasibility, and efficacy of RFA and cementoplasty. Please discussion advantage/benefit of steerable RFA technique over the traditional one. This should be the center of discussion. Thanks to the reviewer for this comment. We tried to underline this concept in the central part of the discussion as following:

“The percutaneous approach to a bone lesion can sometimes be particularly complex based on the anatomical site and morphology of the lesion. Furthermore, to obtain a sufficiently large ablation area, such as to include the pathological tissue, it is often necessary to insert more than one electrode needles. In most cases, a percutaneous approach using one or more working cannulas is technically feasible; but it can represent a procedural bet when the lesion is localized in complex locations, when it is necessary to respect load or force lines of the bone segment oto avoid damaging muscular or nerve structures adjacent to the treatment site. In such situations it is particularly advantageous to be able to reach the lesion through a single safe access and to have a steerable ablation device instead of a fixed tip. In load sites, such as the bony structures of the pelvis, it becomes crucial to use a direct access to the lesion that can preserve and follow the normal load lines (such as the neck of the femur, rather than the ischium or ileus branches -pubic) (Figure 3).

The choice of a steerable bipolar radiofrequency probe for difficult to reach extraspinal bone metastases was based on the advantages of articulating distal segment of the ablation probe into multiple portions of the tumor from a single osseous access channel [18] (Figure 4).

As reported in the literature, some extra-spinal bone metastases are technical challenging to approach [19]. The navigational tip of the probe instead of a fixed one can be directed in different placements through the same access introducer for accessing lesions in challenging location as well as achieving larger overlapping ablation zones [20].”

 

 

Conclusions

• The first statement of the conclusion should say :” RFA steerable device in combination with cementoplasty is safe and feasible for patients with painful bone metastases 275 challenging for morphology”. Since the safety and feasibility was the aim of the study.
• Omit “seems”.  Both the changes have been made. In particular the sentence has been changed as following “the combined treatment of RFA, with a steerable device, and cementoplasty is a safe, feasible promising clinical option for the management of painful bone metastases challenging for morphology and location, resulting in an improvement of the quality of life of patients”.

 

Figures

 

Figure 1

Please connect the mean pain on this figure to show linear changes in the pain. A red line has been added as suggested by the reviewer

 

Figure 2

Redundant. please omit. The figure has been removed

 

Figure 3

Ok

 

Figure 4

Ok

 

Figure 5

Redundant. please omit Thanks to the reviewer for this comment. However we think that this figure may be useful showing a 12 months follow-up control, differently from the other cases.

 

Tables

 

Table 1

Ok

 

Table 2

Ok

 

Author Response File: Author Response.docx

Reviewer 2 Report

The authors present an original research on "radiofrequency ablation in combination with cementoplasty for the treatment of large, irregular and challenging extraspinal bone metastases". This focus should be better explained in the introduction, as the peculiarity of the steerable instrumentation used and the specific locations of the treated lesion is not clear. 

Excellent cases and figures.

English requires revision by a native to improve fluency and correctness of some terms (e.g. "ambulatory").

In the M&M inclusion and exclusion criteria should be better described.

Tablel 1 is too long and should be condensed.

Author Response

REVIEWER 2

The authors present an original research on "radiofrequency ablation in combination with cementoplasty for the treatment of large, irregular and challenging extraspinal bone metastases". This focus should be better explained in the introduction, as the peculiarity of the steerable instrumentation used and the specific locations of the treated lesion is not clear. 

Thanks to the reviewer for this comment which allow us to be more clear. The last part of the introduction, before the aim of the study, has been modified. Also a focus on the steerable RFA device has been introduced “The choice of a steerable bipolar radiofrequency probe can result an essential tool for difficult to reach and large extraspinal bone metastases, when articulating the distal segment of the ablation probe into multiple portions of the tumor, can achieve a complete ablation area through a single osseous access channel”.

Excellent cases and figures.

English requires revision by a native to improve fluency and correctness of some terms (e.g. "ambulatory").
All the text has been reviewed to improve fluency and some terms has been changed following the reviewer’ suggestion. In particular, “ambulatory” has been changed with pre-procedural consultation

In the M&M inclusion and exclusion criteria should be better described. Thanks to the reviewer for the comment. The following sentence has been added in the M&M section: “Only patients with lytic bone lesions technically challenging with a standard straight ablative probe due to the location and irregular morphology within the bone were included in the study. Patients with coagulopathy and extra-osseous component were excluded.”

Tablel 1 is too long and should be condensed. Thanks for this advice. We wanted to show mets characteristics patient by patient. How do you suggest to condense the table?

Author Response File: Author Response.docx

Round 2

Reviewer 1 Report

The authors have addressed all comments.

Author Response

Thanks to the reviewer