Transjugular Helix Leadless Pacing System Implantation in Adult Congenital Heart Disease Patient with Previous Tricuspid Valve Surgery for Ebstein Anomaly

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

I congratulate the authors on sharing this interesting case report and on the good clinical outcome achieved for the patient.

My comments are below and are minor. They include the presentation of procedural risks and adjustment of the wording of the manuscript that is required prior to publication.

Overall, it is an interesting and well-written case report that adds to existing literature and will be of interest to those caring for ACHD patients.

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Abstract 20-21: LPS following TV surgery has no complications? Surely this should read ‘low risk of complications’ or similar (as per lines 46-47).

Introduction 47-48: Consider rewording to, ‘There are some data on the safety…’ and including mention of the numbers involved in these data, as the reference is of a multicentre study containing 40 patients. So although there are no complications in this small group, the size of this study should be referenced for caution, as more data will be needed to comment on the complication rate in this patient group.

Materials 81-82. Please change word ‘closed’. Consider, alternative description, ie. ‘The right femoral vein was occluded following a previous venous thrombus…’

Materials: Why was a coronary sinus lead not considered? Reference 4 is included in the introduction and refers to an RCT containing 63 patients and although this paper did not find a significant reduction in TR in the LV-CS group, the small number should be noted. For patients with repaired TV. Others have reported the safe use of LV-CS leads following tricuspid valve repair and this should be mentioned as an alternative for this patient.

Discussion 125-129: Please revise the final sentence (‘A major advantage…’) to reflect the possible advantages of the LPS, but not to dismiss all complications, some of which still overlap with TVP. Risks of LPS include device migration, cardiac perforation, tricuspid valve damage and venous damage / vascular access complications. I agree entirely that LPS are a very attractive option in select ACHD patients, but the relative risks must still be outlined and not dismissed.

Discussion 141: Please replace the word ‘peculiar’. Consider other words such as unique, novel or notable.

Conclusion 147: Correct giugular. Please replace with jugular.

Conclusion 148-149: Please rephrase final sentence, as it does not read well ‘based on our case and the literature...’. Consider revision to similar to, ‘This case adds to existing literature on the safe use of LPS in the ACHD population … and we believe…”

Comments on the Quality of English Language

Quality of English language quality is good. I have made some suggestions (above) which are minor and include some potential alternative choices for wording.

Author Response

I congratulate the authors on sharing this interesting case report and on the good clinical outcome achieved for the patient.

My comments are below and are minor. They include the presentation of procedural risks and adjustment of the wording of the manuscript that is required prior to publication.

Overall, it is an interesting and well-written case report that adds to existing literature and will be of interest to those caring for ACHD patients.

Abstract 20-21: LPS following TV surgery has no complications? Surely this should read ‘low risk of complications’ or similar (as per lines 46-47).

We have corrected the sentence.

Introduction 47-48: Consider rewording to, ‘There are some data on the safety…’ and including mention of the numbers involved in these data, as the reference is of a multicentre study containing 40 patients. So although there are no complications in this small group, the size of this study should be referenced for caution, as more data will be needed to comment on the complication rate in this patient group.

We agree and we have specified the small population enrolled in this study.

Materials 81-82. Please change word ‘closed’. Consider, alternative description, ie. ‘The right femoral vein was occluded following a previous venous thrombus…’

The word “closed” was changed into “occluded”.

Materials: Why was a coronary sinus lead not considered? Reference 4 is included in the introduction and refers to an RCT containing 63 patients and although this paper did not find a significant reduction in TR in the LV-CS group, the small number should be noted. For patients with repaired TV. Others have reported the safe use of LV-CS leads following tricuspid valve repair and this should be mentioned as an alternative for this patient.

We thank the reviewer for the comment. A CS lead was not considered the first option because a transvenous pacemaker was considered to increase the risk of infection in this patient. In addition, due to the relatively low percentage of expected pacing, extended longevity, and the possibility of dual-chamber upgrade, LPS was preferred.

Discussion 125-129: Please revise the final sentence (‘A major advantage…’) to reflect the possible advantages of the LPS, but not to dismiss all complications, some of which still overlap with TVP. Risks of LPS include device migration, cardiac perforation, tricuspid valve damage and venous damage / vascular access complications. I agree entirely that LPS are a very attractive option in select ACHD patients, but the relative risks must still be outlined and not dismissed.

We agree with the reviewer and we have rephrased the sentence including complication also related with LPS.

Discussion 141: Please replace the word ‘peculiar’. Consider other words such as unique, novel or notable.

We have changed peculiar with We agree with the reviewer, and we have rephrased the sentence, including complications related to LPS.unique.

Conclusion 147: Correct giugular. Please replace with jugular.

We have corrected the typo.

Conclusion 148-149: Please rephrase final sentence, as it does not read well ‘based on our case and the literature...’. Consider revision to similar to, ‘This case adds to existing literature on the safe use of LPS in the ACHD population … and we believe…”

We have changed the conclusion according to the reviewer’s suggestion.

Reviewer 2 Report

Comments and Suggestions for Authors

The paper is well written and describes for the first time the procedure in a special case i.e. the transjugular approach of a leadless pacing system  in a female patient with ACHD procedure. Whether this would be an alternative in other cases has to be demonstrated in a series of comparable cases - this limitation could be added to the discussion part.

Author Response

The paper is well written and describes for the first time the procedure in a special case i.e. the transjugular approach of a leadless pacing system  in a female patient with ACHD procedure. Whether this would be an alternative in other cases has to be demonstrated in a series of comparable cases - this limitation could be added to the discussion part.

We thank the reviewer for the appreciative comments. We have added this limitation in the discussion paragraph.

Reviewer 3 Report

Comments and Suggestions for Authors

Very interesting work congratulations to the authors 

Author Response

Very interesting work congratulations to the authors.

We thank the reviewer for the appreciative comment.

Reviewer 4 Report

Comments and Suggestions for Authors

The authors present the use of leadless pacemakers (LPS) in patients with adult congenital heart disease (ACHD), particularly those with prior tricuspid valve surgery. It highlights the limitations of traditional pacemaker implantation due to anatomical challenges and presents LPS as a safer alternative. The transjugular approach for LPS implantation is also shown to be feasible in ACHD patients, as demonstrated in a case involving Ebstein's anomaly, atrial septal defect closure, and advanced atrioventricular block. 

My questions for the authors are as follows:

• Once the jugular approach was chosen, did it influence the decision on the type of device to be used, in this case, the Aveir?

• Did you perform a CT scan prior to implantation to ensure that the longer length of the Aveir, compared to the MICRA, would not cause issues with the tricuspid valve apparatus?

• Was the monocameral Aveir implanted in the ventricle with the possibility of upgrading to a dual-chamber device in mind? If so, how did you plan to upgrade to an atrial lead, considering the femoral approach doesn't seem feasible? (Implanting the Aveir in the atrium via the jugular is almost impossible.)It would be helpful to include this information in the text for completeness.

Author Response

The authors present the use of leadless pacemakers (LPS) in patients with adult congenital heart disease (ACHD), particularly those with prior tricuspid valve surgery. It highlights the limitations of traditional pacemaker implantation due to anatomical challenges and presents LPS as a safer alternative. The transjugular approach for LPS implantation is also shown to be feasible in ACHD patients, as demonstrated in a case involving Ebstein's anomaly, atrial septal defect closure, and advanced atrioventricular block. 

My questions for the authors are as follows:

Once the jugular approach was chosen, did it influence the decision on the type of device to be used, in this case, the Aveir?

We planned an Aveir implant before choosing the jugular approach. The reasons were the possibility of a future upgrade to dual-camber stimulation if needed, the possibility of mapping before implanting the device (very useful in this setting of patients considering the chance of having low sensing and high thresholds), the longer battery life in VR compared to MICRA, and the retrival possibility.

Did you perform a CT scan prior to implantation to ensure that the longer length of the Aveir, compared to the MICRA, would not cause issues with the tricuspid valve apparatus?

We did not perform a CT scan but we performed several measurements using transthoracic echocardiography, and we were confident that an Aveir device would fit in the RV without TV entrapment or interaction.

Was the monocameral Aveir implanted in the ventricle with the possibility of upgrading to a dual-chamber device in mind? If so, how did you plan to upgrade to an atrial lead, considering the femoral approach doesn't seem feasible? (Implanting the Aveir in the atrium via the jugular is almost impossible.)It would be helpful to include this information in the text for completeness.

We agree with the reviewer regarding the virtual impossibility of implanting an atrial Aveir module from the jugular vein. However, if needed, the left femoral vein, even if small, was patent, and that would be the access for an atrial module. We have added this remark in the discussion section.

Reviewer 5 Report

Comments and Suggestions for Authors

The case report presented is of clinical interest for treating patients with congenital heart disease needing a LLPM. The approach is feasible and original and may help interventional cardiologists in this particular situation. The discussion is well elaborated.

Author Response

The case report presented is of clinical interest for treating patients with congenital heart disease needing a LLPM. The approach is feasible and original and may help interventional cardiologists in this particular situation. The discussion is well elaborated.

We thank the reviewer for the comments.