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Regarding “Novel temporary endovascular shunt technique to assist in situ fenestration for endovascular reconstruction of the distal aortic arch”
JOURNAL OF VASCULAR SURGERY August 2015
540 Letters to the Editor
is in regard to a severe complication not previously reported from this procedure. As such, the decision-making is less important in reporting this case than is the complication that occurred. We should also clarify the wording “using the EnligHTN-1 protocol.” The patient claimed to have been recruited and consented for the trial, but no follow-up was evident at the treating institution from review of state-wide records. She also stated that she was not reviewed by the treating team after the procedure. This suggests that she was not considered part of the trial. Her procedural records read that she was treated with the EnlighHTN sheath, thus treated “using the EnlighHTN-1 protocol,” but not in the trial. The published trial results do not include this patient because there was no development of severe renal artery stenosis (RAS) in the results.1 Worthley and colleagues suggest that this is not the first case of RAS reported quoting the results of the Symplicity and EnligHTN1 trials.1,2 The Symplicity trial clearly states that there were no cases of RAS after the procedure but mentions a distal side branch irregularity developing in an untreated area. The EnligHTN-1 trial reports two patients with pre-existing RAS (<30% as per exclusion criteria) that showed progression of RAS after the procedure, one to a level >50%.1 However, this report clearly demonstrates for the first time the development of severe RAS in normal renal arteries after renal artery denervation. This also is the first report of severe clinical sequelae from RAS after renal artery denervation. We agree that it is vital that we understand the potential complications for any procedure so that we can provide informed consent. It is difficult to comment on predictors for the development of RAS after renal artery denervation given this is the first report, but it should be clear from the article that normal renal anatomy does not exclude the possibility. James I. Spark, FRCS (Gen), FRCS (Vasc), MD Abhilash P. Chandra, MBBS (Hons), PhD Conor D. Marron, FRCS (Gen), FEBVS, MD Phillip Puckridge, FRACS (Vasc) Flinders Medical Center Bedford Park, Australia REFERENCES 1. Worthley SG, Tsioufis CP, Worthley MI, Sinhal A, Chew DP, Meredith IT, et al. Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial. Eur Heart J 2013;34:2132-40. 2. Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, et al. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet 2009;373:1275-81. http://dx.doi.org/10.1016/j.jvs.2014.02.048
Regarding “Novel temporary endovascular shunt technique to assist in situ fenestration for endovascular reconstruction of the distal aortic arch” We read with great interest the article, “Novel temporary endovascular shunt technique to assist in situ fenestration for endovascular reconstruction of the distal aortic arch “by Xiong et al1 from Beijing, China. The authors have to be congratulated on their successful endovascular treatment of an arch aneurysm with the in situ technique with the help of temporary endovascular shunts. We think that the technique has a great potential in the future. The authors claim that this is a novel technique. However, the technique with endovascular shunts and their safety in regard to flow capacity has already been tested in an experimental model, and the results were published in 2012 in the Journal of Vascular Surgery.2 Further, the first published case of a total endovascular aortic arch reconstruction with the in situ technique has also not been mentioned in their report.3 Both of these publications might be of interest for readers of the Journal of Vascular Surgery and for those working in this particular anatomical field. Björn Sonesson, MD Tim Resch, MD Nuno Dias, MD Martin Malina, MD Vascular Center Skåne University Hospital Malmö, Sweden
REFERENCES 1. Xiong J, Guo W, Liu X, Jia X, Ma X, Wang L. Novel temporary endovascular shunt technique to assist in situ fenestration for endovascular reconstruction of the distal aortic arch. J Vasc Surg 2015;62: 226-8. 2. Sonesson B, Resch T, Dias N, Malina M. New temporary internal introducer shunt for brain perfusion during total endovascular arch replacement with in situ fenestration technique. J Vasc Surg 2012;56: 1162-5. 3. Sonesson B, Resch T, Allers M, Malina M. Endovascular total aortic arch replacement by in situ stent graft fenestration technique. J Vasc Surg 2009;49:1589-91. http://dx.doi.org/10.1016/j.jvs.2014.03.284
540 Letters to the Editor
is in regard to a severe complication not previously reported from this procedure. As such, the decision-making is less important in reporting this case than is the complication that occurred. We should also clarify the wording “using the EnligHTN-1 protocol.” The patient claimed to have been recruited and consented for the trial, but no follow-up was evident at the treating institution from review of state-wide records. She also stated that she was not reviewed by the treating team after the procedure. This suggests that she was not considered part of the trial. Her procedural records read that she was treated with the EnlighHTN sheath, thus treated “using the EnlighHTN-1 protocol,” but not in the trial. The published trial results do not include this patient because there was no development of severe renal artery stenosis (RAS) in the results.1 Worthley and colleagues suggest that this is not the first case of RAS reported quoting the results of the Symplicity and EnligHTN1 trials.1,2 The Symplicity trial clearly states that there were no cases of RAS after the procedure but mentions a distal side branch irregularity developing in an untreated area. The EnligHTN-1 trial reports two patients with pre-existing RAS (<30% as per exclusion criteria) that showed progression of RAS after the procedure, one to a level >50%.1 However, this report clearly demonstrates for the first time the development of severe RAS in normal renal arteries after renal artery denervation. This also is the first report of severe clinical sequelae from RAS after renal artery denervation. We agree that it is vital that we understand the potential complications for any procedure so that we can provide informed consent. It is difficult to comment on predictors for the development of RAS after renal artery denervation given this is the first report, but it should be clear from the article that normal renal anatomy does not exclude the possibility. James I. Spark, FRCS (Gen), FRCS (Vasc), MD Abhilash P. Chandra, MBBS (Hons), PhD Conor D. Marron, FRCS (Gen), FEBVS, MD Phillip Puckridge, FRACS (Vasc) Flinders Medical Center Bedford Park, Australia REFERENCES 1. Worthley SG, Tsioufis CP, Worthley MI, Sinhal A, Chew DP, Meredith IT, et al. Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial. Eur Heart J 2013;34:2132-40. 2. Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, et al. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet 2009;373:1275-81. http://dx.doi.org/10.1016/j.jvs.2014.02.048
Regarding “Novel temporary endovascular shunt technique to assist in situ fenestration for endovascular reconstruction of the distal aortic arch” We read with great interest the article, “Novel temporary endovascular shunt technique to assist in situ fenestration for endovascular reconstruction of the distal aortic arch “by Xiong et al1 from Beijing, China. The authors have to be congratulated on their successful endovascular treatment of an arch aneurysm with the in situ technique with the help of temporary endovascular shunts. We think that the technique has a great potential in the future. The authors claim that this is a novel technique. However, the technique with endovascular shunts and their safety in regard to flow capacity has already been tested in an experimental model, and the results were published in 2012 in the Journal of Vascular Surgery.2 Further, the first published case of a total endovascular aortic arch reconstruction with the in situ technique has also not been mentioned in their report.3 Both of these publications might be of interest for readers of the Journal of Vascular Surgery and for those working in this particular anatomical field. Björn Sonesson, MD Tim Resch, MD Nuno Dias, MD Martin Malina, MD Vascular Center Skåne University Hospital Malmö, Sweden
REFERENCES 1. Xiong J, Guo W, Liu X, Jia X, Ma X, Wang L. Novel temporary endovascular shunt technique to assist in situ fenestration for endovascular reconstruction of the distal aortic arch. J Vasc Surg 2015;62: 226-8. 2. Sonesson B, Resch T, Dias N, Malina M. New temporary internal introducer shunt for brain perfusion during total endovascular arch replacement with in situ fenestration technique. J Vasc Surg 2012;56: 1162-5. 3. Sonesson B, Resch T, Allers M, Malina M. Endovascular total aortic arch replacement by in situ stent graft fenestration technique. J Vasc Surg 2009;49:1589-91. http://dx.doi.org/10.1016/j.jvs.2014.03.284