Article
Reference
Surgical or Transcatheter Aortic-Valve Replacement
NOBLE, Stéphane Laurent, BURRI, Haran Kumar, ROFFI, Marco
NOBLE, Stéphane Laurent, BURRI, Haran Kumar, ROFFI, Marco. Surgical or Transcatheter Aortic-Valve Replacement. New England Journal of Medicine , 2017, vol. 377, no. 2, p. 196-7
PMID : 28704020
DOI : 10.1056/NEJMc1706234
Available at:
http://archive-ouverte.unige.ch/unige:99061
Correspondence
Tien Y. Wong, F.R.C.S.E., Ph.D.
Singapore National Eye Center Singapore, Singapore ophwty@ nus . edu . sg
Dr. Wong reports receiving travel support, honoraria, re- search support, and fees for serving on advisory boards from Allergan, Bayer, Novartis, Pfizer, and Solvay. No other potential conflict of interest relevant to this letter was reported.
1. The DCCT/EDIC Research Group. Frequency of evidence- based screening for retinopathy in type 1 diabetes. N Engl J Med 2017; 376: 1507-16.
2. Wong TY, Mwamburi M, Klein R, et al. Rates of progression in diabetic retinopathy during different time periods: a system- atic review and meta-analysis. Diabetes Care 2009; 32: 2307-13.
3. Scanlon PH. The English National Screening Programme for diabetic retinopathy 2003-2016. Acta Diabetol 2017; 54: 515-25.
4. Wang LZ, Cheung CY, Tapp RJ, et al. Availability and vari- ability in guidelines on diabetic retinopathy screening in Asian countries. Br J Ophthalmol 2017 March 14 (Epub ahead of print).
5. Moreton RB, Stratton IM, Chave SJ, Lipinski H, Scanlon PH.
Factors determining uptake of diabetic retinopathy screening in Oxfordshire. Diabet Med 2017 March 11 (Epub ahead of print).
DOI: 10.1056/NEJMc1706322
The authors reply: Lamoureux and colleagues question the applicability of the DCCT/EDIC findings, and they argue that neither our patients nor their clinical course are representative of pa- tients with type 1 diabetes today. They also assert that the seven-field fundus photography used in our study is no longer relevant, since most clini- cal evaluations are now performed with one-field or two-field screening.
The clinical characteristics and course of reti- nopathy of the participants in the DCCT conven- tional-therapy group were similar to those of a population-based cohort.1 Furthermore, Lamou- reux et al. cite a meta-analysis that showed that the clinical course of retinopathy changed be-
tween two periods: 1975–1985 and 1985–2005.2 The DCCT/EDIC was conducted primarily during the second period, from 1983 through the present.
In addition, although the method of screen- ing for retinopathy in England shifted to one- field or two-field photography between 2003 and 2016, those fields had to subtend approximately the same area as the seven-field method.3 As compared with the seven-field reference standard, one-field and two-field photography was shown to have acceptable specificity and sensitivity.3
Finally, Lamoureux et al. suggest that the per- sonalized approach is unlikely to be adopted worldwide. However, we think that should not impede the implementation, whenever feasible, of the improved, data-driven, and cost-saving screening strategy we have described.
David M. Nathan, M.D.
Massachusetts General Hospital Diabetes Center Boston, MA
Ionut Bebu, Ph.D.
John M. Lachin, Sc.D.
Biostatistics Center, George Washington University Rockville, MD
jml@ bsc . gwu . edu
Since publication of their article, the authors report no fur- ther potential conflict of interest.
1. Klein R, Moss S. A comparison of the study populations in the Diabetes Control and Complications Trial and the Wisconsin Epidemiologic Study of Diabetic Retinopathy. Arch Intern Med 1995; 155: 745-54.
2. Wong TY, Mwamburi M, Klein R, et al. Rates of progression in diabetic retinopathy during different time periods: a system- atic review and meta-analysis. Diabetes Care 2009; 32: 2307-13.
3. Scanlon PH. The English National Screening Programme for diabetic retinopathy 2003-2016. Acta Diabetol 2017; 54: 515-25.
DOI: 10.1056/NEJMc1706322
Surgical or Transcatheter Aortic-Valve Replacement
To the Editor: Reardon et al. (April 6 issue)1 re- port the results of the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial. They state that transcatheter aortic-valve replacement (TAVR) was a noninferior alterna- tive to surgery in patients with severe aortic ste- nosis who were at intermediate surgical risk.
In older adults, cognitive decline is a poten- tial complication of many surgical procedures, including aortic-valve replacement.2 Cognitive de- cline may not be reversible and may cause devas-
tating consequences with respect to function, communication, and quality of life.3 Reardon et al.
did not consider postprocedure cognitive decline as an outcome, and previous studies comparing TAVR with surgical aortic-valve replacement in intermediate-risk patients have not addressed this issue.4 TAVR is gaining in popularity as a viable alternative to surgery, but data from prospective studies to evaluate the potential for cognitive de- cline after TAVR in moderate-risk patients are lacking.
Bernardo J. Reyes, M.D.
Alberto A. Sabates, M.D.
Joel A. Casale, M.D.
Florida Atlantic University Boca Raton, FL
jcasale3@ health . fau . edu
No potential conflict of interest relevant to this letter was re- ported.
1. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk pa- tients. N Engl J Med 2017; 376: 1321-31.
2. Zimpfer D, Czerny M, Kilo J, et al. Cognitive deficit after aortic valve replacement. Ann Thorac Surg 2002; 74: 407-12.
3. Zimpfer D, Kilo J, Czerny M, et al. Neurocognitive deficit following aortic valve replacement with biological/mechanical prosthesis. Eur J Cardiothorac Surg 2003; 23: 544-51.
4. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgi- cal aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016; 374: 1609-20.
DOI: 10.1056/NEJMc1706234
To the Editor: An analysis of the results of the SURTAVI trial arouses some concerns. First, TAVR was associated with better hemodynamic performance that resulted in lower mean aortic- valve gradients and larger aortic-valve areas than surgery. However, 78.1% of patients in the TAVR group received a bioprosthesis that was 29 mm in diameter or larger, and 70.7% of pa- tients in the surgery group received a biopros- thesis that was 23 mm in diameter or smaller.
Thus, there may have been a mismatch between the patients and the implanted valves, with the patients in the surgery group receiving valves that were smaller than those of the patients in the TAVR group.1 Does this explain why 9.5% of the patients in the surgery group had a mean transvalvular gradient greater than 20 mm Hg at discharge?
TAVR is only one approach to aortic-valve replacement that is less invasive than convention- al surgery involving a full sternotomy. A mini- mally invasive surgical approach with suture- less valves, which has been associated with excellent postoperative outcomes and has been proposed as an appropriate treatment option for high-risk patients who can undergo surgery, may be a better alternative to TAVR2 than open surgery.
A fair comparison between the latest TAVR techniques and a new surgical approach would have reflected the real world of aortic-valve re- placement.
Antonio Miceli, M.D., Ph.D.
Antonio Lio, M.D.
Mattia Glauber, M.D., Ph.D.
Istituto Clinico Sant’Ambrogio Milan, Italy
antoniomiceli79@ alice . it
Drs. Miceli and Glauber report receiving consulting fees from LivaNova Group. No other potential conflict of interest relevant to this letter was reported.
1. Pibarot P, Dumesnil JG. Prosthesis-patient mismatch: defi- nition, clinical impact, and prevention. Heart 2006; 92: 1022-9.
2. Glauber M, Miceli A. Minimally invasive aortic valve replace- ment with sutureless valve is the appropriate treatment option for high-risk patients and the “real alternative” to transcatheter aortic valve implantation. J Thorac Cardiovasc Surg 2016; 151:
610-3.
DOI: 10.1056/NEJMc1706234
To the Editor: In the trial by Reardon et al., mortality at 2 years was similar among patients who received a new permanent pacemaker and those who did not, and this rate of death was lower than the rate among patients who had pre- viously received a permanent pacemaker. How- ever, the percentage of patients who received a new pacemaker was high. This is a weakness of self-expanding bioprostheses, especially in the treatment of patients with a long life expec- tancy.
The authors stated that among the patients who received the Evolut R device (16% of the patients in the TAVR group), the rate of per- manent pacemaker implantation of 26.7% was higher than expected. Indeed, the rate of per- manent pacemaker implantation was lower in the U.S. registry (16.4%, and 19.7% when the patients who had previously received pacemak- ers were excluded).1 However, the rate in the SURTAVI trial is similar to that in our study from Geneva (23.9%),2 a study from Israel (20.4%),3 and a study from Germany (20.0%)4 (Table 1).
We think that rates of permanent pacemaker implantation may be influenced by local prac- tice. Can the authors describe the distribution of these rates after TAVR and surgical aortic-valve replacement between countries and centers? In addition, we think that to have a more accurate assessment of the need for new pacemakers after TAVR, in the rate calculation, patients who had received pacemakers previously should be ex- cluded (Table 1).
Correspondence
Stephane Noble, M.D.
Haran Burri, M.D.
Marco Roffi, M.D.
University Hospital of Geneva Geneva, Switzerland stephane . noble@ hcuge . ch
Dr. Noble reports receiving fees from Medtronic for serving as a proctor for the Evolut R device. No other potential conflict of interest relevant to this letter was reported.
1. Popma JJ, Reardon MJ, Khabbaz K, et al. Early clinical out- comes after transcatheter aortic valve replacement using a novel self-expanding bioprosthesis in patients with severe aortic steno- sis who are suboptimal for surgery: results of the Evolut R U.S.
study. JACC Cardiovasc Interv 2017; 10: 268-75.
2. Perrin N, Roffi M, Frei A, et al. Thirty-day outcome follow- ing CoreValve Evolut R transcatheter aortic valve implantation:
an all-comers prospective study. Rev Esp Cardiol (Engl Ed) 2016 December 26 (Epub ahead of print).
3. Ben-Shoshan J, Konigstein M, Zahler D, et al. Comparison of the Edwards SAPIEN S3 versus Medtronic Evolut-R devices for transcatheter aortic valve implantation. Am J Cardiol 2017; 119:
302-7.
4. Gomes B, Geis NA, Chorianopoulos E, et al. Improvements of procedural results with a new-generation self-expanding transfemoral aortic valve prosthesis in comparison to the old- generation device. J Interv Cardiol 2017; 30: 72-8.
DOI: 10.1056/NEJMc1706234
The authors reply: Reyes and colleagues com- ment that cognitive decline after TAVR could be a serious problem and that the SURTAVI trial and other randomized trials have not specifically looked for cognitive decline. We agree that if cognitive decline occurs, it can be a serious detri- ment to the patient who undergoes either TAVR or surgery. Data from prospective studies to spe- cifically address this issue are lacking.
Miceli and colleagues raise the question of the size of the valves used in TAVR and surgical aortic-valve replacement in our trial. Surgical valves are labeled according to external diameter, and the actual internal diameter varies between models.
The TAVR valves used are labeled according to the inflow diameter of the sealing skirt and not according to the size of the supraannular valve itself. Comparison of these numbers is not mean- ingful. All the surgeons in this trial had a mini- mum of 5 years of experience and worked in carefully selected experienced valve centers. These surgeons produced outstanding results with an
Series and Group Patients
Patients with Pacemaker at
Baseline Patients with New Pacemaker
All Patients
Excluding Patients with Pacemaker at
Baseline
no. no./total no. (%)
SURTAVI trial in the United States, Europe, and Canada
Surgery 796 72/796 (9.0) 52/796 (6.5) 52/724 (7.2)
TAVR 864 84/864 (9.7) 224/864 (25.9%)† 224/780 (28.7)
U.S. registry1 241‡ 39/241 (16.2) 39/237 (16.4) 39/198 (19.7)
Geneva2 71 7/71 (9.9) 17/71 (23.9) 17/64 (26.6)
Tel-Aviv3
Evolut R 108 20/108 (18.5) 22/108 (20.4) 22/88 (25.0)
SAPIEN 3 124 16/124 (12.9) 26/124 (21.0) 26/108 (24.1)
Heidelberg4
Evolut R 100 15/100 (15.0) 20/100 (20.0) 20/84 (23.8)§
SAPIEN 3 100 10/100 (10.0) 21/100 (21.0) 21/90 (23.3)
* SURTAVI denotes Surgical Replacement and Transcatheter Aortic Valve Implantation, and TAVR transcatheter aortic- valve replacement.
† A total of 25.5% of these patients received a CoreValve device, and 26.7% received an Evolut R device.
‡ The Evolut R valve was implanted in 237 of the 241 patients who underwent attempted pacemaker implantation.
§ The denominator is 84 because one patient died during the procedure.
Table 1. Rate of Implantation of New Permanent Pacemakers.*
exceedingly low mortality. Both minimally inva- sive surgery and commercially available suture- less valves were allowed in the trial. However, the published data do not suggest that the re- sults of minimally invasive aortic-valve surgery would be better than those of a sternotomy ap- proach in a way that would probably change the results of this trial.1,2 Sutureless valves have been introduced into surgical use and appear to pro- vide good hemodynamics but a greater need for new pacemakers and more paravalvular leaks than stented biologic valves, and data on the durability of sutureless valves are lacking.3 In a randomized trial involving patients who were at high risk for standard surgery, we found that elements of the surgical technique did not influ- ence outcomes.4
Noble and colleagues emphasize the ongoing, considerable need for permanent pacemakers in patients who undergo TAVR. Although the clini- cal implications of these new pacemaker implants remain a matter of ongoing debate, the SURTAVI trial suggests no immediate penalty in terms of survival up to 2 years among elderly patients. We agree that rates of conduction disturbance after TAVR need to improve moving forward when TAVR is performed in young patients with a low operative risk and long life expectancy. We agree with Noble et al. that a revised uniform method to report rates of pacemaker implantation after TAVR using the number of patients who have not received a pacemaker as the denominator should be encouraged.
Michael J. Reardon, M.D.
Methodist DeBakey Heart and Vascular Center Houston, TX
mreardon@ houstonmethodist . org
Nicolas M. Van Mieghem, M.D., Ph.D.
Erasmus University Medical Center Rotterdam, the Netherlands
Jeffrey J. Popma, M.D.
Beth Israel Deaconess Medical Center Boston, MA
Since publication of their article, the authors report no fur- ther potential conflict of interest.
1. Kirmani BH, Jones SG, Malaisrie SC, Chung DA, Williams RJ. Limited versus full sternotomy for aortic valve replacement.
Cochrane Database Syst Rev 2017; 4: CD011793.
2. Semsroth S, Matteucci Gothe R, Raith YR, et al. Comparison of two minimally invasive techniques and median sternotomy in aortic valve replacement. Ann Thorac Surg 2017 April 19 (Epub ahead of print).
3. Sian K, Li S, Selvakumar D, Mejia R. Early results of the Sorin Perceval S sutureless valve: systematic review and meta-analysis.
J Thorac Dis 2017; 9: 711-24.
4. Gaudiani V, Deeb GM, Popma JJ, et al. Causes of death from the randomized CoreValve US Pivotal High-Risk Trial. J Thorac Cardiovasc Surg 2017; 153(6): 1293-1301.e1.
DOI: 10.1056/NEJMc1706234
Correspondence Copyright © 2017 Massachusetts Medical Society.
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