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• W3093021880 abstract "The author reported no conflicts of interest.The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.In this issue of the Journal, Tam and colleagues1Muneretto C. Solinas M. Folliguet T. Di Bartolomeo R. Repossini A. Laborde F. et al.Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: a multi-institutional study.J Thorac Cardiovasc Surg. 2022; 163: 925-935.e5Abstract Full Text Full Text PDF Scopus (10) Google Scholar present a critique of the recently published observational study by Muneretto and colleagues2Tam D.Y. Makhdoum A. Cohen D.J. Unmeasured, unknown, and hidden: confounders are not always in plain sight.J Thorac Cardiovasc Surg. 2022; 163: e237-e238Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar comparing sutureless aortic valve replacement with transcatheter aortic valve replacement (TAVR) in patients at intermediate surgical risk. Tam and colleagues present several arguments to support their conclusion that despite appropriate propensity-score matching, residual confounding is likely to explain differences in treatment-related end points presented in the aforementioned analysis.It is always possible, in observational studies, that residual confounding may explain difference in treatment effect when comparing 2 groups of patients. Conversely, the beauty of appropriately powered and executed, prospective enrollment with randomization is that it accounts, by design, for both measured and unmeasured sources of bias.3Senn S. Seven myths of randomisation in clinical trials.Stat Med. 2013; 32: 1439-1450Crossref PubMed Scopus (96) Google Scholar The major disadvantage of randomized controlled trials is the lack of generalizability of results to populations excluded by design. For these reasons, both prospective registry and prospective randomized designs are essential to establish our evidence base in cardiac surgery.Within the constraints of the dataset of the analysis in question, the propensity score–matched analysis resulted in a comparison of 291 matched pairs from a total of 967 available patients. The ability to match only 60% of the original cohort should be our first indication that the 2 groups being compared were quite different at the outset. The matched pairs appear well balanced on the available covariates (standardized mean difference <0.1 for all variables except insulin-dependent diabetes). Of note, surrogates of frailty such as a 5-meter walk test result >7 seconds and serum albumin <3.5 g/dL were included in the model—2 variables also reported in the PARTNER (Placement of Aortic Transcatheter Valves) II trial.4Makkar R.R. Thourani V.H. Mack M.J. Kodali S.K. Kapadia S. Webb J.G. et al.Five-year outcomes of transcatheter or surgical aortic-valve replacement.N Engl J Med. 2020; 382: 799-809Crossref PubMed Scopus (295) Google ScholarEven with an appropriate propensity-score match, Tam and colleagues1Muneretto C. Solinas M. Folliguet T. Di Bartolomeo R. Repossini A. Laborde F. et al.Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: a multi-institutional study.J Thorac Cardiovasc Surg. 2022; 163: 925-935.e5Abstract Full Text Full Text PDF Scopus (10) Google Scholar are correct in asserting that unmeasured confounding may remain to explain the differences in outcomes between the 2 treatments. Two of the additional tools described—falsification end points and instrumental variables—are methods that can help identify residual confounding but usually require a priori knowledge of possible imbalance. In prospectively collected databases, such as the aforementioned one analyzed—the additional variables required to perform these types of analyses are rarely collected. In longitudinal, electronic medical record-based datasets, these approaches are more feasible, but practically, hard to execute.Tam and colleagues1Muneretto C. Solinas M. Folliguet T. Di Bartolomeo R. Repossini A. Laborde F. et al.Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: a multi-institutional study.J Thorac Cardiovasc Surg. 2022; 163: 925-935.e5Abstract Full Text Full Text PDF Scopus (10) Google Scholar compare and contrast the findings of the aforementioned analysis to those of the PARTNER II randomized controlled trial. However, there are key differences in the populations studied in these 2 patient cohorts. The 5-year all-cause mortality in PARTNER II was 42.1% for surgical replacement and 46.0% for TAVR (hazard ratio, 1.09; 95% confidence interval, 0.95-1.25), yet in the aforementioned study, 5-year all-cause mortality was 16.1% for surgical replacement and 28.9% for TAVR (P = .007) with 100% complete 5-year follow-up in both studies. The average age in PARTNER II was 81.6 years and STS risk 5.8% compared with 80.5 years and 6% in the study by Muneretto and colleagues, making these differences in event rates difficult to reconcile. One explanation may be the greater average life expectancy in the countries in the study, ie, Italy (83.6 years), France (82.5 years), and Germany (81.2 years), compared with an average life expectancy of 78.9 years in the United States.5 In addition, the rate of previous coronary artery bypass grafting was 24.6% in PARTNER II and 4.3% in Muneretto and colleagues, signifying different patient populations, not directly comparable. There may be more to all-cause mortality in this age range than meets the eye.Regardless of differences in patient cohorts, the overall 30-day mortality of 5.5% in the matched TAVR patients, along with 11-day mean length of stay, 1.7% tracheostomy rate, 7.9% vascular complication rate, are all quite high and likely due to the fact that only 66.2% of TAVRs were implanted via transfemoral approach for anatomic reasons.2Tam D.Y. Makhdoum A. Cohen D.J. Unmeasured, unknown, and hidden: confounders are not always in plain sight.J Thorac Cardiovasc Surg. 2022; 163: e237-e238Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar Newer-generation TAVR devices have brought smaller sheath sizes enabling transfemoral approach for most patients, and technical expertise has improved, leading to much lower procedural complication rates in the most recent low-risk trials.Context is critical in the interpretation of study results. Tam and colleagues have brought important additional insight into the discussion of the aforementioned results, and their thoughtful appraisal of the manuscript is undoubtedly appreciated by the readership of the Journal.Truth be told, no design or methodology is perfect—and we, as surgeon–scientists, should always be cautious to accept “truths” or “certainty,” regardless of the old adage: “a surgeon may be sometimes wrong, but never in doubt.” As scientists, we must always be in doubt. The author reported no conflicts of interest.The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest. The author reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest. In this issue of the Journal, Tam and colleagues1Muneretto C. Solinas M. Folliguet T. Di Bartolomeo R. Repossini A. Laborde F. et al.Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: a multi-institutional study.J Thorac Cardiovasc Surg. 2022; 163: 925-935.e5Abstract Full Text Full Text PDF Scopus (10) Google Scholar present a critique of the recently published observational study by Muneretto and colleagues2Tam D.Y. Makhdoum A. Cohen D.J. Unmeasured, unknown, and hidden: confounders are not always in plain sight.J Thorac Cardiovasc Surg. 2022; 163: e237-e238Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar comparing sutureless aortic valve replacement with transcatheter aortic valve replacement (TAVR) in patients at intermediate surgical risk. Tam and colleagues present several arguments to support their conclusion that despite appropriate propensity-score matching, residual confounding is likely to explain differences in treatment-related end points presented in the aforementioned analysis. It is always possible, in observational studies, that residual confounding may explain difference in treatment effect when comparing 2 groups of patients. Conversely, the beauty of appropriately powered and executed, prospective enrollment with randomization is that it accounts, by design, for both measured and unmeasured sources of bias.3Senn S. Seven myths of randomisation in clinical trials.Stat Med. 2013; 32: 1439-1450Crossref PubMed Scopus (96) Google Scholar The major disadvantage of randomized controlled trials is the lack of generalizability of results to populations excluded by design. For these reasons, both prospective registry and prospective randomized designs are essential to establish our evidence base in cardiac surgery. Within the constraints of the dataset of the analysis in question, the propensity score–matched analysis resulted in a comparison of 291 matched pairs from a total of 967 available patients. The ability to match only 60% of the original cohort should be our first indication that the 2 groups being compared were quite different at the outset. The matched pairs appear well balanced on the available covariates (standardized mean difference <0.1 for all variables except insulin-dependent diabetes). Of note, surrogates of frailty such as a 5-meter walk test result >7 seconds and serum albumin <3.5 g/dL were included in the model—2 variables also reported in the PARTNER (Placement of Aortic Transcatheter Valves) II trial.4Makkar R.R. Thourani V.H. Mack M.J. Kodali S.K. Kapadia S. Webb J.G. et al.Five-year outcomes of transcatheter or surgical aortic-valve replacement.N Engl J Med. 2020; 382: 799-809Crossref PubMed Scopus (295) Google Scholar Even with an appropriate propensity-score match, Tam and colleagues1Muneretto C. Solinas M. Folliguet T. Di Bartolomeo R. Repossini A. Laborde F. et al.Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: a multi-institutional study.J Thorac Cardiovasc Surg. 2022; 163: 925-935.e5Abstract Full Text Full Text PDF Scopus (10) Google Scholar are correct in asserting that unmeasured confounding may remain to explain the differences in outcomes between the 2 treatments. Two of the additional tools described—falsification end points and instrumental variables—are methods that can help identify residual confounding but usually require a priori knowledge of possible imbalance. In prospectively collected databases, such as the aforementioned one analyzed—the additional variables required to perform these types of analyses are rarely collected. In longitudinal, electronic medical record-based datasets, these approaches are more feasible, but practically, hard to execute. Tam and colleagues1Muneretto C. Solinas M. Folliguet T. Di Bartolomeo R. Repossini A. Laborde F. et al.Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: a multi-institutional study.J Thorac Cardiovasc Surg. 2022; 163: 925-935.e5Abstract Full Text Full Text PDF Scopus (10) Google Scholar compare and contrast the findings of the aforementioned analysis to those of the PARTNER II randomized controlled trial. However, there are key differences in the populations studied in these 2 patient cohorts. The 5-year all-cause mortality in PARTNER II was 42.1% for surgical replacement and 46.0% for TAVR (hazard ratio, 1.09; 95% confidence interval, 0.95-1.25), yet in the aforementioned study, 5-year all-cause mortality was 16.1% for surgical replacement and 28.9% for TAVR (P = .007) with 100% complete 5-year follow-up in both studies. The average age in PARTNER II was 81.6 years and STS risk 5.8% compared with 80.5 years and 6% in the study by Muneretto and colleagues, making these differences in event rates difficult to reconcile. One explanation may be the greater average life expectancy in the countries in the study, ie, Italy (83.6 years), France (82.5 years), and Germany (81.2 years), compared with an average life expectancy of 78.9 years in the United States.5 In addition, the rate of previous coronary artery bypass grafting was 24.6% in PARTNER II and 4.3% in Muneretto and colleagues, signifying different patient populations, not directly comparable. There may be more to all-cause mortality in this age range than meets the eye. Regardless of differences in patient cohorts, the overall 30-day mortality of 5.5% in the matched TAVR patients, along with 11-day mean length of stay, 1.7% tracheostomy rate, 7.9% vascular complication rate, are all quite high and likely due to the fact that only 66.2% of TAVRs were implanted via transfemoral approach for anatomic reasons.2Tam D.Y. Makhdoum A. Cohen D.J. Unmeasured, unknown, and hidden: confounders are not always in plain sight.J Thorac Cardiovasc Surg. 2022; 163: e237-e238Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar Newer-generation TAVR devices have brought smaller sheath sizes enabling transfemoral approach for most patients, and technical expertise has improved, leading to much lower procedural complication rates in the most recent low-risk trials. Context is critical in the interpretation of study results. Tam and colleagues have brought important additional insight into the discussion of the aforementioned results, and their thoughtful appraisal of the manuscript is undoubtedly appreciated by the readership of the Journal. Truth be told, no design or methodology is perfect—and we, as surgeon–scientists, should always be cautious to accept “truths” or “certainty,” regardless of the old adage: “a surgeon may be sometimes wrong, but never in doubt.” As scientists, we must always be in doubt. Unmeasured, unknown, and hidden: Confounders are not always in plain sightThe Journal of Thoracic and Cardiovascular SurgeryVol. 163Issue 3PreviewWe read with interest the recent study by Muneretto and colleagues1 that compared outcomes of patients with severe aortic stenosis at intermediate surgical risk undergoing either sutureless aortic valve replacement (SuAVR) or transcatheter aortic valve replacement (TAVR). In their propensity score–matched analysis of 291 patient pairs treated between 2008 and 2015, Muneretto and colleagues1 found that SuAVR reduced rates of all-cause mortality at both 30 days and 5 years relative to TAVR. Notwithstanding these results, however, we believe that their findings must be interpreted in the context of several important limitations, and as such, the conclusions of Muneretto and colleagues1 regarding the superiority of SuAVR relative to TAVR and the resulting need for a randomized trial comparing these 2 approaches directly should be tempered. Full-Text PDF" @default.
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• W3093021880 title "Reply: “Truth” in research—the road to truth is paved with doubt" @default.
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