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Intermediate-Term Outcomes Following Transcatheter Aortic Valve Implantation in Patients with a History of Chest Radiation Therapy: A Propensity Score Matched Analysis
Abstract
Chest radiation therapy (XRT) has been associated with a higher rate of mortality following surgical aortic valve replacement. We performed a single-center retrospective analysis of patients with severe AS who underwent TAVI from 01/01/2012 to 07/31/2020 comparing patients with and without XRT. A total of 915 patients met inclusion criteria, with a total of fifty patients found to have a history of XRT. At a mean follow-up of 2.4 years, unadjusted and propensity score matching analysis demonstrated no differences in mortality, heart failure or bleeding-related hospitalization, overall stroke and 30-day pacemaker implantation in patients with and without XRT.
J INVASIVE CARDIOL 2023;35(6):E291-E293 Epub April 14
Key words: aortic stenosis, transcatheter aortic valve implantation, radiation therapy, outcomes
Introduction
A history of chest radiation therapy (XRT) to the mediastinum has been associated with a higher rate of mortality following surgical aortic valve replacement (SAVR) due to increased fibrosis, calcium deposition and radiation induced changes to tissues resulting in a challenging surgical substrate.1,2 Prior studies have demonstrated that patients with history of prior XRT have similar short-term outcomes following transcatheter aortic valve implantation (TAVI) compared to those without prior XRT.3-5 While 30-day and one year data exist in patients undergoing TAVI with or without prior XRT,4,5 there is limited information regarding intermediate to long-term mortality and clinical outcomes following TAVI. The goal of this study was to evaluate the intermediate-term differences in mortality and clinical outcomes between patients with and without a prior history of chest XRT following TAVI.
Methods
We performed a single center retrospective analysis of patients with severe AS who underwent TAVI from 01/01/2012 to 07/31/2020 (Figure 1A). Patients with a history of XRT were identified prior to the index TAVI procedure. The primary outcome was all-cause mortality. Secondary outcomes defined per Valve Academic Research Consortium 2 criteria included overall stroke, heart failure and bleeding-related hospitalization and 30-day permanent pacemaker implantation.
Descriptive analysis and baseline differences for the total cohort of patients were tested using two-sided paired T-tests for means/proportions. Kaplan Meier survival analysis was performed via a Cox proportional hazard ratio model. A propensity score matching model was calculated using multivariable logistic regression to derive two matched groups for comparative outcomes analysis in patients with XRT vs. no XRT (Supplementary Table 1). A nearest-neighbor 1:3 without replacement was applied using a caliper width of 0.01. The covariates included demographic variables (age & gender) and comorbidities (diabetes, hypertension, hyperlipidemia, smoking, chronic heart failure, coronary artery disease, atrial fibrillation, chronic obstructive pulmonary disease, and chronic kidney disease). All analyses were performed with SPSS version 26 (IBM Corporation).
Results
A total of 915 patients met inclusion criteria, with an average age of 78.5 ± 9.8 years. 58.7% of the cohort were female. The mean Society of Thoracic Surgeons (STS) score was 5.5%. Fifty patients were found to have a history of chest XRT prior to TAVI. At baseline, patients with history of XRT had a significantly lower STS score and were similar in age to those without prior XRT (4.0 vs. 5.5% P=.008 and 76.6 vs. 78.6 years P=.16). Aortic valve area (AVA) was similar in patients with a history of XRT vs. those without XRT (AVA 0.78 vs. 0.81 cm2, P=.63). Mean and maximum aortic valve pressure gradients were also similar between the two groups (mean 45 vs. 42 mmHg P=.28 and maximum 75 vs. 70 mmHg P=.19), respectively.
At a mean follow-up duration of 2.4 years, the rate of mortality was 26% in patients with a history of XRT versus 18% in those without XRT (P=.16). Kaplan-Meier survival curves for all-cause mortality is shown in Figure 1B. In unadjusted analysis, patients with and without a history of XRT had similar overall rates of heart failure hospitalization (10% vs. 11%, P=.9), bleeding-related hospitalization (6% vs. 5%, P=.8), overall stroke (4% vs. 2%, P=.3) and 30-day pacemaker implantation (2% vs. 8%, P=.9), respectively. Following propensity-matching, patients with XRT had higher all-cause mortality during follow-up compared to those without, though this did not reach statistical significance (26% vs 17%, P=.1). Similarly, clinical outcomes in patients with and without a history of XRT were not statistically different: rate of heart failure hospitalization (9% vs. 12%, P=.6), bleeding-related hospitalization (6% vs. 3%, P=.4), overall stroke (4% vs. 1%, P=.1), and 30-day pacemaker implantation (2% vs. 10%, P=.07) (Table 1 and Figure 1C).
Discussion
Patients with a history of XRT demonstrate similar mortality and clinical outcomes compared to those without XRT in our study with follow-up extending to 28 months. The current study has many important clinical implications. As TAVI turns towards a lower risk cohort with more advances in radiation-oncology, more patients with history of XRT are currently being referred for percutaneous based interventions. Data from our study helps understanding intermediate-term prognosis in these patients, which in turn may help more accurately offer the best therapy for severe AS in this patient subgroup. This holds especially true for otherwise low-risk patients, as the TAVI valve durability is yet to be established in long-term.
Limitations. The limitations of this study include being a single-center analysis and a smaller sample size, thus power to detect statistically significant differences is limited. However, we attempted to mitigate these limitations via propensity matched analysis.
Conclusions
In conclusion, in patients with a prior history XRT vs. those without there are similar rates of all-cause mortality and clinical outcomes following TAVI. TAVI may be considered an initial choice of therapy for patients with prior XRT, despite a younger age group with low STS risk.
Affiliations and Disclosures
From Oregon Health and Science University, Portland, Oregon.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.
Manuscript accepted January 27, 2023.
Address for correspondence: Harsh Golwala, MD, Assistant Professor of Medicine, Knight Cardiovascular Institute, Oregon Health & Science University, UHN‐62, Oregon Health & Science University, 3181 Southwest Sam Jackson Park Road, Portland, OR 97239. Email: golwala@ohsu.edu
References
- Wu W, Masri A, Popovic ZB, et al. Long‐term survival of patients with radiation heart disease undergoing cardiac surgery: a cohort study. Circulation. 2013;127:1476-1485. doi: 10.1161/CIRCULATIONAHA.113.001435
- Donnellan E, Masri A, Johnston DR, et al. Long-Term Outcomes of Patients With Mediastinal Radiation-Associated Severe Aortic Stenosis and Subsequent Surgical Aortic Valve Replacement: A Matched Cohort Study. J Am Heart Assoc. 2017;6(5):e005396. doi: 10.1161/JAHA.116.005396
- Lind A, Totzeck M, Mahabadi AA, et al. Impact of Cancer in Patients Undergoing Transcatheter Aortic Valve Replacement: A Single-Center Study. JACC CardioOncol. 2020;2(5):735-743. eCollection 2020 Dec.. doi: 10.1016/j.jaccao.2020.11.008
- Zhang D, Guo W, Al-Hijji MA, et al. Outcomes of Patients With Severe Symptomatic Aortic Valve Stenosis After Chest Radiation: Transcatheter Versus Surgical Aortic Valve Replacement. J Am Heart Assoc. 2019;8(10):e012110. doi: 10.1161/JAHA.119.012110
- Agrawal N, Kattel S, Waheed S, et al. Clinical Outcomes after Transcatheter Aortic Valve Replacement in Cancer Survivors Treated with Ionizing Radiation. CardioOncology. 2019;5:8. Epub 2019 Jul 22. doi: 10.1186/s40959-019-0044-7.
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