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Alternative Access Versus Transfemoral Transcatheter Aortic Valve Replacement in Nonagenarians
Abstract: Objectives. Previous studies suggest that alternative access (AA) such as transapical (TA) approach to transcatheter aortic valve replacement (TAVR) is inferior to transfemoral (TF) approach. However, there is a paucity of data characterizing these outcomes, and studies often do not consider transaortic (TAO) and transaxillary (TAX) TAVR approaches. Therefore, the purpose of this study was to compare the outcomes of nonagenarians undergoing AA-TAVR compared to TF-TAVR. Methods. A concurrent cohort study of 148 consecutive nonagenarian patients (≥90 years old) undergoing TAVR from April 2012 to July 2017 was carried out. We stratified the patient cohort into two groups based on access approach: TF-TAVR (n = 112); and AA-TAVR (n = 36), which included TA (n = 24), TAX (n = 8), and TAO (n = 4) approaches. Preoperative, operative, and postoperative outcomes and 5-year actuarial survival rates were analyzed. Results. Compared to TF-TAVR, patients undergoing AA-TAVR were more likely to require blood transfusions (28% vs 69%; P<.001) and readmission (16% vs 58%; P<.001). AA-TAVR also resulted in significantly higher rates of postoperative complications, such as stroke (1% vs 8%; P=.02) and atrial fibrillation (19% vs 36%; P=.03). There was no significant difference in aortic valve gradients (P>.05), operative mortality rate (6% vs 8%; P=.66), or actuarial 5-year survival rate (68% vs 44%, log-rank P=.10). Conclusion. There is a higher risk of adverse events following
J INVASIVE CARDIOL 2019;31(6):171-175. Epub 2019 April 15.
Key words: age, aortic valve surgery, outcomes, transapical, transaxillary, transcatheter valve replacement, transfemoral approach
Transcatheter aortic valve replacement (TAVR) has emerged as a safe and effective alternative to surgical aortic valve replacement in high-risk groups.1 Elderly patients comprise a disproportionate fraction of this high-risk group; thus, a growing number of elderly patients are receiving TAVR as a treatment option for aortic stenosis, with studies showing good outcomes and improvement in quality of life.2-4 Specifically, TAVR is increasingly used to treat aortic stenosis in nonagenarians, who often exhibit increased frailty and multiple age-related comorbidities.
There are various ways to implant the prosthetic valve, with current practice favoring the transfemoral (TF) approach due to its less invasive nature and ability to use local anesthesia. However, due to vasculopathy that limits the TF approach, alternative access (AA) approaches, such as transapical (TA), transaortic (TAO), and transaxillary (TAX), play a role. Some studies have shown that TA-TAVR is associated with adverse events and prolonged recovery.5-7 However, other studies have demonstrated comparable outcomes between TF and AA routes, indicating that femoral vasculopathy may not preclude patients from receiving TAVR.8-12
Due to a TF-first access strategy in many TAVR studies and the lack of evidence based on randomized trials, AA-TAVR outcomes compared with TF-TAVR outcomes remain equivocal. Furthermore, most studies compare TA-TAVR approach with TF-TAVR, and little is known concerning the outcomes of TAO and TAX approaches. Our study seeks to compare AA-TAVR and TF-TAVR by comparing clinical outcomes and long-term survival of nonagenarians.
Methods
Study design and conduct. This is a retrospective cohort study of prospectively collected data from consecutive nonagenarian patients who underwent TAVR procedure. Utilizing the TAVR database at JFK Medical Center in New York, New York, we queried all nonagenarians (n = 148) undergoing TAVR from April 2012 to July 2017. Baseline demographics, preoperative data, operative characteristics, and postoperative outcomes were recorded and entered prospectively in a prespecified database by study investigators. Study approval was sought and obtained from the Western Institutional Review Board. Patient confidentiality was maintained at all times, consistent with regulations set forth by the Health Insurance Portability and Accountability Act in 1996.
Data analysis. We stratified the patient cohort into two groups based on access approach: (1) TF-TAVR (n = 112); and (2) AA-TAVR (n = 36), which includes TA (n = 24), TAX (n = 8), and TAO (n = 4) approaches. Summary statistics and comparative analyses were performed using SAS statistical software 14.0.0 (SAS Institute, Inc), with continuous variables reported as medians and interquartile ranges (IQRs) and categorical variables reported as frequencies and percentages. For comparative analysis, continuous variables were analyzed using a t-test and categorical variables were analyzed using a Pearson’s Chi-squared test. All tests were two-tailed, and a P-value of <.05 was considered statistically significant. Kaplan-Meier unadjusted survival estimates were calculated and compared using a log-rank test for TF-TAVR patients vs AA-TAVR patients.
Results
Preoperative characteristics. The preoperative characteristics of both study groups are summarized in Table 1. Patients undergoing AA-TAVR had a lower age range than TF-TAVR patients (90-96 years vs 90-99 years, respectively; P=.03) and were more likely to have a previous cardiac surgery recorded in their histories (56% vs 26%, respectively; P<.01). In general, all TAVR patients exhibited high rates of comorbidities such as atrial fibrillation, heart failure, hypertension, and prior myocardial infarction, with a median Society of Thoracic Surgery (STS) risk score of 6% (range, 5%-8%).
Operative characteristics. Operative characteristics of TF and AA patients undergoing TAVR procedures are presented in Table 2. All patients underwent predeployment balloon valvuloplasty. Within the AA-TAVR group, 24 (76%) had TA approach, 8 (22%) had TAX approach, and 4 (11%) had TAO approach. Edwards Sapien devices (Edwards Lifesciences) were implanted in 87% of all TAVR patients. The Sapien S3 was the valve of choice once it became available at our institution after July 2015. Evolut or CoreValve devices (Medtronic) were more likely to be used for TF-TAVR than for AA-TAVR (13% vs 0%, respectively; P=.048). No significant differences were detected in postdeployment balloon aortic valvuloplasty (BAV), conversion to open heart surgery, or vascular complications.
Postoperative characteristics. Postoperative characteristics are depicted in Table 3, while Table 4 shows the comparisons of preoperative and postoperative gradients across the aortic valve between groups. Patients undergoing AA-TAVR were more likely to require blood transfusions than TF-TAVR patients (69% vs 28%, respectively; P<.001) had higher rates of readmission (58% vs 16%, respectively; P<.001), and had significantly higher rates of postoperative stroke (8% vs 1%, respectively; P=.02) and atrial fibrillation (36% vs 19%, respectively; P=.03). Stroke complicated TAVR in 2 TA patients, 1 TAX patient, and 1 TF patient. No significant difference was detected in operative mortality (6% for TF patients vs 8% for AA patients; P=.66) (Table 3) or in aortic valve gradients among TF and AA patients either preoperatively or postoperatively (Table 4).
Survival analysis. Median follow-up time was 27 months (IQR, 16-41 months). Actuarial Kaplan-Meier survival estimates are presented in Figure 1. Actuarial 5-year survival was lower for patients undergoing AA-TAVR, although this difference did not reach statistical significance (68% for TF patients vs 44% for AA patients; P=.10).
Discussion
As TAVR is increasingly used in nonagenarians with complex comorbidities and frailty, understanding clinical outcomes of various approaches is essential to elucidate best practices and limit risk during procedures for this high-risk group. Our study is among the first to compare early clinical outcomes and actuarial survival between TF-TAVR and AA-TAVR in nonagenarians. Most studies are limited to the comparison of TF vs TA approaches.5-7
Preoperative characteristics. Overall, baseline characteristics were similar for AA-TAVR and TF-TAVR nonagenarian groups. Patients undergoing TF-TAVR approach had an age range greater than those undergoing AA-TAVR and were less likely to have had cardiac surgery. Nonetheless, STS risk score suggests that the two groups are comparable in terms of projected operative mortality for TAVR procedure.
Operative characteristics. In this study, the preferred TAVR device was the Edwards Sapien prosthesis. The device choice was determined by physician preference and annular diameter; however, the Sapien valve was the only device available and designed for TA access in our study as well as previous studies.13 In general, our order of preference for AA approach for TAVR was TA, TAX, and TAO. A previous study showed that 51.3% of 339 patients could not undergo TF-TAVR due to existing stents, peripheral vascular disease, tortuosity, and kinks and calcification in the aorta.14 This large proportion of patients who were not candidates for TF-TAVR suggests the need for elucidating safe AA approaches, especially in high-risk nonagenarians. Nonetheless, while increased postoperative complications exist, operative mortality was comparable, suggesting that AA approaches may be safely performed in this high-risk patient group. Due to the evolution of transcatheter valves, TAVR via TF approach is now feasible in 95% of patients as per the transcutaneous valve registry.
Our study suggests the efficacy of AA-TAVR as a comparable approach to TF-TAVR. In our study, AA-TAVR in nonagenarians was performed with acceptable mortality (8%), which is comparable to TF-TAVR (6%) and existing literature. The mortality rate is also on par with the predicted median STS mortality score of 7% (IQR, 6%-9%). A previous study by McNeely et al reported a TA-TAVR operative mortality rate of 8.4%, and a study by Mack et al reported TA-TAVR and TAO-TAVR operative mortality rates of 9.4% and 11.4%, respectively.- In this study, no significant difference in operative mortality was detected between AA-TAVR and TF-TAVR groups, suggesting that AA-TAVR can be performed with success rates similar to TF-TAVR.
Postoperative morbidity. Compared with TF-TAVR, AA-TAVR patients exhibited increased rates of postoperative stroke and atrial fibrillation, and increased requirements for blood transfusions and hospital readmissions. McNeely et al found that postoperative stroke rate of nonagenarians undergoing TAVR was 1.8% for TF-TAVR vs 2.0% for AA-TAVR procedures (P=.69).7 Similarly, in the PARTNER-1 trial, the stroke rate was 3.2% in TF-TAVR patients and 2.0% in TA-TAVR patients (P=.70).5 Atrial fibrillation rates in AA cases have been reported at up to 41%.2 A study by Vora et al showed a higher incidence of atrial fibrillation in patients undergoing AA-TAVR (16.5%) compared with TF-TAVR (4.4%), similar to the results of our study.15 McNeely et al reported higher 30-day and 6-month readmission rates for nonagenarians undergoing TA-TAVR compared with TF-TAVR.7 The PARTNER-1 trial reported increased need for transfusions in TA-TAVR cases.5 These findings agree with our results.
Survival analysis. Actuarial 5-year survival was worse for AA-TAVR patients compared with TF-TAVR patients; however, the difference did not reach statistical significance (Figure 1). Differences in survival rates occur between 1-2 years after surgery, at which time AA-TAVR patients experience a precipitous drop in survival, consistent with the higher risk profile and vasculopathy of AA-TAVR patients. Early mortality was comparable between TF-TAVR and AA-TAVR patients during the first 2 years post TAVR, while the two survival curves separate with a precipitous decrease in AA-TAVR survival. The 1-year mortality rates were less in the present study than rates reported by McNeely et al (31.6% in TA-TAVR patients and 23.8% in TF-TAVR patients).7 Similarly, the PARTNER-1 trial reported a mortality rate of 28.7% in TA-TAVR patients vs 18.1% in TF-TAVR patients.5
Clinical implications. This study included a real-world unselected cohort, a single-institution methodology, and prospective data entry by a dedicated data management collection center. We were able to document higher postoperative rates of stroke, atrial fibrillation, and readmission, as well as a trend toward decreased survival after the first 2 years with AA-TAVR compared with TF-TAVR. This is the first study to compare TF-TAVR with AA-TAVR, including not only TA but also TAO and TAX approaches. In our study, AA-TAVR in nonagenarians was performed with acceptable morbidity and mortality in a high-risk group with operative mortality comparable to TF-TAVR. However, increased adverse events as well as a decreased (although not significantly decreased) 5-year survival rate associated with AA-TAVR suggest a higher risk profile and co-morbidities of AA-TAVR patients affecting long-term survival beyond the first 2 years post TAVR. Nonetheless, while AA-TAVR may not be the preferred primary strategy in TAVR procedures, it offers a viable option for patients with compromised femoral access.
Study limitations. Limitations of this study include the retrospective, single-institution methodology. Because AA-TAVR is often used as a secondary option, patients who require AA-TAVR may have greater underlying risk. In our cohort, TF-TAVR patients were relatively younger and had a lower rate of previous cardiac surgery compared with AA patients, suggesting a higher risk profile in AA patients. In addition, grouping TA, TAO, and TAX into a single AA-TAVR group did not allow us to characterize the risk unique to individual access approach. Furthermore, transcarotid access was not available at our institution during this study period. A larger sample size with increased frequency and distribution of TA, TAO, and TAX cases may be more revealing of access approach. The small sample size for AA nonagenarian patients did not allow conduction of propensity-score matching between the two groups. In our study, AA-TAVR was not associated with a statistically significant decrease in survival at 2 years, compared with TF-TAVR, possibly secondary to a small sample size (type II error).
Conclusion
Our study shows promising outcomes for alternative-access TAVR approach in a nonagenarian group. AA-TAVR patients were more likely to suffer stroke and atrial fibrillation, and to require blood transfusion and readmission, than TF-TAVR patients. Five-year actuarial survival for alternative-access patients was lower, although not significantly so; nonetheless, operative mortality was comparable, suggesting alternative access as a safe alternative approach if transfemoral access is compromised. Future studies are required to further elucidate the differences in late survival of AA-TAVR vs TF-TAVR patients.
References
1. Smith C, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187-2198.
2. Kayatta MO, Thourani VH, Jensen HA, et al. Outcomes for transcatheter aortic valve replacement in nonagenarians. Ann Thorac Surg. 2015;100:1261-1267; discussion 1267.
3. Biancari F, D’Errigo P, Rosato S, et al. Transcatheter aortic valve replacement in nonagenarians: early and intermediate outcome from the OBSERVANT study and meta-analysis of the literature. Heart Vessels. 2017;32:157-165.
4. Mack MC, Szerlip M, Herbert MA, et al. Outcomes of treatment of nonagenarians with severe aortic stenosis. Ann Thorac Surg. 2015;100:74-80.
5. Blackstone EH, Suri RM, Rajeswaran J, et al. Propensity-matched comparisons of clinical outcomes after transapical or transfemoral transcatheter aortic valve replacement: a placement of aortic transcatheter valves (PARTNER)-I trial substudy. Circulation. 2015;131:1989-2000.
6. Biancari F, Rosato S, D’Errigo P, et al. Immediate and intermediate outcome after transapical versus transfemoral transcatheter aortic valve replacement. Am J Cardiol. 2016;117:245-251.
7. McNeely C, Zajarias A, Robbs R, Markwell S, Vassileva CM. Transcatheter aortic valve replacement outcomes in nonagenarians stratified by transfemoral and transapical approach. Ann Thorac Surg. 2017;103:1808-1814.
8. Thourani VH, Li C, Devireddy C, et al. High-risk patients with inoperative aortic stenosis: use of transapical, transaortic, and transcarotid techniques. Ann Thorac Surg. 2015;99:817-823.
9. Guyton RA, Block PC, Thourani VH, Lerakis S, Babaliaros V. Carotid artery access for transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2013;82:E583-E586.
10. Zierer A, Wimmer-Greinecker G, Martens S, Moritz A, Doss M. The transapical approach for aortic valve implantation. J Thorac Cardiovasc Surg. 2008;136:948-953.
11. Panchal HB, Ladia V, Amin P, et al. A meta-analysis of mortality and major adverse cardiovascular and cerebrovascular events in patients undergoing transfemoral versus transapical transcatheter aortic valve implantation using Edwards valve for severe aortic stenosis. Am J Cardiol. 2014;114:1882-1890.
12. Caceres M, Braud R, Roselli EE. The axillary/subclavian artery access route for transcatheter aortic valve replacement: a systematic review of the literature. Ann Thorac Surg. 2012;93:1013-1018.
13. Noorani A, Bapat V. Differences in outcomes and indications between Sapien and CoreValve transcatheter aortic valve implantation prostheses. Interv Cardiol. 2014;9:121-125.
14. Rodes-Cabau J, Webb JG, Cheung A, et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010;55:1080-1090.
15. Vora AN, Dai D, Matsuoka R, et al. Incidence, management, and associated clinical outcomes of new-onset atrial fibrillation following transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2018;11:1746-1756.
From the Departments of Cardiology and Cardiothoracic Surgery, JFK Medical Center, Atlantis, Florida.
Funding and Disclaimer: This research was supported (in whole or in part) by HCA Healthcare and/or an HCA Healthcare affiliated entity. The views expressed in this publication represent those of the author(s) and do not necessarily represent the official views of HCA Healthcare or any of its affiliated entities.
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 submitted November 12, 2018, provisional acceptance given November 28, 2018, final version accepted December 26, 2018.
Address for correspondence: Sotiris C. Stamou, MD, PhD, JFK Medical Center, 180 JFK Drive, Suite 320, Atlantis, FL 33462. Email: sotiris.stamou@hcahealthcare.com
