Transcarotid vs subclavian/axillary access for transcatheter aortic valve replacement with SAPIEN 3
Selected in Annals of Thoracic Surgery by M. Alasnag
The purpose of this study is to report outcomes of TC and TAx access using the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves from the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies (TVT) Registry.
References
Authors
Kirker E, Korngold E , Hodson RW , Jones BM, Raymond McKay R, Cheema M, Heimansohn D, Moainie S, Hermiller J, Chatriwalla A, Saxon J, Allen KB
Reference
Ann Thorac Surg. 2020 Jul 23;S0003-4975(20)31196-6. doi: 10.1016/j.athoracsur.2020.05.141.
Published
23 July 2020
Link
Read the abstractReviewer
My Comment
Why this study? – the rationale/objective
Transcatheter aortic valve replacement (TAVR) has now become the mainstream therapy for eligible high-risk, intermediate and even low-risk individuals. The majority of the studies have provided comparative outcomes for transfemoral TAVR. However, there is a growing number of individuals in whom the transfemoral approach is not suitable. Alternative access options have been expanded to include transapical (TA), subclavian/axillary (TAx), transcarotid (TC), transaortic (TAo), and trans-caval access. Many operators default to TAx access route under the assumption that it is easier and has lower complication rates. There are few head-to-head comparisons of these alternative approaches. Recently Allen KB et al demonstrated a higher rate of stroke with TAx compared withTA/TAo (Allen KB, Chhatriwalla AK, Cohen D, et al. Transcarotid Versus Transapical and Transaortic Access for Transcatheter Aortic Valve Replacement. Ann Thorac Surg. 2019;108(3):715-722).
The purpose of this study is to report outcomes of TC and TAx access using the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves from the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies (TVT) Registry.
How was it executed? – the methodology
Data was collected from the TVT Registry. Patients undergoing TAVR with the SAPIEN 3 and Ultra valves delivered through the TC or TAx access between June 2015 to October 2019 were included. TAVR performed using transfemoral, TA/TAo and other access sites were excluded. All valve-in-valve and valve-in-transcatheter valve procedures were also excluded. Propensity score matching and logistic regression analysis were used to analyze outcomes. Multivariate analysis was used to determine independent predictors of 30-day stroke.
Important covariates included age, sex, STS risk score, prior percutaneous coronary intervention (PCI), prior coronary artery bypass grafting (CABG), prior stroke, carotid disease, hypertension, diabetes, porcelain aorta, and atrial fibrillation.
What is the main result?
A total of 801 TC and 3102 TAx were populated from the TVT Registry during the study period. Upon review of the baseline characteristics, it was noted that the TC cohort had a higher STS score, more women, more peripheral arterial disease, more carotid disease, and more patients had undergone a previous CABG. The propensity scoring accounted for these variables. The procedural data revealed a higher procedure time (117.0 vs 132.4 min) and fluoroscopy time (16.6 vs 21.6 min) as well as a higher contrast volume (78.5 vs 96.7 mL) with the TAx route. TC had a shorter ICU length of stay (24.3 vs 25.0 hours) and in-hospital length of stay (2.0 vs 3.0 days). The TC cohort also had a larger percentage of patients discharged to home (82.9% vs 74.6%).
With respect to major adverse cardiac events, the all-cause mortality was similar for both approaches (4.3% vs. 5.2%). The rates of cardiac death, new atrial fibrillation, readmission, new pacemaker, life-threatening bleeding, and major vascular complications were also similar. The rate of stroke, however, was significantly lower in the TC cohort (4.2% vs. 7.4%).
Critical reading and the relevance for clinical practice:
The rate of alternative access TAVR is increasing globally. The data provided reflects contemporary real-world practice and certainly highlights an important trend, namely, an overall increase in the number of procedures using alternative access especially TC. With such expanded use, it is important to examine outcomes and safety of the different routes. It is reassuring that both TC and TAx are feasible and safe options. The higher stroke rate with TAx, however, is concerning and worth exploring. Several mechanisms may explain the difference including the cross-clamping that serves as an embolic protection technique. Additionally, the more direct access to the aortic valve prevents scraping along the aortic arch and hence a lower risk of embolization. The stroke rate may be attributable to the TAx itself during which significant manipulation occurs. A limitation of this study is its inability to discern which TAx are higher risk (right versus left or surgical cutdown versus percutaneous access). Teasing out these fine differences may explain the difference in stroke rates and is only possible through a randomized study.
What is reassuring from this study, is the length of stay and discharge data. This suggests that alternative access does not necessarily mean a longer hospital or ICU stay.
The registry data reflects outcomes of high volume centers that have developed expertise in case selection and the execution of the TC technique. These results are not applicable to small volume centers with limited experience. The growth of the TC TAVR approach suggests it may be easy to learn and adopt with the appropriate proctorship. Furthermore, the conclusions cannot be extended to self-expanding valves nor can they be extended to valve-in-valve procedures.
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