Regional registries serve many purposes. They provide insight into unique demographic issues that may be specific to the region. There may be esoteric challenges that arise, ranging from patient screening and consent to anatomical complexities and quality-of-life outcomes. Such registries provide information on the external validity for pivotal trials and serve as a comparison to the large registries in the United States and Europe. Lastly, they may provide insights into processes that may be adopted more widely to improve the patient experience and patient outcomes.
In this issue of Cardiovascular Revascularization Medicine, Alasnag et al. present their findings from the Gulf TAVR Registry, the first of its kind in the region[1]. They present a retrospective cohort study of transcatheter aortic valve replacement (TAVR) in 8 centers in the Gulf region to assess procedure success, complications, and one-year outcomes. A total of 795 patients over a period of 3 years were included in the registry.
The demographics reveal a younger population, with a mean age of only 74.6 years, but with significant co-morbidities and the majority (61%) being classified as frail. The majority of procedures were performed under moderate sedation via the transfemoral approach. Valve Academic Research Consortium (VARC)-2 outcomes were comparable to outcomes reported in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry[2].
Some important points the authors highlight include the high rate of vascular complications, use of dual antiplatelet therapy, and rehospitalization for heart failure and heart block. As a comparison to practice in the United States, the data from the Gulf Registry (2017–2019) are compared with contemporary (2018) data from the TVT Registry in Table 1[1, 2]. The patients in the Gulf tended to be several years younger but with similar risk profiles to patients in the United States. Rates of transfemoral access were similar but with higher rates of transapical access for alternative access in the Gulf. In-hospital death, stroke, and permanent pacemaker implantation rates were similar, but there was a much higher rate of life threatening bleeding in patients in the Gulf TAVR registry. Length of stay was longer in the Gulf, but one0year mortality was impressively low.
Table 1.
Patient Characteristics in GULF TAVR, TVT registries
Variable | 2017–2019 GULF TAVR (n=795) | 2018 TVT Registry (n=59,168) |
---|---|---|
Age (years) | 74.6 (mean) | 81 (median) |
Female sex | 43.8% | 45.6% |
STS risk of mortality | 4.90% (mean) | 4.9% (median) |
Transfemoral access | 95.8% | 94.2% |
Transapical access | 3.4% | 0.6% |
Subclavian access | 0.4% | 2.0% |
Transaortic access | 0.4% | 0.8% |
In-hospital death | 2.1% | 1.5% |
In-hospital stroke | 1.1% | 1.8% |
In-hospital pacemaker implant | 9.7% | 9.4% |
Life threatening bleed | 15% | 1.9% |
Conversion to surgery | 1.4% | 0.5% |
Length of stay (days) | 4 (median) | 2 (median) |
1 year death | 5.4% | 12.6% |
STS = Society of Thoracic Surgeons; TAVR = transcatheter aortic valve replacement; TVT Registry = Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry
The authors identify areas for improvement – better heart failure optimization, algorithms to manage conduction disease, and use of ultrasound imaging for vascular access. The young population treated may present its own challenges in terms of lifetime management of patients with aortic valve disease when these patients eventually return with transcatheter heart valve failure. This high-risk but young patient population will be an interesting cohort to follow. The authors should be congratulated on this important effort to collect real-world data in their region. We look forward to further data from this group as the registry matures.
Biography
Footnotes
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References
- [1].Alasnag M, AlMerri K, Almoghairi A, Alenezi A, Bardooli F, Al-Sheikh S, et al. One Year Outcomes for Patients Undergoing Transcatheter Aortic Valve Replacement: The Gulf TAVR Registry. Cardiovascular Revascularization Medicine 2022. [DOI] [PubMed] [Google Scholar]
- [2].Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2020;76:2492–516. [DOI] [PubMed] [Google Scholar]