To our knowledge, this is the first attempt to create an Egyptian TAVI registry. It captures the real-world experience in Egypt dealing with a new therapeutic modality that is both expensive and technically demanding. The high cost of the procedure and the lack of governmental reimbursement have resulted in a slow and limited number of patients enrolled in this registry. The preliminary data showed acceptable in-hospital and 30-day mortality of 4.16% for both. The mean age was 77.17 years and almost half of patients were females. The rate of general anesthesia and TEE were high (59.37%) due to the use of old generation valves among the retrospective patients collected.
The transfemoral approach was adopted in 89.58% of our 96 patients, compared to 74.1% in the US transcatheter valve therapy (TVT) and 74.4% in the UK registry. This could be attributed to the fact that most of the valves used in our registry were of the newer generation (Sapien XT and the Corevalve Evolut R) which have a lower profile. Moreover, the fact that TF-TAVI was found to be associated with reduced mortality encouraged all operators to attain the femoral approach as the main route of implantation [11].
An Edwards balloon-expandable valve was implanted in 48.95% of our patients and a Medtronic self-expandable device in 51.05%. In TVT registry, 76.9% of patients had balloon expandable while only 21.1% had the Medtronic Corevalve [12]. This could be attributed to the delayed introduction of the self-expandable platform in the American market. In the UK, the ratio of balloon expandable to the self-expandable is not far off our registry with 54.5% balloon expandable and 41.7% self-expandable [13].
In-hospital mortality in our study was 4.16%, which is comparable to that of the TVT and UK registries being 4.0% and 2.9%, respectively. This entails the acceptable procedural safety and health care system dealing with a new therapeutic modality that needs both trained staff and multidisciplinary management of frail and high-risk patients. In our study, not only the mortality was comparable but also the rate of complications. One of the highest encountered complications were vascular access problems 11.5% vs. 7.1% of the patient in the TVT registry and only 2.3% of the patient in the UK. This might partly be explained by the increased ratio of femoral route of performed procedures in our study. In our registry, 14.58% of the patient had life-threating, disabling, or major bleeding versus 8.4% of the patients in the TVT registry.
The need for permanent pacemaker was only 7.29% in our registry, compared to 11.8% in the TVT and 12.4% in the UK registry. This could be explained as almost half of our patient received Edwards Sapien XT valve which is known to cause less conduction disturbances, compared to other platforms, including the Lotus valve (Boston scientific transcatheter valve in 2014) which has caused conduction abnormalities in up to 30.7% of the patients requiring permanent pacemaker implantation reported in the last audit report published in 2018 by the UK registry.
In our study, we delineated the patient demographics which had significant differences than that of the western community. Major differences involved being younger in age, higher BMI, higher percentage of diabetics, and patients suffering from end stage renal disease and yet they yield a lower STS score than that of TVT and UK registries. This could be explained as our patient showed lower rates of AF and previous cardiac surgeries. This fact emphasizes the need to specific risk scores that are designed to address TAVI patients putting in consideration the frailty of such age group. As we have noticed, most of our patients were frail (Katz index ≤ 5 (0.2)).
Our initial experience has shown an increased use of general anesthesia (GA) approaching 70% of cases from start till end of 2016; however, by the end of 2017, the GA dropped to 48% of cases and this was calculated in the last 36 patients. This was achieved after building experience and abiding to minimalistic approaches. This trend is also seen in each international registry. In the UK, the use of GA declined over time dropping from 93% in 2010–2011 reaching only 20% according to their annual report published in 2018 [12]. This shift in the mode of anesthesia is supported by association in reductions in procedural inotrope requirement, intensive care unit and hospital length of stay (6.0 versus 6.5 days, P < 0.001), and combined 30-day death/stroke rates (4.8% versus 6.4%, P < 0.001) [14].
Other procedural complications (stroke, aortic regurgitation post-implantation, cardiac tamponade) were comparable to the UK and TVT registries raising no red herring. Also, the mean hospital stay across registries showed small variations, 4.35 days in our study versus 6.2 and 5.5 in the TVT and UK registry, respectively. This might be attributed that we started our program in a later stage that provided us with the newer platforms of devices that had lower profile than those used in other registries. Also, the limited number of our cohort may have also contributed to this difference.
Follow-up data was limited, as only 24 patients had completed the 6-month follow-up and 11 completed the 1-year follow-up. Those patients had improved NYHA classification, exercise tolerance, and their MLHF score was significantly better.
Limitations and challenges
Our study included limited number of patients for statistical correlations to be deducted. Moreover, the follow-up data was only provided from a single center. The study only included patients that underwent TAVI in the 5 centers who accepted the participation in our project, while patients that underwent TAVI in different facilities were not included in this study. Another limitation was the fact that no core lab that was involved in our study and all complications were reported by the operating centers.
The high cost and availability of the valves were pivotal barriers in patient recruitment. Finally, the lack of standardized database and records in the included centers resulted in incomplete data collection and also defective follow-up data.