|Year : 2019 | Volume
| Issue : 2 | Page : 604-609
Transcatheter aortic valve implantation versus surgical replacement in high-risk patients with aortic stenosis
Ahmed L Dokhan1, Ali H Taher2, Amr M Allama1, Medhat R Nashy1, Ahmed M Fekry2
1 Department of Cardiothoracic Surgery, Faculty of Medicine, Menoufia University, Shibin El-Kom, Egypt
2 Department of Cardiac Surgery, National Heart Institute, Giza, Egypt
|Date of Submission||14-Dec-2017|
|Date of Acceptance||09-Jan-2018|
|Date of Web Publication||25-Jun-2019|
Ahmed M Fekry
Al Amal Street, 8th District, Sheikh Zayed City 41516, Giza
Source of Support: None, Conflict of Interest: None
The aim of this study was to demonstrate whether transcatheter aortic valve implantation (TAVI) improves mortality and morbidity compared with surgical aortic valve replacement in high-risk patients who require intervention for aortic valve stenosis (AS). Many patients with severe AS and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, TAVI has been suggested as a less invasive treatment for high-risk patients with AS.
Patients and methods
Fifty patients with severe AS for aortic valve intervention were classified as follows: group A, as TAVI group, included 25 patients who underwent aortic valve replacement by transcatheter femoral approach, and group B, as surgical aortic valve replacement group, included 25 patients who underwent aortic valve replacement by median sternotomy.
Intraoperatively, procedure duration was 101.8 ± 10.6 and 191.2 ± 7.5 min in group A and B, respectively (P < 0.001). Major vascular complications occurred in 20% of patients in group A and 0% of patients in group B (P = 0.018). Postoperative follow-up mean ICU stay was 3 ± 2.4 and 4.8 ± 3.5 days in groups A and B, respectively (P = 0.035). In group A, 32% of patients needed permanent pacemaker. In group A, 12% of patients developed stroke or transient ischemic attacks. Paravalvular aortic regurgitation occurred in 36.3 and 4.5% of patients in groups A and B, respectively (P = 0.009).
In high-risk patients with severe AS, transcatheter and surgical procedures for aortic valve replacement were comparable for survival at 3 months, although there were important differences in periprocedural outcomes.
Keywords: aortic valve stenosis, risk, sternotomy, transcatheter aortic valve replacement
|How to cite this article:|
Dokhan AL, Taher AH, Allama AM, Nashy MR, Fekry AM. Transcatheter aortic valve implantation versus surgical replacement in high-risk patients with aortic stenosis. Menoufia Med J 2019;32:604-9
|How to cite this URL:|
Dokhan AL, Taher AH, Allama AM, Nashy MR, Fekry AM. Transcatheter aortic valve implantation versus surgical replacement in high-risk patients with aortic stenosis. Menoufia Med J [serial online] 2019 [cited 2020 May 27];32:604-9. Available from: http://www.mmj.eg.net/text.asp?2019/32/2/604/260934
| Introduction|| |
Aortic stenosis represents an important issue of public health because of its bad prognosis and high prevalence, strongly linked to the phenomenon of aging among population. The severe form of aortic stenosis when symptomatic has high mortality rates and is therefore an indication for valvular replacement,.
Surgical aortic valve replacement (SAVR) is the standard of care in the treatment of affected patients by alleviating symptoms and improving survival. Despite favorable results even among high-risk patients, surgical replacement is not performed in up to one-third of eligible patients, owing to advanced age, comorbidities, previous cardiac surgery, concomitant coronary artery disease, and patient refusal,.
In 2002, transcatheter aortic valve implantation (TAVI) was introduced as an option for this patient group, and it has shown to reduce mortality and length of hospital stay. Although TAVI was originally designed to treat such a group of patients with severe aortic stenosis who were at prohibitive risk of open heart surgery, nowadays it is being performed worldwide, even in lower risk population,.
Studies of TAVI have primarily been observational registries without control populations. In particular, there is little knowledge on the comparative operative and perioperative mortality and morbidity of high-risk patients undergoing TAVI compared with a conventional surgical approach. Our study compared 3-month mortality rates and morbidities of patients with high-risk aortic stenosis treated with TAVI against a group of high-risk patients who were surgically treated when TAVI was an inappropriate option for them for various reasons, including coronary anatomy, aortic annulus and root anatomy, peripheral vasculature, patient preference, and lack of funding.
| Patients and Methods|| |
This study was approved by Ethical Committee of Menoufia Faculty of Medicine. This prospective study was conducted on 50 patients in National Heart Institute and Dar Alfouad hospital from 2015 to 2017. Informed consent was taken from each patient. All patients had severe aortic valve stenosis (AS) and were listed for aortic valve intervention. They were deemed at high surgical risk based on risk profiling after calculating European System for Cardiac Operative Risk (EuroSCORE) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM). Patients were classified into group A, TAVI group, which included 25 patients who underwent aortic valve replacement by transcatheter femoral approach, and group B, SAVR group, which included 25 patients who underwent aortic valve replacement by median sternotomy. The patients were assigned to either procedure according to the decision of the heart team, which was composed of a cardiologist, a cardiac surgeon, an anesthesiologist, and an intensivist. The team assessed demographic characteristics, health status before intervention, comorbidities, and technical suitability for TAVI.
Exclusion criteria were bicuspid aortic valve, concomitant ischemic heart disease requiring revascularization, left ventricular ejection fraction (EF) 20% or less, severe aortic regurgitation, and severe mitral regurgitation.
Patient's medical history including age, sex, New York Heart Association (NYHA) classification, and preoperative risk factors was recorded. Echocardiography was done for all patients, and assessment was done for all patients before surgery and 3 months after. Our echocardiographic study was to assess paravalvular aortic regurgitation (AR) that was graded using all available parameters, including the circumferential extent of AR from multiple parasternal short-axis views, in accordance with the Valve Academic Research Consortium recommendations: mild, moderate, and severe when the circumferential extent was less than 10, 10–20, more than 20%, respectively. When there was more than one jet, the values of all regurgitation jets of at least mild were added. Echocardiography was used for assessment of EF, diameter of left ventricle, and aortic valve mean pressure gradient.
All SAVR patients received a bioprosthesis with the specific type and size determined during the procedure, which was performed through a standard midline sternotomy with cardiopulmonary bypass and systemic hypothermia. Calcified aortic valve was excised, followed by implanting a new valve, using polyester sutures circumferentially. Patients who underwent TAVI received the CoreValve self-expanding bioprosthesis (Medtronic, Minneapolis, Minnesota, USA), via femoral artery. Using fluoroscopy, a guidewire was advanced to the aorta and a sheath was sutured to the puncture site. A balloon was advanced to the aortic valve and balloon aortic valvuloplasty was performed. The delivery system was then advanced, and the stent with the valve was aligned along the balloon within the aorta. All available CoreValve sizes (23, 26, 29, or 31 mm) were used. The procedure was performed under general anesthesia. All TAVI and SAVR patients received similar periprocedural prophylactic antibiotics and postoperative antiplatelet and anticoagulation regimes.
Overall mortality during hospital stay from the intervention was the primary end point. Secondary end points included overall mortality within 3 months; incidence of stroke, defined as any new persistent neurological deficit; vascular complications, defined as any access site complication requiring surgical or percutaneous treatment; myocardial infarction; permanent pacemaker insertion; and red blood cell transfusion.
The data were collected, tabulated, and statistically analyzed by Statistical Package for Social Science (SPSS, version 22.0; IBM Corp., Armonk, New York, USA) on IBM compatible computer. Two types of statistics were used: descriptive statistics as percentage (%), mean, and SD, and analytic statistics as χ2-test, which was used to study association between two qualitative variables, and Fisher's exact test, which was used to study association between two qualitative variables and at least one cell of expected was less than 5. Student's t-test is a test of significance used for comparison between two groups having normally distributed quantitative variables. Mann–Whitney test (U) (nonparametric test) is a test of significance used for comparison between two groups having not normally distributed quantitative variables, and paired t-test as a test of significance is used for one group of units that has been tested twice (a 'repeated measures' t-test), that is, between two related normally distributed quantitative variables.
| Results|| |
In group A, mean patients' age was 76.1 ± 2.9 years, whereas in group B, it was 75.5 ± 1.9 years, with no statistical significance (P = 0.14). In both groups, 14 (56%) patients were males and 11 (44%) were females, with no statistical significance (P = 1) [Table 1].
|Table 1: Sociodemographic characteristics and anthropometric measurements of studied groups (n=25)|
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Mean EF in group A was 56 ± 5.8%, whereas in group B, it was 58 ± 4.2%, with no statistical significance (P = 0.61). Aortic valve (AV) mean pressure gradient (PG) in group A was 50.2 ± 9 mmHg, whereas in group B, it was 50.6 ± 8.7 mmHg, with no statistical significance (P = 0.87) [Table 2].
|Table 2: Comparison between studied groups regarding preoperative echo data (n=25)|
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Mean procedure duration was 101.8 ± 10.6 and 191.2 ± 7.5 min in group A and group B, respectively, with statistical significance (P < 0.001). Major vascular complications, including pelvic vessels dissection, aortic dissection, and access site hematoma, occurred in five (20%) patients in group A, in contrast to no (0%) patients in group B; this resulted in statistical significance (P = 0.018). Major bleeding that resulted in hemodynamic instability and warranted immediate inotropic support and/or blood transfusion occurred in five (20%) patients in group A, in contrast to one (4%) patient only in group B, with no statistical significance (P = 0.082) [Table 3].
|Table 3: Comparison between studied groups regarding procedure data and postoperative clinical outcomes (n=25)|
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Regarding postoperative follow-up data, patients in group A required 2.2 ± 2.3 transfused blood units, whereas in group B, patients required 3.6 ± 2.1 units, with statistical significance (P = 0.023). Mean ICU stay was 3 ± 2.4 and 4.8 ± 3.5 days in group A and group B, respectively; this resulted in statistical significance (P = 0.035). In group A, eight (32%) patients needed permanent pacemaker, in contrast to two (8%) patients in group B, with statistical significance (P = 0.034). In group A, three (12%) patients developed stroke/transient ischemic attacks (TIAs), in contrast to no (0%) patients in group B, with statistical significance (P = 0.037) [Table 4].
|Table 4: Comparison between survivors in studied groups regarding 3-month postoperative data (n=23)|
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Regarding 3-month follow-up data, one (4.3%) patient needed repeat hospitalization for noncardiac reasons, whereas in group B, two (8.7%) patients needed repeat hospitalization. There was no statistical significance (P = 0.55). Regarding 3-month mortality, one (4.3%) patient died in group A, and another patient died in group B (4.3%). There was no statistical significance (P = 1) [Table 5].
|Table 5: Comparison between survivors in studied groups regarding 3-month postoperative echo data (n=22)|
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Regarding 3-month follow-up echocardiographic data, AV mean PG was 9.6 ± 2.9 and 12.8 ± 1.6 mmHg in group A and group B, respectively. This was statistically significant (P < 0.001). Paravalvular AR occurred in eight (36.3%) patients and one (4.5%) patient in group A and group B, respectively. This finding was stati stically significant (P = 0.009) [Figure 1].
|Figure 1: Patient flow chart. SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve replacement.|
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| Discussion|| |
Prognosis in patients with severe, symptomatic high-grade aortic stenosis is poor if treated medically. Surgical valve replacement can be done at low operative risk for inpatients without significant comorbidities. However, with increasing age and increasing comorbidities, surgical operative mortality has been reported to increase significantly.
Previously, SAVR was the only effective treatment, but after being introduced in 2002, TAVI became an option for certain patients with severe symptomatic AS who were considered inoperable or in patients at high risk for surgical complications.
More recently, observational studies have demonstrated acceptable mortality outcomes in low-risk and intermediate-risk patients,; however, few randomized clinical trials have been conducted in high-risk patient population.
In our study, there was no significant difference between the two groups regarding the demographic data and preoperative comorbidities. There was also no significant difference between the two groups regarding preoperative left ventricular end-diastolic diameter and left ventricular end-systolic diameter as well as EF. Our preoperative left ventricular study is similar to that of Little et al. who reported high-surgical risk in their patients.
Our study revealed that mean procedure duration in group A was shorter than group B, with statistical significance. This finding was also reported by Thyregod et al. In their study, the mean procedure time in TAVI group was 90.3 ± 38.6 min and 177.2 ± 39.8 min in SAVR group. However, less consumed time was reported in both procedures in their study and can be attributed to more experience as well as larger number of cases operated upon at the center where they conducted their study.
One more statistically significant operative finding in our study was major vascular complications, whose incidence in group A was more than group B. This finding coincides with Leon et al. who reported 16.2% in TAVI group and 1.1% in SAVR group. Deeb et al. had also endorsed the same finding in their study, reporting 7% in TAVI group and only 2% in SAVR group.
Regarding postoperative blood transfusion, patients in group A needed less blood transfusion than patients in group B, with statistical significance. Tamburino et al. had also reported statistical significance when it came to comparing the mean number of transfused blood units in their two groups, with a mean of 2.3 ± 2.2 units in TAVI group and 3.6 ± 3.6 units in SAVR group.
Mean ICU stay in our study in group A was shorter than group B, with statistical significance. Stöhr et al.in their study conducted between 2008 and 2010 reported statistical significance as well when they compared mean ICU stay. Patients in their TAVI group had a mean ICU stay of 3.3 ± 3.1 days, whereas those in SAVR group stayed in ICU for 6.6 ± 10.5 days. This could be attributed to the cumulative experience in critical care, and technological advances. On the contrary, Tamburino et al.had reported no statistical significance comparing the mean ICU stay in TAVR and SAVR groups; however, the ICU stay in their TAVR group was quite close to ours, with a mean of 3.2 ± 4.7 days. However, the mean ICU stay of patients in SAVR group was 3.8 ± 7.7 days.
In our study, more patients in group A required postoperative permanent pacemaker insertion than patients in group B. These rates have resulted in statistical significance. Thyregod et al. reported similar statistical significance when they compared both groups; as 34.1% of patients in TAVI group needed permanent pacemaker compared to only 1.6% in SAVR group. D'Errigo et al. had also reported 16% of patients in TAVI group and 0.8% of patients in SAVR group who needed permanent pacemaker insertion, resulting in statistical significance.
Stroke and/or TIAs have complicated the postoperative course of more patients in group A than patients in group B, and this was of statistical significance. Smith et al. had also described statistical significance when they compared the incidence of either postoperative stroke or TIAs in 5.5% of patients in TAVI group and 2.4% of patients in SAVR group. Kodali et al. had also delineated in their study the incidence of stroke/TIAs in 8.7 and 4.3% of patients in TAVI and SAVR groups, respectively, with statistical significance.
The same number of patients in both groups had died, and this comparable rate between the two groups did not equate to any statistical significance. Leon et al. had also found no statistical significance. The rate was 9% in their TAVI group and 2.8% in SAVR group. Stöhr et al. had also described no statistical significance when they compared the mortality rates in TAVI and SAVR groups, which were 12 and 7.6%, respectively. Leon et al. and Stöhr et al. had attributed the early mortality to cardiac causes. In our study, we have also found that the cause of death of the four patients was persistent low cardiac output in spite of maximal inotropic support.
During the 3-month follow-up in our study, one patient in group A died of stroke, whereas another patient in group B died of cerebral hemorrhage. There was no statistical significance. Thyregod et al. found no statistical significance either when they compared mortality in the two groups of their study, reporting 2.1% in TAVI group and 3.7% in SAVR group.
Regarding the 3-month follow-up echocardiography, AV mean PG in group A was less than that in group B, and this has resulted in a statistically significant difference. This goes in agreement with Little et al. who noted that TAVI had resulted in a lower aortic valve mean pressure gradient (9.1 ± 3.5 mmHg) compared with SAVR group (12.4 ± 7.4 mmHg); they had also reported a statistically significant difference comparing both groups. These observations are also consistent with D'Errigo et al.who reported a mean AV mean PG of 10.8 ± 6.4 mmHg in TAVI group, which was lower than the mean of 13.6 ± 8.6 mmHg in SAVR group, with statistical significance.
Regarding postoperative aortic valve regurgitation in our study, more patients in group A experienced paravalvular regurgitation than patients in group B. This resulted in a statistical significant difference. These findings are consistent with D'Errigo et al. who had reported the incidence of paravalvular regurgitation in 39.1% of patients in TAVI group and 11.2% in SAVR group, with statistical significance.
Small sample size was one of the limitations we encountered in our study as our trial aimed to compare TAVI versus SAVR and therefore excluded patients with significant coronary artery disease. The high cost of TAVI was a considerable reason that made several patients prefer to undergo conventional surgery, even though they were suitable candidates for TAVI.
Interobserver variability in interpretation of the echocardiographic finding was another limitation in our study, especially when it came to evaluating the degree of postoperative paravalvular regurgitation.
Short-term follow-up in our study was considered a limitation, as long-term studies will determine the long-term durability of transcatheter and surgical aortic valves and may reveal additional parameters associated with mortality hazard that were not significant at 3 months.
| Conclusion|| |
A 3-month follow-up of high-surgical risk patients with severe AS supports TAVI as an alternative to surgery. The two treatments were similar with respect to mortality, but paravalvular regurgitation, vascular complications, stroke/TIAs, and permanent pacemaker insertion were more frequent after TAVI.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]