Author + information
- Received September 7, 2010
- Revision received September 13, 2010
- Accepted September 16, 2010
- Published online November 1, 2010.
- Cosmo Godino, MD⁎,†,⁎ (, )
- Francesco Maisano, MD‡,
- Matteo Montorfano, MD⁎,
- Azeem Latib, MD⁎,†,
- Alaide Chieffo, MD⁎,
- Iassen Michev, MD⁎,†,
- Rasha Al-Lamee, MD⁎,†,
- Marta Bande, MD⁎,
- Marco Mussardo, MD⁎,
- Francesco Arioli, MD⁎,
- Alfonso Ielasi, MD⁎,
- Micaela Cioni, MD‡,
- Maurizio Taramasso, MD‡,
- Irina Arendar, MD‡,
- Antonio Grimaldi, MD‡,
- Pietro Spagnolo, MD§,
- Alberto Zangrillo, MD∥,
- Giovanni La Canna, MD‡,
- Ottavio Alfieri, MD‡ and
- Antonio Colombo, MD⁎,†
- ↵⁎Reprint requests and correspondence:
Dr. Cosmo Godino, San Raffaele Scientific Institute, Via Olgettina 60, 20132 Milan, Italy
Objectives Our aim was to assess clinical outcome after transcatheter aortic valve implantation (TAVI) performed with the 2 commercially available valves with 3 delivery approaches selected in a stepwise fashion.
Background Limited data exist on the results of a comprehensive TAVI program using different valves with transfemoral, transapical, and transaxillary approaches for treatment of severe aortic stenosis.
Methods We report 30-day and 6-month outcomes of high-risk patients consecutively treated in a single center with either the Medtronic-CoreValve (MCV) (Medtronic, Minneapolis, Minnesota) or Edwards-SAPIEN valve (ESV) (Edwards Lifesciences, Irvine, California) delivered via the transfemoral or transaxillary approaches and ESV via the transapical approach.
Results A total of 137 patients underwent TAVI: 107 via transfemoral (46 MCV and 61 ESV), 15 via transaxillary (12 MCV and 3 ESV), and 15 via transapical approach. After the transfemoral approach, the procedural success rate was 93.5%, and major vascular complication rate was 20.6%. No intra-procedural deaths occurred. The procedural success rates of transapical and transaxillary approaches were 86.6% and 93.3%, respectively. The 30-day mortality rate was 0.9% in transfemoral group and 13.3% in transapical, and no deaths occurred after transaxillary access. Cumulative death rate at 6 months was 12.2% in transfemoral, 26.6% in transapical, and 18.2% in transaxillary groups. At multivariable analysis, logistic European System for Cardiac Operative Risk Evaluation, body surface area, and history of cerebrovascular disease were significantly associated with an increased risk of major adverse cardiac and cerebrovascular events.
Conclusions Routine TAVI using both MCV and ESV with a selection of approaches is feasible and allows treatment of a wide range of patients with good overall procedural success rates and 30-day and 6-month outcomes.
Surgical aortic valve replacement (SAVR) is frequently not an option for patients with symptomatic severe aortic stenosis considered at high or prohibitive operative risk. For this patient cohort transcatheter aortic valve implantation (TAVI) represents a promising strategy (1–5). Most studies have evaluated the results of TAVI either according to the approach used (i.e., transfemoral [1,2], transaxillary , or transapical ) or to the device implanted—Medtronic CoreValve (MCV) (Medtronic, Minneapolis, Minnesota) (2,5,6) or Edwards-SAPIEN valve (ESV) (Edwards Lifesciences, Irvine, California) (1,7,8). Patients are evaluated for TAVI in the setting of a multidisciplinary program encompassing interventional cardiology and cardiac surgery teams, with the selection of 1 approach over the other on the basis of the size and/or disease of the iliofemoral arteries. Limited data exist on the results of a comprehensive TAVI program including transfemoral, transaxillary, and transapical approaches and implantation of MCV or ESV. The objective of this single-center retrospective study was to evaluate the acute and midterm follow-up results and the factors predictive of outcome with the 2 commercially available valves with all 3 delivery approaches selected in a stepwise fashion.
From November 2007, all patients with severe symptomatic aortic stenosis consecutively referred to our institution (San Raffaele Scientific Institute, Milan, Italy) for TAVI were evaluated. All patients were evaluated by a multidisciplinary team, including 2 interventional cardiologists, 1 cardiac surgeon, and an anesthesiologist. The decision to perform TAVI was made in patients with the following characteristics: severe symptomatic aortic stenosis with an aortic valve area <1 cm2 plus 1 of the following: high surgical risk, as defined as a logistic European System for Cardiac Operative Risk Evaluation (logistic-EuroSCORE) ≥20%, Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) ≥10%; associated comorbidities not captured by the 2 scores, such as thoracic radiotherapy, coronary artery bypass surgery with patent grafts (a patent graft with right internal mammary artery, which crosses from right to left under the sternum and/or a patent left internal mammary artery, which might be damaged with the second sternotomy required for SAVR), porcelain aorta, or liver cirrhosis (in Child-Pugh Class B and C); or marked patient frailty that the cardiac surgeon considered to increase the risk for standard SAVR. The treatment selection algorithm is shown in Figure 1 (9). The transfemoral approach was considered the treatment of choice; if the peripheral vascular anatomy was not suitable, the transaxillary or the transapical access was evaluated. Pulmonary hypertension was defined as a pulmonary systolic pressure ≥60 mm Hg as estimated by Doppler echocardiography or measured by cardiac catheterization. Frailty was defined according to the criteria of Fried et al. (10). Chronic kidney disease was defined as an estimated glomerular filtration rate <60 ml/min/1.73 m2 (11). Acute renal failure was defined as a decrease >25% in estimated glomerular filtration rate at 48 h after the procedure (Risk, Injury, Failure, Loss and End-stage Kidney criteria) (12) or the need of renal replacement therapy (RRT) during index hospital stay. All patients provided written informed consent for the procedures.
Procedures and devices
Procedures were performed in a catheterization laboratory, with the exception of transapical procedures, which were performed in an operating room. Depending on the preference of the physician, clinical conditions, and evaluation of the patient by the anesthesiologist, the procedure was performed under either general anesthesia or local anesthesia with conscious sedation. The transapical procedures were all carried out under general anesthesia. The devices used in this study were the Edwards-SAPIEN THV (Edwards Lifesciences) and the Medtronic CoreValve ReValving Technology (Medtronic). We began with the ESV in November 2007 and then later added the MCV to our practice in July 2008. The transfemoral and the transaxillary routes were used for both valves, whereas the transapical was used only for the ESV. After TAVI, dual antiplatelet therapy was recommended with aspirin, 100 mg daily indefinitely and clopidogrel, 75 mg daily or ticlopidine, 250 mg twice daily (for 3 months for the ESV valve and 6 months for the MCV).
Transfemoral Delivery Technique
Arterial access and closure of the access sites were performed percutaneously with a “crossover protection technique” previously described by our group (13). The valve was crossed and implanted as previously described (1). After the valve was deployed, the delivery system was removed; the large introducer sheath was retrieved up to the junction of the distal aorta and the right common iliac artery while an appropriately sized Fox PTA balloon (Abbott Vascular, Santa Clara, California) was passed over the guidewire into the right common iliac artery. Contrast was injected to identify any right common or external iliac rupture; if none was present, the PTA balloon was advanced into the external iliac artery, and the sheath was further removed (13). Once sutures were secured, the PTA balloon was deflated. If there was any evidence of extravasation, the balloon was left inflated for 10 min at 2 atm. A check angiography was performed, and if no leak was evident the balloon was removed and arterial sheaths appropriately removed after protamine was given in a 1:1 fashion with heparin (10 mg of protamine/1,000 UI of heparin). Hemostasis was achieved on the contralateral side through manual compression. If rupture was evidenced, surgical or percutaneous repair was performed; in this case, 1 or more covered endoprostheses, such as the CP STENT (NuMed, Inc., Hopkinton, New York), the Gore Viabahn (W.L. Gore and Associates, Inc., Flagstaff, Arizona), and the Gore Hemobahn (W.L. Gore and Associates, Inc.) were used.
All patients received general anesthesia and an anterolateral mini-thoracotomy was performed with opening of the anterolateral segment of the pericardium near the apex, and the valve was then implanted as previously reported (14).
This procedure required surgical isolation of the left axillary artery. Once the artery was isolated, a purse string suture was placed to allow subsequent closure at the end of the procedure. The artery was punctured at the distal end of the purse string, and a 6-F sheath was placed into the artery. The standard 0.035-inch guidewire was then exchanged for a pre-shaped 0.035-inch Amplatz Super or Extra Stiff guidewire, and a 10-F sheath was positioned in the axillary artery. The valve was crossed with the same procedure as previously described for the transfemoral approach (1). The axillary access site was surgically repaired.
Procedural, 30-day, and 6-month outcome were evaluated. “Device success” was defined as implantation of the device with final mean transaortic gradient ≤20 mm Hg without aortic regurgitation grade ≥3 (effective implantation) and no valve embolization or need to implant a second valve. “Procedural success” was defined as an effective valve implantation without intraprocedural mortality or conversion to open heart surgery. “Vascular complications” were divided into major and minor complications according to the definitions previously provided (15). “Major vascular complications” were defined as vessel rupture and/or limb-threatening ischemia or bleeding requiring additional percutaneous treatment with stent implantation and/or nonplanned vascular surgery; aortic dissection was also included. Timing of events was: procedural (until the patient left the catheterization laboratory and/or occurring before extubation), 30-day, and 6-month clinical follow-up. Outcome measures included major adverse cardiac and cerebrovascular events (MACCEs) at 30 days and 6 months and major adverse valve-related events at 30 days. The MACCEs included cardiovascular death (death related to cardiac causes and major vascular complications such as retroperitoneal hematoma and TAVI-related aortic dissection), myocardial infarction, stroke, aortic valve re-intervention, or urgent cardiac or vascular surgery. Major adverse valve-related events included valve-related mortality, valve-related morbidity, and need for new permanent pacemaker or defibrillator within 14 days after the procedure (7).
Continuous variables were reported as mean ± SD or median (25th to 75th interquartile range) and compared with Student t test or Mann-Whitney or Wilcoxon rank-sum test, depending on variable distribution. Categorical variables were compared with chi-square test with Yates correction for continuity or the Fisher exact test as appropriate (16). The 1-way analysis of variance was used to test the hypothesis that several echocardiographic measurements are equal. Levene's test was used to test homogeneity of variance, and the Bonferroni test was performed as post hoc range test (17). Procedural and outcome results of transfemoral, transapical, and transaxillary approaches are provided but not compared, due to the differences in baseline and procedural characteristics. Multivariable binary logistic regression analysis (with a purposeful selection algorithm) was performed to determine the independent predictors of death and MACCEs at 6-month follow-up. Variables associated in the univariate binary logistic regression analysis with death and MACCEs (p < 0.1) and those judged to be of clinical importance from previous published data were eligible for inclusion into the multivariable model-building process. To avoid over-fitting the number of independent variables entered into the final multivariable model was limited to a maximum of 1 for every 10 events. Major vascular events were not included in the multivariate model of predictors of MACCEs, because they are already part of the MACCEs definition. Model discrimination was measured by the C-statistic and the Hosmer-Lemeshow goodness-of-fit test (18). All statistical analysis was performed with SPSS version 16.0 (SPSS, Inc., Chicago, Illinois), with significance set at the 2-tailed 0.05 level.
Between November 2007 and February 2010, 137 patients with symptomatic, severe aortic stenosis underwent TAVI in our center and were included in this analysis. Baseline clinical and echocardiographic characteristics of the study population are shown in Table 1. The approach for TAVI was transfemoral in 107 patients (78%), transaxillary in 15 (11%), and transapical in 15 (11%). The ESV was implanted in 79 patients (57.7%), 61 (77%) via the transfemoral approach, 15 (19%) via the transapical approach, and 3 (4%) via the transaxillary approach. Four (6.6%) of these patients had an ESV implanted for a degenerated bioprosthetic aortic valve (valve-in-valve). The MCV device was implanted in 58 patients (42.3%); 46 patients (79.3%) were treated via the transfemoral approach, and 12 (20.7%) were treated via the transaxillary approach. Assessment of the transfemoral approach showed that the only difference between patients treated with ESV and MCV was related to the aortic annulus diameter, which was significantly smaller in the ESV group (p < 0.001) (Table 2).
Procedural and 30-day outcomes
Procedural and 30-day clinical outcomes are reported in Table 3. The transfemoral approach was performed under general anesthesia in 30 of 107 patients (28%), 24 of 61 patients with ESV (39.3%), and in 6 of 46 patients with MVC (13%), p < 0.003. Elective surgical cut down of the common femoral artery was used in 5.6% of cases (4.3% ESV and 6.6% MCV). Procedural success was observed in 93.5% of patients and was significantly higher in the ESV group compared with the MCV group (98.4% vs. 89%, respectively; p = 0.040). There were no intra-procedural deaths. A total of 22 major vascular complications (20.6%) occurred (Table 4).
Procedural failure occurred in 1 of 61 patients (1.6%): the patient had an ascending aortic dissection soon after implantation of ESV (in a bicuspid valve), and the procedure was immediately converted to open surgical repair. No valve embolization occurred with the ESV. The major vascular complication rate was 21.3% (Table 4). Two patients (3.3%) had neurological events: 1 patient had a transient ischemic attack, and 1 experienced a stroke on the same day of the procedure. No death occurred at 30-day clinical follow-up.
Procedural failure occurred in 5 of 46 patients (11%): 5 patients needed a second valve implantation during the same MCV implantation. In 3 of them a second valve was successfully implanted, after embolization of the first MCV in the ascending aorta and/or aortic arch after implantation. In 2 patients (4.3%) severe residual aortic regurgitation after the first MCV required implantation of a second valve (valve after valve): in 1 patient an MCV 29 mm was immediately implanted in an MCV 26 mm; in a second patient an ESV 26 mm was implanted to decrease the severity of residual aortic regurgitation 6 days after implantation of an MCV 29 mm (for primary aortic regurgitation). One patient (2.2%) had a transient ischemic attack. No strokes occurred more than 24 h after the procedure. The overall incidence of permanent pacemaker implantation was 17.8% and was significantly higher with the MCV than the ESV (26.1% vs. 11.5%, respectively; p = 0.050). One death (2.2%) occurred within 48 h of the procedure from hemorrhagic shock due to retroperitoneal bleeding in a patient with vascular rupture treated with covered stent implantation (Patient #14 in Table 4).
Procedural and clinical outcomes are reported in Table 5. Procedural failure occurred in 2 of 15 patients (13.4%): 1 patient (6.7%) had left ventricular rupture successfully treated with placement of a patch during extracorporeal circulation oxygenation; a second patient had residual massive aortic regurgitation after the first ESV 23 mm implantation that required a second ESV 23 mm (valve after valve) implantation during extracorporeal circulation oxygenation. No intra-procedural death occurred. In 1 patient ESV implantation caused right coronary artery ostium occlusion without clinical consequence (nondominant vessel). One patient had a transient ischemic attack within 24 h after the procedure. The 30-day cardiovascular death rate was 13.4% (n = 2): 1 patient died 72 h after a transapical procedure from a cardiac arrest (ventricular fibrillation) with unsuccessful cardiopulmonary resuscitation; a second patient died after 5 days for untreatable ventricular fibrillation storm without any evident underlying cause.
Procedural and clinical outcomes are reported in Table 5. Procedural failure occurred in 1 of 15 patients (6.6%): the patient had residual severe aortic regurgitation after the first MCV 26 mm that required early implantation of a second MCV 29 mm (valve after valve). Moreover, other complications (not defined as procedure failure) occurred in 2 patients: 1 had residual aortic dissection after MCV implantation treated conservatively (the patient had a transitory ischemic attack 48 h later); a second patient had dissection of the subclavian artery and consequent occlusion of the left internal mammary artery graft to the left anterior descending coronary artery soon after implantation of an ESV valve. This patient remained clinically stable and an unsuccessful attempt to re-open the graft was made. No death occurred in the transaxillary group. Echocardiographic results are summarized in Figure 2. Post-procedural mild para-valvular regurgitation was a recurrent finding (trivial or mild: 72%, moderate: 4%, severe: 1.5%) (Fig. 2B). No significant differences in terms of post-procedural moderate-to-severe para-valvular regurgitation was found after comparison of ESV and MCV devices (5.1% vs. 6.9%).
6-month clinical follow-up
At 6 months, 98 of 107 patients (92%) were eligible for follow-up and no patient was lost to follow-up. The results are reported in Table 3. The cumulative all-cause mortality rate was 12.2% (12 patients). Two deaths were adjudicated as cardiac (2%), both involving patients treated with MCV (p = 0.073), and both were sudden deaths occurring at 63 and 121 days. Six patients died 30 days after the procedure while still in-hospital: 3 died of hemorrhagic shock (2 retroperitoneal hematoma, and 1 after tracheostomy), 2 because of multi-organ failure from sepsis, and 1 after ascending aortic dissection. A further 3 patients died out-of-hospital from multi-organ failure and recurrent infection. One patient had a stroke at 136 days and died some days later.
Transapical and Transaxillary Approaches
Six-month clinical outcomes are reported in Table 5. Clinical follow-up was performed in all transapical patients and in 11 of 15 (73%) transaxillary patients considered eligible for 6-month follow-up. In the transapical group, the cumulative death rate was 26.6% (n = 4), and all were cardiac-related (2 within 30 days as previously described). Of the 2 deaths that occurred after 30 days, 1 was related to a myocardial infarction (at 142 days), and 1 involved a patient with a post-procedural ventricular septal defect (at 84 days). In the transaxillary group, the overall death rate was 18.2% (2 deaths), and 1 was cardiac due to chronic heart failure. In this series of patients, 8 of 30 (26%) patients with porcelain aorta had a logistic-EuroSCORE <15. Of these, 5 patients were treated by the transfemoral approach, and 2 were treated by the transapical approach. A major vascular complication occurred in 2 of them (2 iliac ruptures treated with stent implantation). Only 1 death occurred at 64-day follow-up and was cardiac-related (congestive heart failure).
Predictors of 6-month Adverse Events
Results of multivariable logistic regression analysis are reported in Table 6 (univariate analysis in Online Table 7). In the multivariable analysis, logistic-EuroSCORE, body surface area and a prior history of cerebrovascular disease emerged as the most significant independent predictors for MACCEs. Moreover, significant predictors of death during the 6-month follow-up period were low LVEF and post-TAVI acute renal failure requiring RRT.
To the best of our knowledge, this is the first study reporting TAVI outcomes from a single center offering all possible combinations for transcatheter treatment of symptomatic aortic stenosis, using both devices currently available on the market and 3 types of access. The overall procedural success rate of 92.7% is encouraging, suggesting that—with careful screening and appropriate technique—immediate procedural success can be achieved in most patients in whom the procedure is attempted. In this series no death occurred during the procedure.
The overall 30-day death rate with the ESV of 2.5% (2 deaths, both after the transapical approach) is low compared with published death rates and is 1 of the lowest reported at 30-day for the ESV. The 30-day rate of death was 8.5% in the combined transapical and transfemoral arms of the SOURCE (SAPIEN Aortic Bioprosthesis European Outcome) Registry (the largest consecutive patient TAVI registry reported to date) (8). Webb et al. (7) reported a 30-day mortality of 11.3%, lower in the transfemoral group than transapical (8.0% vs. 18.2%), whereas in a more recent multicenter report on ESV from Canada the overall death rate at 30 days was 10.4% with no significant difference between the transfemoral and the transapical approach (19). With regard to the MCV our overall 30-day mortality rate was 1.7% (1 death), compared with the lowest reported mortality rate of 6.7% for the transfemoral approach (20) and 9.4% for transaxillary approach (21) (Figs. 3 and 4⇓⇓). The low rate of procedural and 6-month mortality cannot be explained by the baseline characteristics of our patients. The mean logistic-EuroSCORE of our patients treated with transfemoral and transapical approach was 26.6% and 32.2%, respectively, and was similar to that reported by Webb et al. (7) (25% and 35%, respectively). However, it is possible that the opportunity to select between 2 different devices and 3 different delivery approaches and the use of the crossover balloon technique has allowed us to implant the best possible valve by the best delivery method for each patient with a safer approach. Furthermore, the increased overall mortality rate at 6-month follow-up (14.5%) might be explained by the large burden of disease, due to multiple comorbid factors associated with this complex patient population, resulting in poor long-term prognosis.
Comparison of transfemoral ESV and MCV implantation
Presently, there are few data reporting a direct comparison between the 2 types of device within a single center (22–24). In our experience, patients selected for the transfemoral approach with both valves were no different in terms of baseline clinical characteristics except for differences in the aortic annulus diameter, which was predictably smaller in the ESV patients. The MCV implantation was characterized by a significantly lower rate of procedural success (p = 0.040), a higher rate of valve embolization (p = 0.041), and need for a second valve (“valve after valve,” p = 0.013). Moreover, the frequency of permanent pacemaker implantation is greater after an MCV procedure compared with ESV (26.1% vs. 11.5%, p = 0.073). In the study reported by Tchetche et al. (22), the rate of permanent pacemaker was 28.6% and 4.2% in the MVC and ESV groups, respectively (p = 0.002). Similarly, Bleiziffer et al. (23) reported a rate of permanent pacemaker of 27% and 6%, respectively (p = 0.008). As previously reported (22) there was no statistically significant difference in vascular complication between ESV and MCV patients.
Major vascular complications
Major vascular complications, primarily iliofemoral dissection or perforation, occurred in 22 patients (20.6%) with the transfemoral approach (18%, considering all patients with a transarterial approach). Our rate of vascular complications was not much higher than the range of 4% to 16.7% in previously published reports, which varied on the basis of the specific definitions of major vascular complications (Online Table 8) and the kind of prosthesis used in each study. In previous studies with ESV, Webb et al. (7) reported a vascular injury rate of 8%, whereas Ducrocq et al. (25) quoted a rate of 16.7%. Similarly, Bleiziffer et al. (26) in a single-center registry of 153 transfemoral TAVI procedures (most of which were performed with MCV) reported a femoral vessel complication rate of 16%. In addition, the availability of the option to treat our patients with both valves and the use of the “crossover protection technique” allowed us to use the transfemoral approach without the need for elective surgical closure in 94.4%. However, it is important to highlight that, despite a high occurrence of major vascular complications, the transarterial approach 30-day mortality was only 2.2%. The recent introduction of the SAPIEN XT valve with 18- and 19-F introducers might further help to minimize the risk of vascular complications in centers using only this valve (27).
Predictors of clinical outcome
We analyzed various clinical, quantitative, morphological, and procedural events potentially affecting 6-month outcome. It is not surprising that low ejection fraction and acute renal failure requiring RRT were significant independent predictors of death, because both are important indexes of patient vulnerability. In a recently published report by Bagur et al. (28) acute kidney injury after TAVI was found to be associated with a 4-fold increase in the risk of post-operative mortality. Additionally, the incidence of MACCEs was predicted by lower body surface area and a prior history of cerebrovascular disease. That logistic-EuroSCORE was an independent predictor of MACCEs but not mortality might be because this score was constructed as a pre-assessment tool for surgical procedures and might be inaccurate at predicting outcome after percutaneous procedures. Recently, Piazza et al. (29) found a moderate correlation between logistic-EuroSCORE and Society of Thoracic Surgeons Predicted Risk of Mortality score and reported that both risk scores had suboptimal discriminatory power and calibration. Similarly, Thomas et al. (8) demonstrated low discriminatory power of the logistic-EuroSCORE for TAVI patients enrolled in the SOURCE Registry. A general shortcoming of all surgical risk scores is the lack of several measurable and immeasurable risk factors that can influence patient selection and outcome. Additionally, in both scores a number of variables, such as porcelain aorta, chest radiation, liver cirrhosis, marked patient frailty, and others, are omitted.
This study reflects a single-center experience, and although the sample size is acceptable, the number of patients treated with each combination of valve type and approach was relatively limited. Moreover, the number of ESV is almost double the number of MCV. In our center the MCV became available later than the ESV, and therefore some vascular complications that occurred with the early ESV experience could have been avoided with the MCV and might be a reflection of our learning curve with the procedure. The small number of patients might have had implications on the validity of our analysis of predictors due to a lack of sufficient power, particularly with respect to the detection of confounding factors. Finally, this analysis focused on outcome events up to 180 days from the procedure and was thus not aimed at detecting complications associated with longer-term follow-up.
Transcatheter aortic valve implantation is a very promising strategy that has great potential in allowing the treatment of patients with severe aortic stenosis, who are at very high surgical risk and were previously deemed unfit for SAVR. In this study the availability of 2 different devices, delivered via 3 different approaches, has made this intervention increasingly feasible for a wider range of high-risk patients. Although our preliminary results are encouraging, only randomized controlled trials and larger registries with longer follow-up will help to delineate the safety and durability of this strategy. At present, rigorous patient selection, individualized decision-making, and full cooperation of the multidisciplinary team is paramount to ensure that each individual receives the best possible treatment modality with the maximal safety and efficacy.
For supplementary tables, please see the online version of this article.
Outcomes Following Transcatheter Aortic Valve Implantation (TAVI) with both Edwards SAPIEN and CoreValve Devices in a Single Center: the Milan Experience
The authors have reported that they have no relationships to disclose.
- Abbreviations and Acronyms
- Edwards-SAPIEN valve
- European System for Cardiac Operative Risk Evaluation
- major adverse cardiac and cerebrovascular event(s)
- renal replacement therapy
- surgical aortic valve replacement
- transcatheter aortic valve implantation
- Received September 7, 2010.
- Revision received September 13, 2010.
- Accepted September 16, 2010.
- American College of Cardiology Foundation
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