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Abstract
Background—There is a lack of information on the incidence and predictors of early mortality at 30 days and late mortality between 30 days and 1 year after transcatheter aortic valve implantation (TAVI) with the self-expanding CoreValve Revalving prosthesis.
Methods and Results—A total of 663 consecutive patients (mean age 81.0±7.3 years) underwent TAVI with the third generation 18-Fr CoreValve device in 14 centers. Procedural success and intraprocedural mortality were 98% and 0.9%, respectively. The cumulative incidences of mortality were 5.4% at 30 days, 12.2% at 6 months, and 15.0% at 1 year. The incidence density of mortality was 12.3 per 100 person-year of observation. Clinical and hemodynamic benefits observed acutely after TAVI were sustained at 1 year. Paravalvular leakages were trace to mild in the majority of cases. Conversion to open heart surgery (odds ratio [OR] 38.68), cardiac tamponade (OR 10.97), major access site complications (OR 8.47), left ventricular ejection fraction <40% (OR 3.51), prior balloon valvuloplasty (OR 2.87), and diabetes mellitus (OR 2.66) were independent predictors of mortality at 30 days, whereas prior stroke (hazard ratio [HR] 5.47), postprocedural paravalvular leak ≥2+ (HR 3.79), prior acute pulmonary edema (HR 2.70), and chronic kidney disease (HR 2.53) were independent predictors of mortality between 30 days and 1 year.
Conclusions—Benefit of TAVI with the CoreValve Revalving System is maintained over time up to 1 year, with acceptable mortality rates at various time points. Although procedural complications are strongly associated with early mortality at 30 days, comorbidities and postprocedural paravalvular aortic regurgitation ≥2+ mainly impact late outcomes between 30 days and 1 year.
Transcatheter aortic valve implantation (TAVI) has emerged as a promising alternative to conventional aortic valve replacement for patients with severe, symptomatic aortic stenosis who are otherwise left untreated due to the perceived high risk of operative mortality.1 Since the first-in-man procedure in 2002,2 several improvements have been achieved in TAVI device technologies and procedural management, leading to incremental success rates.3,–,9 Presently, 2 TAVI devices are under postmarketing surveillance in Europe: the balloon-expandable Edwards SAPIEN prosthesis (Edwards Lifesciences, CA) and the self-expandable CoreValve Revalving prosthesis (Medtronic Inc, MN). Short- and mid-term clinical outcomes with the Edwards SAPIEN prosthesis have been recently reported using a collaborative approach of transarterial and transapical TAVI.7,10 In contrast, the available reports of TAVI with the CoreValve prosthesis mainly focus on procedural success and short-term clinical outcomes.8,9,11 These studies provide limited information on the durability and midterm survival with the CoreValve prosthesis, and fail to differentiate between predictors of early (30 days) and late (30 to 365 days) mortality after TAVI. To shed more light on this subject, this study was designed to determine the incidence and predictors of mortality in patients undergoing TAVI with the third generation (18-Fr) CoreValve prosthesis, using data from a large multicenter registry.
Editorial see p 239
Clinical Perspective on p 308
Methods
Study Design and Patient Population
From June 2007 to December 2009, a total of 663 consecutive patients undergoing TAVI with the third-generation 18-Fr CoreValve device in 14 Italian centers were prospectively included into a dedicated web-based database. Clinical follow-up was documented in all patients at a median of 18 months (interquartile range [IQR] 16 to 22 months) and a mean of 19±6 months (minimum 9 months, maximum 39 months) from the index procedure. One year clinical follow-up was available in 94% of patients. Local institutional ethical committees approved the study protocol. The principal investigators of the first 4 centers who began CoreValve implantation in Italy (C.T., A.R., A.S.P., F.E.) designed the study as part of their role on the steering committee, in collaboration with the sponsor, Endotech. The sponsor financed the web-based database and was involved in collection, source verification, and quality control of the data, with oversight by an independent clinical events committee (A.E., E.R., U.C., A.P.). The authors wrote the manuscript and vouch for the completeness and accuracy of the data gathering and analysis. The sponsor had no role in data analysis or editing of the final manuscript.
All patients had severe symptomatic aortic stenosis with valve area <1 cm2. Eligibility for TAVI was established at each center based on the consensus of a local multidisciplinary team that included clinical cardiologists, cardiac surgeons, and cardiac anesthesiologists. All of the procedures were approved for compassionate use in patients with no reasonable surgical option, according to accepted inclusion and exclusion criteria.3 Written informed consent was obtained in all cases.
Device Description and Procedure
Design features of the third generation CoreValve Revalving System and technical details of the procedure have been described elsewhere.4 Briefly, the device consists of a trileaflet biological valve sewed in a self-expanding nitinol 3-level frame. The upper level of the frame favors the prosthesis fixation to the aorta wall and crosses the system parallel to the blood flow, providing longitudinal stability; the middle level carries the valve and has a convex design to avoid the coronary ostia; the lower level has high radial force to anchor firmly the prosthesis to the aortic annulus, preventing migration and paravalvular leakages.
General anesthesia was used at the beginning of the experience and later replaced by local anesthesia and mild sedation. Depending on the size and disease of iliofemoral arteries, patients were selected for femoral or subclavian approach. In case of femoral access, the procedure was accomplished with standard techniques, as previously described.8 In case of subclavian access, the left subclavian/axillary artery was preferred, due to a more favorable orientation of the delivery system through the aortic annulus.
All patients received acetylsalicylic acid 100 mg before the procedure, and lifelong thereafter. A loading dose of clopidogrel 300 mg was administered the day before the procedure followed by 75 mg daily for 3 to 6 months. During the intervention unfractioned heparin 100 UI/kg was administered to achieve an activated clotting time of 200 to 250 seconds for the duration of the procedure.
Definitions and Data Collection
Outcomes measures included procedural success, death, and major adverse cardiovascular and cerebrovascular events, defined as the composite of death, myocardial infarction or stroke.12 Procedural success was defined as implantation of a functioning prosthetic valve within the aortic annulus, with stable hemodynamic conditions, absence of severe paravalvular regurgitation, and without intraprocedural mortality. Death was defined as mortality from all causes after prosthesis insertion. Myocardial infarction was defined as creatine kinase-myocardial band >3 times the upper limit of normal. Major access site complication was defined as vascular rupture with fatal bleeding or need for urgent vascular surgery or transcatheter repair. Major bleeding was defined as fatal bleeding, bleeding in a critical organ (retroperitoneal, intracranial, or intraocular), deep hematoma, or overt bleeding associated with a 2 g/dL or greater decrease in hemoglobin level or leading to the transfusion of at least 2 U of packed red blood cells. Procedure-related events were defined as those occurring during or as a direct result of the TAVI procedure within the subsequent 24 hours.
Data collection by a dedicated web-based case report form included baseline clinical, laboratory, echocardiographic, computed tomography, and angiographic data, as well as procedural data and clinical follow-up data at prespecified time-points (1, 3, 6, 12, and 24 months). Clinical follow-up was obtained by clinical visits and/or through telephone contacts. Referring cardiologists, general practitioners and patients were contacted whenever necessary for further information. Death, myocardial infarction and stroke at any time during follow-up were recorded. Echocardiographic follow-up was not mandatory, but recommended at 1, 3, 6, 12, and 24 months. Echocardiographic measurements were performed according to current guidelines.13 Grading of (para)valvular regurgitation was performed semiquantitatively based on jet width in the left outflow tract.
All data provided by each interventional site were anonymized, centrally collected, and assessed for quality. In particular, all outcome data were confirmed by source documentation collected from each participating center and reviewed by an independent clinical event adjudication committee.
Statistical Analysis
Continuous variables were analyzed for a normal distribution with the Shapiro-Wilk test. Continuous variables following a normal distribution are presented as mean±standard deviations and were compared using a Student's unpaired t test for comparisons between groups and a Student's paired t test for within-group comparisons. Variables not following a normal distribution are expressed as median (IQR), and were compared with a Mann-Whitney test for comparisons between groups and a Wilcoxon test for within-group comparisons. Categorical variables are presented as counts and percentages, and were compared using χ2 or Fisher exact tests, as appropriate. The cumulative incidences of clinical events at follow-up were assessed with the Kaplan-Meier method. Patients not eligible for 1-year follow-up due to the enrollment time or lost to follow-up accounted for 6% of the overall population and were considered at risk until the date of last contact, at which point they were censored. The incidence of mortality was provided as cumulative incidence and incidence density. Incidence density was defined as the number of patients who died divided by the total number of patient-years, and it was expressed as a number per 100 patient-years of observation. Receiver-operating characteristic analysis was performed for an exploratory evaluation of the best cut-off point of EuroSCORE to predict 30-day and 1-year mortality in our study population. Sensitivity and specificity were derived using this cut-off value. A stepwise logistic regression analysis including all variables from Tables 1 and 2 with probability value ≤0.20 in the univariate analysis was used to determine independent predictors of early (30-day) mortality; results are presented as odds ratio (OR) with 95% confidence intervals. A stepwise Cox multivariate analysis including all variables from Tables 1 and 2 with probability value ≤0.20 in each Cox univariate analysis was used to determine independent predictors of overall and late (>30 days up to 1 year) mortality. Results are presented as HR with 95% confidence intervals. The validity of the proportionality assumption was verified for all covariates by a visual examination of the log (minus log) curves and a test based on the Schoenfeld residuals. All probability values reported are 2-sided, and a probability value <0.05 was considered to be significant. All data were processed using the Statistical Package for Social Sciences, version 15 (SPSS, Chicago, IL).
Baseline Characteristics
Procedural Outcomes
Results
Table 1 summarizes baseline demographic, clinical, and echocardiographic characteristics of the study population. Mean age was 81.0±7.3 years, and 56% of patients were female. All patients had severe symptomatic aortic stenosis (mean transvalvular pressure gradient 51.8±17.0 mm Hg, mean aortic valve area 0.6±0.2 cm2). The mean predicted mortality by logistic EuroSCORE was 23.0±13.7%. A total of 434 patients (71.5%) patients were in New York Heart Association (NYHA) functional class III or IV before the procedure. Porcelain aorta was the reason for TAVI in 10.9% of patients.
Procedural Outcomes
Procedural outcomes are listed in Table 2. The mean procedural time was 79.1±33.6 minutes, with 90.3% of the procedures accomplished by means of a transfemoral approach and 72.4% of the procedures performed under local anesthesia. Proctored cases were 244 (36.8%). Procedural success was obtained in 98% of patients. Intraprocedural death occurred in 6 (0.9%) patients. The composite of procedure-related major adverse cardiovascular and cerebrovascular events was 2.1%. Valve embolization occurred in 4 cases successfully managed with implantation of 2 (in-series) CoreValve prostheses (n=2), conversion to surgery (n=1), and balloon aortic valvuloplasty (n=1). Valve-in-valve implantation was needed in 18 cases for high deployment and 6 cases for low deployment of the prosthesis. Postdilatation was performed in 68 (10.2%) patients. Major access site complications were observed in 13 (2.0%) patients. A permanent pacemaker was implanted in 16.6% of patients within 2 weeks from the procedure and 17.4% at 30 days.
Incidence of Mortality
A total of 114 (17.2%) patients died during the follow-up period, at a median of 69 days (IQR 30 to 124 days). The incidence density of mortality was 12.3 per 100 person-year of observation. Death occurred early within 30 days in 39 of 114 (34%) patients and late within the first year in another 60 (53%) patients. The other 15 (13%) patients died after 1 year. The cumulative incidence of early mortality at 30 days was 5.4%, with a median time to occurrence of 6 days (IQR 1 to 12 days). Late mortality occurred at a median of 101 days (IQR 77 to 169) and a cumulative incidence of 12.2% at 6 months and 15.0% at 1 year (Figure 1). In aggregate, the cumulative incidence of mortality over time showed an initial steep rise with 25% of cases occurring within 14 days, followed by an almost linear increase in the remaining events up to 1 year (Figure 2). The slope of the linear portion of the cumulative curve of mortality between 30 days and 1 year was 0.9% per month.
Cumulative incidence of death (upper row) and death, myocardial infarction or stroke (lower row) in the total study population and subdivided into early and late events.
Distribution of mortality over time.
The potential for a learning curve across cases performed in the first tertile of the study period and those performed in the second and third tertiles was noted for mortality at 30 days (7.9% versus 3.6% versus 5.0%, P=0.04). The absolute risk difference across tertile was similar in magnitude but no longer statistically significant at 1 year (17.6% versus 13.1% versus 14.2%, P=0.34) (Figure 3). Interestingly, the observed difference in 30-day mortality across tertiles was not driven by significant changes of procedural success over time and could be more related to progresses in postprocedural care. The logistic EuroSCORE did not change significantly across tertiles (24.0±13.6 versus 22.5±14.0 versus 22.4±13.6, P=0.45).
Learning curve across study periods.
Follow-up clinical results are listed in Table 3. The major adverse cardiovascular and cerebrovascular events actuarial rates were 6.4% at 30 days, 14.0% at 6 months, and 16.6% at 1 year (Figure 1).
One-Year Clinical Results
Predictors of Mortality
Differences in baseline and procedural variables between patients who died and those who did not are shown in Table 1 and 2. Patients who died were more likely to present with risk factors such as diabetes mellitus, chronic renal failure, prior acute pulmonary edema, and systolic pulmonary artery pressure >60 mm Hg. The mean logistic EuroSCORE for patients who died was 24.9±15.1% compared with 22.6±13.4% for patients who survived (P=0.13). The discriminative ability of the logistic EuroSCORE for predicting the risk of 30-day and 1-year mortality was weak (c-statistic 0.55 for both). The best discriminative cut-off value of the logistic EuroSCORE was 21 for both 30-day (sensitivity 67%, specificity 56%) and 1-year mortality (sensitivity 57%, specificity 55%).
Stepwise multivariate Cox regression analysis revealed intraprocedural stroke (HR 15.76), preprocedural mitral regurgitation 3+ or 4+ (HR 4.62), systolic pulmonary artery pressure >60 mm Hg (HR 3.21), prior acute pulmonary edema (HR 2.75), and diabetes mellitus (HR 2.45) as independent predictors of overall mortality (Table 4). The need for conversion to open heart surgery was the main predictor of 30-day mortality by stepwise logistic regression (OR 38.68), followed by cardiac tamponade (OR 10.97), major access site complications (OR 8.47), left ventricular ejection fraction <40% (OR 3.51), prior balloon valvuloplasty (OR 2.87), and diabetes mellitus (OR 2.66) (Table 4). The Hosmer-Lemeshow goodness-of-fit test was not statistically significant (P=0.66), indicating accuracy of the analysis. Prior stroke (HR 5.47), postprocedural paravalvular leak ≥2+ (HR 3.79), prior acute pulmonary edema (HR 2.70), and chronic kidney disease (HR 2.53) were identified as independent predictors of late mortality between 30 days and 1 year (Table 4).
Multivariate Analysis
Prosthesis Performance Over 1-Year Follow-Up
In successful procedures, a substantial improvement in the NYHA functional class was observed at 30 days and 1 year, with most patients in NYHA class I or II at each time point regardless of baseline functional class (Figure 4). Peak and mean pressure gradients decreased acutely from 85.5±23.6 and 54.2±16.5 (pre-TAVI) to 17.5±8.0 and 10.0±4.6 mm Hg (post-TAVI), respectively (P<0.001 for both comparisons). In patients with echocardiographic follow-up at 30 days and 1 year, no significant changes in peak (18.7±7.6 versus 18.3±7.8, P=0.62), mean (9.9±4.0 versus 10.0±4.9, P=0.57) pressure gradients, or aortic valve area (1.6±0.3 versus 1.6±0.5, P=0.73) were observed over time. Paravalvular aortic regurgitation after successful TAVI was a frequent finding at each time point, but it was trace to mild in the vast majority of cases (Figure 5). Conversely, valvular regurgitation was almost entirely absent or mild (Figure 5). No cases of structural valve deterioration were observed.
Thirty-day (A) and 1-year (B) NYHA functional class stratified by baseline NYHA functional class in patients alive at 30 days. Data are given for patients with actuarial 30-day and 1-year follow-up, including patients alive and with actual follow-up for a given time point and those theoretically at follow-up but who died in the meantime. Whether the functional class improved or worsened is indicated.
Aortic regurgitation (AR) in patients undergoing successful TAVI. Data are given for patients with actuarial 30-day and 1-year follow-up (n), including all patients alive and with actual follow-up for a given time point, as well as those theoretically at follow-up but with missing/incomplete echocardiography data or death in the meantime, as described by Webb et al.7 The upper row displays changes in paravalvular AR at 30 days (left) and 1 year (right). The second row displays changes in valvular AR at 30 days (left) and 1 year (right). To compare changes among patients with different postprocedural degrees of AR, data are presented according to the degree of AR after TAVI, and whether the grade improved or worsened is indicated.
Discussion
The results of the Italian multicenter experience with the CoreValve Revalving System in the largest cohort of high-risk patients with symptomatic severe aortic stenosis published so far add to the evidence about TAVI with the following observations: death occurred with an incidence density of 12.3 per 100 person-years and a cumulative incidence of 15.0% at 1 year; 1/3 of deaths were observed within the first 30 days after the procedure and almost 25% occurred within the first 2 weeks, frequently as the effect of procedure-related issues; the incidence of mortality after 30 days did not stop, but continued at a steady state of 0.9% per month during the first year, driven primarily by comorbidities unrelated to aortic valve disease.
Recent developments in the field of device technology have led to a renewed interest in transcatheter techniques for aortic valve disease. TAVI using stent-based prostheses has been performed by number of operators in different centers as an alternative to conventional surgery for patients with unacceptable anticipated operative risk driven by age and comorbidities. However, the majority of TAVI reports from literature are limited by their small, single-center design, a limitation which also hampers the attempt to identify meaningful predictors of outcome. In addition, due to the novelty of the technique, the research to date has tended to focus on early outcomes, such as procedural success and 30-day mortality, while data on the durability and midterm outcome of TAVI remain sparse.
What we know about late outcomes with the balloon-expandable Edwards SAPIEN prosthesis is largely based on a recently published multicenter Canadian experience.10 The authors showed that TAVI with the Edwards SAPIEN device may be accomplished with 93.3% procedural success and 10.4% mortality at 30 days, a rate comparable to that predicted by surgical risk calculators. The actuarial survival rates were 76% and 64% at 1- and 2-year follow-up, and both procedural factors and cardiac or noncardiac comorbidities were associated with worse outcomes. These data added to the evidence provided by a single center study from Webb et al, reporting sustained functional improvement and hemodynamic benefit of TAVI with the Edwards SAPIEN prosthesis up to 1 year.7
On the other hand, data on late outcomes of TAVI between 30 days and 1 year with the self-expandable CoreValve Revalving System are even less. Grube et al reported their single center experience on 136 patients treated with 3 different generations of CoreValve device.8 With the third-generation (18-Fr) prosthesis currently in use (n=102), procedural success was obtained in 91.2% of patients, and 30-day mortality was 10.8%. Twelve-month follow-up was completed in 50 patients, with a mortality rate of 16%.8 To date, the large, multicenter, expanded evaluation registry has not disclosed data on late outcomes following TAVI.9 Adding to the limited information on midterm survival, difficulties arise when an attempt is made to identify the key predictors of operative and late mortality between 30 days and 1 year in patients with the CoreValve device. No study, in fact, has investigated the association between baseline/procedural factors and mortality in this setting.
This study highlights the fact that different causes may be called into question when analyzing the incidence of mortality within a short or late timeframe following the percutaneous procedure. Not surprisingly, 30-day mortality is strongly impacted by procedural complications. The need for emergency open-heart surgery conversion carries out by itself the highest risk, increasing the chance of death at 30 days approximately 39-fold. Other technique-related issues that weigh heavily on 30-day outcomes are conditions associated with hemodynamic instability, such as cardiac tamponade and major vascular access site complications. A history of prior valvuloplasty was also associated with operative mortality, most likely contributing to identify a high risk subset of patients with poorer baseline presentation.14
Despite the detrimental impact of procedural complications and poor baseline conditions on early outcome, we found a low 5.4% rate of 30-day mortality, which compares favorably with the 7% to 14% reported in earlier experiences with the third-generation CoreValve device4,8,9,11,15 and the 6.3% of patients treated with a transfemoral approach in the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) registry with the Edwards SAPIEN device.16 In these studies, the anticipated 30-day mortality predicted by the EuroSCORE ranged between 19% and 25%, similar to the 23% reported in the present experience. Therefore, it seems possible that patients in this series benefited from reduced fatal complications in line with procedural experience, development of bailout strategies to address technical-related issues and progress in postprocedural care. On the other hand, it should be noted that predictive scores such as EuroSCORE tend to overestimate the actual rates of mortality in patients with severe aortic valve stenosis treated percutaneously to a possibly larger extent than that observed in patients treated surgically. In our cohort, EuroSCORE showed a weak discriminative ability. Waiting for novel TAVI-specific predictive scores, including comorbidities not integrated in surgical risk calculators, such as porcelain aorta and frailty,17 a EuroSCORE cut-off around 20 could offer the best discriminative ability in terms of 30-day and 1-year mortality.
A permanent pacemaker was needed in 17.4% of cases at 30 days. This percentage is lower than that reported in other series of TAVI with the CoreValve prosthesis,18,–,20 possibly as the result of a lower prevalence of preexisting conduction disorders (eg, right bundle branch block) than that reported in those studies.
With regards to midterm outcomes, the 1-year mortality rate of 15.0% found in this study is similar to that reported on a small-scale basis by Grube et al.8 Differently from key predictors identified in the operative period, late predictors of mortality between 30 days and 1 year were generally related to baseline clinical comorbidities. In particular, histories of stroke or acute pulmonary edema were associated with almost 5- and 2-fold increased risks of late mortality. Both stroke and advanced heart failure are well-established predictors of poor outcome at follow-up.21,–,23 Consistently with previous studies, we also found chronic kidney disease to be independently associated with worse outcomes in patients undergoing TAVI.10,24 Multiple factors may account for the mechanism linking chronic kidney disease and late mortality in TAVI patients.25 It is important to note that TAVI, by itself, has been associated with a 12% to 57% incidence of postprocedural acute kidney injury24,26 and a 2% to 4% incidence of stroke.7,8,10 This combination of findings provides some support for the conceptual premise that prognostic factors traditionally considered high-risk criteria for surgery should be also taken into account when estimating the long-term benefit/risk ratio of TAVI, especially in patients with hemodynamic instability, cerebrovascular disease, or advanced renal impairment.
The durable efficacy of TAVI up to 1 year has been suggested in surviving patients treated with both the commercially available devices.7,8 We confirmed these data showing that 1 year after TAVI the vast majority of patients maintain the downgrade to a lower NYHA functional class observed acutely after the procedure, in line with parallel sustained benefits observed in terms of peak and mean pressure gradient reductions with the device in place. Paravalvular and valvular aortic regurgitations were absent or mild in the majority of cases both at 30 days and 1 year. A study recently suggested that paravalvular leak ≥2+ is associated with a significantly increased risk of in-hospital mortality, but this finding was not replicated in our study.27 However, in our series, paravalvular leak ≥2+ was identified as an independent predictor of mortality between 30 and 1 year, thus highlighting a role for suboptimal procedural results leading to hemodynamic instability in affecting midterm clinical outcomes.
Study Limitations
Regarding the present study, a number of important limitations need to be noted. The most important limitation lies in the fact that we reported results obtained in a nonrandomized fashion with the lack of comparative arms of patients with severe aortic stenosis treated with surgery or medical therapy alone. Although high-quality randomized data on TAVI versus surgical aortic valve replacement are still lacking, the superiority of TAVI versus medical therapy has been recently demonstrated.28
Another caveat of our study is that follow-up is ongoing, so ≥1 year clinical follow-up was not available in a small (≈6%) proportion of patients. Finally, differences in TAVI experience among the participating centers have the potential to bias the results. However, no significant differences in the rates of 30-day and 1-year mortality were seen in this study after stratification by the median of cases entered in the database by each center.
Conclusions
This large multicenter experience demonstrates that TAVI with the CoreValve Revalving System is associated with early and sustained clinical and hemodynamic benefits in patients with severe aortic stenosis at high risk for surgery-related mortality. Thirty-day mortality is acceptably low when compared to the anticipated risk calculated by means of the EuroSCORE and is strongly associated with the occurrence of procedural complications. Late mortality continues to occur after 30 days from TAVI up to 1 year, primarily as the effect of postprocedural moderate to severe paravalvular aortic regurgitation and nonvalve related comorbidities such as cerebrovascular disease, chronic kidney disease, and heart failure.
Sources of Funding
Supported by Endotech.
Disclosures
Gianpaolo Ussia, Angelo Ramondo, Anna Sonia Petronio, Federica Ettori, and Gennaro Santoro are physician proctors for Medtronic Inc. None of the other authors have conflicts of interest to report.
Footnotes
-
Continuing medical education (CME) credit is available for this article. Go to http://cme.ahajournals.org to take the quiz.
- Received February 16, 2010.
- Accepted October 26, 2010.
- © 2011 American Heart Association, Inc.
References
Clinical Perspective
Transcatheter aortic valve implantation using the self-expandable CoreValve prosthesis was performed in 663 patients with severe aortic stenosis and high surgical risk in 14 Italian centers. Procedural success was 98% and intraprocedural mortality was 0.9%. The mortality rates at 30 days and 1 year were 5.4% and 15.0%, respectively. Early mortality was acceptably low compared with the anticipated risk calculated by means of the EuroSCORE and was strongly associated with the occurrence of procedural complications. Late mortality continued to occur from 30 days to 1 year after TAVI, primarily as the effect of postprocedural paravalvular aortic regurgitation ≥2+ and nonvalve related comorbidities such as cerebrovascular disease, chronic kidney disease and heart failure. Clinical and hemodynamic benefits observed acutely after TAVI were sustained at 1 year.
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