Skip main navigation

Patients at Intermediate Surgical Risk Undergoing Isolated Interventional or Surgical Aortic Valve Implantation for Severe Symptomatic Aortic Valve Stenosis

One-Year Results From the German Aortic Valve Registry
Originally publishedhttps://doi.org/10.1161/CIRCULATIONAHA.117.033048Circulation. 2018;138:2611–2623

Abstract

Background:

Transcatheter aortic valve replacement (TAVR) is increasingly being used for treatment of severe aortic valve stenosis in patients at intermediate risk for surgical aortic valve replacement (SAVR). Currently, real-world data comparing indications and clinical outcomes of patients at intermediate surgical risk undergoing isolated TAVR with those undergoing SAVR are scarce.

Methods:

We compared clinical characteristics and outcomes of patients with intermediate surgical risk (Society of Thoracic Surgeons score 4%–8%) who underwent isolated TAVR or conventional SAVR within the prospective, all-comers German Aortic Valve Registry.

Results:

A total of 7613 patients at intermediate surgical risk underwent isolated TAVR (n=6469) or SAVR (n=1144) at 92 sites in Germany between 2012 and 2014. Patients treated by TAVR were significantly older (82.5±5.0 versus 76.6±6.7 years, P<0.001) and had higher risk scores (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 21.2±12.3% versus 14.2±9.5%, P<0.001; Society of Thoracic Surgeons score: 5.6±1.1 versus 5.2±1.0, P<0.001). Multivariable analyses revealed that advanced age, coronary artery disease, New York Heart Association class III/IV, pulmonary hypertension, prior cardiac decompensation, elective procedure, arterial occlusive disease, no diabetes mellitus, and a smaller aortic valve area were associated with performing TAVR instead of SAVR (all P<0.001). Unadjusted in-hospital mortality rates were equal for TAVR and SAVR (3.6% versus 3.6%, P=0.976), whereas unadjusted 1-year mortality was significantly higher in patients after TAVR (17.5% versus 10.8%, P<0.001). After propensity score matching, the difference in 1-year mortality between patients with TAVR and SAVR was no longer significant (17.1% versus 15.7%, P=0.59).

Conclusions:

Patients at intermediate risk undergoing TAVR differ significantly from those treated with SAVR with regard to age and baseline characteristics. Isolated TAVR and SAVR were associated with an in-hospital mortality rate of 3.6%. In the propensity score analysis, there was no significant difference in 1-year mortality between patients with TAVR and SAVR.

Clinical Perspective

What Is New?

  • This analysis from a German all-comers population showed that the majority of patients at intermediate risk were treated with transcatheter aortic valve replacement (TAVR) rather than surgical aortic valve replacement between 2012 and 2014.

  • Multivariable analysis revealed that patients in a worse clinical and functional condition and at higher age were more likely to be treated by TAVR.

  • The present analysis suggests that patients at intermediate surgical risk may undergo either isolated TAVR or surgical aortic valve replacement in a real-world setting at an in-hospital mortality rate of 3.6%.

  • In a propensity score analysis, 1-year mortality rates of TAVR and surgical aortic valve replacement were not statistically different in a real-world population at intermediate surgical risk.

What Are the Clinical Implications?

  • In accordance with the results from randomized controlled trials, this large registry analysis suggests that both TAVR and surgical aortic valve replacement are reasonable treatment options in a real-world population with aortic stenosis and intermediate surgical risk.

  • An individualized therapeutic decision by a dedicated heart team that is based on the clinical characteristics of the patient and the potential procedural risks may be the best approach for the group of patients at intermediate surgical risk.

Introduction

Editorial, see p 2624

In daily clinical practice, transcatheter aortic valve replacement (TAVR) is increasingly used in patients at intermediate risk with severe aortic stenosis.1–8 The PARTNER II trial (Placement of Aortic Transcatheter Valves Trial II) and the SURTAVI study (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) have provided evidence on the safety and efficacy of TAVR in an intermediate-risk population.9,10 Such randomized controlled trials, however, are known to cover highly selected patients who do not fully represent real-world populations. For instance, PARTNER II excluded patients with severe comorbidities such as advanced renal impairment or severe ventricular dysfunction. Large prospective registries, including the German Aortic Valve Registry (GARY), are important additional tools that provide information on the short- and longer-term safety and efficacy of a treatment strategy in a real-world population. The purpose of the present study was to compare clinical characteristics and outcomes of an all-comers clinical population at intermediate surgical risk undergoing isolated TAVR or surgical aortic valve replacement (SAVR) for severe aortic stenosis.

Methods

The data, analytic methods, and study materials will be available to other researchers on request from the authors for purposes of reproducing the results or replicating the procedure.

Registry Design and Ethical Considerations

GARY is a nationwide, prospective, multicenter registry initiated in 2010 to monitor the safety and efficacy of all invasive aortic valve procedures in Germany. The registry is based on an all-comers design with voluntary participation; lack of informed consent by the patient is the only exclusion criterion. Clinical follow-up is obtained at 30 days and 1, 3, and 5 years after the index aortic valve procedure. Initial ethical approval for GARY was obtained from Freiburg University, and patient written informed consent was obtained preprocedurally. The registry design has been previously described in detail.5,11,12

Study Population

The present study focuses on patients treated with isolated TAVR or SAVR between January 2012 and December 2014. We examined 22.4% (13 182/58 950) of all patients included in the registry who were at intermediate surgical risk as defined by a Society of Thoracic Surgeons (STS) score of 4% to 8%. Of these patients, 64.0% (8437/13 182) were treated by TAVR and 36% (4745/13 182) were treated by SAVR. Excluded from the present analysis were patients who underwent combined procedures (SAVR and coronary artery bypass grafting: n=13 643 or TAVR and percutaneous coronary intervention: n=383), patients who underwent other combined procedures (such as SAVR and surgical mitral valve repair or TAVR and mitral valve intervention), patients with porcelain aorta, poor prognosis for severe comorbidities, aortic aneurysm, severe left main disease (≥50% stenosis), isolated aortic valve regurgitation, or active endocarditis, patients with cardiopulmonary resuscitation within 48 h prior to the index procedure and patients with any other combined procedure. Thus, from the entire study population of 7613 patients, 6469 who underwent TAVR and 1144 who underwent SAVR were included in this analysis (Figure 1).

Figure 1.

Figure 1. Selection of patients for the underlying analysis. CABG indicates coronary artery bypass grafting; PCI, percutaneous coronary intervention; SAVR, surgical aortic valve replacement; STS, Society of Thoracic Surgeons; and TAVR, transcatheter aortic valve replacement.

The completeness of follow-up data at 1-year survival was 96.9% (6266/6469) in patients undergoing TAVR and 97.7% (1118/1144) in patients undergoing SAVR. Patients who were event-free at last contact were deemed alive.

Aortic Valve Prosthesis

Patients treated with all licensed TAVR devices and all types of surgical biological aortic valve prostheses were eligible for inclusion in GARY. The vast majority of patients were treated with 2 transcatheter aortic valve devices: the Edwards SAPIEN valve prosthesis, 48.1% (SAPIEN XT, 23.9%; SAPIEN XT TA, 11.7%; SAPIEN 3, 6.4%; Edwards Lifesciences) or the Medtronic CoreValve prosthesis, 30.0% (Medtronic). All other interventional prostheses were used at a frequency of <5% each.

In the SAVR patient group, 25.7% received a Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, 11.5% a St Jude Medical Trifecta prosthesis, 11.2% a Carpentier-Edwards Perimount Magna Ease Pericardial Aortic Bioprosthesis, 10.7% a St Jude Medical Epic Supra Stented Porcine Bioprosthesis, 8.9% a Medtronic Hancock II Porcine Bioprosthesis, and 5.5% a Mitroflow Pericardial Bioprosthesis (Sorin). All other types of surgical aortic valve prostheses were implanted at a rate of <5% each.

Procedural Characteristics and Clinical End Points

The primary end point was the outcome of patients at intermediate risk treated with TAVR or SAVR in Germany. Furthermore, procedural characteristics and rates of adverse events (eg, myocardial infarction, stroke, acute kidney injury, permanent pacemaker implantation, bleeding or vascular complications, and aortic valve regurgitation ≥ grade II) were analyzed. In this study, all clinical end points were predefined and analyzed according to previous reports.11

Statistical Analysis

All statistical analyses were performed using the SPSS statistical package version 22.0.0 (IBM Corp). Continuous variables were described using mean and SD. Categorical variables were described using absolute numbers and percentages. Univariate comparisons between patients who underwent SAVR or TAVR were performed using the χ2 test or Fisher exact test for categorical parameters and the Mann-Whitney U test for continuous variables. Kaplan-Meier curves were derived to assess survival during the 12-month postprocedural period and were compared by log-rank test. Logistic regression analysis was performed to identify clinical variables associated with the performance of TAVR rather than SAVR. All baseline parameters that were significantly associated (P<0.05) with the parameter SAVR/TAVR in univariate analysis were used as independent variables in the model, including age, sex, prior cardiac decompensation, moderate to severe tricuspid valve regurgitation, moderate to severe mitral valve regurgitation, coronary artery disease, New York Heart Association class III/IV, body mass index <22 and >35, prior percutaneous coronary intervention, prior myocardial infarction, prior pacemaker implantation, prior cardioverter-defibrillator implantation, atrial fibrillation, chronic renal impairment, left ventricular ejection fraction <35% and >50%, preprocedural aortic valve area, preprocedural mean aortic pressure gradient, diabetes mellitus, arterial hypertension, neurological dysfunction (central, modified Rankin scale ≥2), prior cardiac surgery, cardiogenic shock, pulmonary hypertension, arterial occlusive disease (symptomatic peripheral arterial occlusive disease, carotid artery disease with stenosis ≥50%, aortic aneurysm >5 cm, or other arterial occlusive disease), and whether or not the procedure was elective.

Propensity score analyses were used to reduce confounding in the statistical comparison of 1-year mortality of patients after SAVR and TAVR. The propensity scores were calculated by using the above-mentioned logistic regression model. Resulting propensity scores were used as estimators of the probability of undergoing a TAVR procedure. One-year mortality rates and estimators of the differences between treatment groups were determined for propensity score quintiles.13 Quintiles were summarized by direct standardization, and stratified estimators describing adjusted mortality rates for patients who underwent SAVI/TAVR were determined. In addition, a propensity score–matched analysis was performed based on the nearest-neighbor approach.14 Differences were interpreted as being significant for P values <0.05. All P values were derived from 2-tailed tests. Data management and descriptive parts of the statistical analyses were performed by the BQS Institute for Quality and Patient Safety, Duesseldorf, Germany. The authors had full access to and take full responsibility for the data integrity. All authors have read and agreed to the manuscript as written.

Results

Population of Patients at Intermediate Risk Undergoing TAVR or SAVR in Clinical Practice

Among the study population of 7613 patients, 6469 underwent isolated TAVR (85%) and 1144 underwent isolated SAVR (15%). In 78.9% (5101/6469) of the patients treated by TAVR, a transvascular access was used, whereas a transapical access was used in 21.1% (1368/6469). In the transvascular TAVR group, the majority of patients were treated by using a transfemoral access (98.3%), whereas only a minority of patients (1.7%) were treated by using a different vascular access such as transaortal or transaxillary. Patients treated by either TAVR or SAVR had major differences in baseline characteristics and risk profiles (Table 1). The decision to perform TAVR was made by an interdisciplinary heart team in 93.3% of all patients. Documented reasons for performing TAVR in patients at intermediate surgical risk were age (82.5%), frailty (50.8%), patient request (26.2%), and malignant diseases (0.8%) (Table 2). Of all TAVR procedures, 87.3% were elective, and, of all SAVR procedures, 77.2% were elective, with a significantly higher percentage of urgent or emergent procedures in the SAVR group (22.8% versus 12.7%, P<0.001). There were major differences in the proportion of patients with intermediate surgical risk who were treated by TAVR between the 92 sites contributing to the registry, ranging from 36.1% to 100% (Figure 2).

Table 1. Demographics and Comorbidities of Patients at Intermediate Surgical Risk Treated by TAVR or SAVR From 2012 to 2014 Within GARY (Unadjusted Data)

Demographics and ComorbiditiesSAVRTAVRP Value
n=1144n=6469
Demographics
 Age76.6±6.782.5±5.0<0.001
 Female739 (64.6)4063 (62.8)0.247
 Body mass index28.9±6.527.0±5.0< 0.001
 NYHA III–IV868 (75.9)5623 (86.9)< 0.001
Cardiac comorbidities
 Hypertension1042/1139 (91.5)5687/6380 (89.1)0.017
 Diabetes mellitus596/1143 (52.1)2302/6461 (35.6)<0.001
 s/p myocardial infarction98 (8.6)827 (12.8)<0.001
 s/p percutaneous coronary intervention152 (13.3)1770 (27.4)<0.001
 Permanent pacemaker89/1132 (7.9)762/6368 (12.0)<0.001
 Atrial fibrillation284 (24.8)2114 (32.7)<0.001
 Mitral regurgitation ≥ grade II176/1122 (15.7)1793/6320 (28.4)<0.001
 Tricuspid valve insufficiency ≥2°80/1097 (7.3)1167/6232 (18.7)<0.001
 Pulmonary hypertension98/1124 (8.7)1242/6332 (19.6s)<0.001
 Previous cardiac surgery157/1142 (13.7)1144/6456 (17.7)0.001
 Prior balloon valvuloplasty8/1078 (0.7)173/6327 (2.7)<0.001
 Ejection fraction, mean, %54.4±13.652.8±13.2<0.001
 s/p cardiac decompensation267/1137 (23.5)2425/6288 (38.6)<0.001
 Cardiogenic shock (≤48 h)28/1137 (2.5)94/6435 (1.5)0.014
 Aortic valve area before procedure, mean, cm20.74±0.290.69±0.25<0.001
 Aortic pressure gradient, mean, mm Hg46.3±16.543.7±16.5<0.001
Extracardiac comorbidities
 Neurological dysfunction (central, modified Rankin scale ≥2)19/1143 (1.7)180/6464 (2.8)0.028
 Lung disease387/1144 (33.8)1438/6466 (22.2)<0.001
 Chronic obstructive pulmonary disease222/1144 (19.4)848/6466 (13.1)<0.001
 Renal replacement therapy55 (4.8)94 (1.5)<0.001
 Creatinine >2 mg/dL72/1058 (6.8)266/6350 (4.2)<0.001
 Peripheral arterial vascular disease115/1141 (10.1)1131/6462 (17.5)<0.001
Risk scoring
 Log EuroSCORE I14.2±9.521.2±12.3<0.001
 STS score5.2±1.05.6±1.1<0.001
 German AV score4.4±2.76.6±3.6<0.001

Values indicate mean±SD or n (%). For a different total n than the totals listed in the column headers, this is indicated by n/total n (%). AV indicates aortic valve; EuroSCORE, European System for Cardiac Operative Risk Evaluation; GARY, German Aortic Valve Registry; NYHA, New York Heart Association; SAVR, surgical aortic valve replacement; s/p, status post; STS, Society of Thoracic Surgeons; and TAVR, transcatheter aortic valve replacement.

Table 2. Medical Indications and Procedural Characteristics of Patients at Intermediate Surgical Risk Undergoing SAVR or TAVR.

CharacteristicsSAVRTAVRP Value
n=1144n=6469
Clinical factors for TAVR indication
 Age5334 (82.5)
 Frailty3286 (50.8)
 Requested by patient1695 (26.2)
 Malignancy49 (0.8)
 Heart team decision6037 (93.3)
Procedural characteristics
 TAVR procedures
  Transvascular access5101 (78.9)
   Transfemoral5016 (77.5)
   Transaortal45 (0.7)
   Transaxillary29 (0.5)
   Other transvascular access11 (0.2)
 Transapical access1368 (21.1)
   Elective883 (77.2)5645 (87.3)<0.001
   Urgent/emergent261 (22.8)824 (12.7)<0.001
   Procedural duration, mean, min169.4±57.083.7±41.7<0.001
   Radiation, mean, min17.6±28.2
   Contrast, mean, mL141.8±78.1
   General anesthesia4025 (62.2)
   Prosthesis pressure gradient ≥15 mm Hg (postimplantation)259/738 (35.1)708 (15.1)<0.001
Periprocedural complications
 Pericardial tamponade0 (0.0)56 (0.9)0.002
 Conversion to open-heart surgery57 (0.9)
 Vascular complication4 (0.3)206 (3.2)<0.001

Values indicate mean±SD or n (%). For a different total n than the totals listed in the column headers, this is indicated by n/total n (%). SAVR indicates surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.

Figure 2.

Figure 2. Proportion of patients at intermediate risk treated by TAVR at each of the 92 sites in relation to all patients at intermediate risk at that site. TAVR indicates transcatheter aortic valve replacement.

In-Hospital Clinical Outcome

In-hospital mortality was 3.6% (41/1144) in patients after TAVR and 3.6% (233/6469) in patients following SAVR (P=0.976) (Table 3). The rate of major stroke during in-hospital course was 1.4% for TAVR versus 1.0% for SAVR (P=0.201). New-onset pacemaker or cardioverter-defibrillator implantation (18.1% versus 4.0%, P<0.001), vascular complications (7.8% versus 0.9%, P<0.001), and aortic valve regurgitation ≥ grade II (4.3% versus 0.5%, P<0.001) were more frequent after TAVR. In contrast, there was a significantly higher rate of postprocedural bleeding with a need for transfusion (22.1% versus 59.6%, P<0.001) or reintervention (1.0% versus 4.7%, P<0.001) and temporary dialysis related to the procedure (1.8% versus 6.5%, P<0.001) among patients who underwent SAVR (Table 3).

Table 3. In-Hospital Outcome and Complication Rates of Patients at Intermediate Surgical Risk Treated by TAVR or SAVR (Unadjusted Data)

Outcome and Complication RatesSAVRTAVRP Value
n=1144n=6469
In-hospital mortality
 In-hospital mortality41 (3.6)233 (3.6)0.976
In-hospital complications
 Stroke (major)11 (1.0)93 (1.4)0.201
 TIA (minor stroke)10 (0.9)59 (0.9)0.901
 Myocardial infarction9 (0.8)20 (0.3)0.016
 New-onset atrial fibrillation71/842 (8.4)239/4239 (5.6)0.002
 New pacemaker/ICD42/1043 (4.0)1014/5606 (18.1)<0.001
 Bleeding ≥2 RBC units675/1132 (59.6)1412/6389 (22.1)<0.001
 Vascular complications10 (0.9)505 (7.8)<0.001
 New-onset dialysis75 (7.1)131 (2.0)<0.001
 Temporary69/1058 (6.5)117/6350 (1.8)
 Chronic6/1058 (0.6)14/6350 (0.2)
 Postoperative stay in ICU, mean, days4.6±8.03.2±5.0<0.001
 Postoperative hospital stay, mean, days13.6±10.311.3±9.9<0.001
 Aortic valve regurgitation ≥ grade II5/ 055 (0.5)236/6172 (4.3)<0.001
 Bleeding/hematoma54 (4.7)67 (1.0)<0.001
 Low cardiac output3 (0.3)3 (0.0)0.016
 Tamponade20 (1.7)16 (0.2)<0.001
 Wound infection/mediastinitis7 (0.6)3 (0.0)<0.001

Values indicate mean±SD or n (%). For a different total n than the totals listed in the column headers, this is indicated by n/total n (%). ICD indicates implantable cardioverter-defibrillator; ICU, intensive care unit; RBC, red blood cell; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement; and TIA, transient ischemic attack.

Clinical Outcome at 1-Year Follow-Up

The mortality rate at 1-year follow-up was 17.5% (1131/6469) after TAVR in comparison with 10.8% (123/1144) after SAVR (P<0.001) (Table 4). Patients treated by transvascular TAVR had a 1-year mortality rate of 16.5% in comparison with 21.1% in patients treated by the transapical approach (P=0.001). Using product-limit estimations for comparison of all-cause 1-year mortality rates of all TAVR patients (transvascular and transapical) with SAVR (Figure 3A) or transvascular TAVR with SAVR (Figure 3B), we found a significantly higher mortality rate in patients treated by TAVR than by SAVR (P<0.001) (Table 4).

Table 4. Clinical Outcome and Complication Rates in Survivors After SAVR or TAVR at 1-Year Follow-Up (Unadjusted Data)

Outcome and Complication RatesSAVRTAVRP Value
n=1144n=6469
Mortality at 1-year follow-up
 One-year mortality rate123/1144 (10.8)1131/6469 (17.5)<0.001
  Transvascular access843/5101 (16.5)
   Transfemoral815/5016 (16.2)
   Transaortal18/45 (40)
   Transaxillary7/29 (24.1)
   Other transvascular access3/11 (27.3)
 Transapical access288/1368 (21.1)
Complication rates at 1-year follow-up
 Myocardial infarction4/820 (0.5)28/4138 (0.7)0.537
 New pacemaker/ICD (implanted either during hospital stay or within 1-year follow-up)37/746 (5.0)726/3594 (20.2)<0.001
 Stroke (major)13/821 (1.6)73/4145 (1.8)0.721
 TIA (minor stroke)15/821 (1.8)59/4145 (1.4)0.383
 Rehospitalization298/819 (36.4)1546/4139 (37.4)0.601
  Because of complication related to the aortic valve intervention45/819 (5.5)137/4139 (3.3)0.004
  Because of heart/circulatory problems126/819 (15.4)639/4139 (15.4)0.754
 NYHA0.063
  I278/811 (34.3)1317/4078 (32.3)
  II300/811 (37.0)1441/4078 (35.3)
  III198/811 (24.4)1177/4078 (28.9)
  IV35/811 (4.3)143/4078 (3.5)

Values indicate n (%). For a different total n than the totals listed in the column headers, this is indicated by n/total n (%). ICD indicates implantable cardioverter-defibrillator; NYHA, New York Heart Association; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement; and TIA, transient ischemic attack.

Figure 3.

Figure 3. One-year Kaplan-Meier survival curves of patients at intermediate surgical risk treated by TAVR or SAVR (unadjusted data).A, One-year Kaplan-Meier survival curves of patients at intermediate surgical risk treated by transvascular and transapical TAVR or SAVR (total population, unadjusted data). B, One-year Kaplan-Meier survival curves of patients at intermediate surgical risk treated by transvascular TAVR (TAVR-TV) versus transapical TAVR (TAVR-TA) versus SAVR (unadjusted data). SAVR indicates surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.

Multivariable Analysis of Predictors of Performing TAVR Instead of SAVR

Multivariable analysis determined that the following clinical variables were associated with the performance of TAVR instead of SAVR: increased age per year, coronary artery disease, New York Heart Association class III/IV, pulmonary hypertension, prior cardiac decompensation, elective procedure, arterial occlusive disease, no diabetes mellitus, and a smaller aortic valve area before the procedure (P<0.001). In addition, a central neurological dysfunction (modified Rankin scale ≥2, P=0.001), a lower mean aortic pressure gradient before the procedure (P=0.001), mitral valve regurgitation ≥ grade II (P=0.01), atrial fibrillation (P=0.01), and no arterial hypertension (P=0.02) were also associated with TAVR (Table 5).

Table 5. Clinical Factors Associated With the Performance of TAVR in Multivariable Analysis

VariableWaldOdds Ratio95% CIP Value
 Increased age per year3461.2111.188–1.236<0.001
 Coronary artery disease120.31.9921.662–2.387<0.001
 NYHA class III/IV542.4101.908–3.049<0.001
 Pulmonary hypertension43.82.7962.062–3.792<0.001
 Prior cardiac decompensation372.0461.624–2.576<0.001
 Elective procedure28.32.0551.576–2.680<0.001
 Arterial occlusive disease15.81.6701.230–2.146<0.001
 No diabetes mellitus12.91.4481.183–1.773<0.001
 Smaller aortic valve area (before procedure)10.51.7631.251–2.4840.001
 Neurological dysfunction (central, modified Rankin scale ≥2)10.33.5341.647–7.6330.001
 Lower mean aortic pressure gradient10.31.0091.003–1.0140.001
 Mitral valve regurgitation ≥grade II*6.61.3991.082–1.8080.01
 Atrial fibrillation6.21.3301.063–1.6640.013
 No arterial hypertension5.11.5571.059–2.2870.024
 Prior cardiac surgery3.41.3560.982–1.8720.064

NYHA indicates New York Heart Association; and TAVR, transcatheter aortic valve replacement.

*Patients in whom 2 heart valves were operated on were excluded for the present analysis.

Propensity Score Analysis of 1-Year Mortality

Patients were stratified according to their individual propensity score and allocated to quintiles representing their probability of being treated by TAVR instead of SAVR. Quintile 1 represents patients with the lowest probability of undergoing TAVR and consequently the lowest mortality rate. In general, the 1-year mortality rate increased in both treatment groups with increasing probability of undergoing TAVR. In quintiles 1 to 3, reflecting a low to moderate probability of undergoing TAVR instead of SAVR, 1-year mortality was proportionally higher in patients treated by TAVR; however, this difference was only significant in the first quintile (Tables 6 and 7). In contrast, patients with a high probability of undergoing TAVR instead of SAVR (quintiles 4–5) had somewhat higher 1-year mortality rates (P=not significant). After summarizing the propensity scores by using a stratified estimator, we did not detect any significant difference in 1-year mortality between TAVR (transvascular and transapical) and SAVR (17.1% versus 15.7%, P=0.59) or between transvascular TAVR and SAVR (16.1% versus 15.5%, P=0.82) (Tables 6 and 7).

Table 6. One-Year Mortality Distribution by Propensity Score Quintile in Patients After TAVR (Transvascular and Transapical) or SAVR

Stratified Estimate for Whole PopulationSAVRTAVRDifference (95% CI)P Value
Counts, n/NMortality, %Counts, n/NMortality, %
Quintile 169/7349.40113/82613.68+4.28 (+1.13 to +7.43)0.012
Quintile 227/23211.64199/125815.82+4.18% (–0.41 to +8.77)0.106
Quintile 312/10811.11217/135416.03+4.92% (–1.33 to +11.16)0.171
Quintile 410/4422.73259/146017.74–4.99% (–17.52 to +7.55)0.430
Quintile 54/1723.53329/148822.11–1.42% (–21.69 to +18.85)0.939
Stratified estimate15.717.11.4% (–3.7 to +6.4)0.59

SAVR indicates surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.

Table 7. One-Year Mortality Distribution by Propensity Score Quintile in Patients After Transvascular TAVR or SAVR

Stratified Estimate for Whole PopulationSAVRTAVR (Transvascular Only)Difference (95% CI)P Value
Counts, n/NMortality, %Counts, n/NMortality, %
Quintile 169/7349.4090/66413.55+4.15 (+0.80 to +7.51)0.019
Quintile 227/23211.64141/94514.92+3.28 (–1.43 to +7.99)0.208
Quintile 312/10811.11159/106814.89+3.78 (–2.52 to +10.08)0.278
Quintile 410/4422.73190/115216.49–6.23 (–18.80 to +6.33)0.301
Quintile 54/1723.53252/120420.93–2.60 (–22.89 to +17.70)0.842
Stratified estimate15.516.10.6% (–4.4 to 5.6)0.82

SAVR indicates surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.

Matched Propensity Score Analysis of 1-Year Mortality

In the cohort of 661 propensity score–matched patients at intermediate surgical risk, transvascular TAVR and SAVR were associated with similar 1-year mortality rates (transvascular TAVR: 12.8% versus SAVR: 12.1%, P=0.76). Patients treated by TAVR by using a transapical access had significantly higher 1-year mortality rates than patients treated by SAVR or by transvascular TAVR (transapical TAVR versus SAVR: 22.1% versus 12.1%, P=0.001; transapical versus transvascular TAVR: 22.1% versus 12.8%, P=0.003; Figure 4). We performed additional subanalyses to exclude a possible bias in 1-year mortality attributable to site volume or to the different proportional use of TAVR between the participating sites. After exclusion of all sites with 100% TAVR use, no significant difference was found in 1-year mortality between TAVR and SAVR in comparison with the initial propensity-matched analysis (Figures IA, IB, II, and III in the online-only Data Supplement). There was also no difference in 1-year mortality of sites with >80% TAVR use versus that of sites with <80% TAVR use (Figures IVA, IVB, and V in the online-only Data Supplement).

Figure 4.

Figure 4. One-year Kaplan-Meier survival curves depicting the propensity score–matched population treated by transvascular (TV) TAVR, transapical (TA) TAVR, and SAVR. SAVR indicates surgical aortic valve replacement; and TAVR, transcatheter aortic valve replacement.

Discussion

GARY provides a unique opportunity to evaluate all available catheter-based and surgical treatment options for aortic stenosis in a real-world setting. This analysis of a total of 7613 patients treated either by isolated TAVR or SAVR is the largest analysis of an intermediate-risk population reported to date. In the propensity score analysis of matched patients, there was no significant difference in 1-year mortality between TAVR and SAVR for the entire patient cohort.

In this German real-world population, the majority of patients at intermediate surgical risk were treated by TAVR rather than SAVR between 2012 and 2014. This finding is somewhat surprising considering that the PARTNER II trial demonstrating good results in patients at intermediate risk was not published until 2016. Based on our findings, treatment decisions by interdisciplinary heart teams were also based on a multitude of additional clinical factors that are not considered in surgical risk scores but are well known to influence patient outcome. This is in line with current guideline recommendations to consider additional individual and clinical factors that are not reflected in the available risk scores but appreciably influence outcome.15,16 Risk scores like the STS score or the EuroSCORE (European System for Cardiac Operative Risk Evaluation) were validated to predict short-term mortality after cardiac surgery in a selected patient population and show notable inaccuracies when transferred to a patient population undergoing TAVR, in particular over- or underestimation of a patient’s actual risk.6,8,17,18 In the present analysis, 50% of patients treated by TAVR at intermediate surgical risk were classified as frail. Frailty as a clinical condition needs to be characterized precisely, but no scores have been recommended by recent guidelines. Frailty previously was shown to be associated with higher morbidity and mortality rates of patients undergoing cardiac surgery or TAVR.7,19 Because frailty was only recorded in patients undergoing TAVR, our propensity model did not include frailty, which possibly biased the results of the propensity analysis against TAVR. The trend toward treating an increasing number of elderly patients at intermediate surgical risk by TAVR in daily practice is in accordance with several previous reports from clinical registries.1–4,9,10,20,21 We observed that GARY showed major differences in the proportion of patients at intermediate risk treated by TAVR between participating sites; our finding was similar to that of a recent analysis from an European Association of Percutaneous Cardiovascular Interventions survey that 45% of 301 interventional centers in Europe performed TAVR in patients at intermediate risk, showing large regional and institutional differences between participating sites.22

Clinical Populations From Randomized Controlled Trials and GARY

The TAVR subpopulation of GARY showed demographic and clinical characteristics that were similar to those of the PARTNER II trial cohort.23 Patients at intermediate risk in the recently published SURTAVI trial of TAVR with a self-expandable aortic valve prosthesis or SAVR were slightly younger than the patients in GARY and had a lower STS score.24 Nevertheless, both populations from PARTNER II and SURTAVI who underwent TAVR were the result of a distinct patient selection process, and, consequently, all comparisons of clinical outcome with results from GARY need to be made with caution. Because of major differences with regard to age, surgical risk scores, and baseline characteristics, the surgical subpopulations from PARTNER II and SURTAVI are not comparable to the SAVR patient group from GARY.

Clinical Outcome and Major Adverse Events

In our analyses, the unadjusted in-hospital mortality rate was the same (3.6%) for patients treated by TAVR or SAVR, whereas the 1-year mortality rate was 17.5% after TAVR and 10.8% following SAVR. The in-hospital mortality rate in our intermediate-risk TAVR cohort is in accordance with results from the PARTNER II trial, which reported a 30-day mortality rate of 3.9% in their TAVR group; in addition, the STS score of 5.8% and the mean age of 81.5±6.7 years were also comparable to our cohort from GARY (STS score, 5.6%; age, 82.5±5.0 years).23 The unadjusted 1-year mortality rate among patients undergoing TAVR in GARY was higher (17.5%) than in PARTNER II (12.3%), which is most likely because of a highly selected population in PARTNER II. In patients treated by SAVR, unadjusted data from GARY showed lower rates of in-hospital (3.6%) and 1-year mortality (10.8%) than PARTNER II (30-days, 4.1%; 1-year, 12.9%). This can also be explained by major differences in baseline characteristics and risk profile between the groups. Thus, the results from the 2 SAVR groups cannot be compared.23 The lower 30-day (2.2%) and 1-year (6.7%) mortality rates in SURTAVI can mainly be explained by a lower STS score and a younger patient population.24

Unadjusted 1-year mortality was significantly higher in patients after transvascular TAVR than after SAVR in our study. However, product limit estimator analysis showed congruent mortality rates after TAVR and SAVR within the first 60 days after treatment (Figure 3B). Not until after 60 days did patients treated by transvascular TAVR have higher mortality rates than those who underwent SAVR (Figure 3B). This finding underlines the differences in baseline characteristics between the underlying populations that possibly led to higher mortality in patients treated by TAVR. Consequently, procedure-related differences between TAVR and SAVR do not seem to play an important role in mortality within the first 2 months.

Multivariable Analysis/Propensity Score Analysis

Our data reflect everyday clinical practice and a reasonable selection of patients for TAVR or SAVR by a heart team. As such, the multivariable analysis identified a worse clinical condition and more advanced aortic valve disease as clinical factors associated with performing TAVR rather than SAVR.

To adjust for baseline characteristics and to reduce confounding, we additionally performed a propensity score analysis. No significant differences in 1-year mortality were observed for patients undergoing TAVR and SAVR. In a second step, propensity score matching was performed by comparing the clinical outcomes of 661 patients with similar propensity scores (similar probability of receiving a TAVR). Transvascular TAVR and SAVR were associated with similar 1-year mortality rates (12.8% versus 12.1%, P=0.76) (Figure 4), which were similar to all-cause 1-year mortality rates from PARTNER II (TAVR: 12.3% versus SAVR: 12.9%, P=0.69).23 The SURTAVI trial reported lower all-cause 1-year mortality rates than our results for GARY (TAVR: 6.7% versus SAVR: 6.8%), which might be primarily attributable to differences in risk scores and baseline characteristics.24

Our results are also in accordance with 3 smaller observational studies using propensity score matching, all of which found no significant differences in 1-year mortality between TAVR and SAVR in an intermediate-risk population.25–27

Clinical Implications

Taking into account the differences in complication rates between TAVR and SAVR, an individualized evaluation of a patient’s procedural risk by a dedicated heart team with subsequent treatment allocation may be the best approach. One should bear in mind, however, that even the most recent TAVR trials did not include the latest state-of-the-art technology. In the meantime, new prostheses (such as the Edwards SAPIEN 3 transcatheter heart valve and the CoreValve Evolut R prosthesis) have shown a further reduction in relevant complication rates.28,29 Long-term data for TAVR (>10 years) are not yet available.

Conclusions

This analysis of a large, real-world population shows comparable 1-year mortality in patients at intermediate risk treated by TAVR or SAVR. An individualized therapeutic decision by a dedicated heart team based on a patient’s clinical situation, relevant comorbidities, and individual procedural risk may currently be the best approach for patients with intermediate surgical risk.

Limitations

There are some limitations to this study. GARY is performed on a voluntary basis for all participating institutions, and for the patients, as well. Therefore, reliable data concerning the completeness of procedures, and the patients, as well, are not available. Nevertheless, we believe that the relatively large number of patients included in this registry from 92 sites is a solid basis for this analysis and enables a realistic survey of invasive aortic valve treatment in patients at intermediate surgical risk in Germany today. The nature of the study is exploratory and the findings need to be interpreted with caution, because confounding factors may have affected the outcome. The TAVR and SAVR populations of GARY differed markedly. Consequently, even the most accurately performed propensity score analysis is not able to compensate for all possible confounders, especially if they are neither detected nor documented. In addition, our propensity score–matched cohort represents ≈18% of the total intermediate-risk population only; the need for exclusion of a majority of patients underlines the difficulty in comparing 2 vastly different patient groups. In our analyses, all patients were stratified retrospectively into different groups of surgical risk according to their STS score, which is supposedly the most reliable score available. All available surgical risk scores, however, are known to be imprecise, especially when applied to a TAVR patient population.6,30–32 The focus on surgical risk scores does not take other important clinical factors (eg, frailty) into account that possibly limit a patient’s prognosis. These factors might have influenced the treatment allocation of the heart team and possibly have had a relevant impact on short- and long-term clinical outcome. In GARY, frailty was only recorded in patients treated by TAVR. This represents an important limitation in comparing the 2 treatment groups and possibly biased our propensity model against TAVR. Because of the lack of uniform neurological adjudication in the registry, neurological events are possibly underestimated.

Footnotes

*Drs Werner and Zahn contributed equally.

Sources of Funding, see page 2621

https://www.ahajournals.org/journal/circ

The online-only Data Supplement is available with this article at https://www.ahajournals.org/doi/suppl/10.1161/CIRCULATIONAHA.117.033048.

Nicolas Werner, MD, Medizinische Klinik B, Klinikum Ludwigshafen, Bremserstraße 79, 67063 Ludwigshafen, Germany. Email

References

  • 1. Eggebrecht H, Mehta RH. Transcatheter aortic valve implantation (TAVI) in Germany 2008-2014: on its way to standard therapy for aortic valve stenosis in the elderly?EuroIntervention. 2016; 11:1029–1033. doi: 10.4244/EIJY15M09_11CrossrefMedlineGoogle Scholar
  • 2. Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, Fournial G, Iung B, Donzeau-Gouge P, Tribouilloy C, Debrux JL, Pavie A, Gueret P; FRANCE Registry Investigators. Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry.Eur Heart J. 2011; 32:191–197. doi: 10.1093/eurheartj/ehq261CrossrefMedlineGoogle Scholar
  • 3. Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrié D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients.N Engl J Med. 2012; 366:1705–1715. doi: 10.1056/NEJMoa1114705CrossrefMedlineGoogle Scholar
  • 4. Lange R, Bleiziffer S, Mazzitelli D, Elhmidi Y, Opitz A, Krane M, Deutsch MA, Ruge H, Brockmann G, Voss B, Schreiber C, Tassani P, Piazza N. Improvements in transcatheter aortic valve implantation outcomes in lower surgical risk patients: a glimpse into the future.J Am Coll Cardiol. 2012; 59:280–287. doi: 10.1016/j.jacc.2011.10.868CrossrefMedlineGoogle Scholar
  • 5. Mohr FW, Holzhey D, Möllmann H, Beckmann A, Veit C, Figulla HR, Cremer J, Kuck KH, Lange R, Zahn R, Sack S, Schuler G, Walther T, Beyersdorf F, Böhm M, Heusch G, Funkat AK, Meinertz T, Neumann T, Papoutsis K, Schneider S, Welz A, Hamm CW; GARY Executive Board. The German Aortic Valve Registry: 1-year results from 13,680 patients with aortic valve disease.Eur J Cardiothorac Surg. 2014; 46:808–816. doi: 10.1093/ejcts/ezu290CrossrefMedlineGoogle Scholar
  • 6. Piazza N, Wenaweser P, van Gameren M, Pilgrim T, Tzikas A, Tsikas A, Otten A, Nuis R, Onuma Y, Cheng JM, Kappetein AP, Boersma E, Juni P, de Jaegere P, Windecker S, Serruys PW. Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons Predicted Risk of Mortality score in patients implanted with the CoreValve ReValving system–a Bern-Rotterdam Study.Am Heart J. 2010; 159:323–329. doi: 10.1016/j.ahj.2009.11.026CrossrefMedlineGoogle Scholar
  • 7. Sündermann SH, Dademasch A, Seifert B, Rodriguez Cetina Biefer H, Emmert MY, Walther T, Jacobs S, Mohr FW, Falk V, Starck CT. Frailty is a predictor of short- and mid-term mortality after elective cardiac surgery independently of age.Interact Cardiovasc Thorac Surg. 2014; 18:580–585. doi: 10.1093/icvts/ivu006CrossrefMedlineGoogle Scholar
  • 8. Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management of valvular heart disease (version 2012).Eur Heart J. 2012; 33:2451–2496.CrossrefMedlineGoogle Scholar
  • 9. Mack MJ, Brennan JM, Brindis R, Carroll J, Edwards F, Grover F, Shahian D, Tuzcu EM, Peterson ED, Rumsfeld JS, Hewitt K, Shewan C, Michaels J, Christensen B, Christian A, O’Brien S, Holmes D. Outcomes following transcatheter aortic valve replacement in the United States.JAMA. 2013; 310:2069–2077.CrossrefMedlineGoogle Scholar
  • 10. Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, Antoniucci D, Napodano M, De Carlo M, Fiorina C, Ussia GP. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis.Circulation. 2011; 123:299–308. doi: 10.1161/CIRCULATIONAHA.110.946533LinkGoogle Scholar
  • 11. Beckmann A, Hamm C, Figulla HR, Cremer J, Kuck KH, Lange R, Zahn R, Sack S, Schuler GC, Walther T, Beyersdorf F, Böhm M, Heusch G, Funkat AK, Meinertz T, Neumann T, Papoutsis K, Schneider S, Welz A, Mohr FW; GARY Executive Board. The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis.Thorac Cardiovasc Surg. 2012; 60:319–325. doi: 10.1055/s-0032-1323155CrossrefMedlineGoogle Scholar
  • 12. Hamm CW, Möllmann H, Holzhey D, Beckmann A, Veit C, Figulla HR, Cremer J, Kuck KH, Lange R, Zahn R, Sack S, Schuler G, Walther T, Beyersdorf F, Böhm M, Heusch G, Funkat AK, Meinertz T, Neumann T, Papoutsis K, Schneider S, Welz A, Mohr FW; GARY-Executive Board. The German Aortic Valve Registry (GARY): in-hospital outcome.Eur Heart J. 2014; 35:1588–1598. doi: 10.1093/eurheartj/eht381CrossrefMedlineGoogle Scholar
  • 13. Rosenbaum PR, Rubin DB. Reducing bias in observational studies using subclassification on the propensity score.J Am Stat Assoc. 1984; 79:516–524.CrossrefGoogle Scholar
  • 14. Austin PC. A comparison of 12 algorithms for matching on the propensity score.Stat Med. 2014; 33:1057–1069. doi: 10.1002/sim.6004CrossrefMedlineGoogle Scholar
  • 15. Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Muñoz D, Rosenhek R, Sjögren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease.Eur Heart J. 2017; 38:2739–2791. doi: 10.1093/eurheartj/ehx391CrossrefMedlineGoogle Scholar
  • 16. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O’Gara PT, Rigolin VH, Sundt TM, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.Circulation. 2017; 135:e1159–e1195. doi: 10.1161/CIR.0000000000000503LinkGoogle Scholar
  • 17. Gummert JF, Funkat A, Osswald B, Beckmann A, Schiller W, Krian A, Beyersdorf F, Haverich A, Cremer J. EuroSCORE overestimates the risk of cardiac surgery: results from the national registry of the German Society of Thoracic and Cardiovascular Surgery.Clin Res Cardiol. 2009; 98:363–369. doi: 10.1007/s00392-009-0010-8CrossrefMedlineGoogle Scholar
  • 18. O’Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2–isolated valve surgery.Ann Thorac Surg. 2009; 88:S23–S42.CrossrefMedlineGoogle Scholar
  • 19. Sündermann S, Dademasch A, Praetorius J, Kempfert J, Dewey T, Falk V, Mohr FW, Walther T. Comprehensive assessment of frailty for elderly high-risk patients undergoing cardiac surgery.Eur J Cardiothorac Surg. 2011; 39:33–37. doi: 10.1016/j.ejcts.2010.04.013CrossrefMedlineGoogle Scholar
  • 20. Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.Circulation. 2010; 122:62–69. doi: 10.1161/CIRCULATIONAHA.109.907402LinkGoogle Scholar
  • 21. Wenaweser P, Stortecky S, Schwander S, Heg D, Huber C, Pilgrim T, Gloekler S, O’Sullivan CJ, Meier B, Jüni P, Carrel T, Windecker S. Clinical outcomes of patients with estimated low or intermediate surgical risk undergoing transcatheter aortic valve implantation.Eur Heart J. 2013; 34:1894–1905. doi: 10.1093/eurheartj/eht086CrossrefMedlineGoogle Scholar
  • 22. Petronio AS, Capranzano P, Barbato E, Piazza N, Baumbach A, Haude M, Windecker S. Current status of transcatheter valve therapy in Europe: results from an EAPCI survey.EuroIntervention. 2016; 12:890–895. doi: 10.4244/EIJY16M06_01CrossrefMedlineGoogle Scholar
  • 23. Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.N Engl J Med. 2016; 374:1609–1620. doi: 10.1056/NEJMoa1514616CrossrefMedlineGoogle Scholar
  • 24. Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Søndergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients.N Engl J Med. 2017; 376:1321–1331. doi: 10.1056/NEJMoa1700456CrossrefMedlineGoogle Scholar
  • 25. Latib A, Maisano F, Bertoldi L, Giacomini A, Shannon J, Cioni M, Ielasi A, Figini F, Tagaki K, Franco A, Covello RD, Grimaldi A, Spagnolo P, Buchannan GL, Carlino M, Chieffo A, Montorfano M, Alfieri O, Colombo A. Transcatheter vs surgical aortic valve replacement in intermediate-surgical-risk patients with aortic stenosis: a propensity score-matched case-control study.Am Heart J. 2012; 164:910–917. doi: 10.1016/j.ahj.2012.09.005CrossrefMedlineGoogle Scholar
  • 26. Piazza N, Kalesan B, van Mieghem N, Head S, Wenaweser P, Carrel TP, Bleiziffer S, de Jaegere PP, Gahl B, Anderson RH, Kappetein AP, Lange R, Serruys PW, Windecker S, Jüni P. A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate-risk surgical patients.JACC Cardiovasc Interv. 2013; 6:443–451. doi: 10.1016/j.jcin.2013.01.136CrossrefMedlineGoogle Scholar
  • 27. Thourani VH, Kodali S, Makkar RR, Herrmann HC, Williams M, Babaliaros V, Smalling R, Lim S, Malaisrie SC, Kapadia S, Szeto WY, Greason KL, Kereiakes D, Ailawadi G, Whisenant BK, Devireddy C, Leipsic J, Hahn RT, Pibarot P, Weissman NJ, Jaber WA, Cohen DJ, Suri R, Tuzcu EM, Svensson LG, Webb JG, Moses JW, Mack MJ, Miller DC, Smith CR, Alu MC, Parvataneni R, D’Agostino RB, Leon MB. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis.Lancet. 2016; 387:2218–2225. doi: 10.1016/S0140-6736(16)30073-3CrossrefMedlineGoogle Scholar
  • 28. Grube E, Van Mieghem NM, Bleiziffer S, Modine T, Bosmans J, Manoharan G, Linke A, Scholtz W, Tchétché D, Finkelstein A, Trillo R, Fiorina C, Walton A, Malkin CJ, Oh JK, Qiao H, Windecker S; FORWARD Study Investigators. clinical outcomes with a repositionable self-expanding transcatheter aortic valve prosthesis: the International FORWARD Study.J Am Coll Cardiol. 2017; 70:845–853. doi: 10.1016/j.jacc.2017.06.045CrossrefMedlineGoogle Scholar
  • 29. Vahanian A, Urena M, Walther T, Treede H, Wendler O, Lefèvre T, Spence MS, Redwood S, Kahlert P, Rodes-Cabau J, Leipsic J, Webb J. Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial.EuroIntervention. 2016; 12:e235–e243. doi: 10.4244/EIJV12I2A37CrossrefMedlineGoogle Scholar
  • 30. Ben-Dor I, Gaglia MA, Barbash IM, Maluenda G, Hauville C, Gonzalez MA, Sardi G, Laynez-Carnicero A, Torguson R, Okubagzi P, Xue Z, Goldstein SA, Suddath WO, Kent KM, Lindsay J, Satler LF, Pichard AD, Waksman R. Comparison between Society of Thoracic Surgeons score and logistic EuroSCORE for predicting mortality in patients referred for transcatheter aortic valve implantation.Cardiovasc Revasc Med. 2011; 12:345–349. doi: 10.1016/j.carrev.2011.04.005CrossrefMedlineGoogle Scholar
  • 31. Hemmann K, Sirotina M, De Rosa S, Ehrlich JR, Fox H, Weber J, Moritz A, Zeiher AM, Hofmann I, Schächinger V, Doss M, Sievert H, Fichtlscherer S, Lehmann R. The STS score is the strongest predictor of long-term survival following transcatheter aortic valve implantation, whereas access route (transapical versus transfemoral) has no predictive value beyond the periprocedural phase.Interact Cardiovasc Thorac Surg. 2013; 17:359–364. doi: 10.1093/icvts/ivt132CrossrefMedlineGoogle Scholar
  • 32. Wang TKM, Wang MTM, Gamble GD, Webster M, Ruygrok PN. Performance of contemporary surgical risk scores for transcatheter aortic valve implantation: A meta-analysis.Int J Cardiol. 2017; 236:350–355. doi: 10.1016/j.ijcard.2016.12.188CrossrefMedlineGoogle Scholar

eLetters(0)

eLetters should relate to an article recently published in the journal and are not a forum for providing unpublished data. Comments are reviewed for appropriate use of tone and language. Comments are not peer-reviewed. Acceptable comments are posted to the journal website only. Comments are not published in an issue and are not indexed in PubMed. Comments should be no longer than 500 words and will only be posted online. References are limited to 10. Authors of the article cited in the comment will be invited to reply, as appropriate.

Comments and feedback on AHA/ASA Scientific Statements and Guidelines should be directed to the AHA/ASA Manuscript Oversight Committee via its Correspondence page.