The presence of severe atherosclerosis of the ascending aorta, and its extreme form the “porcelain” aorta, is associated with a worse clinical outcome in patients undergoing surgical aortic valve replacement. Percutaneous transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis can overcome this problem: 1,374 TAVI procedures were performed at 27 hospitals in 147 patients (10.7%) with and 1,227 (89.3%) without a porcelain aorta. The mean reported prevalence of a porcelain aorta at the hospitals was 7.8% ± 14.8% (range 0% to 70%). Diabetes mellitus (46.3% vs 33.2%, p = 0.00018), chronic obstructive pulmonary disease (43.5% vs 22.2%, p <0.0001), and peripheral arterial obstructive disease (34.7% vs 20.0%, p <0.0001) were more prevalent in patients with a porcelain aorta. In patients with a porcelain aorta, coronary ischemia occurred more often (2.0% vs 0.1%, p <0.0001), with a tendency toward a greater stroke rate (5.5% vs 2.8%, p = 0.08), greater in-hospital death rate (10.9% vs 8.1%, p = 0.24), and greater death or stroke rate (14.4% vs 10.2%, p = 0.12). On multivariate analysis, the presence of a porcelain aorta was not associated with in-hospital death (odds ratio 1.36, 95% confidence interval 0.72 to 2.55, p = 0.3441) nor in-hospital death or stroke (odds ratio 1.50, 95% confidence interval 0.81 to 2.47, p = 0.2207). In conclusion, in this real-world TAVI registry, a “porcelain” aorta was diagnosed in almost every tenth patient. Although differences were found in its frequency among the participating hospitals, the presence of a porcelain aorta was not associated with in-hospital death or stroke.
Definitions of what is termed “atherosclerosis of the ascending aorta” in the published data differ significantly. Most often they have relied on the intraoperative subjective judgment of the treating surgeon. In another study, atherosclerosis was described according to autopsy findings. Furthermore, currently, only limited data are available on the outcome of patients with severe atherosclerosis of the ascending aorta, the so-called porcelain aorta, being treated with transcatheter aortic valve implantation (TAVI). To determine the prevalence of a porcelain aorta in the current clinical practice of TAVI, to determine interventional differences between patients with and without a porcelain aorta, and to evaluate the influence of this entity on cerebral events and clinical outcomes, we analyzed the German Transcatheter Aortic Valve Interventions Registry.
Methods
The German Transcatheter Aortic Valve Interventions Registry is a multicenter prospective registry. The aim is to monitor the current use and outcome of transcatheter aortic valve interventions, including TAVI and balloon valvuloplasty alone, in daily clinical practice. The registry is completely independent from industry. Details of the registry have been previously described.
Since January 2009, all participating hospitals have committed to include all consecutive patients with severe symptomatic aortic stenosis treated with either balloon valvuloplasty alone or treated with TAVI. The proposed inclusion criteria for treatment were the following: severe symptomatic aortic valve stenosis with a valve area ≤1 cm 2 , with or without aortic valve regurgitation and age ≥80 years and a logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥20% or logistic EuroSCORE <20% and ≥1 of the following criteria: liver cirrhosis, pulmonary insufficiency (forced expiratory volume in 1 second ≤1 L), or a porcelain aorta. Furthermore, the technical feasibility, such as feasible arterial access and a fitting aortic annulus diameter according to the available prostheses sizes, should have been recorded.
All patients gave written informed consent before the procedure and also gave written informed consent for processing their anonymous data.
Preintervention patient screening typically included transthoracic and transesophageal echocardiography, multislice computed tomography, and an invasive cardiac evaluation with coronary angiography, supra-aortic angiography, and left ventriculography. The baseline operative risk of the patients was estimated using the logistic EuroSCORE. The patient was considered high risk if the inclusion criteria were met as confirmed by an independent senior cardiologist and senior cardiac surgeon. The decision to treat a patient was left to the discretion of the treating physician. However, we strongly suggested that such a decision should be made by a multidisciplinary team, typically consisting of an interventional cardiologist, a cardiac surgeon and an anesthesiologist, as suggested by the current recommendations.
An “urgent procedure” was defined when a patient presented with acute cardiac decompensation and could not be sufficiently recompensated with medical therapy only. TAVI had to be performed within a few days. An “emergency procedure” was defined when TAVI had to be performed in acute circumstances, normally when the patient developed cardiogenic shock.
All decisions regarding the procedure, such as simultaneous revascularization of coronary diameter stenoses >50%, was left to the discretion of the individual center and/or physician and was not prespecified by the protocol.
Our registry was open to all available prostheses. However, at that time, only 2 prostheses were commercially available in Germany: the Medtronic CoreValve (Medtronic CoreValve, Irvine, California) and the Edwards Sapien (Edwards Lifesciences, Irvine, California) prostheses. Both devices have been previously described. During this period, the 26-mm and 29-mm prostheses were available for the Medtronic CoreValve. Implantation was done as previously reported. For the balloon-expandable Edwards Sapien bovine valve, the Novaflex transarterial catheter and Ascendra transapical catheter were used, and 2 prosthesis sizes were available, with a 23- and 26-mm expanded diameter. Implantation was done as previously reported.
For the present analysis of our registry, we included all patients treated with TAVI from January 2009 until June 2010. We compared TAVI patients with and without a porcelain aorta. The diagnosis of a porcelain aorta was left to the treating physician.
Data were collected by way of the Internet by the Institut für Herzinfarktforschung at the Heart Centre Ludwigshafen. The absolute numbers and percentages and mean ± SD or median (interquartile range) were computed to describe the patient population. Categorical values were compared using the chi-square test and continuous variables using the 2-tailed Wilcoxon rank sum test. No fixed 30-day evaluation occurred, because many patients by then were already in a rehabilitation program, making it difficult to contact them. Therefore, the 30-day events were either reported by the treating hospital or follow-up telephone calls performed by the Institut für Herzinfarktforschung. The 30-day death rate was then calculated using the Kaplan-Meier survival analysis method. Logistic regression analysis was used to determine the risk factors for the occurrence of in-hospital death, death, or stroke. The following variables were examined: age, gender, shock or heart failure at admission, complications at the puncture site, residual aortic insufficiency ≥II° after implantation, renal insufficiency, dialysis, previous balloon valvuloplasty, peripheral arterial obstructive disease, impaired left ventricular ejection fraction, the presence of a porcelain aorta, and those variables that showed a difference when stratified by the occurrence of the end point on univariate analysis with p <0.1. The logistic EuroSCORE was not included in the model to allow the single components used for its calculation to be entered in the model. The area under the receiver operating characteristic curve, as assessed by the c statistic, was used to determine the association of the predicted probabilities and observed response of the logistic regression model.
p Values <0.05 were considered significant. All p values are the result of 2-tailed tests. The tests were performed using the SAS statistical package, version 9.2 (SAS Institute, Cary, North Carolina).
We had full access to, and take full responsibility for, the integrity of the data, and all have read and agreed to the report as written.
Results
From January 2009 to June 2010, 1,374 TAVI procedures with information on a porcelain aorta were included by the participating 27 hospitals: 147 patients (10.7%) with and 1,227 (89.3%) without a porcelain aorta. The distribution of TAVI patients with a porcelain aorta at the different hospitals is shown in Figure 1 . The mean reported prevalence of a porcelain aorta was 7.8 ± 14.8% (range 0% to 70%).
The mean age of the patients with a porcelain aorta was not significantly different from that of the patients without a porcelain aorta (p = 0.19). Concomitant diseases such as diabetes mellitus (p = 0.00018), chronic obstructive pulmonary disease (p <0.0001), and peripheral arterial obstructive disease (p <0.0001) were more prevalent in the patients with a porcelain aorta, contributing to a slightly greater logistic EuroSCORE in patients with a porcelain aorta (median 17.4% vs 16.5%, p = 0.06; Table 1 ). The presence of a porcelain aorta was also associated with a lower percentage of patients for whom their decision markedly contributed to the indication to perform TAVI (4.9% vs 18.8%, p <0.0001).
| Variable | Porcelain Aorta | p Value | |
|---|---|---|---|
| Yes (n = 147) | No (n = 1,227) | ||
| Age (yrs) | 81.4 ± 6.2 | 81.8 ± 6.3 | 0.19 |
| Men | 40.1% (59/147) | 42.1% (517/1,227) | 0.64 |
| Body mass index (kg/m²) | 25.9 ± 4.1 | 27.0 ± 10.4 | 0.30 |
| Previous coronary bypass | 17.8% (26/146) | 18.2% (224/1,226) | 0.87 |
| Previous percutaneous coronary intervention | 39.0% (57/146) | 34.3% (419/1,222) | 0.25 |
| Any previous valve surgery | 1.7% (2/146) | 3.8% (47/1,226) | 0.13 |
| Previous balloon valvuloplasty | 4.1% (6/146) | 12.7% (156/1,226) | <0.01 |
| Previous stroke | 8.2% (12/147) | 8.1% (99/1,225) | 0.97 |
| Diabetes mellitus | 46.3% (68/147) | 33.2% (407/1,225) | 0.0018 |
| Chronic obstructive pulmonary disease | 43.5% (64/147) | 22.2% (272/1,226) | <0.0001 |
| Peripheral arterial obstructive disease | 34.7% (51/147) | 20.0% (245/1,226) | <0.0001 |
| Renal failure ∗ | 68.0% (100/147) | 60.1% (738/1,227) | 0.06 |
| Clinical presentation | |||
| New York Heart Association class | |||
| III | 72.1% (106/147) | 71.8% (877/1,222) | 0.93 |
| IV | 19.7% (29/147) | 16.6% (203/1,222) | 0.34 |
| American Society of Anesthesiologists class † | |||
| I | 0.7% (1/146) | 1.2% (15/1,219) | 0.56 |
| II | 24.0% (35/146) | 29.0% (353/1,219) | 0.21 |
| III | 50.7 (74/146) | 58.5% (713/1,219) | 0.07 |
| IV | 21.9% (32/146) | 9.9% (121/1,219) | <0.0001 |
| V | 2.7% (4/146) | 1.4% (17/1,219) | 0.21 |
| Logistic European System for Cardiac Operative Risk Evaluation score | |||
| Median | 17.4 | 16.5 | 0.06 |
| Interquartile range | 11.0–30.7 | 10.7–26.2 | |
| Indication for intervention | |||
| Surgical high risk (European System for Cardiac Operative Risk Evaluation score >20%) | 45.9% (67/146) | 38.7% (467/1,208) | 0.09 |
| Frailty | 15.2% (22/145) | 17.6% (215/1,221) | 0.46 |
| Patient decision | 4.9% (7/144) | 18.8% (229/1,220) | <0.0001 |
| Limiting concomitant malignancy | 5.6% (8/144) | 3.8% (46/1,220) | 0.30 |
∗ Glomerular filtration rate <60 ml/min/m 2 .
The presence of a porcelain aorta was associated with a greater rate of coronary heart disease (p = 0.04), and a severely calcified valve was found more often than in patients without a porcelain aorta (82.3% vs 64.5%, p <0.0001; Table 2 ).
| Variable | Porcelain Aorta | p Value | |
|---|---|---|---|
| Yes (n = 147) | No (n = 1,227) | ||
| Diseased coronary arteries (n) | 32.2% (47/146) | 41.0% (501/1,222) | 0.04 |
| 1 | 26.0% (38/146) | 20.9% (255/1,222) | 0.15 |
| 2 | 19.2% (28/146) | 13.3% (162/1,222) | 0.05 |
| 3 | 22.6% (33/146) | 24.9% (304/1,222) | 0.55 |
| Left main artery | 8.2% (12/146) | 5.8% (71/1,220) | 0.25 |
| Left ventricular ejection fraction (%) | 55.99 ± 14.98 | 52.40 ± 14.76 | 0.003 |
| Severely reduced ejection fraction (≤30%) | 6.8% (10/147) | 12.4% (152/1,227) | 0.048 |
| Aortic valve characteristics | |||
| Aortic valve area (cm 2 ) | 0.70 ± 0.23 | 0.67 ± 0.39 | <0.01 |
| Mean gradient (mm Hg) | 52.77 ± 20.03 | 47.45 ± 16.69 | <0.01 |
| Bicuspid valve | 0.7% (1/146) | 2.6% (32/1,227) | 0.15 |
| Severely calcified valve | 82.3% (121/147) | 64.5% (791/1,226) | <0.0001 |
| Aortic annulus diameter (mm) | 23.14 ± 2.78 | 23.29 ± 2.59 | 0.16 |
| Low-output–low-gradient stenosis | 9.0% (13/145) | 11.5% (136/1,183) | 0.36 |
| Concomitant aortic insufficiency grade ≥3 | 5.4% (8/147) | 3.7% (45/1,226) | 0.29 |
| Concomitant mitral insufficiency grade ≥3 | 1.4% (2/146) | 3.5% (43/1,227) | 0.17 |
| Peak systolic pulmonary pressure (mm Hg) | 44.6 ± 16.7 | 45.4 ± 33.0 | 0.90 |
| Pulmonary hypertension | 64.8% (94/145) | 66.9% (811/1,213) | 0.62 |
| Atrial fibrillation | 19.9% (29/146) | 25.4% (311/1,224) | 0.14 |
The interventional characteristics are listed in Table 3 . In patients with a porcelain aorta, interventions were performed more often on an emergency basis, as expressed by more urgent interventions (p <0.0001) and more patients requiring mechanical ventilation (p <0.01).
| Variable | Porcelain Aorta | p Value | |
|---|---|---|---|
| Yes (n = 147) | No (n = 1,227) | ||
| Elective intervention | 64.6% (95/147) | 85.5% (1049/1,227) | <0.0001 |
| Urgent intervention | 29.9% (44/147) | 13.7% (168/1,227) | <0.0001 |
| Emergency intervention | 5.4% (8/147) | 0.6% (7/1,227) | <0.0001 |
| Patient required mechanical ventilation | 3.4% (5/147) | 0.9% (11/1,226) | <0.01 |
| Intervention during resuscitation | 0.0% (0/147) | 2.0% (25/1,225) | 0.08 |
| Transcatheter aortic valve implantation | |||
| Transfemoral | 81.6% (120/147) | 87.9% (1083/1,227) | 0.03 |
| Transsubclavian | 5.4% (8/147) | 2.8% (34/1,227) | 0.08 |
| Transapical or transaortic | 12.9% (19/147) | 9.3% (114/1,227) | 0.16 |
| Valve type used | |||
| Medtronic CoreValve Revalving system | 83.7% (123/147) | 80.2% (982/1,224) | 0.32 |
| 26 mm | 55.3% (68/123) | 45.8% (452/986) | 0.046 |
| 29 mm | 44.7% (55/123) | 54.2% (534/986) | 0.046 |
| Edwards Sapien | 15.6% (23/147) | 17.9% (219/1,224) | 0.50 |
| 23 mm | 41.7% (10/24) | 45.6% (108/237) | 0.71 |
| 26 mm | 58.3 (14/24) | 54.4% (129/237) | 0.71 |
| Procedural characteristics | |||
| Intervention time (min) | 92.4 ± 52.8 | 89.1 ± 49.6 | 0.35 |
| Fluoroscopy time (min) | 15.1 ± 7.6 | 15.5 ± 7.4 | 0.41 |
| Amount of contrast dye used (ml) | 140.33 ± 62.44 | 166.73 ± 72.43 | <0.0001 |
| Interventional closure of puncture site | 96.7% (116/120) | 90.8% (972/1,071) | 0.02 |
| Surgical closure of puncture site | 3.3% (4/120) | 9.2% (99/1,071) | 0.02 |
| Concomitant percutaneous coronary intervention | 8.9% (13/146) | 3.9% (48/1,222) | <0.01 |
Patients with a porcelain aorta were less likely to be treated by the transfemoral access route (p = 0.03) and, therefore, were more often treated through the trans-subclavian or transapical route. Overall, 19 of the 147 patients (12.9%) with a porcelain aorta had surgical access, 16 transapical and 3 transaortic.
The technical success rates and the incidence of residual aortic insufficiency were not different between the 2 groups. In patients with a porcelain aorta, coronary ischemia occurred more often (p <0.0001), and a tendency was noted toward a greater stroke rate (p = 0.08). Also, a trend was seen toward a greater in-hospital and 30-day death rate (10.9% vs 8.1%, p = 0.24; and 12.9% vs 7.6%, p = 0.03), and a greater death or stroke rate (14.4% vs 10.2 %, p = 0.12; Table 4 ).
| Variable | Porcelain Aorta | p Value | |
|---|---|---|---|
| Yes (n = 147) | No (n = 1,227) | ||
| Procedure outcome | |||
| Technically successful | 97.3% (143/147) | 97.3% (1,193/1,226) | 0.98 |
| Conversion to open heart surgery | 1.4% (2/147) | 1.2% (15/1,226) | 0.89 |
| Unsuccessful termination | 1.4% (2/147) | 1.5% (18/1,226) | 0.92 |
| Mean gradient after procedure (mm Hg) | 4.2 ± 4.8 | 6.4 ± 6.9 | <0.001 |
| Residual aortic insufficiency | 67.6% (98/145) | 69.0% (836/1,211) | 0.72 |
| None | 32.4% (47/145) | 31.0% (375/1,211) | 0.72 |
| Grade 1 | 51.7% (75/145) | 54.3% (658/1,211) | 0.55 |
| Grade 2 | 14.5% (21/145) | 13.2% (160/1,211) | 0.67 |
| Grade 3 | 1.4% (2/145) | 1.2% (15/1,211) | 0.89 |
| Grade 4 | 0.0% (0/145) | 0.2% (3/1,211) | 0.55 |
| Pacemaker implantation | 46.9% (68/145) | 33.5% (403/1,202) | <0.01 |
| Intensive care unit stay (days) | 2.8 ± 2.6 | 3.0 ± 2.9 | 0.49 |
| Groin problems | 20.0% (29/145) | 22.9% (274/1,199) | 0.44 |
| Not severe | 15.9% (23/145) | 20.5% (247/1,203) | 0.18 |
| Severe | 4.1% (6/145) | 3.7% (44/1,199) | 0.78 |
| Need for hemodynamic support ∗ | 0.0% (0/146) | 0.7% (8/1,192) | 0.32 |
| Pericardial tamponade | 1.4% (2/146) | 0.9% (11/1,202) | 0.60 |
| Aortic dissection | 0.0% (0/146) | 0.5% (6/1,202) | 0.39 |
| Coronary ischemia | 2.1% (3/146) | 0.1% (1/1,202) | <0.0001 |
| Myocardial infarction | 0.7% (1/146) | 0.5% (6/1,207) | 0.77 |
| Stroke | 5.5% (8/145) | 2.8% (34/1,203) | 0.08 |
| Pulmonary embolism | 3.4% (5/145) | 1.5% (18/1,202) | 0.09 |
| In-hospital death | 10.9% (16/147) | 8.1% (99/1,227) | 0.24 |
| In-hospital death or stroke | 14.4% (21/146) | 10.2 % (124/1,218) | 0.12 |
| 30-Day death rate | 12.9% | 7.6% | 0.03 |
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