Percutaneous Axillary Artery Access for Endovascular Treatment of Complex Thoraco-abdominal Aortic Aneurysms.

OBJECTIVE: The aim of this study was to determine the feasibility and safety of percutaneous axillary artery (AxA) access using vascular closure devices (VCD) for endovascular repair (ER) of thoraco-abdominal aortic aneurysms (TAAA) using fenestrated, branched, and chimney stent grafts. METHODS: Between September 2013 and December 2017, 40 high risk patients (27 men; mean age: 72.7 ± 7.4 years) with TAAA underwent total percutaneous endovascular aortic repair by percutaneous puncture of the third segment of the left AxA, using a 12F sheath for delivery of the bridging visceral stent grafts. Percutaneous closure was performed using ultrasound guidance and two Perclose ProGlide VCDs per puncture site. Endpoints were device success defined as successful haemostasis of the axillary puncture site by VCD, procedure success defined as endovascularly assisted haemostasis of the AxA, major cerebrovascular and peripheral neurological complications, and 30 day mortality. RESULTS: The median diameter of the AxA in the third segment was 6.5 mm (range 4.4-10.4 mm). The procedure success was 100%. Device success was achieved in 33 patients (82.5%). Device success in patients with AxA diameter >5 mm was 97%. All patients with diameter of the AxA <5 mm developed stenosis or occlusions of the vessel (n = 6), which were treated by percutaneous stent implantation. One bleeding at the AxA puncture site was treated with trans-femoral implantation of a covered stent. No secondary open procedures were required. No neurological deficit of the left upper limb was seen at discharge. Overall mortality at 30 days was 10%. CONCLUSIONS: Direct puncture of the AxA in the third segment and its use as an access vessel for large sheaths during total percutaneous treatment of complex endovascular aortic procedures appear to be feasible and safe in arteries with a diameter >5 mm. Complications can be managed using endovascular techniques.

Thrombelastometry guided blood-component therapy after cardiac surgery: a randomized study.

BACKGROUND: Significant bleeding is a well known complication after cardiac surgical procedures and is associated with worse outcome. Thrombelastometry (ROTEM®) allows point-of-care testing of the coagulation status but only limited data is available yet. The aim was to evaluate the ROTEM®-guided blood component therapy in a randomized trial. METHODS: In case of significant postoperative bleeding (> 200 ml/h) following elective isolated or combined cardiac surgical procedures (including 14% re-do procedures and 4% requiring circulatory arrest) patients were randomized to either a 4-chamber ROTEM®-guided blood-component transfusion protocol or received treatment guided by an algorithm based on standard coagulation testing (control). One hundred four patients (mean age: 67.2 ± 10.4 years, mean log. EuroSCORE 7.0 ± 8.8%) met the inclusion criteria. Mean CPB-time was 112.1 ± 55.1 min., mean cross-clamp time 72.5 ± 39.9 min. RESULTS: Baseline demographics were comparable in both groups. Overall there was no significant difference in transfusion requirements regarding red blood cells, platelets, plasma, fibrinogen or pooled factors and the re-thoracotomy rate was comparable (ROTEM®: 29% vs. control: 25%). However, there was a trend towards less 24-h drainage loss visible in the ROTEM®-group (ROTEM®: 1599.1 ± 834.3 ml vs. control: 1867.4 ± 827.4 ml; p = 0.066). In the subgroup of patients with long CPB-times (> 115 min.; n = 55) known to exhibit an increased risk for diffuse coagulopathy ROTEM®-guided treatment resulted in a significantly lower 24-h drainage loss (ROTEM®: 1538.2 ± 806.4 ml vs. control: 2056.8 ± 974.5 ml; p = 0.032) and reduced 5-year mortality (ROTEM®: 0% vs. control: 15%; p = 0.03). CONCLUSION: In case of postoperative bleeding following cardiac surgical procedures a treatment algorithm based on "point-of-care" 4-chamber ROTEM® seems to be at least as effective as standard therapy. In patients with long CPB-times ROTEM®-guided treatment may result in less bleeding, a marked reduction in costs and long-term mortality. TRIAL REGISTRATION: German Clinical Trials Register, TRN: DRKS00017367 , date of registration: 05.06.2019, 'retrospectively registered'.

Tricuspid Valve Repair after Previous Mitral Valve Surgery.

Tricuspid valve (TV) regurgitation in patients after previous mitral valve surgery is usually a secondary failure and conditioned by a long-lasting left-sided valve failure. TV surgery in these patients represents a high-risk procedure regarding the operative strategy and perioperative management. This article will discuss the indication for TV surgery in patients with secondary TV regurgitation and previous mitral valve surgery, the choice of surgical access, as well as TV repair techniques and their postoperative results.

Aortic valve calcium score for paravalvular aortic insufficiency (AVCS II) study in transapical aortic valve implantation.

BACKGROUND: Transapical aortic valve implantation (TAAVI) has evolved into a routine procedure for select high-risk patients. The aim was to study the impact of native aortic valve calcification on paravalvular leaks in cardiac contrast-enhanced computed tomography (CT). METHODS: The degree and distribution of valve calcification were quantified using an Aortic Valve Calcium Score (AVCS) for each cusp separately (3mensio Valves). To reduce an artificial increase of the AVCS due to the presence of contrast material, we used thresholds for density [mean aortic density + 2*SD] and volume [0, 3, 5, 25, and 50 mm3] of calcification. RESULTS: 111 consecutive patients prior to TAAVI with preoperative CT aged 79.8 ± 5.8 years were included using the Edwards Sapien prosthesis. Paravalvular leaks were significantly associated with eccentric calcified plaques (r [Spearman] = 0.37; χ2-statistic = 15.4; P = .002), presence of LVOT calcium (r [Spearman] = 0.28; χ2-statistic = 11.3; P = .009), and the commissural gap at the anatomic ventriculo-arterial junction (r [Spearman] = 0.41-0.63; χ2-statistic = 50.8-53.0; P = .002-≤.001). There was no significant association between the total AVCS and PV leaks (r [Spearman] = 0.076; χ2-statistic = 1.471; P = .240, 120 kV, 850 hounsfield units) with no additional use of a volume-based threshold. CONCLUSION: Asymmetry of leaflet calcium distribution, LVOT calcium, and the commissural gap between leaflets were significantly associated with paravalvular leaks. Moreover, quantification of aortic valve calcification in contrast enhanced CTs shows only a weak correlation with paravalvular leakage and is therefore not reliable as a predictor, respectively.

Not all porcelain is the same: classification of circular aortic calcifications (porcelain aorta) according to the impact on therapeutic approach.

Severe aortic calcification, also known as "porcelain aorta," has a major impact on patient outcome. Its presence also influences the choice of procedure depending on where it is located. However, to date there is no clear definition on how this term should be employed, being often used as an exclusion criteria for conventional surgery where aortic clamping and/or cannulation is required.We here suggest a classification of the "porcelain aorta" regarding its location and how it influences particular therapeutic options. Therefore, making more clear what procedures would represent an increased risk for the patient and which are more suitable when discussed in a "Heart Team."Type I implies localization of a circumferential calcification in the ascending aorta. Type IA represents the calcified aorta with no possibility of clamping and Type IB represents the calcified aorta with possible clamping. Type II addresses the calcification of the descending aorta including or not the aortic arch.

Predictors of permanent pacemaker implantation after Medtronic CoreValve bioprosthesis implantation.

AIMS: High-grade conduction disturbances requiring permanent pacemaker (PPM) implantation occur in up to 40% of patients following transcatheter aortic valve implantation (TAVI). The aim of this study was to identify pre-operative risk factors for PPM implantation after TAVI with the Medtronic CoreValve prosthesis (CVP). METHODS AND RESULTS: We retrospectively analysed 109 patients following transfemoral CVP implantation performed between 2008 and 2009 at the Leipzig Heart Center. Patients who had indwelling PPM at the time of TAVI (n = 21) were excluded, leaving 88 patients for analysis. Mean age was 80.3 ± 6.6 years and logistic EuroScore predicted risk of mortality was 23.3 ± 12.1%. A total of 32 patients (36%) underwent PPM implantation post-TAVI during the same hospital admission. A total of 27/88 (31%) had evidence of pre-operative abnormal conduction, including first degree AV block and left bundle brunch block. Statistically significant risk factors for the need for post-operative PPM were patient age >75 years [P = 0.02, odds ratio (OR) 4.6], pre-operative heart rate <65 beats per minute (b.p.m.; P = 0.04, OR 2.9), CVP oversizing >4 mm (P = 0.03, OR 2.8), CVP prosthesis >26 mm (OR 2.2), atrial fibrillation (P = 0.001, OR 5.2), and ventricular rate <65 b.p.m. at the first post-operative day (P = 0.137, OR 6.0). CONCLUSION: PPM implantation occurs frequently after transfemoral TAVI with the CVP. Older age, chronic atrial fibrillation, pre-operative bradycardia, and larger or significantly oversized prostheses were independent risk factors for PPM implantation following TAVI with the CVP.

Extensive calcification of the mitral valve annulus in transcatheter aortic valve implants.

OBJECTIVES: This study sought to report the calcification pattern of the mitral valve annulus and its implications for procedural and safety outcomes in transcatheter aortic valve implantation. METHODS: Between November 2018 and September 2019, a total of 305 patients had transcatheter aortic valve implants at our institution. The extent of calcification of the mitral valve annulus was analysed, and the impact on safety outcomes was evaluated. RESULTS: The prevalence of mitral annular calcification (MAC) was 43%. Calcification of the mitral valve annulus was either less than or at least one-third of the posterior annulus (34% and 32%), the whole posterior annulus (28%) or the extension to the attachment of the anterior leaflets (7%). Severe circumferential MAC revealed moderate paravalvular leaks in 5/8 (63%) patients and was associated with right branch bundle block [odds ratio (OR) 2.01 (0.39-3.06); P = 0.098] and low cardiac output [OR 3.12 (1.39-7.04); P = 0.033]. Subannular calcification at the anterolateral trigonum represented a risk factor for left ventricular outflow tract injury [OR 3.54 (1.38-8.27); P = 0.001] in balloon-expandable valves, associated with relevant rhythm disorders [OR 2.26 (1.17-5.65); P = 0.014] and female gender (7/8, 88%). The 30-day all-cause mortality in circumferential MAC reaching into the anterior annulus (grade IV) compared to patients with less MAC (grade I-III) was 13% vs 2% with a mean valve size of 24.6 vs 25.7 mm. CONCLUSIONS: Extensive MAC was associated with moderate paravalvular leaks, with implications for the prosthesis size and survival in transcatheter aortic valve implants. In severe MAC, we recommend implanting oversized self-expandable prostheses, the goal being to reduce the risk of right branch bundle block and paravalvular leaks. SUBJ COLLECTION: 122, 125.

Thromboembolic complications in transfemoral aortic valve implantation due to aortic wall thrombus and shaggy aorta syndrome.

OBJECTIVES: Aortic wall thrombus (AWT) can affect suitability to endovascular repair, while its most aggressive entity is better known as shaggy aorta syndrome. Primary objective was to study the procedural and clinical outcome with regard to atherothrombotic AWT in transfemoral aortic valve implantation. METHODS: In a retrospective, single-centre analysis, a qualitative 0-10 AWT score classification system was used. The most severely affected aortic area in computed tomography angiography cross-section was assessed for the number of affected segments, thrombus type, thickness, area and circumference. Primary endpoints were 30-day mortality, neurologic, renal and pulmonary events and signs of solid organ infarction. RESULTS: Between November 2017 and September 2019, 604 patients underwent transfemoral transcatheter aortic valve implantation in our institution. Computed tomography-guided analysis revealed AWT in 11.3% and shaggy aorta syndrome in 6 patients (1.0% with 83.3% male). AWT was mainly present in the descending thoracic and abdominal aorta and was associated with acute renal failure (11.8% vs 3.2%, P ≤ 0.001) and a seven-fold increased rate of disabling peri-interventional stroke (4.4% vs 0.6%, P ≤ 0.001). In all patients with disabling peri-interventional stroke a balloon-expandable prosthesis was used (P ≤ 0.001). In case of shaggy aorta, mortality was more than six-fold increased (2.8% vs 16.7%, P = 0.046). CONCLUSIONS: Severe and irregular thrombus of the descending thoracic and abdominal aorta has been strongly associated with acute respiratory failure and peri-interventional stroke in transfemoral aortic valve implantation, being more likely using balloon-expandable devices. Our results imply important changes with regard to device design and present international transcatheter aortic valve implantation guidelines.

Endovascular Repair of the Thoracic or Thoracoabdominal Aorta Following the Frozen Elephant Trunk Procedure.

BACKGROUND: This study evaluated the outcomes of endovascular repair of the thoracoabdominal aorta following the frozen elephant trunk (fET) procedure. METHODS: Between October 2014 and July 2018, 249 patients underwent thoracic or thoracoabdominal endovascular aortic repair in our institution. Of these, 10 patients (50% male) underwent second-stage endovascular repair after previous fET implantation. Feasibility and outcomes were evaluated. RESULTS: The mean interval between fET implantation and the second-stage endovascular repair was 136 days (range, 14-282 days). Indications for second-stage endovascular repair were thoracoabdominal aortic aneurysm Crawford type I (n = 3) or Crawford type II (n = 4) and complicated residual aortic dissection after fET (n = 3). We implanted 4 branched custom-made devices and 4 off-the-shelf thoracic stent grafts. Two patients were treated using the provisional extension to induce complete attachment (PETTICOAT) technique through a percutaneous access. The median intensive care unit stay was 1 day (range, 0-3 days), and median hospital stay was 7 days (range, 5-12 days). Spinal cord preconditioning was performed in 70% of our patients with zero paraplegia at 30 days. Computed tomographic scans at 8.5 ± 11.4 months of follow-up showed complete false lumen thrombosis of all type B aortic dissections and 1 type III endoleak with constant aneurysm diameter. Branch patency was 100%. CONCLUSIONS: Second-stage endovascular repair after a previous fET is feasible with good midterm results. This staged hybrid procedure is extremely effective in patients whose aneurysms are confined both to the arch and thoracoabdominal aorta, leading to an excellent functional result. In case of favorable anatomy, endovascular repair in residual type B aortic dissection led to complete false lumen thrombosis.

The role of the heart team in complicated transcatheter aortic valve implantation: a 7-year single-centre experience.

OBJECTIVES: European guidelines recommend to perform transcatheter aortic valve implantation (TAVI) within a multidisciplinary heart team. However, there is a strong drive--despite existing guidelines--to perform TAVI outside of specialized centres. The aim of this study was to clarify the necessity of on-site cardiac surgery by providing a clear insight into the complications during/after TAVI that needed surgical management. METHODS: A total of 2287 (1523 transfemoral, 752 transapical and 12 transaortic) patients, with a mean age of 84.5 ± 5.3 years, and a mean log EuroSCORE of 21.7 ± 16.3, of which 205 were female (84%), underwent TAVI since February 2006 at our institution. All procedure-related complications that required surgical interventions, whether immediate or delayed but within the initial hospital stay, were recorded and retrospectively analysed. RESULTS: Out of this cohort, 245 (10.7%) patients required surgical treatment due to major complications. A total of 42 patients (1.8%) underwent conversion to full sternotomy and 27 (1.2%) were dependent on the short-term use of the heart-lung machine. Vascular complications with surgical intervention were seen in 85 patients (3.7%), 54 patients (2.4%) had to have a rethoracotomy within their initial stay and 15 (0.7%) required a cardiac reoperation. CONCLUSIONS: Severe complications during TAVI that can only be resolved surgically will continue to occur. Therefore, each TAVI procedure should be conducted or accompanied by a cardiac surgeon and an experienced team within a specialized centre.

Minimally invasive aortic valve replacement: the Leipzig experience.

BACKGROUND: Minimally invasive techniques are progressively challenging traditional approaches in cardiothoracic surgery. Minimally invasive aortic valve replacement (AVR) has become a routine procedure at our institution. METHODS: We retrospectively analyzed all patients undergoing minimally invasive isolated AVR between January 2003 and March 2014, at our institution. Mean follow-up was 4.7±4.3 years (range: 0-18 years) and was 99.8% complete. RESULTS: There were 1,714 patients who received an isolated minimally invasive AVR. The mean (± SD) patient age was 65±12.8 years, ejection fraction 60%±12% and log EuroSCORE 5.3%±5.1%. Mean cross-clamp time was 58±18 minutes and mean cardiopulmonary bypass (CPB) time was 82.9±26.7 minutes. Thirty-day survival was 97.8%±0.4%, and 69.4%±1.7% at 10-years. The multivariate analysis revealed age at surgery [P=0.016; odds ratio (OR), 1.1], length of surgery time (P=0.002; OR, 1.01), female gender (P=0.023; OR, 3.54), preoperative myocardial infarction (MI) (P=0.006; OR, 7.87), preoperative stroke (P=0.001; OR, 13.76) and preoperative liver failure (P=0.015; OR, 10.28) as independent risk factors for mortality. Cox-regression analysis revealed the following predictors for long term mortality: age over 75 years (P<0.001; OR, 3.5), preoperative dialysis (P<0.01; OR, 2.14), ejection fraction less than 30% (P=0.003; OR, 3.28) and urgent or emergency operation (P<0.001; OR, 2.3). CONCLUSIONS: Minimally invasive AVR can be performed safely and effectively with very few perioperative complications. The early and long-term outcomes in these patients are acceptable.

Improved mitral valve performance after transapical aortic valve implantation.

BACKGROUND: Concomitant mitral regurgitation (MR) is frequently present before the performance of transapical aortic valve implantation (TA-AVI). Our aim was to study the impact of MR on outcome and the effect of TA-AVI on MR using the Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, CA). METHODS: A total of 439 patients aged 81.5±6.4 years, 64.0% of whom were women, underwent TA-AVI between February 2006 and August 2011. The mean logistic EuroSCORE was 29.7%±15.7% and the mean Society of Thoracic Surgeons (STS) score was 11.4%±7.6%. Outcome was assessed in patients with absent (9.8%), mild or trivial (58.5%), moderate (29.7%), and severe (2.0%) MR by pre- and postoperative echocardiography. RESULTS: Patients with moderate/severe MR versus mild or trivial MR had an increased in-hospital mortality (adjusted hazard ratio [HR], 3.98; 95% confidence interval [CI], 1.79-8.84; p=0.001) but a comparable 4-year survival (adjusted HR, 1.29; 95% CI, 0.47-3.49; p=0.623). During postoperative echocardiographic examination, there was an overall improvement in mitral incompetence (absent in 23.6%, mild in 58.6%, moderate in 17.8%, and severe in none). Independent multivariate variables associated with improved MR were MR greater than 1+ (odds ratio [OR], 7.73; p<0.001), the presence of functional MR (OR, 3.66; p=0.011), left ventricular ejection fraction (LVEF) of 60% or more (OR, 3.28; p=0.002), and a mean transaortic gradient (OR, 1.03; p=0.005). CONCLUSIONS: Moderate/severe MR before TA-AVI is associated with an increased early, but a comparable late, mortality. We observed an overall improved mitral valve performance, possibly resulting from reducing both subvalvular traction and closure forces acting on the mitral valve.

Transapical aortic valve-in-valve-in-valve implantation as a procedural rescue option.

Device malposition and dysfunction with resultant severe aortic insufficiency are known complications of transcatheter aortic valve implantation (TAVI). Fortunately, these complications can often be successfully treated with a transcatheter valve-in-valve (VinV) implantation. However, prosthetic leaflet dysfunction or immobility from the VinV configuration can lead to severe central aortic insufficiency. We report the first known case of implantation of a third SAPIEN prosthesis (Edwards Lifesciences, Irvine, CA) during TAVI as a valuable bailout strategy to deal with severe aortic insufficiency after VinV implantation.

Is the new EuroSCORE II a better predictor for transapical aortic valve implantation?

OBJECTIVES: Conventional surgical risk scores are used to identify suitable candidates for transapical aortic valve implantation (TA-AVI) at present. However, these scores do not consider multiple high-risk conditions, including porcelain aorta, mediastinal irradiation or frailty. The aim of this study was to compare the predictive ability of the new EuroSCORE II with the surgical risk scores currently in use. METHODS: From February 2006 to May 2011, 360 consecutive high-risk patients, age 81.6 ± 6.4 years, 64.4% female, were included using the Edwards SAPIEN™ prosthesis. The prognostic value of the EuroSCORE II was evaluated and compared with the logistic EuroSCORE and STS mortality score by receiver operating characteristics (ROC) curve analysis. In addition, a Spearman correlation analysis was performed, and a stepwise multivariate Cox regression used to identify the independent risk factors of mortality. RESULTS: The STS score and EuroSCORE II (r = 0.504, P < 0.001) showed a good correlation, while a strong correlation was found between the logistic EuroSCORE and EuroSCORE II (r = 0.717, P < 0.001). Thirty-day and in-hospital mortality rates were 10.6% (38 of 360) and 11.4% (41 of 360), respectively. In-hospital mortality rate was estimated by the logistic EuroSCORE: 30.0 ± 15.7%, the STS score: 11.7 ± 7.8% and the EuroSCORE II: 6.7 ± 5.1%. The prognostic values of the STS score, logistic EuroSCORE and the recent EuroSCORE II systems were analysed by ROC curve analysis for the prediction of 30-day (area under the curve, AUC: 0.64 vs 0.55 vs 0.50) and in-hospital mortality (AUC: 0.65 vs 0.54 vs 0.49). Multivariate regression analysis revealed length of preoperative hospital stay >5 days, body weight <65 kg, preoperative aortic annular diameter ≤ 20 mm, vital capacity <70% and concomitant mitral regurgitation >1+ as independent risk factors. CONCLUSION: In patients undergoing TA-AVI, the new EuroSCORE II correlates strongly with the logistic EuroSCORE, but is a poorer predictor of 30-day and in-hospital mortality than the STS score. A true transcatheter aortic valve implantation risk score would be desirable beyond the established scores.

Inter-individual variance and cardiac cycle dependency of aortic root dimensions and shape as assessed by ECG-gated multi-slice computed tomography in patients with severe aortic stenosis prior to transcatheter aortic valve implantation: is it crucial for correct sizing?

To evaluate the inter-individual variance and the variability of the aortic root dimensions during the cardiac cycle by computed tomography (CT) in patients with severe aortic stenosis prior to transcatheter aortic valve implantation (TAVI). Fifty-six patients (m/w = 16/40, 81 ± 6.8 years), scheduled for a transapical aortic valve implantation with available preprocedural ECG-gated CT were retrospectively included. The evaluation included sizing of the aortic annulus and the aortic sinus, measurements of the coronary topography, aortic valve planimetry and scoring of calcification. The new defined aortic annulus sphericity ratio revealed a mostly elliptical shape with increasing diastolic deformation. The calculated effective diameter (ED), determined from the annulus' lumen area, turned out to be the parameter least affected from cardiac cycle changes while systolic and diastolic annulus dimensions and shape (diameter and area) differed significantly (p < 0.001). In about 70 % of the patients with relevant paravalvular leaks the finally implanted prosthesis was too small according to the CT based calculated ED. The ostial height of the coronaries showed a high variability with a critical minimum range <5 mm. The degree of the aortic calcification did not have an influence on the aortic annulus deformation during the cardiac cycle, but on the occurrence of paravalvular leaks. The aortic root anatomy demonstrated a high inter-individual variability and cardiac cycle dependency. These results must be strongly considered during the patient evaluation prior to TAVI to avoid complications. The systolic effective diameter, as measured by ECG-gated CT, represents an appropriate parameter for sizing the aortic annulus.

Surgical therapy of atrial fibrillation.

Atrial fibrillation (AF) can be found in an increasing number of cardiac surgical patients due to a higher patient's age and comorbidities. Atrial fibrillation is known, however, to be a risk factor for a greater mortality, and one aim of intraoperative AF treatment is to approximate early and long-term survival of AF patients to survival of patients with preoperative sinus rhythm. Today, surgeons are more and more able to perform less complex, that is, minimally invasive cardiac surgical procedures. The evolution of alternative ablation technologies using different energy sources has revolutionized the surgical therapy of atrial fibrillation and allows adding the ablation therapy without adding significant risk. Thus, the surgical treatment of atrial fibrillation in combination with the cardiac surgery procedure allows to improve the postoperative long-term survival and to reduce permanent anticoagulation in these patients. This paper focuses on the variety of incisions, lesion sets, and surgical techniques, as well as energy modalities and results of AF ablation and also summarizes future trends and current devices in use.

Aortic valve calcium scoring is a predictor of significant paravalvular aortic insufficiency in transapical-aortic valve implantation.

OBJECTIVE: Transapical-aortic valve implantation (TA-AVI) has evolved as routine for selected high-risk patients. However, paravalvular leaks >1+ remain an unsolved issue using current generations of transcatheter valve devices. The purpose of this study was to investigate the impact of native aortic valve calcification on paravalvular leaks and outcomes using the Edwards SAPIEN™ prosthesis. METHODS: One hundred and twenty consecutive patients (out of 307 TA-AVIs) with preoperative computed tomography aged 82.6 ± 6.2 years, 75.0% female were included. Implanted prosthetic valve sizes were 23 mm (n = 31) and 26 mm (n = 89), respectively. Mean logistic European System for Cardiac Operative Risk Evaluation-Score was 30.1 ± 15.5% and mean Society of Thoracic Surgeons-Score was 12.8 ± 7.9%. Electrocardiographic (ECG)-gated cardiac computed tomography allowed to quantify the amount of calcification of aortic valve leaflets using a scoring analogous to the Agatston calcium scoring of coronary arteries [Aortic Valve Calcium Scoring (AVCS)]. Paravalvular leaks were assessed intraoperatively by echocardiography and root angiography. RESULTS: All valves were implanted successfully. The mean AVCS in patients without paravalvular leaks (n = 66) was 2704 ± 1510; with mild paravalvular leaks (n = 31) was 3804 ± 2739 (P = 0.05); and with moderate paravalvular leaks (n = 4) was 7387 ± 1044 (P = 0.002). There was a significant association between the AVCS and paravalvular leaks [odds ratio (OR; per AVCS of 1000), 11.38; 95% confidence interval (CI) 2.33-55.53; P = 0.001)] and a trend towards a higher incidence of new pacemaker implantation (OR 1.27; 95% CI 0.85-1.89; P = 0.26). No association was found to 30-day mortality, major cardiac events and stroke rate (OR 1.05; 95% CI 0.84-1.32; P = 0.68; OR 0.92; 95% CI 0.68-1.25; P = 0.57 and OR 0.90; 95% CI 0.41-1.96; P = 0.79, respectively). Overall 30-day mortality was 14.2%. CONCLUSION: Severe native valve calcifications are predictive for postoperative relevant paravalvular leak. AVCS prior to TA-AVI might serve as an additional tool to reconsider the TAVI indication to reduce the risk of paravalvular leaks especially in so-called operable patients.