| 1. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370(19):1790-1798. |
Experimental-Tx |
795 Patients |
To compare transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. |
A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke. |
1 |
| 2. Buellesfeld L, Gerckens U, Schuler G, et al. 2-year follow-up of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis. J Am Coll Cardiol. 2011;57(16):1650-1657. |
Observational-Tx |
126 patients |
To evaluate the safety, device performance, and clinical outcome up to 2 years for patients undergoing TAVI. |
In all, 126 patients (mean age 82 years, 42.9% male, mean logistic European System for Cardiac Operative Risk Evaluation score 23.4%) with severe aortic valve stenosis (mean gradient 46.8 mm Hg) underwent the TAVI procedure. Access was transfemoral in all but 2 cases with subclavian access. Retrospective risk stratification classified 54 patients as moderate surgical risk, 51 patients as high-risk operable, and 21 patients as high-risk inoperable. The overall technical success rate was 83.1%. 30-day all-cause mortality was 15.2%, without significant differences in the subgroups. At 2 years, all-cause mortality was 38.1%, with a significant difference between the moderate-risk group and the combined high-risk groups (27.8% vs 45.8%, P=0.04). This difference was mainly attributable to an increased risk of noncardiac mortality among patients constituting the high-risk groups. Hemodynamic results remained unchanged during follow-up (mean gradient: 8.5 +/- 2.5 mm Hg at 30 days and 9.0 +/- 3.4 mm Hg at 2 years). Functional class improved in 80% of patients and remained stable over time. There was no incidence of structural valve deterioration. |
2 |
| 3. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-1607. |
Observational-Tx |
358 patients |
To report the outcomes with TAVI as compared with standard therapy among the patients in the PARTNER trial who were not suitable candidates for surgery. |
A total of 358 patients with AS who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan-Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (HR with TAVI, 0.55; 95% CI, 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (HR, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs 1.1%, P=0.06) and major vascular complications (16.2% vs 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram |
2 |
| 4. Meredith Am IT, Walters DL, Dumonteil N, et al. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol. 2014;64(13):1339-1348. |
Observational-Tx |
120 Patients |
To assess safety and performance of REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System (REPRISE II) in patients at high risk for surgical intervention. |
Mean age was 84.4 years, 57% of the patients were female, and 76% were New York Heart Association functional class III/IV. Mean aortic valve area was 0.7 0.2 cm2. The valve was successfully implanted in all patients, with no cases of valve embolization, ectopic valve deployment, or additional valve implantation. All repositioning (n ¼ 26) and retrieval (n ¼ 6) attempts were successful; 34 patients (28.6%) received a permanent pacemaker. The primary device performance endpoint was met, because the mean gradient improved from 46.4 15.0 mm Hg to 11.5 5.2 mm Hg. At 30 days, the mortality rate was 4.2%, and the rate of disabling stroke was 1.7%; 1 (1.0%) patient had moderate PVR, whereas none had severe PVR. |
2 |
| 5. Mohr FW, Holzhey D, Mollmann H, et al. The German Aortic Valve Registry: 1-year results from 13,680 patients with aortic valve disease. Eur J Cardiothorac Surg. 2014;46(5):808-816. |
Review/Other-Tx |
13,860 Patients |
To gather clinical information on all aortic valve procedures (transcutaneous and conventional, including patients being treated for coronary disease) currently being performed in Germany. |
The 1-year mortality rate was 6.7% for conventional AVR patients (n = 6523) and 11.0% for patients who underwent AVR with coronary artery bypass grafting (n = 3464). The 1-year mortality rate was 20.7 and 28.0% in TV- and TA-TAVR patients, respectively (n = 2695 and 1181). However, if patients were stratified into four risk groups by means of the EuroSCORE and the German AV Score, the highest risk cohorts showed the same mortality at 1 year with either therapy. More than 80% of patients in all groups were in the same or better state of health at 1 year post-intervention and were satisfied with the procedural outcome. |
4 |
| 6. Schymik G, Lefevre T, Bartorelli AL, et al. European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry. JACC Cardiovasc Interv. 2015;8(5):657-669. |
Observational-Tx |
2,688 Patients |
To describe the baseline risk factors in the patient population undergoing TAVR with the balloon-expandable valve and the clinical outcomes at 30 days and 1 year after implantation of the SAPIEN XT valve in a real-world setting. |
The mean age was 81.4 +/- 6.6 years, 42.3% were male, and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 20.4 +/- 12.4%. Patients had a high burden of coronary disease (44.2%), diabetes (29.4%), renal insufficiency (28.9%), atrial fibrillation (25.6%), and peripheral vascular disease (21.2%). Survival was 93.7% at 30 days and 80.6% at 1 year. At 30-day follow-up, the stroke rate was 3.6%, the rate of major vascular complications was 6.5%, the rate of life-threatening bleeding was 5.5%, the rate of new pacemakers was 9.5%, and the rate of moderate/severe paravalvular leak was 5.5%. Multivariable analysis identified nontransfemoral approach (hazard ratio [HR]: 1.84; p < 0.0001), renal insufficiency (HR: 1.53; p < 0.0001), liver disease (HR: 1.67; p = 0.0453), moderate/severe tricuspid regurgitation (HR: 1.47; p = 0.0019), porcelain aorta (HR: 1.47; p = 0.0352), and atrial fibrillation (HR: 1.41; p = 0.0014), with the highest HRs for 1-year mortality. Major vascular complications and major/life-threatening bleeding were the most frequently seen complications associated with a significant increase in 1-year mortality. |
2 |
| 7. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187-2198. |
Experimental-Tx |
699 patients |
To describe the results for the highrisk subgroup of patients in the PARTNER trial who were still candidates for surgical valve replacement and who were randomly assigned to undergo either transcatheter or surgical replacement of the aortic valve. |
The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% CI, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference. |
1 |
| 8. Thomas M, Schymik G, Walther T, et al. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011;124(4):425-433. |
Observational-Tx |
463 transfemoral patients and 575 transapical patients |
To present the outcomes of the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry which was designed to assess initial post commercial clinical TAVI results of the Edwards SAPIEN valve in consecutive patients in Europe. |
Cohort 1 consists of 1,038 patients enrolled at 32 centers. 1-year outcomes are presented. Patients with the transapical approach (n=575) suffered more comorbidities than transfemoral patients (n=463) with a significantly higher logistic EuroSCORE (29% vs 25.8%; P=0.007). These groups are different; therefore, outcomes cannot be directly compared. Total Kaplan Meier 1-year survival was 76.1% overall, 72.1% for transapical and 81.1% for transfemoral patients, and 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II at 1 year. Combined transapical and transfemoral causes of death were cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent noncardiac causes of death. Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest HRs for 1-year mortality whereas carotid artery stenosis, hyperlipidemia, and hypertension were associated with lower mortality. |
2 |
| 9. Webb J, Gerosa G, Lefevre T, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 64(21):2235-43, 2014 Dec 02. |
Observational-Dx |
150 |
To evaluate whether TAVR with this third-generation valve would be a viable alternative to high- or intermediate-risk surgery for severe aortic stenosis. |
Patients were 83.6 +/- 5.0 years of age, with multiple comorbidities reflected by a Society of Thoracic Surgeons score of 7.4 +/- 4.5% and logistic EuroSCORE of 21.6 +/- 12.3%. A transfemoral approach was chosen in 64.0% and alternative access (transapical/direct aortic) in the remainder. At 30 days, paravalvular regurgitation was none to mild in 96.4% and moderate in 3.5%. No patient had severe regurgitation. Transfemoral implantation was associated with low mortality (2.1%), no disabling stroke (0.0%), and fully percutaneous access and closure in 95.8%. Nontransfemoral alternative access was associated with higher rates of mortality (11.6%) and stroke (5.6%). |
2 |
| 10. Zahn R, Gerckens U, Grube E, et al. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J. 2011;32(2):198-204. |
Observational-Tx |
697 patients |
To evaluate indications, interventions, and clinical outcome as well as quality of life measurements of the TAVI procedure in routine clinical practice. |
Between January 2009 and December 2009, a total of 697 patients (81.4 +/- 6.3 years, 44.2% males, and logistic EuroScore 20.5 +/- 13.2%) underwent TAVI. Preoperative aortic valve area was 0.6 +/- 0.2 cm(2) with a mean transvalvular gradient of 48.7 +/- 17.2 mmHg. TAVI was performed percutaneously in the majority of patients [666 (95.6%)]. Only 31 (4.4%) procedures were done surgically: 26 (3.7%) transapically and 5 (0.7%) transaortically. The Medtronic CoreValve prosthesis was used in 84.4%, whereas the Sapien Edwards prosthesis was used in the remaining cases. Technical success was achieved in 98.4% with a post-operative mean transaortic pressure gradient of 5.4 +/- 6.2 mmHg. Any residual aortic regurgitation was observed in 72.4% of patients, with a significant aortic insufficiency (=Grade III) in only 16 patients (2.3%). Complications included pericardial tamponade in 1.8% and stroke in 2.8% of patients. Permanent pacemaker implantation after TAVI became necessary in 39.3% of patients. In-hospital death rate was 8.2% and the 30-day death rate 12.4%. |
1 |
| 11. Ueshima D, Fovino LN, D'Amico G, Brener SJ, Esposito G, Tarantini G. Transcatheter versus surgical aortic valve replacement in low- and intermediate-risk patients: an updated systematic review and meta-analysis. Cardiovasc Interv Ther. 34(3):216-225, 2019 Jul. |
Meta-analysis |
17 articles (9805 patients) |
To comprehensively assess outcomes of low- and intermediate-risk patients with symptomatic severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) vs. surgical valve replacement (SAVR) in randomized and observational studies. |
Seventeen articles including 9805 (4956 TAVR and 4849 SAVR) patients were eligible. There was no significant difference in all-cause mortality at short term [odds ratio (OR) 0.83, 95% confidence interval (CI) 0.63-1.09], 1 year (OR 1.01, 95% CI 0.86-1.20) and 2 years (OR 0.86, 95% CI 0.64-1.16) between treatment groups. Subgroup analyses stratified by surgical risk score (low-risk subgroup: STS < 4% or EuroSCORE < 10%, intermediate-risk subgroup: the others) did not show interaction on primary endpoints. Compared to SAVR, TAVR had similar rates of neurological events, significantly lower risk of MI and AKI, but higher risk of vascular complications, new PM implantation and moderate/severe PVL. In low- and intermediate-risk patients, TAVR and SAVR have similar short- and mid-term all-cause mortality. Compared to SAVR, TAVR carries higher rates of vascular complications, PM implantation and moderate/severe PVL, but lower risk of MI and AKI. |
Good |
| 12. Achenbach S, Delgado V, Hausleiter J, Schoenhagen P, Min JK, Leipsic JA. SCCT expert consensus document on computed tomography imaging before transcatheter aortic valve implantation (TAVI)/transcatheter aortic valve replacement (TAVR). J Cardiovasc Comput Tomogr. 2012;6(6):366-380. |
Review/Other-Dx |
N/A |
This consensus document provides recommendations about the use of CT imaging in patients scheduled for TAVR/TAVI, including data acquisition, interpretation, and reporting. |
CT imaging plays an important role in procedural planning for TAVI/TAVR and should be a fully integrated component of any TAVI/TAVR program. The use of CT in TAVI/TAVR is multifaceted and should include the assessment of vascular access of the aortic valve, annulus, and root and of the orientation of the annulus plane. Importantly, the person responsible for the interpretation of the CT examination should be integrated in the TAVI/TAVR team to ensure appropriate incorporation into the patient selection process and procedure planning. |
4 |
| 13. Barbanti M, Yang TH, Rodes Cabau J, et al. Anatomical and procedural features associated with aortic root rupture during balloon-expandable transcatheter aortic valve replacement. Circulation. 2013;128(3):244-253. |
Observational-Dx |
31 Patients |
To identify predictors of aortic root rupture during balloon-expandable TAVR by using multidetector computed tomography. |
There were no significant differences between the 2 groups in any preoperative clinical and echocardiographic variables. Aortic root rupture was identified in 20 patients and periaortic hematoma in 11. Patients with root rupture had a higher degree of subannular/LVOT calcification quantified by the Agatston score (181.2±211.0 versus 22.5±37.6, P<0.001), and a higher frequency of =20% annular area oversizing (79.4% versus 29.0%, P<0.001) and balloon postdilatation (22.6% versus 0.0%, P=0.005). In conditional logistic regression analysis for the matched data, moderate/severe LVOT/subannular calcifications (odds ratio, 10.92; 95% confidence interval, 3.23–36.91; P<0.001) and prosthesis oversizing =20% (odds ratio, 8.38; 95% confidence interval, 2.67–26.33; P<0.001) were associated with aortic root contained/noncontained rupture. |
2 |
| 14. Binder RK, Leipsic J, Wood D, et al. Prediction of optimal deployment projection for transcatheter aortic valve replacement: angiographic 3-dimensional reconstruction of the aortic root versus multidetector computed tomography. Circ Cardiovasc Interv. 2012;5(2):247-252. |
Observational-Dx |
40 patients |
To evaluate the ability and practicability of 3D angiographic reconstructions to find the optimal perpendicular valve projection for accurate positioning and deployment of valve prosthesis in TAVR and compared this method with MDCT. |
Patients underwent preimplant 3D angiographic reconstructions and 68% underwent preimplant MDCT. 3D angiographic reconstructions were generated from images of a C-arm rotational aortic root angiogram during breath-hold, rapid ventricular pacing, and injection of 32 mL contrast medium at 8 mL/s. Two independent operators prospectively predicted perpendicular valve projections. The implant angle was chosen at the discretion of the physician performing TAVR. The angles from 3D angiographic reconstructions, from MDCT, the implant angle, and the postdeployment perpendicular prosthesis view were compared. The shortest distance from the postdeployment perpendicular prosthesis projection to the regression line of predicted perpendicular projections was calculated. All but 1 patient had adequate image quality for reproducible angle predictions. There was a significant correlation between 3D angiographic reconstructions and MDCT for prediction of perpendicular valve projections (r=0.682, P<0.001). Deviation from the regression line of predicted angles to the postdeployment prosthesis view was 5.1+/-4.6 degrees for 3D angiographic reconstructions and 7.9+/-4.9 degrees for MDCT (P=0.01). |
2 |
| 15. Binder RK, Webb JG, Willson AB, et al. The impact of integration of a multidetector computed tomography annulus area sizing algorithm on outcomes of transcatheter aortic valve replacement: a prospective, multicenter, controlled trial. J Am Coll Cardiol. 62(5):431-8, 2013 Jul 30. |
Observational-Dx |
266 Patients |
To investigate the impact of integration of a multidetector computed tomography (MDCT) annular area sizing algorithm on transcatheter aortic valve replacement (TAVR) outcomes. |
Of 266 patients, 133 consecutive patients underwent TAVR (SAPIEN XT THV) in the MDCT group and 133 consecutive patients were in the control group. More than mild PAR was present in 5.3% (7 of 133) of the MDCT group and in 12.8% (17 of 133) in the control group (p = 0.032). The combined secondary endpoint occurred in 3.8% (5 of 133) of the MDCT group and in 11.3% (15 of 133) of the control group (p = 0.02), driven by the difference of severe PAR. |
2 |
| 16. Bloomfield GS, Gillam LD, Hahn RT, et al. A practical guide to multimodality imaging of transcatheter aortic valve replacement. JACC Cardiovasc Imaging. 2012;5(4):441-455. |
Review/Other-Dx |
N/A |
To address the requirements for and utility of multimodality imaging in the continuum of TAVR patient care. |
No results stated in abstract. |
4 |
| 17. Gurvitch R, Wood DA, Leipsic J, et al. Multislice computed tomography for prediction of optimal angiographic deployment projections during transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2010;3(11):1157-1165. |
Observational-Dx |
20 patients |
To describe a novel method of predicting optimal angiographic deployment projections for TAVI and assess whether such predictions may result in improved valve positioning and outcomes. |
Correct final deployment projections were more frequent in the MSCT-guided compared with non-MSCT-guided group: excellent or satisfactory projections (90% vs 65%, P=0.06). The MSCT angle prediction was accurate but dependent on optimal images (optimal images: 93% of predicted angles were excellent or satisfactory, suboptimal images: 73% of predicted angles were poor). A “line of perpendicularity” could be generated with optimal projections across the right-to-left anterior oblique plane by adding the correct cranial or caudal angulation. |
3 |
| 18. Hayashida K, Lefevre T, Chevalier B, et al. Transfemoral aortic valve implantation new criteria to predict vascular complications. JACC Cardiovasc Interv. 2011;4(8):851-858. |
Observational-Dx |
130 Patients |
To evaluate the incidence, impact, and predictors of vascular complications in transcatheter aortic valve implantation (TAVI). |
In our cohort of elderly patients (83.3 +/- 5.9 years), the logistic EuroScore was 25.8% +/- 11.9%. The Edwards valve was used in 102 cases (18- to 24-F) and the CoreValve in 27 (18-F). The minimal femoral artery diameter was 8.17 +/- 1.14 mm, and the calcification (0 to 3) and tortuosity scores (0 to 3) were 0.58 +/- 0.72 and 0.28 +/- 0.53, respectively. The mean sheath diameter was 8.10 +/- 0.82 mm, and the mean SFAR was 0.99 +/- 0.16. Vascular complications occurred in 27.6% (VARC major: 17.3%, minor: 10.2%), and major vascular complications predicted 30-day mortality (22.7% vs. 7.6%, p = 0.049). The SFAR (hazard ratio [HR]: 186.20, 95% confidence interval [CI]: 4.41 to 7,855.11), center experience (HR: 3.66, 95% CI: 1.17 to 11.49), and femoral calcification (HR: 3.44, 95% CI: 1.16 to 10.17) predicted major complications by multivariate analysis. An SFAR threshold of 1.05 (area under the curve = 0.727) predicted a higher rate of VARC major complications (30.9% vs. 6.9%, p = 0.001) and 30-day mortality (18.2% vs. 4.2%, p = 0.016). |
2 |
| 19. Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366(18):1686-1695. |
Observational-Tx |
699 Patients |
To describe the 2-year (and longer) clinical outcomes and echocardiographic findings after TAVR or surgical aortic-valve replacement in the high-risk patients in the PARTNER trial who could undergo surgery. |
The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). |
1 |
| 20. Kurra V, Kapadia SR, Tuzcu EM, et al. Pre-procedural imaging of aortic root orientation and dimensions: comparison between X-ray angiographic planar imaging and 3-dimensional multidetector row computed tomography. JACC Cardiovasc Interv. 2010;3(1):105-113. |
Observational-Dx |
40 patients |
To examine whether contrast-enhanced MDCT allows prediction of X-ray angiographic planes for the root angiogram in the context of TAVI. |
The cranial angulation in the left anterior oblique X-ray angiograms (mean left anterior oblique: 39+/- 8, n=38) and matched MDCT images were not significantly different (cranial: 25 +/- 7 vs 23 +/- 8; P=0.214). There was a small but significant difference between the caudal angulation in the right anterior oblique angiogram (mean right anterior oblique: 25 +/- 5, n=40) and matched CT images (caudal: 21 +/- 9 vs 29 +/- 10; P=0.002). The annulus diameter in the left anterior oblique projection was not significantly different between X-ray angiography and contrast-enhanced MDCT (2.3 +/- 0.3 vs 2.4 +/- 0.3; P=0.052), whereas there was a small but significant difference in the annulus diameter in right anterior oblique projections between angiography and MDCT (2.4 +/- 0.3 vs 2.2 +/- 0.3; P=0.029). |
2 |
| 21. Mack MJ. Access for transcatheter aortic valve replacement: which is the preferred route? JACC Cardiovasc Interv. 2012;5(5):487-488. |
Review/Other-Tx |
N/A |
Commentary on method of delivery access for TAVR. |
No results stated in abstract. |
4 |
| 22. Mylotte D, Dorfmeister M, Elhmidi Y, et al. Erroneous measurement of the aortic annular diameter using 2-dimensional echocardiography resulting in inappropriate CoreValve size selection: a retrospective comparison with multislice computed tomography. JACC Cardiovasc Interv. 2014;7(6):652-661. |
Observational-Dx |
157 Patients |
To assess the differential adherence to transcatheter heart valve (THV)-oversizing principles between transesophageal echocardiography (TEE) and multislice computed tomography (CT) and its impact on the incidence of paravalvular leak (PVL). |
Using TEE-derived annulus measurements, 157 patients underwent CoreValve implantation (23 mm: n = 66; 29 mm: n = 91). The estimated THV oversizing on the basis of TEE was 20.1 +/- 8.2%. Retrospective CT analysis yielded larger annular diameters than TEE (p < 0.0001). When these CT diameters were used to recalculate the percentage of oversizing achieved with the TEE-selected CoreValve, the actual THV oversizing was only 10.4 +/- 7.8%. Consequently, CT analysis suggested that up to 50% of patients received an inappropriate CoreValve size. When CT-based sizing criteria were satisfied, the incidence of PVL was 21% lower than that with echocardiography (14% vs. 35%; p = 0.003). Adherence to CT-based oversizing was independently associated with a reduced incidence of PVL (odds ratio 0.36; 95% confidence interval: 0.14 to 0.90; p = 0.029); adherence to TEE-based sizing was not. |
3 |
| 23. Okuyama K, Jilaihawi H, Kashif M, et al. Transfemoral access assessment for transcatheter aortic valve replacement: evidence-based application of computed tomography over invasive angiography. Circulation. Cardiovascular imaging. 8(1), 2015 Jan. |
Observational-Dx |
496 transfemoral cases |
To compare the predictive value of vascular CT and angiography for VCs, to identify the optimal imaging strategy to best predict VCs, and thereby streamline and provide a clear evidence base for practice. |
In patients undergoing both contrast CT and angiography (n=283; 35 SRCs), contrast CT showed a greater predictive value than angiography by area under the curve P<0.001): 0.87 (95% confidence interval: 0.82–0.91) versus 0.72 (95% confidence interval: 0.66–0.77). In patients undergoing both noncontrast CT and angiography (n=103; 17 SRCs), there was no difference between noncontrast CT and angiography: 0.79 (95% confidence interval: 0.70–0.86) versus 0.73 (95% confidence interval: 0.63–0.81). Three dimensional assessments of calcification and tortuosity provided limited additional value for SRC prediction. |
3 |
| 24. Ribeiro HB, Webb JG, Makkar RR, et al. Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: insights from a large multicenter registry. J Am Coll Cardiol. 2013;62(17):1552-1562. |
Observational-Dx |
44 Patients |
To evaluate the main baseline and procedural characteristics, management, and clinical outcomes of patients from a large cohort of patients undergoing transcatheter aortic valve implantation (TAVI) who suffered coronary obstruction (CO). |
Baseline and procedural variables associated with CO were older age (p < 0.001), female sex (p < 0.001), no previous coronary artery bypass graft (p = 0.043), the use of a balloon-expandable valve (p = 0.023), and previous surgical aortic bioprosthesis (p = 0.045). The left coronary artery was the most commonly involved (88.6%). The mean left coronary artery ostia height and sinus of Valsalva diameters were lower in patients with obstruction than in control subjects (10.6 +/- 2.1 mm vs. 13.4 +/- 2.1 mm, p < 0.001; 28.1 +/- 3.8 mm vs. 31.9 +/- 4.1 mm, p < 0.001). Differences between groups remained significant after the case-matched analysis (p < 0.001 for coronary height; p = 0.01 for sinus of Valsalva diameter). Most patients presented with persistent severe hypotension (68.2%) and electrocardiographic changes (56.8%). Percutaneous coronary intervention was attempted in 75% of the cases and was successful in 81.8%. Thirty-day mortality was 40.9%. After a median follow-up of 12 (2 to 18) months, the cumulative mortality rate was 45.5%, and there were no cases of stent thrombosis or reintervention. |
3 |
| 25. Toggweiler S, Gurvitch R, Leipsic J, et al. Percutaneous aortic valve replacement: vascular outcomes with a fully percutaneous procedure. J Am Coll Cardiol. 2012;59(2):113-118. |
Observational-Dx |
137 Patients |
To evaluate vascular complications in a consecutive patient population undergoing transfemoral percutaneous aortic valve replacement (PAVR) using current Valve Academic Research Consortium (VARC) definitions. |
PAVR was performed in 137 consecutive patients. All but 1 patient underwent planned arteriotomy closure using a percutaneous pre-closure technique. Smaller sheaths, rigorous angiographic and computed tomographic screening and patient selection, and percutaneous vascular repair techniques were increasingly used over this period. From 2009 to 2010, major vascular complications decreased from 8% to 1% (p = 0.06), minor vascular complications decreased from 24% to 8% (p < 0.01), major bleeds fell from 14% to 1% (p < 0.01), and unplanned surgery decreased from 28% to 2% (p < 0.01). A minimal artery diameter smaller than the external sheath diameter, moderate or severe calcification, and peripheral vascular disease were associated with higher vascular complication rates. |
2 |
| 26. Blanke P, Weir-McCall JR, Achenbach S, et al. Computed Tomography Imaging in the Context of Transcatheter Aortic Valve Implantation (TAVI)/Transcatheter Aortic Valve Replacement (TAVR): An Expert Consensus Document of the Society of Cardiovascular Computed Tomography. JACC Cardiovasc Imaging 2019;12:1-24. |
Review/Other-Dx |
N/A |
No abstract available |
No abstract available |
4 |
| 27. Nishimura RA, Otto CM, Bonow RO, et al. 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 Practice Guidelines. J Am Coll Cardiol. 2014;63(22):e57-185. |
Review/Other-Dx |
N/A |
To provide guidelines for the management of patients with valvular heart disease. |
No results in abstract |
4 |
| 28. Baumgartner H, Hung J, Bermejo J, et al. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. J Am Soc Echocardiogr. 2009;22(1):1-23; quiz 101-102. |
Review/Other-Dx |
N/A |
To detail the recommended approach to the echocardiographic evaluation of valve stenosis, including recommendations for specific measures of stenosis severity, details of data acquisition and measurement, and grading of severity. |
No results stated in abstract. |
4 |
| 29. Bonow RO, Carabello BA, Chatterjee K, et al. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008;52(13):e1-142. |
Review/Other-Dx |
N/A |
To provide guidelines for the management of patients with valvular heart disease. |
No results stated in abstract. |
4 |
| 30. Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012;42(4):S1-44. |
Review/Other-Dx |
N/A |
To provide guidelines on the management of valvular heart disease (2012). |
No results stated in abstract. |
4 |
| 31. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2022;43:561-632. |
Review/Other-Dx |
N/A |
To provide guidelines on valvular heart disease that summarize and evaluate available evidence with the aim of assisting health professionals in proposing the best management strategies for an individual patient. |
No results available |
4 |
| 32. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2021;143:e72-e227. |
Review/Other-Dx |
N/A |
To provide guidelines on the diagnosis and management of adult patients with valvular heart disease (VHD). |
No results available |
4 |
| 33. American College of Radiology. ACR–NASCI–SIR–SPR Practice Parameter for the Performance and Interpretation of Body Computed Tomography Angiography (CTA). Available at: https://www.acr.org/-/media/ACR/Files/Practice-Parameters/body-cta.pdf. |
Review/Other-Dx |
N/A |
Guidance document to promote the safe and effective use of diagnostic and therapeutic radiology by describing specific training, skills and techniques. |
No abstract available. |
4 |
| 34. Petronio AS, Angelillis M, De Backer O, et al. Bicuspid aortic valve sizing for transcatheter aortic valve implantation: Development and validation of an algorithm based on multi-slice computed tomography. Journal of cardiovascular computed tomography. 14(5):452-461, 2020 Sep - Oct. |
Observational-Dx |
19 patients in Cohort 1; 21 patients in Cohort 2 |
To develop and validate a Multi-Slice Computed Tomography (MSCT)-based algorithm for transcatheter heart valve (THV) sizing in patients with stenotic BAV under evaluation for TAVI. |
In the first cohort, a high correlation was found between the raphe-level area measured at pre-procedural MSCT and the smallest THV area measured at post-procedural MSCT (p < 0.001). Moreover, reduced THV expansion was observed among patients with higher calcium burden (p = 0.048). Then, a new algorithm for TAVI sizing in BAV was develop (CASPER: Calcium Algorithm Sizing for bicusPid Evaluation with Raphe). This algorithm is based on the reassessment of the perimeter/area derived annulus diameter, according to three main anatomical features: 1) the ratio between raphe length and annulus diameter; 2)calcium burden; 3)calcium distribution in relation to the raphe. The algorithm was then validated in a new cohort of 21 patients, achieving 100% of procedural success and excellent TAVI performance. |
1 |
| 35. Kim WK, Liebetrau C, Fischer-Rasokat U, et al. Challenges of recognizing bicuspid aortic valve in elderly patients undergoing TAVR. Int J Cardiovasc Imaging. 36(2):251-256, 2020 Feb. |
Observational-Dx |
2583 patients |
To assess the diagnostic value of echocardiography applied in routine clinical practice for the detection of bicuspid aortic valve (BAV) among patients undergoing TAVR. |
Using MDCT criteria, BAV was found in 235 (9.1%) (age 80.1 years [interquartile range 76.4; 83.4], 44.3% female). Of these, only 27/235 (11.5%) had been identified as BAV according to echocardiography reports, whereas 6/2348 (0.3%) with TAV had been wrongly diagnosed as BAV (p < 0.001; sensitivity 11.5%, specificity 99.7%). Correct diagnosis of BAV by echocardiography was more likely when transesophageal echocardiography was available (odds ratio (OR) 5.12 [95% confidence interval (CI) 2.22; 11.80]; p < 0.001) and the reader was experienced (OR 5.28 [95% CI 1.55; 18.04]; p = 0.008). Furthermore, correct diagnosis of BAV was more likely in bicommissural-type BAV (OR 2.22 [95% CI 0.90; 5.48]; p = 0.08), whereas heavy aortic valve calcification lead to misdiagnosis (OR 0.39 [95% CI 0.14; 1.06]; p = 0.07). In elderly patients with severe aortic stenosis that are candidates for TAVR, the presence of BAV may be considerably underestimated when relying solely on routine echocardiography. This underlines the value of MDCT for the screening of BAV in this patient population. |
2 |
| 36. Yoon SH, Kim WK, Dhoble A, et al. Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2020;76:1018-30. |
Observational-Dx |
1,034 Patients |
To evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. |
A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). |
3 |
| 37. Kim WK, Renker M, Rolf A, et al. Annular versus supra-annular sizing for TAVI in bicuspid aortic valve stenosis. EuroIntervention. 15(3):e231-e238, 2019 Jun 12. |
Observational-Dx |
217 BAV patients |
To compare annular versus supra-annular sizing for transcatheter aortic valve implantation (TAVI) in patients with a bicuspid aortic valve (BAV). |
Overall there was no significant difference between ICD and Ann (25.1 [23.5; 27.3] vs. 25.4 [23.6; 27.1] mm; p=0.24); intra-individually, ICD was similar to Ann in 26.7%, smaller in 40.1%, and larger in 33.2%. Annular sizing was appropriate in 96.3%, oversized in 0.5%, and undersized in 3.2% of cases. Supra-annular sizing would have resulted in a divergent size selection in 38.7% (smaller: 17.5%, larger: 19.8%, ICD out of range for TAVI prostheses: 1.4%) with potential improvement in a few cases with annular sizing errors, but potential worsening due to improper size selection in a much larger proportion of patients. |
4 |
| 38. Harbaoui B, Montoy M, Charles P, et al. Aorta calcification burden: Towards an integrative predictor of cardiac outcome after transcatheter aortic valve implantation. Atherosclerosis. 246:161-8, 2016 Mar. |
Observational-Tx |
164 patients |
To determine the effect of total aortic calcification (TAC) burden on outcomes (cardiac mortality, all-cause mortality, and heart failure (HF)) after transcatheter aortic valve implantation (TAVI).To assess the contribution of each segment of the aorta to these outcomes. |
Median duration of follow-up was 565 (interquartile range: 246 to 1000) days. TAC (tertile3 vs. tertile1) was significantly and strongly associated with cardiac mortality (hazard ratio [HR]: 16.74; 95% confidence interval [CI]: 2.21 to 127.05; p = 0.006) and all-cause mortality (HR: 2.39; 95% CI: 1.18 to 4.84; p = 0.015) but not with HF (HR: 1.84; 95% CI: 0.87 to 3.90; p = 0.110). Each segment was associated with cardiac mortality, while only AsAC (tertile 3 vs. tertile 1) appeared predictive of HF (hazard ratio: 2.29; 95% CI: 1.12 to 4.66; p = 0.023). |
2 |
| 39. Murphy DT, Blanke P, Alaamri S, et al. Dynamism of the aortic annulus: Effect of diastolic versus systolic CT annular measurements on device selection in transcatheter aortic valve replacement (TAVR). J Cardiovasc Comput Tomogr. 10(1):37-43, 2016 Jan-Feb. |
Observational-Dx |
507 patients with severe aortic stenosis |
To assess both the variability of aortic annular dimensions throughout the cardiac cycle across a range of sub-annular calcification using computed tomography (CT) and the impact of this variability on device size selection for balloon-expandable valves in a large, all-comer multi-center cohort. |
Mean annular dimensions were larger during systole than diastole (area: 474.4 ± 87.4 mm(2) vs. 438.3 ± 84.3 mm(2) or 8.23%, p < 0.001; perimeter: 78.5 ± 7.2 mm vs. 75.9 ± 7.2 mm or 3.36%, p < 0.001). The magnitude of annular area and perimeter change (systolic minus diastolic measurement) was greater among patients without calcification compared to patients with grade 3 calcification. Using diastolic rather than systolic data for device sizing resulted in a change of the recommended valve size in nearly half of patients for both annular area and perimeter. |
4 |
| 40. Knobloch G, Sweetman S, Bartels C, et al. Inter- and intra-observer repeatability of aortic annulus measurements on screening CT for transcatheter aortic valve replacement (TAVR): Implications for appropriate device sizing. Eur J Radiol. 105:209-215, 2018 Aug. |
Observational-Dx |
82 patients |
To investigate intra- and inter-observer repeatability of aortic annulus CT measurements for transcatheter aortic valve replacement (TAVR) by readers with different levels of experience and evaluate the impact of different multi-reader paradigms to improve prosthesis sizing. |
Intra-observer variability did not differ significantly (range: 50.1-67.8mm2). However, we found significant differences in mean inter-observer variance (p = 0.001). Multi-reader paradigms led to significantly increased precision (lower variability) for scenarios [B] and [C] (p = 0.03, p < 0.05). Compared to single readers, all multi-reader strategies clearly lowered the rate of discrepant device size categorization between repeated measurements (22-26% to 5-10%). |
3 |
| 41. Khalique OK, Hahn RT, Gada H, et al. Quantity and location of aortic valve complex calcification predicts severity and location of paravalvular regurgitation and frequency of post-dilation after balloon-expandable transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2014;7(8):885-894. |
Observational-Dx |
150 patients |
To determine the impact of quantity and location of aortic valve calcification (AVC) on paravalvular regurgitation (PVR) and rates of post-dilation (PD) immediately after transcatheter aortic valve replacement (TAVR). |
Quantity of and asymmetry of AVC for all regions of the aortic valve complex predicted greater than or equal to mild PVR by receiver-operating characteristic analysis (area under the curve = 0.635 to 0.689), except Leaflet asymmetry. Receiver-operating characteristic analysis for PD was significant for quantity and asymmetry of AVC in all regions, with higher area under the curve values than for PVR (area under the curve = 0.648 to 0.741). On multivariable analysis, Leaflet and AnnulusLVOT calcification were independent predictors of both PVR and PD regardless of multidetector row computed tomography area cover index. |
3 |
| 42. Mehier B, Dubourg B, Eltchaninoff H, et al. MDCT planning of trans catheter aortic valve implantation (TAVI): determination of optimal c-arm angulation. Int J Cardiovasc Imaging. 36(8):1551-1557, 2020 Aug. |
Observational-Dx |
79 patients |
To assess the accuracy of MDCT in predicting c-arm angulation at the cath. lab. |
In this single center study, we investigated MDCT prediction of c-arm angulation in patients having undergone a TAVI procedure using SAPIEN 3® (Edwards Lifesciences, USA). Prior to the procedure, an experienced radiologist had reported the angulation using dedicated software (CTreport). After the procedure, a blinded experienced radiologist retrospectively measured the angles using the same method (CTstudy). Interobserver variability was drawn from the comparison between CTreport and CTstudy. Then, the mean angular difference between the predicted MDCT angles (CTstudy) was compared to the working view recorded at the cath. lab. Seventy-nine patients (M/F = 0.65; mean age: 85.2 years ± 5.3) were included. Interobserver variability was 5.9 ± 6.1°. The mean absolute difference between MDCT and fluoroscopy was 8.8 ± 7.1°. The present study showed that MDCT could predict the coplanar fluoroscopic angles prior to TAVI using a balloon-expandable bioprosthesis Sapien 3® placed via a transfemoral approach with a mean angular difference of 8.8 ± 7.1°. Reproducibility was considered good as the mean difference between two independent measures was 5.9 ± 6.1°. |
3 |
| 43. Hansson NC, Norgaard BL, Barbanti M, et al. The impact of calcium volume and distribution in aortic root injury related to balloon-expandable transcatheter aortic valve replacement. J Cardiovasc Comput Tomogr 2015;9:382-92. |
Observational-Tx |
33 patients with aortic root injury and 153 patients with no aortic root injury (control group) |
To delineate the effect of calcium volume and distribution on aortic root injury during TAVR. |
Calcium volumes in the upper LVOT (median, 29 vs 0 mm(3); P < .0001) and overall LVOT (median, 74 vs 3 mm(3); P = .0001) were higher in patients who experienced aortic root injury compared with the control group. Calcium in the aortic valve region did not differ between groups. Upper LVOT calcium volume was more predictive of aortic root injury than overall LVOT calcium volume (area under receiver operating curve [AUC], 0.78; 95% confidence interval, 0.69-0.86 vs AUC, 0.71; 95% confidence interval, 0.62-0.82; P = .010). Upper LVOT calcium below the noncoronary cusp was significantly more predictive of aortic root injury compared to calcium underneath the right coronary cusp or the left coronary cusp (AUC, 0.81 vs 0.68 vs 0.64). Prosthesis oversizing >20% (likelihood ratio test, P = .028) and redilatation (likelihood ratio test, P = .015) improved prediction of aortic root injury by upper LVOT calcium volume. |
2 |
| 44. Waldschmidt L, Gossling A, Ludwig S, et al. Impact of left ventricular outflow tract calcification in patients undergoing transfemoral transcatheter aortic valve implantation. EuroIntervention 2021. |
Observational-Tx |
1,207 patients who underwent transfemoral TAVI |
To assess the prevalence of LVOT calcification as well as its impact on outcomes in a contemporary TAVI patient cohort. |
Significant LVOT calcification, defined as >10 mm3, was present in 37.4% (n=451) of the patient cohort. After applying propensity score matching there was no difference between patients without (w/o; n=358) and with (w; n=358) significant LVOT calcification with respect to baseline clinical characteristics. At 30 days, the composite of all-cause mortality and non-disabling/disabling stroke occurred more often in patients w LVOT calcification compared to those w/o (4.6 vs 10.1%, p=0.008). Moreover, the composite VARC-3 endpoint of device success at 30 days was in favour of patients w/o LVOT calcification (82.2% vs 73.4%, p=0.007). According to Kaplan-Meier analysis, all-cause mortality one year after TAVI was higher in patients w vs w/o LVOT calcification (12.9 vs 21.4 %, p=0.004). |
2 |
| 45. Francone M, Budde RPJ, Bremerich J, et al. CT and MR imaging prior to transcatheter aortic valve implantation: standardisation of scanning protocols, measurements and reporting-a consensus document by the European Society of Cardiovascular Radiology (ESCR). Eur Radiol. 30(5):2627-2650, 2020 May. |
Review/Other-Dx |
N/A |
• To provide a reference document for CT and MR acquisition techniques, taking into account the significant technological variation of available scanners.• To review all relevant measurements that are required and define a step-by-step guided approach for the measurements of different structures implicated in the procedure.• To propose a CT/MR reporting template to assist in consistent communication between various sites and specialists involved in the procedural planning. |
No results provided |
4 |
| 46. Ruile P, Blanke P, Krauss T, et al. Pre-procedural assessment of aortic annulus dimensions for transcatheter aortic valve replacement: comparison of a non-contrast 3D MRA protocol with contrast-enhanced cardiac dual-source CT angiography. Eur Heart J Cardiovasc Imaging. 2016;17(4):458-466. |
Observational-Dx |
104 Patients |
To evaluate the feasibility of a non-contrast three-dimensional (3D)-FLASH magnetic resonance angiography (MRA) protocol for pre-procedural aortic annulus assessment for transcatheter aortic valve replacement (TAVR) in comparison with cardiac dual-source computed tomography angiography (CTA). |
In this prospective study, 69 of 104 consecutive patients (mean age 81.8 +/- 5.4 years, 37.7% arrhythmic) with severe aortic stenosis who had undergone pre-TAVR cardiac CTA received a respiratory and ECG-triggered, non-contrast 3D-FLASH MRA at 3 T. Annular area measurements were obtained at mid-diastole for both modalities whereas maximum systolic area was assessed by CTA only. Systolic MRA dimensions were modelled, by adding the relative difference of systolic and diastolic CTA area dimensions as a corrective factor. Hypothetical prosthesis sizing was performed based on systolic CTA, diastolic, and modelled systolic MRA area measurements. MR image quality and degree of annular calcifications were evaluated using 4-point-grading scales. The mean acquisition time was 14 +/- 4.2 min. The mean image quality was 3.1 +/- 0.9 with only two examinations rated non-diagnostic. The mean degree of calcifications was equal. As assessed by Bland-Altman analysis, there was no relevant systematic difference between area measurements for modelled systolic MRA and systolic CTA [the mean difference -3.1 mm(2) (limits of agreement -44.4 mm(2); 38.2 mm(2))]. Agreement for hypothetical prosthesis sizing was found in 63 of 67 (94%) patients for systolic CTA and modelled systolic MRA. |
1 |
| 47. Chaturvedi A, Hobbs SK, Ling FS, Chaturvedi A, Knight P. MRI evaluation prior to Transcatheter Aortic Valve Implantation (TAVI): When to acquire and how to interpret. Insights Imaging 2016;7:245-54. |
Review/Other-Dx |
N/A |
To discuss the emerging indications of non-contrast MRI in preoperative assessment for TAVI and describe the commonly used MRI sequences. |
No results provided |
4 |
| 48. Mayr A, Klug G, Reinstadler SJ, et al. Is MRI equivalent to CT in the guidance of TAVR? A pilot study. Eur Radiol. 28(11):4625-4634, 2018 Nov. |
Observational-Dx |
16 patients |
To compare a comprehensive cardiovascular magnetic resonance imaging (MRI) protocol with contrast-enhanced computed tomography angiography (CTA) for guidance in transcatheter aortic valve replacement (TAVR) evaluation. |
Aortic annulus measurements by MRI and CTA showed a very strong correlation (r=0.956, p<0.0001; effective annulus area for MRI 430±74 vs. 428±78 mm2 for CTA, p=0.629). Regarding decision for valve size there was complete consistency between MRI and CTA. Moreover, vessel luminal diameters and angulations of aortoiliofemoral access as measured by MRA and CTA showed overall very strong correlations (r= 0.819 to 0.996, all p<0.001), the agreement of minimal vessel diameter between the two modalities revealed a bias of 0.02 mm (upper and lower limit of agreement: 1.02 mm and -0.98 mm). |
1 |
| 49. Pamminger M, Klug G, Kranewitter C, et al. Non-contrast MRI protocol for TAVI guidance: quiescent-interval single-shot angiography in comparison with contrast-enhanced CT. Eur Radiol 2020;30:4847-56. |
Observational-Dx |
26 patients with MRI and CTA; 9 patients with MRI only |
To prospectively compare unenhanced quiescent-interval single-shot MR angiography (QISS-MRA) with contrast-enhanced computed tomography angiography (CTA) for contrast-free guidance in transcatheter aortic valve intervention (TAVI). |
QISS-MRA and CTA-based measurements of aortoiliofemoral vessel diameters correlated moderately to very strong (r = 0.572 to 0.851, all p = 0.002) with good to excellent inter-observer reliability (intra-class correlation coefficient (ICC) = 0.862 to 0.999, all p < 0.0001) regarding QISS assessment. Mean diameters of the infrarenal aorta and iliofemoral vessels differed significantly (bias 0.37 to 0.98 mm, p = 0.041 to < 0.0001) between the two modalities. However, inter-method decision for transfemoral access route was comparable (? = 0.866, p < 0.0001). Aortic root parameters assessed by 3D whole heart MRI strongly correlated (r = 0.679 to 0.887, all p = 0.0001) to CTA measurements. |
1 |
| 50. Bernhardt P, Rodewald C, Seeger J, et al. Non-contrast-enhanced magnetic resonance angiography is equal to contrast-enhanced multislice computed tomography for correct aortic sizing before transcatheter aortic valve implantation. Clin Res Cardiol 2016;105:273-8. |
Observational-Dx |
52 patients who underwent TAVI that had MSCT and MRI |
To compare measurements of a non-contrast magnetic resonance imaging (MRI) technique with MSCT serving as the reference standard. |
Mean age of the study cohort was 82.2 ± 4.9 years, log EuroScore was 25.2 ± 4.8 %. Mean aortic annulus perimeter as measured by MSCT was 76.7 ± 6.9 mm. MRI yielded a mean perimeter of 76.5 ± 6.7 mm with a good correlation coefficient (r = 0.93, p < 0.0001). Decision for valve size showed good correlation between both imaging modalities (r = 0.94, p < 0.0001). |
1 |
| 51. Wang J, Jagasia DH, Kondapally YR, Herrmann HC, Han Y. Comparison of Non-Contrast Cardiovascular Magnetic Resonance Imaging to Computed Tomography Angiography for Aortic Annular Sizing Before Transcatheter Aortic Valve Replacement. J Invasive Cardiol. 29(7):239-245, 2017 Jul. |
Observational-Dx |
21 patients with severe aortic stenosis |
To compare the feasibility and accuracy of a fast 3D SSFP-slab CMR approach, 2D SSFP-cine CMR to contrast-enhanced CT in annular measurements. |
The mean systolic annular area was not significantly different between CT and 3D-CMR (480.0 ± 77.9 mm² vs 479.4 ± 66.2 mm²; P=.98) in systole. There was no clinically relevant systematic difference between area measurements [mean difference, 0.6 mm²; limits of agreement -38.2 mm²; 39.3 mm²] using Bland-Altman analyses. Interobserver correlation was excellent. The diagnostic systolic 3D-CMR annular sizing scan was achieved in 4.4 ± 2.7 min. |
1 |
| 52. Woldendorp K, Bannon PG, Grieve SM. Evaluation of aortic stenosis using cardiovascular magnetic resonance: a systematic review & meta-analysis. J Cardiovasc Magn Reson 2020;22:45. |
Meta-analysis |
23 studies |
To review the current literature on use of CMR for aortic valve assessment in comparison to both TTE and transesophageal echocardiography (TEE). |
Twenty-three relevant, prospective articles were included in the meta-analysis, totalling 1040 individual patients. There was no significant difference in AVA measured as by CMR compared to TEE. CMR measurements of AVA size were larger compared to TTE by an average of 10.7% (absolute difference: + 0.14cm2, 95% CI 0.07-0.21, p < 0.001). Reliability was high for both inter- and intra-observer measurements (0.03cm2 +/- 0.04 and 0.02cm2 +/- 0.01, respectively). |
Good |
| 53. Queiros S, Morais P, Dubois C, et al. Validation of a Novel Software Tool for Automatic Aortic Annular Sizing in Three-Dimensional Transesophageal Echocardiographic Images. J Am Soc Echocardiogr. 31(4):515-525.e5, 2018 04. |
Observational-Dx |
101 patients with preoperative MDCT and 3D TEE |
To present and evaluate a novel software tool for automatic accurate aortic annulus (AoA) sizing by three-dimensional (3D) transesophageal echocardiography (TEE). |
The software showed very good agreement with manual values obtained using MDCT and 3D TEE, with the interactive approach having slightly narrower limits of agreement. The latter also had excellent intra- and interobserver variability. Both fully automatic and interactive analyses showed excellent test-retest reproducibility, with the first having a faster analysis time. Finally, either approach led to good sizing agreement against the true implanted sizes (>77%) and against MDCT-based sizes (>88%). |
2 |
| 54. Garcia-Martin A, Lazaro-Rivera C, Fernandez-Golfin C, et al. Accuracy and reproducibility of novel echocardiographic three-dimensional automated software for the assessment of the aortic root in candidates for thanscatheter aortic valve replacement. European heart journal cardiovascular Imaging. 17(7):772-8, 2016 Jul. |
Observational-Dx |
31 patients undergoing D-TOE, 2D- and 3D-TOE, and angiography; 10 patients undergoing D-TOE, 2D- and 3D-TOE, angiography, and MDCT |
To compare the measurements of the aortic annulus (AA) obtained by the new model to that obtained by 3D-TOE and multidetector computed tomography (MDCT) in candidates to transcatheter aortic valve implantation (TAVI) and to assess the reproducibility of this new method. |
We included 31 patients who underwent TAVI. The AA diameters and area were evaluated by the manual 3D-TOE method and by the automatic software. We showed an excellent correlation between the measurements obtained by both methods: intra-class correlation coefficient (ICC): 0.731 (0.508-0.862), r: 0.742 for AA diameter and ICC: 0.723 (0.662-0.923), r: 0.723 for the AA area, with no significant differences regardless of the method used. The interobserver variability was superior for the automatic measurements than for the manual ones. In a subgroup of 10 patients, we also found an excellent correlation between the automatic measurements and those obtained by MDCT, ICC: 0.941 (0.761-0.985), r: 0.901 for AA diameter and ICC: 0.853 (0.409-0.964), r: 0.744 for the AA area. |
2 |
| 55. Rong LQ, Hameed I, Salemi A, et al. Three-Dimensional Echocardiography for Transcatheter Aortic Valve Replacement Sizing: A Systematic Review and Meta-Analysis. Journal of the American Heart Association. 8(19):e013463, 2019 10. |
Meta-analysis |
19 studies |
To compare 3D TEE and MDCT for pre-TAVR measurements. |
Nineteen studies with a total of 1599 patients were included. Correlations between 3D TEE and MDCT annular area, annular perimeter, annular diameter, and left ventricular outflow tract area measurements were strong (0.86 [95% CI, 0.80-0.90]; 0.89 [CI, 0.82-0.93]; 0.80 [CI, 0.70-0.87]; and 0.78 [CI, 0.61-0.88], respectively). Mean differences between 3D TEE and MDCT between measurements were small and nonsignificant. Interobserver and intraobserver agreement and discriminatory abilities for paravalvular aortic regurgitation were good for both 3D TEE and MDCT. |
Good |
| 56. Zahn R, Schiele R, Gerckens U, et al. Transcatheter aortic valve implantation in patients with "porcelain" aorta (from a Multicenter Real World Registry). Am J Cardiol 2013;111:602-8. |
Experimental-Dx |
147 patients with and 1,227 without a porcelain aorta (1,374 total TAVI procedures) |
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. |
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). |
3 |
| 57. Kinnel M, Faroux L, Villecourt A, et al. Abdominal aorta tortuosity on computed tomography identifies patients at risk of complications during transfemoral transcatheter aortic valve replacement. Arch Cardiovasc Dis. 113(3):159-167, 2020 Mar. |
Observational-Dx |
175 patients |
To investigate whether simple arterial variables from computed tomography scanning can predict the occurrence of severe early complications in patients undergoing transfemoral TAVR. |
Overall, 175 patients were included. The primary endpoint was observed in 60 patients (35%). Abdominal aorta tortuosity was identified in 28 patients (16%) and was strongly associated with the occurrence of a complication (adjusted odds ratio 2.7, 95% confidence interval 1.1-6.6; P=0.03). There was no significant association between iliofemoral tortuosity or vascular calcification and the occurrence of complications. |
3 |
| 58. Otto CM, Kumbhani DJ, Alexander KP, et al. 2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults With Aortic Stenosis: A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol 2017;69:1313-46. |
Review/Other-Dx |
N/A |
No abstract available |
No abstract available |
4 |
| 59. Mach M, Poschner T, Hasan W, et al. The Iliofemoral tortuosity score predicts access and bleeding complications during transfemoral transcatheter aortic valve replacement: DataData from the VIenna Cardio Thoracic aOrtic valve registrY (VICTORY). Eur J Clin Invest 2021;51:e13491. |
Observational-Dx |
240 patients |
To investigate the impact of novel scoring methods of iliofemoral tortuosity on access and bleeding complications after TF-TAVR. |
Among 240 patients, only the IFT score demonstrated a good positive correlation with the composite primary endpoint of access and bleeding complications(P = 0.031). A higher incidence of access and bleeding complications was found in patients with a higher IFT score (56 [36.8%] vs 17 [19.3%]; P = 0.003). In a multivariate logistic regression analysis, only the IFT score was a significant predictor of the primary endpoint (OR: 2.11; 95% CI: 1.09-4.05; P = 0.026). |
3 |
| 60. Arnett DM, Lee JC, Harms MA, et al. Caliber and fitness of the axillary artery as a conduit for large-bore cardiovascular procedures. Catheter Cardiovasc Interv 2018;91:150-56. |
Observational-Tx |
208 patients |
To describe the caliber and vascular health of the subclavian and axillary arteries as related to their potential utilization in complex cardiovascular procedures. |
208 consecutive patients undergoing routine CTA prior to transcatheter aortic valve replacement were retrospectively evaluated in a systematic analysis of upper and lower extremity vasculature. Minimal luminal diameters (MLDs) for the axillary arteries and iliofemoral arteries were 6.0 ± 1.1 mm and 6.6 ± 1.8 mm respectively. Compared to the iliofemoral arteries, the axillary arteries demonstrated substantially lower rates of significant stenosis (2% vs. 12%, p < 0.01) and significantly lower rates of moderate to severe calcification disease (9% vs. 64%, p < 0.01). Diabetes and tobacco use were independently associated with smaller axillary artery caliber by MLD (p < 0.01) but not with significant stenotic disease. |
3 |
| 61. Gleason TG, Schindler JT, Hagberg RC, et al. Subclavian/Axillary Access for Self-Expanding Transcatheter Aortic Valve Replacement Renders Equivalent Outcomes as Transfemoral. Ann Thorac Surg. 105(2):477-483, 2018 Feb. |
Experimental-Dx |
202 patients (Subclavian/Axillary Group), 202 patients (Transfemoral Group) |
To examine if the subclavian/axillary arterial (SCA) access offers equivalent risks and outcomes as transfemoral (TF) access. |
Matching was successful, with no significant baseline differences in the SCA group and the TF group, except the SCA group had more past or present smokers (79.2% vs 61.4%, p < 0.001) and fewer patients with anemia requiring transfusion (18.5% vs 27.5%, p = 0.04). SCA patients experienced a significantly longer time from enrollment to procedure (8.6 ± 19.1 vs 5.3 ± 6.3 days; p = 0.02), likely the result of case planning. Significant differences in procedural outcomes include less post-TAVR balloon dilation (17.9% vs 26.7%, p = 0.03) and more general anesthesia (99.0% vs 89.6%, p < 0.001) for the SCA accesses. There were no differences in procedure time (57.8 ± 45.3 vs 57.5 ± 32.1 min, p = 0.94) or Valve Academic Research Consortium I-defined procedure success between groups (p = 0.89). Event rates at 30 days or 1 year were similar, with a trend toward fewer pacemakers with SCA accesses. |
3 |
| 62. Cannao PM, Muscogiuri G, Schoepf UJ, et al. Technical Feasibility of a Combined Noncontrast Magnetic Resonance Protocol for Preoperative Transcatheter Aortic Valve Replacement Evaluation. J Thorac Imaging 2018;33:60-67. |
Observational-Dx |
5 patients that underwent CTA and 10 healthy volunteers underwent noncontrast MRA |
To prospectively evaluate the technical feasibility of a noncontrast magnetic resonance angiography (MRA) protocol using investigational prototype self-navigated 3D (SN3D) radial whole-heart and quiescent-interval single-shot (QISS) pulse sequences regarding their potential in planning transcatheter aortic valve replacement (TAVR). |
The combined SN3D and QISS protocol provided a 10.1±1.6-minute acquisition time. TAVR-relevant evaluation was technically feasible in healthy volunteers. All measurements showed good agreement with CTA in patients (all P>0.098). SN3D and QISS produced similar image quality both in volunteers and in patients (all P>0.122). There was no difference in qualitative ratings between MRA and CTA (all P>0.119). Interobserver agreement was good for MRA (?=0.71 to 0.76) and excellent for CTA (?=0.82 to 0.84). Thoracic SN3D provided a similar CNR compared with CTA (P=0.117). CTA yielded higher CNR in the abdominopelvic region compared with QISS (P=0.006). |
1 |
| 63. Essa E, Makki N, Bittenbender P, et al. Vascular Assessment for Transcatheter Aortic Valve Replacement: Intravascular Ultrasound Compared With Computed Tomography. J Invasive Cardiol. 28(12):E172-E178, 2016 Dec. |
Observational-Dx |
15 patients undergoing pre-TAVR coronary angiography and hemodynamic assessment |
To compare CTA with intravascular ultrasound (IVUS) in patients undergoing TAVR evaluation. |
Correlation between IVUS and CTA was strong for minimum luminal diameter (r=0.62). Concordance was also strong between CTA and invasive iliofemoral angiography for assessment of tortuosity (r=0.75). Utilizing Bland-Altman analysis, vessel diameters obtained by IVUS were consistently greater than those obtained by CTA. The angiography and IVUS strategy was associated with a lower overall mean contrast utilization (29 cc vs 100 cc; P<.001), reduced mean radiation exposure (527 mGy vs 998 mGy; P=.045), and no significant difference in mean test duration (13.3 minutes vs 10 minutes; P=.12). |
1 |
| 64. American College of Radiology. ACR Appropriateness Criteria® Radiation Dose Assessment Introduction. Available at: https://www.acr.org/-/media/ACR/Files/Appropriateness-Criteria/RadiationDoseAssessmentIntro.pdf. |
Review/Other-Dx |
N/A |
To provide evidence-based guidelines on exposure of patients to ionizing radiation. |
No abstract available. |
4 |
