Although transcatheter aortic valve implantation (TAVI) is still currently guided by transesophageal echocardiography (TEE) in a considerable number of hospitals, exclusive angiographic (Angio) guidance seems a reasonable approach in this setting. To date, however, no studies have directly compared the outcomes of TAVI according to the imaging modality used for procedural guidance. We, therefore, used data from a large multicenter data repository to compare the outcomes of TAVI guided exclusively by Angio and ATEE. All consecutive patients with severe aortic stenosis who underwent TAVI with the CoreValve Revalving System (CRS) in 9 Italian centers from September 2007 to March 2014, dichotomized according to the imaging support used to guide the procedure (ATEE and Angio), were included. Thirty-day and 12-month clinical outcomes were evaluated. Propensity matching analysis was performed to adjust for baseline differences. A total of 625 patients were included (256 and 369 patients were included in the ATEE and Angio groups, respectively). Patients from the ATEE more frequently underwent TAVI under general anesthesia compared with Angio group (37.9% vs 22.8%, respectively, p <0.001). Importantly, ∼80% of the patients experienced mild or even less aortic regurgitation as assessed by angiography after the procedure, without between-group differences. Postdilation and valve-in-valve rates were equivalent (24.7% vs 25%, p = 0.934 and 5.5% vs 3.4%, respectively, p = 0.217). No differences were revealed in the rates of death, cardiovascular death, and stroke or transient ischemic attack at 12-month follow-up. These results were sustained after propensity matching analysis. In conclusion, as long as a comprehensive procedural planning is performed, TAVI with CRS may be performed exclusively under angiographic guidance without the need for associated TEE.
Transcatheter aortic valve implantation (TAVI) is an effective therapy for patients with symptomatic severe aortic stenosis (AS) and high or prohibitive risk for conventional surgical aortic valve replacement. Precise valve positioning and subsequent deployment are critical to obtain optimized results and to avoid complications in this scenario. Furthermore, the assessment of procedural results is of utmost importance as paravalvular regurgitation ≥2 after procedure has been demonstrated an independent predictor of mortality after TAVI. In fact, a considerable number of centers worldwide use angiography combined with transesophageal echocardiography (TEE) guidance aiming at enhancing the accuracy of the intervention, assessing its results, and identifying potential complications. These numbers are particularly high in the United States. Nonetheless, TEE during TAVI usually requires either general anesthesia or profound sedation because of the discomfort induced by the TEE probe and the availability of a dedicated cardiologist with TEE expertise to be present in every procedure, which leads to increased staff requirements and net procedural costs. Few single-center experiences have demonstrated that TAVI performed exclusively under angiographic guidance is feasible and associated with reasonably good outcomes, similar to those of angiography + TEE-guided procedures; however, besides being single-center investigations, these data were limited by the lack of direct comparison between the 2 strategies (i.e., angiography vs angiography + TEE guided) and limited sample sizes. We, therefore, used data from a large prospective, multicenter Italian data repository to compare clinical outcomes at 30-day and 12-month follow-up in patients who underwent TAVI guided by angiography with and without adjunctive TEE.
Methods
Starting from June 2007, all consecutive patients with degenerative severe AS who underwent TAVI with the third-generation 18-Fr CoreValve Revalving System (CRS) device (Medtronic Inc., Minneapolis, Minnesota) in 9 Italian centers were prospectively included in the ClinicalService Project ( http://clinicaltrials.gov/ct2/show/NCT01007474 ). This is a nation-based clinical data repository and medical care project aimed at describing and improving the use of implantable devices in Italian clinical practice. The project was approved by each site’s institutional review board or medical director and conforms to the principles outlined in the Declaration of Helsinki. Each patient signed an informed consent for data collection and analysis. Clinical and echocardiographic follow-up were performed at 30 days, 12 months, and then yearly with visits or telephone contacts according to each center’s clinical practice. All events were site reported. All data provided by each interventional site were anonymized, centrally collected, and assessed for quality. In particular, all outcome data were confirmed by source documentation collected from each participating center. TAVI program in all the participating sites was supported by a local heart team. For the purpose of the present study, patients who underwent TAVI with CRS from September 2007 to March 2014 were dichotomized according to the imaging support used to guide the procedure, as follows: angiography + TEE (ATEE) and angiography-only (Angio) group. Aiming at comparing more homogeneous groups, patients in whom TAVI was carried out using angiography as the primary imaging guidance for the procedure but who underwent transthoracic echocardiography (TTE) in the catheterization laboratory to check the results and eventually perform further intervention (i.e., postdilation) were excluded from the present analysis. End points were defined according to Valve Academic Research Consortium definitions.
Design features of the CRS and technical details of the procedures have been previously described. The CRS, available in 26- and 29-mm sizes and, starting from September 2011 and August 2012 respectively, even in 31- and 23-mm sizes, was implanted using the transfemoral, subclavian, and transaortic approaches with an 18-Fr delivery catheter, later improved by an AccuTrak Stability Layer (Medtronic Inc.). All procedures were performed under local anesthesia (with or without additional sedation and/or analgesia) or general anesthesia and endotracheal intubation (i.e., decided by the heart team during preoperative meetings), under angiography associated with TEE guidance (i.e., ATEE group) or exclusive angiographic guidance (i.e., Angio group), in a standard cardiac catheterization laboratory with surgical backup or in a hybrid operating room. After valve deployment, the angiographic assessment of aortic regurgitation (AR) severity was performed using a previously described method. Evaluation was initially performed by 2 treating physicians, and discrepancies in the measured degree of post-TAVI AR were resolved by consensus. Besides imaging assessment, the results of the procedure were also evaluated by patients’ hemodynamics in both groups. After the procedure, most patients were managed in an intensive care unit or coronary care unit for at least a day, and a temporary pacemaker was left in place for at least 48 hours. All patients received acetylsalicylic acid (at least 100 mg before the procedure and lifelong) and clopidogrel (300-mg loading dose plus 75 mg/day for 3 to 6 months unless prolonged administration was required for previous coronary intervention with drug-eluting stents). During the intervention, unfractionated heparin 70 to 100 IU/kg was administered to achieve an activated clotting time of 200 to 250 seconds for the duration of the procedure.
Continuous data were summarized as mean and standard deviation or median and twenty-fifth to seventy-fifth percentiles in case of skewed distributions. Absolute and relative frequencies were reported for categorical variables. Continuous variables were compared using the Mann–Whitney test. Normality of distribution was tested, calculating skewness and kurtosis values. Comparisons of categorical variables were performed by means of the Fisher’s exact test for extreme proportions or, otherwise, chi-square. Thirty-day outcomes were compared using logistic regression. Survival analysis was carried out by means of the Kaplan–Meier method. Different curves were compared using the log-rank test. A 2-tailed value of p <0.05 was considered significant. A 2-way analysis of variance or analysis of covariance for repeated measures was used to evaluate the effects of time (baseline vs discharge vs follow-up) and group on echocardiographic variables. Propensity score matching was performed using a greedy algorithm. The covariates used for the matching were, as follows: gender, age, logistic EuroScore, New York Heart Association classification, AF before procedure, anesthesia type, left anterior hemiblock , procedural time, contrast media, and fluoroscopy time. A logistic regression model has been fitted with these covariates to calculate the propensity scores for each observation. Finally, a total number of 189 patients in the Angio group have been matched to 189 patients in the ATEE group. In a separate propensity matching analysis that included 90 patients in each group, we added on top of the previous variables the center and the year of the procedure. For statistical analysis, SAS 9.3 for Windows (SAS Inst. Inc., Cary, North Carolina) was used.
Results
A total of 625 patients fulfilled the criteria and were included in the present analysis (256 patients were included in the ATEE and 369 were included in the Angio group). Notably, patients from the Angio group represented only 20% of the total number of patients in the first 4 years of the Project. Baseline characteristics are demonstrated in Table 1 . Preprocedural echocardiographic features are provided in ( Table 2 ).
| Patient Characteristics | TOTAL (N = 625) | ATEE (N = 256) | Angio (N = 369) | p-value |
|---|---|---|---|---|
| Age (years) Mean± Standard Deviation | 81.6 ± 6.9 | 81.7 ± 7.1 | 81.5 ± 6.8 | 0.412 |
| Male | 47.4% (296/625) | 43.8% (112/256) | 49.9% (184/369) | 0.132 |
| Log EuroScore (%) | ||||
| N | 584 (93.4%) | 248 (96.9%) | 336 (91.1%) | 0.070 |
| Minimum – Maximum | 1 – 88 | 2 – 85 | 1 – 88 | |
| Median | 20.1 | 19.2 | 21.0 | |
| 25 th Percentile – 75 th Percentile | 12 – 31 | 11 – 29 | 14 – 32 | |
| Mean ± Standard Deviation | 23.9 ± 16.2 | 22.7 ± 15.7 | 24.7 ± 16.5 | |
| STS Score | ||||
| N | 451 (72.2%) | 220 (85.9%) | 231 (62.6%) | 0.096 |
| Minimum – Maximum | 1 – 77 | 1 – 77 | 1 – 72 | |
| Median | 6.6 | 7.2 | 6.2 | |
| 25 th Percentile – 75 th Percentile | 4 – 12 | 5 – 13 | 4 – 12 | |
| Mean ± Standard Deviation | 10.3 ± 10.4 | 11.1 ± 11.8 | 9.4 ± 8.9 | |
| Creatinine (mg/dL) | ||||
| Median | 1.2 | 1.1 | 1.2 | 0.159 |
| 25 th Percentile – 75 th Percentile | 1 – 2 | 1 – 2 | 1 – 2 | |
| Glomerular filtration rate <30 ml/min | 24.0% (146/608) | 23.0% (59/256) | 24.7% (87/352) | 0.634 |
| NYHA III-IV | 79.7% (498/625) | 72.7% (186/256) | 84.6% (312/369) | <0.001 |
| Hypertension | 78.7% (492/625) | 75.4% (193/256) | 81.0% (299/369) | 0.090 |
| Diabetes mellitus | 28.7% (178/621) | 27.5% (70/255) | 29.5% (108/366) | 0.577 |
| Prior stroke | 6.9% (43/625) | 3.1% (8/256) | 9.5% (35/369) | 0.002 |
| Atrial fibrillation pre-procedure | 18.4% (115/625) | 22.7% (58/256) | 15.4% (57/369) | 0.022 |
| Coronary artery disease | 47.0% (292/621) | 46.9% (120/256) | 47.1% (172/365) | 0.951 |
| Prior myocardial infarction | 18.2% (113/621) | 18.4% (47/256) | 18.1% (66/365) | 0.930 |
| Prior percutaneous coronary intervention | 28.3% (176/622) | 27.7% (71/256) | 28.7% (105/366) | 0.795 |
| Peripheral vascular disease | 27.8% (174/625) | 23.8% (61/256) | 30.6% (113/369) | 0.062 |
| Chronic obstructive pulmonary disease | 23.0% (144/625) | 21.1% (54/256) | 24.4% (90/369) | 0.336 |
| Prior coronary artery bypass grafting | 17.6% (110/625) | 15.6% (40/256) | 19.0% (70/369) | 0.280 |
| Permanent pacemaker | 15.0% (91/605) | 14.5% (37/255) | 15.4% (54/350) | 0.755 |
| Left bundle brunch block | 9.3% (58/625) | 9.8% (25/256) | 8.9% (33/369) | 0.727 |
| Right bundle brunch block | 6.4% (40/625) | 6.6% (17/256) | 6.2% (23/369) | 0.838 |
| Left anterior hemiblock | 11.7% (73/625) | 16.8% (43/256) | 8.1% (30/369) | 0.001 |
| Any conduction disturbance | 22.6% (141/625) | 26.2% (67/256) | 20.1% (74/369) | 0.072 |
| Patient Characteristics | TOTAL (N = 625) | ATEE (N = 256) | Angio (N = 369) | p-value |
|---|---|---|---|---|
| Mean aortic gradient (mmHg) | ||||
| Mean ± Standard Deviation | 51.1 ± 16.1 | 50.8 ± 14.8 | 51.3 ± 17.0 | 0.864 |
| Aortic regurgitation ≥3+ | 36.3% (215/592) | 37.6% (94/250) | 35.4% (121/342) | 0.579 |
| Aortic valve area (cm 2 ) | 0.42 ± 0.16 | 0.38 ± 0.13 | 0.45 ± 0.17 | <0.001 |
| Mitral regurgitation ≥3+ | 44.7% (264/590) | 48.6% (121/249) | 41.9% (143/341) | 0.108 |
| Left ventricle ejection fraction (%) | ||||
| Mean ± Standard Deviation | 50.5 ± 13.2 | 51.2 ± 13.0 | 50.0 ± 13.4 | 0.264 |
| Left ventricle ejection fraction (%) | ||||
| <35 | 14.6% (90/618) | 13.3% (34/256) | 15.5% (56/362) | 0.564 |
| 35-55 | 46.3% (286/618) | 45.3% (116/256) | 47.0% (170/362) | |
| >35 | 39.2% (242/618) | 41.4% (106/256) | 37.6% (136/362) | |
| Systolic pulmonary artery pressure >60 mmHg | 10.4% (65/625) | 12.9% (33/256) | 8.7% (32/369) | 0.089 |
Procedural details are described in Table 3 . Importantly, the observed differences in procedural time were mainly observed from 2007 to 2010, whereas from 2011 to 2014, procedures were longer in the ATEE compared with the Angio group (p <0.001). Postdilation rates were equivalent (24.7% vs 25%, p = 0.934), whereas a few cases (∼5%) required the implantation of a second valve (i.e., valve-in-valve), without between-group differences. Importantly, ∼80% of the patients experienced mild or even AR as assessed by angiography immediately after the procedure, without between-group differences ( Table 3 ). Inhospital outcomes are described in Table 4 . Although higher rates of acute kidney injury (AKI) were observed in the ATEE group, the vast majority of them were AKI class I ( Table 4 ). The rates of new permanent pacemaker implantation were 28% versus 21%, respectively (p <0.001).
| Patient Characteristics | TOTAL (N = 625) | ATEE (N = 256) | Angio (N = 369) | p-value |
|---|---|---|---|---|
| Access | ||||
| Femoral | 79.8% (499/625) | 83.2% (213/256) | 77.5% (286/369) | 0.081 |
| Subclavian | 13.4% (84/625) | 9.8% (25/256) | 16.0% (59/369) | |
| Aortic | 6.7% (42/625) | 7.0% (18/256) | 6.5% (24/369) | |
| General anesthesia | 29.0% (181/625) | 37.9% (97/256) | 22.8% (84/369) | <0.001 |
| Second CoreValve deployed | 5.6% (35/625) | 6.3% (16/256) | 5.1% (19/369) | 0.556 |
| Valve-in-valve | 4.3% (26/605) | 5.5% (14/255) | 3.4% (12/350) | 0.217 |
| Valve embolization | 0.0% (0/625) | 0.0% (0/256) | 0.0% (0/369) | —— |
| Prosthesis size | ||||
| 23mm | 1.0% (6/625) | 0.8% (2/256) | 1.1% (4/369) | 0.003 |
| 26mm | 43.8% (274/625) | 48.4% (124/256) | 40.7% (150/369) | |
| 29mm | 45.4% (284/625) | 46.1% (118/256) | 45.0% (166/369) | |
| 31mm | 9.8% (61/625) | 4.7% (12/256) | 13.3% (49/369) | |
| Post-dilation | 24.9% (152/611) | 24.7% (63/255) | 25.0% (89/356) | 0.934 |
| Device success | 91.8% (574/625) | 90.0% (229/256) | 93.5% (345/369) | 0.069 |
| Procedural time (min) | ||||
| Median | 106.0 | 90.0 | 120.0 | <0.001 |
| 25 th Percentile – 75 th Percentile | 66 – 127 | 60 – 120 | 87 – 148 | |
| Fluoroscopy time (min) | ||||
| Median | 20.0 | 18.0 | 20.0 | 0.019 |
| 25 th Percentile – 75 th Percentile | 15 – 26 | 14 – 25 | 16 – 27 | |
| Contrast media (ml) | ||||
| Median | 167.5 | 152.0 | 180.0 | 0.002 |
| 25 th Percentile – 75 th Percentile | 120 – 220 | 119 – 200 | 120 – 230 | |
| Aortic Regurgitation (angiography) | ||||
| None/Trivial | 25.7% (147/573) | 28.5% (70/246) | 23.5% (77/327) | 0.270 |
| Mild | 53.4% (306/573) | 48.8% (120/246) | 56.9% (186/327) | |
| Moderate | 17.6% (101/573) | 19.5% (48/246) | 16.2% (53/327) | |
| Severe | 3.3% (19/573) | 3.3% (8/246) | 3.4% (11/327) |
| Patient Characteristics | TOTAL (N = 625) | ATEE (N = 256) | Angio (N = 369) | p-value |
|---|---|---|---|---|
| Cardiac tamponade | 1.9% (12/625) | 3.1% (8/256) | 1.1% (4/369) | 0.067 |
| Conversion to surgery | 0.3% (2/625) | 0.8% (2/256) | 0.0% (0/369) | 0.089 |
| Transfusion of ≥3 units of blood | 4.5% (28/625) | 3.9% (10/256) | 4.9% (18/369) | 0.564 |
| Major bleeding | 7.7% (48/625) | 6.3% (16/256) | 8.7% (32/369) | 0.263 |
| Life-threatening or disabling bleeding | 2.6% (16/625) | 2.3% (6/256) | 2.7% (10/369) | 0.776 |
| In-hospital stroke/transient ischemic attack | 1.6% (10/625) | 1.2% (3/256) | 1.9% (7/369) | 0.477 |
| In-hospital death | 4.6% (29/625) | 4.7% (12/256) | 4.6% (17/369) | 0.962 |
| In-hospital cardiovascular death | 2.6% (16/625) | 3.5% (9/256) | 1.9% (7/369) | 0.208 |
| Peri-procedural myocardial infarction | 1.1% (7/625) | 0.4% (1/256) | 1.6% (6/369) | 0.149 |
| Acute kidney injury | 20.8% (117/562) | 30.3% (74/244) | 13.5% (43/318) | <0.001 |
| Acute kidney injury classes | ||||
| No | 79.2% (445/562) | 69.7% (170/244) | 86.5% (275/318) | <0.001 |
| 1 | 20.3% (114/562) | 29.1% (71/244) | 13.5% (43/318) | |
| 2 | 0.4% (2/562) | 0.8% (2/244) | 0.0% (0/318) | |
| 3 | 0.2% (1/562) | 0.4% (1/244) | 0.0% (0/318) |
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