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Redo-TAVR for Transcatheter Prosthesis Dysfunction
Study Questions:
What are the outcomes of repeat transcatheter aortic valve replacement (TAVR) for transcatheter heart valve (THV) dysfunction?
Methods:
The investigator-initiated, prospective Redo-TAVR registry commenced in February 2019. A total of 37 centers from Europe, North America, and the Middle East contributed patient-level data for all of their consecutive redo-TAVR procedures using a dedicated case report form. Data collection and TAVR outcomes were assessed according to Valve Academic Research Consortium-2 (VARC-2) definitions. Principal endpoints were 30-day and 1-year all-cause mortality and THV performance by echocardiography (residual mean gradient and degree of regurgitation). Secondary endpoints included periprocedural and in-hospital outcomes as defined by VARC-2. Cases of acute procedural failure treated with a second THV during the same procedure as the native valve TAVR (bailout THV-in-THV) were excluded. Patients undergoing redo-TAVR within 1 year of initial TAVR were classified as probable TAVR procedural failure, while those who presented beyond 1 year were classified as probable THV device failure.
Results:
Of 63,876 TAVR patients treated at participating centers, 212 (0.33%) had previously undergone TAVR. Among the redo-TAVR patients, 138 (64%) were treated 1 year or more following initial TAVR. Median follow-up after redo-TAVR was 15 months (range 3-36). Mean patient age was 79.0 ± 8.2 years, and 127 patients (59.9%) were male. Mean Society of Thoracic Surgeons (STS) score was 7.0 ± 5.8%. Most patients (169, 80%) presented for redo-TAVR with New York Heart Association (NYHA) class III-IV symptoms. Transfemoral access was used in 193 redo-TAVR patients (89%). Native valve TAVR was performed with self-expandable prostheses in 130 patients (61%), and redo-TAVR was performed with self-expandable prostheses in 105 patients (50%).
For patients undergoing redo-TAVR within 1 year of initial TAVR, isolated aortic regurgitation was a more common indication for the procedure than among patients undergoing redo-TAVR >1 year following initial TAVR (54 patients, 73% vs. 41 patients, 29.7%; p < 0.0001). Mean transaortic gradient was higher among patients undergoing redo-TAVR >1 year following initial TAVR as compared to those undergoing redo-TAVR sooner (34.7 ± 19.9 vs. 19.9 ± 18.6 mm Hg, p < 0.0001). THV implantation was successful in 180 patients (85.1%), with most failures attributable to residual gradients ≥20 mm Hg (24 patients, 14.1%) or moderate or greater residual aortic regurgitation (17 patients, 8.9%). No difference in procedural success was observed between patients undergoing redo-TAVR before or after the 1-year mark.
Post-procedurally, 90% of patients reported NYHA class I-II symptomatology at the 30-day mark, and this effect was sustained at the 1-year mark (89%, p < 0.001 for improvement compared to preprocedure). At 30-day follow-up, 13 cases (1.4%) of disabling stroke had occurred, and new permanent pacemaker implantation was required in 20/208 patients (9.6%). Survival rate was 97.2% at 30 days and 86.5% at 1 year. Patients with baseline THV stenosis had higher mean gradients at 30 days and 1 year following redo-TAVR than patients with baseline THV regurgitation or mixed stenosis-regurgitation (15.1 vs. 11.3 mm Hg, p = 0.003 and 16.9 vs. 10.4 mm Hg, p = 0.004, respectively).
Conclusions:
Redo-TAVR was successful in most patients, with relatively low rates of serious complications. Most patients experienced symptomatic improvement post-procedurally. Patients requiring redo-TAVR within 1 year of initial TAVR were more likely to have THV regurgitation as the indication for the procedure, whereas those undergoing redo-TAVR beyond the 1-year mark were more likely to have THV stenosis or mixed stenosis-regurgitation.
Perspective:
Despite the fact that this was an international, multicenter registry including many high-volume centers, the total number of redo-TAVRs included in study was limited, and follow-up time was relatively short. Patients with THV dysfunction who did not undergo redo-TAVR, some of whom likely had anatomic contraindications or prohibitive comorbidities, were not included. Although the findings are encouraging, larger, longer-term studies are needed to assess durability of redo-TAVR benefits.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Aortic Valve Insufficiency, Cardiac Surgical Procedures, Constriction, Pathologic, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Pacemaker, Artificial, Prosthesis Failure, Stroke, Transcatheter Aortic Valve Replacement
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