Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation: The PURPOSE Study.

BACKGROUND: Severe pure aortic regurgitation (AR) carries a high mortality and morbidity risk, and it is often undertreated because of the inherent surgical risk. Transcatheter heart valves (THVs) have been used off-label in this setting with overall suboptimal results. The dedicated "purpose-built" Jena Valve Trilogy (JVT, JenaValve Technology) showed an encouraging performance, although it has never been compared to other THVs. OBJECTIVES: The aim of our study was to assess the performance of the latest iteration of THVs used off-label in comparison to the purpose-built JVT in inoperable patients with severe AR. METHODS: We performed a multicenter, retrospective registry with 18 participating centers worldwide collecting data on inoperable patients with severe AR of the native valve. A bicuspid aortic valve was the main exclusion criterion. The primary endpoints were technical and device success, 1-year all-cause mortality, and the composite of 1-year mortality and the heart failure rehospitalization rate. RESULTS: Overall, 256 patients were enrolled. THVs used off-label were used in 168 cases (66%), whereas JVT was used in 88 (34%). JVT had higher technical (81% vs 98%; P < 0.001) and device success rates (73% vs 95%; P < 0.001), primarily driven by significantly lower incidences of THV embolization (15% vs 1.1%; P < 0.001), the need for a second valve (11% vs 1.1%; P = 0.004), and moderate residual AR (10% vs 1.1%; P = 0.007). The permanent pacemaker implantation rate was comparable and elevated for both groups (22% vs 24%; P = 0.70). Finally, no significant difference was observed at the 1-year follow-up in terms of mortality (HR: 0.99; P = 0.980) and the composite endpoint (HR: 1.5; P = 0.355). CONCLUSIONS: The JVT platform has a better acute performance than other THVs when used off-label for inoperable patients with severe AR. A longer follow-up is conceivably needed to detect a possible impact on prognosis.

Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: The PANTHEON International Project.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with pure severe native aortic valve regurgitation (NAVR) has been associated with suboptimal results. The available evidence concerns mostly outdated transcatheter heart valves (THVs). OBJECTIVES: The aim of this study was to investigate the performance of new-generation THVs in patients treated for pure severe NAVR. METHODS: The PANTHEON (Performance of Currently Available Transcatheter Aortic Valve Platforms in Inoperable Patients With Pure Aortic Regurgitation of a Native Valve) study retrospectively included patients who underwent TAVR with currently available devices (both self-expanding [SE] and balloon expandable [BE]) for severe NAVR. Technical and device success rates as well as a composite of all-cause mortality and heart failure rehospitalization at 1 year were evaluated. The rate and clinical consequences of acute transcatheter valve embolization or migration (TVEM) were also considered. RESULTS: A total of 201 patients were included. Overall technical and device success rates were 83.6% and 76.1%, respectively, and did not differ between SE and BE devices. These figures were due mostly to TVEM occurrence (14.6% vs 16.1%; P = 0.47) and residual moderate or greater aortic regurgitation (9.2% vs 10.1%; P = 0.87). Patients who experienced TVEM compared with those without TVEM had a significantly higher incidence of the composite endpoint at 1 year (25.7% vs 15.8%; P = 0.05). CONCLUSIONS: Despite improved THV platforms and techniques, TAVR for pure severe NAVR remains a challenging procedure, with significant risk for TVEM. SE and BE platforms demonstrated comparable performance in this setting. (Performance of Currently Available Transcatheter Aortic Valve Platforms in Inoperable Patients With Pure Aortic Regurgitation of a Native Valve [PANTHEON]; NCT05319171).

Incidence, predictors, and prognostic impact of new permanent pacemaker implantation after TAVR with self-expanding valves

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices.

BACKGROUND: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR). AIMS: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices. METHODS: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification. RESULTS: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001). CONCLUSIONS: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.

Prosthesis-patient mismatch following transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT-PPM international project.

Background: A severe prosthesis-patient mismatch (PPM) is associated with adverse outcomes following transcatheter aortic valve replacement (TAVR) for de novo aortic stenosis or a failed surgical bioprosthesis. The impact of severe PPM in patients undergoing TAV-in-TAVR is unknown. Aim: We sought to investigate the incidence and 1-year outcomes of different grades of PPM in patients undergoing TAV-in-TAVR. Materials and methods: The TRANSIT-PPM is an international registry, including cases of degenerated TAVR treated with a second TAVR. PPM severity, as well as in-hospital, 30-day, and 1-year outcomes were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria. Results: Among 28 centers, 155 patients were included. Severe PPM was found in 6.5% of patients, whereas moderate PPM was found in 14.2% of patients. The rate of severe PPM was higher in patients who underwent TAV-in-TAVR with a second supra-annular self-expanding (S-SE) TAVR (10%, p = 0.04). Specifically, the rate of severe PPM was significantly higher among cases of a SE TAVR implanted into a balloon-expandable (BE) device (19%, p = 0.003). At 1-year follow-up, the rate of all-cause mortality, and the rate of patients in the New York Heart Association (NYHA) class III/IV were significantly higher in the cohort of patients with severe PPM (p = 0.016 and p = 0.0001, respectively). Almost all the patients with a severe PPM after the first TAVR had a failed < 23 mm BE transcatheter heart valve (THV): the treatment with an S-SE resolved the severe PPM in the majority of the cases. Conclusion: After TAV-in-TAVR, in a fifth of the cases, a moderate or severe PPM occurred. A severe PPM is associated with an increased 1-year all-cause mortality. Clinical trial registration: [https://clinicaltrials.gov], identifier [NCT04500964].

Management and Outcome of Failed Percutaneous Edge-to-Edge Mitral Valve Plasty: Insight From an International Registry.

OBJECTIVES: This study evaluated the incidence, management, and outcome of patients who experienced MitraClip (Abbott Vascular) failure secondary to loss of leaflet insertion (LLI), single leaflet detachment (SLD), or embolization. BACKGROUND: Transcatheter edge-to-edge repair with MitraClip is an established therapy for the treatment of mitral regurgitation (MR), but no data exist regarding the prevalence and outcome according to the mode of clip failure. METHODS: Between January 2009 and December 2020, we retrospectively screened 4,294 procedures of MitraClip performed in 19 centers. LLI was defined as damage to the leaflet where the MitraClip was attached, SLD as demonstration of complete separation between the device and a single leaflet tissue, and clip embolization as loss of contact between MitraClip and both leaflets. RESULTS: A total of 147 cases of MitraClip failure were detected (overall incidence = 3.5%), and these were secondary to LLI or SLD in 47 (31.9%) and 99 (67.3%) cases, respectively, whereas in 1 (0.8%) case clip embolization was observed. MitraClip failure occurred in 67 (45.5%) patients with functional MR, in 64 (43.5%) patients with degenerative MR, and 16 (10.8%) with mixed etiology. Although the majority of MitraClip failures were detected before discharge (47 intraprocedural and 42 in the hospital), up to 39.5% of cases were diagnosed at follow-up. In total, 80 (54.4%) subjects underwent a redo procedure, either percutaneously with MitraClip (n = 51, 34.7%) or surgically (n = 36, 24.5%) including 4 cases of surgical conversion of the index procedure and 7 cases of bailout surgery after unsuccessful redo MitraClip. After a median follow-up of 163 days (IQR: 22-720 days), 50 (43.9%) subjects presented moderate to severe MR, and 43 (29.3%) patients died. An up-front redo MitraClip strategy was associated with a trend toward a reduced rate of death at follow-up vs surgical or conservative management (P = 0.067), whereas postprocedural acute kidney injury, age, and moderate to severe tricuspid regurgitation were independent predictors of death. CONCLUSIONS: MitraClip failure secondary to LLI and SLD is not a rare phenomenon and may occur during and also beyond hospitalization. Redo MitraClip strategy demonstrates a trend toward a reduced risk of death compared with bailout surgery and conservative management. A third of those patients remained with more than moderate MR and had substantial mortality at the intermediate-term follow-up.

Endovascular entry closure of a late type A aortic dissection after implantation of a self-expanding transcatheter heart valve (Evolut R): a case report.

BACKGROUND: Late Stanford type A aortic dissections (TAADs) are a very rare complication after transcatheter aortic valve implantation (TAVI). Surgery is the treatment of choice, but perioperative mortality (25%) and neurological complications (18%) remain high. CASE SUMMARY: An 85-year-old male patient presented with acute chest pain 5 months after a transfemoral Evolut R 34 mm transcatheter heart valve (THV) implantation. On multi-slice computed tomography (MSCT) a TAAD was found with a 7 mm primary entry at the supra-annular aortic edge of the THV expanding to the innominate artery without re-entry. Due to extensive comorbidities including two bypass operations in the history, the Heart Team declined surgery. Within 6 months of watchful waiting the maximal aortic diameter (MAD) increased from 57 to 62 mm. The decision was made to perform an endovascular closure of the inflow to the false lumen by implanting a 25 mm Amplatzer™ Cribriform Septal Occluder. MSCT 4 weeks after occlusion showed the false lumen almost completely filled with thrombus, MSCT 3 months later showed a MAD reduction to 55 mm with shrinkage of the false lumen. DISCUSSION: Presumably, the late TAAD was caused by the supra-annular edge of the Evolut-stent. Because of the extreme risk surgical repair was not an option and a stent graft would have occluded the vein grafts. This case shows that in absence of any other treatment options endovascular closure of the entry to the false lumen can be successfully performed in a TAAD after TAVI.

Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement: VIVID Registry.

BACKGROUND: Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). OBJECTIVES: The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. METHODS: Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. RESULTS: A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). CONCLUSIONS: In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.

Outcomes of valve-in-valve transcatheter aortic valve implantation with and without bioprosthetic valve fracture.

BACKGROUND: Bioprosthetic valve fracture (BVF) is a technique to reduce gradients in valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) procedures. The outcome of VIV-TAVI with BVF has not been compared with VIV-TAVI without BVF. AIMS: The aim of this study was to evaluate the outcome of VIV-TAVI with BVF compared to VIV-TAVI without BVF. METHODS: In total, 81 cases of BVF VIV-TAVI (BVF group) from 14 centres were compared to 79 cases of VIV-TAVI without BVF (control group). RESULTS: VARC-2-defined device success was 93% in the BVF group and 68.4% in the control group (p<0.001). The mean transvalvular gradient decreased from 37±13 mmHg to 10.8±5.9 mmHg (p<0.001) in the BVF group and from 35±16 mmHg to 15.8±6.8 mmHg (p<0.001) in the control group with a significantly higher final gradient in the control group (p<0.001). The transvalvular gradients did not change significantly over time. In-hospital major adverse events occurred in 3.7% in the BVF group and 7.6% in the control group (p=0.325). A linear mixed model identified BVF, self-expanding transcatheter heart valves (THVs) and other surgical aortic valve (SAV) types other than Mitroflow as predictors of lower transvalvular gradients. CONCLUSIONS: Compared to VIV-TAVI alone, VIV-TAVI with BVF resulted in a significantly lower transvalvular gradient acutely and at follow-up. Independent predictors of lower gradients were the use of self-expanding THVs and the treatment of SAVs other than Mitroflow, irrespective of BVF performance. BVF significantly reduced the gradient independently from transcatheter or surgical valve type.

Bioprosthetic valve fracture: Predictors of outcome and follow-up. Results from a multicenter study.

OBJECTIVES: To evaluate outcome and its predictors of bioprosthetic valve fracture (BVF) in patients undergoing valve-in-valve transcatheter aortic valve replacement (VIV-TAVR). BACKGROUND: BVF is feasible and reduces transvalvular gradients in VIV-TAVR-procedures, but follow-up-data and information on factors influencing the outcome are missing. METHODS: The 81 cases of BVF-VIV-TAVR were collected from 14 international centers. RESULTS: Predominantly transcatheter heart valve (THV) was implanted first, followed by BVF. VARC-2 defined device success was 93%, most failures were attributed to residual high gradients. Mean gradients decreased from 37 ± 13 mmHg to 10.8 ± 5.9 mmHg (p < 0.001). BVF reduced the gradient by 16 mmHg. During follow-up (FU, 281 ± 164 days) mean gradient remained stable (10.8 ± 5.9 mmHg at discharge, 12.4 ± 6.3 mmHg at FU, p = ns). In-hospital major adverse events occurred in 3.7%. Event-free survival at 276 ± 237.6 days was 95.4%. The linear mixed model identified balloon-expandable valves (BEV), Mitroflow surgical valve, stenotic surgical bioprostheses and balloon only 1 mm larger than the true internal diameter of the surgical valve as predictors for higher gradients. CONCLUSIONS: BVF is safe and can significantly reduce gradients, which remain stable at FU. BEV, Mitroflow surgical valve, stenotic bioprostheses and balloon larger than the true internal diameter of the surgical valve of only 1 mm are predictors for higher final gradients.

Does valve in valve TAVR carry a higher risk for thromboembolic events compared to native valve TAVR?

OBJECTIVE: To evaluate the risk for brain lesions in valve in valve (VIV)-transcatheter aortic valve replacement (TAVR) compared to native valve procedures (NV-TAVR). BACKGROUND: TAVR is associated with the risk of stroke and a high incidence of brain lesions in diffusion-weighted magnetic resonance imaging (DW-MRI). The risk in VIV procedures is unknown. METHODS: Patients were included, if they received a Sapien-3 or an Evolut-R valve for an NV-TAVR or VIV-TAVR and a DW-MRI within 3-5 days after the procedure. RESULTS: Two hundred nine patients had NV-TAVR and 41 patients had VIV-TAVR. The VIV group was significantly younger (mean 82.3 vs. 74.7 years old, p < .001) but had higher mean EuroSCORE II (4.8 vs. 7.8, p < .001). Predilatation was significantly more common with native valve (39% vs. 2%, p < .01), postdilatation rate was lower in VIV but without statistical significance (17% vs. 7%, p = .110). Combined in-hospital safety outcome was comparable [13(6.6%) vs. 5(12.2%), p = .205]. Any stroke was documented in four (0.5%) patients after native valve and in one (2.4%) after VIV-TAVR. New DW-MRI brain lesions were significantly more often found in patients with native valves [153(73.2%) vs. 21(51.2%), p = .005], mean number of new lesions was also higher with native valve (2.8 ± 3.2 vs. 1.0 ± 1.4, p < .001). Forward stepwise of logistic regression found age and post dilatation significant predictors of new MRI lesions. CONCLUSIONS: Compared to native valves, VIV procedures were associated with lower incidence and number of brain lesions according to DW-MRI; these were explained by lower patients' age and lower rate of postdilatation.

Rotational atherectomy in CTO lesions: too risky? Outcome of rotational atherectomy in CTO lesions compared to non-CTO lesions.

AIMS: The aim of this study was to determine the feasibility of rotational atherectomy (RA) in chronic total occlusion (CTO) PCI and compare the success and complication rates of RA in CTO lesions versus non-occluded lesions. Data on RA in CTO are rare and it is unknown how procedural success and risk of RA in CTO lesions compare to RA in non-CTO lesions. METHODS AND RESULTS: RA was performed in 392 out of 17,919 PCI procedures (2.2% of the PCI cohort) and classified as RA CTO (n=75) and RA non-CTO (n=317). Procedural success and MACCE in both groups were assessed by two investigators. All RA procedures were analysed for dissections prior to RA, which were defined according to the NHLBI classification. Baseline characteristics were not significantly different in the two groups but, in RA CTO, lesion type was more complex (p<0.001), stented segments were longer (35.0±22.7 vs. 46.0±24.8 mm, p<0.001) and mean burr size was smaller (1.61±0.17 vs. 1.49±0.18 mm, p<0.001). Procedural success and complications were not different (RA non-CTO 96.2% and RA CTO 94.7%, RA non-CTO 2.5% and RA CTO 4.0%, respectively). RA performed in dissection planes had a 100% procedure success rate in CTO and a 92% success rate in non-CTO. CONCLUSIONS: RA in CTO is as safe and as effective as RA in non-CTO. The presence of dissections prior to RA in CTO lesions as well as in non-CTO lesions does not seem to have a negative impact on outcome.