Background: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence. Methods: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years. Results: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio‚ 0.88 [95% CI, 0.66–1.18]; P =0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio‚ 0.97 [95% CI, 0.76–1.24]; P =0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or or 0.10). Conclusions: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.
Two subtypes of atrial functional mitral regurgitation (AFMR) have been described, one is characterized by Carpentier type I and the other by Carpentier type IIIb leaflet motion. The authors sought to analyze echocardiographic characteristics and outcomes of AFMR subtypes undergoing mitral valve transcatheter edge-to-edge repair (M-TEER). Of 1,047 consecutive patients who underwent M-TEER, the authors identified those with isolated mitral annulus dilation (Carpentier I), termed AFMR-IAD, and those with atriogenic hamstringing characterized by restricted posterior mitral leaflet motion (Carpentier IIIb), termed AFMR-AH. Echocardiographic baseline characteristics and outcomes up to 1-year were analyzed. A total of 128 patients (12.2%) met AFMR criteria; 75 (58.6%) were identified as AFMR-IAD and 53 (41.4%) as AFMR-AH. AFMR-AH displayed greater left atrial and left ventricular volumes, greater mitral annulus, shorter and steeper posterior mitral leaflet, and more pronounced MR (all P < 0.05). Technical success was achieved in 98.7% (AFMR-IAD) and 86.8% (AFMR-AH) of patients (P = 0.009). At discharge, device detachments were exclusively observed in AFMR-AH (10.0%). MR ≤II was achieved in 95.6% and 78.6% at 30 days (P = 0.009) and in 93.0% and 74.1% at 1 year (P = 0.038) in patients with AFMR-IAD and AFMR-AH, respectively. AFMR-AH was associated with procedural failure (OR: 1.17 [95% CI: 1.00-1.38]; P = 0.045) at 30 days (43.4% vs 24.0%; P = 0.023) and all-cause mortality (HR: 2.54 [95% CI: 1.09-5.91]; P = 0.031) at 1 year (77% vs 92%, Kaplan-Meier estimated 1-year survival; P = 0.017). AFMR-AH shows worse procedural and clinical outcomes following M-TEER than AFMR-IAD. Thus, vigilance regarding this pathology is warranted and alternative mitral valve therapies might need to be considered.
5 September 2023 in Catheterization and Cardiovascular Interventions
Background: Preprocedural computed tomography planning improves procedural safety and efficacy of transcatheter aortic valve implantation (TAVI). However, contemporary imaging modalities do not account for device‐host interactions.Aims: This study evaluates the value of preprocedural computer simulation with FEops HEARTguideTM on overall device success in patients with challenging anatomies undergoing TAVI with a contemporary self‐expanding supra‐annular transcatheter heart valve.Methods: This prospective multicenter observational study included patients with a challenging anatomy defined as bicuspid aortic valve, small annulus or severely calcified aortic valve. We compared the heart team's transcatheter heart valve (THV) planning decision based on (1) conventional multislice computed tomography (MSCT) and (2) MSCT imaging with FEops HEARTguideTM simulations. Clinical outcomes and THV performance were followed up to 30 days.Results: A total of 77 patients were included (median age 79.9 years (IQR 74.2–83.8), 42% male). In 35% of the patients, preprocedural planning changed after FEops HEARTguideTM simulations (change in valve size selection [12%] or target implantation height [23%]). A new permanent pacemaker implantation (PPI) was implanted in 13% and >trace paravalvular leakage (PVL) occurred in 28.5%. The contact pressure index (i.e., simulation output indicating the risk of conduction abnormalities) was significantly higher in patients with a new PPI, compared to those without (16.0% [25th–75th percentile 12.0–21.0] vs. 3.5% [25th–75th percentile 0–11.3], p < 0.01) The predicted PVL was 5.7 mL/s (25th–75th percentile 1.3–11.1) in patients with none‐trace PVL, 12.7 (25th–75th percentile 5.5–19.1) in mild PVL and 17.7 (25th–75th percentile 3.6–19.4) in moderate PVL (p = 0.04).Conclusion: FEops HEARTguideTM simulations may provide enhanced insights in the risk for PVL or PPI after TAVI with a self‐expanding supra‐annular THV in complex anatomies.
24 December 2024 in JACC: Cardiovascular Interventions
Transradial secondary access (TR-SA) may serve as an alternative to the traditional femoral secondary access (TF-SA) for pigtail placement in transcatheter aortic valve replacement (TAVR). The aim of this study was to assess the incidence of secondary access-related vascular complications after TR-SA or TF-SA in TAVR. The PULSE (Plug or sUture based vascuLar cloSurE after TAVR) registry retrospectively evaluated data of 10,120 patients who underwent transfemoral TAVR at 10 heart centers from 2016 to 2021. We compared TR-SA and TF-SA groups of 8,851 patients with available data regarding the secondary access location and validated observed data in 1:1 propensity score matching. Outcomes were evaluated according to Valve Academic Research Consortium 3 definitions. The median age was 82.0 ± 6.9 years, and 49.1% (4,346/8,851) of patients were female. TR-SA was selected in 1,686 patients (19.0%) and TF-SA in 7,165 (81.0%) overall. Vascular complications at the secondary access occurred in 0.3% (5/1,686 [TR-SA]) vs 3.2% (232/7,165 [TF-SA]; P < 0.001) and were considered major in 0.2% (3/1,686 [TR-SA]) vs 1.5% (109/7,165 [TF-SA]) and minor in 0.1% (2/1,686 [TR-SA]) vs 1.7% (123/7,165 [TF-SA]; P < 0.001 for both). Surgical repair was required in 0 TR-SA patients and in 0.9% (66/7,165) of TF-SA patients. Primary access vascular complications were similar (11.6% (196/1,686 [TR-SA]) vs 11.5% (825/7,165 [TF-SA]); P = 0.93); bleeding type III/IV occurred less with TR-SA (2.5% [42/1,686] vs 4.7% [334/7,165] with TF-SA; P < 0.001). After propensity score matching, secondary access-related vascular complication rates remained lower for TR-SA (0.2% [1/512] vs 2.9% [15/512] for TF-SA; P < 0.001). During transfemoral TAVR, TR-SA was associated with lower rates of access site complications and severe bleeding compared to TF-SA. In fact, secondary access-related complications were 10× higher for TF-SA and frequently required invasive treatments. These findings challenge the fact that most TAVR procedures are still performed with TF-SA.
25 November 2024 in JACC: Cardiovascular Interventions
Prosthesis-patient mismatch after transcatheter aortic valve replacement (TAVR) can be measured echocardiographically (measured prosthesis-patient mismatch [PPMm]) or predicted (predicted prosthesis-patient mismatch [PPMp]) using published effective orifice area (EOA) reference values. However, the clinical implications of PPM post-TAVR remain unclear. This study aimed to elucidate the prevalence of PPMm and PPMp post-TAVR and their impact on mortality in a large international cohort. The IMPPACT TAVR (Impact of Measured or Predicted Prosthesis-pAtient mismatCh after TAVR) registry included 38,808 TAVR patients from 26 international centers. Valve Academic Research Consortium 3 criteria were used to define prosthesis-patient mismatch severity. EOA was determined echocardiographically (PPMm) or predicted (PPMp) based on core lab-derived EOA reference values. The primary endpoint was 2-year all-cause mortality. The prevalence of PPMp (moderate: 6.8%, severe: 0.6%) was significantly lower than that of PPMm (moderate: 20.7%, severe: 4.3%; P < 0.001) with negligible correlation between the 2 methods (Kendall's tau c correlation coefficient: 0.063; P < 0.001). In unadjusted analyses, severe PPMm adversely influenced 2-year survival (HR: 1.22; 95% CI: 1.02-1.45; P = 0.027), whereas severe PPMp was not associated with outcomes (HR: 0.81; 95% CI: 0.55-1.19; P = 0.291). After adjusting for confounders, neither PPMm nor PPMp had a significant effect on 2-year all-cause mortality. PPMm and PPMp were associated with different patient characteristics, with PPMm tending toward worse (especially low flow) and PPMp toward better (especially women) survival. After adjusting for confounders, neither PPMm nor PPMp significantly affected 2-year all-cause mortality. Hence, valve selection should not solely be based on hemodynamics but rather on a holistic approach, including patient and procedural specifics.