Tom Adriaenssens

BACKGROUND: The prognostic value of rapid atrial pacing (RAP)-induced Wenckebach atrioventricular block (W-AVB) as a diagnostic test for predicting permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) remains unclear and requires further validation. The objective of this study was to evaluate the predictive value of RAP-induced W-AVB for PPI and sudden cardiac death within 30 days post-TAVR. METHODS: This prospective, investigator-initiated, multicenter study (PACE-TAVR) included 640 patients undergoing TAVR across 12 centers. RAP was performed before and after TAVR to assess for W-AVB. Using negative predictive values and negative likelihood ratios, the predictive value of W-AVB was evaluated for the primary end point: sudden cardiac death or guideline-based indications for PPI, including complete AVB or alternating bundle branch block (Class I), and preexisting conduction disturbances with new ECG changes, new-onset left bundle branch block, a positive electrophysiology study, or sinus node dysfunction (Class II). RESULTS: RAP was successfully performed post-TAVR in 556 patients, with RAP-induced W-AVB observed in 192 (34.5%). W-AVB was associated with baseline conduction disturbances, amiodarone use, pre-TAVR RAP-induced W-AVB, and anesthesia type. The primary end point was more frequent in patients with W-AVB (15.6% versus 9.3%; odds ratio, 1.80 [95% CI, 1.06–3.04]; P =0.029). However, the absence of W-AVB had a negative predictive value of only 90.7% and a poor negative likelihood ratio (0.79). The test’s utility declined in subgroups at high risk for PPI, including self-expanding valve recipients (odds ratio, 1.47 [95% CI, 0.84–2.58]; negative predictive value, 88.4%; negative likelihood ratio, 0.86) and patients with a baseline or new left bundle branch block (odds ratio, 1.14 [95% CI, 0.54–2.42]; negative predictive value, 81.3%; negative likelihood ratio, 0.95). CONCLUSIONS: RAP-induced W-AVB demonstrates limited utility in predicting post-TAVR PPI or sudden cardiac death, particularly in patients at high risk for PPI. Clinicians should be cautious when using this test for post-TAVR rhythm management. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05278585.

Ischaemic cerebrovascular events (CVEs) are a major complication of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis. We aimed to determine the incidence and risk factors for CVE at 30 days and 1 year after TAVI in a large, real-world patient cohort and evaluate the association of these events with all-cause mortality at 1 year. All consecutive patients undergoing TAVI at a single centre between April 2008 and February 2024 were included in the analysis. CVE were defined as a composite of stroke and transient ischaemic attack. One thousand and three patients (mean age 81.8 ± 7.0 years, 52.6% male, median EuroSCORE II 6% [Q1 = 3.51%; Q3 = 10.9%]) underwent TAVI with a self-expandable valve (SEV) (n = 275; 27.4%) or balloon-expandable valve (BEV) (n = 728; 72.6%). The cumulative incidence of CVE was 3.6% (95% confidence interval (95% CI) = [2.6%; 4.9%], n = 36) at 30 days (77.8% within 48 h) and 6.2% (95% CI = [4.8%; 7.8%], n = 62) at 1 year. Risk factors associated with a lower risk of CVE at 30 days included BEV vs. SEV (OR 0.32 [0.16-0.63], p = 0.0009) and larger baseline aortic valve area (AVA) (OR_{Unit = 0.1 cm2} 0.74 [0.61-0.91], p = 0.0035), while the risk was higher in the case of new-onset atrial fibrillation (AF) (OR 3.19 [1.18-8.59], p = 0.0218), diabetes (OR 2.00 [1.01-3.97], p = 0.0484), and conversion to sternotomy (OR 16.57 [4.62-59.48], p < 0.0001). Analysis at 1-year follow-up identified the same associations. Finally, the occurrence of CVE significantly increased 1-year all-cause mortality (OR 2.44 [1.32-4.50], p = 0.0045). CVE after TAVI were associated with double the odds of 1-year all-cause mortality. Risk factors associated with CVE include the use of a SEV, new-onset AF, diabetes, conversion to sternotomy, and a smaller AVA.

Since its introduction in clinical practice, patient selection and procedural technique for transcatheter aortic valve implantation (TAVI) have continued to evolve. We investigated temporal trends in patient profiles, procedural, 30-day and 1-year clinical outcomes in all consecutive patients undergoing TAVI at our centre from March 2008 to February 2024 (n = 1000). Patients were stratified into eight consecutive 2-year calendar cohorts. Outcomes were reported according to VARC-III criteria. Median age was 82 y (53% male). Over the consecutive cohorts, we observed significant decreases in STS score (8.1 ± 3.1 to 4.4 ± 2.6%) and EuroSCORE II (10.2 ± 8.0 to 6.4 ± 7.0; p < 0.001 for both). In-hospital death rates decreased significantly (9.4% to 1.3%; p = 0.030). The incidence of major vascular complications, life-threatening bleeding, and cardiac tamponade decreased significantly over time (p < 0.05 for all). Enhanced learning and a shift to a minimalist approach resulted in reduced need for intensive care (from 4 [3-5] to 0 days) and shorter hospital stay (from 13 [8-19] to 2 [2-4] days) (p < 0.001 for both). Overall 30-day survival was 96.4%, with significant improvement across cohorts (93.4% to 98.7%), while 1-year survival was 88.1% with a similar gradual increase (81.3% to 90.2%). Composite VARC-III endpoints demonstrated high technical success and significant improvements in device success and early safety across the eight 2-year cohorts. Over 15 years we observed a shift from very high-risk towards predominantly intermediate- to high-risk patients, together with substantial procedural simplification and a marked reduction in in-hospital complications and length of stay. These improvements translated into a significant increase in 30-day and 1-year survival.

Long-term data on hemodynamic performance and valve durability are essential to guide bioprosthetic valve selection and to safely expand transcatheter aortic valve implantation (TAVI) to lower-risk patients with severe aortic stenosis (AS). This study aimed to assess the hemodynamic valve performance in a large cohort of patients undergoing TAVI with balloon-expandable (BEV) or self-expandable valves (SEV) and identify possible predictors of bioprosthetic valve degeneration (BVD). All patients undergoing TAVI for native AS in a single centre between March 2008 and September 2023 underwent sequential echocardiographic follow-up at 30 days, 6 months and yearly thereafter. BVD was categorised as moderate or severe according to the Valve Academic Research Consortium 3 criteria. 784 patients (82 ± 7 years, 53.1% male, median EuroSCORE II 6.0% (3.6;10.7)) were treated with BEV (n = 584; 74.5%) or SEV (n = 200; 25.5%). Patients treated with BEV had a significantly higher 30-day mean transprosthetic gradient (TPG) (10.8 (95% CI 10.4-11.2) vs 6.8 mmHg (95% CI 6.3-7.4), p < 0.0001), but fewer more-than-mild aortic regurgitation as compared with SEV. Moderate/severe BVD were observed in 29 and 8 patients respectively, corresponding with a 6-year cumulative incidence of 7.3% (95% CI 5.0-10.1%). BVD was significantly associated with all-cause mortality for moderate (HR 2.2, 95% CI 1.3-4.0, p = 0.0051) and severe BVD (HR 4.5, 95% CI 1.4-14.1, p = 0.0105). Both a mean post-implantation TPG > 9 mmHg (HR 2.2; 95% CI 1.0-5.0, p = 0.0456) and implantation of the 20 mm SAPIEN BEV (n = 4) (HR 6.8; 95% CI 1.5-30.3, p = 0.0114) were associated with an increased incidence of BVD. BVD is a rare complication in elderly intermediate-to-high risk patients undergoing TAVI. However, BVD is associated with increased mortality.

Valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) is increasingly used for the treatment of surgical bioprosthetic valve degeneration (sBVD). We investigated clinical outcomes and hemodynamic valve performance in all consecutive patients undergoing ViV-TAVI for sBVD in a single centre and assessed differences in patients who received a balloon-expandable (BEV) versus self-expandable valve (SEV) at 1, 6 and 12 months (m), and annually thereafter. Between 25 November 2011 and 4 September 2023, 86 patients (mean age 80.3 ± 6.6y; 53.5% female; median STS score 5.1% (3.7%;8.6%) underwent ViV-TAVI with BEV (n = 53) or SEV (n = 33). Overall, the cumulative incidences of all-cause and cardiovascular mortality at 12 m were 7.4% (3.4%;15.8%) and 3.6% (0.9%; 9.3%), respectively (comparison of SEV versus BEV within the first year: p = 0.253 and p = 0.168, and comparison for the entire follow-up (median 2.6 (0.9;4.6) years): p = 0.962 and p = 0.942). Aortic valve area (AVA) and peak and mean transprosthetic gradients (TPG) improved significantly from baseline to 1, 6 and 12 m follow-up (p < 0.001 for all). Peak and mean TPG were 10.5 (1.8;19.2) and 7.1 (1.6;12.7) mmHg lower in SEV as compared with BEV at 1 m (p = 0.019 and 0.012, respectively). Similarly, AVA of SEV was 0.23 (0.03;0.44) and 0.54 (0.28;0.81) cm² larger as compared with BEV at 1 and 6 m (p = 0.027 and p < 0.001, respectively). No significant differences in hemodynamic valve performance between BEV and SEV were observed during further follow-up. ViV-TAVI is a safe and effective treatment for patients presenting sBVD. Improved hemodynamic valve performance with SEV over BEV observed during early follow-up did not translate into long-term lower mortality rates.

Resorbable magnesium scaffolds (RMS) represent a conceptually attractive alternative to polymeric scaffolds for the treatment of significant coronary artery lesions. Promising outcomes at 24 months...

The DAPT score is a recently-proposed decision tool for guiding optimal duration of dual antiplatelet therapy (DAPT). It showed modest accuracy in prior derivation and validation cohorts of patients with ≥12 months DAPT. This study was aimed to evaluate the validity of the DAPT score in a cohort of patients with 6 or 12 months DAPT after implantation of predominantly second-generation drug-eluting stents. We analyzed data of patients enrolled in the ISAR-SAFE trial. Patients were classified into low (<2) or high (≥2) DAPT score groups. Primary ischaemic (all-cause death, myocardial infarction, definite stent thrombosis or stroke) and bleeding (TIMI major or minor) outcomes were analyzed in the low and high DAPT score groups. Data of 3976 patients were available for DAPT score calculation. 2407 patients (60.5%) were classified in the low DAPT score group and 1569 patients (39.5%) in the high DAPT score group. In the low DAPT score group there were no significant differences between 6 and 12 months DAPT regarding ischaemic (1.0% vs. 1.4%, HR=0.74, 95% CI, 0.35–1.57; p=0.43) or bleeding outcomes (0.3% vs. 0.8%, HR=0.44, 95% CI, 0.13–1.42; p=0.17). In the high DAPT score group there were also no significant differences between 6 and 12 months DAPT regarding ischaemic (1.9% vs. 1.8%, HR=1.02, 95% CI, 0.49–2.14; p=0.96) or bleeding (0.3% vs. 0.5%, HR=0.51, 95% CI, 0.09–2.78; p=0.44) outcomes. In conclusion, the DAPT score failed to show a differential treatment effect in patients receiving 6 or 12 months DAPT after contemporary drug-eluting stent implantation.

(2010). Ulnar and cerebellar embolization from an ulcerative subclavian artery lesion. Acta Cardiologica: Vol. 65, No. 6, pp. 693-694.