Three-year outcome after transcatheter aortic valve implantation: Comparison of a restrictive versus a liberal strategy for pacemaker implantation.

BACKGROUND: Conduction disturbances after transcatheter aortic valve implantation (TAVI) are common, heterogeneous, and frequently result in permanent pacemaker implantation (PPI). Pacemaker therapy with a high rate of right ventricular pacing is associated with heart failure, hospitalizations, and reduced quality of life. OBJECTIVE: The purpose of this study was to compare medium-term outcomes between PPI implantation strategies, as choosing the right indication for PPI is still an area of uncertainty and information on outcomes of PPI regimens beyond 1 year is rare. METHODS: We compared outcomes after 3 years between a restrictive PPI strategy, in which the lowest threshold for PPI was left bundle branch block (LBBB) (QRS >120 ms) with the presence of new atrioventricular block (PQ >200 ms), and a liberal PPI regimen, in which PPI already was performed in patients with new-onset LBBB. RESULTS: Between January 2014 and December 2016, TAVI was performed in 884 patients at our center. Of these, 383 consecutive, pacemaker-naive patients underwent TAVI with the liberal PPI strategy and subsequently 384 with the restrictive strategy. The restrictive strategy significantly reduced the percentage of patients undergoing PPI before discharge (17.2% vs 38.1%; P <.001). The incidence of the primary endpoint (all-cause-mortality and hospitalization for heart failure) after 3 years was similar in both groups (30.7% vs 35.2%; P = .242), as was all-cause-mortality (26.6% vs 29.2%; P = .718). Overall, patients who required PPI post-TAVI had significantly more hospitalizations due to heart failure (14.8% vs 7.8%; P = .004). CONCLUSION: A restrictive PPI strategy after TAVI reduces PPI significantly and is safe in medium-term follow-up over 3 years.

Impact of high-sensitivity cardiac troponin T on survival and rehospitalization after transcatheter aortic valve replacement.

BACKGROUND: Constant elevations of the serum concentration of cardiac troponin T (TnT) indicate a myocardial injury that may affect the long-term outcome of transcatheter aortic valve replacement (TAVR). OBJECTIVES: We sought to investigate the impact of pre-TAVR TnT on outcomes after TAVR during long-term follow-up. METHODS: In a retrospective, observational study we compared long term outcomes after TAVR between tertiles of preinterventional high-sensitivity TnT. Systematic follow-up was performed annually for 5 years. The primary endpoint was a composite of all-cause death and any rehospitalization. RESULTS: Between 2010 and 2018, 2,129 patients with severe aortic valve stenosis underwent TAVR at our institution (mean age 82.6 years, 57.2% female, logistic EuroSCORE 20.5 ± 15.8). Boundaries for TnT tertiles were <21 ng/L and >42 ng/L. The median follow-up was 895 days. Three-year incidences for the primary endpoint were 70.9%, 76.6%, and 81.7% in the low, middle, and high tertile (log rank p < .001). Compared with the first tertile, the corresponding adjusted hazard ratios were 1.23 (95%-CI 1.08-1.40, p < .001) and 1.50 (95%-CI 1.32-1.70, p < .001) for the second and third tertile. We found consistent differences between TnT strata for all-cause death (3-year incidences 23.3%, 33.3%, and 47.1%; adjusted p < .001) and rehospitalization (3-year incidences 64.7%, 68.7% and 72.0%; adjusted p < .001), including significant differences in deaths (p < .001). The association between TnT and outcome was independent of coronary artery disease or low aortic valve gradient. CONCLUSIONS: TnT before TAVR is strongly associated with all-cause death and rehospitalization during 3-year follow-up.

Effect of a restrictive pacemaker implantation strategy on mortality after transcatheter aortic valve implantation.

OBJECTIVES: We sought to assess the safety of a restrictive permanent pacemaker implantation (PPI) strategy after transcatheter aortic valve implantation (TAVI) as compared to a liberal strategy. BACKGROUND: Conduction disturbances resulting in PPI are common after TAVI. However, conduction disturbances may be transient and PPI may be superfluous in some patients. METHODS: Until August 2015, we performed PPI in all patients with new complete left bundle branch block (LBBB, QRS > 120 milliseconds) or higher degree atrioventricular (AV) blocks (liberal strategy). From September 2015 onwards, LBBB established an indication for PPI only in the presence of new-onset AV block (PQ > 200 milliseconds) (restrictive strategy). We analyzed the impact of the restrictive strategy on pacemaker implantation rate, duration of hospital stay, and 1-year mortality. RESULTS: Between January 2014 and December 2016, 383 consecutive, pacemaker-naive patients underwent TAVI with the liberal PPI strategy and subsequently 384 with the restrictive strategy. The restrictive strategy significantly reduced the percentage of patients undergoing PPI before discharge (17.2% vs. 38.1%, p < .001) and length of hospital stay (intensive care unit 52 ± 55 vs. 60 ± 52 hours, p < .001; general ward 10.6 ± 5.7 vs. 11.5 ± 5.7 days, p = .001). One-year all-cause mortality was not significantly different between groups (14.1% vs. 11.7%, log-rank p = .28). However, sudden death was more frequent in the restrictive group (3.4% vs. 1.3%, log-rank p = .049). CONCLUSIONS: As compared to a liberal indication for PPI, a restrictive indication reduced PPI rate and length of hospital stay without significantly affecting all-cause mortality. The observed increase in the risk of sudden death with the restrictive PPI indication deserves further investigation.

Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement.

BACKGROUND: Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials. OBJECTIVES: This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. METHODS: Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications. RESULTS: A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). CONCLUSIONS: Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521).

Hemodynamic classification of paravalvular leakage after transcatheter aortic valve implantation compared with angiographic or echocardiographic classification for prediction of 1-year mortality.

OBJECTIVES: We sought to assess angiographic, echocardiographic and hemodynamic grading of paravalvular leakage (PVL) after transcatheter aortic valve implantation (TAVI) with respect to prediction of 1-year mortality. BACKGROUND: Meaningful criteria for the severity of PVL are needed to allow intraprocedural guidance and patient management after TAVI. METHODS: We pooled the prospective TAVI databases of 2 German centers. During TAVI, PVL was assessed angiographically and by the aortic regurgitation index (ARI). ARI was calculated as ratio of the gradient between diastolic blood pressure and left ventricular end-diastolic pressure to systolic blood pressure times hundred. In addition, we performed transthoracic echocardiography before discharge. RESULTS: A total of 723 patients undergoing TAVI with self-expandable (20.9%) or balloon-expandable (79.1%) valves were included. Grades of PVL as assessed during the procedure by angiography or ARI (below the previously defined cut-off of 25) did not show a significant association with 1-year mortality (P = 0.312 and 0.776, respectively). One-year mortality was 15.7% (39/249) in patienths with an ARI < 25 and 16.5% (71/430) in patients with an ARI ≥ 25. Echocardiographic classes of PVL at discharge showed a significant (P = 0.029) association with 1-year mortality, which was 11.5% (37/322) in patients with no/trace PVL, 18.0% (62/345) in patients with mild PVL and 23.1% (6/26) in patients with more than mild PVL. These findings prevailed after multivariable adjustment. CONCLUSIONS: ARI did not help identify PVLs that are relevant to 1-year survival. Angiographic assessment during the procedure was less predictive than echocardiographic assessment before discharge.