Clinical Characteristics and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement: The TriACT Registry.

BACKGROUND: Transcatheter tricuspid valve replacement (TTVR) abolishes tricuspid regurgitation (TR) and has emerged as a definitive treatment for TR. OBJECTIVES: The purpose of this multicenter, observational study was to determine the clinical characteristics and short-term outcomes of patients with TR screened for TTVR. METHODS: Patients underwent TTVR screening at 7 centers on a compassionate-use basis. The primary endpoints were NYHA functional class and TR grade at 30-day follow-up. Secondary endpoints included all-cause mortality, heart failure hospitalization, technical success, and reasons for TTVR screening failure. RESULTS: A total of 149 patients (median age 79 years [Q1-Q3: 72-84 years], 54% women) underwent TTVR screening. The TTVR screening failure rate was 74%, mainly related to large tricuspid annular diameter. Patients undergoing TTVR (n = 38) had significant functional improvements (NYHA functional class I or II from 21% to 68%; P < 0.001), with TR ≤1+ in 97% at 30-day follow-up (P < 0.001 from baseline). Technical success was achieved in 91%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 8%, heart failure hospitalization 5%, major bleeding 18%, and reintervention 9%. Patients who failed screening for TTVR and subsequently underwent "bailout" transcatheter edge-to-edge repair (n = 26) had favorable outcomes (NYHA functional class I or II from 27% to 58%; P < 0.001), with TR ≤1+ in 43% at 30-day follow-up (P < 0.001 from baseline). CONCLUSIONS: This first real-world report of TTVR screening demonstrated a high screening failure rate, mainly related to large tricuspid annular diameter. Patients undergoing TTVR had superior TR reduction and symptom alleviation compared with bailout tricuspid transcatheter edge-to-edge repair, at the cost of greater procedural complications.

Incidence of Persistent Left Bundle Branch Block After Rapid-Deployment Aortic Valve Replacement.

BACKGROUND: We evaluated the incidence, prognosis, and predictive factors of new onset of persistent left bundle branch block (NOP-LBBB) after rapid-deployment aortic valve replacement (RD-AVR). METHODS: This was an observational, retrospective, single-center study of 274 consecutive patients with no baseline ventricular conduction disorder and no previous permanent pacemaker implantation (PPI) who underwent RD-AVR with an INTUITY valve (n = 55) or INTUITY Elite Valve (n = 219) (Edwards Lifesciences). Transthoracic echocardiography and 12-lead electrocardiography was performed preoperatively, at discharge, and at 1-month and 1-year intervals. The incidence, prognosis, and predictive factors of NOP-LBBB were evaluated. RESULTS: NOP-LBBB occurred in 58 patients (21.2%) after discharge. In multivariate analysis, age (P < .01), INTUITY valve diameter ≥23 mm (P = .02), and INTUITY Elite implantation (P = .01) were independent predictors of NOP-LBBB. By 1:1 propensity matching analysis between the NOP-LBBB group and the control group, there were no significant differences in 1-year overall mortality (P = .23), hospitalization for congestive heart failure (P = .99), or PPI (P = .99). NOP-LBBB exposed patients to a high rate of dysrhythmic events (12.1% vs 1.4%, P < .01) and was associated with a significant decrease in left ventricular ejection fraction (0.62 ± 0.095 vs 0.652 ± 0.0783, P = .02) without an impact on New York Heart Association functional status (1.25 ± 0.32 and 1.52 ± 0.70, P = .32). PPI was performed in 17 patients (6.2%) before discharge, including 14 NOP-LBBB patients. CONCLUSIONS: NOP-LBBB after RD-AVR is prevalent in patients with no prior conduction disorders. INTUITY Elite is associated with a significantly higher rate of NOP-LBBB. The persistence of NOP-LBBB predisposed patients to the occurrence of high-grade conduction disorders and might have led to PPI but did not increase death or hospitalization for congestive heart failure.

Advantages and disadvantages of drug challenge during electrophysiological study in patients with new left bundle branch block after transaortic valve implantation.

AIMS: Electrophysiological study (EPS) is recommended in case of new-onset persistent left bundle branch block (NOP-LBBB) after transaortic valve implantation (TAVI) to identify patients at high risk of delayed atrioventricular block (D-AVB). We evaluated the added value of drug challenge, after normal baseline EPS, to predict D-AVB in such patients. METHODS: We conducted a comparative single-centre study of two successive periods, during which we used baseline EPS alone (first period) or drug challenge in case of normal baseline EPS (second period), for patients with NOP-LBBB after TAVI. The primary endpoint was a composite of pacemaker use, documented D-AVB, cardiac syncope, sudden death, or delayed pacemaker implantation. RESULTS: Among 736 patients with TAVI implantation between January 2016 and September 2019, 64 with NOP-LBBB were included. During the first period, 4/22 (18.2%) presented with a positive baseline EPS. After a mean (standard deviation [SD]) of 15.6 (8.3) months, 7/22 (31.8%) reached the primary endpoint. During the second period, 19/42 (45.2%) presented with a positive EPS. After a mean (SD) of 12.8 (3.5) months, 8/42 (19.0%) reached the primary endpoint. There was a tendency to increased sensitivity (42.9-87.5%; P = 0.12) and negative predictive value (77.8-95.7%; P = 0.15) of the EPS, respectively during the first to the second period. However, the specificity decreased (93.3-64.7%; P = 0.04). CONCLUSION: Diagnostic yield improved with drug challenge in case of normal baseline EPS. However, the decrease in specificity led to a high rate of unnecessary pacemaker implantation.