Outcomes with post-dilation following transcatheter aortic valve replacement: the PARTNER I trial (placement of aortic transcatheter valve).

This study sought to characterize the patients receiving post-implantation balloon dilation (PD) following transcatheter aortic valve replacement (TAVR) and evaluate procedural outcomes in the PARTNER (Placement of Aortic Transcatheter Valve) I trial. Following TAVR, PD has been used to treat paravalvular regurgitation. The PARTNER I trial cohort A (n = 304) and cohort B (n = 194) patients randomized to TAVR and the nonrandomized continued access TAVR (n = 1,637) patients were included in the analysis. PD was performed at the discretion of the operator. Clinical events and echocardiographic variables were collected prospectively out to 1 year. The overall incidence of PD was 12.4%. PD patients had significantly less prosthesis-patient mismatch (p < 0.001) and larger effective orifice areas (p < 0.001) throughout the follow-up period. There were significantly more subacute strokes (occurring <7 days: 4.9% vs. 2.6%; p = 0.04) in PD patients but no difference in late stroke, either at 7 to 30 days (0.0% vs. 0.8%; p = 0.16) or >30 days (1.9 vs. 1.7%; p = 0.75). Although there was no significant increase in early mortality with PD, at 1 year, there was a trend for higher all-cause mortality (p = 0.054) and a significant difference in death or stroke (p = 0.04). When the subgroup of patients with none/trace paravalvular regurgitation were evaluated, there was no significant association of PD with mortality (p = 0.61) and death or stroke (p = 0.96). Multivariable analysis failed to show a relationship between PD and mortality. PD is associated with reduced rates of moderate or severe prosthesis-patient mismatch with no evidence for short-term structural deterioration of the balloon-expandable transcatheter valve. Although PD is associated with a greater incidence of early stroke, there is no significant association between PD and stroke beyond 7 days. Multivariable analysis shows no significant association between PD and mortality.

Hahn RT ，Pibarot P ，Webb J ，Rodes-Cabau J ，Herrmann HC ，Williams M ，Makkar R ，Szeto WY ，Main ML ，Thourani VH ，Tuzcu EM ，Kapadia S ，Akin J ，McAndrew T ，Xu K ，Leon MB ，Kodali SK ... -  《-》

Clinical impact of aortic regurgitation after transcatheter aortic valve replacement: insights into the degree and acuteness of presentation.

The aim of this study was to determine the impact of the degree of residual aortic regurgitation (AR) and acuteness of presentation of AR after transcatheter aortic valve replacement (TAVR) on outcomes. The degree of residual AR after TAVR leading to excess mortality remains controversial, and little evidence exists on the impact of the acuteness of presentation of AR. A total of 1,735 patients undergoing TAVR with balloon-expandable or self-expanding valves were included. The presence and degree of AR were evaluated by transthoracic echocardiography; acute AR was defined as an increase in AR severity of ≥1 degree compared with pre-procedural echocardiography. Residual AR was classified as mild in 761 patients (43.9%) and moderate to severe in 247 patients (14.2%). The presence of moderate to severe AR was an independent predictor of mortality at a mean follow-up of 21 ± 17 months compared with none to trace (adjusted hazard ratio [HR]: 1.81, 95% confidence interval [CI]: 1.32 to 2.48; p < 0.001) and mild AR (adjusted HR: 1.68, 95% CI: 1.27 to 2.24; p < 0.001) groups. There was no increased risk in patients with mild AR compared with those with none to trace AR (p = 0.393). In patients with moderate to severe AR, acute AR was observed in 161 patients (65%) and chronic AR in 86 patients (35%). Acute moderate to severe AR was independently associated with increased risk of mortality compared with none/trace/mild AR (adjusted HR: 2.37, 95% CI: 1.53 to 3.66; p < 0.001) and chronic moderate to severe AR (adjusted HR: 2.24, 95% CI: 1.17 to 4.30; p = 0.015) [corrected]. No differences in survival rate were observed between patients with chronic moderate to severe and none/trace/mild AR (p > 0.50). AR occurred very frequently after TAVR, but an increased risk of mortality at ∼2-year follow-up was observed only in patients with acute moderate to severe AR.

Jerez-Valero M ，Urena M ，Webb JG ，Tamburino C ，Munoz-Garcia AJ ，Cheema A ，Dager AE ，Serra V ，Amat-Santos IJ ，Barbanti M ，Immè S ，Alonso Briales JH ，Al Lawati H ，Benitez LM ，Cucalon AM ，Garcia del Blanco B ，Revilla A ，Dumont E ，Barbosa Ribeiro H ，Nombela-Franco L ，Bergeron S ，Pibarot P ，Rodés-Cabau J ... -  《-》

Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry.

The purpose of this study was to identify predictors and clinical implications of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR). Cardiac conduction disturbances requiring PPM are a frequent complication of TAVR. However, limited data is available regarding this complication after TAVR with a balloon-expandable valve. The study included patients without prior pacemaker who underwent TAVR in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry and investigated predictors and clinical effect of new PPM. Of 2,559 TAVR patients, 586 were excluded due to pre-existing PPM. A new PPM was required in 173 of the remaining 1,973 patients (8.8%). By multivariable analysis, predictors of PPM included right bundle branch block (odds ratio [OR]: 7.03, 95% confidence interval [CI]: 4.92 to 10.06, p < 0.001), prosthesis diameter/left ventricular (LV) outflow tract diameter (for each 0.1 increment, OR: 1.29, 95% CI: 1.10 to 1.51, p = 0.002), LV end-diastolic diameter (for each 1 cm, OR: 0.68, 95% CI: 0.53 to 0.87, p = 0.003), and treatment in continued access registry (OR: 1.77, 95% CI: 1.08 to 2.92, p = 0.025). Patients requiring PPM had a longer mean duration of post-procedure hospitalization (7.3 ± 2.7 days vs. 6.2 ± 2.8 days, p = 0.001). At 1 year, new PPM was associated with significantly higher repeat hospitalization (23.9% vs. 18.2%, p = 0.05) and mortality or repeat hospitalization (42.0% vs. 32.6%, p = 0.007). There was no difference between groups in LV ejection fraction at 1 year. PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year. (THE PARTNER TRIAL: Placement of AoRtic TraNscathetER Valves Trial; NCT00530894).

Nazif TM ，Dizon JM ，Hahn RT ，Xu K ，Babaliaros V ，Douglas PS ，El-Chami MF ，Herrmann HC ，Mack M ，Makkar RR ，Miller DC ，Pichard A ，Tuzcu EM ，Szeto WY ，Webb JG ，Moses JW ，Smith CR ，Williams MR ，Leon MB ，Kodali SK ，PARTNER Publications Office ... -  《-》

Pre-Procedural Hemodynamic Status Improves the Discriminatory Value of the Aortic Regurgitation Index in Patients Undergoing Transcatheter Aortic Valve Replacement.

The aims of this study were to increase the discriminatory value of the aortic regurgitation index (ARI) for the assessment of paravalvular regurgitation (PVR) and to further elucidate the association between aortic regurgitation severity and mortality after transcatheter aortic valve replacement (TAVR). Hemodynamic parameters such as the ARI complement predominantly angiographically guided TAVR. However, the ARI depends on several baseline and periprocedural characteristics. The ARI was prospectively calculated before and after TAVR in 600 patients. The severity of PVR was assessed in all patients by angiography and echocardiography according to a 3-class scheme. To account for pre-procedural hemodynamic status, the ARI ratio was calculated as post- over pre-procedural ARI. Apart from the degree of PVR (β = -0.396, p < 0.001), pre-procedural hemodynamic status in the form of the ARI before TAVR (β = 0.227, p < 0.001) was associated with post-procedural ARI in multivariate regression analysis. The ARI ratio increased the specificity of post-procedural ARI alone for the prediction of both more than mild PVR and 1-year mortality from 75.1% to 93.2% and from 75.0% to 93.3%, respectively. Patients with post-procedural ARI values <25 after TAVR had significantly increased 1-year mortality only when the ARI ratio was <0.60 (50.0% vs. 26.3%, p = 0.001). The ARI ratio integrating pre- and post-procedural hemodynamic status increases the discriminatory value of post-procedural ARI. The ARI ratio, which reflects acute hemodynamic changes after TAVR, is useful to identify patients with negative outcomes.

Sinning JM ，Stundl A ，Pingel S ，Weber M ，Sedaghat A ，Hammerstingl C ，Vasa-Nicotera M ，Mellert F ，Schiller W ，Kovac J ，Welz A ，Grube E ，Werner N ，Nickenig G ... -  《-》

Impact of balloon post-dilation on clinical outcomes after transcatheter aortic valve replacement with the self-expanding CoreValve prosthesis.

The aim of this study was to assess the incidence and clinical impact of balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR) with the CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota). BPD is a widely adopted strategy to reduce the degree of paraprosthetic regurgitation in case of transcatheter heart valve underexpansion. However, controversies still remain regarding its real effectiveness and safety. The ClinicalService (a nation-based data repository and medical care project) dataset was analyzed. All patients were dichotomized according to the need for BPD during the index procedure. Among 1,376 patients, BPD of the transcatheter heart valve was performed in 272 (19.8%). In 37% of cases, it was unsuccessful at reducing the paravalvular regurgitation to mild or less. No case of valve embolization, new intravalvular regurgitation, coronary occlusion, and aortic root injury occurred during BPD. There were no statistically significant differences between the 2 groups in the incidence of in-hospital all-cause and cardiovascular mortality, neurological events, myocardial infarction, bleeding, conversion to open-chest surgery, and the need for a permanent pacemaker. The need for BPD did not emerge as an independent risk factor for all-cause (adjusted hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 0.81 to 2.19, p = 0.264) and cardiovascular (adjusted HR: 1.48, 95% CI: 0.74 to 2.97, p = 0.265) mortality at 1 year after the procedure. In addition, BPD did not predispose to higher odds of neurological events during 12 months after TAVR (HR: 0.92, 95% CI: 0.45 to 1.88, p = 0.815). This large study showed that BPD after TAVR was safe and not associated with increased rates of cerebrovascular events, mortality, myocardial infarction, and aortic root injury.

Barbanti M ，Petronio AS ，Capodanno D ，Ettori F ，Colombo A ，Bedogni F ，De Marco F ，De Carlo M ，Fiorina C ，Latib A ，Testa L ，Bruschi G ，Poli A ，Giannini C ，Curello S ，Maffeo D ，Sgroi C ，Martina P ，Gulino S ，Patanè M ，Ohno Y ，Attizzani GF ，Immè S ，Cannata S ，Gentili A ，Rossi A ，Tamburino C ... -  《-》