Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: analysis from the German transcatheter aortic valve interventions registry.

To determine predictors of permanent pacemaker (PPM) implantation up to 30 days after transcatheter aortic valve implantation (TAVI) in a prospective multicenter registry. Conduction disorders requiring PPM implantation are one of the most common complications seen after TAVI. Knowledge about possible predictors may help to decrease the rate of PPM implantations. In total, 1347 consecutive patients who underwent TAVI in 22 centers were prospectively enrolled in the German transcatheter aortic valve interventions registry. Both Medtronic CoreValve™ and Edwards Sapien™ valves were implanted. Patients with preprocedurally implanted PPM or implantable cardioverter defibrillator were excluded from the analysis (n = 199). Regression analysis of baseline and procedure characteristics of the remaining 1,147 patients was performed. Procedural success was achieved in 97.4% of the cases. The rate for PPM after TAVI was 33.7%. The absence of prior valve surgery, the use of Medtronic CoreValve™ prosthesis and the presence of a porcelain aorta were identified as independent predictors for PPM after TAVI. Mortality at 30 days did not differ between patients with or without PPM necessity (6.0% vs. 8.1%, respectively; HR 0.72; CI (0.45-1.16); P = 0.17). PPM is a common postprocedure requirement after TAVI. The absence of prior valve surgery, the implantation of Medtronic CoreValve™ prosthesis, and the presence of a porcelain aorta were independently associated with PPM after TAVI.

Ledwoch J ，Franke J ，Gerckens U ，Kuck KH ，Linke A ，Nickenig G ，Krülls-Münch J ，Vöhringer M ，Hambrecht R ，Erbel R ，Richardt G ，Horack M ，Zahn R ，Senges J ，Sievert H ，German Transcatheter Aortic Valve Interventions Registry Investigators ... -  《-》

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 ... -  《-》

Impact of aortic valve calcification on the outcome of transcatheter aortic valve implantation: results from the prospective multicenter German TAVI registry.

Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis. Whether the degree of aortic valve calcification impacts the outcome after TAVI has not been thoroughly evaluated. We analyzed data from the prospective multicenter German TAVI registry, including 1,365 patients as of July 2010. Patients were divided into three groups, based on the degree of aortic valve calcification: mild (n = 67), moderate (n = 392), and severe (n = 906) valve calcification, determined by visual estimation by the operator. Mean age was 81.7 ± 6.2 years; mean logistic EUROscore was 20.6 ± 13.7%. Patients with severe aortic valve calcification had a higher mean and peak-to-peak gradient before the intervention (P < 0.0001). Technical success was achieved in 97%, similar in each group. The Medtronic CoreValve was implanted in 80.8%, the Sapien Edwards prosthesis in the remaining cases. The duration of the procedure and fluoroscopy was higher in the group with severe calcification (P < 0.01 for procedure and P < 0.05 for fluoroscopy). During the periprocedural period there were no differences among the groups regarding in-hospital death, cerebrovascular events, myocardial infarction, thromboembolic events, aortic dissection, or severe vascular complications. Furthermore, there was no significant difference in postprocedural aortic mean gradient (7.0 mm Hg vs. 5.6 mm Hg vs. 6.3 mm Hg; P = 0.07), in residual aortic regurgitation (74% vs. 72% vs. 68%; P = 0.3) or postprocedure pacemaker implantation (38% vs. 30.4% vs. 34.2%; P = 0.35). During 30-day follow up there was no difference in regard to the number of death, strokes, and myocardial infarctions. Our results of a real-world registry suggest that the extent of aortic valve calcification does not influence the success or procedural outcome significantly.

Staubach S ，Franke J ，Gerckens U ，Schuler G ，Zahn R ，Eggebrecht H ，Hambrecht R ，Sack S ，Richardt G ，Horack M ，Senges J ，Steinberg DH ，Ledwoch J ，Fichtlscherer S ，Doss M ，Wunderlich N ，Sievert H ，German Transcatheter Aortic Valve Implantation-Registry Investigators ... -  《-》

Effect of permanent pacemaker on mortality after transcatheter aortic valve replacement.

Engborg J ，Riechel-Sarup C ，Gerke O ，Mickley H ，Sandgaard NC ，Nissen H ，Diederichsen AC ... -  《-》

Conduction disorders in the setting of transcatheter aortic valve implantation: a clinical perspective.

The presence of periprocedural conduction disorders (CDs) and the need for permanent pacemaker (PPM) after transcatheter aortic valve implantation (TAVI) are frequent findings in clinical practice. Notwithstanding, robust information on the prognostic and therapeutic implications of these complications are lacking. The newly occurrence of CD after TAVI seems related to the trauma of the conduction system during procedure. On the contrary, major predictors for PPM implantation after TAVI seem to be the use of CoreValve prosthesis (Medtronic, Minneapolis, MN) and the presence of CD before TAVI. An accurate pre-TAVI screening, careful valve implantation, as well as post-TAVI monitoring must be pursued to prevent avoidable PPM implantation. The aim of this report is to analyze the available data on this field and to propose some practical clinical tips to prevent or to manage these complications.

Fraccaro C ，Napodano M ，Tarantini G 《-》