One-year clinical and echocardiographic outcomes of direct implantation of a self-expanding valve.

OBJECTIVE: To present 1 year clinical and echocardiographic outcomes of the randomized DIRECT (Pre-dilatation in Transcatheter Aortic Valve Implantation Trial) trial. BACKGROUND: Intermediate-term data from randomized studies investigating the safety and efficacy of direct implantation are lacking. METHODS: DIRECT trial randomized 171 consecutive patients with severe aortic stenosis at four tertiary centers to undergo TAVI with the use of self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). The primary endpoint was device success according to the VARC-2 criteria. All patients underwent a clinical and echocardiographic follow-up at 1 year. All-cause and cardiac mortality, stroke, heart failure hospitalization, and new pacemaker implantation were recorded. RESULTS: At 1 year, four deaths were recorded in pre-BAV group (4.7%) and three deaths in no-BAV group (3.5%). There was no difference in Kaplan-Meier plots between the two groups in all-cause mortality at 1 year (log-rank p = .72). Similarly, there was no difference in the incidence of permanent pacemaker implantation between the two groups at 1 year (27/67-40.3% in no-BAV group versus 20/69-29% in pre-BAV group, log-rank p = .24). There was no significant difference between pre-BAV and no BAV group in aortic valve area (1.84 ± 0.39 cm2 vs. 1.85 ± 0.44 cm2 , p = .90), mean aortic valve gradient (8.36 ± 5.04 vs. 8.00 ± 4.04 mmHg, p = .65) and moderate or severe paravalvular regurgitation (5-6.6 vs. 4-5.7%, respectively) at 1 year. The same applied independently from the performance of post-dilatation at baseline. CONCLUSIONS: Direct, without pre-dilatation, implantation of a self-expanding valve has no impact on one-year clinical and echocardiographic outcomes, independently also from the baseline performance of post-dilatation.

Long-Term Functional and Structural Durability of Bioprosthetic Valves Placed in the Aortic Valve Position via Percutaneous Rout in Israel.

There is limited organized "real life" data regarding the long-term structural and functional durability of transcatheter aortic valve implants, a topic of major importance. We assessed the 5-year structural and functional integrity outcomes following trans-catheter aortic valve implantation (TAVI) with both self-expandable and balloon-expandable prosthetic valve devices. This study included 450 consecutive patients who underwent TAVI for severe symptomatic aortic stenosis (AS) between September 2008 and December 2011. Data were acquired from a multicenter Israeli registry and the median follow up time was 5.6 years. In 184 patients (40.9%) who survived 5 years, prostheses displayed sustained hemodynamic performance, with average peak and mean aortic valve gradients of 16.2 ± 8.9 and 9.2 ± 6.6 mm Hg, respectively. Late structural valve deterioration was found in 22 (12.3%) patients. Of these, 16 (8.9%) experienced valve deterioration and 6 (3.3%) experienced valve failure. Among the 6 patients with bioprosthetic valve failure, only 3 underwent re-interventions. Bioprosthetic valve dysfunction occurred more frequently in patients with small valves (23 mm) and high peak and mean transvalvular gradients at baseline. In conclusion, a relatively low rate of valve deterioration or failure was noted in our long-term follow-up study after TAVI procedures with both the catheter-based self-expandable and balloon-expandable prosthetic valves.

Pre-Dilatation Versus No Pre-Dilatation for Implantation of a Self-Expanding Valve in All Comers Undergoing TAVR: The DIRECT Trial.

OBJECTIVES: The aim of this study was to compare the implantation of a self-expanding valve with or without balloon aortic valvuloplasty (BAV) in an open-label, noninferiority, randomized trial. BACKGROUND: There are no randomized studies comparing the implantation of a self-expanding valve with (pre-BAV) or without BAV. METHODS: Consecutive patients with severe aortic stenosis were randomly assigned to undergo transcatheter aortic valve replacement with the use of self-expanding prostheses with (pre-BAV) or without (no-BAV) pre-dilatation. The primary endpoint was device success according to the Valve Academic Research Consortium 2 criteria. Secondary endpoints included periprocedural mortality and stroke, new permanent pacemaker implantation, vascular complications, and 1-year mortality. The trial was scheduled to show noninferiority (Δ = 15%) of the direct versus the pre-BAV approach. RESULTS: A total of 171 patients were randomized at 4 centers. Of these, 86 underwent transcatheter aortic valve replacement with pre-dilatation and 85 without. Device success was noninferior in the no-BAV group compared with the pre-BAV group (65 of 85 [76.5%] for no-BAV vs. 64 of 86 [74.4%] for pre-BAV; mean difference 2.1%; 90% confidence interval: -8.9% to 13%). In the no-BAV group, 25 patients (29.4%) underwent post-balloon dilatation, and in the pre-BAV group, 13 patients (15.1%) underwent post-balloon dilatation (p = 0.03). Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54). In 1-month completed follow-up for all patients, there was 1 periprocedural stroke (0.5%), without any deaths. CONCLUSIONS: Direct, without balloon pre-dilatation, transcatheter aortic valve replacement with a self-expanding prosthesis system is noninferior to the pre-dilatation procedure. Lower post-dilatation rates were encountered in the group with pre-dilatation. (The Predilatation in Transcatheter Aortic Valve Implantation Trial [DIRECT]; NCT02448927).

Electrocardiographic Predictors of Morbidity and Mortality in Patients With Acute Myocarditis: The Importance of QRS-T Angle.

BACKGROUND: Acute myocarditis carries a variable prognosis. We evaluated the morbidity and mortality rates in patients with acute myocarditis and admission electrocardiographic predictors of outcome. METHODS AND RESULTS: Patients admitted to a tertiary hospital with a clinical diagnosis of acute myocarditis were evaluated; 193 patients were included. Median follow-up was 5.7 years, 82% were male, and overal median age was 30 years (range 21-39). The most common clinical presentations were chest pain (77%) and fever (53%). The 30-day survival rate was 98.9%. Overall survival during follow-up was 94.3%. The most common abnormalities observed on electrocardiography were T-wave changes (36%) and ST-segment changes (32%). Less frequent changes included abnormal T-wave axis (>105° or < -15°; 16%), abnormal QRS axis (12%), QTc >460 ms (11%), and QRS interval ≥120 ms (5%). Wide QRS-T angle (≥100°) was demonstrated in 13% of the patients and was associated with an increased mortality rate compared with patients with a narrow QRS-T angle (20% vs 4%; P = .007). The rate of heart failure among patients with a wide QRS-T angle was significantly higher (36% vs 10%; P = .001). Cox regression analysis demonstrated that a wide QRS-T angle (≥100°) was a significant independent predictor of heart failure (hazard ratio [HR] 3.20, 95% confidence interval [CI] 1.35-7.59; P < .01) and of the combined end point of death or heart failure (HR 2.56, 95% CI 1.14-5.75; P < .05). CONCLUSIONS: QRS-T angle is a predictor of increased morbidity and mortality in acute myocarditis.

The Use of Adenosine to Enable Safe Implantation of Transcatheter Tricuspid Valve.

High precision is necessary during percutaneous transcatheter heart valve implantation. The precision of the implantation has been established by increasing the heart rate (usually to 200 beats per minute) to the point of significantly reduced cardiac output and thus minimizing valve movement. Routinely, this tachycardia is induced by rapid pacing. Here we report a case of failure to pace during valve-in-valve (VIV) Edwards Sapien XT implantation in the tricuspid valve position. Transient cardiac arrest was induced by intravenous adenosine injection enabling accurate valve implantation.