Panagiotis Tzamalis

A comparison of transcatheter aortic valve implantation and surgical aortic valve replacement in 1,141 patients with severe symptomatic aortic stenosis and less than high risk

To assess outcomes for patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement but with less than high risk.

Feasibility of transcatheter aortic valve implantation in patients with coronary heights ≤7 mm: insights from the transcatheter aortic valve implantation Karlsruhe (TAVIK) registry

OBJECTIVES Transcatheter aortic valve implantation (TAVI) in patients with low coronary heights is generally denied but is not impossible. Information about these high-risk procedures is sparse. METHODS Since May 2008, data of more than 3000 patients who had TAVI were prospectively collected in the institutional TAVI Karlsruhe registry. Characteristics, peri- and postoperative outcome of patients with low coronary heights of ≤7 mm were analysed according to the Valve Academic Research Consortium-2. RESULTS Eighty-six patients with an average coronary height of 6.4 ± 1.1 mm (mean age 81.0 ± 5.3 years, logistic EuroSCORE I 19.6 ± 13.3%) were treated. TAVI was performed in 72 transfemoral (83.7%) and 14 transapical (16.3%) cases using 44 CoreValve/Evolut R (51.2%), 21 Sapien XT/S3 (24.4%), 14 ACURATE (16.3%), 5 Lotus (5.8%) and 2 Portico (2.3%) prostheses. Ten procedures were valve-in-valve (VinV) TAVI (VinV, 11.6%). The 72-h, 30-day, 1-year and follow-up (3.0 ± 1.6 years) mortality rates were 2.3%, 8.0%, 10.5% and 26.7%, respectively. Within 30 days, 4 cardiac deaths and 3 non-cardiac deaths occurred (4.7% and 3.5%). Three coronary obstructions (3.5%) occurred-2 during VinV TAVI. One patient was connected to extracorporeal circulation that could not be weaned later due to an unsuccessful percutaneous coronary intervention. Another patient, the only conversion (1.2%), required delayed surgical valve replacement. The third patient died of right heart failure after aortic dissection. The procedural success rate was 95.3%. VinV procedures were associated with increased follow-up deaths (P < 0.001; hazard ratio 7.96). CONCLUSIONS Coronary-related complications in TAVI procedures in patients with coronary heights ≤7 mm occurred less frequently, but once they occurred, they were serious. These TAVI procedures are feasible, with a high procedural success rate, but meticulous preoperative planning should be mandatory. In VinV procedures, the follow-up mortality rate is increased; therefore, we do not recommend these procedures.

Evolution of transcatheter aortic valve implantation over 7 years: results of a prospective single-centre registry of 2000 patients in a large municipal hospital (TAVIK Registry)

Objectives Use of transcatheter aortic valve implantation (TAVI) to treat severe aortic stenosis (AS) has gained popularity, accompanied by an evolution of patient and clinical factors. We aimed to characterise changes and evaluate their impact on outcomes. Setting In this single-centre, German TAVIK registry patients undergoing TAVI between 2008 and 2015 were documented prospectively. Participants/interventions 2000 consecutive patients with AS undergoing TAVI were divided in four cohorts. 500 patients underwent TAVI in each of the following time bins: April 2008 to July 2010 (cohort I), July 2010 to April 2013 (cohort II), April 2012 to October 2013 (cohort III) and October 2013 to March 2015 (cohort IV). Results The mean age was 81.8 years, without significant variation across cohorts. Compared with cohort I, prior MI (5.4%vs11.0%; p<0.001) and New York Heart Association class IV (10.0%vs3.6%; p<0.001) were less common in cohort IV. Across cohorts, there was a fall in EuroSCORE (24.3%–18.7%), frailty (48.4%–17.0%) and use of transapical access (43.6%–29.0%), while transfemoral access increased (56.4%–71.0%; p<0.001 for each). Periprocedurally, there was a fall in moderate/severe aortic regurgitation (3.2%–0.0%) and rate of unplanned cardiopulmonary bypass (4.0%–1.0%; both p<0.001). A similar trend applied to 30-day rate of major vascular complications (5.2%–1.8%; p=0.006), life-threatening bleeding (7.0%–3.0%; p<0.001) and cardiovascular mortality (4.4%–1.8%; p=0.020). One-year post-TAVI, mortality and stroke rates did not differ. Conclusions Evolution of TAVI between 2008 and 2015 saw a trend towards its usage in lower risk patients and rapid progression towards improved safety. Evaluation and refinement should now continue to further lessen stroke and pacemaker rates.

Two-Year Outcomes of Transcatheter Compared With Surgical Aortic Valve Replacement in “Minimal-Risk” Patients Lacking EuroSCORE Co-morbidities (from the TAVIK Registry)

We aimed to compare the outcomes of transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in an elderly but nonfrail, minimally co-morbid population. Although data comparing these 2 procedures in intermediate- and low-risk patients are mounting, no distinction has been made between co-morbidity and age/gender as driving forces for surgical risk. Patients undergoing isolated TAVI or SAVR between May 2008 and March 2015 were documented. Data for 225 patients (TAVI 132, SAVR 93) aged ≥75 and <86 years and fulfilling minimal-risk criteria were analyzed. Patients who underwent TAVI were older (80.7 vs 77.4 years, p <0.0001) and had a higher mean Society of Thoracic Surgeons score (2.16% vs 1.72%, p <0.0001). Mild prosthetic valve regurgitation (odds ratio [OR] 4.9, 95% confidence interval [CI] 3.34 to 7.20) was more likely after TAVI, as were renal complications (predominantly stage I acute kidney injury; OR 2.86, 95% CI 1.79 to 4.55) and new pacemaker implantation (OR 3.33, 95% CI 1.76 to 6.26) at 30 days; however, life-threatening bleeding (OR 0.58, 95% CI 0.36 to 0.93) and reintervention for bleeding (OR 0.03, 95% CI 0.01 to 0.13) were less likely. Survival was comparable between groups at 30 days (99.2% vs 100%, p = 1.0) and 1 year (96.2% vs 96.8%, OR 0.85, 95% CI 0.20 to 3.63, p = 0.823), but it was poorer for patients who underwent TAVI at 2 years (OR 0.31, 95% CI 0.16 to 0.61). In conclusion, the short-term outcomes of TAVI in elderly, low-risk, minimally co-morbid patients appear to be similar to those of SAVR, with access-specific complications. Although these results point toward the potential for more liberal use of TAVI in minimal-risk patients, poorer midterm survival remains a concern, requiring further exploration.

Impact of Dialysis on the Prognosis of Patients undergoing Transcatheter Aortic Valve Implantation

End-stage renal disease (ESRD) affects approximately 2% to 4% of patients with severe aortic stenosis. It is because these patients have been excluded from clinical trials, the impact of transcatheter aortic valve implantation (TAVI) in this patient group has not been thoroughly investigated. Between April 2008 and March 2015, 2,000 patients (dialysis group, n = 56 [2.8%]) were consecutively enrolled when diagnosed with severe aortic stenosis and eligible to undergo TAVI. Procedural and longer-term outcomes were analyzed and adjusted for differences in baseline characteristics. Patients on dialysis had a higher periprocedural mortality (10.7% vs 1.7%; adjusted odds ratio [adjOR] 5.65, 95% confidence interval [CI] 1.91 to 16.67; p = 0.002) and a lower Valve Academic Research Consortium (VARC)-II (VARC) defined device success (adjOR 0.34, 95% CI 0.15 to 0.79; p = 0.012). At 30 days, there was an increased rate of all-cause mortality (21.4 vs 4.8%; adjOR 4.90, 95% CI 1.96 to 12.26; p = 0.001), cardiovascular (adjOR 3.67, 95% CI 1.43 to 9.41; p = 0.007) and noncardiovascular mortality (adjOR 6.28, 95% CI 1.36 to 9.41; p = 0.019), myocardial infarction (adjOR 9.39, 95% CI 1.84 to 48.03; p = 0.007), bleeding (adjOR 2.48, 95% CI 1.06 to 5.83; p = 0.036) as well as the VARC-II defined early safety combined end point (adjOR 2.97, 95% CI 1.28 to 6.90; p = 0.012) associated with dialysis. Dialysis was associated with poor survival at one (57.1% vs 84.2%) and 3 years (26.8% vs 66.9%) with or without the consideration of the first 72 hours (p <0.001; adjusted p <0.001). Although, in the multivariable regression analysis, reduced ejection fraction, peripheral arterial disease, pulmonary hypertension (PH), frailty and dialysis were associated with 1-year mortality, only PH (>60 mm Hg) remained significant in an analysis restricted to the dialysis patients (adjusted hazard ratio 2.68; 95% CI 1.18 to 5.88; p = 0.018). PH had a sensitivity of 45.8%, a specificity of 81.3%, and a positive predictive value of 64.7%. In conclusion, dialysis is an independent predictor of mortality in patients who underwent TAVI. Long-term mortality in dialysis patients appears to be largely determined by the kidney disease and/or dialysis itself whereas VARC-II defined complications are largely unaffected. An increased short-term mortality still calls for (pre-) procedural optimization.

TCT-758 Long-Term Outcomes following TAVI in patients with severe aortic stenosis and a reduced left ventricular Ejection Fraction – a single-center experience in 2.000 patients (TAVIK Register)

Left ventricular (LV) systolic dysfunction is associated with increased peri-operative risk in patients undergoing surgical aortic valve replacement (SAVR) and is a common reason for patients to be denied surgical intervention. We aimed to assess Impact of a low EF in patients undergoing