Valve-Related Complications in TAVI Leading to Emergent Cardiac Surgery.

Transcatheter aortic valve implantation (TAVI) is now a standard procedure for the treatment of symptomatic aortic valve stenosis in many patients. In Germany, according to the annual reports from the German Institute for Quality Assurance and Transparency in Healthcare (Institut für Qualitätssicherung und Transparenz im Gesundheitswesen), the rate of serious intraprocedural complications, such as valve malpositioning or embolization, coronary obstruction, aortic dissection, annular rupture, pericardial tamponade, or severe aortic regurgitation requiring emergency cardiac surgery has decreased markedly in recent years from more than 5.5% in 2012 to 2.0% in 2019. However, with increased use, the total number of adverse events remains about 500 per year, about 100 of which require conversion to sternotomy. These, sometimes, fatal events can occur at any time and are still challenging. Therefore, the interdisciplinary TAVI heart team should be prepared and aware of possible rescue strategies.

Transcatheter aortic valve implantation in severe calcified annulus using the Lotus valve system: Increased incidence of fatal major vascular complications.

OBJECTIVES: This study reports the outcome of a highly selected transcatheter aortic valve implantation (TAVI) population. BACKGROUND: In patients with aortic valve stenosis and severe calcification of the left ventricular outflow tract and/or the annulus, the Boston Scientific Lotus valve provided a low paravalvular leakage rate omitting the risk of annular rupture. METHODS: Until now more than 3,600 TAVI procedures were performed at our institution. Between 8/2015 and 2/2017, 634 TAVI procedures were performed, of which 80 TAVI patients with severe calcifications consecutively received the Lotus valve. Valve Academic Research Consortium (VARC)-2 criteria of these procedures were prospectively documented in our institutional TAVI registry. One year follow-up for the Lotus treated patients was completed. RESULTS: Mean age was 82.0 ± 5.5 years. Device success was 95.0%. Conversion was required in two cases (2.5%). New permanent pacemaker implantation rate was 33.3%. Vascular complications occurred more frequent in comparison to non-Lotus treated patients (13.8 vs. 8.1%; p < .05): five minor and six major vascular complications (6.3 and 7.5%), including four fatal aortic injuries (three acute aortic dissections type A, one rupture of the aortic arch). Seventy-two-hour and 30-day mortality rates were also higher in Lotus patients (6.3 and 12.5% vs. 0.3 and 2.5%; each p < .05). One-year mortality in Lotus patients was 22.5%. CONCLUSIONS: In TAVI procedures with the Lotus valve occurrence of vascular complications including lethal aortic injuries and mortality rates were considerably high. Furthermore, in every TAVI procedure careful examination of the aorta should be mandatory and be a part of planning it.

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.

OBJECTIVES: To assess outcomes for patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement but with less than high risk. BACKGROUND: While there is abundant data for high risk patients there is insufficient data for reduced risk. METHODS: Patients undergoing TAVI or SAVR between 2007 and 2012 in Karlsruhe were considered. They were assessed by cardiac computed tomography, transoesophageal echocardiogram, and logistic EuroSCORE I (ES) and groups compared using Propensity Score Matching. RESULTS: The mean ES was 10.1±2.8 in the TAVI group (n = 419) and 5.7 ± 3.2 in the SAVR group (n = 722; P < 0.0001). Mean survival probability over 3 years was higher in patients undergoing surgery (P < 0.0001). A total of 432 patients were considered for the matched-pairs analysis based on propensity scores (216 in each group). Major vascular complications (10.6% vs. 0.0%; P < 0.0001), new pacemaker implantation (13.9% vs. 4.6%; P < 0.001) and moderate aortic insufficiency (3.2% vs. 0.5%; P = 0.03) were more frequent in patients undergoing TAVI. Major (20.8% vs. 4.2%; P < 0.0001) and life-threatening (14.5% vs. 2.3%; P < 0.0001) bleeding complications were more frequent in those undergoing surgery. Survival probability over 3 years in the propensity matched cohort was comparable between both groups (P = 0.16). CONCLUSIONS: In this large, single center, real world dataset there was no difference in mortality between patients undergoing TAVI or SAVR during a 3-year follow-up but there was a TAVI related increase in major vascular complications, new pacemaker implantation and aortic insufficiency and a SAVR related increased bleeding risk.

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.

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.

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.

Transcatheter aortic valve implantation in patients with a reduced left ventricular ejection fraction: a single-centre experience in 2000 patients (TAVIK Registry).

BACKGROUND: Previous studies into the effect of a reduced left ventricular ejection fraction (EF) on the short- and long-term prognosis of patients undergoing transcatheter aortic valve implantation (TAVI) have reported conflicting findings. We analysed data from the Karlsruhe TAVI registry with the aim of addressing this question. METHODS AND RESULTS: Patients with aortic stenosis undergoing TAVI were divided into sub-groups according to EF: severely reduced (<30%; n = 109), reduced (≥30 and ≤40%; n = 201), and mid-range/preserved (>40%; n = 1690). VARC complications at 30 days for the population with severely reduced EF did not differ in comparison to the patients with mid-range/preserved EF. Patients with severely reduced EF had a significantly lower survival at 48 h (91.7 vs. 99.0%; p < 0.001), at 30 days (84.4 vs. 95.8%; p < 0.001) and at 1 year (66.1 vs. 85.0%, p < 0.001) compared to those with mid-range/preserved EF. The risk of death increased with age, peripheral arterial disease, poor self-care and chronic renal failure in patients with severely reduced EF. CONCLUSIONS: Mortality post-TAVI was higher for patients with a reduced EF, although the excess comorbidity burden likely contributed to this. A reduced EF should not be considered a contraindication for TAVI per se, but the additional presence of comorbidity indicates increased risk for these patients.

Clinical impact of a new left bundle branch block following TAVI implantation: 1-year results of the TAVIK cohort.

BACKGROUND: Compared with surgical aortic valve replacement, transcatheter aortic valve implantation (TAVI) is associated with a higher risk of developing a new conduction disorder that necessitates permanent pacemaker implantation (PM). The most frequently observed conduction disorder is left bundle branch block (LBBB), which impairs left ventricular function. OBJECTIVES: The primary objective of this study was to assess the incidence and prognostic significance of persistent new-onset LBBB following TAVI. Factors predictive of persistent new-onset LBBB were also explored. METHODS: This study included a total of 793 patients who underwent TAVI between May 2008 and April 2012. Patients were divided into two groups: those with persistent new-onset LBBB and those without persistent new-onset LBBB. Follow-up was conducted within 1-year of TAVI. RESULTS: Persistent new-onset LBBB was observed in 31.1 % (n = 197) out of 634 eligible patients. At 30 days and 1-year post-TAVI, the all-cause mortality rate was higher in patients with persistent new-onset LBBB (6.1 %, n = 12 and 20.8 %, n = 41, respectively) than in patients without new-onset LBBB (3.3 %, n = 10 and 13.0 %, n = 57, respectively; p = 0.014 and p = 0.010 for the two time points). Multivariate regression analyses revealed, that persistent new-onset LBBB was an independent predictor of all-cause mortality at 1 year (HR 1.84, 95 %CI 1.35-2.02). PM implantation was observed slightly more frequently in patients with persistent new-onset LBBB (14.2 %) than in those without (9.4 %; HR 1.60, 95 %CI 0.96-2.67). Risk factors for pacemaker (PM) were baseline RBBB (HR 6.23, 95 %CI 3.76-10.33), chronic atrial fibrillation (HR 1.75, 95 %CI 1.10-2.56) and the Medtronic CoreValve implantation (HR 2.40, 95 %CI 1.55-3.75). At 1-year follow-up, the mean survival of patients with PM (81.2 %) was slightly lower, but not significantly different from that of patients without PM (85.0 %; p = 0.377). Upon multivariable logistic binary regression analysis Medtronic CoreValve was associated with an increase rate of persistent new-onset LBBB (HR 2.52, 95 %CI 1.67-3.80) and PM implantation. Mortality during 1 year of follow-up, however, was neither increased in the total population (p = 0.232), nor in a subgroup of those with LBBB in a comparison of Medtronic CoreValve and Edwards SAPIEN. CONCLUSION: This study demonstrated that persistent new-onset LBBB was associated with increased mortality in patients undergoing TAVI. Compared with the Edwards SAPIEN valve, implantation of the Medtronic CoreValve resulted in a higher rate of both persistent new-onset LBBB and PM but not death.

Long-term results of transapical versus transfemoral TAVI in a real world population of 1000 patients with severe symptomatic aortic stenosis.

BACKGROUND: Transapical transcatheter aortic valve implantation is generally perceived to be associated with increased morbidity compared with transfemoral transcatheter aortic valve implantation. We aimed to compare access-related complications and survival using propensity score matching. METHODS AND RESULTS: Prospective, single-center registry of 1000 consecutive patients undergoing transapical and transfemoral transcatheter aortic valve implantation between May 2008 and April 2012. Transapical was performed in 413 patients and transfemoral in 587 patients. Patients with transapical access were less often women and less had pulmonary hypertension. Further they had more peripheral arterial disease, coronary artery disease, carotid stenosis, and recurrent surgery and a higher logistic EuroSCORE I (24.3% ± 16.2% for transapical versus 22.2% ± 16.2% for transfemoral; P < 0.01). After building 2 propensity score-matched groups of 354 patients each with either access route (total 708 patients), baseline characteristics were comparable. In this analysis, there was no significant difference in 30 day mortality (5.9% transapical versus 8.5% transfemoral; P = 0.19), the rate of myocardial infarction (2.5% transapical versus 2.0% transfemoral; P = 0.61), stroke (2.0% transapical versus 2.3% transfemoral; P = 0.79), bleeding complications, pacemaker implantation rates, or moderate aortic insufficiency. Stage 1 renal complications were more common in transapical patients (odds ratio, 2.81; 95% confidence interval, 1.93-4.09), whereas major vascular complications were less common (odds ratio, 0.14; 95% confidence interval, 0.06-0.29). Survival probability over the long term was not statistically different (hazard ratio, 0.89; 95% confidence interval, 0.72-1.10; log-rank Test, P = 0.27). CONCLUSIONS: The data demonstrate that in an experienced multidisciplinary heart team, either access route can be performed with comparable results.