Transcatheter aortic valve implantation (TAVI) has developed from a procedure for patients with aortic stenosis inoperable or high risk for surgery, into a treatment option even for intermediate risk ...elderly patients. This development has been facilitated by the clinical learning curve and constant improvements of transcatheter heart valves used. We present total 1-year results of SOURCE 3, the European post-approval multicentre registry of the latest generation balloon expandable SAPIEN 3TM (Edwards Lifesciences, Irvine, CA, USA).
Participating centres have submitted their consecutive experience with the SAPIEN 3, dependent on patients consent. Data were prospectively collected and all end point-related outcomes adjudicated according to VARC-2 definitions by an independent committee. Between July 2014 and October 2015, in total 1946 patients (mean age 81.6 ± 6.7 years, 52% male) were enrolled in 80 centres from 10 European countries. At 1 year, all-cause mortality was 12.6%, cardiovascular mortality 8.0%, stroke 3.1%, disabling stroke 1.4%, and rate of new pacemakers 13.2%. Causes of death were 62.0% cardiovascular and 38.0% non-cardiovascular, with heart failure (13.4%) and pulmonary complications (12.7%) being the main reasons for fatal outcomes. Multivariable analysis identified New York Heart Association Class IV and renal insufficiency as predictors of mortality, while higher BMI's improved survival. Severe (zero) and moderate paravalvular leakage (2.6%) was rare at 1 year.
In SOURCE 3, we observe a low complication rate and mortality at 1 year. Given the low incidence of higher degree paravalvular leakages, this variable did no longer affect outcome. Clinicaltrial.gov number: NCT02698956.
Aim is to report on the results of an optimized balloon filling algorithm and suggest a refinement of the implantation approach to maximize safety. Appropriate sizing of balloon expandable valves ...during transcatheter aortic valve implantation is crucial. Study comprised 370 consecutive patients receiving SAPIEN 3 valve between 2015 and 2018. Valve expansion/recoil measurement in the inflow area, annular area, and outflow area was performed previously and postimplantation. Nominal balloon filling resulted in underexpansion—23 mm (20.96 mm), 26 mm (23.88 mm), and 29 mm (27.56 mm) SAPIEN 3 valves at the annular level. Increased balloon filling by 2 cc resulted in a gradual increase in valve diameter reaching 97.35% (23 mm), 96.50% (26 mm), and 96.11% (29 mm) of the nominal valve diameter. Final diameters were usually higher in the valvular inflow and outflow tracts. The 29 mm valve did not reach its nominal diameter with 2 cc overfilling and in none of inflow area (95.48%), annular area (96.11%), or outflow area (96.86%). Device success (by VARC II) was 96.2%. No root or septal rupture, device migration, mitral valve injury, coronary obstruction, or dissection occurred. Rate of new permanent pacemaker implantation was 8.3%. Paravalvular leakage was none or trace in most patients. Mean valve gradient was 10.77 mm Hg postprocedure. 1.9% of the patients had a maximum gradient of >40 mm Hg, 2.2% >20 mm Hg. In conclusion, an optimized balloon filling algorithm resulted in appropriate valve gradients, low levels of paravalvular leakage, low rates of permanent pacemaker implantation and no annular rupture.
The optimal treatment of patients with acute and severe decompensation of aortic stenosis is unclear due to recent advances in transcatheter interventions and supportive therapies. Our aim was to ...assess the early outcome of emergency transcatheter aortic valve implantation (eTAVI) versus emergency balloon aortic valvuloplasty (eBAV) followed by TAVI under elective circumstances.
Emergency conditions were defined as: cardiogenic shock with requirement of catecholamine therapy, severe acute dyspnoea (NYHA IV), cardiac resuscitation or mechanic respiratory support. The data were collected according to the Valve Academic Research Consortium 2 (VARC-2) criteria.
In five German centres, 23 patients (logistic Euroscore 37.7%±18.1) underwent eTAVI and 118 patients underwent eBAV (logistic Euroscore 35.3%±20.8). In the eTAVI group, immediate procedural mortality was 8.7%, compared with 20.3% for the eBAV group (p=0.19). After 30 days, cardiovascular mortality for the eTAVI group was 23.8% and for the eBAV group 33.0% (p=0.40). Analyses adjusting for potential confounders did not provide evidence of a difference between groups. Of note, the elective TAVI performed after eBAV (n=32, logistic Euroscore 25.9%±13.9) displayed an immediate procedural mortality of 9.4% and a cardiovascular mortality after 30 days of 15.6%. Major vascular complications were significantly more likely to occur after eTAVI (p=0.01) as well as stroke (p=0.01).
In this multicentre cohort, immediate procedural and 30-day mortality of eTAVI and eBAV were high, and mortality of secondary TAVI subsequent to eBAV was higher than expected. Randomised study data are required to define the role of emergency TAVI in tertiary care centres with current device generations.
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.
Background
Several observational studies have suggested a worrying reduction in hospitalisations for acute coronary syndromes in the emergency cardiology department in the last few months all over ...the world. The aim of the present study is to assess the impact of the current COVID-19 health crisis on admission for acute coronary syndrome (ACS) in the cardiology department of a tertiary general hospital in Germany with a COVID-19 ward.
Methods and results
The authors retrieved clinical data evaluating consecutive patients with ACS admitted to their emergency cardiology department. Data from January to June 2020, as well as for a 5-week period corresponding to this yearʼs COVID-19 outbreak in south-west Germany (23rd March–26th April), were analysed and compared to data from equivalent weeks in the previous 2 years. A trend of reduction in admissions for ACS was observed from the beginning of the outbreak in the region at the end of March 2020. This trend continued and even intensified after a fall in COVID-19 cases in the area; the number of ACS patients in April 2020 was 25% and in June 29% lower than in January 2020 (
p
-value for linear trend <0.001). An even more consistent reduction was observed as compared with the equivalent weeks in the previous 2 years (38% and 30% lower than in 2019 and 2018, respectively;
p
= 0.009).
Conclusions
The COVID-19 health and social crisis has caused a worrying trend of reduced cardiological admissions for ACS, without evidence of a decrease in its incidence. Understanding and counteracting the causes appears to be crucial to avoiding major long-term consequences for healthcare systems worldwide.
Objectives. The PROGRESS PVL registry evaluated transcatheter aortic valve implantation (TAVI) in patients treated with ACURATE neo, a supra-annular self-expanding bioprosthetic aortic valve. ...Background. While clinical outcomes with TAVI are comparable with those achieved with surgery, residual aortic regurgitation (AR) and paravalvular leak (PVL) are common complications. The ACURATE neo valve has a pericardial sealing skirt designed to minimize PVL. Methods. The primary endpoint was the rate of total AR over time, as assessed by a core echocardiographic laboratory. The study enrolled 500 patients (mean age: 81.8 ± 5.1 years; 61% female; mean baseline STS score: 6.0 ± 4.5%) from 22 centers in Europe and Canada; 498 patients were treated with ACURATE neo. Results. The rate of ≥ moderate AR was 4.6% at discharge and 3.1% at 12 months; the rate of ≥ moderate PVL was 4.6% at discharge and 2.6% at 12 months. Paired analyses showed significant improvement in overall PVL between discharge and 12 months (P<0.001); 64.6% of patients had no change in PVL grade, 24.9% improved, and 10.5% worsened. Patients also exhibited significant improvement in transvalvular gradient (P<0.001) and effective orifice area (P=0.01). The mortality rate was 2.2% at 30 days and 11.3% at 12 months. The permanent pacemaker implantation (PPI) rate was 10.2% at 30 days and 12.2% at 12 months. Conclusions. Results from PROGRESS PVL support the sustained safety and performance of TAVI with the ACURATE neo valve, showing excellent valve hemodynamics, good clinical outcomes, and significant interindividual improvement in PVL from discharge to 12-month follow-up.
Diabetes mellitus (DM) on insulin is a patient-related factor in the assessment of surgical risk based on the EuroSCORE II and, as such, it confers additional risk on outcomes after transcatheter ...aortic valve implantation (TAVI). The aim of this study was to investigate the effect of diabetes mellitus treated with insulin and oral antidiabetic drugs on clinical outcomes after TAVI.
This study is an analysis of 2000 patients who underwent TAVI between 2008 and 2015. Patients were stratified post hoc into the following categories: without diabetes (n = 1337), with diabetes treated with oral antidiabetic drugs (OAD; n = 387) and with diabetes treated using insulin (n = 276).
There was no significant difference in device success (89.5% vs 89.4% vs 88.8%, adjusted odds ratio (adjOR) 1.10 95% confidence interval (CI) 0.64-1.91) and VARC-2-defined major complications among the three groups of patients (without DM, OAD, and insulin, respectively). Minor but not major or disabling strokes (adjOR 2.19; 95% CI 1.11-4.3) and overall renal complications (but not stage 2/3 alone) (adjOR 1.46; 95% CI 1.18-1.81) were more common in patients with diabetes than in those without diabetes. Insulin-treated patients had a significantly lower survival rate than that of patients with orally treated diabetes and of those without diabetes at 1 year (75.7% vs. 84.5% vs 84.7%, pairwise p < 0.01) and 3 years (56.9% vs. 65.9% vs. 67.9%, adj. p < 0.05) after TAVI. However, insulin-treated diabetes was not identified as an independent risk factor for higher mortality in the first (HR 1.29; 95% CI 0.97-1.72, p = 0.084) and 3rd years (HR 1.21; 95% CI 0.98-1.49; p = 0.079) after multivariable adjustment.
Although insulin-dependent DM is an established component of surgical risk assessment, it was not identified as an independent factor associated with reduced survival in TAVI. DM treated with oral antidiabetic drugs or insulin may have less role in decision making of treatment in TAVI candidates.
The purpose of this article is to assess aortic root and iliofemoral vessel anatomy and the frequency of clinically significant incidental findings on aortoiliac CT angiography (CTA) performed for ...planning of transcutaneous aortic valve implantation.
Aortoiliac CTA studies of 207 patients scheduled for transcutaneous aortic valve implantation were analyzed. Anatomic dimensions relevant to the interventional procedure, including diameter of the aortic annulus and sinus of Valsalva, distance between aortic annulus and coronary ostia, coronary leaflet length, left ventricular outflow tract diameter, and vessel diameter of iliac arteries, were analyzed. Clinically significant incidental findings were recorded.
The mean (± SD) maximum and minimum diameters of the aortic annulus were 29 ± 3.9 mm and 23.5 ± 4.1 mm, respectively. The mean distances between aortic annulus and the ostium of the left and right coronary artery were 13.5 ± 3.2 mm and 14.8 ± 3.9 mm, respectively. The mean maximum and minimum diameters of the left ventricular outflow tract were 27 ± 4 mm and 1.9 ± 4 mm, respectively. The mean diameter of the sinus of Valsalva was 33.4 ± 5.1 mm. The mean diameters of the right and left external iliac artery were 8 ± 1 and 8 ± 2 mm, respectively. Almost half the patients (101/207) had clinically significant incidental findings, including noncalcified pulmonary nodules larger than 8 mm (n = 7), pulmonary embolism (n = 3), or aortic aneurysm (n = 12).
Aortoiliac CTA provides relevant information on aortic root and iliofemoral vessel anatomy for preinterventional planning. CTA reveals clinically significant incidental findings in a high number of patients considered for transcutaneous aortic valve implantation, which may have a significant impact on patient selection.
Effective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. Cryoballoon (CB) ablation has been developed as an alternative to the use of ...radiofrequency (RF) energy for electrical isolation of the pulmonary veins. Herein, we provide long-term data regarding the efficacy of CB ablation in comparison to RF.
FreezeAF was a randomised non-inferiority study comparing CB ablation with RF ablation for the treatment of patients with drug-refractory paroxysmal AF. Procedural success for the long-term follow-up (30 months) was defined as freedom from AF with an absence of persistent complications.
Of the 315 patients that were randomised and received catheter ablation, 292 (92.7%) completed the 30-month follow-up (147 in the RF group and 145 in the CB group). The baseline characteristics of the RF and CB groups were similar. Single-procedure success was achieved by 40% of patients in the RF group and 42% of the CB group (p < 0.001 for non-inferiority). When including re-do procedures in the analysis, the multiple procedure success rate was 72% in the RF group and 76% in the CB group.
The data provide long-term evidence that CB ablation is non-inferior to RF ablation, with high proportions of patients reporting freedom from AF 30 months after the index procedure.
ClinicalTrials.gov Identifier: NCT00774566 ; first registered October 16, 2008; first patient included October 20, 2008.
Transcatheter aortic valve implantation (TAVI) carries the risk of intraprocedural complications that may ultimately require emergent cardiac surgery (ECS). However, few data exist on the incidence, ...reasons and outcomes of patients needing ECS during TAVI. We analysed data from 2,307 TAVI patients, prospectively enrolled in the multicentre Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry.
Twenty-seven (1.2%) of 2,307 patients required ECS. The rates of ECS were similar for patients undergoing transapical TAVI compared with transfemoral TAVI (1.1% vs. 1.2%). The leading causes for ECS were embolisation/migration of the TAVI valve prosthesis (9/27, 33%) and procedure-related aortic injury (n=7, 26%). Thirty-day mortality of ECS was high (51.9%) and showed cause-specific differences, with 100% mortality in patients with aortic rupture or cardiac tamponade, 0% death in those with acute aortic regurgitation and intermediate risk of death or intermediate mortality in those with aortic injury or valve embolisation/migration.
Rates of ECS during TAVI were low (1.2%). Although ECS was performed without time delay, emergent surgery was associated with a 30-day mortality of 52%. Complications with dramatic acute consequences (annular rupture, aortic injury) had higher mortality than those with less acute deterioration (aortic regurgitation). Prevention of complications requiring ECS during TAVI appears to be of critical importance, focusing on less traumatic, more flexible delivery catheter systems and retrievable valves to reduce the risk of aortic injury and valve embolisation, the two most common causes of ECS.
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