scholarly journals Intravascular haemolysis after transcatheter aortic valve implantation with self-expandable prosthesis: incidence, severity, and impact on long-term mortality

2020 ◽  
Vol 22 (Supplement_F) ◽  
pp. F44-F50
Author(s):  
Andrea Širáková ◽  
Petr Toušek ◽  
František Bednář ◽  
Hana Línková ◽  
Marek Laboš ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Regurgitation ◽  
Aortic Valve Area ◽  
Intravascular Haemolysis ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation ◽  
Valve Area

Abstract We aimed to determine the incidence, severity, and long-term impact of intravascular haemolysis after self-expanding transcatheter aortic valve implantation (TAVI). We believe this should be evaluated before extending the indications of TAVI to younger low-risk patients. Prospective, academic, single centre study of 94 consecutive patients treated with supra-annular self-expandable TAVI prosthesis between April 2009 and January 2014. Haemolysis at 1-year post-TAVI was defined per the published criteria based on levels of haemoglobin, reticulocyte and schistocyte count, lactate dehydrogenase (LDH), and haptoglobin. All patients had long-term clinical follow-up (6 years). The incidence of haemolysis at 1-year follow-up varied between 9% and 28%, based on different haemolysis definitions. Haemolysis was mild in all cases, no patient had markedly increased LDH levels. The presence of moderate/severe paravalvular aortic regurgitation was associated with haemolysis (7.7% vs. 23.1%, P = 0.044) and aortic valve area post-TAVI did not differ between groups with or without haemolysis (1.01 vs. 0.92 cm2/m2, P = 0.23) (definition including schistocyte count). The presence of haemolysis did not have any impact on patient prognosis after 6 years with log-rank test P = 0.80. Intravascular haemolysis after TAVI with self-expandable prosthesis is present in 9–28% of patients depending on the definition of haemolysis. The presence of haemolysis is associated with moderate/severe paravalvular aortic regurgitation but not with post-TAVI aortic valve area. Haemolysis is mild with no impact on prognosis.

P5583Micro-movement during transcatheter aortic valve implantation with a contemporary self-expandable prosthesis

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K Hellhammer ◽  
K Piayda ◽  
V Veulemans ◽  
S Afzal ◽  
I Hennig ◽  
...  
Keyword(s):  
Risk Factor ◽  
Aortic Valve ◽  
Aortic Regurgitation ◽  
Aortic Valve Area ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Coronary Cusp ◽  
Valve Implantation ◽  
Valve Area

Abstract Background Precise positioning of the prosthesis is a crucial step during transcatheter aortic valve implantation. In some cases, contemporary self-expandable prostheses show micro-movement (MM) during the final phase of release. Purpose We aimed to establish a definition for MM, evaluated the incidence of MM using the CoreValve Evolut RTM, investigated potential risk factors for MM and the associated clinical outcomes. Methods MM was defined as movement of the prosthesis of at least 1.5 mm from its position directly before release compared to its final position. Patients were grouped according to the occurrence (+MM) or absence (-MM) of MM. Baseline characteristics, imaging data and outcome parameters in accordance with the updated valve academic research consortium (VARC-2) criteria were retrospectively analyzed. Results We identified 258 eligible patients. MM occurred in 31.8% (n=82) of cases with a mean magnitude of 2.8±2.2 mm in relation to the left coronary cusp and 3.0±2.1 mm to the non-coronary cusp. Clinical and hemodynamic outcomes were similar in both groups. The mean pressure gradient was effectively reduced after TAVI (-MM vs. +MM: 7±3.4 mmHg vs. 8±3.9 mmHg, p=0.326) with consistency over a follow-up period of at least three months (-MM vs. +MM: 6.7±3.7 mmHg vs. 7.9±8.4 mmHg, p=0.168). At three months follow-up most of the patients presented with no aortic regurgitation (-MM vs. +MM: 64% vs. 67.9%, p=0.569). Mild aortic regurgitation was observed in 34.2% of the -MM group and in 29.5% of the +MD group (p=0.414). Moderate aortic regurgitation occurred in 1.9% of all patients with no differences between groups (-MM vs. +MM: 1.9% vs. 2.6%, p=0.662). Patients with MM presented with a more symmetric calcification pattern (-MM vs. +MM: 27.3% vs. 40.2%; p=0.037) and a larger aortic valve area (-MM vs. +MM: 0.6 cm2 ± 0.3 vs. 0.7 cm2 ± 0.2; p=0.014), which was found to be a potential risk factor for the occurrence of MM in a multivariate regression analysis (OR 3.5; 95% CI: 1.1–10.9; p=0.032) Conclusion MM occurred in nearly one third of patients and did not affect clinical and hemodynamic outcome. A larger aortic valve area was the only independent risk factor for the occurrence of MM.

Long-term outcomes after transcatheter aortic valve implantation. An analysis of 5-year survival and beyond

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Stathogiannis ◽  
M Drakopoulou ◽  
G Oikonomou ◽  
S Soulaidopoulos ◽  
P Toskas ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Nyha Class ◽  
Aortic Valve Area ◽  
Class Iii ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Background Transcatheter aortic valve implantation (TAVI) has seen an unprecedented rise in the past decade and has become the gold-standard therapy for inoperable, high- and intermediate-risk patients with aortic valve stenosis. Purpose To investigate the long-term clinical outcomes (5-year survival and beyond) of patients undergoing TAVI. Methods Consecutive patients who underwent TAVI with a self-expanding valve between 2012 - 2015 were included in the study. Patients with bicuspid valves and valve-in-valve procedures were excluded. Clinical follow-up was performed at specified time intervals (30-day post TAVI and yearly thereafter). The primary endpoint of this study was to evaluate survival rates in the long-term (≥5 years). Secondary endpoints were echocardiographic findings and clinical status at 5 years. All endpoints were considered as per the VARC-2 criteria and the latest consensus documents. Results In total, 267 patients were included in the study. Complete follow-up was complete in 189 (70%) patients. The mean age at implantation was 80.71±6.81 years, 129 (48%) were female, mean logistic EuroSCORE was 24.28±8.64% and 73% of patients were at NYHA Class III. The median follow-up was 4.0±1.5 years. Before the procedure, ejection fraction (EF) was 49.92±9.37%, mean gradient was 48.83±14.68mmHg, pulmonary artery systolic pressure (PASP) was 44.31±12.72mmHg and aortic valve area was 0.98±5.02cm2. All patients received the self-expanding valve (mean valve size was 27.60±2.12mm), with the majority of them undergoing transfemoral TAVI (71%). Predilation was performed in 77% of the population and post TAVI dilation was performed in 20%. Compared to pre TAVI values, EF was higher at 50.66±9.37% (p=0.041), mean gradient was lower at 9.41±4.65mmHg (p<0.001), PASP was lower at 41.55±9.93mmHg (p=0.005) and aortic valve area was higher at 1.69±0.81cm2 (p<0.001) post TAVI. At the end of the fifth year, 160 (60%) patients were alive. Mean survival post TAVI was 32 months (median: 32.2 months, range: 0–91.2 months) and the majority of deaths were non-cardiac in nature (78%). Also, 43% patients of patients were at NYHA Class I, 50% were at NYHA Class II and 7% were at NYHA Class III. At multivariate analysis, sole independent predictor of death at 5 years was baseline PASP levels (OR 1.027, 95% CI: 1–1.054, p=0.049). Conclusion Transcatheter aortic valve implantation offers a viable solution for aortic stenosis patients and long-term results beyond 5 years are reassuring. Further studies are necessary in order to shed a light for very long-term outcomes. Funding Acknowledgement Type of funding source: None

Safety and Efficacy of Different Antithrombotic Strategies After Transcatheter Aortic Valve Implantation: A Network Meta-Analysis

2021 ◽  
Author(s):  
Eliano Pio Navarese ◽  
Leonardo Grisafi ◽  
Enrico Spinoni ◽  
Marco Giovanni Mennuni ◽  
Andrea Rognoni ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Transcatheter Aortic Valve ◽  
Safety Endpoint ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Background. The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) remains uncertain. We compared efficacy and safety of various antiplatelet and anticoagulant approaches after TAVI by a network meta-analysis. Methods. A total of 14 studies (both observational and randomized) were considered, with 24,119 patients included. Primary safety endpoint was the incidence of any bleeding complications during follow-up. Secondary safety endpoint was major bleeding. Efficacy endpoints were stroke, myocardial infarction and cardiovascular mortality. A frequentist network meta-analysis was conducted with a random-effects model. The following strategies were compared: dual antiplatelet therapy (DAPT), single antiplatelet therapy (SAPT), oral anticoagulation (OAC), OAC+SAPT. Mean follow-up was 15 months. Results. In comparison to DAPT, SAPT was associated with a 44% risk reduction of any bleeding (OR, 0.56 [95% CI, 0.39-0.80]). SAPT was ranked as the safest strategy for the prevention of any bleeding (P-score, 0.704), followed by OAC alone (P-score, 0.476) and DAPT (P-score, 0.437). Consistent results were observed for major bleeding. The incidence of cardiovascular death and secondary ischemic endpoints did not differ among the tested antithrombotic approaches. In patients with indication for long-term anticoagulation, OAC alone showed similar rates of stroke (OR 0.92 [95% CI 0.41-2.05], p=0.83) and reduced occurrence of any bleeding (OR 0.49 [95% CI 0.37-0.66], p<0.01) vs OAC+SAPT. Conclusions. The present network meta-analysis supports after TAVI the use of SAPT in patients without indication for OAC and OAC alone in those needing long-term anticoagulation.

P1136Is there a negative impact of permanent pacemaker implantation in long-term outcomes after transcatheter aortic valve implantation?

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
T J Carvalho Mendonca ◽  
L Patricio ◽  
M Oliveira ◽  
I Rodrigues ◽  
G Portugal ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Cardiovascular Mortality ◽  
Total Mortality ◽  
Permanent Pacemaker ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Introduction Transcatheter aortic valve implantation (TAVI) is an established treatment in patients (P) with aortic stenosis. Despite the continuous developments of this procedure, high-grade conduction disturbances requiring permanent pacemaker (PPM) implantation is still a major and common complication of TAVI. Furthermore, long-term chronic right ventricular pacing has been associated with negative effects on ventricular function and heart failure (HF). Aim   to evaluate the long-term impact of PPM after TAVI focusing on mortality and HF hospitalization. Methods  We retrospectively examined P who underwent TAVI with a self-expanding valve from 2009 to 2018 at our institution. All P had pre-procedural clinical evaluation, including ECG, cardiac computed tomographic angiography and transthoracic echocardiography. P with previous PPM were excluded. Results  265P (57% male, mean age 81.4 years, 20% with left ventricular ejection fraction &lt;40%) were analysed. Mean STS score and mean Euroscore II were 6.33% and 7.07%, respectively. Mean transvalvular gradient was 52.78 mmHg and mean aortic valve area 0.67 cm2. Forty-seven P (17%) underwent PPM implantation during the first 30 days after TAVI. P requiring PPM had higher prevalence of diabetes mellitus, chronic renal disease, atrial fibrillation and right bundle branch block. During a mean follow-up of 20.3 months, post-TAVI PPM was associated with similar mortality rate (29.8% vs. 25.6%, HR 1.28, 95% CI 0.72-2.29, p = 0.42) and similar cardiovascular mortality (9.8% vs. 6.4%, HR 0.72, 95% CI 0.21-2.4, p = 0.59) compared to P without PPM. There were no significant differences in HF hospitalization (4.9% vs. 2.4%, p = 0.47). Kaplan-Meier curves of total mortality and cardiovascular mortality according to the need for PPM post-TAVI were similar.  Conclusions  In P submitted to TAVI, PPM implantation is a relatively common finding, not associated with higher risk of total mortality, cardiovascular mortality or HF hospitalization in a long-term follow-up.

P1676De novo aortic insufficiency following long term LVAD support can be successfully treated with TAVI and a pre-stenting technique

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Kofler ◽  
A Unbehaun ◽  
S Buz ◽  
C Klein ◽  
A Meyer ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Regurgitation ◽  
Transcatheter Aortic Valve Implantation ◽  
High Rate ◽  
Landing Zone ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation ◽  
Lvad Support

Abstract Background/Introduction Long-term continuous flow left ventricular assist device (cf-LVAD) can result in the development of relevant aortic regurgitation (AR). Although its impact on survival is still controversial, it causes heart failure related symptoms. Current evidence for less invasive strategies to treat AR in cf-LVAD patients is limited. Purpose This study sought to investigate the value of transcatheter aortic valve implantation (TAVI) to treat severe de novo AR in patients on long-term cf-LVAD support. Methods We performed a retrospective analysis of 13 patients with severe AR following cf-LVAD implantation treated with TAVI between 2010 and 2019. TAVI's were performed via transfemoral (n=11), transapical (n=1) and transaxillary (n=1) access route. CoreValve (n=2), LotusValve (n=1), SapienXT (n=1) and Sapien3 (n=9) were used as transcatheter heart valves. In 4 patients, a new off-label strategy using landing-zone pre-stenting with a Sinus-XL stent was used (Figure 1). Results The median time interval from LVAD-implantation to TAVI was 1.7 years [interquartile range (IQR): 1.0 - 3.1]. Median age was 62 years [IQR: 57 - 67]. No procedural mortality or stroke was observed. Overall, device success according to VARC-II criteria was low due to a high rate of second valve necessity (54%). In contrast to the standard implantation technique, device success was 100% when the newly developed pre-stenting technique was applied (Table 1). Aortic regurgitation at discharge was none/trace in all patients. Valve function remained stable in all patients during a median echocardiographic follow-up time of 105 days [IQR: 11 - 298]. Table 1 Overall Sinus-XL prestenting (n=4) NO prestenting (n=9) Device success 7 (54) 4 (100) 3 (33) Procedural mortality 0 (0) 0 (0) 0 (0) Correct positioning of a single valve 7 (54) 4 (100) 3 (33) Intended valve performance 13 (100) 4 (100) 9 (100) Moderate or severe aortic regurgitation 0 (0) 0 (0) 0 (0) Figure 1 Conclusions Transcatheter aortic valve implantation is an efficient tool to treat cf-LVAD induced severe AR. The challenging anatomy of the non-calcified device landing zone causes a relatively high rate of primary device failure, which could be overcome with a pre-stenting technique. Acknowledgement/Funding None

Long-Term Follow-Up of Transcatheter Aortic Valve Implantation With Portico Versus Evolut Devices

2020 ◽  
Vol 125 (8) ◽  
pp. 1209-1215 ◽  
Author(s):  
Nicola Corcione ◽  
Giuseppe Biondi-Zoccai ◽  
Paolo Ferraro ◽  
Alberto Morello ◽  
Sirio Conte ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Transcatheter Aortic Valve ◽  
Long Term Follow Up ◽  
Aortic Valve Implantation ◽  
Valve Implantation

4069From first in man transcatheter aortic valve implantation, a 15-year experience

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Avinee ◽  
E Durand ◽  
T Levesque ◽  
P Y Litzler ◽  
J N Dacher ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Transcatheter Aortic Valve ◽  
Kaplan Meier ◽  
Transcatheter Heart Valve ◽  
Structural Valve Deterioration ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Background Since the first-in-man transcatheter aortic valve implantation (TAVI) performed in 2002, the number of procedures has dramatically increased. However, long-term data regarding outcome and valve durability remain poor. Purpose We aimed to evaluate the evolution of 30-day outcomes over years and long-term mortality and valve durability after TAVI. Methods All consecutive patients presenting with severe symptomatic aortic stenosis treated by TAVI in our center were included prospectively. Clinical and echocardiographic follow-up was performed at 30 days and annually thereafter. Survival curves were constructed using Kaplan-Meier analysis. We also evaluated valve durability according to the European standardized definition of structural valve deterioration. Results Between 2002 and 2018, 1530 consecutive patients underwent TAVI including 1285 (84.0%) patients via a femoral approach. A balloon-expandable transcatheter heart valve was predominantly used (1421 patients; 92.9%). The annual transfemoral approach rate increased progressively to reach 93.3%. Age of patients remained stable over time with a global mean age of 83.7±6.5 years old. Logistic EuroSCORE decreased from 49.2±8.2% to 14.3±8.6% (p<0.0001). Thirty-day mortality dramatically decreased below 3% since 2015 and was 0% in 2018. Similarly, major vascular complications decreased from 50.0% in the first year to less than 1% since 2017 (p=0.001). The length of hospital-stay progressively shortened up to a median of 2 days in 2018. The Kaplan-Meier survival estimation was 82.3%, 60.3%, 33.0%; 11.7% and 8.9% respectively at 1, 3, 5, 8 and 10 years. On long-term follow-up the mean aortic gradient remained unchanged (Figure), and only five patients presented a severe prosthetic valve deterioration. Among them, four patients successfully benefited from a valve in valve TAVI procedure. The competing risk analysis at 10 years estimates risk for severe and moderate-or-severe valve deterioration of 1.9±0.9% and 4.3±1.3% respectively. TEE mean transaortic gradient Conclusions Long-term (up to 10 years) follow-up of our large pioneer series of patients treated by TAVI shows a dramatic improvement of outcomes and no warning signs of valve deterioration suggesting very encouraging valve durability, using predominantly, a balloon expandable prosthesis. Further studies are warranted to study valve durability after TAVI before extension to lower risk patients.

P1793Eight-year clinical outcome and valve durability after transcatheter aortic valve implantation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
B Lattuca ◽  
A Meilhac ◽  
C Robert ◽  
D Vandenbergh ◽  
F Manna ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Transcatheter Aortic Valve Implantation ◽  
Predictive Factors ◽  
Severe Aortic Stenosis ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Background With the growing indications of transcatheter aortic valve implantation (TAVI) worldwide and among lower risk patients, valve durability has become a crucial issue. Purpose To assess mid and long-term evolution of different generations of percutaneous balloon-expandable prostheses, predictive factors of valve deterioration and its correlation with long-term mortality. Methods All consecutive patients undergoing TAVI for severe aortic stenosis with balloon-expandable prosthesis between 2009 and 2014 and with a minimum follow-up of one-year were included in this monocentric prospective study. All echocardiograms were reviewed by two independent experts. Clinical events were defined according to the Valve Academic Research Consortium criteria. Valve deterioration was defined according to the 2017 EAPCI-ESC-EACTS international consensus statement at the longest follow-up. Results A total of 160 patients were included with a median follow-up of 3.4 years [1.5–4.9] and a maximum of 8 years. Patients were mostly implanted with the first generation Sapien XT valve (n=138, 86.2%). Median age was 85 [79–86] years, with 42.5% of women and a median logistic Euro-SCORE of 14.2% [10.6–23.2]. Immediately after TAVI, mean aortic gradient decreased dramatically from 51±12mmHg to 9±2.6mmHg (p<0.0001) and remained overall stable with a mean gradient of 12±1mmHg at 8 years. Valve deterioration occurred in 5.6% (n=9) of patients, of which 3.7% (n=6) with severe deterioration. Moderate or severe peri-prosthetic aortic regurgitation was observed in 2.5% (n=4) of patients. The eight-year survival rate was 12.9%. During follow-up, hospitalization for acute heart failure was required for 23.7% (n=38) of patients, a myocardial infarction or a stroke occurred respectively among 1.9% (n=3) and 5% (n=8) of patients. After multivariate analysis, size or generation of valves were not independent predictive factors of valve deterioration. Evolution of mean aortic gradient Conclusions After a maximal 8-year follow-up, valve deterioration after balloon-expandable TAVI is very low. In this high-risk population, TAVI seems to be a safe and durable alternative to surgery in severe aortic stenosis regardless of prosthesis generation. Acknowledgement/Funding Edwards Lifesciences

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