scholarly journals Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement – rationale and design of the international IMPACT registry

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Farhad Bakhtiary ◽  
Ali El-Sayed Ahmad ◽  
Rüdiger Autschbach ◽  
Peter Benedikt ◽  
Nikolaos Bonaros ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Primary Objective ◽  
Surgical Aortic Valve Replacement ◽  
Open Label ◽  
Specific Patient ◽  
Link Type ◽  
Structural Valve Deterioration ◽  
The Impact

Abstract Background Degenerative aortic valve disease accounts for 10–20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research. Methods The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation. Discussion IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses. Trial registration ClinicalTrials.gov identifier: NCT04053088.

Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design

2018 ◽  
Vol 68 (02) ◽  
pp. 114-123 ◽  
Author(s):  
Roberto Lorusso ◽  
Thierry Folliguet ◽  
Malakh Shrestha ◽  
Bart Meuris ◽  
Arie Pieter Kappetein ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Severe Aortic Stenosis ◽  
Artery Bypass ◽  
Randomized Study ◽  
Primary Objective ◽  
Surgical Aortic Valve Replacement ◽  
Open Label ◽  
Number Of Patients

Abstract Introduction Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance. Materials and Methods PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years. Discussion PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years.

Abstract 276: Gender Disparity in the Treatment of Aortic Stenosis-an Analysis of the National Inpatient Sample 2009-2015

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Richard Tangel ◽  
Ankur Sethi ◽  
John Kassotis
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Gender Gap ◽  
Pacemaker Implantation ◽  
Gender Disparity ◽  
Chronic Obstructive ◽  
Surgical Aortic Valve Replacement ◽  
The Impact

Background: It is well known that there is a significant gender gap in both the referral and outcomes of patients eligible for cardiac surgery. The impact of transcatheter aortic valve replacement (TAVR) on the gender disparity in the management of aortic stenosis (AS) has not been well established. The aim of this study was to analyze the referrals to and outcomes of both surgical aortic valve replacement (SAVR) and TAVR for management of AS as a function of gender in a contemporary United States population. Methods: We used the National Inpatient database 2009-2015 to study the gender distribution of admissions for both SAVR and TAVR for the treatment of AS and its effect on inpatient outcomes. The survey estimation commands were used to determine weighted national estimates. Results: During the study period there were 3,443,274 (Males (M) 46.6 ± 0.1%; Females (F) 53.3 ± 0.1%) admissions for AS diagnosis, 325,264 SAVR (M 62.0 ± 0.2%; F 37.9 ± 0.2%) and 56,542 TAVR (M 52.6 ± 0.5%; F 47.3 ± 0.5%). The gender disparity was more prominent in Whites (Wh) than Non-whites (NWh) for both SAVR (Wh M 62.7 ± 0.2%, Wh F 37.2 ± 0.2%; NWh M 57.3 ± 0.5%, NWF 42.6 ± 0.5%) and TAVR (Wh M 53.1 ± 0.5%, Wh F 46.8 ± 0.5%; NWh M 47.2 ± 1.3%, NWh F 52.7 ± 1.3%). Female TAVR patients were older and more likely to have Medicare but less likely to have diabetes, chronic kidney disease (CKD), peripheral artery disease (PAD), prior coronary bypass surgery (CABG) and percutaneous coronary intervention (PCI), and chronic obstructive pulmonary disease (COPD). They also had lower Charlson comorbidity index (CCI). However, female TAVR patients had higher inpatient deaths (OR = 1.34;1.09-1.64), bleeding (OR = 1.51; 1.40-1.62) and stroke (OR = 1.47; 1.16-1.88), but a lower rate of pacemaker implantation (0.86; 0.76-0.97) and acute renal failure (ARF) (OR = 0.78; 0.71- 0.87). SAVR females were older, more likely to have Medicare, hypertension, and heart failure but less likely to have diabetes, CKD, PAD, prior CABG and PCI, and COPD. They also had lower CCI. SAVR female patients had higher inpatient deaths (OR = 1.40; 1.29-1.53), pacemaker implantation (OR =1.19; 1.11-1.28), blood transfusion (OR = 1.40; 1.35-1.45), and stroke (OR =1.19; 1.08-1.30), but lower ARF (OR = 0.80; 0.76-0.83). Conclusion: A gender disparity in the management of aortic stenosis continues to exist; however, our study showed that TAVR appears to bridge this gap. The reduction in gender disparity was most pronounced among Non-white patients. Despite having less comorbidities, outcomes after both SAVR and TAVR remain worse in women.

scholarly journals Preoperative Atrial Fibrillation is associated with long-term morTality in patients undergoing suRgical AortiC valvE Replacement

2021 ◽  
Author(s):  
Mohamed Farag ◽  
Yusuf Kiberu ◽  
Ashwin Reddy ◽  
Ahmad Shoaib ◽  
Mohaned Egred ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cardiac Surgery ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Surgical Aortic Valve Replacement ◽  
Term Survival ◽  
The Impact ◽  
Long Term Mortality

Introduction Atrial fibrillation (AF) is frequent after any cardiac surgery, but evidence suggests it may have no significant impact on survival if sinus rhythm (SR) is effectively restored early after the onset of the arrhythmia. In contrast, management of preoperative AF is often overlooked during or after cardiac surgery despite several proposed protocols. This study sought to evaluate the impact of preoperative AF on mortality in patients undergoing isolated surgical aortic valve replacement (AVR). Methods We performed a retrospective, single-centre study involving 2,628 consecutive patients undergoing elective, primary isolated surgical AVR from 2008 to 2018. A total of 268/ 2,628 patients (10.1%) exhibited AF before surgery. The effect of preoperative AF on mortality was evaluated with univariate and multivariate analyses. Results Short-term mortality was 0.8% and was not different between preoperative AF and SR cohorts. Preoperative AF was highly predictive of long-term mortality (median follow-up of 4 years [Q1-Q3 2-7]; HR: 2.24, 95% CI: 1.79-2.79, P<0.001), and remained strongly and independently predictive after adjustment for other risk factors (HR: 1.54, 95% CI: 1.21-1.96, P<0.001) compared with preoperative SR. In propensity score-matched analysis, the adjusted mortality risk was higher in the AF cohort (OR: 1.47, 95% CI: 1.04-1.99, P=0.03) compared with the SR cohort. Conclusions Preoperative AF was independently predictive of long-term mortality in patients undergoing isolated surgical AVR. It remains to be seen whether concomitant surgery or other preoperative measures to correct AF may impact long-term survival.

P909Echocardiographic Assessment of Left Ventricular Function in Patients with Aortic Stenosis and the short-term effects after intervention

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Alfarih ◽  
C Leu ◽  
J Moon ◽  
A Hughes ◽  
P Nihoyannopoulos ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Left Ventricular ◽  
Myocardial Deformation ◽  
P Value ◽  
Compensatory Mechanisms ◽  
Surgical Aortic Valve Replacement ◽  
The Impact

Abstract Introduction Aortic stenosis (AS) is the most prevalent form of acquired valvular heart disease, it affects ∼2% of people aged over 75. Series of compensatory mechanisms occur, in order for LV to adapt to high pressure overload. Aortic valve replacement has been the mainstay AS treatment either surgically or percutaneously. The evaluation of myocardial strains after Transcatheter Aortic Valve Implantation (TAVI) and Surgical Aortic Valve Replacement (SAVR) is still underexplored and there is no single study to date scouting the difference between TAVI and SAVR. Aim To assess the impact of unloading LV after TAVI and SAVR on LV remodelling. Methods In this prospective study, we have recruited 111 patients (75±11 years, 63% were females) with varying degrees of aortic stenosis. Of the 111 patients, 43 patients and 11 patients underwent TAVI and SAVR respectively between November 2017 and May 2018. Demographics, clinical and echocardiographic measurements along with speckle tracking parameters were recorded for all participants and again 4±2 weeks after intervention. Results Pre-TAVI LV-GLS mean was −10.8±3.5% and after implantation of aortic prosthesis immediate improvement of the myocardial deformation to −13.98±2.9% was observed after one month of the intervention, mean difference of −3.16% following procedure. There was an evidence of significant improvement in LV-GRS after TAVI (44.86±12.9% to 49.77±10.8%, P value= 0.047). Per contra, when comparing pre and post TAVI LV-GCS, no statistical evidence was noted. However, a difference of −2.4% in GCS following the intervention might be clinically important, but no previous evidence can support this. This is attributed to the poor reproducibility and yet not available standardisation. Table 1 Variables TAVI (n=43) SAVR (n=11) P value† Pre Post P* value Pre Post P* value GLS (%) −10.82±3.5 −13.98±2.9 <0.001 −12.75±4.3 −16.1±2 0.021 0.152 GCS (%) −30.1±8.1 −32.49±9.2 0.134 −27±9.8 −33.9±4.69 0.063 0.062 GRS (%) 44.86±12.9 49.77±10.8 0.047 36.6±13.3 44.97±4.9 0.074 0.058 Data are expressed as mean ± SD. Comparisons were performed using paired Student's t tests. *Pre and post intervention. †Post TAVI vs. post SAVR. Comparison done using unpaired t test of the differences. Conclusion Significant improvement was evident in myocardial deformation parameters – in particular GLS – after weeks of the intervention demonstrating a strong evidence of reversed remodelling following SAVR and TAVI.

scholarly journals Meta-Analysis Comparing Renal Outcomes after Transcatheter versus Surgical Aortic Valve Replacement

2019 ◽  
Vol 2019 ◽  
pp. 1-9 ◽  
Author(s):  
Kuldeep Shah ◽  
Zakeih Chaker ◽  
Tatiana Busu ◽  
Rishita Shah ◽  
Mohammed Osman ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Meta Analysis ◽  
Kidney Injury ◽  
Surgical Aortic Valve Replacement ◽  
Renal Outcomes ◽  
Risk Patients ◽  
Surgical Valve Replacement ◽  
The Impact

Background. Acute kidney injury (AKI) is a common complication of aortic valve replacement. However, comparative on the incidence of (AKI) following transcatheter (TAVR) versus surgical valve replacement (SAVR) is sparse. Methods. We performed a meta-analysis of the randomized controlled trials (RCT) and propensity-matched observational studies comparing (A) incidence of AKI and (B) incidence of dialysis-requiring AKI at 30 days after TAVR and SAVR. Results. Twenty-six studies (20 propensity-matched studies; 6 RCTs) including 19,954 patients were analyzed. The incidence of AKI was lower after TAVR than after SAVR (7.1% vs. 12.1%, OR 0.52; 95%CI, 0.39-0.68; p<0.001, I2=57%), but the incidence of dialysis-requiring AKI was similar (2.8% vs. 4.1%, OR 0.78; 95%CI, 0.49-1.25; p=0.31, I2=70%). Similar results were observed in a sensitivity analysis including RCTs only for both AKI ([5 RCTs; 5,418 patients], 2.0% vs. 5.0%, OR 0.39; 95%CI, 0.28-0.53; p<0.001, I2=0%), and dialysis-requiring AKI ([2 RCTs; 769 patients]; 2.9% vs. 2.6%, OR 1.1; 95%CI, 0.47-2.58; p=0.83, I2=0%). However, in studies including low-intermediate risk patients only, TAVR was associated with lower incidence of AKI ([10 studies; 6,510 patients], 7.6% vs. 12.4%, OR 0.55, 95%CI 0.39-0.77, p<0.001, I2=57%), and dialysis-requiring AKI, ([10 studies; 12,034 patients], 2.0% vs. 3.6%, OR 0.57, 95%CI 0.38-0.85, p=0.005, I2=23%). Conclusions. TAVR is associated with better renal outcomes at 30 days in comparison with SAVR, especially in patients at low-intermediate surgical risk. Further studies are needed to assess the impact of AKI on long-term outcomes of patients undergoing TAVR and SAVR.

scholarly journals Structural valve deterioration after aortic valve replacement with the Trifecta valve

2020 ◽  
Vol 32 (1) ◽  
pp. 39-46
Author(s):  
Paul Werner ◽  
Jasmin Gritsch ◽  
Sabine Scherzer ◽  
Christoph Gross ◽  
Marco Russo ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Surgical Aortic Valve Replacement ◽  
Kaplan Meier ◽  
Single Centre Experience ◽  
Structural Valve Deterioration ◽  
Long Term Follow Up ◽  
Valve In Valve

Abstract OBJECTIVES Despite promising short- and mid-term results for durability of the Trifecta valve, contradictory reports of early structural valve deterioration (SVD) do exist. We investigated the incidence of SVD after surgical aortic valve replacement (SAVR) with the Trifecta in our single-centre experience. METHODS Data of 347 consecutive patients (mean age 71.6 ± 9.5 years, 63.4% male) undergoing SAVR with the Trifecta between 2011 and 2017 were analysed. Clinical and echocardiographic reports were obtained with a median follow-up of 41 months (1114 patient years). RESULTS Isolated SAVR was performed in 122 patients (35.2%), whereas 225 patients (64.8%) underwent concomitant procedures. The median EuroSCORE II was 4.0 (0.9; 7.1) and 30-day mortality was 3.7% (n = 13). Kaplan–Meier estimates for the freedom of overall mortality at 1, 5 and 7 years were 88.7 ± 1.7%, 73.7 ± 2.6% and 64.7 ± 4.2%, respectively. SVD was observed in 25 patients (7.2%) with a median time to first diagnosis of 73 months. Freedom of SVD was 92.5 ± 0.9% at 5 years and 65.5 ± 7.1% at 7 years. Thirteen patients underwent reintervention for SVD (6 re-SAVR, 7 valve-in-valve), resulting in a freedom of reintervention for the SVD of 98.5 ± 1.1% at 5 years and 76.9 ± 6.9% at 7 years. CONCLUSIONS We herein report one of the highest rates of SVD after SAVR with the Trifecta. These data indicate that the durability of the prosthesis decreases at intermediate to long-term follow-up, leading to considerable rates of reintervention due to SVD.

Surgical explantation of a failed transcatheter aortic valve

2021 ◽  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Lower Risk ◽  
Transcatheter Aortic Valve Replacement ◽  
Surgical Aortic Valve Replacement ◽  
Native Valve ◽  
Transcatheter Aortic Valve ◽  
Structural Deterioration ◽  
Structural Valve Deterioration

With transcatheter aortic valve replacement being increasingly utilized in a younger and lower risk population, we can expect to see larger numbers of patients presenting with structural deterioration of aortic valves replaced by the transcatheter route that now require explantation and surgical replacement. Surgical aortic valve replacement after transcatheter aortic valve replacement is associated with operative morbidity and mortality rates significantly higher than those seen in the setting of surgical replacement of the native valve, which had a 30-day mortality of 12–20% in recent series. Centers performing transcatheter aortic valve replacement in lower risk patients with longer expected lifespans and a higher probability of late structural deterioration of the transcatheter aortic valve replacement should carefully consider their choice of valve type (balloon-expandable versus self-expanding) and patient anatomy, including annulus and root diameter, at the time of the initial valve intervention. Further, one should not forget the mechanical surgical aortic valve replacement option in younger patients with risk factors for early structural valve deterioration such as obesity, metabolic syndrome, and chronic kidney disease. The objectives of this tutorial are to describe the preoperative workup for a patient with late structural valve deterioration after transcatheter aortic valve replacement, detail the explantation approach specific to self-expanding valves, and illustrate the key decisions and techniques needed for subsequent surgical aortic valve replacement.

scholarly journals The impact of surgical aortic valve replacement on quality of life—a multicenter study

2019 ◽  
Author(s):  
Fredrike Blokzijl ◽  
Saskia Houterman ◽  
Bart H.M. van Straten ◽  
Edgar Daeter ◽  
George J. Brandon Bravo Bruinsma ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Multicenter Study ◽  
Surgical Aortic Valve Replacement ◽  
The Impact

P1840Mid-term results of bioprosthetic aortic valve replacement with the Trifecta valve: A word of caution

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Werner ◽  
M Russo ◽  
M Seewald ◽  
I Coti ◽  
T Haberl ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Pressure Gradient ◽  
Valve Replacement ◽  
Composite Endpoint ◽  
Surgical Aortic Valve Replacement ◽  
Structural Valve Deterioration ◽  
Mean Pressure ◽  
Overall Mortality

Abstract Background Structural valve deterioration (SVD) with associated bioprosthetic valve dysfunction remains an unsolved problem, exposing patients to the risk of aortic valve re-intervention after surgical aortic valve replacement (SAVR). Several strategies have been proposed to improve prosthesis design for optimal performance. The leaflets of the Trifecta valve are mounted on the outside of the prosthetic stent to achieve a larger orifice area. Although favourable early clinical outcomes have been reported, long-term durability still needs to be assessed. Purpose The aim of the current study was to assess the mid-term overall mortality and re-intervention rate in patients who received a Trifecta valve with a follow-up >5 years. Methods Patients who underwent SAVR at our centre between 2011 and 2012 were identified in the internal, prospective database. All patients with implantation of a Trifecta valve in aortic position were included. Primary endpoints were freedom from overall mortality and from re-operation at latest follow-up (FU). Additionally, assessment of echocardiographic parameters at baseline and follow-up was performed. Results Seventy-six patients (age 77.3±9.5 years, BMI 28.6±5.8, 68% male) were included in the study. EuroScore II was 7.2% (± 7.7) while mean STS-Mortality score was 2.4±1.1%. Of all procedures, 53% were isolated aortic valve replacements, whereas concomitant procedures were performed in 47% of cases (37% CABG, 12% mitral surgery, 8% tricuspid surgery). Baseline echocardiographic assessment showed a mean pressure gradient (MPG) of 51±21 mmHG, a peak pressure gradient (PPG) of 78±36 mmHG and a peak velocity (Vmax) of 4.2±1.1 m/s. Thirty-day mortality was 7%. Freedom from overall mortality at 1 year and 5 years was 84% and 73%, respectively. Freedom from death and freedom from re-operation at latest FU (6.7±0.5 years) was 68% and 90%, respectively. In a composite endpoint analysis, freedom from death or re-intervention at latest follow up was 60%. A total of 7 patients underwent aortic valve re-interventions (re-replacements n=5, valve-in-valve n=2). Indications for re-interventions were SVD (n=5), NSVD (n=1, pannus ingrowth) and endocarditis (n=1). One case of re-stenosis occurred in a patient who was deemed not feasible for aortic valve re-intervention and died. Kaplan Meier analysis Conclusion(s) To our knowledge, this patient cohort presents with the lowest rate of freedom from re-operation (90%, 6.7±0.5 years) after SAVR with the Trifecta valve. A relatively high number of SVD and NSVD has been observed, which might be attributable to the specific leaflet mounting or the deformable valve frame of the first generation. Current results call for further investigation with prospective echocardiographic follow-up in this patient group. Acknowledgement/Funding None

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