scholarly journals Single centre experience in 1202 biological prosthesis: a comparison between sutured, sutureless and surgical transcatheter aortic valve

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
C Mariani ◽  
G Murana ◽  
L Botta ◽  
G Gliozzi ◽  
G Folesani ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Primary Outcome ◽  
Pacemaker Implantation ◽  
Kidney Injury ◽  
P Value ◽  
Valve Prosthesis ◽  
Biological Prosthesis ◽  
Secondary Outcomes

Abstract Background/Introduction Different types of bio-prosthesis are now available for the treatment of aortic valve disease. In absence of the “ideal” heart valve prosthesis, the best choice may be customized on the basis of the patient's profile. Purpose The aim of this study was to compare results in different subgroups of bio-prosthesis in elderly patients (>75 years old) undergoing conventional or surgical trans-catheter aortic valve replacement (AVR). Primary outcome was all cause mortality, secondary outcomes were: early post-operative complications (stroke, AV-block, acute kidney injury requiring temporary dialysis), freedom from structural vascular disease (SVD) and from re-operation. Methods In this retrospective study we analysed 1202 patients over 75 years old, underwent AVR from 2002 to 2018. Inclusion criteria were: age >75 years underwent AVR; we divided our population in 3 groups according to different strategy: primary aortic valve replacement with sutured (group 1, n=1005), sutureless (group 2, n=103) or surgical trans-catheter aortic valve replacement (group 3, n=94). Exclusion criteria: concomitant cardiac procedure other than coronary artery by-pass graft (CABG) or endocarditis. Patient and disease characteristics are described as numbers and percentages, continuous data were expressed using mean and standard deviation. Differences between groups were evaluated using either Student t-test or Mann-Whitney U test or ANOVA test. Survival curves of the primary outcome and freedom from secondary outcomes were built with the Kaplan-Meier method. Results The mean age of the overall population was 80.5±3.6 years with a mean STS score of assessed at 2.79±2.2% (2.27±1.0 for standard AVR, 3.3±2.2% for sutureless and 6.4±4.5 for S-TAVR, p-value<0.001). Early outcomes are depicted in figure 1. The overall 30-day mortality was 2.9%; among the different groups we observed 2.3%, 4.9% and 7.2% for sutured, sutureless and surgical-TAVR, respectively (p-value=0.01). The groups statistically differed also for permanent pacemaker implantation (sutured AVR 2.2%, sutureless AVR 4.9%, TAVR 9.6% (p-value<0.001) and acute renal failure requiring temporary dialysis sutured AVR 3%, Sutureless AVR 1.9% and Surgical TAVR 9.6% (p-value=0.004). The survival rate at follow-up was significantly different among group (log-rank <0.001, figure 2). Instead, freedom from reoperation was similar between cohorts (figure 2.) Conclusion(s) The outcomes of surgical AVR in a elderly population could be safely guaranteed with different biological prosthesis and operative techniques. A patient tailored approach should be always advised to improve current available transcatheter options. FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Figure 2

Abstract 20: Use of Administrative Claims to Ascertain Outcomes in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings From the Extending Trial-based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Jordan B Strom ◽  
Yuansong Zhao ◽  
Kamil F Faridi ◽  
Neel Butala ◽  
Hector Tamez ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Claims Data ◽  
Pacemaker Implantation ◽  
Kidney Injury ◽  
Trial Data ◽  
P Value ◽  
Administrative Claims ◽  
Transcatheter Aortic Valve ◽  
Linkage Rate ◽  
Secondary Outcomes

Introduction: Administrative claims may be a low cost alternative to traditional clinical trial event adjudication, but whether claims data can validly substitute for adjudicated outcomes to reproduce trial-derived treatment effects is uncertain. Methods: We linked adults aged ≥65 in the US CoreValve Pivotal High Risk (HiR) and Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients (SURTAVI) Trials to 100% Medicare inpatient claims (2003-2016). Primary (i.e. death and stroke) and secondary trial endpoints (i.e. bleeding, acute kidney injury, cardiogenic shock, pacemaker implantation, aortic valve reintervention, myocardial infarction, and major adverse cerebrovascular and cardiovascular events [MACCE]) were compared across treatment arms (i.e. TAVR vs. SAVR) using outcomes derived from claims at 1 year (HiR) or 2 years (SURTAVI), and compared with trial-adjudicated outcomes. Results: Among 600 linked HiR participants (linkage rate 80.0%), the rate of the trial’s primary endpoint of all-cause mortality at 1-year was 13.7% for TAVR and 16.4% for SAVR using both trial data (HR 0.84, 95% CI 0.65-1.09; p = 0.33) and claims data (HR 0.86, 95% CI 0.66-1.11; p = 0.34; interaction p-value = 0.80) ( Figure ). Among 1004 linked SURTAVI trial participants (linkage rate 60.5%), the trial’s primary endpoint of combined death and stroke at 2-years was 12.9% for TAVR and 13.1% for SAVR using trial data (HR 1.08, 95% CI 0.79-1.48, p = 0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (HR 1.02, 95% CI 0.73-1.41, p = 0.58; interaction p-value = 0.89) ( Figure ). Procedural secondary outcomes (e.g., aortic valve reintervention, pacemaker implantation) were more concordant between trials and claims than non-procedural outcomes (e.g. bleeding, cardiogenic shock, stroke). Acute kidney injury, myocardial infarction, and MACCE outcomes were also concordant between data types. Conclusions: In both HiR and SURTAVI trials, ascertainment of trial primary endpoints using claims reproduced both the magnitude and direction of treatment effect observed in adjudicated event data. Non-fatal secondary outcomes displayed variable concordance. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be a valid alternative for some endpoints.

91Transcatheter valve-in-valve versus redo surgical aortic valve replacement for the management of failed biological prosthesis: early and late outcomes

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D Tam ◽  
C Dharma ◽  
H C Wijeysundera ◽  
P Austin ◽  
M Ouzounian ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Pacemaker Implantation ◽  
Permanent Pacemaker ◽  
Early Mortality ◽  
Surgical Aortic Valve Replacement ◽  
Late Mortality ◽  
Biological Prosthesis ◽  
Valve In Valve

Abstract Background While the gold standard for the management of failed previous biological prosthesis was redo surgical aortic valve replacement (SAVR), valve-in-valve (ViV) transcatheter AVR (TAVR) has emerged as a less invasive option. Published studies comparing the two techniques have been small and limited to early outcomes. Herein, we compare early mortality, morbidity and late mortality between ViV TAVR and redo SAVR. Methods Clinical and administrative databases for Canada's most populous province, Ontario (>13 million patients), were linked to identify patients undergoing ViV and redo SAVR for a failed biological prosthesis. Baseline characteristics were compared and 1:1 propensity score matching (PSM) was performed to account for baseline differences. Standardized mean differences (SMD) were used to assess adequacy of PSM, whereby a SMD<0.10 indicated a good match. Early outcomes were compared in the matched groups using McNemar's test. In accordance to government privacy legislation, outcomes with <6 events, were presented as absolute risk difference (ARD) between ViV and Redo SAVR to prevent patient re-identification. Late mortality was compared between the matched groups using Kaplan-Meier survival curves and a Cox-proportional hazard model. Results Records of 558 patients undergoing intervention for a failed biological prosthesis between March 2008 to September 2017 in 11 Ontario institutions were reviewed (ViV = 214, redo SAVR = 344). Patients who underwent ViV were older (78.2±8.2 vs 69.1±11.4, p<0.001, SMD=0.92) and had more hypertension, diabetes, ischemic heart disease, atrial fibrillation, congestive heart failure compared to redo SAVR before PSM (SMD>0.20). Propensity matching on 24 variables yielded similar groups for comparison (n=133 pairs). Ages were similar between ViV and Redo SAVR (76.0±6.2 vs 76.0±8.7, SMD=0.003) along with all other comorbidities (SMD<0.1). 30-day mortality was significantly lower with ViV compared to Redo SAVR (ARD: −7.4%, 95% confidence interval (95% CI): −12.4%, −2.3%). The rate of permanent pacemaker implantation (ARD: −8.1%, 95% CI: −14.2%, −2.1%), blood transfusions (ARD: −62.2%, 95% CI: −75.2%, −49.1%) and length of stay (LOS) (mean difference: −7.8 days, 95% CI: −11.0, −4.6 days) were also lower with ViV. All-cause mortality at 5 years was similar between ViV and redo SAVR (Figure, p=0.19). Figure 1 Conclusion ViV TAVR was associated with lower early mortality, risk of permanent pacemaker implantation, any blood transfusion, and hospital LOS compared to redo SAVR in the largest PSM study to date. While there was no difference in late mortality at 5 years, additional studies with more subjects and longer follow-up are necessary. ViV TAVR may be the preferred approach for the treatment of failed biological prosthesis.

Prosthesis-Patient Mismatch Causes a Significantly Increased Risk of Operative Mortality in Aortic Valve Replacement

2014 ◽  
Vol 17 (3) ◽  
pp. 127 ◽  
Author(s):  
Muhammad Shahzeb Khan ◽  
Faizan Imran Bawany ◽  
Asadullah Khan ◽  
Mehwish Hussain
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Operative Mortality ◽  
Univariate Analysis ◽  
Female Gender ◽  
Valve Prosthesis ◽  
Predictors Of Mortality ◽  
Increased Risk ◽  
Urgent Operation

<p><b>Background:</b> Small aortic prosthesis can lead to prosthesis-patient mismatch (PPM). Implanting such small prosthesis remains a controversial issue. This study was done to investigate whether or not PPM causes an increased operative mortality in aortic valve replacement (AVR).</p><p><b>Methods:</b> Two-hundred-two consecutive patients undergoing primary AVR in a tertiary hospital were included. The sample was grouped according to the aortic valve prosthesis size: ?21 mm (small) and >21 mm (standard). The effect of variables on outcomes was determined by univariate and multivariable regression analyses.</p><p><b>Results:</b> PPM was found significantly more among patients with AVR ? 21mm (<i>P</i> < 0.0001). Moreover, the likelihood of mortality also was significantly higher in these patients (<i>P</i> < 0.0001). Univariate analysis demonstrated small prosthesis size, urgent operation, PPM, female gender, and NYHA Class IV as significant predictors of mortality. Multivariate regression identified female gender, PPM, and urgent operation as the key independent predictors of mortality.</p><p><b>Conclusion:</b> PPM and female gender are significant predictors of mortality. Care should be taken to prevent PPM by implanting larger prosthesis especially in females.</p>

scholarly journals Long-term survival after Carpentier-Edwards Perimount aortic valve replacement in Western Denmark: a multi-centre observational study

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Lytfi Krasniqi ◽  
Mads P. Kronby ◽  
Lars P. S. Riber
Keyword(s):  
Risk Factors ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Significant Risk ◽  
Valve Prosthesis ◽  
Term Survival ◽  
Long Term Survival ◽  
All Cause Mortality

Abstract Background This study describes the long-term survival, risk of reoperation and clinical outcomes of patients undergoing solitary surgical aortic valve replacement (SAVR) with a Carpentier-Edwards Perimount (CE-P) bioprosthetic in Western Denmark. The renewed interest in SAVR is based on the questioning regarding the long-term survival since new aortic replacement technique such as transcatheter aortic-valve replacement (TAVR) probably have shorter durability, why assessment of long-term survival could be a key issue for patients. Methods From November 1999 to November 2013 a cohort of a total of 1604 patients with a median age of 73 years (IQR: 69–78) undergoing solitary SAVR with CE-P in Western Denmark was obtained November 2018 from the Western Danish Heart Registry (WDHR). The primary endpoint was long-term survival from all-cause mortality. Secondary endpoints were survival free from major adverse cardiovascular and cerebral events (MACCE), risk of reoperation, cause of late death, patient-prothesis mismatch, risk of AMI, stroke, pacemaker or ICD implantation and postoperative atrial fibrillation (POAF). Time-to-event analysis was performed with Kaplan-Meier curve, cumulative incidence function was performed with Nelson-Aalen cumulative hazard estimates. Cox regression was applied to detect risk factors for death and reoperation. Results In-hospital mortality was 2.7% and 30-day mortality at 3.4%. The 5-, 10- and 15-year survival from all-cause mortality was 77, 52 and 24%, respectively. Survival without MACCE was 80% after 10 years. Significant risk factors of mortality were small valves, smoking and EuroSCORE II ≥4%. The risk of reoperation was < 5% after 7.5 years and significant risk factors were valve prosthesis-patient mismatch and EuroSCORE II ≥4%. Conclusions Patients undergoing aortic valve replacement with a Carpentier-Edwards Perimount valve shows a very satisfying long-term survival. Future research should aim to investigate biological valves long-term durability for comparison of different SAVR to different TAVR in long perspective.

scholarly journals Post hoc patient satisfaction with the choice of valve prosthesis for aortic valve replacement: results of a single-centre survey

2021 ◽  
Author(s):  
Laure Bryssinck ◽  
Siel De Vlieger ◽  
Katrien François ◽  
Thierry Bové
Keyword(s):  
Patient Satisfaction ◽  
Aortic Valve ◽  
Confidence Interval ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Odds Ratio ◽  
Mechanical Valve ◽  
Decisional Conflict ◽  
Valve Prosthesis ◽  
Post Hoc

Abstract OBJECTIVES Our goal was to examine post hoc patient satisfaction and the decision-making process of choosing a prosthesis for aortic valve replacement (AVR). METHODS We surveyed 113 patients who were operated on for AVR at 60–70 years of age, including 74 patients with a mechanical valve (MECH) and 39 with a bioprosthesis (BIO). The study focused on quality of life and the decision pathway in relation to prosthesis choice and valve-related complications. Decisional conflict was defined as the post hoc uncertainty perceived by patients regarding their choice of prosthesis. RESULTS The survey was performed at a median of 5.2 (3.2–8.1) years after the AVR. Patients with a biological valve were older (BIO: 68.4 years [66.2–69.4] vs MECH: 63.9 [61.9–66.7]; P &lt; 0.001). Global post hoc satisfaction with prosthesis choice was high in both groups (MECH: 95.9%; BIO: 100%), and 85.1% (MECH) and 92.3% (BIO) of them would repeat their choice. Conflict about their decision was equal (MECH: 30.3%; BIO: 32.6%) for different reasons: MECH patients experienced more anticoagulation-related inconvenience (25.9% vs 0%), fear of bleeding (31.1% vs 0%) and prosthesis noise (26.2% vs 0%), whereas more BIO patients feared prosthesis failure (39.7% vs 17.4%) or reoperation (43.5% vs 18.1%). Active involvement in the decision (odds ratio 0.37, 95% confidence interval 0.16–0.85; P = 0.029) and adequate information about the prosthesis (odds ratio 0.34, 95% confidence interval 0.14–0.86; P = 0.020) decreased the risk of conflict about the decision. CONCLUSIONS Although 30% of the responders showed a decisional conflict related to prosthesis-specific interferences, global patient satisfaction with the prosthesis choice for AVR is excellent. Increasing the patient’s involvement in the prosthesis choice through shared accountability and improved information is recommended to decrease the choice-related uncertainty.

scholarly journals Aortic Valve Neocuspidization Using Autologous Pericardium (Ozaki Procedure): an Alternative to Aortic Valve Replacement in Adult Cardiac Surgery?

2021 ◽  
Author(s):  
Luca Koechlin ◽  
Friedrich S. Eckstein
Keyword(s):  
Cardiac Surgery ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Pacemaker Implantation ◽  
Unmet Need ◽  
Heart Team ◽  
Autologous Pericardium ◽  
Potential Benefits ◽  
Adult Cardiac Surgery

Abstract Purpose of the Review The aim of this article is to describe the technique of aortic valve neocuspidization using autologous pericardium (AVNeo, “OZAKI procedure”) in adult cardiac surgery, to analyze recent findings, and to discuss benefits and limitations of this technique. Recent Findings Potential benefits of this technique include excellent hemodynamic performances, minimal use of foreign material, low rates of permanent pacemaker implantation, and omission of oral anticoagulation. However, data regarding the durability of the procedure are hitherto limited, and the procedure is associated with a higher complexity compared to aortic valve replacement. Summary AVNeo using autologous pericardium in adult cardiac surgery is a promising technique providing several benefits. However, there is a major unmet need for more data, especially regarding long-term durability. Thus, based on currently available data, we recommend careful patient selection within the heart team and shared decision-making with the informed patient.

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