scholarly journals Benefits and Pitfalls of the Perceval Sutureless Bioprosthesis

2022 ◽  
Vol 8 ◽  
Author(s):  
Aleksander Dokollari ◽  
Basel Ramlawi ◽  
Gianluca Torregrossa ◽  
Michel Pompeu Sá ◽  
Serge Sicouri ◽  
...  

Objective: To highlight the main target points covered by clinical studies on the Perceval sutureless valve for surgical aortic valve replacement (SAVR) and raise a point of discussion for further expansion of its use when compared with stented bioprostheses (SB) and transcatheter aortic valve replacement (TAVR).Methods: We reviewed clinical trials and retrospective studies published up to date and compared the outcomes in terms of mortality, myocardial infarction (MI) stroke, paravalvular leak (PVL), permanent pacemaker implantation (PPI), bleeding and long-term outcomes.Results: Clinical studies showed that 30-day mortality ranged from 0–4% for Perceval and 2.9–7% for TAVR. The incidence of PVL (Perceval 1.9–19.4 vs. TAVR 9–53.5%), PPI (Perceval 2–11.2 vs. TAVR 4.9–25.5%), stroke (Perceval 0 vs. TAVR 0–2.8%), MI (Perceval 0 vs. TAVR 0–3.5%), were all higher in the TAVR group. Compared to other SB, mortality ranged from 0–6.4% for Perceval and 0–5.9% for SB. The incidence of PVR (Perceval 1–19.4 vs. SB 0–1%), PPI (Perceval 2–10.7 vs. SB 1.8–8.5%), stroke (Perceval 0–3.7 vs. SB 1.8–7.3%) and MI (Perceval 0–7.8 vs. SB 0–4.3%) were comparable among the groups. In patients with a bicuspid aortic valve, mortality rate was (0–4%) and PVL incidence was (0–2.3%). However, there was a high incidence of PPI (0–20%), and stroke (0–8%). Long-term survival ranged between 96.7–98.6%.Conclusions: The Perceval bioprosthesis has proved to be a reliable prosthesis for surgical aortic valve replacement due to its implantation speed, the reduced cardiopulmonary bypass time, the reduced aortic cross-clamp time and the shorter intensive care unit and hospital length of stay.

2020 ◽  
Vol 31 (3) ◽  
pp. 398-404
Author(s):  
Samuli J Salmi ◽  
Tuomo Nieminen ◽  
Juha Hartikainen ◽  
Fausto Biancari ◽  
Joonas Lehto ◽  
...  

Abstract OBJECTIVES We sought to study the indications, long-term occurrence, and predictors of permanent pacemaker implantation (PPI) after isolated surgical aortic valve replacement with bioprostheses. METHODS The CAREAVR study included 704 patients (385 females, 54.7%) without a preoperative PPI (mean ± standard deviation age 75 ± 7 years) undergoing isolated surgical aortic valve replacement at 4 Finnish hospitals between 2002 and 2014. Data were extracted from electronic patient records. RESULTS The follow-up was median 4.7 years (range 1 day to 12.3 years). Altogether 56 patients received PPI postoperatively, with the median 507 days from the operation (range 6 days to 10.0 years). The PPI indications were atrioventricular block (31 patients, 55%) and sick sinus syndrome (21 patients, 37.5%). For 4 patients, the PPI indication remained unknown. A competing risks regression analysis (Fine–Gray method), adjusted with age, sex, diabetes, coronary artery disease, preoperative atrial fibrillation (AF), left ventricular ejection fraction, New York Heart Association class, AF at discharge and urgency of operation, was used to assess risk factors for PPI. Only AF at discharge (subdistribution hazard ratio 4.34, 95% confidence interval 2.34–8.03) was a predictor for a PPI. CONCLUSIONS Though atrioventricular block is the major indication for PPI after surgical aortic valve replacement, >30% of PPIs are implanted due to sick sinus syndrome during both short-term follow-up and long-term follow-up. Postoperative AF versus sinus rhythm conveys >4-fold risk of PPI. Clinical trial registration clinicaltrials.gov Identifier: NCT02626871


Open Heart ◽  
2016 ◽  
Vol 3 (1) ◽  
pp. e000338 ◽  
Author(s):  
Mansour T A Sharabiani ◽  
Francesca Fiorentino ◽  
Gianni D Angelini ◽  
Nishith N Patel

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Nauffal ◽  
C Bay ◽  
P Shah ◽  
P Sobieszczyk ◽  
T Kaneko ◽  
...  

Abstract Introduction Mediastinal radiation can lead to long-term cardiac sequelae, including aortic valve disease. Surgical aortic valve replacement (SAVR) is associated with poor outcomes in this population. Transcatheter aortic valve replacement (TAVR) now provides an alternative treatment strategy that may improve outcomes. Purpose To compare 30-day outcomes after TAVR vs. isolated SAVR for radiation-associated severe symptomatic aortic stenosis using the Society of Thoracic Surgery (STS) National Adult Cardiac Surgery Database. Methods We evaluated 1,668 TAVR and 2,611 isolated SAVR patients enrolled in the STS national database from July 2011 through December 2018. A propensity score for TAVR vs. SAVR was derived using a non-parsimonious logistic regression model that included 29 pre-operative variables and was used to generate a 1:1 matched cohort (NTotal=1,560). 30-day outcomes in TAVR vs. SAVR patients were compared in the matched cohort using conditional logistic regression. We also tested for temporal trends in 30-day mortality separately for TAVR and SAVR in the matched cohort, adjusted for potential confounders, to see if outcomes varied across the study period. Results In the propensity-matched cohort, baseline demographics, comorbidities and preoperative characteristics were balanced between the TAVR and SAVR groups. The mean age was 73.3 years and 75% were females in each group. In the propensity-matched cohort, TAVR was associated with significantly reduced 30-day all-cause [OR=0.50 (0.30–0.84), p=0.01] and cardiovascular mortality as compared to SAVR [OR=0.33 (0.14–0.78), p=0.01]. Similarly, post-operative complications occurred less in the TAVR group except for stroke/transient ischemic attack (TIA) [OR=3.17 (1.27–7.93), p=0.01] and pacemaker implantation [OR=1.71 (1.21–2.44), p=0.003] which were significantly higher with TAVR (Figure 1A). While, 30-day mortality associated with both procedures improved over the course of the study, the trend was only statistically significant in the TAVR group following adjustment for potential confounders. TAVR was consistently associated with better survival than SAVR in the matched cohort across the study period (Figure 1B). Conclusion Our findings suggest that TAVR is a safe alternative to SAVR for radiation-associated severe symptomatic aortic stenosis and is associated with lower 30-day mortality and post-operative complications. The risk of stroke/TIA and pacemaker implantation is higher with TAVR and should be considered when choosing therapy. Additional prospective studies to validate our findings and evaluate long-term outcomes are needed to further guide clinical decision making in this population. Figure 1 Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Funding to support acquisition of the data from the Society of Thoracic Surgery was obtained from discretionary funds available to Dr. Anju Nohria from the Cardiovascular Medicine Division.


Author(s):  
Mohamed Farag ◽  
Yusuf Kiberu ◽  
Ashwin Reddy ◽  
Ahmad Shoaib ◽  
Mohaned Egred ◽  
...  

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.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Sanchez Recalde ◽  
A Pardo ◽  
L Salido Tahoces ◽  
J L Mestre ◽  
R Hernandez Antolin ◽  
...  

Abstract Background Transcatheter valve-in-valve (tVIV) implantation for degenerated aortic bioprosthesis has become an alternative to surgical aortic valve replacement (sAVR) in the past few years. However, some concerns have been raised regarding to the long-term safety and efficacy of tVIV. The objective was to compare the clinical and echocardiographic outcomes of tVIV implantation with redo cAVR. Methods After an extensive search of PubMed we included 7 observational studies (3 used propensity score matching) comparing tVIV versus sAVR in 762 patients The primary endpoint was all-cause mortality determined from the longest available survival data. Other outcomes of interest were stroke, permanent pacemaker implantation, paravalvular leak, hospital stay and postoperative aortic valve gradient. The review was conducted according to the MOOSE recomendations. Der Simonian and Laird random effects model was used to estimate summary measures and their 95% CI. Results Patients in the tVIV group were significantly older (78 vs 73 y.o.) and had a higher baseline risk compared to those in the re-sAVR group (Euroscore 19.7 vs 14.3). There was no statistical difference in procedural or 30-day mortality 5.4% vs 5.3% in tVIV and sAVR, respectively (RR 0.98, 95% CI 0.54–1.80; p=0.96], and long-term mortality (from 6 month to 5 years) 18.7% versus 16.5% (RR 1.13, 95% CI 0.80–1.60; P=0.50). The risk of stroke was similar (1.5% in tVIV vs 2.4% in sAVR, p=0.47). tVIV was associated with a significantly lower rate of permanent pacemaker implantations 6.9% vs 12.1% (RR 0.58, 95% CI 0.36–0.94; P=0.03) and shorter hospital length stay (7 days vs 12 days, p=0.02). However, echocardiographic postoperative aortic valve gradients were lower in sAVR group than in tVIV (RR 1.83, 95% CI 0.75–2.91, p<0.001). 30-day and long-term mortality Conclusion This meta-analysis suggests that patients with aortic degenerated bioprosthesis treated with tVIV have similar 30-day and long-term mortality with lower need of permanent pacemaker and length stay than sAVR. Thus tVIV is a valid alternative to standard surgical treatment.


2021 ◽  
Vol 10 (23) ◽  
pp. 5554
Author(s):  
Keti Vitanova ◽  
Felix Wirth ◽  
Johannes Boehm ◽  
Melchior Burri ◽  
Rüdiger Lange ◽  
...  

Background: Recently, the use of surgically implanted aortic bioprostheses has been favoured in younger patients. We aimed to analyse the long-term survival and postoperative MACCE (Major Adverse Cardiovascular and Cerebral Event) rates in patients after isolated aortic valve replacement. Methods: We conducted a single-centre observational retrospective study, including all consecutive patients with isolated aortic valve replacement. 1:1 propensity score matching of the preoperative baseline characteristics was performed. Results: A total of 2172 patients were enrolled in the study. After propensity score matching the study included 428 patients: 214 biological vs. 214 mechanical prostheses, divided into two subgroups: group A < 60 years and group B > 60 years. The mean follow-up time was 7.6 ± 3.9 years. Estimated survival was 97 ± 1.9% and 89 ± 3.4% at 10 years for biological and mechanical prosthesis, respectively in group A (p = 0.06). In group B the survival at 10 years was 79.1 ± 5.8% and 69.8 ± 4.4% for biological and mechanical prosthesis, respectively (p = 0.83). In group A, patients with a bioprosthesis exhibited a tendency for higher cumulative incidence MACCE rates compared to patients with a mechanical prosthesis, p = 0.83 (bio 7.3 ± 5.3% vs. mech 4.6 ± 2.2% at 10 years). In group B, patients with a mechanical prosthesis showed a tendency for higher cumulative incidence MACCE rates compared to patients with bioprosthesis, p = 0.86 (bio 4.3 ± 3.1% vs. mech 9.1 ± 3.1% at 10 years). Conclusions: Long-term survival after surgical aortic valve replacement is similar in patients with a biological and mechanical prosthesis, independent of the patients’ age. Moreover, younger patients (<60 years) with bioprosthesis showed a survival benefit, compared to patients with mechanical prosthesis in this age group.


Author(s):  
Suvitesh Luthra ◽  
Pietro Giorgio Malvindi ◽  
Hannah Masraf ◽  
Anna Podonyi ◽  
Taha Ramadan ◽  
...  

Background The aim of this study was to analyse the perioperative results and long term survival of re-sternotomy for surgical aortic valve replacement (SAVR) in octogenarians. Methods This is a retrospective, single centre study (Apr 2000 – Dec 2019). Perioperative data were compared for re-sternotomy with isolated SAVR (Isolated redoSAVR) and re-sternotomy with SAVR and concomitant cardiac procedure (Associated redoSAVR). Regression analyses were performed to identify predictors of in patient mortality. Hazard ratios were calculated, and Kaplan Meier survival curves were compared for groups. Results There were 163 patients (Isolated redoSAVR; 69, Associated redoSAVR; 94). Mean age was 83±3 years and mean logEuroSCORE was 21±12. Follow up was 4.2±3.5 years. Inpatient mortality was 4.9% (1.4% versus 7.4% for Isolated redoSAVR and Associated redoSAVR respectively, p=0.08). TIA/stroke rate was 8% (9% versus 7% for Isolated redoSAVR and Associated redoSAVR respectively, p=0.78). COPD was a predictor of inpatient mortality (OR; 8.86, 95%CI; 1.19, 66.11, p=0.03). Survival was 88.7% at 1 year, 86.4% at 2 years, 70.1% at 5 years, 49.5% at 7 years and 26.3% at 10 years. There was no survival difference between Isolated redoSAVR and Associated redoSAVR (logrank p=0.36, Wilcoxon p=0.84). Significant predictors of adverse long term survival were COPD, postoperative TIA/stroke and length of stay. Survival is lower than age and gender matched first time SAVR and general population of UK. Conclusions RedoSAVR in octogenarians is associated with acceptable but significant morbidity and mortality. Shared decision making should consider emerging transcatheter therapies as viable options in selected patients.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Jelani Grant ◽  
Bertrand Ebner ◽  
Louis Vincent ◽  
Jennifer Maning ◽  
neal olarte ◽  
...  

Introduction: A history of malignancy is incorporated in the Society of Thoracic Surgeons (STS) Score to assess presurgical risk in patients undergoing surgical aortic valve replacement (SAVR), however data on the prognostic importance in those undergoing TAVR remains limited. Methods: The National Inpatient Sample Database was queried from 2012 to 2017 to identify patients who underwent TAVR using International Classification of Diseases (ICD) 9 and 10 procedure codes. These patients were classified into those who had a history of malignancy or not using ICD 9 and 10 diagnostic codes. Results: There were 24,615 patients who underwent TAVR, of these 4,735 patients had a prior history of malignancy whereas 19,880 patients had no prior history of malignancy. Patients with a history of malignancy were older than those without (81.1±7.9 vs. 80.1± 6.7 years old, p<0.001). Baseline characteristics are shown in Table 1. Patients with a history of malignancy had similar rates of post-TAVR pacemaker implantation (7.6% vs. 6.8%,p=0.05), deep vein thrombosis/pulmonary embolism (2.8% vs.3.1%, p=0.231), paravalvular leak (0.9% vs. 1.1%, p=0.312) and cardiogenic shock (0.3% vs. 0.3%, p=0.828) as those without. The occurrence of post TAVR ischemic strokes were higher in those without a history of malignancy ( 4.8% vs. 3.6%, p<0.001). Using a multivariate logistic regression model to adjust for confounding factors such as age, gender, hypertension, diabetes, heart failure, chronic kidney disease and coronary artery disease, a history of malignancy was predictive of decreased odds of death in patients undergoing TAVR (odds ratio: 0.69, 95% confidence interval 0.53-0.90, p=0.007). Conclusions: In patients with severe symptomatic AS and a history of malignancy, TAVR appears safe with comparable in-hospital outcomes. A history of malignancy should not preclude TAVR in patients with severe symptomatic AS, however larger studies are needed to confirm this finding.


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