Comparison of Self-Expanding RDV Perceval S versus TAVI ACURATE neo/TF

Author(s):  
Victor Mauri ◽  
Stephen Gerfer ◽  
Elmar Kuhn ◽  
Matti Adam ◽  
Kaveh Eghbalzadeh ◽  
...  

Abstract Background Rapid deployment aortic valve replacement (RDAVR) and transcatheter aortic valve implantation (TAVI) have emerged as increasingly used alternatives to conventional aortic valve replacement to treat patients at higher surgical risk. Therefore, in this single-center study, we retrospectively compared clinical outcomes and hemodynamic performance of two self-expanding biological prostheses, the sutureless and rapid deployment valve (RDV) Perceval-S (PER) and the transcatheter heart valve (THV) ACURATE neo/TF (NEO) in a 1:1 propensity-score-matching (PSM) patient cohort. Methods A total of 332 consecutive patients with symptomatic aortic valve stenosis underwent either singular RDAVR with PER (119) or TAVI with NEO (213) at our institutions between 2012 and 2017. To compare the unequal patient groups, a 1:1 PSM for preoperative data and comorbidities was conducted. Afterward, 59 patient pairs were compared with regard to relevant hemodynamic parameter, relevant paravalvular leak (PVL), permanent postoperative pacemaker (PPM) implantation rate, and clinical postoperative outcomes. Results Postoperative clinical short-term outcomes presented with slightly higher rates for 30-day all-cause mortality (PER = 5.1% vs. NEO = 1.7%, p = 0.619) and major adverse cardiocerebral event in PER due to cerebrovascular events (transient ischemic attack [TIA]-PER = 3.4% vs. TIA-NEO = 1.7%, p = 0.496 and Stroke-PER = 1.7% vs. Stroke-NEO = 0.0%, p = 1). Moreover, we show comparable PPM rates (PER = 10.2% vs. NEO = 8.5%, p = 0.752). However, higher numbers of PVL (mild—PER = 0.0% vs. NEO = 55.9%, p = 0.001; moderate or higher—PER = 0.0% vs. NEO = 6.8%, p = 0.119) after TAVI with NEO were observed. Conclusion Both self-expanding bioprostheses, the RDV-PER and THV-NEO provide a feasible option in elderly and patients with elevated perioperative risk. However, the discussed PER collective showed more postoperative short-term complications with regard to 30-day all-cause mortality and cerebrovascular events, whereas the NEO showed higher rates of PVL.

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Charbel Abi Khalil ◽  
Barbara Ignatiuk ◽  
Guliz Erdem ◽  
Hiam Chemaitelly ◽  
Fabio Barilli ◽  
...  

AbstractTranscatheter aortic valve replacement (TAVR) has shown to reduce mortality compared to surgical aortic valve replacement (sAVR). However, it is unknown which procedure is associated with better post-procedural valvular function. We conducted a meta-analysis of randomized clinical trials that compared TAVR to sAVR for at least 2 years. The primary outcome was post-procedural patient-prosthesis-mismatch (PPM). Secondary outcomes were post-procedural and 2-year: effective orifice area (EOA), paravalvular gradient (PVG) and moderate/severe paravalvular leak (PVL). We identified 6 trials with a total of 7022 participants with severe aortic stenosis. TAVR was associated with 37% (95% CI [0.51–0.78) mean RR reduction of post-procedural PPM, a decrease that was not affected by the surgical risk at inclusion, neither by the transcatheter heart valve system. Postprocedural changes in gradient and EOA were also in favor of TAVR as there was a pooled mean difference decrease of 0.56 (95% CI [0.73–0.38]) in gradient and an increase of 0.47 (95% CI [0.38–0.56]) in EOA. Additionally, self-expandable valves were associated with a higher decrease in gradient than balloon ones (beta = 0.38; 95% CI [0.12–0.64]). However, TAVR was associated with a higher risk of moderate/severe PVL (pooled RR: 9.54, 95% CI [5.53–16.46]). All results were sustainable at 2 years.


Author(s):  
Stephen Gerfer ◽  
Kaveh Eghbalzadeh ◽  
Elmar Kuhn ◽  
Thorsten Wahlers ◽  
Sarah Brinkschröder ◽  
...  

Abstract Background The role of conventional surgical aortic valve replacement (SAVR) is increasingly questioned since the indication for transcatheter aortic valve implantations (TAVIs) is currently extended. While the number of patients referred to SAVR decreases, it is unclear if SAVR should be performed by junior resident surgeons in the course of a heart surgeons training. Methods Patients with isolated aortic valve replacement (AVR) were analyzed with respect to the surgeon's qualification. AVR performed by resident surgeons was compared with AVR by senior surgeons. The collective was analyzed with respect to clinical short-term outcomes comparing full sternotomy (FS) with minimally invasive surgery and ministernotomy (MS) with right anterior thoracotomy (RAT) after a 1:1 propensity score matching. Results The 30-day all-cause mortality was 2.3 and 3.4% for resident versus senior AVR groups, cerebrovascular event rates were 1.1 versus 2.6%, and no cases of significant paravalvular leak were detected. Clinical short-term outcomes between FS and minimally invasive access, as well after MS and RAT were comparable. Conclusion Our current data show feasibility and safety of conventional SAVR procedure performed by resident surgeons in the era of TAVI. Minimally invasive surgery should be trained and performed in higher volumes early in the educational process as it is a safe treatment option.


Author(s):  
Enrico Ferrari ◽  
Giuseppe Siniscalchi ◽  
Piergiorgio Tozzi ◽  
Ludwig von Segesser

Rapid deployment aortic valve replacement (RDAVR) with the use of rapid deployment valve systems represents a smart alternative to the use of standard aortic bioprosthesis for aortic valve replacement. Nevertheless, its use is still debatable in patients with pure aortic valve regurgitation or true bicuspid aortic valve because of the risk of postoperative paravalvular leak. To address this issue, an optimal annulus-valve size match seems to be the ideal surgical strategy. This article describes a new technique developed to stabilize the aortic annulus and prevent paravalvular leak after RDAVR. To confirm the feasibility, this technique was performed in six patients with severe symptomatic aortic stenosis who were scheduled to undergo aortic valve replacement at our center. All patients survived surgery and were discharged from the hospital. There were no new intracardiac conduction system disturbances observed, and a permanent pacemaker implantation was not required in any of the patients. The intraoperative and postoperative echocardiogram confirmed successful positioning of the valve, and no paravalvular leak was observed. In this preliminary experience, RDAVR through a full sternotomy or an upper hemisternotomy approach with the use of aortic annulus stabilization technique was safe, and no leak was observed. Future studies on large series of patients are necessary to confirm the safety and effectiveness of this technique in preventing paravalvular leak in patients with true bicuspid aortic valves or pure aortic regurgitation.


Author(s):  
Aristidis Lenos ◽  
Anno Diegeler

During the past decade, many surgeons have focused their interest on the development and improvement of minimally invasive techniques for aortic valve replacement. Although the minimally invasive approaches for the treatment of mitral valve disease have been standardized, the preferred route for aortic valve replacement remains a matter of debate. Access through a right minithoracotomy avoids opening the sternum; however, it requires a greater surgical ability and a learning period, even for experienced surgeons. This enhances the role of sutureless prostheses because these devices are associated with easier placement, excellent hemodynamic performance, and acceptable rates of pacemaker implantation and paravalvular leak. Herein, we report a series of 10 consecutive patients who received an EDWARDS INTUITY rapid deployment valve (Edwards Lifesciences, Irvine, CA USA) by a right minithoracotomy.


Author(s):  
Elmar Kuhn ◽  
Amila Cizmic ◽  
Kaveh Eghbalzadeh ◽  
Carolyn Weber ◽  
Parwis Baradaran Rahmanian ◽  
...  

Abstract Objective This study aimed to assess short-term outcomes of patients with failed aortic valve bioprosthesis undergoing valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) or redo surgical aortic valve replacement (rSAVR). Methods Between 2009 and 2019, 90 patients who underwent ViV-TAVR (n = 73) or rSAVR (n = 17) due to failed aortic valve bioprosthesis fulfilled the inclusion criteria. Groups were compared regarding clinical end points, including in-hospital all-cause mortality. Patients with endocarditis and in a need of combined cardiac surgery were excluded from the study. Results ViV-TAVR patients were older (78.0 ± 7.4 vs. 62.1 ± 16.2 years, p = 0.012) and showed a higher prevalence of baseline comorbidities such as atrial fibrillation, diabetes mellitus, hyperlipidemia, and arterial hypertension. In-hospital all-cause mortality was higher for rSAVR than in the ViV-TAVR group (17.6 vs. 0%, p < 0.001), whereas intensive care unit stay was more often complicated by blood transfusions for rSAVR patients without differences in cerebrovascular events. The paravalvular leak was detected in 52.1% ViV-TAVR patients compared with 0% among rSAVR patients (p < 0.001). Conclusion ViV-TAVR can be a safe and feasible alternative treatment option in patients with degenerated aortic valve bioprosthesis. The choice of treatment should include the patient's individual characteristics considering ViV-TAVR as a standard of care.


Author(s):  
Markus Schlömicher ◽  
Matthias Bechtel ◽  
Dritan Useini ◽  
Hamid Naraghi ◽  
Peter Lukas Haldenwang ◽  
...  

Abstract Objectives Rapid-deployment valves can reduce procedural times and may facilitate minimally invasive surgery. In our institution, more than 500 patients underwent rapid deployment aortic valve replacement (AVR). Methods A total of 510 patients underwent rapid deployment AVR between March 2012 and September 2017, of whom 270 patients underwent isolated AVR and 240 underwent AVR with concomitant procedures. The cumulative follow-up time was 1,444 patient-years, the median follow-up time 2.8 years, respectively Results An early all-cause mortality of 3.5% (n = 18) was seen with a cumulative survival of 91.9 ± 2.2% after 12 months. Mean cross-clamp times were 37 ± 19 minutes for isolated AVR and 93 ± 29 minutes for AVR with concomitant procedures. The rate of new pacemaker implantation was 7.8% (n = 40). No case of structural degeneration occurred in the follow-up. Three (0.6%) cases of endocarditis were registered. Conclusions Rapid deployment AVR can be performed safely with low complication rates and good hemodynamic results. Therefore, the relevance in aortic valve surgery can be stressed.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Lytfi Krasniqi ◽  
Mads P. Kronby ◽  
Lars P. S. Riber

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.


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