Minimally Invasive Implantation of the EDWARDS INTUITY Rapid Deployment Aortic Valve via a Right Minithoracotomy

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):  
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):  
Mattia Glauber ◽  
Lorenzo Di Bacco ◽  
Jose Cuenca ◽  
Roberto Di Bartolomeo ◽  
Max Baghai ◽  
...  

Objective To report the early and mid-term results of patients who underwent minimally invasive aortic valve replacement (MI-AVR) with a sutureless prosthesis from an international prospective registry. Methods Between March 2011 and September 2018, among 957 patients included in the prospective observational SURE-AVR (Sorin Universal REgistry on Aortic Valve Replacement) registry, 480 patients underwent MI-AVR with self-expandable Perceval aortic bioprosthesis (LivaNova PLC, London, UK) in 29 international institutions through either minithoracotomy ( n = 266) or ministernotomy ( n = 214). Postoperative, follow-up, and echocardiographic outcomes were analyzed for all patients. Results Patient age was 76.1 ± 7.1 years; 64.4% were female. Median EuroSCORE I was 7.9% (interquartile range [IQR], 4.8 to 10.9). Median cardiopulmonary bypass and cross-clamp times were 81 minutes (IQR 64 to 100) and 51 minutes (IQR 40 to 63). First successful implantation was achieved in 97.9% of cases. Two in-hospital deaths occurred, 1 for noncardiovascular causes and 1 following a disabling stroke. In the early (≤30 days) period, stroke rate was 1.4%. Three early explants were reported: 2 due to nonstructural valve dysfunction (NSVD) and 1 for malpositioning. One mild and 1 moderate paravalvular leak were reported. In 16 patients (3.3%) pacemaker implantation was needed. Mean follow-up was 2.4 years (maximum = 7 years). During follow-up 5 explants were reported, 3 due to endocarditis and 2 due to NSVD. Follow-up stroke rate was 2.5%. Three structural valve deteriorations not requiring reintervention were reported. Five-year survival was 91.45%. Conclusions In this large prospective international registry, MI-AVR with Perceval valve confirmed to be safe, reproducible, and effective in an intermediate-risk population, providing excellent clinical recovery both in early and mid-term follow-up.


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.


2018 ◽  
Vol 106 (3) ◽  
pp. 685-690 ◽  
Author(s):  
Matthew A. Romano ◽  
Michael Koeckert ◽  
Mubashir A. Mumtaz ◽  
Frank N. Slachman ◽  
Himanshu J. Patel ◽  
...  

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):  
Augusto D’Onofrio ◽  
Chiara Tessari ◽  
Giulia Lorenzoni ◽  
Giorgia Cibin ◽  
Gian Luca Martinelli ◽  
...  

2019 ◽  
Vol 56 (4) ◽  
pp. 793-799 ◽  
Author(s):  
Paolo Berretta ◽  
Martin Andreas ◽  
Thierry P Carrel ◽  
Marco Solinas ◽  
Kevin Teoh ◽  
...  

Abstract OBJECTIVES: The impact of sutureless and rapid deployment (SURD) valves on the clinical outcomes of patients undergoing minimally invasive aortic valve replacement (MI-AVR) has still to be defined. The aim of this study was to assess clinical characteristics and in-hospital results of patients receiving SURD-AVR through less invasive approaches in the large population of the Sutureless and Rapid Deployment International Registry (SURD-IR). METHODS: Of the 1935 patients who received primary isolated SURD-AVR between 2009 and 2018, a total of 1418 (73.3%) underwent MI interventions and were included in this analysis. SURD-AVR was performed using upper ministernotomy in 56.4% (n = 800) of cases and anterior right thoracotomy in 43.6% (n = 618). Perceval S was implanted in 1011 (71.3%) patients and Edwards Intuity or Intuity Elite in 407 (28.7%) patients. RESULTS: Overall in-hospital mortality and stroke rates were 1.7% and 2%, respectively. A definitive pacemaker implantation was reported in 9% of cases and significantly decreased over the observational period, from 20.6% to 5.6% (P = 0.002). The Perceval valve was associated with shorter operative times and was more frequently implanted in patients receiving anterior right thoracotomy incision. The Intuity valve was preferred in younger patients and revealed superior postoperative haemodynamic results. CONCLUSIONS: SURD-AVR was largely performed through less invasive approaches and can be considered as a primary indication in MI surgery. In the SURD-IR cohort, MI SURD-AVR using both Perceval and Intuity valves appeared a safe and reproducible procedure associated with promising early results.


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.


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