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Martin Andreas - One of the best experts on this subject based on the ideXlab platform.

  • conduction disturbances following surgical aortic valve replacement with a Rapid Deployment bioprosthesis
    The Journal of Thoracic and Cardiovascular Surgery, 2021
    Co-Authors: Iuliana Coti, Alfred Kocher, Christoph Schukro, Fitim Drevinja, T Haberl, Alexandra Kaider, Guenther Laufer, Martin Andreas
    Abstract:

    Abstract Background The implantation of Rapid-Deployment aortic valves may interfere with the conduction system of the heart. This study evaluates the occurrence and predictive factors of conduction anomalies in patients undergoing surgical aortic valve replacement (SAVR) with a Rapid-Deployment balloon-expandable bioprosthesis in a single-center, real-world experience. Methods Between May 2010 and April 2019, 700 consecutive patients were included in a prospective, ongoing database with a longitudinal follow-up preoperatively, at discharge, and at 3 months, 1 year, 3 years, and 5 years postoperatively. Thirty-seven patients (5.3%) had a permanent pacemaker at baseline and were excluded from further analysis, leaving 663 patients for analysis. Assessment of conduction anomalies was performed by electrocardiography (ECG) monitoring and repeated 12-lead ECG during the hospital stay and at postoperative follow-ups. Results Preoperatively, 126 patients (19.0%) presented with different conduction disturbances. New permanent pacemaker implantation (PPI) occurred in 61 patients during the first 14 days (cumulative incidence, 9.4%). The indication for PPI was complete atrioventricular block in 47 cases (77%). Preoperative conduction anomalies, such as right bundle branch block, as well as operative characteristics (concomitant procedures) were found to be independent predictors for new PPI. One-year survival was 98% in patients with new early PPI and 96% in those without new early PPI (P = .60). Conclusions The PPI rate was in the range of previous reports for Rapid-Deployment prostheses. PPI did not have a significant influence on short- to intermediate-term survival. Case selection with exclusion of patients presenting with baseline conduction disturbances may decrease the rate of new PPIs after SAVR with Rapid-Deployment balloon-expandable bioprostheses.

  • Rapid Deployment aortic valves for patients with a small aortic root a single center experience
    The Annals of Thoracic Surgery, 2020
    Co-Authors: Iuliana Coti, Alfred Kocher, Thomas Binder, T Haberl, Guenther Laufer, Shiva Shabanian, Sabine Scherzer, Martin Andreas
    Abstract:

    Background Aortic valve replacement in patients with a small aortic root is a matter of concern in terms of prosthesis-patient mismatch. We evaluated the survival and hemodynamic performance after implantation of a small Rapid-Deployment aortic valve (EDWARDS INTUITY valve system sizes 19 and 21 mm). Methods Between May 2010 and November 2018, 659 consecutive patients with severe aortic stenosis who received a Rapid-Deployment valve were included in a prospective and ongoing database. A small aortic bioprosthesis (sizes 19 mm and 21 mm) was implanted in 217 (32.9%) patients (mean age 74.9 ± 7.9 years, 85.3% women). Preoperative characteristics, operative parameters, and postoperative outcomes were assessed. Results Mean gradients at discharge and 1 year were 14.8 ± 5.6 mm Hg and 13.6 ± 4.9 mm Hg, respectively. Mean effective orifice area and the indexed effective orifice area at discharge were 1.55 ± 0.36 cm2 and 0.87 ± 0.22 cm2/m2, respectively, and prosthesis-patient mismatch occurred in 77 (35.5%) patients (25.8% moderate and 9.7% severe). Perioperative mortality was 1.8% (n = 4 of 217) and overall survival at 1 year and 5 years was 91% and 79%, respectively. The presence of any prosthesis-patient mismatch degree did not have a significant influence on overall survival (hazard ratio, 0.95; 95% confidence interval, 0.75-1.19; P = .638). At the last follow-up, mean New York Heart Association functional class was 1.5 ± 0.7 vs 2.8 ± 0.6 at baseline (P Conclusions Surgical aortic valve replacement with Rapid-Deployment valves has shown improved results concerning hemodynamic performance, with decreased rates of prosthesis-patient mismatch. We observed excellent early-term and midterm survival and a significant improvement in functional class in this subgroup of patients with a small annulus.

  • minimally invasive aortic valve replacement with sutureless and Rapid Deployment valves a report from an international registry sutureless and Rapid Deployment international registry
    European Journal of Cardio-Thoracic Surgery, 2019
    Co-Authors: Paolo Berretta, Martin Andreas, Thierry Carrel, Kevin Teoh, Emmanuel Villa, Theodor Fischlein, Marco Solinas, Giuseppe Santarpino, Thierry Folliguet, Bart Meuris
    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.

  • intermediate term outcome of 500 consecutive Rapid Deployment surgical aortic valve procedures
    European Journal of Cardio-Thoracic Surgery, 2019
    Co-Authors: Martin Andreas, Alfred Kocher, Thomas Binder, Raphael Rosenhek, Dominik Wiedemann, Iuliana Coti, Shiva Shabanian, Stephane Mahr, K Uyanikuenal, Guenther Laufer
    Abstract:

    OBJECTIVES The Edwards INTUITY Valve System is a balloon-expandable bioprosthesis, inspired from the Edwards Magna valve and transcatheter technology, with a subvalvular stent frame to enable Rapid Deployment. We report a single-centre experience of aortic valve replacement with this novel bioprosthesis. METHODS Five hundred consecutive patients, of whom 45.6% were female with a mean age of 73.5 [standard deviation (SD) 7.9 years], with severe aortic stenosis who received a Rapid Deployment aortic valve between May 2010 and July 2017 were included in a prospective and ongoing database. The median follow-up time was 12 months, and the total accumulated follow-up time was 818 patient years. Preoperative characteristics, operative parameters, survival, valve-related adverse events and valve haemodynamics were assessed. RESULTS Thirty-day mortality was 0.8% (4/500), and overall survival at 1, 3 and 5 years was 94%, 89% and 81%, respectively. A minimally invasive surgical approach was chosen in 236 patients (47%), of which 122 (24%) were operated on through an anterior right thoracotomy. Cross-clamp and cardiopulmonary bypass times for isolated aortic valve replacement were 53 (SD 17) and 89 (SD 29) min for full sternotomy as well as 75 (SD 23) and 110 (SD 31) min for minimally invasive surgery approaches (P < 0.001). Mean gradients at discharge, 1, 3 and 5 years were 13 (SD 5), 11 (SD 4), 12 (SD 5) and 11 (SD 3) mmHg, respectively. New pacemaker implantation was necessary in 8.6% of patients. A single case (0.2%) of structural degeneration was registered after 6 years. Valve explantation for non-structural dysfunction or endocarditis occurred in 9 patients (1.8%). CONCLUSIONS This Rapid Deployment aortic valve has shown excellent results concerning haemodynamic performance, durability and safety. Implantation requires specific training, and the rate of pacemaker implantation remains a matter of concern. This novel valve also facilitates minimally invasive approaches and may be beneficial in complex combined procedures.

  • sutureless and Rapid Deployment aortic valve replacement international registry surd ir early results from 3343 patients
    European Journal of Cardio-Thoracic Surgery, 2018
    Co-Authors: Marco Di Eusanio, Martin Andreas, Paolo Berretta, Thierry Carrel, Giuseppe Santarpino, Thierry Folliguet, Bart Meuris, Kevin Phan, Roberto Di Bartolomeo, Carmelo Mignosa
    Abstract:

    OBJECTIVES The Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR) was established by a consortium of 18 research centres-the International Valvular Surgery Study Group (IVSSG)-to overcome limitations of the literature and provide adequately powered evidence on sutureless and Rapid-Deployment aortic valves replacement (SURD-AVR). METHODS Data from 3343 patients undergoing SURD-AVR over a 10-year period (2007-2017) were collected in the registry. The mean age of the patients was 76.8 ± 6.7 years, with 36.4% being 80 years or older. The average logistic EuroSCORE was 11.3 ± 9.7%. RESULTS Isolated SURD-AVR was performed in 70.7% (n = 2362) of patients using full sternotomy (35.3%) or less invasive approaches (64.8%). Overall hospital mortality was 2.1%, being 1.4% in patients who had isolated SURD-AVR and 3.5% in those who had concomitant procedures (P < 0.001). When considering baseline risk profile, mortality rate was 0.8% and 1.9% in low risk (logistic EuroSCORE <10%) isolated SURD-AVR and combined SURD-AVR, respectively, and 2.2% and 3.7% in higher risk patients (logistic EuroSCORE ≥10%). Postoperative neurological complications included stroke (2.8%) and transient ischaemic attack (1.1%). New atrioventricular block requiring pacemaker occurred in 10.4% of the patients. The rate of pacemaker implantation significantly decreased over time [from 17.2% (2007-2008) to 5.4% (2016); P = 0.02]. CONCLUSIONS Our findings showed that SURD-AVR is a safe and effective alternative to conventional aortic valve replacement and is associated with excellent clinical outcomes. Further adequately powered statistical analyses from the retrospective and prospective SURD-IR will allow for the development of high-quality evidence-based clinical guidelines for SURD-AVR.

Thorsten Wahlers - One of the best experts on this subject based on the ideXlab platform.

  • outcomes of a Rapid Deployment aortic valve versus its conventional counterpart a propensity matched analysis
    Innovations, 2018
    Co-Authors: Thorsten Wahlers, Parwis B Rahmanian, Martin Andreas, Pascal Candolfi, Barbora Zemanova, Christophe Giot, Enrico Ferrari, Gunther Laufer
    Abstract:

    ObjectiveThe aim of this study was to compare outcomes after Rapid-Deployment aortic valve replacement (RDAVR) and conventional aortic valve replacement (AVR) from two studies.MethodsPatients who u...

  • Rapid Deployment aortic valve replacement excellent results and increased effective orifice areas
    The Annals of Thoracic Surgery, 2018
    Co-Authors: Parwis B Rahmanian, Sureyya Kaya, Kaveh Eghbalzadeh, Hruy Menghesha, Navid Madershahian, Thorsten Wahlers
    Abstract:

    Background The aim of this study was to evaluate the effects of Rapid Deployment aortic valve replacement (RDAVR) on surgical outcome and hemodynamics compared with standard aortic valve replacement (AVR). Methods One hundred sixty-three RDAVR patients (isolated, n = 67; combined with coronary artery bypass graft surgery [CABG], n = 96) were compared with a propensity matched control group (n = 163). Primary endpoints included association between valve type and procedure times, prosthesis size, transvalvular gradient, and indexed effective orifice area. Secondary endpoints were postoperative mortality and morbidity. Results Aortic cross-clamp and cardiopulmonary bypass times in the RDAVR group were 55 ± 23 and 88 ± 38 minutes, respectively, compared with 77 ± 22 and 105 ± 38 minutes in the control group ( p p p  = 0.002). Mean transvalvular gradients and indexed effective orifice areas were 9 ± 5 mm Hg and 1.11 ± 0.11, respectively, in the RDVAR group compared with 13 ± 5 mm Hg and 0.95 ± 0.08 in the control group ( p p  = 1.000). Postoperative pacemaker rates were 3.5% (n = 3 of 67) for isolated RDAVR versus 3.0% (n = 2 of 67; p  = 0.649) for isolated AVR and 12.5% (n = 12 of 96) for RDAVR/CABG versus 4.2% (n = 4 of 96; p  = 0.032) for AVR/CABG. Conclusions RDAVR facilitates reduced aortic cross-clamp and cardiopulmonary bypass times compared with standard AVR, particularly in patients undergoing concomitant procedures, allowing the use of larger prostheses and resulting in lower transvalvular gradients and higher indexed effective orifice area compared with standard AVR. Therefore, RDAVR may help to overcome patient-prosthesis mismatch in some patients.

  • direct comparison of the edwards intuity elite and sorin perceval s Rapid Deployment aortic valves
    The Annals of Thoracic Surgery, 2018
    Co-Authors: Oliver J Liakopoulos, Parwis B Rahmanian, Kaveh Eghbalzadeh, Stephen Gerfer, Simone Weider, Mohamed Zeriouh, Anton Sabashnikov, Yeonghoon Choi, Jens Wippermann, Thorsten Wahlers
    Abstract:

    Background Rapid Deployment aortic valve replacement (RDAVR) has emerged as an attractive alternative to conventional aortic valve replacement. This single-center study directly compared two commercially available Rapid Deployment valves with regard to clinical outcomes, valve-related complications, and hemodynamic performance. Methods A total of consecutive 156 patients underwent RDAVR with the Intuity Elite (Edwards Lifesciences, Irvine, CA [Intuity group, n = 117] or the Perceval S (Sorin Group Italia Srl, Saluggia, Italy [Perceval group, n = 39]) between September 2012 and March 2016 at our institution. Perioperative data, including 30-day all-cause mortality, and echocardiographic measurements were assessed and retrospectively analyzed from our institutional database. Results Preoperative variables, including mean age (77 ± 5 years), European System for Cardiac Operative Risk Evaluation (6.8 ± 2.1), and body mass index (27 ± 5 kg/m 2 ), did not differ between groups. More male patients (60% versus 15%) with a higher body surface area (1.9 ± 0.2 m 2 versus 1.7 ± 0.2 m 2 ) and body weight (78 ± 13 kg versus 71 ± 15 kg) were in the Intuity group compared with the Perceval group, respectively ( p Conclusions Performing RDAVR with the Intuity and Perceval Rapid Deployment valves provides comparable good clinical outcomes and valve hemodynamics, with low valve-related complication rates. The rate of pacemaker implantation was comparable for both Rapid Deployment valves, ranging from 8% to 13%.

  • early outcomes after isolated aortic valve replacement with Rapid Deployment aortic valve
    The Journal of Thoracic and Cardiovascular Surgery, 2016
    Co-Authors: Thorsten Wahlers, Michael A Borger, Martin Misfeld, Friedrich W Mohr, Malakh Shrestha, Alfred Kocher, Thomas Walther, Matthias Roth, A Haverich, Joerg Kempfert
    Abstract:

    Abstract Objective Minimal access aortic valve replacement is associated with favorable clinical outcomes; however, several meta-analyses have reported significantly longer crossclamp times compared with a full sternotomy. We examined the procedural and early safety outcomes after isolated Rapid Deployment aortic valve replacement by surgical approach in patients enrolled in the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve trial. Methods The Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve trial was a prospective, multicenter, single-arm study, with successful implants in 287 patients with aortic valve stenosis who underwent Rapid Deployment aortic valve replacement using the EDWARDS INTUITY Valve System (Edwards Lifesciences, Irvine, Calif). Patients were evaluated perioperatively for procedural times and technical success rates; at discharge, for hospital length of stay; and, at 30 days, for early adverse events. Results A total of 158 patients underwent isolated aortic valve replacement through a full sternotomy (n = 71), upper hemisternotomy (n = 77), or right anterior thoracotomy (n = 10). Mean age at baseline was 75.7 ± 7.2 years. Mean aortic crossclamp and cardiopulmonary bypass times (minutes) were similar for full sternotomy and upper hemisternotomy, 43.5 ± 32.5/71.6 ± 41.8 and 43.1 ± 13.1/69.6 ± 19.1, respectively, and significantly longer for right anterior thoracotomy, 88.3 ± 18.6/122.2 ± 22.1 ( P Conclusions These data suggest that isolated Rapid Deployment aortic valve replacement through an upper hemisternotomy can lead to shorter crossclamp times than has been reported historically in the literature. This may facilitate minimal access aortic valve replacement by eliminating the issue of prolonged crossclamp times. Further, low in-hospital mortality and new permanent pacemaker implant rates were observed regardless of surgical approach.

  • three year hemodynamic performance left ventricular mass regression and prosthetic patient mismatch after Rapid Deployment aortic valve replacement in 287 patients
    The Journal of Thoracic and Cardiovascular Surgery, 2014
    Co-Authors: Axel Haverich, Thorsten Wahlers, Michael A Borger, Martin Misfeld, Friedrich W Mohr, Malakh Shrestha, Alfred Kocher, Thomas Walther, Matthias Roth, Joerg Kempfert
    Abstract:

    Objective Superior aortic valve hemodynamic performance can accelerate left ventricular mass regression and enhance survival and functional status after surgical aortic valve replacement. This can be achieved by Rapid Deployment aortic valve replacement using a subannular balloon-expandable stent frame, which functionally widens and reshapes the left ventricular outflow tract, to ensure a larger effective orifice area compared with conventional surgical valves. We report the intermediate-term follow-up data from a large series of patients enrolled in the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial. Methods In a prospective, multicenter (6 European hospitals), single-arm study, 287 patients with aortic stenosis underwent Rapid Deployment aortic valve replacement using a stented trileaflet bovine pericardial bioprosthesis. Core laboratory echocardiography was performed at baseline, discharge, and 3 months, 1 year, and 3 years after Rapid Deployment aortic valve replacement. Results The mean patient age was 75.7 ± 6.7 years (range, 45-93; 49.1% women). The mean aortic valve gradient significantly decreased from discharge to 3 years of follow-up. The mean effective orifice area remained stable from discharge to 3 years. At 1 year, the left ventricular mass index had decreased by 14% (P  Conclusions In a large series of elderly patients with symptomatic severe aortic stenosis, Rapid Deployment aortic valve replacement using a subannular balloon-expandable stent frame demonstrated excellent hemodynamic performance and significant left ventricular mass regression. With continued follow-up, future studies will establish whether these favorable structural changes correlate with improvement in long-term survival and functional status.

Paolo Berretta - One of the best experts on this subject based on the ideXlab platform.

  • current trends of sutureless and Rapid Deployment valves an 11 year experience from the sutureless and Rapid Deployment international registry
    European Journal of Cardio-Thoracic Surgery, 2020
    Co-Authors: Paolo Berretta, Martin Misfeld, Sebastian Arzt, Antonio Fiore, Thierry Carrel, Kevin Teoh, Emmanuel Villa, Alberto Albertini, Theodor Fischlein, Gian Luca Martinelli
    Abstract:

    Objectives Current evidence on sutureless and Rapid Deployment aortic valve replacement (SURD-AVR) is limited and does not allow for the assessment of the clinical impact and the evolution of procedural and clinical outcomes of this new valve technology. The Sutureless and Rapid Deployment International Registry (SURD-IR) represents a unique opportunity to evaluate the current trends and outcomes of SURD-AVR interventions. Methods Data from 3682 patients enrolled between 2007 and 2018 were analysed. Patients were divided according to the date of surgery into 6 equal groups and by the type of intervention: isolated SURD-AVR (n = 2472) and combined SURD-AVR (n = 1086). Results Across the 11-year study period, significant changes occurred in patient characteristics including a decrease in age and in estimated surgical risk. Less invasive approaches for isolated SURD-AVR increased considerably from 49.4% to 85.5%. The overall in-hospital mortality rate was 1.6% and 3.9% in isolated and combined procedures, respectively, with no change over time. The rate of perioperative stroke decreased significantly (from 4% to 0.5%), as did the rates of postoperative pacemaker implantation (from 12.8% to 5.9%) and aortic regurgitation (from 17.8% to 2.7%). Conclusions The present study provides a comprehensive analysis of the current trends and results of SURD-AVR interventions. The most notable changes over time were the increasing implantation of SURD valves in a younger population, with more frequent utilization of less invasive techniques. SURD-AVR demonstrated remarkable improvements in clinical outcomes with a significant reduction in the rates of stroke, pacemaker implantation and postoperative aortic regurgitation.

  • minimally invasive aortic valve replacement with sutureless and Rapid Deployment valves a report from an international registry sutureless and Rapid Deployment international registry
    European Journal of Cardio-Thoracic Surgery, 2019
    Co-Authors: Paolo Berretta, Martin Andreas, Thierry Carrel, Kevin Teoh, Emmanuel Villa, Theodor Fischlein, Marco Solinas, Giuseppe Santarpino, Thierry Folliguet, Bart Meuris
    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.

  • operative outcome of patients at low intermediate high and very high surgical risk undergoing isolated aortic valve replacement with sutureless and Rapid Deployment prostheses results of the surd ir registry
    European Journal of Cardio-Thoracic Surgery, 2019
    Co-Authors: Giuseppe Santarpino, Martin Misfeld, Paolo Berretta, Thierry Carrel, Kevin Teoh, Theodor Fischlein, Mattia Glauber, Carlo Savini, Utz Kappert, Emmanuel Villa
    Abstract:

    Objectives The ideal strategy for the treatment of severe aortic valve stenosis in patients of varying risk categories has become a debated topic in the last years: should the transcatheter or surgical approach be adopted? The aim of this study was to evaluate the outcomes of low-, intermediate-, high- and very high-risk patients undergoing sutureless, Rapid Deployment aortic valve replacement. Methods From 2007 to 2017, data on a total of 3651 patients were collected from the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR). Of these, 2057 patients who underwent primary isolated aortic valve replacement were considered for this analysis and classified as being at low (EuroSCORE 20; n = 156) preoperative risk. Results Overall, a less invasive approach was used in 74.1% of patients and represented the most frequent (>50%) approach in all risk categories. The Perceval prosthesis was used more frequently than other devices, especially in patients at high and very high risk. Hospital mortality was 1.6%, 0.8%, 1.9% and 2.7% in low-, intermediate-, high- and very high-risk patients, respectively, with no significant differences among subgroups. Similarly, postoperative complication rates were similar across the different risk categories. Conclusions Surgical aortic valve replacement using sutureless, Rapid Deployment biological valve prostheses is associated with excellent results and represents a safe and effective treatment option for patients with severe aortic valve stenosis. This seems to be particularly true in patients with a higher risk profile.

  • sutureless and Rapid Deployment aortic valve replacement international registry surd ir early results from 3343 patients
    European Journal of Cardio-Thoracic Surgery, 2018
    Co-Authors: Marco Di Eusanio, Martin Andreas, Paolo Berretta, Thierry Carrel, Giuseppe Santarpino, Thierry Folliguet, Bart Meuris, Kevin Phan, Roberto Di Bartolomeo, Carmelo Mignosa
    Abstract:

    OBJECTIVES The Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR) was established by a consortium of 18 research centres-the International Valvular Surgery Study Group (IVSSG)-to overcome limitations of the literature and provide adequately powered evidence on sutureless and Rapid-Deployment aortic valves replacement (SURD-AVR). METHODS Data from 3343 patients undergoing SURD-AVR over a 10-year period (2007-2017) were collected in the registry. The mean age of the patients was 76.8 ± 6.7 years, with 36.4% being 80 years or older. The average logistic EuroSCORE was 11.3 ± 9.7%. RESULTS Isolated SURD-AVR was performed in 70.7% (n = 2362) of patients using full sternotomy (35.3%) or less invasive approaches (64.8%). Overall hospital mortality was 2.1%, being 1.4% in patients who had isolated SURD-AVR and 3.5% in those who had concomitant procedures (P < 0.001). When considering baseline risk profile, mortality rate was 0.8% and 1.9% in low risk (logistic EuroSCORE <10%) isolated SURD-AVR and combined SURD-AVR, respectively, and 2.2% and 3.7% in higher risk patients (logistic EuroSCORE ≥10%). Postoperative neurological complications included stroke (2.8%) and transient ischaemic attack (1.1%). New atrioventricular block requiring pacemaker occurred in 10.4% of the patients. The rate of pacemaker implantation significantly decreased over time [from 17.2% (2007-2008) to 5.4% (2016); P = 0.02]. CONCLUSIONS Our findings showed that SURD-AVR is a safe and effective alternative to conventional aortic valve replacement and is associated with excellent clinical outcomes. Further adequately powered statistical analyses from the retrospective and prospective SURD-IR will allow for the development of high-quality evidence-based clinical guidelines for SURD-AVR.

Giuseppe Santarpino - One of the best experts on this subject based on the ideXlab platform.

  • peri procedural thrombocytopenia after aortic bioprosthesis implant a systematic review and meta analysis comparison among conventional stentless Rapid Deployment and transcatheter valves
    International Journal of Cardiology, 2019
    Co-Authors: Giuseppe Santarpino, Federica Jiritano, Giuseppe Filiberto Serraino, Hugo Ten Cate, Matteo Matteucci, Dario Fina, Pasquale Mastroroberto
    Abstract:

    Abstract Background Thrombocytopenia has been shown to occur soon after surgical biological aortic valve replacement (AVR), and recently reported also after transcatheter valve implantation (TAVI). The mechanism underlying this phenomenon is still unknown, and its clinical impact on the peri-operative outcome has been poorly investigated. Methods A systematic review and a meta-analysis of all available studies reporting data about peri-procedural thrombocytopenia on isolated bio-AVR, comparing Rapid-Deployment (RDV), stentless (stentless-AVR), and TAVI vs. stented (stented-AVR) valves, have been performed. Results Fifteen trials (2.163 patients) were included in the meta-analysis. Perioperative platelet reduction ranged from 35% to 55% in stented-AVR, from 60% to 77% in stentless-AVR, from 53% to 60% in RDV, and from to 21% to 72% in TAVI (apparently, balloon-expandable valves more frequently associated to thrombocytopenia). Stented-AVR required more red blood cells transfusion than stentless-AVR (P  Conclusions Thrombocytopenia-related major adverse events were mainly reported in TAVI patients, whereas clinically meaningless in surgical patients. Transient peri-procedural thrombocytopenia is common after bio-AVR, regardless of prosthesis’s type or implant modality. It should receive appropriate monitoring and focused investigations.

  • minimally invasive aortic valve replacement with sutureless and Rapid Deployment valves a report from an international registry sutureless and Rapid Deployment international registry
    European Journal of Cardio-Thoracic Surgery, 2019
    Co-Authors: Paolo Berretta, Martin Andreas, Thierry Carrel, Kevin Teoh, Emmanuel Villa, Theodor Fischlein, Marco Solinas, Giuseppe Santarpino, Thierry Folliguet, Bart Meuris
    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.

  • operative outcome of patients at low intermediate high and very high surgical risk undergoing isolated aortic valve replacement with sutureless and Rapid Deployment prostheses results of the surd ir registry
    European Journal of Cardio-Thoracic Surgery, 2019
    Co-Authors: Giuseppe Santarpino, Martin Misfeld, Paolo Berretta, Thierry Carrel, Kevin Teoh, Theodor Fischlein, Mattia Glauber, Carlo Savini, Utz Kappert, Emmanuel Villa
    Abstract:

    Objectives The ideal strategy for the treatment of severe aortic valve stenosis in patients of varying risk categories has become a debated topic in the last years: should the transcatheter or surgical approach be adopted? The aim of this study was to evaluate the outcomes of low-, intermediate-, high- and very high-risk patients undergoing sutureless, Rapid Deployment aortic valve replacement. Methods From 2007 to 2017, data on a total of 3651 patients were collected from the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR). Of these, 2057 patients who underwent primary isolated aortic valve replacement were considered for this analysis and classified as being at low (EuroSCORE 20; n = 156) preoperative risk. Results Overall, a less invasive approach was used in 74.1% of patients and represented the most frequent (>50%) approach in all risk categories. The Perceval prosthesis was used more frequently than other devices, especially in patients at high and very high risk. Hospital mortality was 1.6%, 0.8%, 1.9% and 2.7% in low-, intermediate-, high- and very high-risk patients, respectively, with no significant differences among subgroups. Similarly, postoperative complication rates were similar across the different risk categories. Conclusions Surgical aortic valve replacement using sutureless, Rapid Deployment biological valve prostheses is associated with excellent results and represents a safe and effective treatment option for patients with severe aortic valve stenosis. This seems to be particularly true in patients with a higher risk profile.

  • sutureless and Rapid Deployment aortic valve replacement international registry surd ir early results from 3343 patients
    European Journal of Cardio-Thoracic Surgery, 2018
    Co-Authors: Marco Di Eusanio, Martin Andreas, Paolo Berretta, Thierry Carrel, Giuseppe Santarpino, Thierry Folliguet, Bart Meuris, Kevin Phan, Roberto Di Bartolomeo, Carmelo Mignosa
    Abstract:

    OBJECTIVES The Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR) was established by a consortium of 18 research centres-the International Valvular Surgery Study Group (IVSSG)-to overcome limitations of the literature and provide adequately powered evidence on sutureless and Rapid-Deployment aortic valves replacement (SURD-AVR). METHODS Data from 3343 patients undergoing SURD-AVR over a 10-year period (2007-2017) were collected in the registry. The mean age of the patients was 76.8 ± 6.7 years, with 36.4% being 80 years or older. The average logistic EuroSCORE was 11.3 ± 9.7%. RESULTS Isolated SURD-AVR was performed in 70.7% (n = 2362) of patients using full sternotomy (35.3%) or less invasive approaches (64.8%). Overall hospital mortality was 2.1%, being 1.4% in patients who had isolated SURD-AVR and 3.5% in those who had concomitant procedures (P < 0.001). When considering baseline risk profile, mortality rate was 0.8% and 1.9% in low risk (logistic EuroSCORE <10%) isolated SURD-AVR and combined SURD-AVR, respectively, and 2.2% and 3.7% in higher risk patients (logistic EuroSCORE ≥10%). Postoperative neurological complications included stroke (2.8%) and transient ischaemic attack (1.1%). New atrioventricular block requiring pacemaker occurred in 10.4% of the patients. The rate of pacemaker implantation significantly decreased over time [from 17.2% (2007-2008) to 5.4% (2016); P = 0.02]. CONCLUSIONS Our findings showed that SURD-AVR is a safe and effective alternative to conventional aortic valve replacement and is associated with excellent clinical outcomes. Further adequately powered statistical analyses from the retrospective and prospective SURD-IR will allow for the development of high-quality evidence-based clinical guidelines for SURD-AVR.

Thierry Carrel - One of the best experts on this subject based on the ideXlab platform.

  • current trends of sutureless and Rapid Deployment valves an 11 year experience from the sutureless and Rapid Deployment international registry
    European Journal of Cardio-Thoracic Surgery, 2020
    Co-Authors: Paolo Berretta, Martin Misfeld, Sebastian Arzt, Antonio Fiore, Thierry Carrel, Kevin Teoh, Emmanuel Villa, Alberto Albertini, Theodor Fischlein, Gian Luca Martinelli
    Abstract:

    Objectives Current evidence on sutureless and Rapid Deployment aortic valve replacement (SURD-AVR) is limited and does not allow for the assessment of the clinical impact and the evolution of procedural and clinical outcomes of this new valve technology. The Sutureless and Rapid Deployment International Registry (SURD-IR) represents a unique opportunity to evaluate the current trends and outcomes of SURD-AVR interventions. Methods Data from 3682 patients enrolled between 2007 and 2018 were analysed. Patients were divided according to the date of surgery into 6 equal groups and by the type of intervention: isolated SURD-AVR (n = 2472) and combined SURD-AVR (n = 1086). Results Across the 11-year study period, significant changes occurred in patient characteristics including a decrease in age and in estimated surgical risk. Less invasive approaches for isolated SURD-AVR increased considerably from 49.4% to 85.5%. The overall in-hospital mortality rate was 1.6% and 3.9% in isolated and combined procedures, respectively, with no change over time. The rate of perioperative stroke decreased significantly (from 4% to 0.5%), as did the rates of postoperative pacemaker implantation (from 12.8% to 5.9%) and aortic regurgitation (from 17.8% to 2.7%). Conclusions The present study provides a comprehensive analysis of the current trends and results of SURD-AVR interventions. The most notable changes over time were the increasing implantation of SURD valves in a younger population, with more frequent utilization of less invasive techniques. SURD-AVR demonstrated remarkable improvements in clinical outcomes with a significant reduction in the rates of stroke, pacemaker implantation and postoperative aortic regurgitation.

  • minimally invasive aortic valve replacement with sutureless and Rapid Deployment valves a report from an international registry sutureless and Rapid Deployment international registry
    European Journal of Cardio-Thoracic Surgery, 2019
    Co-Authors: Paolo Berretta, Martin Andreas, Thierry Carrel, Kevin Teoh, Emmanuel Villa, Theodor Fischlein, Marco Solinas, Giuseppe Santarpino, Thierry Folliguet, Bart Meuris
    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.

  • operative outcome of patients at low intermediate high and very high surgical risk undergoing isolated aortic valve replacement with sutureless and Rapid Deployment prostheses results of the surd ir registry
    European Journal of Cardio-Thoracic Surgery, 2019
    Co-Authors: Giuseppe Santarpino, Martin Misfeld, Paolo Berretta, Thierry Carrel, Kevin Teoh, Theodor Fischlein, Mattia Glauber, Carlo Savini, Utz Kappert, Emmanuel Villa
    Abstract:

    Objectives The ideal strategy for the treatment of severe aortic valve stenosis in patients of varying risk categories has become a debated topic in the last years: should the transcatheter or surgical approach be adopted? The aim of this study was to evaluate the outcomes of low-, intermediate-, high- and very high-risk patients undergoing sutureless, Rapid Deployment aortic valve replacement. Methods From 2007 to 2017, data on a total of 3651 patients were collected from the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR). Of these, 2057 patients who underwent primary isolated aortic valve replacement were considered for this analysis and classified as being at low (EuroSCORE 20; n = 156) preoperative risk. Results Overall, a less invasive approach was used in 74.1% of patients and represented the most frequent (>50%) approach in all risk categories. The Perceval prosthesis was used more frequently than other devices, especially in patients at high and very high risk. Hospital mortality was 1.6%, 0.8%, 1.9% and 2.7% in low-, intermediate-, high- and very high-risk patients, respectively, with no significant differences among subgroups. Similarly, postoperative complication rates were similar across the different risk categories. Conclusions Surgical aortic valve replacement using sutureless, Rapid Deployment biological valve prostheses is associated with excellent results and represents a safe and effective treatment option for patients with severe aortic valve stenosis. This seems to be particularly true in patients with a higher risk profile.

  • sutureless and Rapid Deployment aortic valve replacement international registry surd ir early results from 3343 patients
    European Journal of Cardio-Thoracic Surgery, 2018
    Co-Authors: Marco Di Eusanio, Martin Andreas, Paolo Berretta, Thierry Carrel, Giuseppe Santarpino, Thierry Folliguet, Bart Meuris, Kevin Phan, Roberto Di Bartolomeo, Carmelo Mignosa
    Abstract:

    OBJECTIVES The Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR) was established by a consortium of 18 research centres-the International Valvular Surgery Study Group (IVSSG)-to overcome limitations of the literature and provide adequately powered evidence on sutureless and Rapid-Deployment aortic valves replacement (SURD-AVR). METHODS Data from 3343 patients undergoing SURD-AVR over a 10-year period (2007-2017) were collected in the registry. The mean age of the patients was 76.8 ± 6.7 years, with 36.4% being 80 years or older. The average logistic EuroSCORE was 11.3 ± 9.7%. RESULTS Isolated SURD-AVR was performed in 70.7% (n = 2362) of patients using full sternotomy (35.3%) or less invasive approaches (64.8%). Overall hospital mortality was 2.1%, being 1.4% in patients who had isolated SURD-AVR and 3.5% in those who had concomitant procedures (P < 0.001). When considering baseline risk profile, mortality rate was 0.8% and 1.9% in low risk (logistic EuroSCORE <10%) isolated SURD-AVR and combined SURD-AVR, respectively, and 2.2% and 3.7% in higher risk patients (logistic EuroSCORE ≥10%). Postoperative neurological complications included stroke (2.8%) and transient ischaemic attack (1.1%). New atrioventricular block requiring pacemaker occurred in 10.4% of the patients. The rate of pacemaker implantation significantly decreased over time [from 17.2% (2007-2008) to 5.4% (2016); P = 0.02]. CONCLUSIONS Our findings showed that SURD-AVR is a safe and effective alternative to conventional aortic valve replacement and is associated with excellent clinical outcomes. Further adequately powered statistical analyses from the retrospective and prospective SURD-IR will allow for the development of high-quality evidence-based clinical guidelines for SURD-AVR.