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The Northern New England rapid deployment Valve Experience: Survival and Procedural Outcomes From 2015 to 2021

INNOVATIONS-TECHNOLOGY AND TECHNIQUES IN CARDIOTHORACIC AND VASCULAR SURGERY 2024年第1期19卷 54-63页

作者： Fallon, John M. Malenka, David J. Ross, Cathy S. Ramkumar, Niveditta Seshasayee, Shravanthi M. Westbrook, Benjamin M. Hirashima, Fuyuki Quinn, Reed D. Maine Med Ctr Dept Cardiac Surg Portland ME USA Dartmouth Hitchcock Med Ctr Dept Cardiol Lebanon NH USA Catholic Med Ctr Manchester NH USA Univ Vermont Med Ctr Burlington VT USA

Objective: The optimal approach and choice of initial aortic valve replacement (AVR) is evolving in the growing era of transcatheter AVR. Further survival and hemodynamic data are needed to compare the emerging role of rapid deployment (rdAVR) versus stented (sAVR) valve options for ***: The Northern New England Cardiovascular Database was queried for patients undergoing either isolated AVR or AVR + coronary artery bypass grafting (CABG) with rdAVR or sAVR aortic valves between 2015 and 2021. Exclusion criteria included endocarditis, mechanical valves, dissection, emergency case status, and prior sternotomy. This resulted in a cohort including 1,616 sAVR and 538 rdAVR cases. After propensity weighting, procedural characteristics, hemodynamic variables, and survival outcomes were examined. Results: The breakdown of the overall cohort (2,154) included 1,164 isolated AVR (222 rdAVR, 942 sAVR) and 990 AVR + CABG (316 rdAVR, 674 sAVR). After inverse propensity weighting, cohorts were well matched, notable only for more patients <50 years in the sAVR group (4.0% vs 1.9%, standardized mean difference [SMD] = -0.12). Cross-clamp (89 vs 64 min, SMD = -0.71) and cardiopulmonary bypass (121 vs 91 min, SMD = -0.68) times were considerably longer for sAVR versus rdAVR. Immediate postreplacement aortic gradient decreased with larger valve size but did not differ significantly between comparable sAVR and rdAVR valve sizes or overall (6.5 vs 6.7 mm Hg, SMD = 0.09). Implanted rdAVR tended to be larger with 51% either size L or XL versus 37.4% of sAVR >= 25 mm. Despite a temporal decrease in pacemaker rate within the rdAVR cohort, the overall pacemaker frequency was less in sAVR versus rdAVR (4.4% vs 7.4%, SMD = 0.12), and significantly higher rates were seen in size L (10.3% vs 3.7%, P < 0.002) and XL (15% vs 5.6%, P < 0.004) rdAVR versus sAVR. No significant difference in major adverse cardiac events (4.6% vs 4.6%, SMD = 0.01), 30-day survival (1.5% vs 2.6%, SMD = 0.08), or

关键词： aortic stenosis sutureless bioprothesis rapid deployment Perceval valve Intuity valve

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Risk Factors for Postoperative Pacemaker Implantation After rapid deployment Aortic Valve Replacement: Results from the RADAR Registry

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ADVANCES IN THERAPY 2021年第4期38卷 1832-1842页

作者： Gonzalez-Barbeito, Miguel Arribas, Jose Maria Vazquez, Alejandro Carnero, Manuel Sarralde, Jose Aurelio Cal-Purrinos, Natalia Canovas, Sergio J. Maroto, Luis Gutierrez, Francisco Hornero, Fernando Bautista-Hernandez, Victor Complexo Hosp Univ A Coruna Dept Cardiovasc Surg La Coruna Spain Hosp Virgen Arrixaca Dept Cardiovasc Surg Murcia Spain Inst Murciano Invest Biosanitaria Virgen Arrixaca Murcia Spain Hosp La Fe Dept Cardiovasc Surg Valencia Spain Hosp Clin San Carlos Dept Cardiovasc Surg Madrid Spain Hosp Marques Valdecilla Dept Cardiovasc Surg Santander Spain Prof Novoa Santos Fdn La Coruna Spain Hosp Clin Valencia Valencia Spain Inst Invest Biomed A Coruna INIBIC Congenital & Struct Heart Dis La Coruna Spain

Introduction rapid deployment aortic valve replacement has been recently introduced in clinical practice. Different studies have reported a significant reduction in surgical times with excellent hemodynamic profiles and short-term results. However, an increase in permanent pacemaker requirements compared with conventional aortic valve replacement has been described. Nevertheless, risk factors for postoperative pacemaker implantation are not well known. The aim of this study is to report our early outcomes with rapid deployment aortic valve replacement within the RADAR Registry, especially focusing on risk factors for postoperative pacemaker implantation. Methods Between April 2012 and January 2016, 164 patients undergoing isolated or combined aortic valve replacement with Edwards INTUITY Elite (Edwards Lifesciences, Irvine, CA, USA) were included in the RADAR Registry. Pre-, intra- and postoperative clinical data results and complications were recorded, especially focusing on risk factors for the development of postoperative complete or high-grade AV block requiring pacemaker implantation. Patients were followed up for up to 1 year with evaluation of clinical and echocardiographic outcomes. Results A total of 164 consecutive patients were included in this study, where 128 patients (78.05%) had an isolated aortic valve replacement (group 1) and 36 (21.95%) a concomitant procedure (group 2). The surgical approach was ministernotomy in 61 patients (37.20%) and median sternotomy in 100 patients (60.98%). Complications with valve implantation were observed in three patients. Postoperative complete or high-degree AV block requiring a permanent pacemaker implantation developed in ten patients (6.9%). Seven patients died in-hospital (4.27%). No significant differences between groups were found in terms of stroke, postoperative infection, mortality, atrial fibrillation and postoperative atrioventricular block. Seven patients presented acute renal impairment (5.51%) in group

关键词： Aortic valve Aortic valve replacement Bioprosthesis rapid deployment

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rapid deployment aortic valve replacement through anterior right thoracotomy: Clinical outcomes and haemodynamic performance

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JOURNAL OF CARDIAC SURGERY 2020年第7期35卷 1420-1424页

作者： Sabry, Haytham Baltabaeva, Aigul Gkikas, Andreas Valencia, Oswaldo Sarri, Georgia Mirsadraee, Saeed Mittal, Tarun Bahrami, Toufan Royal Brompton & Harefield Trust Dept Cardiothorac Surg Harefield Hosp London England Royal Brompton & Harefield Trust Dept Cardiol Harefield Hosp London England St Georges Univ Hosp Dept Cardiothorac Surg London England Royal Brompton & Harefield Trust Dept Radiol Harefield Hosp London England

Background The ease of implantation of the rapid deployment (RD) and sutureless valves has contributed to the adoption of anterior right thoracotomy (ART) approach for aortic valve replacement (AVR). Aim of the study This study evaluates the safety and haemodynamic performance of minimally invasive AVR through ART using the RD valves. Methods This is a retrospective, single-center review of a total of 50 consecutive patients who received RD-AVR through ART. Results The median age of patients was 75 years (interquartile range [IQR]: 69-80), and median Euroscore II was 5.1 (IQR: 2.4-7.5). ART RD-AVR was successfully performed in all cases with no conversion to sternotomy, paravalvular leaks or need for valve explantation. The mean size of the implanted valve was 23.2 +/- 2.3 mm. In-hospital mortality was 2%. The mean and maximum pressure gradients across the aortic prosthesis were 10 mm Hg (IQR: 9-12) and 19 mm Hg (IQR: 16-23). Conclusions rapid deployment aortic valve replacement can be safely performed through anterior right thoracotomy wit excellent haemodynamic performance and low postoperative complications rate.

关键词： anterior right thoracotomy aortic valve replacement minimally invasive rapid deployment

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Slow Progress on UN rapid deployment: The Pitfalls of Policy Paradigms in International Organizations

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INTERNATIONAL STUDIES REVIEW 2021年第3期23卷 455-483页

作者： Coleman, Katharina P. Lundgren, Magnus Oksamytna, Kseniya Univ British Columbia Vancouver BC Canada Stockholm Univ Stockholm Sweden Kings Coll London London England

When reform negotiations in international organizations (IOs) produce limited substantive progress, the diagnosis is typically a lack of political will. We identify a different dynamic: in protracted negotiations, international policy paradigms can emerge that enshrine a politically realistic but incomplete issue definition and thereby focus the debate on a subset of policy instruments that do not fully address the underlying problem. We draw on the multilateral negotiations literature to show how policy paradigms-which are widely explored in Comparative Politics, but largely neglected in International Relations-can emerge even in heterogenous IOs, where deep cognitive cohesion is unlikely. The risk of negotiation failure incentivizes negotiators to adopt and maintain "achievable" issue and goal definitions, which over time are accepted as axiomatic by diplomats, IO officials, and policy experts. The resulting international policy paradigms help avoid institutional paralysis, but can also impede more ambitious reforms. To establish the empirical plausibility of this argument, we highlight the contemporary international policy paradigm of rapid deployment in UN peacekeeping, which focuses more on establishing an initial brigade-sized presence than on rapid deployment of the full peacekeeping force. Drawing on primary documents and interviews, we identify the roots of this First Brigade policy paradigm in reactions to the UN's failure to respond to the 1994 Rwandan genocide and trace its consolidation during UN reform negotiations in the 2000s and early 2010s. We also demonstrate that an alternative explanation of the paradigm as reflecting operational lessons-learned does not hold: a brigade-sized initial presence is rarely sufficient for mandate implementation, does not reliably speed up full deployment, and creates risks for peacekeepers. By highlighting the existence and impact of international policy paradigms, our study adds to scholarship on the role of ideas i

关键词： Policy paradigm rapid deployment peacekeeping

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Short-term outcome of the intuity rapid deployment prosthesis: a systematic review and meta-analysis

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INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 2020年第4期31卷 427-436页

作者： Klop, Idserd David Gerard Kougioumtzoglou, Athina M. Kloppenburg, Geoffrey T. L. van Putte, Bart P. Sprangers, Mirjam A. G. Klein, Patrick Nieuwkerk, Pythia T. St Antonius Hosp Dept Cardiothorac Surg Koekoekslaan 1 NL-3435 CM Nieuwegein Netherlands Univ Amsterdam Acad Med Ctr Dept Cardiothorac Surg Med Ctr Amsterdam Netherlands Univ Amsterdam Amsterdam Publ Hlth Res Inst Acad Med Ctr Dept PsycholAmsterdam Univ Med Ctr Amsterdam Netherlands

OBJECTIVES: Limited access aortic valve replacement is an alternative approach for the treatment of calcified aortic valve disease. To facilitate limited access aortic valve replacement, rapid deployment valve prostheses have been developed aiming to reduce surgical impact. This systematic review gives an overview of current literature regarding the INTUITY or INTUITY Elite rapid deployment biological valve prosthesis. Methods: Cochrane, Embase and MEDLINE were searched to identify relevant studies. All studies reporting on patients who underwent isolated or combined surgical aortic valve replacement with the INTUITY or INTUITY Elite valve prosthesis were considered eligible. Primary end points were technical success rate, 30-day mortality, cerebrovascular accident, paravalvular leak and permanent pacemaker implantation. Secondary end points included procedural data such as aortic cross-clamping time, cardiopulmonary bypass time and procedural approach. Results: A total of 16 articles fulfilled the inclusion and exclusion criteria and comprised 4.184 patients. Thirty-day mortality was 2.7% (1.9-3.7%), cerebrovascular accident 2.6% (1.4-4.7%), permanent pacemaker implantation 7.9% (6.6-9.5%) and severe postoperative paravalvular leak requiring a reintervention 3.3% (1.7-6.1%). Technical success rate varied between 93.9% and 100%. Conventional median sternotomy was most commonly performed, ranging from 21.7% to 89.6%. Upper hemi-sternotomy was performed more often than anterior right thoracotomy, ranging from 10.4% to 63.3% and 2.2% to 26.1%. The mean transvalvular pressure gradient ranged between 9.0 and 10.3mmHg at 1 year postoperatively. Conclusions: This review demonstrates that the technical success rate of the INTUITY or INTUITY Elite rapid deployment valve system is high, also in limited access aortic valve replacement. Mortality and cerebrovascular accident rates are low, but the need for postoperative permanent pacemaker implantation and reintervention rate f

关键词： rapid deployment INTUITY Review Systematic analysis Aortic valve replacement

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Midterm outcomes of aortic valve replacement using a rapid-deployment valve for aortic stenosis: TRANSFORM trial

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JTCVS OPEN 2024年 17卷 55-63页

作者： Malaisrie, S. Chris Mumtaz, Mubashir A. Barnhart, Glenn R. Chitwood, Randolph Ryan, William H. Accola, Kevin D. Patel, Himanshu J. Woo, Y. Joseph Dewey, Todd M. Koulogiannis, Konstantinos Dorsey, Michael P. Grossi, Eugene A. Northwestern Univ Div Cardiac Surg Chicago IL 60611 USA Univ Pittsburgh Dept Cardiovasc & Thorac Surg Med Ctr Harrisburg Harrisburg PA USA Swedish Heart & Vasc Inst Struct Heart Program Seattle WA USA East Carolina Univ Dept Cardiovasc Sci Greenville NC USA Baylor Plano Heart Hosp Cardiac Surg Specialists Plano TX USA Florida Hosp Orlando Florida Hosp Cardiovasc Inst Orlando FL USA Univ Michigan Dept Cardiac Surg Ann Arbor MI USA Stanford Univ Dept Cardiothorac Surg Palo Alto CA USA Sarah Cannon Res Inst London England Morristown Med Ctr Cardiovasc Core Lab Morristown NJ USA NYU Langone Med Ctr Dept Cardiothorac Surg New York NY USA

Background: The use of rapid-deployment valves (RDVs) has been shown to reduce the operative time for surgical aortic valve replacement (AVR). Long-term core laboratory-adjudicated data are scarce, however. Here we report final 7-year data on RDV use. Methods: TRANSFORM was a prospective, nonrandomized, multicenter, single-arm trial implanting a stented bovine pericardial valve with an incorporated balloon-expandable sealing frame. A prior published 1-year analysis included 839 patients from 29 centers. An additional 46 patients were enrolled and implanted, for a total of 885 patients. Annual clinical and core laboratory-adjudicated echocardiographic outcomes were collected through 8 years. Primary endpoints were structural valve deterioration (SVD), all-cause reintervention, all-cause valve explantation, and all-cause mortality. Secondary endpoints included hemodynamic performance assessed by echocardiography. The mean duration of follow-up was 5.0 +/- 2.0 years. Results: The mean patient age was 73.3 +/- 8.2 years. Isolated AVR was performed in 62.1% of the patients, and AVR with concomitant procedures was performed in 37.9%. Freedom from all-cause mortality at 7 years was 76.0% for isolated AVR and 68.2% for concomitant AVR. Freedom from SVD, all-cause reintervention, and valve explantation at 7 years was 97.5%, 95.7%, and 97.8%, respectively. The mean gradient and effective orifice area at 7 years were 11.1 +/- 5.3 mm Hg and 1.6 +/- 0.3 cm(2), respectively. Paravalvular leak at 7 years was none/trace in 88.6% and mild in 11.4%. In patients undergoing isolated AVR, the cumulative probability of pacemaker implantation was 13.9% at 30 days, 15.5% at 1 year, and 21.8% at 7 years. Conclusions: AVR for aortic stenosis using an RDV is associated with low rates of late adverse events. This surgical pericardial tissue platform provides excellent and stable hemodynamic performance through 7 years.

关键词： aortic valve replacement rapid deployment sutureless valve minimally invasive

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Conduction disturbances following surgical aortic valve replacement with a rapid-deployment bioprosthesis

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JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY 2021年第3期162卷 803-811页

作者： Coti, Iuliana Schukro, Christoph Drevinja, Fitim Haberl, Thomas Kaider, Alexandra Kocher, Alfred Laufer, Guenther Andreas, Martin Med Univ Vienna Div Cardiac Surg Dept Surg Vienna Austria Med Univ Vienna Div Cardiol Dept Internal Med 2 Vienna Austria Med Univ Vienna Ctr Med Stat Informat & Intelligent Syst Vienna Austria

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 bio-prosthesis 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.

关键词： permanent pacemaker implantation conduction disturbances aortic valve replacement rapid deployment

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Early-Term Results of rapid-deployment Aortic Valve Replacement versus Standard Bioprosthesis Implantation Combined with Coronary Artery Bypass Grafting

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The Thoracic and Cardiovascular Surgeon 2022年第7期71卷 519-527页

作者： Zulfugar T. Taghiyev Matthias Bechtel Markus Schlömicher Dritan Useini Hamid Naraghi Taghi Vadim Moustafine Justus T. Strauch Department of Cardiothoracic SurgeryRuhr-University Hospital Bergmannsheil Bochum Germany Department of Adult and Pediatric Cardiovascular Surgery University Hospital of Giessen and Marburg Giessen Germany

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rapid deployment modular building solutions and climatic adaptability: Case based study of a novel approach to "thermal capacity on demand"

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ENERGY AND BUILDINGS 2018年第May期167卷 124-135页

作者： Ceranic, Boris Beardmore, John Cox, Adrian Univ Derby Markeaton St Derby DE22 3AW England T4 Sustainabil Derby England Green 4 Architects Derby England

In this research, a novel "thermal capacity on demand" approach to modular thermal storage design has been discussed, seen as a key to the climatic adaptability of a proposed Smart-POD building system and its energy performance. Smart-POD is a unique and innovative research project which provides an alternative to traditional classroom design. It proposes a rapid deployment building solution, temporary or permanent in its use, modular in design, flexible in set-up and self-sustaining in use, requiring minimal site preparation, and meeting all its energy demands from renewable energy sources. Its feasibility was tested by a design case study which investigated climatic adaptability based on the proposed approach. This approach uniquely combines balancing of energy demand and supply using renewable technologies and a bespoke low temperature thermal store. It further proposes to use an open source Building energy Management System (oBeMS) conceived in this research, to intelligently manage thermal, ventilation and humidity control strategies which adapt to the climate, season and weather in which the building is placed. The predicted performance of proposed system demonstrates potential for an effective diurnal climatic adaptability, enhanced by integrated passive design strategies, and intelligent modes of building control. The method of BIM integrated sustainable design analysis (SDA) and building management system (BMS) has also been deliberated, as a framework for exploring the integration of proposed building management system into smart building environments (SBEs). Crown Copyright (C) 2018 Published by Elsevier B.V. All rights reserved.

关键词： Thermal capacity Climatic adaptability Modular Sustainable rapid deployment Transportable Building management system

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rapid deployment or sutureless versus conventional bioprosthetic aortic valve replacement: A meta-analysis

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JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY 2018年第6期155卷 2402-+页

作者： Sohn, Suk Ho Jang, Myoung-jin Hwang, Ho Young Kim, Kyung Hwan Seoul Natl Univ Coll Med Seoul Natl Univ Hosp Dept Thorac & Cardiovasc Surg 101 Daehak Ro Seoul 03080 South Korea Seoul Natl Univ Coll Med Seoul Natl Univ Hosp Med Res Collaborating Ctr Seoul South Korea

Objectives: This meta-analysis was conducted to compare the early and follow-up outcomes of aortic valve replacement using rapid deployment or sutureless (RD) valves (RDAVR group) with aortic valve replacement using conventional bioprostheses (CAVR group). Methods: A literature search of 5 online databases was conducted. The primary outcomes were postoperative complications and the secondary outcomes included the aortic cross-clamp (ACC) and cardiopulmonary bypass (CPB) times and early mortality and all-cause mortality during follow-up. Results: Twenty-one articles (RDAVR group = 1297 patients;CAVR group = 1488 patients) were selected. The pooled analyses showed that the ACC and CPB times were significantly shorter in the RDAVR group than in the CAVR group (mean difference, -26.34;95% confidence interval [CI], -31.86 to -20.82 and mean difference, -25.33;95% CI, -30.79 to -19.87, respectively). The pooled risk ratios (RRs) of any paravalvular leak and permanent pacemaker (PPM) insertion were significantly higher in the RDAVR group than in the CAVR group (RR, 2.32;95% CI, 1.53-3.51 and RR, 2.08;95% CI, 1.49-2.90, respectively). The pooled analysis showed that the risk of a paravalvular leak grade >= 2 in the RDAVR group did not significantly differ between the RDAVR and CAVR groups (RR, 2.05;95% CI, 0.71-5.93). The risk of PPM insertion remained significant when only studies reporting adjusted outcomes were pooled. The risks of other postoperative complications, early mortality, and all-cause mortality during follow-up were not significantly different between the RDAVR and CAVR groups. Conclusions: RDAVR is associated with significantly shorter ACC and CPB times than CAVR, although this difference did not translate into improved postoperative outcomes, early mortality, and all-cause mortality during follow-up. Care might be needed when implanting RD valves because they are associated with a higher incidence of PPM insertion, regardless of the RD valve type.

关键词： rapid deployment sutureless aortic valve replacement meta-analysis

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