European Journal of Cardio-Thoracic Surgery, Feb 28, 2019
OBJECTIVES: The impact of sutureless and rapid deployment (SURD) valves on the clinical outcomes ... more 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.
Objective.The aim of this multicenter study was to evaluated whether cold or warm cardioplegia ar... more Objective.The aim of this multicenter study was to evaluated whether cold or warm cardioplegia are associated with postoperative atrial fibrillation (POAF) and the prognostic role of the latter on early stroke and neurological mortality.Methods.This was a retrospective analysis of prospective collected data from 9 cardiac centers in Italy and the United States including patients undergoing surgery between 2010 and 2018. From the 9 institutional databases, 17,231 patients underwent isolated CABG on-pump, using either warm cardioplegia (n = 7,730) or cold cardioplegia (n = 9,501); among the latter group blood and crystalloid cardioplegia were used in 691 and 8,810 patients, respectively. After matching, two pairs of 4,162 patients (overall cohort 8,324) were analyzed.Results.In matched population, the rate of POAF was 18% (1472 cases), 15% (608) in warm group versus 21% (864) in cold group (p<0.001). Multivariable analysis confirmed that cold cardioplegia was associated with higher rate of POAF, along with age, hypercholesterolemia, LVEF, reoperation, preoperative IABP, previous stroke, cardiopulmonary and cross-clamp. Moreover, cold cardioplegia as well as POAF increased the rate of postoperative stroke as well as early mortality and neurological mortality Propensity-weighted cohort included 11830 (70%) patients out of 17231. After adjustment, both cold blood and cold crystalloid cardioplegia negatively influenced POAF, stroke and neurological mortality.Conclusions.Warm cardioplegia may reduce the rate of POAF in CABG patients with respect to cold cardioplegia, either blood or crystalloid. This has a prognostic impact on postoperative stroke and neurological mortality.
Journal of the American Heart Association, Dec 17, 2019
The following work is licensed under a Creative Commons: Attribution-NonCommercial-NoDerivatives ... more The following work is licensed under a Creative Commons: Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) License.
European Journal of Cardio-Thoracic Surgery, Jan 25, 2019
OBJECTIVES: The ideal strategy for the treatment of severe aortic valve stenosis in patients of v... more 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 <5; n = 500), intermediate (EuroSCORE 5-10; n = 901), high (EuroSCORE 11-20; n = 500) and very high (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. †The first two authors contributed equally to the study.
This is a PDF file of an article that has undergone enhancements after acceptance, such as the ad... more This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
This is a PDF file of an article that has undergone enhancements after acceptance, such as the ad... more This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Objectives The aim of this study was to investigate the need for postoperative permanent pacemake... more Objectives The aim of this study was to investigate the need for postoperative permanent pacemaker implantation (PPI) following sutureless and rapid-deployment aortic valve replacement (SuRD-AVR) in the context of a progress report from a large multicenter international registry (SURD-IR). Methods We retrospectively analyzed 4,166 patients who underwent SuRD-AVR between 2008 and 2019. The primary outcome was the need for PPI before discharge. The study population was analyzed separately according to the implanted prostheses (Su cohort and RD cohort). Each cohort was divided into two groups based on the operation date: an early group (“EG” = 2008–2016) and a late group (“LG” = 2017–2019). Results The rate of PPI decreased significantly in the Su cohort over time (EG = 10.8% vs LG = 6.3%, p < 0.001). In the Su cohort, a decrease in age, risk profile, and incidence of bicuspid aortic valve, increased use of anterior right thoracotomy, reduction of cardiopulmonary bypass time and of ...
OBJECTIVESHealthcare systems worldwide have been overburdened by the coronavirus disease 2019 (C... more OBJECTIVESHealthcare systems worldwide have been overburdened by the coronavirus disease 2019 (COVID-19) outbreak. Accordingly, hospitals had to implement strategies to profoundly reshape both non-COVID-19 medical care and surgical activities. Knowledge about the impact of the COVID-19 pandemic on cardiac surgery practice is pivotal. The goal of the present study was to describe the changes in cardiac surgery practices during the health emergency at the national level.METHODSA 26-question web-enabled survey including all adult cardiac surgery units in Italy was conducted to assess how their clinical practice changed during the national lockdown. Data were compared to data from the corresponding period in 2019.RESULTSAll but 2 centres (94.9%) adopted specific protocols to screen patients and personnel. A significant reduction in the number of dedicated cardiac intensive care unit beds (−35.4%) and operating rooms (−29.2%), along with healthcare personnel reallocation to COVID depart...
Introduction: Permanent pacemaker (PPM) implantation represents a potential event after cardiac s... more Introduction: Permanent pacemaker (PPM) implantation represents a potential event after cardiac surgery. However, comprehensive investigation of robust patient cohorts in this respect is unavailable. Hypothesis: A multicenter retrospective study was undertaken to assess in-hospital and long-term postoperative outcome of a large patient population undergoing PPM soon after cardiac surgery procedures. Methods: Among 94.693 patients submitted to cardiac surgery procedures in 16 centers from 2000 to 2013, there were 1.156 patients (1.2 %) with PPM implantation during hospitalization postoperatively. Preoperative, in-hospital, and follow-up data were collected with a common dataset and analyzed. Follow-up was performed by direct visit, and PPM dependency was assessed by electrocardiogram and pacemaker check during periodic examinations. The identification of potential predictors of PPM dependency at follow-up was evaluated with a multivariate logistic regression. Results: Patient mean ag...
Background. Objective of this study was to assess clinical and hemodynamic outcomes of trans-apic... more Background. Objective of this study was to assess clinical and hemodynamic outcomes of trans-apical aortic valve implantation (TA-TAVI) in a large cohort of patients. Methods. We analyzed data from 566 high-risk or inoperable patients who underwent TA-TAVI from April 2008 through May 2011 in 20 cardiac surgery centers. Data were prospectively collected in our National Registry of Trans-Apical Aortic Valve Implantation. Outcomes were also analyzed according to the impact of intraoperative complications, procedural volume (high volume centers: >20 cases, low volume < 20 cases) and to the learning curve (first 50% cases vs. second 50% cases of each center). Results: Mean age was 81±7 years (Range: 44-95), 59.1% were female, mean logistic EUROscore was 26±14%. Preoperative peak (PG) and mean (MG) transaortic gradients were 82±24 and 51±16 mmHg, respectively. Mean follow-up was 10±8 months (range: 1-32). Hospital mortality was 7.7% (44 patients). Intraoperative severe complications...
on behalf of the GIROC Investigators Permanent pacemaker implantation (PPI) represents a rare com... more on behalf of the GIROC Investigators Permanent pacemaker implantation (PPI) represents a rare complication after cardiac surgery, with no uniform agreement on timing and no information on follow-up. A multicenter retrospective study was designed to assess pacemaker dependency (PMD) and longterm mortality after cardiac surgery procedures. Between 2004 and 2016, PPI-patients from 18 centers were followed. Time-to-event data were evaluated with semiparametric regression Cox models and semiparametric Fine and Gray model for competing risk framework. Of 859 (0.90%) PPI-patients, 30% were pacemaker independent (PMI) at 6 months. PMD showed higher mortality compared with PMI (10-year survival 80.1% § 2.6% and 92.2% +2.4%, respectively, log-rank p-value < 0.001) with an unadjusted hazard ratio for death of 0.36 (95% CI 0.20 to 0.65, p< 0.001 favoring PMI) and an adjusted hazard ratio of 0.19 (95% CI 0.08 to 0.45, p< 0.001 with PMD as reference). Crude cumulative incidence function of restored PMI rhythm at follow-up at 6 months, 1 year and 12 years were 30.5% (95% CI 27.3% to 33.7%), 33.7% (95% CI 30.4% to 36.9%) and 37.2% (95% CI 33.8% to 40.6%) respectively. PMI was favored by preoperative sinus rhythm with normal conduction (SR) (HR 2.37, 95% CI 1.65 to 3.40, p< 0.001), whereas coronary artery bypass grafting and aortic valve replacement were independently associated with PMD (HR 0.63, 95% CI 0.45 to 0.88, p = 0.006 and HR 0.807, 95% CI 0.65 to 0.99, p = 0.047 respectively). Time-to-implantation was not associated with increased rate of PMI.
The Journal of Thoracic and Cardiovascular Surgery, 2021
This is a PDF file of an article that has undergone enhancements after acceptance, such as the ad... more This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery, 2020
Objective Cardiac conduction system disturbances potentially leading to permanent pacemaker impla... more Objective Cardiac conduction system disturbances potentially leading to permanent pacemaker implantation are significant postoperative complications after aortic valve replacement. The aim of this study was to assess the impact of sutureless prosthetic valve oversizing on permanent pacemaker implantation rate. Methods This multicenter retrospective study included 306 patients who underwent minimally invasive aortic valve replacement with the Perceval sutureless valve. Oversizing was determined by the implanted valve size indexed to body surface area. Data were analyzed with a multivariable logistic regression model. Results This study confirmed excellent postoperative results for minimally invasive aortic valve replacement with right anterior minithoracotomy approach and rapid deployment sutureless valves. Mortality rate was 1%. Eighteen (5.9%) patients received a new permanent pacemaker. Multivariable logistic regression model ( P = 0.05) found oversizing as significant risk factor...
Background: Benefits of sutureless and rapid deployment (SURD) bioprostheses in bicuspid aortic v... more Background: Benefits of sutureless and rapid deployment (SURD) bioprostheses in bicuspid aortic valves (BAV) are controversial. The aim of this study is to report the outcomes of patients undergoing aortic valve replacement (AVR) for BAV from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR). Methods: Of the 4,636 patients who received primary isolated SURD-AVR between 2007 and 2018, 191 (4.1%) BAV patients underwent AVR with SURD valve. Results: Overall 30-day mortality was 1.6%. The Intuity valve was implanted in 53.9% of cases, whereas the Perceval was implanted in 46.1%. Rate of stroke for isolated AVR was 4.2%. No case of endocarditis, thromboembolism, myocardial infarction, valve dislocation or structural valve deterioration was reported in the early phase. Rate of pacemaker implantation and moderate-severe aortic regurgitation (AR) were 7.9% and 3.7%, respectively. Conclusions: BAV is not considered a contraindication for the implantation of SURD valves. However, detailed information of aortic root geometry as well as the knowledge of some technical considerations are mandatory for a good outcome.
OBJECTIVES Minimally invasive surgical techniques with optimal outcomes are of paramount importan... more OBJECTIVES Minimally invasive surgical techniques with optimal outcomes are of paramount importance. Sutureless and rapid deployment aortic valves are increasingly implanted via minimally invasive approaches. We aimed to analyse the procedural outcomes of a full sternotomy (FS) compared with those of minimally invasive cardiac surgery (MICS) and further assess MICS, namely ministernotomy (MS) and anterior right thoracotomy (ART). METHODS We selected all isolated aortic valve replacements in the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR, n = 2257) and performed propensity score matching to compare aortic valve replacement through FS or MICS (n = 508/group) as well as through MS and ART accesses (n = 569/group). RESULTS Postoperative mortality was 1.6% in FS and MICS patients who had a mean logistic EuroSCORE of 11%. Cross-clamp and cardiopulmonary bypass (CPB) times were shorter in the FS group than in the MICS group (mean difference 3.2...
The International Journal of Artificial Organs, 2009
ObjectivesA multicentric European Clinical Study is ongoing to evaluate safety and efficacy of a ... more ObjectivesA multicentric European Clinical Study is ongoing to evaluate safety and efficacy of a new pulsatile implantable LVAD (BestBeat), smaller and lighter than similar devices, capable of providing synchronous and counterpulsating flow with respect to the LV of end-stage heart failure patients. Preliminary clinical results are reported.MethodsThe new BestBeat LVAD was used, consisting of an implantable pulsatile blood pump, electromechanically driven by a ball screw mechanism, and a wearable electronic controller and power sources. The clinical trial was conducted at 5 European centers. Adult patients affected by CHF in NYHA Class IV despite optimized medical treatment were enrolled. The primary study endpoint was survival at 90 days. Further study endpoints were maintenance of adequate LVAD pump flow and a minimum rate of adverse events during support.ResultsAs of June 2008, 6 patients received the implant. Cumulative support time was 3.7 years, median support time 176 days. A...
European Journal of Cardio-Thoracic Surgery, Feb 28, 2019
OBJECTIVES: The impact of sutureless and rapid deployment (SURD) valves on the clinical outcomes ... more 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.
Objective.The aim of this multicenter study was to evaluated whether cold or warm cardioplegia ar... more Objective.The aim of this multicenter study was to evaluated whether cold or warm cardioplegia are associated with postoperative atrial fibrillation (POAF) and the prognostic role of the latter on early stroke and neurological mortality.Methods.This was a retrospective analysis of prospective collected data from 9 cardiac centers in Italy and the United States including patients undergoing surgery between 2010 and 2018. From the 9 institutional databases, 17,231 patients underwent isolated CABG on-pump, using either warm cardioplegia (n = 7,730) or cold cardioplegia (n = 9,501); among the latter group blood and crystalloid cardioplegia were used in 691 and 8,810 patients, respectively. After matching, two pairs of 4,162 patients (overall cohort 8,324) were analyzed.Results.In matched population, the rate of POAF was 18% (1472 cases), 15% (608) in warm group versus 21% (864) in cold group (p<0.001). Multivariable analysis confirmed that cold cardioplegia was associated with higher rate of POAF, along with age, hypercholesterolemia, LVEF, reoperation, preoperative IABP, previous stroke, cardiopulmonary and cross-clamp. Moreover, cold cardioplegia as well as POAF increased the rate of postoperative stroke as well as early mortality and neurological mortality Propensity-weighted cohort included 11830 (70%) patients out of 17231. After adjustment, both cold blood and cold crystalloid cardioplegia negatively influenced POAF, stroke and neurological mortality.Conclusions.Warm cardioplegia may reduce the rate of POAF in CABG patients with respect to cold cardioplegia, either blood or crystalloid. This has a prognostic impact on postoperative stroke and neurological mortality.
Journal of the American Heart Association, Dec 17, 2019
The following work is licensed under a Creative Commons: Attribution-NonCommercial-NoDerivatives ... more The following work is licensed under a Creative Commons: Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) License.
European Journal of Cardio-Thoracic Surgery, Jan 25, 2019
OBJECTIVES: The ideal strategy for the treatment of severe aortic valve stenosis in patients of v... more 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 <5; n = 500), intermediate (EuroSCORE 5-10; n = 901), high (EuroSCORE 11-20; n = 500) and very high (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. †The first two authors contributed equally to the study.
This is a PDF file of an article that has undergone enhancements after acceptance, such as the ad... more This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
This is a PDF file of an article that has undergone enhancements after acceptance, such as the ad... more This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Objectives The aim of this study was to investigate the need for postoperative permanent pacemake... more Objectives The aim of this study was to investigate the need for postoperative permanent pacemaker implantation (PPI) following sutureless and rapid-deployment aortic valve replacement (SuRD-AVR) in the context of a progress report from a large multicenter international registry (SURD-IR). Methods We retrospectively analyzed 4,166 patients who underwent SuRD-AVR between 2008 and 2019. The primary outcome was the need for PPI before discharge. The study population was analyzed separately according to the implanted prostheses (Su cohort and RD cohort). Each cohort was divided into two groups based on the operation date: an early group (“EG” = 2008–2016) and a late group (“LG” = 2017–2019). Results The rate of PPI decreased significantly in the Su cohort over time (EG = 10.8% vs LG = 6.3%, p < 0.001). In the Su cohort, a decrease in age, risk profile, and incidence of bicuspid aortic valve, increased use of anterior right thoracotomy, reduction of cardiopulmonary bypass time and of ...
OBJECTIVESHealthcare systems worldwide have been overburdened by the coronavirus disease 2019 (C... more OBJECTIVESHealthcare systems worldwide have been overburdened by the coronavirus disease 2019 (COVID-19) outbreak. Accordingly, hospitals had to implement strategies to profoundly reshape both non-COVID-19 medical care and surgical activities. Knowledge about the impact of the COVID-19 pandemic on cardiac surgery practice is pivotal. The goal of the present study was to describe the changes in cardiac surgery practices during the health emergency at the national level.METHODSA 26-question web-enabled survey including all adult cardiac surgery units in Italy was conducted to assess how their clinical practice changed during the national lockdown. Data were compared to data from the corresponding period in 2019.RESULTSAll but 2 centres (94.9%) adopted specific protocols to screen patients and personnel. A significant reduction in the number of dedicated cardiac intensive care unit beds (−35.4%) and operating rooms (−29.2%), along with healthcare personnel reallocation to COVID depart...
Introduction: Permanent pacemaker (PPM) implantation represents a potential event after cardiac s... more Introduction: Permanent pacemaker (PPM) implantation represents a potential event after cardiac surgery. However, comprehensive investigation of robust patient cohorts in this respect is unavailable. Hypothesis: A multicenter retrospective study was undertaken to assess in-hospital and long-term postoperative outcome of a large patient population undergoing PPM soon after cardiac surgery procedures. Methods: Among 94.693 patients submitted to cardiac surgery procedures in 16 centers from 2000 to 2013, there were 1.156 patients (1.2 %) with PPM implantation during hospitalization postoperatively. Preoperative, in-hospital, and follow-up data were collected with a common dataset and analyzed. Follow-up was performed by direct visit, and PPM dependency was assessed by electrocardiogram and pacemaker check during periodic examinations. The identification of potential predictors of PPM dependency at follow-up was evaluated with a multivariate logistic regression. Results: Patient mean ag...
Background. Objective of this study was to assess clinical and hemodynamic outcomes of trans-apic... more Background. Objective of this study was to assess clinical and hemodynamic outcomes of trans-apical aortic valve implantation (TA-TAVI) in a large cohort of patients. Methods. We analyzed data from 566 high-risk or inoperable patients who underwent TA-TAVI from April 2008 through May 2011 in 20 cardiac surgery centers. Data were prospectively collected in our National Registry of Trans-Apical Aortic Valve Implantation. Outcomes were also analyzed according to the impact of intraoperative complications, procedural volume (high volume centers: >20 cases, low volume < 20 cases) and to the learning curve (first 50% cases vs. second 50% cases of each center). Results: Mean age was 81±7 years (Range: 44-95), 59.1% were female, mean logistic EUROscore was 26±14%. Preoperative peak (PG) and mean (MG) transaortic gradients were 82±24 and 51±16 mmHg, respectively. Mean follow-up was 10±8 months (range: 1-32). Hospital mortality was 7.7% (44 patients). Intraoperative severe complications...
on behalf of the GIROC Investigators Permanent pacemaker implantation (PPI) represents a rare com... more on behalf of the GIROC Investigators Permanent pacemaker implantation (PPI) represents a rare complication after cardiac surgery, with no uniform agreement on timing and no information on follow-up. A multicenter retrospective study was designed to assess pacemaker dependency (PMD) and longterm mortality after cardiac surgery procedures. Between 2004 and 2016, PPI-patients from 18 centers were followed. Time-to-event data were evaluated with semiparametric regression Cox models and semiparametric Fine and Gray model for competing risk framework. Of 859 (0.90%) PPI-patients, 30% were pacemaker independent (PMI) at 6 months. PMD showed higher mortality compared with PMI (10-year survival 80.1% § 2.6% and 92.2% +2.4%, respectively, log-rank p-value < 0.001) with an unadjusted hazard ratio for death of 0.36 (95% CI 0.20 to 0.65, p< 0.001 favoring PMI) and an adjusted hazard ratio of 0.19 (95% CI 0.08 to 0.45, p< 0.001 with PMD as reference). Crude cumulative incidence function of restored PMI rhythm at follow-up at 6 months, 1 year and 12 years were 30.5% (95% CI 27.3% to 33.7%), 33.7% (95% CI 30.4% to 36.9%) and 37.2% (95% CI 33.8% to 40.6%) respectively. PMI was favored by preoperative sinus rhythm with normal conduction (SR) (HR 2.37, 95% CI 1.65 to 3.40, p< 0.001), whereas coronary artery bypass grafting and aortic valve replacement were independently associated with PMD (HR 0.63, 95% CI 0.45 to 0.88, p = 0.006 and HR 0.807, 95% CI 0.65 to 0.99, p = 0.047 respectively). Time-to-implantation was not associated with increased rate of PMI.
The Journal of Thoracic and Cardiovascular Surgery, 2021
This is a PDF file of an article that has undergone enhancements after acceptance, such as the ad... more This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery, 2020
Objective Cardiac conduction system disturbances potentially leading to permanent pacemaker impla... more Objective Cardiac conduction system disturbances potentially leading to permanent pacemaker implantation are significant postoperative complications after aortic valve replacement. The aim of this study was to assess the impact of sutureless prosthetic valve oversizing on permanent pacemaker implantation rate. Methods This multicenter retrospective study included 306 patients who underwent minimally invasive aortic valve replacement with the Perceval sutureless valve. Oversizing was determined by the implanted valve size indexed to body surface area. Data were analyzed with a multivariable logistic regression model. Results This study confirmed excellent postoperative results for minimally invasive aortic valve replacement with right anterior minithoracotomy approach and rapid deployment sutureless valves. Mortality rate was 1%. Eighteen (5.9%) patients received a new permanent pacemaker. Multivariable logistic regression model ( P = 0.05) found oversizing as significant risk factor...
Background: Benefits of sutureless and rapid deployment (SURD) bioprostheses in bicuspid aortic v... more Background: Benefits of sutureless and rapid deployment (SURD) bioprostheses in bicuspid aortic valves (BAV) are controversial. The aim of this study is to report the outcomes of patients undergoing aortic valve replacement (AVR) for BAV from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR). Methods: Of the 4,636 patients who received primary isolated SURD-AVR between 2007 and 2018, 191 (4.1%) BAV patients underwent AVR with SURD valve. Results: Overall 30-day mortality was 1.6%. The Intuity valve was implanted in 53.9% of cases, whereas the Perceval was implanted in 46.1%. Rate of stroke for isolated AVR was 4.2%. No case of endocarditis, thromboembolism, myocardial infarction, valve dislocation or structural valve deterioration was reported in the early phase. Rate of pacemaker implantation and moderate-severe aortic regurgitation (AR) were 7.9% and 3.7%, respectively. Conclusions: BAV is not considered a contraindication for the implantation of SURD valves. However, detailed information of aortic root geometry as well as the knowledge of some technical considerations are mandatory for a good outcome.
OBJECTIVES Minimally invasive surgical techniques with optimal outcomes are of paramount importan... more OBJECTIVES Minimally invasive surgical techniques with optimal outcomes are of paramount importance. Sutureless and rapid deployment aortic valves are increasingly implanted via minimally invasive approaches. We aimed to analyse the procedural outcomes of a full sternotomy (FS) compared with those of minimally invasive cardiac surgery (MICS) and further assess MICS, namely ministernotomy (MS) and anterior right thoracotomy (ART). METHODS We selected all isolated aortic valve replacements in the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR, n = 2257) and performed propensity score matching to compare aortic valve replacement through FS or MICS (n = 508/group) as well as through MS and ART accesses (n = 569/group). RESULTS Postoperative mortality was 1.6% in FS and MICS patients who had a mean logistic EuroSCORE of 11%. Cross-clamp and cardiopulmonary bypass (CPB) times were shorter in the FS group than in the MICS group (mean difference 3.2...
The International Journal of Artificial Organs, 2009
ObjectivesA multicentric European Clinical Study is ongoing to evaluate safety and efficacy of a ... more ObjectivesA multicentric European Clinical Study is ongoing to evaluate safety and efficacy of a new pulsatile implantable LVAD (BestBeat), smaller and lighter than similar devices, capable of providing synchronous and counterpulsating flow with respect to the LV of end-stage heart failure patients. Preliminary clinical results are reported.MethodsThe new BestBeat LVAD was used, consisting of an implantable pulsatile blood pump, electromechanically driven by a ball screw mechanism, and a wearable electronic controller and power sources. The clinical trial was conducted at 5 European centers. Adult patients affected by CHF in NYHA Class IV despite optimized medical treatment were enrolled. The primary study endpoint was survival at 90 days. Further study endpoints were maintenance of adequate LVAD pump flow and a minimum rate of adverse events during support.ResultsAs of June 2008, 6 patients received the implant. Cumulative support time was 3.7 years, median support time 176 days. A...
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