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1.
Eur J Cardiothorac Surg ; 62(4)2022 09 02.
Article in English | MEDLINE | ID: mdl-35290444

ABSTRACT

OBJECTIVES: Sutureless aortic valves demonstrated non-inferiority to standard stented valves for major cardiovascular and cerebral events at 1 year after aortic valve replacement. We aim to assess the factors correlating with permanent pacemaker implantation (PPI) in both cohorts. METHODS: PERSIST-AVR is a prospective, randomized, open-label trial. Patients undergoing aortic valve replacement were randomized to receive a sutureless aortic valve replacement (Su-AVR) or stented sutured bioprosthesis (SAVR). Multivariable analysis was performed to identify possible independent risk factors associated with PPI. A logistic regression analysis was performed to estimate the risk of PPI associated to different valve size. RESULTS: The 2 groups (Su-AVR; n = 450, SAVR n = 446) were well balanced in terms of preoperative risk factors. Early PPI rates were 10.4% in the Su-AVR group and 3.1% in the SAVR. PPI prevalence correlated with valve size XL (P = 0.0119) and preoperative conduction disturbances (P = 0.0079) in the Su-AVR group. No predictors were found in the SAVR cohort. Logistic regression analysis showed a significantly higher risk for PPI with size XL compared to each individual sutureless valve sizes [odds ratio (OR) 0.272 vs size S (95%confidence interval 0.07-0.95), 0.334 vs size M (95% CI 0,16-0; 68), 0.408 vs size L (95% CI 0,21-0.81)] but equivalent risk of PPI rates for all other combination of valve sizes. CONCLUSIONS: Su-AVR is associated with higher PPI rate as compared to SAVR. However, the increased PPI rate appears to be size-dependent with significant higher rate only for size XL. The combination of preoperative conduction disorder and a size XL can lead to a higher probability of early PPI in Su-AVR. CLINICAL TRIAL REGISTRATION NUMBER: NCT02673697.


Subject(s)
Aortic Valve Stenosis , Bioprosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Pacemaker, Artificial , Aortic Valve/surgery , Aortic Valve Stenosis/etiology , Aortic Valve Stenosis/surgery , Bioprosthesis/adverse effects , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Humans , Pacemaker, Artificial/adverse effects , Prospective Studies , Prosthesis Design , Risk Factors , Treatment Outcome
2.
Eur J Cardiothorac Surg ; 56(6): 1140-1146, 2019 Dec 01.
Article in English | MEDLINE | ID: mdl-31365061

ABSTRACT

OBJECTIVES: The transcarotid (TC) approach for transcatheter aortic valve implantation (TAVI) is potentially an optimal alternative to the transfemoral (TF) approach. Our goal was to compare the safety and efficacy of TC- and TF-TAVI. METHODS: Patients who underwent TF-TAVI or TC-TAVI in the prospectively collected FRANCE TAVI registry between January 2013 and December 2015 were compared. Propensity score inverse probability weighting methods were employed to minimize the impact of bias related to non-random treatment assignment. RESULTS: Of the 11 033 patients included in the current study, 10 598 (96%) underwent a TF-TAVI and 435 (4.1%) had a TC-TAVI. Patients in the TC-TAVI access group presented with a higher risk profile but were significantly younger. There were no differences in the perioperative and 2-year mortality rates after adjustment [odds ratio (OR) 1.02, 95% confidence interval (CI) 0.62-1.68; P = 0.99 and hazard ratio 1.03, 95% CI 0.7-1.35; P = 0.83). TC-TAVI was associated with a significant risk of stroke (OR 2.42, 95% CI 2.01-2.92; P < 0.001), ST-elevation myocardial infarction (OR 7.32, 95% CI 3.87-13.87; P < 0.001), infections (OR 2.36, 95% CI 2.04-2.71; P < 0.001), bleeding (OR 2.01, 95% CI 1.76-2.29; P < 0.001), renal failure (OR 2.23, 95% CI 1.90-2.60; P < 0.001) and need for dialysis (OR 2.36, 95% CI 2.01-2.76, P < 0.001). Conversely, TC-TAVI was not confirmed as a risk factor for pacemaker implantation after adjustment (OR 1.05, 95% CI 0.96-1.15; P < 0.28) and was a protective factor for vascular complications (OR 0.37, 95% CI 0.32-0.43; P < 0.001). CONCLUSIONS: TC-TAVI is a safe procedure compared to TF-TAVI, although it holds an increased risk of perioperative complications. It should be considered in case of non-femoral peripheral access as the second access choice, to increase the overall safety of TAVI procedures.


Subject(s)
Aortic Valve/surgery , Carotid Arteries/surgery , Femoral Artery/surgery , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Female , Humans , Male , Postoperative Complications , Propensity Score , Prospective Studies , Stroke , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Transcatheter Aortic Valve Replacement/mortality , Treatment Outcome
3.
Eur J Cardiothorac Surg ; 56(1): 38-43, 2019 Jul 01.
Article in English | MEDLINE | ID: mdl-30689828

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 <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. 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.


Subject(s)
Aortic Valve/surgery , Heart Valve Prosthesis Implantation , Aged , Aortic Valve Stenosis/surgery , Female , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/mortality , Humans , Male , Middle Aged , Postoperative Complications/epidemiology , Risk Factors , Treatment Outcome
4.
Innovations (Phila) ; 11(5): 337-341, 2016.
Article in English | MEDLINE | ID: mdl-27832045

ABSTRACT

OBJECTIVE: In this paper, we present an endoscopic expandable sizer conceived to allow thoracoscopic aortic valve replacement with a sutureless prosthesis using a dynamic sizing of the aortic annulus. METHODS: Ten aortic torsos were prepared using a five-trocar thoracoscopic setting. Once the aortotomy was performed and the aortic valve leaflets removed, the technical feasibility of the endoscopic sizing (introduction into the trocar, expansion into the aortic annulus, determination of the valve size, and retraction) with the device was assessed. In case of successful thoracoscopic sizing, endoscopic implantation of a sutureless valve (five LivaNova Perceval prosthesis and five Medtronic 3f Enable bioprosthesis) was performed. Before ascending aorta closure, we assessed the appropriate sealing of the bioprosthesis in the native annulus with camera visualization and a nerve hook inspection. RESULTS: All the 10 endoscopic sizings were technically feasible. The scheduled aortic sutureless valve implantations were successfully performed. In all cases, fitting and placement of the sutureless bioprosthesis in the flaccid heart was satisfactory, with no paraprosthetic leakage detectable by the nerve hook. CONCLUSIONS: The use of the endoscopic expandable sizer is technically possible. In this early-stage test in the flaccid heart, selection of the valve size was satisfactory during thoracoscopic sutureless aortic bioprosthesis implantation. Further laboratory evaluation with fluid dynamics (aortic root pressurization) will be performed before a clinical study is started.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Transcatheter Aortic Valve Replacement/instrumentation , Bioprosthesis , Heart Valve Prosthesis , Humans , Prosthesis Design , Thoracoscopy
5.
Innovations (Phila) ; 11(3): 165-73, 2016.
Article in English | MEDLINE | ID: mdl-27540996

ABSTRACT

OBJECTIVE: To define the benefit of sutureless and rapid deployment valves in current minimally invasive approaches in isolated aortic valve replacement. METHODS: A panel of 28 international experts with expertise in both minimally invasive aortic valve replacement and rapid deployment valves was constituted. After thorough literature review, the experts rated evidence-based recommendations in a modified Delphi approach. RESULTS: No guideline could be retrieved. Thirty-three clinical trials and 9 systematic reviews could be identified for detailed text analysis to obtain a total of 24 recommendations. After rating by the experts 12, final recommendations were identified: preoperative computed tomographic scan as well as intraoperative transesophageal echocardiography are highly recommended. Suitable annular sizes are 19 to 27 mm. There is a contraindication for bicuspid valves only for type 0 and for annular abscess or destruction due to infective endocarditis. The use of sutureless and rapid deployment valves reduces extracorporeal circulation and aortic cross-clamp time and leads to less early complications as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions, paravalvular leakages and aortic regurgitation, and renal replacement therapy, respectively. These clinical outcomes result in reduced intensive care unit and hospital stay and reduced costs. The use of sutureless and rapid deployment valves will lead to a higher adoption rate of minimally invasive approaches in aortic valve replacement. Respect should be taken to a necessary short learning curve for both sutureless and minimally invasive programs. CONCLUSIONS: Sutureless and rapid deployment aortic valve replacement together with minimally invasive approaches offers an attractive option in aortic valve placement for patients requiring biological valve replacement.


Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation/methods , Clinical Trials as Topic , Evidence-Based Medicine , Humans , Minimally Invasive Surgical Procedures/instrumentation , Suture Techniques
8.
Article in English | MEDLINE | ID: mdl-27188445

ABSTRACT

Transcatheter aortic valve implantation is a well-recognized treatment option for high-risk patients with aortic stenosis. The femoral approach is possible in 80% of cases. Initially, only the transcarotid and subclavian approaches were performed as alternative routes. Both approaches have advantages and disadvantages. The carotid approach is a new approach that offers direct vascular access to the aortic valve. The technique of access is very simple and well known to all cardiovascular surgeons, and the morbidity is minimal. It avoids a thoracotomy with all its complications. We present here our technique and results of our initial experience.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Carotid Arteries/surgery , Transcatheter Aortic Valve Replacement/methods , Humans , Patient Selection , Treatment Outcome
9.
Eur J Cardiothorac Surg ; 49(3): 709-18, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26516193

ABSTRACT

OBJECTIVES: After a panel process, recommendations on the use of sutureless and rapid deployment valves in aortic valve replacement were given with special respect as an alternative to stented valves. METHODS: Thirty-one international experts in both sutureless, rapid deployment valves and stented bioprostheses constituted the panel. After a thorough literature review, evidence-based recommendations were rated in a three-step modified Delphi approach by the experts. RESULTS: Literature research could identify 67 clinical trials, 4 guidelines and 10 systematic reviews for detailed text analysis to obtain a total of 28 recommendations. After rating by the experts, 12 recommendations were identified and degree of consensus for each was determined. Proctoring and education are necessary for the introduction of sutureless valves on an institutional basis as well as for the individual training of surgeons. Sutureless and rapid deployment should be considered as the valve prosthesis of first choice for isolated procedures in patients with comorbidities, old age, delicate aortic wall conditions such as calcified root, porcelain aorta or prior implantation of aortic homograft and stentless valves as well as for concomitant procedures and small aortic roots to reduce cross-clamp time. Intraoperative transoesophageal echocardiography is highly recommended, and in case of right anterior thoracotomy, preoperative computer tomography is strongly recommended. Suitable annular sizes are 19-27 mm. There is a contraindication for bicuspid valves only for Type 0 and for annular abscess or destruction due to infective endocarditis. Careful but complete decalcification of the aortic root is recommended to avoid paravalvular leakage; extensive decalcification should be avoided not to create annular defects. Proximal anastomoses of concomitant coronary artery bypass grafting should be placed during a single aortic cross-clamp period or alternatively with careful side clamping. Available evidence suggests that the use of sutureless and rapid deployment valve is associated with (can translate into) reduced early complications such as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions and renal replacement therapy, respectively, and may result in reduced intensive care unit and hospital stay in comparison with traditional valves. CONCLUSION: The international experts recommend various benefits of sutureless and rapid deployment technology, which may represent a helpful tool in aortic valve replacement for patients requiring a biological valve. However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves.


Subject(s)
Aortic Valve/surgery , Bioprosthesis , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Stents , Consensus , Humans
10.
J Thorac Cardiovasc Surg ; 150(1): 84-8, 2015 Jul.
Article in English | MEDLINE | ID: mdl-25940415

ABSTRACT

OBJECTIVE: A prospective trial was designed to evaluate the feasibility of the Perceval sutureless aortic valve. We report the 5-year clinical and hemodynamic outcome. METHODS: A total of 30 patients (mean age: 80.4 ± 3.8 years; mean logistic European System for Cardiac Operative Risk Evaluation [euroSCORE]: 13.2 ± 7.3) received the valve in 3 European centers, between April 2007 and February 2008. Cumulative follow-up was 92.67 patient-years, with a median of 4.2 years. Patients with a small annulus were selected because only sizes 21 and 23 mm (covering annuli diameters from 19 to 23 mm) were available at this early stage of the trial. In 37% of the patients, a 21-mm valve was used; 63% received a 23-mm valve; 14 patients had concomitant coronary artery bypass grafting. Clinical and hemodynamic follow-up evaluation were performed annually, including echocardiography. RESULTS: Procedural success was 100%. Cardiopulmonary bypass time and cross-clamp time in isolated aortic valve replacement were 46.4 ± 6.7 minutes and 29.3 ± 8.0 minutes, respectively. One patient died during the hospital stay. Postoperative complications included 1 patient with mediastinal bleeding, and 1 with atrioventricular block that led to pacemaker implantation. No stroke occurred in either the early or late period. At the last available follow-up, 22 patients were alive. The mean gradient was 9.3 mm Hg, with an effective orifice area of 1.7 cm(2) at 5 years. No dislodgement, structural valve deterioration, hemolysis, or valve thrombosis was reported. CONCLUSIONS: This study reports the first and longest experience with a truly sutureless valve, evaluating implantation feasibility and valve safety. Results from up to 5 years of follow up confirmed the performance and safety of this device, even in a medium- to high-risk patient population with a small aortic annulus.


Subject(s)
Aortic Valve/surgery , Heart Valve Prosthesis , Aged , Aged, 80 and over , Feasibility Studies , Female , Humans , Male , Pilot Projects , Prospective Studies , Prosthesis Design , Time Factors
11.
Ann Thorac Surg ; 98(4): 1294-300, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25106682

ABSTRACT

BACKGROUND: The Perceval (Sorin Group, Milan, Italy) is a self-anchoring sutureless aortic valve prosthesis. We report the short- to midterm results of combined aortic valve replacement (AVR) with concomitant procedures in elderly patients undergoing operation as part of 3 consecutive prospective multicenter European studies. METHODS: From April 2007 to February 2013, 243 patients (mean age, 79.7 ± 5.1 years; female patients, 61%; median EuroSCORE, 9%) underwent AVR with concomitant procedures. The concomitant procedures were coronary artery bypass grafting (CABG) (182 cases), septal myectomy (21 cases), CABG + other procedures (18 cases), and 22 other procedures. Primary and secondary end points included implant feasibility and safety (for mortality and morbidity) and efficacy (New York Heart Association [NYHA] class improvement and hemodynamic results) of the prosthesis at the different follow-up periods. Data were expressed as mean ± standard deviation. Kaplan-Meier analysis was performed for survival analysis. RESULTS: Mean aortic cross-clamp and extracorporeal circulation (ECC) times were 50.7 ± 22.8 minutes and 78.9 ± 32.3 minutes, respectively. Thirty-day mortality was 2.1%. Mean postoperative gradient and effective orifice area were 10.1 ± 4.7 mm Hg and 1.5 ± 0.4 cm(2) and 8.9 ± 5.6 mm Hg and 1.6 ± 0.4 cm(2), respectively, at 1 year. There were early explantations, 4 of which resulted from paravalvular leaks. One additional valve explantation resulted from aortic root bleeding, probably caused by excessively extensive decalcification. In the late period, there was 1 mild paravalvular leak and no intravalvular insufficiency. No migration, dislodgement, or degeneration of the valve occurred during follow-up. Median follow-up was 444 days. CONCLUSIONS: These trials confirm the safety and efficacy of the Perceval sutureless aortic valve, especially in elderly patients requiring AVR + concomitant procedures. In this patient group, sutureless valves may be advantageous compared to transcatheter valve implantations as concomitant procedures other than percutaneous coronary artery angioplasty are not always possible in the latter.


Subject(s)
Aortic Valve/surgery , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Aged , Aged, 80 and over , Coronary Artery Bypass , Female , Heart Valve Prosthesis Implantation/mortality , Humans , Male , Suture Techniques
12.
Ann Thorac Surg ; 96(5): 1866-8, 2013 Nov.
Article in English | MEDLINE | ID: mdl-24182479

ABSTRACT

We report a case of aortic valve replacement with a sutureless valve in a degenerated aortic homograft. This technique allows rapid aortic valve replacement in a heavily calcified aortic root. It avoids the problems of postoperative prosthetic disinsertion frequently encountered after aortic valve replacement in a calcified annulus. It is particularly suitable in redo procedures for homograft degeneration. It avoids performing a redo Bentall operation with its known morbidity.


Subject(s)
Aortic Valve/surgery , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Allografts , Humans , Male , Middle Aged , Prosthesis Design , Prosthesis Failure , Reoperation
13.
Ann Thorac Surg ; 93(5): 1483-8, 2012 May.
Article in English | MEDLINE | ID: mdl-22541180

ABSTRACT

BACKGROUND: The Perceval S bioprosthesis (Sorin Biomedica Cardio Srl, Sallugia, Italy) is a self-expanding valve designed to preserve aortic sinuses and sinotubular junction. We report the midterm results of a prospective, multicenter clinical study evaluating the safety and efficacy of this stented bioprosthesis in patients undergoing aortic valve replacement with or without concomitant procedures. METHODS: From January 2007 to September 2011, a total of 208 high-risk patients (mean European system for cardiac operative risk evaluation: 8.7±5.3 years) received a Perceval bioprosthesis in 2 European centers. Median follow up was 10±20 months and 100% complete, and the total accumulated follow-up was 156 patient-years. Ten patients have reached a 4-year follow-up. Valve function was assessed in all patients. RESULTS: Valve implantation resulted in significant improvement of patients' symptoms. Mean preoperative and postoperative gradients were 48.6±18.6 mm Hg and 10.4±4.3 mm Hg, respectively, and preoperative and postoperative mean effective orifice areas were 0.7±0.2 and 1.4±0.4 cm2. Survival at 12 months was 87.1%, success of implantation was 95%, and freedom from reoperation was 96%. In hospital mortality was 2.4%. During follow-up, 9 patients (4%) required reoperation for paravalvular regurgitation; 7 early and 2 late reoperations. Mean cross-clamp time (CCT) and extracorporeal circulation time (ECT) were, respectively, 33±14 minutes and 54±24 minutes, including 45 patients who underwent surgery through ministernotomy. Concomitant coronary bypass was done in 48 patients with mean CCT 43±13 and ECT 68±25 minutes. CONCLUSIONS: Perceval sutureless is a safe bioprosthesis that can easily be implanted, including by a minimally invasive technique. It provides excellent hemodynamic with significant clinical improvement. Overall, these data confirm the safety and utility of the Perceval bioprosthesis aortic valve replacement for high-risk patients.


Subject(s)
Aortic Valve Stenosis/surgery , Bioprosthesis , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Echocardiography, Doppler , Female , Follow-Up Studies , France , Heart Valve Prosthesis Implantation/adverse effects , Humans , Kaplan-Meier Estimate , Male , Minimally Invasive Surgical Procedures , Prospective Studies , Prosthesis Design , Risk Assessment , Severity of Illness Index , Survival Rate , Sutures , Treatment Outcome
14.
Innovations (Phila) ; 6(2): 66-76, 2011 Mar.
Article in English | MEDLINE | ID: mdl-22437890

ABSTRACT

OBJECTIVE: : The purpose of this consensus conference was to deliberate the evidence regarding whether minimally invasive mitral valve surgery via thoracotomy improves clinical and resource outcomes compared with conventional open mitral valve surgery via median sternotomy in adults who require surgical intervention for mitral valve disease. METHODS: : Before the consensus conference, the consensus panel reviewed the best available evidence up to March 2010, whereby systematic reviews, randomized trials, and nonrandomized trials were considered in descending order of validity and importance. The accompanying meta-analysis article in this issue of the Journal provides the systematic review of the evidence. Based on this systematic review, evidence-based statements were created for prespecified clinical questions, and consensus processes were used to derive recommendations. The American Heart Association/American College of Cardiology system was used to label the level of evidence and class of each recommendation. RESULTS AND CONCLUSIONS: : Considering the underlying level of evidence, and notwithstanding the limitations of the evidence base (retrospective studies with important differences in baseline patient characteristics, which may produce bias in results of the evidence syntheses), the consensus panel provided the following evidence-based statements and overall recommendation:In patients with mitral valve disease, minimally invasive surgery may be an alternative to conventional mitral valve surgery (Class IIb), given that there was comparable short-term and long-term mortality (level B), comparable in-hospital morbidity (renal, pulmonary, cardiac complications, pain perception, and readmissions) (level B), reduced sternal complications, transfusions, postoperative atrial fibrillation, duration of ventilation, and intensive care unit and hospital length of stay (level B). However, this should be considered against the increased risk of stroke (2.1% vs 1.2%) (level B), aortic dissection (0.2% vs 0%) (level B), phrenic nerve palsy (3% vs 0%) (level B), groin infections/complications (2% vs 0%) (level B), and, prolonged cross-clamp time, cardiopulmonary bypass time, and procedure time (level B). The available evidence consists almost entirely of observational studies and must not be considered definitive until future adequately controlled randomized trials further address the risk of stroke, aortic complications, phrenic nerve complications, pain, long-term survival, need for reintervention, quality of life, and cost-effectiveness.

15.
Innovations (Phila) ; 6(2): 84-103, 2011 Mar.
Article in English | MEDLINE | ID: mdl-22437892

ABSTRACT

OBJECTIVE: : This meta-analysis sought to determine whether minimally invasive mitral valve surgery (mini-MVS) improves clinical outcomes and resource utilization compared with conventional open mitral valve surgery (conv-MVS) in patients undergoing mitral valve repair or replacement. METHODS: : A comprehensive search of MEDLINE, Cochrane Library, EMBASE, CTSnet, and databases of abstracts was undertaken to identify all randomized and nonrandomized studies up to March 2010 of mini-MVS through thoracotomy versus conv-MVS through median sternotomy for mitral valve repair or replacement. Outcomes of interest included death, stroke, myocardial infarction, aortic dissection, need for reintervention, and any other reported clinically relevant outcomes or indicator of resource utilization. Relative risk and weighted mean differences and their 95% confidence intervals were analyzed as appropriate using the random effects model. Heterogeneity was measured using the I statistic. RESULTS: : Thirty-five studies met the inclusion criteria (two randomized controlled trials and 33 nonrandomized studies). The mortality rate after mini-MVS versus conv-MVS was similar at 30 days (1.2% vs 1.5%), 1 year (0.9% vs 1.3%), 3 years (0.5% vs 0.5%), and 9 years (0% vs 3.7%). A number of clinical outcomes were significantly improved with mini-MVS versus conv-MVS including atrial fibrillation (18% vs 22%), chest tube drainage (578 vs 871 mL), transfusions, sternal infection (0.04% vs 0.27%), time to return to normal activity, and patient scar satisfaction. However, the 30-day risk of stroke (2.1% vs 1.2%), aortic dissection/injury (0.2% vs 0%), groin infection (2% vs 0%), and phrenic nerve palsy (3% vs 0%) were significantly increased for mini-MVS versus conv-MVS. Other clinical outcomes were similar between groups. Cross-clamp time, cardiopulmonary bypass time, and procedure time were significantly increased with mini-MVS; however, ventilation time and length of stay in intensive care unit and hospital were reduced. CONCLUSIONS: : Current evidence suggests that mini-MVS maybe associated with decreased bleeding, blood product transfusion, atrial fibrillation, sternal wound infection, scar dissatisfaction, ventilation time, intensive care unit stay, hospital length of stay, and reduced time to return to normal activity, without detected adverse impact on long-term need for valvular reintervention and survival beyond 1 year. However, these potential benefits for mini-MVS may come with an increased risk of stroke, aortic dissection or aortic injury, phrenic nerve palsy, groin infections/complications, and increased cross-clamp, cardiopulmonary bypass, and procedure time. Available evidence is largely limited to retrospective comparisons of small cohorts comparing mini-MVS versus conv-MVS that provide only short-term outcomes. Given these limitations, randomized controlled trials with adequate power and duration of follow-up to measure clinically relevant outcomes are recommended to determine the balance of benefits and risks.

16.
Cardiol Res Pract ; 2010: 175450, 2010.
Article in English | MEDLINE | ID: mdl-20339505

ABSTRACT

Objectives. Robotic surgery enables to perform coronary surgery totally endoscopically. This report describes our experience using the da Vinci system for coronary artery bypass surgery. Methods. Patients requiring single-or-double vessel revascularization were eligible. The procedure was performed without cardiopulmonary bypass on a beating heart. Results. From April 2004 to May 2008, fifty-six patients were enrolled in the study. Twenty-four patients underwent robotic harvesting of the mammary conduit followed by minimal invasive direct coronary artery bypass (MIDCAB), and twenty-three patients had a totally endoscopic coronary artery bypass (TECAB) grafting. Nine patients (16%) were converted to open techniques. The mean total operating time for TECAB was 372 +/- 104 minutes and for MIDCAB was 220 +/- 69 minutes. Followup was complete for all patients up to one year. There was one hospital death following MIDCAB and two deaths at follow up. Forty-eight patients had an angiogram or CT scan revealing occlusion or anastomotic stenoses (>50%) in 6 patients. Overall permeability was 92%. Conclusions. Robotic surgery can be performed with promising results.

17.
J Robot Surg ; 4(4): 241-6, 2010 Dec.
Article in English | MEDLINE | ID: mdl-27627952

ABSTRACT

Robotically assisted surgery enables coronary surgery to be performed totally or partially endoscopically. Using the Da Vinci robotic technology allows minimally invasive treatments. We report on our experience with coronary artery surgery in our department: patients requiring single or double vessel surgical revascularization were eligible. The procedure was performed without cardiopulmonary bypass on a beating heart. From April 2004 to May 2008, 55 consecutive patients were enrolled in the study, and were operated on by a single surgical team. Operative outcomes included operative time, estimated blood loss, transfusions, ventilation time, intensive care unit (ICU) and hospital length of stay. Average operative time was 270 ± 101 min with an estimated blood loss of 509 ± 328 ml, a postoperative ventilation time of 6 ± 12 h, ICU stay of 52 ± 23 h, and a hospital stay of 7 ± 3 days. Nine patients (16%) were converted to open techniques, and transfusion was required in four patients (7%). Follow-up was complete for all patients up to 1 year. There was one hospital death (1.7%) and two deaths at follow-up. Coronary anastomosis was controlled in 48 patients by either angiogram or computed tomography scan, revealing occlusion or anastomotic stenoses (>50%) in six patients. Overall permeability was 92%. Major adverse events occurred in 12 patients (21%). One-year survival was 96%. Our initial experience with robotically assisted coronary surgery is promising: it avoids sternotomy and with a methodical approach we were able to implement the procedure safely and effectively in our practice, combining minimal mortality with excellent survival.

18.
Eur J Cardiothorac Surg ; 28(1): 172-3, 2005 Jul.
Article in English | MEDLINE | ID: mdl-15982601

ABSTRACT

We report our initial experience with aortic valve replacement using robotic assistance. All procedures were performed with peripheral cardiopulmonary bypass, transthoracic aortic cross-clamp, and antegrade cold crystalloid cardioplegia. One or two ports and a 5-cm intercostal incision in the right chest were used for access. All patients had aortic valve replacement performed robotically. Between February and September 2004, five patients underwent robotic aortic valve replacement. The mean age was 59 years (range 35-82 years). There were no incisional conversions, death, stokes, or reoperations for bleeding. Overall mean study times were as follows: procedure, 231.2 min (range 180-315 min); cardiopulmonary bypass, 121.5 min (range 83-173 min), and cross-clamp, 98.2 min (range 67-140 min). One patient developed postoperative pneumonia. Aortic valve replacement can be successfully performed with the da Vinci robotic system.


Subject(s)
Aortic Valve/surgery , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation/methods , Robotics/methods , Adult , Aged , Aged, 80 and over , Feasibility Studies , Female , Humans , Male , Middle Aged , Thoracic Surgery, Video-Assisted/methods
19.
Heart Surg Forum ; 7(6): E551-3, 2004.
Article in English | MEDLINE | ID: mdl-15769684

ABSTRACT

We have developed a technique that enables robotic aortic valve replacement with port access via a small right anterior thoracotomy and minimally invasive aortic cross clamping. The procedure is performed under video guidance with all the annular sutures placed with the robot. In the case we report, the patient's postoperative course was extremely simple and pain was minimal. We believe that this is the first reported aortic valve replacement using robotic technology and that it opens a new field of application for robotic assisted surgery.


Subject(s)
Aortic Valve Insufficiency/surgery , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Robotics/methods , Surgery, Computer-Assisted/methods , Humans , Male , Middle Aged , Treatment Outcome
20.
Heart Surg Forum ; 6(5): 297-301, 2003.
Article in English | MEDLINE | ID: mdl-14721797

ABSTRACT

BACKGROUND: To evaluate the advantages and benefits of a minimized extracorporeal circulation system in the performance of coronary artery bypass grafts. METHODS: From September 2000 to February 2003, 279 consecutive patients underwent isolated coronary artery bypass grafting with minimal extracorporeal circulation. A group of 243 patients at good risk as defined by a Euro- SCORE of 3 underwent complete bypass and blood cardioplegia, and a high-risk group of 45 patients (EuroSCORE, 6) underwent operations with partial assistance and a beating heart. In a prospective substudy analysis of thrombocyte and platelet counts, transfusion requirements, PaO2/FIO2, leukocyte count, C-reactive protein level, postoperative bleeding, intensive care unit stay, and ventilation, 40 patients from the good-risk group were matched and compared with 40 patients who underwent operations with a conventional extracorporeal system. RESULTS: Revascularization was complete with a mean of 2.8 distal anastomoses in the good-risk group and 2.4 in the high-risk group. Mortality rates were 1.2% and 4%, respectively. The system provided either complete or partial bypass assistance and depended on preload and afterload. The system also allowed easy access to all territories with perfect hemodynamic stability. Priming was reduced to 400 mL, and arterial and venous saturation monitoring revealed excellent maintenance of pH values. No complications or failure of the system occurred. Hemodilution, inflammatory response, and transfusion requirements were reduced in the minimal extracorporeal circulation group. CONCLUSIONS: Minimal extracorporeal circulation allows minimal hemodilution and reduces transfusion requirements. The method allows safe and complete revascularization of either an arrested or a beating heart.


Subject(s)
Coronary Artery Bypass/methods , Extracorporeal Circulation/methods , Aged , Anastomosis, Surgical/methods , Anticoagulants/administration & dosage , Case-Control Studies , Coronary Artery Bypass/mortality , Extracorporeal Circulation/instrumentation , Extracorporeal Circulation/mortality , Female , Heart Arrest, Induced/methods , Hemodilution , Heparin/administration & dosage , Humans , Male
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