Ten-year experience with sutureless Perceval bioprosthesis: single-centre analysis in 1157 implants.

AIMS: We describe long-term clinical and echocardiographic outcomes in the largest single-centre cohort of patients who underwent aortic valve replacement (AVR) with sutureless Perceval (CorCym, Italy) bioprosthesis. METHODS: Between March 2011 and March 2021, 1157 patients underwent AVR with Perceval bioprosthesis implantation. Mean age was 77 ±â€Š6 years (range: 46-89 years) and mean EuroSCORE II was 6.7 ±â€Š3.2% (range: 1.7-14.2%). Concomitant procedures were performed in 266 patients (23%). RESULTS: Thirty-day mortality was 1.38% (16/1157). Eight hundred and twenty of 891 (92%) isolated AVRs underwent minimally invasive surgery with a ministernotomy ( n  = 196) or right minithoracotomy ( n  = 624) approach. Cardiopulmonary bypass and aortic cross-clamp times were 81.1 ±â€Š24.3 and 50.6 ±â€Š11.7 min for isolated AVR and 144.5 ±â€Š34.7 and 96.4 ±â€Š21.6 min for combined procedures. At mean follow-up of 53.08 ±â€Š6.7 months (range: 1-120.5 months), survival was 96.5% and mean transvalvular pressure gradient was 13.7 ±â€Š5.8 mmHg. Left ventricular mass decreased from 152.8 to 116.1 g/m 2 ( P  < 0.001) and moderate paravalvular leakage occurred in three patients without haemolysis not requiring any treatment. Freedom from reoperation was 97.6%. Eight patients required surgical reintervention and 19 patients transcatheter valve-in-valve procedure for structural prosthesis degeneration at a mean of 5.6 years after first operation (range: 2-9 years). CONCLUSION: AVR with a Perceval bioprosthesis is associated with good clinical results and excellent haemodynamic performance in our 10-year experience. Structural degeneration rate of Perceval is comparable with other bioprosthetic aortic valves. Sutureless technology may reduce operative time especially in combined procedures and enable minimally invasive AVR.

Right anterior mini-thoracotomy and sutureless valves: the perfect marriage.

BACKGROUND: A minimally invasive approach (MIA) reduces mortality and morbidity in patients referred for aortic valve replacement (AVR). Sutureless technology facilitates a MIA. We describe our experience with the sutureless Perceval (LivaNova, Italy) aortic bioprosthesis through a right anterior mini-thoracotomy (RAMT) approach. METHODS: Between March 2011 and October 2019, 1,049 patients underwent AVR with Perceval bioprosthesis. Five hundred and three patients (48%) were operated through a RAMT approach in the second intercostal space. Considering only isolated AVR (881), 98% of patients were operated with MIA, and Perceval in RAMT approach was performed in 57% of these patients. Eight patients (1.6%) had previously undergone cardiac surgery. The prosthesis sizes implanted were: S (n=91), M (n=154), L (n=218) and XL (n=40). Concomitant procedures were mitral valve surgery (n=6), tricuspid valve repair (n=1), mitral valve repair and tricuspid valve repair (n=1) and miectomy (n=2). Mean age was 78±4 years (range, 65-89 years), 317 patients were female (63%) and EuroSCORE II was 5.9%±8.4%. RESULTS: The 30-day mortality was 0.8% (4/503). Cardiopulmonary bypass (CPB) and aortic cross-clamp times were 81.6±30.8 and 50.3±24.5 minutes respectively for stand-alone procedures. In two patients, early moderate paravalvular leakage appeared as a result of incomplete expansion of the sutureless valve due to oversizing of the bioprosthesis, requiring reoperations at two and nine postoperative days with sutured aortic bioprosthesis implantation. Permanent pacemaker implantation within the first thirty days was necessary in 26 (5.2%) patients. At the mean follow-up of 4.6 years (range, 1 month to 8.6 years), survival was 96%, freedom from reoperation was 99.2%, and mean transvalvular pressure gradient was 11.9±4.3 mmHg. CONCLUSIONS: AVR with the Perceval bioprosthesis in a RAMT approach is a safe and feasible procedure associated with low mortality and excellent hemodynamic performance. Sutureless technology facilitates a RAMT approach.

Aortic Valve Replacement With Perceval Bioprosthesis: Single-Center Experience With 617 Implants.

BACKGROUND: This study describes the clinical and echocardiographic outcomes in a large single-center cohort of patients who underwent aortic valve replacement (AVR) with a sutureless Perceval (LivaNova, Milan, Italy) aortic bioprosthesis. METHODS: Between March 2011 and December 2015, 617 patients underwent AVR with a Perceval bioprosthesis. The mean age was 76 ± 7 years, 388 patients were female (63%), and the mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) II was 6.2% ± 5.4%. Concomitant procedures were mitral valve surgery (n = 74), tricuspid valve repair (n = 22), coronary artery bypass grafting (n = 42), myectomy (n = 3), and ascending aorta replacement (n = 2). RESULTS: The 30-day mortality rate was 1.9% (12 of 617). A total of 475 of 516 (92%) patients who had isolated AVR underwent minimally invasive surgery with an upper ministernotomy (n = 81) or a right anterior minithoracotomy (n = 394) approach. Cardiopulmonary bypass and aortic cross-clamp times were 81.7 ± 29.1 minutes and 50.5 ± 19.8 minutes for isolated AVR and 139.7 ± 51.5 minutes and 91.5 ± 29.5 minutes for combined procedures, respectively. At mean follow-up of 16.3 months (range, 0 to 51.9 months), the survival rate was 91.3%, the rate of freedom from reoperation was 99%, and the mean transvalvular pressure gradient was 11.9 ± 5.4 mm Hg. Left ventricular ejection fraction increased from 53.6% ± 8.4% to 54.5% ± 4.8% (p = 0.40), left ventricular mass decreased from 146.5 to 112.6 g/m2 (p < 0.001), and moderate paravalvular leakage occurred in 3 patients without hemolysis who did not require any treatment. CONCLUSIONS: AVR with the Perceval bioprosthesis is associated with low mortality rates and excellent hemodynamic performance. Sutureless technology may reduce operative times, especially in combined procedures, and may make minimally invasive AVR more easily reproducible.

EuroSCORE Performance in Minimally Invasive Cardiac Surgery: Discrimination Ability and External Calibration.

OBJECTIVE: Prediction of operative risk in adults undergoing cardiac surgery remains a challenge. The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is one of the most commonly used in clinical settings. Recently, the new EuroSCORE II was published attempting to improve the accuracy of risk prediction. We sought to assess the predictive value of EuroSCORE or EuroSCORE II in selected field of minimally invasive cardiac surgery. METHODS: Patients who underwent cardiac surgery operation with minimally invasive approach from 2007 to 2013 identified from prospective cardiac surgical database. Additional variables included in EuroSCORE II, but not in original EuroSCORE, were retrospectively collected via electronic health records reviewing. The C-statistic was calculated for the EuroSCORE (additive and logistic) and EuroSCORE II. The Hosmer-Lemeshow test was used to assess model calibration by comparing observed and expected morality in number of risk strata. RESULTS: There were 39 hospitals deaths (1.6%). A total of 2472 patients were identified from the main database. The mean ± SD logistic EuroSCORE was 7.6 ± 8.3, mean ± SD additive EuroSCORE was 6.1 ± 2.7, and mean ± SD EuroSCORE II was 2.9 ± 4.2. EuroSCORE logistic model performed with substantial accuracy of 0.78, EuroSCORE additive performed with accuracy of 0.78, and EuroSCORE II performed as almost perfect 0.82. Model calibration was poor in EuroSCORE II (χ = 17.57, P = 0.02), calibration for logistic EuroSCORE was also poor (χ = 140.58, P < 0.01), and additive model also (χ = 94.95, P < 0.01). The area under the curve was high in all algorithms; logistic EuroSCORE was 0.78 (95% confidence interval = 0.71-0.85), additive EuroSCORE was 0.79 (95% confidence interval = 0.71-0.86), and EuroSCORE II was 0.82 (95% confidence interval = 0.75-0.89). CONCLUSIONS: In overall settings, original EuroSCORE and EuroSCORE II perform poorly in minimally invasive operation conditions. Data suggest that EuroSCORE could not be used for estimating operative risks correctly. New risk score should be explored, developed, and implemented for selective minimally invasive cohorts.

Antegrade and retrograde perfusion in minimally invasive mitral valve surgery with transthoracic aortic clamping: a single-institution experience with 1632 patients over 12 years.

Objectives: The aim of the present study was to evaluate the impact of a retrograde arterial perfusion (RAP) strategy versus an antegrade arterial perfusion (AAP) strategy in a consecutive, large cohort of patients who underwent minimally invasive mitral valve surgery with transthoracic aortic clamping through a right minithoracotomy. Methods: Between 2003 and 2015, 1632 consecutive patients underwent first-time minimally invasive mitral valve surgery with transthoracic aortic clamping at our institution; 141 (8.6%) of these patients received retrograde perfusion with femoral artery cannulation, whereas 1421 (91.4%) received antegrade perfusion with ascending aorta cannulation. Logistic regression was used to evaluate outcomes and risk factors for death and stroke between groups. Results: The overall frequency of 30-day mortality was 0.7% (13/1632) and was similar between groups (retrograde arterial perfusion RAP 0.7% vs AAP 0.8%; P = 0.903). The overall postoperative stroke rate was 1.3% (22/1632). The stroke rate was significantly higher in patients receiving retrograde perfusion (3.5% vs 1.1%; P = 0.005). Risk factors for death were advanced age (odds ratio (OR) = 1.3; P = 0.004), mitral valve replacement (OR = 3.9; P = 0.05), emergent procedure (OR = 3.4; P = 0.014) and conversion to sternotomy (OR = 3.7; P = 0.001). Multivariable regression analysis revealed that retrograde perfusion was an independent risk factor for stroke (OR = 3.3; P = 0.004). Other risk factors were conversion to sternotomy (OR = 12; P = 0.001), active endocarditis (OR = 5.8; P = 0.07) and hypercholesterolaemia (OR = 2.4; P = 0.048). Interaction modelling revealed that the only significant risk factor for a neurological event was the use of retrograde perfusion in patients older than 70 years with an atherosclerotic burden (OR = 6.4; P = 0.033). Conclusions: Minimally invasive mitral valve procedures can be performed with low morbidity and mortality. The use of retrograde perfusion is associated with a higher incidence of neurological complications in older patients with atherosclerotic burden. Central aortic cannulation permits avoidance of complications associated with retrograde perfusion and extends the suitability of minimally invasive mitral procedures to those patients who have an absolute contraindication for femoral artery cannulation.

Exploring the learning curve for minimally invasive sutureless aortic valve replacement.

OBJECTIVE: The study objective was to assess the learning process and quality of care of right minithoracotomy aortic valve replacement with a sutureless bioprosthesis at a single institution. METHODS: We performed an analysis of the first 300 consecutive patients (aged 76 ± 6 years; logistic European System for Cardiac Operative Risk Evaluation 9 ± 6) who underwent sutureless valve implantation via a right minithoracotomy by 6 surgeons at the G. Pasquinucci Heart Hospital between 2011 and 2015. The learning curve was analyzed by dividing the study population into tertiles of 100 patients each. Departmental and individual learning curves were calculated using sequential probability cumulative sum failure analysis. Quality indicators were 2 composite end points reflecting the technical success and 30-day complications. RESULTS: The overall mortality was 0.7% (2 patients). No significant differences were noted in terms of mortality and complications between tertiles. The sutureless valve was implanted successfully in 99% of patients (298/300). Cumulative sum analysis failed to identify any significant learning effects for technical success. Nevertheless, surgeons A, B, and C had a small initial learning curve, and surgeons D, E, and F did not, reflecting a trend toward a positive effect of cumulative institutional experience on the individual learning curve. The 30-day complications analysis revealed a cluster of failures at the beginning of the experience. This cluster prompted an internal audit and modification of the patients' selection process. Consecutively, the procedure returned in control. CONCLUSIONS: Right minithoracotomy sutureless valve implantation can be performed safely without learning curve effects. Cumulative sum analysis is a valuable tool to describe and monitor the learning process. The analysis can identify periods of less than expected performance and alert the team to react.

Minimally invasive mitral valve surgery in high-risk patients: operating outside the boxplot.

OBJECTIVES: (i) To establish who is at high risk for mitral surgery. (ii) To assess the performance of minimally invasive mitral valve surgery in high-risk patients by presenting early and late outcomes and compare these with those of the non-high-risk population. METHODS: We reviewed our database of prospective data of 1873 consecutive patients who underwent minimally invasive mitral surgery from 2003 to 2015. To establish an unbiased definition of risk cut-off, we considered as high-risk the 'outliers of risk' identified using boxplot analysis in relation to EuroSCORE II. RESULTS: Two hundred and five patients were outliers, with 98 as minor (EuroSCORE II ≥ 6%) and 107 as major outliers (EuroSCORE II ≥ 9%). Outliers accounted for several different comorbidities. Nineteen patients died while in hospital (9.2%); different postoperative complications were observed. Outliers had a significantly lower mean survival time and a higher risk of cardiac-related death than the general population; however, the worst outcomes were observed in major outliers. No statistically significant difference was found with regard to the need for mitral reintervention and the degree of mitral regurgitation at follow-up. CONCLUSIONS: Boxplot analysis helped to achieve an internal definition of risk cut-off, starting from EuroSCORE II ≥ 6%. Minimally invasive mitral surgery in these outliers of risk was associated with acceptable early and long-term results; however, major outliers with EuroSCORE II ≥ 9% may benefit from catheter-based procedures.

Minimally Invasive Mitral Valve Surgery in Truly High-Risk Patients: Are We Pushing the Boundaries?: An Observational Study.

OBJECTIVE: This study aimed to assess in a retrospective series of truly high-risk patients who underwent minimally invasive mitral valve surgery: (1) postoperative and long-term results and (2) logistic EuroSCORE and EuroSCORE II discrimination power. METHODS: Between 2003 and 2013, we reviewed in our institution patients who underwent minimally invasive mitral valve surgery with or without tricuspid valve repair via right minithoracotomy with logistic EuroSCORE of 20 or higher. RESULTS: Among a total number of 1604, 88 patients were identified. Median logistic and EuroSCORE II was 27.29 (interquartile range, 15.3) and 12.7% (11.3%), respectively. Mean (SD) age was 71.9 (8.4) years; 42 were female (47.7%); 60 patients (68.1%) underwent previous sternotomy. Mitral valve was replaced in 59 (67%) and repaired in 29 (32.9%) patients; tricuspid valve repair was performed in 23 patients (26.1%). Median cardiopulmonary bypass and cross-clamp times were 157 minutes (interquartile range, 131-187 minutes) and 83 minutes (81-116 minutes), respectively; conversion to sternotomy and reopening for bleeding was necessary in 4 (4.5%) and 3 (3.4%) patients; permanent and transient neurological injuries were reported in 6 (6.8%) and 3 (3.4%) patients; acute kidney injury was reported in 13 patients (14.7%); 15 patients (17%) had pulmonary complications. Ten patients died while in the hospital (11.2%). Survival at 6 years was 78% (95% confidence interval, 69-88). CONCLUSIONS: In this series of truly high-risk patients, minimally invasive mitral surgery was associated with acceptable early mortality and morbidity as well as long-term outcomes; both logistic and EuroSCORE II showed suboptimal discrimination power.

Accuracy of EuroSCORE II in patients undergoing minimally invasive mitral valve surgery.

OBJECTIVES: EuroSCORE II has been implemented with the view to providing better performance than the previous logistic EuroSCORE. However, until now, no external validations have been carried out in the minimally invasive context. Therefore, we sought to validate the accuracy of EuroSCORE II in a retrospective series of consecutive patients undergoing minimally invasive mitral valve surgery. METHODS: Data of 1609 consecutive patients who underwent minimally invasive mitral valve surgery in our institution were retrospectively reviewed. The accuracy of EuroSCORE II was assessed in terms of discrimination and calibration. Discrimination was tested via analysis of the area under the curve of receiver operator characteristic; calibration was achieved by calculating the observed versus expected mortality ratio and the Hosmer-Lemeshow test for test probability; global accuracy was assessed by using Brier's score; results were compared with the previous logistic EuroSCORE version. EuroSCORE II performance was also tested for discrimination of postoperative complications. Discrimination subgroup analysis was carried out for single surgeon results, and for high-risk patients those outliers were defined after boxplot analysis (EuroSCORE II ≥6%). RESULTS: EuroSCORE II showed good discrimination power (area under the curve 0.846), and was statistically superior to logistic EuroSCORE (P = 0.01). In terms of calibration, both EuroSCORE II and logistic over-predicted mortality; with regard to adverse events, the discrimination of EuroSCORE II was adequate for acute renal failure, low-output syndrome and increased intensive care unit stay; area under the curve of receiver operating characteristic for high-risk patients with EuroSCORE ≥6% was suboptimal (0.654); single surgeon results did not influence the discrimination of EuroSCORE II. CONCLUSIONS: EuroSCORE II showed good discrimination power in our series of minimally invasive mitral valve patients; however, it over-predicted mortality. Individual performance did not influence discrimination. Performance was suboptimal for prediction of complications and for high-risk subgroup in-hospital mortality.

Enhancing quality control and performance monitoring in thoracic aortic surgery: a 10-year single institutional experience.

OBJECTIVES: The aim of the present study was to monitor performance and learning effects for thoracic aortic surgery. In addition, we evaluated the volume-outcome relationship of patients undergoing surgery of the thoracic aorta, comparing the results of two higher-volume surgeons (HVSs) with six lower volume surgeons. METHODS: A total of 867 thoracic aortic procedures (elective cases n = 753 and Type A acute dissection n = 114) were performed from 2003 to 2013 by eight surgeons (range 28-238 procedures) at our institution. Departmental and individual performance was monitored using control charts, with a predetermined acceptable failure rate of 10%. Perioperative death or one or more of four adverse events constituted failure. Moreover, results of two higher-volume operators (n = 460; 53%) were compared with those of six lower-volume operators (n = 407; 47%). RESULTS: The incidence rate of in-hospital mortality for elective cases was 2% and for Type A dissection repair 9.6%. Institutional control charts revealed that the surgical process was under control for all the study periods apart from small periods of worse than expected performance which were congruent with new surgeons joining the programme. The predominant surgical failure was reoperation for bleeding. There were differences between surgeons with regard to the learning curves and performance. No significant differences were observed between high- and low-volume surgeons in terms of mortality and morbidity for elective cases. However, high-volume surgeons presented a trend suggesting a higher mortality rate in Type A aortic dissection repair (17.1 vs 6.3%; P = 0.09). CONCLUSIONS: Thoracic aortic surgery can be performed with similar results by high- and low-volume surgeon. Control charts can facilitate learning effects and performance monitoring. Implementation of continuous departmental and individual performance monitoring is practicable.

Minimally invasive right thoracotomy approach for mitral valve surgery in patients with previous sternotomy: a single institution experience with 173 patients.

OBJECTIVE: This study presents a review of our experience with minimally invasive mitral valve surgery (MIMVS) in patients with a previous cardiac procedure performed through a sternotomy over a 10-year period. METHODS: From November 2003 to August 2013, 173 patients (age 61.3 ± 12.4 years) underwent reoperative MIMVS through a right minithoracotomy. Previous operations were coronary artery bypass grafting (n = 49; 28.6%), a mitral valve procedure (n = 120; 70.1%), an aortic valve procedure (n = 32; 18.7%), and other operations (n = 14; 8.1%). The mean euroSCORE was 11.2 ± 3.8. The time to redo surgery was 6.9 ± 4.2 years. RESULTS: Procedures were performed with central aortic cannulation in 55 patients (31.7%) and peripheral cannulation in 118 (68.3%). A transthoracic clamp was used in 58 patients (33.5%), an endoaortic balloon in 72 (41.6%), hypothermic ventricular fibrillation in 23 (13.2%), and beating heart in 20 (11.5%). Mean cardiopulmonary bypass and crossclamp times were 160 ± 58 minutes and 82 ± 49 minutes, respectively. Mitral repair was performed in 53 patients (30.6%). Forty-three patients (24.7%) had an additional cardiac procedure. Conversion to sternotomy was necessary in 2 patients (1.1%) and reoperation for bleeding in 11 patients (6.3%). Thirty-day mortality was 4.1% (n = 7). Major morbidities included stroke (n = 11; 6%) and new-onset dialysis requirement (n = 4; 2.3%). The mean blood transfusion requirement was 1.4 ± 1.1 units. Mean follow-up was 3.3 ± 2.6 years. Survival at 1, 5, and 10 years was 93.1% ± 1.9%, 87.5% ± 2.7%, and 79.7% ± 3.8%, respectively. CONCLUSIONS: Reoperative mitral valve surgery can be safely performed through a right minithoracotomy with good early and late outcomes. The avoidance of extensive surgical dissection, optimal valve exposure, and low blood transfusion are the main advantages of this technique.

Aortic valve replacement through right anterior minithoracotomy: can sutureless technology improve clinical outcomes?

BACKGROUND: The impact of sutureless prosthesis on the clinical outcome in minimally invasive aortic valve replacement is still unclear. We assessed mid-term outcomes of the sutureless and conventional valves implanted through right anterior minithoracotomy. METHODS: Five hundred fifteen patients undergoing primary aortic valve replacement through a right anterior minithoracotomy (269 conventional versus 246 sutureless prostheses) between 2004 and 2014 were reviewed. The most common sutured prostheses were Carpentier-Edwards Perimount and Medtronic Mosaic, and the Sorin Perceval S mainly composed the sutureless prosthesis group. One hundred thirty-three pairs of patients were propensity matched and retrospectively analyzed. RESULTS: Cardiopulmonary bypass (p<0.0001) and cross-clamping (p<0.0001) times were shorter in the sutureless group (S group). We observed the same in-hospital mortality (1 versus 2; p=0.62) and incidence of postoperative stroke and pacemaker implant between the groups, but shorter duration of mechanical ventilation (6 versus 7 hours; p=0.001) in the S group. Generally, larger prostheses were implanted in the S group (p<0.0001). Follow-up was longer (p<0.0001) for sutured valves: 52 versus 15 months (overall median, 21 months). Overall Kaplan-Meier survival rate was 87.2% versus 97.0% (p=0.33) and 50% versus 100% (p=0.02) in elderly patients for sutured versus sutureless prostheses, respectively. Freedom from reoperation at follow-up (p=0.64) and transaortic gradients (12 versus 11 mm Hg; p=0.78) did not differ in the two groups. CONCLUSIONS: In the present limited cohort of patients, sutureless prostheses reduced operative times for aortic valve replacement and the duration of mechanically assisted ventilation and might have influenced early and mid-term survival. Larger studies are needed to confirm our data and compare long-term outcomes.

Training surgeons in minimally invasive mitral valve repair: a single institution experience.

BACKGROUND: We aimed to study the results of minimally invasive mitral valve repair performed by 5 young surgeons who were trained in mitral valve repair directly through a minimally invasive approach, and a senior surgeon who introduced the technique at our institution and was responsible for the training program. METHODS: This was a retrospective, observational cohort study of prospectively collected data from 595 consecutive patients who underwent minimally invasive mitral repair performed by 5 trainees (n = 240, 40.3%) and by our lead consultant (n = 355, 59.7%) between 2007 and 2013. Treatment selection bias was controlled by constructing a propensity score from core patient characteristics and it was included along with the comparison variable in the multivariable analyses of outcome. RESULTS: Patients operated on by trainees were more likely to be female (p = 0.04), older (p = 0.001), and with history of atrial fibrillation (p = 0.001). Trainees required a significant longer cardiopulmonary bypass (137 ± 56 vs 123 ± 52 minutes; p = 0.003) and aortic clamp time (97 ± 41 vs 83 ± 40 minutes; p = 0.001). I-hospital mortalities were 1.3% in the trainees group and 0.8% in the senior surgeon group (p = 0.6). The incidence of stroke (1.7% vs 2.5%; p = 0.5), conversion to sternotomy (2.6% vs 3.5%; p = 0.5), and conversion to mitral valve replacement (12.5% vs 10.9%; p = 0.6) were similar between groups. No differences were found regarding other complications. Five-year survival (88.9% vs 89.5%; p = 0.4) and freedom from reoperation (94.5% vs 95.1; p = 0.6) were similar between groups. CONCLUSIONS: Minimally invasive mitral valve repair is a safe and reproducible surgical technique that can be taught successfully to cardiac trainees.

Two alternative sutureless strategies for aortic valve replacement: a two-center experience.

OBJECTIVE: Important comorbid conditions in patients referred for aortic valve replacement (AVR) require less invasive strategies. We describe our initial experience with the Perceval S (Sorin Group, Saluggia, Italy) and 3f Enable (Medtronic, Minneapolis, MN USA) sutureless aortic bioprostheses. METHODS: We compared intraoperative data, postoperative clinical outcomes, and echocardiographic results from patients receiving a Perceval S (P group; n = 97) or a 3f Enable (E group; n = 32) prosthesis in two cardiac surgery departments (Nuremberg, Germany, and Massa, Italy). RESULTS: Baseline patient characteristics were similar in both groups, except for mean ± SD body surface area (P group = 2.01 ± 2.9 m, E group = 1.83 ± 3.8 m; P < 0.001). Sixty-five patients (67%) in the P group and 19 patients (59.5%) in the E group (P = 0.22) underwent minimally invasive AVR with either ministernotomy or right anterior minithoracotomy approach. Concomitant procedures were performed in 37 patients (38%) in the P group and 9 patients (28%) in the E group (P = 0.56). In-hospital mortality was 2%. The mean ± SD prosthesis diameter was 23.5 ± 1.4 mm (P group) compared with 22.1 ± 2 mm (E group) (P < 0.001). In isolated AVR, aortic cross-clamp time was 36 ± 12.7 minutes in the P group and 66 ± 18 minutes in the E group (P < 0.001). At a mean ± SD follow-up of 8.3 ± 4.5 months, survival was 97% (one death in the P group). In five patients (P group = 1, E group = 4), a moderate paravalvular leak was present (P = 0.013). The mean ± SD transvalvular gradient was 9.1 ± 3.3 mm Hg with the Perceval S and 11.2 ± 5.2 mm Hg with the 3f Enable (P = 0.017). CONCLUSIONS: Aortic valve replacement with sutureless aortic bioprosthesis is feasible, also with a minimally invasive approach. The Perceval S showed lower operative times and moderate paravalvular leaks and lower mean transvalvular gradients than did the 3f Enable, related to the larger diameter of the Perceval S implanted. Both prostheses showed an excellent hemodynamic performance. This new technology needs long-term follow-up.

Sutureless implantation of the perceval s aortic valve prosthesis through right anterior minithoracotomy.

BACKGROUND: Many new, less invasive strategies are proposed for aortic valve operation in elderly patients. Rapid deployment sutureless aortic valve prosthesis has been recently introduced. We analyzed our experience with a sutureless valve implanted through a minimally invasive approach. METHODS: A retrospective observational study with prospectively registered data was conducted on 137 patients undergoing aortic valve replacement through a right anterior minithoracotomy. Between April 2011 and January 2013, 137 consecutive patients underwent aortic valve replacement with a recently introduced, rapid deployment, sutureless pericardial valve in minithoracotomy access (47 men; mean age, 76.6 ± 7.1 years). There were 35 obese patients with a body mass index of more than 30 kg/m(2). Mean logistic EuroSCORE I was 10.0; 74 (54%) patients were in New York Heart Association functional class III and IV. In all, 19 (13.9%), 45 (32.8%), and 73 (53.3%) patients received 21-, 23-, and 25-mm valve prostheses, respectively. RESULTS: The mean aortic cross-clamp and cardiopulmonary bypass times were 59.3 ± 19 min and 92.3 ± 27 min, respectively. No operative mortality occurred. Median stay in the intensive care unit was 1 day, with assisted ventilation necessary for a median of 6 hours. Three cases of postoperative ischemic stroke were observed (1 patient with a previous history of an ischemic cerebral event). Median hospital length of stay was 6 days. CONCLUSIONS: A sutureless valve for minimally invasive aortic valve replacement is a feasible, effective, and safe tool. Ultimately amplifying indications for less invasive aortic valve replacement in a high surgical risk subset of patients, it can become a valid alternative for transcatheter aortic valve implantation.

Sutureless aortic valve implantation through an upper v-type ministernotomy: an innovative approach in high-risk patients.

OBJECTIVE: Aortic valve replacement in minimally invasive approach has shown to improve clinical outcomes even with a prolonged cardiopulmonary bypass and aortic cross-clamp (ACC) time. Sutureless aortic valve implantation may ideally shorten operative time. We describe our initial experience with the sutureless 3f Enable (Medtronic, Inc, ATS Medical, Minneapolis, MN USA) aortic bioprosthesis implanted in minimally invasive approach in high-risk patients. METHODS: Between May 2010 and May 2011, thirteen patients with severe aortic stenosis underwent aortic valve replacement with the 3f Enable bioprosthesis through an upper V-type ministernotomy interrupted at the second intercostal space. The mean ± SD age was 77 ± 3.9 years (range, 72-83 years), 10 patients were women, and the mean ± SD logistic EuroSCORE was 15% ± 13.5%. Echocardiography was performed preoperatively, at postoperative day 1, at discharge, and at follow-up. Clinical data, adverse events, and patient outcomes were recorded retrospectively. The median follow-up time was 4 months (interquartile range, 2-10 months). RESULTS: Most of the implanted valves were 21 mm in diameter (19-25 mm). The CPB and ACC times were 100.2 ± 25.3 and 66.4 ± 18.6 minutes. At short-term follow-up, the mean ± SD pressure gradient was 14 ± 4.9 mm Hg; one patient showed trivial paravalvular leakage. No patients died during hospital stay or at follow-up. CONCLUSIONS: The 3f Enable sutureless bioprosthesis implanted in minimally invasive approach through an upper V-type ministernotomy is a feasible, safe, and reproducible procedure. Hemodynamic and clinical data are promising. This innovative approach might be considered as an alternative in high-risk patients. Reduction of CPB and ACC time is possible with increasing of experience and sutureless evolution of actual technology.

Antegrade and retrograde arterial perfusion strategy in minimally invasive mitral-valve surgery: a propensity score analysis on 1280 patients.

OBJECTIVES: Recent studies have suggested an increased risk of stroke in patients undergoing minimally invasive mitral-valve surgery with retrograde perfusion when compared with antegrade perfusion. The aim of the present study was therefore to evaluate the impact on early outcome of retrograde arterial perfusion (RAP) strategy vs antegrade arterial perfusion strategy in a consecutive large cohort of patients who underwent minimally invasive mitral-valve surgery through a right minithoracotomy. METHODS: Between 2003 and 2012, 1280 consecutive patients underwent first-time minimally invasive mitral-valve surgery at our institution. A total of 167 (13%) of these patients received a retrograde perfusion, while 1113 (87%) received antegrade perfusion. Logistic analysis was used to evaluate outcomes and risk factors for stroke. Treatment selection bias was controlled by constructing a propensity score from core patient characteristics. The propensity score was the probability of receiving retrograde perfusion and was included along with the comparison variable in the multivariable analyses of outcome. RESULTS: The overall frequency of in-hospital mortality was 1.1% (14/1280) and postoperative stroke was 1.6% (21/1280). After adjusting for the propensity score, RAP was associated with a higher incidence of stroke (5 vs 1%; P = 0.002), postoperative delirium (14 vs 5%, P = 0.001) and aortic dissection (1.7 vs 0%; P = 0.01). Multivariable regression analysis revealed that the use of retrograde perfusion was an independent risk factor for stroke [odds ratio (OR) 4.28; P = 0.02] and postoperative delirium (OR 3.51; P = 0.001). CONCLUSIONS: Minimally invasive mitral valve procedure can be performed with low morbidity and mortality. The use of retrograde perfusion is associated with a higher incidence of neurological complications and aortic dissection when compared with antegrade perfusion. Central aortic cannulation allows the avoidance of complications associated with retrograde perfusion while extending the suitability of minimally invasive mitral procedures also to those patients who have an absolute contraindication to femoral artery cannulation.

Severe mitral regurgitation in patients with postinfarction interventricular septal defect: a simple way of simultaneous valve repair.

Ventricular septal defect, a potentially deadly complication of transmural myocardial infarction, is often accompanied by ischaemic mitral regurgitation. It has been recognized that the presence and persistence of the latter negatively affect survival rates in patients after myocardial infarction. We present a simple endoventricular edge-to-edge technique of mitral repair using a single U-shaped stitch of polytetrafluoroethylene and a refined double-patch 'exclusion' technique of postinfarction interventricular septal defect (PVSD) closure in the treatment of two consecutive cases of PVSD and concomitant ischaemic mitral regurgitation. This technique is effective and reproducible to address mitral incompetence in patients undergoing surgical correction of PVSD.

Short-term follow up with the 3f Enable aortic bioprosthesis: clinical and echocardiographic results.

BACKGROUND AND AIM OF THE STUDY: High-risk patients referred for aortic valve replacement (AVR) may benefit from sutureless technology in order to reduce mortality and morbidity. Herein is described the authors' initial experience and short-term results of the sutureless 3f Enable aortic bioprosthesis. METHODS: A total of 28 patients (19 females, nine males; mean age 76.8 +/- 5.1 years; range: 66 to 86 years) with symptomatic aortic valve disease underwent AVR with the 3f Enable bioprosthesis between May 2010 and May 2011. Preoperatively, the mean logistic EuroSCORE was 13.7 +/- 10.8%. Concomitant procedures included mitral valve replacement (n = 1), tricuspid valve repair (n = 3) and coronary artery bypass grafting (n = 5). Echocardiography was performed preoperatively, at postoperative day 1, at discharge, and at follow up. RESULTS: The in-hospital mortality was 3.5% (1/28). Seventeen patients underwent minimally invasive AVR via an upper partial ministernotomy (n = 13) or a right anterior minithoracotomy (n = 4) approach. The cardiopulmonary bypass (CPB) and aortic cross-clamp (ACC) times were 99.4 +/- 22.9 and 65.9 +/- 18.0 min, respectively, for isolated AVR, and 138.8 +/- 62.2 and 100.5 +/- 52.2 min, respectively, for combined procedures. One patient underwent aortic root replacement for an intimal aortic lesion after sutureless implantation. At a median follow up of four months (range: 2-10 months), survival was 96.5%, freedom from reoperation was 96.5%, and the mean transvalvular pressure gradient was 11.1 +/- 5.4 mmHg. CONCLUSION: AVR with the 3f Enable bioprosthesis in high-risk patients is a safe and feasible procedure that is associated with a low mortality and excellent hemodynamic performance.

Enhancing departmental quality control in minimally invasive mitral valve surgery: a single-institution experience.

OBJECTIVES: In recent years, there has been an increasing interest in monitoring the quality of cardiac surgical performance. The aim of the present study was to apply control charts (CUSUM curves) to monitor the performance of minimally invasive mitral valve procedures to enhance quality control for that operation. METHODS: A total of 936 minimally invasive mitral valve procedures were performed from September 2003 to March 2011 by seven surgeons (range 26-401 procedures) at a single institution. Institutional and individual surgeons' performances were monitored using descriptive statistics and control charts, with a predetermined acceptable failure rate of 10% and calculated 80% alert and 95% alarm lines. Perioperative death or one or more of seven adverse events constituted failure. RESULTS: The incidence of in-hospital mortality was 1.8% (17/936) and compared favourably with the predicted mortality (logistic EuroSCORE 7.3%). Institutional CUSUM analysis revealed an initial learning curve and then the surgical process remained in control for all the study period. There were differences between surgeons with regard to the learning curves and perioperative complications (7.3-11.3%, P = 0.9). Five surgeons crossed the 95% reassurance boundary between operations 23 and 48. One surgeon crossed the 95% reassurance boundary after 116 operations. No surgeon crossed the 95% alarm line, which indicates unacceptably high failure rates. CONCLUSIONS: Minimally invasive mitral surgery can be safely performed with low morbidity and mortality. CUSUM curve analysis is a simple statistical method to implement continuous individual and departmental performance monitoring.