Glauber Mattia 1

Presenter disclosure information Dr Glauber disclose a financial relationship for educational program with Sorin Group. Dr Glauber is Principal Investigator of Fundation Study sponsored by Edwards and is part of Medtronic Advisory Board.

1. Right Anterior Minithoracotomy92% 2. Ministernotomy 8% MIAVR Surgical Access in 593 Pts

CT evaluation: anatomical complexity Complexity is lower if at the level of PA bifurcation: Rule 1. Aorta is rightward (>50% aorta from right sternal) Rule 2. The distance from ascending aorta to sternum < 10 cm

α Angle α ≥45° CT evaluation: anatomical complexity

Exclusion criteria: Severe enphisema and COPD Need for ascending aortic surgery Redo’s with bioprosthetic valve replacement

Causesn/N (%) unexpected right pleural cavity adhesions2/13, 15.4% technical impossibility to advance the percutaneous venous cannula 2/13, 15.4% bleeding5/13, 38.5% arterial hypotension with haemodynamic instability1/13, 7.7% difficult weaning from CPB1/13, 7.7% perivalvular leak2/13, 15.4% 13 patients (0.2%) out 593 needed conversion to full sternotomy

Methods Retrospective observational study Prospectively collected data from consecutive patients Time frame: August 2004 – May patients Median follow up: 31 months (interquartile range, months; cumulated follow-up 1531 patient-years) Follow-up 98% complete

Baseline preoperative data Variable(n=593) Age, years73.8 ( ) Female283 (47.7%) Body mass index, kg/sq m 26.4±4.1 Obesity114 (19.2%) Arterial hypertension412 (69.5%) Hypercolesterolemia348 (58.7%) Diabetes mellitus type II124 (20.9%) Smoke history183 (30.9%) Family history of CAD178 (30.0%) Variable(n=593) Extracardiac arteriopathy93 (15.7%) Previous TIA4 (0.67%) Previous stroke10 (1.7%) Preoperative atrial fibrillation46 (7.8%) Previous pacemaker implant12 (2.0%) Chronic renal failure30 (5.1%) Dialysis6 (1.0%)

Variable(n=593) COPD79 (13.3%) Previous interventional cardiologic procedure 55 (9.3%) Redo surgery9 (1.5%) Previous myocardial infarction 20 (3.4%) Preoperative critical status2 (0.33%) Liver cirrhosis5 (0.84%) Aortic valve lesion - Stenosis - Mixed lesion - Regurgitation 452 (76.2%) 55 (9.3%) 86 (14.5%) Baseline preoperative data Variable (n=593) Peak gradient [mmHg] 80 (62-97) LVEF [%] 60 (55-60) LVEF < 30% 8 (1.3%) NYHA III or IV 171 (28.8%) Urgency or emergency86 (14.5%) EuroSCORE version I6.00 ( ) Logistic EuroSCORE5.76 ( )

Intraoperative data Variable (n=593) Associated procedures 52 (8.8%) - Mitral valve procedure 33 (5.6%) - Tricuspid valve procedure 6 (1.0%) - AF ablation 15 (2.5%) - Others (septal myectomy by Morrow, left atrial appendage closure, VSD repair, aortic annulus reconstruction) 8 (1.3%)

% Intraoperative data

Implanted prosthesis N (%) MECHANICAL VALVES:15 (2.5%) Sorin Bicarbon Slimline10 (1.7%) Carbomedics3 (0.51%) St Jude2 (0.34%) BIOLOGICAL VALVES (SUTURED): 283 (47.7%) Carpentier-Edwards Perimount pericardial265 (44.7%) Metronic Mosaic porcine bioprosthesis 18 (3.0%) BIOLOGICAL VALVES (SUTURELESS): 295 (50%) Edwards Intuity aortic valve system6 (1.0%) ATS 3F Enable sutureless bioprosthesis3 (0.51%) Perceval sutureless prosthesis286 (48.2%)

Results Variable Overall population (n=593) Isolated AVR (n=541) Isolated AVR with sutured prostheses (n=258) Isolated AVR with sutureless prostheses (n=283) Δ CPB time min 107 (86-135) 104 (84-129) 121 ( ) 78 (77-107) 23% X-clamp time min 74 (55-96) 71 (54-92) 87 (75-109) 51 (37- 68) 37% Operative times: overall data and comparison between subgroups

Results Variable cohort (n=593) ICU length of stay, days1 (1-1) Prolonged ICU stay ( > 1 day)53 (8.9%) Assisted ventilation time, <12h6 (5-9) Prolonged ventilation support ( > 12h)22 (3.7%) Hospital length of stay, days6 (6-7) In-hospital mortality9 (1.5%)

Results Variable (n=593) Reopening for bleeding or cardiac tamponade 30 (5.1%) Perioperative AMI 9 (1.5%) Infective complications19 (3.2%) Stroke10 (1.7%) Transient ischemic attack6 (1.0%) Perioperative acute kidney injury23 (3.9%) New onset CVVH 2 (0.34%) Complete AV block and PM implant 19 (3.2%)

Results

Results Variable Hazard ratio (Exp (B)) 95% confidence interval P value NYHA CLASS logistic EuroSCORE ventilation time complete AV block and pacemaker implant sutureless/sutured prosthesis Independent predictors of mortality by Cox multivariate proportional hazards regression analysis

Results Multivariable logistic regression analysis: independent predictors of complete AV block Variable Odds ratio 95% confidence interval P value family history of CAD logistic EuroSCORE fourth quartile of logistic EuroSCORE chronic bronchodilators use patient’s height p=0.81 for goodness-of-fit by Hosmer-Lemeshow

Minimally invasive AVR is SAFE: low perioperative morbidity low rates of reoperation and death at late fup Excellent outcomes can be achieved with minimally invasive AVR through RAMT Sutureless prostheses facilitate minimally invasive AVR and are associated with reduced operative times Conclusions

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