Minimally Invasive Versus Full Sternotomy Sutureless Aortic Bioprosthesis Implantation: Results From An International Registry
Marco Solinas1, Giovanni Concistrè1, Jose Cuenca2, Roberto Di Bartolomeo3, Max Baghai4, Daniela Zakova5, Theodor Fischlein6, Giovanni Troise7, Giorgio Vigano8, Lorenzo Di Bacco9, Mattia Glauber9.
1Ospedale del Cuore G.Pasquinucci, Massa, Italy, 2Complexo Hospitalario Universitario A Coruña, Coruña, Spain, 3Policlinico Sant'Orsola, Bologna, Italy, 4King's College Hospital, London, United Kingdom, 5CKTCH, Brno, Czech Republic, 6Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany, 7Fondazione Poliambulanza, Brescia, Italy, 8UMCG, Groningen, Netherlands, 9Istituto Clinico Sant'Ambrogio, Milan, Italy.
BACKGROUND: Recent studies have showed the advantages of using sutureless biological prostheses in minimally invasive cardiac surgery (MICS), thereby reducing the risks associated with prolonged myocardial ischaemia. Aim of this report is to compare the outcomes of patients enrolled in an international registry, who received a sutureless prosthesis through a minimally invasive approach, against to those operated through a conventional full sternotomy. METHODS: Between March 2011 and September 2019, 1369 patients underwent a surgical aortic valve replacement (sAVR) with sutureless aortic valve prosthesis in 55 institutions within the prospective SURE-AVR registry through either MICS (n = 661) or full sternotomy (n = 708). Clinical and echocardiographic outcomes were collected up to 7 years. Median and cumulative follow-ups were 12.3 months (Q1 0.4; Q3 36.8) and 2389.6 patient-years. RESULTS: There was no statistical significant difference in age between the groups, while in the MICS cohort there was a female prevalence (61.7 vs 51%, p<0.001) and the mortality risk was lower (mean logistic EuroSCORE I: 3.1% vs 5.2%, p<0.001). In the MICS group, mini sternotomy was performed in 52.2% of the cases, while mini thoracotomy in 47.8%. Concomitant procedures were performed mainly in full sternotomy (62.7 vs 4.5%, p<0.01). The implant success rate was 98.3% in full sternotomy and 98.6% in MICS. For isolated procedures mean cross-clamp and cardio-pulmonary bypass time were 52.9±20.0 and 81.2±30.0 min in MICS, while 51.3±21.0 and 76.4±30.2 min in full sternotomy. Mean intensive care unit stay was shorter in MICS (1.9 vs 2.8 days, p<0.001). Mean aortic pressure gradient decreased from 45.8±16.4 mmHg preoperatively to 13.4±5.1 mmHg at discharge; the trend didn’t differ between the groups. Overall 5-year survival was 82.2% in MICS and 69.1% in the full sternotomy group (p=0.02). Early and late results are reported in the Table. CONCLUSIONS: Sutureless aortic valve prostheses enable short procedure times in MICS, similar to the conventional approach. Although the cohorts were not matched for pre-operative risk and characteristics, this analysis shows better overall 5-year survival in the MICS group. Minimally invasive cardiac surgery in combination with sutureless bioprostheses could represent a valuable alternative to percutaneous interventions.
|Early events (≤30 days) MICS n (% in 661 patients)||Early events (≤30 days) FULL STERNOTHOMY n (% in 708 patients)||Early events (≤30 days) P value||Late event (>30days) MICS n (% in 1455.1 patient-years)||Late event (>30days) FULL STERNOTHOMY n (% in 934.5 patient-years)||Late event (>30days) P value|
|All-cause death||3 (0.5)||5 (0.7)||0.727||58 (4.0)||53 (5.7)||0.428|
|Valve-related reintervention||7 (1.1)||4 (0.6)||0.372||15 (1.0)||5 (0.5)||0.022|
|Disabling Stroke||2 (0.3)||4 (0.6)||0.688||4 (0.3)||2 (0.2)||0.438|
|Transient ischemic attack||5 (0.8)||1 (0.1)||0.113||8 (0.5)||3 (0.3)||0.133|
|Bleeding||6 (0.9)||11 (1.6)||0.334||10 (0.7)||6 (0.6)||0.286|
|Structural valve deterioration||0||0||0||8 (0.5)||3 (0.3)||0.133|
|Paravalvular leak||15 (2.3)||2 (0.3)||<0.001||14 (1.0)||1 (0.1)||<0.001|
|Paravalvular leak (grade >2)||1 (0.2)||0||na||0||0||0|
|Permanent pacemaker implant||27 (4.1)||49 (6.9)||0.017||18 (1.2)||17 (1.8)||0.735|
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