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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 and late adverse events (na: not available)

	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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