Abstract
OBJECTIVES
Current evidence on transcatheter aortic valve implantation (TAVI) has been generated exclusively by cardiology studies and no operative data from cardiac surgeons are available. Here, we describe the development of our TAVI programme and report the results of transfemoral (TF) TAVI done by cardiac surgeons on their own.
METHODS
This study included all the TAVI procedures on native valve performed at Cardiac Surgery Unit, Ospedali Riuniti di Ancona, during the period October 2018 to July 2022. Relevant prospectively collected preoperative, intraprocedural and postoperative data were retrieved from the Institutional database.
RESULTS
A total of 413 patients were included in the study. Mean patients’ age was 82 years and among them 44% (180/413) were male. STS score was 3.1% (2.2–4.4). Eighty patients underwent transapical TAVI and 333 patients had a TF approach. We progressively moved from transapical TAVI towards TF procedures that are now routinely performed on conscious sedation and using a fully percutaneous approach. After TF TAVI, 30-day mortality rate was 1%, cerebral stroke occurred in 2% of the cases, permanent pacemaker implantation was necessary in 23% of the patients and in 6% of the cases there was a moderate/severe degree of aortic regurgitation. There was no association between operators performing TAVI and 30-day mortality.
CONCLUSIONS
The acquisition of catheter-based skills and an adequate training allowed cardiac surgeons to perform on their own awake and fully percutaneous TF TAVI with similar results when compared with major randomized clinical trials and registries’ experiences.
Keywords: Aortic valve, TAVI, Aortic valve replacement, Transcatheter
During the last decade, transcatheter interventions have become a fundamental tool in the treatment of aortic valve stenosis.
INTRODUCTION
During the last decade, transcatheter interventions have become a fundamental tool in the treatment of aortic valve stenosis. Consolidated early and mid-term results and the progressive improvement in techniques and technologies have allowed a spread of these procedures beyond inoperable, high-risk and frail patients [1–4]. The latest European Society of Cardiology (ESC) and ACC/AHA guidelines favour a transcatheter aortic valve implantation (TAVI) approach in elderly and higher-risk patients with a wide area of discretion in septuagenarians according to anatomical factors impacting the surgical/transcatheter procedure and clinical characteristics affecting patients’ prognosis [5, 6].
Surgical aortic valve replacement and TAVI present peculiar advantages and potential drawbacks making their alternative use necessary in order to provide a tailored treatment to the increasing and heterogenous population of patients with aortic valve stenosis. The concept of Heart Valve Team (HVT) has been therefore developed to promote a shared decision-making among different specialties in pursuing the best allocation of therapies and resources according to patients’ profile. Nevertheless, in the daily practice, as highlighted by anecdotical scientific reports, the role of HVT for TAVI referrals has declined with the accrual of transcatheter experiences [7] mostly limited to cardiologists who are nowadays performing TAVI also in centre without an on-site cardiac surgery programme [8].
Looking at the rapid spread of transcatheter technologies in the whole cardiovascular field, a specialized figure of professionals with catheter-based skills and mastering surgical and transcatheter cardiac and vascular procedures is required in order to provide a modern and successful treatment of heart and aortic pathologies. Fort this reason, alongside an established surgical activity, we have started and developed a transcatheter programme led and run by cardiac surgeons. We present in this study our early results in transcatheter aortic valve implantation and discuss the steps taken in developing and promoting our experience.
MATERIALS AND METHODS
Population
The internal TAVI database of Cardiac Surgery Unit at Lancisi Cardiovascular Centre, Ospedali Riuniti di Ancona, was searched to identify patients who underwent native valve transcatheter aortic valve implantation during the study period October 2018 to July 2022.
Ethical statement
This study was approved by the local Ethic Committee (CERM 2019 361); patients’ informed consent was waived due to the nature and design of this study.
Study design, data collection and outcomes
This study is a retrospective outcome evaluation from institutional records with prospective data entry collected and used in compliance with institutional data protection and confidentiality policies. The data were collected from the hospital database system and patients’ records.
The following data were collected:
Preoperative details: age; gender; body mass index (kg/m2); history/diagnosis of systemic hypertension; diabetes mellitus; chronic obstructive pulmonary disease (COPD); creatinine (mg/dl); previous cerebral stroke; extracardiac arteriopathy; previous acute myocardial infarction; New York Heart Association (NYHA) class; left ventricular ejection fraction; haemodynamic of valve pathology (aortic stenosis, regurgitation); STS score.
Operative data: type of access: transapical (TA) or transfemoral (TF); type of anaesthesia; open and percutaneous groin access; type and size of prosthesis; intraoperative complications; protection of coronary arteries; operators.
Postoperative outcomes: 30-day mortality; bleeding; renal replacement therapy/CVVHD; new postoperative neurologic deficit (permanent stroke, TIA); respiratory failure requiring (re) intubation; sepsis; postoperative atrial fibrillation; wound complications; permanent pacemaker implantation (predischarge and 30 days); intensive care unit length of stay; postoperative hospital length of stay; aortic valve prostheses’ peak and mean gradients; degree of postoperative regurgitation.
Definitions
The preoperative data collected were as previously defined for EuroSCORE [9]. Postoperative outcomes were aligned according to the VARC-3 criteria [10].
How we started the TAVI programme and established our heart team
Three cardiac surgeons from our centre attended several educational courses before a 2-week training programme including the possibility to assist in TA and TF TAVI (more than 50 cases) and to perform transcatheter aortic valve procedures under direct supervision. In October 2018, we officially started the TAVI programme in our Cardiac Surgery Unit with proctorship training and using the transapical approach. The procedures were all performed in one of our theatres with the support of fluoroscopy C-Arm; the operative team always included the 3 surgeons, 1 cardiac anaesthesiologist, 1 perfusionist—responsible of the preparation of the delivery system and the valve—and 3 nurses.
All the patients were discussed with the referring Cardiologist/Cardiology Unit. Within our department, they were then thoughtfully evaluated considering their baseline clinical characteristics, the anatomical features and technical aspects by Cardiac Surgeons, Cardiac Anaesthesiologists and specialists from our Echo Lab and Cardiovascular Radiology. The patients were ultimately accepted for surgical aortic valve replacement using a minimally invasive access or full sternotomy, or for transcatheter aortic valve implantation through a femoral of transapical access.
Towards awake, percutaneous transfemoral transcatheter aortic valve implantation
We started with TA valve implantation using Sapien 3 (Edwards Lifesciences Corp., One Edwards Way, Irvine, CA, USA) prostheses. TF procedures with balloon-expandable valves were introduced afterwards with surgical isolation of the femoral vessels, general anaesthesia and TOE control for the first 50 cases. Self-expandable prostheses (Medtronic, Minneapolis, MN, USA) were implanted after the first 90 cases. Awake procedures and the use of percutaneous access were embedded in July 2019 and May 2020, respectively, and were routinely adopted thereafter.
Training and skills transfer
The same operator—first-generation TAVI surgeon of our unit (M.D.E.)—performed the first 60 cases assisted by 2 cardiac surgeons (F.C. and P.B.)—the second-generation TAVI surgeons—who started routinely performing TAVI procedures afterwards following the same pathway in the adoption of different prostheses platforms and percutaneous access [Manta™ Vascular Closure Device, Essential Medical Inc., Malvern, PA, USA; Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System, Abbot Laboratories, Abbott Park, IL, USA].
Statistical analysis
Continuous variables were presented as mean [standard deviation (SD)] or median [1 interquartile range (IQR), 3 IQR]. Categorical variables were presented as number (%).
A post hoc analysis after χ2 was performed to study the changing proportion of TAVI and surgical aortic valve replacement during the study period. A logistic regression was performed to study the association between the activity of first-generation TAVI surgeon versus second generation of TAVI surgeons performing independently and 30-day mortality. A P-value of ≤0.05 was considered statistically significant.
A risk-adjusted cumulative sum analysis was performed to study the changes in 30-day mortality during the study period, both for first generation and second generations surgeons [11].
Statistical analyses were performed using the Stat-View Statistical Software Package 5.0 (SAS Institute, Inc., Cary, NC, USA), NCSS 2001 (Number Cruncher Statistical System, Kaysville, UT, USA).
RESULTS
Preoperative characteristics and operative data
During the period October 2018 and July 2022, 413 patients underwent TAVI procedure on native aortic valve. There was a progressive increase in the number of transcatheter procedures that nowadays account for about the 50% of the cases of isolated aortic valve interventions performed in our Unit with a significant increase from 2020 compared to previous years (P < 0.001) (Fig. 1).
Figure 1:
Number of transcatheter aortic valve procedures on native aortic valve (A) and trend of isolated aortic valve interventions—surgical aortic valve replacement and TAVI—during the period 2016–2022 (B).
Mean patients’ age was 82 (SD: 5.1) years and among them 44% (180/413) were male. STS score was 3.1% (2.2–4.4). Fifty-eight percent of the patients presented with a NYHA class III–IV; history of coronary artery disease was registered in 40% of the cases as common was the diagnosis of COPD on steroids and/or inhalers (22%), cerebrovascular disease (14%), peripheral vascular disease (16%) and chronic kidney disease (40% of the patients with a preoperative eGFR < 50). All the patients but one had severe symptomatic aortic valve stenosis. Left ventricular ejection fraction was impaired in 20% of the cases and 34 patients had a preoperative mitral regurgitation degree more than moderate. Table 1 details about preoperative characteristics.
Table 1:
Preoperative characteristics of the overall, TF and TA TAVI populations
| Variables | TAVI (N = 413) | TAVI TF (N = 333) | TAVI TA (N = 80) | P-value |
|---|---|---|---|---|
| Age, mean (SD) | 81.9 (5.1) | 82.3 (5.0) | 80.7 (5.2) | 0.011 |
| Gender male/female | 180/233 | 138/195 | 42/38 | 0.073 |
| BMI, mean (SD) | 25.9 (4.8) | 26.3 (4.7) | 24.9 (4.9) | 0.018 |
| STS score, median (1st to 3rd IQR) | 3.1 (2.2–4.4) | 3.1 (2.2–4.4) | 3.2 (2.6–4.1) | 0.39 |
| Hypertension, N (%) | 318 (76) | 253 (76) | 65 (81) | 0.31 |
| Diabetes, N (%) | 104 (25) | 82 (25) | 22 (28) | 0.59 |
| Dyslipidaemia, N (%) | 221 (53) | 168 (50) | 53 (67) | 0.011 |
| COPD, N (%) | 91 (22) | 70 (21) | 21 (26) | 0.31 |
| CVD, N (%) | 59 (14) | 40 (12) | 19 (24) | 0.007 |
| PVD, N (%) | 68 (16) | 23 (7) | 45 (57) | <0.001 |
| eGFR < 50, N (%) | 162 (40) | 130 (39) | 32 (40) | 0.87 |
| History of CAD, N (%) | 167 (40) | 115 (35) | 52 (65) | <0.001 |
| Previous AMI, N (%) | 31 (8) | 18 (5) | 13 (16) | <0.001 |
| History of AF, N (%) | 110 (27) | 91 (27) | 19 (24) | 0.52 |
| NYHA ≥III, N (%) | 240 (58) | 184 (55) | 56 (70) | 0.016 |
| Bicuspid AV, N (%) | 14 (3) | 12 (4) | 2 (3) | 0.88 |
| AV stenosis, N (%) | 412 (99) | 332 (99) | 80 (100) | 0.44 |
| AR ≥moderate, N (%) | 37 (9) | 27 (8) | 10 (12) | 0.22 |
| MR ≥moderate, N (%) | 34 (8) | 26 (8) | 8 (10) | 0.52 |
| LVEF < 50%, N (%) | 81 (20) | 63 (19) | 18 (23) | 0.18 |
AF: atrial fibrillation; AMI: acute myocardial infarction; AR: aortic regurgitation; AV: aortic valve; BMI: body mass index; CAD: coronary artery disease; COPD: chronic obstructive pulmonary disease; CVD: cerebrovascular disease; IQR: interquartile range; LVEF: left ventricular ejection fraction; MR: mitral regurgitation; NYHA: New York Heart Association; PVD: peripheral vascular disease; SD: standard deviation.
Eighty patients underwent transapical TAVI and 333 patients had a TF approach (Table 1). Balloon-expandable valves were used in 192 patients while self-expandable prostheses in 141 patients. Figure 2 shows the trend and the prevalence of adoption of TA and TF as well as of balloon and self-expandable prostheses according to the progressive number of procedures performed. General anaesthesia was used in 182 patients (102/333 TF TAVI, 31%; 80 TA TAVI), while surgical cut down and femoral vessels isolation in 119 out of 333 patients (36%) who underwent TF TAVI. Figure 2 shows the trend and the prevalence of adoption of awake procedures and percutaneous access management that characterized, respectively, the 98% and 95% of TF TAVI cases performed during the last year.
Figure 2:
Trend in the adoption of TF procedure, self-expandable prostheses, awake procedures and percutaneous access management according to the progression of our experience.
Coronary artery(ies) protection was necessary in 12 cases (10 TF, 2 TA). There were 7 cases with major intraprocedural complications in TF group: one patient experienced coronary arteries occlusion with cardiac arrest, rescue sternotomy, CPB institution and surgical aortic valve replacement; there was one case of prosthesis migration requiring a successful surgical retrieval of the TAVI prosthesis and aortic valve replacement; another patient had a malposition of a self-expandable valve ultimately leading to a mild intraprosthetic regurgitation; one patient developed a focal dissection of the ascending aorta and in one case there was perioperative evidence of asymptomatic haematoma of the ascending aorta, both treated with conservative management; one patient developed haemopericardium requiring percutaneous drainage; in one case, a lesion of the left mammary artery lead to massive haemothorax and required a chest drain insertion and percutaneous embolization of the vessel. In one patient who underwent TA TAVI, we were forced to intraoperative conversion to get control of persistent bleeding from the left ventricular apex.
30-day outcomes
Overall 30-day mortality was 1.5% (6 patients). Three patients died after TF procedure (mortality 1%) due to respiratory failure with ARDS, haemorrhagic stroke and following left ventricular rupture during permanent pacemaker insertion. Three patients died after TA TAVI (mortality 3%) due to septic shock, complications following acute kidney injury and respiratory failure, and sudden death after discharge home. Table 2 details about the common postoperative complications and the intensive care unit and hospital stay.
Table 2:
Postoperative data
| Variables | TAVI (N = 413) | TAVI TF (N = 333) | TAVI TA (N = 80) | P-value |
|---|---|---|---|---|
| 30-day mortality, N (%) | 6 (1.5) | 3 (1) | 3 (3) | 0.16 |
| Reoperation(s) for bleeding, N (%) | 5 (1) | 4 (1) | 1 (1) | 0.59 |
| Respiratory failure, N (%) | 9 (2) | 5 (2) | 4 (5) | 0.13 |
| TND, N (%) | 20 (5) | 17 (5) | 3 (4) | 0.83 |
| PND, N (%) | 8 (2) | 8 (2) | 0 | 0.34 |
| CVVHD, N (%) | 6 (1) | 3 (1) | 3 (2) | 0.16 |
| Permanent PM, N (%) | 85 (21) | 78 (23) | 7 (9) | 0.003 |
| Wound complications, N (%) | 3 (1) | 3 (1) | 0 | 0.90 |
| Sepsis, N (%) | 3 (1) | 2 (1) | 1 (1) | 0.90 |
| Postop AF, N (%) | 30 (7) | 12 (4) | 18 (23) | <0.001 |
| ICU stay (h), median (1st to 3rd IQR) | 21 (0–24) | 19 (0–24) | 24 (21–32) | <0.001 |
| Hospital stay (days), median (1st to 3rd IQR) | 6 (5–7) | 6 (5–7) | 6 (5–8) | 0.12 |
| AV peak gradient (mmHg), median (1st to 3rd IQR) | 19 (15–24) | 19 (14–24) | 20 (16–24) | 0.30 |
| AV mean gradient (mmHg), median (1st to 3rd IQR) | 10 (8–13) | 10 (8–13) | 10 (8–13) | 0.73 |
| AR ≥moderate, N (%) | 24 (5.8) | 20 (6.0) | 4 (5.0) | 0.94 |
AF: atrial fibrillation; AR: aortic regurgitation; AV: aortic valve; CVVHD: continuous veno-venous haemodialysis; ICU: intensive care unit; PM: pacemaker; PND: permanent neurologic deficit; SD: standard deviation; TND: temporary neurologic deficit.
Postoperative echocardiogram revealed a postimplant aortic regurgitation more than moderate in 24 patients (5.8%). After TF TAVI, 16 patients had moderate aortic regurgitation, while 2 patients presented severe aortic regurgitation, in one of these last 2 cases surgical aortic valve replacement was ultimately performed before patient’s discharge. Four patients who had TA TAVI were discharged with moderate aortic regurgitation.
Impact of internal training
The first-generation TAVI surgeon performed the initial 60 cases (32 TA and 28 TF procedures) assisted by 2 cardiac surgeons who were progressively internally trained to both TA and TF interventions and represent our second-generation TAVI surgeons. Figure 3A details about the percentage of procedures performed by the first and the second-generation TAVI operators according to the progression of our experience. The introduction of awake interventions and percutaneous access management in TF TAVI was immediately receipted by the second-generation operators as these 2 features became almost invariably used in all our TF TAVI procedures (see Fig. 3B and C). The independent practice of the second-generation TAVI operators was not associated with postoperative 30-day mortality (first generation surgeon vs second generation surgeons, log regression including STS score P = 0.96). Figure 4 shows the risk-adjusted cumulative sum chart of death occurring during the first 30 days after TAVI.
Figure 3:
Percentage of TAVI procedures performed by first-generation and second-generation TAVI surgeons according to the progression of our experience (A). Trend in the adoption of awake procedures (B) and percutaneous access management (C) by first and second-generation operators according to the progression of our experience.
Figure 4:
Risk-adjusted cumulative sum of death occurring during the first 30 days after surgery with 95% point-wise prediction limits. The horizontal axis is scaled by patient number. Blue line represents the activity of first-generation TAVI surgeon. Red line represents the activity of second-generation TAVI surgeons.
DISCUSSION
Transcatheter aortic valve implantation is nowadays a fully established treatment for aortic valve stenosis. Several RCTs and registries provided the evidence that these procedures are safe and effective not only in patients with high surgical risk as they might be advantageous also in younger and lower-risk patients [1–3, 12, 13].
The availability of TAVI facility and the establishment of HVTs did improve the approach to patients with aortic valve stenosis [14–16], increased the volume of patients undergoing aortic valve interventions and was associated with better results in surgical patients regardless their preoperative risk profile [17–20].
Our results well compare with those reported in previous studies both in high-risk and lower risk patients [2–4, 21, 22] (Fig. 5). Alongside supportive early outcomes in terms of low 30-day mortality, low rate of perioperative stroke and major vascular complications, we were able to successfully manage or rescue all the patients who had intraprocedural complications.
Figure 5:
Comparison of our results with available RCTs and registries in patients with STS score < 4 (A) and in patients with STS score >4 (B).
We have registered a high incidence of postoperative permanent pacemaker implantation, 28% in self-expandable and 18% in balloon-expandable prostheses, with no significant changes throughout our experience. The comparison of this outcome remains difficult due to the partial availability in previous studies of preoperative electrocardiogram features, the great heterogeneity in medical and interventional management of conduction disorders before and after TAVI [23], and the inclusion/exclusion of patients with bicuspid aortic valve, recent myocardial infarction or revascularization.
Looking at the growing literature on transcatheter heart valve interventions, previous experiences have generally included procedures performed by interventional cardiologists or by interventional cardiologists and cardiac surgeons working together. The last situation was probably common at the very beginning of the TAVI era with the need of surgical access also for TF procedures, the attempt of pursuing and developing other routes for valve delivery (transaortic, trans carotid), and the non-negligible risk of major cardiovascular thoracic complications or procedural unsuccess requiring a surgical conversion. Nowadays, the progressive refinement of techniques and technologies allows in the vast majority of the patients a TF procedure using a completely percutaneous approach as in many centres interventional cardiologists independently perform TF TAVI without a cardiac surgical backup [24].
The results of our TAVI programme showed that cardiac surgeons can acquire and master catheter-based skills and provide successful transcatheter treatment of heart valves pathologies. We have moved through several steps before starting and while developing our TAVI programme.
The learning curve in TAVI procedures has been seldomly evaluated in literature; however, within different settings, an appropriate level of experience could be reached after the first 30–50 cases [25–27] and is associated with both increased procedural safety and better early postoperative outcomes [28, 29]. Few studies focused on the contribution of an initial proctorship, but many experiences included authors who were proctors for transcatheter prostheses factories [29].
After an adequate educational activity and practical preceptorship sessions during international mini-fellowship, we started our experience with a more familiar surgical setting using the transapical approach with the supervision of an external proctor. After the first 30 cases, we were able to perform TF procedures—with proctored supervision for the first 20 cases—under general anaesthesia and with surgical isolation of the femoral vessels. Awake TAVI and fully percutaneous management of the femoral access were progressively embedded and represent nowadays our daily practice in transcatheter valve interventions. Nevertheless, TA approach has not been abandoned as it remains an advantageous tool in case of severe peripheral artery disease and, as showed by our data, can guarantee good early results in patients with high preoperative risk profile and technical limitations for conventional surgery or TF TAVI.
A consistent internal training programme allowed the creation of a TAVI team performing with similar results with no effect during the learning curve and using consolidated practice and protocols with a balanced alternance of first operators, thus fully meeting the recommendations—within the best practice of a HVT at specialized Heart Valve Centres [5]—for a structured and high-volume training. In addition, a transcatheter interventions teaching programme was also included in our cardiac surgery residency course in order to eliminate the barriers posed by the lack of formal training dedicated to catheter-based techniques and technologies that cardiac surgery residents may experience during their training period [30].
The HVT approach is the official recommendation of both ESC and the European Association for Cardio-Thoracic Surgery (EACTS) [5]. Its original concept has been and is important in the treatment of patients with heart valve disease and, especially in the setting of aortic valve stenosis, has promoted a considerable improvement in the evaluation and the management of high-risk, frail and comorbid patients through an active collaboration of different figures including personnel with expertise in cardiovascular imaging and dedicated to heart valve disease treatment and follow-up. Our system provides for an initial assessment and diagnosis by a network of referring Cardiologists and Cardiology Departments. Patients referred for heart disease are then reviewed by in-house Cardiologists at our specialist Echo-Lab and undergo the necessary imaging under Interventional Cardiologists and cardiovascular Radiologists. In our high volume centre, we treat all types of acquired and congenital heart and vascular disease and routinely perform minimally invasive valve, aortic and coronary artery bypass grafting surgery, complex aortic and redo operations, and transcatheter procedures including treatment of aortic and mitral valve disease, aortic aneurysm and dissection. Furthermore, as suggested by the European guidelines [5], our centre supports a lively research and external training program both in the surgical and transcatheter fields which welcomes different figures of healthcare specialists including residents, surgeons, anaesthetists and perfusionist (https://www.minicardiacsurgery-univpm-research.com/).
The fact that properly trained surgeons were able to plan and execute their own TAVI procedures does not place our practice at odds with the principles of the team approach, which, moreover, strongly emphasize the need for multi-specialist knowledge and skills that, as evidenced by our experience, can be successfully acquired and mastered by experienced surgical practitioners. The possibility of providing the full spectrum of procedures for the treatment of aortic valve stenosis—minimally invasive and full sternotomy conventional surgery, TF and TA TAVI—guarantees no bias in our decision-making using a thoughtful patients’ screening based on clinical characteristics, anatomical features and technical factors. Furthermore, the experience acquired with TAVI interventions has facilitated the embedment of transcatheter procedures for mitral pathologies and promoted the use of catheter-based techniques in cerebral protection and hybrid aortic surgery.
With an adequate teaching and training, cardiac surgeons can perform on their own TF TAVI interventions achieving similar early results when compared with previous RCTs and national registries’ experiences. A step-by-step adoption of catheter-based techniques and technologies allows a progressive and safe refinement of TAVI procedures and a successful internal training with surgeon-to-surgeon skills and proficiency transfer.
Conflict of interest: none declared.
Glossary
ABBREVIATIONS
- COPD
Chronic obstructive pulmonary disease
- HVT
Heart Valve Team
- IQR
Interquartile range
- NYHA
New York Heart Association
- SD
Standard deviation
- TA
Transapical
- TAVI
Transcatheter aortic valve implantation
- TF
Transfemoral
Contributor Information
Pietro Giorgio Malvindi, Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.
Paolo Berretta, Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.
Filippo Capestro, Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.
Olimpia Bifulco, Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.
Jacopo Alfonsi, Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.
Mariano Cefarelli, Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.
Michele Danilo Pierri, Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.
Marco Di Eusanio, Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.
DATA AVAILABILITY
The data underlying this article will be shared on reasonable request to the corresponding author.
Author contributions
Pietro Giorgio Malvindi: Conceptualization; Data curation; Formal analysis; Investigation; Methodology; Software; Writing—original draft; Writing—review & editing. Paolo Berretta: Conceptualization; Data curation; Investigation; Methodology; Project administration; Validation; Writing—review & editing. Filippo Capestro: Data curation; Investigation; Project administration; Resources; Validation. Olimpia Bifulco: Data curation; Investigation. Jacopo Alfonsi: Data curation; Investigation; Methodology; Project administration; Resources. Mariano Cefarelli: Data curation; Investigation; Project administration; Resources; Writing—review & editing. Michele Danilo Pierri: Data curation; Investigation; Methodology; Project administration. Marco Di Eusanio: Conceptualization; Formal analysis; Investigation; Methodology; Project administration; Supervision; Validation; Writing—original draft; Writing—review & editing.
Reviewer information
Interdisciplinary CardioVascular and Thoracic Surgery thanks Jörg Kempfert, Gry Dahle, Mizuki Miura and the other, anonymous reviewer(s) for their contribution to the peer review process of this article.
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Data Availability Statement
The data underlying this article will be shared on reasonable request to the corresponding author.