Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System

Surgery Clinical Trial

Official title:

Prospective Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System: HUMANITAS Gavazzeni Contribution (Studio Dell'Applicazione Della Chirurgia Robotica Con Robot daVinci X (IS4200) di Ultima Generazione Sulla Valvulopatia Mitralica: Contributo di HUMANITAS Gavazzeni)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04415138
• Other study ID #: GAV 213/20
• Status: Active, not recruiting
• Start date: March 10, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2020
• Source: Cliniche Humanitas Gavazzeni
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Robotic assistance allows performance of mitral valve operations with a truly minimally invasive and totally thoracoscopic approach, with significant advantages for patients compared to sternotomy-based surgery. Nonetheless, its diffusion has been limited by: 1) significant learning curve and technical requirements; 2) increased immediate financial costs due to dedicated equipment and materials. The aim of the present study is to perform a prospective data collection and evaluation of the in-hospital and follow-up clinical results of mitral valve repair using the last generation DaVinci X robotic platform. A cost-effectiveness analysis of this approach will be also conducted, under a global healthcare system perspective (including the overall patients' pathway starting from diagnosis of mitral valve disease until the completion of the 1st postoperative year). Since the 'competitor' surgical technique is not represented by sternotomy-based mitral surgery, but instead by minimally invasive, video-assisted mitral surgery, patients operated on using such technique will serve as controls.

Description:

In an observational, prospective, case-control investigation, the clinical data of all adult (18 years-old or more) patients undergoing robotic-assisted mitral surgery in the Sponsor hospital during the study period will be collected, including preoperative, intraoperative and early postoperative variables. Patients need to be affected by severe mitral regurgitation due to degenerative lesions and be eligible to robotic-assisted surgery. An informed consent for inclusion in the study and management of personal data will be asked from all participants. A total of 30 Baseline variables, 9 intraoperative variables, 26 early postoperative variables and 55 follow-up variables will be collected. Systematic in-house follow-up (clinical and echocardiographic) will be performed at the 3rd, 6th and 12th postoperative months. The database will be managed by research assistants under the supervision of the surgical team. Operations will be performed according to the Institutional protocol using the DaVinci X robotic platform by a trained multidisciplinary team including cardiac surgeons, anesthesiologists, cardiologists, perfusionists and scrub nurses.

The same data will be obtained for all patients undergoing minimally invasive, video-assisted non-robotic-assisted mitral repair during the study period. These patients will serve as controls.

Study Endpoints will include procedural success, early postoperative complications, postoperative functional recovery (both immediate and at follow-up), echocardiographic results of mitral repair.

Such data will be compared with those from control patients undergoing minimally invasive, non-robotic-assisted mitral surgery in our Department during the study period.

In cooperation with Hospital Administration Team, all direct and indirect costs (Euros) associated with the in-hospital pathway of each individual patient will be quantified (17 variables per patient within a separate database). Data collection will be expanded to any hospitalisation occurring during the 1st postoperative year. Such data collection will include patients undergoing both the robotic-assisted and the minimally invasive video-assisted non-robotic-assisted strategy.

Data will be analysed using intergoup comparison statistical tests.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged at least 18, willing to complete the study follow-up, having signed the informed consent for participation and data management.

• Severe mitral regurgitation due to degenerative disease with indication to mitral repair surgery.

• If of female gender, being neither pregnant nor lactating.

Exclusion Criteria:

• Previous right chest surgery or severe right intrapleural adhesions.

• Diameter of femoral arteries equal or lesser than 6 mm.

• Left ventricular systolic dysfunction (LVEF <60%).

• Severe right ventricular dysfunction.

• Aortic valve regurgitation >1+/4+.

• Pulmonary artery hypertension (PASP >50 mmHg).

• Chest deformities preventing either robotic-assisted or minimally invasive video-assisted surgery.

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency
• Surgery

Intervention

Device:
• Robotic-assisted mitral valve repair
Mitral valve repair using robotic technology (DaVinci X platform)

Locations

Country	Name	City	State
Italy	Cliniche HUMANITAS Gavazzeni	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
Cliniche Humanitas Gavazzeni

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Agnino A, Antonazzo A, Albano G, Panisi P, Gerometta P, Piti A, Anselmi A. Strategy-specific durability of mitral valve repair through the video-assisted right minithoracotomy approach. J Cardiovasc Med (Hagerstown). 2019 Mar;20(3):137-144. doi: 10.2459/J — View Citation

Agnino A, Graniero A, Roscitano C, Villari N, Marvelli A, Verhoye JP, Anselmi A. Continued follow-up of the free margin running suture technique for mitral repair. Eur J Cardiothorac Surg. 2020 May 7. pii: ezaa122. doi: 10.1093/ejcts/ezaa122. [Epub ahead — View Citation

Agnino A, Parrinello M, Panisi P, Anselmi A. Novel nonresectional posterior leaflet remodeling approach for minimally invasive mitral repair. J Thorac Cardiovasc Surg. 2017 Oct;154(4):1247-1249. doi: 10.1016/j.jtcvs.2017.04.076. Epub 2017 May 23. — View Citation

Gillinov AM, Mihaljevic T, Javadikasgari H, Suri RM, Mick SL, Navia JL, Desai MY, Bonatti J, Khosravi M, Idrees JJ, Lowry AM, Blackstone EH, Svensson LG. Early results of robotically assisted mitral valve surgery: Analysis of the first 1000 cases. J Thora — View Citation

Hawkins RB, Mehaffey JH, Mullen MG, Nifong WL, Chitwood WR, Katz MR, Quader MA, Kiser AC, Speir AM, Ailawadi G; Investigators for the Virginia Cardiac Services Quality Initiative. A propensity matched analysis of robotic, minimally invasive, and conventio — View Citation

Nifong LW, Chitwood WR, Pappas PS, Smith CR, Argenziano M, Starnes VA, Shah PM. Robotic mitral valve surgery: a United States multicenter trial. J Thorac Cardiovasc Surg. 2005 Jun;129(6):1395-404. — View Citation

Rodriguez E, Nifong LW, Bonatti J, Casula R, Falk V, Folliguet TA, Kiaii BB, Mack MJ, Mihaljevic T, Smith JM, Suri RM, Bavaria JE, MacGillivray TE, Chitwood WR Jr. Pathway for surgeons and programs to establish and maintain a successful robot-assisted adu — View Citation

Suri RM, Thompson JE, Burkhart HM, Huebner M, Borah BJ, Li Z, Michelena HI, Visscher SL, Roger VL, Daly RC, Cook DJ, Enriquez-Sarano M, Schaff HV. Improving affordability through innovation in the surgical treatment of mitral valve disease. Mayo Clin Proc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of ICU stay (hours) and Hospital stay (days and hours)	Duration of stay inside healthcare facility providing index operation. Average value and standard deviation will be presented.	Up to 30 days after index surgery.
Primary	Rate of Major Adverse Cerebral and Cardiovascular Events (MACCE)	Rate of stroke/TIA, myocardial infarction, cardiac reoperation (presented through both individual and aggregated rates).	Day of index surgery until 30th postoperative day or discharge
Primary	Economic evaluation (direct and indirect costs).	Direct and indirect costs associated with robotic-assisted mitral surgery. These will be evaluated for each individual patient and expressed in Euros, under the form of average value and standard deviation. Direct costs will be categorized as follows: total supplies, total drugs, unit operating costs, unit supporting costs).	Up to 90 days after index surgery.
Secondary	Rate of residual mitral regurgitation (Early).	Data will be obtained from pre-discharge echocardiography. Residual Mitral Regurgitation is defined as being at least of degree 2+/4+ according to current Echocardiography recommendations.	Up to 60 days after index surgery.
Secondary	Rate of residual mitral regurgitation (follow-up).	Data will be obtained from echocardiography performed at the 3rd, 6th and 12th postoperative months. Residual Mitral Regurgitation is defined as being at least of degree 2+/4+ according to current Echocardiography recommendations.	From the 3rd until the 12th month after index surgery.