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

NCT04415138 | Unknown DMC FDA Device

• 1 other identifier: GAV 213/20
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Regurgitation; Surgery

Keywords

Robotic Surgery; Outcomes; Cost analysis

Outcome Measures

Primary Outcomes (3)

• 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.

• 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

• 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 Outcomes (2)

• Rate of residual mitral regurgitation (Early).

  Up to 60 days after index surgery.

• Rate of residual mitral regurgitation (follow-up).

  From the 3rd until the 12th month after index surgery.

Study Arms (2)

Robotic-assisted Group

Device: Robotic-assisted mitral valve repair

Video-assisted Group

Interventions

Robotic-assisted mitral valve repair DEVICE

Mitral valve repair using robotic technology (DaVinci X platform)

Robotic-assisted Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by severe mitral regurgitation due to degenerative disease (Leaflet prolapse/flail) with indication to surgical mitral repair using either a robotic-assisted approach or a minimally invasive video-assisted non-robotic-assisted approach. Includes patients referred to a tertiary cardiac surgical centre.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniche Humanitas Gavazzeni: lead

Study Sites (1)

Cliniche HUMANITAS Gavazzeni

Bergamo, 24125, Italy

Location

Related Publications (8)

• 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. doi: 10.1016/j.jtcvs.2004.07.050.

  PMID: 15942584 RESULT

• 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. No abstract available.

  PMID: 28606395 RESULT

• 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 adult cardiac surgery program. J Thorac Cardiovasc Surg. 2016 Jul;152(1):9-13. doi: 10.1016/j.jtcvs.2016.05.018. No abstract available.

  PMID: 27343904 RESULT

• 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 Thorac Cardiovasc Surg. 2018 Jan;155(1):82-91.e2. doi: 10.1016/j.jtcvs.2017.07.037. Epub 2017 Aug 1.

  PMID: 28893396 RESULT

• 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 conventional mitral valve surgery. Heart. 2018 Dec;104(23):1970-1975. doi: 10.1136/heartjnl-2018-313129. Epub 2018 Jun 18.

  PMID: 29915143 RESULT

• 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. 2013 Oct;88(10):1075-84. doi: 10.1016/j.mayocp.2013.06.022.

  PMID: 24079678 RESULT

• 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/JCM.0000000000000753.

  PMID: 30601192 RESULT

• 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 Oct 1;58(4):847-854. doi: 10.1093/ejcts/ezaa122.

  PMID: 32380519 RESULT

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Director of Robotic and Video-Assisted Cardiac Surgery Division

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 4, 2020
• Study Start: March 10, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: June 4, 2020

Record last verified: 2020-05

Locations

IT (1)