What is the DaVinci trial?

The DaVinci Trial: Robotic-Assisted Minimally Invasive Mitral Valve Surgery

The DaVinci trial was a multicenter, phase 2 clinical trial that led to FDA approval of the da Vinci robotic surgical platform for minimally invasive mitral valve repair and replacement (MIMVR) in 2002. 1

Historical Context and Development

• The first robotic-assisted minimally invasive mitral valve repairs using the da Vinci platform were performed independently in 1998 by Mohr et al. and Carpentier et al., followed closely by Chitwood et al. 1

• The results of the DaVinci trial were reported in 2005 by Nifong et al., establishing the safety and efficacy of the robotic platform for cardiac procedures. 1

• Since FDA approval, multiple investigators have reported good to excellent outcomes in large series of patients undergoing robotic-assisted MIMVR. 1

Technical Aspects of the da Vinci System

• The da Vinci surgical system consists of a surgeon console connected to a surgical arm cart, with instrument arms and a central arm to guide the endoscope. 2

• The "EndoWrist technology" offers seven degrees of movement, exceeding the capacity of a surgeon's hand in open surgery, allowing for precise dissection in difficult-to-reach areas. 2

• The system has evolved through several models including the standard da Vinci robot, the da Vinci S, and the newer da Vinci Si model which offers dual console capabilities for training. 1

Clinical Applications Beyond Cardiac Surgery

• Following the success in cardiac surgery, the da Vinci system has been applied to various specialties:
  • General thoracic procedures including thymectomies, fundoplications, and pulmonary lobectomies 2
  • Urologic procedures such as prostatectomies and partial nephrectomies 3
  • Ophthalmologic procedures like pterygium surgery 4
  • Laryngeal microsurgery 5

Training and Credentialing for Robotic Surgery

• A structured robotic surgery training curriculum (RSTC) includes both preclinical and clinical components to minimize the impact of surgical education on patient outcomes. 1

• Preclinical training involves:

  • Didactic sessions on the technical aspects of the robot 1
  • Hands-on tutorials for docking, instrument insertion, and console operation 1
  • Dry lab practice with basic skills tasks (ring-peg transfer, precision cutting, suturing) 1
  • Virtual reality simulation when available 1
  • Animate or cadaveric robotic training for complex procedural tasks 1

• Clinical training requires a graduated, step-wise progression under expert supervision, with the trainee advancing through increasingly difficult steps as proficiency is demonstrated. 1

Patient Selection for Robotic-Assisted MIMVR

• The ideal candidate for robotic-assisted MIMVR is tall and thin, providing generous intrathoracic workspace once the right lung is collapsed, allowing for easy triangulation of the camera and instruments. 1

• Patient anatomy and vascular status are critical considerations for suitability for the robotic approach. 1

Challenges and Limitations

• The learning curve for robotic surgery is steep, with early complications often occurring within the first cases of a surgeon's experience. 6

• Limited availability of appropriate instruments can be a disadvantage, particularly for complex procedures like pulmonary lobectomies. 2

• The high cost of the system, especially with advanced features like the dual console (approximately $500,000 additional), can be prohibitive for many training programs. 1

• Unlike traditional open surgery, robotic surgery separates the mentor and trainee in space, with only one surgeon able to operate at the console at a time (unless using the dual console system). 1

Impact on Surgical Education

• The da Vinci Si model with dual console capability allows for expert surgeon direction and supervision during training, enhancing the educational experience. 1

• Video recording and review of operative performance with mentors provides valuable formative feedback for trainees. 1

• The development of virtual reality simulators integrated with the da Vinci system allows for skills practice without requiring the patient-side cart or instruments. 1

The DaVinci trial represented a pivotal moment in the evolution of minimally invasive cardiac surgery, establishing robotic assistance as a viable approach for mitral valve procedures with subsequent expansion to numerous other surgical specialties.