Challenge

Project 2

Robotic Kidney Transplantation

Normally, patient needing kidney transplantation requires 15-25 cm long incision depending on the body stature; obese patients requiring larger incision. Retraction of the wound is required for carrying out kidney transplantation leading to soft tissue injury and hence is more painful. Using da Vinci robotic platform, kidney transplantation is carried out with just 6 cm long incision and placement of 5 or 6 ports; each port site is about 1 cm long. There is no need of retraction. In adult females, kidney can go through vagina and transplantation carried out without any large incision on the abdomen!! This is not only cosmetic but also associated with less pain, early ambulation, and rapid recovery of the recipient.

The length of the kidney is about 11 cm and width is about 5 cm. A kidney can easily go through a 6 cm incision into the abdomen without any trauma to it. Similarly, vagina is elastic and hence normal delivery of the baby is possible. Size of the kidney is smaller than the head of the baby and it can easily entered through the vagina into the abdomen. Surgeon trained both in robotic surgery and robotic kidney transplantation operates the robot.

Total cost of robotic kidney transplantation including pre-operative investigations, pre-operative hemodialysis, operative charges, disposable, drugs and hospital stay maximum up to 30 days would be about 5 lakhs rupees. In fact, hospital stay can be reduced due to minimally invasive operation and patient may go earlier to home.

Robot Assisted Kidney Transplantation (RAKT)
Kidney Transplantation (KT) is the most preferred standard care of treatment for patients with end stage renal disease. Traditionally, kidney transplantation has been carried out by open surgery i.e by making large incisions. However, in the recent times, the procedure is being done with minimally invasive surgical procedures.

Robot Assisted Kidney Transplantation (RAKT) is a minimally invasive technique that uses a robotic support to perform the KT. As a high level of expertise is required in KT and robotic surgery, RAKT is performed by transplant surgeons with extensive training and experience in robotics and transplant surgery.

Technique

Compared to conventional open kidney transplant surgery, a much smaller incision (about 7cm) is made in RAKT to remove the diseased kidney and insert the donor kidney into the abdomen and then to stitch the blood vessels and the ureter. Another four or five small (0.5 to 1cm) incisions are used to insert the instruments into the abdomen. One of the arms holds a high magnification 3D camera which is inserted into the abdomen through one of the key holes and provides a high-definition, magnified (12×), 3-D view of the surgical site. The other mechanical arms have surgical instruments attached to it that are designed to mimic the movement of the human hands and wrists. The surgeon uses the console of the computer to manipulate the small surgical instruments that are more flexible and manoeuvrable as compared to the human hand.

Advantage of robotic kidney transplant surgery over open kidney transplant surgery

  • The robot replicates the surgeon’s hand movements, while minimizing hand tremors. The surgeon thus can not only make use of his/her experience and skills, but also operate with precision, dexterity and control in complex procedures.
  • Useful when the operative field is deep and narrow, and requires fine dissection and micro suturing.
  • Improve patient outcomes
  • Decreased chances of complications as compared to open surgery, especially in immunocompromised and end-stage renal disease patients undergoing KT.
  • Safer and more efficacious for obese patients who are otherwise not recommended for transplants.
  • Minimal invasive surgery helps in reduced
    • blood loss
    • hospital stays
    • pain
    • postoperative complication rate
    • recovery time
    • surgical scars

Source: https://www.yashodahospitals.com/diseases-treatments/robotic-kidney-transplant-benefits-risks-cost-success-rate/#:~:text=Robot%20Assisted%20Kidney%20Transplantation%20(RAKT,in%20robotics%20and%20transplant%20surgery.

Risks of Kidney Transplantation using Robotic Assisted Surgery

Risks related to kidney transplants are drastically minimized with the robotic assistance but the possible risks that are specific to kidney transplant procedure include:

  • Damage to surrounding structures
  • Development of a hernia due to the small incisions made for the instruments, known as ‘port site hernia’
  • Twisting of the kidney (torsion) after the transplant
  • Scarring affecting the bowel in the long term (adhesive obstruction)
  • Trapping of carbon dioxide used during surgery in the abdomen
  • Nerve compression
  • Life threatening risks are miniscule.

Preparations Required Before Robotic Kidney Transplantation

Before robotic kidney transplantation the patient should

  • Stop smoking or drinking
  • Lose any excess weight
  • Regular exercise
  • Vaccinations as advised
  • Dialysis before transplant
  • Necessary lab tests

Success Rate

The graft survival rate i.e the survival rate of the donor kidney is dependent on the inherent characteristics of the recipient’s body, hence there are no significant differences between the open surgery and robot assisted kidney transplant surgery. However, the robotic kidney transplant surgery offers significant benefits in terms of

  • Low surgical site infection (range 0-8%)
  • Incisional hernia rates (range 0-6%)
  • Improved aesthetic outcomes
Factors considered to choose hospitals for Robotic Kidney Transplantation

Since kidney transplant is a major surgery, it is important to ensure that the hospital has the infrastructure and trained team to support the pre-operative and post-operative needs. Certain factors to be considered are:

  • Latest transplant technology and organ preservation facilities.
  • Expertise of the kidney transplant surgeons and his team. Specialized training in robotics, number of surgeries performed and success rate indicate the expertise of your surgeon.
  • Number and type of robotic kidney and other organ transplants that the center performs every year.
  • Transplant center’s organ donor and recipient survival rates.
  • Support services such as diagnostics, pharmacy, modular OT, ICU etc.

Factors for cost of Robotic Kidney Transplantation

The cost of surgery usually depends on a multitude of factors, the primary ones being:

  • Experience and expertise of the kidney transplant surgeon and team.
  • Length of surgery and post surgical complications.
  • Underlying co-morbidities and age of the patient which may affect the – additional tests and medicine requirement.
  • Hospital stays – Room category availed; depending on the hospital’s billing policy.

Case Study

Robotic assisted nephrectomy for living donation (RANLD) is a rapid emerging surgical technique competing for supremacy with totally laparoscopic and laparoscopic hand assisted techniques. Opinions about the safety of specific techniques of vascular closure in minimally invasive living kidney donation are heterogeneous and may be different for laparoscopic and robotic assisted surgical techniques.

Perioperation was analysed and short-term outcomes of RANLD was performed with the da Vinci Si surgical platform. Vascular closure of renal vessels was performed by either double clipping or a combination of clips and non-transfixing suture ligatures.

RANLD almost quintupled for the observed time period. A total of n=21 (52.5%) left kidneys and n=19 (47.5%) right kidneys were procured. Renal vessel sealing with two locking clips was performed in 18 cases (45%) Both, clips and non-transfixing ligatures were used in 22 cases (55%). Mean donor age was 53.075±11.68 years (range, 28–70). The average total operative time was 150.75±27.30 min. Right donor nephrectomy (139±22 min) was performed significantly faster than left (160.95±27.93 min, P=0.01). Warm ischemia time was similar for both vascular sealing techniques and did not differ between left and right nephrectomies. No conversion was necessary. Clavien-Dindo Grade ≤IIIb complications occurred in (n=5) 12.5%. Grade IV and V complications did not develop. In particular no hemorrhage occurred using multiple locking clips or suture ligatures for renal vascular closure. Mortality was 0%. Thirteen kidneys (32.5%) were transplanted across the AB0 barrier.

Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186662/

The da Vinci technology for Kidney Transplantation

Doctors recommend a partial or radical nephrectomy, which is surgery to remove some (partial) or all (radical) of the affected kidney or kidneys. In radical nephrectomies for kidney cancer, surgeons also remove the adrenal gland that sits above the kidney, surrounding fat, and nearby lymph nodes, which will be tested to see if the cancer has spread. In a partial nephrectomy, also called “kidney-sparing” surgery, the surgeon removes the tumor while leaving as much healthy kidney tissue as possible.

Surgeons using da Vinci technology may be able to perform kidney surgery through a few small incisions (cuts). During surgery, your surgeon sits at a console next to you and operates using tiny instruments. The da Vinci system translates every hand movement your surgeon makes in real time to bend and rotate the instruments with precision. A camera provides a high-definition, 3D magnified view inside your body. Your surgeon may use Firefly fluorescence imaging, which offers visualization beyond the human eye by activating injected dye to light up and clearly show the kidney structures and blood vessels. Firefly is commonly used to assess the blood flow to the kidney, which may help your surgeon during the procedure in a partial nephrectomy.
Features
The benefits of robotic kidney transplantation include easier vascular anastomosis, better cosmetic results, and a lower complication rate, including in the obese population. Many concerns remain over the potential impairment of graft function due to pneumoperitoneum and warm ischemia and the technical difficulties related to the vascular anastomosis. Refinement of the robotic tactile feedback and development of a cold ischemia device may lead to further improvement in this novel technique.

Robotic surgery allows kidney transplantation to be performed under optimal operative conditions, reducing complications while maintaining the functional results achieved by the open approach. The evolution of this technique is in progress.

Block diagram of Robotic Kidney Transplant is attached below.
Storage of Kidney
Doctors have pioneered a breakthrough cooling technique that gives surgeons more time to robotically transplant kidneys from living donors. This cooling technique increases the chances of a successful transplant by helping preserve kidney tissue.

During this innovative approach doctors:

  • Place the donated kidney in special gauze wrapping
  • Immediately cool the wrapped, donated kidney in a sterile ice mixture

Source: https://www.henryford.com/services/transplant/kidney/process/robotic-assisted#:~:text=What%20is%20robotic%2Dassisted%20kidney,to%20transplant%20the%20donor%20kidney.

Artificial Intelligence (AI) technologies are increasingly being used to enhance kidney transplant outcomes. AI technologies were used to help in diagnostic, predictive and medication management purposes for kidney transplant patients. AI is an emerging tool in kidney transplantation. However, there is a research gap exploring the limitations associated with implementing AI technologies in the field. Research is also needed to recognize clinical educational needs and other barriers to promote adoption and standardization of care for KT patients amongst clinicians.
Steps Taken
Preoperative care
A well-preserved kidney provides enough time to prepare the recipient and if necessary dialyze to normalize electrolyte and volume imbalance. The recipient should have routine systemic tests such as CBC, platelet count, electrolytes, serum glucose, BUN, serum creatinine, PT, PTT, INR, liver function tests, urinanalysis, ECG, chest radiograph and 2D Echocardiogram. Evaluation of cardiac function is of central importance. To help detect coronary artery disease and perhaps to lower the risk of adverse effects with transplantation, all patients and especially diabetic patients with ESRD are evaluated for the presence and/or absence of coronary artery disease. Besides routine ECG, echocardiogram and treadmill test, dobutamine stress echocardiogram is being increasingly used as the initial noninvasive test, given the superiority of this test compared with other examinations and the potential adverse effects of catheterization. Dialysis if indicated is done within 24 hrs of the operation. Overzealous ultrafiltration is best avoided. Volume status is roughly estimated by their dry weight. Loss of more than 2kg during dialysis suggests significant intravascular depletion. Antihypertensives drugs should be continued until the time of surgery. Oral hypoglycemic agents should be held on the morning of the surgery. Sliding scale insulin regimen may be used intraoperatively if blood glucose levels are high. Antibiotic prophylaxis includes a first generation cephalosporin or if penicillin allergic, vancomycin. Induction of immunosupression is started before entering operating theatre.
Blood thinners need to be avoided including aspirin for at least one week prior to surgery. The day before surgery, light meals is eaten until noon and then clear liquids. Patient should stay well hydrated and on the day of surgery, patient should drink clear liquids until two hours before arrival at the hospital. Patient should not eat any solid food or complex liquids after mid-day before surgery. Make sure that patient has a good bowel movement either the night before, or the morning of surgery. If patient has difficulty with bowel movements start a clear liquid diet one day before surgery and if necessary, a laxative is taken.
Perioperative care

Successful use of regional anaesthesia has been reported by some centers. Certain factors to be considered for the use of regional anaesthesia areuraemic bleeding tendency, effect of residual heparin given during dialysis, altered platelet function, decrease in coagulation factors and the duration of surgery. The advantages of combined spinal-epidural technique arerapid onset and good muscle relaxation from spinal and supplemental analgesia through epidural during and after surgery. Most centers however use balanced general anaesthesia to provide stable hemodynamics, excellent muscle relaxation and predictable depth of anaesthesia. Standard ASA monitors are adequate, although, patients with more advanced co-morbid conditions require extensive monitoring such as continuous arterial pressure or CVP monitoring. Those with the most severe co-morbid conditions, such as symptomatic CAD or history of congestive heart failure, should be monitored with a pulmonary artery catheter or transesophageal echocardiography. Strict asepsis should be maintained at all times.

Transplantation carries significant mortality benefit compared to dialysis in end-stage kidney disease. Increased perioperative risk, however, results in a higher mortality in the first 3 months post-transplantation compared to remaining on haemodialysis. Consequently, optimal perioperative management is essential. Patients presenting for kidney transplantation require rapid assessment and preparation for theatre to minimise ischaemic times and improve mortality and graft outcomes. This task is often complicated by the presence of multiple medical comorbidities. Furthermore, early complications of hypotension, delayed graft function, renovascular and ureteric surgical complications and rejection render the perioperative phase of transplant challenging for the recipient and for the transplant team. In this chapter, we outline current practices in the assessment and management of kidney transplant recipients during the perioperative period, particularly focusing on their clinical application and the evidence underpinning them.

Postoperative care

Renal transplant recipients should be reversed and extubated once the established criterion for extubation is fulfilled and there is no concern for airway protection. In general, renal transplant patients are postoperatively nursed in a high-dependency unit. They rarely require intensive care unit admission unless there is fluid overload, a cardiac event or sepsis. Strict monitoring of fluid input output is essential. Re-exploration of the wound should not be delayed if kinking of the vascular attachments or obstruction of the ureter along its course is suspected.

Postoperative pain is usually mild to moderate after renal transplant. Patient controlled analgesia with opioids and intercostals nerve blocks have been successfully used. Non-steroidal anti-inflammatory drugs inhibit prostaglandins synthesis which are integral for renal blood flow and glomerular filtration rate autoregulation. Hence, these drugs are absolutely contra indicated.

Ethical Issues
The ethical issues of living donor kidney transplantation, which is the treatment of choice for patients with end-stage renal failure, are the focus of intense debate. Some of those issues are
  • Safety of the operation for the donor and others are related to the motivation of the donor
  • Approach to and evaluation of the donor, donation by strangers, the commercialization of donation, surrogate consent for donation, and the acceptance of minors as donors
  • The autonomy of the donor and recipient and the utility of the procedure. The transplant team must inform the donor of all the risks. The recipient must also accept that the donor is placing himself at great risk
  • Live donors should be informed of the probable risks, benefits and consequences of donation in a complete and understandable fashion
  • They should be legally competent and capable of weighing the information
  • They should be acting willingly, free of any undue influence or coercion
  • Supply of cadaveric (deceased) organs does not meet the increasing demand for organs

Source: https://www.revistanefrologia.com/en-ethical-aspects-living-donor-kidney-transplantation-articulo-X2013251410051424

Standards from the International Electrotechnical Commission (http://www.iec.ch/):

  • IEC 60601-2-2: Particular requirements for the basic safety and essential performance of highfrequency surgical equipment and high-frequency surgical accessories
  • IEC 60601-2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
  • IEC/TR 60930: It is advisable to embed this report into the hospital quality system for medical technology. An international workgroup regularly updates the report
The IEC/TR 60930 describes the equipment life cycle from this user perspective. It deals with points such as:
  • Involving potential users in the prepurchase and purchase phases
  • Preparing a program of essential requirements from the user perspective
  • Training and manuals for use and service
  • Recording of periodic maintenance and repairs
  • Commissioning testing for acceptance after purchase and delivery
  • The important fact that it’s all about the people who work with the equipment and systems
  • Electrical safety

IEC 60601-1 designated for market admission of medical equipment. Before medical equipment is approved for commercial release, it must pass a stringent “type test” against the requirements listed in the basic safety standard IEC 60601-1. This standard applies worldwide for CE (which refers to "Conformité Européene") marking in the European Union (via the Medical Device Directive), for FDA approval in the USA, and all countries that maintain regulations for medical equipment. Of course it is superfluous to go through this complete type test for every individual device after purchase or maintenance. The IEC 62353 is available for that purpose. Different equipment categories have dedicated particular standards for treating particular aspects of each specific equipment category (e.g. IEC 60601-2-2 for electro-surgical equipment). IEC 60601-1 contains an extensive number of safety tests (some of which are destructive) and conditions that manufacturers must satisfy before any medical equipment that uses electricity is approved for daily practice. Once equipment is approved, a more compact set of essential tests can be applied to monitor the condition of the equipment.

IEC 62353 describes routine safety tests (e.g. tests for leakage of electrical current) on medical electrical
equipment and systems (such as surgical robots) for the following points in time:

  • Before the equipment is put into service
  • During maintenance and inspection, as well as after repair
  • During periodic testing.

IEC 62353 can also be applied to equipment that has not been built according to IEC 60601-1, provided that
the safety standards for that equipment category are taken into account. The measurement methods of IEC
62353 can be applied regardless which IEC 60601-1 edition applies to the device. The standard is not intended to specify mandatory periodic testing intervals, but in case the manufacturer has not specified an interval. IEC 62353 offers methods to monitor the aging process of equipment with structured regular checks; for example, insulation checks.

Image: Robotic kidney transplantation
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