Project description:Aortic valve surgery is the preferred procedure for replacing a damaged valve with an artificial one. The ValveTech robotic platform comprises a flexible articulated manipulator and surgical interface supporting the effective delivery of an artificial valve by teleoperation and endoscopic vision. This article presents our recent work on force-perceptive, safe, semiautonomous navigation of the ValveTech platform prior to valve implantation. First, we present a force observer that transfers forces from the manipulator body and tip to a haptic interface. Second, we demonstrate how hybrid forward/inverse mechanics, together with endoscopic visual servoing, lead to autonomous valve positioning. Benchtop experiments and an artificial phantom quantify the performance of the developed robot controller and navigator. Valves can be autonomously delivered with a 2.0±0.5 mm position error and a minimal misalignment of 3.4±0.9°. The hybrid force/shape observer (FSO) algorithm was able to predict distributed external forces on the articulated manipulator body with an average error of 0.09 N. FSO can also estimate loads on the tip with an average accuracy of 3.3%. The presented system can lead to better patient care, delivery outcome, and surgeon comfort during aortic valve surgery, without requiring sensorization of the robot tip, and therefore obviating miniaturization constraints.
Project description:BackgroundObservational studies have shown reduced perioperative bleeding in patients undergoing minimally invasive, compared with full sternotomy, aortic valve replacement. Data from randomized trials are conflicting.MethodsThis was a Swedish single center study where adult patients with aortic stenosis, 100 patients were randomly assigned in a 1:1 ratio to undergo either minimally invasive (ministernotomy) or full sternotomy aortic valve replacement. The primary outcome was severe or massive bleeding defined by the Universal Definition of Perioperative Bleeding in adult cardiac surgery (UDPB). Secondary outcomes included blood product transfusions, chest tube output, re-exploration for bleeding, and several other clinically relevant events.ResultsOut of 100 patients, three patients randomized to ministernotomy were intraoperatively converted to full sternotomy (none was bleeding-related). Three patients (6%) in the full sternotomy group and 3 patients (6%) in the ministernotomy group suffered severe or massive postoperative bleeding according to the UDPB definition (p = 1.00). Mean chest tube output during the first 12 postoperative hours was 350 (standard deviation (SD) 220) ml in the full sternotomy group and 270 (SD 190) ml in the ministernotomy group (p = 0.08). 28% of patients in the full sternotomy group and 36% of patients in the ministernotomy group received at least one packed red blood cells transfusion (p = 0.39). Two patients in each group (4%) underwent re-exploration for bleeding.ConclusionsMinimally invasive aortic valve replacement did not result in less bleeding-related outcomes compared to full sternotomy.Clinical trial registrationhttp://www.Clinicaltrialsgov . Unique identifier: NCT02272621.
Project description:Since their introduction, it has been demonstrated that minimally invasive aortic valve replacement (MIAVR) approaches are safe and effective for the treatment of aortic valve diseases. To date, the main advantage of these approaches is represented by the reduced surgical trauma, with a subsequent reduced complication rate and faster recovery. This makes such approaches an appealing choice also for frail patients [obese, aged, chronic obstructive pulmonary disease (COPD)]. The standardization of the minimally invasive techniques, together with the implementation of preoperative workup and anesthesiological intra- and post-operative care, led to an amelioration of surgical results and reduction of surgical times. Moreover, the improvement of surgical technology and the introduction of new devices such as sutureless and rapid deployment (SURD) valves, has helped the achievement of comparable results to traditional surgery. However, transcatheter technologies are nowadays more and more important in the treatment of aortic valve disease, also in low risk patients. For this reason surgeons should put new efforts for further reducing the surgical trauma in the future, even taking inspiration from other disciplines. In this review, we aim to present a review of literature evidences regarding minimally invasive treatment of aortic diseases, also reflecting our personal experience with MIAVR techniques. This review could represent a tool for a well-structured patient assessment and preoperative planning, in order to safely carrying out an MIAVR procedure with satisfactory outcomes.
Project description:AimTo evaluate the impact of minimally invasive aortic valve replacement (mini-AVR) on clinical outcomes in comparison with the gold standard.MethodsWe retrospectively reviewed the records of all patients who underwent isolated AVR at the University Hospital Center Zagreb from 2010 to 2020. Patients undergoing mini-AVR were compared with patients undergoing conventional AVR (fs-AVR). The primary outcome measure was blood product consumption. Propensity score matching was used to create a balanced covariate distribution across treatment groups. Additionally, we compared the contemporary outcomes with a historical control.ResultsThe final sample consisted of 1088 patients. In the unmatched cohorts, mini-AVR patients were younger (65±12 vs 68±10 years, P<0.001) and had lower risk profiles (EuroSCORE2 2.8±2.0 vs 3.5±3.1, P=0.003). After matching, mini-AVR patients required less blood transfusion than fs-AVR patients (270 [0-790] vs 510 [0-970] mL, P=0.029). The incidences of stroke, dialysis, new AV block, and mortality were comparable. Cross-clamp times were longer in the mini-AVR group (71 [60-87] vs 66 [53-83] minutes, P=0.013). Outcomes were improved in the contemporary mini-AVR era compared with our early mini-AVR experience across multiple metrics. Blood product consumption was reduced in the latter tercile of experience (0 [0-520] vs 500 [0-1018] mL, P<0.001), and the operation was performed more expeditiously (cross-clamp times: 63 [54,80] vs 74 [62,88] minutes, P<0.001) in comparison with earlier periods.ConclusionsWe showed that mini-AVR was associated with less blood product requirement than conventional surgery. Our data supports wider adoption of minimally invasive techniques in dedicated centers of excellence.
Project description:ObjectiveIn minimally invasive aortic valve replacement via a right minithoracotomy for patients with significant aortic insufficiency, optimal cardioplegia delivery procedures remain controversial. This study aimed to describe and evaluate endoscopically assisted selective cardioplegia delivery in minimally invasive aortic valve replacement for aortic insufficiency.MethodsBetween September 2015 and February 2022, 104 patients (mean age, 66.0 ± 14.3 years) with moderate or greater aortic insufficiency underwent endoscopically assisted minimally invasive aortic valve replacement at our institutions. For myocardial protection, potassium chloride and landiolol were systemically administered before aortic crossclamping, and cold crystalloid cardioplegia was delivered selectively to the coronary arteries using step-by-step endoscopic procedures. The early clinical outcomes were also evaluated.ResultsEighty-four patients (80.7%) had severe aortic insufficiency, and 13 patients (12.5%) had aortic stenosis and moderate or greater aortic insufficiency. A regular prosthesis was used in 97 cases (93.3%), and a sutureless prosthesis was used in 7 cases (6.7%). The mean operative, cardiopulmonary bypass, and aortic crossclamping times were 169.3 ± 36.5, 102.4 ± 25.4, and 72.5 ± 21.8 minutes, respectively. No patients underwent a conversion to full sternotomy or required mechanical circulatory support during or after surgery. No operative deaths or perioperative myocardial infarctions occurred. The median intensive care unit and hospital stays were 1 and 5 days, respectively.ConclusionsEndoscopically assisted selective antegrade cardioplegia delivery is safe and feasible for treating minimally invasive aortic valve replacement in patients with significant aortic insufficiency.
Project description:A 60-year-old man was about to undergo minimally invasive aortic valve replacement when transesophageal echocardiography revealed an intracardiac mass on the left atrial free wall. Multimodal images from 5 months earlier had shown no mass. We converted the procedure to open surgery. The excised mass resembled a cardiac myxoma but was determined to be a papillary fibroelastoma. This case illustrates that papillary fibroelastomas can form and grow rapidly, warranting alertness for their unexpected discovery before and during cardiac surgical procedures.
Project description:ObjectivesSutureless aortic valve prostheses have been introduced to facilitate the implant process, speed up the operating time and improve haemodynamic performance. The goal of this study was to assess the potential advantages of using sutureless prostheses during minimally invasive aortic valve replacement in a large multicentre population.MethodsFrom 2011 to 2019, a total of 3402 patients in 11 hospitals underwent isolated aortic valve replacement with minimal access approaches using a bioprosthesis. A total of 475 patients received sutureless valves; 2927 received standard valves. The primary outcome was the incidence of 30-day deaths. Secondary outcomes were the occurrence of major complications following procedures performed with sutureless or standard bioprostheses. Propensity matched comparisons was performed based on a multivariable logistic regression model.ResultsThe annual number of sutureless valve implants increased over the years. The matching procedure paired 430 sutureless with 860 standard aortic valve replacements. A total of 0.7% and 2.1% patients with sutureless and standard prostheses, respectively, died within 30 days (P = 0.076). Cross-clamp times [48 (40-62) vs 63 min (48-74); P = 0.001] and need for blood transfusions (27.4% vs 33.5%; P = 0.022) were lower in patients with sutureless valves. No difference in permanent pacemaker insertions was observed in the overall population (3.3% vs 4.4% in the standard and sutureless groups; P = 0.221) and in the matched groups (3.6% vs 4.7% in the standard and sutureless groups; P = 0.364).ConclusionsThe use of sutureless prostheses is advantageous and facilitates the adoption of a minimally invasive approach, reducing cardiac arrest time and the number of blood transfusions. No increased risk of permanent pacemaker insertion was observed.
Project description:ObjectivesWe report on real-world safety and performance outcomes of minimally invasive rapid-deployment aortic valve replacement using the EDWARDS INTUITY Elite aortic valve system.MethodsThe study valve system was used in a European, prospective, multicentre post-market study. Various procedural, haemodynamic and clinical outcomes were evaluated through 6 months of post-implant.ResultsA total of 276 patients out of 280 (98.6%) enrolments were successfully implanted with the study valve using a minimally invasive approach between February 2016 and April 2017. Of these 276 patients, 240 (87%) underwent partial sternotomy and 36 (13%) patients underwent right thoracotomy. Mean cross-clamp time was 51.9 [standard deviation (SD): 16.0] min. From baseline to 6 months, the mean effective orifice area increased from 0.8 (SD: 0.3) to 1.8 (SD: 0.6) cm2 and the mean systolic gradient decreased from 46.0 (SD: 14.1) to 8.8 (SD: 3.7) mmHg. After 6 months, 70.7% and 26.4% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major paravalvular leak, reoperation and device explant at 6 months were 96.0%, 98.5%, 98.8%, 99.2% and 99.2%, respectively.ConclusionsThese results demonstrate that the study valve is a safe and effective choice for patients undergoing aortic valve replacement via minimally invasive surgery.Name and registration of registryMISSION (Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve System in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry). clinicaltrials.gov ID #NCT02907463.