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1.
Ann Thorac Surg ; 117(2): 474-478, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37890817

ABSTRACT

PURPOSE: A new automated expanded polytetrafluoroethylene (ePTFE) suture placement device and a new customized titanium fastener deployment device were clinically evaluated in open and less-invasive mitral valve repair (MVr). DESCRIPTION: Twelve patients were monitored for 1 year after undergoing MVr using the study devices. The study end points included surgical outcomes, operative times, valve repair durability, adverse events, and mortality. EVALUATION: Three patients received 1 ePTFE chord using the study technology, and 9 patients received 2 chords. Mitral regurgitation at 30 days was absent in 8 patients, trace in 2, and mild in 2. At the 1-year follow-up, mitral regurgitation was absent in 7 patients, trace in 2, mild in 2, and moderate in 1. There were no replacement chord failures, reoperations, or death. CONCLUSIONS: The initial outcomes of new automated ePTFE suture placement and titanium fastener deployment devices encourage further clinical evaluations.


Subject(s)
Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Humans , Mitral Valve Insufficiency/etiology , Mitral Valve/surgery , Titanium , Treatment Outcome , Sutures , Heart Valve Prosthesis Implantation/adverse effects , Chordae Tendineae/surgery
2.
Innovations (Phila) ; 17(6): 506-512, 2022.
Article in English | MEDLINE | ID: mdl-36447382

ABSTRACT

OBJECTIVE: This study evaluated the ergonomics and time requirements of using a novel automated suturing and titanium fastener deployment technology for chordal replacement in human heart specimens in open and minimally invasive cardiac surgery (MICS) simulators. METHODS: Five cardiac surgeons used novel, manually powered expanded polytetrafluoroethylene (ePTFE) suturing devices to automate suture placement between mitral leaflets and papillary muscles in explanted cadaver hearts, along with customized titanium fastener delivery devices to secure suture and trim suture tails. This mitral chordal replacement test was conducted using surgical models simulating open and MICS mitral repair access. The study was approved by the institutional ethical board. RESULTS: After a brief introduction to this technique using plastic models, study surgeons performed 48 chordal replacements in human mitral valves, placing 18 in an open model and 30 in a right minithoracotomy model. The time range to complete a single chordal replacement was between 55 s and 8 min, with an overall mean duration of 3.6 ± 1.5 min. No difference in duration of implantation was recorded for the MICS and open sternotomy simulators used. Good control of suture delivery was reported in 95.8% (n = 46) of leaflet aspect of the sutures and in 100% (N = 48) of papillary muscle sutures. CONCLUSIONS: Automated mitral chordal ePTFE suturing simulated through open and MICS access demonstrated quality handling and accurate placement of sutures in human heart specimens. A clinical trial using this technology is currently ongoing. This innovation may present an important advance facilitating enhanced minimally invasive mitral valve repair.


Subject(s)
Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Mitral Valve Prolapse , Humans , Mitral Valve Prolapse/surgery , Titanium , Chordae Tendineae/surgery , Mitral Valve/surgery , Mitral Valve Insufficiency/surgery , Sutures , Polytetrafluoroethylene , Suture Techniques
5.
Innovations (Phila) ; 16(2): 175-180, 2021.
Article in English | MEDLINE | ID: mdl-33470874

ABSTRACT

OBJECTIVE: Bilateral internal thoracic artery (BITA) bypass can enable more complete arterial revascularization procedures. Minimally invasive cardiac surgery (MICS) can offer significant patient benefits. New minimally invasive technology for sternal retraction and tissue manipulation is needed to enable ergonomic and reliable minimally invasive ITA harvesting. The goal of this research was to develop technology and techniques, along with experimental testing and training models, for a sternal-sparing approach to in situ BITA harvesting through a small subxiphoid access site. METHODS: This study focused on optimizing custom equipment and methods for subxiphoid BITA harvesting initially in a porcine model (19 pig carcasses, 36 ITAs) and subsequently in 7 cadavers (14 ITAs). RESULTS: Fifty consecutive ITAs were successfully harvested using this remote access approach. The last 20 ITA specimens harvested from the porcine model were explanted and measured; the average length of the free ITA grafts was 12.8 ± 0.9 cm (range 10.8 to 14.2 cm) with a mean time of 23.3 ± 5.2 minutes (range 13 to 25 minutes) for each harvest. CONCLUSIONS: Early results demonstrate that both ITAs can be reliably harvested in a skeletonized fashion in situ through sternal-sparing, small subxiphoid access in 2 experimental models. This innovative approach warrants further exploration toward facilitating complete arterial revascularization and the further adoption of minimally invasive coronary artery bypass graft surgery.


Subject(s)
Mammary Arteries , Animals , Coronary Artery Bypass , Humans , Mammary Arteries/surgery , Minimally Invasive Surgical Procedures , Sternum , Swine , Tissue and Organ Harvesting
6.
Thorac Cardiovasc Surg ; 68(6): 503-506, 2020 09.
Article in English | MEDLINE | ID: mdl-31683327

ABSTRACT

Severe tricuspid regurgitation constitutes a growing disease burden. Conventional surgery for tricuspid valve disease has an increased risk while several interventional procedures are currently under clinical investigation, yet do not offer comprehensive solutions. We investigated a novel surgical approach for off-pump beating-heart tricuspid annuloplasty in circulating blood through a single port in the right atrium. Early feasibility results in preclinical porcine in vivo studies encourage further development of this approach, combining the proven concept of surgical annuloplasty with the benefits of minimally invasive off-pump procedures in a hybrid setting.


Subject(s)
Cardiac Valve Annuloplasty , Heart Valve Prosthesis Implantation , Tricuspid Valve Insufficiency/surgery , Tricuspid Valve/surgery , Animals , Cadaver , Cardiac Valve Annuloplasty/adverse effects , Cardiac Valve Annuloplasty/instrumentation , Feasibility Studies , Heart Valve Prosthesis Implantation/instrumentation , Hemodynamics , Humans , Models, Animal , Sus scrofa , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/physiopathology , Tricuspid Valve Insufficiency/diagnostic imaging , Tricuspid Valve Insufficiency/physiopathology
7.
Surg Technol Int ; 36: 207-211, 2020 May 28.
Article in English | MEDLINE | ID: mdl-31821520

ABSTRACT

Minimally invasive cardiac surgery continues to evolve and expand as technology and surgeon experience develops. Among the barriers to the adoption of non-sternotomy minimally invasive valve surgery are the challenges associated with suture placement. Automated technology enables ergonomic remote suture placement that allows for reproducible results while shortening the learning curve. The objective of this review is to describe the latest advancements in automated suturing technology for minimally invasive valve surgery.


Subject(s)
Cardiac Surgical Procedures , Heart Valve Prosthesis Implantation , Aortic Valve/surgery , Minimally Invasive Surgical Procedures , Mitral Valve/surgery , Sutures , Treatment Outcome
8.
Minim Invasive Ther Allied Technol ; 29(4): 194-201, 2020 Aug.
Article in English | MEDLINE | ID: mdl-31082283

ABSTRACT

Background: Significant advances in minimally invasive implantation of mechanical circulatory support devices have been made. These approaches are technically challenging and associated with a learning curve. Simulation and training opportunities in these techniques are limited. We developed a high-fidelity novel model for minimally invasive left ventricular assist device implantation.Material and methods: Using a modified inanimate simulator (LSI SOLUTIONS®) and an animal tissue model, a hybrid simulator was created, with a porcine ex vivo heart secured within the inanimate simulator in the normal anatomic position. Key components of the minimally invasive left ventricular assist device implantation were performed, including left ventricular apical coring, attachment of the apical ring, attachment of the assist device, and creation of the aortic-outflow graft anastomosis.Results: A novel composite inanimate and tissue model for minimally invasive left ventricular assist device implantation was successfully developed. These simulation techniques were reproducible, and the model demonstrated ability to successfully simulate key components of the procedure.Conclusions: This high-fidelity, reproducible hybrid model allows for crucial components of minimally invasive LVAD implantation to be performed. This model has the potential to be used as an adjunct to surgical training, providing a safe and controlled learning environment for trainees to acquire skills in minimally invasive LVAD implantation.


Subject(s)
Heart Ventricles/surgery , Heart-Assist Devices , Minimally Invasive Surgical Procedures/methods , Prosthesis Implantation/methods , Anastomosis, Surgical/methods , Animals , Humans , Male , Models, Anatomic , Retrospective Studies , Swine
9.
Interact Cardiovasc Thorac Surg ; 30(4): 636-645, 2020 04 01.
Article in English | MEDLINE | ID: mdl-31848598

ABSTRACT

OBJECTIVES: Surgical repair is considered the gold standard treatment for severe symptomatic tricuspid valve (TV) regurgitation. However, patients undergoing isolated surgical tricuspid repair face a high perioperative mortality while long-term data on interventional treatment options are currently missing. We investigated a novel, minimally invasive approach for transatrial off-pump beating-heart tricuspid annular plication based on the surgical Hetzer repair. METHODS: TV annular plication for the creation of a double-orifice valve using novel devices for automated annular suturing was performed in 10 human heart specimens in an ex vivo perfusion model under endoscopic guidance. Additionally, the technique was tested in an in vivo porcine model using the transatrial access under echocardiographic and fluoroscopic guidance. RESULTS: Endoscopically guided conduction of the procedure was successful in all 10 human heart specimens in the ex vivo perfusion model with 1 observed suture pull-through of 60 sutures placed (1.7%). TV measurements yielded significant reductions of the TV septal-lateral diameter (50.9 ± 7.3 vs 42.6 ± 7.9 mm; P = 0.015) and the TV area (1208 ± 399 vs 193 ± 122 mm2; P < 0.0001). TV plication without direct vision using device-embedded intracardiac echocardiography, epicardial echocardiography and fluoroscopy was feasible in both acute animals with no observed device-related adverse events. CONCLUSIONS: Successful plication was completed in 10 ex vivo human hearts, additionally proof-of-concept was conducted in 2 animals. We herein present encouraging early preclinical results of a novel minimally invasive technique for TV repair, which warrants further investigation.


Subject(s)
Cardiac Catheterization/methods , Cardiac Surgical Procedures/methods , Plastic Surgery Procedures/methods , Suture Techniques , Tricuspid Valve Insufficiency/surgery , Aged , Aged, 80 and over , Animals , Disease Models, Animal , Endoscopy , Female , Humans , Male , Models, Anatomic , Swine , Tissue Culture Techniques
10.
Innovations (Phila) ; 13(6): 455-457, 2018.
Article in English | MEDLINE | ID: mdl-30540590

ABSTRACT

Traditionally, pacing leads are placed transvenously, although smaller pediatric patients who require permanent pacemakers may benefit from delaying tranvenous lead placement until they are larger. Alternative, minimally invasive atrioventricular pacing options have not previously existed for this patient population, leaving many of these children with large sternotomies or thoracotomies. Using three port sites and an adjustable shaft dual-needle suturing device, we placed a steroid-eluting, sew-on epicardial lead on the right atrium of a 9-year-old patient. This is one of the earliest reported cases of a minimally invasive technique for sew-on epicardial lead placement on the atrium of a child. Although based on a single case, we believe that this approach is safe, reliable, and reproducible and that it can be used to place leads on any aspect of the heart. Adoption of this technique will allow for earlier atrioventricular pacing, which may decrease the incidence of pacemaker syndrome, and thus improve overall outcomes in this patient population.


Subject(s)
Heart Defects, Congenital/surgery , Minimally Invasive Surgical Procedures/methods , Pacemaker, Artificial , Prosthesis Implantation/methods , Child , Electrodes, Implanted , Female , Humans
11.
Ann Transl Med ; 6(15): 314, 2018 Aug.
Article in English | MEDLINE | ID: mdl-30211202

ABSTRACT

Focused research targeting an identified clinical problem may result in more rapid development of medical devices, technologies, and surgical techniques that directly impact patient care. These medical advances to improve patient care may be expedited by adopting an interactive translational research model in which inventors, designers, and engineers work in collaboration with surgeons. In addition, cadaveric simulation is a high-fidelity model that is bridging the translational and logistical gap to bring new surgical devices, technologies, and techniques to patients. We describe the partnership between the University of Rochester and LSI SOLUTIONS® in which an interactive translational research model utilizing cadaveric simulation has been successfully applied to accelerate bringing minimally invasive cardiac surgical techniques and innovative devices to patients.

12.
Ann Thorac Surg ; 105(2): 645-649, 2018 Feb.
Article in English | MEDLINE | ID: mdl-29174775

ABSTRACT

PURPOSE: Annular suture placement during minimally invasive right anterior thoracotomy aortic valve replacements (MI-AVR) can be challenging. We present the early clinical experience with novel automated suturing technology that may reduce the technical difficulty of this operation. DESCRIPTION: The technology presented involves an automated articulating suturing device that simultaneously drives dual-curved needles through the aortic annulus to place a pledgeted horizontal mattress suture remotely; a second device with 2 straight needles places suture through the sewing cuff of a prosthetic heart valve. EVALUATION: Automated annular suturing was used in five MI-AVR procedures, which were successfully completed, with no paravalvular leaks detected and a mean aortic valve gradient of 6.4 mm Hg postprocedure. Mean aortic cross-clamp and cardiopulmonary bypass times were 100 and 134 minutes, respectively. All 5 patients were successfully discharged home, with a mean intensive care unit and total length of stay of 2 and 7 days, respectively. CONCLUSIONS: Automated suturing during MI-AVRs is feasible and may reduce the technical challenge of this operation. Further research is necessary to determine its effect on patient outcomes.


Subject(s)
Aortic Valve/surgery , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation/methods , Minimally Invasive Surgical Procedures/methods , Suture Techniques/instrumentation , Sutures , Feasibility Studies , Humans
13.
Innovations (Phila) ; 11(6): 400-406, 2016.
Article in English | MEDLINE | ID: mdl-27930604

ABSTRACT

OBJECTIVE: Mitral valve (MV) chordae replacements can be technically challenging. Technology that remotely delivers and accurately secures artificial chordae may reduce the learning curve and improve the reliability of MV repairs. METHODS: The technology involved two devices: a remote suturing device for delivery of expanded polytetrafluoroethylene (ePTFE) suture to the papillary muscle and a Coaxial titanium suture fastener (TF) device with integrated saline infusion for real-time determination of chordae length during fixation. A mechanical model simulating MV chordae tension in a beating heart quantified the durability of 120 coaxially fastened ePTFE sutures using TF over time. Investigation of the technology was performed in ex vivo porcine, ovine, and in situ cadaver hearts, whereas live-tissue testing was conducted in a survivor ovine model. Mitral valve repair procedures involved the iatrogenic induction of mitral regurgitation by the resection of one to two native MV chordae, followed by implantation of ePTFE suture using the technology. Epicardial echocardiography, saline infusion testing, and histologic analysis evaluated MV competence, repair integrity, and long-term healing. RESULTS: Durability testing of ePTFE suture secured with TF demonstrated no degradation of TF pull-apart forces of for 440 million cycles. Mitral valve repairs using the technology were performed in eight sheep; four demonstrating proof of concept and four survived for an average of 6.5 months after completion of the procedure. At reoperation, echocardiography demonstrated trace to no mitral regurgitation with near complete endothelialization of the TF and artificial chordae. CONCLUSIONS: This technology successfully enabled the implantation of artificial chordae while providing real-time adjustment of chordae length during MV repair. These results encourage further investigation of its use clinically.


Subject(s)
Cardiac Surgical Procedures/instrumentation , Chordae Tendineae/surgery , Mitral Valve/surgery , Robotic Surgical Procedures/methods , Animals , Cadaver , Humans , Minimally Invasive Surgical Procedures , Models, Biological , Polytetrafluoroethylene , Reproducibility of Results , Sheep , Suture Techniques/statistics & numerical data , Swine
14.
Innovations (Phila) ; 11(5): 327-336, 2016.
Article in English | MEDLINE | ID: mdl-27561176

ABSTRACT

OBJECTIVE: Prostheses attachment is critical in aortic valve replacement surgery, yet reliable prosthetic security remains a challenge. Accurate techniques to analyze prosthetic fixation pressures may enable the use of fewer sutures while reducing the risk of paravalvular leaks (PVL). METHODS: Customized digital thin film pressure transducers were sutured between aortic annulus models and 21-mm bioprosthetic valves with 15 × 4-mm, 12 × 4-mm, or 9 × 6-mm-wide pledgeted mattress sutures. Simulating open and minimally invasive access, 4 surgeons, blinded to data acquisition, each secured 12 valves using manual knot-tying (hand-tied [HT] or knot-pusher [KP]) or automated titanium fasteners (TFs). Real-time pressure measurements and times were recorded. Two-dimensional (2D) and 3D pressure maps were generated for all valves. Pressures less than 80 mm Hg were considered at risk for PVL. RESULTS: Pressures under each knot (intrasuture) fell less than 80 mm Hg for 12 of 144 manual knots (5/144 HT, 7/144 KP) versus 0 of 288 TF (P < 0.001). Pressures outside adjacent sutures (extrasuture) were less than 80 mm Hg in 10 of 60 HT, zero of 60 KP, and zero of 120 TF sites for 15 × 4-mm valves; 17 of 48 HT, 25 of 48 KP, and 12 of 96 TF for 12 × 4-mm valves; and 15 of 36 HT, 17 of 36 KP, and 9 and 72 TF for 9 × 6-mm valves; P < 0.001 all manual versus TF. Annular areas with pressures less than 80 mm Hg ranged from 0% of the sewing-ring area (all open TF) to 31% (12 × 4 mm, KP). The average time per manual knot, 46 seconds (HT, 31 seconds; KP, 61 seconds), was greater than TF, 14 seconds (P < 0.005). CONCLUSIONS: Reduced operative times and PVL risk would fortify the advantages of surgical aortic valve replacement. This research encourages continued exploration of technical factors in optimizing prosthetic valve security.


Subject(s)
Aortic Valve/surgery , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/methods , Humans , Prosthesis Design , Prosthesis Failure , Suture Techniques
15.
Innovations (Phila) ; 9(2): 111-6; discussion 116, 2014.
Article in English | MEDLINE | ID: mdl-24755535

ABSTRACT

OBJECTIVE: This study compared the strength, consistency, and speed of prosthetic attachment sutures secured with automated fasteners with those of manual knots using an ex vivo porcine mitral valve annuloplasty model. A novel miniature pressure transducer system was developed to quantify pressures between sutured prosthetic rings and underlying cardiac tissue. METHODS: Sixteen mitral annuloplasty rings were sewn into ex vivo pig hearts. Eight rings were secured with the COR-KNOT device; and eight rings, with hand-tied knots using a knot pusher. A cardiac surgeon and a surgery resident each completed four manually tied rings and four COR-KNOT rings via a thoracotomy trainer. The total time to knot and cut each ring's sutures was recorded. Suture attachment pressures were measured within (intrasuture) and between (extrasuture) each suture loop using a 0.5 × 2.0-mm microtransducer probe system. RESULTS: The suture holding pressures for the COR-KNOT fasteners were significantly greater than for the manually tied knots (median, 1008.9 vs 415.8 mm Hg, P < 0.001). All automated fasteners measured greater than 500 mm Hg, whereas 56% of the hand-tied knots were less than 500 mm Hg, and 14% were less than 75 mm Hg. There was less variation in attachment pressures for the COR-KNOT fasteners than for the hand-tied knots (SD, 401.6 vs 499.3 mm Hg, P = 0.04). Significant time savings occurred with the use of the COR-KNOT compared with manual tying (12.4 vs 71.1 seconds per knot, P = 0.001). CONCLUSIONS: The novel microtransducer technology provided an innovative means of evaluating cardiac prosthetic anchoring sutures. In this model, mitral annuloplasty ring sutures secured with the COR-KNOT device were stronger, more consistent, and faster than with manually tied knots.


Subject(s)
Automation/instrumentation , Education, Medical, Continuing/methods , Minimally Invasive Surgical Procedures/education , Mitral Valve Annuloplasty/methods , Suture Techniques/education , Suture Techniques/instrumentation , Sutures , Animals , Computer Simulation , Disease Models, Animal , Equipment Design , Humans , Swine
16.
Innovations (Phila) ; 8(1): 50-5, 2013.
Article in English | MEDLINE | ID: mdl-23571794

ABSTRACT

OBJECTIVE: A safe and reliable direct percutaneous approach for transapical access to the left ventricle would be a significant advance toward decreasing the invasiveness of intracardiac interventions. This report presents results from a surviving porcine beating heart model in which transapical access sites were closed using an automated suturing technique ultimately intended for percutaneous use. METHODS: Through an approved protocol including general anesthesia, the cardiac apex in 10 beating pig hearts was surgically exposed, permitting transapical passage of a 0.035-in guidewire and a 5.5F, 0.9-mL Fogarty balloon catheter. An automated suturing device was passed over the guidewire and the Fogarty onto the transapical access site. Two pledgeted horizontal mattress sutures were simultaneously placed concentrically around the apical access site with a single squeeze of the device's lever. A 25F dilator was passed into the left ventricle over the guidewire and subsequently removed. The sutures were then secured using pledgeted titanium knots. Chest wall and skin incisions were closed. The animals were recovered from anesthesia and resumed a normal diet. RESULTS: Under general anesthesia, the transapical access site of each animal was re-exposed, five at 1-week and five at 2-week intervals. Hemostasis was complete, and all wounds healed well. CONCLUSIONS: The evaluation of transapical wound closures in this surviving porcine heart model demonstrates complete hemostasis and excellent healing through the use of this automated remote suturing technology.


Subject(s)
Heart Valve Prosthesis Implantation/methods , Heart Ventricles/surgery , Suture Techniques/instrumentation , Wound Healing/physiology , Animals , Cardiac Catheterization/methods , Equipment Design , Equipment Safety , Female , Minimally Invasive Surgical Procedures/methods , Models, Animal , Sutures , Swine , Titanium
17.
Ann Thorac Surg ; 92(4): 1494-8, 2011 Oct.
Article in English | MEDLINE | ID: mdl-21958800

ABSTRACT

PURPOSE: A readily applied and reliable means to create and close transapical wound access sites through a small intercostal opening could benefit many cardiac patients. Using relevant surgical tissue models, this research evaluated a new approach to enable single-port transapical wound site closure toward the eventual development of safe percutaneous access to the left ventricle. DESCRIPTION: Novel techniques and technologies were developed and successfully tested for remote automated placement of 2 pledgeted horizontal mattress sutures delivered concentrically around a transmural apical guidewire, which provided a tract to enable therapeutic intervention. Mechanical pledgeted knots secured these sutures after cannula removal. EVALUATION: Automated transapical closures were created in 47 ex vivo porcine hearts and in 10 human cadavers, 8 through a thoracotomy and 2 thoracoscopically. Automated apical closures achieved hemostasis in an acute beating heart thoracotomy model in 3 anesthetized pigs. An ex vivo porcine heart pressurized infusate model demonstrated the intraventricular pressure tolerated by automated closures (mean, 327 mm Hg) compared with hand-sutured closures (mean, 303 mm Hg). CONCLUSIONS: All automated apical closures were effective. Early results encourage further evaluation.


Subject(s)
Automation/instrumentation , Cardiac Surgical Procedures , Heart Diseases/surgery , Telemedicine/instrumentation , Wound Closure Techniques/instrumentation , Animals , Cadaver , Cardiac Catheterization , Disease Models, Animal , Equipment Design , Heart Atria , Humans , Swine , Wound Healing
18.
Urology ; 78(6): 1211-7, 2011 Dec.
Article in English | MEDLINE | ID: mdl-21996106

ABSTRACT

OBJECTIVE: To describe the first clinical experience, pathologic, and perioperative outcomes of natural orifice transluminal endoscopic surgery (NOTES) radical prostatectomy. NOTES represents the evolution of minimally invasive surgery. The conceptual feasibility has been shown in careful laboratory and animal studies, but a scarcity of information regarding clinical applications exists. METHODS: After institutional review board approval, 2 patients agreed to undergo NOTES radical prostatectomy for localized prostate cancer. The prostate was radically resected using a 26F resectoscope, 550-µm laser fiber, and holmium laser. The prostate was delivered into the bladder and removed at the conclusion of the procedure through a suprapubic cystotomy for histopathologic analysis. The vesicourethral anastomosis was completed using a cannula scope, urethral-vesical suturing device, and titanium knot applier. Cystograms were taken immediately postoperatively and at catheter removal. RESULTS: Both patients tolerated the procedure without operative complications. All intraoperative cystograms showed watertight anastomoses. The pathologic examination revealed Gleason score 3 + 3 and Stage pT2aNxMx for 1 patient and Gleason score 3 + 4 and Stage pT2cNxMx for 1 patient, with negative margins for both. No blood transfusions were required. Patient 2 experienced some left-sided gluteal and suprapubic pain postoperatively. CONCLUSION: NOTES radical prostatectomy appears to be a safe and feasible option for the management of carefully selected, organ-confined prostate cancer. The perioperative and pathologic outcomes show promise with this new technique; however, the high standards of oncologic and functional outcomes demand close and longer follow-up before adoption into the surgical armamentarium can be recommended.


Subject(s)
Adenocarcinoma/pathology , Adenocarcinoma/surgery , Natural Orifice Endoscopic Surgery/methods , Prostatectomy/methods , Prostatic Neoplasms/pathology , Prostatic Neoplasms/surgery , Aged , Aged, 80 and over , Humans , Male , Natural Orifice Endoscopic Surgery/adverse effects , Natural Orifice Endoscopic Surgery/instrumentation , Neoplasm Staging , Pain, Postoperative/etiology , Prostatectomy/adverse effects , Prostatectomy/instrumentation
19.
Gastrointest Endosc ; 67(6): 964-9, 2008 May.
Article in English | MEDLINE | ID: mdl-18440387

ABSTRACT

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) is a novel, potentially less invasive alternative to laparoscopic surgery. However, the problems of transluminal access and closure represent significant obstacles to its successful introduction in humans. OBJECTIVE: Our purpose was to evaluate the feasibility and safety of a novel device designed for transluminal access and closure. DESIGN: Experimental endoscopic study of transcolonic incision and closure with use of a prototype device in a survival porcine model. SUBJECTS: Four adult female Yorkshire pigs were used in the study. INTERVENTIONS: While under general anesthesia, the animals were prepped with multiple tap water enemas followed by instillation of an antibiotic suspension and povidone-iodine lavage. At a distance of 15 to 20 cm from the anus, the prototype device deployed a circumscribing purse-string suture around the planned incision site and subsequently used a blade mechanism to create a 2.5-cm linear incision. The peritoneum was then accessed with a standard double-channel enodoscope. The transcolonic incision was then closed by cinching and securing the purse-string suture with a titanium knot by use of a separate hand-activated suture-locking device. All animals were allowed to eat immediately after recovering from general anesthesia. MAIN OUTCOME MEASUREMENTS: The animals were monitored daily for signs of peritonitis and sepsis and were electively killed on day 14. The peritoneal cavity was examined for peritonitis, and the colonic incision site was examined for wound dehiscence, pericolic abscess formation, and gross adhesions. Tissue samples from both incisional and random peritoneal sites were obtained for histologic examination. RESULTS: Transcolonic incision and closure were successful in all 4 animals. The device performed in a rapid and reproducible fashion. All animals recovered without septic complications. At necropsy, there was no evidence of peritonitis, abscesses, or wound dehiscence. Salpingocolonic and colovesicular adhesions were noted in 3 of 4 animals. Histologic examination revealed microabscesses at the incision site in all animals. CONCLUSIONS: The prototype incision and closure device represents a promising solution to the problems of transluminal access for NOTES. The presence of incision-related adhesions and microabscesses signal the need for further refinement in aseptic technique.


Subject(s)
Endoscopes, Gastrointestinal/standards , Endoscopy, Gastrointestinal/methods , Stomach Diseases/surgery , Suture Techniques/instrumentation , Animals , Colon , Disease Models, Animal , Equipment Design , Female , Reproducibility of Results , Stomach Diseases/mortality , Stomach Diseases/pathology , Survival Rate , Swine
20.
J Endourol ; 16(7): 431-43, 2002 Sep.
Article in English | MEDLINE | ID: mdl-12396434

ABSTRACT

BACKGROUND AND PURPOSE: Despite a 10% to 15% failure rate, endopyelotomy remains the treatment of choice for most patients with ureteropelvic junction (UPJ) obstruction. We present a novel technique of percutaneous endopyeloplasty, wherein a precise, full-thickness approximation of a standard longitudinal endopyelotomy incision is performed in a horizontal Heineke-Mikulicz fashion through the conventional solitary percutaneous tract via a nephroscope. We assess the feasibility and efficacy of percutaneous endopyeloplasty in a chronic porcine bilateral UPJ obstruction model and compare outcome data with those#10; of conventional endopyelotomy and laparoscopic pyeloplasty. MATERIALS AND METHODS: Partial UPJ obstruction was created in 20 kidneys (11 pigs) by laparoscopic ligation of the upper ureter over a 5F ureteral catheter. After development of hydronephrosis over a period of 4 to 6 weeks, percutaneous endopyeloplasty (N = 10), conventional percutaneous endopyelotomy (N = 5), or laparoscopic pyeloplasty (N = 5) was performed. The essential steps of percutaneous endopyeloplasty include retrograde ureteral catheterization, standard percutaneous endopyelotomy incision, mobilization of the distal ureteral lip, horizontal suturing of the endopyelotomy incision through the nephroscope, and nephrostomy drainage and ureteral stenting. Suturing was performed using a modified 5-mm laparoscopic device (Sew Right 5 SR; LSI Solutions, Rochester, NY), which was passed through the nephroscope. RESULTS: Percutaneous endopyeloplasty was technically successful in all 10 kidneys with a mean total operative time of 81.4 minutes (range 51-117 minutes). The mean endopyeloplasty suturing time was 29.4 minutes (range 20-64 minutes). Three kidneys required two sutures, while seven kidneys required three sutures to complete the endopyeloplasty. The solitary complication was a lower-pole infundibular stenosis. Over a mean follow-up of 7.7 weeks, all renal units showed relief of obstruction, as evidenced by regression of hydronephrosis,#10; improvement in T(1/2) and glomerular filtration rate on renogram, and a low intrapelvic pressure on Whitaker test. At autopsy, the endopyeloplasty site showed a fine, well-healed transverse scar with no evidence of residual suture on the mucosal surface. The mean caliber of the UPJ following endopyeloplasty (13.8F +/- 2.2F) was significantly greater (P = 0.01) than that following endopyelotomy (7.5F +/- 1.9F). Intraoperative extravasation on completion of endopyeloplasty was absent (N = 6) or mild (N = 4) compared with that seen in all five kidneys following endopyelotomy. CONCLUSION: Percutaneous endopyeloplasty is feasible, simple, reproducible, and effective. Its advantages over conventional endopyelotomy include transrenal performance of a Fenger-plasty, wider caliber of the UPJ, absence of extravasation, and shorter duration of ureteral stenting.


Subject(s)
Hydronephrosis/surgery , Kidney Pelvis/surgery , Laparoscopy/methods , Ureter/surgery , Ureteral Obstruction/surgery , Urologic Surgical Procedures/methods , Animals , Feasibility Studies , Female , Kidney Pelvis/pathology , Laparoscopes , Models, Animal , Reproducibility of Results , Stents , Suture Techniques/instrumentation , Swine , Treatment Outcome , Ureter/pathology , Urinary Catheterization/methods , Wound Healing
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