Ethicon Inc Research Articles

Impact of Inner Layer Renorrhaphy Suture on Renal Artery Pseudoaneurysm Formation Following Robotic-assisted Partial Nephrectomy

To report the impact of resection base inner layer renorrhaphy suture type on renal artery pseudoaneurysm (RAP) rate following robotic-assisted partial nephrectomy (RAPN). Five hundred and sixty-three consecutive RAPNs performed by a single surgeon were retrospectively reviewed. Patients were classified into 3 categories: (1) No base suture, (2) monofilament barbed suture (2-0 V-Loc 180 absorbable suture, Medtronic, Minneapolis, MN), (3) polyglactin 910 (2-0 Vicryl coated suture, Ethicon Inc, Cincinnati, OH). In a secondary analysis, we evaluated suturing (Vicryl and V-Loc) vs no base suture. All patients had outer cortical renorrhaphy performed with 0-Vicryl suture utilizing the standard sliding clip technique. One hundred ten patients (19.5%) had V-Loc suturing, 255 patients (45.3%) had Vicryl suturing, and 198 patients (35.2%) had no base suture. Patients had a median age of 62.8years (interquartile range: 53.5-69.7) and median RENAL score was 8 (6-9). Median mass size from preoperative imaging was 3.0 cm (2.5-4.0) for V-Loc, 3.3 cm (2.5-4.2) for Vicryl, and 2.0 cm (1.8-3.0) for no base suture (P < .001). Overall, 21 patients (3.7%) developed a symptomatic postoperative RAP. The rate of RAP was 3.6% (4/110) for V-Loc, 3.9% (10/255) for 2-0 Vicryl, and 3.5% (7/198) for no base suture (P = 1.00). Similarly, the rate of RAP was 3.5% (7/198) for no base suture and 3.8% (14/365) for base suture (P = 1.00). Utilization of base suture and type of base suture used during RAPN was not predictive of postoperative RAP development.

EFFICACY AND SAFETY OF KNOTLESS BARBED SUTURES IN CAPSULAR CLOSURE FOLLOWING DISTAL FEMUR FRACTURE FIXATION.

Good wound closure is an important step in management of distal femur fracture to prevent infection and faster rehabilitation. Knotless barbed sutures can save time and distribute wound tension evenly. However, its role in terms of functional outcome, closure time, and postoperative complications has not been studied in a distal femur fracture. A total of 47 patients aged more than 18 years of distal femur fracture treated with distal femur locking plate were randomized either into either barbed or traditional suture groups. in the barbed group, capsular wound closure was carried out with 2-0 bidirectional barbed knotless sutures (Quill SRS® PDO, Angiotech, Vancouver, BC, Canada). In patients assigned to group B, capsular closure was done with 1-0 Vicryl® (Ethicon inc. Somerville, NJ) and 5-0 Ethibond® alternatively. The mean flexion at the knee joint was 105.7±15.6 degrees in the study group while it was 110.4±13.7 in the control group (p= 0.2133). Mean estimated closure time was significantly shorter in the study group as compared to the control group (p<0.05). Cases of needle prick injury were higher in traditional suture group. Patients developed stitch abscess and superficial infection in both groups. However, the difference in incidence between the two was not statistically significant. Barbed suture is an efficient method of wound closure. It reduces wound closure time with similar complication rate as with use of conventional sutures. Evidence Level II; Randomized Clinical Trial.

Laparoscopic myomectomy using barbed or conventional sutures

To assess the differences in surgical outcomes between bidirectional barbed suture and conventional suture for myoma bed closure during laparoscopic myomectomy. Study design: Ninety-two patients with one to three symptomatic myomas were randomized in a 1:1 ratio to the barbed suture group or the conventional suture group. Myoma bed was sutured either with barbed suture (STRATAFIX™, Ethicon Inc, USA) or continuous conventional suture with intracorporeal knot tying (Vicryl; Ethicon, USA). The surgeon assessed the degree of suturing difficulty using a visual analog scale ranging from 1 (least difficult suturing) to 10 (most difficult suturing). Results: Suturing with barbed suture was easier than suturing with conventional suture (3.04±1.47 Vs. 4.75± 1.35, P &lt; 0.001). Suturing time of the myoma bed was significantly shorter in the barbed suture group (14.98±4.81 Vs 22.09±6.9 min; P &lt; 0.001). Operative time was comparable between both groups (69.67±17.63 Vs 74.15±19.79 min; P = 0.255). The mean intraoperative blood loss was significantly higher in conventional suture group (337.24±234.15 ml Vs 211.3±107.62; P= 0.002). Conclusion: The barbed suture facilitates suturing of the myoma bed during laparoscopic myomectomy. Compared with conventional suture, barbed suture reduces the time needed to suture the myoma bed and the intraoperative blood loss.&#x0D;

Endoscopic Posterior Rotation Flap for Posterior Glottic Insufficiency.

Endoscopic Posterior Rotation Flap for Posterior Glottic Insufficiency.

Microvascular Decompression of Facial Nerve and Pexy of the Left Vertebral Artery for Left Hemifacial Spasm: 3-Dimensional Operative Video.

A 73-yr-old man presented with intractable left hemifacial spasm of 4 yr duration. Brain magnetic resonance imaging showed significant compression of left facial nerve by the left vertebral artery (VA) and anterior inferior cerebellar artery (AICA).The patient underwent a left retrosigmoid craniotomy and a microvascular decompression of the cranial nerve (CN) VII. Intraoperatively, we found that the distal AICA had a protracted subarcuate extradural course.1 This was relieved by intra/extradural dissection. The left VA and the AICA loop were compressing the root exit zone of CN VII. The VA was mobilized, and pexy into the petrosal dura was done with 8-0 nylon sutures (Ethilon Nylon Suture, Ethicon Inc, a subsidiary of Johnson & Johnson, Somerville, New Jersey). Once this was done, the lateral spread disappeared.2 The AICA loop was decompressed with 2 pieces of Teflon felt (Bard PTFE felt, Bard peripheral Vascular Inc, a subsidiary of CR Bard Inc, Temp, Arizona). After this, wave V of the brainstem auditory evoked potential (BAEP) disappeared completely, with no recovery despite the application of the nicardipine on the internal auditory artery (IAA). The IAA appeared to be stretched by the microvascular decompression. Arachnoidal dissection was done to release the CN VIII and an additional felt piece was placed to elevate the AICA loop; the BAEP recovered completely. The patient had a complete disappearance of the hemifacial spasm postoperatively, and hearing was unchanged.This 3-D video shows the technical nuances of performing a vertebropexy, release of the AICA from its extradural subarcuate course, and the surgical maneuvers in the event of an unexpected change in neuromonitoring response. The suture technique of vertebropexy is preferred to a loop technique, to avoid kinking of the VA.3Informed consent was obtained from the patient prior to the surgery that included videotaping of the procedure and its distribution for educational purposes. All relevant patient identifiers have also been removed from the video and accompanying radiology slides.

Modified Laparoscopic Lateral Suspension: The Mulayim Technique

To demonstrate a modified technique of laparoscopic lateral suspension for pelvic organ prolapse (POP). A video illustrating this modified technique of laparoscopic lateral suspension (Canadian Task Force classification III). The benign gynecology department at a university hospital. Laparoscopic lateral suspension using mesh is a minimally invasive technique that effectively treats POP [1-4]. We present a modified technique of laparoscopic lateral suspension that differs from previously described methods [1-4]. The prominent differences are as follows: first, our modified technique uses Mersilene tape on a 48-mm round-bodied needle (Ethicon Inc, Somerville, NJ,USA). We suspend the vaginal vault, taking a double bite using Mersilene tape without knotting placed as a transversal hammock. Thanks to the Mersilene tape, meshes, sutures, tackers, or fasteners are not needed. Mersilene tape ensures much easier suturing and an inexpensive artificial material. The second difference is that port placement sites (Fig. 1). The third difference is the number of incisions we make (Fig. 1). We do not need 2 additional incisions as used in previously described methods references [1-4]. We use the same incision for lateral trocar insertion and for pulling out the distal end of the Mersilene tape, which is 2 cm above the iliac crest and 4 cm posterior to the anterior superior iliac spine (Fig. 1). Our technique has the potential to be easier, shorter, more cost-efficient, less invasive, and safer when compared with previously described methods. Modified laparoscopic lateral suspension, the so-called Mulayim technique, might be considered as an alternative treatment for POP surgery; however, studies should be conducted in a larger number of patients with longer postoperative follow-up periods (Fig. 1).

Harmonic devices: The workhorse for surgical resection of vascular malformations

Management of vascular malformations is multimodal with documented role of surgical resection in specific facets of this condition. Surgical resection of these lesions is technically challenging owing to diffuse and relatively ill-defined extent with involvement of multiple tissue planes limitation of access and excessive intra-operative bleeding. An observational study was conducted in 24 cases taken up for surgical resection of vascular malformations. The cases were divided into two groups based on the hemostasis technique used: Group A: Harmonic shears (n = 12) (Ethicon Inc. Somerville, New Jersey, United States). Group B: Electrosurgery (monopolar/bipolar) with standard knot tying (n = 12). We conclude that use of harmonic scalpel in surgical resection causes less parallel tissue damage, secures haemostasis promptly, does not impede vision and aids surgical dissection thereby significantly reducing the operative time and improving the surgical outcome, typically in large vascular malformations of head and neck region.

Reverse Sural Adipofascial Flaps with Acellular Dermal Matrix and Negative-Pressure Wound Therapy.

The reverse sural adipofascial flap (RSAF) is used to reconstruct challenging wounds of the foot and ankle. It offers several advantages over the traditional reverse sural flap, including less venous congestion. To complete the reconstruction, split-thickness skin grafting (STSG) may be done immediately or in a delayed fashion; however, both scenarios result in suboptimal take rates and prolonged healing. An acellular dermal matrix (ADM; Integra; Ethicon Inc, Somerville, New Jersey) and negative-pressure wound therapy (NPWT) combined with RSAF followed by delayed STSG may decrease wound healing time.In this study, 8 patients underwent reconstruction of lower-extremity wounds with RSAF. Four patients underwent RSAF with immediate STSG, and 4 underwent RSAF with placement of the ADM and a vacuum-assisted closure device, with STSG at a later date.The 4 patients who underwent RSAF and immediate STSG had an average time to heal of 141.2 days, and 2 patients required reoperation. The 4 patients who underwent RSAF with an ADM and NPWT had an average time to heal of 104.5 days, and 1 patient required reoperation. Average time until STSG was 41.5 days. The latter group demonstrated a reduction in time to heal by an average of 36.7 days, or 25%. All 8 patients achieved successful wound closure.The RSAF is a durable option for complex lower-extremity reconstruction. Interim placement of ADM and NPWT may increase STSG take rates. Using this technique in conjunction with RSAF may decrease the overall healing time compared with RSAF with immediate STSG.

Erratum: Primary versus Staged Closure of Exomphalos Major: Cardiac Anomalies Do Not Affect Outcome.

Aim The objective of the study is to describe management of exomphalos major and investigate the effect of congenital cardiac anomalies. Methods A single-center retrospective review (with audit approval) was performed of neonates with exomphalos major (fascial defect ≥ 5cm ± liver herniation) between 2004 and 2014. Demographic and operative data were collected and outcomes compared between infants who had primary or staged closure. Data, median (range), were analyzed appropriately. Results A total of 22 patients were included, 20 with liver herniation and 1 with pentalogy of Cantrell. Gestational age was 38 (30–40) weeks, birth weight 2.7 (1.4–4.6) kg, and 13 (60%) were male. Two were managed conservatively due to severe comorbidities, 5 underwent primary closure, and 15 had application of Prolene (Ethicon Inc) mesh silo and serial reduction. Five died, including two managed conservatively, none primarily of the exomphalos. Survivors were followed up for 38 months (2–71). Cardiac anomalies were present in 20 (91%) patients: 8 had minor and 12 major anomalies. Twelve (55%) patients had other anomalies. Primary closure was associated with shorter length of stay (13 vs. 85 days, p = 0.02), but infants had similar lengths of intensive care stay, duration of parenteral feeds, and time to full feeds. Infants with cardiac anomalies had shorter times to full closure (28 vs. 62 days, p = 0.03), but other outcomes were similar. Conclusion Infants whose defect can be closed primarily have a shorter length of stay, but other outcomes are similar. Infants with more significant abdominovisceral disproportion are managed with staged closure; the presence of major cardiac anomalies does not affect surgical outcome.

Does Barbed Suture Lower Cost and Improve Outcome in Total Knee Arthroplasty? A Randomized Controlled Trial

BackgroundWound closure is key to prevent infection, facilitate immediate rehabilitation, and improve efficiency of total knee arthroplasty (TKA). Continuous knotless suturing with barbed suture can potentially save time and distribute tension more evenly. However, its role in TKA in terms of cost-effectiveness and wound complications is not clear. This study aims at comparing barbed and traditional sutures' wound closure time and cost in primary TKA. MethodsOne hundred nine knees were randomized into either barbed or traditional group. Synthetic absorbable sutures (Vicryl, Ethicon Inc) and bidirectional barbed sutures (Stratafix, Ethicon Inc) were used. Arthrotomy and subcutaneous wound closure time, wound complications, and rehabilitation parameters in terms of range of motion and Knee Society Score were compared. Patients were followed up to 3 months. ResultsTraditional sutures had significantly more positive leak tests (10 vs 2, P value <.05) and wound complications (11 vs 2, P value <.05). No differences in range of motion and Knee Society Score were noted. Arthrotomy and subcutaneous closure time were significantly shorter with barbed sutures (arthrotomy 325 seconds vs 491 seconds; subcutaneous 306 seconds vs 381 seconds, P value <.05). Concerning cost of suture material and operation time, barbed suture on average saved USD 48.7 per TKA in our local institute. ConclusionBidirectional barbed suture improves the cost-effectiveness of TKA through reducing wound closure time and wound complications.

Peri-Implant Mucositis and Peri-Implantitis: A Current Understanding of Their Diagnosis, Clinical Implications, and a Report of Treatment Using a Combined Therapy Approach.

Abstract The clinical condition involving dental implants, characterized by soft tissue inflammation, bleeding, suppuration and rapid bone loss is widely known as peri implantitis. The main objective in the treatment of peri-implantis is to arrest the progression of the disease and at the same time to keep the dental implant in the mouth solving the inflammations signs of bleeding and pain. The aim of this paper is to highlight the effectiveness of the use of titanium brush and antimicrobial photodynamic therapy (aPDT) to decontaminate the implant surface, in association with regenerative procedures by means of autologous bone and demineralized bovine bone mineral (DBBM) in the treatment of peri-implantitis defects.

Nilotinib Vs Dasatinib As Second-Line Therapy in Patients with Philadelphia-Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP) Who Are Resistant or Intolerant to Imatinib: A Cost-Effectiveness Analysis (CEA) Based on Real-World Data

Nilotinib Vs Dasatinib As Second-Line Therapy in Patients with Philadelphia-Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP) Who Are Resistant or Intolerant to Imatinib: A Cost-Effectiveness Analysis (CEA) Based on Real-World Data

Skin Staples versus Intradermal Wound Closure following Primary Hip Arthroplasty: A Prospective, Randomised Trial Including 231 Cases

Intradermal wound closure is controversial in primary total hip arthroplasty. Randomised, controlled trials in wound closure following a total hip arthroplasty (THA) are scarce. Our hypothesis was that skin staples closure would be related to a similar complication rate and operative time as intradermal closure with polypropylene. From September 2011 to May 2012, 231 THAs in 219 patients with an average age of 62 years old (range: 21-91) were performed. No differences were observed in both groups according to sex, age, BMI and comorbidities (p = 0,82). Cases were divided into 3 groups according to medical factors that influence wound healing: group 1 (no medical history, 70.5%), group 2 (diabetes, tobacco smokers, obesity, corticosteroids, rheumatoid disease, 25%) and group 3 (organ transplantation, neoplastic patients or 2 or factors of group 2, 4.5%). Once randomised using a computer-generated method, all patients remained within the group to which they were allocated to wound closure with skin staples (Leukosan® SkinStapler PTW-35, BSN, Germany) that were used in 112 THAs in 105 patients (48%), or continuous 3.0 intradermal non-absorbable polypropylene suture (Prolene™ 0, Ethicon Inc. Somerville, New Jersey, USA) in 119 THA´s in 115 patients (52%). A 3.8% wound complication rate was observed in this series, with a 2.1% complication rate for the group that was closed with skin staples and a 1.7% rate for the group with intradermal suture (p = 0.7). All the complications were treated conservatively except for one acute deep infection (0.4%) that was successfully treated with debridement, component retention and intravenous antibiotics. There were no differences in both groups related to operative time or wound length.In these series of primary elective THAs, skin staples were associated with a similar complication rate to an intradermal closure technique.

A comparison of hysteroscopic mechanical tissue removal with bipolar electrical resection for the management of endometrial polyps in an ambulatory care setting: preliminary results.

To assess and compare efficacy, pain, and the learning curve associated with diagnostic therapeutic hysteroscopy using mechanical tissue removal versus bipolar electrical resection in the management of endometrial polyps in an ambulatory care setting. A randomized controlled clinical trial (Canadian Task Force classification I). Hospital de Igulada, Barcelona, Spain. A total of 133 patients diagnosed with endometrial polyp(s) were included and randomly assigned to 1 of the 2 hysteroscopic methods. Criteria assessed were total hysteroscopy time, full polypectomy procedure time, pain experienced by patients, and learning curve of staff in training. The average time to perform total hysteroscopy using the mechanical tissue removal system (TRUCLEAR 5.0 System; Smith & Nephew Inc., Andover, MD) was 6 minutes 49 seconds versus 11 minutes 37 seconds required for the bipolar electrosurgery system (GYNECARE VERSAPOINT; Ethicon Inc, Somerville, NJ) (p < .01). Results for complete polypectomy time favored the TRUCLEAR System at 3 minutes 7 seconds over the VERSAPOINT System at 8 minutes 25 seconds (p < .01). If a successful procedure is predicated on access to cavity, visualization, and complete resection and excision of endometrial polyp, the mechanical TRUCLEAR Tissue Removal System shows a higher success rate than the VERSAPOINT Bipolar Electrosurgery System at 92% and 77%, respectively. Analysis of pain using the visual analog scale revealed no significant differences between the 2 techniques (p > .05). A study of the residents' learning curve showed a higher level of autonomy with hysteroscopy using the TRUCLEAR Tissue Removal System with which residents showed a higher level of confidence compared with hysteroscopy with the VERSAPOINT Bipolar Electrosurgery System. In hysteroscopic polypectomy, the mechanical tissue removal system was significantly faster, achieved a greater success rate for complete polypectomy, and required a shorter learning curve from staff being trained in the management of endometrial polyps when compared with bipolar electrical resection.

Chlorhexidine gluconate–impregnated central-line dressings and necrosis in complicated skin disorder patients

Although chlorhexidine gluconate (CHG) disks have been shown to help reduce the incidence of central line–associated blood stream infections, their use can result in local skin necrosis. The effects of CHG disks on patients with complex skin pathology have not been studied. We report 6 cases of dermal necrosis associated with Biopatch (Ethicon Inc, Somerville, NJ) CHG disks in adults with complex skin pathology including those with Stevens-Johnson syndrome, toxic epidermal necrolysis syndrome, graft-versus-host disease, burns, and anasarca. All patients had a CHG disk placed at a central venous catheter insertion site. Age range was from 21 to 84 years. Discovery of the reaction ranged from 4 to 14 days after disk placement. Resultant skin erosions required 2 to 10 weeks to reepithelialize. Complicated skin disorder patients represent a rare subset of the critically ill who appear prone to CHG disk necrosis. Continuous contact of CHG under occlusive dressings is speculated to predispose Stevens-Johnson syndrome, toxic epidermal necrolysis syndrome, graft-versus-host disease, and burn patients to local chemical injury secondary to loss of the epithelial tissue barrier, decreased cohesion of the epidermal-dermal junction, and increased tissue permeability. In these patients, the risk of placing the CHG disk may present more risk than using alternative antimicrobial dressings.

Three-Year Follow-Up of a Single Immediate Implant Placed in an Infected Area: A New Approach for Harvesting Autogenous Symphysis Graft

Three-Year Follow-Up of a Single Immediate Implant Placed in an Infected Area: A New Approach for Harvesting Autogenous Symphysis Graft

Vaginal Vault Dehiscence After Robotic Hysterectomy for Gynecologic Cancers: Search for Risk Factors and Literature Review

Vaginal vault dehiscence following robotic-assisted hysterectomy for gynecologic cancer may be attributed to surgical techniques and postoperative therapeutic interventions. We searched for risk factors in patients with gynecologic cancers and complemented this with a literature review. Evaluation of prospectively gathered information on all consecutive robotic surgeries for gynecologic cancers was performed in a tertiary academic cancer center between December 2007 and March 2012. The literature was reviewed for articles relevant to "gynecologic oncology" and "robotics" with "vaginal cuff dehiscence" in the English and French languages. Respective authors were contacted to complete relevant information. Seven dehiscences were identified of 441 cases with established gynecologic cancers. The closures in these 7 were performed using interrupted 1-Vicryl (Ethicon Inc) (3/167; 1.8%), combination of interrupted 1-Vicryl and 1-Biosyn (Covidien Inc) (3/156, 1.9%), and V-Loc (Covidien Inc) (1/118, 0.8%) sutures. Associated risk factors included adjuvant chemotherapy and/or brachytherapy, early resumption of sexual activity, and low body mass index (mean, 23 ± 3.23 kg/m²). Dehiscences occurred regardless of suturing by staff or trainees. Review of operative videos did not reveal a detectable etiologic factor, such as excessive cautery damage to the vaginal cuff or shallow tissue sutured. All 7 colporrhexis repairs were performed through a vaginal approach without the need of laparoscopy or laparotomy. Postoperative chemotherapy, brachytherapy, and early resumption of sexual activities are risk factors for vaginal vault dehiscence. Surgical technique, particularly the use of delayed absorbable sutures, deserves further evaluation.

Use of oxidized regenerated cellulose to prevent pocket hematomas after cardiac electronic device implantation in patients on anticoagulants or dual antiplatelet therapy

Up to 30% of patients remain on anticoagulants or antiplatelet agents at the time of implantation of cardiac electronic devices [1]. The use of clopidogrel alone, dual antiplatelet therapy (DAPT) or intravenous heparin significantly increases the risk of hematoma post device implantation [2–4]. Then again, withholding anticoagulants or antiplatet therapy peri-operatively may result in thromboembolic complications. Surgicel® FibrillarTM Hemostat (Ethicon Inc. USA) is a form of oxidized regenerated cellulose (ORC), a plant-based topical hemostatic agent that is used adjunctively in surgical procedures to help control capillary, venous and small arterial hemorrhage when conventional methods of hemostasis are impractical [5,6]. It is fully absorbablewithin 14 days and has in-vitro bactericidal properties [6,7]. We describe a pilot series of 42 patients who received Surgicel® FibrillarTM Hemostat during implantation of cardiac pacemakers or defibrillators whilst remaining on anticoagulants or DAPT. We aim to assess the safety and efficacy of ORC in prevention of pocket hematomas in this group of individuals at high risk of bleeding complications postimplant. In our institution, patients on antiplatelet therapy or warfarin remain on these medications when they undergo implantation of cardiac pacemakers or defibrillators. The international normalized ratio (INR) is titrated to less than 3. A pocket hematoma is defined as a palpable mass that protrudes N2 cm (minor hematoma) or N4 cm (significant hematoma). Between 1 April 2012 and 31 January 2013, we identified 42 patients onwarfarin or DAPT inwhom implantation of cardiac electronic devices was indicated (See Table 1). Their mean age was 68 ± 8 years, 28 were males. Eighteen patients were onwarfarinwith a mean INR of 2.5 ± 0.2 peri-operatively. Of these 18 patients, 3 were on both warfarin and clopidogrel 75 mg daily. Twenty-four patients were on DAPT consisting of aspirin 100 mg and clopidogrel 75 mg daily. Each patient received 1 dose of intravenous cephazolin 1 h prior to the procedure. During implantation, a subcutaneous pocket was created in the pre-pectoral region with the use of electrocautery. All visible bleeding sites, especially arterial ones, were meticulously cauterized. Vascular access was obtained through subclavian or axillary venous punctures under fluoroscopy guidance. Each lead was implanted via a separate venous puncture. Following placement of the pulse generator in the pocket, Surgicel® FibrillarTM Hemostat was peeled off in the desired amount and the pieces fitted into the pocket, above and to the sides of the pulse generator. The wound was then closed in 2 layers with absorbable sutures and a sterile dressing applied. Each patient was prescribed a 1-week course of oral cephalexin post-implant. They were examined daily until hospital discharge and they returned for outpatient follow-up on Day 7 and 1 month postimplant for wound inspection and device check. Subsequent follow-up was at 3 to 6 monthly intervals. There was no case of pocket hematoma or infection with a mean follow-up period of 6 ±2.3 months. Despite the continued use of warfarin and DAPT peri-operatively, none of our patients developed pocket hematoma or infection. ORC appeared to be safe and effective in prevention of bleeding complications in high-risk individuals during device implantation. In the setting of anticogulation or DAPT, capillary or venous ooze is common. Conventional methods to achieve hemostasis may prove ineffective, especially in the confined areas of the subcutaneous pocket. The benefit of topical hemostatic agents in such settings is controversial. Milic et al. reported that the administration of fibrin sealant in patients on anticoagulation eliminated post-operative pocket hematomas after pacemaker implantation [8]. Recently, Ohlow et al. published data showing that the use of D-Stat HemostatTM (Vascular Solutions Inc. USA) tended towards a higher incidence of pocket hematoma requiring evacuation and pocket infections [9]. ORC is ready for use straight out of the packaging. It can be cut or peeled into customized sizes and fitted into the subcutaneous pocket. It provides a matrix for platelet adhesion and aggregation by melting into bleeding tissue, thereby serving as a hemostatic adjunct in the control of capillary, venous and small arterial hemorrhage. It is fully absorbed from the sites of implantation within 1 to 2 weeks with no tissue reaction. In-vitro studies highlight its bactericidal properties [7]. Given such features, ORC may potentially be suitable as a topical hemostat during cardiac electronic device implantation. Our study is limited by its small sample size and non-randomized design with no control arm. Large randomized trials comparing ORC versus standard care are necessary to fully evaluate the effectiveness and

Transatrial Antegrade Approach for Double Mitral and Tricuspid “Valve-in-Ring” Implantation

Within the last 5 years, the number of transcatheter aortic valve implantation (TAVI) procedures has increased continuously and, in parallel, the indications for TAVI have expanded (eg, failing surgical valves and rings). Furthermore, alternative TAVI access routes such as transaxillary and transaortic have been applied successfully. We report on, to our knowledge, the first-in-human case of a combined off-pump antegrade transatrial implantation of a transcatheter valve within a mitral and tricuspid annuloplasty ring through an anterolateral minithoracotomy. The patient showed severe mitral valve and tricuspid valve stenosis and regurgitation 15 years after mitral valve repair and 7 years after aortic valve replacement and tricuspid valve repair.

The Hyoplatysmal Ligament

The Hyoplatysmal Ligament