Ultrasound-Accelerated Thrombolysis and Venoplasty for the Treatment of the Postthrombotic Syndrome: Results of the ACCESS PTS Study.

Background Postthrombotic syndrome is a common complication of deep vein thrombosis, with limited treatment options. Methods and Results ACCESS PTS (Accelerated Thrombolysis for Post-Thrombotic Syndrome Using the Acoustic Pulse Thrombolysis Ekosonic Endovascular System) is a multicenter, single-arm, prospective study evaluating patients with chronic deep vein thrombosis and postthrombotic syndrome (Villalta score ≥8) who received minimum 3 months of anticoagulation. Patients underwent percutaneous transluminal venoplasty and ultrasound-accelerated thrombolysis, with data collected on clinical characteristics, postthrombotic syndrome, imaging, and quality of life to 1 year. The primary efficacy outcome was a reduction of ≥4 points in the Villalta score 30 days after procedure. The primary safety outcomes were major bleeding episodes within 72 hours and symptomatic pulmonary embolism during the index hospitalization. A total of 82 limbs (78 patients) were treated (age, 54.6±12.7 years; 32.1% women; mean Villalta score, 15.5±5.2). The primary end point was met in 64.6% (51/79). At 1 year, 77.3% (51/66) of limbs continued with a Villalta reduction ≥4. At 365 days, >90% of segments had patency with ultrasound flow present. Baseline to 1-year Physical Component Summary mean score of the Short Form-36 increased from 38.9±9.5 to 45.2±9.8 (P≤0.0001), and mean VEINES-QOL (Venous Insufficiency Epidemiological and Economic Study-Quality of Life) increased from 61.9±19.7 to 82.6±20.8 at 1 year (P<0.0001). Iliofemoral venous stenting was performed in 42 patients, with similar improvements seen in all outcomes, regardless of stenting status. One patient developed severe bleeding within 72 hours of the intervention and died at 32 days after procedure (1.3% mortality rate). Conclusions Percutaneous transluminal venoplasty and ultrasound-accelerated thrombolysis resulted in successful recanalization of chronic venous obstruction with improved postthrombotic syndrome severity and quality of life. Results were sustained at 1-year after procedure. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02159521.

Real-World Outcomes of EKOS Ultrasound-Enhanced Catheter-Directed Thrombolysis for Acute Limb Ischemia.

BACKGROUND: Ultrasound-enhanced catheter-directed thrombolysis (UET) using the Ekosonic® Endovascular System device for acute, peripheral arterial ischemia has been purported in clinical trials to accelerate the fibrinolytic process to reduce treatment time and lytic dosage. We aim to describe outcomes of UET in a real-world clinical setting. METHODS: We performed a retrospective review of all patients undergoing UET for acute limb ischemia at a single institution. Data collected included patient demographics, procedural details, and 30-day and 1-year outcomes. The primary endpoints for analysis were major adverse limb events (MALEs; reintervention and/or amputation) and mortality within 30-days and 1-year. Secondary endpoints included technical success, use of adjunctive therapies, and postoperative complications. RESULTS: A total of 32 patients (mean age 67.4 ± 14.9 years; 25% women) underwent UET for acute limb ischemia between 2014 and 2018. The Rutherford Acute Limb Ischemia Classification was Rutherford (R) 1 in 56.3%, R2a in 31.3%, and R2b in 12.5%. Etiology was thrombosis of native artery in 12.5% of patients, prosthetic bypass in 31.3%, autogenous bypass in 6.3%, and stented native vessel in 50.0%. Mean duration of thrombolytic therapy was 22.2 ± 11.3 hr, and mean tissue plasminogen activator dose was 24.5 ± 15.3 mg. MALEs occurred in 16.7% of patients within the first 30 days and 38.9% experienced a MALE by 1 year. Limb salvage at 30 days and 1 year was 93.8% and 87.5%, respectively. Ipsilateral reintervention was required in 12.5% of patients within 30 days and 37.5% of patients within 1 year. Overall mortality was 6.2% at 30 days and 13.5% at 1 year. In-line flow to the foot was re-established in 90.6% of patients, with a significant improvement in preoperative to postoperative ankle-brachial index (0.31 ± 0.29 vs. 0.78 ± 0.34, P < 0.001) and number of patent tibial runoff vessels (1.31 ± 1.20 vs. 1.96 ± 0.86, P < 0.001). There was no significant difference in revascularization success between occluded vessel types. All but one patient required adjunctive therapy such as further thromboaspiration, stenting, or balloon angioplasty. Major bleeding complications occurred in 3 patients (9.4%), including 1 intracranial hemorrhage (3.1%). CONCLUSIONS: UET with the EKOS device demonstrates acceptable real-world outcomes in the treatment of acute limb ischemia. UET is generally safe and effective at re-establishing in-line flow to yield high limb salvage rates. However, UET is associated with a high rate of reintervention. Further investigation is needed into specific predictors of limb salvage and need for reintervention, as well as cost-efficacy of this technology compared with that of traditional methods.

Ultrasound-Accelerated, Catheter-Directed Thrombolysis for Submassive Pulmonary Embolism: Single-Center Retrospective Review with Intermediate-Term Outcomes.

PURPOSE: To evaluate ultrasound-accelerated, catheter-directed thrombolysis (CDT) for treatment of acute submassive pulmonary embolism (PE). MATERIALS AND METHODS: This single-center, retrospective study included patients who underwent CDT for acute submassive PE (N = 113, 52% men/48% women) from 2013 to 2017. Baseline characteristics included history of deep venous thrombosis (12%), history of PE (6%), and history of cancer (18%). Of cohort patients, 88% (n=99) had a simplified PE severity index score of ≥ 1 indicating a high risk of mortality. RESULTS: A technical success rate of 100% was achieved with 84% of patients having bilateral catheter placements. Average tissue plasminogen activator (tPA) therapy duration was 20.7 hours ± 1.5, and median tPA dose was 21.5 mg. Three patients (2.6%) experienced minor hemorrhagic complications. Mean hospital length of stay was 6 days. Mean pulmonary arterial pressure decreased from 55 mm Hg on presentation to 37 mm Hg (P < .01) 1 day following initiation of thrombolytic therapy. All-cause mortality rate of 4% (n = 4) was noted on discharge, which increased to 6% (n = 7) at 6 months. At 6-month follow-up compared with initial presentation, symptom improvements (93%), physiologic improvements (heart rate 72 beats/min vs 106 beats/min, P < .01), oxygen requirement improvements (fraction of inspired oxygen 20% vs 28%, P < .01), and right ventricular systolic pressure improvements by echocardiography (30 mm Hg vs 47 mm Hg, P < .01) were observed. CONCLUSIONS: CDT for acute submassive PE was associated with low complications and mortality, decreased right ventricular systolic pressure, high rates of clinical improvement, and improved intermediate-term clinical outcomes.

EkoSonic Endovascular System for patients with acute pulmonary embolism and contraindication to systemic fibrinolysis.

AIMS: The aim of this study was to evaluate the safety and efficacy of the EkoSonic Endovascular System (EKOS) in patients with acute pulmonary embolism (APE) at high or intermediate-high risk and contraindication to systemic fibrinolysis. METHODS: This is a retrospective study including consecutive patients admitted due to high-risk or intermediate-high-risk APE and treated by EKOS because of an absolute or relative contraindication to systemic fibrinolysis. The primary efficacy end-point was the change from baseline to 72 h in right to left ventricular dimension ratio [right ventricular/left ventricular (RV/LV) ratio]; pulmonary embolic burden using the Qanadli Index; and systolic pulmonary arterial pressure (SPAP). The primary safety end-point was the occurrence of bleeding (GUSTO classification) within 72 h. RESULTS: Eighteen patients (5 men, 13 women; mean age 74 ±â€Š12.7 years) affected by high-risk APE (n = 5; 27.8%) or intermediate-high-risk APE (n = 13; 72.2%) were included. A significant reduction of mean RV/LV ratio (1.38 ±â€Š0.3 vs. 0.97 ±â€Š0.16; P < 0.0005); Qanadli Index [27.06 ±â€Š2.6 vs. 18.8 ±â€Š7.8 (P < 0.001) and SPAP (71.1 ±â€Š12 vs. 45.2 ±â€Š16 mmHg; P < 0.001)] was observed within 72 h after EKOS. Five bleeding events occurred: one fatal and four moderates; three out of them led to the access site hematoma, two due to pre-existing active bleeding. CONCLUSION: EKOS is an effective tool to treat patients with APE at high or intermediate-high risk and contraindication to fibrinolysis. It is a relatively safe therapy considering the critical conditions and high bleeding risk of the receiving population.

Catheter-Directed Treatment of Pulmonary Embolism: A Systematic Review and Meta-Analysis of Modern Literature.

We summarize the evidence for the safety and efficacy of catheter-directed thrombolysis (CDT) with and without ultrasound-assisted therapy for treating submassive and massive pulmonary embolism (PE) in a systematic review. The primary efficacy outcome was mortality. Outcomes were pooled across studies with the random-effects model. Twenty-four studies enrolled 700 patients in total; 653 received mechanical thromboembolectomy treatments for PE (mortality rate, 9% [95% confidence interval (CI), 6%-13%], P = .12; rate of minor complications, 6% [95% CI, 2%-13%]). In the ultrasound-accelerated thrombolysis (USAT) studies, the mortality rate was 4% (95% CI, 1%-11%) and in the non-USAT studies, it was 9% (95% CI, 6%-13%). Secondary safety outcomes were all bleeding events, which occurred in 12% (95% CI, 7%-20%) of the USAT studies and in 10% (95% CI, 5%-20%) of the non-USAT studies. Current clinical evidence does not prove USAT is superior over CDT methods.

Comparative Outcomes of Ultrasound-Assisted Thrombolysis and Standard Catheter-Directed Thrombolysis in the Treatment of Acute Pulmonary Embolism.

OBJECTIVES: The objective of this study was to compare the outcomes of patients undergoing ultrasound-accelerated thrombolysis (USAT) and standard catheter-directed thrombolysis (CDT) for the treatment of acute pulmonary embolism (PE). METHODS: The records of all patients in our institution having undergone CDT or USAT for massive or submassive PE from 2009 to 2014 were retrospectively reviewed. Standard statistical methods were used to compare characteristics and to assess for longitudinal change in outcomes. RESULTS: Sixty-three patients, 27 CDT and 36 USAT, were treated for massive (12.7%) or submassive (87.3%) PE. Of which, 96.8% were treated for bilateral PE. Baseline patient characteristics did not differ between the 2 treatment groups. There was no difference in total dose of lytic administered (CDT: 23.2 ± 13.7 mg; USAT: 27.5 ± 12.9 mg; P = .2). Two patients in the CDT and 1 in the USAT groups required conversion to surgical thrombectomy (CDT: 7.4%; USAT: 2.8%; P = .6). Rates of major and minor bleeding complications (CDT: 11.0%; USAT: 13.9%; P = .8) did not differ significantly between the CDT and USAT groups. Estimated survival at 90 days was 92% for CDT and 93% for USAT and 82% at 1 year for both groups (P = .8). All echocardiographic parameters improved significantly from baseline to 1-year follow-up, but quantitative improvement did not differ between groups. CONCLUSION: This study suggests no statistical differences in clinical and hemodynamic outcomes or procedural complication rates between USAT and standard CDT for the treatment of acute PE. Prospective studies are needed to further evaluate comparative and cost-effectiveness of different interventions for acute massive and submassive PE.

A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study.

OBJECTIVES: This study conducted a prospective, single-arm, multicenter trial to evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis, using the EkoSonic Endovascular System (EKOS, Bothell, Washington). BACKGROUND: Systemic fibrinolysis for acute pulmonary embolism (PE) reduces cardiovascular collapse but causes hemorrhagic stroke at a rate exceeding 2%. METHODS: Eligible patients had a proximal PE and a right ventricular (RV)-to-left ventricular (LV) diameter ratio ≥0.9 on chest computed tomography (CT). We included 150 patients with acute massive (n = 31) or submassive (n = 119) PE. We used 24 mg of tissue-plasminogen activator (t-PA) administered either as 1 mg/h for 24 h with a unilateral catheter or 1 mg/h/catheter for 12 h with bilateral catheters. The primary safety outcome was major bleeding within 72 h of procedure initiation. The primary efficacy outcome was the change in the chest CT-measured RV/LV diameter ratio within 48 h of procedure initiation. RESULTS: Mean RV/LV diameter ratio decreased from baseline to 48 h post-procedure (1.55 vs. 1.13; mean difference, -0.42; p < 0.0001). Mean pulmonary artery systolic pressure (51.4 mm Hg vs. 36.9 mm Hg; p < 0.0001) and modified Miller Index score (22.5 vs. 15.8; p < 0.0001) also decreased post-procedure. One GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries)-defined severe bleed (groin hematoma with transient hypotension) and 16 GUSTO-defined moderate bleeding events occurred in 15 patients (10%). No patient experienced intracranial hemorrhage. CONCLUSIONS: Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis decreased RV dilation, reduced pulmonary hypertension, decreased anatomic thrombus burden, and minimized intracranial hemorrhage in patients with acute massive and submassive PE. (A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE) [SEATTLE II]; NCT01513759).

Incidence of additional treatments in women treated with MR-guided focused US for symptomatic uterine fibroids: review of 138 patients with an average follow-up of 2.8 years.

PURPOSE: To assess long-term outcomes of magnetic resonance (MR)-guided focused ultrasound (US) treatments of uterine fibroids. MATERIALS AND METHODS: A retrospective follow-up of 138 patients treated at a single institution between March 2005 and November 2011 was conducted. The patients were not part of a clinical study and were followed through retrospective review of their medical records and telephone interviews to assess additional treatments for fibroid-related symptoms. Survival methods, including Cox proportional hazards models, were used to assess the association between incidence of additional treatments and patient data obtained during screening before treatment. RESULTS: The average length of follow-up was 2.8 years (range, 1-7.2 y). The cumulative incidence of additional treatments at 36 months and 48 months after MR-guided focused US was 19% and 23%, respectively. Women who did not need additional treatment were older than women who did (46.3 y ± 5.6 vs 43.0 y ± 5.8; P = .006; hazard ratio, 0.855; 95% confidence interval, 0.789-0.925). Additionally, women with heterogeneous or bright fibroids on T2-weighted MR imaging were more likely to require additional treatment compared with women with homogeneously dark fibroids (hazard ratio, 5.185 or 5.937, respectively; 95% confidence interval, 1.845-14.569 or 1.401-25.166, respectively). Physician predictions of treatment success, recorded during the screening process, had significant predictive value (P = .018). CONCLUSIONS: The long-term rates of additional interventions after MR-guided focused US of symptomatic uterine fibroids were found to be comparable with other uterine-sparing procedures, such as uterine artery embolization or myomectomy. Older patient age and homogeneously dark fibroids were associated with fewer additional treatments. Physician assessment of treatment success was found to be a valuable tool in patient screening.

Ultrasound-accelerated vs standard catheter-directed thrombolysis--a comparative study in patients with iliofemoral deep vein thrombosis.

PURPOSE: To compare the thrombolytic efficacy and safety of standard catheter-directed thrombolysis (CDT) and ultrasound (US)-accelerated thrombolysis (UAT) for the treatment of iliofemoral deep vein thrombosis (DVT). MATERIALS AND METHODS: All medical records of patients who underwent CDT or UAT for DVT between June 2004 and October 2011 at a single tertiary care center were reviewed. Target vein patency was graded according to a reporting standard by an independent interventional radiologist. RESULTS: CDT was performed in 19 patients and UAT in 64 patients. The baseline parameters and DVT characteristics, including the duration of symptoms, the location, and the extension did not differ significantly between groups. Both treatment modalities were associated with a similar substantial resolution of thrombus load (CDT = 89%; interquartile range [IQR], 70%-100%; UAT = 82%; IQR, 55%-92% (P = .560). No significant differences in the lytic drug infusion rates, the total lytic doses, the total infusion time, and the use of adjunctive procedures were observed between groups. Major and minor bleeding complications were observed in 8.4% and 4.8% of the patients, with no difference between the treatment groups (P = .709 and P = .918, respectively). During a median follow-up of 35 months (20-55 months), three deaths and 16 cases of repeated thrombosis were observed. The estimated mean event-free survival time was longer after CDT (69 mo) compared with UAT (33 mo) (log-rank test P = .310). CONCLUSIONS: The present study failed to prove any substantial clinical benefit provided by UAT with regard to effectiveness or safety compared with standard CDT. Given the added costs of the US delivery device, prospective randomized data are needed to justify its widespread use for DVT treatment.

Ultrasound-accelerated thrombolysis for lower extremity ischemia: multicenter experience and literature review.

AIM: This study evaluates the short-term outcome of ultrasound-accelerated thrombolysis in patients with lower extremity ischemia caused by thromboembolic occlusions. METHODS: A retrospective cohort study was conducted from December 2008 to May 2011 of 57 patients (42 men; median age, 66 ± 11 years) undergoing 62 episodes of ultrasound-accelerated thrombolysis for thromboembolic arterial occlusions of the lower extremities. The EKOS EndoWave System (EKOS Corporation, Bothell, WA, USA) was combined with urokinase (100000 IU/hour). Thirty-day and 6-month follow-up consisted of clinical evaluation, and Duplex scan or magnetic resonance angiography of the treated extremity. RESULTS: Initial technical success was 97%, radiologic success was 82%, and overall clinical success was 77%. Median thrombolysis time was 21 hours (IQR, 15-24). In 38 of 51 procedures with successful lysis (75%) complete lysis was achieved within 24 hours. Major hemorrhage occurred in 2 procedures (3%), and distal embolization in 2 procedures (3%). During the initial hospitalization, the major amputation rate was 8% (N.=5) and the mortality rate was 2% (N.=1). The 30-day patency rate was 81%, without additional mortality. During a median 6-month (range, 2-14) follow-up, 9 reinterventions were performed. Two patients underwent major amputation and 3 patients died; because of malignancy (N.=2) and stroke (N.=1). CONCLUSION: Initial success rates of ultrasound-accelerated thrombolysis are high and complication rate is low. However, reintervention rate during short-term follow-up for recurrent ischemia is substantial. Results from a randomized controlled trial comparing ultrasound-accelerated thrombolysis with standard thrombolysis for lower extremity ischemia (DUET, Current Controlled Trials, ISRCTN72676102) are eagerly awaited.

Fatal end of a safety algorithm for pulmonary vein isolation with use of high-intensity focused ultrasound.

BACKGROUND: High-intensity focused ultrasound (HIFU) can achieve pulmonary vein isolation (PVI), but there are safety concerns after severe complications. Therefore, we evaluated an esophageal temperature (ET)-guided safety algorithm to apply HIFU safely. METHODS AND RESULTS: After standard left atrial access, HIFU was repeatedly applied until PVI was complete. A safety algorithm was used: or=40.0 degrees C, use of power modulation (PM) at ET 39.0 degrees C: to reduce ablation temperature in surrounding tissue, acoustic power is switched on/off at 1 Hz; in all first ablations, use of PM after 50% of programmed time. Touch-up radiofrequency ablation was used when PVI failed. Periprocedural ET monitoring and endoscopy 2 days after ablation were performed. Twenty-eight patients (18 males; mean age at enrollment, 63 years), with paroxysmal atrial fibrillation (AF; n=19) and persistent AF (n=9) were included. In 84 of 109 PV (9 of 25 patients), PVI was achieved using HIFU only. In 9 of 109 PV, HIFU was aborted because of high ET. Mean ET at the end of the ablations with and without use of PM were 38.1+/-2.0 degrees C and 37.4+/-1.0 degrees C (P=0.0002). During endoscopy in 2 of 26 patients, a small thermal lesion was found. Other complications included 2 persistent phrenic nerve palsies, 1 ischemic stroke, 1 pericardial effusion 48 days after ablation, 1 unexplained death 49 days after ablation, and 1 lethal atrial-to-esophageal fistula 31 days after ablation. CONCLUSIONS: The safety algorithm failed to prevent lethal complications. Currently HIFU does not meet the safety standards required for treatment of atrial fibrillation.

Comparison of percutaneous ultrasound-accelerated thrombolysis versus catheter-directed thrombolysis in patients with acute massive pulmonary embolism.

Acute massive pulmonary embolism (PE) is a life-threatening condition that requires prompt and aggressive interventions, including anticoagulation, catheter-directed thrombolysis (CDT), mechanical thrombectomy, or surgical thromboembolectomy. The aim of this study was to evaluate the treatment outcome in patients with massive PE who were treated with either ultrasound-accelerated thrombolysis using the EkoSonic Endovascular System (EKOS) or CDT intervention. During a recent 10-year period, the clinical records of all patients with massive PE undergoing catheter-directed interventions were evaluated. Patients were divided into two treatment groups: EKOS versus CDT interventions. Comparisons were made with regard to the treatment outcome between the two groups. Twenty-five patients underwent 33 catheter-directed interventions for massive PE during the study period. Among them, EKOS or CDT was performed in 15 (45%) and 18 (55%) procedures, respectively. In the EKOS group, complete thrombus removal was achieved in 100% cases. In the CDT cohort, complete or partial thrombus removal was accomplished in 7 (50%) and 2 (14%) cases, respectively. Comparing treatment success based on thrombus removal, EKOS treatment resulted in an improved treatment outcome compared with the CDT group (p < .02). The mean time of thrombolysis in EKOS and CDT group was 17.4 +/- 5.23 and 25.3 +/- 7.35 hours, respectively (p = .03). The mortality rate in the EKOS and CDT group was 9.1% and 14.2%, respectively (not significant). Treatment-related hemorrhagic complication rates in the EKOS and CDT group were 0% and 21.4%, respectively (p = .02). A significant reduction in Miller scores was noted in both groups following catheter-based interventions. No significant difference in relative Miller score improvement was observed between groups. Ultrasound-accelerated thrombolysis using the EkoSonic system is an effective treatment modality in patients with acute massive PE. When compared with CDT, this treatment modality provides similar treatment efficacy with reduced thrombolytic infusion time and treatment-related complications.

Can harmonic focus curved shear effectively seal the pancreatic ducts and prevent pancreatic leak? Feasibility evaluation and testing in ex vivo and in vivo porcine models.

BACKGROUND: The purpose of this study was to evaluate the ability of Harmonic energy technology to transect and seal the pancreatic duct compared with the standard monopolar electrosurgery transection and oversew technique in a porcine distal pancreatectomy survival model. Harmonic energy technology is as effective as standard oversew technique for preventing pancreatic leak after distal pancreatectomy. METHODS: The animal protocol used for this study was approved by the Institutional Animal Care and Use Committee (IACUC) prior to the conduct of the study. Spleen-preserving distal pancreatectomy was performed in seven pigs (80-100 lb) by the same surgeon. In four animals, the pancreas was divided with the Harmonic Focus Curved Shears (test group) with no additional suturing for control of hemostasis or leak. In three animals, the pancreas was divided using monopolar electrosurgery (30 W coagulation) and the cut end of the pancreas was oversewn with a locking suture (control group). A previously worked out standard operative technique was used in all procedures. Operating end points included surgery time and blood loss. Animals were euthanized and necropsied at 7 to 8 d following surgery. Survival endpoints included clinical response to surgery, serum chemistry profiles before surgery and at necropsy, and histology of the pancreas transection site. RESULTS: Mean operative time for pancreatic resection was 15min in the control group and 10min in the test group. No significant blood loss was noted in either group. The median size of the resected pancreas was 4.3 cm. Three animals in the control group and three in the test group completed the study without complications. One animal in the test group failed to eat, appeared dehydrated, and was taken off study on POD#2. In this animal, there was a doubling of serum lipase at euthanasia and gross evidence of ileus, which was attributed to a pancreatic leak. Histologic examination of the residual pancreas in both groups at necropsy revealed a 2-5 mm band of necrotic tissue associated with neutrophilic infiltration in the control group, and less than a 1mm band of necrotic tissue in the test group. CONCLUSION: The Harmonic Focus Curved Shears, using Harmonic energy technology, appears to seal the pancreatic ducts and prevent pancreatic leak at 75% (3/4) efficiency in this survival model. However, the survival leak rate, 25% (1/4) was higher in the Harmonic Focus Curved Shears test group compared with the control oversewn group 0% (0/3). This feasibility study shows potential for Harmonic technology to be used to seal the pancreatic ducts, but additional testing and optimization of surgical techniques are needed.