Major Procedural Complications Research Articles

Jejunostomy Tube Insertion for Enteral Nutrition: Comparison of Outcomes after Laparoscopic versus Radiologic Insertion

PurposeTo retrospectively compare technical success and major complication rates of laparoscopically versus radiologically inserted jejunostomy tubes. Materials and MethodsIn this single-institution retrospective study, 115 patients (60 men; mean age, 59.7 y) underwent attempted laparoscopic jejunostomy tube insertion as a standalone procedure during a 10-year period and 106 patients (64 men; mean age, 61.0 y) underwent attempted direct percutaneous radiologic jejunostomy tube insertion during an overlapping 6-year period. Clinical outcomes were retrospectively reviewed with primary focus on predictors of procedure-related major complications within 30 days. ResultsPatients undergoing laparoscopic jejunostomy tube insertion were less likely to have previous major abdominal surgery (P < .001) or to be critically ill (P < .001) and had a higher body mass index (P = .001) than patients undergoing radiologic insertion. Technical success rates were 95% (110 of 115) for laparoscopic and 97% (103 of 106) for radiologic jejunostomy tube insertion (P = .72). Major procedural complications occurred in 7 patients (6%) in the laparoscopic group and in 5 (5%) in the radiologic group (P = 1.0). For laparoscopic jejunostomy tubes, only previous major abdominal surgery was significantly associated with a higher major procedure complication rate (14% [5 of 37] vs 3% [2 of 78] in those without; P = .039). In the radiologic jejunostomy group, only obesity was significantly associated with a higher major complication rate: 20% (2 of 10) vs 3% (3 of 96) in nonobese patients (P = .038). ConclusionsLaparoscopic and radiologic jejunostomy tube insertion both showed high success and low complication rates. Previous major abdominal surgery and obesity may be pertinent discriminators for patient selection.

Long-term outcomes of per-oral endoscopic myotomy compared to laparoscopic Heller myotomy for achalasia: a single-center experience

Many centers have reported excellent short-term efficacy of per-oral endoscopic myotomy (POEM) for the treatment of achalasia. However, long-term data are limited and there are few studies comparing the efficacy of POEM versus Heller Myotomy (HM). To compare the long-term clinical efficacy of POEM versus HM. Using a retrospective, parallel cohort design, all cases of POEM or HM for achalasia between 2010 and 2015 were assessed. Clinical failure was defined as (a) Eckardt Score > 3 for at least 4weeks, (b) achalasia-related hospitalization, or (c) repeat intervention. All index manometries were classified via Chicago Classification v3. Pre-procedural clinical, manometric, radiographic data, and procedural data were reviewed. 98 patients were identified (55 POEM, 43 Heller) with mean follow-up of 3.94years, and 5.44years, respectively. 83.7% of HM patients underwent associated anti-reflux wrap (Toupet or Dor). Baseline clinical, demographic, radiographic, and manometric data were similar between the groups. There was no statistical difference in overall long-term success (POEM 72.7%, HM 65.1% p = 0.417, although higher rates of success were seen in Type III Achalasia in POEM vs Heller (53.3% vs 44.4%, p < 0.05). Type III Achalasia was the only variable associated with failure on a univariate COX analysis and no covariants were identified on a multivariate Cox regression. There was no statistical difference in GERD symptoms, esophagitis, or major procedural complications. POEM and HM have similar long-term (4-year) efficacy with similar adverse event and reflux rates. POEM was associated with greater efficacy in Type III Achalasia.

3:18 PM Abstract No. 310 Outcomes of infrapopliteal stenting for critical limb ischemia

To evaluate outcomes of infrapopliteal artery stenting including target lesion revascularization (TLR), patency, and subsequent major adverse limb events (MALE) in the setting of critical limb ischemia (CLI). A retrospective single-center review was performed of patients undergoing stenting for early restenosis or failed angioplasty within the tibioperoneal trunk, tibial or peroneal arteries for CLI between January 2010 and August 2019 (n = 49 limbs in 43 patients). Patients received at least one or more drug-eluting (n = 48) or bare-metal stents (n = 1). Freedom from TLR was the primary measure defined as any repeat percutaneous intervention of the target lesion. Other measures included primary and secondary patency, defined with ultrasound Doppler showing peak systolic velocity ratio >2.0 or confirmed angiographically. Limb salvage was defined as freedom from major amputation at or above the ankle. Freedom from MALE was composite freedom from TLR, primary patency, and major amputation. Patient demographics were mean age 70 ± 12 years (SD) with 67% men, 90% hypertension, 56% dyslipidemia, 54% diabetes, 27% ESRD, 45% smoking history and 100% CLI. Mean follow-up time was 10.3 months (range, 0-52); 9 patients underwent TLR (18% limbs). Kaplan-Meier analysis at 12-months for freedom from TLR, primary patency, and freedom from MALE (±SE) were 80 ± 7.1%, 67 ± 10.3%, and 60 ± 8.7%, respectively. Overall limb salvage rate was 71% (35/49) with 2 of the major amputations occurring beyond 12 months from index procedure. No major procedural complications occurred. One stent fracture with occlusion was observed. 1 patient had a non-fatal myocardial infarction and 1 patient had a stroke; 7 other patients died during follow-up, with 2 PAD-related deaths at 1 and 12 months. Other deaths were from cardiac, pulmonary embolus, pancreatic cancer, pneumonia, and one unknown cause 4-33 months post stenting. Stenting in the infrapopliteal arteries had high rates of freedom from target vessel revascularization and limb salvage. Further studies involving long-term outcomes and safety profiles are needed for currently used stents within the infrapopliteal vasculature.

Radiation exposure during transjugular intrahepatic portosystemic shunt creation in patients with complete portal vein thrombosis or portal cavernoma.

This study aims to evaluate radiation exposure in patients with complete portal vein thrombosis (CPVT) or portal cavernoma (PC) undergoing transjugular intrahepatic portosystemic shunt (TIPS) creation using real-time ultrasound guidance for portal vein targeting. This is a single institution retrospective analysis. Between August 2009 and September 2018, TIPS was attempted in 49 patients with CPVT or PC. Radiation exposure (dose area product [DAP], air KERMA (AK) and fluoroscopy time [FT]), technical success, clinical success, complications and survival were analyzed. In total, 29 patients had CPVT and 20 patients had PC. 41/49 patients had cirrhosis. TIPS indications were refractory ascites (n = 25), variceal bleeding (n = 16) and other (n = 8). TIPS was successfully placed in 94% (46/49) of patients via a transjugular approach alone (n = 40), a transjugular/transhepatic approach (n = 5) and a transjugular/transsplenic approach (n = 1). Median DAP was 261Gy * cm2 (range 29-950), median AK was 0.2Gy (range 0.05-0.5), and median FT was 28.2min (range 7.7-93.7). Mean portosystemic pressure gradient decreased from 16.8 ± 5.1mmHg to 7.5 ± 3.3 mmHg (P < 0.01). There were no major procedural complications. Overall clinical success was achieved in 77% of patients (mean follow-up of 21.1months). Encephalopathy was observed in 16 patients (34%), grade II-III encephalopathy in 7 patients (15%). TIPS revision was performed in 15 patients (32%). Overall survival rate was 75%. In our experience, the use of real-time ultrasound guidance allowed the majority of the TIPS to be performed via a transjugular approach alone with a reasonably low radiation exposure considering the high technical difficulties of the selected cohort of patients with CVPT or PC.

Evaluation of the NuCLEUS-X™ balloon valvuloplasty catheter for severe pulmonic stenosis in dogs

Introduction/objectivesBalloon instability is commonly encountered during balloon pulmonary valvuloplasty (BPV) and may result in an unsuccessful procedure. The NuCLEUS-X™ catheter is a recently developed BPV catheter with a unique barbell shape and an ordered pattern of inflation that stabilizes the balloon to span the valve annulus before expansion of the balloon center. AnimalsTen client-owned dogs with severe valvular pulmonic stenosis (PS). Materials and methodsProspective observational study. The BPV procedure was performed by standard technique with use of NuCLEUS-X™ catheters targeting a balloon-to-annulus ratio between 1.2 and 1.5. Balloon stability, safety, and procedural success were assessed. Procedural success was defined as either a reduction in the Doppler transpulmonic PG by at least 50% of the pre-procedural PG or <80 mmHg one month post procedure. ResultsBalloon stability centered at the pulmonic valve on the first inflation was achieved in 10/10 cases. The mean PG before BPV was 141 mmHg ±41 mmHg, and the PG after BPV at one month was 83 mmHg ±41 mmHg. Procedural success was achieved in 56% of patients. All dogs survived the BPV, and no major procedural complications were encountered using the NuCLEUS-X™ catheter. ConclusionsThe use of the NuCLEUS-X™ catheter is feasible for BPV in dogs with severe PS. The unique balloon shape provided catheter stability on the first inflation in all dogs, which may be beneficial when stabilization of a conventional BPV catheter cannot be achieved.

Patent foramen ovale and stroke: current evidence and treatment options.

Recent data have changed the landscape of patent foramen ovale (PFO) closure for secondary stroke prevention. This review synthesizes the data and provides a framework for optimal management of stroke patients with PFO. The cumulative evidence indicates that PFO closure reduces the risk of recurrent stroke in carefully selected young cryptogenic stroke patients, with an annualized risk reduction of ∼0.6%. The benefit of PFO closure is particularly evident in patients with embolic appearing strokes, large right-to-left shunt, or an associated atrial septal aneurysm. There may be little or no benefit in patients with small deep infarcts, a small PFO, or an indication for long-term anticoagulation. Closure is accompanied by a small risk of major procedural complication and atrial fibrillation. The annual risk of stroke from PFO is low relative to other stroke mechanisms, but the life-time cumulative risk in young patients who have experienced a prior stroke may be substantial, in which case the absolute benefit of closure is likely impactful. PFO is highly prevalent in the general population, present in about one in four adults, and should not be considered to be the cause of the stroke until a thorough workup has excluded alternative mechanisms.

Ventricular tachycardia ablation in patients with structural heart disease: single centre experience

Objective: We intended to report our institutional experience with ventricular tachycardia (VT) ablation in patients with structural heart disease. &#x0D; Patients and Methods: A total of 36 consecutive patients (31 male, age: 62.8 ± 13.2 years) who had undergone VT ablation in our institution between 01.01.2017 and 01.05.2019 were included in the analysis. &#x0D; Results: A total of 27 patients with the diagnosis of ischemic cardiomyopathy and 9 patients with the diagnosis of nonischemic cardiomyopathy had undergone VT ablation. VT ablation was successful in 32 (88.9%) patients. There were no major procedural complications; however, one patient with ischemic cardiomyopathy died 48 hours after the procedure because of post-ablation cardiogenic shock. Another patient with unsuccessful VT ablation died during hospitalization due to electrical storm. Endocardial ablation was performed in 23 (63.9%) patients and epicardial or combined endocardial and epicardial ablation was performed in 13 (36.1%) patients. Substrate ablation was the dominant strategy in 29 (80.6%) patients whereas activation mapping and isthmus ablation was performed in 7 (19.4%) patients. &#x0D; Conclusion: Our experience confirms the effectiveness and safety of VT ablation in patients with structural heart disease who are resistant to medical therapy and/or who receive recurrent implantable cardioverter-defibrillator shocks.

Meta-Analysis of Transcatheter Versus Surgical Aortic Valve Replacement in Low Surgical Risk Patients

Current guidelines recommend transcatheter aortic valve implantation (TAVI) for patients with severe aortic stenosis at elevated surgical risk, but not for patients at low surgical risk. Our objective is to compare major clinical outcomes and procedural complications with TAVI versus surgical aortic valve replacement in patients with severe aortic stenosis at low surgical risk. We conducted a systematic review and meta-analysis of randomized controlled trials, identified through a systematic search of the MEDLINE, Embase, and Cochrane databases. Count data were pooled across trials using random-effects models with inverse variance weighting to obtain relative risks (RRs) and corresponding 95% confidence intervals (CIs). Three randomized controlled trials (n = 2,629) were included. At 30 days, TAVI was associated with a substantial reduction in all-cause mortality (RR: 0.45, 95%CI: 0.20 to 0.99), atrial fibrillation (RR: 0.27, 95%CI: 0.17 to 0.41), life threatening/disabling bleeding (RR: 0.29, 95%CI: 0.12 to 0.69), and acute kidney injury (RR: 0.28, 95%CI: 0.14 to 0.57). The reduction in atrial fibrillation persisted at 12 months (RR: 0.32, 95%CI: 0.21 to 0.49). However, TAVI patients had an increased risk of permanent pacemaker implantation at both 30 days (RR: 3.13, 95%CI: 1.36 to 7.21) and 12 months (RR: 2.99, 95%CI: 1.19 to 7.51). Due to the low absolute numbers of events, results were inconclusive at 30 days and 12 months for cardiovascular mortality, stroke, transient ischemic attack, and myocardial infarction. In conclusion, while some outcomes remained inconclusive, these data suggest that TAVI should be considered as a first-line therapy for the treatment of severe aortic stenosis in low surgical risk patients.

Renal artery embolization: A minimally invasive technique in the treatment of acute intractable iatrogenic hematuria – Experience at a tertiary care center

Introduction: Hematuria following iatrogenic trauma or renal vascular malformations is less common but important causes warranting definite emergency procedure in cases not responding to conservative management. Endovascular embolization is accepted as an effective technique for the treatment of acute intractable hematuria. Considering the need of microcatheter for selective embolization, its use during the procedure increases the procedural cost significantly. The purpose of the present study is to assess the effectiveness and safety of selective renal artery embolization in patients with intractable hematuria using a 4-F glide catheter (GC). The microcatheter usage during our study was intended to be restricted to cases where the GC was not navigable to the optimal site for embolization. Materials and Methods: A retrospective analysis was done for 21 cases with acute intractable hematuria referred to our center between January 2015 and February 2019. Fifteen male and 6 female patients were included. Seventeen cases followed iatrogenic injury during a renal biopsy, 2 cases were due to renal neoplasm, and 1 each due to PCN and abdominal trauma. Embolization was carried out after selective catheterization of the feeding artery, with a 4-F GC using polyvinyl alcohol (PVA) particles in combination with pushable coils in all cases. Results: The source of bleeding was identified as arteriovenous fistula (AVF) in 14, AVF with pseudoaneurysm (PA) in 3, PA alone in 2, and abnormal tumor vascularity in 2 patients. In all but 2 cases, the hematuria stopped within 24 h after embolization. In the remaining 2 cases, hematuria stopped completely within 72 h. One patient developed minor puncture site bleed with no major procedural complications or recurrence on follow-up. Conclusion: Endovascular embolization is a highly effective minimally invasive technique for the treatment of acute intractable hematuria. Good results were achieved without using any microcatheter (hence cost-effective) with no clinically significant nontarget embolization.

Thromboangiitis obliterans: Aggressive angioplasty provides a potential solution (randomized pilot study).

Background:Thromboangiitis obliterans is an inflammatory disease affecting both medium- and small-sized vessels. Vasodilators, antiplatelets were proposed for treatment but the effect was minimal.Objective:This study was conducted to investigate the effect of balloon angioplasty on patients with Buerger’s disease compared to medical treatment.Methods:Between January 2006 and December 2016, 82 patients with Buerger’s disease were enrolled in the study, of whom 52 were randomized to the aggressive endovascular intervention and 30 were randomized medically by cilostazol and aspirin as a control group. In all, 23% of the patients presented with severe claudication, 50% with ischemic rest pain and 27% with ischemic ulcers. Randomization was done using the opaque envelope method. Allocation concealment was maintained to ensure no selection bias. Patient groups were compared for the duration of ulcer healing, ankle–brachial index, peak systolic velocity changes and transcutaneous oximetry (TcPO2) level for 30 months.Results:No major procedural complications occurred in the endovascular group. Angiographic success was achieved in 100% of supragenicular lesions but in 90% of infrapopliteal lesions. The endovascular group showed a statistically significant improvement in the ulcer healing size and duration at 6 months after the procedure with a mean time of 3 ± 0.9 months compared to 5.8 ± 1.69 months for the medical treatment group (p < 0.001), the mean TcPO2 from 27.23 ± 16.75 mm Hg (range: 0–56 mm Hg) before the procedure to 71.32 ± 12.94 mm Hg (range: 52–92 mm Hg) following revascularization (p < 0.01). The mean ankle–brachial index significantly improved from 0.54 ± 0.14 preoperatively to 0.82 ± 0.08 at final follow-up (p < 0.01).Conclusion:The endovascular therapy should be considered as an effective, safe, minimally invasive method in the light of the promising results after a modification of the standard technique.

Transcatheter Aortic Valve Implantation With the Third Generation Balloon-Expandable Bioprosthesis in Patients With Severe Landing Zone Calcium

Device success of earlier generation balloon-expandable transcatheter heart valves (BE-THV) is lower in patients with severe landing zone calcium (LZC). We sought to explore the impact of LZC on the outcome of transcatheter aortic valve implantation (TAVI) with the next generation Edwards Sapien 3 BE-THV. In the present study, severe LZC was defined as severe aortic valve cusp calcium (AVC) and/or left ventricular outflow tract calcium (LVOTC) on computed tomography. Patients who underwent TAVI for pure/predominant aortic regurgitation, bicuspid aortic valve disease, or failed bioprosthetic valve were excluded. Out of 350 patients who underwent TAVI with the Edwards Sapien 3 (age 80.7 ± 6.1, female: 45.1%, Society of Thoracic Surgeons score: 4.9 ± 3.8, transfemoral: 97.4%), 106 (30.3%) had severe LZC; 78 severe AVC (22.3%) and 49 severe LVOTC (14.0%). Severe LZC was associated with lower device success (96.2% vs 100%, p = 0.008) driven by more prosthetic valve regurgitation (PVR, p = 0.008). On multivariable analysis, PVR was associated with severe LVOTC (odds ratio [95% confidence interval] 2.130 [1.092 to 4.158]) but not with severe AVC (1.529 [0.835 to 2.800]). Balloon predilatation (BPreD) was performed in 42.5% of patients with severe LZC (vs 19.3% in nonsevere LZC; p <0.001) and was associated with prolonged procedural time (p = 0.001) and higher irradiation exposure (p = 0.027). Device success (p = 0.311), major procedural complications (p = 0.132), 30-day safety end point (p = 0.815), and PVR (p = 0.684) were not significantly different between patients with severe LZC who underwent BPreD versus direct TAVI. In conclusion, device success of the third generation BE-THV is lower in severe LZC driven by more PVR, especially in patients with severe LVOTC. In those patients, BPreD prolonged the procedure without improving THV performance.

Preprocedural three-dimensional planning aids in transcatheter ductal stent placement: A single-center experience.

Describe the use of three-dimensional (3D) patent ductus arteriosus (PDA) modeling to better define ductal anatomy to improve preprocedural planning for ductal stent placement. Ductal stenting is an alternative to surgical shunting in patients with ductal dependent pulmonary blood flow. Ductal anatomy is often complex with extreme tortuosity and risk of pulmonary artery isolation, thus increasing procedural risks. CT angiograms were segmented to produce 3D PDA models. Ductal morphology was characterized with attention to access approach, degree of pulmonary artery offset/risk of isolation and ductal tortuosity. 3D models were retrospectively compared with biplane angiography. 3D modeling was performed in 12 patients with adequate image quality for complete analysis in 11; median (interquartile range) age/weight 17 days (8-20 days) and 3.1 kg (2.4-3.9 kg). The PDA was reverse oriented in nine with average length of 17.2 ± 2.5 mm and high tortuosity (mean tortuosity index 52, range 3-108). From 3D modeling, two patients were excluded from ductal stenting-extreme ductal tortuosity and threatened pulmonary artery discontinuity, respectively. Ductal stenting was successful in the remaining nine with no major procedural complications. 3D modeling predicted a successful access approach based on the aortic orientation of the ductus in all patients (five carotid, two axillary, two femoral). When comparing 2D angiography with 3D models, angiography consistently underestimated ductal length (-3.2 mm ± 1.6 mm) and tortuosity (-14.8 ± 7.2). 3D modeling prior to ductal stent placement for ductal dependent pulmonary blood flow is useful in procedural planning, specifically for eligibility, access approach, and accurate ductal measurements. Further studies are needed to determine if 3D planning improves procedural outcomes.

Safety and efficacy of stenting for aortic arch hypoplasia in patients with coarctation of the aorta.

BackgroundDespite a successful repair procedure for coarctation of the aorta (CoA), up to two-thirds of patients remain hypertensive. CoA is often seen in combination with abnormal aortic arch anatomy and morphology. This might be a substrate for persistent hypertension. Therefore, we performed endovascular aortic arch stent placement in patients with CoA and concomitant aortic arch hypoplasia or gothic arch morphology. The goal of this retrospective analysis was to investigate the safety and efficacy of aortic arch stenting.MethodsA retrospective analysis was performed in patients who underwent stenting of the aortic arch at the University Medical Center Utrecht. Measurements collected included office blood pressure, use of antihypertensive medication, invasive peak-to-peak systolic pressure over the arch, and aortic diameters on three-dimensional angiography. Data on follow-up were obtained at the date of most recent outpatient visit.ResultsTwelve patients underwent stenting of the aortic arch. Mean follow-up duration was 14 ± 11 months. Mean peak-to-peak gradient across the arch decreased from 39 ± 13 mm Hg to 7 ± 8 mm Hg directly after stenting (p < 0.001). There were no major procedural complications. Mean systolic blood pressure decreased from 145 ± 16 mm Hg at baseline to 128 ± 9 mm Hg at latest follow-up (p = 0.014).ConclusionThis retrospective study shows that stenting of the aortic arch is successful when carried out in a state-of-the-art manner. A direct optimal angiographic and haemodynamic result was shown. No major complications occurred during or after the procedure. At short- to medium-term follow-up a decrease in mean systolic blood pressure was observed.

Safety and long-term efficacy of thoracoscopic Epicardial ablation in patients with paroxysmal atrial fibrillation: a retrospective study

BackgroundThe aim of this study is to report the long-term efficacy and safety of thoracoscopic epicardial left atrial ablation (TELA) in patients with paroxysmal atrial fibrillation (AF).MethodsThis was a retrospective review of medical records. We included all patients diagnosed with paroxysmal AF who underwent TELA at our institution between 04/2011 and 06/2017. TELA included pulmonary vein isolation, LA dome lesions and LA appendage exclusion. All (n = 55) patients received an implantable loop recorder (ILR), 30 days post-operatively. Antiarrhythmic and anticoagulation therapy were discontinued at 90 and 180 days postoperatively, respectively, if patients were free of AF recurrence. Failure was defined as ≥two minutes of continuous AF, or atrial tachycardia.ResultsFifty-five patients (78% males, mean age = 61.6 years) qualified for the study. The average duration in AF was 3.64 +/− 3.4 years, mean CHA2DS2-VASc Score was 2.0 +/− 1.6. The procedure was attempted in 57 patients and completed successfully in 55 (96.5%). Two patients experienced a minor pulmonary vein bleed that was managed conservatively. Post procedure, one patient experienced pulmonary edema, another experienced a pneumothorax requiring a chest tube and another experienced acute respiratory distress syndrome resulting in longer hospitalization. Otherwise, there were no major procedural complications. Success rates were 89.1% (n = 49/55), 85.5% (n = 47/55) and 76.9% (n = 40/52) at 6, 12 and 24 months, respectively. In the multivariate cox-proportional hazard model, survival at the mean of covariates was 86 and 74% at 12 and 24 months, respectively.ConclusionIn this single center experience, TELA was a safe and efficacious procedure for patients with paroxysmal AF.

Transseptal puncture performed with the new needle-free 'SafeSept' guidewire: a multicentre experience.

Increasing numbers of transseptal punctures (TSP) are performed for different cardiac interventions, especially for left atrial (LA) ablation of atrial fibrillation (AF). Significant TSP-related complications may occur even by experienced operators. Any strategies to mitigate these should be adopted. Previous reports have confirmed the safety and efficacy of the first generation nitinol guidewire for TSP. The objective was to assess the safety and efficacy of a new nitinol 'needle free' SafeSept guidewire (NFSG) for TSP. The distal J-shaped tip (0.014in.) of the NFSG is unchanged in design; however, the shaft is thicker (0.0315in.) and stiffer. This is a multicentre study evaluating TSP without a transseptal needle, using the NFSG via a standard transseptal sheath-dilator, in patients with an indication for TSP. A total of 145 consecutive unselected patients were studied. The mean patient age was 59 ± 15. Thirty-one (21.4%) were female and 43 (29.7%) had a previous procedure requiring TSP. The mean transverse LA diameter was 4.0 ± 0.8cm. AF or LA tachycardia comprised the major indication for TSP (n = 115). Transesophageal echocardiography for direct guidance of TSP was utilised in cases performed under general anesthesia (n = 66, 45.5%). LA access by TSP using the NFSG was achieved successfully in 100% of cases after 1.6 ± 2.3 passes. There were no TSP or other major procedural complications. Use of the NFSG appears to be a safe and effective method in performing TSP. The major improvement in the design of the NFSG is that TSP can be performed without a transseptal needle and exchange for a standard guidewire is not required upon establishing LA access.

Percutaneous cryoablation for the treatment of extra-abdominal desmoid tumors.

BackgroundDesmoid tumors are rare locally invasive, benign neoplasms that develop along aponeurotic structures. Current treatment is complicated by associated morbidity and high recurrence rates.MethodsA retrospective, single‐institution review identified 23 patients (age: 16‐77) with extra‐abdominal desmoid tumors who received CT‐guided percutaneous cryoablation as either a first‐line (61%) or salvage (39%) treatment in 30 sessions between 2014 and 2018. Median maximal lesion diameter was 69 mm (range: 11‐209). Intent was curative in 52% and palliative in 48%. Contrast‐enhanced cross‐sectional imaging was obtained before and after treatment in addition to routine clinical follow‐up.ResultsTechnical success was achieved in all patients. The median follow‐up was 15.4 months (3.5‐43.4). Symptomatic improvement was demonstrated in 89% of patients. At 12 months, the average change in viable volume was −80% (range −100% to + 10%) and response by modified response evaluation criteria in solid tumors (mRECIST) was CR 36%, PR 36%, and SD 28% No rapid postablation growth or track seeding was observed. Four patients underwent repeat cryoablation for either residual or recurrent disease. Two patients sustained a major procedural complication consisting of significant neuropraxia.ConclusionCryoablation for desmoid tumors demonstrates a high degree of symptom improvement and local tumor control on early follow‐up imaging with relatively low morbidity.

Acute and midterm outcomes of the post-approval MELODY Registry: a multicentre registry of transcatheter pulmonary valve implantation.

The post-approval MELODY Registry aimed to obtain multicentre registry data after transcatheter pulmonary valve implantation (TPVI) with the Melody™ valve (Medtronic plc.) in a large-scale cohort of patients with congenital heart disease (CHD). Retrospective analysis of multicentre registry data after TPVI with the Melody™ valve. Eight hundred and forty-five patients (mean age: 21.0 ± 11.1 years) underwent TPVI in 42 centres between December 2006 and September 2013 and were followed-up for a median of 5.9 years (range: 0-11.0 years). The composite endpoint of TPVI-related events during follow-up (i.e. death, reoperation, or reintervention >48 h after TPVI) showed an incidence rate of 4.2% per person per year [95% confidence interval (CI) 3.7-4.9]. Transcatheter pulmonary valve implantation infective endocarditis (I.E.) showed an incidence rate of 2.3% per person per year (95% CI 1.9-2.8) and resulted in significant morbidity and in nine deaths. In multivariable Cox proportional hazard models, the invasively measured residual right ventricle (RV)-to-pulmonary artery (PA) pressure gradient (per 5 mmHg) was associated with the risk of the composite endpoint (adjusted hazard ratio: 1.21, 95% CI 1.12-1.30; P < 0.0001) and the risk of TPVI I.E. (adjusted hazard ratio: 1.19, 95% CI 1.07-1.32; P = 0.002). Major procedural complications (death, surgical, or interventional treatment requirement) occurred in 0.5%, 1.2%, and 2.0%, respectively. Acutely, the RV-to-PA pressure gradient and the percentage of patients with pulmonary regurgitation grade >2 improved significantly from 36 [interquartile range (IQR) 24-47] to 12 (IQR 7-17) mmHg and 47 to 1%, respectively (P < 0.001 for each). The post-approval MELODY Registry confirms the efficacy of TPVI with the Melody™ valve in a large-scale cohort of CHD patients. The residual invasively measured RV-to-PA pressure gradient may serve as a target for further improvement in the composite endpoint and TPVI I.E. However, TPVI I.E. remains a significant concern causing significant morbidity and mortality.

Comparison of Outcomes Using the First and Second Generation Cryoballoon to Treat Atrial Fibrillation

Pulmonary vein isolation using cryoballoon ablation is an effective treatment for patients with atrial fibrillation. We sought to compare outcomes with the first and second generation cryoballoon, with the second generation balloon incorporating the Achieve Lasso catheter, in terms of freedom from symptomatic recurrence and major complications. The first 200 patients who underwent cryoballoon ablation with the first generation balloon were compared with the first 200 patients using the second-generation balloon. All patients had symptomatic atrial fibrillation and had failed at least one antiarrhythmic drug. The primary efficacy endpoint was freedom from symptomatic recurrence of atrial fibrillation (AF) after a single pulmonary vein isolation (PVI) procedure using the cryoballoon. The primary safety endpoint was major procedural complications. At 12 months, freedom from symptomatic AF after a single procedure in the first generation cohort was 64.3% compared with 78.6% in the second-generation cohort (p = 0.002). At 24 months, freedom from symptomatic AF in the first generation cohort was 51.3% compared with 72.6% in the second-generation cohort (p < 0.001). Procedural time (150 min vs 101 min; p < 0.001) and fluoroscopy time (32.5 min vs 21.4 min; p < 0.001) was lower in the second-generation group. The rate of major complications was comparably low in both groups. The second-generation cryoballoon was associated with improved freedom from symptomatic AF with reduction in procedure and fluoroscopy time, with a similar low rate of major complications.

03:36 PM Abstract No. 164 Mechanical thrombectomy (MT) for anterior circulation emergent large vessel occlusions (ELVOs) performed by vascular interventional radiologists: single-center experience

To report a single-center experience of the technical success and clinical 90-day outcomes of MT for anterior circulation ELVOs performed by interventional radiologists. A retrospective review identified 178 consecutive patients from January 2016 to March 2018 who underwent MT for anterior circulation ELVOs within 6 hours of symptom onset and initial NCCT ASPECTS ≥6, or presenting >6 hours but further selected with CT perfusion. Eight interventional radiologists performed the procedures. Technical and clinical outcomes were compared to the HERMES dataset. Eight patients were excluded for spontaneous revascularization. The average age was 66 years versus 68 years for HERMES. The average NIHSS was 17 for both groups. Vessel occlusions included: M1 59% (100/170) versus 69% (439/633), M2 12% (20/170) versus 8.0% (51/633), ICA 29% (50/170) versus 21% (133/633), and tandem ICA origin/M1 17% (29/170) (not reported in all trials), respectively. The overall mTICI 2b/3 reperfusion rate was 87% (148/170) versus 72% (405/633), respectively (p<0.05). The mRS 90-day outcome 0-2 rate was 40% (68/170) versus 46% (223/645), respectively (p=0.14). Major procedural complications were 3.5% (6/171) including 2 ICA dissections, 1 M2 MCA air embolization, 1 MCA wire perforation, 1 femoral hematoma requiring transfusion, and 1 anaphylaxis. Symptomatic intracranial hemorrhage rate was 4.1% (7/171) versus 4.4% (28/633), respectively. This single-center experience describes similar technical success and 90-day outcomes for MT of anterior ELVOs by interventional radiologists to the HERMES data set.

03:45 PM Abstract No. 301 Percutaneous cryoablation for the treatment of extra-abdominal desmoid tumors

Desmoid tumors are a rare form of locally invasive, benign neoplasms that develop along aponeurotic structures with high recurrence rate after surgical resection. The purpose of this study was to evaluate the safety and efficacy of cryoablation for local disease control. A retrospective search of our single-institution database identified 23 patients with extra-abdominal desmoid tumors who were treated with percutaneous cryoablation as both de novo (61% pts) and salvage (39% pts) treatment in 28 sessions between 2014 and 2018. Mean lesion diameter was 7.0 cm, ranging from 1.1 - 14.0 cm. 48% of patients were treated with the goal of complete ablation, while 52% were treated for palliative debulking. Patient age ranged from 16 to 77 years. Tumors were treated in the abdominal wall, chest wall, shoulder girdle, upper extremity, hip girdle, lower extremity, and head and neck. Imaging was evaluated for baseline tumor size, MR characteristics, and enhancing tumor volume. Technical success was achieved in 100% of patients. 90% of patients who were symptomatic on presentation showed clinical improvement following ablation. One patient suffered a major procedural complication consisting of significant neuropraxia. The average imaging follow-up was 14.6 months (SD ± 10.9). Of 11 patients with follow-up imaging at 12 months, the enhancing tumor volume showed either complete response (CR) or partial response (PR) in all patients (CR 27%, PR 73%), and the total lesion volume showed either CR or PR in 9 of 11 patients. No treatments demonstrated rapid post-ablation growth or track seeding. Three patients underwent repeat cryoablation for either residual or progressive disease. Cryoablation for desmoid tumors demonstrates a high degree of symptom improvement and local tumor control on early follow-up imaging with relatively few side effects. Study limitations include variable follow-up, small sample size, and the retrospective nature of this case series; however, further studies should be pursued as these data provide promising results.