Significant Difference In Freedom Research Articles

Image-Guided Superficial Radiation Therapy for Basal and Squamous Cell Carcinomas Produces Excellent Freedom from Recurrence Independent of Risk Factors

Background/Objectives: Basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs) are non-melanoma skin cancers (NMSCs) and the most prevalent cancers in the United States. Image-guided superficial radiotherapy (IGSRT) is a relatively new treatment option that uses high-resolution dermal ultrasound integrated with superficial radiotherapy to improve tumor visualization. IGSRT is a clinically equivalent non-surgical alternative to Mohs micrographic surgery at 2 years of follow-up in early-stage NMSC, but larger cohort studies with longer follow-up periods that allow for analysis of patient outcomes by demographic and disease characteristics are needed. Methods: This large, retrospective cohort study was conducted to determine the effect of risk factors (tumor location, tumor stage, and sex) on 2-, 4-, and 6-year freedom from recurrence rates in 19,988 NMSC lesions treated with IGSRT, including lesions with complete treatment courses. Results: Overall freedom from recurrence rates were 99.68% at 2 years, 99.54% at 4 years, and 99.54% at 6 years; rates did not differ significantly by tumor location (head/neck versus other locations, p = 0.9) or sex (male versus female, p = 0.4). In contrast, there was a significant difference in freedom from recurrence rates when analyzed by tumor stage (p = 0.004). Conclusions: There was no significant effect of tumor location or sex on freedom from recurrence in IGSRT-treated NMSC. Although there was a significant difference according to tumor stage, freedom from recurrence rates exceeded 99% at all stages.

Clinical Outcomes and Predictors of Valved Homograft Conduits Used for Right Ventricular Outflow Tract Reconstruction.

We conducted a retrospective review of patients who underwent valved homograft conduits (VHC) for right ventricular outflow tract (RVOT) reconstruction at our center. Long-term outcomes were analyzed, and risk factors affecting the long-term durability of VHC were explored. Kaplan-Meier survival curves were used to evaluate survival, freedom from VHC reintervention, and freedom from VHC dysfunction. Multivariate Cox proportional hazards regression model was used to analyze the risk factors for late VHC dysfunction. A total of 290 patients who underwent VHC for RVOT reconstruction in our center were enrolled. Seven patients occurred early death, all of which were in the non-Ross group. Two hundred and sixty-five patients were followed up for 85 (0.3-176.0) months. Six patients occurred late death, all in the non-Ross group. Six patients underwent VHC reintervention. During the follow-up period, 52 patients developed VHC dysfunction. Freedom from VHC dysfunction was higher in the Ross group than in the non-Ross group in the whole cohort. Multivariate Cox regression analysis showed that age < 6 years and non-Ross operation were independent risk factors for VHC dysfunction. Freedom from VHC dysfunction was higher in the Ross group than in the non-Ross group in patients younger than 6 years of age at surgery. However, there was no significant difference in freedom from VHC dysfunction between the two groups in patients older than 6 years. Long-term outcomes of VHC for RVOT reconstruction are satisfactory. Age < 6 years and non-Ross operation are independent risk factors for VHC dysfunction. The long-term survival rate and durability of VHC in Ross group were better than those in non-Ross group. The advantage of long-term durability of VHC in the Ross group was mainly reflected in patients aged < 6 years at operation.

Five-year outcomes of endovascular treatment for aortic dissection from the Global Registry for Endovascular Aortic Treatment

ObjectiveThe Global Registry for Endovascular Aortic Treatment (GREAT) is an International prospective multicenter registry collecting real-world data on performance of Gore aortic endografts. The purpose was to analyze the long-term outcomes and patient survival rates, as well as device performance in patients undergoing thoracic endovascular aortic repair for acute and chronic and complicated or uncomplicated type B aortic dissection (TBAD). MethodsFrom August 2010 to October 2016, 5014 patients were enrolled in the GREAT registry. The study population were patients treated with thoracic endovascular aortic repair for TBAD through 5-year follow-up (days 0-2006). The primary outcomes for this analysis were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, and any reintervention through 5 years. ResultsWe identified 265 patients. The mean age was 60.9 ± 11.9 years (range, 19-84 years; 211 males [79.6%]). Devices used were the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis. There were 228 patients (86.0%) who underwent primary endovascular treatment (144 off-label [54.3%]); 22 (8.3%) underwent reintervention after prior endovascular procedure and 15 (5.7%) underwent reintervention after prior open procedure. Kaplan-Meier estimated freedom from all-cause mortality at 5 years was 71.1%. Freedom from aortic-related mortality through 5 years was 95.8%. There was no significant difference in freedom from all-cause mortality during the follow-up period in complicated or uncomplicated disease. At 30 days and through 5 years, respectively, for all the following outcomes, the aortic rupture rate was 1.1% (n = 3) and 1.9% (n = 5). The stroke rate was 1.1% (n = 3) and 4.2% (n = 11). The spinal cord ischemic event rate was 1.5% (n = 4) and 2.6% (n = 7). Reinterventions were required in 6.4% (n = 17) and 21.1% (n = 56) of patients. The need for conversion to open repair was 0.4% (n = 1) and 2.6% (n = 7). Additional graft placement was required in 3 patients (1.1%) and 16 patients (6.0%). The endoleak rate at 30 days was 3.4% (n = 9); type IA (n = 1 [0.4%]), type IB (n = 4 [1.5%]), type II (n = 1 [0.4%]), type III (n = 1 [0.4%]), and unspecified (n = 4 [1.6%]). Through 5 years, the endoleak rate was 12.1% (n = 32); type IA (n = 7 [2.6%]), type IB (n = 10 [3.8%]), type II (n = 9 [3.4%]), type III (n = 2 [0.8%]), and unspecified (n = 12 [4.5%]). There were no cases of stent migration, compression or fracture through 5 years. ConclusionsResults at the 5-year follow-up demonstrate that the use of the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis can be supported in treatment of TBAD (acute, chronic, complicated, and uncomplicated). These data demonstrate strong device durability, beneficial patient outcomes, and support for the treatment of thoracic aortic dissection with an endovascular approach. Complete 10-year follow-up in GREAT as planned will be advantageous.

J-curved phenomenon between the prevalence of left atrial low-voltage areas and body mass index existed in patients with atrial fibrillation ablation

Abstract Background Left atrial low-voltage areas (LVAs) were known to be associated with atrial fibrosis and atrial fibrillation (AF) recurrence after catheter ablation. However, the association between body mass index (BMI) and prevalence of LVAs has not been fully elucidated. We hypothesized that LVAs were more frequently found in patients with abnormal BMI than in those with normal BMI. Purpose The purpose of this study was to clarify the association between body mass index (BMI) and the prevalence of LVAs in patients with AF ablation. Methods Between December 2014 and March 2022, 1,479 (age, 68±10 years; female, 500 [34%]) consecutive patients who underwent initial AF ablation were enrolled. BMI was divided into four groups, namely &amp;lt;18.5 kg/m², 18.5-25 kg/m², 25-30 kg/m², ≥30 kg/m². LVAs was defined as areas with bipolar voltage of &amp;lt;0.5 mV covered ≥5 cm² of left atrium. Rhythm outcome following the catheter ablation procedure was also followed for 24 months. Results LVAs were found in 349 (24%) patients. J-curved phenomenon existed between BMI and the prevalence of LVAs (Figure 1). In particular, BMI &amp;lt;18.5 kg/m² was an independent predictor of LVAs on multivariate analysis (odds ratio, 1.9; 95% confidence interval: 1.01–3.5; p=0.046). As for rhythm outcome, there was significant difference in freedom from AF recurrence among groups stratified by BMI (Figure 2). Conclusions Between BMI and the prevalence of LVAs, J-curved phenomenon existed in patients with AF ablation. There was significant difference in rhythm outcome following AF ablation among groups stratified by BMI.Figure 1Figure 2

Safety and Effectiveness of Pulsed Field Ablation for Atrial Fibrillation in Patients With Heart Failure

BackgroundAtrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). ObjectivesThis study sought to assess the outcomes of pulsed field ablation (PFA) in HF. MethodsMANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a multicenter, patient-level registry of consecutive patients undergoing PFA for paroxysmal AF or persistent AF (PerAF). In this substudy, patients were stratified as no history of HF (no-HF), HF with preserved EF (HFpEF) (left ventricular EF of ≥50%) or HF with reduced/mildly reduced EF (HFmr/rEF) (left ventricular EF of <50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30 seconds and major adverse events, respectively. ResultsOf the 1,381 patients, 85% (n = 1,174) were no-HF, 6.2% (n = 87) were HFpEF, and 8.6% (n = 120) were HFmr/rEF. No-HF patients had less PerAF than patients with HF (P < 0.001), with no difference between HF subtypes (P > 0.99). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF patients than in those with HFpEF or HFmr/rEF (79.9%, 71.3%, and 67.5%, respectively; P < 0.001) but similar between patients with HFmr/rEF and HFpEF (P = 0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFpEF vs HFmr/rEF for those with paroxysmal AF (82.8%, 82.4%, and 71.7%, respectively; P = 0.09) and PerAF (73.3%, 64.2%, and 64.9%, respectively; P = 0.14). Major adverse event rates were similar between the no-HF, HFpEF, and HFmr/rEF groups (1.9%, 0%, and 2.5%, respectively). ConclusionsPFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

Five-year outcomes of fenestrated and branched endovascular repair of complex aortic aneurysms based on aneurysm extent

ObjectiveThe aim of this study was to evaluate the 5-year outcomes of fenestrated/branched endovascular aortic repair (F/BEVAR) for the treatment of complex aortic aneurysms stratified by the aneurysm extent. MethodsPatients with the diagnosis of complex aortic aneurysm, who underwent F/BEVAR at a single center were included in this study and retrospectively analyzed. The cohort was divided according to the aneurysm extent, comparing group 1 (types I-III thoracoabdominal aneurysms [TAAAs]), group 2 (type IV TAAAs), and group 3 (juxtarenal [JRAAs], pararenal [PRAAs], or paravisceral [PVAAs] aortic aneurysms). The primary endpoints were 30-day and 5-year survival. The secondary endpoints were technical success, occurrence of spinal cord ischemia, primary patency of the visceral arteries, freedom from target vessel instability, and secondary interventions. ResultsOf 436 patients who underwent F/BEVAR between July 2012 and May 2023, 131 presented with types I to III TAAAs, 69 with type IV TAAAs, and 236 with JRAAs, PRAAs, or PVAAs. All cases were treated under a physician-sponsored investigational device exemption protocol with a patient-specific company-manufactured or off-the-shelf device. Group 1 had significantly younger patients than group 2 or 3 respectively (69.6 ± 8.7 vs 72.4 ± 7.1 vs 73.2 ± 7.3 years; P < .001) and had a higher percentage of females (50.4% vs 21.7% vs 17.8%; P < .001). Prior history of aortic dissection was significantly more common among patients in group 1 (26% vs 1.4% vs 0.9%; P < .001), and mean aneurysm diameter was larger in group 1 (64.5 vs 60.7 vs 63.2 mm; P = .033). Comorbidities were similar between groups, except for coronary artery disease (P < .001) and tobacco use (P = .003), which were less prevalent in group 1. Technical success was similar in the three groups (98.5% vs 98.6% vs 98.7%; P > .99). The 30-day mortality was 4.5%, 1.4%, and 0.4%, in groups 1, 2, and 3, respectively, and was significantly higher in group 1 when compared with group 3 (P = .01). The incidence of spinal cord ischemia was significantly higher in group 1 compared with group 3 (5.3% vs 4.3% vs 0.4%; P = .004). The 5-year survival was significantly higher in group 3 when compared with group 1 (P = .01). Freedom from secondary intervention was significantly higher in group 3 when compared with group 1 (P = .003). At 5 years, there was no significant difference in freedom from target vessel instability between groups or primary patency in the 1652 target vessels examined. ConclusionsLarger aneurysm extent was associated with lower 5-year survival, higher 30-day mortality, incidence of secondary interventions, and spinal cord ischemia. The prevalence of secondary interventions in all groups makes meticulous follow-up paramount in patients with complex aortic aneurysm treated with F/BEVAR.

Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions

ObjectiveIn two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up. MethodsIn a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality. ResultsA total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR. ConclusionsTreatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.

Impact of a Less Than 50% Residual Stenosis Following Vessel Preparation in Femoropopliteal Drug-Coated Balloon Angioplasty.

Drug-coated balloon (DCB) has been established as first-line therapy in femoropopliteal (FP) intervention, and successful vessel preparation (VP) is considered a key element. However, the clinical impact of successful VP remains unknown. This retrospective study examined the clinical impact of successful VP in DCB FP intervention. In total, 268 patients (308 limbs) who underwent successful FP intervention using DCB without atherectomy devices for symptomatic lower extremity artery disease between March 2018 and December 2019 were included in this study (high-dose DCB: 69.8%; low-dose DCB: 30.2%). Successful VP was defined as <50% residual stenosis and <dissection grade D before DCB (the successful VP group). The primary outcome measure was primary patency, and its associated factors were evaluated. The median follow-up period was 2.1 (interquartile range=1.1-2.7) years. Successful VP was achieved in 163 patients (60.8%). Primary patency and freedom from clinically-driven target lesion revascularization (CD-TLR) were significantly higher in the successful VP group than in the nonsuccessful VP group (54.2% vs 33.0%, p<0.001; 69.9% vs 57.7%, p=0.047). In the successful VP group, high-dose DCB and low-dose DCB were comparable in primary patency and freedom from CD-TLR (53.2% vs 53.6%, p=0.48; 68.7% vs 70.9%, p=0.69). In nonsuccessful VP group, high-dose DCB demonstrated numerically higher primary patency but not statistically significant than low-dose DCB (44.5% vs 16.0%, p=0.06), whereas no significant difference in freedom from CD-TLR was observed (56.0% vs 58.9%, p=0.29). On multivariate analysis, successful VP and preballoon size to reference vessel diameter ratio were significantly associated with primary patency. Achieving successful VP before DCB was independently associated with primary patency in DCB FP intervention. This study revealed that the successful vessel preparation (VP) before DCB and preballoonsize to reference vessel diameter ratio were independently associated with primary patency in DCB femoropopliteal intervention. When successful VP was achieved only before DCB treatment, the clinical outcomes were comparable between high-dose DCB and low-dose DCB at midterm follow-up.To maximized DCB efficacy, successful VP is very important in daily clinical practice.

Driveline infection according to driveline positioning in left ventricular assist device implant recipients.

We conducted a prospective, open-labeled, clinical trial, with a two-by-two factorial design, of argon cold plasma application and two different types of driveline positioning for the prevention of driveline infection (DLI) in 80 patients with a left ventricular assist device (LVAD) implant. Here, we present the results of intracorporeal loop positioning (n = 40) versus no intracorporeal loop positioning (n = 40). Patients were followed up for 1 year. According to the Driveline Expert STagINg and carE grading (DESTINE) system, a DLI was considered in case of a stage 2 or higher graded infection. During follow-up, 29 (36%) patients experienced a DLI, 16 in the group with intracorporeal loop positioning and 13 in the group with no intracorporeal loop positioning. Kaplan-Meier estimates of freedom from DLI showed no statistically significant difference between study groups during follow-up (p = 0.33). In detail, 30-day freedom from DLI was for the groups with and without intracorporeal loop positioning 92 and 92%, respectively, and 1-year freedom from DLI was 51 and 62%, respectively. In conclusion, this controlled clinical trial was unable to show a statistically significant difference in freedom from DLI during one year of follow-up in groups with or without intracorporeal loop positioning. However, larger trials have to confirm these results.

Comparison of bare and nonbare stent grafts during thoracic endovascular aneurysm repair of the aortic arch

ObjectiveWe compared the outcomes of patients treated with nonbare stents (NBS) and proximal bare stents (PBS) endografts with a proximal landing zone in the aortic arch during thoracic endovascular aortic repair (TEVAR). MethodsWe conducted a retrospective cohort, observational, multicenter study that included 361 consecutive TEVAR procedures undertaken between November 2005 and December 2021. TEVAR patients with both BS and NBS Relay stent graft configurations with proximal landing in zones 1, 2, or 3 were enrolled. Preoperative anamnestic and morphological data, clinical outcomes, and aortic modifications 30 days after surgery and at the latest follow-up available were collected. The primary outcome was freedom from proximal endoleak (type IA) comparing the two configurations. Total and detailed endoleak rates, clinical and technical success, intraoperative additional maneuvers, major adverse events, and reinterventions were secondary outcomes. ResultsThe median follow-up was 4.9 (interquartile range, 2.0-8.1) years. No statistically significant difference between NBS and PBS patients concerning 30-day major adverse events, retrograde aortic dissection, disabling stroke, or late type IA endoleak (10.8% vs 7.8%; P = .597). Aneurysmal disease (P = .026), PLZ diameter of >34 mm (P = .026), aortic tortuosity index of >1.4 (P = .008), type III aortic arch (P = .068), and PLZ thrombus (P = .014) identified as risk factors by univariate Cox regression analysis. PLZ thrombus was the only type IA endoleak risk factor at multivariate Cox regression (P = .016). ConclusionsWe found no statistically significant difference in freedom from type IA endoleak, retrograde dissection, or disabling stroke observed between the NBS and the BS configuration of the Relay endograft. Proximal landing zone thrombotic apposition was a prominent risk factor for type IA endoleak after TEVAR.

Late Toxicity of Prostate Ultrahypofractionated Radiation Therapy Compared With Moderate Hypofractionation in a Randomized Trial

PurposeWe report late toxicity, quality of life (QOL) and urinary symptom score with prostate cancer radiotherapy in a randomized trial comparing moderate hypofractionation (MHF) and ultrahypofrationation (UHF) Methods and MaterialsPatients with intermediate and high risk prostate cancer were randomized to either Arm 1 (70Gy/28 fractions) or Arm 2 (36.25Gy/5 weekly fractions). Late toxicity was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) and Radiation Therapy Oncology Group/Subjective, Objective, Management, Analytic (RTOG/SOMA) scales. QOL was assessed with the Expanded Prostate Inventory Composite-26 Short Form (EPIC-26) and urinary function with the International Prostate Symptom Score (IPSS). ResultsEighty participants were randomized. Two from Arm 1 withdrew, leaving 36 patients in Arm 1 and 42 in Arm 2. There were no significant differences in baseline characteristics, except for worse IPSS in Arm 2. No difference was observed in freedom from grade 3 or worse toxicity between treatments (p=0.921), with only a single grade 3 event in each arm. There was no significant difference in freedom from grade 2 or worse toxicity (p=0.280). No difference was observed in freedom from grade 2 or worse genitorurinary toxicity, with cumulative probabilities of 69.0% and 87.0% at 5-years for Arms 1 and 2, respectively (0.132). No difference was observed in freedom from grade 2 or worse gastrointestinal toxicity, with cumulative probabilities of 74.0% in Arm 1 and 80.0% in Arm 2 (p=0.430). There were no significant differences in EPIC-26 QOL between arms. ConclusionUHF, delivered weekly, is well tolerated with no significant differences in freedom from late toxicity compared to MHF.

50-W vs 40-W During High-Power Short-Duration Ablation for Paroxysmal Atrial Fibrillation: A Multicenter Prospective Study

BackgroundHigh-power short-duration (HPSD) radiofrequency ablation of atrial fibrillation (AF) increases first-pass pulmonary vein isolation (PVI) and freedom from atrial arrhythmias while decreasing procedural time. However, the optimal power setting in terms of safety and efficacy has not been determined. ObjectivesThis study compared the procedural characteristics and clinical outcomes of 50-W vs 40-W during HPSD ablation of paroxysmal AF. MethodsPatients from the REAL-AF prospective multicenter registry (Real-World Experience of Catheter Ablation for Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation) undergoing HPSD ablation of paroxysmal AF, either using 50-W or 40-W, were included. The primary efficacy outcome was freedom from all-atrial arrhythmias. The primary safety outcome was the occurrence of any procedural complication at 12 months. Secondary outcomes included procedural characteristics, AF-related symptoms, and the occurrence of transient ischemic attack or stroke at 12 months. ResultsA total of 383 patients were included. Freedom from all-atrial arrhythmias at 12 months was 80.7% in the 50-W group and 77.3% in the 40-W group (Log-rank P = 0.387). The primary safety outcome occurred in 3.7% of patients in the 50-W group vs 2.8% in the 40-W group (P = 0.646). The 50-W group had a higher rate of first-pass PVI (82.3% vs 76.2%; P = 0.040) as well as shorter procedural (67 minutes [IQR: 54-87.5 minutes] vs 93 minutes [IQR: 80.5-111 minutes]; P < 0.001) and radiofrequency ablation times (15 minutes [IQR: 11.4-20 minutes] vs 27 minutes [IQR: 21.5-34.6 minutes]; P < 0.001) than the 40-W group. ConclusionsThere was no significant difference in freedom from all-atrial arrhythmias or procedural safety outcomes between 50-W and 40-W during HPSD ablation of paroxysmal AF. The use of 50-W was associated with a higher rate of first-pass PVI as well as shorter procedural times.

Surgical aortic valvuloplasty is a better primary intervention for isolated congenital aortic stenosis in children with bicuspid aortic valve than balloon aortic valvuloplasty

ObjectivesSurgical aortic valvuloplasty (SAV) and balloon aortic valvuloplasty (BAV) are two main treatments for children with isolated congenital aortic stenosis (CAS). We aim to compare the two procedures' midterm outcomes, including valve function, survival, reintervention, and replacement. MethodsFrom January 2004 to January 2021, children with isolated CAS undergoing SAV (n = 40) and BAD (n = 49) at our institution were included in this study. Patients were also categorized into subgroups based on the aortic leaflet number(Tricuspid = 53, Bicuspid = 36) to compare the two procedures’ outcomes. Clinical and echocardiogram data were analyzed to identify risk factors for suboptimal outcomes and reintervention. ResultsPostoperative peak aortic gradient (PAG) and PAG at follow-up in the SAV group were lower compared with the BAV group (p < 0.001, p = 0.001, respectively). There was no difference in moderate or severe AR in the SAV group compared with the BAV group before discharge (5.0% vs 12.2%, p = 0.287) and at the last follow-up (30.0% vs 32.7%, p = 0.822). There were no early death but three late deaths (SAV = 2, BAV = 1). Kaplan-Meier estimated survivals were 86.3% and 97.8% in SAV and BAV groups respectively at 10 years (p = 0.54). There was no significant difference in freedom from reintervention (p = 0.22). For patients with bicuspid aortic valve morphology, SAV achieved higher freedom from reintervention (p = 0.011) and replacement (p = 0.019). Multivariate analysis indicated that residual PAG was a risk factor for reintervention (p = 0.045). ConclusionsSAV and BAV achieved excellent survival and freedom from reintervention in patients with isolated CAS. SAV performed better in PAG reduction and maintenance. For patients with bicuspid AoV morphology, SAV was the preferred choice.

Comparison of Pericardial and Prosthetic Rings for Mitral Repair: Are Pericardial Rings Durable in the Mid- to Long-Term Follow Up?

While prosthetic rings are commonly used for mitral valve repairs, autologous pericardium is an alternative ring material that can be used in these procedures. In this report, we aim to present a comparison of two types of rings used for mitral repair. Between January 2005 and January 2009, 107 patients who underwent mitral valve repair surgery were analyzed. Patients were divided into two groups, according to the type of ring that was used for mitral annular stabilization. Glutaraldehyde-treated pericardial rings were used for 31 patients (group 1), whereas prosthetic rings were used for 76 patients (group 2). Survival, freedom from reoperation, recurrent mitral regurgitation, and the effects of rheumatic mitral disease on these parameters were evaluated and compared for both groups. Follow-up time for our cohort was 4.24±0.4 years. There were four and seven late mortalities in groups 1 and 2, respectively, and five reoperations in each group. There was no significant difference between the groups, in terms of survival, freedom from reoperation, and recurrent mitral regurgitation (log-rank analyses for both groups were P = 0.777, P = 0.346, and P = 0.781, respectively). There was no significant difference in freedom from reoperation and recurrent mitral regurgitation for both groups, in terms of underlying rheumatic valvular disease and other types of pathology. Pericardial ring annuloplasty shows to be a considerable alternative technique for mitral valve repair procedures in the mid- to long-term follow up. Rheumatic mitral valves had poor outcomes, when compared with other types of structural valvular pathologies in cases where pericardial rings were used in the repair procedure.

Comparing the impact of the loss of patency between treatment with drug-coated balloon angioplasty and drug-eluting stent placement

ObjectiveTo compare the results of endovascular treatment with drug-eluting stents (DES) and drug-coated balloons (DCB) in atherosclerotic lesions in the femoropopliteal artery, as well as to assess restenotic patterns. MethodsClinical data from 617 cases treated with DES or DCB for femoropopliteal diseases were analyzed in this multicenter, retrospective cohort study. From these, 290 DES and 145 DCB cases were extracted by propensity score matching. Outcomes investigated were 1- and 2-year primary patency, reintervention, and restenotic pattern and its impact on symptoms in each group. ResultsThe primary patency rates at 1 and 2 years in the DES group were superior to those in the DCB group (84.8% and 71.1% vs 81.3% and 66.6%, P = .043), whereas there was no significant difference in freedom from target lesion revascularization (91.6% and 82.6% vs 88.3% and 78.8%, P = .13). Compared with what was measured before the index procedures, exacerbated symptoms, rate of occlusion, and an increase in the occluded length at loss of patency were more frequent in the DES group than in the DCB group. The odds ratios were 3.53 (95% confidence interval, 1.31-9.49; P = .012), 3.61 (1.09-11.9; P = .036), and 3.82 (1.15-12.7; P = .029), respectively. On the other hand, the frequency of an increase in lesion length and requirement of target lesion revascularization were similar between the two groups. ConclusionsPrimary patency was significantly higher at 1 and 2 years in the DES than in the DCB group. However, DES were associated with exacerbated clinical symptoms and complicated lesion characteristics at the point of loss of patency.

Empiric Slow Pathway Cryoablation in Symptomatic Children Without Documented Supraventricular Tachycardia.

In symptomatic children without documented supraventricular tachycardia (SVT) and non-inducible atrioventricular nodal reentry tachycardia (AVNRT) the benefit of empiric slow pathway (SP) ablation is unknown. We evaluated 62 symptomatic patients without documented SVT that underwent electrophysiology study (EPS). The purpose of this study was to determine if symptoms improved after empiric SP ablation in children without documented SVT and without inducible AVNRT. Sixty-two symptomatic patients without previously documented SVT underwent EPS; 31 (50%) had inducible AVNRT and underwent SP ablation, 20 (32%) were non-inducible and underwent empiric SP ablation, 11 (18%) were non-inducible and had no ablation. After a mean follow-up of 23 ± 18months there was no significant difference in freedom from symptoms within the non-inducible cohort regardless of whether empiric SP ablation was performed (p = 0.135). There was a significant improvement in symptoms at follow-up after SP ablation when comparing inducible and non-inducible patients (p = 0.020). During follow-up no patients had documented SVT. Symptomatic children without documented SVT do not benefit from empiric SP ablation when AVNRT cannot be induced.

Cardioneuroablation for vasovagal syncope: Asystematic review and meta-analysis.

Cardioneuroablation (CNA) has emerged as promising therapy for patients with refractory vasovagal syncope (VVS). The purpose of this study was to provide a freedom from syncope estimate for CNA, including subgroup analysis by method and target of ablation. A systematic search was performed in MEDLINE and EMBASE according to the PRISMA guidelines until February 14, 2022. Observational studies and clinical trials reporting freedom from syncope were included. Meta-analysis was performed with a random-effects model. A total of 465 patients were included across 14 studies (mean age 39.8 ± 4.0 year; 53.5% female). Different techniques were used to guide CNA: 50 patients (10.8%) by mapping fractionated electrograms, 73 (15.7%) with the spectral method, 210 (45.2%) with high-frequency stimulation, 73 (15.7%) with a purely anatomically guided method, and 59 (12.6%) with a combination. The target was biatrial in 168 patients (36.1%), left atrium only in 259 (55.7%), and right atrium only in 38 (8.2%). The freedom from syncope was 91.9% (95% confidence interval [CI] 88.1%-94.6%; I2 = 6.9%; P = .376). CNA limited to right atrial ablation was associated with a significant lower freedom from syncope (81.5%; 95% CI 51.9%-94.7%; P <.0001) vs left atrial ablation only (94.0%; 95% CI 88.6%--6.9%) and biatrial ablation (92.7%; 95% CI 86.8%-96.1%). Subgroup analysis according to the technique used to identify ganglionated plexi did not show any significant difference in freedom from syncope (P = .206). This meta-analysis suggests a high freedom from syncope after CNA in VVS. Well-designed, double-blind, multicenter, sham-controlled randomized clinical trials are needed to provide evidence for future guidelines.

Retrospective Multicenter Comparison Between Viabahn Covered Stent-Grafts and Supera Interwoven Nitinol Stents for Endovascular Treatment in Severely Calcified Femoropopliteal Artery Disease: The ARMADILLO Study (Adjusted Retrospective coMparison of scAffolDs In caLcified LesiOns)

Purpose: The previous single-arm registries showed the acceptable primary patency after endovascular therapy (EVT) using covered stent-graft (CSG) and Supera interwoven nitinol stent (Supera peripheral stent [SPS]) in calcified femoropopliteal lesions. The aim of this study was to compare the safety and efficacy between CSG and SPS in calcified femoropopliteal lesions in clinical practice. Materials and Methods: We retrospectively analyzed 341 cases who had Rutherford class 2 to 6 peripheral artery disease and underwent EVT with either CSG (n=137) or SPS (n=204) for femoropopliteal lesions with bilateral calcification in fluoroscopic image, based on the Peripheral Arterial Calcium Scoring System (PACSS) classification, between April 2017 and February 2021 at 7 cardiovascular centers in Japan. Results: After propensity score (PS) matching, the final study population consisted of 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between CSG and SPS groups (81.4% vs 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The stratification analysis demonstrated that advanced age, current smoking, diabetes mellitus, and PACSS grade 4 had a significant interaction on the association of CSG versus SPS implantation with restenosis (interaction p<0.05). Conclusions: In patients with bilaterally calcified femoropopliteal lesions, 1-year primary patency was not significantly different between treatments using CSG and SPS after the PS matching. Clinical Impact Covered stent-graft (CSG) and Supera interwoven nitinol stent (SPS) are reliable endovascular devices in calcified femoropopliteal lesions. This retrospective multicenter study compared the clinical outcomes between the two devices. After propensity score matching, 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between the CSG and SPS group (81.4% vs. 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs. 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The two devices showed the similar efficacy in calcified femoropopliteal lesions.

Long-Term Results after Fallot Repair.

The aim of this study was to evaluate the long-term outcome and freedom from pulmonary valve replacement (PVR) after initial repair of tetralogy of Fallot (TOF). The cohort of 306 patients treated between 1980 and 2017 was divided into anatomical subgroups according to the diagnosis of TOF-pulmonary stenosis, TOF-pulmonary atresia and TOF-double outlet right ventricle. Patients were treated with transannular patch (TAP), valve sparing repair (VSR), or conduits from the right ventricle to the pulmonary arteries (RVPA conduits). There were 21 deaths (6.9%), 14 being hospital deaths (4.6%) after primary correction and four deaths (1.3%) occurred after PVR. One patient died after a non-cardiac operation (0.3%). There were two late deaths (0.7%). During the past 12 years no early mortality has been observed. Ninety-one patients (30.4%) received PVR after a median of 12.1 ± 7.0 years with an early mortality of 4.4% (n = 4) and no late mortality. A significant difference in freedom from reoperation after TAP, VSR, and RVPA-conduits could be identified. Multivariate analysis displayed transannular repair (p = 0.016), primary palliation (p <0.001), the presence of major aortopulmonary collateral arteries (MAPCA; p = 0.023), and pulmonary valve Z-scores < - 4.0 (p = 0.040) as significant risk factors for PVR. TOF repair has a beneficial long-term prognosis with low morbidity and mortality. Pulmonary valve Z-scores < - 4.0, transannular repair, and presence of MAPCAs are associated with earlier PVR. Non-VSRs and TOF-pulmonary atresia lead to earlier reoperation but have no negative impact on survival.

CARC18: Towards Equitable Care: Exploring The Association Between Geographic Household Median Income And Clinical Outcomes Following Left Ventricular Assist Device Implantation

Purpose: Socioeconomic status (SES) is hypothesized to be an important predictor of clinical outcomes following left ventricular assist device (LVAD) implantation due to high costs of care. We investigated whether median income of a patient’s residing neighborhood predicts mortality or rate of readmission in LVAD therapy. Methods: 210 patients implanted with an LVAD between January 2010 and April 2020 at a single tertiary care center in the United States were retrospectively enrolled in this study. Patients were classified into tertiles based on published neighborhood median income data and compared for survival and freedom from readmission. Results: The study cohort comprised 135 unique ZIP codes, with 34 (25.2%) above and 101 (74.8%) below the national median income level. The low, middle, and high income groups had a total survivorship of 92.8%, 95.5%, and 92.5% at 1 year and 85.5%, 89.4%, and 85.1% at 3 years, respectively. Low median income was not significantly associated with worse outcomes at 1-year (P=0.400) and 3-years (P=0.689) following LVAD implantation. There was similarly no significant difference in freedom from readmissions at 3 years. Conclusion: LVAD recipients with a lower geographic median income were not more likely to experience worse outcomes after LVAD implantation. These findings were contrary to prior published reports showing worse clinical outcomes in heart transplant patients with lower SES patients. Factors such as institution-specific and system-wide patient assistance programs and risk factor modification measures may have mitigated the impact of reduced SES on patient care and helped eliminate the effect of income disparity on long-term clinical outcome post LVAD implantation. Further research to study such potential association is warranted.