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PURPOSE: Patients with chronic kidney disease are predisposed to heart rhythm disorders including atrial fibrillation (AF). Several studies have suggested that radiofrequency catheter ablation of AF improves renal function. However, little data exists for pulmonary vein isolation with cryoballoon ablation (CBA). The purpose of this study is to assess change in renal function following CBA for AF. METHOD: This is a single-center retrospective study that included patients who underwent CBA for AF between 2011 and 2016. Patients were grouped by baseline-estimated glomerular filtration rate (eGFR): ≥ 90 (Stage G1), 60–89.9 (Stage G2), and 30–59.9 mL/min/1.73 m(2) (Stage G3). Change in eGFR was assessed > 3 months post-ablation. RESULTS: A total of 306 patients with both pre- and post-ablation serum creatinine measurements available were included. Baseline eGFRs for Stages G1, G2, and G3 patients were 103.5 ± 12.9 (n = 82), 74.7 ± 8.2 (n = 184), and 52.6 ± 6.6 mL/min/1.73 m(2) (n = 40), respectively. Renal function was assessed 310.8 ± 104.2 days post-ablation. Average intra-procedural contrast use was 58.4 ± 23.8 mL. There was no significant change in eGFR following CBA in Stage G1 patients (p = 0.10). For those with Stages G2 and G3 renal function, eGFR improved by 6.1% (4.2 mL/min/1.73 m(2), p < 0.01) and 13.8% (7.2 mL/min/1.73 m(2), p < 0.01), respectively. This improvement was seen regardless of the presence or absence of recurrent atrial arrhythmias. CONCLUSIONS: CBA for AF may be associated with an improvement in renal function, particularly among those with a reduced baseline eGFR despite recurrence of atrial arrhythmias and intra-procedural contrast use. more...

Background Rotating and laser sheaths are both routinely used in transvenous lead extraction (TLE) which can lead to catastrophic complications including death. The efficacy and risk of each approach are uncertain. To perform a meta-analysis to compare success and mortality rates associated with rotating and laser sheaths. Methods We searched electronic academic databases for case series of consecutive patients and randomized controlled trials published 1998–2017 describing the use of rotating and laser sheaths for TLE. Among 48 studies identified, rotating sheaths included 1,094 patients with 1,955 leads in 14 studies, and laser sheaths included 7,775 patients with 12,339 leads in 34 studies. Patients receiving rotating sheaths were older (63 versus 60 years old) and were more often male (74% versus 72%); CRT-P/Ds were more commonly extracted using rotating sheaths (12% versus 7%), whereas ICDs were less common (37% versus 42%), p > 0.05 for all. Infection as an indication for lead extraction was higher in the rotating sheath group (59.8% versus 52.9%, p = 0.002). The mean time from initial lead implantation was 7.2 years for rotating sheaths and 6.3 years for laser sheaths (p > 0.05). Results Success rates for complete removal of transvenous leads were 95.1% in rotating sheaths and 93.4% in laser sheaths (p p = 0.01). Conclusions Laser sheaths were associated with lower complete lead removal rate and a 9.3-fold higher risk of death. more...

Aims Rotating sheaths and laser sheaths are commonly used for transvenous lead extraction. This study aims to compare observed mortality between both approaches. Methods and results The Manufacturer and User Facility Device Experience database was searched from 2011 to 2016 to determine number of deaths associated with each sheath. An independent analytics firm provided estimates for number of cases done, allowing calculation of market share. A sensitivity analysis was performed to determine relative risk (RR) of mortality at the calculated market share (36% rotating/64% laser) and two others. Additional sensitivity analyses assumed underreporting of deaths associated with rotating sheaths. An estimated 50 545 extractions were performed. Thirteen deaths were associated with rotating sheaths compared to 167 with laser sheaths. Of these, 92% (rotating) and 95% (laser) were due to cardiovascular injury. At the calculated market share, the RR of death was 7.2 times greater with laser sheaths [95% confidence interval (CI) 4.1–12.7, P Conclusions Lead extraction with laser sheaths appears to be associated with a higher risk of mortality compared to rotating sheaths. Further studies are warranted to confirm this finding. more...

PURPOSE: Cryoballoon ablation (CBA) is an effective technique for pulmonary vein isolation (PVI). To date, there are no risk models to predict very late recurrence of atrial fibrillation (VLRAF) after CBA. METHODS: Retrospective analysis of a single-center database was performed. Inclusion criteria included PVI using CBA for atrial fibrillation (AF) without additional ablation targets, follow-up > 365 days, and no recurrent AF between 90 and 365 days after procedure. The primary endpoint was recurrent AF > 30 s > 12 months post-CBA. A risk model was created using clinical variables. RESULTS: Of 674 CBA performed from 2011 to 2016, 300 patients (200 male, 62.0 ± 9.9 years) met inclusion criteria. Of these, 159 (53.0%) patients had paroxysmal AF. Patients had an average of 9.5 ± 2.7 cryoballoon freezes, and no patients required additional radiofrequency ablation lesion sets. Over a follow-up of 995 ± 490 days, 77/300 (25.7%) patients exhibited VLRAF. Univariate and multivariate analyses demonstrated that Structural heart disease (1 point), Coronary artery disease (3 points), left Atrial diameter > 43 mm (1 point), Left bundle branch block (3 points), Early return of AF (4 points), and non-paroxysmal AF (3 points) were risk factors for VLRAF. Combining these variables into a risk model, SCALE-CryoAF, (min 0; max 15) predicted VLRAF with an area under the curve of 0.73. CONCLUSION: SCALE-CryoAF is the first risk model to specifically predict first recurrence of AF beyond 1 year, VLRAF, after CBA. Model discrimination demonstrates that SCALE-CryoAF predicts VLRAF after CBA significantly better than other risk models for AF recurrence. more...

PURPOSE: Pulmonary vein isolation (PVI) by cryoballoon ablation (CBA) has emerged as a commonly used technique for the treatment of atrial fibrillation. We sought to explore the incidence, risk factors for, and characterization of post-CBA-PVI atrial flutter. METHODS: We analyzed a prospective registry of patients who underwent CBA-PVI at a single institution. We included patients with more than 3 months of follow-up data and excluded those with a history of cavotricuspid isthmus (CTI) ablation. Locations of post-CBA-PVI atrial flutters were determined by analysis of intracardiac electrograms and electroanatomic maps. RESULTS: There were 556 patients included in the analysis. The mean age was 61.0 ± 10.6 years, 67.4% were male, the number of failed anti-arrhythmic medication trials was 1.2 ± 0.8, and the duration of atrial fibrillation pre-CBA was 54.3 ± 69.1 months. The 28-mm second-generation cryoballoon was used almost exclusively. Over a median follow-up time of 22.7 ± 17.9 months, 25 (4.5%) patients developed post-CBA-PVI atrial flutter after the 3-month blanking period. Of those 25 patients, 15 (60%) underwent subsequent ablation to eliminate the atrial flutter circuit, with 60% being CTI-dependent and the remainder left-sided (p value not significant). Risk factors for the development of atrial flutter included NYHA class ≥ 2 (OR 5.02, p < 0.001), presence of baseline bundle branch block (OR 4.33, p = 0.006), and left ventricular ejection fraction < 50% (OR 3.36, p = 0.007). CONCLUSIONS: The rate of post-CBA-PVI atrial flutter is low after the blanking period even with medium-term follow-up. The origin of atrial flutter is equally divided between the right and left atria. more...

BACKGROUND: While several studies have evaluated predictors for atrial fibrillation (AF) recurrence following catheter ablation, there are limited data specific to cryoballoon ablation (CBA). METHODS: We analyzed a prospective registry of patients at a single institution who underwent CBA. Recurrence of AF (RAF) was defined as recurrence of AF by 12-month follow-up, excluding the 3-month blanking period. Univariate analysis was performed to evaluate predictors of RAF. Receiver operating characteristic analysis was used to compare and evaluate the performance of various risk scores for discriminating risk of RAF. RESULTS: There were 542 patients included in the analysis with mean age 61.3 ± 10.6 years, 67.9% male, and 51.6% paroxysmal AF (PAF). Overall, only left atrial diameter (LAD) > 40 mm and ERAF (early recurrence of AF within 0-3 month blanking period) were significant predictors of RAF. In the PAF specific subgroup, LAD > 40 mm, AF duration > 12 months, prior stroke or transient ischemic attack, ERAF, and having previously failed an antiarrhythmic drug were significant predictors of RAF. In persistent AF (PeAF) subgroup, obstructive sleep apnea (OSA) and ERAF were significant predictors of RAF. Out of clinical risk scores tested, BASEAF2 had the highest performance with area under the curve of 0.646 (95% confidence interval [0.548, 0.708]; P < .01). CONCLUSIONS: In this single-center retrospective study of CBA, we found only LAD > 40 mm and ERAF to be predictors of RAF. We identified OSA as a potential targetable risk factor in PeAF patients undergoing CBA. Out of risk scores tested for discriminating risk of RAF, BASEAF2 had the best performance. more...

The efficacy of novel oral anticoagulants (NOACs) in severely obese patients is uncertain as volume of distribution is related to weight, and few such patients were enrolled in the pivotal trials. As the month after direct-current cardioversion (DCCV) for atrial fibrillation and atrial flutter is a high-risk period for stroke, we sought to evaluate the safety of performing DCCV in obese patients on NOAC. All patients who underwent DCCV after ≥3 weeks of NOAC or therapeutic warfarin treatment without a previous transesophageal echocardiogram over a 3-year period at a single center were included. Obesity groups were defined as normal (body mass index [BMI] < 25), overweight (BMI 25 to more...

Objective The objective of this study was to determine the features of carbohydrate antigen (CA) 19-9 decline that correlates best with survival benefit in patients with metastatic pancreatic cancer. Methods This is a retrospective study of 225 patients with metastatic pancreatic cancer receiving first-line therapy. Analysis was performed by the Kaplan-Meier method and Cox-proportional hazards ratios. CA 19-9 decline was grouped into quartiles within different CA 19-9 baseline groups. Time to nadir and CA 19-9 decline at month-2 (M2) of therapy were evaluated for patients with a baseline level ≥1000 U/mL. Results No significant trend in survival was observed across baseline CA 19-9 levels. The greatest survival benefit was seen with a ≥75% decline to nadir. Among those with a ≥75% decline and baseline ≥1000 U/mL, 43 of 57 patients had a >50% decline at M2 of therapy and additional survival benefit was observed with a slower decline to nadir. Small sample sizes limited analysis of other baseline groups. CA 19-9 decline at M2 was not predictive. Conclusions In patients with a CA 19-9 ≥1000 U/mL, serial CA 19-9 levels may be considered as a surrogate for serial imaging to evaluate treatment response, with a ≥75% decline indicating the greatest survival benefit. Survival was improved further in the setting of a slower decline to nadir with the highest benefit seen in patients with a nadir occurring at 4 months or longer. more...

Objective Determine whether a regimen of fixed dose rate gemcitabine plus capecitabine is effective and tolerable for advanced pancreatic adenocarcinoma. Methods We performed a retrospective analysis of 62 patients with locally advanced or metastatic pancreatic adenocarcinoma treated at the University of California San Francisco between 2008 and 2016. Treatment was an alternate week schedule of fixed dose rate 1000 mg/m gemcitabine and capecitabine 1000 mg/m (58 patients), 1200 mg/m (12 patients), or 650 mg/m (1 patient) for intended 12 cycles. We evaluated overall survival (OS), progression-free survival (PFS), radiologic response, and adverse events necessitating treatment modification. Results For metastatic patients, median OS was 10.3 months (95% confidence interval [CI], 6.7-12.1 months), and PFS was 5.6 months (95% CI, 2.6-7.7 months). In locally advanced patients, OS was 12.0 months (95% CI, 4.9-17.1 months), and PFS was 5.4 months (95% CI, 2.5-9.4 months). Radiologic response for metastatic disease (42 patients) was 19% objective response, 45% stable disease, and 36% progressive disease. Treatment required modification for 22 patients due to adverse events, most frequently hand-foot syndrome (18 patients). Conclusions Alternate week schedule of fixed dose rate gemcitabine and capecitabine was active and tolerable for advanced pancreatic adenocarcinoma. Overall survival and PFS were comparable to first-line treatments. Importantly, adverse effects appear less severe than first-line treatments. more...

Importance Cardiovascular disease is the leading cause of death in the US. The burden of cardiovascular disease morbidity and mortality disproportionately affects racial/ethnic minority groups, who now compose almost 40% of the US population in aggregate. As part of the 2010 American Heart Association (AHA) Strategic Impact Goal, the AHA established 7 cardiovascular health (CVH) metrics (also known as Life’s Simple 7) with the goal to improve the CVH of all individuals in the US by 20% by 2020. National estimates of CVH are important to track and monitor at the population level but may mask important differences across and within racial/ethnic minority groups. It is critical to understand how CVH may differ between racial/ethnic minority groups and consider how these differences in CVH may contribute to disparities in cardiovascular disease burden and overall longevity. Observations This narrative review summarizes the available literature on individual CVH metrics and composite CVH scores across different race/ethnic minority groups (specifically Hispanic/Latino, Asian, and non-Hispanic Black individuals) in the US. Disparities in CVH persist among racial/ethnic groups, but key gaps in knowledge exist, in part, owing to underrepresentation of these racial/ethnic groups in research or misrepresentation of CVH because of aggregation of race/ethnicity subgroups. A comprehensive, multilevel approach is needed to target health equity and should include (1) access to high-quality health care, (2) community-engaged approaches to adapt disruptive health care delivery innovations, (3) equitable economic investment in the social and built environment, and (4) increasing funding for research in racial/ethnic minority populations. Conclusions and Relevance Significant differences in CVH exist within racial/ethnic groups. Given the rapid growth of diverse, minority populations in the US, focused investigation is needed to identify strategies to optimize CVH. Opportunities exist to address inequities in CVH and to successfully achieve both the interim (AHA 2024) and longer-term (AHA 2030) Impact Goals in the coming years. more...

Pulmonary vein isolation (PVI) by cryoballoon ablation (CBA) has emerged as a commonly used technique for the treatment of atrial fibrillation, but there is a paucity of information about the incidence, risk factors for and characterization of post-CBA-PVI atrial flutter. We analyzed a prospective more...

Novel oral anticoagulants (NOACs) are used in patients undergoing direct-current cardioversion (DCCV) for atrial fibrillation and atrial flutter (AF/AFL). There are concerns about their efficacy and safety in severely obese patients as volume of distribution is related to weight and few such more...

Rotating cutting and laser sheaths are both routinely used in transvenous lead extraction (TLE) which can cause catastrophic complications including death. Because of their uncertainty in efficacy and risk, we performed a meta-analysis aimed at comparing success and mortality rates associated with more...

e15758 Background: Phase III trials support the use of FOLFIRINOX and gemcitabine plus albumin-bound paclitaxel as first-line treatment options in patients with APC. However, these treatments have significant side effects including cumulative neuropathy and cytopenias that limit their use. Our group previously reported results from a phase II trial evaluating a regimen of alternating-week FDR GEM/CAP showing promising efficacy as well as good tolerability. In the current analysis, we examined a larger retrospective cohort of APC patients treated using this strategy. Methods: Eligible patients received FDR GEM (1000 mg/m2) infusion on days 1 and 15, along with CAP 1,000 mg/m2 on days 1 to 7 and 15-22, in 28-day cycles. We evaluated OS, PFS, and objective radiologic response (ORR) by RECIST 1.1; as well as tabulated adverse events that necessitated dose or schedule modification. Results: 62 patients were treated at UCSF from 2008-2016 (52% male; and 48% female with a median age of 64.3 years. 49 had metastatic disease and 13 were locally advanced. Median OS was 10.3 and 12.0 months in the metastatic and locally advanced cohorts, respectively; median PFS was 5.4 and 5.6 months. ORR in evaluable patients with metastatic disease was 19% (all partial responses), with a disease control rate of 64%. In total, 37% of patients required dose modification at some point during therapy; the most common reason was hand-foot syndrome. Conclusions: FDR GEM/CAP represents an active and safe regimen for patients with APC, with OS and PFS rates comparable to those achieved with other first-line treatments. This regimen, based on its ease of administration and tolerability, may represent a suitable alternative option in select patients. more...

e15240 Background: Changes in CA 19-9 during chemotherapy have been reported to be of prognostic importance in MPC. However, the baseline CA 19-9 that can be considered useful for evaluation of suc... more...