Introduction Several recent studies have raised concern about noise detections on Tendril pacemaker leads, which may represent insulation failure or algorithm‐driven overreporting of physiologic signals. Methods We identified all pacemaker leads actively followed at Albany Medical Center, of which 1111 leads (262 Abbott Tendril, 576 Medtronic CapSure, 30 Fineline, 195 Ingevity, 48 Dextrus) in 703 patients were included in this observational study. Electrical abnormalities, comprising low‐impedance measurements <200 Ω and repeated noise detections, were catalogued, as was initial management and subsequent need for surgical intervention. Results During 54 months median follow‐up (interquartile range 24–105), 63 leads (5.7%) demonstrated electrical abnormalities, including low impedances in 21 and noise in 59. Tendril leads manifested abnormalities most frequently (n = 50; 19.1%) compared with CapSure (n = 9; 1.6%), Fineline (n = 0), Ingevity (n = 0), and Dextrus (n = 4; 8.3%) leads. The risk of abnormalities was significantly higher in Tendril leads (HR 9.6, 95% CI 5.2–17.6; p < .001). Low impedances were measured on 19 Tendril leads, a significantly higher risk than on other leads (HR 23.8, 95% CI 5.5–102.1; p < .001). Although observation and reprogramming sensitivity were the initial management strategy for 45 and 7 leads, respectively, 18 ultimately required surgical intervention, including 15 Tendrils. No electrical abnormalities were observed in 12 non‐Tendril leads attached to Abbott devices compared with 48 of 252 Tendrils attached to Abbott devices (log‐rank p = .035). Conclusion Tendril leads demonstrate significantly higher risk of repeated low impedances and noise compared to other manufacturers' models, raising concern that these findings reflect early insulation failure. Increased scrutiny is warranted.
Background: CMS has initiated a rule testing 2 new cardiac related retrospective episode payment models (bundles) targeting Medicare beneficiaries receiving services during AMI or CABG admissions. Purpose of the rule is to test innovative delivery models that reduce costs while preserving quality. Providers are incentivized to lower costs through improved care coordination and QI while focusing on decreased utilization of costly resources (re-admissions, etc.). Medicare beneficiaries with HF represent an opportunity to test innovative models of health care delivery. Participation in advanced payment models requires institutional commitment, organizational structure and dedicated resources in order for both goals (QI and cost-containment) to be met. This represents an ongoing CMS frame-shift of care delivery from fee-for-service to valuebased reimbursement. Objective: We describe the process of initiating a novel HF bundle within our next generation ACO for high risk HF patients that will focus on improved care transitions, quality of care delivery and decreased utilization of unnecessary high cost resources (i.e. hospital admissions/readmissions). Methods: Claims data of Medicare patients with a HF DRG in our next generation ACO were used to screen patients. Milliman Advanced Risk Adjusters (MARA) software was used to identify a high risk cohort for hospital admission who will be the pilot group. Global cost will be tracked for the pilot group for 12 months starting in July 2017 and savings/risk will be shared amongst ACO members. We will utilize the following strategies developed to ensure effective value-based care delivery. (1) 24 hour HF hotline staffed by HF MD's who can triage and deploy resources to patients in need of acute services. (2) On site ED HF team members (hospitalists and case managers) who will triage HF patients prior to hospital admission to the appropriate level of acute care service (48 hour observation unit, dedicated infusion center or home with same/next day appointment to the advanced heart failure clinic. (3) Direct hand-off of admitted HF patients to dedicated care managers who will coordinate and assist in navigating complex health care services. (4) Use of a social needs assessment tool for deployment of community health workers who will provide pre-specified services (food prescriptions with personal shoppers, direct observed medication adherence, transportation assistance for OP visits) to the highest risk patients. (5) Use of palliative care services already embedded in the HF clinic to deliver home palliative/hospice services. Conclusions: The HF patient cohort is a prevalent and high risk group that utilizes a large percentage of costly health care resources. Innovative health care delivery strategies that focus on value-based care are needed to decrease unnecessary use of high cost resources.
AimsRemote haemodynamic monitoring (RHM) decreases hospitalization rates in patients with chronic heart failure (HF). Many patients with chronic HF develop pulmonary hypertension (PH) secondary to left heart disease with some acquiring combined pre‐capillary and post‐capillary PH (Cpc‐PH). The efficacy of RHM in achieving pulmonary pressure reductions in patients with Cpc‐PH vs. isolated post‐capillary PH (Ipc‐PH) is unknown. The purpose of this study is to evaluate whether a higher baseline diastolic pressure gradient (DPGbaseline) measured at the time of CardioMEMS™ HF sensor implantation is associated with lower reductions in pulmonary artery diastolic pressures (PADP).Methods and resultsThis was a retrospective analysis of 32 patients meeting clinical indications for CardioMEMS™ implantation. DPGbaseline categorized patients as Cpc‐PH (DPG ≥ 7 mmHg) or Ipc‐PH (DPG < 7 mmHg). Minimum achievable PADP (PADPmin) and ∆PADP (PADPbaseline − PADPmin) were determined. Pearson's correlation analysis and comparison of mean pressure changes were assessed. Median age was 69 years, and median left ventricular ejection fraction (LVEF) was 25%. Eight patients (25%) had a LVEF ≥40%. Twenty‐five patients (78%) met criteria for Ipc‐PH and seven (22%) for Cpc‐PH. Neither PADPmin (ρ = 0.27; P = 0.13) nor ΔPADP (ρ = 0.07; P = 0.72) was correlated with DPGbaseline. A trend towards higher ΔPADP was seen in Cpc‐PH vs. Ipc‐PH patients (15.2 vs. 9.88 mmHg; P = 0.12). There was a moderate positive correlation between baseline PADP and ΔPADP [ρ = 0.55 (0.26–0.76); P < 0.001].ConclusionsDecreased PADP reduction was not seen in Cpc‐PH vs. Ipc‐PH patients. Higher PADPbaseline was associated with greater ΔPADP. Larger studies are needed to elaborate our findings.
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