key: cord-0916107-nvbj390p authors: Nabutovsky, Irene; Breitner, Daniel; Heller, Alexis; Klempfner, Yarin; Klempfner, Robert title: Adherence to Remote Cardiac Rehabilitation During the Coronavirus Pandemic: A Retrospective Cohort Analysis date: 2021-03-03 journal: J Cardiopulm Rehabil Prev DOI: 10.1097/hcr.0000000000000593 sha: 3e12e0a89b51fcd983425b1565fc7c0e7bfd2622 doc_id: 916107 cord_uid: nvbj390p nan T he American College of Cardiology/American Heart Association guidelines recommend exercise training (typically in a cardiac rehabilitation [CR] setting) to improve functional status in patients with symptomatic heart failure with reduced ejection fraction (HFrEF) able to participate (Class I recommendation, level of evidence A). To date, few studies have determined CR referral and enrollment rates in heart failure (HF) patients. [1] [2] [3] [4] These studies have found that CR referral and participation rates for HF patients are low (10.4% and 2.6-41%, respectively). [1] [2] [3] [4] A major barrier to CR referral was the lack of insurance coverage. 5, 6 In 2014, the Centers for Medicare & Medicaid Services (CMS) initiated coverage of CR for selected patients with HFrEF (ie, those who meet CMS referral criteria). It would be expected that the introduction of this CMS coverage would result in greater CR referral and participation rates. To this point, a previous study reported that CR participation rates were 41% in patients with HFrEF following CMS coverage 3 ; however, referral rates were not reported. Other studies reporting CR referral and participation rates following CMS coverage approval have found low CR participation rates 1, 4 ; however, it is unclear whether these patients met CMS entry criteria for CR. Thus, we sought to assess CR referral, enrollment, and graduation rates in patients with HFrEF following introduction of CMS coverage for CR. This was a historical cohort study that included 265 consecutive patients residing in Olmsted County, Minnesota, who had a primary diagnosis of HFrEF at any inpatient or outpatient visit from January 1, 2009, to October 31, 2012 (ie, 2009-2012 cohort) and January 1, 2014, to March 31, 2019 (ie, 2014-2019 cohort). The 2009-2012 cohort was included to establish a baseline estimate of CR referral, enrollment, and graduation prior to CMS approval of CR. Patients were initially identified using the International Classification of Diseases (ICD-9/10) code 428/I.50 (HF) and were excluded if they had a left ventricular ejection fraction (LVEF) >35%, history of stroke with persistent and debilitating symptoms (eg, paralysis), or lacked valid research authorization as required by the Minnesota statute. An LVEF >35% was used as exclusion criteria, as the CMS has approved coverage for CR for HFrEF patients with an LVEF ≤35%. This study was approved by the Mayo Clinic Institutional Review Board, and all patients agreed to the use of their medical records for research. Electronic medical record (EMR) review was performed to obtain all the patient-level data. The LVEF measurements from outpatient echocardiography visits that were closest to the discharge date were recorded (<180 d). Referral and enrollment (ie, attending ≥1 outpatient CR session) were determined via the EMR. Graduation was defined as EMR documentation that a patient had a final CR graduation assessment or attended ≥25 CR sessions. All analyses were completed using R. Patient characteristics are reported as mean ± SD or as n (%). Normality was assessed using the Shapiro-Wilk test and nonparametric tests were used when appropriate. Participant characteristics and referral rates were compared using unpaired t tests or χ 2 tests when appropriate. Associations between categorical patient characteristics and CR referral as well as graduation of ≥25 CR sessions were assessed using OR, 95% CI, and P values from univariate logistic regression. In all cases, two-tailed P < .05 was considered statistically significant. The Table shows Univariate predictors of CR referral included age (ie, ≥75 yr; OR = 0.53: 95% CI, 0.27-0.99), ischemic etiology (OR = 2.30: 95% CI, 1.25-4.28), and chronic obstructive pulmonary disease diagnosis (OR = 0.18: 95% CI, 0.04-0.54). Age (ie, ≥75 yr) was the only univariate predictor of completing ≥25 CR sessions in this cohort (OR = 27.00: 95% CI, 4.17-539.74). Sex, care center, LVEF, systolic blood pressure, diabetes, hypertension, as well as β-blockers, angiotensin-converting enzyme inhibitor/angiotensin receptor blockers, and diuretic use were not significant predictors of CR referral or completing ≥25 CR sessions (all, P ≥ .10). We expected the CR referral rate to be substantially higher in the present study following introduction of coverage by the CMS. In contrast, we found that the referral rates were not different between our 2009-2012 and 2014-2019 cohorts (28% vs 28%), albeit higher than previously reported (ie, 10.4%). 1 Patient factors associated with low likelihood of CR referral in the 2014-2019 cohort included older age (ie, ≥75 yr) and chronic obstructive pulmonary disease diagnosis, consistent with previous studies in HF and coronary artery disease patients. 1, 7, 8 An additional factor contributing to the low referral rates may be the CMS referral restriction of 6 wk for the HFrEF patients to become stable on medication therapy. A recent study investigating CR participation rates following CMS approval found that CR participation rates were 41% for HFrEF patients. 3 In contrast, the enrollment rate (relative to referral rate) in the 2014-2019 cohort presented was substantially greater (ie, 69%). This finding suggests that referral is a major barrier limiting HFrEF patients from enrolling (and graduating from) CR. An additional important finding of the present study was that the CR graduation rate was 41% in the 2014-2019 cohort. In contrast to coronary artery disease, 7 older age (ie, ≥75 yr) was the only significant predictor of completing ≥25 CR sessions in the 2014-2019 cohort. In conclusion, we found that CR was underutilized and that participation rates did not significantly improve following the introduction of CMS coverage, suggesting the presence of T he global crisis of COVID-19 has highlighted how the health care system needs to adapt. Telemedicine services have proven to be essential during this time. 1 Previous studies have shown that telemedicine reduces hospitalizations, enhances care, and increases treatment compliance. 2 During the pandemic, Israel had a partial lockdown (January 15, 2020, to May 10, 2020). Extreme restrictions were implemented, which are shown to have an adverse effect on physical and mental health in patients with chronic diseases. 3, 4 Remote cardiac rehabilitation programs (RCRP), however, continued. Previous studies have shown that RCRP are effective, safe, and equivalent to institutional rehabilitation. 5 So far, few have analyzed the susceptibility of patients to telemedicine programs during COVID-19. The objectives of this study were to characterize the first of its kind program in Israel at the level of the patients and care team during the crisis compared with normal. We explored the following: (1) how restrictions on movement and fear of infection will affect patient activity; (2) how the crisis will affect the performance of the RCRP care team; and (3) the concerns and satisfaction levels of patients during the crisis. (P1)-9 wk before the lockdown; period-2 (P2)-7 wk during the lockdown. The following were assessed for both periods: aerobic exercise (min) and time in target heart rate (min) as well as the steps/d and mobile application use/wk. We also examined patterns of the care team: the number of contacts with the patient/wk and the ratio between automatic and manual follow-up tasks. Patients were sent an anonymous survey at the end of isolation to assess their training; compare workouts during the two periods; assess the level of satisfaction/concerns with the program; and assess how much the program helps maintain a healthy lifestyle. A description of the program was previously published. 6 The program involves structured remote exercise. Remote cardiac rehabilitation programs set the following goals for patients: (1) 3-5 aerobic workouts/wk (150 min); (2) ≥120 min at a target heart rate; and (3) ≥8000 steps/d. Patients were asked to frequently use the mobile app. The program duration was 3-12 mo. During the lockdown, the RCRP protocol remained unchanged; however, there was a reduction of care team workers, decreasing the weekly working hours (from 60 to 40). Descriptive statistics for the study population are presented as counts/percentages for discrete variables and mean ± SD for continuous data. Selected variables were represented as their weekly averages and trends were analyzed. The studied duration was split into two groups, P1 (wk 1-9) and P2 (wk 10-16). We compared variables between the two periods, using the Student t test and Wilcoxon rank sum test, for normally and nonnormally distributed data, respectively. All analyses were performed using R 3.6.2 (The R Foundation). Statistical significance was set at P < .05 (two-sided). The analysis included 38 patients who participated during P1 and P2. Patients were mostly male (92%), <65 yr (58 ± 11 yr), with a recent diagnosis of cardiovascular disease following myocardial infarction or coronary interventions (57%), without significant left ventricular dysfunction or residual clinical ischemia. During P2, there was an increase in patient activity: total aerobic minutes and minutes in the target heart rate ( Figure) . Other variables remained unchanged from P1 to P2. The survey conducted revealed that 83% of patients believed that they were exercising as much or more. More than 86% of patients reported feeling safe and satisfied with RCRP. Only 6% of patients were afraid of contracting COVID-19. More were concerned that the lockdown would prevent them from reaching program goals (35%). Others (46%) had no significant concerns. Overall, 84% of participants answered that RCRP helped them maintain a healthy lifestyle. In addition, care team working hours were reduced by a third in P2. The total number of opened tasks/wk remained unchanged during the lockdown; however, the number of manually opened tasks decreased by 39%. This study evaluated the feasibility of a cardiac rehabilitation program at home during COVID-19 lockdown. Our results showed that RCRP patients exercised with no significant changes. We hypothesize that factors such as having more free time due to the lockdown, receiving daily video material, and automatic exercise reminders helped maintain patient activity. It has been proven that isolation endangers mental health and causes sensations similar to post-trauma. 7 Previous studies have shown that prolonged (>10 d) quarantine was associated with a significant deterioration in mental health. 8 Unlike previous studies, 9 our survey showed that RCRP patients in lockdown did not experience anxiety or fear. Similar to a recent study, 7 we hypothesize that regular communication, access to remote psychological support, and daily educational materials prevented feelings of loneliness/isolation. The RCRP algorithm for automatically opening tasks and ensuring adherence to protocol existed before the pandemic and has already proven to be reliable. This allowed the reduced staff to successfully maintain a normal workload during the lockdown. These findings are consistent with recent studies on the effectiveness of similar algorithms for remote monitoring and treating patients. 10 Unlike previous studies that highlighted telemedicine limitations, 11 our study shows how a well-functioning telemedicine system can effectively cope with current global challenges. Our study has several limitations. First, the number of participants is relatively small due to the RCRP program being fairly new and the requirement of patients to train for at least 2 mo before the lockdown. Second, the Israeli Ministry of Health has approved the RCRP for only low-risk patients, who are often younger and more technologically oriented than high-risk patients. In conclusion, during the lockdown due to COVID-19, RCRP were proven to be effective in maintaining the mental and physical health of patients, even with a substantial reduction in staff. This shows how telemedicine has the potential to prevent the detrimental effects of a national crisis on chronic patient care. Cardiopulmonary Assessment Prior to Lung Lobectomy: A Challenging Case in Patient With Permanent Tracheostomy T he cardiopulmonary exercise test (CPX) is a robust, reproducible, and easily performed test to predict both patient outcomes and the level of care required post-operatively. In the last decades, CPX has received increasing attention as a tool to determine readiness for major cancer surgery, becoming a fundamental test to risk stratify patients undergoing evaluation for major thoracic resections. The examination is conventionally performed stressing the patient on a bicycle or a treadmill, using a tight-fitting face mask for the analysis of ventilation and gas exchange. Certain groups of patients present a challenge for conducting CPX, for example those with permanent tracheostomy postlaryngectomy. [1] [2] [3] [4] The lack of an upper airway represents the main problem, especially considering that the CPX system is specifically designed for use with a unique face mask. This report describes a method to obtain a CPX in presence of a permanent tracheostomy, without having suitable medical fittings for connecting to gas analyzer components. A 67-y-old man underwent radical neck dissection for laryngeal squamous carcinoma in 2016 resulting in a permanent tracheostomy. He was disease free for 3 yr since surveillance total body computed tomography (CT) in 2019 revealed a right lower pulmonary nodule suspicious for neoplasm. The CT-driven fine-needle biopsy of the lesion revealed a primitive adenocarcinoma of the lung. Once the clinical staging, according to positron emission tomography (PET), confirmed the single pulmonary location without obvious nodal involvement or disease outside the chest, the patient was referred to our division for thoracic surgery evaluation. According to tumor location and current clinical practice guidelines (IA), a right lower lobectomy and mediastinal nodal dissection was suggested. 5 Pulmonary function test (forced expiratory volume in 1 sec [FEV 1 ]/forced vital capacity = 65% and diffusion lung carbon monoxide [DLCO] = 51%) and the cardiology assessment suggested the completion of pre-operative work-up with a CPX. 3 Based on experience, we found that the standard cycle-based CPX set-up in the cardiac rehabilitation unit Gerathem Respiratory (Ergostik) was not compatible with the tracheal cannula, neither with a tracheostomy tube nor a silicon laryngeal ring on stoma adhesive support. We initially contacted the CPX system manufacturer, but unfortunately, they did not have any information or experience with the CPX via tracheostomy. As shown in the Figure, the CPX flow sensor (a) has an ovoid shape specifically designed for use with the face mask for standard CPX examinations. It does not conform to the standard diameter connections found on anaesthetic breathing circuits. To obtain an effective and quick solution, we used a silicon rubber connector easily available in many stores (Figure b ). This small gasket was adaptable to the ovoid shape of the sensor and allowed it to be connected to a classic ventilation mount (Figure c) , which replaced the usual CPX mask. We considered the respiratory dead space added by the mount to be approximately comparable with the same space between the inner surface of the face mask and the patient face (8 mL, volume obtained by filling the mount system with water). The underwater tests showed no air leaks, resulting in a perfect watertight seal of the adapted system. We then placed a #7 cuffed plastic Shiley tracheostomy cannula using 2% lidocaine lubricating jelly and allowed 10 min for patient acclimation. The balloon was then inflated to the point of eliminating leak with Valsalva during cannula occlusion (10 cc air). At this point, the flow sensor was connected to the patient and to the usual CPX circuit and metabolic cart (Figure 1d ). Using this set-up, the patient was able to breathe comfortably through the circuit with reproducible breath-to-breath volumes and no evidence of leaks. The test was completed after 12 min of pedaling, 2 min unloaded and 5 min at 10 W min −1 . The anaerobic threshold was achieved, and all valuable data recorded confirmed that the patient was fit enough to proceed to his lower right lung lobectomy. Head, neck, and lung cancers often have coexistent chronic obstructive lung disease complicating their operative risk for curative resections. Furthermore, tracheostomized patients after oncological surgery of the larynx are often former smokers, with coronary heart disease. In these cases, when a major lung resection is needed, the CPX should be provided for a strict pre-operative work-up. In patients with pre-resection lung values for FEV 1 and DLCO <80%, various methods to predict post-resection physiology have been proposed, but risk stratification for patients being considered for lung resection surgery remains an inexact science. In thoracic surgery, CPX with an anaerobic threshold value of <10 mL•kg −1 •min −1 objectively predicts the cardiovascular reserve in operative patients more accurately compared with morbidity indices like POSSUM or the Revised Cardiac Risk Index (RCRI). 6 The increased survival of patients treated for laryngeal cancer leads to a greater chance of developing lung cancer, also taking into consideration common risk factors. Consequently, the demand for CPX in this set of patients is now considerably increased, but system manufacturers are frequently unable to provide suitable devices for a tracheostomy-based examination, as they have not designed them yet. In literature, some authors already reported customized adapters constructed on demand for CPX in similar clinical cases, but no solution has been found for the discrepancies between Ergostik flow sensors and common tracheostomy ring connectors. [6] [7] [8] [9] We describe here the results of creatively using a silicon rubber gasket made for hydraulics, which was low cost and sterilizable. This was able to provide the hermetic seal we needed to perform an effective cardiopulmonary exercise. This system provided us with both satisfactory and reproducible CPX test results, and has been used successfully in two other subjects so far (Figure e and f) . Although a solution produced by the system manufacturer is desirable, the lack of this option led us to seek an independent solution. Paolo Albino Ferrari, MD Division of Thoracic Surgery, "A. 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