Effect of Metrics-Based Simulation Training to Proficiency on Procedure Quality and Errors Among Novice Cardiac Device Implanters: The IMPROF Randomized Trial.

Importance: In cardiac device implant training, there is no common system to objectively assess trainees' ability to perform tasks at predetermined performance levels before in vivo practice; therefore, patients are potentially exposed to risks related to operators' early learning curve. Objective: To assess the effect on implant performance quality of novel metrics-based simulation training to proficiency (proficiency-based progression [PBP]) vs traditional simulation-based training (SBT). Design, Setting, and Participants: In this prospective randomized trial, conducted between March 8, 2022 and November 24, 2022, novice implanters were randomized (blinded) 1:1 to participate in an SBT curriculum (procedural knowledge e-learning and in-person simulation training) at an international skills training center, with proficiency demonstration requirements at each training stage for advancing (PBP approach) or without the requirements. Ultimately, trainees performed a cardiac resynchronization therapy (CRT) implant using virtual reality simulation. The procedure was video-recorded and subsequently scored using previously validated metrics by 2 independent assessors blinded to group. Physicians who had already implanted more than 20 pacemakers or defibrillators and fewer than 200 CRT systems as the first operator were eligible. Thirty-two implanters from 10 countries voluntarily enrolled in the training program and were randomized; 30 (15 per group) started and completed training. Data analysis was performed from November 27 to December 22, 2022. Intervention: Training with PBP vs SBT. Main Outcome and Measures: The primary outcome comprised 4 objectively assessed performance metrics derived from the video-recordings: number of procedural steps completed, errors, critical errors, and all errors combined. Results: Baseline experience of the 30 participants (19 [63%] male; mean [SD] number of years in implant practice, 2.0 [1.8]; median [IQR] number of implanted pacemakers or defibrillators, 47.5 [30.0-115.0]; median [IQR] number of implanted CRT systems, 3.0 [1.25-10.0]) was similar between study groups. Compared with the SBT group, the PBP group completed 27% more procedural steps (median [IQR], 31 [30-32] vs 24 [22-27]; P < .001) and made 73% fewer errors (median [IQR], 2 [1-3] vs 7 [5-8]; P < .001), 84% fewer critical errors (median [IQR], 1 [0-1] vs 3 [3-5]; P < .001), and 77% fewer all errors combined (errors plus critical errors) (median [IQR], 3 [1-3] vs 11 [8-12]; P < .001); 14 of the 15 PBP trainees (93%) demonstrated the predefined target performance level vs 0 of the 15 SBT trainees. Conclusions and Relevance: In this randomized trial, the PBP approach to novice implanter training generated superior objectively assessed performance vs SBT. If implemented broadly and systematically, PBP training may ensure safe and effective performance standards before trainees proceed to (supervised) in vivo practice. Future studies are needed to verify implications on procedure-related patient complications. Trial Registration: ClinicalTrials.gov Identifier: NCT05952908.

A Critical Evaluation of Patient Pathways and Missed Opportunities in Treatment for Heart Failure.

BACKGROUND: Heart failure (HF) is a global problem responsible for significant morbidity and mortality. METHODS: This review describes the patient pathways and missed opportunities related to treatment for patients with HF. RESULTS: The contemporary management strategies in HF, including medical therapies, device therapy, transplant, and palliative care. Despite the strong evidence base for therapies that improve prognosis and symptoms, there remains a large number of patients that are not optimally managed. The treatment of patients with HF is highly influenced by those who are caring for them and varies widely across geographical regions. HF patients can be broadly classified into two key groups: those who have known HF, and those who are incidentally found to have reduced left ventricular systolic dysfunction or other cardiac abnormality when an echocardiogram is performed. While all patients are under the care of a general practitioner or family doctor, in other instances, non-cardiologist physicians, cardiologists, and specialist HF nurses-each will have varying levels of expertise in managing HF-are part of the broader team involved in the specialist management of patients with HF. CONCLUSIONS: There are many potential missed opportunities in HF treatment, which include general opportunities, medications, etiology-specific therapy, device therapy, therapies when initial treatments fail, and palliative care.

Missed Opportunities in the Diagnosis of Heart Failure: Evaluation of Pathways to Determine Sources of Delay to Specialist Evaluation.

Missed opportunities are incidents where different actions by those involved could have resulted in more desirable events. Heart failure is a complex clinical syndrome presenting as symptoms and signs common to other diagnoses, in patients frequently with multiple co-morbidities. Heart failure itself is not a diagnosis, but is the common clinical presentation of a variety of cardiac conditions. Correct diagnosis involves amalgamation of the clinical presentation, the results of general and specific investigations, and the clinician's ability to synthesize the overall picture. It is not surprising therefore that misdiagnosis can occur at any level of the heart failure journey and can occur because of patient, clinician, and health economy related factors. Delayed diagnosis leads to excess morbidity and mortality in these patients. In this review, we define the pathways for diagnosis of heart failure and then highlight missed opportunities related to delay and misdiagnosis. In addition, we consider how the earlier opportunity may impact patients, clinicians and health services.

Efficacy and safety of leadless pacemaker: A systematic review, pooled analysis and meta-analysis.

BACKGROUND: Leadless pacemakers have been designed as an alternative to transvenous systems which avoid some of the complications associated with transvenous devices. We aim to perform a systematic review of the literature to report the safety and efficacy findings of leadless pacemakers. METHODS: We searched MEDLINE and EMBASE to identify studies reporting the safety, efficacy and outcomes of patients implanted with a leadless pacemaker. The pooled rate of adverse events was determined and random-effects meta-analysis was performed to compare rates of adverse outcomes for leadless compared to transvenous pacemakers. RESULTS: A total of 18 studies were included with 2496 patients implanted with a leadless pacemaker and success rates range between 95.5 and 100%. The device or procedure related death rate was 0.3% while any complication and pericardial tamponade occurred in 3.1% and 1.4% of patients, respectively. Other complications such as pericardial effusion, device dislodgement, device revision, device malfunction, access site complications and infection occurred in less than 1% of patients. Meta-analysis of four studies suggests that there was no difference in hematoma (RR 0.67 95%CI 0.21-2.18, 3 studies), pericardial effusion (RR 0.59 95%CI 0.15-2.25, 3 studies), device dislocation (RR 0.33 95%CI 0.06-1.74, 3 studies), any complication (RR 0.44 95%CI 0.17-1.09, 4 studies) and death (RR 0.45 95%CI 0.15-1.35, 2 studies) comparing patients who received leadless and transvenous pacemakers. CONCLUSION: Leadless pacemakers are safe and effective for patients who have an indication for single chamber ventricular pacing and the findings appear to be comparable to transvenous pacemakers.

Misdiagnosis of aortic dissection: A systematic review of the literature.

BACKGROUND: Aortic dissection is a rare but potentially catastrophic condition. Misdiagnosis of aortic dissection is not uncommon as symptoms can overlap with other diagnoses. OBJECTIVE: We conducted a systematic review to better understand the factors contributing to incorrect diagnosis of this condition. METHODS: We searched MEDLINE and EMBASE for studies that evaluated the misdiagnosis of aortic dissection. The rate of misdiagnosis was pooled and results were narratively synthesized. RESULTS: A total of 12 studies with were included with 1663 patients. The overall rate of misdiagnosis of aortic dissection was 33.8%. The proportion of patients presenting with chest pain, back pain and syncope were 67.5%, 24.8% and 6.8% respectively. The proportion of patients with pre-existing hypertension was 55.4%, 30.5% were smokers while the proportion of patients with coronary artery disease, previous cardiovascular surgery or surgical trauma and Marfan syndrome was 14.7%, 5.8%, and 3.7%, respectively. Factors related to misdiagnosis included the presence of symptoms and features associated with other diseases (such as acute coronary syndrome, stroke and pulmonary embolism), the absence of typical features (such as widened mediastinum on chest X-ray) or concurrent conditions such congestive heart failure. Factors associated with more accurate diagnosis included more comprehensive history taking and increased use of imaging. CONCLUSIONS: Misdiagnosis in patients with an eventual diagnosis of aortic dissection affects 1 in 3 patients. Clinicians should consider aortic dissection as differential diagnosis in patients with chest pain, back pain and syncope. Imaging should be used early to make the diagnosis when aortic dissection is suspected.

Real-world evidence in a national health service: results of the UK CardioMEMS HF System Post-Market Study.

AIMS: The CardioMEMS HF System Post-Market Study (COAST) was designed to evaluate the safety, effectiveness, and feasibility of haemodynamic-guided heart failure (HF) management using a small sensor implanted in the pulmonary artery of New York Heart Association (NYHA) Class III HF patients in the UK, Europe, and Australia. METHODS AND RESULTS: COAST is a prospective, international, multicentre, open-label clinical study (NCT02954341). The primary clinical endpoint compares annualized HF hospitalization rates after 1 year of haemodynamic-guided management vs. the year prior to sensor implantation in patients with NYHA Class III symptoms and a previous HF hospitalization. The primary safety endpoints assess freedom from device/system-related complications and pressure sensor failure after 2 years. Results from the first 100 patients implanted at 14 out of the 15 participating centres in the UK are reported here. At baseline, all patients were in NYHA Class III, 70% were male, mean age was 69 ± 12 years, and 39% had an aetiology of ischaemic cardiomyopathy. The annualized HF hospitalization rate after 12 months was 82% lower [95% confidence interval 72-88%] than the previous 12 months (0.27 vs. 1.52 events/patient-year, respectively, P < 0.0001). Freedom from device/system-related complications and pressure sensor failure at 2 years was 100% and 99%, respectively. CONCLUSIONS: Remote haemodynamic-guided HF management, using frequent assessment of pulmonary artery pressures, was successfully implemented at 14 specialist centres in the UK. Haemodynamic-guided HF management was safe and significantly reduced hospitalization in a group of high-risk patients. These results support implementation of this innovative remote management strategy to improve outcome for patients with symptomatic HF. Clinical registration number: ClinicalTrials.gov identifier: NCT02954341.

The Impact of Charlson Comorbidity Index on De Novo Cardiac Implantable Electronic Device Procedural Outcomes in the United States.

OBJECTIVE: To investigate the utility of Charlson comorbidity index (CCI) as a measure of comorbidity burden to predict procedural outcomes after de novo cardiac implantable electronic device (CIED) implantation. METHODS: All de novo CIED implantations in the United States National Inpatient Sample between 2015 and 2018 were retrospectively analyzed, stratified by CCI score (0=no comorbidity burden, 1=mild, 2=moderate, ≥3=severe). Multivariable logistic regression models were performed to examine the association between unit CCI score (scale) and in-hospital outcomes (major adverse cerebrovascular and cardiovascular events [MACCE]: composite of all-cause mortality, acute ischemic stroke, thoracic and cardiac complications, and device-related complications; and MACCE individual components). RESULTS: Of 474,475 CIED procedures, the distribution of CCI score was as follows: CCI=0 (17.7%), CCI=1 (21.8%), CCI=2 (18.7%), and CCI=3+ (41.8%). Charlson comorbidity index score was associated with increased odds ratios of MACCE (1.10; 95% CI, 1.09 to 1.11), all-cause mortality (1.23; 95% CI, 1.21 to 1.25), and acute stroke (1.45; 95% CI, 1.44 to 1.46). This finding was consistent across all CIED groups except the cardiac resynchronization therapy groups in which CCI was not associated with increased risk of mortality. A higher CCI score was not associated with increased odds of procedural (thoracic and cardiac) and device-related complications. CONCLUSION: In a nationwide cohort of CIED procedures, higher comorbidity burden as measured by CCI score was associated with an increased risk of in-hospital mortality and acute ischemic stroke, but not procedure-related (thoracic and cardiac) or device-related complications. Objective assessment of comorbidity burden is important to risk-stratify patients undergoing CIED implantation for better prognostication of their in-hospital survival.

Performance of first pacemaker to use smart device app for remote monitoring.

BACKGROUND: High adherence to remote monitoring (RM) in pacemaker (PM) patients improves outcomes; however, adherence remains suboptimal. Bluetooth low-energy (BLE) technology in newer-generation PMs enables communication directly with patient-owned smart devices using an app without a bedside console. OBJECTIVE: To evaluate the success rate of scheduled RM transmissions using the app compared to other RM methods. METHODS: The BlueSync Field Evaluation was a prospective, international cohort evaluation, measuring the success rate of scheduled RM transmissions using a BLE PM or cardiac resynchronization therapy PM coupled with the MyCareLink Heart app. App transmission success was compared to 3 historical "control" groups from the Medtronic de-identified CareLink database: (1) PM patients with manual communication using a wand with a bedside console (PM manual transmission), (2) PM patients with wireless automatic communication with the bedside console (PM wireless); (3) defibrillator patients with similar automatic communication (defibrillator wireless). RESULTS: Among 245 patients enrolled (age 64.8±15.6 years, 58.4% men), 953 transmissions were scheduled through 12 months, of which 902 (94.6%) were successfully completed. In comparison, transmission success rates were 56.3% for PM manual transmission patients, 77.0% for PM wireless patients, and 87.1% for defibrillator wireless patients. Transmission success with the app was superior across matched cohorts based on age, sex, and device type (single vs dual vs triple chamber). CONCLUSION: The success rate of scheduled RM transmissions was higher among patients using the smart device app compared to patients using traditional RM using bedside consoles. This novel technology may improve patient engagement and adherence to RM.

Smoking cessation after acute coronary syndrome: A systematic review and meta-analysis.

BACKGROUND: Smoking cessation is an effective secondary prevention measure after acute coronary syndrome (ACS). We conducted a systematic review with the aim to better understand which patients have a greater propensity to quit smoking and the risk factors for continued smoking after ACS. METHODS: We searched MEDLINE and EMBASE for studies that evaluated smoking cessation after ACS. The pooled rate of smoking cessation across included studies was performed. Random effects meta-analysis for different variables and their association with smoking cessation was conducted. RESULTS: A total of 39 studies with 11 228 patients were included in this review. The pooled rate of smoking cessation following ACS across 38 studies was 45.0%. Factors associated with greater likelihood of smoking cessation were attendance at cardiac rehabilitation (OR 1.90 95% CI 1.44-2.51), married/not alone (OR 1.68 95% CI 1.32-2.13), intention/attempt to quit smoking (OR 1.27 95% CI 1.11-1.46), diabetes mellitus (OR 1.24 95% CI 1.03-1.51) and hospitalised duration (OR 1.09 95% CI 1.02-1.15). Variables associated with a lower likelihood of smoking cessation were depression (OR 0.57 95% CI 0.43-0.75), chronic obstructive pulmonary disease/lung disease (OR 0.73 95% CI 0.57-0.93), previous admission with acute myocardial infarction/cardiac admission (OR 0.61 95% CI 0.47-0.80), cerebrovascular disease/transient ischaemic attack (OR 0.42 95% CI 0.30-0.58) and unemployment (OR 0.37 95% CI 0.17-0.80). CONCLUSIONS: The majority of smokers with an ACS continue to smoke after admission. Patients attending cardiac rehabilitation show increased odds of quitting while people who are depressed and those with chronic lung disease were less likely to quit smoking and should be targeted for intensive smoking cessation interventions.

Misdiagnosis of Heart Failure: A Systematic Review of the Literature.

BACKGROUND: Heart failure (HF) is a chronic disease associated with a significant burden to patients, families, and health services. The diagnosis of HF can be easily missed owing to similar symptoms with other conditions especially respiratory diseases. METHODS AND RESULTS: We conducted a systematic review to determine the rates of HF and cardiomyopathy misdiagnosis and explored the potential causes. The included studies were narratively synthesized. Ten studies were identified including a total of 223,859 patients. There was a lack of definition of HF misdiagnosis in the studies and inconsistent diagnostic criteria were used. The rates of HF misdiagnosis ranged from 16.1% in hospital setting to 68.5% when general practitioner referred patients to specialist setting. The most common cause for misdiagnosis was chronic obstructive pulmonary disease (COPD). One study using a COPD cohort showed that HF was unrecognized in 20.5% of patients and 8.1% had misdiagnosis of HF as COPD. Another study suggests that anemia and chronic kidney disease are associated with an increase in the odds of unrecognized left ventricular systolic dysfunction. Other comorbidities such as obesity, old age, atrial fibrillation, and ischemic heart disease are prevalent in patients with a misdiagnosis of HF. CONCLUSIONS: The misdiagnosis of HF is an unfortunate part of everyday clinical practice that occurs with a variable rate depending on the population studied. HF is frequently misdiagnosed as COPD. More research is needed to better understand the missed opportunities to correctly diagnose HF so that harm to patients can be avoided and effective treatments can be implemented.

The role of the Tei index in assessing for cardiotoxicity from anthracycline chemotherapy: a systematic review.

BACKGROUND: Anthracycline agents are known to be effective in treating tumors and hematological malignancies. Although these agents improve survival, their use is associated with cardiotoxic effects, which most commonly manifests as left ventricular systolic dysfunction (LVSD). As such, guidelines recommend the periodic assessment of left ventricular ejection fraction (LVEF). However, as diastolic dysfunction likely proceeds systolic impairment in this setting, the role of Tei index may offer additional benefit in detecting subclinical LVSD. METHODS: We conducted a systematic review to investigate the evidence for the use of Tei index in assessing subclinical cardiotoxicity in patients receiving anticancer agents. A search of Medline and EMBASE was performed and relevant studies were reviewed and narratively synthesized. RESULTS: A total of 13 studies were included with a total of 800 patients (mean age range 46-62 years, percentage of male participants ranged from 0-86.9%). An increase in Tei index was observed in 11 studies, which suggested a decline in cardiac function following chemotherapy. Out of these, six studies indicated that the Tei index is a useful parameter in predicting cardiotoxic LVSD. Furthermore, five studies indicated Tei index to be superior to LVEF in detecting subclinical cardiotoxicity. CONCLUSIONS: Though there are some studies that suggest that Tei index may be a useful indicator in assessing subclinical anthracycline-related cardiotoxicity, the findings are inconsistent and so more studies are needed before the evaluation of Tei index is performed routinely in patients receiving chemotherapy.

Septal Flash as a Predictor of Cardiac Resynchronization Therapy Response: A Systematic Review and Meta-Analysis.

Cardiac resynchronization therapy (CRT) in heart failure patients has been shown to improve patient outcomes in some but not all patients. A few studies have identified that septal flash on imaging is associated with response to CRT, but there has yet to be systematic review to evaluate the consistency of the finding across the literature. A search of MEDLINE and EMBASE was conducted to identify studies, which evaluate septal flash and its association with CRT response. Studies that met the inclusion criteria were statistically pooled with random-effects meta-analysis and heterogeneity was assessed using the I2 statistic. A total of nine studies were included with 2307 participants (mean age 76 years, 67% male). Septal flash on imaging before CRT implantation was seen in 53% of patients and the proportion of CRT responders from the included studies varied from 52% to 77%. In patients who were CRT responders, septal flash was seen in 40% of patients compared to 10% in those deemed to be CRT nonresponders. Meta-analysis of eight of the nine included studies suggests that the presence of septal flash at preimplant was associated with an increased likelihood of CRT response (relative risk 2.55 95% confidence interval 2.04-3.19, P < 0.001, I2 = 51%). Septal flash was also reported to be associated with left ventricular reverse remodeling, but the association with survival and symptomatic improvement was less clear. Septal flash is a well-defined and distinctive contraction pattern that is easily recognizable on cardiac imaging. Septal flash may be associated with CRT response and should be evaluated in the patients that are considered for CRT devices.

Impact of COVID-19 on cardiac procedure activity in England and associated 30-day mortality.

AIMS: Limited data exist on the impact of COVID-19 on national changes in cardiac procedure activity, including patient characteristics and clinical outcomes before and during the COVID-19 pandemic. METHODS AND RESULTS: All major cardiac procedures (n = 374 899) performed between 1 January and 31 May for the years 2018, 2019, and 2020 were analysed, stratified by procedure type and time-period (pre-COVID: January-May 2018 and 2019 and January-February 2020 and COVID: March-May 2020). Multivariable logistic regression was performed to examine the odds ratio (OR) of 30-day mortality for procedures performed in the COVID period. Overall, there was a deficit of 45 501 procedures during the COVID period compared to the monthly averages (March-May) in 2018-2019. Cardiac catheterization and device implantations were the most affected in terms of numbers (n = 19 637 and n = 10 453), whereas surgical procedures such as mitral valve replacement, other valve replacement/repair, atrioseptal defect/ventriculoseptal defect repair, and coronary artery bypass grafting were the most affected as a relative percentage difference (Δ) to previous years' averages. Transcatheter aortic valve replacement was the least affected (Δ -10.6%). No difference in 30-day mortality was observed between pre-COVID and COVID time-periods for all cardiac procedures except cardiac catheterization [OR 1.25 95% confidence interval (CI) 1.07-1.47, P = 0.006] and cardiac device implantation (OR 1.35 95% CI 1.15-1.58, P < 0.001). CONCLUSION: Cardiac procedural activity has significantly declined across England during the COVID-19 pandemic, with a deficit in excess of 45 000 procedures, without an increase in risk of mortality for most cardiac procedures performed during the pandemic. Major restructuring of cardiac services is necessary to deal with this deficit, which would inevitably impact long-term morbidity and mortality.

Sex Disparities in the Choice of Cardiac Resynchronization Therapy Device: An Analysis of Trends, Predictors, and Outcomes.

BACKGROUND: There is limited evidence on the influence of sex on the decision to implant a cardiac resynchronization therapy device with pacemaker (CRT-P) or defibrillator (CRT-D) and the existence of sex-dependent differences in complications that may affect this decision. METHODS: All patients undergoing de novo CRT implantation (2004-2014) in the United States National Inpatient Sample were included and stratified by device type (CRT-P and CRT-D). Multivariable logistic regression models were conducted to assess the association of female sex with receipt of CRT-D and periprocedural complications. RESULTS: Out of 400,823 weighted CRT procedural records, the overall percentages of women undergoing CRT-P and CRT-D implantations were 41.5% and 27.8%, respectively, and these percentages increased compared with men over the study period. Women were less likely to receive CRT-D (odds ratio 0.66, 95% confidence interval 0.64-0.67), and this trend remained stable throughout the study period (P = 0.06). Furthermore, compared with men, women were associated with increased odds of procedure-related complications (bleeding, thoracic, and cardiac) in the CRT-D group but not in the CRT-P group. Factors such as atrial fibrillation, malignancies, renal failure, advanced age (> 60 years), and admission to nonurban/small hospitals favoured the receipt of CRT-P over CRT-D, whereas history of ischemic heart disease, cardiac arrest ,or ventricular arrhythmias favoured the receipt of CRT-D over CRT-P. CONCLUSIONS: Women were associated with persistently reduced odds of receipt of CRT-D compared with men over an 11-year period. This study identifies important factors that predict the choice of CRT device offered to patients in the United States.

MAGNETO cardiography parameters to predict future Sudden Cardiac Death (MAGNETO-SCD) or ventricular events from implantable cardioverter defibrillators: study protocol, design and rationale.

INTRODUCTION: Predicting sudden cardiac death (SCD) is challenging as current risk predictors have significant limitations. Evaluating magnetocardiogram (MCG) parameters could be of great value and we plan to assess the capability of a new mobile unshielded MCG device in predicting SCD and ventricular arrhythmias (VA) in patients undergoing implantable cardioverter defibrillator (ICD) implantation. METHODS AND ANALYSIS: A prospective multicentre (University Hospitals Coventry and Warwickshire (UHCW) National Health Service (NHS) Trust/University Hospital North Midlands NHS Trust, UK) observational study evaluating the VitalScan MCG (Creavo Medical Technologies, UK) to predict future VA risk; 270 patients meeting criteria for primary or secondary prevention ICDs (ischaemic or non-ischaemic aetiology) are being recruited. The first patient was recruited September 2019 and the study will be completed at final participant follow-up. The primary endpoint is appropriate ICD therapy for VA, secondary endpoint is SCD. Previous trials using MCG identified late QRS signals/QRS fragmentation as potential indicators of SCD in small samples using large shielded expensive MCG devices that were difficult to use clinically. It is hoped the MAGNETO-SCD trial will show this new MCG device can provide real world risk stratification for SCD/VA risk. The trial has recruited 25 patients (13 with secondary prevention indication) from a single site (UHCW) with recruitment starting at the second site in March 2020. ETHICS AND DISSEMINATION: Research Ethics Committee, Yorkshire and Humber Sheffield Research Ethics Committee UK (Ref: 19/YH/0143) and Health Research Authority (IRAS reference 254466, EDGE ID: 123146) approval received on 17/07/2019. The Medicines and Healthcare products Regulatory Agency approval received 11/07/2019. Results will be disseminated via a peer-reviewed publication and presentation at international conferences. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov Registry (NCT04352816) and EU Clinical Trials Registry (EudraCT2019-002994-78).

Do all patients with implantable cardioverter defibrillator need a generator change? A health service evaluation of patients who underwent generator changes from a single tertiary center.

BACKGROUND: The patient characteristics, therapy received and outcomes after one or more implantable cardioverter defibrillator (ICD) generator changes from contemporary practice is not well known. METHODS: We conducted a health service evaluation of patients who underwent ICD implantation and generator change. Patients who had generator changes from February 2016 to October 2019 were identified from our database and electronic records were reviewed for patient characteristics, number of generator changes, receipt of therapy and death. RESULTS: Our database included 88 patients with a generator change. A total of 22 patients (25.0%) received dual chamber ICD, 10 patients (11.4%) received single chamber ICD, 54 patients (61.3%) received cardiac resynchronization therapy defibrillator and 2 patients (2.3%) received subcutaneous ICD. A second generator change occurred in 18 patients and a third generator changes was performed in 6 patients. There were 29 deaths and a follow up period of 9.4 ± 2.9 years. From implant to initial generator change 39 patients had appropriate antitachycardia pacing (ATP), 6 patient had inappropriate ATP, 29 patients had appropriate shocks and 5 patients had an inappropriate shock. Between the 1st and 2nd generator change and the 2nd and 3rd there were no cases of inappropriate ATP or shock. Overall, 42 patients out of the 88 had appropriate therapy (47.7%) and 7 patients had inappropriate therapy (8.0%). CONCLUSIONS: Most patients with ICDs do not receive therapy and a minority have inappropriate therapy which typically occur before the first generator change as we observed no inappropriate therapy beyond the first generator change.

Prevalence and in-hospital outcomes of patients with malignancies undergoing de novo cardiac electronic device implantation in the USA.

AIMS: To study the outcomes of cancer patients undergoing cardiac implantable electronic device (CIED) implantation. METHODS AND RESULTS: De novo CIED implantations (2004-15; n = 2 670 590) from the National Inpatient Sample were analysed for characteristics and in-hospital outcomes, stratified by presence of cancer (no cancer, historical and current cancers) and further by current cancer type (haematological, lung, breast, colon, and prostate). Current and historical cancer prevalence has increased from 3.3% to 7.8%, and 5.8% to 7.8%, respectively, between 2004 and 2015. Current cancer was associated with increased adjusted odds ratio (OR) of major adverse cardiovascular events (MACE) [composite of all-cause mortality, thoracic and cardiac complications, and device-related infection; OR 1.26, 95% confidence interval (CI) 1.23-1.30], all-cause mortality (OR 1.43, 95% CI 1.35-1.50), major bleeding (OR 1.38, 95% CI 1.32-1.44), and thoracic complications (OR 1.39, 95% CI 1.35-1.43). Differences in outcomes were observed according to cancer type, with significantly worse MACE, mortality and thoracic complications with lung and haematological malignancies, and increased major bleeding in colon and prostate malignancies. The risk of complications was also different according to CIED subtype. CONCLUSION: The prevalence of cancer patients amongst those undergoing CIED implantation has significantly increased over 12 years. Overall, current cancers are associated with increased mortality and worse outcomes, especially in patients with lung, haematological, and colon malignancies whereas there was no evidence that historical cancer had a negative impact on outcomes.

A validation study of intraoperative performance metrics for training novice cardiac resynchronization therapy implanters.

AIMS: Pacing/cardiac resynchronization therapy (CRT) implant training currently lacks a common system to objectively assess trainee ability to perform required tasks at predetermined performance levels. The purpose of this study was to primarily examine construct validity and reliability, secondarily discriminative validity of novel intraoperative performance metrics, developed for a reference approach to training novice CRT implanters. METHODS: Fifteen novice and eleven experienced CRT implanters performed a 3-lead implant procedure on a virtual reality simulator. Performances were video-recorded, then independently scored using predefined metrics endorsed by an international panel of experts. First, Novice and Experienced group scores were compared for steps completed and errors made. Secondly, each group was split in two around the median score of the group and subgroup scores were compared. RESULTS: The mean number of scored metrics per performance was 108 and the inter-rater reliability for scoring was 0.947. Compared with novices, experienced implanters completed more procedural Steps correctly (mean 87% vs. 73%, p = 0.001), made fewer procedural Errors (6.3 vs. 11.2, p = 0.005), Critical Errors (1.8 vs. 4.4, p = 0.004), and total errors (8.1 vs. 15.6, p = 0.002). Furthermore, the differences between the two Novice subgroups were 25% for steps completed correctly and 94% for total errors made (p < 0.001); the differences between the two Experienced subgroups were respectively 16% and 191% (p < 0.001). CONCLUSIONS: The procedure metrics used in this study reliably distinguish novice and experienced CRT implanters' performances. The metrics further differentiated performance levels within a group with similar experience. These performance metrics will underpin quality-assured novice implanter training.

Unplanned hospital readmissions after acute myocardial infarction: a nationwide analysis of rates, trends, predictors and causes in the United States between 2010 and 2014.

BACKGROUND: Unplanned hospital readmissions are an important quality metric for benchmarking, but there are limited data following an acute myocardial infarction (AMI). This study aims to examine the 30-day unplanned readmission rate, predictors, causes and outcomes after hospitalization for AMI. METHODS: The USA Nationwide Readmission Database was utilized to analyze patients with a primary diagnosis of AMI between 2010 and 2014. Rates of readmissions, causes and costs were determined and multiple logistic regressions were used to identify predictors of readmissions. RESULTS: Of 2 204 104 patients with AMI, the 30-day unplanned readmission rate was 12.3% (n = 270 510), which changed from 13.0 to 11.5% between 2010 and 2014. The estimated impact of readmissions in AMI was ~718 million USD and ~281000 additional bed days per year. Comorbidities such as diabetes [odds ratio (OR) 1.27, 95% confidence interval (CI) 1.25-1.29], chronic lung disease (OR 1.29, 95% CI 1.26-1.31), renal failure (OR 1.38, 95% CI 1.35-1.40) and cancer (OR 1.35, 95% CI 1.30-1.41) were independently associated with unplanned readmission. Discharge against medical advice was the variable most strongly associated with unplanned readmission (OR 2.40, 95% CI 2.27-2.54). Noncardiac causes for readmissions accounted for 52.9% of all readmissions. The most common cause of cardiac readmission was heart failure (14.3%) and for noncardiac readmissions was infections (8.8%). CONCLUSION: Readmissions during the first month after AMI occur in more than one in 10 patients resulting in a healthcare cost of ~718 million USD per year and ~281000 additional bed days per year. These findings have important public health implications. Strategies to identify and reduce readmissions in AMI will dramatically reduce healthcare costs for society.