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1.
Int J Cardiol ; 328: 247-249, 2021 04 01.
Article in English | MEDLINE | ID: mdl-33278416

ABSTRACT

BACKGROUND: Remote monitoring (RM) technology embedded in cardiac rhythm devices permits continuous monitoring of device function, and recording of selected cardiac physiological parameters and cardiac arrhythmias and may be of utmost utility during Coronavirus (COVID-19) pandemic, when in-person office visit for regular follow-up were postponed. However, patients not alredy followed-up via RM represent a challenging group of patients to be managed during the lockdown. METHODS: We reviewed patient files scheduled for an outpatient visit between January 1, 2020 and May 11th, 2020 to assess the proportion of patients in whom RM activation was possible without office visit, and compared them to those scheduled for visit before the lockdown. RESULTS: During COVID-19 pandemic, RM activation was feasible in a minority of patients (7.8% of patients) expected at outpatient clinic for a follow-up visit and device check-up. This was possible in a good proportion of complex implantable devices such as cardiac resynchronization therapy and implantable cardioverter defibrillator but only in a minority of patients with a pacemaker the RM function could be activated during the period of restricted access to hospital. CONCLUSIONS: Our experience strongly suggest to consider the systematic activation of RM function at the time of implantation or - by default programming - in all cardiac rhythm management devices.


Subject(s)
Arrhythmias, Cardiac/therapy , COVID-19/prevention & control , Cardiac Resynchronization Therapy Devices/standards , Defibrillators, Implantable/standards , Remote Sensing Technology/standards , Aged , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/epidemiology , COVID-19/epidemiology , Cardiac Resynchronization Therapy Devices/trends , Communicable Disease Control/standards , Communicable Disease Control/trends , Defibrillators, Implantable/trends , Female , Follow-Up Studies , Humans , Male , Pandemics/prevention & control , Remote Sensing Technology/trends
3.
J Cardiovasc Med (Hagerstown) ; 21(9): 634-640, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32740496

ABSTRACT

AIM: Adherence to guidelines was not homogeneous in Europe, according to the survey on cardiac resynchronization therapy conducted in 2008-2009. The aim of our study was to compare the results in the Italian and European cohorts of the Second European Cardiac Resynchronization Therapy Survey. METHODS: Patients' characteristics, procedural data and follow-up were collected. Italian records were compared with European countries. RESULTS: Italian hospitals enrolled 526 patients. The italian cohort was older (71.6 ±â€Š9.5 vs. 68.4 ±â€Š10.8; P < 0.00001), had less severe NYHA class (>II 47.2 vs. 59.6%; P < 0.00001), higher ejection fraction (30.3 ±â€Š7.4 vs. 28.4 ±â€Š8.2%; P < 0.00001), and less atrial fibrillation prevalence (34.4 vs. 41.2%; P = 0.00197) than the European cohort. Italian patients were more frequently hospitalized for heart failure in the previous year (51.9 vs. 46.2%; P = 0.01118) and had lower mean QRS duration (151 ±â€Š26 vs. 157 ±â€Š27 ms; P < 0.0001). CRT-D were more often implanted in Italian patients (79.3 vs. 69.3%; P < 0.00001). The complication rate was similar (4.6% vs. 5.6%; ns). The rate of use of ACEi/ARBs in Italy was lower than in Europe (77.2 vs. 86.9%; P < 0.00001). Patients were followed up in the implantation centre (92.1 vs. 86%; P = 0.00014), but rarely with remote monitoring (25.9 vs. 30%; P = 0.04792). CONCLUSION: The survey demonstrates important similarities as well as substantial differences regarding most of the aspects evaluated. Efforts to implement adherence to guidelines will be endorsed in Italy.


Subject(s)
Cardiac Resynchronization Therapy Devices/trends , Cardiac Resynchronization Therapy/trends , Cardiologists/trends , Heart Failure/therapy , Practice Patterns, Physicians'/trends , Aged , Aged, 80 and over , Cardiac Resynchronization Therapy/adverse effects , Female , Guideline Adherence/trends , Health Care Surveys , Healthcare Disparities/trends , Heart Failure/diagnosis , Heart Failure/epidemiology , Heart Failure/physiopathology , Humans , Italy/epidemiology , Male , Middle Aged , Practice Guidelines as Topic , Time Factors , Treatment Outcome
4.
J Cardiovasc Med (Hagerstown) ; 21(4): 305-314, 2020 Apr.
Article in English | MEDLINE | ID: mdl-32073430

ABSTRACT

AIMS: The aim of this study was to evaluate the use of remote monitoring in Italian clinical practice and its trend over the last 5 years. METHODS: In 2012 and 2017, two surveys were conducted. Both were open to all Italian implanting centres and consisted of 25 questions on the characteristics of the centre, their actual use of remote monitoring, applied organizational models and administrative and legal aspects. RESULTS: The questionnaires were completed by 132 and 108 centres in 2012 and 2017, respectively (30.6 and 24.7% of all Italian implanting centres). In 2017, significantly fewer centres followed up fewer than 200 patients by remote monitoring than in 2012, while more followed up more than 500 patients (all P < 0.005). In most of the centres (77.6%) that responded to both surveys, the number of patients remotely monitored significantly increased from 2012 to 2017.In both surveys, remote monitoring was usually managed by physicians and nurses. Over the period, primary review of transmissions by physicians declined, while it was increasingly performed by nurses; the involvement of technicians rose, while that of manufacturers' technical personnel decreased. The percentage of centres in which transmissions were submitted to the physician only in critical cases rose (from 28.3 to 64.3%; P < 0.001). In 86.7% of centres, the lack of a reimbursement system was deemed the main barrier to implementing remote monitoring. CONCLUSION: In the last 5 years, the number of patients followed up by remote monitoring has increased markedly. In most Italian centres, remote monitoring has increasingly been managed through a primary nursing model. The lack of a specific reimbursement system is perceived as the main barrier to implementing remote monitoring .


Subject(s)
Defibrillators, Implantable/trends , Pacemaker, Artificial/trends , Practice Patterns, Nurses'/trends , Practice Patterns, Physicians'/trends , Remote Sensing Technology/trends , Telemedicine/trends , Cardiac Resynchronization Therapy Devices/trends , Health Care Surveys , Humans , Informed Consent , Insurance, Health, Reimbursement/trends , Italy , Practice Patterns, Nurses'/economics , Practice Patterns, Physicians'/economics , Prosthesis Failure , Remote Sensing Technology/economics , Remote Sensing Technology/instrumentation , Telemedicine/instrumentation , Time Factors
5.
Scand Cardiovasc J ; 54(4): 239-247, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32054352

ABSTRACT

Objectives: To investigate cardiac implantable electrical device (CIED) first implants in patients with hypertrophic cardiomyopathy (HCM) in a Swedish tertiary university hospital. Design: Clinical and technical data on pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) first implants performed in HCM patients at the Karolinska University Hospital from 2005 to 2016 were extracted from the Swedish Pacemaker and ICD Registry. Echocardiographic data were obtained by review of hospital recordings. Results: The number of first pacemaker implants in HCM patients was 70 (1.5% of total pacemaker implants). The mean age of HCM pacemaker patients was 71 ± 10 years. Pacemaker implants were almost uniformly distributed between genders. Dual-chamber pacemakers with or without CRT properties were prevalent (6 and 93%, respectively). The number of first ICD implants in HCM patients was 99 (5.1% of total ICD implants). HCM patients receiving an ICD were 53 ± 15 years and prevalently men (70%). Sixty-five (66%) patients were implanted for primary prevention. Dual-chamber ICDs with or without CRT were 21 and 65%, respectively. Obstructive HCM was present in 47% pacemaker patients and 25% ICD patients with available pre-implant echo. Conclusions: This retrospective registry-based study provides a picture of CIED first implants in HCM patients in a Swedish tertiary university hospital. ICDs were the most commonly implanted devices, covering 59% of CIED implants. HCM patients receiving a pacemaker or an ICD had different epidemiological and clinical profiles.


Subject(s)
Cardiac Pacing, Artificial/trends , Cardiomyopathy, Hypertrophic/therapy , Defibrillators, Implantable/trends , Electric Countershock/trends , Pacemaker, Artificial/trends , Practice Patterns, Physicians'/trends , Adult , Aged , Aged, 80 and over , Cardiac Resynchronization Therapy/trends , Cardiac Resynchronization Therapy Devices/trends , Cardiomyopathy, Hypertrophic/diagnostic imaging , Cardiomyopathy, Hypertrophic/epidemiology , Electric Countershock/instrumentation , Female , Hospitals, University/trends , Humans , Male , Middle Aged , Registries , Retrospective Studies , Sweden/epidemiology , Tertiary Care Centers/trends , Time Factors , Treatment Outcome
6.
Arch Cardiovasc Dis ; 112(11): 713-722, 2019 Nov.
Article in English | MEDLINE | ID: mdl-31706879

ABSTRACT

BACKGROUND: The first European Cardiac Resynchronization Therapy (CRT) Survey, conducted in 2008-2009, showed considerable variations in guideline adherence and implantation practice. A second prospective survey (CRT Survey II) was then performed to describe contemporary clinical practice regarding CRT among 42 European countries. AIM: To compare the characteristics of French CRT recipients with the overall European population of CRT Survey II. METHODS: Demographic and procedural data from French centres recruiting all consecutive patients undergoing either de novo CRT implantation or an upgrade to a CRT system were collected and compared with data from the European population. RESULTS: A total of 11,088 patients were enrolled in CRT Survey II, 754 of whom were recruited in France. French patients were older (44.7% aged≥75 years vs 31.1% in the European group), had less severe heart failure symptoms, a higher baseline left ventricular ejection fraction and fewer co-morbidities. Additionally, French patients had a shorter intrinsic QRS duration (19.1% had a QRS<130ms vs 12.3% in the European cohort). Successful implantation rates were similar, but procedural and fluoroscopy times were shorter in France. French patients were more likely to receive a CRT pacemaker than European patients overall. Of note, antibiotic prophylaxis was reported to be administered less frequently in France, and a higher rate of early device-related infection was observed. Importantly, French patients were less likely to receive optimal drugs for treating heart failure at hospital discharge. CONCLUSION: This study highlights contemporary clinical practice in France, and describes substantial differences in patient selection, implantation procedure and outcomes compared with the other European countries participating in CRT Survey II.


Subject(s)
Cardiac Resynchronization Therapy Devices/trends , Cardiac Resynchronization Therapy/trends , Healthcare Disparities/trends , Heart Failure/therapy , Practice Patterns, Physicians'/trends , Aged , Aged, 80 and over , Cardiac Resynchronization Therapy/adverse effects , Comorbidity , Europe , Female , Health Care Surveys , Heart Failure/diagnosis , Heart Failure/physiopathology , Humans , Male , Middle Aged , Patient Selection , Recovery of Function , Stroke Volume , Time Factors , Treatment Outcome , Ventricular Function, Left
7.
Int J Cardiol ; 293: 109-114, 2019 10 15.
Article in English | MEDLINE | ID: mdl-31147194

ABSTRACT

BACKGROUND: Cardiac Resynchronization Therapy Defibrillator (CRT-D) has been one of the most important therapies for patients with cardiomyopathy over the last decades. Cardiac perforation occurs infrequently but can be fatal. The occurrence of cardiac perforation after CRT-D implantation has not been studied well. The aim of study is to investigate the occurrence, mortality and predictors of cardiac perforation in patients receiving CRT-D during the index hospitalization. METHODS: Data were obtained from the National Inpatient Sample, the largest all-player inpatient dataset in the United States. Patients who received CRT-D from 2002 to 2012 were identified using ICD-9 codes. Multivariate analyses were used to identify predictors of cardiac perforation. Complications including in-hospital death and cardiac perforation were identified using ICD-9 codes. RESULTS: A total of 77,827 patients with CRT-D implantation were included into our analysis. After the CRT-D implantation, the in-hospital and rate of cardiac perforation was between 0.24 and 0.48% and had increased significantly (p = 0.02). Although occurrence of cardiac perforation is rare (0.32%), the mortality was 10.6% among those patients with cardiac perforation. In Multivariate analysis identified female as independent risk factors for cardiac perforation (OR: 2.628, 95% CI 1.926-3.585, p < 0.0001). CONCLUSION: Despite rapid progress of the tools and skills for CRT-D implantation, the occurrence of cardiac perforation has not improved. While cardiac perforation is rare, it carries the highest rate of mortality, especially in female patients. Implanting physicians should be familiar with the comorbidities and patient demographics that put them at a higher risk for complications.


Subject(s)
Cardiac Resynchronization Therapy Devices/adverse effects , Cardiac Resynchronization Therapy/adverse effects , Cardiac Resynchronization Therapy/mortality , Heart Injuries/mortality , Postoperative Complications/mortality , Registries , Adolescent , Adult , Aged , Aged, 80 and over , Cardiac Resynchronization Therapy/trends , Cardiac Resynchronization Therapy Devices/trends , Databases, Factual/trends , Female , Heart Injuries/diagnosis , Heart Injuries/etiology , Humans , Male , Middle Aged , Mortality/trends , Postoperative Complications/diagnosis , Postoperative Complications/etiology , Predictive Value of Tests , United States/epidemiology , Young Adult
8.
Scand Cardiovasc J ; 53(1): 9-13, 2019 02.
Article in English | MEDLINE | ID: mdl-30761919

ABSTRACT

OBJECTIVES: To compare the contemporary practice of CRT implantation in Scandinavia and Europe. DESIGN: We used data from The European CRT Survey II to highlight similarities and differences in the practice of CRT implantation between Europe (EUR) and Scandinavia (SCAND) and between the Scandinavian countries Denmark, Norway and Sweden. Implant data from the national pacemaker registries were used to calculate coverage. RESULTS: The coverage was 24% in SCAND and 11% in EUR. SCAND patients were more often referred from another centre and follow-up was less often to be performed at the operating centre. Telemonitoring was more commonly used. More patients had AV-block or pacemaker dependency/expected high RV pacing percentage as indication for CRT. A CRT-P was more commonly used, and ischaemic aetiology was slightly less common. Echocardiography was more often used to determine LVEF, as well as occlusive venography and placing the RV lead first. In DK implanters tended to choose a septal RV position. Quadripolar leads were more often and a test shock less often used. The paced QRS duration was slightly longer and the narrowing of QRS with CRT more limited. Procedure times and preoperative LVEF were similar. CONCLUSIONS: In Scandinavia AV-conduction disturbance and/or a ventricular pacing indication was a more common indication for CRT, suggesting adaptation of the most recent guidelines ahead of their publication. A test shock was almost never performed, in agreement with recent scientific evidence. CRT-P was more often used, the procedures seem more centralized and quadripolar leads were preferred.


Subject(s)
Arrhythmias, Cardiac/therapy , Cardiac Resynchronization Therapy Devices/trends , Cardiac Resynchronization Therapy/trends , Heart Failure/therapy , Outcome and Process Assessment, Health Care/trends , Practice Patterns, Physicians'/trends , Aged , Aged, 80 and over , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/physiopathology , Benchmarking/trends , Clinical Decision-Making , Female , Guideline Adherence/trends , Health Care Surveys , Heart Failure/diagnosis , Heart Failure/physiopathology , Humans , Male , Middle Aged , Practice Guidelines as Topic , Registries , Scandinavian and Nordic Countries , Treatment Outcome
9.
Int J Cardiol ; 277: 173-177, 2019 Feb 15.
Article in English | MEDLINE | ID: mdl-30409733

ABSTRACT

BACKGROUND: A significant proportion of patients receiving CRT are non-responders. We evaluated the efficacy of Cardiac Contractility Modulation in subjects with reduced LVEF who, despite cardiac resynchronization therapy (CRT), continued to experience clinically significant symptoms. METHODS: This was a multi-center, open label, treatment-only, feasibility study of 17 CRT non-responders who received CCM therapy. Changes in NYHA class, ejection fraction (EF), Minnesota Living with Heart Failure Questionnaire (MLWHFQ) score, and exercise tolerance (6 minute walk test; 6MWT and peak VO2) were analyzed over 6 months. Mortality and hospitalization rates were determined. RESULTS: Patients (82% male) were 69.4 ±â€¯9.6 years of age with baseline EF = 22.8 ±â€¯6.5%. Among primary endpoints, peak VO2 increased 1.1 ±â€¯1.6 ml/kg/min (p = 0.03) and MLWHFQ improved (-16 ±â€¯16 points; p < 0.01). Mean NYHA class improved (-0.33 ±â€¯0.49; p = 0.02), 6MWT increased (52 ±â€¯60 m; p < 0.01), while EF trended up (2.9 ±â€¯5.8%; p = 0.08) at 6 months. During the 6-month follow-up period, there were 18 hospitalizations in 9 subjects and 2 patients died. CONCLUSIONS: Patients with heart failure and reduced ejection fraction who remain moderately to severely symptomatic despite use of CRT, may benefit from CCM therapy with improvement in quality of life and exercise tolerance. A larger prospective study in this population is warranted.


Subject(s)
Cardiac Resynchronization Therapy Devices/trends , Cardiac Resynchronization Therapy/methods , Cardiac Resynchronization Therapy/trends , Heart Failure/physiopathology , Heart Failure/therapy , Myocardial Contraction/physiology , Aged , Feasibility Studies , Female , Heart Failure/mortality , Humans , Male , Middle Aged , Mortality/trends , Stroke Volume/physiology , Treatment Outcome
10.
Heart Fail Clin ; 15(1): 109-125, 2019 Jan.
Article in English | MEDLINE | ID: mdl-30449374

ABSTRACT

Implantable cardioverter-defibrillator and cardiac resynchronization therapy devices have been prescribed for patients with heart failure for several decades. Factors leading to increased usage include significant enhancements in technology and availability of multiple randomized clinical trials demonstrating their benefit with improved implementation of evidence-based guidelines. Despite these advances, gaps still exist in the utilization and referral of these devices, particularly among women. This article reviews the literature on these devices with a focus on gender differences and proposes reasons for why they exist.


Subject(s)
Cardiac Resynchronization Therapy Devices , Defibrillators, Implantable , Heart Failure/therapy , Procedures and Techniques Utilization , Referral and Consultation , Cardiac Resynchronization Therapy Devices/classification , Cardiac Resynchronization Therapy Devices/trends , Female , Humans , Male , Needs Assessment , Sex Factors
11.
Circ Cardiovasc Qual Outcomes ; 11(12): e004763, 2018 12.
Article in English | MEDLINE | ID: mdl-30562069

ABSTRACT

BACKGROUND: Little is known about real-world facility-level preferences for cardiac resynchronization therapy devices with (CRT-D) and without (CRT-P) defibrillator backup. We quantify this variation at the facility level and exploit this variation to compare outcomes of patients receiving these 2 devices. METHODS AND RESULTS: Claims data from fee-for-service Medicare beneficiaries were used to identify new CRT-P and CRT-D implants, 2006 to 2012. We modeled factors associated with receipt of each device, and compared mortality, hospitalizations, and reoperations for patients receiving each using both logistic regression and instrumental variable analysis to account for confounding. Among 71 459 device recipients (CRT-P, 11 925; CRT-D, 59 534; 31% women), CRT-P recipients were older, more likely to be women, and had more comorbidities. Variation in device selection among facilities was substantial: After adjustment for patient characteristics, the odds of receiving a CRT-P (versus CRT-D) device were 7.6× higher for a patient treated at a facility in the highest CRT-P use quartile versus a facility in the lowest CRT-P use quartile. Logistic modeling suggested a survival advantage for CRT-D devices but with falsification end points indicating residual confounding. By contrast, in the instrumental variable analysis using facility variability as the proposed instrument, clinical characteristics and falsification end points were well balanced, and 1-year mortality in patients who received CRT-P versus CRT-D implants did not differ, while CRT-P patients had a lower probability of hospitalizations and reoperations in the year following implant. CONCLUSIONS: CRT-P versus CRT-D selection varies substantially among facilities, adjusted for clinical factors. After instrumental variable adjustment for clinical covariates and facility preference, survival was no different between the devices. Therefore, CRT-P may be preferred for Medicare beneficiaries considering new CRT implantation.


Subject(s)
Cardiac Resynchronization Therapy Devices/trends , Cardiac Resynchronization Therapy/trends , Defibrillators, Implantable/trends , Electric Countershock/trends , Healthcare Disparities/trends , Heart Failure/therapy , Outcome and Process Assessment, Health Care/trends , Practice Patterns, Physicians'/trends , Administrative Claims, Healthcare , Aged , Aged, 80 and over , Cardiac Resynchronization Therapy/adverse effects , Cardiac Resynchronization Therapy/mortality , Clinical Decision-Making , Databases, Factual , Electric Countershock/adverse effects , Electric Countershock/instrumentation , Electric Countershock/mortality , Female , Heart Failure/diagnosis , Heart Failure/mortality , Heart Failure/physiopathology , Humans , Male , Medicare , Patient Selection , Risk Factors , Time Factors , Treatment Outcome , United States
12.
J Am Heart Assoc ; 7(15): e008775, 2018 08 07.
Article in English | MEDLINE | ID: mdl-30371225

ABSTRACT

Background This study assessed trends in heart failure ( HF) hospitalizations and health resource use in patients with adult congenital heart disease ( ACHD ). Methods and Results The Nationwide Inpatient Sample was used to compare ACHD with non- ACHD HF hospitalization and health resource trends. Health resource use was assessed using total hospital charges, hospital length of stay, and procedural burden. A total of 87 175±2676 ACHD -related HF hospitalizations occurred between 1998 and 2011. During this time, ACHD HF hospitalizations increased 91% (4620±438-8809±740, P<0.0001) versus a 21% increase in non- ACHD HF hospitalizations ( P=0.003). ACHD HF hospitalization was associated with longer length of stay ( ACHD HF versus non- ACHD HF, 7.2±0.09 versus 6.8±0.02 days; P<0.0001), greater procedural burden, and higher charges ($81 332±$1650 versus $52 050±$379; P<0.0001). ACHD HF hospitalization charges increased 258% during the study period ($26 533±$1816 in 1998 versus $94 887±$8310 in 2011; P=0.0002), more than double that for non- ACHD HF ( P=0.04). Patients with ACHD HF hospitalized in high-volume ACHD centers versus others were more likely to undergo invasive hemodynamic testing (30.2±0.6% versus 20.7±0.5%; P<0.0001) and to receive cardiac resynchronization/defibrillator devices (4.7±0.3% versus 1.8±0.2%; P<0.0001) and mechanical circulatory support (3.9±0.2% versus 2.4±0.2%; P<0.0001). Conclusions ACHD -related HF hospitalizations have increased dramatically in recent years and are associated with disproportionately higher costs, procedural burden, and health resource use.


Subject(s)
Health Services/trends , Heart Defects, Congenital/therapy , Heart Failure/therapy , Hospitalization/trends , Adolescent , Adult , Aged , Cardiac Resynchronization Therapy Devices/trends , Defibrillators, Implantable/trends , Ebstein Anomaly , Female , Health Resources/trends , Heart Defects, Congenital/complications , Heart Defects, Congenital/etiology , Heart Failure/economics , Heart Failure/etiology , Heart Septal Defects , Hospital Charges/trends , Humans , Length of Stay/trends , Male , Middle Aged , Tetralogy of Fallot , Transposition of Great Vessels , United States , Young Adult
13.
Int Heart J ; 59(5): 1002-1007, 2018 Sep 26.
Article in English | MEDLINE | ID: mdl-30158380

ABSTRACT

Several studies have reported that the left ventricular (LV) lead implant success rate ranges between 88.0% and 92.4%. Coronary venous anatomy differs among patients thus, necessitating multiple types of leads. To date, the implant success rate among Japanese patients utilizing a pre-specified family LV leads (including bipolar and quadripolar) is not well known. The Attain Success Japan Study enrolled patients indicated for a de novo or an upgrade cardiac resynchronization therapy implant. Patients were followed for 3 months, and the implant success rates with Medtronic Attain family LV leads as well as the incidence of complications related to the LV lead were evaluated.Three hundred 53 patients were enrolled from 29 sites in Japan; 346 patients had LV lead implant attempts. The LV lead was successfully implanted in 336 patients (97.1%). Bipolar and quadripolar LV lead implants were successful in 97.2% and 99.2% of patients, respectively (P = 0.43). Four complications (1.2%) related to the LV leads were reported; all of which occurred in patients receiving bipolar LV leads. The quadripolar LV leads were more frequently implanted in the apical segment compared with bipolar leads (21.6% versus 3.8%, P < 0.01). This study demonstrated a high implant success rate and a low LV lead-related complication rate, regardless of bipolar, or quadripolar in a Japanese cohort of patients.


Subject(s)
Cardiac Resynchronization Therapy Devices/trends , Cardiac Resynchronization Therapy/adverse effects , Heart Ventricles/physiopathology , Aftercare , Aged , Aged, 80 and over , Cardiac Resynchronization Therapy/statistics & numerical data , Cardiac Resynchronization Therapy Devices/statistics & numerical data , Coronary Circulation/physiology , Equipment Design/adverse effects , Equipment Design/statistics & numerical data , Female , Heart Ventricles/surgery , Humans , Japan/epidemiology , Male , Middle Aged , Prospective Studies
14.
J Cardiovasc Electrophysiol ; 29(10): 1425-1435, 2018 10.
Article in English | MEDLINE | ID: mdl-30016005

ABSTRACT

BACKGROUND: The utilization of cardiac resynchronization therapy defibrillator (CRT-D) has increased significantly, since its initial approval for use in selected patients with heart failure. Limited data exist as for current trends in implant-related in-hospital complications and cost utilization. The aim of our study was to examine in-hospital complication rates associated with CRT-D and their trends over the last decade. METHODS AND RESULTS: Using the Nationwide Inpatient Sample, we estimated 378 248 CRT-D procedures from 2003 to 2012. We investigated common complications, including mechanical, cardiovascular, pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with CRT-D, defining them by the validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. Mechanical complications (5.9%) were the commonest, followed by cardiovascular (3.6%), respiratory failure (2.4%), and pneumothorax (1.5%). Age (≥65 years), female gender (OR, 95% CI; P value) (1.08, 1.03-1.13; 0.001), and the Charlson score ≥3 (1.52, 1.45-1.60; <0.001) were significantly associated with increased mortality/complications. CONCLUSIONS: The overall complication rate in patients undergoing CRT-D has been increasing in the last decade. Age (≥65), female sex, and the Charlson score ≥3 were associated with higher complications. In patients who underwent CRT-D implantation, postoperative complications were associated with significant increases in cost.


Subject(s)
Cardiac Resynchronization Therapy Devices/economics , Cardiac Resynchronization Therapy/economics , Defibrillators, Implantable/economics , Electric Countershock/economics , Heart Failure/economics , Heart Failure/therapy , Hospital Costs , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , Cardiac Resynchronization Therapy/adverse effects , Cardiac Resynchronization Therapy/mortality , Cardiac Resynchronization Therapy/trends , Cardiac Resynchronization Therapy Devices/trends , Comorbidity , Databases, Factual , Defibrillators, Implantable/trends , Electric Countershock/adverse effects , Electric Countershock/mortality , Electric Countershock/trends , Female , Heart Failure/diagnosis , Heart Failure/mortality , Hospital Costs/trends , Hospital Mortality , Humans , Length of Stay/economics , Male , Middle Aged , Risk Assessment , Risk Factors , Sex Factors , Time Factors , Treatment Outcome , United States/epidemiology , Young Adult
15.
Int J Cardiol ; 272: 137-141, 2018 Dec 01.
Article in English | MEDLINE | ID: mdl-30045818

ABSTRACT

INTRODUCTION: Cardiac tamponade is a severe complication of cardiac resynchronization therapy (CRT) implantations. We provide a contemporary large-scale study evaluating the incident trends, predictors and impact of cardiac tamponade in patients undergoing CRT. METHOD: Data were obtained from the Nationwide Inpatient Sample (NIS) of 2007 through 2014. Trends in the annual rates of tamponades in CRT implantation were assessed using negative binomial regressions. Hierarchical mixed-effects logistic regression models were built to determine the independent predictors of tamponade in CRT implantation and 1:1 propensity-matched analysis performed to examine the impact of tamponade on outcomes. RESULT: An estimated 310,704 CRT implantations were performed in the United States between 2007 and 2014, out of which 536 patients (0.17%) developed procedure-related cardiac tamponade. A significant increasing trend in the tamponade incidence was observed over the 8-year study period [1.65 per 10,000 CRT implantation in 2007 to 38.16 in 2014 (p < 0.001)]. After multivariable adjustment, female sex and coagulation disorder were found to be independently associated with higher odds of tamponade. Conversely, prior history of CABG procedure was associated with lower odds of tamponade. CRT complicated with tamponade had significantly increased in-hospital mortality, bleeding requiring transfusion, prolonged hospital stay and increased cost. CONCLUSION: We found an increasing trend in the incidence of post CRT tamponade among hospitalized patients between 2007 and 2014. Female gender and coagulation disorder were associated with the development of tamponade among recipients of CRT. Risk stratification of patients who are undergoing CRT is crucial to improving outcome in CRT implantation.


Subject(s)
Cardiac Resynchronization Therapy Devices/adverse effects , Cardiac Resynchronization Therapy/adverse effects , Cardiac Tamponade/diagnosis , Cardiac Tamponade/epidemiology , Aged , Aged, 80 and over , Cardiac Resynchronization Therapy/trends , Cardiac Resynchronization Therapy Devices/trends , Databases, Factual/trends , Defibrillators, Implantable/adverse effects , Defibrillators, Implantable/trends , Female , Humans , Incidence , Male , Middle Aged , Treatment Outcome
16.
Clin Res Cardiol ; 107(Suppl 2): 100-104, 2018 Aug.
Article in English | MEDLINE | ID: mdl-29951805

ABSTRACT

Endocardial pacing has experienced a tremendous evolution since the 1960s. A lot of challenges associated with pacemaker and ICD devices have already been successfully targeted. However, a relevant number of problems have not been solved to date. Not all patients with accepted indication for biventricular pacing have benefited from cardiac resynchronisation therapy (CRT) despite extensive efforts to reduce the rate of non-responders. Current strategies to optimize lead position, multipolar left-ventricular (LV) pacing leads, new strategies to gain access to the left-ventricle (atrial transseptal or ventricular transseptal access) or alternative right-ventricular (septal, His bundle pacing) pacing sites, and "leadless" LV pacing have the potential to increase response to device-based heart-failure treatment. The opportunity of pacemaker and ICD remote monitoring led to relevant improvements in therapy management by timely detection of events requiring medical or invasive interventions (e.g., external cardioversion of atrial fibrillation, increasing effective biventricular pacing, catheter ablation of ventricular tachycardias, or changes in heart-failure medication). Two completely endocardial leadless "all-in-one" pacemaker systems recently became available. Besides these innovations, new "synergistic" therapy concepts combining catheter ablation and device therapy proved to affect clinical endpoints (e.g., ATAAC study and CASTLE-AF study).


Subject(s)
Cardiac Resynchronization Therapy Devices/trends , Disease Management , Heart Failure/therapy , Equipment Design , Humans
17.
Int J Cardiol ; 259: 88-93, 2018 05 15.
Article in English | MEDLINE | ID: mdl-29579617

ABSTRACT

OBJECTIVE: Cardiac resynchronisation therapy (CRT) is limited by a substantial proportion of non-responders. Left ventricular endocardial pacing (LVEP) may offer enhanced possibility to deliver CRT in patients with a failed attempt at implantation and to improve clinical status of CRT non-responders. METHODS: The ALternate Site Cardiac ResYNChronisation (ALSYNC) study was a prospective, multi-centre cohort study that included 118 CRT patients with a successfully implanted endocardial left ventricular (LV) lead, including 90 failed coronary sinus (CS) implants and 28 prior non-responders who had worsened or unchanged heart failure status after at least 6 months of optimal conventional CRT therapy. RESULTS: Patients were followed for 19 ±â€¯9 months. At baseline, prior non-responders were sicker as evidenced by a larger LV end-diastolic diameter (70 ±â€¯12 vs 65 ±â€¯9 mm, p = .03) and a trend towards larger LV end-systolic volume index (LVESVi, 95 ±â€¯51 vs 74 ±â€¯39 ml/m2, p = .07), and were more frequently anti-coagulated (96% vs 72%, p = .008) despite similar history of atrial fibrillation (54% vs 51%, p = .83). At 6 months, LVEP significantly improved LV ejection fraction (2.3 ±â€¯7.5 and 8.6 ±â€¯10.0%), New York Heart Association Class (0.4 ±â€¯0.9 and 0.7 ±â€¯0.8), LVESVi (9 ±â€¯16 and 18 ±â€¯43 ml/m2), and six-minute walk test (56 ±â€¯73 and 54 ±â€¯92 m) in prior non-responders and failed CS implants, relative to baseline (all p < .05), respectively. LVESVi reduction ≥15% was seen in 47% of the prior non-responder patients and 57% of failed CS patients. CONCLUSION: These data suggest that a sizable proportion of CRT non-responders can improve by LVEP, though to a lesser extent than failed CS implants. Clinical trial registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01277783.


Subject(s)
Cardiac Resynchronization Therapy Devices/trends , Cardiac Resynchronization Therapy/trends , Equipment Failure , Heart Failure/therapy , Stroke Volume/physiology , Ventricular Dysfunction, Left/therapy , Aged , Cardiac Resynchronization Therapy/standards , Cardiac Resynchronization Therapy Devices/standards , Cohort Studies , Female , Follow-Up Studies , Heart Failure/diagnostic imaging , Heart Failure/physiopathology , Humans , Male , Middle Aged , Prospective Studies , Treatment Outcome , Ventricular Dysfunction, Left/diagnostic imaging , Ventricular Dysfunction, Left/physiopathology
18.
Europace ; 20(4): 643-653, 2018 04 01.
Article in English | MEDLINE | ID: mdl-29016747

ABSTRACT

Aims: Common methodologies for analysis of analogous data sets are needed for international comparisons of treatment and outcomes. This study tests using administrative hospital discharge (HD) databases in five European countries to investigate variation/trends in pacemaker (PM) and implantable cardioverter defibrillator (ICD) implant rates in terms of patient characteristics/management, device subtype, and initial implantation vs. replacement, and compares findings with existing literature and European Heart Rhythm Association (EHRA) reports. Methods and results: HD databases from 2008 to 2012 in Austria, England, Germany, Italy and Slovenia were interrogated to extract admissions (without patient identification) associated with PM and ICD implants and replacements, using direct cross-referencing of procedure codes and common methodology to compare aggregate data. 1 338 199 records revealed 212 952 PM and 62 567 ICD procedures/year on average for a 204.4 million combined population, a crude implant rate of about 104/100 000 inhabitants for PMs and 30.6 for ICDs. The first implant/replacement rate ratios were 81/24 (PMs) and 25/7 (ICDs). Rates have increased, with cardiac resynchronization therapy (CRT) subtypes for both devices rising dramatically. Significant between- and within-country variation persists in lengths of stay and rates (Germany highest, Slovenia lowest). Adjusting for age lessened differences for PM rates, scarcely affected ICDs. Male/female ratios remained stable at 56/44% (PMs) and 79/21% (ICDs). About 90% of patients were discharged to home; 85-100% were inpatient admissions. Conclusion: To aid in policymaking and track outcomes, HD administrative data provides a reliable, relatively cheap, methodology for tracking implant rates for PMs and ICDs across countries, as comparisons to EHRA data and the literature indicated.


Subject(s)
Cardiac Pacing, Artificial/trends , Defibrillators, Implantable/trends , Electric Countershock/trends , Pacemaker, Artificial/trends , Practice Patterns, Physicians'/trends , Process Assessment, Health Care/trends , Adolescent , Adult , Aged , Cardiac Resynchronization Therapy/trends , Cardiac Resynchronization Therapy Devices/trends , Child , Child, Preschool , Databases, Factual , Europe/epidemiology , Female , Healthcare Disparities/trends , Humans , Infant , Infant, Newborn , Male , Middle Aged , Patient Discharge/trends , Quality Indicators, Health Care/trends , Time Factors , Young Adult
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