Giuseppe D'Ancona
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Previous Organizations / Institutes
The organizations / institutes from the scholar's other articles in the past ten years
Research Subjects
Research Interests
Giuseppe D'Ancona has a total of 140 co-authors. Here are the top co-authors by number of shared publications:
Hüseyin Ince
25 shared publicationsStephan Kische
Department of Cardiology, Vivantes Klinikum Am Urban and im Friedrichshain, Berlin, Germany
15 shared publicationsJasmin Ortak
Department of Cardiology, Vivantes Klinikum Am Urban and im Friedrichshain, Berlin, Germany
12 shared publicationsErdal Safak
Department of Cardiology, Vivantes Klinikum Am Urban and im Friedrichshain, Berlin, Germany and Rostock University, Rostock, Germany
9 shared publicationsAlper Öner
Department of Cardiology, Vivantes Klinikum Am Urban & im Friedrichshain, Berlin, Germany & Rostock University Medical Center, Rostock, Germany
5 shared publications- Alper Öner
Department of Cardiology, Rostock University Medical Center, Rostock, Germany
4 shared publications
Latest Publications
- Open Access
- 18 March 2026
- Published by Oxford University Press (OUP) in European Heart Journal - Case Reports
- Vol. 10 (5)
Troponin T/I discordance in immune checkpoint inhibitor myositis in a patient with ischaemic cardiac disease: a case report
Background: Immune checkpoint inhibitors (ICIs) are increasingly used in oncology and can cause immune-related adverse events, including cardiotoxicity. Discrepancies between cardiac troponin T (cTnT) and cardiac troponin I (cTnI) have been described in ICI-associated myositis with otherwise normal cardiac findings and may help differentiate myositis from myocarditis. In this case, cTnT elevation was first detected on routine troponin testing performed because myocarditis is a recognized immune-related adverse event of nivolumab, despite the absence of typical cardiac symptoms. Case summary: A 72-year-old man receiving nivolumab developed marked cTnT elevation. He was referred to cardiology for suspected ICI-related myocarditis. Cardiac MRI was unremarkable. Because of cardiovascular risk factors and unexplained troponinaemia, coronary angiography was performed and revealed an 80% stenosis of the LAD, which was treated with a drug-eluting stent. Post-intervention, cTnT continued to rise while cTnI remained normal on repeated measurements. Differential diagnoses included myositis, myocarditis, and in-stent thrombosis. Taken together, the clinical, imaging, and biomarker findings, in particular the troponin T/I discrepancy, made a cardiac cause of cTnT elevation unlikely. Immune-mediated myositis was confirmed, and mycophenolate mofetil therapy led to clinical and biochemical improvement. Conclusion: This case may expand current knowledge by showing that, in an ICI-treated patient, troponin T/I discrepancy may not only help differentiate myositis from myocarditis but also assist in distinguishing skeletal muscle involvement from other cardiac causes, including ACS and in-stent thrombosis. Recognition of this pattern may improve diagnostic accuracy and guide appropriate therapeutic strategies in oncological patients presenting with troponinaemia.
- 18 March 2026
- Published by Oxford University Press (OUP) in European Heart Journal - Case Reports
- Vol. 10 (5)
Open AccessTroponin T/I discordance in immune checkpoint inhibitor myositis in a patient with ischaemic cardiac disease: a case report
Background: Immune checkpoint inhibitors (ICIs) are increasingly used in oncology and can cause immune-related adverse events, including cardiotoxicity. Discrepancies between cardiac troponin T (cTnT) and cardiac troponin I (cTnI) have been described in ICI-associated myositis with otherwise normal cardiac findings and may help differentiate myositis from myocarditis. In this case, cTnT elevation was first detected on routine troponin testing performed because myocarditis is a recognized immune-related adverse event of nivolumab, despite the absence of typical cardiac symptoms. Case summary: A 72-year-old man receiving nivolumab developed marked cTnT elevation. He was referred to cardiology for suspected ICI-related myocarditis. Cardiac MRI was unremarkable. Because of cardiovascular risk factors and unexplained troponinaemia, coronary angiography was performed and revealed an 80% stenosis of the LAD, which was treated with a drug-eluting stent. Post-intervention, cTnT continued to rise while cTnI remained normal on repeated measurements. Differential diagnoses included myositis, myocarditis, and in-stent thrombosis. Taken together, the clinical, imaging, and biomarker findings, in particular the troponin T/I discrepancy, made a cardiac cause of cTnT elevation unlikely. Immune-mediated myositis was confirmed, and mycophenolate mofetil therapy led to clinical and biochemical improvement. Conclusion: This case may expand current knowledge by showing that, in an ICI-treated patient, troponin T/I discrepancy may not only help differentiate myositis from myocarditis but also assist in distinguishing skeletal muscle involvement from other cardiac causes, including ACS and in-stent thrombosis. Recognition of this pattern may improve diagnostic accuracy and guide appropriate therapeutic strategies in oncological patients presenting with troponinaemia.
- Open Access
- 1 January 2025
- Published by Wiley in Journal of Interventional Cardiology
- Vol. 2025 (1)
Determinants of Increased Transmitral Gradients Under Dynamic Isometric Handgrip Exercise After Edge‐to‐Edge Repair With the Fourth‐Generation MitraClip
Aim: Mitral regurgitation (MR) is a prevalent cardiovascular condition, and its treatment remains challenging, especially in high‐risk patients. The fourth‐generation MitraClip system (NTW and XTW) offers enhanced capabilities for repairing mitral valves (MVs) with complex anatomies. This study evaluates the haemodynamic function of MVs after edge‐to‐edge with wide MitraClip under physical stress induced by handgrip exercise stress echocardiography. Methods: This prospective study included 27 patients with severe MR. All patients underwent successful MitraClip implantation, and handgrip stress echocardiography was performed predischarge. The primary endpoint was a postprocedure mean transmitral gradient (TMG) < 5 mmHg under stress. A machine learning (ML) model using logistic regression as the learner and advanced data augmentation techniques, including random splitting of data into training and testing subsets and repeating the process 50 times, were employed to ensure robustness. Results: MitraClip implantation reduced MR severity from 3.02 ± 0.22 to 0.98 ± 0.43 ( p < 0.0001). Stress‐induced increases in heart rate, blood pressure and TMG were significant (TMG: 3.04 ± 0.90 mmHg at rest vs. 4.11 ± 1.53 mmHg under stress, p < 0.0001). Thirty‐seven percent of patients exhibited TMG ≥ 5 mmHg during stress. Predictors of elevated TMG included secondary MR, BMI, and multiple clip implantation (AUC = 0.90; 95% CI: 0.79–0.96). Despite increased TMG, no patients experienced significant symptoms or pathological MR. Conclusion: Wide MitraClips effectively reduce MR with satisfactory haemodynamic performance. Handgrip stress echocardiography is a feasible and valuable tool for assessing postprocedure valve function. Larger cohorts are necessary to confirm the impact of secondary MR and use of multiple clips on increased TMG under stress.
- 1 January 2025
- Published by Wiley in Journal of Interventional Cardiology
- Vol. 2025 (1)
Open AccessDeterminants of Increased Transmitral Gradients Under Dynamic Isometric Handgrip Exercise After Edge‐to‐Edge Repair With the Fourth‐Generation MitraClip
Aim: Mitral regurgitation (MR) is a prevalent cardiovascular condition, and its treatment remains challenging, especially in high‐risk patients. The fourth‐generation MitraClip system (NTW and XTW) offers enhanced capabilities for repairing mitral valves (MVs) with complex anatomies. This study evaluates the haemodynamic function of MVs after edge‐to‐edge with wide MitraClip under physical stress induced by handgrip exercise stress echocardiography. Methods: This prospective study included 27 patients with severe MR. All patients underwent successful MitraClip implantation, and handgrip stress echocardiography was performed predischarge. The primary endpoint was a postprocedure mean transmitral gradient (TMG) < 5 mmHg under stress. A machine learning (ML) model using logistic regression as the learner and advanced data augmentation techniques, including random splitting of data into training and testing subsets and repeating the process 50 times, were employed to ensure robustness. Results: MitraClip implantation reduced MR severity from 3.02 ± 0.22 to 0.98 ± 0.43 ( p < 0.0001). Stress‐induced increases in heart rate, blood pressure and TMG were significant (TMG: 3.04 ± 0.90 mmHg at rest vs. 4.11 ± 1.53 mmHg under stress, p < 0.0001). Thirty‐seven percent of patients exhibited TMG ≥ 5 mmHg during stress. Predictors of elevated TMG included secondary MR, BMI, and multiple clip implantation (AUC = 0.90; 95% CI: 0.79–0.96). Despite increased TMG, no patients experienced significant symptoms or pathological MR. Conclusion: Wide MitraClips effectively reduce MR with satisfactory haemodynamic performance. Handgrip stress echocardiography is a feasible and valuable tool for assessing postprocedure valve function. Larger cohorts are necessary to confirm the impact of secondary MR and use of multiple clips on increased TMG under stress.
- Open Access
- 1 August 2024
- Published by AME Publishing Company in Journal of Thoracic Disease
- Vol. 16 (8) , 4914-4923
Deep learning to predict long-term mortality from plain chest X-ray in patients referred for suspected coronary artery disease
Background: The hypothesis that a deep learning (DL) model can produce long-term prognostic information from chest X-ray (CXR) has already been confirmed within cancer screening programs. We summarize our experience with DL prediction of long-term mortality, from plain CXR, in patients referred for angina and coronary angiography. Methods: Data of patients referred to an Italian academic hospital were analyzed retrospectively. We designed a deep convolutional neural network (DCNN) that, from CXR, could predict long-term mortality. External validation was performed on patients referred to a Dutch academic hospital. Results: A total of 6,031 were used for model training (71%; n=4,259) and fine-tuning/validation (10%; n=602). Internal validation was performed with the remaining patients (19%; n=1,170). Patients’ stratification followed the DL-CXR risk score quartiles division. Median follow-up was 6.1 years [interquartile range (IQR), 3.3–8.7 years]. We observed an increment in estimated mortality with the increase of DL-CXR risk score (low-risk 5%, moderate 17%, high 29%, very high 46%; PConclusions: In patients referred for coronary angiogram because of angina, the DL-CXR risk score could be used to stratify mortality risk and predict long-term outcome better than age and coronary artery disease status.
- 1 August 2024
- Published by AME Publishing Company in Journal of Thoracic Disease
- Vol. 16 (8) , 4914-4923
Open AccessDeep learning to predict long-term mortality from plain chest X-ray in patients referred for suspected coronary artery disease
Background: The hypothesis that a deep learning (DL) model can produce long-term prognostic information from chest X-ray (CXR) has already been confirmed within cancer screening programs. We summarize our experience with DL prediction of long-term mortality, from plain CXR, in patients referred for angina and coronary angiography. Methods: Data of patients referred to an Italian academic hospital were analyzed retrospectively. We designed a deep convolutional neural network (DCNN) that, from CXR, could predict long-term mortality. External validation was performed on patients referred to a Dutch academic hospital. Results: A total of 6,031 were used for model training (71%; n=4,259) and fine-tuning/validation (10%; n=602). Internal validation was performed with the remaining patients (19%; n=1,170). Patients’ stratification followed the DL-CXR risk score quartiles division. Median follow-up was 6.1 years [interquartile range (IQR), 3.3–8.7 years]. We observed an increment in estimated mortality with the increase of DL-CXR risk score (low-risk 5%, moderate 17%, high 29%, very high 46%; PConclusions: In patients referred for coronary angiogram because of angina, the DL-CXR risk score could be used to stratify mortality risk and predict long-term outcome better than age and coronary artery disease status.
- Open Access
- 17 October 2022
- Published by IMR Press in Reviews in Cardiovascular Medicine
- Vol. 23 (10) , 349
From an Unfolding Emergency Treatment to a Universal Shift in Therapy: The History and Evolution of the Catheter-Based Treatment of Aortic Valve Stenosis
Aortic valve stenosis (AVS) is the most frequent valvular heart disease in industrialized countries, presenting with very high mortality if left untreated. While drug treatment can sometimes alleviate symptoms, it fails to stop progression or cure the underlying disease. Until the first decade of this millennium, surgical aortic valve replacement (SAVR) remained the only available therapy option with a positive impact on mortality and morbidity. Even though several studies reported highly positive effects of SAVR regarding the improved quality of life and better physical performance, SAVR remained an intervention that, due to its remarkable complexity and the need for heart-lung machine and cardioplegia, was limited by the patients’ comorbid profile. While unsatisfying hemodynamic results after transcatheter aortic balloon valvuloplasty in high-risk surgical patients limited its adoption as an alternative treatment, it provided the impetus for further interventional approaches to the therapy of AVS. This review considers the invention and development of transcatheter aortic valve implantation (TAVI), which established itself as a catheter-based, minimally invasive procedure over the past decade, and has become an equivalent treatment method for high-risk surgical patients. For that matter, early TAVI concepts, their amendments, and the associated pioneers are recognized for paving the way to a revolutionary diversification in AVS treatment.
- 17 October 2022
- Published by IMR Press in Reviews in Cardiovascular Medicine
- Vol. 23 (10) , 349
Open AccessFrom an Unfolding Emergency Treatment to a Universal Shift in Therapy: The History and Evolution of the Catheter-Based Treatment of Aortic Valve Stenosis
Aortic valve stenosis (AVS) is the most frequent valvular heart disease in industrialized countries, presenting with very high mortality if left untreated. While drug treatment can sometimes alleviate symptoms, it fails to stop progression or cure the underlying disease. Until the first decade of this millennium, surgical aortic valve replacement (SAVR) remained the only available therapy option with a positive impact on mortality and morbidity. Even though several studies reported highly positive effects of SAVR regarding the improved quality of life and better physical performance, SAVR remained an intervention that, due to its remarkable complexity and the need for heart-lung machine and cardioplegia, was limited by the patients’ comorbid profile. While unsatisfying hemodynamic results after transcatheter aortic balloon valvuloplasty in high-risk surgical patients limited its adoption as an alternative treatment, it provided the impetus for further interventional approaches to the therapy of AVS. This review considers the invention and development of transcatheter aortic valve implantation (TAVI), which established itself as a catheter-based, minimally invasive procedure over the past decade, and has become an equivalent treatment method for high-risk surgical patients. For that matter, early TAVI concepts, their amendments, and the associated pioneers are recognized for paving the way to a revolutionary diversification in AVS treatment.
- 15 October 2021
- Published by Springer Nature in Clinical Research in Cardiology
- Vol. 111 (1) , 105-113
Left atrial appendage closure with the watchman device reduces atrial fibrillation management costs
Aims To report hospitalization costs of patients with non-valvular atrial fibrillation (AF) submitted to percutaneous left atrial appendage closure (LAAC) with the Watchman device. Methods Pre- and post-procedural hospitalization AF-related costs were calculated using the DRG system (diagnosis-related groups) and compared. Results Between 2012 and 2016, 677 non-valvular AF patients underwent LAAC. Median time from first cardiac hospitalization to LAAC was 5.9 years (IQR 1.6–9.1) and median follow-up after LAAC was 4.8 years (IQR 3.6–5.6). LAAC mortality was 1.3% and follow-up mortality 16.9%. Median pre-LAAC hospitalization cost was € 17,867 (IQR € 7512–35,08) and post-LAAC € 8772 (IQR € 1183–25,159) (p < 0.0001). Annualized cost pre-LAAC was 3773 € (IQR € 1644–8,493) and post-LAAC 2,001 € (IQR € 260–6913) (p < 0.0001). Follow-up survivors had significantly lower post-LAAC costs (p < 0.0001) and after a survival cut-off time of 4.6 years LAAC procedural and post-procedural hospitalization costs achieved parity with pre-LACC costs (AUC 0.64; p = 0.02). CHA2DS2-VASc score (B = 0.04; p = 0.02; 95% CI 0.006–0.08), and HAS-BLED score (B = 0.08; p = 0.004; 95% CI 0.02–0.14) were independent determinants for annualized hospitalization costs post-LAAC. At Cox-regression analysis the DRG mean clinical complexity level (CCL) was the only independent determinant for follow-up mortality (OR = 2.2; p < 0.0001; 95% CI 1.6–2.8) with a cut-off value of 2.25 to predict follow-up mortality (AUC 0.72; p < 0.0001; Spec. 70%; Sens. 70%). Conclusion Hospitalization costs pre-LAAC are consistent, and after LAAC, they are significantly reduced. Costs seem related to the patient's risk profile at the time of the procedure. With the increase in post-LAAC survival time, the procedure becomes economically more profitable. Graphic abstract
- 15 October 2021
- Published by Springer Nature in Clinical Research in Cardiology
- Vol. 111 (1) , 105-113
Left atrial appendage closure with the watchman device reduces atrial fibrillation management costs
Aims To report hospitalization costs of patients with non-valvular atrial fibrillation (AF) submitted to percutaneous left atrial appendage closure (LAAC) with the Watchman device. Methods Pre- and post-procedural hospitalization AF-related costs were calculated using the DRG system (diagnosis-related groups) and compared. Results Between 2012 and 2016, 677 non-valvular AF patients underwent LAAC. Median time from first cardiac hospitalization to LAAC was 5.9 years (IQR 1.6–9.1) and median follow-up after LAAC was 4.8 years (IQR 3.6–5.6). LAAC mortality was 1.3% and follow-up mortality 16.9%. Median pre-LAAC hospitalization cost was € 17,867 (IQR € 7512–35,08) and post-LAAC € 8772 (IQR € 1183–25,159) (p < 0.0001). Annualized cost pre-LAAC was 3773 € (IQR € 1644–8,493) and post-LAAC 2,001 € (IQR € 260–6913) (p < 0.0001). Follow-up survivors had significantly lower post-LAAC costs (p < 0.0001) and after a survival cut-off time of 4.6 years LAAC procedural and post-procedural hospitalization costs achieved parity with pre-LACC costs (AUC 0.64; p = 0.02). CHA2DS2-VASc score (B = 0.04; p = 0.02; 95% CI 0.006–0.08), and HAS-BLED score (B = 0.08; p = 0.004; 95% CI 0.02–0.14) were independent determinants for annualized hospitalization costs post-LAAC. At Cox-regression analysis the DRG mean clinical complexity level (CCL) was the only independent determinant for follow-up mortality (OR = 2.2; p < 0.0001; 95% CI 1.6–2.8) with a cut-off value of 2.25 to predict follow-up mortality (AUC 0.72; p < 0.0001; Spec. 70%; Sens. 70%). Conclusion Hospitalization costs pre-LAAC are consistent, and after LAAC, they are significantly reduced. Costs seem related to the patient's risk profile at the time of the procedure. With the increase in post-LAAC survival time, the procedure becomes economically more profitable. Graphic abstract
- 30 September 2021
- Published by Elsevier in International Journal of Cardiology
- Vol. 344, 84-85
Rehospitalization and actual management costs after percutaneous left atrial appendage closure: Facing the conundrum
- 30 September 2021
- Published by Elsevier in International Journal of Cardiology
- Vol. 344, 84-85
Rehospitalization and actual management costs after percutaneous left atrial appendage closure: Facing the conundrum
- Open Access
- 21 April 2021
- Published by JMIR Publications Inc. in JMIR Cardio
- Vol. 5 (1) , e21055
Implantation of an Innovative Intracardiac Microcomputer System for Web-Based Real-Time Monitoring of Heart Failure: Usability and Patients’ Attitudes
Background: Heart failure (HF) management guided by the measurement of intracardiac and pulmonary pressure values obtained through innovative permanent intracardiac microsensors has been recently proposed as a valid strategy to individualize treatment and anticipate hemodynamic destabilization. These sensors have potential to reduce patient hospitalization rates and optimize quality of life. Objective: The aim of this study was to evaluate the usability and patients’ attitudes toward a new permanent intracardiac device implanted to remotely monitor left intra-atrial pressures (V-LAP, Vectorious Medical Technologies, Tel Aviv, Israel) in patients with chronic HF. Methods: The V-LAP system is a miniaturized sensor implanted percutaneously across the interatrial septum. The system communicates wirelessly with a “companion device” (a wearable belt) that is placed on the patient’s chest at the time of acquisition/transmission of left heart pressure measurements. At first follow-up after implantation, the patients and health care providers were asked to fill out a questionnaire on the usability of the system, ease in performing the various required tasks (data acquisition and transmission), and overall satisfaction. Replies to the questions were mainly given using a 5-point Likert scale (1: very poor, 2: poor, 3: average, 4: good, 5: excellent). Further patient follow-ups were performed at 3, 6, and 12 months. Results: Use and acceptance of the first 14 patients receiving the V-LAP technology worldwide and related health care providers have been analyzed to date. No periprocedural morbidity/mortality was observed. Before discharge, a tailored educational session was performed after device implantation with the patients and their health care providers. At the first follow-up, the mean score for overall comfort in technology use was 3.7 (SD 1.2) with 93% (13/14) of patients succeeding in applying and operating the system independently. For health care providers, the mean score for overall ease and comfort in use of the technology was 4.2 (SD 0.8). No significant differences were found between the patients’ and health care providers’ replies to the questionnaires. There was a general trend for higher scores in patients’ usability reports at later follow-ups, in which the score related to overall comfort with using the technology increased from 3.0 (SD 1.4) to 4.0 (SD 0.7) (P=.40) and comfort with wearing and adjusting the measuring thoracic belt increased from 2.8 (SD 1.0) to 4.2 (SD 0.4) (P=.02). Conclusions: Despite the gravity of their HF pathology and the complexity of their comorbid profile, patients are comfortable in using the V-LAP technology and, in the majority of cases, they can correctly and consistently acquire and transmit hemodynamic data. Although the overall patient/care provider satisfaction with the V-LAP system seems to be acceptable, improvements can be achieved after ameliorating the design of the measuring tools. Trial Registration: ClincalTrials.gov NCT03775161; https://clinicaltrials.gov/ct2/show/NCT03775161
- 21 April 2021
- Published by JMIR Publications Inc. in JMIR Cardio
- Vol. 5 (1) , e21055
Open AccessImplantation of an Innovative Intracardiac Microcomputer System for Web-Based Real-Time Monitoring of Heart Failure: Usability and Patients’ Attitudes
Background: Heart failure (HF) management guided by the measurement of intracardiac and pulmonary pressure values obtained through innovative permanent intracardiac microsensors has been recently proposed as a valid strategy to individualize treatment and anticipate hemodynamic destabilization. These sensors have potential to reduce patient hospitalization rates and optimize quality of life. Objective: The aim of this study was to evaluate the usability and patients’ attitudes toward a new permanent intracardiac device implanted to remotely monitor left intra-atrial pressures (V-LAP, Vectorious Medical Technologies, Tel Aviv, Israel) in patients with chronic HF. Methods: The V-LAP system is a miniaturized sensor implanted percutaneously across the interatrial septum. The system communicates wirelessly with a “companion device” (a wearable belt) that is placed on the patient’s chest at the time of acquisition/transmission of left heart pressure measurements. At first follow-up after implantation, the patients and health care providers were asked to fill out a questionnaire on the usability of the system, ease in performing the various required tasks (data acquisition and transmission), and overall satisfaction. Replies to the questions were mainly given using a 5-point Likert scale (1: very poor, 2: poor, 3: average, 4: good, 5: excellent). Further patient follow-ups were performed at 3, 6, and 12 months. Results: Use and acceptance of the first 14 patients receiving the V-LAP technology worldwide and related health care providers have been analyzed to date. No periprocedural morbidity/mortality was observed. Before discharge, a tailored educational session was performed after device implantation with the patients and their health care providers. At the first follow-up, the mean score for overall comfort in technology use was 3.7 (SD 1.2) with 93% (13/14) of patients succeeding in applying and operating the system independently. For health care providers, the mean score for overall ease and comfort in use of the technology was 4.2 (SD 0.8). No significant differences were found between the patients’ and health care providers’ replies to the questionnaires. There was a general trend for higher scores in patients’ usability reports at later follow-ups, in which the score related to overall comfort with using the technology increased from 3.0 (SD 1.4) to 4.0 (SD 0.7) (P=.40) and comfort with wearing and adjusting the measuring thoracic belt increased from 2.8 (SD 1.0) to 4.2 (SD 0.4) (P=.02). Conclusions: Despite the gravity of their HF pathology and the complexity of their comorbid profile, patients are comfortable in using the V-LAP technology and, in the majority of cases, they can correctly and consistently acquire and transmit hemodynamic data. Although the overall patient/care provider satisfaction with the V-LAP system seems to be acceptable, improvements can be achieved after ameliorating the design of the measuring tools. Trial Registration: ClincalTrials.gov NCT03775161; https://clinicaltrials.gov/ct2/show/NCT03775161
- Open Access
- 8 June 2020
- Published by JMIR Publications Inc. in JMIR Preprints
Implantation of an Innovative Intracardiac Microcomputer System for Web-Based Real-Time Monitoring of Heart Failure: Usability and Patients’ Attitudes (Preprint)
BACKGROUND Heart failure (HF) management guided by the measurement of intracardiac and pulmonary pressure values obtained through innovative permanent intracardiac microsensors has been recently proposed as a valid strategy to individualize treatment and anticipate hemodynamic destabilization. These sensors have potential to reduce patient hospitalization rates and optimize quality of life. OBJECTIVE The aim of this study was to evaluate the usability and patients’ attitudes toward a new permanent intracardiac device implanted to remotely monitor left intra-atrial pressures (V-LAP, Vectorious Medical Technologies, Tel Aviv, Israel) in patients with chronic HF. METHODS The V-LAP system is a miniaturized sensor implanted percutaneously across the interatrial septum. The system communicates wirelessly with a “companion device” (a wearable belt) that is placed on the patient’s chest at the time of acquisition/transmission of left heart pressure measurements. At first follow-up after implantation, the patients and health care providers were asked to fill out a questionnaire on the usability of the system, ease in performing the various required tasks (data acquisition and transmission), and overall satisfaction. Replies to the questions were mainly given using a 5-point Likert scale (1: very poor, 2: poor, 3: average, 4: good, 5: excellent). Further patient follow-ups were performed at 3, 6, and 12 months. RESULTS Use and acceptance of the first 14 patients receiving the V-LAP technology worldwide and related health care providers have been analyzed to date. No periprocedural morbidity/mortality was observed. Before discharge, a tailored educational session was performed after device implantation with the patients and their health care providers. At the first follow-up, the mean score for overall comfort in technology use was 3.7 (SD 1.2) with 93% (13/14) of patients succeeding in applying and operating the system independently. For health care providers, the mean score for overall ease and comfort in use of the technology was 4.2 (SD 0.8). No significant differences were found between the patients’ and health care providers’ replies to the questionnaires. There was a general trend for higher scores in patients’ usability reports at later follow-ups, in which the score related to overall comfort with using the technology increased from 3.0 (SD 1.4) to 4.0 (SD 0.7) (P=.40) and comfort with wearing and adjusting the measuring thoracic belt increased from 2.8 (SD 1.0) to 4.2 (SD 0.4) (P=.02). CONCLUSIONS Despite the gravity of their HF pathology and the complexity of their comorbid profile, patients are comfortable in using the V-LAP technology and, in the majority of cases, they can correctly and consistently acquire and transmit hemodynamic data. Although the overall patient/care provider satisfaction with the V-LAP system seems to be acceptable, improvements can be achieved after ameliorating the design of the measuring tools. CLINICALTRIAL ClincalTrials.gov NCT03775161; https://clinicaltrials.gov/ct2/show/NCT03775161
- 8 June 2020
- Published by JMIR Publications Inc. in JMIR Preprints
Open AccessImplantation of an Innovative Intracardiac Microcomputer System for Web-Based Real-Time Monitoring of Heart Failure: Usability and Patients’ Attitudes (Preprint)
BACKGROUND Heart failure (HF) management guided by the measurement of intracardiac and pulmonary pressure values obtained through innovative permanent intracardiac microsensors has been recently proposed as a valid strategy to individualize treatment and anticipate hemodynamic destabilization. These sensors have potential to reduce patient hospitalization rates and optimize quality of life. OBJECTIVE The aim of this study was to evaluate the usability and patients’ attitudes toward a new permanent intracardiac device implanted to remotely monitor left intra-atrial pressures (V-LAP, Vectorious Medical Technologies, Tel Aviv, Israel) in patients with chronic HF. METHODS The V-LAP system is a miniaturized sensor implanted percutaneously across the interatrial septum. The system communicates wirelessly with a “companion device” (a wearable belt) that is placed on the patient’s chest at the time of acquisition/transmission of left heart pressure measurements. At first follow-up after implantation, the patients and health care providers were asked to fill out a questionnaire on the usability of the system, ease in performing the various required tasks (data acquisition and transmission), and overall satisfaction. Replies to the questions were mainly given using a 5-point Likert scale (1: very poor, 2: poor, 3: average, 4: good, 5: excellent). Further patient follow-ups were performed at 3, 6, and 12 months. RESULTS Use and acceptance of the first 14 patients receiving the V-LAP technology worldwide and related health care providers have been analyzed to date. No periprocedural morbidity/mortality was observed. Before discharge, a tailored educational session was performed after device implantation with the patients and their health care providers. At the first follow-up, the mean score for overall comfort in technology use was 3.7 (SD 1.2) with 93% (13/14) of patients succeeding in applying and operating the system independently. For health care providers, the mean score for overall ease and comfort in use of the technology was 4.2 (SD 0.8). No significant differences were found between the patients’ and health care providers’ replies to the questionnaires. There was a general trend for higher scores in patients’ usability reports at later follow-ups, in which the score related to overall comfort with using the technology increased from 3.0 (SD 1.4) to 4.0 (SD 0.7) (P=.40) and comfort with wearing and adjusting the measuring thoracic belt increased from 2.8 (SD 1.0) to 4.2 (SD 0.4) (P=.02). CONCLUSIONS Despite the gravity of their HF pathology and the complexity of their comorbid profile, patients are comfortable in using the V-LAP technology and, in the majority of cases, they can correctly and consistently acquire and transmit hemodynamic data. Although the overall patient/care provider satisfaction with the V-LAP system seems to be acceptable, improvements can be achieved after ameliorating the design of the measuring tools. CLINICALTRIAL ClincalTrials.gov NCT03775161; https://clinicaltrials.gov/ct2/show/NCT03775161
- 26 March 2020
- Published by Taylor & Francis in Future Cardiology
- Vol. 16 (4) , 237-250
Percutaneous Left Atrial Appendage Closure for Cerebrovascular Accident Prevention: rationale, indications, Technical aspects, Clinical Results and Future Perspective
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. The most feared complication of AF is thromboembolism. Oral anticoagulation (OAC) is the standard treatment to reduce throm...
- 26 March 2020
- Published by Taylor & Francis in Future Cardiology
- Vol. 16 (4) , 237-250
Percutaneous Left Atrial Appendage Closure for Cerebrovascular Accident Prevention: rationale, indications, Technical aspects, Clinical Results and Future Perspective
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. The most feared complication of AF is thromboembolism. Oral anticoagulation (OAC) is the standard treatment to reduce throm...