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Mate Vamos - One of the best experts on this subject based on the ideXlab platform.
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clinical outcomes after implantation of quadripolar compared to bipolar Left Ventricular Leads in patients undergoing cardiac resynchronization therapy a systematic review and meta analysis
Europace, 2019Co-Authors: Julia W Erath, Alexander P Benz, Stefan H Hohnloser, Mate VamosAbstract:AIMS Some retrospective and prospective studies in heart failure patients with indication for cardiac resynchronization therapy (CRT) suggest better clinical outcomes for quadripolar (QP) Left Ventricular (LV) Leads over bipolar (BP) Leads. Although, lead failure remains an important safety concern, when using these more complex, novel electrodes. To evaluate safety and efficacy outcomes for QP vs. BP LV Leads in patients receiving CRT. METHODS AND RESULTS We performed a comprehensive literature search through 2018 in PubMed, Cochrane Library, and Google Scholar databases to identify studies comparing patients with QP and BP LV CRT Leads. A total of 12 studies were selected for analysis comprising 31 403 patients (QP lead: 22 429 patients; BP lead: 8974 patients). Eight studies examined the effects of CRT on survival. In these studies, use of QP electrodes was associated with significantly better survival compared to patients with BP LV Leads (OR 0.61, 95% CI 0.50-0.76; P < 0.01). Clinical improval measured in New York Heart Association functional class (OR 0.59, 95% CI 0.34-1.01; P = 0.05) and hospitalization rates (OR 0.67, 95% CI 0.55-0.83; P < 0.01) were also improved in patients receiving QP Leads. Lead malfunctions defined as LV lead failure resulting in lead deactivation (OR 0.57, 95% CI 0.34-0.98; P = 0.04) or LV lead dislodgement requiring LV lead replacement/repositioning (OR 0.48; 95% CI 0.31-0.75; P < 0.01) were more often encountered among patients with BP Leads compared to patients with QP Leads. CONCLUSION Our meta-analysis suggests distinct benefits of QP over BP electrodes in patients undergoing CRT.
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effects of implantation of quadripolar Left Ventricular Leads on crt response
Journal of Interventional Cardiac Electrophysiology, 2019Co-Authors: Julia W Erath, Mate Vamos, Dominika Domokos, Alexander P Benz, Zsolt Bari, Peter Bogyi, Gabor Z Duray, Stefan H HohnloserAbstract:The use of quadripolar (QP) Left Ventricular Leads for cardiac resynchronization therapy (CRT) is intended to improve outcomes compared with conventional bipolar Leads (BP). Hence, the number of implanted quadripolar CRT systems is increasing despite limited long-term data. The aim of this study is to evaluate clinical response and long-term outcomes of CRT recipients who were implanted with quadripolar versus bipolar Left Ventricular Leads. Data from consecutive patients receiving a CRT defibrillator in one German and one Hungarian tertiary referral center were retrospectively collected. Long-term survival and response to CRT were analyzed. A total of 536 patients with structural heart disease and a mean Left Ventricular ejection fraction (LVEF) of 25% received a CRT defibrillator (CRT-D) system for primary (79%) or secondary (21%) prevention of sudden death. Comorbidities did not differ significantly between patients receiving a QP (n = 123) or a BP lead (n = 413). Procedure (101 vs. 120 min) and fluoroscopy times (14 vs. 20 min) were shorter in patients implanted with QP compared with BP (both p < 0.001). At 6 months follow-up, QP patients were more likely to respond to CRT measured as improvement in the New York Heart Association (NYHA) functional class (77% vs. 63%; p < 0.001). Use of QP Left ventricle/Left Ventricular (LV) Leads was associated with greater reduction in QRS duration compared with patients implanted with BP LV Leads (− 21 ± 30 vs. − 8 ± 35 ms, p = 0.004). Mortality was not significantly different between patients with QP and patients with BP LV Leads at a mean follow-up of 39 ± 31 months. Implantation of quadripolar Left Ventricular Leads was associated with better CRT response compared with bipolar Left Ventricular Leads.
Simon Claridge - One of the best experts on this subject based on the ideXlab platform.
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cost effectiveness analysis of quadripolar versus bipolar Left Ventricular Leads for cardiac resynchronization defibrillator therapy in a large multicenter uk registry
JACC: Clinical Electrophysiology, 2017Co-Authors: Jonathan M Behar, Julian Bostock, Hui Men Selina Chin, Steve Fearn, Julian O M Ormerod, James Gamble, Paul W X Foley, Simon ClaridgeAbstract:Abstract Objectives The objective of this study was to evaluate the cost-effectiveness of quadripolar versus bipolar cardiac resynchronization defibrillator therapy systems. Background Quadripolar Left Ventricular (LV) Leads for cardiac resynchronization therapy reduce phrenic nerve stimulation (PNS) and are associated with reduced mortality compared with bipolar Leads. Methods A total of 606 patients received implants at 3 UK centers (319 Q, 287 B), between 2009 and 2014; mean follow-up was 879 days. Rehospitalization episodes were costed at National Health Service national tariff rates, and EQ-5D utility values were applied to heart failure admissions, acute coronary syndrome events, and mortality data, which were used to estimate quality-adjusted life-year differences over 5 years. Results Groups were matched with regard to age and sex. Patients with quadripolar implants had a lower rate of hospitalization than those with bipolar implants (42.6% vs. 55.4%; p = 0.002). This was primarily driven by fewer hospital readmissions for heart failure (51 [16%] vs. 75 [26.1%], respectively, for quadripolar vs. bipolar implants; p = 0.003) and generator replacements (9 [2.8%] vs. 19 [6.6%], respectively; p = 0.03). Hospitalization for suspected acute coronary syndrome, arrhythmia, device explantation, and lead revisions were similar. This lower health-care utilization cost translated into a cumulative 5-year cost saving for patients with quadripolar systems where the acquisition cost was Conclusions In a UK health-care 5-year time horizon, the additional purchase price of quadripolar cardiac resynchronization defibrillator therapy systems is largely offset by lower subsequent event costs up to 5 years after implantation, which makes this technology highly cost-effective compared with bipolar systems.
G B Forleo - One of the best experts on this subject based on the ideXlab platform.
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hospitalization rates and associated cost analysis of cardiac resynchronization therapy with an implantable defibrillator and quadripolar vs bipolar Left Ventricular Leads a comparative effectiveness study
Europace, 2015Co-Authors: G B Forleo, Luigi Di Biase, Nirav Dalal, Luca Santini, Rupinder Bharmi, Germana Panattoni, Annalisa Pollastrelli, Manfredi Tesauro, Andrea NataleAbstract:Aims This study compares, from a prospective, observational, non-randomized registry, the post-implant hospitalization rates and associated healthcare resource utilization of cardiac resynchronization therapy-defibrillator (CRT-D) patients with quadripolar (QUAD) vs. bipolar (BIP) Left Ventricular (LV) Leads. Methods and results Between January 2009 and December 2012, 193 consecutive patients receiving de novo CRT-D implants with either a QUAD ( n = 116) or a BIP ( n = 77) LV lead were enrolled at implant and followed until July 2013 at a single-centre, university hospital. Post-implant hospitalizations related to heart failure (HF) or LV lead surgical revision and associated payer costs were identified using ICD-9-CM diagnosis and procedure codes. Italian national reimbursement rates were determined. Propensity scores were estimated using a logistic regression model based upon 11 pre-implant baseline characteristics and were used to derive a 1 : 1 matched cohort of QUAD ( n = 77) and BIP ( n = 77) patients. Hospitalization rates for the two groups were compared using negative binomial regression and associated payer costs were compared using non-parametric bootstrapping (×10 000) and one-sided hypothesis test. Hospitalization rates of the QUAD group [0.15/ patient (pt)-year] were lower than those of the BIP group (0.32/ pt-year); the incidence rate ratio was 0.46, P = 0.04. The hospitalization costs for the QUAD group (434 ± 128 €/pt-year) were lower than those for the BIP group (1136 ± 362 €/pt-year). The average difference was 718 €/pt-year, P = 0.016. Conclusions In this comparative effectiveness assessment of well-matched groups of CRT-D patients with quadripolar and bipolar LV Leads, QUAD patients experienced a lower rate of hospitalizations for HF and LV lead surgical revision, and a lower cost burden. This has important implications for LV pacing lead choice.
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non invasive hemodynamic analysis in cardiac resynchronization therapy patients wearing quadripolar Left Ventricular Leads the importance of pacing electrode selection
European Review for Medical and Pharmacological Sciences, 2014Co-Authors: Luca Santini, J Legramante, F Condemi, L Santucci, M Panattoni, P Crobeddu, Domenico Sergi, G B Forleo, Francesco RomeoAbstract:Quadripolar Left Ventricular (LV) Leads offer multiple choices for LV pacing increasing programming flexibility. Aim of this study is to assess the influence of LV pacing vector selection on hemodynamic parameters for patients who underwent cardiac resynchronization therapy (CRT) using quadripolar LV lead chronically evaluated with a non-invasive approach by Nexfin(®) system provided analysis (BMEYE B.V., Amsterdam, The Netherlands).
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non invasive hemodynamic analysis in cardiac resynchronization therapy patients wearing quadripolar Left Ventricular Leads the importance of pacing electrode selection
Minerva Cardioangiologica, 2014Co-Authors: Luca Santini, J Legramante, F Condemi, L Santucci, M Panattoni, P Crobeddu, Domenico Sergi, G B Forleo, Francesco RomeoAbstract:AIM Quadripolar Left Ventricular (LV) Leads offer multiple choices for LV pacing increasing programming flexibility. Aim of this study is to assess the influence of LV pacing vector selection on hemodynamic parameters for patients who underwent cardiac resynchronization therapy (CRT) using quadripolar LV lead chronically evaluated with a non-invasive approach by Nexfin(®) system provided analysis (BMEYE B.V., Amsterdam, The Netherlands). METHODS AND RESULTS In 16 CRT patients implanted with a quadripolar LV lead (mean follow-up 8,8 ±13,4 months after implantation), we measured Cardiac Output (CO), Mean Blood Pressure (MBP), Total Peripheral Resistance (TPR), LV dP/dt max and Stroke volume (SV) from each one of the ten available bipolar pacing configurations. All the recorded parameters showed marked differences among the ten pacing configurations, but dP/dt max, SV and TPR were those showing the wider range, depending of the selected pacing vector. The average delta for the whole group of subjects between the maximum and minimum hemodynamic values for each pacing configuration were 15.9% for SV, 21.1% for dP/dt max and 20.3% for TPR. Inter-individual analysis of data failed to identify a link between a specific pacing vector and the hemodynamic response. CONCLUSION Our study demonstrates that different bipolar pacing configurations, even if arising from a single CS branch, substantially modify the hemodynamic effect of LV pacing in CRT patients. Moreover, the non-invasive hemodynamic analysis suggests the better pacing configuration should be established individually and could represent an important issue in optimizing CRT during follow-up.
Julian Bostock - One of the best experts on this subject based on the ideXlab platform.
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cost effectiveness analysis of quadripolar versus bipolar Left Ventricular Leads for cardiac resynchronization defibrillator therapy in a large multicenter uk registry
JACC: Clinical Electrophysiology, 2017Co-Authors: Jonathan M Behar, Julian Bostock, Hui Men Selina Chin, Steve Fearn, Julian O M Ormerod, James Gamble, Paul W X Foley, Simon ClaridgeAbstract:Abstract Objectives The objective of this study was to evaluate the cost-effectiveness of quadripolar versus bipolar cardiac resynchronization defibrillator therapy systems. Background Quadripolar Left Ventricular (LV) Leads for cardiac resynchronization therapy reduce phrenic nerve stimulation (PNS) and are associated with reduced mortality compared with bipolar Leads. Methods A total of 606 patients received implants at 3 UK centers (319 Q, 287 B), between 2009 and 2014; mean follow-up was 879 days. Rehospitalization episodes were costed at National Health Service national tariff rates, and EQ-5D utility values were applied to heart failure admissions, acute coronary syndrome events, and mortality data, which were used to estimate quality-adjusted life-year differences over 5 years. Results Groups were matched with regard to age and sex. Patients with quadripolar implants had a lower rate of hospitalization than those with bipolar implants (42.6% vs. 55.4%; p = 0.002). This was primarily driven by fewer hospital readmissions for heart failure (51 [16%] vs. 75 [26.1%], respectively, for quadripolar vs. bipolar implants; p = 0.003) and generator replacements (9 [2.8%] vs. 19 [6.6%], respectively; p = 0.03). Hospitalization for suspected acute coronary syndrome, arrhythmia, device explantation, and lead revisions were similar. This lower health-care utilization cost translated into a cumulative 5-year cost saving for patients with quadripolar systems where the acquisition cost was Conclusions In a UK health-care 5-year time horizon, the additional purchase price of quadripolar cardiac resynchronization defibrillator therapy systems is largely offset by lower subsequent event costs up to 5 years after implantation, which makes this technology highly cost-effective compared with bipolar systems.
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142 cardiac resynchronisation therapy are two Left Ventricular Leads better than one
Heart, 2010Co-Authors: Matthew Ginks, Simon G Duckett, Shoaib Hamid, Anoop Shetty, Julian Bostock, Reza Razavi, Christopher A RinaldiAbstract:Introduction Cardiac Resynchronisation Therapy (CRT) has revolutionised the treatment of patients with heart failure. However, there remains a significant proportion of patients who do not derive clear clinical benefit. One approach to address this problem is the use of two Left Ventricular (LV) Leads. Intuitively, this may better correct dyssynchrony in a dilated Left ventricle and may confer greater efficacy in pacing around areas of scar. We assessed the acute haemodynamic effect of single site and dual site Left Ventricular pacing in the CRT patient population. Methods Seventeen patients fulfilling criteria for CRT were studied. Sixteen were male, nine had an ischaemic heart failure aetiology. Thirteen patients were in sinus rhythm and four were in atrial fibrillation. Mean age was 64±11 yrs, EF 24±6%, NYHA 2.4±0.5, QRS duration 159±28 ms. During the CRT implant, a pressure wire was passed to the LV via the femoral or radial artery. After balloon occlusive coronary sinus (CS) venography, two guide sheaths were positioned to place two Leads. One was positioned empirically in the posterolateral branch (LV1) and the second was positioned in another vein (LV2) which was felt to be the anatomically less preferable position. Lead capture was confirmed and steady state pacing achieved. Three Recordings of mean peak dP/dt max were taken over ≥10 s each in intrinsic rhythm, with LV pacing in each vein and with combined (dual site) LV pacing at 100 beats per minute. Results 16/17 (94%) patients had successful placement of two coronary sinus Leads. The LV1 lead was placed in the posterolateral vein. The LV2 lead was lateral in four cases, anterolateral in 11, and in the middle cardiac vein in one case. There was one CS dissection during placement of the first LV guide sheath which precluded placement of a second LV lead. Intrinsic mean peak dP/dt was 731±170 mm Hg/s. This improved to 924±228 mm Hg /s with LV1 pacing (p Conclusions Empirical posterolateral LV pacing gives similar acute haemodynamic response to dual site LV pacing. Dual site LV pacing confers further acute haemodynamic benefit only in the case of suboptimal LV lead positioning and may represent a therapeutic approach to CRT non-responders.
Luca Santini - One of the best experts on this subject based on the ideXlab platform.
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hospitalization rates and associated cost analysis of cardiac resynchronization therapy with an implantable defibrillator and quadripolar vs bipolar Left Ventricular Leads a comparative effectiveness study
Europace, 2015Co-Authors: G B Forleo, Luigi Di Biase, Nirav Dalal, Luca Santini, Rupinder Bharmi, Germana Panattoni, Annalisa Pollastrelli, Manfredi Tesauro, Andrea NataleAbstract:Aims This study compares, from a prospective, observational, non-randomized registry, the post-implant hospitalization rates and associated healthcare resource utilization of cardiac resynchronization therapy-defibrillator (CRT-D) patients with quadripolar (QUAD) vs. bipolar (BIP) Left Ventricular (LV) Leads. Methods and results Between January 2009 and December 2012, 193 consecutive patients receiving de novo CRT-D implants with either a QUAD ( n = 116) or a BIP ( n = 77) LV lead were enrolled at implant and followed until July 2013 at a single-centre, university hospital. Post-implant hospitalizations related to heart failure (HF) or LV lead surgical revision and associated payer costs were identified using ICD-9-CM diagnosis and procedure codes. Italian national reimbursement rates were determined. Propensity scores were estimated using a logistic regression model based upon 11 pre-implant baseline characteristics and were used to derive a 1 : 1 matched cohort of QUAD ( n = 77) and BIP ( n = 77) patients. Hospitalization rates for the two groups were compared using negative binomial regression and associated payer costs were compared using non-parametric bootstrapping (×10 000) and one-sided hypothesis test. Hospitalization rates of the QUAD group [0.15/ patient (pt)-year] were lower than those of the BIP group (0.32/ pt-year); the incidence rate ratio was 0.46, P = 0.04. The hospitalization costs for the QUAD group (434 ± 128 €/pt-year) were lower than those for the BIP group (1136 ± 362 €/pt-year). The average difference was 718 €/pt-year, P = 0.016. Conclusions In this comparative effectiveness assessment of well-matched groups of CRT-D patients with quadripolar and bipolar LV Leads, QUAD patients experienced a lower rate of hospitalizations for HF and LV lead surgical revision, and a lower cost burden. This has important implications for LV pacing lead choice.
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non invasive hemodynamic analysis in cardiac resynchronization therapy patients wearing quadripolar Left Ventricular Leads the importance of pacing electrode selection
European Review for Medical and Pharmacological Sciences, 2014Co-Authors: Luca Santini, J Legramante, F Condemi, L Santucci, M Panattoni, P Crobeddu, Domenico Sergi, G B Forleo, Francesco RomeoAbstract:Quadripolar Left Ventricular (LV) Leads offer multiple choices for LV pacing increasing programming flexibility. Aim of this study is to assess the influence of LV pacing vector selection on hemodynamic parameters for patients who underwent cardiac resynchronization therapy (CRT) using quadripolar LV lead chronically evaluated with a non-invasive approach by Nexfin(®) system provided analysis (BMEYE B.V., Amsterdam, The Netherlands).
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non invasive hemodynamic analysis in cardiac resynchronization therapy patients wearing quadripolar Left Ventricular Leads the importance of pacing electrode selection
Minerva Cardioangiologica, 2014Co-Authors: Luca Santini, J Legramante, F Condemi, L Santucci, M Panattoni, P Crobeddu, Domenico Sergi, G B Forleo, Francesco RomeoAbstract:AIM Quadripolar Left Ventricular (LV) Leads offer multiple choices for LV pacing increasing programming flexibility. Aim of this study is to assess the influence of LV pacing vector selection on hemodynamic parameters for patients who underwent cardiac resynchronization therapy (CRT) using quadripolar LV lead chronically evaluated with a non-invasive approach by Nexfin(®) system provided analysis (BMEYE B.V., Amsterdam, The Netherlands). METHODS AND RESULTS In 16 CRT patients implanted with a quadripolar LV lead (mean follow-up 8,8 ±13,4 months after implantation), we measured Cardiac Output (CO), Mean Blood Pressure (MBP), Total Peripheral Resistance (TPR), LV dP/dt max and Stroke volume (SV) from each one of the ten available bipolar pacing configurations. All the recorded parameters showed marked differences among the ten pacing configurations, but dP/dt max, SV and TPR were those showing the wider range, depending of the selected pacing vector. The average delta for the whole group of subjects between the maximum and minimum hemodynamic values for each pacing configuration were 15.9% for SV, 21.1% for dP/dt max and 20.3% for TPR. Inter-individual analysis of data failed to identify a link between a specific pacing vector and the hemodynamic response. CONCLUSION Our study demonstrates that different bipolar pacing configurations, even if arising from a single CS branch, substantially modify the hemodynamic effect of LV pacing in CRT patients. Moreover, the non-invasive hemodynamic analysis suggests the better pacing configuration should be established individually and could represent an important issue in optimizing CRT during follow-up.