Publications by authors named "Massimo Giammaria"

47 Publications

Prevalence and predictors of atrial fibrillation in patients with embolic stroke of undetermined source: a real-life single-center retrospective study.

Neurol Sci 2021 Jan 14. Epub 2021 Jan 14.

SC Neurologia 1 - Ospedale Maria Vittoria, Via Cibrario 72, 10144, Torino, Italy.

Introduction: Up to one-third of ischemic strokes remained cryptogenic despite extensive investigations. Atrial fibrillation may be detected in a significant proportion of patients with embolic stroke of undetermined source, particularly after the introduction of implantable loop recorder in clinical practice.

Methods: We retrospectively included all the consecutive patients with embolic stroke of undetermined source referred to our units in the period November 2013 to December 2018 and in which an implantable loop recorder was positioned within 6 months from stroke event. Prevalence and predictors of atrial fibrillation were investigated.

Results: One hundred thirty-eight patients with embolic stroke of undetermined source fulfilling inclusion criteria were identified. The crude prevalence of atrial fibrillation at the end of observation period was of 45.7%. Incidence rates at 6, 12, 18, 24, and 36 months resulted, respectively, 31.8% (95% CI, 30.4-46.7), 38.0% (95% CI, 30.4-46.9), 42.6% (95% CI, 34.5-51.6), 46.6% (95% CI, 38.2-55.8), and 50.4% (95% CI, 41.6-59.9). On multivariate analysis, only excessive supraventricular electric activity and left atrial enlargement resulted to be significant predictors of atrial fibrillation (p = 0.037 and p < 0.0001, respectively).

Conclusions: Atrial fibrillation may be detected in a relevant proportion (up to 50%) of patients with embolic stroke of undetermined source if a careful and extensive diagnostic work-up is employed. Excessive supraventricular electric activity and left atrial enlargement are significant predictors of the occurrence of atrial fibrillation in these patients.
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http://dx.doi.org/10.1007/s10072-020-04963-9DOI Listing
January 2021

Gender differences in acute coronary syndromes patterns during the COVID-19 outbreak.

Am J Cardiovasc Dis 2020 15;10(4):506-513. Epub 2020 Oct 15.

Division of Cardiology, A.O.U Città della Salute e della Scienza di Torino Turin, Italy.

Background: Mortality from acute coronary syndromes (ACS) is strictly related to early management. As female patients usually experience longer delays before diagnosis and treatment, we assessed whether women were more affected by the dramatic drop in hospital admissions for ACS during the Covid-19 pandemic.

Methods: We performed a retrospective analysis of clinical and angiographic characteristics of consecutive patients who were admitted for ACS at 15 hospitals in Northern Italy comparing men and women data. The study period was defined as the time between the first confirmed case of Covid-19 in Italy (February 20, 2020) and March 31, 2020. We compared hospitalization rates between the study period and two control periods: the corresponding period during the previous year (February 20 to March 31, 2019) and the earlier period during the same year (January 1 to February 19, 2020). Incidence rate ratios comparing the study period with each of the control periods were calculated with the use of Poisson regression.

Results: Of the 547 patients who were hospitalized for ACS during the study period, only 127 (23%) were females, accounting for a mean of 3.1 admissions per day, while ACS hospitalized males were 420, with a mean of 10.2 admissions per day. There was a significant decrease driven by a similar reduction in ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) diagnosis in both sexes compared to the control periods. A trend toward a greater reduction in admitted females was shown in the intra-year control period (46% admission reduction in females vs 37% in males, with females accounting for 26% of ACS, P=0.10) and a significant reduction when compared to the previous year control period (40% admission reduction in females vs 23% in males, with females accounting for 28% of ACS, P=0.03), mainly related to Unstable Angina diagnosis.

Conclusion: The Covid-19 pandemic period closed the gap between men and women in ACS, with similar rates of reduction of hospitalized STEMI and NSTEMI and a trend toward greater reduction in UA admission among women. Furthermore, many typical differences between males and females regarding ischemic heart disease presentations and vessel distribution were leveled.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7675165PMC
October 2020

Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial.

Open Heart 2020 10;7(2)

Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.

Background: The role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.

Methods And Analysis: PULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.

Trial Registration Number: NCT04144881.
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http://dx.doi.org/10.1136/openhrt-2020-001253DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7597506PMC
October 2020

Syncope as the presenting symptom of COVID-19 infection.

HeartRhythm Case Rep 2020 Jul 5;6(7):363-366. Epub 2020 May 5.

Cardiology Division, Maria Vittoria Hospital, Turin, Italy.

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http://dx.doi.org/10.1016/j.hrcr.2020.04.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7198999PMC
July 2020

Atrial signal amplitude predicts atrial high-rate episodes in implantable cardioverter defibrillator patients: Insights from a large database of remote monitoring transmissions.

J Arrhythm 2020 Apr 2;36(2):353-362. Epub 2020 Mar 2.

Ospedale Vito Fazzi Lecce Italy.

Background: Parameters measured during implantable cardioverter defibrillator (ICD) implant also depend on bioelectrical properties of the myocardium. We aimed to explore their potential association with clinical outcomes in patients with single/dual-chamber ICD and cardiac resynchronization therapy defibrillator (CRT-D).

Methods: In the framework of the Home Monitoring Expert Alliance, baseline electrical parameters for all implanted leads were compared by the occurrence of all-cause mortality, adjudicated ventricular arrhythmia (VA), and atrial high-rate episode lasting ≥24 hours (24 h AHRE).

Results: In a cohort of 2976 patients (58.1% ICD) with a median follow-up of 25 months, event rates were 3.1/100 patient-years for all-cause mortality, 18.1/100 patient-years for VA, and 9.3/100 patient-years for 24 h AHRE. At univariate analysis, baseline shock impedance was consistently lower in groups with events than without, with a 40 Ω cutoff that better identified high-risk patients. However, at multivariable analysis, the adjusted-hazard ratios (HRs) lost statistical significance for any endpoint. Baseline atrial sensing amplitude during sinus rhythm was lower in patients with 24 h AHRE than in those without (2.45 [IQR: 1.65-3.85] vs 3.51 [IQR: 2.37-4.67] mV,  < .01). The adjusted HR for 24 h AHRE in patients with atrial sensing >1.5 mV vs those with values ≤1.5 mV was 0.52 (95% CI: 0.33-0.83),  = .006.

Conclusions: Although lower baseline shock impedance was observed in patients with events, the association lost statistical significance at multivariable analysis. Conversely, low sinus rhythm atrial sensing (≤1.5 mV) measured with standard transvenous leads could identify subjects at high risk of atrial arrhythmia.
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http://dx.doi.org/10.1002/joa3.12319DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7132187PMC
April 2020

Clinical and economic impact of multipoint left ventricular pacing: A comparative analysis from the Italian registry on multipoint pacing in cardiac resynchronization therapy (IRON-MPP).

J Cardiovasc Electrophysiol 2020 05 12;31(5):1166-1174. Epub 2020 Mar 12.

Division of Cardiology, Santa Maria della Misericordia Hospital, Rovigo, Italy.

Introduction: Early evidence suggests that multipoint left ventricular pacing (MPP) may improve response to cardiac resynchronization therapy (CRT). It is unknown whether this benefit is sustained and cost-effective. We used real-world data to evaluate long-term impact of MPP-ON clinical status, heart failure hospitalizations (HFH) and costs.

Methods: The Italian registry on multipoint left ventricular pacing is a prospective, multicenter registry of patients implanted with MPP-enabled CRT devices. For this analysis, clinical and echocardiographic data were collected through 24 months and compared between patients with (MPP-ON) or without (MPP-OFF) early MPP activation at implant. The total cost of each HFH was estimated with national Italian reimbursement rates.

Results: The study included 190 MPP-OFF and 128 MPP-ON patients with similar baseline characteristics. At 1 and 2 years, the MPP-ON group had lower rates of HFH vs MPP-OFF (1-year hazard ratio [HR]: 0.14, P = .0014; 2-year HR: 0.38, P = .009). The finding persisted in a subgroup of patients with consistent MPP activation through follow-up (1-year HR: 0.19; P = .0061; 2-year HR: 0.39, P = .022). Total HFH per-patient costs were lower in the MPP-ON vs the MPP-OFF group at 1 year (€101 ± 50 vs €698 ± 195, P < .001) and 2 years (€366 ± 149 vs €801 ± 203, P = .038). More MPP-ON patients had ≥5% improvement in ejection fraction (76.8% vs 65.4%, P = .025) and clinical composite score (66.7% vs 47.5%, P = .01).

Conclusions: In this multicenter clinical study, early MPP activation was associated with a significant reduction in cumulative HFH and related costs after 1 and 2 years of follow-up.
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http://dx.doi.org/10.1111/jce.14433DOI Listing
May 2020

Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations: An Analysis From the RAIN-CARDIOGROUP VII Study.

Circ Cardiovasc Interv 2020 03 27;13(3):e008325. Epub 2020 Feb 27.

Division of Cardiology, Department of Medical Science, Città della Salute e della Scienza, Turin (F.D., A.S., F.F., A. Montefusco, G.d.L., F.B., P.O., M.R., F.C., M.D., G.M.D.F.).

Background: There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations.

Methods: All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique.

Results: Two thousand seven hundred forty-two patients were included. At 16 months (8-20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; =0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; =0.030) and target lesion revascularization (7.3% versus 15.2%; =0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; =0.034), while long overlap was not (6.8% versus 5.4%; =0.567).

Conclusions: In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03544294.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008325DOI Listing
March 2020

Impact of multipoint pacing on projected battery longevity in cardiac resynchronization therapy. An IRON-MPP study sub-analysis.

J Cardiovasc Electrophysiol 2019 12 5;30(12):2885-2891. Epub 2019 Nov 5.

Department of Cardiology, Ospedale GB Grassi, Ostia, Italy.

Background: Multipoint pacing (MPP) may improve clinical outcomes in patients with cardiac resynchronization therapy defibrillators (CRT-D), but its impact on battery longevity in a real-world population has not been investigated in large trials.

Objective: Compare projected battery longevity in CRT-D patients with and without MPP during long-term follow-up.

Methods: The Italian registry on multipoint left ventricular pacing (IRON-MPP) is a prospective, multicenter registry of patients implanted with MPP-capable CRT-D devices. Projected battery longevity during follow-up was compared for patients with MPP (MPP ON) vs single-site (MPP OFF) left ventricular pacing at CRT-D implantation. A sub-analysis excluded crossover patients with MPP activation or deactivation occurring after implantation. A second sub-analysis excluded patients with a right or left ventricular pacing amplitude >2.5 V.

Results: Out of 237 CRT-D patients (71 ± 9 years, 81% male) followed for 1.9 ± 0.8 years, 102 (43%) had MPP ON at implantation. Programmed atrial and ventricular outputs and percentage of pacing were similar between groups. MPP was associated with a 0.44 years reduction in projected battery longevity (P = .03) during long-term follow-up. Results were similar for the first and second sub-analyses, with a 0.57 years (P < .001) and 0.71 years (P < .001) reduction in projected longevity, respectively.

Conclusion: In this long-term real-world registry, early MPP activation is associated with less than a 1-year reduction in projected battery life compared to single-site biventricular pacing.
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http://dx.doi.org/10.1111/jce.14254DOI Listing
December 2019

Are Atrial High-Rate Episodes Associated With Increased Risk of Ventricular Arrhythmias and Mortality?

JACC Clin Electrophysiol 2019 10 28;5(10):1197-1208. Epub 2019 Aug 28.

Department of Arrhythmias, CardioArrhythmology Center, Rome, Italy.

Objectives: This study evaluated the temporal association between atrial high-rate episodes (AHREs) and sustained ventricular arrhythmias (VAs) in a remotely monitored cohort with implantable cardioverter-defibrillators (ICD) with and/or without cardiac resynchronization therapy with a defibrillator (CRT-D).

Background: Clinical relevance of AHREs in terms of VA rate and survival has not been outlined yet.

Methods: This study analyzed data of patients with ICDs and CRT-Ds from the nationwide Home Monitoring Expert Alliance network. The cohort included 2,435 patients with a median follow-up of 25 months (interquartile range: 13 to 42 months) and age 70 years (range 61 to 77 years); 19.7% were women, 51.4% had coronary artery disease, and 45.2% had a CRT-D. There were 3,410 appropriate VA episodes; 498 (14.6%) were preceded by AHREs within 48 h; in 85.5% of this group, AHREs were still ongoing at episode onset.

Results: In a longitudinal analysis, the odds ratios (ORs) of experiencing any VA in a 30-day interval with AHREs versus intervals without AHREs were 2.35 (95% confidence interval [CI]: 1.86 to 2.97; p < 0.001) for ventricular tachycardia (VT), 3.06 (95% CI: 2.35 to 3.99; p < 0.001) for fast VT, 1.84 (95% CI: 1.36 to 2.48; p < 0.001) for self-extinguishing ventricular fibrillation (VF), and 2.31 (95% CI: 1.17 to 4.57; p = 0.01) for VF. ORs decreased with increasing AHRE burden. Patients with AHREs 48 h before VAs were more likely to experience VA recurrences (adjusted hazard ratio [HR]: 1.78; 95% CI: 1.41 to 2.24; p < 0.001) and had higher overall mortality (HR: 2.67; 95% CI: 1.68 to 4.23; p < 0.001).

Conclusions: AHREs were not uncommon 48 h before VAs, which tended to be distributed around intervals with AHREs. Temporal connection between AHREs and VAs was a marker of increased risk of VA recurrence and a poorer prognosis.
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http://dx.doi.org/10.1016/j.jacep.2019.06.018DOI Listing
October 2019

Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries.

Catheter Cardiovasc Interv 2020 02 5;95(3):522-529. Epub 2019 Aug 5.

Division of Cardiology, A.O.U. Città della Salute e della Scienza, University of Turin, Turin, Italy.

Objectives: Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation.

Background: PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation.

Methods: We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints.

Results: Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8-20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p = .19 and 1.8 vs. 1.1%, p = .42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p = .49 and .76), for non-ULM group (2.1 vs. 3.4%, p = .56 and 1.2 vs. 1.7%, p = .78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p = .75 and .91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p = .04) with higher although not significant rates of ST (3 vs. 0%, p = .45).

Conclusions: PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST.
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http://dx.doi.org/10.1002/ccd.28413DOI Listing
February 2020

[Infero-postero-lateral acute myocardial infarction caused by left ventricular myxoma embolism].

G Ital Cardiol (Rome) 2019 Feb;20(2):117-119

Divisione di Cardiologia, Dipartimento di Medicina Interna, Ospedale Maria Vittoria, Torino.

The majority of myxomas are located in the left atrium (75%) followed by the right atrium (20%). In rare cases, myxomas can be found in the ventricles, with 2.5% reported for myxomas in the left ventricle. Systemic emboli, mostly cerebral, occur in two thirds of such patients, while coronary emboli are rare. Here we report a case of left ventricular myxoma causing infero-postero-lateral myocardial infarction, successfully treated by intracoronary thromboaspiration of myxoma embolus.
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http://dx.doi.org/10.1714/3093.30859DOI Listing
February 2019

Subcutaneous implantable cardioverter defibrillator in patients with arrhythmogenic right ventricular cardiomyopathy: Results from an Italian multicenter registry.

Int J Cardiol 2019 04 12;280:74-79. Epub 2019 Jan 12.

Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Italy. Electronic address:

Background: Despite expanding indication of the subcutaneous implantable cardioverter defibrillator (S-ICD) in clinical practice, limited data exists on safety and efficacy of S-ICD in arrhythmogenic right ventricular cardiomyopathy (ARVC) patients. The aim of this multicenter study was to evaluate the safety and efficacy of S-ICD in ARVC patients.

Methods: The study population included 44 consecutive patients with definite ARVC diagnosis according to the 2010 ITF criteria (57% male, mean age 37 ± 17 years [range 10-75 years]) who received an S-ICD. Eighteen (41%) patients were implanted for secondary prevention.

Results: At implant, all inducible patients (34/44) had conversion of ventricular fibrillation at 65 J. No early complications occurred. During a median follow-up of 12 months (7-19), 3 (6.8%) patients experienced complications requiring surgical revision. No local or systemic device-related infections were observed. Six patients (14%) received a total of 61 appropriate and successful shocks on ventricular arrhythmias. Six (14%) patients experienced 8 inappropriate shocks for oversensing of cardiac signal (4 cases) and non-cardiac signal (4 cases) with one patient requiring device explantation. No patients had the device explanted due to the need for antitachycardia pacing.

Conclusions: The study shows that S-ICD provides safe and effective therapy for termination of both induced and spontaneous malignant ventricular tachyarrhythmias with high energy shocks in ARVC patients, but the risk of inappropriate shocks and complications needing surgical revision should be considered.
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http://dx.doi.org/10.1016/j.ijcard.2019.01.041DOI Listing
April 2019

Optimization of coronary sinus lead placement targeted to right-to-left delay in patients undergoing cardiac resynchronization therapy.

Europace 2019 Mar;21(3):502-510

Arrhythmologic Center, Ospedali del Tigullio, Via Don Bobbio 24, Lavagna, Italy.

Aims: Anatomical placement of the coronary sinus (CS) lead in basal or mid-ventricular positions of the posterior and lateral walls is associated with a better clinical outcome of cardiac resynchronization therapy (CRT). We hypothesized that optimization of CS lead placement targeted the right-to-left electrical delay (RLD) predicts an additional clinical benefit.

Methods And Results: The CS lead was placed according to current standards in 90 patients (Conventional group) and at the site of the longest RLD in 121 patients (RLD group). Non-responders were defined as those who died or underwent hospitalization for heart failure or did not improve in their Clinical Composite Score within 6 months. There were 67 (32%) non-responders. Compared with Conventional group, the final CS pacing site was more frequently in the basal segments in the RLD group (40% vs. 23%, P = 0.007); moreover, the RLD ratio (%RLD) of the total QRS width was longer (77 ± 13 vs. 73 ± 15, P = 0.05) and biventricular QRS shortened more from the baseline (-31 ± 21 ms vs. -21 ± 26 ms, P = 0.004). Nevertheless, the rate of non-responders was similar in the RLD and Conventional groups (35% vs. 28%, P = 0.30), as was %RLD (76 ± 16 vs. 75 ± 13, P = 0.66). QRS width during right ventricular (RV) pacing was an independent predictors of adverse outcome, with a 2% increase in the risk of failure for each 1 ms increase in QRS (P = 0.006).

Conclusion: Optimization of CS lead placement targeted to latest electrical activation does not provide additional clinical benefit to anatomical placement in basal or mid-ventricular positions of the posterior and lateral walls. QRS width during RV pacing was a strong predictor of CRT failure.

Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT03204864.
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http://dx.doi.org/10.1093/europace/euy275DOI Listing
March 2019

Remote monitoring of subcutaneous implantable cardioverter defibrillators.

J Interv Card Electrophysiol 2018 Dec 1;53(3):373-381. Epub 2018 Oct 1.

Marche Polytechnic University, Ancona, Italy.

Background: Remote monitoring (RM) of implantable cardioverter defibrillators (ICD) has been shown to improve patient safety and reduce in-office visits. The subcutaneous ICD (S-ICD) is an effective alternative to transvenous ICD and has recently been endowed with the RM function. However, the RM communicator for S-ICD requires patient interaction to activate data transmission. We assessed patient compliance and acceptance.

Methods: Patients with S-ICD received the communicator and were followed up for 15 months. Weekly remote transmissions were programmed. Compliance with checks was measured as the number of checks performed by the patient divided by the number of automatic notifications by the communicator. A questionnaire on acceptance of the system was administered to patients.

Results: A total of 106 patients were analyzed. The proportion of weekly checks properly executed by the patients was 94% during the first 3 months and 93% from months 12 to 15. Of the checks performed, 93% were on the same day as the automatic notification. On a patient basis, compliance with weekly checks was > 85% (less than one check missed per month) in 88% of patients during the first 3 months and in 82% from months 12 to 15 (p = 0.615). No variables emerged as predictors of lower (≤ 85%) long-term compliance with weekly checks. During follow-up, 49 alerts were transmitted and the mean delay between the detected event and the patient transmission was 2 ± 2 days. The majority of patients found the system easy to use and felt confident about being remotely monitored.

Conclusions: The level of patient compliance with remote checks is high with current technology for RM of S-ICD. The vast majority of data transmissions are consistently performed on a weekly basis on the day scheduled.
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http://dx.doi.org/10.1007/s10840-018-0459-3DOI Listing
December 2018

Eligibility of cardiac resynchronization therapy patients for subcutaneous implantable cardioverter defibrillators.

J Interv Card Electrophysiol 2019 Jan 4;54(1):49-54. Epub 2018 Sep 4.

Boston Scientific Italy, Milan, Italy.

Background: Before subcutaneous implantable cardioverter defibrillator (S-ICD) implantation, the adequacy of sensing is required to be verified through surface ECG screening. Our objective was to determine whether S-ICD can be considered as a supplementary therapy in patients who are receiving biventricular (BIV) pacing.

Methods: We evaluated 48 patients with BIV devices to determine S-ICD candidacy during BIV, left ventricular (LV), right ventricular (RV) pacing, and intrinsic conduction (left bundle branch block-LBBB) by using an automated screening tool. Eligibility was defined by the presence of at least one appropriate vector in the supine and standing positions.

Results: Eligibility was verified during BIV pacing in 34 (71%) patients. In patients screened-out, QRS duration was longer (p = 0.035) and ischemic cardiomyopathy was more frequent (p = 0.027). LV-only pacing was associated with a lower passing rate (46%) (p < 0.001 versus BIV). The LBBB QRS morphology during inhibited ventricular pacing was acceptable in 51% of patients. The QRS generated by RV pacing was acceptable in 25% of patients. In patients who passed the screening test during BIV, the QRS was not acceptable in 76% during RV pacing (i.e., accidental loss of LV capture). The concomitant adequacy during inhibited ventricular pacing (i.e., possible intrinsic conduction) was not assessed in 40% of patients.

Conclusions: S-ICD may be a supplemental therapy in the majority of CRT patients. Standard BIV pacing should be preferred to the LV-only pacing mode, as it is more frequently associated with adequacy of S-ICD sensing. Spontaneous LBBB and RV-paced QRS morphologies are frequently inadequate. Therefore, in patients selected for concomitant S-ICD and CRT implantation, accidental loss of LV capture or possible intrinsic conduction must be prevented.
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http://dx.doi.org/10.1007/s10840-018-0437-9DOI Listing
January 2019

Subcutaneous implantable cardioverter defibrillator implantation: An analysis of Italian clinical practice and its evolution.

Int J Cardiol 2018 Dec 31;272:162-167. Epub 2018 Jul 31.

Second Cardiology Division, Cardio-Thoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.

Background: The subcutaneous implantable cardioverter defibrillator (S-ICD) is a relatively novel alternative to the transvenous ICD for the treatment of life-threatening ventricular arrhythmias, and is currently used in the clinical practice of several centers. The aim of this analysis was to describe current Italian practice regarding S-ICD implantation and its evolution over the years.

Methods: We analyzed 607 consecutive patients (78% male, 48 ± 16 years) who underwent S-ICD implantation in 39 Italian centers from 2013 to 2017.

Results: Structural cardiomyopathy was present in 78% of patients and 30% of patients received their device for secondary prevention. The proportion of patients with dilated cardiomyopathy and with left ventricular ejection fraction ≤35% increased from ≤2014 to 2017 (from 38% to 58%, from 33% to 53%, respectively; both p < 0.05). Almost all procedures (97%) were performed in electrophysiology laboratories. Over the last 4 years, the 2-incision implantation technique has been widely adopted, with sub- or inter-muscular positioning of the generator, under local anesthesia or deep sedation (≤2014 versus 2017: all p < 0.001). Defibrillation testing was performed in 81% of patients. Shock energy of ≤65 J was successful in 93.9% of patients and the overall cardioversion success rate at ≤80 J was 99.8%.

Conclusions: Our analysis confirmed that the S-ICD continues to be preferentially used in specific patients (younger, less frequently with dilated cardiomyopathy and low ejection fraction.). Nonetheless, we noted a trend toward the wider use of S-ICD in patients with dilated cardiomyopathy and systolic dysfunction over the years. Novel approaches have been adopted while the acute efficacy of the system has remained stably high.
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http://dx.doi.org/10.1016/j.ijcard.2018.07.139DOI Listing
December 2018

Chronic Apical and Nonapical Right Ventricular Pacing in Patients with High-Grade Atrioventricular Block: Results of the Right Pace Study.

Biomed Res Int 2018 22;2018:1404659. Epub 2018 May 22.

Ospedale Pugliese-Ciaccio, Catanzaro, Italy.

Objective: The aim of the study was to compare the two approaches to chronic right ventricular pacing currently adopted in clinical practice: right ventricular apical (RVA) and non-RVA pacing.

Background: Chronic RVA pacing is associated with an increased risk of atrial fibrillation, morbidity, and even mortality. Non-RVA pacing may yield more physiologic ventricular activation and provide potential long-term benefits and has recently been adopted as standard procedure at many implanting centers.

Methods: The Right Pace study was a multicenter, prospective, single-blind, nonrandomized trial involving 437 patients indicated for dual-chamber pacemaker implantation with a high percentage of RV pacing.

Results: RV lead-tip target location was the apex or the interventricular septum. RVA (274) and non-RVA patients (163) did not differ in baseline characteristics. During a median follow-up of 19 months (25th-75th percentiles, 13-25), 17 patients died. The rates of the primary outcome of death due to any cause or hospitalization for heart failure were comparable between the groups (log-rank test, = 0.609), as were the rates of the composite of death due to any cause, hospitalization for heart failure, or an increase in left ventricular end-systolic volume ≥ 15% as compared with the baseline evaluation (secondary outcome, = 0.703). After central adjudication of X-rays, comparison between adjudicated RVA (239 patients) and non-RVA (170 patients) confirmed the absence of difference in the rates of primary ( = 0.402) and secondary ( = 0.941) outcome.

Conclusions: In patients with indications for dual-chamber pacemaker who require a high percentage of ventricular stimulation, RVA or non-RVA pacing resulted in comparable outcomes. This study is registered with ClinicalTrials.gov (identifier: NCT01647490).
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http://dx.doi.org/10.1155/2018/1404659DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5987304PMC
January 2019

The EUROpean and Chinese cardiac and renal Remote Ischemic Preconditioning Study (EURO-CRIPS CardioGroup I): A randomized controlled trial.

Int J Cardiol 2018 04;257:1-6

Division of Cardiology, Città Della Salute e Della Scienza, Turin, Italy.

Background: The potential protective effects of remote ischemic preconditioning (RIPC) on contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) remain to be defined.

Methods And Results: A double blind, randomized, placebo controlled multicenter study was performed. Patients younger than 85years old, with a renal clearance of 30-60ml/min/1.73m, who were candidates for PCI for all clinical indications except for primary PCI, were allocated 1:1 to RIPC or to standard therapy. The primary endpoint was incidence of CIN. The secondary endpoint was incidence of peri-procedural myocardial infarction (PMI). From February 2013 to April 2014, 3108 patients who were scheduled for coronary angiography were screened for the study. 442 fulfilled the inclusion criteria and 223 received PCI. These patients were randomized to sham RIPC (n=107) or treatment group (n=116). The only pre-specified subgroup of diabetic patients included 85 (38%) cases. RIPC significantly reduced CIN incidence in the overall population (12.1% vs. 26.1%, p=0.01, with a NNT=9) and in non-diabetic patients (9.2% vs. 25.0%, p=0.02), but showed no benefit in diabetics (16.7% vs. 28.2%, p=0.21). A trend for lower PMI was seen in the intervention arm (creatine kinase - muscle brain >5 URL; 8.4% vs. 16.4%, p=0.07; troponin T >5 URL; 27% vs. 38%, p=0.21).

Conclusions: Remote ischemic preconditioning significantly reduces the incidence of acute kidney injury in non-diabetic patients undergoing PCI. Larger sample size is presumably needed to assess the effect of RIPC for patients with diabetes mellitus. Clinical Trial number:NCT02195726https://www.clinicaltrial.gov/.
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http://dx.doi.org/10.1016/j.ijcard.2017.12.033DOI Listing
April 2018

Does the CHADS-VASc score reliably predict atrial arrhythmias? Analysis of a nationwide database of remote monitoring data transmitted daily from cardiac implantable electronic devices.

Heart Rhythm 2018 07 1;15(7):971-979. Epub 2018 Mar 1.

Ospedale Vito Fazzi, Lecce, Italy.

Background: CHADS-VASc is a validated score for predicting stroke in patients with atrial fibrillation (AF).

Objective: The purpose of this study was to assess whether the CHADS-VASc score can predict new-onset AF in a cohort of patients with a cardiac implantable electronic device (CIED) followed with remote monitoring.

Methods: Using the database of the Home Monitoring Expert Alliance project, we selected 2410 patients with no documented AF who had received a CIED with diagnostics on atrial high rate episodes (AHREs). The primary endpoint was time to first day with cumulative AHRE burden ≥15 minutes, 5 hours, 24 hours, and ≥7 consecutive days.

Results: During a median duration of 24.1(11.5-42.9) months, the incidence of AHRE increased with increasing CHADS-VASc. At 6 years, occurrence of ≥15-minute AHRE was 80.2% (CHADS-VASc ≤1) vs 93.7% (CHADS-VASc ≥5), whereas ≥5-hour AHRE incidence was 68.4% (CHADS-VASc ≤1) vs 92.5% (CHADS-VASc ≥5). Occurrence of ≥24-hour and ≥7-day AHREs also increased with increasing CHADS-VASc: 9.1% and 3.9% (CHADS-VASc ≤1) vs 40.4% and 28.7% (CHADS-VASc ≥5), respectively. Adjusted hazard ratio for unitary CHADS-VASc increase ranged from 1.09 (confidence interval 1.04-1.14; P <.001) with AHRE burden ≥15 minutes to 1.26 (confidence interval 1.11-1.42; P <.001) with AHRE burden ≥7 days. At receiver operating curve analysis, CHADS-VASc ≥2 was estimated to predict persistent forms of AHREs with 95.8% sensitivity but 11.7% specificity at 3 years. CHADS-VASc ≥5 had 77.0% specificity but 34.6% sensitivity.

Conclusion: In a CIED population with no previous diagnosis of clinical AF, AHRE incidence increased with increasing CHADS-VASc score. The association was stronger with longer AHREs, but the accuracy of CHADS-VASc as AHRE predictor was moderate.
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http://dx.doi.org/10.1016/j.hrthm.2018.02.023DOI Listing
July 2018

Optimization of coronary sinus lead placement targeted to the longest right-to-left delay in patients undergoing cardiac resynchronization therapy: The Optimal Pacing SITE 2 (OPSITE 2) acute study and protocol.

Pacing Clin Electrophysiol 2017 Dec 16;40(12):1350-1357. Epub 2017 Nov 16.

Ospedali del Tigullio, Lavagna, Italy.

Aims: Left ventricular (LV) lead positioning at the site of delayed electrical activation is associated with better response to cardiac resynchronization therapy (CRT). We hypothesized that a long electrical conduction delay between right ventricular (RV) and coronary sinus (CS) leads during RV pacing (RLD index) is correlated with a better clinical outcome METHODS AND RESULTS: RLD is measured intraprocedurally, during RV pacing, as the time interval between the intracardiac electrograms of RV and CS leads. Initially, we did a prove-of-concept, feasibility, acute study in 97 patients who underwent CRT implantation. The CS lead position was assessed in the 40° right anterior oblique and 40° left anterior oblique views and assigned to one of 11 prespecified segments of a schematic eyeball depiction of the LV walls. Acute outcomes were QRS width during biventricular (BIV) pacing. The longest RLD were found in the basal and mid lateral segments; these accounted for 82% and 78%, respectively, of the total QRS width (%RLD). %RLD was inversely correlated with BIV-paced QRS (P  =  0.0001). A similar slope was present either in the 78 patients with preserved atrioventricular (AV) conduction and in the 19 without AV conduction (- 0.34 vs - 0.27, P  =  0.7).

Conclusion: We showed that RLD can be used to guide lead placement at the time of CRT implantation and that it is correlated with BIV-QRS width, an indirect predictor of clinical outcome. Based on these findings we started the prospective, multicenter Optimal Pacing SITE 2 (OPSITE 2) trial with the objective to demonstrate a relationship between RLD and clinical outcomes assessed as death, hospitalization for heart failure, New York Heart Association class, and clinical composite score. The protocol is provided.
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http://dx.doi.org/10.1111/pace.13212DOI Listing
December 2017

ANMCO/SIT Consensus Document: telemedicine for cardiovascular emergency networks.

Eur Heart J Suppl 2017 May 2;19(Suppl D):D229-D243. Epub 2017 May 2.

Italian Society for Telemedicine and eHealth (Digital SIT), Florence, Italy.

Telemedicine has deeply innovated the field of emergency cardiology, particularly the treatment of acute myocardial infarction. The ability to record an ECG in the early prehospital phase, thus avoiding any delay in diagnosing myocardial infarction with direct transfer to the cath-lab for primary angioplasty, has proven to significantly reduce treatment times and mortality. This consensus document aims to analyse the available evidence and organizational models based on a support by telemedicine, focusing on technical requirements, education, and legal aspects.
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http://dx.doi.org/10.1093/eurheartj/sux028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5520753PMC
May 2017

Automatic atrial capture device control in real-life practice: A multicenter experience.

J Arrhythm 2017 Apr 11;33(2):139-143. Epub 2016 Jul 11.

Cardiology, Ivrea Hospital, Ivrea, Italy.

Background: Device-based fully automatic pacing capture detection is useful in clinical practice and important in the era of remote care management. The main objective of this study was to verify the effectiveness of the new ACAP Confirm® algorithm in managing atrial capture in the medium term in comparison with early post-implantation testing.

Methods: Data were collected from 318 patients (66% male; mean age, 73±10 years); 237 of these patients underwent device implantation and 81 box changes in 31 Italian hospitals. Atrial threshold measurements were taken manually and automatically at different pulse widths before discharge and during follow-up (7±2 months) examination.

Results: The algorithm worked as expected in 73% of cases, considering all performed tests. The success rate was 65% and 88% pre-discharge and during follow-up examination (<0.001), respectively, in patients who had undergone implantation. We did not detect any difference in the performance of the algorithm as a result of the type of atrial lead used. The success rate was 70% during pre-discharge testing in patients undergoing device replacement. Considering all examination types, manual and automatic measurements yielded threshold values of 1.07±0.47 V and 1.03±0.47 V at 0.2-ms pulse duration (=0.37); 0.66±0.37 V and 0.67±0.36 V at 0.4 ms (=0.42); and 0.5±0.28 V and 0.5±0.29 V at 1 ms (=0.32).

Conclusions: The results show that the algorithm works before discharge, and its reliability increases over the medium term. The algorithm also proved accurate in detecting the atrial threshold automatically. The possibility of activating it does not seem to be influenced by the lead type used, but by the time from implantation.
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http://dx.doi.org/10.1016/j.joa.2016.06.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5388052PMC
April 2017

Comparison between IEGM-based approach and echocardiography in AV/PV and VV delay optimization in CRT-D recipients (Quicksept study).

Indian Pacing Electrophysiol J 2016 Mar-Apr;16(2):59-65. Epub 2016 Jun 3.

Cardiology Department, Ospedali Riuniti, Via Rivalta, 29, Rivoli, TO, Italy.

Background: AtrioVentricular (AV) and InterVentricular (VV) delay optimization can improve ventricular function in Cardiac Resynchronization Therapy (CRT) and is usually performed by means of echocardiography. St Jude Medical has developed an automated algorhythm which calculates the optimal AV and VV delays (QuickOpt™) based on Intracardiac ElectroGrams, (IEGM), within 2 min. So far, the efficacy of the algorhythm has been tested acutely with standard lead position at right ventricular (RV) apex. Aim of this project is to evaluate the algorhythm performance in the mid- and long-term with RV lead located in mid-septum.

Methods: AV and VV delays optimization data were collected in 13 centers using both echocardiographic and QuickOpt™ guidance in CRTD implanted patients provided with this algorhythm. Measurements of the aortic Velocity Time Integral (aVTI) were performed with both methods in a random order at pre-discharge, 6-month and 12-month follow-up.

Results: Fifty-three patients were studied (46 males; age 68 ± 10y; EF 28 ± 7%). Maximum aVTI obtained by echocardiography at different AV delays, were compared with aVTI acquired at AV delays suggested by QuickOpt. The AV Pearson correlations were 0.96 at pre-discharge, 0.95 and 0,98 at 6- and 12- month follow-up respectively. After programming optimal AV, the same approach was used to compare echocardiographic aVTI with aVTI corresponding to the VV values provided by QuickOpt. The VV Pearson Correlation were 0,92 at pre-discharge, 0,88 and 0.90 at 6-month and 12- month follow-up respectively.

Conclusions: IEGM-based optimization provides comparable results with echocardiographic method (maximum aVTI) used as reference with mid-septum RV lead location.
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http://dx.doi.org/10.1016/j.ipej.2016.05.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5832617PMC
September 2016

Active implanted cardiac devices and magnetic resonance: results of a survey among cardiologists of Piedmont.

J Cardiovasc Med (Hagerstown) 2017 Mar;18(3):185-195

aHead of the SOS Elettrophisiology, Cardiology, Maria Vittoria Hospital, Turin bCardiology, Rivoli Hospital (TO) cCardiology, Maria Vittoria Hospital, Turin dHead of the Elettrophisiology and Electro stimulation Laboratory, Civil Hospital of Brescia.

The recent introduction of Magnetic Resonance-conditional implantable cardiac device has abolished the previous absolute or relative contraindications to magnetic resonance scan also in patients implanted with such devices. The present survey aimed at investigating the level of knowledge of terms and conditions for a well-tolerated use of Magnetic Resonance-conditional devices prior, during and after magnetic resonance scan among cardiologists in Piedmont (Italy). A questionnaire consisting of 32 questions was distributed to 256 cardiologists and 73 responded to the survey. The interviewed considered loop recorders (18%), pacemakers (13%), implantable cardiac defibrillators (23%), and joint prostheses (20%) as an absolute contraindication to magnetic resonance. For pacemakers and implantable cardiac defibrillators, 87-77% of the respondents respectively indicated that the specific type of device may allow magnetic resonance, regardless the type of device. Ninety-three percent of the cardiologists did not perfectly recognize the meaning of the term 'Magnetic Resonance-conditional.' Half of respondents did not recognize the preliminary check to be performed on implanted electronic device before Magnetic Resonance. About 35% of the cardiologists replied that a magnetic resonance could not be prescribed in patients with implanted electronic devices because of a specific prohibition by Italian law. The results of the present survey highlight the need to fill knowledge gaps among cardiology specialists on this topic.
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http://dx.doi.org/10.2459/JCM.0000000000000387DOI Listing
March 2017

[ANMCO/SIT Consensus document: Telemedicine and the emergency/urgency care network].

G Ital Cardiol (Rome) 2016 Jun;17(6):508-28

Presidente Società Italiana Telemedicina e sanità elettronica (SIT), Firenze.

Telemedicine has deeply innovated the field of emergency cardiology, particularly the treatment of acute myocardial infarction. The ability to record an ECG in the early prehospital phase, thus avoiding any delay in diagnosing myocardial infarction with direct transfer to the cath-lab for primary angioplasty, has proven to significantly reduce treatment times and mortality. This consensus document aims to analyze the available evidence and organizational models based on a support by telemedicine, focusing on technical requirements, education and legal aspects.
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http://dx.doi.org/10.1714/2262.24356DOI Listing
June 2016

Geographic and socioeconomic differences in access to revascularization following acute myocardial infarction.

Eur J Public Health 2016 10 23;26(5):760-765. Epub 2016 May 23.

Epidemiology Unit, ASL TO3, Piedmont Region, Grugliasco, Italy.

Background: Geographic and socioeconomic barriers may hinder fair access to healthcare. This study assesses geographic and socioeconomic disparities in access to reperfusion procedures in acute myocardial infarction (AMI) patients residing in Piedmont (Italy).

Methods: Coronary Care Units (CCUs) were geocoded with a geographic information system (GIS) and the shortest drive time from CCUs to patients' residence was computed and categorized as 0 to <20, 20 to <40 and ≥40 min. Using data on AMI emergency hospitalizations in 2004-2012, we employed a log-binomial regression model to evaluate the relation between drive time and use of Percutaneous Transluminal Coronary Angioplasty (PTCA) occurring within 2 days after a hospitalization for an episode of AMI, and whether this relation varied depending on the period of hospitalization.

Results: A total of 29% of all cases with a diagnosis of AMI (n = 66 097), were revascularized within 2 days from the index admission. The further AMI patients lived from CCUs, the less likely they were to receive revascularization: compared with distance <20 min, RRs were respectively 0.84 [95% CI 0.80-0.88] and 0.78 [95% CI 0.71-0.86]. Findings also showed that less educated people had a lower relative risk of being revascularized compared to more educated people (RR = 0.78; 95% CI = 0.74-0.82). Both inequalities have reduced in recent years.

Conclusion: This study provides evidence of reduced geographical and socioeconomic differences in revascularization use over time. Geography and socioeconomic status should not determine the type of treatment received for life-threatening conditions such as AMI.
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http://dx.doi.org/10.1093/eurpub/ckw062DOI Listing
October 2016

Multipoint pacing via a quadripolar left-ventricular lead: preliminary results from the Italian registry on multipoint left-ventricular pacing in cardiac resynchronization therapy (IRON-MPP).

Europace 2017 Jul;19(7):1170-1177

Azienda Ospedaliera Universitaria, Padova, Italy.

Aims: This registry was created to describe the experience of 76 Italian centres with a large cohort of recipients of multipoint pacing (MPP) capable cardiac resynchronization therapy (CRT) devices.

Methods And Results: A total of 507 patients in whom these devices had been successfully implanted were enrolled between August 2013 and May 2015. We analysed: (i) current clinical practices for the management of such patients, and (ii) the impact of MPP on heart failure clinical composite response and on the absolute change in ejection fraction (EF) at 6 months. Multipoint pacing was programmed to 'ON' in 46% of patients before discharge. Methods of optimizing MPP programming were most commonly based on either the greatest narrowing of the QRS complex (38%) or the electrical delays between the electrodes (34%). Clinical and echocardiographic follow-up data were evaluated in 232 patients. These patients were divided into two groups according to whether MPP was programmed to 'ON' (n = 94) or 'OFF' (n = 138) at the time of discharge. At 6 months, EF was significantly higher in the MPP group than in the biventricular-pacing group (39.1 ± 9.6 vs. 34.7 ± 7.6%; P < 0.001). Even after adjustments, early MPP activation remained an independent predictor of absolute increase in LVEF of ≥5% (odds ratio 2.5; P = 0.001). At 6 months, an improvement in clinical composite score was recorded in a greater proportion of patients with MPP-ON than in controls (56 vs. 38%; P = 0.009). On comparing optimal MPP and conventional vectors, QRS was also seen to have decreased significantly (P < 0.001).

Conclusion: This study provides information that is essential in order to deal with the expected increase in the number of patients receiving MPP devices in the coming years. The results revealed different practices among centres, and establishing the optimal programming that can maximize the benefit of MPP remains a challenging issue. Compared with conventional CRT, MPP improved clinical status and resulted in an additional increase in EF.

Clinical Trial Registration: http://www.clinicaltrial.gov/. Unique identifier: NCT02606071.
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http://dx.doi.org/10.1093/europace/euw094DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5834139PMC
July 2017