Immediate or staged complete revascularisation in patients presenting with acute coronary syndrome by number of diseased vessels: a substudy of the BIOVASC randomised trial.

BACKGROUND: In patients presenting with acute coronary syndrome (ACS), the number of diseased vessels may affect the efficacy of a complete revascularisation strategy. AIMS: The authors sought to evaluate the safety and efficacy of immediate complete revascularisation (ICR) and staged complete revascularisation (SCR) in patients presenting with ACS stratified by the number of diseased vessels. METHODS: In this prespecified analysis of the BIOVASC trial, ICR was compared with SCR in patients with two-vessel disease (2VD) or three-vessel disease (3VD). The primary endpoint was a composite of all-cause mortality, myocardial infarction (MI), any unplanned ischaemia-driven revascularisation or cerebrovascular events at 1 year after the index procedure. Comparisons were performed using Cox regression. RESULTS: A total of 1,525 patients were enrolled in the BIOVASC trial, of whom 1,177 presented with 2VD and 265 with 3VD. In the 2VD group, 613 patients were assigned to ICR and 564 to SCR. In the 3VD group, 117 patients were assigned to ICR and 148 to SCR. ICR and SCR led to similar results in both the 2VD (hazard ratio [HR] 0.76, 95% confidence interval [CI]: 0.50-1.13; p=0.18) and 3VD groups (HR 0.79, 95% CI: 0.39-1.59; p=0.51) (pinteraction=0.91) in terms of the primary endpoint. ICR was associated with a lower rate of MI in patients with 3VD (HR 0.21, 95% CI: 0.046-0.93; p=0.04) (pinteraction=0.30). CONCLUSIONS: ICR might be an option in patients presenting with extensive 3VD and might be associated with a lower rate of myocardial infarction compared with SCR.

Timing of Complete Multivessel Revascularization in Patients Presenting With Non-ST-Segment Elevation Acute Coronary Syndrome.

BACKGROUND: Complete revascularization of the culprit and all significant nonculprit lesions in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and multivessel disease (MVD) reduces major adverse cardiac events, but optimal timing of revascularization remains unclear. OBJECTIVES: This study aims to compare immediate complete revascularization (ICR) and staged complete revascularization (SCR) in patients presenting with NSTE-ACS and MVD. METHODS: This prespecified substudy of the BIOVASC (Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndrome and Multivessel Disease) trial included patients with NSTE-ACS and MVD. Risk differences of the primary composite outcome of all-cause mortality, myocardial infarction (MI), unplanned ischemia-driven revascularization (UIDR), or cerebrovascular events and its individual components were compared between ICR and SCR at 1 year. RESULTS: The BIOVASC trial enrolled 1,525 patients; 917 patients presented with NSTE-ACS, of whom 459 were allocated to ICR and 458 to SCR. Incidences of the primary composite outcome were similar in the 2 groups (7.9% vs 10.1%; risk difference 2.2%; 95% CI: -1.5 to 6.0; P = 0.15). ICR was associated with a significant reduction of MIs (2.0% vs 5.3%; risk difference 3.3%; 95% CI: 0.9 to 5.7; P = 0.006), which was maintained after exclusion of procedure-related MIs occurring during the index or staged procedure (2.0% vs 4.4%; risk difference 2.4%; 95% CI: 0.1 to 4.7; P = 0.032). UIDRs were also reduced in the ICR group (4.2% vs 7.8%; risk difference 3.5%; 95% CI: 0.4 to 6.6; P = 0.018). CONCLUSIONS: ICR is safe in patients with NSTE-ACS and MVD and was associated with a reduction in MIs and UIDRs at 1 year.

Stent expansion in calcified coronary chronic total occlusions: The impact of different stent platforms.

OBJECTIVES: To evaluate the stent expansion of the durable-polymer Zotarolimus-eluting stent (dp-ZES), the durable-polymer Everolimus-eluting stent (dp-EES), and the bioabsorbable-polymer Sirolimus-eluting stent (bp-SES) in calcified coronary chronic total occlusions (CTO). BACKGROUND: The newer generation stents with ultrathin struts might raise concerns regarding reduced radial strength and higher stent recoil (SR) when implanted in calcified CTOs. METHODS: Between January 2017 and June 2021 consecutive patients with CTO undergoing percutaneous coronary intervention with dp-ZES, dp-EES, or bp-SES were evaluated. The analysis was performed in calcific and in noncalcific CTOs. Quantitative coronary angiography analysis was used to assess diameter stenosis (DS), absolute and relative SR, absolute and relative focal SR, absolute and relative balloon deficit (BD), and absolute and relative focal BD. The primary endpoint was DS. RESULTS: A total of 213 CTOs were evaluated, 115 calcific CTOs (dp-ZES:25, dp-EES:29, bp-SES:61) and 98 non-calcific CTOs (dp-ZES:41, dp-EES:11, bp-SES:46). In calcific CTOs, residual DS was lower in dp-ZES than in dp-EES and bp-SES (-1.00% [-6.50-6.50] vs. 13.00% [7.0-19.00] vs. 15.00% [5.00-20.00]; p < 0.001). Dp-ZES was also an independent predictor of residual DS ≤ 10% (OR 11.34, 95% CI 2.6-49.43, p = 0.001). Absolute and relative focal SR and absolute and relative SR were similar between dp-ZES, dp-EES, and bp-SES (p = 0.913, p = 0.890, p = 0.518, p = 0.426, respectively). In noncalcified CTOs, the residual DS was similar in the three groups (p = 0.340). High relative focal SR was less frequent in dp-ZES than in dp-EES and in bp-SES (19.5% vs. 54.5% vs. 37.0%; p < 0.048). CONCLUSIONS: The three stent platforms demonstrated an overall low residual DS when implanted in CTOs. However, dp-ZES was associated with the lowest residual DS and identified as independent predictor of residual DS ≤ 10% in patients with calcific CTOs. Dp-ZES was associated with a lower incidence of high relative focal stent recoil, in noncalcific CTOs. Balloon deficit might be considerate as a surrogate for stent expansion in calcified CTOs.

Propensity Matched Comparison of Clinical Outcome After Immediate Versus Staged Complete Revascularization in Patients With Acute Coronary Syndrome and Multivessel Disease.

Complete revascularization (CR) in patients with acute coronary syndromes (ACS) and multivessel disease (MVD) improves clinical outcomes compared with culprit-only revascularization, but the optimal timing for non-culprit lesions treatment remains unclear. This study evaluated patients presenting with ACS and MVD admitted between January 2015 and September 2021 at the Erasmus University Medical Center. Clinical outcomes were compared between immediate and staged CR in terms of major adverse cardiac and cerebrovascular events (MACCEs), a composite of all-cause mortality, myocardial infarction, stroke, and any unplanned revascularization. A total of 1,400 patients presenting with ACS and MVD who underwent immediate or staged CR were included in this study. Using 1/many propensity score matching without replacement, 299 patients in the staged CR group were matched to 598 patients in the immediate CR group (mean 1:2 ratio), rendering a total of 897 patients for analysis. The median follow-up period was 648 days. MACCE rate was significantly higher in the staged CR group than in the immediate CR group (adjusted hazard ratio [95% confidence interval] 1.60 [1.05 to 2.45], p = 0.03). Furthermore, number of stents, stent length, and contrast usage were significantly greater in the staged revascularization group. Immediate CR was associated with less risk of MACCE than was staged CR. Staged CR required overall more contrast and stent material.

Initial experience with orbital atherectomy in a tertiary centre in the Netherlands.

BACKGROUND: In January 2021, the Diamondback 360 orbital atherectomy (OA) system received CE mark approval and became available in Europe. The first procedure in Europe was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. AIMS: To report the procedural safety and efficacy of the initial experience with OA in a tertiary care institution in the Netherlands. METHODS: Patients with de novo severely calcified coronary artery disease who were treated with intended invasive imaging-guided OA were included in a prospective single-centre registry. Device success, defined as less than 50% stenosis after OA, and procedural success, defined as successful stent implantation with less than 50% residual stenosis, were evaluated. Calcium debulking effects were assessed by invasive imaging. Safety was assessed up to 30 days after the index procedure. RESULTS: Between February 2021 and June 2021, 29 patients with a total of 39 coronary arteries underwent OA. Target lesions were heavily calcified with a mean length of 32 mm and a calcium arc of 320 degrees. Invasive imaging was applied in all but one patient and 36 vessels. Superficial sanding was observed in almost all vessels (90%) and fracturing of deeper medial calcium in more than half of the vessels (63%), with a device success of 66% and procedural success of 94%. The mean stent symmetry index was 0.84, indicating good circular stent expansion. No primary safety events occurred during 30 days of follow-up. CONCLUSION: Our initial experience with OA for heavily calcified coronary lesions demonstrated favourable debulking effects and plaque modification, with high procedural success and clinical safety.

Diagnostic accuracy of angiography-based vessel fractional flow reserve after chronic coronary total occlusion recanalization.

BACKGROUND: Angiography-based vessel fractional flow reserve (vFFR) demonstrated a strong correlation with invasive fractional flow reserve (FFR) in both a pre- and post-percutaneous coronary intervention (PCI) setting. However, the role of vFFR and its correlation with post-PCI FFR in chronic coronary occlusions (CTO) has not been evaluated yet. We sought to investigate the diagnostic performance of post-PCI vFFR with post-PCI FFR as a reference in patients undergoing successful CTO PCI. METHODS: Between March 2016 and April 2020, a total of 80 patients from the FFR-SEARCH (prospective registry) and FFR REACT (randomized controlled trial) studies underwent successful CTO recanalization with post-PCI FFR measurements. RESULTS: A total of 50 patients (median age 66 (interquartile range [IQR]: 56-74) years, 76% were male) were eligible for the analysis. Median post-PCI FFR was 0.89 (IQR: 0.84-0.94), while median post-PCI vFFR was 0.91 (IQR: 0.85-0.94) (p 0.10). Suboptimal physiological results, defined as FFR and vFFR <0.90, were identified in 26 (52%) and in 21 (42%) patients, respectively. A strong correlation (r = 0.82) was found between vFFR and FFR with a mean bias of 0.013 ± 0.051. Receiver-operating characteristics curve analysis revealed an excellent accuracy of vFFR in predicting FFR <0.90 (area under the curve: 0.97; 95% confidence interval: 0.93-1.00). CONCLUSION: Post-PCI vFFR shows a good correlation with post-PCI FFR and a high diagnostic accuracy for post-PCI FFR ≤0.90 in patients undergoing successful PCI of a CTO lesion.

Very Long-Term Clinical Outcomes After Direct Stenting in Patients Presenting With ST-Segment Elevation Myocardial Infarction.

BACKGROUND/PURPOSE: Direct Stenting (DS) could be associated with reduced distal embolization and improved reperfusion in patients with ST-segment elevation myocardial infarction (STEMI). However, the impact of DS on long-term outcomes remains unclear, therefore we evaluated the impact of DS on very long-term clinical outcome in STEMI. METHODS/MATERIALS: Between April 2002 and December 2004, patients presenting with STEMI undergoing percutaneous coronary intervention were investigated. The study population was divided into two groups: DS and conventional stenting (CS) and stratified according to initial TIMI flow. Major adverse cardiac events (MACE) were assessed at 10 years and all-cause mortality at 15 years. Cox proportional hazards models were used. When the proportional hazards assumption was not satisfied, landmark analysis at mid-term (2 years) was performed. RESULTS: A total of 812 consecutive patients were evaluated, 6 patients were excluded due to inadequate angiographic images, 450 (55.8%) underwent DS and 356 (44.2%) CS. At 15 years follow-up, DS was associated with a reduction in all-cause mortality (DS 35.0% vs. CS 45.3%, aHR 0.74, 95% CI 0.58-0.93, p = 0.010). The landmark analysis at 2 years identifies reduced 2-year MACE in DS compared with CS (6.8% vs.14%, aHR 0.67, 95% CI 0.49-0.93, p = 0.015) and beyond 2 years no significant differences were found between the groups (27.4% vs. 29.3%, aHR 1.00, 95% CI 0.74-1.36, p = 0.999). In patients with baseline TIMI 0-1, DS was associated with lower 10-year MACE and 15-year mortality compared with CS (aHR0.71, 95%CI 0.55-0.92, p = 0.010 and aHR0.65, 95%CI 0.50-0.84, p = 0.001, respectively). CONCLUSIONS: DS was associated with reduced 15-year all-cause mortality and reduced mid-term MACE rate in patients with STEMI. Clinical events reduction associated with DS was particularly relevant in patients with initial TIMI flow 0-1.

Elastic stent recoil in coronary total occlusions: Comparison of durable-polymer zotarolimus eluting stent and ultrathin strut bioabsorbable-polymer sirolimus eluting stent.

OBJECTIVES: To compare stent recoil (SR) of the thin-strut durable-polymer Zotarolimus-eluting stent (dp-ZES) and the ultrathin-strut bioabsorbable-polymer Sirolimus-eluting stent (bp-SES) in chronic total occlusions (CTOs) and to investigate the predictors of high SR in CTOs. BACKGROUND: Newer ultrathin drug eluting stent might be associated with lower radial force and higher elastic recoil due to the thinner strut design, possibly impacting on the rate of in-stent restenosis and thrombosis. METHODS: Between January 2017 and November 2019, consecutive patients with CTOs undergoing percutaneous coronary intervention were evaluated. Only patients treated with dp-ZES or bp-SES were included and stratified accordingly. Quantitative coronary angiography analysis was used to assess absolute SR, relative SR, absolute focal SR, relative focal SR, high absolute, and high relative focal SR. RESULTS: A total of 128 lesions (67 treated with dp-ZES and 61 with bp-SES) in 123 patients were analyzed. Between bp-SES and dp-ZES no differences were found in absolute SR (p = .188), relative SR (p = .138), absolute focal SR (p = .069), and relative focal SR (p = .064). High absolute and high relative focal SR occurred more frequently in bp-SES than in dp-ZES (p = .004 and p = .015). Bp-SES was a predictor of high absolute focal SR (Odds ratio [OR] 3.29, 95% confidence interval [CI] 1.50-7.22, p = .003]. High-pressure postdilation and bp-SES were predictors of high relative focal SR (OR 2.22, 95% CI 1.01-4.86, p = .047; OR 2.74, 95% CI 1.24-6.02, p = .012, respectively). CONCLUSIONS: Both stents showed an overall low SR. However, ultra-thin strut bp-SES was a predictor of high absolute and high relative focal SR.

Culprit Lesion Detection in Patients Presenting With Non-ST Elevation Acute Coronary Syndrome and Multivessel Disease.

BACKGROUND/PURPOSE: Identification of the culprit lesion in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) allows appropriate coronary revascularization but may be unclear in patients with multivessel coronary disease (MVD). Therefore, we investigated the rate of culprit lesion identification during coronary angiography in NSTE-ACS and multivessel disease. METHODS/MATERIALS: Consecutive patients presenting with NSTE-ACS and MVD, between January 2012 and December 2016 were evaluated. Coronary angiograms, intravascular imaging, and ECGs were analyzed for culprit lesion identification. Long-term clinical outcomes in terms of major adverse cardiac events (MACE) and mortality were reported in patients with or without culprit identification. RESULTS: A total of 1107 patients with NSTE-ACS and MVD were included in the analysis, 310 (28.0%) with unstable angina and 797 (72.0%) with non-ST elevation myocardial infarction. The culprit lesion was angiographically identified in 952 (86.0%) patients, while no clear culprit lesion was found in 155 (14.0%) patients. ECG analysis allowed to predict the location of the culprit vessel with low sensitivity (range 28.4%-36.7%) and high specificity (range 90.6%-96.5%). Higher lesion complexity was associated with inability to identify the culprit. Intravascular imaging was applied in 55 patients and helped to identify the culprit lesion in 53 patients (96.4%). There was no difference in all-cause mortality (21.4% vs. 25.8%, p = 0.24) and MACE (39.2% vs. 47.6%, p = 0.07) between the cohorts with or without culprit lesion identification by angiography. CONCLUSIONS: The culprit lesion appeared unclear by coronary angiography in >10% of patients with NSTE-ACS and MVD. Complementary invasive imaging substantially enhanced the diagnostic accuracy of culprit lesion detection.

ECG evaluation in 11 949 Italian teenagers: results of screening in secondary school.

AIM: There is lack of evidence regarding the screening role of ECG for sudden cardiac death (SCD) prevention. Our aim was to evaluate the prevalence of ECG abnormalities among teenagers according to sport participation and competitive status. METHODS: Eleven thousand nine hundred and forty-nine Italian pupils from 179 secondary schools (13-19 years) were consecutively enrolled. ECG abnormalities were divided into minor and major. Medical history, clinical examination and sport activity information were acquired. Further evaluations were suggested in case of major ECG abnormalities. Follow-up was performed at 2 years. RESULTS: N = 1945 (16%) pupils had ECG abnormalities. Major ECG abnormalities were detected in 13% of the cohort, minor in 34%. ECG abnormalities were more common in nonathletes compared with athletes. A diagnosis of cardiac disease was reached in 25 (1.6%) of the pupils with major ECG abnormalities. CONCLUSION: ECG abnormalities are common among young populations and more prevalent in nonathletes. Among pupils with major ECG abnormalities 1.6% had a cardiac disease diagnosis. Our results are in line with the data supporting ECG screening in the general young population.

Impact of thrombus burden on long-term clinical outcomes in patients with either anterior or non-anterior ST-segment elevation myocardial infarction.

Large thrombus burden (LTB) during ST-segment elevation myocardial infarction (STEMI) could translate into worse clinical outcomes. The impact of a LTB in terms of long-term clinical outcomes on different myocardial infarct territories has not yet been fully evaluated. From April 2002 to December 2004, consecutive patients with STEMI undergoing percutaneous coronary intervention with drug eluting stent were evaluated. The study sample was stratified in two groups: anterior STEMI and non-anterior STEMI. LTB was considered as a thrombus larger than or equal to 2-vessel diameters, and small thrombus burden less than 2-vessel diameters. Major adverse cardiac events (MACE) were evaluated at 10-year and survival data were collected up to 15-year. A total of 812 patients were evaluated, 6 patients were excluded due to inadequate angiographic images, 410 (50.9%) had an anterior STEMI and 396 (49.1%) a non-anterior STEMI. Patients with LTB had higher rates of 10-year mortality (aHR 2.27, 95%CI 1.42-3.63; p = 0.001) and 10-year MACE (aHR 1.46, 95%CI 1.03-2.08; p = 0.033) in anterior STEMI, but not in non-anterior STEMI (aHR 0.78, 95%CI 0.49-1.24; p = 0.298; aHR 0.71, 95%CI 0.50-1.02; p = 0.062). LTB was associated with increased 30-day mortality (aHR 5.60, 95%CI 2.49-12.61; p < 0.001) and 30-day MACE (aHR 2.72, 95%CI 1.45-5.08; p = 0.002) in anterior STEMI, but not in non-anterior STEMI (aHR 0.39, 95%CI 0.15-1.06; p = 0.066; aHR 0.67, 95%CI 0.31-1.46; p = 0.316). Beyond 30-day, LTB had no impact on mortality and MACE in both groups. In anterior STEMI, LTB is associated with worse long-term clinical outcomes, this effect was driven by early events.

Impact of Large Thrombus Burden on Very Long-Term Clinical Outcomes in Patients Presenting With ST-Segment Elevation Myocardial Infarction.

OBJECTIVES: The impact of large thrombus burden (LTB) on very long-term clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) is unknown. We compared very long-term clinical outcomes in STEMI patients with either LTB or small thrombus burden (STB). METHODS: Between 2002 and 2004, thrombus burden (TB) was evaluated in consecutive patients with STEMI undergoing percutaneous coronary intervention (PCI). In occluded infarct-related arteries, TB was reclassified after flow restoration. LTB was defined as thrombus ≥2 vessel diameters. Major adverse cardiac event (MACE) rate was evaluated at 10-year follow-up and survival data were collected up to 15 years post PCI. RESULTS: A total of 812 patients were enrolled, and TB assessment was available for 806 patients (99.3%); 580 patients (72.0%) had STB and 226 patients (28.0%) had LTB. Patients with LTB experienced more no reflow (4.0% vs 0.5%; P<.01) and distal embolization (17.3% vs 3.4%; P<.001) than STB patients. Ten-year MACE rate (42.5% vs 42.4%; P=.59), 10-year mortality rate (27.0% vs 26.4%; P=.75), and 15-year mortality rate (31.9% vs 35.9%; P=.29) were similar between STB and LTB groups, respectively. By landmark analysis, MACE rate was higher in the LTB group (15.9% vs 8.8%; P<.01) at 30 days, but not beyond (31.6% vs 36.9%; P=.28). There was no difference in mortality at any time point (at 30 days, 9.7% vs 6.2%; P=.08; beyond 30 days, 17.3% vs 20.5%; P=.48). LTB was an independent predictor of MACE at 30 days post PCI (hazard ratio, 1.60; 95% confidence interval, 1.01-2.51; P=.04). CONCLUSIONS: In STEMI patients, LTB might identify a subpopulation at high risk of no-reflow, distal embolization, and early ischemic events, but is not associated with worse clinical outcomes at long-term follow-up.

Management of Septal Branch Perforation and Septal Hematoma During Retrograde Treatment of Coronary Chronic Total Occlusion Using Fat Embolization.

Septal vessel perforation followed by septal hematoma is a rare complication of retrograde approach for treatment of coronary chronic total occlusions, possibly leading to septal rupture. We report 2 cases of patients with septal vessel perforation and subsequent hematoma successfully treated with autologous fat embolization. Such technique is inexpensive, omnipresent, and relatively easy to perform.

Revascularization Strategies in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Coronary Disease.

The optimal revascularization strategy for residual coronary stenosis following primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) remains controversial. This is a retrospective single-centre study including patients with STEMI and MVD. Based on the revascularization strategy, 3 groups were identified: (1) culprit only (CO), (2) ad hoc multivessel revascularization (MVR), and (3) staged MVR. Clinical outcomes were compared in terms of major adverse cardiac events (MACE), a composite of cardiac death, any myocardial infarction, and any unplanned revascularization at a long-term follow-up. A total of 958 patients were evaluated, 489 in the CO, 254 in the ad hoc, and 215 in the staged group. In the staged group, 65.6% of the patients received planned percutaneous coronary intervention, 9.7% coronary artery bypass grafting, 8.4% no further intervention after lesion reassessment, and in 16.3% an event occurred before the planned procedure. At 1,095 days, MACE was 36.1%, 16.7%, and 31% for CO, ad hoc, and staged groups, respectively. A MVR strategy was associated with lower rate of all-cause death compared with CO (HR 0.50; 95%CI [0.31 to 0.80]; p = 0.004). Complete revascularization reduced the rate of MACE (HR 0.30 [0.21 to 0.43] p < 0.001) compared with incomplete revascularization. Ad hoc MVR had lower rate of MACE compared with staged MVR (HR 0.61 [0.39 to 0.96] p = 0.032) mainly driven by less unplanned revascularizations. In conclusion, in patients with STEMI and MVD, complete revascularization reduced the risk of MACE. Ad hoc MVR appeared a reasonable strategy with lower contrast and stent usage and costs.

Current approaches for treatment of coronary chronic occlusions.

Introduction: Coronary chronic total occlusions (CTO) represent a challenging subset in interventional cardiology.Areas covered: During the last decade, improvements in materials, techniques, and meticulous pre-procedural lesion assessment have increased the success rate in CTO lesions. Several scores have been developed to address overall lesion evaluation and help select the most appropriate treatment strategy. In addition, specific algorithms such as the hybrid algorithm have been introduced to provide a framework for CTO operators and a rapid management of the various challenging aspects of the procedure. The hybrid approach requires operator's ability to switch from one treatment strategy to another when the first one appears to be unsuccessful. Adequate training and operators' experience remain crucial to improve the likelihood of success.Expert opinion: The aim of this review is to provide insights and guidance for operators on current approaches for treatment of CTO and complication management.

[Leadless pacing: present and future of cardiac stimulation]. / Leadless pacing: presente e futuro della stimolazione cardiaca.

Leadless pacemaker therapy now represents a reality in the field of cardiac pacing. It was developed with the aim of reducing post-procedural complications due to endocavitary leads and with the intention to propose itself as a valid alternative in patients who have contraindications to conventional pacing. Leadless pacemakers to date allow right ventricular stimulation and are implanted through a percutaneous venous femoral access. Currently, the system available is the MicraTM Transcatheter Pacing System. On November 2017, the worldwide implants of the NanostimTM Leadless Pacemaker System were halted. These devices have shown promising results in the various clinical trials with complications mostly due to the implant procedure. In order to avoid these complications, a correct learning curve of the operators has resulted very important. Recently, a new system, the WiSE-CRT, has been introduced as a leadless alternative to cardiac resynchronization therapy. While the results of randomized trials and long-term follow-up studies are still pending, in this paper we will review the main clinical data that have been published to date, comparing them to the traditional devices for transvenous endocardial stimulation.

Role of cardiac 123I-mIBG imaging in predicting arrhythmic events in stable chronic heart failure patients with an ICD.

BACKGROUND: Despite therapeutic improvement, the prognosis of chronic heart failure (CHF) remains unfavorable partly due to arrhythmia and sudden cardiac death (SCD). This prospective study evaluated myocardial 123I-meta-iodobenzylguanidine (123I-mIBG) scintigraphy as a predictor of arrhythmic events (AE) in CHF patients. METHODS: 170 CHF patients referred for implantable cardioverter-defibrillator (ICD) implantation for both primary and secondary prevention were enrolled. All patients underwent planar and SPECT imaging. Early and late heart-to-mediastinum (H/M) ratio, 123I-mIBG washout (WO), early and late summed SPECT scores were calculated The primary endpoint was an AE: sustained ventricular tachycardia, resuscitated cardiac arrest, appropriate ICD therapy or SCD. The secondary endpoint was appropriate ICD therapy. RESULTS: During a median follow-up of 23.3 months, 69 patients experienced an AE. Early summed score (ESS) was the only independent predictor of AE [HR 1.023 (1.003-1.043)]. Focussing on only patients with an ICD for primary prevention, ESS was the only independent predictor of AE [HR 1.028 (1.007-1.050)]. 123I-mIBG-derived parameters failed to be independent predictors of appropriate ICD therapy. However there was a "bell-shaped" relation between 123I-mIBG scintigraphy-derived parameters and AE and appropriate ICD therapy, i.e., those with intermediate 123I-mIBG abnormalities tended to be at higher risk of events. CONCLUSION: Although SPECT 123I-mIBG scintigraphy was associated with AE in CHF patients with ICD implantation for primary and secondary prevention, no association was found between 123I-mIBG scintigraphy-derived parameters and appropriate ICD therapy.