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Introduction and objectives The pocket sized KardiaMobile (KM) is a monitoring device for ECG recording through a smartphone-based application. This system is generally aimed as screening tool to detect alterations in cardiac rhythm but its diagnostic potential for detection of ST changes remains largely unknown. This study sought to assess the diagnostic sensitivity of the KM system for detection of ST changes in patients with ST elevated myocardial infarction (STEMI). Methods Patients admitted with diagnosis of STEMI were consecutively included. Recordings with KM were obtained in leads I, II and anterior precordial. KM recordings were obtained as well from healthy individuals. All recordings were submitted for blinded assessment. Results A total of 112 patients with STEMI and 25 healthy individuals were included. Among those showing ST changes, these consisted mostly in depression (75%). Sensitivity was modest for individual leads (57-58%). The combination of 2-leads, when including the precordial, and the combination of 3-leads markedly increased sensitivity (88-98% and 100% respectively) for both inferior and anterior STEMI. Specificity was very high (96-100%) and the Youden's J statistic was excellent for the 2-leads combinations that included the precordial lead (0.84-0.94) and for the 3-leads combination (0.96). Conclusions The Kardia Mobile system with the combination of 2-leads (I + precordial or II + precordial) or 3-leads shows a very high sensitivity for both anterior and inferior STEMI.

Central aortic blood pressure could be helpful in the evaluation of patients with aortic stenosis (AS). The SphygmoCor XCEL device estimates central blood pressure (BP) measurement with its easy-to-use, operator-independent procedure. However, this device has not been properly validated against invasive measurement in patients with severe AS. We evaluated the relationship between cuff-brachial BP, transfer function- estimated and invasively measured central aortic pressure in patients with severe AS before and after transcatheter aortic valve replacement (TAVR). Agreement between techniques was analyzed and, according to the ARTERY Society recommendations, the minimum acceptable error was a mean difference ± SD ≤5 ± ≤8 mm Hg. A total of 94 patients with AS undergoing TAVR had simultaneous non-invasive and invasive measurements of central BP before and after the procedure. Before TAVR central systolic BP was in average slightly underestimated, though with wide variability, when using the default calibration of brachial-cuff SBP (mean difference ± SD, −3 ± 15 mm Hg), and after TAVR the degree of underestimation increased (mean difference ± SD, −9 ± 13 mm Hg). The agreement tended to improve for those patients with low aor- tic gradient stenosis compared to those with high gradient at baseline (mean dif- ference ± SD, −2 ± 11 mm Hg vs. −4 ± 17, respectively, p = .3). The cuff-brachial systolic BP yielded numerically lower degree of agreement and weaker correlation with invasive measurements than SphygmoCor XCEL. In patients with severe AS the SphygmoCor XCEL cuff device, despite showing strong correlation, does not meet the ARTERY Society accuracy criteria for non-invasive measurement of central SBP.

This study sought to determine, in patients with new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI), the incidence and factors associated with (i) LBBB recovery and (ii) permanent pacemaker implantation (PPI) at 1-year follow-up. This was a multicenter study including 153 patients (mean age: 81 ± 5 years, 56% of women) with NOP-LBBB post-TAVI (balloon-expandable valve in 112 patients). Delta PR (ΔPR) and delta QRS (ΔQRS) were defined as the difference in PR and QRS length between baseline and hospital discharge ECG, and the relative ΔPR and ΔQRS as absolute ΔPR and ΔQRS divided by baseline PR and QRS length, respectively. The patients had a clinical visit and 12-lead ECG at 1-year follow-up. LBBB recovery was observed in 50 patients (33%), and 14 patients (9%) had advanced conduction disturbances requiring PPI during the follow-up period. No clinical or ECG variables were associated with LBBB recovery, including prosthesis type (self- or balloon-expandable valve, p = 0.563), QRS width at baseline/discharge or absolute/relative ΔQRS (p >0.10 for all). The presence of atrial fibrillation at baseline (0.026), a longer PR interval at discharge (0.009), and a longer absolute and relative ΔPR (p = 0.002 and p = 0.004, respectively) were associated with an increased risk of PPI at 1-year follow-up. In conclusion, NOP-LBBB post-TAVI resolved in one-third of patients at 1-year follow-up, but no clinical or ECG variables were associated with LBBB recovery. Conversely, a nonsinus rhythm at baseline and a longer ΔPR were associated with an increased risk of PPI within the year after TAVI.

OBJECTIVES We investigated the safety and efficacy of the bioabsorbable polymer-coated, everolimus-eluting coronary stent (SYNERGY) stent in a real-world study population with acute coronary syndromes (ACS). BACKGROUND A number of clinical trials support the overall efficacy and safety of the SYNERGY stent. However, a recent trial (TIDES-ACS) in the context of ACS reported worrying figures of infarction and definite/probable stent thrombosis in the SYNERGY control arm. METHODS This is a multicenter registry (10 centers) including consecutive patients with ACS (unstable angina, non-ST elevated myocardial infarction, ST elevated myocardial infarction) who underwent percutaneous revascularization with the implantation of SYNERGY stent. The primary endpoint was the composite of cardiac death, myocardial infarction and target lesion revascularization at 12 months. RESULTS A total of 1008 patients were included with age 65.4 ± 14.8 years, 23.8% females and a 24.5% diabetics. Regarding presentation, a 15.2% with unstable angina, 43% with non-ST elevated myocardial infarction and 41.8% with ST elevated myocardial infarction. Primary outcome was met in 3% (7% in SYNERGY TIDES-ACS arm, P superiority

BACKGROUND The arrhythmic burden after discharge in patients with new-onset left bundle branch block (LBBB) undergoing transcatheter aortic valve replacement (TAVR) with the balloon-expandable SAPIEN 3 (S3) valve remains largely unknown. OBJECTIVE The purpose of this study was to determine the incidence of late arrhythmias in patients with new-onset LBBB undergoing TAVR with the balloon-expandable S3 valve. METHODS This was a multicenter, prospective study that included 104 consecutive TAVR patients with new-onset persistent LBBB following TAVR with the S3 valve. An implantable cardiac monitor (Reveal XT, Reveal LINQ) was implanted before discharge. The primary endpoint was the incidence of high-degree atrioventricular block or complete heart block (HAVB/CHB). RESULTS A total of 40 patients (38.5%) had at least 1 significant arrhythmic event, leading to a treatment change in 17 (42.5%). Significant bradyarrhythmias occurred in 20 of 104 patients (19.2%) (34 HAVB/CHB episodes, 252 severe bradycardia episodes), with 10 of 20 patients (50%) exhibiting at least 1 episode of HAVB/ CHB. Most HAVB/CHB episodes ( 60%) occurred within 4 weeks after discharge. Nine patients ( 8.7%) underwent permanent pacemaker implantation at 12 months based on the Reveal findings (6 HAVB/CHB, 3 severe bradycardia). CONCLUSION S3 valve recipients with new-onset LBBB have a high arrhythmic burden, with more than one-third of patients exhibiting at least 1 significant arrhythmic episode within 12 months (HAVB/ CHB in 10% of patients). About one-half of bradyarrhythmic events occurred within 4 weeks after discharge. These results should inform future strategies on the use of continuous electrocardiographic monitoring in TAVR S3 patients with new conduction disturbances following the procedure.

Aims We determined the incidence and type of arrhythmias at 2-year follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). Methods and results Multicentre prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR (SAPIEN XT/3: 53; CoreValve/Evolut R: 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted before hospital discharge and patients had continuous monitoring for up to 2 years. Arrhythmic events were adjudicated in a central core lab. 1836 new arrhythmic events (tachyarrhythmias: 1655 and bradyarrhythmias: 181) occurred at 2 years. Of these, 283 (15%) occurred beyond 1 year (tachyarrhythmias 212, bradyarrhythmias 71) in 33 (36%) patients, without differences between valve type. Most late (>1 year) arrhythmic events were asymptomatic (94%) and led to a treatment change in 17 (19%) patients. A total of 71 late bradyarrhythmias [high-degree atrioventricular block (HAVB): 3, severe bradycardia: 68] were detected in 17 (21%) patients. At 2 years, 18 (17%) patients had received a permanent pacemaker (PPM) or implantable cardiac-defibrillator. PPM implantation due to HAVB predominated in the early phase post-TAVR, with only 1 HAVB event requiring PPM implantation after 1 year. Conclusion Patients with new-onset LBBB post-TAVR exhibited a very high burden of arrhythmic events within the 2 years post-procedure. While new tachyarrhythmic events were homogeneously distributed over time, the vast majority of new HAVB episodes leading to PPM implantation occurred early after the procedure. These results should help to guide the management of this challenging group of patients. (clinicaltrials.gov: NCT02153307)

AIMS The aim of this study was to investigate the diagnostic performance of quantitative flow ratio (QFR) in assessing the physiological relevance of coronary lesions in the presence of severe aortic valve stenosis (SAS). METHODS AND RESULTS A total of 115 SAS patients (138 coronary arteries) were included. Functional assessment of coronary stenoses was performed with fractional flow reserve (FFR) before transcatheter aortic valve implantation (TAVI). Subsequently, QFR was calculated at a central core laboratory, blinded to FFR results. The diagnostic yield of QFR was assessed using FFR as reference. Coronary stenoses were intermediate (diameter stenosis 48±10%, FFR 0.84 [0.77-0.89], QFR 0.82 [0.73-0.89]). Per-vessel sensitivity, specificity, area under the ROC curve and accuracy of QFR were 84% (95% CI: 71-92%), 80% (95% CI: 69-88%), 0.88 (95% CI: 0.82-0.93) and 81%, respectively. Diagnostic accuracy of QFR decreased significantly in patients with aortic valve area (AVA)

Background: Transfemoral approach has been commonly used as secondary access in transcatheter aortic valve replacement (TAVR). Scarce data exist on the use and potential clinical benefits of the transradial approach as secondary access during TAVR procedures. The objective of the study is to determine the occurrence of vascular complications (VC) and clinical outcomes according to secondary access (transfemoral versus transradial) in patients undergoing TAVR. Methods: This was a multicenter study including 4949 patients who underwent TAVR (mean age, 81±8 years, mean Society of Thoracic Surgeons score, 4.9 [3.3–7.5]). Transfemoral and transradial approaches were used as secondary access in 4016 (81.1%) and 933 (18.9%) patients, respectively. The 30-day clinical events (vascular and bleeding complications, stroke, acute kidney injury, and mortality) were evaluated and defined according to Valve Academic Research Consortium-2 criteria. Clinical outcomes were analyzed according to the secondary access (transfemoral versus transradial) in the overall population and in a propensity score-matched population involving 2978 transfemoral and 928 transradial patients. Results: Related-access VC occurred in 834 (16.9%) patients (major VC, 5.7%) and were related to the secondary access in 172 (3.5%) patients (major VC, 1.3%). The rate of VC related to the secondary access was higher in the transfemoral group (VC, 4.1% versus 0.9%, P P P P P P =0.043), acute kidney injury (transfemoral: 9.9%, transradial: 5.7%; P P =0.047). Conclusions: The use of transradial approach as secondary access in TAVR procedures was associated with a significant reduction in vascular and bleeding complications and improved 30-day outcomes. Future randomized studies are warranted.

Aims This study sought to investigate the prognostic effect of a protocol with optimisation targets for intravascular ultrasound (IVUS)-guided left main (LM) revascularisation. Methods and results A protocol was prospectively applied for IVUS-guided LM revascularisation (IVUS-PRO group) including predefined optimisation targets. Using propensity score matching, we selected as control groups patients with angiography-guided PCI (ANGIO group) and IVUS-guided PCI (IVUS group) from a large multicentre registry. The primary endpoint was a composite of cardiac death, LM-related infarction and LM revascularisation at 12 months. In each group, 124 patients with comparable characteristics were included. The incidence of the primary outcome was significantly higher in the ANGIO group compared to the IVUS-PRO group (12.9% vs 4.8%, HR 0.35, 95% CI: 0.15 to 0.82, p=0.02), but not with respect to the IVUS group (12.9% vs 8%, HR 0.51, 95% CI: 0.20 to 1.22, p=0.1), driven by a lower rate of LM revascularisation (8% in the ANGIO group, 6.4% in the IVUS group and 3.2% in the IVUS-PRO group). IVUS-PRO resulted in being an independent risk predictor (HR 0.45, 95% CI: 0.15 to 0.98; p=0.041). Conclusions IVUS guidance of LM stenting provides prognostic benefit with respect to the use of angiography alone, particularly when following a protocol with these predefined optimisation criteria.

Objectives The authors sought to determine: 1) the global arrhythmic burden; 2) the rate of arrhythmias leading to a treatment change; and 3) the incidence of high-degree atrioventricular block (HAVB) at 12-month follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). Background Controversial data exist on the occurrence of significant arrhythmias in patients with LBBB post-TAVR. Methods This was a multicenter prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR with the balloon-expandable SAPIEN XT/3 valve (n = 53), or the self-expanding CoreValve/Evolut R system (n = 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted at 4 (3 to 6) days post-TAVR, and patients had continuous electrocardiogram monitoring for 12 months. All arrhythmic events were adjudicated in a central electrocardiography core lab. Primary endpoints were the incidence of arrhythmias leading to a treatment change, and the incidence of HAVB at 12-month follow-up. Results A total of 1,553 new arrhythmic events were detected in 44 patients (1,443 episodes of tachyarrhythmia in 26 patients [atrial fibrillation/flutter/atrial tachycardia: 1,427, ventricular tachycardia 16]; 110 episodes of bradyarrhythmia in 21 patients [HAVB 54, severe bradycardia 56]). All arrhythmic events were silent in 34 patients (77%), the arrhythmic event led to a treatment change in 19 patients (18%), and 11 patients (11%) required pacemaker or implantable cardioverter-defibrillator implantation (due to HAVB, severe bradycardia, or ventricular tachycardia episodes in 9, 1, and 1 patient, respectively). A total of 12 patients died at 1-year follow-up, 1 from sudden death. Conclusions A high incidence of arrhythmic events was observed at 1-year follow-up in close to one-half of the patients with LBBB post-TAVR. Significant bradyarrhythmias occurred in one-fifth of the patients, and PPM was required in nearly one-half of them. These data support the use of a cardiac monitoring device for close follow-up and expediting the initiation of treatment in this challenging group of patients. (Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation [MARE study]: NCT02153307)

The aim of this study was to determine the impact of new-onset persistent (NOP) left bundle branch block (LBBB) on long-term (2 year) outcomes after transcatheter aortic valve replacement (TAVR).The impact of NOP-LBBB after TAVR remains controversial and no data exist regarding long-term outcomes.A total of 1,020 consecutive patients without pre-existing LBBB or permanent pacemaker implantation (PPI) undergoing TAVR were included. NOP-LBBB was defined as any new LBBB post-TAVR that persisted at hospital discharge. Follow-up clinical and echocardiographic data were obtained at a median of 3 years (interquartile range: 2 to 5 years) post-TAVR.NOP-LBBB occurred in 212 patients (20.1%) following TAVR. There were no differences between NOP-LBBB and no NOP-LBBB groups, except for a higher use of the self-expandable CoreValve system in the NOP-LBBB group (p 0.001). At follow-up, there were no differences between NOP-LBBB and no NOP-LBBB groups in all-cause mortality (45.3% vs. 42.5%; adjusted hazard ratio [HR]:1.09; 95% confidence interval [CI]: 0.82 to 1.47; p = 0.54), cardiovascular mortality (14.2% vs. 14.4%; adjusted HR: 1.02; 95% CI: 0.56 to 1.87; p = 0.95), or heart failure rehospitalization (19.8% vs. 15.6%; adjusted HR: 1.44; 95% CI: 0.85 to 2.46; p = 0.18). NOP-LBBB was associated with an increased risk of permanent pacemaker implantation at follow-up (15.5% vs. 5.4%; adjusted HR: 2.45; 95% CI: 1.37 to 4.38; p = 0.002), with the highest risk within the first 12 months. Left ventricular ejection fraction increased over time in patients with no NOP-LBBB but slightly decreased in those with NOP-BBB (p 0.001 for changes in left ventricular ejection fraction between groups).After a median follow-up of 3 years post-TAVR, NOP-LBBB was not associated with a higher mortality or heart failure rehospitalization. However, NOP-LBBB increased the risk of permanent pacemaker implantation and negatively impacted left ventricular function over time. These results should inform future efforts for improving the management of patients with NOP-LBBB post-TAVR.

Objectives This study sought to evaluate the long-term clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR). Background Conduction disturbances leading to PPI are common following TAVR. However, no data exist regarding the impact of PPI on long-term outcomes post-TAVR. Methods This was a multicenter study including a total of 1,629 patients without prior PPI undergoing TAVR (balloon- and self-expandable valves in 45% and 55% of patients, respectively). Follow-up clinical, echocardiographic, and pacing data were obtained at a median of 4 years (interquartile range: 3 to 5 years) post-TAVR. Results PPI was required in 322 (19.8%) patients within 30 days post-TAVR (26.9% and 10.9% in patients receiving self- and balloon-expandable CoreValve and Edwards systems, respectively). Up to 86% of patients with PPI exhibited pacing >1% of the time during follow-up (>40% pacing in 51% of patients). There were no differences between patients with and without PPI in total mortality (48.5% vs. 42.9%; adjusted hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 0.95 to 1.39; p = 0.15) and cardiovascular mortality (14.9% vs. 15.5%, adjusted HR: 0.93; 95% CI: 0.66 to 1.30; p = 0.66) at follow-up. However, patients with PPI had higher rates of rehospitalization due to heart failure (22.4% vs. 16.1%; adjusted HR: 1.42; 95% CI: 1.06 to 1.89; p = 0.019), and the combined endpoint of mortality or heart failure rehospitalization (59.6% vs. 51.9%; adjusted HR: 1.25; 95% CI: 1.05 to 1.48; p = 0.011). PPI was associated with lesser improvement in LVEF over time (p = 0.051 for changes in LVEF between groups), particularly in patients with reduced LVEF before TAVR (p = 0.005 for changes in LVEF between groups). Conclusions The need for PPI post-TAVR was frequent and associated with an increased risk of heart failure rehospitalization and lack of LVEF improvement, but not mortality, after a median follow-up of 4 years. Most patients with new PPI post-TAVR exhibited some degree of pacing activity at follow-up.

Objectives We sought to compare the procedural implications of using bioresorbable everolimus-eluting scaffolds (BVS) and Pt-Cr everolimus-eluting stent with abluminal bioabsorbable polymer (Synergy). Background There are important differences in the respective platforms, which could impact on procedural performance, complications and outcomes. Methods A prospective, randomized single center study including consecutive patients in stable clinical condition and with lesions amenable to be treated with BVS according to predefined criteria. Patients were randomized to either treatment with BVS or Synergy. All procedural data were collected and 12 months clinical follow up conducted. Primary objectives were fluoroscopy time, median dose-area product, contras agent volumen, and peri-procedural troponin release. Results A total of 200 patients were included, 100 in BVS group and 100 in Synergy group. No significant differences were observed in baseline clinical and angiographic characteristics. Predilatation (97.6 vs. 25.4%; P

Patients in cardiogenic shock benefit from mechanical reperfusion, but their mortality remains high even using intra-aortic balloon. It is not well known if a Mechanical Circulatory Support Program (MCSP) might improve the long term outcome of these patients. We have compared in-hospital and 1 year