Catheter navigation by intracardiac echocardiography enables zero-fluoroscopy linear lesion formation and bidirectional cavotricuspid isthmus block in patients with typical atrial flutter.

INTRODUCTION: One of the most helpful aspects of intracardiac echocardiography (ICE) implementation in electrophysiological studies (EPS) is the real-time visualisation of catheters and cardiac structures. In this prospective study, we investigated ICE-guided zero-fluoroscopy catheter navigation during radiofrequency (RF) ablation of the cavotricuspid isthmus (CTI) in patients with typical atrial flutter (AFL). METHODS AND RESULTS: Thirty consecutive patients (mean age 72.9 ± 11.4 years, 23 male) with ongoing (n = 23) or recent CTI-dependent AFL underwent an EPS, solely utilizing ICE for catheter navigation. Zero-fluoroscopy EPS could be successfully accomplished in all patients. Mean EPS duration was 41.4 ± 19.9 min, and mean ablation procedure duration was 20.8 ± 17.1 min. RF ablation was applied for 6.0 ± 3.1 min (50W, irrigated RF ablation). Echocardiographic parameters, such as CTI length, prominence of the Eustachian ridge (ER), and depth of the CTI pouch on the ablation plane, were assessed to analyse their correlation with EPS- or ablation procedure duration. The CTI pouch was shallower in patients with an ablation procedure duration above the median (4.8 ± 1.1 mm vs. 6.4 ± 0.9 mm, p = 0.04), suggesting a more lateral ablation plane in these patients, where the CTI musculature is stronger. CTI length or ER prominence above the respective median did not correlate with longer EPS duration. CONCLUSIONS: Zero-fluoroscopy CTI ablation guided solely by intracardiac echocardiography in patients with CTI-dependent AFL is feasible and safe. ICE visualisation may help to localise the optimal ablation plane, detect and correct poor tissue contact of the catheter tip, and recognise early potential complications during the ablation procedure.

WATCH-BPM-Comparison of a WATCH-Type Blood Pressure Monitor with a Conventional Ambulatory Blood Pressure Monitor and Auscultatory Sphygmomanometry.

BACKGROUND: Smart devices that are able to measure blood pressure (BP) are valuable for hypertension or heart failure management using digital technology. Data regarding their diagnostic accuracy in comparison to standard noninvasive measurement in accordance to Riva-Rocci are sparse. This study compared a wearable watch-type oscillometric BP monitor (Omron HeartGuide), a wearable watch-type infrared BP monitor (Smart Wear), a conventional ambulatory BP monitor, and auscultatory sphygmomanometry. METHODS: Therefore, 159 consecutive patients (84 male, 75 female, mean age 64.33 ± 16.14 years) performed observed single measurements with the smart device compared to auscultatory sphygmomanometry (n = 109) or multiple measurements during 24 h compared to a conventional ambulatory BP monitor on the upper arm (n = 50). The two BP monitoring devices were simultaneously worn on the same arm throughout the monitoring period. In a subgroup of 50 patients, single measurements were also performed with an additional infrared smart device. RESULTS: The intraclass correlation coefficient (ICC) between the difference and the mean of the oscillometric Omron HeartGuide and the conventional method for the single measurement was calculated for both systole (0.765) and diastole (0.732). This is exactly how the ICC was calculated for the individual mean values calculated over the 24 h long-term measurement of the individual patients for both systole (0.880) and diastole (0.829). The ICC between the infrared device and the conventional method was "bad" for SBP (0.329) and DBP (0.025). Therefore, no further long-term measurements were performed with the infrared device. CONCLUSION: The Omron HeartGuide device provided comparable BP values to the standard devices for single and long-term measurements. The infrared smart device failed to acquire valid measurement data.

Distal versus conventional radial access for coronary angiography and intervention: Design and rationale of DISCO RADIAL study.

BACKGROUND: Transradial access (TRA) has become the default access method for coronary diagnostic and interventional procedures. As compared to transfemoral access, TRA has been shown to be safer, cost-effective and more patient-friendly. Radial artery occlusion (RAO) represents the most frequent complication of TRA, and precludes future coronary procedures through the radial artery, the use of the radial artery as a conduit for coronary artery bypass grafting or as arteriovenous fistula for patients on hemodialysis. Recently, distal radial access (DRA) has emerged as a promising alternative to TRA, yielding potential for minimizing the risk of RAO. However, an international multicenter randomized comparison between DRA, and conventional TRA with respect to the rate of RAO is still lacking. TRIAL DESIGN: DISCO RADIAL is a prospective, multicenter, open-label, randomized, controlled, superiority trial. A total of 1300 eligible patients will be randomly allocated to undergo coronary angiography and/or percutaneous coronary intervention (PCI) through DRA or TRA using the 6 Fr Glidesheath Slender sheath introducer. Extended experience with both TRA and DRA is required for operators' eligibility and optimal evidence-based best practice to reduce RAO systematically implemented by protocol. The primary endpoint is the incidence of forearm RAO assessed by vascular ultrasound at discharge. Several important secondary endpoints will also be assessed, including access-site cross-over, hemostasis time, and access-site related complications. SUMMARY: The DISCO RADIAL trial will provide the first large-scale multicenter randomized evidence comparing DRA to TRA in patients scheduled for coronary angiography or PCI with respect to the incidence of RAO at discharge.

BIOSOLVE-IV-registry: Safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients.

OBJECTIVES: We aimed to assess the safety and performance of the Magmaris sirolimus-eluting bioresorbable magnesium scaffold in a large patient population. BACKGROUND: Magmaris has shown good outcomes in small-sized controlled trials, but further data are needed to confirm its usability, safety, and performance. METHODS: BIOSOLVE-IV is an international, single arm, multicenter registry including patients with a maximum of two single de novo lesions. Follow-up is scheduled up to 5 years; the primary outcome is target lesion failure (TLF) at 12 months. RESULTS: A total of 1,075 patients with 1,121 lesions were enrolled. Mean patient age was 61.3 ± 10.5 years and 19.2% (n = 206) presented with non-ST-elevation myocardial infarction (NSTEMI). Lesions were 3.2 ± 0.3 mm in diameter and 14.9 ± 4.2 mm long; 5.1% (n = 57) were bifurcation lesions. Device success was 97.3% (n = 1,129) and procedure success 98.9% (n = 1,063). The Kaplan-Meier estimate of TLF at 12 months was 4.3% [95% confidence interval, CI: 3.2, 5.7] consisting of 3.9% target lesion revascularizations, 0.2% cardiac death, and 1.1% target-vessel myocardial infarction. Definite/probable scaffold thrombosis occurred in five patients (0.5% [95% CI: 0.2, 1.1]), thereof four after early discontinuation of antiplatelet/anticoagulation therapy. CONCLUSION: BIOSOLVE-IV confirms the safety and performance of the Magmaris scaffold in a large population with excellent device and procedure success and a very good safety profile up to 12 months in a low-risk population.

Cerebrovascular events, bleeding complications and device related thrombi in atrial fibrillation patients with chronic kidney disease and left atrial appendage closure with the WATCHMAN™ device.

BACKGROUND: Impaired renal function increases the bleeding risk, leading to a conservative prescription and frequent discontinuation of oral anticoagulation in atrial fibrillation patients with chronic kidney disease (CKD). Interventional left atrial appendage closure (LAAC) might be an alternative therapeutic strategy for these patients. METHODS: We aimed to prospectively assess cerebrovascular (CE) and bleeding events, as well as peri-procedural and long-term complications in a cohort of consecutive patients undergoing interventional LAAC using the WATCHMAN™ device, with focus on CKD patients. RESULTS: One hundred and eighty-nine consecutive patients undergoing interventional LAAC were included in this analysis; 171 (90.5%) patients had a reduced estimated glomerular filtration rate (eGFR; patients for each CKD stage: II = 66; IIIa = 32; IIIb = 43; IV = 18; V = 12). During a follow-up of 310 patient years three (1.0%) patients suffered a CE (two strokes, one transitory ischemic attack) and five (1.6%) other ones a bleeding complication. The observed stroke rate was more than two-thirds and the bleeding risk more than half lower than expected. Device related thrombi (DRT) were detected in twelve (6.5%) patients; women had significantly more DRT than men (12.5% vs. 2.6%; p = 0.009). Patients with an eGFR< 30 ml/min/1.73m2 showed a trend to a higher DRT rate as compared to the opposite group (13.3% vs. 5.1%; p = 0.10). Thrombus resolved with temporary oral anticoagulation therapy in ten patients without sequelae; thrombus consolidation was confirmed by serial TEE controls in the remaining two patients. CONCLUSIONS: Atrial fibrillation patients with CKD have low CE and bleeding rates after LAAC with the WATCHMAN™ device. DRT risk is higher in female and patients with severe CKD. More frequent post-interventional TEE controls might be justified for early DRT detection and safe management of patients at high DRT risk. TRIAL REGISTRATION: (German Clinical Trials Register ID: DRKS00 010768 ; Registration Date 07.07.2016).

Intracardiac echocardiography versus fluoroscopy for endovascular and endocardial catheter navigation during cryo-ablation of the slow pathway in AVNRT patients.

BACKGROUND: A new zero-fluoroscopy technique for electrophysiology catheter navigation relying on intracardiac echocardiography (ICE) has been recently reported (Ice&ICE trial). We investigated potential differences in efficacy, safety or procedural performance between conventional fluoroscopy- and ICE-guided cryothermal ablation (CA) in symptomatic AVNRT patients. METHODS: Clinical and electrophysiological data of AVNRT patients included in the Ice&ICE trial (22 patients, 16 females; =zero-fluoroscopy group) were compared to those of consecutive AVNRT patients, who underwent fluoroscopy-guided CA (25 patients, 17 females; = fluoroscopy group) during the last 2 years in our institution. RESULTS: Slow pathway ablation or modulation was successful in all patients. Fluoroscopy time and radiation dose in the fluoroscopy group were 11.2 ± 9.0 min and 20.3 ± 16.2Gycm2, whereas no fluoroscopy was used in the opposite group (p <  0.001, respectively). EPS duration was not different between the groups (zero-fluoroscopy:101.6 ± 40.2 min, fluoroscopy:99.4 ± 37.2 min, p = n.s.). Catheter placement time was significantly shorter in the fluoroscopy group (2.2 ± 1.6 min vs. 12.0 ± 7.5 min, p <  0.05), whereas cryo-application duration (from the first cryo-mapping to the last CA) was significantly shorter in the zero-fluoroscopy group (27.5 ± 37.0 min vs. 38.1 ± 33.9 min, p <  0.05). Mean cryo-mapping and CA applications were numerically lower in the zero-fluoroscopy group (CM:7.5 ± 5.7 vs. 8.8 ± 6.2; CA:3.1 ± 1.7 vs. 3.2 ± 2.0, p = n.s.). No major adverse events occurred in both groups. After 15.0 ± 4.2 months, arrhythmia recurrence was not different between the groups (4.5% vs. 8.0%, p = n.s.). CONCLUSIONS: Zero-fluoroscopy ICE-guided EP catheter navigation shows comparable efficacy and safety to fluoroscopic guidance during CA in AVNRT patients. ICE visualization of catheters and endocardial structures within the triangle of Koch shortens the cryo-application duration, though time needed for catheter placement is longer, when compared with conventional fluoroscopic guidance, which results in similar mean EPS duration with both navigation techniques. TRIAL REGISTRATION: (German Clinical Trials Register ID: DRKS00011360 ; Registration Date 14.12.2016).

Recording of Bipolar Multichannel ECGs by a Smartwatch: Modern ECG Diagnostic 100 Years after Einthoven.

Aims: Feasibility study of accurate three lead ECG recording (Einthoven I, II and III) using an Apple Watch Series 4. Methods: In 50 healthy subjects (18 male; age: 40 ± 12 years) without known cardiac disorders, a 12-lead ECG and three bipolar ECGs, corresponding to Einthoven leads I, II and III were recorded using an Apple Watch Series 4. Einthoven I was recorded with the watch on the left wrist and the right index finger on the crown, Einthoven II with the watch on the left lower abdomen and the right index finger on the crown, Einthoven III with the watch on the left lower abdomen and the left index finger on the crown. Four experienced cardiologists were independently asked to assign the watch ECGs to Einthoven leads from 12-lead ECG for each subject. Results: All watch ECGs showed an adequate signal quality with 134 ECGs of good (89%) and 16 of moderate signal quality (11%). Ninety-one percent of all watch ECGs were assigned correctly to corresponding leads from 12-lead ECG. Thirty-nine subjects (78%) were assigned correctly by all cardiologists. All assignment errors occurred in patients with similar morphologies and amplitudes in at least two of the three recorded leads. Erroneous assignment of all watch ECGs to leads from standard ECG occurred in no patient. Conclusion: Recording of Einthoven leads I-III by a smartwatch is accurate and highly comparable to standard ECG. This might contribute to an earlier detection of cardiac disorders, which are associated with repolarization abnormalities or arrhythmias.

Single-Lead ECG Recordings Including Einthoven and Wilson Leads by a Smartwatch: A New Era of Patient Directed Early ECG Differential Diagnosis of Cardiac Diseases?

BACKGROUND: Smartwatches that are able to record a bipolar ECG and Einthoven leads were recently described. Nevertheless, for detection of ischemia or other cardiac diseases more leads are required, especially Wilson's chest leads. OBJECTIVES: Feasibility study of six single-lead smartwatch (Apple Watch Series 4) ECG recordings including Einthoven (I, II, III) and Wilson-like pseudo-unipolar chest leads (Wr, Wm, Wl). METHODS: In 50 healthy subjects (16 males; age: 36 ± 11 years, mean ± SD) without known cardiac disorders, a standard 12-lead ECG and a six single-lead ECG using an Apple Watch Series 4 were performed under resting conditions. Recording of Einthoven I was performed with the watch on the left wrist and the right index finger on the crown, Einthoven II was recorded with the watch on the left lower abdomen and the right index finger on the crown, Einthoven III was recorded with the watch on the left lower abdomen and the left index finger on the crown. Wilson-like chest leads were recorded corresponding to the locations of V1 (Wr), V4 (Wm) and V6 (Wl) in the standard 12-lead ECG. Wr was recorded in the fourth intercostal space right parasternal, Wm was recorded in the fifth intercostal space on the midclavicular line, and Wl was recorded in the fifth intercostal space in left midaxillary line. For all Wilson-like chest lead recordings, the smartwatch was placed on the described three locations on the chest, the right index finger was placed on the crown and the left hand encompassed the right wrist. Both hands and forearms also had contact to the chest. Three experienced cardiologists were independently asked to allocate three bipolar limb smartwatch ECGs to Einthoven I-III leads, and three smartwatch Wilson-like chest ECGs (Wr, Wm, Wl) to V1, V4 and V6 in the standard 12-lead ECG for each subject. RESULTS: All 300 smartwatch ECGs showed a signal quality useable for diagnostics with 281 ECGs of good signal quality (143 limb lead ECGs (95%), 138 chest lead ECGs (92%). Nineteen ECGs had a moderate signal quality (7 limb lead ECGs (5%), 12 chest lead ECGs (8%)). One-hundred percent of all Einthoven and 92% of all Wilson-like smartwatch ECGs were allocated correctly to corresponding leads from 12-lead ECG. Forty-six subjects (92%) were assigned correctly by all cardiologists. Allocation errors were due to similar morphologies and amplitudes in at least two of the three recorded Wilson-like leads. Despite recording with a bipolar smartwatch device, morphology of all six leads was identical to standard 12-lead ECG. In two patients with acute anterior myocardial infarction, all three cardiologists recognized the ST-elevations in Wilson-like leads and assumed an occluded left anterior descending coronary artery correctly. CONCLUSION: Consecutive recording of six single-lead ECGs including Einthoven and Wilson-like leads by a smartwatch is feasible with good ECG signal quality. Thus, this simulated six-lead smartwatch ECG may be useable for the detection of cardiac diseases necessitating more than one ECG lead like myocardial ischemia or more complex cardia arrhythmias.

Impact of procedure-related conduction disturbances after transcatheter aortic valve implantation on myocardial performance and survival evaluated by conventional and speckle tracking echocardiography.

OBJECTIVES: Although procedure-related new cardiac conduction disturbances (CCDs) remain an important issue in transcatheter aortic valve implantation (TAVI), their effect on myocardial function and overall patient outcome remains unclear. The goal of this study was to analyze the influence of procedure-related CCDs on systolic and diastolic LV performance and on patient survival after TAVI. METHODS AND RESULTS: Ninety-five patients who underwent TAVI for severe symptomatic aortic stenosis (AS) and had a complete follow-up were evaluated with respect to procedure-related CCDs. Left ventricular (LV) performance was measured using standard echocardiographic parameters and speckle tracking analysis. Survival was assessed during longer-term follow-up (mean: 29.1 ± 16.9 months). After TAVI, the improvement of global LV function expressed as ejection fraction (LVEF; from 45.5 ± 10.0 to 47.8 ± 13.9%, P = .13) was not significant. New CCDs were found in 35.7% of TAVI recipients. A comparison between patients with and without new CCDs showed that LV systolic function improved in those without CCDs, while it tended to deteriorate in patients with CCDs (change in LVEF: 5.5 ± 12.3% vs -4.9% ± 11.5%, P = .001; change in global longitudinal strain (GLS): -1.1 ± 4.6% vs 1.2 ± 4.5%, P = .01). Changes in diastolic function did not differ significantly between the groups (changes in transmitral E/A-ratio: -0.3 ± 0.6 vs -0.5 ± 0.5, P = .1). Kaplan-Meier survival analysis revealed no significant differences between the two cohorts (P = .795). CONCLUSION: Procedure-related conduction abnormalities after TAVI lead to an LBBB-related dyssynchrony with impairment of LV performance but not of overall survival.

Transcatheter Aortic Valve Implantation in Nonagenarians: Procedural Outcome and Mid-Term Results.

BACKGROUND: For nonagenarians with symptomatic severe aortic stenosis transcatheter aortic valve implantation (TAVI) has become a feasible therapeutic option. Therefore, the aim of this study was to evaluate the procedural outcomes and mid-term follow-up in this patient group and compare this to octogenarians. METHODS: From 1359 patients who underwent TAVI at our institution between March 2009 and February 2016, 82 patients were nonagenarians and 912 were octogenarians. In nonagenarians, mean age was 91.9±1.4years and compared to octogenarians showed a significantly higher logistic EuroScore (27.7±14.8% vs. 23.1±14.4, p=0.005) and STS Score (8.5±4.8% vs. 6.3±6.7, p=0.001). RESULTS: There were no significant differences with regard to stroke rate, pacemaker implantation rate and major vascular complications between the two groups. Thirty-day mortality was 9.8% in nonagenarians and 4.1% in octogenarians (p=0.04). At 1 year, all-cause mortality increased to 30.9% vs. 18.6% (n.s.). CONCLUSION: Nonagenarians showed an increased periprocedural mortality during TAVI and higher mortality in follow-up compared to octogenarians. Age alone is not a predictive factor but indication for treatment should be carefully evaluated by the heart team on an individual basis.

Third generation drug eluting stent (DES) with biodegradable polymer in diabetic patients: 5 years follow-up.

OBJECTIVE: To report the long-term safety and efficacy data of a third generation drug eluting stent (DES) with biodegradable polymer in the complex patient population of diabetes mellitus after a follow-up period of 5 years. BACKGROUND: After percutaneous coronary intervention patients with diabetes mellitus are under higher risk of death, restenosis and stent thrombosis (ST) compared to non-diabetic patients. METHODS: In 126 centers worldwide 3067 patients were enrolled in the NOBORI 2 registry, 888 patients suffered from diabetes mellitus (DM), 213 of them (14%) being insulin dependent (IDDM). Five years follow-up has been completed in this study. RESULTS: At 5 years, 89.3% of the patients were available for follow-up. The reported target lesion failure (TLF) rates at 5 years were 12.39% in DM group and 7.34% in non-DM group; (p < 0.0001). In the DM group, the TLF rate in patients with IDDM was significantly higher than in the non-IDDM subgroup (17.84 vs. 10.67%; p < 0.01). The rate of ST at 5 years was not different among diabetic versus non-diabetic patients or IDDM versus NIDDM. Only 10 (<0.4%) very late stent thrombotic events beyond 12 months occurred. CONCLUSIONS: The Nobori DES performed well in patients with DM. As expected patients with DM, particularly those with IDDM, had worse outcomes. However, the very low rate of very late stent thrombosis in IDDM patients might have significant clinical value in the treatment of these patients. Clinical trial registration ISRCTN81649913; http://www.controlled-trials.com/isrctn/search.html?srch=81649913&sort=3&dir=desc&max=10.

Transradial Coronary Angiography--Insights to the One-Catheter Concept.

Transradial coronary angiography (TRC) can be performed applying only one catheter fitting into the right and left coronary ostia (R/LCO). In this bicentric study (n = 2953), we analyzed the ostial performance of the Tiger_II_catheter widely used in TRC. Compared to Judkins catheters, the Tiger_II is frequently associated with ostial instability within the LCO but fits better into the RCO-irrespective of tube size. Judkins catheters generally need more peri-procedural contrast and radiation exposure. TRC may be started using a 5F_Tiger_II on the right side in order to be switched to 5F Judkins in case of propable LCO instability.

Temporal changes in coronary plaque as assessed by an artificial intelligence-based optical coherence tomography: from the first-in-human trial on DREAMS 3G scaffold.

AIMS: The aim of the study is to assess the impact of the baseline plaque composition on the DREAMS 3G luminal late loss and to compare the serial plaque changes between baseline and 6 and 12 months (M) follow-up. METHODS AND RESULTS: A total of 116 patients were enrolled in the BIOMAG-I trial. Patients were imaged with optical coherence tomography (OCT) pre- and post-DREAMS 3G implantation and at 6 and 12 M. OCTPlus software uses artificial intelligence to assess composition (i.e. lipid, calcium, and fibrous tissue) of the plaque. The differences between the OCT-derived minimum lumen area (MLA) post-percutaneous coronary intervention and 12 M were grouped into three terciles. Patients with larger MLA differences at 12 M (P = 0.0003) had significantly larger content of fibrous tissue at baseline. There was a reduction of 24.8% and 20.9% in lipid area, both P < 0.001, between the pre-DREAMS 3G OCT and the 6 and 12 M follow-up. Conversely, the fibrous tissue increased by 48.4% and 36.0% at 6 and 12 M follow-up, both P < 0.001. CONCLUSION: The larger the fibrous tissue in the lesion at baseline, the larger the luminal loss seen at 6 and 12 M. Following the implantation of DREAMS 3G, favourable healing of the vessel coronary wall occurs as shown by a decrease in the lipid area and an increase in fibrous tissue.

Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI): a randomized trial.

Objectives: Cardiac arrhythmias predict poor outcome after myocardial infarction (MI). We studied if arrhythmia monitoring with an insertable cardiac monitor (ICM) can improve treatment and outcome. Design: BIO|GUARD-MI was a randomized, international open-label study with blinded outcome assessment. Setting: Tertiary care facilities monitored the arrhythmias, while the follow-up remained with primary care physicians. Participants: Patients after ST-elevation (STEMI) or non-ST-elevation MI with an ejection fraction >35% and a CHA2DS2-VASc score ≥4 (men) or ≥5 (women). Interventions: Patients were randomly assigned to receive or not receive an ICM in addition to standard post-MI treatment. Device-detected arrhythmias triggered immediate guideline recommended therapy changes via remote monitoring. Main outcome measures: MACE, defined as a composite of cardiovascular death or acute unscheduled hospitalization for cardiovascular causes. Results: 790 patients (mean age 71 years, 72% male, 51% non-STEMI) of planned 1,400 pts were enrolled and followed for a median of 31.6 months. At 2 years, 39.4% of the device group and 6.7% of the control group had their therapy adapted for an arrhythmia [hazard ratio (HR) = 5.9, P < 0.0001]. Most frequent arrhythmias were atrial fibrillation, pauses and bradycardia. The use of an ICM did not improve outcome in the entire cohort (HR = 0.84, 95%-CI: 0.65-1.10; P = 0.21). In secondary analysis, a statistically significant interaction of the type of infarction suggests a benefit in the pre-specified non-STEMI subgroup. Risk factor analysis indicates that this may be connected to the higher incidence of MACE in patients with non-STEMI. Conclusions: The burden of asymptomatic but actionable arrhythmias is large in post-infarction patients. However, arrhythmia monitoring with an ICM did not improve outcome in the entire cohort. Post-hoc analysis suggests that it may be beneficial in non-STEMI patients or other high-risk subgroups. Clinical Trial Registration: [https://www.clinicaltrials.gov/ct2/show/NCT02341534], NCT02341534.

Intracoronary versus intravenous bolus abciximab during primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction: a randomised trial.

BACKGROUND: Intracoronary administration of an abciximab bolus during a primary percutaneous coronary intervention results in a high local drug concentration, improved perfusion, and reduction of infarct size compared with intravenous bolus application. However, the safety and efficacy of intracoronary versus standard intravenous bolus application in patients with ST-elevation myocardial infarction (STEMI) undergoing this intervention has not been tested in a large-scale clinical trial. METHODS: The AIDA STEMI trial was a randomised, open-label, multicentre trial. Patients presenting with STEMI in the previous 12 h with no contraindications for abciximab were randomly assigned in a 1:1 ratio by a central web-based randomisation system to intracoronary versus intravenous abciximab bolus (0·25 mg/kg bodyweight) during percutaneous coronary intervention with a subsequent 12 h intravenous infusion 0·125 µg/kg per min (maximum 10 µg/min). The primary endpoint was a composite of all-cause mortality, recurrent infarction, or new congestive heart failure within 90 days of randomisation. Secondary endpoints were the time to occurrence of the primary endpoint, each individual component of that endpoint, early ST-segment resolution, thrombolysis in myocardial infarction (TIMI) flow grade, and enzymatic infarct size. A masked central committee adjudicated the primary outcome and its components. Treatment allocation was not concealed from patients and investigators. This trial is registered with ClinicalTrials.gov, NCT00712101. FINDINGS: Between July, 2008, and April, 2011, 2065 patients were randomly assigned intracoronary abciximab (n=1032) or intravenous abciximab (n=1033). Intracoronary, as compared with intravenous abciximab, resulted in a similar rate of the primary composite clinical endpoint at 90 days in 1876 analysable patients (7·0%vs 7·6%; odds ratio [OR] 0·91; 95% CI 0·64-1·28; p=0·58). The incidence of death (4·5%vs 3·6%; 1·24; 0·78-1·97; p=0·36) and reinfarction (1·8%vs 1·8%; 1·0; 0·51-1·96; p=0·99) did not differ between the treatment groups, whereas less patients in the intracoronary group had new congestive heart failure (2·4%vs 4·1%; 0·57; 0·33-0·97; p=0·04). None of the secondary endpoints or safety measures differed significantly between groups. INTERPRETATION: In patients with STEMI undergoing primary percutaneous coronary intervention, intracoronary as compared to intravenous abciximab did not result in a difference in the combined endpoint of death, reinfarction, or congestive heart failure. Since intracoronary abciximab bolus administration is safe and might be related to reduced rates of congestive heart failure the intracoronary route might be preferred if abciximab is indicated. FUNDING: Lilly, Germany. University of Leipzig-Heart Centre. University of Leipzig, Clinical Trial Centre Leipzig, supported by the Federal Ministry of Education and Research (BMBF).

Balloon expandable sheath for transfemoral aortic valve implantation: a viable option for patients with challenging access.

BACKGROUND AND OBJECTIVES: Transcatheter aortic valve replacement (TAVR) via femoral access is a new option for patients with severe aortic valve stenosis considered to be at high risk for conventional open-heart surgery. This procedure requires peripheral arteries that are able to accommodate the large sheaths required for valve delivery. We present a series of patients with suboptimal vascular conditions, who received a self-expandable vascular sheath. METHODS AND RESULTS: From January 2009 to September 2011, a total of 96 patients (43% male) were treated with the 18F Medtronic CoreValve (Medtronic, Minneapolis, MN, USA). The patients' average age was 82.5 ± 4.6 years, and the mean EuroSCORE was 29%. In eight cases, vascular conditions were inadequate either due to advanced atherosclerotic disease (n = 5, 62.5%), or an arterial diameter ≤7 mm (n = 3, 37.5%). Instead of the standard 18F sheath, a balloon-expandable transfemoral introducer (SoloPath Introducer, Onset Medical Corporation, Irvine, CA, USA) was delivered and removed without complications in all but one (87.5%) patient. In the last case, rupture of the right femoral artery occurred after removal of the sheath with the need of vascular surgery. CONCLUSION: The SoloPath sheath is a feasible alternative to conventional sheaths for transfemoral TAVR patients with difficult femoral vascular access.

Elite athletes with mitral or aortic regurgitation and their cardiopulmonary capability.

BACKGROUND: Aortic or mitral valvular regurgitation (left cardiac valvular regurgitation, LCVR) of less than second-degree (< degree II) occasionally found in competitive athletes is of questionable relevance. Precisely detectable by echocardiography there is scarce published data that clarifies cardiopulmonary capacity or any limitations LCVR < degree ll may cause. METHODS: In this single-centre study we consecutively recruited highly trained athletes (n= 14) with LCVR < degree ll detected in 2D echo. Not included were athletes with multi- or right-cardiac valvular dysfunction and structural heart disease other than bicuspid aortic valve or mitral valve prolaps. Target parameters were determined by 2D echo and spiroergometry. RESULTS: There were no significant differences with regard to age and body mass index. Echocardiographically determined muscle mass index was increased in both groups (134 14.7 vs 129.6+/-27.5; P=0.69), whereas the left-ventricular end-diastolic diameter index was significant higher in the LCVR < degree II group (27.3 +/- 1.3 vs 25.2 +/- 2.4; P = 0.04). However, there were no significant differences with regard to (oxygen uptake) V02, at baseline (athletes with LCVR < degree II 5.7 +/- 0.9 vs controls 5 +/- 0.96, P= 0.06), at the anaerobic threshold (athletes with LCVR < degree II 47.3 +/-8.4 vs controls 47.4 +/- 5, P= 0.97) and maximally (VO2max; athletes with LCVR < degree II 57.7 6.3 vs controls 57.1 +/- 5.1, P= 0.81). Neither levels of lactate nor of brain natriuretic peptide differed significantly. CONCLUSION: High level athletes presenting with aortic or mitral regurgitation < degree II in are not disadvantaged with regard to their cardiopulmonary capability.

Confusion in a patient with premature ventricular complexes originating in the left ventricular summit.

Background: Premature ventricular complexes (PVCs) originating in the ventricular outflow tracts are mostly of benign character. Case Summary: We describe a rare case of pulmonary hypertension with severe hypoxaemia and confusion caused by a significant mitral regurgitation (MR) during PVC originating in the left ventricle summit. After successful PVC ablation, all above-mentioned clinical parameters had normalized. Discussion: Premature ventricular complexes originating in the outflow tracts should be considered as a potential though rare cause of severe MR and pulmonary hypertension.

One- and two-year clinical outcomes of treatment with resorbable magnesium scaffolds for coronary artery disease: the prospective, international, multicentre BIOSOLVE-IV registry.

BACKGROUND: Bioresorbable scaffolds have been developed to overcome the limitations of drug-eluting stents and to reduce long-term adverse events. AIMS: We aimed to assess the long-term safety and efficacy of a sirolimus-eluting resorbable magnesium scaffold to ensure its safe rollout into clinical routine. METHODS: BIOSOLVE-IV is a prospective, international, multicentre registry including more than 100 centres in Europe, Asia, and Asia-Pacific. Enrolment started directly after the commercialisation of the device. Follow-up assessments are scheduled at 6 and 12 months, and annually for up to 5 years; we herein report the 24-month outcomes. RESULTS: Overall, 2,066 patients with 2,154 lesions were enrolled. Patients were 61.9±10.5 years old, 21.6% had diabetes, and 18.5% had non-ST-elevation myocardial infarction (NSTEMI). Lesions were 14.8±4.0 mm long with a reference vessel diameter of 3.2±0.3 mm. Device and procedure success were 97.5%, and 99.1%, respectively. The 24-month target lesion failure (TLF) rate was 6.8%, mainly consisting of clinically driven target lesion revascularisations (6.0%). Patients with NSTEMI had significantly higher TLF rates than those without (9.3% vs 6.2%; p=0.025), whereas there were no significant differences observed for patients with diabetes or with type B2/C lesions (a 24-month TLF rate of 7.0% and 7.9%, respectively). The 24-month rate of definite or probable scaffold thrombosis was 0.8%. Half of the scaffold thromboses occurred after premature discontinuation of antiplatelet/anticoagulation therapy, and only one scaffold thrombosis occurred beyond the 6-month follow-up, on day 391. CONCLUSIONS: The BIOSOLVE-IV registry showed good safety and efficacy outcomes, confirming a safe rollout of the Magmaris into clinical practice.

Coronary stent imaging in photon counting computed Tomography: Optimization of reconstruction kernels in a phantom.

PURPOSE: Imaging stents and in-stent stenosis remains a challenge in coronary computed tomography angiography (CCTA). In comparison to conventional Computed Tomography, Photon Counting CT (PCCT) provides decisive clinical advantages, among other things by providing low dose ultra-high resolution imaging of coronary arteries. This work investigates the image quality in CCTA using clinically established kernels and those optimized for the imaging of cardiac stents in PCCT, both for in-vitro stent imaging in 400 µm standard resolution mode (SRM) and 200 µm Ultra High Resolution Mode (UHR). METHODS: Based on experimental scans, vascular reconstruction kernels (Bv56, Bv64, Bv72) were optimized. In an established phantom, 10 different coronary stents with 3 mm diameter were scanned in the first clinically available PCCT. Scans were reconstructed with clinically established and optimized kernels. Four readers measured visible stent lumen, performed ROI-based density measurements and rated image quality. RESULTS: Regarding the visible stent lumen, UHR is significantly superior to SRM (p < 0.001). In all levels, the optimized kernels are superior to the clinically established kernels (p < 0.001). One optimized kernel showed a significant reduction of noise compared to the clinically established kernels. Overall image quality is improved with optimized kernels. CONCLUSIONS: In a phantom study PCCT UHR with optimized kernels for stent imaging significantly improves the ability to assess the in-stent lumen of small cardiac stents. We recommend using UHR with an optimized sharp vascular reconstruction kernel (Bv72uo) for imaging of cardiac stent.