Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial.

BACKGROUND: Refinements in stent design affecting strut thickness, surface polymer, and drug release have improved clinical outcomes of drug-eluting stents. We aimed to compare the safety and efficacy of a novel, ultrathin strut cobalt-chromium stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-eluting stent. METHODS: We did a randomised, single-blind, non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland. We randomly assigned (1:1) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction. Patients and outcome assessors were masked to treatment allocation, but treating physicians were not. The primary endpoint, target lesion failure, was a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularisation at 12 months. A margin of 3·5% was defined for non-inferiority of the biodegradable polymer sirolimus-eluting stent compared with the durable polymer everolimus-eluting stent. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01443104. FINDINGS: Between Feb 24, 2012, and May 22, 2013, we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-eluting stents (1063 patients, 1594 lesions) or everolimus-eluting stents (1056 patients, 1545 lesions). 407 (19%) patients presented with ST-segment elevation myocardial infarction. Target lesion failure with biodegradable polymer sirolimus-eluting stents (69 cases; 6·5%) was non-inferior to durable polymer everolimus-eluting stents (70 cases; 6·6%) at 12 months (absolute risk difference -0·14%, upper limit of one-sided 95% CI 1·97%, p for non-inferiority <0·0004). No significant differences were noted in rates of definite stent thrombosis (9 [0·9%] vs 4 [0·4%], rate ratio [RR] 2·26, 95% CI 0·70-7·33, p=0·16). In pre-specified stratified analyses of the primary endpoint, biodegradable polymer sirolimus-eluting stents were associated with improved outcome compared with durable polymer everolimus-eluting stents in the subgroup of patients with ST-segment elevation myocardial infarction (7 [3·3%] vs 17 [8·7%], RR 0·38, 95% CI 0·16-0·91, p=0·024, p for interaction=0·014). INTERPRETATION: In a patient population with minimum exclusion criteria and high adherence to dual antiplatelet therapy, biodegradable polymer sirolimus-eluting stents were non-inferior to durable polymer everolimus-eluting stents for the combined safety and efficacy outcome target lesion failure at 12 months. The noted benefit in the subgroup of patients with ST-segment elevation myocardial infarction needs further study. FUNDING: Clinical Trials Unit, University of Bern, and Biotronik, Bülach, Switzerland.

Intracoronary injection of bone marrow-derived mononuclear cells early or late after acute myocardial infarction: effects on global left ventricular function.

BACKGROUND: Intracoronary administration of autologous bone marrow-derived mononuclear cells (BM-MNC) may improve remodeling of the left ventricle (LV) after acute myocardial infarction. The optimal time point of administration of BM-MNC is still uncertain and has rarely been addressed prospectively in randomized clinical trials. METHODS AND RESULTS: In a multicenter study, we randomized 200 patients with large, successfully reperfused ST-segment elevation myocardial infarction in a 1:1:1 pattern into an open-labeled control and 2 BM-MNC treatment groups. In the BM-MNC groups, cells were administered either early (i.e., 5 to 7 days) or late (i.e., 3 to 4 weeks) after acute myocardial infarction. Cardiac magnetic resonance imaging was performed at baseline and after 4 months. The primary end point was the change from baseline to 4 months in global LV ejection fraction between the 2 treatment groups and the control group. The absolute change in LV ejection fraction from baseline to 4 months was -0.4±8.8% (mean±SD; P=0.74 versus baseline) in the control group, 1.8±8.4% (P=0.12 versus baseline) in the early group, and 0.8±7.6% (P=0.45 versus baseline) in the late group. The treatment effect of BM-MNC as estimated by ANCOVA was 1.25 (95% confidence interval, -1.83 to 4.32; P=0.42) for the early therapy group and 0.55 (95% confidence interval, -2.61 to 3.71; P=0.73) for the late therapy group. CONCLUSIONS: Among patients with ST-segment elevation myocardial infarction and LV dysfunction after successful reperfusion, intracoronary infusion of BM-MNC at either 5 to 7 days or 3 to 4 weeks after acute myocardial infarction did not improve LV function at 4-month follow-up. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00355186.

Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: rationale and design of the BIOSCIENCE trial.

BACKGROUND: Biodegradable polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy. We designed a large scale clinical trial to compare a novel thin strut, cobalt-chromium drug-eluting stent with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the durable polymer-based Xience Prime/Xpedition everolimus-eluting stent (EES) (Xience Prime/Xpedition stent, Abbott Vascular, IL) in an all-comers patient population. DESIGN: The multicenter BIOSCIENCE trial (NCT01443104) randomly assigned 2,119 patients to treatment with biodegradable polymer sirolimus-eluting stents (SES) or durable polymer EES at 9 sites in Switzerland. Patients with chronic stable coronary artery disease or acute coronary syndromes, including non-ST-elevation and ST-elevation myocardial infarction, were eligible for the trial if they had at least 1 lesion with a diameter stenosis >50% appropriate for coronary stent implantation. The primary end point target lesion failure (TLF) is a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization within 12 months. Assuming a TLF rate of 8% at 12 months in both treatment arms and accepting 3.5% as a margin for noninferiority, inclusion of 2,060 patients would provide more than 80% power to detect noninferiority of the biodegradable polymer SES compared with the durable polymer EES at a 1-sided type I error of 0.05. Clinical follow-up will be continued through 5 years. CONCLUSION: The BIOSCIENCE trial will determine whether the biodegradable polymer SES is noninferior to the durable polymer EES with respect to TLF.

Impact of preload changes on positive and negative left ventricular dP/dt and systolic time intervals: preload changes on left ventricular function.

AIM/OBJECTIVES: Previous work has shown that the electromechanical activation time (EMAT) is prolonged in patients with abnormally low left ventricular (LV) dP/dt. In the present study, we investigated whether EMAT was responsive to rapid changes in LV systolic function induced by abrupt increases in LV preload. METHODS AND RESULTS: A total of 116 patients were assessed before and after LV angiography with a bolus injection of 40 mL of non-ionic contrast dye. Left ventricular end-diastolic pressure (LVEDP) increased from 18 ± 7 mmHg to 20 ± 8 mmHg (P < 0.01). In patients with a baseline dP/dt < 1500 mmHg/sec, dP/dt increased from 1098 ± 213 mmHg/sec to 1146 ±306 mmHg/sec (P=0.02) and EMAT decreased from 106 ± 29 ms to 103 ±18 ms (P=0.02). In patients with a baseline dP/dt > 1500 mmHg/sec, dP/dt decreased from 1894 ± 368 mmHg/sec to 1762 ± 403 mmHg/sec (P=0.01) and EMAT increased from 88 ± 13 ms to 93 ± 16 ms (P=0.02). Changes in negative dP/dt were similar to changes in dP/dt. CONCLUSION: Electromechanical activation time is a non-invasively measured parameter that allows accurate and rapid detection of changes in LV contractility.

Clinical Features and Prognoses of Middle-Aged Women With ST-Elevation Myocardial Infarction With a Focus on Spontaneous Coronary Artery Dissection.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) has become an increasingly recognized cause of acute coronary syndrome, particularly in young women, over the last decade. The goal of this study was to determine the prognoses and characteristics of adult women with SCAD who presented with ST-elevation myocardial infarction (STEMI). METHODS: This retrospective cohort study enrolled all adult women under the age of 60 who had undergone coronary artery angiography in the setting of STEMI. The patients were divided into 3 groups based on their angiographic characteristics: STEMI-SCAD (STEMI due to SCAD), STEMI-ATH (STEMI caused by an atherosclerotic lesion), and STEMI-others (STEMI due to other etiologies including Takotsubo cardiomyopathy and myopericarditis, as well as STEMI despite a normal epicardial coronary angiography). RESULTS: Fifteen women out of 311 female patients aged below 60 years with STEMI were diagnosed with SCAD (4.8%). There were no significant differences in body mass index, hypertension, dyslipidemia, smoking status, opium addiction status, family history, previous percutaneous coronary intervention, coronary artery bypass grafting, and cerebrovascular accidents between the STEMI-SCAD and STEMI-ATH groups. Nevertheless, the STEMI-SCAD and STEMI-others groups were more likely to be younger, less likely to be diabetic, and less likely to have 3 cardiovascular risk factors or more than was the STEMI-ATH group. The left anterior descending artery was the most common culprit lesion in the STEMI-SCAD group (80%) and the other 2 groups. Out of the 311 patients, 7 patients died during the index hospitalization: 1 patient in the STEMI-SCAD group, 6 patients in the STEMI-ATH group, and 0 patients in the STEMI-others group. None of the patients in the STEMI-others group experienced any major adverse cardiac events during the follow-up. In the other 2 groups, the most experienced outcomes were myocardial infarction and in-hospital cardiac death, followed by target lesion revascularization and target vessel revascularization. CONCLUSIONS: STEMI-SCAD is one of the known causes of STEMI in young women. Still, despite the complexity of revascularization in our patients with STEMI-SCAD, they had more favorable prognoses in both conservative and revascularization management modalities than our patients with STEMI-ATH.

Thromboembolic acute myocardial infarction in a congenital double chambered left ventricle.

A 61-year-old woman with a congenital double-chamber left ventricle (DCLV) was admitted because of an anterior ST-elevation myocardial infarction (STEMI). Urgent coronary angiography showed a thrombotic occlusion of the distal part of the left anterior descending artery (LAD). The left ventricular injection revealed a slightly reduced ejection fraction, antero-apical akinesia and an accessory chamber. Two dimensional and three dimensional echocardiography showed anterior akinesia with an accessory chamber at the apex which was separated by a fibromuscular ridge distal to the papillary muscles. The DCLV with myocardial contraction in the additional chamber was originally diagnosed seven years ago during a routine follow-up echocardiography in the course of management for thyroid cancer and at that time left ventricular function was described to be normal. Thromboembolism was assumed to have originated from the hypocontractile left accessory chamber and the patient was set on oral anticoagulation. During follow-up global left ventricular function normalized.

Cell-based therapy for myocardial repair in patients with acute myocardial infarction: rationale and study design of the SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction (SWISS-AMI).

BACKGROUND: Recent studies report that intracoronary administration of autologous bone marrow mononucleated cells (BM-MNCs) may improve remodeling of the left ventricle after acute myocardial infarction (AMI). Subgroup analysis suggest that early treatment between days 4 and 7 after AMI is probably most effective; however, the optimal time point of intracoronary cell administration has never been addressed in clinical trials. Furthermore, reliable clinical predictors are lacking for identifying patients who are thought to have most benefit from cellular therapy. STUDY DESIGN: In a multicenter trial, 192 patients with AMI successfully treated by percutaneous coronary intervention (PCI) of the infarct-related artery will be randomized in a 1:1:1 pattern to 1 control and 2 BM-MNC treatment groups. The control group will be treated with state-of-the-art medical management. The treatment groups will receive intracoronary administration of autologous BM-MNC at 5 to 7 days or 3 to 4 weeks after the initial event, respectively. Left ventricular function as well as scar size, transmural extension, and regional wall motion score will be assessed by cardiac magnetic resonance (CMR) studies at baseline and after 4 and 12 months. METHODS: Fifty milliliters of bone marrow will be harvested by aspiration from the iliac crest and then carried by courier to a centralized cell processing facility. The mononucleated cell fraction will be isolated by density gradient centrifugation, washed, and resuspended in 10 mL of injection medium. The cells will be characterized by fluorescence-activated cell sorting analysis and tested for sterility and potency both "in vitro" and "in vivo." Bone marrow MNC will then be reinfused directly in the infarct-related coronary artery. END POINTS: The primary end point is the change in global left ventricular (LV) ejection fraction by CMR at 4 months as compared to baseline. Comparisons will then be made between each of the prespecified therapy subgroups (early and late after AMI) and the control group. Secondary end points include change in infarct size, change in regional myocardial thickness, and wall motion at 4 and 12 months compared to baseline. Infarct extension (size and transmural extension), time delay to PCI, and coronary flow characteristics after PCI will be assessed as potential predictors of LV remodeling and change after cell therapy. Major adverse cardiac events (MACE) (death, myocardial infarction, coronary revascularization, rehospitalization for heart failure) will be assessed at 4, 12, and 24 months and time to MACE will be estimated. DISCUSSION: With the present study, we aim to determine the optimal time point of intracoronary administration of autologous BM-MNC after AMI on LV remodeling.

Improved cardiac performance through pacing-induced diaphragmatic stimulation: a novel electrophysiological approach in heart failure management?

AIMS: Pharmacological conditioning of the phrenic nerve can positively influence systolic performance, and diaphragm activation improves ventilatory function. Here we investigate whether pacing-induced diaphragmatic stimulation (PIDS) may improve left ventricular (LV) systolic function. METHODS AND RESULTS: We studied a total of 35 patients (4 females, mean age 67 +/- 9 years, ejection fraction 61 +/- 14%) within 7 days following open heart surgery. The haemodynamic impact of different PIDS and ventricular pacing configurations and coupling intervals was tested in 132 episodes. Success of PIDS was assessed using fluoroscopy and palpation. Left ventricular systolic performance was recorded using the electromechanical activation time (EMAT) obtained through acoustic cardiography. Eighteen subjects were tested in the catheter laboratory and 17 in the intensive care unit. For both groups, EMAT significantly improved when the diaphragm was stimulated 20 ms after the onset of ventricular pacing. In all instances, PIDS could be induced with or without causing patient symptoms, and LV systolic performance improvement was comparable in symptomatic and asymptomatic modes. No desensitization of the diaphragm was observed following PIDS delivery 4-6 and 24 h following open heart surgery. CONCLUSION: Pacing-induced diaphragmatic stimulation, if synchronized to the onset of ventricular contraction with a fixed, non-zero coupling delay, can improve LV systolic function reproducibly for at least 1 h without causing patient symptoms. The absence of diaphragm desensitization further underscores the potential of PIDS as a practical therapeutic approach in device-based heart failure management.

Noninvasive detection of left ventricular systolic dysfunction by acoustic cardiography in cardiac failure patients.

BACKGROUND: Despite its shortcomings, ejection fraction (EF) is widely used to detect left ventricular systolic dysfunction (LVSD) as has prolonged QRS duration as indirect evidence of LVSD. However, acoustic cardiography provides other parameters for detecting LVSD without these limitations. One parameter, the electromechanical activation time (EMAT), is prolonged in LVSD. We compared the abilities of acoustic cardiography, EF, and QRS duration to detect LVSD. METHODS AND RESULTS: We studied a sample of 108 patients who underwent elective diagnostic cardiac catheterization. The diagnostic findings included left ventricular filling pressures, angiographic EF, and maximum left ventricular dP/dt. We defined LVSD as a maximum left ventricular dP/dt of <1600 mm Hg/s. At thresholds of 35% and 50% to detect LVSD, the sensitivities of angiographic EF were 39% and 74%; specificities were 89% and 70%, respectively. At QRS duration thresholds of 100 and 120 ms, sensitivities were 63% and 35%; specificities, 63% and 89%, respectively. At thresholds of 100 and 110 ms, EMAT had sensitivities of 53% and 42%, and specificities of 90% and 100%, respectively. EMAT performed better than LV EF or QRS duration in hemodynamic subgroups. CONCLUSIONS: Acoustic cardiography is a convenient, automated diagnostic method whose performance for detecting LVSD exceeds both angiographic EF and QRS duration alone.

Comparison of different approaches for optimization of atrioventricular and interventricular delay in biventricular pacing.

AIMS: It has been shown that optimizing atrioventricular (AV) and interventricular (VV) delay improves cardiac performance in patients with biventricular pacemakers. However, there is no standard method for optimization available yet. The aim of this study was to compare echocardiographic parameters-displacement imaging, A wave duration, and aortic velocity time integral (VTI)-and acoustic cardiography derived electromechanical activation time (EMAT) using different approaches of AV and VV delay optimization. We tested whether the initial optimization of the AV interval followed by VV optimization at that optimal AV interval or initial optimization of the VV interval followed by AV optimization at the determined optimal VV interval was accurate and consistent, and how this compared to testing every conceivable combination of AV and VV intervals available. METHODS AND RESULTS: A group of 20 patients with biventricular pacemakers was included. Displacement imaging, A wave duration, and aortic VTI were determined at different combinations of AV (100, 150, 200, 250 ms) and VV (RV40, 0, LV40 ms) intervals. If AV duration was determined first, displacement imaging identified the best setting in 8/20, aortic VTI in 10/20, A duration in 13/20, and EMAT in 18/20 patients. With VV duration determined first, the best setting was more difficult to identify regardless of the method used. There was a poor agreement in optimal AV and VV delays of the different methods, and there was no single patient in whom all four methods yielded the same delay combination. CONCLUSION: It is advisable to measure a full grid of AV and VV delays to identify optimal settings rather than optimizing one of the two delays first. Different techniques for delay optimization resulted in different optimal delay combinations.

Precordial low voltage in patients with ascites.

AIMS: Electrocardiographic (ECG) changes in patients with ascites are not well studied. The aim of this study was to evaluate ECG changes in patients with ascites. METHODS AND RESULTS: Prospective analysis of patients with ascites who were referred for paracentesis. Three ECGs were recorded before paracentesis. ECG 1 was a standard 12-lead ECG. For ECG 2 the precordial leads were placed 1 intercostal space (ICS) and for ECG 3, 2 ICS cranially. The sums (Sigma) of the QRS in ECG1 were compared with ECG 2 and 3. In six patients the same ECG protocol was performed after removal of ascites. Ten hospitalized patients without ascites served as controls. Twenty patients with ascites were analysed. Limbs leads low voltage was present in 11 patients and precordial low voltage in four patients. Cranial placement of the precordial electrodes increased SigmaQRS in all patients with ascites. The most prominent voltage changes appeared in the leads V4-V6 (+62%). Paracentesis of ascites normalized precordial leads low-voltage, while limbs leads low voltage remained. Cranial placement of the precordial electrodes in patients without ascites decreases SigmaV1-V6. CONCLUSION: We describe a phenomenon of precordial voltage changes in patients with ascites, not reported in the literature yet. By placing the precordial electrodes 1 and 2 ICS cranially the voltage changes can be 'corrected' and this should be done in all patients prior to further diagnostic workup. Removal of the ascites normalizes the precordial leads low voltage.

Functional mitral stenosis: a rare complication of the Impella assist device.

In patients with left ventricular output failure, the Impella left ventricular assist device increases total cardiac output despite a drop in output provided by the left ventricle itself. We present a patient with cardiogenic shock after myocardial infarction in whom an Impella recover 2.5 was implanted. Correct placement was ensured by fluoroscopy, pressure and current signals displayed on the console of the system, and transthoracic echocardiography. On follow-up, the Impella device was dislocated with the shaft of the device lying on the anterior mitral leaflet causing a functional mitral stenosis evident by an increased transmitral diastolic flow gradient. After removing the device, the patients' haemodynamics improved within minutes. Other than a mild regurgitation, mitral valve was without pathological findings. Although infrequent, this case shows a possible complication of the Impella ventricular assist device and highlights the importance of periodical echocardiographic surveillance, especially in patients who show a poor response to therapy.

Does absolute neutrophilia predict early congestive heart failure after acute myocardial infarction? A cross-sectional study.

BACKGROUND: Acute myocardial infarction (AMI) is usually associated with increased neutrophil count. However, it has not clearly been defined whether neutrophilia can cause myocardial injury. In this study, we hypothesized that absolute neutrophilia can predict the occurrence of congestive heart failure (CHF) after AMI. METHODS: A cross-sectional study was carried out on 312 patients with a diagnosis of AMI. Patients with a history of chest pain for more than 12 hours before admission, heart failure with Killip class III and IV, history of recent gastrointestinal bleeding, major trauma, infection, malignancy, renal failure and corticosteroid consumption were excluded. A blood sample was drawn for leukocyte count and an echocardiogram was obtained 4 days after admission. Congestive heart failure was defined as an ejection fraction less than 40% on echocardiogram or clinical heart failure according to the Framingham's criteria for diagnosis of heart failure. RESULTS: After excluding 19 patients, data for 293 patients were analyzed. Among them, 152 (51.9%) patients developed new onset CHF. Two hundred and two patients (68.9%) had neutrophilia (neutrophil count >7500/mic/lit). The risk of developing heart failure was higher in patients with neutrophilia (OR = 2.32; 95% CI = 1.33-4.03, P = 0.000). There was a negative correlation between ejection fraction and neutrophil count (r = -0.191, P = 0.000). After adjustment for age, sex, serum creatinine level, peak enzyme CK-MB level and MI location, the relationship between the absolute neutrophil count and the presence of congestive heart failure remained significant (OR = 2.14; 95% CI = 1.19-3.84, P = 0.011). CONCLUSIONS: The study shows that the presence of absolute neutrophilia during the first 12 hours after AMI can predict the occurrence of CHF. This association may help identify high-risk individuals, who might benefit from more aggressive interventions.

Biological aortic valve replacement: advantages and optimal indications of stentless compared to stented valve substitutes. A review.

Controversy still surrounds the optimal biological valve substitute for aortic valve replacement. In light of the current literature, we review advantages and optimal indications of stentless compared to stented aortic bio-prostheses. Recent meta-analyses, prospective randomized controlled trials and retrospective studies comparing the most frequently used stentless and stented aortic bio-prostheses were analyzed. In the present review, the types and implantation techniques of the bio-prosthesis that are seldom taken into account by most studies and reviews were integrated in the interpretation of the relevant reports. For stentless aortic root bio-prostheses, full-root vs. sub-coronary implantation offered better early transvalvular gradients, effective orifice area and left ventricular mass regression as well as late freedom from structural valve deterioration in retrospective studies. Early mortality and morbidity did not differ between the stentless and stented aortic bio-prostheses. Early transvalvular gradients, effective orifice area and regression of left ventricular hypertrophy were significantly better for stentless, especially as full-root, compared to stented bio-prostheses. The long-term valve-related survival for stentless aortic root and Toronto SPV bio-prosthesis was as good as that for stented pericardial aortic bio-prostheses. For full-root configuration this survival advantage was statistically significant. There seems to be not one but different ideal biological valve substitutes for different subgroups of patients. In patients with small aortic root or exposed to prosthesis-patient mismatch full-root implantation of stentless bio-prostheses may better meet functional needs of individual patients. Longer follow-ups on newer generation of stented bio-prostheses are needed for comparison of their hemodynamic performance with stentless counterparts especially in full-root configuration.

Technique and Patient Selection Criteria of Right Anterior Mini-Thoracotomy for Minimal Access Aortic Valve Replacement.

Aortic valve stenosis has become the most prevalent valvular heart disease in developed countries, and is due to the aging of these populations. The incidence of the pathology increases with growing age after 65 years. Conventional surgical aortic valve replacement through median sternotomy has been the gold standard of patient care for symptomatic aortic valve stenosis. However, as the risk profile of patients worsens, other therapeutic strategies have been introduced in an attempt to maintain the excellent results obtained by the established surgical treatment. One of these approaches is represented by transcatheter aortic valve implantation. Although the outcomes of high-risk patients undergoing treatment for symptomatic aortic valve stenosis have improved with transcatheter aortic valve replacement, many patients with this condition remain candidates for surgical aortic valve replacement. In order to reduce the surgical trauma in patients who are candidates for surgical aortic valve replacement, minimally invasive approaches have garnered interest during the past decade. Since the introduction of right anterior thoracotomy for aortic valve replacement in 1993, right anterior mini-thoracotomy and upper hemi-sternotomy have become the predominant incisional approaches among cardiac surgeons performing minimal access aortic valve replacement. Beside the location of the incision, the arterial cannulation site represents the second major landmark of minimal access techniques for aortic valve replacement. The two most frequently used arterial cannulation sites include central aortic and peripheral femoral approaches. With the purpose of reducing surgical trauma in these patients, we have opted for a right anterior mini-thoracotomy approach with a central aortic cannulation site. This protocol describes in detail a technique for minimally invasive aortic valve replacement and provides recommendations for patient selection criteria, including cardiac computer tomography measurements. The indications and limitations of this technique, as well as its alternatives, are discussed.

Drug-coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET-SMALL 2.

The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug-eluting stents (DES) have limited efficacy due to increased rates of instent-restenosis, mainly caused by late lumen loss. Drug-coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten-Effektivitäts Trial: Drug-Coated Balloons vs. Drug-Eluting Stents in Small Vessel Interventions (BASKET-SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty-eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target-vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long-term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long-term safety and efficacy for the treatment of SVD in a large all-comer population.

Improved response to cardiac resynchronization therapy through optimization of atrioventricular and interventricular delays using acoustic cardiography: a pilot study.

BACKGROUND: The purpose of this pilot study was to determine the utility of acoustic cardiography for the optimization of atrioventricular (AV) and interventricular (VV) delays in cardiac resynchronization therapy (CRT). METHODS AND RESULTS: We evaluated 14 patients (86% male, mean age 64 +/- 9 years, mean time since implant 15 +/- 18 months). Subjects were enrolled >10 weeks after CRT implant. Spiroergometry and 2-dimensional/3-dimensional echocardiography were used to assess cardiac performance for "out-of-the-box" settings (baseline settings: AV 120 ms, VV 0 ms) versus optimal settings (determined by acoustic cardiography). Cardiac performance measurements were performed 6 weeks after settings were modified. Optimal AV/VV settings were determined based on the lowest electromechanical activation time (EMAT, the time from the onset of QRS to the mitral valve component of the first heart sound). Statistical analysis was performed using a paired 2-tailed Student's t-test. In comparison to "out-of-the-box" settings, AV/VV delay optimization with acoustic cardiography improved cardiac performance as indicated by significant changes in work capacity, maximum oxygen uptake, oxygen pulse, ejection fraction, end-systolic volume, and velocity-time integral in left ventricular outflow tract. CONCLUSIONS: AV and VV optimization by acoustic cardiography produces significant improvements in objective clinical and hemodynamic parameters in comparison to typical "out-of-the-box" settings.

Percutaneous closure of patent foramen ovale without echocardiographic guidance.

BACKGROUND: A percutaneous patent foramen ovale (PFO) closure procedure includes transesophageal or intracardiac echocardiographic guidance at many centers. We investigated the feasibility and complications of the PFO closure without echocardiography. METHODS AND RESULTS: A total of 420 consecutive patients (185 women and 235 men, mean age 51 +/- 12 years) underwent percutaneous PFO closure without echocardiographic guidance using 7 different devices. Of these, 106 patients (25%) had an associated atrial septal aneurysm. The implantation was successful in 418 patients (99%). There were 12 procedural complications (3%), including embolization of the device or of parts of it with successful percutaneous removal in 5 cases, pericardial tamponade requiring pericardiocentesis in 1 patient, air embolism with transient symptoms in 3 patients, and vascular access problems in 3 patients. In none of the cases, echocardiography had to be summoned during the case or its lack was associated with acute or subsequent problems. The fluoroscopy time and procedure time were 5.4 +/- 2.7 and 25 +/- 17 minutes, respectively. Transthoracic contrast echocardiography, 24 hours after device implantation, detected a residual shunt in 19% of the patients. CONCLUSIONS: Percutaneous PFO closure with fluoroscopic guidance only is feasible and has low complication rates, especially with Amplatzer PFO Occluders. The added time and cost of echocardiography during the procedure is not warranted.

Full-root Aortic Valve Replacement by Stentless Aortic Xenografts in Patients with Small Aortic Roots.

In patients with small aortic roots who need an aortic valve replacement with biological valve substitutes, the implantation of the stented pericardial valve might not meet the functional needs. The implantation of a too-small stented pericardial valve, leading to an effective orifice area indexed to a body surface area less than 0.85 cm2/m2, is regarded as prosthesis-patient mismatch (PPM). A PPM negatively affects the regression of left ventricular hypertrophy and thus the normalization of left ventricular function and the alleviation of symptoms. Persistent left ventricular hypertrophy is associated with an increased risk of arrhythmias and sudden cardiac death. In the case of predictable PPM, there are three options: 1) accept the PPM resulting from the implantation of a stented pericardial valve when comorbidities of the patient forbid the more technically demanding operative technique of implanting a larger prosthesis, 2) enlarge the aortic root to accommodate a larger stented valve substitute, or 3) implant a stentless biological valve or a homograft. Compared to classical aortic valve replacement with stented pericardial valves, the full-root implantation of stentless aortic xenografts offers the possibility of implanting a 3-4 mm larger valve in a given patient, thus allowing significant reduction in transvalvular gradients. However, a number of cardiac surgeons are reluctant to transform a classical aortic valve replacement with stented pericardial valves into the more technically challenging full-root implantation of stentless aortic xenografts. Given the potential hemodynamic advantages of stentless aortic xenografts, we have adopted full-root implantation to avoid PPM in patients with small aortic roots necessitating an aortic valve replacement. Here, we describe in detail a technique for the full-root implantation of stentless aortic xenografts, with emphasis on the management of the proximal suture line and coronary anastomoses. Limitations of this technique and alternative options are discussed.

Direct Re-implantation of Left Coronary Artery into the Aorta in Adults with Anomalous Origin of Left Coronary Artery from the Pulmonary Artery (ALCAPA).

Anomalous origin of the left coronary artery from the pulmonary artery (ALCAPA) is a rare congenital anomaly which is one of leading causes of myocardial ischemia and infarction in children. If left untreated, it results in a 90% mortality rate in the first year of life. In patients who survive to the adulthood, the coronary steal phenomenon and retrograde left-sided coronary flow provide a substrate for chronic subendocardial ischemia, which may lead to left ventricular dysfunction, ischemic mitral regurgitation, malignant ventricular arrhythmias, and sudden cardiac death. The average age of life-threatening presentation is 33 years and of sudden cardiac death 31 years. Therefore, surgical correction is highly recommended as soon as the diagnosis is made, regardless of age. In adult-type ALCAPA originating from the right-facing sinus of the pulmonary artery, direct re-implantation of the ALCAPA into the aorta is the more physiologically sound repair technique to re-establish the dual-coronary perfusion system and is recommended. This protocol describes the technique of direct re-implantation of adult-type ALCAPA into the aorta.