Extracorporeal Life Support in Infarct-Related Cardiogenic Shock.

BACKGROUND: Extracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality. METHODS: In this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy. RESULTS: A total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P = 0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25). CONCLUSIONS: In patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.).

Surgical Ablation of Atrial Fibrillation in High-Risk Patients: Success versus Risk.

BACKGROUND: Surgical atrial ablation is evaluated by surgeons in relation to the estimated surgical risk. We analyze whether high-risk patients (HRPs) experience risk escalation by ablation procedures. METHODS: The CASE-Atrial Fibrillation (AF) registry is a prospective, multicenter, all-comers registry of atrial ablation in cardiac surgery. We analyzed the 1-year outcome regarding survival and rhythm endpoints of 1,000 consecutive patients according to the operative risk classification (EuroSCORE II ≤ 2 vs. >2). RESULTS: Higher NYHA (New York Heart Association) score, ischemic heart failure, status poststroke, renal insufficiency, chronic obstructive pulmonary disease, and diabetes mellitus were strongly represented in HRPs. HRPs exhibit more left ventricular ejection fraction < 40% (19.2 vs. 8.8%; p < 0.001) but identical left atrial diameter and left ventricular end-diastolic diameter compared with low-risk patients (LRPs). CHA2DS-Vasc-score (2.4 ± 1 vs. 3.6 ± 1.5; p < 0.001), sternotomies, combination surgeries, coronary artery bypass graft, and mitral valve procedures were increased in HRPs. LRPs underwent stand-alone ablations as well. Ablation energy did not differ. Left atrial appendage closure was performed in up to 86.1% (mainly cut-and-sew procedures). Mortality corresponded to the original risk class without an escalation that may be related to ablation, stroke rate, or myocardial infarction. A total of 60.6% of HRPs versus 75.1% of LRPs were discharged in sinus rhythm. Long-term EHRA (European Heart Rhythm Association) score symptoms were lower in HRPs. Repeated rhythm therapies were rare. Additional antiarrhythmics received a minority without group dependency. A total of 1.6 versus 4.1% of HRPs (p = 0.042) underwent long-term stroke; excess mortality was not observed. Anticoagulation remained common in HRPs. CONCLUSION: Surgical risk and long-term mortality are determined by the underlying disease. In HRPs, freedom from AF and symptom relief can be achieved. Preoperative risk scores should not lead to withholding an ablation procedure.

The German CArdioSurgEry Atrial Fibrillation Registry: In-Hospital Outcomes.

BACKGROUND: The aim of this study was to describe outcomes of patients undergoing surgical ablation for atrial fibrillation (AF) as either stand-alone or concomitant cardiosurgical procedures in Germany. METHODS: Patients with AF undergoing concomitant or stand-alone surgical ablation were included in the registry. Cardiac surgery centers across Germany were invited to participate and sought to enroll 1,000 consecutive patients. Data was obtained through electronic case report forms. The protocol mandated follow-up interviews at 1 year. RESULTS: Between January 2017 and April 2020, 17 centers enrolled 1,000 consecutive patients. Among concomitant surgical patients (n = 899), paroxysmal AF was reported in 55.4% patients. Epicardial radio frequency (RF) bilateral pulmonary vein isolation (PVI) with excision of the left atrial appendage (LAA) was the most common operative strategy. In the stand-alone cohort (n = 101), persistent AF forms were reported in 84.1% of patients. Moderate-to-severe symptoms were reported in 85.1%. Sixty-seven patients had previously underwent at least two failed catheter ablative procedures. Thoracoscopic epicardial RF bilateral PVI and completion of a "box-lesion" with LAA closure were frequently preformed. Major cardiac and cerebrovascular complications occurred in 38 patients (4.3%) in the concomitant group. No deaths were reported in the stand-alone group. At discharge, sinus rhythm was achieved in 88.1% of stand-alone and 63.4% concomitant patients. CONCLUSION: The CArdioSurgEry Atrial Fibrillation registry provides insights into surgical strategies for AF ablation in a considerable cohort across Germany. This in-hospital data demonstrates that concomitant and stand-alone ablation during cardiac surgery is safe and effective with low complication rates.

The German Cardiosurgery Atrial Fibrillation Registry: 1-Year Follow-up Outcomes.

OBJECTIVES: This study of German Cardiosurgery Atrial Fibrillation (CASE-AF) registry aims to describe the 1-year outcomes of patients undergoing ablative procedures for atrial fibrillation (AF) in a cardiosurgical setting. METHODS: Between January 2017 and April 2020, 17 German cardiosurgical units enrolled 1,000 consecutive patients undergoing concomitant or stand-alone ablation for AF. In-hospital and 1-year follow-up data were collected on web-based electronic case report forms. The protocol mandated telephone-based follow-up contact after 1 year. RESULTS: At 1-year follow-up (median, 14.5 months [12.6-18.2 months]), significant improvement (p < 0.0001) in baseline modified European Heart Rhythm Association Class I was reported in both concomitant and stand-alone patients. Follow-up examinations were completed in 97.9% of cases, and a sinus rhythm was reported in 60.2 and 63.6% of stand-alone and concomitant patients, respectively. Statistically significant factors determining late recurrence were female gender (p = 0.013), preoperative persistent AF (p < 0.0001), and presence of cardiac implantable electronic device (p = 0.011). All-cause mortality at 1 year was 1% (n = 1) in stand-alone patients and 6.7% (n = 58) in concomitant patients. CONCLUSION: Surgical ablation of AF is safe and provides satisfactory results at short-term follow-up, with significant improvement in patient symptoms. Adequate cardiac rhythm monitoring should be prioritized for higher quality data acquisition.

Impact of chronic total occlusion and revascularization strategy in patients with infarct-related cardiogenic shock: A subanalysis of the culprit-shock trial.

BACKGROUND: The impact of coronary artery chronic total occlusion (CTO) and its management with percutaneous coronary intervention (PCI) in the setting of myocardial infarction (MI) related cardiogenic shock (CS) remains unclear. METHODS: This is a pre-specified analysis from the culprit-lesion-only PCI vs multivessel PCI in CS (CULPRIT-SHOCK) trial which randomized patients presenting with MI and multivessel disease complicated by CS to a culprit-lesion-only or immediate multivessel PCI strategy. CTO was defined by central core-laboratory evaluation. The independent associations between the presence of CTO and adverse outcomes at 30 days and 1 year were assessed using multivariate logistics models. RESULTS: A noninfarct related CTO was present in 157 of 667 (23.5%) analyzed patients. Patients presenting with CTO had more frequent diabetes mellitus or prior PCI but less frequently presented with ST segment elevation MI as index event. The presence of CTO was associated with higher rate of death at 30 days (adjusted Odds ratio 1.63; 95% confidence interval [CI] 1.01-2.60). Rate of death at 1 year was also increased but did not reach statistical significance (adjusted Odds ratio 1.62; 95%CI 0.99-2.66). Compare to immediate multivessel PCI, a strategy of culprit-lesion-only PCI was associated with lower rates of death or renal replacement therapy at 30 days in patients with and without CTO (Odds ratio 0.79 95%CI 0.42-1.49 and Odds ratio 0.67 95%CI 0.48-0.96, respectively), without significant interaction (P = .68). CONCLUSIONS: In patients with MI-related CS and multivessel disease, the presence of CTO is associated with adverse outcomes while a strategy of culprit-lesion-only PCI seems beneficial regardless of the presence of CTO.

Does Preoperative Sinus Rhythm Influence Surgical Ablation's Perioperative Safety in Patients with Atrial Fibrillation?

BACKGROUND: Despite excellent data on lowering long-term stroke and all-cause mortality rates, currently, only 25-40% of atrial fibrillation (AF) patients undergo simultaneous surgical ablation therapy (SA) during cardiac surgery. Surgeon's fear exposing their patients to an additional, unjustified, and disproportionate risk when performing SA in AF patients presenting with sinus rhythm (SR) before surgery. To clarify the influence of preoperative SR before SA for AF, we conducted a subgroup analysis of the German Cardiosurgical Atrial Fibrillation (CASE-AF) register. METHODS: Between September 2016 and August 2020, 964 AF patients with an underlying cardiac disease were scheduled for surgery with SA and enrolled in the CASE-AF register. Data prospectively were collected and analyzed retrospectively. We divided the entire cohort into an SR-group (38.2%, N = 368) and an AF-group (61.8%, N = 596), based on preoperative heart rhythm. RESULTS: Over half of the patients were moderately affected by their AF, with no difference between the groups (European Heart Rhythm Association class ≥IIb: SR-group 54.2% versus AF-group 58.5%, P = .238). The AF-group had a higher preoperative EuroSCORE II (4.8 ± 8.0% versus 4.2 ± 6.3%, P = .014). In-hospital mortality (SR-group 0.8% versus AF-group 1.7%, P = .261), major perioperative adverse cardiac and cerebrovascular events (SR-group 2.7% versus AF-group 3.5%, P = .500), and the new pacemaker implantation rate (SR-group 6.0% versus AF-group 5.9%, P = .939) were low and showed and no group difference. Logistic regression analysis showed a protective effect for preoperative SR to perioperative complications in AF patients undergoing SA (odds ratio (OR) 0.72 (95% CI 0.52 - 0.998); P = .0485). CONCLUSIONS: Concomitant SA in AF patients presenting in SR before cardiac surgery is safe, has a low perioperative risk profile, and should be carried out with almost no exceptions.

Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction: Long-Term 6-Year Outcome of the Randomized IABP-SHOCK II Trial.

BACKGROUND: The role of intraaortic balloon counterpulsation (IABP) in cardiogenic shock is still a subject of intense debate despite the neutral results of the IABP-SHOCK II trial (Intraaortic Balloon Pump in Cardiogenic Shock II) with subsequent downgrading in international guidelines. So far, randomized data on the impact of IABP on long-term clinical outcomes in patients with cardiogenic shock complicating acute myocardial infarction are lacking. Furthermore, only limited evidence is available on general long-term outcomes of patients with cardiogenic shock treated by contemporary practice. METHODS: The IABP-SHOCK II trial is a multicenter, randomized, open-label trial. Between 2009 and 2012, 600 patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization were randomized to IABP versus control. RESULTS: Long-term follow-up was performed 6.2 years (interquartile range 5.6-6.7) after initial randomization. Follow-up was completed for 591 of 600 patients (98.5%). Mortality was not different between the IABP and the control group (66.3% versus 67.0%; relative risk, 0.99; 95% CI, 0.88-1.11; P=0.98). There were also no differences in recurrent myocardial infarction, stroke, repeat revascularization, or rehospitalization for cardiac reasons (all P>0.05). Survivors' quality of life as assessed by the EuroQol 5D questionnaire and the New York Heart Association class did not differ between groups. CONCLUSIONS: IABP has no effect on all-cause mortality at 6-year long-term follow-up. Mortality is still very high, with two thirds of patients with cardiogenic shock dying despite contemporary treatment with revascularization therapy. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov/. Unique identifier: NCT00491036.

Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock.

BACKGROUND: Percutaneous mechanical circulatory support devices are increasingly used in acute myocardial infarction complicated by cardiogenic shock (AMI-CS), despite limited evidence for their effectiveness. The aim of this study was to evaluate outcomes associated with use of the Impella device compared with intra-aortic balloon pump (IABP) and medical treatment in patients with AMI-CS. METHODS: Data of patients with AMI-CS treated with the Impella device at European tertiary care hospitals were collected retrospectively. All patients underwent early revascularization and received optimal medical treatment. Using IABP-SHOCK II (Intraaortic Balloon Pump in Cardiogenic Shock II) trial inclusion and exclusion criteria, 372 patients were identified and included in this analysis. These patients were matched to 600 patients from the IABP-SHOCK II trial. The following baseline criteria were used as matching parameters: age, sex, mechanical ventilation, ejection fraction, prior cardiopulmonary resuscitation, and lactate. Primary end point was 30-day all-cause mortality. RESULTS: In total, 237 patients treated with an Impella could be matched to 237 patients from the IABP-SHOCK II trial. Baseline parameters were similarly distributed after matching. There was no significant difference in 30-day all-cause mortality (48.5% versus 46.4%, P=0.64). Severe or life-threatening bleeding (8.5% versus 3.0%, P<0.01) and peripheral vascular complications (9.8% versus 3.8%, P=0.01) occurred significantly more often in the Impella group. Limiting the analysis to IABP-treated patients as a control group did not change the results. CONCLUSIONS: In this retrospective analysis of patients with AMI-CS, the use of an Impella device was not associated with lower 30-day mortality compared with matched patients from the IABP-SHOCK II trial treated with an IABP or medical therapy. To further evaluate this, a large randomized trial is warranted to determine the effect of the Impella device on outcome in patients with AMI-CS. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03313687.

Underweight is associated with inferior short and long-term outcomes after MitraClip implantation: Results from the German TRAnscatheter mitral valve interventions (TRAMI) registry.

BACKGROUND: Underweight and obesity represent classical risk factors for adverse outcome in patients treated for cardiovascular disease. AIMS: The current analysis examines the impact of underweight, overweight and obesity on intra-hospital, short and long-term outcomes in patients treated by MitraClip therapy. METHODS AND RESULTS: From August 2010 until July 2013, 799 patients (age 75.3 ±â€¯8.6 years, male gender 60.7%, median logistic EuroSCORE 20% [12; 31], functional mitral regurgitation (MR): 69.3%) were prospectively enrolled into the multicenter German Transcatheter Mitral Valve Interventions registry. Patients were stratified according to body mass index (BMI) into 4 groups: BMI <20 kg/m2 (underweight), BMI 20.0 to <25.0 kg/m2 (normal weight, reference group), BMI 25.0 to <30.0 kg/m2 (overweight) and BMI ≥30 kg/m2 (obese). Significant increased rates of procedural failure, transfusion/bleeding, sepsis or multiorgan failure and low cardiac output failure were found for underweight patients only. Kaplan-Meier survival curves demonstrated inferior survival for underweight patients, but comparable outcomes for all other patients (global log rank test, P < .01). Multivariable Cox-regression analysis (adjusted for age, gender, creatinine ≥1.5 mg/dL, diabetes, left ventricular ejection fraction <30% and chronic obstructive pulmonary disease) confirmed underweight (as compared to normal weight) as an independent risk factor of death (hazard ratio [HR]: 1.58, 95% confidence interval (CI): 1.01-2.46, P = .044) and overweight as protective against death (HR: 0.71; 95%-CI: 0.55-0.93; P = .011). CONCLUSIONS: Compared to other weight groups, underweight patients undergoing MitraClip implantation are exposed to increased rates of procedural failure, bleeding and low cardiac output as well as increased short- and long-term mortality rates and should therefore be carefully discussed in the heart-team.

Gender-related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1-year results from the German TRAMI registry.

OBJECTIVES: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population. METHODS AND RESULTS: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates. CONCLUSION: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy.

Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better?

OBJECTIVES: To compare baseline characteristics and outcomes in patients treated with either 1 or 2 MitraClips in the German TRAMI (Transcatheter Mitral Valve Interventions) registry. BACKGROUND: The MitraClip community seems to silently assume that results should intrinsically be better after implantation of more than one clip, although data is still sparse. METHODS: In 2010-2013, 803 patients were enrolled prospectively into TRAMI (461 one-clip and 312 two-clip procedures). Follow-up was performed centrally at 30 days and 1 year. RESULTS: Baseline characteristics of TRAMI-patients with two clips differed significantly from single-clip patients regarding constitutional (more men, taller body height) and heart failure-related factors (larger left ventricular dimensions, reduced left ventricular ejection fraction, more severe heart failure). Also, a significant increase in two-clip procedures over time was present. After propensity score matching for differing baseline characteristics, residual moderate mitral regurgitation (MR) occurred more frequently after implantation of two clips, whereas residual severe MR could more frequently be observed after one-clip procedures. However, no or mild residual MR at discharge was present in 71.6% after single-clip and in 70.1% after two-clips implantation (p = .81). After 1 year, no significant differences regarding mortality or New York Heart Association status could be detected in the propensity matched cohorts. However, TRAMI-patients treated with two clips had a significantly higher incidence of cerebral-vascular events (p = .02). CONCLUSIONS: TRAMI data cannot support the theory that implantation of more than one clip is associated with better clinical outcomes. The finding of more cerebral-vascular events after two-clip procedures might be hypothesis-generating.

Percutaneous treatment of mitral regurgitation in patients with impaired ventricular function: Impact of intracardiac electronic devices (from the German Transcatheter Mitral Valve Interventions Registry).

OBJECTIVES: To identify prevalence/impact of previous implantation of cardiac electronic devices (CEDs), such as cardioverter defibrillator (ICD) and cardiac resynchronization (CRT), in a group of MitraClip (MC) candidates with LVEF < 30%. BACKGROUND: MC therapy is nowadays often considered in patients with depressed left ventricular ejection fraction (LVEF%) and symptomatic severe secondary MR. METHODS: Data from the German Transcatheter Mitral Valve Interventions (TRAMIs) registry were analyzed. Patients with pre-procedural LVEF <30% were selected and divided according to the presence of CEDs. Pre-procedural, peri-procedural, and 1-year follow-up data were analyzed. RESULTS: Out of 689 MC patients, 235 had LVEF<30%. Of these, 23% (54/235) had CRT, 36.6% (86/235) ICD, and 40.4% (95/235) had no CEDs. Risk profile was similar (median STS score CRT 6.0 (IQR: 3.0-12.0); ICD 7.0 (IQR: 4.0-12.0); No-CED 6.5 (IQR: 2.0-10.0); p = 0.8). No procedural mortality was observed and hospital mortality was 5.6% in CRT, 2.3% in ICD, and 3.2% in No-CED (p = 0.5). At discharge, severe MV regurgitation was reported in 3.8% of CRT, 3.7% of ICD, and 1.1% of No-CED (p = 0.9). One year estimated survival (CRT 75.7%; ICD 75.8%; No-CED 78%; p = 0.94) and freedom from MACCE (CRT 73.6%; ICD 75.8%; No-CED 74.5%; p = 0.88) were similar. CONCLUSIONS: A third of patients have been already submitted to CEDs implantation at time of referral for MC therapy and 40% of those with severely depressed LVEF% arrive to MC therapy before ICD/CRT implantation. The presence of CED does not impair acute MC therapy success. Mid-term follow-up outcomes are similar in patients with and without CEDs.

Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation.

AIMS: To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF). METHODS AND RESULTS: Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was 'atrial arrhythmia recurrence', secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P < 0.001). Follow-up duration was 441 (CBA) and 511 days (RFA) (P < 0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70-1.04; P = 0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64-0.99; P = 0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26-1.10; P = 0.088). Re-ablations (adjHR 0.46, 95% CI 0.34-0.61; P < 0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48-0.88; P = 0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations. CONCLUSIONS: The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.

Individualised treatment targets in patients with type-2 diabetes and hypertension.

AIM: Patients with type-2 diabetes mellitus (T2DM) are at high risk of cardiovascular events, accentuated in the presence of hypertension. At present, it is unclear to what extent the guidelines for the management of T2DM, advocating reduction in HbA1c levels to below target levels, are being adhered to in clinical practice. METHODS: DIALOGUE was a prospective, observational, non-interventional registry performed across multiple centres in Germany. Patients aged 18 years or older who had T2DM and hypertension for whom the treating physician considered blood glucose lowering medication as inadequate and/or not safe/tolerable and chose to add a further oral drug or switch drug treatment were included. Patients were assigned a treatment target HbA1c value (≤ 6.5% [strict]; > 6.5 to ≤ 7.0% [intermediate]; > 7.0 to ≤ 7.5% [lenient]). RESULTS: 8568 patients with T2DM and hypertension were enrolled. 6691 (78.1%) had 12-month follow-up. Patients who were assigned a strict HbA1c treatment target (n = 2644) were younger, had shorter diabetes duration, and less comorbidity in comparison to those with intermediate (n = 2912) or lenient targets (n = 1135). Only 53.1% of patients achieved their HbA1c treatment target (46.2% [strict], 56.8% [intermediate], 59.4% [lenient]). There was little sign of treatment intensification for patients that had not achieved their HbA1c target. CONCLUSIONS: Achievement of treatment targets was poor, leaving many patients with sub-optimal blood glucose levels. The apparent reluctance of physicians to intensify antidiabetic drug therapy is alarming, especially considering the evidence pointing to an association of hyperglycaemia and microvascular complications in patients with T2DM.

In-hospital major arrhythmias, arrhythmic death and resuscitation after successful primary percutaneous intervention for acute transmural infarction: a retrospective single-centre cohort study.

BACKGROUND: Transmural acute myocardial infarction (AMI) is associated with a high risk for ventricular arrhythmia before, during and after treatment. Consequently, it is recommended that patients diagnosed with transmural AMI be monitored in a cardiac care unit (CCU) so life-threatening arrhythmias can be treated promptly. We examined the incidence and timing of in-hospital malignant ventricular arrhythmias, sudden cardiac or arrhythmic death (SCD/AD) and resuscitation requirements in patients with transmural AMI recovering from percutaneous coronary intervention (PCI) undertaken within 12 h of symptom onset and without antecedent thrombolysis. METHODS: This was a retrospective cohort study using the Duisburg Heart Center (Germany) cardiac patient registry. In total, 975 patients met the inclusion criteria. The composite endpoint was post-PCI ventricular fibrillation or tachycardia, SCD/AD or requirement for resuscitation. We compared the demographic and clinical characteristics of patients who met the composite endpoint with those who did not, recorded the timing of endpoint episodes, and used multivariable logistic regression analysis to identify factors associated with the endpoint criteria. RESULTS: There was no significant difference in the length of CCU or hospital stay between the groups. In-hospital mortality was 6.5%, and the composite endpoint was met in 7.4% of cases. Malignant ventricular tachyarrhythmia occurred in 2.8% of the patients, and SCD/AD occurred in 0.3% of the cases. There was a biphasic temporal distribution of endpoint events; specifically, 76.7% occurred < 96 h after symptom onset, and 12.6% occurred 240-360 h after symptom onset. Multivariable regression analysis identified positive associations between an endpoint episode and the following: age (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.01-1.05] per year); left ventricular ejection fraction (LVEF) < 30% (OR 3.66, 95% CI 1.91-6.99); peak serum creatine phosphokinase concentration (OR 1.01, 95% CI 1.00-1.02 per 100 U/dl); leucocytosis (OR 1.86, 95% CI 1.04-3.32), and coronary thrombus (OR 1.85, 95% CI 1.04-3.27). CONCLUSIONS: Most post-PCI malignant ventricular arrhythmias, SCD/AD and resuscitation episodes occurred within 96 h of transmural AMI (76.7%). A substantial minority (12.6%) of these events arose 240-360 h after symptom onset. Further study is needed to establish the influence of age, LVEF < 30%, peak serum creatine phosphokinase concentration, leucocytosis and coronary thrombus on post-PCI outcomes after transmural AMI.

One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry.

AIMS: The transcatheter mitral valve interventions (TRAMI) registry was established in order to assess safety and efficacy of catheter-based mitral valve interventional techniques in Germany, and prospectively enrolled 828 MitraClip patients (median age 76 years, median log. EuroSCORE I 20.0%) between August 2010 and July 2013. We present the 1-year outcome in this MitraClip cohort-which is the largest published to date. METHODS AND RESULTS: Seven forty-nine patients (90.5%) were available for 1-year follow-up and included in the following analyses. Mortality, major adverse cardiovascular event rates, and New York Heart Association (NYHA) classes were recorded. Predictors of 1-year mortality were identified by multivariate analysis using a Cox regression model with stepwise forward selection. The 1-year mortality was 20.3%. At 1 year, 63.3% of TRAMI patients pertained to NYHA functional classes I or II (compared with 11.0% at baseline), and self-rated health status (on EuroQuol visual analogue scale) also improved significantly by 10 points. Importantly, a significant proportion of patients regained the complete independence in self-care after MitraClip implantation (independence in 74.0 vs. 58.6% at baseline, P = 0.005). Predictors of 1-year mortality were NYHA class IV (hazard ratio, HR 1.62, P = 0.02), anaemia (HR 2.44, P = 0.02), previous aortic valve intervention (HR 2.12, P = 0.002), serum creatinine ≥1.5 mg/dL (HR 1.77, P = 0.002), peripheral artery disease (HR 2.12, P = 0.0003), left ventricular ejection fraction <30% (HR 1.58, P = 0.01), severe tricuspid regurgitation (HR 1.84, P = 0.003), and procedural failure (defined as operator-reported failure, conversion to surgery, failure of clip placement, or residual post-procedural severe mitral regurgitation) (HR 4.36, P < 0.0001). CONCLUSIONS: Treatment of significant MR with MitraClip resulted in significant clinical improvements in a high proportion of TRAMI patients after 12 months. In the TRAMI cohort, the failure of procedural success exhibited the highest hazard ratio concerning the prediction of 1-year mortality.

First-line catheter ablation of paroxysmal atrial fibrillation: outcome of radiofrequency vs. cryoballoon pulmonary vein isolation.

AIMS: First-line ablation prior to antiarrhythmic drug (AAD) therapy is an option for symptomatic paroxysmal atrial fibrillation (PAF); however, the optimal ablation technique, radiofrequency (RF), or cryoballoon (CB) has to be determined. METHODS AND RESULTS: The FREEZE Cohort Study compares RF and CB ablation. Treatment-naïve patients were documented in the FREEZEplus Registry. Periprocedural data and outcome were analysed. From 2011 to 2014, a total of 373/4184 (8.9%) patients with PAF naïve to AAD were identified. Pulmonary vein isolation (PVI) was performed with RF (n = 180) or CB (n = 193). In the RF group, patients were older (65 vs. 61 years, P < 0.01) compared with the CB group. The procedure time was significantly shorter and radiation exposure higher in the CB group. Major adverse events occurred in 1.6% (CB) and 3.7% (RF) of patients (P = 0.22). AF/atrial tachycardia (AT) recurrence until discharge was 4.5% (RF) and 8.5% (CB, P = 0.2). Follow-up (FU) ≥12 months was available in 99 (RF) and 107 (CB) patients. After 1.4 years of FU, freedom from AF/atrial tachycardia (AT) was 61% (RF) and 71% (CB, P = 0.11). In the RF group, more patients underwent cardioversion, and a trend for more repeat ablations was observed. Persistent phrenic nerve palsy was observed in one patient treated by CB. CONCLUSION: First-line ablation for PAF is safe and effective with either RF or CB. The procedure was faster with the CB, but the radiation exposure was higher. Although there was a trend for more recurrences and complications in the RF group, a more favourable risk profile in patients undergoing CB ablation might have biased the results. CLINICALTRIALSGOV IDENTIFIER: NCT01360008.

Evaluation of heart rate measurements in clinical studies: a prospective cohort study in patients with heart disease.

PURPOSE: The purpose of this study was to evaluate the measurement of heart rate undertaken in clinical studies by (1) assessing the repeatability and reproducibility of heart rate measurements by various methods and under various conditions and (2) determining whether a single heart rate measurement at rest is representative of the circadian and inter-day variation of heart rate. METHODS: Prospective cohort study in 102 patients with various types of heart disease at Duisburg Heart Center, Germany between 2011 and 2012. The heart rate measurements were based on self-assessment, ECG tracings at rest, and bicycle stress ECG in the office as well as 24-h Holter ECG. RESULTS: Office measurements and self-assessment at rest as well as 24-h Holter ECG and self-assessment at rest are highly correlated, but no correlation between self-assessment and office recordings/24 h recordings under exercise conditions was seen. Coefficient of variability was below 10 % for the self-assessment and for office measurements at rest. There were no differences in coefficient of variability during the day and within the 6 days for self-assessment of heart rate at rest and circadian variation was normal. CONCLUSIONS: At rest heart rate measurements by various methods agree sufficiently and inter-day/circadian variation is adequately represented. Under exercise conditions self-assessment of heart rate is not valuable and use of 24 h Holter as well as stress ECG recordings is necessary. Thus, self-reported heart rate measurements by the patient at rest seem to be reliable, but should be used in clinical studies only for heart rate assessment at rest.

Azilsartan compared to ACE inhibitors in anti-hypertensive therapy: one-year outcomes of the observational EARLY registry.

BACKGROUND: Azilsartan medoxomil (AZL-M), has been demonstrated to be more effective than the other sartans currently in use; however, there is insufficient information available comparing it with ACE-inhibitors. Therefore, we aimed to compare the efficacy, safety, and tolerability of AZL-M with that of ACE-inhibitors in a real life clinical setting. METHODS: The EARLY registry is a prospective, observational, national, multicentre registry with a follow-up period of 12 months. There were two principal objectives: 1) documentation of the achievement of target BP values set according to recent national and international guidelines, and 2) description of the safety profile of AZL-M. RESULTS: A total of 3 849 patients with essential arterial hypertension were recruited from primary care offices in Germany. Patients who initiated monotherapy at baseline comprising either AZL-M or an ACE-inhibitor were included at a ratio of seven to three. Results demonstrated that a blood pressure target of <140/90 mmHg was achieved by a significantly greater proportion of patients in the AZL-M group (61.1 %) compared with the ACE-inhibitor group (56.4 %; p < 0.05; OR, 1.21; 95 % CI, 1.03-1.42), with this finding maintained after adjusting for differences in baseline characteristics. AZL-M appeared to have an equivalent safety profile to the ACE-inhibitors, with a similar incidence of adverse events in the two patient groups (p = 0.73). CONCLUSIONS: These data add to the results of previous randomized controlled clinical trials suggesting that, compared with other agents that target the renin-angiotensin system, AZL-M provides statistically significant albeit small improvements in blood pressure control.

Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry.

AIMS: To analyze risk and outcomes of complications during and after MitraClip implantation using multicenter data from the prospective German Transcatheter Mitral Valve Interventions (TRAMI) registry. METHODS AND RESULTS: Data of 828 patients (mean age: 76.0 [71-81] years, 327 (40%) females) undergoing MitraClip implantation in Germany between 2010 and 2013 were analyzed. Most patients (85%) underwent elective procedures with on average implantation of 1.4 ± 0.6 clips. Emergent cardiac surgery was not required; a single patient died intraoperatively. During the in-hospital period, complications occurred in 215 (25.9%) patients, of which 106 (12.8%) were considered major. Major bleeding complications were among the most frequent major complications (7.4%), while rates of pericardial tamponade (1.9%) and clip-specific complications (embolization: 0%, partial clip detachment: 1.9%) were low. In-hospital death, stroke or myocardial infarction (MACCE) occurred in 2.2, 0.9, and 0% patients, respectively. Patients with complications appeared to be older and more critically ill pre-interventionally; in-hospital mortality was significantly higher as compared to those without procedural complications. CONCLUSIONS: MitraClip implantation appears to be a safe treatment option with low rates of MACCE and clip-specific complications. Nevertheless, MitraClip therapy is not without complications. Careful patient selection and improvements in preventing peri-procedural bleeding have the potential of reducing post-procedural complications and improving outcomes.