Partial versus Complete Sternotomy for Aortic Valve Replacement-Multicenter Study.

BACKGROUND: The benefits of minimally invasive techniques in cardiac surgery remain poorly defined. We evaluated the short- and mid-term outcomes after surgical aortic valve replacement through partial upper versus complete median sternotomy (MS) in a large, German multicenter cohort. METHODS: A total of 2,929 patients underwent isolated surgical aortic valve replacement via partial upper sternotomy (PUS, n = 1,764) or MS (n = 1,165) at nine participating heart centers between 2016 and 2020. After propensity-score matching, 1,990 patients were eligible for analysis. The primary end point was major adverse cardiac and cerebrovascular events (MACCE), a composite of death, myocardial infarction, and stroke at 30 days and in follow-up, up to 5 years. Secondary end points were acute kidney injury, length of hospital stay, transfusions, deep sternal wound infection, Dressler's syndrome, rehospitalization, and conversion to sternotomy. RESULTS: Unadjusted MACCE rates were significantly lower in the PUS group both at 30 days (p = 0.02) and in 5-year follow-up (p = 0.01). However, after propensity-score matching, differences between the groups were no more statistically significant: MACCE rates were 3.9% (PUS) versus 5.4% (MS, p = 0.14) at 30 days, and 9.9 versus 11.3% in 5-year follow-up (p = 0.36). In the minimally invasive group, length of intensive care unit (ICU) stay was shorter (p = 0.03), Dressler's syndrome occurred less frequently (p = 0.006), and the rate of rehospitalization was reduced significantly (p < 0.001). There were 3.8% conversions to full sternotomy. CONCLUSION: In a large, German multicenter cohort, MACCE rates were comparable in surgical aortic valve replacement through partial upper and complete sternotomies. Shorter ICU stay and lower rates of Dressler's syndrome and rehospitalization were in favor of the partial sternotomy group.

Laser lead extraction in octo- and nonagenarians. A subgroup analysis from the GALLERY registry.

INTRODUCTION: In an aging population with cardiac implantable electronic devices, an increasing number of octo- and even nonagenarians present for lead extraction procedures. Those patients are considered at increased risk for surgical procedures including lead extraction. Here, we investigated safety and efficacy of transvenous lead extraction in a large patient cohort of octo- and nonagenarians. METHODS AND RESULTS: A subgroup analysis of all patients aged ≥80 years (n = 499) in the German Laser Lead Extraction Registry (GALLERY) was performed. Outcomes were compared to the nonoctogenarians from the registry. Primary extraction method was Laser lead extraction, with additional use of mechanical rotational sheaths or femoral snares, if necessary. An analysis of patient- and device characteristics, as well as an assessment of predictors for adverse events via multivariate analyses was conducted. Mean patients age was 84.3 ± 3.7 years in the octogenarians group and 64.1 ± 12.4 years in the nonoctogenarians group. The median lead dwell time was 118.0 months (78; 167) and 92.0 months [60; 133], p < .001 in the octogenarians and nonoctogenarians group, respectively. Clinical procedural success rate was achieved in 97.6% of the cases in octogenarians and 97.9% in nonoctogenarians (p = .70). Overall complication rate was 4.4% in octogenarians and 4.3% in nonoctogenarians (0.91). In octogenarians procedure-related mortality was 0.8% and all-cause in-hospital mortality was 5.4%, while in nonoctogenarians, procedure related and all-cause in-hospital mortality were 0.5% and 3.1%, respectively. A body mass index (BMI) <20 kg/m2 , was the only statistically significant predictor for procedure-related complications in octogenarians, while systemic infection, BMI ≤20 kg/m2 , procedural complications and chronic kidney disease were predictors for in-hospital mortality. CONCLUSIONS: Laser lead extraction in octo- and nonagenarians is safe and effective. BMI ≤20 kg/m2 was the only statistically significant predictor for procedural complications. According to our data, advanced age should not be considered as contraindication for laser lead extraction.

Transvenous lead extraction of implantable cardioverter-defibrillators: A comprehensive outcome-and risk factor analysis.

BACKGROUND: Device complications, such as infection or lead dysfunction necessitating transvenous lead extraction (TLE) are continuously rising amongst patients with transvenous implantable-cardioverter-defibrillator (ICD). OBJECTIVES: Aim of this study was to characterize the procedural outcome and risk-factors of patients with indwelling 1- and 2-chamber ICD undergoing TLE. METHODS: We conducted a subgroup analysis of all ICD patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for procedural failure and all-cause mortality were assessed. RESULTS: We identified 842 patients with an ICD undergoing TLE with the mean age of 62.8 ± 13.8 years. A total number of 1610 leads were treated with lead dysfunction (48.5%) as leading indication for extraction, followed by device-related infection (45.4%). Lead-per-patient ratio was 1.91 ± 0.88 and 60.0% of patients had dual-coil defibrillator leads. Additional extraction tools, such as mechanical rotating dilator sheaths and snares were utilized in 6.5% of cases. Overall procedural complications occurred in 4.3% with 2.0% major complications and a procedure-related mortality of 0.8%. Clinical success rate was 97.9%. All-cause in-hospital mortality was 3.4%, with sepsis being the leading cause for mortality. Multivariate analysis revealed lead-age ≥10 years (OR:5.82, 95%CI:2.1-16.6; p = .001) as independent predictor for procedural failure. Systemic infection (OR:9.57, 95%CI:2.2-42.4; p < .001) and procedural complications (OR:8.0, 95%CI:2.8-23.3; p < .001) were identified as risk factors for all-cause mortality. CONCLUSIONS: TLE is safe and efficacious in patients with 1- and 2-chamber ICD. Although lead dysfunction is the leading indication for extraction, systemic device-related infection is the main driver of all-cause mortality for ICD patients undergoing TLE.

Impact of obesity on acute complications of catheter ablation for cardiac arrhythmia.

INTRODUCTION: The prevalence of obesity is increasing. However, data on the periprocedural complication rate of catheter ablation for arrhythmia in patients stratified by body mass index (BMI) are scarce. METHODS: This study included 1000 consecutive patients (age 62.0 ± 14.4 years) undergoing catheter ablation for cardiac arrhythmia. The primary study endpoint was any periprocedural major complication (cardiac tamponade, pseudoaneurysm, arteriovenous fistula, transient ischemic attack, stroke, valve damage, myocardial infarction, or death). RESULTS: The mean BMI was 27.6 ± 5.1 kg/m2 and the majority of patients were overweight (BMI 25.0-29.9 kg/m2 , 43.4%). A BMI of 30.0-34.9 kg/m2 (Class I obesity) was present in 177 (17.7%) of patients, a BMI of 35.0-39.9 kg/m2 (Class II obesity) in 67 (6.7%), and a BMI ≥ 40 kg/m2 (Class III obesity) in 16 (1.6%). There were 31 major complications (3.1%) and one fatality (0.1%) due to terminal heart failure in a patient undergoing palliative ventricular tachycardia ablation. There was no significant impact of the BMI on the rate of major complications (p = .495). Compared to normal weight patients, odds ratios for complications in overweight patients, as well as Class I, II, and III obesity were 1.1 (95% confidence interval (CI): 0.8, 1.7), 1.3 (CI: 0.6, 2.6), 1.4 (CI: 0.5, 4.1), and 1.6 (CI: 0.4, 6.3), respectively. Radiation exposure and procedure duration were significantly increased in obese patients (p < .001 and p = .001, respectively). CONCLUSION: In this study, obesity did not have a significant impact on the incidence of periprocedural complications after CA for cardiac arrhythmia.

The GermAn Laser Lead Extraction RegistrY: GALLERY.

AIMS: The GermAn Laser Lead Extraction RegistrY: GALLERY is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany. METHODS AND RESULTS: Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. 5499 leads with a median lead dwell time of 96 (62-141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease. CONCLUSION: In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality.

Atrial Fibrillation and Transvenous Lead Extraction-A Comprehensive Subgroup Analysis of the GermAn Laser Lead Extraction RegistrY (GALLERY).

Background: Atrial fibrillation is the most common arrhythmia and has been described as driver of cardiovascular morbidity and risk factor for cardiac device-related complications, as well as in transvenous lead extraction (TLE). Objectives: Aim of this study was to characterize the procedural outcome and risk-factors of patients with atrial fibrillation (AF) undergoing TLE. Methods: We performed a subgroup analysis of all AF patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for all-cause mortality were assessed. Results: A total number of 510 patients with AF were identified with a mean age of 74.0 ± 10.3 years. Systemic infection (38.4%) was the leading cause for TLE, followed by local infection (37.5%) and lead dysfunction (20.4%). Most of the patients (45.9%) presented with pacemaker systems to be extracted. The total number of leads was 1181 with a 2.3 ± 0.96 leads/patient. Clinical procedural success was achieved in 97.1%. Occurrence of major complications was 1.8% with a procedure-related mortality of 1.0%. All-cause mortality was high with 5.9% and septic shock being the most common cause. Systemic device infection (OR: 49.73; 95% CI: 6.56−377.09, p < 0.001), chronic kidney disease (CKD; OR: 2.67; 95% CI: 1.01−7.03, p = 0.048) and a body mass index < 21 kg/m2 (OR: 6.6; 95% CI: 1.68−25.87, p = 0.007) were identified as independent predictors for all-cause mortality. Conclusions: TLE in AF patients is effective and safe, but in patients with systemic infection the mortality due to septic shock is high. Systemic infection, CKD and body mass index <21 kg/m2 are risk factors for death in patient with AF undergoing TLE.

A Simplified Approach to Pulmonary Vein Visualization during Cryoballoon Ablation of Atrial Fibrillation.

Background and Objectives: Selective pulmonary vein (PV) angiography has been established as the gold standard for PV visualization in cryoballoon (CB)-based pulmonary vein isolation (PVI). We sought to simplify this approach to reduce procedural complexity and radiation exposure. Materials and Methods: Patients with paroxysmal and recently diagnosed persistent AF undergoing CB-based PVI from January 2015 to December 2017 were retrospectively analyzed. Patients underwent either selective PV angiography or conventional left atrial (LA) angiography for PV visualization. Results: A total of 336 patients were analyzed. A total of 87 patients (26%) received PV angiography and 249 (74%) LA angiography. LA angiography required fewer cine-sequences for PV visualization, translating into a significant reduction in procedure duration, fluoroscopy time and dose area product. Additionally, less contrast medium was utilized. PV occlusion by the CB, CB temperature and time to isolation showed no significant differences. The number of CB applications and total application time (LA angiography: 1.4 ± 0.02 vs. PV Angiography: 1.6 ± 0.05; p < 0.0001; LA angiography: 297.9 ± 4.62 vs. PV-Angiography: 348.9 ± 11.03; p < 0.001, respectively) per vein were slightly but significantly higher in the PV angiography group. We observed no difference in late AF recurrence (24.7% LA angiography vs. 21.3% PV angiography; p = 0.2657). Conclusions: A simplified protocol, using LA angiography for PV visualization, entails a reduction in procedure time and radiation exposure while equally maintaining procedural efficiency and safety in both groups.

Safety and efficacy of transvenous lead extraction in octogenarians using powered extraction sheaths.

BACKGROUND: In the aging population equipped with cardiac implantable electronic devices, an increasing number of octogenarians require lead extractions. This patient population is often considered as a high-risk group for surgical procedures. We, therefore, investigated the safety and efficacy of transvenous lead extraction in octogenarians using powered extraction sheaths. METHODS: Between January 2013 and March 2017, 403 patients underwent lead extraction at two high-volume lead extraction centers. A total of 71 octogenarians were treated with laser lead extraction and were included in this analysis. Primary extraction method was laser lead extraction, with additional use of mechanical rotational sheaths or femoral snares, if necessary. Patient-based and procedural data were collected and analyzed retrospectively. RESULTS: Mean age was 83.5 ± 3.3 years, 64.7% were males. A total of 152 leads were extracted. The mean lead dwell time of treated leads was 10.2 ± 5.2 years. Complete procedural success rate was 92.9%, while clinical success was achieved in 98.6%. Failure of extraction occurred in one patient (1.4%). In six (7.7%) patients, additional mechanical rotational sheaths or femoral snares were used. Overall complication rate was 4.2%, including one (1.4%) major (RA perforation) and two (2.8%) minor complications. No procedure-related mortality was observed in any of the patients. CONCLUSION: Transvenous lead extraction in octogenarians with old leads is safe and effective when performed in experienced centers. Patient's age should therefore not be considered as contraindication for lead extraction using powered extraction sheaths.

Performance and outcome of the subcutaneous implantable cardioverter-defibrillator after transvenous lead extraction.

AIMS: The subcutaneous cardioverter-defibrillator (S-ICD) may be a valuable option in patients after successful transvenous lead extraction (TLE) without indication for pacemaker therapy and persistent risk of sudden cardiac death. The aim of this study was to evaluate device performance, postoperative outcome, and safety in patients who received a S-ICD after TLE compared to patients who underwent de-novo S-ICD implantation. METHODS: A retrospective analysis of all patients included into our institution's S-ICD database between September 2010 and May 2019 was conducted.The patients were divided in two groups, depending on whether they had received their S-ICD after TLE (n = 31) or de-novo (n = 113). RESULTS: The TLE group was significantly older with a mean age of 54.3 ± 15.7 versus 46.7 ± 14.4 years; p = .007. Leading S-ICD indication in the TLE group was previous infection (50%), whereas in the de-novo group the S-ICD was primarily chosen due to young patient age (74.6%). Median duration of follow-up was 527.0 versus 472.5 days, respectively; p = .576. Most common complication during follow-up was inappropriate ICD therapy (12.9% vs. 13.3%); p = 1.000. Pocket erosion/infection occurred in 3.2% versus 3.5% with no reported cases of systemic (re-)infection in either group; p = 1.000. All-cause mortality was low (6.2% vs. 2.7%) and entirely unrelated to S-ICD implantation or the device itself; p = .293. CONCLUSION: The S-ICD is a safe and effective alternative for patients after TLE with very similar results regarding device performance and postoperative outcome, when compared to patients who underwent de-novo S-ICD implantation.

Probability of sinus rhythm conversion and maintenance in cardiac resynchronization therapy patients with atrial fibrillation during 5-year follow-up.

INTRODUCTION: There is a high prevalence of atrial fibrillation (AF) in patients with heart failure presented for cardiac resynchronization therapy (CRT). It remains unclear whether an atrial lead should be implanted in these patients. We, therefore, analyzed outcomes and course of rhythm in AF patients undergoing CRT implantation during long-term follow-up. METHODS AND RESULTS: Between 2004 and 2018, 328 consecutive patients with a history of AF receiving CRT implantation were included in this study. 132 patients had preoperatively paroxysmal AF (px-AF), while 70 and 126 patients had persistent AF (ps-AF) and long-standing persistent AF (lp-AF), respectively. The outcome data were collected in our institutional database and analyzed retrospectively. Two hundred and seventy-seven patients received an atrial lead at the time of implantation, nine during follow-up. No major lead implantation-associated complications were observed. In patients with px-AF, sinus rhythm (SR) was present in 78.8% at admission, 95.5% (p < .001) at discharge, and 85.7% (p = .965) after 5 years. In ps-AF patients SR was present in 28.6%, 91.4% (p < .001) and 69.7% (p < .001), while all lp-AF patients showed AF at admission and had SR rate of 50.8% (p < .001) at discharge and 44.1% after 5 years (p < .001). CONCLUSION: We observed a high rate of conversion and long-term persistence of SR in AF patients undergoing CRT implantation. Due to the low rate of lead implantation-associated complications and the high successful SR conversion rates, we recommend the implantation of an atrial lead in CRT patients with AF.

Transvenous lead extraction after heart transplantation: How to avoid abandoned lead fragments.

BACKGROUND: Many patients awaiting heart transplantation (HTX) have a cardiac implantable electronic device (CIED). Lead removal is often still a part of the HTX procedure. Abandoned lead fragments carry a risk for infections and prohibit magnetic resonance imaging (MRI) imaging. This study evaluated the concept of an elective lead management algorithm after HTX. METHODS AND RESULTS: Between 2009 and 2018, 102 consecutive patients with previously implanted CIED underwent HTX. Lead removal by manual traction during HTX was performed in 74 patients until December 2014. Afterward, treatment strategy was changed and 28 patients received elective lead extraction procedures in a hybrid operating room (OR) using specialized extraction tools. Total of 74 patients with 157 leads underwent lead extraction by manual traction during HTX. The mean lead age was 32.3 ± 38.7 months. Postoperative X-ray revealed abandoned intravascular lead fragments in 31(41.9%) patients, resulting in a complete lead extraction rate of only 58.1%. The high rate of unsuccessful lead extractions led to the change in the extraction strategy in 2015. Since then, HTX was performed in 28 CIED patients. In those patients, 64 leads with a mean lead age of 53.8 ± 42.8 months were treated in an elective lead extraction procedure. No major or minor complications occurred during lead extraction. All leads could be removed completely, resulting in a procedural success rate of 100%. CONCLUSION: Our results demonstrate that chronically implanted leads should be removed in an elective procedure, using appropriate extraction tools. This enables complete lead extraction, which reduces the infection risk in this patient population with the necessity for permanent immunosuppressive therapy and allows further MRI surveillance.

Long-term efficacy and safety of radiofrequency catheter ablation of atrial fibrillation in patients with cardiac implantable electronic devices and transvenous leads.

INTRODUCTION: Long-term efficacy and safety are uncertain in patients with cardiac implantable electronic devices (CIED) and transvenous leads (TVL) undergoing radiofrequency catheter ablation of atrial fibrillation (AF). Thus, we assessed the outcome of AF ablation in those patients during long-term follow-up using continuous atrial rhythm monitoring (CARM). METHODS AND RESULTS: A total of 190 patients (71.3 ± 10.7 years; 108 (56.8% men) were included in this study. At index procedure 81 (42.6%) patients presented with paroxysmal AF and 109 (57.4%) with persistent AF. The ablation strategy included pulmonary vein isolation in all patients and biatrial ablation of complex fractionated electrograms with additional ablation lines, if appropriate. AF recurrences were assessed by CARM- and CIED-related complications by device follow-up. After a mean follow-up of 55.4 ± 38.1 months, freedom of AF was found in 86 (61.4%) and clinical success defined as an AF burden less than or equal to 1% in 101 (72.1%) patients. Freedom of AF was reported in 74.6% and 51.9% (P = 0.006) and clinical success in 89.8% and 59.3% (P < 0.001) of patients with paroxysmal and persistent AF, respectively. In 3 of 408 (0.7%) ablation procedures, a TVL malfunction occurred within 90 days after catheter ablation. During long-term follow-up 9 (4.7%) patients showed lead dislodgement, 2 (1.1%) lead fracture, and 2 (1.1%) lead insulation defect not related to the ablation procedure. CONCLUSION: Our findings using CARM demonstrate long-term efficacy and safety of radiofrequency catheter ablation of AF in patients with CIED and TVL.

Bleeding risk of submuscular ICD implantation with continued oral anticoagulation versus heparin bridging therapy.

Recent studies have shown that subcutaneous or subfascial pacemaker- and ICD implantation with continued oral anticoagulation therapy is associated with lower risk for bleeding complications, when compared to heparin bridging strategies. However, ICD generators are often implanted submuscularly. We therefore compared the bleeding risk with continued phenprocoumon therapy vs. heparin bridging in patients receiving submuscular ICD implantation. Between 01/2013 and 12/2013, 104 patients with need for oral anticoagulation received submuscular ICD or CRT-D implantation in our institution. 46 patients were implanted under continued phenprocoumon therapy while 58 patients received heparin bridging for implantation procedure. All ICD generators were placed submuscularly. The primary outcome of the study was clinically significant bleeding or device pocket hematoma with need for surgical revision. Mean patients age was 63.7 years, 72.1% were male. In patients with heparin bridging therapy, preoperative INR prior to ICD implantation was 1.2 ± 0.31 while in the group of patients on continued phenprocoumon therapy, mean pre-OP INR was 2.4 ± 0.47. In heparin bridging group, 8 (13.8%) patients experienced a clinically relevant pocket hematoma, while only 1 (2.2%) patient on continued phenprocoumon therapy needed surgical revision for pocket hematoma (P = 0.04). No further bleeding complications or clinically relevant pericardial effusion was observed in any of the groups and no perioperative thromboembolic event occurred. Submuscular ICD implantation under continued phenprocoumon therapy was safe and feasible. Compared to patients with heparin bridging therapy, those with continued phenprocoumon therapy had a lower incidence of clinically relevant bleeding complications.

Differences in laser lead extraction of infected vs. non-infected leads.

We investigated the effect of systemic infection or lead endocarditis on the complexity and the success of laser lead extraction (LLE) procedures. Medical records of all patients undergoing LLE between January 2012 and March 2017 were screened with regard to information on systemic infection or lead endocarditis. We treated 184 patients using high-frequency 80 Hz laser sheaths in patients with lead implant duration of ≥ 12 months. Indications for lead extraction were systemic infection and lead endocarditis in 52 cases (28.3%), local infection in 74 cases (40.2%), lead dysfunction in 37 cases (20.1%) and other indications in 21 cases (11.4%). 386 leads were scheduled for LLE: 235 (60.9%) pacing, 105 (27.2%) ICD and 46 (11.9%) CS leads. The mean time from initial lead implantation (systemic infection 96.8 ± 74.7 months vs. 102.1 ± 82.6 non-infected: months; p = 0.4155) and ratio of ICD leads (26.8 vs. 27.4%; p = 0.3411) did not differ significantly between the two groups. Complete procedural success was significantly higher in the systemic infection group (100 vs. 94.7%; p = 0.0077). The mean laser treatment (60.2 ± 48.7 vs. 72.4 ± 61.5 s; p = 0.2038) was numerically lower in the infection group, while fluoroscopy time (9.3 ± 7.6 vs. 12.8 ± 10.3 min; p = 0.0275) was significantly lower in this group. Minor and major complications were low in both groups and did not reveal any statistically significant difference (infected group: one minor complication; pocket hematoma, non-infected: three major complications; emergent sternotomy due to pericardial tamponade). No extraction related mortality was observed. The presence of systemic infection or lead endocarditis in LLE procedures allows for higher complete procedural success. When compared with LLE of non-infected leads, the infected leads require less laser and fluoroscopy times. Due to the scarcity of minor and major complications in general, no statistical significance was found in that regard.

Direct percutaneous transaxillary implantation of a novel self-expandable transcatheter heart valve for aortic stenosis.

OBJECTIVES: The aim of this study was to evaluate safety, feasibility, and efficacy of transaxillary TAVI using a novel self-expandable transcatheter heart valve (THV) via a direct percutaneous technique. METHODS: The analysis comprises 12 consecutive patients with severe aortic stenosis treated with the ACURATE Neo™ THV (Symetis) by direct percutaneous transaxillary access. RESULTS: Patients presented with a mean age of 79.9 ± 6.2 years and high calculated surgical risk (logEuroSCORE I: 19.55 ± 15.00%; STS PROM score: 5.42 ± 3.25%). Transaxillary TAVI was performed in 11/12 via the left and in 1/12 via the right-sided axillary artery. Device success was achieved in all patients (12/12). Mortality rate at 30 days was 0% (0/12). No major and one minor access site complication (1/12) occurred. No major or life-threatening access site-related bleeding resulted. None of the patients suffered from postprocedural stroke/transient ischemic attack. There was no need for a permanent pacemaker. Mean effective orifice area post implantation was 2.1 ± 0.29 cm2 and mean aortic gradient 6.2 ± 1.5 mm Hg. In none of the patients, greater than moderate aortic regurgitation or paravalvular leakage was detected at discharge (0/12). CONCLUSIONS: Our study suggests that the implantation of the second-generation self-expandable ACURATE Neo™ via a transaxillary access is technically feasible and safe and yields excellent short-term clinical results. © 2017 Wiley Periodicals, Inc.

Pulse wave analysis of the aortic pressure waveform in patients with vasovagal syncope.

Vascular reflex mechanisms contribute to vasovagal syncope. However, the alterations in central haemodynamics in patients with vasovagal syncope are unknown. 30 consecutive patients (36.5 ± 15 years, 14 females) with recurrent vasovagal syncope (VVS) and a positive tilt table test were compared to 39 age- and sex-matched controls (36.9 ± 16 years, 15 females) with a negative tilt table result and no history of syncope. Central aortic pressure parameters including augmentation index and central pulse pressure as markers of aortic stiffness were generated non-invasively by applanation tonometry of the radial artery and use of a validated mathematical transfer function. No difference in aortic augmentation index was observed between groups. (VVS 9 ± 2.6 vs. Control 11 ± 2.4, p = 0.8). However, in patients with vasovagal syncope the aortic pressure waveform significantly differed from healthy controls. A prolonged time to the peak of aortic pressure wave (aortic T2) was observed in patients with vasovagal syncope (226 ± 24 vs. 208 ± 21 ms, p = 0.001). Furthermore time to the first shoulder of the aortic pressure wave (aortic T1) was slightly shorter compared to healthy controls, but did not reach statistical significance (106 ± 22 vs. 110 ± 12 ms, p = 0.33). Patients with vasovagal syncope have an altered aortic pressure waveform at rest, but no signs of elevated aortic stiffness. The underlying mechanisms for these findings may potentially result from a complex imbalance of the autonomic nervous system with a continuous deregulation of the sympathetic and parasympathetic reflex arcs.

Clinical experience of combined HeartWare ventricular assist device and implantable cardioverter defibrillator therapy.

INTRODUCTION: The HeartWare continuous flow ventricular assist device (HVAD) is used in an increasing number of heart failure patients. In those patients, ventricular arrhythmias (VAs) are common and, consequently, many patients already have an implanted implantable cardioverter defibrillator (ICD) in place or receive ICD implantation after left ventricular assist device implantation. However, limited data on feasibility and necessity of combined ICD and HVAD therapy are available. In this study we present our technical and clinical experience. METHODS AND RESULTS: Between 01/2010 and 06/2013, 41 patients received HVAD implantation. Twenty-six HVAD patients who already had an ICD device placed prior to HVAD implantation or received ICD implantation afterwards were enrolled in this study. Peri- and postoperative complications as well as ICD interrogations were documented and analyzed retrospectively. Mean patients age was 58.4 ± 12.6 years; 88.5% of patients were male. During mean follow-up of 12.2 ± 8.9 months, appropriate ICD interventions occurred in 9 patients (34.6%) due to ventricular tachyarrhythmia (n = 7) or ventricular fibrillation (n = 2). An inappropriate ICD intervention was seen in 1 patient (3.9%) due to tachycardic atrial fibrillation. Patients on HVAD with a history of VAs (n = 13) had a significantly higher incidence of ICD interventions compared to patients with primary prophylactic indication for ICD (n = 13; 53.8% vs. 7.7%; P = 0.015). No disturbance of ICD function was seen after HVAD implantation. CONCLUSION: Combined ICD and HVAD therapy was safe and feasible, without electromagnetic interference between ICD and ventricular assist device. The incidence of ICD interventions was high in patients with a history of VAs, but low in patients with ICD implantation for primary prevention.

Efficacy of prophylactic intra-aortic balloon pump therapy in chronic heart failure patients undergoing cardiac surgery.

This study investigated the efficacy of prophylactic intraoperative intra-aortic balloon pump (IABP) usage in chronic heart failure patients with severely reduced left ventricular function undergoing elective cardiac surgery. Between January 2008 and December 2012, 107 patients with severely reduced left ventricular ejection fraction (LVEF <35%) received prophylactic intraoperative IABP implantation during open-heart surgery. Surgical procedures performed were isolated coronary artery bypass grafting (CABG) in 35 patients (32.7%), aortic valve replacement in 12 (11.2%), mitral valve repair or replacement in 15 (14.0%), combined valve and CABG procedures in 27 (25.2%), and other surgical procedures in 18 (16.8%). Results and outcomes were compared with those in a propensity score-matched cohort of 107 patients who underwent cardiac surgery without intraoperative IABP implantation. Matching criteria were age, gender, LVEF, and surgical procedure. Duration of intensive care unit (ICU) stay, duration of hospital stay, and 30-day mortality were markers of outcome. In the IABP group, mean patient age was 69.1 ± 13.7 years; 66.4% (70) were male. All IABPs were placed intraoperatively. Mean duration of IABP application time was 42.4 ± 8.7 h. IABP-related complications occurred in five patients (4.7%), including one case of inguinal bleeding, one case of mesenteric ischemia, and ischemia of the lower limb in three patients. No stroke or major bleeding occurred during IABP support. Mean durations of ICU and hospital stay were 3.38 ± 2.15 days and 7.69 ± 2.02 days, respectively, in the IABP group, and 4.20 ± 3.14 days and 8.57 ± 3.26 days in the control group, showing statistically significant reductions in duration of ICU and hospital stay in the IABP group (ICU stay, P = 0.036; hospital stay, P = 0.015). Thirty-day survival rates were 92.5 and 94.4% in the IABP and control group, respectively, showing no statistically significant difference (P = 0.75). IABP usage in chronic heart failure patients with severely reduced LVEF undergoing cardiac surgery was safe and resulted in shorter ICU and hospital stay but did not influence 7- and 30-day survival rates.