Functional Status and Quality of Life 6 Months After Extracorporeal Membrane Oxygenation Therapy for COVID-19-Related Pulmonary Failure.

Extracorporeal membrane oxygenation (ECMO) is increasingly used in COVID-19-related pulmonary failure and the number of patients recovering from COVID-19 is growing. Here, we assess survival and recovery 6 months after ECMO for COVID-19. From April 2020 to September 2021, n = 60 (60.5 [51.0-65.0] years, 23.3% female) were treated with venovenous/venoarterial ECMO for COVID-19. 41.7% were weaned off ECMO, survival-to-discharge was 40.0% (n = 24). Age (63.0 [60.0-66.8] vs. 55.0 [43.8-60.0] years, p < 0.001), vasoactive support (97.2% vs . 75.0%, p = 0.013), and pre-ECMO SOFA scores (13.0 [12.0-14.8] vs. 12.0 [10.0-13.8] p = 0.036) correlated with nonsurvival. All patients aged >65 years, with histories of neoplasia, immunocompromise, chronic renal failure, or frailty died. After 6 months, 20 were alive (6-month survival 33.3%, survival conditioned on survival-to-discharge 83.3%), with follow-up in 19. 57.9% showed no relevant, 26.3% moderate, 15.8% severe deficits. Cardiopulmonary status was satisfactory (mMRC level: 84.2% ≤2). 73.7% were independent in daily life. Cognitive impairments were frequent (52.6%). 26.3% showed moderate depression, 15.8% posttraumatic stress disorder. Social and work life were considerably affected. Extracorporeal membrane oxygenation thus can serve as salvage therapy in COVID-19, but advanced age, immunocompromise, histories of neoplasia, and frailty must be considered as relative contraindications. Age, vasoactive support, and SOFA scores assist discriminating in daily practice. Deficits after 6 months are substantial, and efforts need to focus on long-term recovery.

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

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

First successful prevention of cardiopulmonary resuscitation during high-risk percutaneous coronary intervention by use of a pulsatile left ventricular assist device: baptism of fire of the iVAC2L device: a case report.

INTRODUCTION: Efforts in percutaneous coronary intervention (PCI) lead to interventional treatment of complex stenoses as an alternative to coronary bypass surgery. Nevertheless, complications during PCI can occur with sudden need for circulatory support. Circulatory support devices are helpful tools during high-risk PCI to generate additional output or maintain sufficient circulation in critical situations. CASE DESCRIPTION: We report the case of the first successful prevention of cardiopulmonary resuscitation by use of transfemoral pulsatile ventricular assist device with up to 2l additional cardiac output during a high-risk PCI in an 80-year old man with complex stenosis and a history of ventricular fibrillation during prior coronary angiography. DISCUSSION: The device managed to maintain an adequate circulation during massive vasospasm and bradycardia. The iVAC2L seems to be a useful tool in high-risk PCI. Its general effect on haemodynamics and patients' outcome has to be evaluated in larger multi-centre studies.

First high-risk percutaneous coronary intervention under use of the iVAC2l system in Germany.

Percutaneous coronary intervention of complex stenoses is becoming more and more of an alternative to coronary bypass surgery. Nevertheless, complications can occur and lead to the need for circulatory support and/or emergency surgery. Circulatory support devices like the intra-aortic balloon pump showed only low benefit in patients' outcome. Devices with higher cardiac output necessitate more complex implantation procedures. We report the case of the first successful use of a transfemoral pulsatile ventricular assist device with up to 2 l additional cardiac output during high-risk percutaneous coronary intervention in a 74-year-old man with complex stenosis. The device was safe and feasible during coronary intervention in its use. Its beneficial effect on hemodynamics and patients' outcome has to be evaluated in larger multicenter studies.

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

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

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

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

Sirolimus-eluting stent implantation versus beta-irradiation for the treatment of in-stent restenotic lesions: clinical and ultrasound results from a randomised trial.

AIMS: Recent trials with different designs indicated that drug-eluting stents may be superior to vascular brachytherapy (VBT) for the treatment of in-stent restenosis (ISR). We performed a randomised, double-centre, clinical, quantitative coronary angiographic (QCA) and intravascular ultrasound (IVUS) acute and 3-years comparison of 90Sr/90Y-VBT and sirolimus-eluting stent implantation (SES) for ISR. METHODS AND RESULTS: Ninety-one (91) consecutive patients were included. By QCA, SES led to a higher acute gain (2.08 ± 0.41 mm vs. 1.54 ± 0.70 mm, p < 0.0001), higher postprocedural minimum lumen diameter (2.76 ± 0.39 mm vs. 2.39 ± 0.52 mm; p < 0.0001), lower late lumen loss at follow-up (0.09 ± 0.29 vs. 0.39 ± 0.79 mm, p = 0.042), and a higher net lumen gain of the target lesion (2.05 ± 0.51 vs 1.18 ± 1.08 mm, p < 0.0001). By IVUS, the smaller acute gain following VBT was the result of residual intima hyperplasia, the intima hyperplasia formation following SES was extremely low, and the edge-effect was virtually absent after SES, respectively. At 6-month follow-up, both the angiographic restenosis rate (4.7 vs. 22.7%; p < 0.0001) and target lesion revascularisation rate (2.3 vs. 10.4%; p = 0.025) were lower in SES. Importantly, SES showed a stable clinical course at 3-year follow-up while VBT was associated with a sustained incidence of target vessel failure (11.6 vs. 46.7%; p < 0.0001). CONCLUSIONS: SES for ISR is associated with superior QCA, IVUS and clinical results at 6-month and 3-year of follow-up when compared with VBT.

Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: two-year angiographic and three-year clinical results from the SPIRIT II study.

BACKGROUND: Little is known about the impact of treatment with drug-eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) in patients with calcified or noncalcified culprit lesions. METHODS: The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six-month and 2-year angiographic follow-up and clinical follow-up up to 3 years were completed. RESULTS: The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6-month in-stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia-driven target lesion revascularization (ID-TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in-stent ABR (7.4% vs. 0%, P = 0.08) and ID-TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID-TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12). CONCLUSIONS: The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley-Liss, Inc.

Nephrotoxicity of iodixanol versus iopamidol in patients with chronic kidney disease and diabetes mellitus undergoing coronary angiographic procedures.

BACKGROUND: The choice of radiographic contrast media for use in patients at increased risk of contrast-induced nephropathy (CIN) is of ongoing interest. METHODS: The current study is a prospective, multicenter, randomized, double-blind design comparing the renal effects of the non-ionic, iso-osmolal agent, iodixanol, versus the non-ionic, low-osmolal agent, iopamidol, in 526 subjects with impaired baseline renal function (chronic kidney disease) and diabetes mellitus undergoing diagnostic and/or therapeutic coronary angiographic procedures. The co-primary end points were the peak increase in serum creatinine (SCr) and the incidence of CIN (increase > or =0.5 mg/dL) in SCr from baseline within 3 days of receiving contrast media. RESULTS: In 418 evaluable subjects with complete postcontrast media SCr data, the median peak increase in SCr in the iodixanol arm was 0.10 mg/dL, whereas in the iopamidol arm, the median peak increase was 0.09 mg/dL (P = .13). The overall CIN incidence was 10.5% (11.2% % in the iodixanol arm and 9.8% in the iopamidol arm, P = .7). The volume of contrast media, volume of saline administered, frequency of coronary interventional procedures, and severity of baseline kidney disease and of diabetes mellitus were similar between treatments. CONCLUSIONS: In the present study, the overall rate of CIN in patients with chronic kidney disease and DM undergoing coronary angiographic procedures was 10.5%. There was no significant difference between iodixanol and iopamidol in either peak increase in SCr or risk of CIN.

Noninvasive coronary angiography focusing on calcification: multislice computed tomography compared with magnetic resonance imaging.

OBJECTIVE: Calcification is a principal problem in noninvasive coronary angiography (CA) performed with multislice computed tomography (MSCT). Magnetic resonance imaging (MRI) supposedly neglects calcium. We compared both modalities. METHODS: Sixty-eight patients admitted for CA underwent MSCT- and MRI-based noninvasive CA the day before. Stenosis detection (>or=50%) was visually performed and validated by quantitative CA. RESULTS: The patient-based overall sensitivity, specificity, positive predictive value, and negative predictive value were 96.2%, 95.2%, 92.6%, and 97.6% for MSCT versus 69.2%, 64.3, 54.5%, 64.3%, and 77.1% for MRI, respectively. The segment-based overall results were 74.7%, 97.8%, 75.7%, and 97.6% for MSCT versus 40%, 93.8%, 37.5%, and 94.4% for MRI, respectively. Investigating the impact of coronary calcifications in the patient group with a volume score of 300 microL or greater resulted in 100%, 80%, 92.3%, and 100% for MSCT versus 70.8%, 86.7%, 89.5%, and 65% for MRI, respectively. The segment group with considerable hardening artifacts resulted in 85.3%, 83.9%, 76.3%, and 90.4% for MSCT versus 52.9%, 92.9%, 81.8%, and 76.5% for MRI, respectively. CONCLUSIONS: There are no major advantages of MRI in cases of advanced coronary calcification.

Stratification for noninvasive coronary angiography: patient preselection considering atypical angina pectoris, conventional cardiovascular risk assessment, and calcium scoring.

BACKGROUND: Noninvasive coronary angiography (NCA) is recommended to be applied as a filter before invasive coronary angiography in patients with intermediate cardiovascular risk. DESIGN: In this prospective single-center study, we validated multislice computed tomography (MSCT) and magnetic resonance imaging (MRI)-based NCA by primarily selecting patients with atypical angina pectoris (AAP). METHODS: In 68 patients (63.6+/-11.4 years) with AAP, the Prospective Cardiovascular Muenster Study score and the Agatston score equivalent (ASE; calcium score) were initially determined for cardiovascular risk assessment. Subsequently, MSCT and MRI-based NCA were performed followed by quantitative invasive coronary angiography for validation. All tests were finally analyzed. RESULTS: CAD (prevalence 38.2%) was diagnosed in 67.7% of patients at high, 61.5% at intermediate, and 37.8% at low cardiovascular risk according to the Prospective Cardiovascular Muenster Study. CAD was diagnosed in 88.2% of patients with an ASE >or=75th percentile and in 90.9% with an ASE >or=90th percentile. With regard to NCA, patient-based analysis resulted in a sensitivity of 96.2% for MSCT versus 69.2% for MRI, in a specificity of 95.2 versus 64.3%, in a positive predictive value of 97.6 versus 77.1%, in a negative predictive value of 92.6 versus 54.5%, and a diagnostic accuracy of 95.6 versus 66.2% (P<0.05). CONCLUSION: In a patient group with a heterogeneous cardiovascular risk, primarily considering AAP allows for effective patient preselection for NCA. This may be optimized by precluding patients with an ASE >or=75th percentile. MSCT rather than MRI may then effectively be involved.

Non-invasive coronary angiography: the clinical value of multi-slice computed tomography in the assessment of patients with prior coronary bypass surgery. Evaluating grafts and native vessels.

BACKGROUND: Contrast enhanced multi-slice computed tomography (MSCT) is the leading modality in non-invasive coronary angiography (CTA) today. We investigated MSCT based assessment of coronary artery bypass grafts (CABG) by analyzing assets and drawbacks of CTA in order to define demands on latest technology. METHODS: In a clinical setting 39 CABG patients (69.2 +/- 1.4 years; male n = 36) underwent CTA (collimation 16 x 0.75 mm, contrast medium 100 ml; 320 mAs, 120 KV). Ninety-seven CABG (61 venous, 36 arterial grafts) were evaluated. A subgroup of 18 patients underwent additional invasive coronary angiography (CA). RESULTS: CTA for CABG assessment resulted in an overall sensitivity (sens.) of 100%, specificity (spec.) of 92.4% and positive and negative predictive values (PPV, NPV) of 60% and 100%, respectively. CABG anastomoses showed slightly inferior diagnostic accuracy than other CABG segments. Limitations in imaging quality caused 21% unevaluable segments of the CABG anastomoses. Evaluation of native vessel segments proximal and distal to the anastomoses resulted in a sens, spec, PPV and NPV of 57.5, 94.6, 92 and 67.3%, respectively. With 28.5% unevaluable segments, the native vessel segments showed serious limitations in imaging quality. Radiation exposure was 9.88 +/- 3.20 mSv (9.69 +/- 3.25 mSv male; 12.08 +/- 1.35 mSv female). CONCLUSION: 16-slice MSCT based CABG assessment offers sufficient diagnostic accuracy. However, focussing on the bypass anastomoses and the native revascularized coronary arteries, clinical value is limited.

Systemic exposure of everolimus after stent implantation: a pharmacokinetic study.

OBJECTIVES: We evaluated the pharmacokinetics of the eluted everolimus by assessing systemic drug release and distribution of everolimus-eluting stents. BACKGROUND: Drugs eluted by a coronary stent might cause adverse events such as tumors, infections, or noncardiac death. The systemic exposure of the drugs is unknown because there are only limited data about pharmacokinetics of drug-eluting stents in humans. METHODS: Venous blood samples in a subset of 39 patients were drawn just before implantation of the first stent (baseline, 0-minute time point) and at 10 and 30 minutes and 1, 2, 4, 6, 12, 24, 36, 48, 72, 168, and 720 hours (30 days) after completion of implantation of the last stent. Whole blood concentrations of everolimus were determined using a sensitive validated high-performance liquid chromatography mass spectrometry/mass spectrometry method. RESULTS: The total dose of everolimus received by the patients ranged from 53 to 588 microg. The last time point up to which whole blood concentrations could be quantified ranged per patient from 4 to 720 hours after implantation of the last stent. Across all dose levels, individual T(max) values ranged from 0.13 and 2.17 hours; individual C(max) ranged from 0.14 to 2.79 ng/mL. CONCLUSION: This study confirms the limited exposure to the systemic circulation of the eluted drug with the use of the XIENCE V Everolimus-Eluting Coronary Stent System (Abbott Vascular, Santa Clara, CA). Therefore, a systemic cause of adverse events is unlikely.

Uncommon intraventricular thrombus formation between the posterior mitral leaflet and the lateral left ventricular wall.

Transthoracic echocardiography demonstrated an intraventricular mass between the posterior mitral leaflet and the lateral left ventricular (LV) free wall in a 61-year-old man. Because of this uncommon localization an intracardial tumor, an endocarditis of the mitral valve or an intraventricular thrombus was suspected. Magnetic resonance imaging (MRI) ruled out an intracardial tumor and revealed a myocardial scarring of the LV free wall covered by an intraventricular thrombus by late gadolinium enhancement. MRI can distinguish subacute clots-which do not enhance after contrast material injection-from organized thrombi. The characterization of thrombi can be used to predict the risk of embolism, which is higher for subacute clots than for organized thrombi.

Sirolimus eluting stent (Cypher) in patients with diabetes mellitus: results from the German Cypher Stent Registry.

BACKGROUND: Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) are at increased risk for adverse outcomes. The use of sirolimus eluting stents (SES) has been shown to improve outcomes in diabetic patients. Since results from randomized trials were derived from selected patients scientific scrutiny under real world conditions is necessary. METHODS AND RESULTS: 1,948 patients with DM and 4,707 patients without DM were included in the German Cypher Registry, a post-marketing survey of use of SES in Germany. In >99% of entry cases a structured clinical follow-up was completed. By angiographic criteria severity of coronary artery disease was higher in diabetic patients compared to non-diabetics. However, procedural success and in-hospital complication rates were comparable between DM- and non-DM-patients. 6 months MACE rate in the DM group was significantly higher than in the non-DM group (16.4% vs. 13.0%) but lower than expected from historical data with the use of bare metal stents (BMS). CONCLUSION: The results with SES in diabetics are encouraging but DM remains a risk factor for poor outcome of PCI. No statement is justified whether the treatment of diabetics with SES is at least as safe as bypass surgery. This intriguing question has to be answered in a direct randomized head-to-head comparison with state of the art surgery.

Myocardial perfusion after transcutaneous/percutaneous myocardial laser revascularization.

The effectiveness of transcutaneous and percutaneous myocardial laser revascularization in patients with endstage coronary artery disease and angina refractory to pharmacological therapy has been proved by various studies. Angiogenesis associated with an improvement of microcirculation and myocardial perfusion may be responsible for the reduction of angina and the improved physical performance. Myocardial perfusion studies published so far are compared to our own results utilizing positron emission tomography before and after percutaneous myocardial laser revascularization.