Optimized patient selection in high-risk protected percutaneous coronary intervention.

Percutaneous mechanical circulatory support (pMCS) is increasingly used in patients with poor left-ventricular (LV) function undergoing elective high-risk percutaneous coronary interventions (HR-PCIs). These patients are often in critical condition and not suitable candidates for coronary artery bypass graft surgery. For the definition of HR-PCI, there is a growing consensus that multiple factors must be considered to define the complexity of PCI. These include haemodynamic status, left-ventricular ejection fraction, clinical characteristics, and concomitant diseases, as well as the complexity of the coronary anatomy/lesions. Although haemodynamic support by percutaneous LV assist devices is commonly adopted in HR-PCI (protected PCI), there are no clear guideline recommendations for indication due to limited published data. Therefore, decisions to use a nonsurgical, minimally invasive procedure in HR-PCI patients should be based on a risk-benefit assessment by a multidisciplinary team. Here, the current evidence and indications for protected PCI will be discussed.

What is known in pre-, peri-, and post-procedural anticoagulation in micro-axial flow pump protected percutaneous coronary intervention?

Interest in the use of percutaneous left ventricular assist devices (p-LVADs) for patients undergoing high-risk percutaneous coronary intervention (PCI) is growing rapidly. The Impella™ (Abiomed Inc.) is a catheter-based continuous micro-axial flow pump that preserves haemodynamic support during high-risk PCI. Anticoagulation is required to counteract the activation of the coagulation system by the patient's procoagulant state and the foreign-body surface of the pump. Excessive anticoagulation and the effect of dual antiplatelet therapy (DAPT) increase the risk of bleeding. Inadequate anticoagulation leads to thrombus formation and device dysfunction. The precarious balance between bleeding and thrombosis in patients with p-LVAD support is often the primary reason that patients' outcomes are jeopardized. In this chapter, we will discuss anticoagulation strategies and anticoagulant management in the setting of protected PCI. This includes anticoagulant therapy with unfractionated heparin, direct thrombin inhibitors, DAPT, purge blockage prevention by bicarbonate-based purge solution, and monitoring by activated clotting time, partial thromboplastin time, as well as anti-factor Xa levels. Here, we provide a standardized approach to the management of peri-interventional anticoagulation in patients undergoing protected PCI.

Handling high-risk patients in the catheterization laboratory.

Protected percutaneous coronary intervention is considered a life-saving procedure for high-risk patients. Therefore it is important that the interventional cardiology team is prepared, the procedure is planned, and potential complications, as well as bail out strategies are considered. Throughout the procedure, it is critical to monitor the patient to identify any early signs of deterioration or changes in patient well-being to avoid any potential complications.

Outcome of thrombus aspiration in STEMI patients: a propensity score-adjusted study.

The use of thrombus aspiration (TA) prior to primary percutaneous coronary intervention (PPCI) has undergone a radical change in intervention guidelines. The clinical implications, however, are still under scrutiny. This study investigated the clinical effects and outcome of TA before PPCI in patients with ST-segment elevation myocardial infarction (STEMI). Overall 1027 patients with STEMI were analyzed in this retrospective, propensity score-adjusted, multicenter study. The primary endpoints were in-hospital and long-term mortality. There were 418 patients in the TA group and 609 in the conventional PPCI group. The in-hospital mortality rate was significantly higher in the TA group (8.7 vs. 5.0%; P = 0.03). During long-term follow-up [median follow-up duration 689 days (IQR 405-959)] the mortality rates were similar (TA 14.3%, conventional PPCI 15.0%; P = 0.85). Survival analysis for the complete observation period revealed no significant benefit of TA [hazard ratio (HR) 1.12; 97.5% CI 0.90-0.71; P = 0.63]. There were also no significant differences between the groups in the following secondary endpoints: composite of cardiovascular death and non-fatal reinfarction at discharge (P = 0.39), post-PPCI thrombolysis in myocardial infarction flow-grade-3 (P = 0.14), left ventricular ejection fraction (P = 0.47), and non-fatal reinfarction during follow-up (P = 0.17). Rehospitalization rate (1.82 vs. 10.3%; P < 0.0001) and Canadian Cardiovascular Society (CCS) grading (P = 0.02) during follow-up were significantly lower in the TA group. In our cohort the in-hospital mortality rate was significantly higher for TA patients, but during long-term follow-up the mortality rates did not differ. The incidence of rehospitalization and CCS grading were lower in the TA-treated patients.

Echocardiographic-Fluoroscopic Fusion Imaging Improves Interventionalists' Learning Curve for Percutaneous Left Atrial Appendage Closure-Initial, Single-Center, Retrospective Observations.

Due to the complex and variable anatomy of the left atrial appendage, percutaneous left atrial appendage closure (LAAC) can be challenging. In this study, we investigated the impact of fusion imaging (FI) on the LAAC learning curve of two interventionalists. The first interventionalist (IC 1) was initially trained without FI and continued his training with FI. The second interventionalist (IC 2) performed all procedures with FI. We compared the first 36 procedures without FI of IC 1 (group 1) with his next 36 interventions with FI (group 2). Furthermore, group 1 was compared to 36 procedures of IC 2 who directly started his training with FI (group 3). Group 1 demonstrated that the learning curve without FI has a flat course with weak correlations for fluoroscopy time, contrast volume, and procedure time, but not for dose area product. Group 2 with FI showed improvement with a steep course and strong correlations for all four parameters. In group 3, we also saw a steep progression with strong correlations. Furthermore, the mean measurements of the parameters in the groups with FI decreased significantly as an indicator of procedural efficacy. We demonstrated that FI may improve the learning curve of experienced and non-experienced ICs.

Comparison of long-term outcome in patients with in-stent restenosis treated with intravascular lithotripsy or with modified balloon angioplasty.

BACKGROUND: Modified balloon angioplasty (MB) using a cutting-/scoring balloon or intravascular lithotripsy (IVL) is used in patients with in-stent restenosis (ISR). However, IVL is an off-label use in this setting. The aim of this subgroup analysis of an all-comers registry was to compare IVL to MB angioplasty in patients with ISR. METHODS: The subgroup (n = 117) included all patients with an ISR treated by MB or IVL between 2019 and 2021. Primary endpoint was strategy success (< 20% residual stenosis). The secondary endpoint was cardiac death, acute myocardial infarction (AMI) and target lesion failure/revascularization (TVR). Quantitative coronary angiography was performed in all patients. RESULTS: A total of n = 36 patients were treated by IVL and n = 81 patients by MB. No significant differences in baseline characteristics were observed between the groups. The primary endpoint was reached in 99 patients (84.6%). Patients in the IVL group had less residual stenosis (2.8% vs. 21.0%; p = 0.012). Multivariate regression analysis revealed that IVL had a significant positive effect on reaching the primary end point (Estimate 2.857; standard error (SE) 1.166; p = 0.014). During the follow-up period (450 days) there were no significant differences in rates of cardiac death (IVL n = 2 (1.7%) vs. MB n = 3 (2.6%); p = 0.643), AMI (IVL n = 2 (1.7%) vs. MB n = 4 (3.4%); p = 0.999) and TVR (IVL n = 5 (4.3%) vs. MB n = 14 (12%); p = 0.851). CONCLUSION: IVL results in a significantly lower rate of residual stenosis than MB in patients with ISR. During the long-term follow-up, no differences in rates of cardiac death, AMI or TVR were observed.

Antithrombotic therapy following transcatheter aortic valve intervention.

Transcatheter aortic valve replacement (TAVR) is increasingly being performed to treat symptomatic patients with aortic stenosis and annual procedure volume has overtaken surgical aortic valve replacement in the United States. However, current international guidelines were written prior to the publication of several important recent studies. Furthermore, European and American guidelines differ in their recommendations of antithrombotic therapy following TAVR. Consequently, there is a need to examine the literature to provide clinicians guidance on the optimum antithrombotic strategy, particularly as different patient populations exist. In this review, we examine the data for antiplatelet and anticoagulation therapy post-TAVR.

Comparison of long-term outcome in patients with calcified stenosis treated with intravascular lithotripsy or with modified balloon angioplasty: a propensity score-adjusted study.

Background: The aim of this two-center, all-comers registry was to compare the effectiveness and safety of intravascular lithotripsy (IVL) to that of modified balloon angioplasty (MB). MB angioplasty using a cutting or scoring balloon is commonly used in patients with calcified coronary arteries. IVL is a new technology for lesion preparation. This is the first study to compare MB with IVL. Methods: The cohort included all patients treated by MB angioplasty or IVL between 2019 and 2021. The primary endpoint was strategy success (<20% residual stenosis). The secondary endpoint was long-term safety outcomes [cardiac death, acute myocardial infarction (AMI), target lesion failure/revascularization (TVR)]. Quantitative coronary angiography (QCA) was performed in all patients. Primary and secondary endpoints were compared using inverse probability of treatment weighting (IPTW) for treatment effect estimation. Results: A total of n = 86 patients were treated by IVL and n = 92 patients by MB angioplasty. The primary endpoint was reached in 152 patients (85.4%). Patients in the IVL group had less residual stenosis (5.8% vs. 22.8%; p = 0.001) in QCA. Weighted multivariable regression analysis revealed that IVL had a significant positive effect on reaching the primary endpoint of strategy success [odds ratio (OR) 24.58; 95% confidence interval (95% CI) 7.40-101.86; p = 0.001]. In addition, severe calcification was shown to result in a lower probability of achieving the primary endpoint (OR 0.08; 95% CI 0.02-0.24; p = 0.001). During the follow-up period (450 days) there was no difference in cardiovascular mortality rate [IVL (n = 5) 2.8% vs. MB (n = 3) 1.7%; p = 0.129]. Patients with unstable angina at the time of the index procedure had the highest probability of cardiovascular death [hazard ratio (HR) 7.136; 95% CI 1.248-40.802; p = 0.027]. No differences were found in long-term rates of AMI (IVL 1.7% vs. MB 2.8%; p = 0.399; IVL HR 2.73; 95% CI 0.4-17.0; p = 0.281) or TVR (IVL 5.6% vs. MB 9%; p = 0.186; IVL HR 0.78; 95% CI 0.277-2.166; p = 0.626). Conclusion: IVL leads to a significantly better angiographic intervention outcome compared to MB angioplasty in our cohort. During long-term follow-up, no differences in cardiovascular mortality, rate of acute myocardial infarction, or target lesion failure/revascularization were observed.

Topical Vancomycin Reduces the Incidence of Deep Sternal Wound Complications After Sternotomy.

BACKGROUND: Deep sternal wound infection remains a significant hazard for cardiosurgical patients undergoing median sternotomy. Although the prophylactic use of topical vancomycin to reduce the incidence of deep sternal wound complications (DSWC) has been repeatedly examined, the method remains controversial. METHODS: We report here on a continuous experience that encompassed a total of 1251 cardiosurgical patients who underwent various procedures via median sternotomy. Beginning in October 2015 and in response to a surge of DSWC (4.4%), 3 surgeons on our team began to apply 2.5 g vancomycin paste to the sternal edges just prior to closure, while the remaining 2 surgeons did not. An interim analysis comparing the 2 groups suggested that vancomycin was indeed effective, and from February 2016 on, all surgeons adopted the routine use of vancomycin in all patients. RESULTS: Retrospective analysis of 496 surgical patients from January to September 2015 had revealed a baseline incidence of DSWC of 4.4%. In the divided-use period between October 2015 and February 2016, DSWC was seen in 8.6% (8 of 93) of the no-vancomycin group. In the vancomycin group, the incidence fell to 0.8% (1 of 129). In March 2016, all surgeons began using vancomycin and the overall rate of DSWC for all surgeons and all patients subsequently declined to 1.1%. No adverse effects were observed. CONCLUSIONS: Topical vancomycin application is highly effective in the prevention of DSWC after median sternotomy.

Feasibility of Coronary Access in Patients With Acute Coronary Syndrome and Previous TAVR.

OBJECTIVES: The aim of this study was to characterize the feasibility of coronary angiography (CA) and percutaneous coronary intervention (PCI) in acute settings among patients who have undergone transcatheter aortic valve replacement (TAVR). BACKGROUND: Impaired coronary access after TAVR may be challenging and particularly in acute settings could have deleterious consequences. METHODS: In this international registry, data from patients with prior TAVR requiring urgent or emergent CA were retrospectively collected. A total of 449 patients from 25 sites with acute coronary syndromes (89.1%) and other acute cardiovascular situations (10.9%) were included. RESULTS: Success rates were high for CA of the right coronary artery (98.3%) and left coronary artery (99.3%) and were higher among patients with short stent-frame prostheses (SFPs) than in those with long SFPs for CA of the right coronary artery (99.6% vs 95.9%; P = 0.005) but not for CA of the left coronary artery (99.7% vs 98.7%; P = 0.24). PCI of native coronary arteries was successful in 91.4% of cases and independent of valve type (short SFP 90.4% vs long SFP 93.4%; P = 0.44). Guide engagement failed in 6 patients, of whom 3 underwent emergent coronary artery bypass grafting and another 3 died in the hospital. Among patients requiring revascularization of native vessels, independent predictors of 30-day all-cause mortality were prior diabetes, cardiogenic shock, and failed PCI but not valve type or success of coronary engagement. CONCLUSIONS: CA or PCI after TAVR in acute settings is usually successful, but selective coronary engagement may be more challenging in the presence of long SFPs. Among patients requiring PCI, prior diabetes, cardiogenic shock, and failed PCI were predictors of early mortality.

Intravascular Lithotripsy in Calcified Coronary Lesions: A Prospective, Observational, Multicenter Registry.

BACKGROUND: Optimal plaque preparation of calcified coronary lesions is key to prevent stent failure. The purpose of this study was to determine the strategy success and safety of intravascular lithotripsy (IVL) in calcified lesions of an all-comers cohort. METHODS: Patients with calcified coronary lesions were screened in 3 centers. Seventy-one patients were eligible for IVL. Patients were assigned to (group A) primary IVL therapy for patients with calcified de-novo lesions (n=39 lesions), (group B) secondary IVL therapy for patients with calcified lesions in which noncompliant balloon dilatation failed (n=22 lesions), and (group C) tertiary IVL therapy in patients with stent underexpansion after previous stenting (n=17 lesions). Primary end point was strategy success (stent expansion with <20% in-stent residual stenosis) and safety outcomes (procedural complications, in-hospital major adverse cardiovascular event). RESULTS: Seventy-eight calcified lesions were treated using the Shockwave C2 balloon. Mean diameter stenosis of calcified lesions was 71.8±13.1% at baseline, decreased to 45.1±17.4% immediately after IVL, and to 17.5±15.2% after stenting. Mean minimal lumen diameter was 1.01±0.49 mm at baseline and increased to 1.90±0.61 after IVL, and to 2.88±0.56 mm after stenting. The primary end point of strategy success was reached in 84.6% (group A), 77.3% (group B), and 64.7% (group C). Device delivery and IVL treatment were possible in all lesions. Four type b dissections were observed without further sequelae. No patient suffered from in-hospital major adverse cardiovascular event. Seven Shockwave balloons ruptured during treatment without any sequelae. CONCLUSIONS: IVL provides a valid strategy for lesion preparation in severely calcified coronary lesions with high success rate, low procedural complications, and low major adverse cardiovascular event rates.

Extracorporeal life support in cardiovascular patients with observed refractory in-hospital cardiac arrest is associated with favourable short and long-term outcomes: A propensity-matched analysis.

AIMS: Extracorporeal life support (ECLS) has shown encouraging survival rates in patients with in-hospital cardiac arrest; however, its routine use is still controversial. We compared the survival of patients with in-hospital cardiac arrest receiving conventional cardiopulmonary resuscitation (CCPR) to that of patients with ECLS as an adjunct to cardiopulmonary resuscitation (ECPR). METHODS: A total of 353 patients with in-hospital cardiac arrest (272 CCPR and 52 ECPR) were included in this retrospective, propensity score-adjusted (1:1 matched), single-centre study. Primary endpoints were survival at 30 days, long-term survival and neurological outcome defined by the cerebral performance categories score. RESULTS: In the unmatched groups patients undergoing ECPR initially had significantly higher APACHE II scores ( P=0.03), increased norepinephrine dosages ( P=0.03) and elevated levels of creatine kinase ( P<0.0001), creatinine ( P=0.04) and lactate ( P=0.02) before cardiopulmonary resuscitation compared with those undergoing CCPR. After equalising these parameters significant differences were observed in short and long-term survival, favouring ECPR over CCPR (27% vs. 17%; P=0.01 (short-term) and 23.1% vs. 11.5%; P=0.008 (long-term); median follow-up duration after discharge 1136 days (interquartile range 823-1416)). There was no significant difference in the incidence of a cerebral performance categories score of 1 or 2 between the matched groups (CCPR 66.7% vs. ECPR 83.3%; P=0.77). ECLS implantation was the only significant and independent predictor of mortality in multivariate Cox regression analysis (hazard ratio 0.57, 95% confidence interval 0.35-0.90; P=0.02). CONCLUSION: In our cohort of cardiovascular patients ECPR was associated with better short- and long-term survival over CCPR, with a good neurological outcome in the majority of the patients with refractory in-hospital cardiac arrest.

Ivabradine therapy to unmask heart rate-independent effects of ß-blockers on pulse wave reflections.

BACKGROUND: Prior studies suggest that ß-blockers lead to increased pulse wave reflections, thereby negating the blood pressure lowering effects on cardiovascular mortality. Parts of these effects may be induced by the heart rate reduction under ß-blockade. The aim of this study was to unmask heart rate-independent effects of ß-blockade on pulse wave reflections by switching therapy from ß-blockers to ivabradine, an I f channel inhibitor without impact on systemic hemodynamics. METHODS: 14 male patients (age 61 ± 3 years, LVEF 62 ± 1 %) with arterial hypertension and coronary artery disease (CAD) under chronic ß-blocker therapy at moderate dosage and additional renin-angiotensin system-blocking therapy were included. We determined radial augmentation index (rAI) by radial applanation tonometry in patients under ß-blockade both at rest and during early recovery after exercise. ß-Blockers were then replaced by ivabradine. Six weeks later, patients were re-tested at rest and after exercise under ivabradine therapy. RESULTS: Mean heart rate (68 ± 3 vs. 63 ± 3 bpm; p = ns) and resting mean arterial pressure (98 ± 2 vs. 98 ± 2 mmHg; p = ns) were not different between ß-blocker or ivabradine therapy, respectively. The rAI remained unchanged after switching therapy from ß-blocker to ivabradine (86 ± 2 vs. 84 ± 4 %; p = ns). Post exercise, the rAI revealed an identical decrease in both groups (-7.2 ± 2.4 vs. -5.4 ± 2.5 %, p = ns). The increase in heart rate between resting conditions and early recovery post exercise was inversely correlated with the decrease of rAI under ß-blockade (r = -0.70; p < 0.01) and showed a trend towards correlation under ivabradine (r = -0.52; p = 0.07). CONCLUSION: In men at the age of 60 years and CAD, ß-blockade does not exert heart rate-independent, pleiotropic effects on peripheral pulse wave reflections, both at rest or after exercise. Our results fit well within recent studies, demonstrating the fundamental influence of heart rate on rAI.

Mobile left ventricular thrombus in left ventricular dysfunction: case report and review of literature.

INTRODUCTION: Left ventricular (LV) thrombi carry a high risk of embolization. Therapeutic recommendations like treatment with low molecular heparin and intravenous unfractionated heparin (UFH), thrombolysis or surgical thrombectomy have failed to reach a consensus. CASE DESCRIPTION: A 56-year-old female patient presented in cardiogenic shock to the emergency department. Echocardiography demonstrated a dilated LV with a severely depressed global systolic function and a large LV apical thrombus. Treatment with UFH was initiated as well as a treatment with catecholamines for stabilizing the patient's hemodynamic situation. On the follow-up echocardiographic examination, extensive free-floating parts of the thrombus could be documented. Given the high risk of embolization in a now hemodynamically stable situation, emergency surgical embolectomy was performed. DISCUSSION: A conservative procedure might be useful for bridging till surgical treatment is available and/or the risk due to surgery is acceptable. CONCLUSION: In absence of evidence-based guidelines for the treatment of LV thrombi, individualized management options concerning surgical, embolization and bleeding risk must be taken into account.

Door-to-implantation time of extracorporeal life support systems predicts mortality in patients with out-of-hospital cardiac arrest.

OBJECTIVE: This study aimed to identify predictors of mortality in patients with out-of-hospital cardiac arrest (OHCA) undergoing in-hospital extracorporeal life support system (ECLS) treatment. METHODS: We retrospectively studied the characteristics and clinical outcomes of 28 patients (January 2010 and December 2011) with OHCA and veno-arterial ECLS implemented during ongoing cardiopulmonary resuscitation (CPR) upon admission to the cath lab. Baseline left ventricular ejection fraction (LVEF) was determined after ECLS implantation and then every 24 h during and after successful weaning from ECLS. RESULTS: Overall 30-day survival rate was 39.3 % (11 of 28 patients). Baseline characteristics, initial laboratory measurements, and LVEF on admission were not significantly different between survivors and non-survivors. There was no difference regarding median CPR duration [survivors 44.0 min (IQR 31.0-45.0) vs. non-survivors 53.0 min (IQR 40.0-61.3); P = 0.23]. Door-to-ECLS implantation time was significantly longer in non-survivors [42.5 min (IQR 28.0-56.5) vs. 25.0 min (IQR 21.0-30.0); P < 0.01]. ECLS treatment duration was not significantly different between the two groups [survivors: 4.0 days (IQR 1.5-7.5) vs. non-survivors 6.5 days (IQR 1.0-8.0); P = 0.69]. LVEF significantly improved in survivors during ECLS treatment (mean ± SD survivor 47.5 ± 14.7 % vs. non-survivor 23.3 ± 14.9 %; P < 0.01). The door-to-ECLS implantation time was the only significant and independent predictor of 30-day mortality in multivariate Cox regression analysis (P = 0.04). Kaplan-Meier survival analysis showed a benefit favouring patients with a door-to-ECLS implantation time <30 min (log rank 6.29; P = 0.01). CONCLUSION: A door-to-ECLS implantation time <30 min significantly improves 30-day outcomes in patients with OHCA.

Effects of a recombinant surfactant protein-C-based surfactant on lung function and the pulmonary surfactant system in a model of meconium aspiration syndrome.

OBJECTIVE: Meconium aspiration syndrome (MAS) remains a relevant cause of neonatal respiratory failure and is characterized by severe impairment of pulmonary gas exchange, surfactant inactivation, and pronounced inflammatory changes. Surfactant administration has been shown as an effective treatment strategy in MAS. The present study aimed at investigating the impact of a recombinant surfactant protein (SP)-C-based surfactant on pulmonary gas exchange and lung function in this model of neonatal lung injury. Furthermore, SP-B and -C were determined on the transcriptional and protein level. DESIGN: Laboratory experiment. SETTING: University laboratory. SUBJECTS: Twenty three newborn piglets (median age 6 days, weight 1900-2500 g). INTERVENTIONS: Piglets were intubated and mechanically ventilated and then received 20% sterile meconium (5 mL/kg) for induction of lung injury. After 30 mins, animals were randomized for control (n = 7, MAS controls), recombinant SP-C surfactant (n = 8), or natural surfactant (n = 8). Surfactant preparations were administered as an intratracheal bolus (75 mg/kg), and animals were ventilated for another 330 mins. Nonventilated newborn piglets at term (n = 28; median weight 1484 g, range 720-1990 g) served as a healthy reference group (healthy controls). MEASUREMENTS AND MAIN RESULTS: Lung function variables, arterial blood gas samples, and lung tissues were obtained. Expression of SP-B and -C messenger RNA was quantified in left lung lobe tissue using real-time polymerase chain reaction. Protein concentrations were determined by enzyme-linked immunosorbent assay. Scanning electron microscopy and transmission electron microscopy were performed in tissue samples of the right lung lobe. Compared with healthy controls, SP-B messenger RNA expression was significantly increased in MAS (p < .02), whereas SP-C messenger RNA expression was found to be significantly reduced (p < .001). SP concentrations, however, were not significantly different. Although a significant improvement of gas exchange and lung function was observed after surfactant administration in both groups, surfactant messenger RNA expression and protein concentrations were not significantly altered. Scanning and transmission electron microscopy showed severe pulmonary ultrastructural changes after meconium aspiration improving after surfactant treatment. CONCLUSIONS: Impairment of lung function in MAS, associated with marked changes in SP messenger RNA expression, can be sufficiently treated using recombinant SP-C-based or natural surfactant. Despite improved lung function and gas exchange as well as pulmonary ultrastructure after treatment, pulmonary SP messenger RNA expression and concentrations remained significantly affected, giving important insight into the time course following surfactant treatment in MAS.