Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock.

BACKGROUND: The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear. METHODS: In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation. RESULTS: A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09). CONCLUSIONS: The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.).

From medical therapy to mechanical support: strategies for device selection and implantation techniques.

Cardiogenic shock (CS) is a complex clinical syndrome with a high risk of mortality. The recent, rapid development of temporary mechanical circulatory support (tMCS) has altered CS treatment. While catecholamines remain the cornerstone of CS therapy, tMCS usage has increased. According to shock severity, different treatment strategies including catecholamines alone, catecholamines and tMCS, or multiple tMCS might be used. State-of-the-art implantation techniques are necessary to avoid complications linked to the invasive nature of tMCS. In particular, bleeding and access-site complications might counteract the potential haemodynamic benefit of a percutaneous ventricular assist device. In this review, we describe the role of catecholamines in CS treatment and present the different tMCS devices with an explanation on how to use them according to CS aetiology and severity. Finally, an overview of the best practice for device implantation is provided.

Recognizing patients as candidates for temporary mechanical circulatory support along the spectrum of cardiogenic shock.

A growing body of evidence indicates that the benefits of temporary mechanical circulatory support (tMCS) in patients with cardiogenic shock (CS) is dependent on its aetiology and timing of implantation. As such, appropriate diagnosis, screening, selection, and treatment is crucial to achieving good outcomes with tMCS. Here, the latest guidance on CS phenotypes and diagnostics for correctly identifying tMCS candidates is discussed. This includes comprehensive overviews of patient screening with attention given to differences in CS presentation between the sexes, and contraindications for mechanical circulatory support.

Mortality risk prediction of high-sensitivity C-reactive protein in suspected acute coronary syndrome: A cohort study.

BACKGROUND: There is limited evidence on the use of high-sensitivity C-reactive protein (hsCRP) as a biomarker for selecting patients for advanced cardiovascular (CV) therapies in the modern era. The prognostic value of mildly elevated hsCRP beyond troponin in a large real-world cohort of unselected patients presenting with suspected acute coronary syndrome (ACS) is unknown. We evaluated whether a mildly elevated hsCRP (up to 15 mg/L) was associated with mortality risk, beyond troponin level, in patients with suspected ACS. METHODS AND FINDINGS: We conducted a retrospective cohort study based on the National Institute for Health Research Health Informatics Collaborative data of 257,948 patients with suspected ACS who had a troponin measured at 5 cardiac centres in the United Kingdom between 2010 and 2017. Patients were divided into 4 hsCRP groups (<2, 2 to 4.9, 5 to 9.9, and 10 to 15 mg/L). The main outcome measure was mortality within 3 years of index presentation. The association between hsCRP levels and all-cause mortality was assessed using multivariable Cox regression analysis adjusted for age, sex, haemoglobin, white cell count (WCC), platelet count, creatinine, and troponin. Following the exclusion criteria, there were 102,337 patients included in the analysis (hsCRP <2 mg/L (n = 38,390), 2 to 4.9 mg/L (n = 27,397), 5 to 9.9 mg/L (n = 26,957), and 10 to 15 mg/L (n = 9,593)). On multivariable Cox regression analysis, there was a positive and graded relationship between hsCRP level and mortality at baseline, which remained at 3 years (hazard ratio (HR) (95% CI) of 1.32 (1.18 to 1.48) for those with hsCRP 2.0 to 4.9 mg/L and 1.40 (1.26 to 1.57) and 2.00 (1.75 to 2.28) for those with hsCRP 5 to 9.9 mg/L and 10 to 15 mg/L, respectively. This relationship was independent of troponin in all suspected ACS patients and was further verified in those who were confirmed to have an ACS diagnosis by clinical coding. The main limitation of our study is that we did not have data on underlying cause of death; however, the exclusion of those with abnormal WCC or hsCRP levels >15 mg/L makes it unlikely that sepsis was a major contributor. CONCLUSIONS: These multicentre, real-world data from a large cohort of patients with suspected ACS suggest that mildly elevated hsCRP (up to 15 mg/L) may be a clinically meaningful prognostic marker beyond troponin and point to its potential utility in selecting patients for novel treatments targeting inflammation. TRIAL REGISTRATION: ClinicalTrials.gov - NCT03507309.

Rapid Classification and Treatment Algorithm of Cardiogenic Shock Complicating Acute Coronary Syndromes: The SAVE ACS Classification.

INTRODUCTION: We aimed to identify the independent "frontline" predictors of 30-day mortality in patients with acute coronary syndromes (ACS) and propose a rapid cardiogenic shock (CS) classification and management pathway. MATERIALS AND METHODS: From 2011 to 2019, a total of 11439 incident ACS patients were treated in our institution. Forward conditional logistic regression analysis was performed to determine the "frontline" predictors of 30 day mortality. The C-statistic assessed the discriminatory power of the model. As a validation cohort, we used 431 incident ACS patients admitted from January 1, 2020, to July 20, 2020. RESULTS: Independent predictors of 30-day mortality included age (OR 1.05; 95% CI 1.04 to 1.07, p < 0.001), intubation (OR 7.4; 95% CI 4.3 to 12.74, p < 0.001), LV systolic impairment (OR severe_vs_normal 1.98; 95% CI 1.14 to 3.42, p=0.015, OR moderate_vs_normal 1.84; 95% CI 1.09 to 3.1, p=0.022), serum lactate (OR 1.25; 95% CI 1.12 to 1.41, p < 0.001), base excess (OR 1.1; 95% CI 1.04 to 1.07, p < 0.001), and systolic blood pressure (OR 0.99; 95% CI 0.982 to 0.999, p=0.024). The model discrimination was excellent with an area under the curve (AUC) of 0.879 (0.851 to 0.908) (p < 0.001). Based on these predictors, we created the SAVE (SBP, Arterial blood gas, and left Ventricular Ejection fraction) ACS classification, which showed good discrimination for 30-day AUC 0.814 (0.782 to 0.845) and long-term mortality (p log-rank < 0.001). A similar AUC was demonstrated in the validation cohort (AUC 0.815). CONCLUSIONS: In the current study, we introduce a rapid way of classifying CS using frontline parameters. The SAVE ACS classification could allow for future randomized studies to explore the benefit of mechanical circulatory support in different CS stages in ACS patients.

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.

Specific clinical vignettes in high-risk protected percutaneous coronary intervention.

There are several cardiac- and patient-related factors that come into play when considering patients for protected percutaneous coronary intervention (PCI). Cardiac factors include complexity/location of coronary lesions, the degree of left or right ventricular impairment, the presence of valvular lesions, and ventricular arrhythmias. Patient related factors include comorbidities that would render the patient at a higher risk of death should cardiogenic shock ensue during the procedure. Comorbidities include chronic lung disease (chronic obstructive airways disease, asthma, pulmonary fibrosis), renal or liver impairment, other cardiovascular diseases (such as previous cerebrovascular accident or transient ischemic attack, peripheral arterial disease, carotid stenosis), diabetes, frailty and advanced age. Here, we present three very different cases where left ventricular support was deemed appropriate to reduce peri-procedural risk and optimize outcomes.

Invasive versus non-invasive management of older patients with non-ST elevation myocardial infarction (SENIOR-NSTEMI): a cohort study based on routine clinical data.

BACKGROUND: Previous trials suggest lower long-term risk of mortality after invasive rather than non-invasive management of patients with non-ST elevation myocardial infarction (NSTEMI), but the trials excluded very elderly patients. We aimed to estimate the effect of invasive versus non-invasive management within 3 days of peak troponin concentration on the survival of patients aged 80 years or older with NSTEMI. METHODS: Routine clinical data for this study were obtained from five collaborating hospitals hosting NIHR Biomedical Research Centres in the UK (all tertiary centres with emergency departments). Eligible patients were 80 years old or older when they underwent troponin measurements and were diagnosed with NSTEMI between 2010 (2008 for University College Hospital) and 2017. Propensity scores (patients' estimated probability of receiving invasive management) based on pretreatment variables were derived using logistic regression; patients with high probabilities of non-invasive or invasive management were excluded. Patients who died within 3 days of peak troponin concentration without receiving invasive management were assigned to the invasive or non-invasive management groups based on their propensity scores, to mitigate immortal time bias. We estimated mortality hazard ratios comparing invasive with non-invasive management, and compared the rate of hospital admissions for heart failure. FINDINGS: Of the 1976 patients with NSTEMI, 101 died within 3 days of their peak troponin concentration and 375 were excluded because of extreme propensity scores. The remaining 1500 patients had a median age of 86 (IQR 82-89) years of whom (845 [56%] received non-invasive management. During median follow-up of 3·0 (IQR 1·2-4·8) years, 613 (41%) patients died. The adjusted cumulative 5-year mortality was 36% in the invasive management group and 55% in the non-invasive management group (adjusted hazard ratio 0·68, 95% CI 0·55-0·84). Invasive management was associated with lower incidence of hospital admissions for heart failure (adjusted rate ratio compared with non-invasive management 0·67, 95% CI 0·48-0·93). INTERPRETATION: The survival advantage of invasive compared with non-invasive management appears to extend to patients with NSTEMI who are aged 80 years or older. FUNDING: NIHR Imperial Biomedical Research Centre, as part of the NIHR Health Informatics Collaborative.

Impella as unloading strategy during VA-ECMO: systematic review and meta-analysis.

Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is used as mechanical circulatory support in cardiogenic shock (CS). It restores peripheral perfusion, at the expense of increased left ventricle (LV) afterload. In this setting, Impella can be used as direct unloading strategy. Aim of this meta-analysis was to investigate efficacy and safety of LV unloading with Impella during ECMO in CS. A systematic search on Medline, Scopus and Cochrane Library was performed using as combination of keywords: extracorporeal membrane oxygenation, Impella, percutaneous micro axial pump, ECPELLA, cardiogenic shock. We aimed to include studies, which compared the use of ECMO with and without Impella (ECPELLA vs. ECMO). Primary endpoint was short-term all-cause mortality; secondary endpoints included major bleeding, haemolysis, need for renal replacement therapy (RRT) and cerebrovascular accident (CVA). Five studies met the inclusion criteria, with a total population of 972 patients. The ECPELLA cohort showed improved survival compared to the control group (RR (Risk Ratio): 0.86; 95% CI (Confidence Interval): 0.76, 0.96; p = 0.009). When including in the analysis only studies with homogeneous comparator groups, LV unloading with Impella remained associated with significant reduction in mortality (RR: 0.85; 95% CI: 0.75, 0.97; p = 0.01). Haemolysis (RR: 1.70; 95% CI: 1.35, 2.15; p < 0.00001) and RRT (RR: 1.86; 95% CI: 1.07, 3.21; p = 0.03) occurred at a higher rate in the ECPELLA group. There was no difference between the two groups in terms of major bleeding (RR: 1.37; 95% CI: 0.88, 2.13; p = 0.16) and CVA (RR: 0.91; 95% CI: 0.61, 1.38; p = 0.66). In conclusion, LV unloading with Impella during ECMO was associated with improved survival, despite increased haemolysis and need for RRT, without additional risk of major bleeding and CVA.

Mid-term clinical outcomes from use of Sirolimus coated balloon in coronary intervention; data from real world population.

BACKGROUND: Use of drug coated balloons (DCBs) in coronary intervention is escalating. There is a plethora of data on Paclitaxcel-DCB. However, when it comes of stents, Limus-drugs are preferred over Paclitaxel. There is very limited data on Sirolimus coated balloons (SCB). MagicTouch-SCB (Concept Medical, FL) elutes Sirolimus via nano-technology and have been used in our centers since March 2018. We report a mid-term follow-up with this relatively novel-technology. METHODS AND RESULTS: We retrospectively analyzed all patients treated with MagicTouch-SCB between March-2018 and February-2019. Results are reported as cardiac-death, target-vessel myocardial-infarction (TVMI), target lesion revascularization (TLR) and Major Adverse Cardiac Events (MACE). During the study period, 288-patients (373-lesions) with a mean age of 65.8 were treated with MagicTouch-SCB. 84% (n = 241) were male, 155 (54%) were in the setting of acute coronary syndrome, 38% (n = 110) had diabetes and 62% (n = 233) were in de-novo lesions. Most lesions treated were in the LAD/diagonal-system (n = 170; 46%). Pre-dilatation was performed in 92% (n = 345) of cases. Bailout stenting was required in 9% lesions (n = 35). The mean diameter and length of SCBs were 2.64 ± 0.56 mm and 24 ± 8.9 mm respectively. During a median follow-up of 363 days (IQR: 278-435), cardiac death and TVMI occurred in 5-patients (1.7%) and 10-patients (3.4%) respectively, TLR per-lesion was 12%. The MACE rate was 10%. There were no documented cases of acute vessel closure. CONCLUSIONS: The results from mid-term follow-up with this relatively new technology SCB is encouraging with a low rates of hard endpoints and acceptable MACE rates despite complex group of patients and lesion subsets.

Prevalence, predictors, and outcomes of patient prosthesis mismatch in women undergoing TAVI for severe aortic stenosis: Insights from the WIN-TAVI registry.

OBJECTIVE: To evaluate the incidence, predictors and outcomes of female patients with patient-prosthesis mismatch (PPM) following transcatheter aortic valve intervention (TAVI) for severe aortic stenosis (AS). BACKGROUND: Female AS TAVI recipients have a significantly lower mortality than surgical aortic valve replacement (SAVR) recipients, which could be attributed to the potentially lower PPM rates. TAVI has been associated with lower rates of PPM compared to SAVR. PPM in females post TAVI has not been investigated to date. METHODS: The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multicenter registry of women undergoing TAVR for severe symptomatic AS. Two hundred and fifty patients with detailed periprocedural and follow-up echocardiographic investigations were included in the WIN-TAVI echocardiographic sub-study. PPM was defined as per European guidelines stratified by the presence of obesity. RESULTS: The incidence of PPM in our population was 32.8%. Patients with PPM had significantly higher BMI (27.4 ± 6.1 vs. 25.2 ± 5.0, p = .002), smaller sized valves implanted (percentage of TAVI ≤23 mm 61% vs. 29.2%, PPM vs. no PPM, p < .001) and were more often treated with balloon expandable valves (48.3 vs. 32.5%, p < .001) rather than self expanding ones (26.3 vs. 52.8%, <.001). BMI (OR = 1.08; 95%CI 1.02-1.14, p = .011) and valve size ≤23 mm (OR = 3.00 95%CI 1.14-7.94, p = .027) were the only independent predictors of PPM. There was no significant interaction between valve size and valve type (p = .203). No significant differences were observed in 1-year mortality or major adverse cardiovascular events. CONCLUSIONS: PPM in females undergoing TAVI occurs in one third of patients. BMI and valve size ≤23 mm are independent predictors. Larger registries are required to determine the impact of PPM on future clinical outcomes.

Outcomes of heart transplantation in patients bridged with Impella 5.0: Comparison with native chest transplanted patients without preoperative mechanical circulatory support.

The Impella (Abiomed, Danvers, MA, USA) has become an important adjunct treatment modality in bridging patients with end-stage heart failure to recovery or orthotopic heart transplantation (HTx). We compared the outcome of patients directly bridged to HTx with the Impella 5.0 versus patients without mechanical circulatory support (MCS). Patients with no previous sternotomy or MCS, who were transplanted between September 2014 and March 2019 were included in this retrospective analysis. Impella 5.0 was implanted using surgical access and transesophageal echocardiography guidance. Forty-two out of 155 transplanted patients fulfilled the insertion criteria. Eight (19%) were bridged with Impella 5.0 to HTx. Recipient and donor baseline characteristics were comparable in both groups. There were no significant differences in survival between the groups at 30-day (94% no MCS vs. 87.5% Impella group, P = .47) or 6 months (94% vs. 87.5%, P = .51). Patients on Impella 5.0 showed a significant recovery of hemodynamic parameters and end-organ function. Average duration of support to HTx was 16 ± 17 days. Impella 5.0, when used in suitable patients in a timely fashion can be a good strategy for bridging patients to HTx. The axillary approach allows for early extubation and mobilization. Outcomes of patients bridged to HTx with Impella 5.0 in acute cardiogenic shock are comparable to those of patients with no MCS.

Initial experience of a self-expanding transcatheter aortic valve with an outer pericardial wrap: The United Kingdom and Ireland Implanters' registry.

OBJECTIVES: The United Kingdom and Ireland Implanters' registry is a multicenter registry which reports on real-world experience with new transcatheter heart valves. BACKGROUND: The Evolut PRO (Medtronic, Minneapolis, MN) transcatheter aortic valve is a self-expanding transcatheter aortic valve with an outer pericardial wrap, designed to minimize paravalvular regurgitation. METHODS: Between July 2017 and December 2018, clinical, procedural, and 30-day outcome data were prospectively collected from all patients receiving the Evolut PRO valve across nine participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2 (VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 317 patients underwent implantation. Mean age was 81.8 ± 6.4 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.5 ± 1.8%. Iliofemoral access was used in 99.1% of patients. Device success was 91.2%. Mean gradient was 7.6 ± 4.7 mmHg and effective orifice area 1.9 ± 0.7 cm2 . The incidence of moderate paravalvular regurgitation was 1.7% and there was no severe paravalvular regurgitation. A new permanent pacemaker was implanted in 17.8% of patients without a pacemaker at baseline. Early safety was demonstrated in 92.7%. At 30 days, all-cause mortality was 0.6%, stroke 3.8%, and major vascular complication 2.8%. CONCLUSIONS: Real-world experience of the Evolut PRO transcatheter aortic valve demonstrated favorable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

Comparison of warfarin versus DOACs in patients with concomitant indication for oral anticoagulation undergoing TAVI; results from the ATLAS registry.

The optimal antithrombotic therapy for patients undergoing TAVI with concomitant indication for oral anticoagulation remains unclear. In this high-risk population group, there is a paucity of data with regards to the use of DOACs. In the present study we compared long-term clinical outcomes of TAVI patients requiring anticoagulation, treated with warfarin versus DOACs. Consecutive patients, who underwent TAVI with indication for oral anticoagulation from the multicenter ATLAS registry were studied and divided in two groups depending on the chosen anticoagulation regimen, warfarin vs. DOACs. 30-day survival, as well as estimated 1 and 2-year all-cause mortality were compared between groups. The secondary endpoint included in-hospital major or life-threatening bleeding. The study group included 217 patients (102 treated with warfarin; 115 treated with DOACs). Kaplan-Meier estimated survival was found to be statistically similar in the warfarin and DOAC groups (90.6% vs. 93.7% for 1-year and 84.5% vs. 88.5%, for 2-year survival, respectively, Plog-rank = 0.984). Adjusted hazard ratio for all cause mortality was similar between the two groups (HRwarfarin vs. DOAC = 1.15; 95% CI 0.33 to 4.04, p = 0.829). Propensity matching revealed similar results. At 30-days, all-cause mortality was found to be comparable between the two groups. With regards to BARC defined bleeding complications, major and life-threatening complications did not differ between the two anticoagulation groups (6% vs. 8% for warfarin and DOACs respectively, p = 0.857). DOACs seem to demonstrate a similar safety and efficacy profile compared to warfarin in TAVI patients with a concomitant indication for oral anticoagulation.

Initial experience with Impella RP in a quaternary transplant center.

Right ventricular failure is one of the most common complications encountered after left ventricular assist device implantation and heart transplantation. It has been reported to have an incidence up to 30%. It increases morbidity and short-term mortality. Impella RP is a small pump that can provide up to 4L/min of flow. We analyzed all the patients with right ventricular failure that were treated with Impella RP in our institution. The Impella RP was implanted percutaneously in the catheterization laboratory guided by fluoroscopy. Overall, 7 patients required the implantation of an Impella RP due to right ventricular failure: 2 after long-term LVAD, 3 presented with acute right ventricular failure immediately after LVAD implantation, and 2 needed it after heart transplantation. Regarding complications, we report 2 patients with hemolysis. Hemodynamic parameters as well as end-organ perfusion and inotropic requirements improved after the insertion of the Impella. Overall, 30-day survival is 58%. Median time of support was 9 (5-19) days. RV failure is one of the most challenging complications after LVAD implantation and heart transplantation. The major challenge is the timing of implantation. The minimally invasive nature of the Impella RP facilitates de-escalation of treatment and paves the road to recovery. Impella RP proved useful in facilitating ECMO wean. Used in a prompt manner alongside the ease of implantation and the minimal rate of complications, Impella RP seems to be an appropriate device to tackle RV failure providing enough flow to allow for recovery or escalation decision-making.

Real-world comparison of the new 34 mm self-expandable transcatheter aortic prosthesis Evolut R to its 31 mm core valve predecessor.

OBJECTIVES: The aim of the present study was to compare the incidence of periprocedural complications and short-term outcomes between the second-generation recapturable 34 mm Evolut-R and its first-generation 31 mm predecessor. BACKGROUND: Although already in extensive clinical use in real world patients, the periprocedural complications and clinical outcomes of the new 34 mm device have not been investigated yet. METHODS: Consecutive patients who had undergone transcatheter aortic valve implantation in two centers with either a 31 mm CoreValve or a 34 mm Evolut-R device were retrospectively studied. Periprocedural complications of malpositioning, valve-in-valve implantation, conversion to full sternotomy or percutaneous coronary intervention and vascular complications were compared between the two groups. Short-term outcomes at discharge were compared using Valve Academic Research Consortium (VARC-2) criteria. RESULTS: The study group included 106 patients (35 Evolut-R 34 mm; 71 CoreValve 31 mm). Significantly lower rates of valve-in-valve implantation were demonstrated for the 34 mm group compared to the first-generation device (0% vs. 11.9%, respectively, P = 0.036). All other periprocedural complications were similar between groups. At discharge, the rates of new pacemaker implantation (5.7% vs. 26.8%, P = 0.037) and bleeding complications (2.9% vs. 19.6%, P = 0.025) were statistically significantly lower among the 34 mm group. With regards to VARC-2 defined combined endpoints, rates of early safety were significantly improved among the 34 mm group compared to 31 mm group (0% vs. 27.9%, respectively, P = 0.004). CONCLUSIONS: The recently introduced 34 mm Evolut-R seems to demonstrate an improved safety profile, as evidenced by the reduced bleeding rates, lower rates of valve-in-valve implantation and lower PPM rates compared to its 31 mm predecessor.

Initial experience of a large, self-expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters' registry.

OBJECTIVES: The UK & Ireland Implanters' registry is a multicenter registry which reports on real-world experience with novel transcatheter heart valves. BACKGROUND: The 34 mm Evolut R transcatheter aortic valve is a self-expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus. METHODS: Between January 2017 and April 2018, clinical, procedural and 30-day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2(VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm2 . Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all-cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%. CONCLUSIONS: Real-world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

The prognostic significance of incomplete revascularization and untreated coronary anatomy following percutaneous coronary intervention: An analysis of 6,755 patients with multivessel disease.

BACKGROUND: More than half of the patients undergoing percutaneous coronary intervention (PCI) have multivessel disease. Whether complete revascularization impacts long-term mortality or whether selected patients or those with specific coronary anatomy benefit from complete revascularization is unclear. METHODS: A total of 14,452 patients underwent PCI between 2004 and 2015 at Harefield Hospital, UK. Of these, 7,076 patients had multivessel disease. We excluded 321 patients with left main-stem stenosis ≥50%, with 6,755 patients included in the analysis (936 patients had complete revascularization). RESULTS: The unadjusted 3-year mortality rates were lower with complete revascularization (10.8% vs 13.1%, P = 0.047). However, multivariable-adjusted analyses indicated that complete revascularization was not independently associated with mortality (HR = 1.01, 95% CI: 0.78-1.31, P = 0.939). These findings were unchanged when addressing measured confounding using propensity-matched analyses (HR = 1.16, 95% CI: 0.81-1.65, P = 0.417) and inverse probability treatment weighted analyses (HR = 1.01, 95% CI: 0.77-1.33, P = 0.950); and unmeasured confounding using instrumental variable analyses (Δ = 0.9%, 95% CI: -2.5%, 4.3%, P = 0.958). There was no association with mortality and untreated LAD disease (HR = 0.92, 95% CI: 0.72-1.17, P = 0.482) and LCx disease (HR = 0.90, 95% CI: 0.74-1.10, P = 0.999). However, untreated proximal LAD disease (HR = 1.23, 95% CI: 1.06-1.51, P = 0.045) and RCA disease (HR = 1.36, 95% CI: 1.08-1.65, P = 0.007) was associated with increased mortality, particularly in patients with ST-elevation acute coronary syndrome (STEACS). CONCLUSIONS: In this study of unselected patients undergoing PCI, complete revascularization did not confer a mortality benefit. However, the presence of untreated proximal LAD and RCA disease was prognostic in patients with STEACS. Thus, complete revascularization may be considered in select patient groups with anatomical subsets of coronary disease.

Genetic variations in the alanine-glyoxylate aminotransferase 2 (AGXT2) gene and dimethylarginines levels in rheumatoid arthritis.

Rheumatoid arthritis (RA) is associated with high rates of cardiovascular events mainly due to coronary and cerebrovascular atherosclerotic disease. Asymmetric (ADMA) and symmetric (SDMA) dimethylarginines are endogenous inhibitors of nitric oxide synthase and have been repeatedly linked with adverse cardiovascular outcomes in the general population and various disease settings. Alanine-glyoxylate aminotransferase 2 (AGTX2) is considered an alternative metabolic pathway contributing to the clearance of dimethylarginines in humans. The aim of the current study was to investigate the effect of specific AGXT-2 gene polymorphisms on circulating levels of ADMA or SDMA in patients with RA. Serum ADMA and SDMA levels were measured in 201 individuals with RA [median age: 67 years (IQR: 59-73), 155 females]. Two single nucleotide polymorphisms (SNPs) in the AGXT-2 gene-rs37369 and rs28305-were genotyped. Distributions of SDMA and ADMA were skewed, hence comparisons across the gene polymorphisms were performed using Kruskal-Wallis tests, and summarized using medians and interquartile ranges. Univariable analysis did not demonstrate a significant difference in the levels of SDMA or ADMA amongst the different genotypic groups of either rs37369AGXT2 (p = 0.800, 0.977) or rs28305AGXT2 (p = 0.463, 0.634). In multivariable analyses, ADMA levels were found to be significantly associated with erythrocyte sedimentation rate and estimated glomerular filtration rate, whilst SDMA levels were significantly associated with estimated glomerular filtration rate and quantitative insulin sensitivity check index. After adjustments for these factors, the relationship between the AGXT2 gene variants and both ADMA and SDMA remained non-significant. Our study in a well-characterized RA population did not show an association between serum concentrations of dimethylarginines and genetic variants of the AGXT2 gene.

Echocardiographic assessment in patients with chronic kidney disease: Current update.

Patients with chronic kidney disease (CKD) carry a high cardiovascular risk. An abundance of evidence has emerged in recent years establishing minor reductions in estimated glomerular filtration rate as an independent risk factor for cardiovascular mortality. Additionally, cardiac changes, such as left ventricular hypertrophy and impaired left ventricular systolic function, have been associated with an unfavorable prognosis. Despite the significant prevalence of underlying cardiac abnormalities, symptoms may not manifest in many patients with CKD. A range of available and emerging echocardiographic modalities may assist with diagnosing heart disease in CKD. Furthermore, some of these emerging techniques can give an important insight into the pathophysiology of subclinical dysfunction in CKD. This review discusses how current and emerging echocardiographic modalities such as speckle tracking echocardiography and 3D echocardiography might help cardiologists in providing important information to help with diagnosis and risk stratification of cardiac-related morbidity and mortality in patients with renal disease, as well applicability of these tools to current clinical practice.