Impact of the COVID-19 Pandemic on Global TAVR Activity: The COVID-TAVI Study.

BACKGROUND: The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. OBJECTIVES: This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. METHODS: This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. RESULTS: We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (-52%; P = 0.001), Central-South America (-33%; P < 0.001), and Asia (-29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity. CONCLUSIONS: TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises.

Echocardiography Assessment of Rheumatic Heart Disease: Implications for Percutaneous Balloon Mitral Valvuloplasty.

Echocardiography is an important diagnostic imaging modality in recognizing rheumatic heart disease, a chronic sequelae of acute rheumatic fever. Left-sided heart valves, especially the mitral valve is typically affected, with stenosis or regurgitation as a consequence. Although assessment of valve area by 2D planimetry is the reference method for mitral stenosis severity, 3D planimetry provides more accurate measurement and diagnostic value. Careful selection of patients in terms of echocardiographic criteria is essential to ensure safety and success of the intervention and better long-term outcomes. Several echocardiographic scores based upon mitral valve mobility, thickening, calcification, and subvalvular thickening are developed to assess mitral valve anatomy and the feasibility of percutaneous mitral commissurotomy. 3D transesophageal echocardiography (TEE) provides detailed information of the mitral anatomy (commissural fusions, and subvalvular apparatus) before intervention. In addition, 3D TEE planimetry provides a more accurate measurement of the valve area compared with 2D echocardiography. Generally, huge annular calcification and lack of commissural fusion are unfavorable echocardiographic markers that increase the risk of complications and preclude the feasibility of percutaneous balloon mitral valvuloplasty. More contemporary prospective echocardiography research studies on patients with RHD from low- and middle-income countries are needed.

Anxiety and depression in patients aged 80 years and older following aortic valve therapy. A six-month follow-up study.

BACKGROUND: Little is known about mental health following advanced cardiac procedures in the oldest patients. AIMS: To study changes in anxiety and depression from baseline to one- and six-month follow-up in older patients following transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). METHODS: Prospective cohort study of patients ≥ 80 years undergoing elective TAVI or SAVR in a tertiary university hospital. Anxiety and depression were assessed with the Hospital Anxiety and Depression Scale. Differences between TAVI/SAVR were analyzed using Welch's t test or chi-squared. Changes over time and group differences were established with longitudinal models using generalized least squares. RESULTS: In 143 patients (83.5 ± 2.7 years), 46% (n = 65) received TAVI. Anxiety was identified in 11% of TAVI patients at baseline. One- and six-months later, percentages were 8% and 9%. In SAVR patients, 18% had baseline scores indicating anxiety. One and six-months later, percentages were 11% and 9%. Depression was identified in 15% of TAVI patients. One- and six-months later, percentages were 11% and 17%. At baseline, 11% of SAVR patients had scores indicating depression. One- and six-months after SAVR, percentages were 15% and 12%. Longitudinal analyses showed reductions (P < 0.001) in anxiety from baseline to one-month, and stable scores between one- and six-months for both treatment groups. There was no change over time for depression among treatment groups (P = 0.21). DISCUSSION AND CONCLUSIONS: SAVR or TAVI in patients ≥ 80 years was associated with anxiety reduction between baseline and follow-up. For depression, there was no evidence of change over time in either treatment group.

Catheter-induced Vasospasm of the Anatomically Normal Right Coronary Artery in a Patient With Non-ST Elevation Myocardial Infarction and Obstructive Disease in the Left Anterior Descending Artery; A Challenging Case Report and Review of the Literature.

This case report illustrates the clinical course and management strategy of severe catheter-induced vasospasm of the right coronary artery (RCA) resulting in brief cardiac arrest in a male patient in his 60s presenting with Non-ST elevation myocardial infarction and obstructive disease in the left anterior descending artery (LAD). The patient was successfully resuscitated and further stay was uneventful. Optical coherence tomography imaging following administration of intracoronary isosorbide dinitrate confirmed normal coronary anatomy and flow restoration in the RCA, suggesting that the index episode was probably a vasospasm of the RCA. After establishing coronary flow in the RCA, the stenosis in the LAD was treated with a drug-eluting stent. Invasive cardiologists should be aware of the catheter-induced coronary artery spasm, which may have important clinical implications particularly in the presence of concomitant atherosclerotic disease in other coronary arteries (in our case the LAD). This approach helps to avoid unnecessary coronary stenting.

Left atrial appendage occlusion vs novel oral anticoagulation for stroke prevention in atrial fibrillation: rationale and design of the multicenter randomized occlusion-AF trial.

BACKGROUND: The prevalence of atrial fibrillation (AF) is increasing globally, which is a major clinical and public health concern due to the 5-fold increased risk of stroke. Oral anticoagulation with novel oral anticoagulants (NOACs) is the current primary option for stroke prevention in patients with AF, although it increases the risk of major bleeding. Patients with prior ischemic cerebrovascular events are at particularly high risk of both recurrent ischemic events and major bleeding. Left atrial appendage occlusion (LAAO) provides an alternative option for stroke prevention in high-risk patients, however, with currently limited evidence. Thus, randomized trials comparing LAAO to NOACs are needed. OBJECTIVE: The Occlusion-AF trial is designed to assess whether LAAO is non-inferior to NOAC therapy for reduction of the combined endpoint of stroke, systemic embolism, major bleeding (Bleeding Academic Research Consortium ≥ 3) and all-cause mortality in patients with AF and a recent ischemic stroke or transient ischemic attack (TIA). METHODS AND ANALYSIS: Investigator-initiated multicenter, multinational, randomized open-label non-inferiority trial with blinded outcome evaluation (PROBE design). Patients with documented AF, and an ischemic stroke or TIA within 6 months will be eligible for enrollment. Major exclusion criteria are modified Rankin Scale > 3 at enrollment, glomerular filtration rate < 15 ml/min, and life-expectancy less than 2 years. A total of 750 patients will be randomized 1:1 to receive either a NOAC or LAAO using the Amplatzer Amulet (Abbott, MN, USA) or Watchman FLX (Boston Scientific, MN, USA) with subsequent life-long aspirin 75 mg daily. Follow-up will be based on in-office and telephone follow-up in combination with long-term follow-up (10 years) through national hospital discharge registries in the individual Nordic countries. The primary outcome will be a composite endpoint of stroke, systemic embolism, major bleeding (BARC ≥ 3) and all-cause mortality at 2-year follow-up. CONCLUSIONS: The Occlusion-AF trial is designed to compare LAAO to NOAC therapy for secondary stroke prevention in AF patients with a high risk of recurrent thromboembolic events, i.e. with previous ischemic stroke or TIA, and otherwise eligible for anticoagulation. The results are expected to contribute significantly to the understanding of the effects of LAAO compared to the standard contemporary pharmacological treatment in these patients.

Effects of Add-On Left Ventricular Assist Device to Extracorporeal Membrane Oxygenation During Refractory Cardiac Arrest in a Porcine Model.

This study evaluated the effects of extracorporeal membrane oxygenation (ECMO) in combination with a percutaneous adjunctive left ventricular assist device (LVAD) in a porcine model during 60 minutes of refractory cardiac arrest (CA). Twenty-four anesthetized swine were randomly allocated into three groups given different modes of circulatory assist: group 1: ECMO 72 ml/kg/min and LVAD; group 2: ECMO 36 ml/kg/min and LVAD; and group 3: ECMO 72 ml/kg/min. During CA and extracorporeal cardiopulmonary resuscitation (ECPR), mean left ventricular pressure (mLVP) was lower in group 1 (p = 0.013) and in group 2 (p = 0.003) versus group 3. Mean aortic pressure (mAP) and coronary perfusion pressure (CPP) were higher in group 1 compared with the other groups. In group 3, mean pulmonary artery flow (mPAf) was lower versus group 1 (p = 0.003) and group 2 (p = 0.039). If the return of spontaneous circulation (ROSC) was achieved after defibrillation, up to 180 minutes of unsupported observation followed. All subjects in groups 1 and 3, and 5 subjects in group 2 had ROSC. All subjects in group 1, five in group 2 and four in group 3 had sustained cardiac function after 3 hours of spontaneous circulation. Subjects that did not achieve ROSC or maintained cardiac function post-ROSC had lower mAP (p < 0.001), CPP (p = 0.002), and mPAf (p = 0.004) during CA and ECPR. Add-on LVAD may improve hemodynamics compared with ECMO alone during refractory CA but could not substitute reduced ECMO flow. Increased mAP and CPP could be related to ROSC rate and sustained cardiac function. Increased mLVP was related to poor post-ROSC cardiac function.

Long-term 5-year outcome of the randomized IMPRESS in severe shock trial: percutaneous mechanical circulatory support vs. intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction.

AIMS: To assess differences in long-term outcome and functional status of patients with cardiogenic shock (CS) treated by percutaneous mechanical circulatory support (pMCS) and intra-aortic balloon pump (IABP). METHODS AND RESULTS: Long-term follow-up of the multicentre, randomized IMPRESS in Severe Shock trial (NTR3450) was performed 5-year after initial randomization. Between 2012 and 2015, a total of 48 patients with severe CS from acute myocardial infarction (AMI) with ST-segment elevation undergoing immediate revascularization were randomized to pMCS by Impella CP (n = 24) or IABP (n = 24). For the 5-year assessment, all-cause mortality, functional status, and occurrence of major adverse cardiac and cerebrovascular event (MACCE) were assessed. MACCE consisted of death, myocardial re-infarction, repeat percutaneous coronary intervention, coronary artery bypass grafting, and stroke. Five-year mortality was 50% (n = 12/24) in pMCS patients and 63% (n = 15/24) in IABP patients (relative risk 0.87, 95% confidence interval 0.47-1.59, P = 0.65). MACCE occurred in 12/24 (50%) of the pMCS patients vs. 19/24 (79%) of the IABP patients (P = 0.07). All survivors except for one were in New York Heart Association Class I/II [pMCS n = 10 (91%) and IABP n = 7 (100%), P = 1.00] and none of the patients had residual angina. There were no differences in left ventricular ejection fraction between the groups (pMCS 52 ± 11% vs. IABP 48 ± 10%, P = 0.53). CONCLUSIONS: In this explorative randomized trial of patients with severe CS after AMI, there was no difference in long-term 5-year mortality between pMCS and IABP-treated patients, supporting previously published short-term data and in accordance with other long-term CS trials.

Intracardiac echocardiography for guidance of transcatheter left atrial appendage occlusion: An expert consensus document.

Transcatheter left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in selected patients with atrial fibrillation. Intraprocedural imaging is a crucial for a successful intervention, with transesophageal echocardiography (TEE) as the current gold standard. Since some important limitations may affect TEE use, intracardiac echocardiography (ICE) is increasingly used as an alternative to TEE for guiding LAAO. The lack of a standardized imaging protocol has slowed the adoption of ICE into clinical practice. On the basis of current research and expert consensus, this paper provides a protocol for ICE support of left atrial appendage occlusion.

Baseline frailty status and outcomes important for shared decision-making in older adults receiving transcatheter aortic valve implantation, a prospective observational study.

AIMS: The objective of this study was to examine baseline frailty status (including cognitive deficits) and important clinical outcomes, to inform shared decision-making in older adults receiving transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We conducted a prospective, observational study of 82 TAVI patients, recruited 2013 to 2015, with 2-year follow-up. Mean age was 83 years (standard deviation (SD) 4.7). Eighteen percent of the patients were frail, as assessed with an 8-item frailty scale. Fifteen patients (18%) had a Mini-Mental Status Examination (MMSE) score below 24 points at baseline, indicating cognitive impairment or dementia and five patients had an MMSE below 20 points. Mean New York Heart Association (NYHA) class at baseline and 6 months was 2.5 (SD 0.6) and 1.4 (SD 0.6), (p < 0.001). There was no change in mean Nottingham Extended Activities of Daily Living (NEADL) scale between baseline and 6 months, 54.2 (SD 11.5) and 54.5 (SD 10.3) points, respectively, mean difference 0.3 (p = 0.7). At 2 years, six patients (7%) had died, four (5%, n = 79) lived in a nursing home, four (5%) suffered from disabling stroke, and six (7%) contracted infective endocarditis. CONCLUSIONS: TAVI patients had improvement in symptoms and maintenance of activity of daily living at 6 months. They had low mortality and most patients lived in their own home 2 years after TAVI. Complications like death, stroke, and endocarditis occurred. Some patients had cognitive impairment before the procedure which might influence decision-making. Our findings may be used to develop pre-TAVI decision aids.

Balanced Biventricular Assist Versus Extracorporeal Membrane Oxygenation in Cardiac Arrest.

Mechanical assist devices in refractory cardiac arrest are increasingly employed. We compared the hemodynamics and organ perfusion during cardiac arrest with either veno-arterial extracorporeal membrane oxygenation (ECMO) or biventricular assisted circulation combining left- and right-sided impeller devices (BiPella) in an acute experimental setting. Twenty pigs were randomized in two equal groups receiving circulatory support either by ECMO or by BiPella during 40 minutes of ventricular fibrillation (VF) followed by three attempts of cardioversion, and if successful, 60 minute observation with spontaneous, unsupported circulation. Hemodynamic variables were continuously recorded. Tissue perfusion was evaluated by fluorescent microsphere injections. Cardiac function was visualized by intracardiac echocardiography. During VF device output, carotid flow, kidney perfusion, mean aortic pressure (AOPmean), and mean left ventricular pressure (LVPmean) were all significantly higher in the ECMO group, and serum-lactate values were lower compared with the BiPella group. No difference in myocardial or cerebral perfusion was observed between groups. In 15 animals with sustained cardiac function for 60 minutes after return of spontaneous circulation, left ventricular subendocardial blood flow rate averaged 0.59 ± 0.05 ml/min/gm during VF compared with 0.31 ± 0.07 ml/min/gm in five animals with circulatory collapse (p = 0.005). Corresponding values for the midmyocardium was 0.91 ± 0.06 vs. 0.65 ± 0.15 ml/min/gm (p = 0.085). Both BiPella and ECMO could sustain vital organ function. ECMO provided a more optimal systemic circulatory support related to near physiologic output. Myocardial tissue perfusion and sustained cardiac function were related to coronary perfusion pressure during VF, irrespective of mode of circulatory support.

Impella use in acute myocardial infarction complicated by cardiogenic shock and cardiac arrest: Analysis of 10 years registry data.

AIMS: To assess characteristics and outcome of patients treated with Impella for acute myocardial infarction (AMI) complicated by severe cardiogenic shock (CS) or cardiac arrest (CA). METHODS AND RESULTS: From 2008 through 2017, 92 patients with AMI complicated by CS were treated with Impella. Survival varied according to clinical presentation. Patients in cardiogenic shock without CA had a 75% 30-day survival. Patients with CA and return of spontaneous circulation (ROSC) had a 43% survival and those with CA and ongoing cardio-pulmonary resuscitation (CPR) had a 6% 30-day survival. Age, pre-existing hypertension, coronary disease, ventilatory support and use of adrenergic agents were associated with worse prognosis. Complications were predominantly access site related. CONCLUSIONS: In this registry of patients with AMICS treated with Impella, hypertension and older age were found to be negatively predictive for survival. Patients without CA had the highest 30-day survival. In patients with ROSC, survival was strongly related to age and comorbidity. Patients with ongoing CPR had very high mortality.

A novel geriatric assessment frailty score predicts 2-year mortality after transcatheter aortic valve implantation.

AIMS: Established surgical scores have limitations in delineating risk among candidates for transcatheter aortic valve implantation (TAVI). Assessment of frailty might help to estimate the mortality risk and identify patients likely to benefit from treatment. The aim of the study was to develop a frailty score to guide the decision for TAVI. METHODS AND RESULTS: We conducted a prospective observational study in patients ≥70 years referred for TAVI during 2011-15. A Heart Team had declined the patients for open heart surgery due to high risk but accepted them for TAVI. Prior to the procedure, a geriatric assessment (GA) was performed. Based on this, an 8-element frailty score with a 0-9 (least frail-most frail) scale was developed. A total of 142 patients, 54% women, mean age 83 (standard deviation 4) years, with severe and symptomatic aortic stenosis were assessed. All-cause 2 year mortality was 11%. The novel GA frailty score predicted 2-year mortality in Cox analyses, also when adjusted for age, gender, and logistic EuroSCORE [hazard ratio (HR) 1.75, 95% confidence interval (CI): 1.28-2.42, P < 0.001]. A receiver operating characteristic (ROC) curve analysis indicated that a GA frailty score cut-off at ≥4 predicted 2-year mortality with a specificity of 80% (95% CI: 73-86%) and a sensitivity of 60% (95% CI: 36-80%). The area under the curve was 0.81 (95% CI 0.71-0.90). CONCLUSION: A novel 8-element GA frailty score identified gradations in survival in patients declined for open heart surgery. Patients with higher GA frailty scores had significantly higher 2-year mortality after TAVI.

Long-term follow-up in patients treated by stent implantation for post-ablation pulmonary vein stenosis.

PURPOSE: Symptomatic severe pulmonary vein stenosis (PVS) after catheter ablation of atrial fibrillation (AF) is a rare but well-recognized complication. Treatment options include pulmonary vein angioplasty with or without drug eluting balloons or angioplasty with stent implantation. The treatment of choice is unclear. In our center, pulmonary vein stenting is the treatment of choice for significantly stenotic veins. We present the long-term clinical outcome of 9 patients treated with stent implantation. METHODS: Between 2001 and 2015, 3048 patients with AF were treated with catheter ablation at our institution, of which 9 developed symptomatic PVS. A total of 11 PVS were treated. Pre-procedural imaging (CT, MR, transesophageal echocardiography, angiography) was performed in all patients. RESULTS: Mean time from ablation to stenting was 18 months. Three patients had recurrent pneumonia and the remaining reduced functional capacity (NYHA 2). All patients were in functional capacity NYHA 1 (p < 0.05) after a mean follow-up of 64 (18-132) months. Three patients still had paroxysmal AF, of which two have undergone repeated ablation. CONCLUSIONS: Symptomatic PVS after AF ablation can be successfully treated by stent implantation with durable results and good clinical outcome. AF ablation is still a feasible option after stent deployment.

Left Versus Biventricular Assist Devices in Cardiac Arrest.

Maintaining adequate organ perfusion during cardiac arrest remains a challenge, and various assist techniques have been evaluated. We assessed whether a right ventricular impeller assist device (RVAD) in adjunct to a left ventricular impeller assist device (LVAD) is beneficial. Twenty anesthetized pigs were randomized to maximized circulatory support by percutaneously implanted left- or biventricular assist device(s) during 30 minutes of electrically induced ventricular fibrillation followed by three attempts of cardioversion. Continuous hemodynamic variables were recorded. Cardiac output and myocardial, cerebral, renal, and ileum mucosa tissue perfusion were measured with fluorescent microspheres, and repeated blood gas analyses were obtained. With biventricular support, an increased LVAD output was found compared with left ventricular (LV) support; 3.2 ± 0.2 (SEM) vs. 2.0 ± 0. 2 L/minute just after start of ventricular fibrillation, 3.2 ± 0.1 vs. 2.0 ± 0.1 L/minute after 15 minutes, and 3.0 ± 0.1 vs. 2.1 ± 0.1 L/minute after 30 minutes of cardiac arrest (pg < 0.001). Biventricular support also increased aortic and LV pressure, in addition to end-tidal CO2. Tissue blood flow rates were increased for most organs with biventricular support. Blood gas analyses showed improved oxygenation and lower s-lactate values. However, myocardial perfusion was degraded with biventricular support and return of spontaneous circulation less frequent (5/10 vs. 10/10; p = 0.033). Biventricular support was associated with high intraventricular pressure and decreased myocardial perfusion pressure, correlating significantly with flow rates in the LV wall. A transmural flow gradient was observed for both support modes, with better maintained subepicardial than midmyocardial and subendocardial perfusion.

Percutaneous Mechanical Circulatory Support Versus Intra-Aortic Balloon Pump in Cardiogenic Shock After Acute Myocardial Infarction.

BACKGROUND: Despite advances in treatment, mortality in acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains high. Short-term mechanical circulatory support devices acutely improve hemodynamic conditions. OBJECTIVES: The aim of this study was to determine whether a new percutaneous mechanical circulatory support (pMCS) device (Impella CP, Abiomed, Danvers, Massachusetts) decreases 30-day mortality when compared with an intra-aortic balloon pump (IABP) in patients with severe shock complicating AMI. METHODS: In a randomized, prospective, open-label, multicenter trial, 48 patients with severe CS complicating AMI were assigned to pMCS (n = 24) or IABP (n = 24). Severe CS was defined as systolic blood pressure <90 mm Hg or the need for inotropic or vasoactive medication and the requirement for mechanical ventilation. The primary endpoint was 30-day all-cause mortality. RESULTS: At 30 days, mortality in patients treated with either IABP or pMCS was similar (50% and 46%, respectively; hazard ratio with pMCS: 0.96; 95% confidence interval: 0.42 to 2.18; p = 0.92). At 6 months, mortality rates for both pMCS and IABP were 50% (hazard ratio: 1.04; 95% confidence interval: 0.47 to 2.32; p = 0.923). CONCLUSIONS: In this explorative randomized controlled trial involving mechanically ventilated patients with CS after AMI, routine treatment with pMCS was not associated with reduced 30-day mortality compared with IABP. (IMPRESS in Severe Shock; NTR3450).

Efficacy and safety of the Lotus Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk: Results from the Nordic Lotus-TAVR registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic valve stenosis (AS) who are ineligible or at high risk for conventional valvular surgery. In Northwestern Europe, the TAVR technology is also increasingly used to treat patients with an intermediate risk profile. METHODS AND RESULTS: The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N=154). Valve Academic Research Consortium (VARC)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization, ectopic valve deployment, or TAV-in-TAV deployment. The VARC-defined combined safety rate at 30days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3.2%. The clinical efficacy rate after 30days was 91.6% - only one patient had moderate aortic regurgitation. When considering only those patients in the late experience group (N=79), the combined safety and clinical efficacy rates were 93.7% and 92.4%, respectively. The pacemaker implantation rate was 27.9% - this rate was 12.8% in case of a combined implantation depth <4mm and a device/annulus ratio<1.05. CONCLUSIONS: The present study demonstrates the efficacy and safety of the repositionable, retrievable Lotus Valve System in intermediate risk patients with AS. The VARC-defined device success rate was 97.4% with a 30-day patient safety and clinical efficacy rate of more than 90%. Less than moderate aortic regurgitation was obtained in 99.4% of patients.