Search

The SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial showed the safety but not efficacy of the Symplicity system (Medtronic, Santa Rosa, CA, USA) at 6 months follow-up in patients with treatment-resistant hypertension. This final report presents the 36-month follow-up results.SYMPLICITY HTN-3 was a single-blind, multicentre, sham-controlled, randomised clinical trial, done in 88 centres in the USA. Adults aged 18-80 years, with treatment-resistant hypertension on stable, maximally tolerated doses of three or more drugs including a diuretic, who had a seated office systolic blood pressure of 160 mm Hg or more and 24 h ambulatory systolic blood pressure of 135 mm Hg or more were randomly assigned (2:1) to receive renal artery denervation using the single electrode (Flex) catheter or a sham control. The original primary endpoint was the change in office systolic blood pressure from baseline to 6 months for the renal artery denervation group compared with the sham control group. Patients were unmasked after the primary endpoint assessment at 6 months, at which point eligible patients in the sham control group who met the inclusion criteria (office blood pressure ≥160 mm Hg, 24 h ambulatory systolic blood pressure ≥135 mm Hg, and still prescribed three or more antihypertensive medications) could cross over to receive renal artery denervation. Changes in blood pressure up to 36 months were analysed in patients in the original renal artery denervation group and sham control group, including those who underwent renal artery denervation after 6 months (crossover group) and those who did not (non-crossover group). For comparisons between the renal artery denervation and sham control groups, follow-up blood pressure values were imputed for patients in the crossover group using their most recent pre-crossover masked blood pressure value. We report long-term blood pressure changes in renal artery denervation and sham control groups, and investigate blood pressure control in both groups using time in therapeutic blood pressure range analysis. The primary safety endpoint was the incidence of all-cause mortality, end stage renal disease, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, hospitalisation for hypertensive crisis unrelated to non-adherence to medications, or new renal artery stenosis of more than 70% within 6 months. The trial is registered with ClinicalTrials.gov, NCT01418261.From Sep 29, 2011, to May 6, 2013, 1442 patients were screened, of whom 535 (37%; 210 [39%] women and 325 [61%] men; mean age 57·9 years [SD 10·7]) were randomly assigned: 364 (68%) patients received renal artery denervation (mean age 57·9 years [10·4]) and 171 (32%) received the sham control (mean age 56·2 years [11·2]). 36-month follow-up data were available for 219 patients (original renal artery denervation group), 63 patients (crossover group), and 33 patients (non-crossover group). At 36 months, the change in office systolic blood pressure was -26·4 mm Hg (SD 25·9) in the renal artery denervation group and -5·7 mm Hg (24·4) in the sham control group (adjusted treatment difference -22·1 mm Hg [95% CI -27·2 to -17·0]; p≤0·0001). The change in 24 h ambulatory systolic blood pressure at 36 months was -15·6 mm Hg (SD 20·8) in the renal artery denervation group and -0·3 mm Hg (15·1) in the sham control group (adjusted treatment difference -16·5 mm Hg [95% CI -20·5 to -12·5]; p≤0·0001). Without imputation, the renal artery denervation group spent a significantly longer time in therapeutic blood pressure range (ie, better blood pressure control) than patients in the sham control group (18% [SD 25·0] for the renal artery denervation group vs 9% [SD 18·8] for the sham control group; p≤0·0001) despite a similar medication burden, with consistent and significant results with imputation. Rates of adverse events were similar across treatment groups, with no evidence of late-emerging complications from renal artery denervation. The rate of the composite safety endpoint to 48 months, including all-cause death, new-onset end-stage renal disease, significant embolic event resulting in end-organ damage, vascular complication, renal artery re-intervention, and hypertensive emergency was 15% (54 of 352 patients) for the renal artery denervation group, 14% (13 of 96 patients) for the crossover group, and 14% (10 of 69 patients) for the non-crossover group.This final report of the SYMPLICITY HTN-3 trial adds to the totality of evidence supporting the safety of renal artery denervation to 36 months after the procedure. From 12 months to 36 months after the procedure, patients who were originally randomly assigned to receive renal artery denervation had larger reductions in blood pressure and better blood pressure control compared with patients who received sham control.Medtronic.

Takotsubo syndrome (TTS) largely affects postmenopausal women but has been shown to carry increased mortality risk in men. We sought to evaluate nationwide in-hospital outcomes between men and women admitted with TTS to better characterize these disparities. Using the National Inpatient Sample database from 2011 to 2018, we identified a total of 48,300 hospitalizations with the primary diagnosis of TTS. The primary end point was in-hospital all-cause mortality. Secondary end points included in-hospital complications, length of stay, and discharge disposition. Men with TTS accounted for 8.9% of hospitalizations, were younger in age (62.0 ± 15.1 vs 66.8 ± 12.1 years, p

Pericardial decompression syndrome, a rare but potentially fatal complication following pericardiocentesis, is defined as paradoxical hemodynamic deterioration. The exact pathophysiology is unknown, but it is likely that several mechanisms involving hemodynamic, ischemic, and autonomic imbalance play a role. There is no specific treatment; however, early supportive interventions should be implemented. (Level of Difficulty: Intermediate.), Graphical abstract

The COVID-19 pandemic has had far-reaching consequences beyond the disease itself, including economic, social, political, religious, and psychological implications. This novel coronavirus has been shown to have cardiovascular manifestations in the form of arrhythmias, conduction disturbances, myocarditis, stress cardiomyopathy, myocardial injury and myocardial ischemia or infarction from increased microvascular and/or macrovascular coagulopathy. However, in addition to these direct effects, we are now starting to recognize indirect cardiovascular effects of COVID-19 in the form of increased incidence of Takutsobo cardiomyopathy in patients without any evidence of coronavirus infection presumably due to the increased psychological stress of social isolation and societal turbulence. In this case series, we present two post-menopausal women, presenting with chest pain and acute coronary syndrome, who are finally diagnosed with stress cardiomyopathy, triggered by increased emotional stress-related to the pandemic. There is data from a retrospective cohort analysis showing a fourfold increase in the incidence of acute coronary syndrome resulting from stress cardiomyopathy during the pandemic period compared to similar times periods before the pandemic. Hence, health care providers need to be cognizant of the emotional ramifications of the ongoing pandemic in the form of increased risk of Takotsubo cardiomyopathy. Moreover, urgent measures need to be taken to help the at-risk population cope with the ongoing stressors to help decrease the incidence of this cardiomyopathy.

Background. Current temporary transvenous pacemaker catheters lack sequential atrioventricular (AV) pacing in synchrony. Therefore, a catheter that could provide sequential AV pacing and maintain synchrony may be useful for patients in sinus rhythm who need temporary pacing. Objective. The purpose of this study was to describe the first in human experience with a novel temporary AV sequential pacing catheter (TAVSP). Methods. We prospectively identified eligible patients undergoing elective cardiac catheterization in whom the TAVSP catheter was delivered and used for temporary AV sequential pacing. Safety endpoints and device performance data were obtained. Results. Ten subjects were screened and enrolled in the study. TAVSP was delivered in all ten subjects, and AV sequential synchronous pacing was successfully obtained. The pacing catheter achieved an excellent pacing threshold and impedance in all ten patients except for one. There were no adverse events during the pacing procedure. Conclusion. Temporary AV sequential pacing using TAVSP catheter is safe and feasible and may be an alternative to conventional temporary pacing catheters to maintain AV synchrony during temporary pacing.

Objectives The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis. Background Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated. Methods The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients. Results The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: −3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (−1.4% difference; Bayesian credible interval: −5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences. Conclusions The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.

Microinvasive, catheter-based mitral valve repair of severe mitral regurgitation utilizes less invasive approaches with less procedural morbidity and mortality. The procedural steps and clinical benefits of the transcatheter transapical mitral valve annuloplasty (AMEND mitral repair implant) and transcatheter transapical chordal repair systems (Neochord DS 1000 device and Harpoon Mitral Valve Repair System) are reviewed in this manuscript.

The Edwards Intuity Elite valve system was designed to facilitate minimally invasive surgery and streamline complex aortic valve replacements and has since gained more popularity. Despite the superior results shown with rapid deployment aortic valve replacement (RDAVR) utilizing this valve system, paravalvular leaks (PVL), as a complication, remains a concern. Currently, there is no universally agreed single treatment option. A 53-year-old male with a history of well-controlled diabetes mellitus and hypertension presented to the emergency room with a 1-month history of angina, syncope on exertion and dyspnea. On further workup, he was found to have severe aortic stenosis in the setting of a bicuspid aortic valve, with non-obstructive coronary artery disease. He proceeded to urgent RDAVR with a 23 mm Edwards Intuity Valve. Six months post-RDAVR he re-presented with dyspnea on exertion and near syncopal episodes. Postoperative transthoracic and transesophageal echocardiography revealed moderate to severe PVL posterior to the prosthetic aortic valve. Balloon valvuloplasty with a 25 mm True Balloon was performed. Resolution of the PVL was confirmed postprocedure both by angiography and echocardiography. The patient was followed for 1 year and remained symptom-free with evidence of mild PVL on surveillance echocardiography. In conclusion, multiple treatment options for RDAVR complicated by PVL exist; however mid to long-term outcome data are lacking. We presented one such case successfully treated with balloon aortic valvuloplasty.

Early discharge strategies are associated with lower cost and resource utilization during hospitalization, as such we sought to evaluate trends, predictors and outcomes of the next day discharge (NDD) approach after transcatheter mitral valve repair (TMVR) procedures with the MitraClip device. The National Inpatient Sample (NIS) was queried between 2013 and 2018 for patients undergoing TMVR using the International Classification of Diseases (ICD) 9 procedure code '3597' and ICD-10 procedure code '02UG3JZ'. Patients undergoing TMVR were stratified into two groups, determined by hospital length of stay (LOS) [≤1 day, NDD versus1-day, non-NDD]. Overall, 22,035 patients underwent TMVR with 35.7% (n = 7,870) belonging to the NDD group (mean age 78.1 ± 9.7 years, women 45%). From 2013 to 2018, the proportion of patients being discharged using the NDD approach trended upward from 18.3% to 46.0%. Amongst demographic and social factors, female sex, black race, and low median household income were predictive of non-NDD (p0.05 for all). Amongst clinical factors, anemia, iron deficiency anemia, major depressive disorder, thrombocytopenia, obesity and end stage renal disease were some predictors of non-NDD (p0.05 for all). In the non-NDD group there was a downward trend of pooled post-procedure complications, post procedure cardiogenic shock, vascular complications, acute kidney injury, mechanical circulatory support use, acute respiratory distress and postoperative ischemic stroke and (p for trend0.001 for all). Despite the overall downward trend, complications began increasing in 2017-18. In conclusion, these trends may reflect improving operator experience, advancement in vascular access device closures and techniques, and prioritization of decreasing length of stay. Ideally, the feasibility and safety of this approach should be confirmed in larger-sized multicenter, randomized trials.

Select patients with atrial fibrillation and contraindication to anticoagulation may benefit from percutaneous left atrial appendage closure (pLAAC).The purpose of this study was to evaluate racial disparities in the nationwide utilization and outcomes of pLAAC.We identified 16,830 hospitalizations for pLAAC between 2015 and 2017 using the National Inpatient Sample. Baseline characteristics, in-hospital mortality, complications, length of stay, and discharge disposition were assessed between White and Black/African American (AA) populations.Black/AA patients represented 4.1% of nationwide pLAAC recipients and were younger, more likely to be female, and had greater prevalence of hypertension, heart failure, hyperlipidemia, obesity, chronic kidney disease, and prior stroke history (P .001 for all). Black/AA patients had significantly increased length of stay and nonroutine discharge (P.001 for both) but comparable in-hospital mortality to White patients. Black/AA patients suffered from greater postoperative stroke (0.7% vs 0.2%), acute kidney injury (4.5% vs 2.1%), bleeding requiring transfusion (4.5% vs 1.4%), and venous thromboembolism (0.7% vs 0.1%; P .01 for all). After controlling for possible confounding factors, Black/AA race was independently associated with significantly increased odds of bleeding requiring blood transfusion, stroke, venous thromboembolism, and nonroutine discharge.Among pLAAC recipients nationwide, Black/AA populations were underrepresented and had greater complication rates, length of stay, and discharge complexity. This study highlights the importance of addressing ongoing racial disparities in both utilization and outcomes of pLAAC.

Introduction: Takotsubo Syndrome (TTS), also known as Stress Induced Cardiomyopathy, is characterized by reversible left ventricular dysfunction without obstructive coronary disease, and largely affects post-menopausal women. However, limited data suggest increased mortality risk in men. We sought to compare national in-hospital outcomes between men and women admitted with TTS. Methods: All patients above 18 years who were admitted with primary diagnosis of TTS between 2012-2017 were identified by International Classification of Diseases (ICD)-9 and ICD-10 diagnostic codes in the National Inpatient Sample (NIS) Database. The primary endpoint was in-hospital all-cause mortality. Secondary endpoints included in-hospital complications, total cost, and duration of hospitalization. Results: A total of 8732 patients (90.8% female) were admitted with primary diagnosis of TTS. Women with TTS were older compared to men (66.9±12.4 vs. 63.1±15.7 years, p Conclusion: TTS occurs predominantly in women but carries increased risk of in-hospital mortality in men, especially when complicated by cardiogenic shock. Perhaps improved risk stratification and early identification of patients with signs of shock or hemodynamic instability may help to improve outcomes.

Background: Inherent characteristics of patients with Obstructive Sleep Apnea (OSA), such as age, obesity, diabetes and hypertension increase the risk for cardiovascular diseases including heart failure (HF). Herein, we sought to elucidate if there is an increased likelihood of having heart failure with preserved ejection fraction (HFpEF) as OSA severity increases. Furthermore, we correlated a validated H2FpEF score system in this cohort with clinical and imaging findings for HFpEF. Results: Out of 585 charts reviewed from patients diagnosed with OSA, a total of 108 patients with a concomitant transthoracic echocardiogram (TTE) and electrocardiogram performed were identified. The median age was 59 years old with 55.6% being males and Hispanic predominance 64.5%. The comorbidities found in our cohort involved hypertension (63.9%), diabetes mellitus (30.6%), coronary artery disease (15.7%), HF (13%), atrial fibrillation (8.3%), and stroke (7.4%). Mean BMI was 32.48 kg/m 2 and average neck size 16.02 inches. TTE findings demonstrated an average ejection fraction of 58±7% and mean pulmonary artery systolic pressure of 24±10 mmHg. OSA severity distribution is shown in Table 1. No significant association was found between grade of severity of OSA with clinical diagnosis of HF, nor with diastolic dysfunction by TTE. The average probability of HFpEF by validated score was 50%, and the distribution of the score was the same across severity of OSA (p=0.260). Pearson’s correlation showed a significant positive relationship between age, BMI and PASP, and H2FpEF score (p Conclusion: Although patients with OSA might have a higher H2FpEF score due to inherent characteristics, the clinical diagnosis of HFpEF in our population was lower than expected by H2FpEF score, in which the degree of severity was not associated with a higher H2FpEF score.

The COVID-19 pandemic has had far-reaching consequences beyond the disease itself, including economic, social, political, religious and psychological implications. This novel coronavirus has been shown to have cardiovascular manifestations in the form of arrhythmias, conduction disturbances, myocarditis, stress cardiomyopathy, myocardial injury and myocardial ischemia or infarction from increased microvascular and/or macrovascular coagulopathy. However, in addition to these direct effects, we are now starting to recognize indirect cardiovascular effects of COVID-19 in the form of increased incidence of Takutsobo cardiomyopathy in patients without any evidence of coronavirus infection. In this case series, we present two post-menopausal women, presenting with chest pain and acute coronary syndrome, who are finally diagnosed with stress cardiomyopathy, triggered by increased emotional stress related to the pandemic. There is data from a retrospective cohort analysis showing a four-fold increase in the incidence of acute coronary syndrome resulting from stress cardiomyopathy during the pandemic period compared to similar times periods before the pandemic. Hence, health care providers need to cognizant of the emotional ramifications of the ongoing pandemic in the form of increased risk of Takotsubo cardiomyopathy. Moreover, urgent measures need to be taken to help at-risk population cope with the ongoing stressors to help decrease the incidence of this cardiomyopathy.

Background Right ventricular systolic dysfunction ( RVSD ) is a known risk factor for adverse outcome in surgical aortic valve replacement. Transcatheter aortic valve replacement ( TAVR ), on the other hand, has been shown to be either beneficial or have no effect on right ventricular systolic function. However, the prognostic significance of RVSD on TAVR has not been clearly determined. We conducted a systematic review and meta‐analysis to define the impact of RVSD on outcomes in terms of 1‐year mortality in patients with severe aortic stenosis undergoing TAVR . Methods and Results An extensive literature review was performed, with an aim to identify clinical studies that focused on the prognosis and short‐term mortality of patients with severe symptomatic aortic stenosis who underwent TAVR . A total of 3166 patients from 8 selected studies were included. RVSD , as assessed with tricuspid annular plane systolic excursion, fractional area change or ejection fraction, was found to be a predictor of adverse procedural outcome after TAVR (hazard ratio, 1.31; 95% CI, 1.1–1.55; P =0.002). Overall, we found that RVSD did affect post‐ TAVR prognosis in 1‐year mortality rate. Conclusions Patients with severe, symptomatic aortic stenosis and concomitant severe RVSD have a poor 1‐year post‐ TAVR prognosis when compared with patients without RVSD . Right ventricular dilation and severe tricuspid regurgitation were associated with increased 1‐year morality post‐ TAVR and should be considered as independent risk factors. Further evaluations of long‐term morbidity, mortality, as well as sustained improvement in functional class and symptoms need to be conducted to determine the long‐term effects.

Background Despite improvements in acute care and survival after non-ST-elevation acute coronary syndrome (NSTE-ACS) hospitalization, early readmissions remain common, and have significant clinical and financial impact. Objectives Determine the predictors and etiologies of 30-day readmissions in NSTE-ACS. Method The study cohort was derived from the National Readmission Database 2014 identifying patients with a primary diagnosis of NSTE-ACS using ICD9 code. Results We identified a total of 300,269 patients admitted with NSTE-ACS; 13.4% were readmitted within 30-day. The most common cause of readmission was heart failure (HF) (15.6%), followed by a recurrent myocardial infarction (MI) (10%). Predictors of increased readmissions were age ≥ 75 years (OR: 1.34, 95% CI: 1.30-1.39), female gender (OR 1.12, 95% CI 1.09-1.16), a Charlson Comorbidity Index (CCI) >3 (OR 2.11, 95% CI: 2.04-2.18), ESRD (OR 2.01, 95% CI 1.89-2.14), CKD (OR: 1.58, 95% CI: 1.51-1.64), length of stay ≥5 days (OR: 1.51, 95% CI 1.46-1.56) and adverse events during the index admission such as AKI (OR:1.31, 95% CI: 1.25-1.36), major bleeding (OR:1.20, 95% CI: 1.12-1.24); whereas admission to a teaching hospital (OR 0.92, 95% CI 0.89-0.95) and PCI (OR 0.70, 95% CI 0.67-0.72) were associated with less likelihood of 30-day readmission. Conclusion Readmission rate at 30-days is high among NSTE-ACS patients and the most common readmission etiologies are HF and recurrent MI. A CCI more than 3 and ESRD were the most significant predictors for readmission; patients undergoing PCI had less odds of readmission.

Transcatheter aortic valve replacement (TAVR) with percutaneous coronary intervention (PCI) has emerged as a less-invasive therapeutic option for high surgical risk patients with aortic stenosis and coronary artery disease. The aim of this study was to determine the outcomes of TAVR when performed with PCI during the same hospitalization. We identified patients using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes from the Nationwide Inpatient Sample between the years 2011 and 2013. A total of 22,344 TAVRs were performed between 2011 and 2013. Of these, 21,736 (97.3%) were performed without PCI (TAVR group) while 608 (2.7%) along with PCI (TAVR + PCI group). Among the TAVR + PCI group, 69.7% of the patients had single-vessel, 22.2% had 2-vessel, and 1.6% had 3-vessel PCI. Drug-eluting stents were more commonly used than bare-metal stents (72% vs 28%). TAVR + PCI group witnessed significantly higher rates of mortality (10.7% vs 4.6%) and complications: vascular injury requiring surgery (8.2% vs 4.2%), cardiac (25.4% vs 18.6%), respiratory (24.6% vs 16.1%), and infectious (10.7% vs 3.3%), p0.001% for all, compared with the TAVR group. The mean length of hospital stay and cost of hospitalization were also significantly higher in the TAVR + PCI group. The propensity score-matched analysis yielded similar results. In conclusion, performing PCI along with TAVR during the same hospital admission is associated with higher mortality, complications, and cost compared with TAVR alone. Patients would perhaps be better served by staged PCI before TAVR.

Background: Valve-in-valve transcatheter aortic valve replacement (TAVR) is an option when a surgical valve demonstrates deterioration and dysfunction. This study reports 3-year results following valve-in-valve with self-expanding TAVR. Methods: The CoreValve US Expanded Use Study is a prospective, nonrandomized, single-arm study that evaluates safety and effectiveness of TAVR in extreme risk patients with symptomatic failed surgical biologic aortic valves. Study end points include all-cause mortality, need for valve reintervention, hemodynamic changes over time, and quality of life through 3 years. Patients were stratified by presence of preexisting surgical valve prosthesis-patient mismatch. Results: From March 2013 to May 2015, 226 patients deemed extreme risk (STS-PROM [Society of Thoracic Surgeons Predicted Risk of Mortality] 9.0±7%) had attempted valve-in-valve TAVR. Preexisting surgical valve prosthesis-patient mismatch was present in 47.2% of the cohort. At 3 years, all-cause mortality or major stroke was 28.6%, and 93% of patients were in New York Heart Association I or II heart failure. Valve performance was maintained over 3 years with low valve reintervention rates (4.4%), an improvement in effective orifice area over time and a 2.7% rate of severe structural valve deterioration. Preexisting severe prosthesis-patient mismatch was not associated with 3-year mortality but was associated with significantly less improvement in quality of life at 3-year follow-up ( P =0.01). Conclusions: Self-expanding TAVR in patients with failed surgical bioprostheses at extreme risk for surgery was associated with durable hemodynamics and excellent clinical outcomes. Preexisting surgical valve prosthesis-patient mismatch was not associated with mortality but did limit patient improvement in quality of life over 3-year follow-up. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01675440.

Background and aim of study The treatment of inoperable patients with concomitant complex coronary artery disease and severe aortic stenosis unsuitable for conventional transcatheter aortic valve replacement (TAVR) poses a significant challenge. Effective treatment is even more difficult in those patients with complex coronary anatomy unamenable to percutaneous revascularization. Our manuscript aims to enlighten clinicians on the management of this complex patient. Methods We conducted a contemporary review of the literature of combined off-pump coronary artery bypass grafting and transaortic TAVR in this patient population and describe our own successful experience in an inoperable patient with a porcelain aorta. Results Including our report, 17 cases have been described in the literature. All patients had multiple comorbidities with elevated STS (range, 2.6-25; 6%) and EuroScore I (range, 13.7-83; 7%) and were not considered candidates for conventional CABG and SAVR. Most had severe, complex, multivessel CAD deemed unsuitable for PCI and structural findings precluding them from other standard percutaneous or alternative TAVR approaches (transfemoral/subclavian/transcaval/transapical). Out of the 17 cases, 5 (29%) had porcelain aortas. Most reports specify the decision-making process is driven by a multidisciplinary team. Conclusion This report demonstrates that hybrid off-pump CABG surgery and transaortic TAVR can be successfully performed in high-risk patients with porcelain aortas who are not candidates for percutaneous methods, on-pump revascularization, transfemoral, subclavian, or transcaval valve implantations. It also highlights that careful study of the CTA scan could predict adequate access for a transaortic approach even in the presence of porcelain aorta in selected patients.

This systematic review and meta‐analysis sought to summarize the available evidence on the use of transcatheter aortic valve replacement (TAVR) in patients with Native Aortic Valve Regurgitation (NAVR) and compare outcomes between first and second generation valves. Owing to the improvements in transcatheter heart valve design and procedural success, TAVR has become increasingly performed in broader aortic valve pathologies. We searched Medline, Embase, Cochrane, and Scopus databases from 2007 to 2018 and performed a systematic review on reports with at least 10 patients with aortic valve regurgitation undergoing TAVR procedure. The main outcome of interest was all‐cause mortality at 30 days. A total of 638 patients across 12 studies were included. Mean age ranged from 68 to 84. Society of Thoracic Surgeons score ranged from 5.4% to 13.1% and Logistic EuroSCORE ranged from 18.2% to 33%. The incidence rate of all‐cause mortality at 30 days was found to be 11% (95% CI 7%‐16%; I (2) = 20.86%). All‐cause mortality at 30 days for first generation valves had an incidence rate of 15% (95% CI 10%‐20%; I (2) = 10%) compared to 7% (95% CI 3%‐13%; I (2) = 37%) in second generation valves with subgroup interaction analysis P = 0.059. Device success incidence rate in second generation valves was 92% (95% CI 83%‐99%; I (2) = 67%) vs 68% (95% CI 59%‐77%; I (2) = 53%) in first generation valves with P = 0.001. TAVR appears to be a feasible treatment choice for NAVR patients at high risk for surgical valve replacement. Second generation valves show promising results in terms of short‐term outcomes.

Objective Evaluate the use of mechanical circulatory support (MCS) devices in high-risk patients undergoing transcatheter aortic valve replacement (TAVR). Background The use of MCS devices in elderly patients with multiple comorbidities undergoing TAVR is underexplored. Methods All patients undergoing TAVR at a single tertiary academic center who required MCS during index procedure between 2008 and 2015 were included in a prospective database. Results MCS was used in 9.4% (54/577) of all TAVRs (n = 52 Edwards Sapien and n = 2 CoreValves) of which 68.5% (n = 37) were used as part of a planned strategy, and 31.5% (n = 17) were used in emergency "bail-out" situations. IABP was the most commonly used device (87%) followed by Impella and ECMO (6% each). Among the MCS group, 22% required cardiopulmonary resuscitation during the procedure (n = 4 elective [11%] vs. n = 8 emergent [47%]) and 15% upgrade to a second device (Impella or CPB after IABP; n = 5 elective [14%] vs. n = 3 emergent [18%]). Median duration of support was 1-day. Device related complications were low (4%). In-hospital mortality in this extremely high-risk population was 24% (13/54) (11% [4/37] for elective cases and 53% [9/17] for emergency cases). Cardiogenic shock (50%) was the most common cause of in-hospital death. Cumulative all-cause 1-year mortality was 35% (19/54) (19% 97/370 for elective and 71% [12/17] for emergency cases). Conclusion Emergent use of MCS during TAVR in extremely high-risk population is associated with high short and long-term mortality rates. Early identification of patients at risk for hemodynamic compromise may rationalize elective utilization of MCS during TAVR.

Background The Trial of Routine Aspiration Thrombectomy with PCI versus PCI alone in patients with STEMI (TOTAL trial) refuted the salutary effect of routine aspiration thrombectomy (AT) in PPCI for patients with ST-elevation myocardial infarction (STEMI). Objectives We performed an updated meta-analysis to assess clinical outcomes with AT prior to PPCI compared with conventional PPCI alone including the additional trial data. Methods and Results Clinical trials (n = 20) that randomized patients (n = 21,281) with STEMI between Routine AT (n = 10,619) and PPCI (n = 10,662) were pooled. There was no difference in all-cause mortality between the 2 groups (RR: 0.89, 95%CI: 0.78–1.01, P = 0.08). Stratifying by follow up at 1-month (RR: 0.87, 95%CI: 0.69–1.10, P = 0.25), up to 6 months (RR: 0.91, 95%CI: 0.74–1.13, P = 0.39 and beyond 6 months (RR: 0.88, 95%CI: 0.74–1.05, P = 0.16) yielded similar results. There was a statistically significant increase risk of stoke rate in the AT arm (RR: 1.51, 95%CI: 1.01–2.25, P = 0.04). The 2 groups were similar with regards to target vessel revascularization (0.94, 95%CI: 0.83–1.06, P = 0.28) recurrent MI (RR: 0.96, 95%CI: 0.80–1.16, P = 0.68, MACE events (RR: 0.91 95%CI: 0.81–1.02, P = 0.11), early (0.59, 95%CI: 0.23–1.50, P = 0.27) and late (RR: 0.91, 95%CI: 0.69–1.18, P = 0.47) stent thrombosis and net clinical benefit (RR 0.99, 95%CI: 0.91–1.07, P = 0.76). Conclusion Routine AT prior to PPCI in STEMI is associated with higher risk of stroke. There is no statistical difference in clinical outcome parameters of mortality, major adverse cardiac events, target vessel revascularization, stent thrombosis, and net clinical benefit between AT and PCI alone. (J Interven Cardiol 2015;28:503–513)

There is lack of evidence for the treatment of statin intolerant patients with dyslipidemia. We aimed to study the safety and efficacy of bempedoic acid (BPA) in this population. Pubmed, Embase, Scopus and Cochrane library were searched for randomized controlled trials in adults with dyslipidemia

Spontaneous coronary artery dissection (SCAD) was once thought to be rare but is now recognized as an important cause of acute coronary syndrome, particularly in young women. Most cases only involve a single coronary vessel and are classically associated with pregnancy or fibromuscular dysplasia (

During the last decade, there has been a rise in recreational drug abuse, with cocaine been one of the most commonly used drugs. Prevalence, characteristics, and outcomes of patients with cocaine-induced myocardial infarction (CIMI) are limited. We compare the characteristics and outcomes of cocaine

Background Prior studies have demonstrated endothelial and smooth muscle brachial artery dysfunction after transradial cardiac catheterization for diagnostic coronary angiography. The duration of this vascular dysfunction is unknown. Objective To determine the time-course of endothelial and smooth muscle cell dysfunction in the upstream brachial artery after transradial cardiac catheterization. Methods We studied 22 consecutive patients with suspected coronary artery disease (age 64.4 ± 7.7 years) undergoing diagnostic transradial cardiac catheterization. Using high-resolution vascular ultrasound, we measured ipsilateral brachial artery diameter changes during reactive hyperemia (endothelium-dependent dilatation) and administration of sublingual nitroglycerin (endothelium-independent dilatation). The measurements were taken at baseline (before cardiac catheterization), 6 h, 24 h, 1 week, and 1 month postprocedure. The contralateral brachial artery served as a control. Results Ipsilateral brachial artery diameter during endothelium-dependent dilatation decreased significantly compared with the contralateral diameters at 6 h and 24 h after transradial cardiac catheterization (3.22 vs. 4.11 and 3.29 vs. 4.11, respectively, P < 0.001). The administration of nitroglycerin did not affect this difference. At 1 week and 1 month postprocedure there was no significant difference in diameter of the ipsilateral versus the contralateral brachial artery. As expected the contralateral brachial artery showed no significant changes in diameter. Conclusion Our results showed that transradial cardiac catheterization causes transient vascular endothelial and smooth muscle dysfunction of the ipsilateral brachial artery, which resolves within 1 week postprocedure. These findings strongly suggest the absence of systemic vascular dysfunction after transradial catheterization both immediately postprocedure as well as 1 week postprocedure. © 2015 Wiley Periodicals, Inc.

Introduction Both transfemoral (TF) and transapical (TA) routes are utilized for Transcatheter Aortic Valve Replacement (TAVR) using Edwards SAPIEN & SAPIEN XT valves. We intended to perform a meta-analysis comparing the complication rates between these two approaches in studies published before and after the standardized Valve Academic Research Consortium (VARC) definitions. Methods We performed a comprehensive electronic database search for studies published until January 2014 comparing TF and TA approaches using the Edwards SAPIEN/SAPIEN XT aortic valve. Studies were analyzed based on the following endpoints: 1-year mortality, 30-day mortality, stroke, new pacemaker implantation, bleeding, and acute kidney injury. Results Seventeen studies were included in the meta-analysis. Patients undergoing TA TAVR had a significantly higher logistic EuroSCORE (24.6 ± 12.9 vs. 21.3 ± 12.0; P

Objectives This paper reviews the published data and reports 3 cases of thrombosis involving CoreValve (Medtronic, Minneapolis, Minnesota) and 1 involving Edward Sapien (Edwards Lifesciences, Irvine, California) devices. Three of these cases had pathological findings at autopsy. Background Only a limited number of cases of valve dysfunction with rapid increase of transvalvular aortic gradients or aortic insufficiency post-transcatheter aortic valve replacement (TAVR) have been described. This nonstructural valvular dysfunction has been presumed to be because of early pannus formation or thrombosis. Methods Through reviews of the published reports and 4 clinical cases, pathological and clinical findings of early valve thrombosis are examined to elucidate methods for recognition and identifying potential causes and treatments. Results This paper presents 4 cases, 2 of which had increasing gradients post-TAVR. All 3 pathology cases showed presence of a valve thrombosis in at least 2 TAV leaflets on autopsy, but were not visualized by transthoracic echocardiogram or transesophageal echocardiogram. One case was medically treated with oral anti coagulation with normalization of gradients. The consequence of valve thrombosis in all 3 pathology patients either directly or indirectly played a role in their early demise. At least 18 case reports of early valve thrombosis have been published. In 12 of these cases, the early treatment with anticoagulation therapy resolved the thrombus formation and normalized aortic pressures gradients successfully. Conclusions These 4 cases elucidate the occurrence of valve thrombosis post-TAVR. Consideration should be given to treatment with dual antiplatelet therapy and oral anticoagulation in patients post-TAVR with increasing mean pressure gradients and maximum aortic valve velocity. Further research should be conducted to create guidelines for antithrombotic therapy following TAVR procedure.

Cardiovascular disease is the leading cause of death among dialysis patients on the kidney transplant list. Moreover, cardiovascular events tend to cluster within the first three months of transplant, and most patients who die with a functioning organ in the first year after transplant died from a cardiovascular cause. Although revascularization tends to benefit patients at the highest risk of events, the end-stage kidney disease (ESKD) population has not been appropriately represented in revascularization clinical trials. A combination of clinical factors, exercise tolerance, noninvasive functional testing, as well as invasive angiography in association with physiological testing can contribute to an appropriate decision of whom to revascularize. Published data from clinical trials focusing on the best strategies for revascularization in this population are scarce at the current time; however, it seems that surgical revascularization has an advantage over percutaneous interventions for dialysis patients with multivessel coronary artery disease (MVCAD), diabetes and patients with complex anatomy. The focus of this chapter is to review the diagnostic tools that facilitate the decision to revascularize patients on the kidney transplant waiting list, and the data supporting both surgical and percutaneous revascularization.

Background— The relationship between operator or institutional volume and outcomes among patients undergoing percutaneous coronary interventions (PCI) is unclear. Methods and Results— Cross-sectional study based on the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample between 2005 to 2009. Subjects were identified by International Classification of Diseases, 9 th Revision, Clinical Modification procedure code, 36.06 and 36.07. Annual operator and institutional volumes were calculated using unique identification numbers and then divided into quartiles. Three-level hierarchical multivariate mixed models were created. The primary outcome was in-hospital mortality; secondary outcome was a composite of in-hospital mortality and peri-procedural complications. A total of 457 498 PCIs were identified representing a total of 2 243 209 PCIs performed in the United States during the study period. In-hospital, all-cause mortality was 1.08%, and the overall complication rate was 7.10%. The primary and secondary outcomes of procedures performed by operators in 4 th [annual procedural volume; primary and secondary outcomes] [>100; 0.59% and 5.51%], 3 rd [45–100; 0.87% and 6.40%], and 2 nd quartile [16–44; 1.15% and 7.75%] were significantly less ( P st quartile [≤15; 1.68% and 10.91%]. Spline analysis also showed significant operator and institutional volume outcome relationship. Similarly operators in the higher quartiles witnessed a significant reduction in length of hospital stay and cost of hospitalization ( P Conclusions— Overall in-hospital mortality after PCI was low. An increase in operator and institutional volume of PCI was found to be associated with a decrease in adverse outcomes, length of hospital stay, and cost of hospitalization.

a Department of Internal Medicine/Cardiology, University of Miami/Jackson Memorial Hospital, Miami, FL, United States b Department of Cardiology, Ochsner Medical Center, New Orleans, LA, United States c Department of Cardiology, Baylor College of Medicine, Houston, TX, United States d Department of Cardiology, Columbia College of Physicians and Surgeons, St. Luke's Hospital, New York, NY, United States

The comparative benefits and harms of TAVR and SAVR for intermediate surgical risk patients with aortic stenosis haven't shown any significant statistical and clinical difference at 30 days and at 1 year. However, the comparison has not been properly characterized at 2 years. This meta-analysis aims

Objectives This retrospective study sought to assess the safety and clinical efficacy of cryoplasty for treatment of side-branch stenoses following main vessel stenting in coronary bifurcation lesions. Background Cryoplasty prevents restenosis by reducing smooth muscle proliferation and extracellular matrix synthesis. Clinical effectiveness has been demonstrated in the peripheral circulation. Treatment of coronary bifurcation lesions remains a challenge. We used a novel strategy of main vessel stenting combined with side-branch cryoplasty to treat high-grade stenoses following main vessel stenting. Methods Eighteen patients with bifurcation lesions had significant plaque shift into a side branch after main vessel intervention. Drug-eluting stents were placed in the main vessel and cryoplasty was performed on the side-branch vessel. Quantitative coronary analysis was performed on all side-branch vessels both pre– and post–main vessel stenting. All patients had clinical follow-up 3 months or more after cryoplasty including either nuclear stress testing or diagnostic coronary angiogram. Results Mean percent stenosis decreased from 80.6% post main vessel stenting to 24.8% following cryoplasty (P