Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Non-ST-Elevation Coronary Syndromes and Multivessel Disease: A Systematic Review and Meta-Analysis.

There is lack of evidence regarding the optimal revascularization strategy in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and multivessel disease (MVD). This systematic review and meta-analysis compares the clinical impact of percutaneous coronary intervention (PCI) with that of coronary artery bypass graft surgery (CABG) in this subset of patients. EMBASE, MEDLINE, and Web of Knowledge were searched for studies including patients with NSTE-ACS and MVD who underwent PCI or CABG up to September 1, 2021. The primary end point of the meta-analysis was all-cause mortality at 1 year. The secondary end points were myocardial infarction (MI), stroke, or repeat revascularization at 1 year. The analysis was conducted using the Mantel-Haenszel random-effects model to calculate the odds ratio (OR) with 95% confidence interval (CI). Four prospective observational studies met the inclusion criteria, including 1,542 patients who underwent CABG and 1,630 patients who underwent PCI. No significant differences were found in terms of all-cause mortality (OR 0.91, 95% CI 0.68 to 1.21, p = 0.51), MI (OR 0.78, 95% CI 0.40 to 1.51, p = 0.46), or stroke (OR 1.54, 95% CI 0.55 to 4.35, p = 0.42) between PCI and CABG. Repeat revascularization was significantly lower in the CABG group (OR 0.21, 95% CI 0.13 to 0.34, p <0.00001). In patients presenting with NSTE-ACS and MVD, 1-year mortality, MI, and stroke were similar between patients treated with either PCI or CABG, but the repeat revascularization rate was higher after PCI.

BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs: design and rationale of the BASELINE trial.

BACKGROUND: Surgical aortic valve bioprostheses may degenerate over time and require redo intervention. Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to redo surgery. The BAlloon Expandable vs. SElf Expanding Transcatheter VaLve for Degenerated BioprosthesIs (BASELINE) trial was designed to compare the performance of the balloon-expandable SAPIEN-3 Ultra and the self-expanding EVOLUT PRO+ valve systems in symptomatic patients with a failing surgical bioprosthesis. METHODS: The BASELINE trial is an investigator-initiated, non-funded, prospective, randomized, open-label, superiority trial enrolling a total of 440 patients in up to 50 sites in 12 countries in Europe and North-America. The primary endpoint is device success at 30-days defined by the Valve Academic Research Consortium-3 Criteria as the composite of technical success, freedom from mortality, freedom for surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication with an intended performance of the valve (mean gradient <20 mmHg and less than moderate aortic regurgitation). The co-primary endpoint at 1 year is defined as the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems. Independent Core Laboratories will conduct uniform analyses of echocardiography (pre-, post-, 1-year post-procedure), multi-sliced computed tomography (pre-, and if available post-procedure) and cine-fluoroscopy studies. CONCLUSIONS: The BASELINE trial is a head-to-head comparative trial investigating the 2 most used contemporary transcatheter heart valves for the treatment of a failing surgical aortic bioprosthesis. (ClinicalTrials.gov number NCT04843072).

Cardiac Catheterizations in Patients With Acute Coronary Syndrome and Prior Coronary Bypass Surgery: Impact of Native vs Graft vs Absent Culprit Lesions on Clinical Outcomes and Treatment Strategy.

BACKGROUND: In patients with prior coronary artery bypass graft surgery (CABG), acute coronary syndrome (ACS) is not uncommon. This study investigated treatment strategy and compared clinical outcomes for native, graft and absent culprit lesions. METHODS: Single-center retrospective cohort study. From July 2010 to July 2019, 642 consecutive ACS patients with prior CABG were screened for eligibility. The primary endpoint was major adverse cardiovascular events (MACE) at 1 year, a composite of all-cause mortality, myocardial infarction, stroke and ischemia-driven revascularization. RESULTS: A total of 549 patients were included, with 215 (39.2 %) having native culprits, 256 (46.6 %) graft culprits and 78 (14.2 %) no clear culprits. Patients with native culprits were treated with native PCI in 94.0 %, re-CABG in 0.9 % and optimal medical therapy (OMT) in 5.1 %. Patients with graft culprits were treated with native PCI in 14.1 %, graft PCI in 81.2 %, re-CABG in 0.8 % and OMT in 3.9 %. All patients without a clear culprit received OMT. The cumulative incidence of 1-year MACE was 24.7 % for native vs 26.2 % for graft vs 21.8 % for absent culprits. Kaplan-Meier curves did not differ significantly. In patients with graft culprit, no significant difference in 1-year MACE was observed between native PCI and graft PCI (30.6 % vs 25.5 %, p = 0.36). CONCLUSIONS: This retrospective study shows that in ACS patients with prior CABG, MACE occurred frequently and was comparable for native, graft and absent culprits. Native PCI as treatment strategy for patients with a graft culprit was relatively common, with no significant difference in MACE as compared to graft PCI.

Pre-hospital treatment with crushed versus integral tablets of prasugrel in patients presenting with ST-Segment Elevation Myocardial Infarction-1-year follow-up results of the COMPARE CRUSH trial.

The present research letter reports the 1-year clinical outcomes of the randomized COMPARE CRUSH trial, which allocated STEMI patients at first medical contact in the ambulance to receive either crushed or integral tablets of prasugrel loading dose. This trial aimed to investigate whether early enhanced antiplatelet effect constituted by the crushed potent oral P2Y12 inhibitor prasugrel could lead to improved early myocardial reperfusion and clinical outcomes.

Frequency, Impact, and Predictors of Access Complications With Plug-Based Large-Bore Arteriotomy Closure - A Patient-Level Meta-Analysis.

BACKGROUND/PURPOSE: The MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications. METHODS/MATERIALS: This patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry. The primary endpoint was the composite of major and minor access complications. Technical success was defined as hemostasis with MANTA closure device without need for vascular surgery or stenting. RESULTS: Eight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n = 814), endovascular aortic repair (n = 71), balloon aortic valvuloplasty (n = 4) or mechanical circulatory support (n = 2). Technical success was 96.4% and median time to hemostasis was 31 (interquartile range: 17-76) seconds. The primary endpoint occurred 9.1% and bailout vascular surgery or stenting was necessary in 32 patients (3.6%). Female gender (OR: 2.63, CI: 1.46-4.73, p = 0.001), left femoral access (OR: 2.18, CI: 1.17-4.06, p = 0.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26-4.10, p = 0.006) independently predicted access complications. Access complications most often consisted of vessel dissection, stenosis or occlusion and predominantly occurred in patients with an unfavorable arteriotomy phenotype. CONCLUSIONS: Large-bore arteriotomy closure with MANTA VCD provided fast and safe hemostasis with an acceptable complication rate. Refined procedure planning and risk-stratification may further improve MANTA VCD performance.

Pharmacodynamic Effects of Pre-Hospital Administered Crushed Prasugrel in Patients With ST-Segment Elevation Myocardial Infarction.

OBJECTIVES: This study sought to compare the pharmacodynamic effects of pre-hospitally administered P2Y12 inhibitor prasugrel in crushed versus integral tablet formulation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI). BACKGROUND: Early dual antiplatelet therapy is recommended in STEMI patients. Yet, onset of oral P2Y12 inhibitor effect is delayed and varies according to formulation administered. METHODS: The COMPARE CRUSH (Comparison of Pre-hospital Crushed Versus Uncrushed Prasugrel Tablets in Patients With STEMI Undergoing Primary Percutaneous Coronary Interventions) trial randomized patients with suspected STEMI to crushed or integral prasugrel 60-mg loading dose in the ambulance. Pharmacodynamic measurements were performed at 4 time points: before antiplatelet treatment, at the beginning and end of pPCI, and 4 h after study treatment onset. The primary endpoint was high platelet reactivity at the end of pPCI. The secondary endpoint was impact of platelet reactivity status on markers of coronary reperfusion. RESULTS: A total of 441 patients were included. In patients with crushed prasugrel, the occurrence of high platelet reactivity at the end of pPCI was reduced by almost one-half (crushed 34.7% vs. uncrushed 61.6%; odds ratio [OR] = 0.33; 95% confidence interval [CI] = 0.22 to 0.50; p < 0.01). Platelet reactivity <150 P2Y12 reactivity units at the beginning of coronary angiography correlated with improved Thrombolysis In Myocardial Infarction flow grade 3 in the infarct artery pre-pPCI (OR: 1.78; 95% CI: 1.08 to 2.94; p = 0.02) but not ST-segment resolution (OR: 0.80; 95% CI: 0.48 to 1.34; p = 0.40). CONCLUSIONS: Oral administration of crushed compared with integral prasugrel significantly improves platelet inhibition during the acute phase in STEMI patients undergoing pPCI. However, a considerable number of patients still exhibit inadequate platelet inhibition at the end of pPCI, suggesting the need for alternative agents to bridge the gap in platelet inhibition.

Patient perspectives on left main stem revascularization strategies, the OPINION-2 study.

BACKGROUND: Treatment preferences in patients with left main (LM) stem disease and no prior revascularization are unknown. The objectives of this study were to determine (i) patient-reported importance ratings of particular features related to percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery, (ii) how these features determine treatment preference, and (iii) how educational and psychosocial background influence this preference. METHODS: In this prospective, multicenter study a total of 500 patients without previous revascularization who underwent diagnostic angiography for suspected coronary disease were asked to complete a case-vignette on a (hypothetical) LM stenosis qualifying for both PCI and CABG, in addition to 6 validated questionnaires to assess the influence of psychosocial factors on treatment preference. RESULTS: Overall, 90% favored PCI over CABG because of the lower bleeding and stroke risk despite a higher likelihood for repeat revascularization. By multivariable regression, the only independent determinant of treatment preference for CABG was lower educational level (14% in low vs. 8% in higher educated patients, OR: 3.22, CI: 1.16-8.95, p=0.025) while psychosocial variables were not associated. Compared to higher educated patients, those with lower educational level suffered more from depression, anxiety, loneliness, and uncertainty. CONCLUSIONS: Overall, patients who are informed about risk and benefits of each treatment modality clearly favor PCI over CABG and particularly value lower short-term morbidity while being aware of higher risk of repeat revascularization. Lower educational level was associated with a higher prevalence of psychosomatic phenotypes and a 14% preference for CABG. Educational and psychosocial background matter in the revascularization strategy decision-making process.

Effect of Prehospital Crushed Prasugrel Tablets in Patients With ST-Segment-Elevation Myocardial Infarction Planned for Primary Percutaneous Coronary Intervention: The Randomized COMPARE CRUSH Trial.

BACKGROUND: Early treatment with a potent oral platelet P2Y12 inhibitor is recommended in patients presenting with ST-segment-elevation myocardial infarction scheduled to undergo primary percutaneous coronary intervention (pPCI). The impact on coronary reperfusion of crushed P2Y12 inhibitor tablets, which lead to more prompt and potent platelet inhibition, is unknown. METHODS: We conducted a randomized controlled, multicenter trial in the Netherlands, enrolling patients with ST-segment-elevation myocardial infarction scheduled to undergo pPCI. Patients were randomly allocated to receive in the ambulance, before transfer, a 60-mg loading dose of prasugrel either as crushed or integral tablets. The independent primary end points were thrombolysis in myocardial infarction (TIMI) 3 flow in the infarct-related artery at initial coronary angiography, and complete (≥70%) ST-segment resolution 1 hour after pPCI. The safety end points were TIMI major and Bleeding Academic Research Consortium ≥3 bleedings. Secondary end points included platelet reactivity and ischemic outcomes. RESULTS: A total of 727 patients were assigned to either crushed or integral tablets of prasugrel loading dose. The median time from study treatment to wire-crossing during pPCI was 57 (47-70) minutes. The primary end point TIMI 3 flow in the infarct-related artery before pPCI occurred in 31.0% in the crushed group versus 32.7% in the integral group (odds ratio, 0.92 [95% CI, 0.65-1.30], P=0.64). Complete ST-segment resolution 1 hour after pPCI was present in 59.9% in the crushed group versus 57.3% in the integral group (odds ratio, 1.11 [95% CI, 0.78-1.58], P=0.55). Platelet reactivity at the beginning of pPCI, measured as P2Y12 reactivity unit, differed significantly between groups (crushed, 192 [132-245] versus integral, 227 [184-254], P≤0.01). TIMI major and Bleeding Academic Research Consortium ≥3 bleeding occurred in 0% in the crushed group versus 0.8% in the integral group, and in 0.3% in the crushed group versus 1.1% in the integral group, respectively. There were no differences observed between groups regarding ischemic events at 30 days. CONCLUSIONS: Prehospital administration of crushed prasugrel tablets does not improve TIMI 3 flow in the infarct-related artery before pPCI or complete ST-segment resolution 1 h after pPCI in patients presenting with ST-segment-elevation myocardial infarction scheduled for pPCI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03296540.

Cause of death after transcatheter aortic valve implantation.

OBJECTIVES: To evaluate survival and cause of death in a consecutive patient cohort undergoing Transcatheter Aortic Valve implantation (TAVI). BACKGROUND: TAVI is a valid treatment option in patients with severe Aortic Stenosis (AS) who are deemed at (very) high operative risk. Because of (non-)cardiac comorbidities life expectancy in this patient, population is reduced when compared with the general population. METHODS: Consecutive patients with symptomatic aortic stenosis undergoing TAVI between November 2005 and December 2011 were included. (1) Survival status was obtained from the Dutch Civil Registry, (2) cause of death was derived by reviewing hospital charts, and (3) contacting referring physicians and patients' general practitioners. RESULTS: Two hundred and thirty-seven consecutive patients were included with an overall all-cause mortality of 31% at a median follow up of 13 months (IQR 2-24 months). Four patients (1.6%) died < 48 hr of the TAVI procedure, and another 16 patients died up to the 30-day interval representing an all-cause 8.4% 30-day mortality. Between 30 days and 1-year another 30 patients died. Twenty-four patients died >1 year post TAVI. The predominant cause of death >48 hr post TAVI was noncardiac. One third of these deaths were due to sepsis/infection, one-fifth to cancer and stroke in 16%. CONCLUSIONS: In our series of AS patients undergoing TAVI, the cause of death >48 hr post procedure was predominantly noncardiac at every time interval. Mortality was driven by sepsis/infection, cancer, and stroke. Rigorous patient selection may improve outcome after TAVI.

Prevalence, factors associated with, and prognostic effects of preoperative anemia on short- and long-term mortality in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: There is scant information on the prevalence and factors associated with preoperative anemia in patients undergoing transcatheter aortic valve implantation (TAVI) and whether it is associated with mortality. We sought to determine the prevalence and factors associated with preoperative anemia in addition to the prognostic effects of the various levels of preoperative hemoglobin level on mortality in patients undergoing TAVI. METHODS AND RESULTS: Ten-center observational study encompassing 1696 patients with aortic stenosis who underwent TAVI was conducted. Anemia was defined by the World Health Organization criteria (hemoglobin <12.0 g/dL in women and <13.0 g/dL in men). The prevalence of preoperative anemia was 57%. Patient-related factors associated with preoperative anemia were (descending order of odds ratio [95% confidence interval]) as follows: anemia-related medication (4.90 [3.08-7.80]), history of heart failure (1.77 [1.43-2.20]), male sex (1.69 [1.32-2.16]), mitral regurgitation grade ≥III (1.61 [1.15-2.25]), history of malignancy (1.44 [1.03-2.09]), and peripheral vascular disease (1.33 [1.04-1.70]). The creatinine clearance was inversely associated with preoperative anemia (odds ratio, 0.92 [0.87-0.97]). In multivariable analyses, preoperative anemia was not associated with 30-day mortality (1.72 [0.96-3.12]; P=0.073) but showed the strongest association with 1-year mortality with a hazard ratio (95% confidence interval) of 2.78 (1.60-4.82) in patients with hemoglobin <10 g/dL. Patients with anemia received ≥1 blood transfusion 2× more often, but the indication of transfusion was unrelated to overt bleeding in 60%. Blood transfusion was associated with mortality at 30 days (odds ratio, 1.25 [95% confidence interval, 1.08-3.67]) and during follow-up (hazard ratio, 1.09 [95% confidence interval, 1.03-1.14]). CONCLUSIONS: Preoperative anemia is prevalent in >50% of patients undergoing TAVI. Various baseline factors were related to anemia, which in turn was associated with 1-year mortality. Patients with anemia received more transfusions but mostly for indications unrelated to overt bleeding, whereas transfusion was independently associated with both early and 1-year mortality. These findings indicate that optimization of baseline factors related to preoperative anemia, in addition to more strict criteria of the use of blood products, may improve outcome after TAVI.

Valve-in-valve-in-valve transcatheter aortic valve implantation to treat a degenerated surgical bioprosthesis in a subaortic position.

Transcatheter aortic valve implantation for aortic stenosis has evolved as an alternative treatment for patients who are at high or excessive surgical risk. We report the case of an 84-year-old man with a degenerated surgically implanted valve in a subaortic position (9 mm below the native annulus) who underwent "valve-in-valve" transcatheter aortic valve implantation with use of a Medtronic CoreValve system. We planned to deploy the CoreValve at a conventional depth in the left ventricular outflow tract; we realized that this might result in paravalvular regurgitation, but it would also afford a "deep" landing site for a second valve, if necessary. Ultimately, we implanted a second CoreValve deep in the left ventricular outflow tract to seal a paravalvular leak. The frame of the first valve--positioned at the conventional depth--enabled secure anchoring of the second valve in a deeper position, which in turn effected successful treatment of the failing subaortic surgical prosthesis without paravalvular regurgitation.

Colombian experience with transcatheter aortic valve implantation of medtronic CoreValve.

At our institutions, increasing numbers of aortic stenosis patients were not candidates for surgical aortic valve replacement. Accordingly, we initiated the Cali Colombian Transcatheter Aortic Valve Implantation (TAVI) program. From March 2008 through January 2011, 53 consecutive patients (mean age, 79 ± 6 yr; men, 58%) underwent TAVI with the Medtronic CoreValve System, and data were prospectively collected. Our study's endpoints conformed with Valve Academic Research Consortium recommendations. We report our clinical results.Predicted mortality rates were 25% (interquartile range, 17%-34%) according to logistic EuroSCORE and 6% (interquartile range, 3%-8%) according to the Society of Thoracic Surgeons score. The 30-day mortality rate was 9% (3 intraprocedural deaths, 5 total). The combined 30-day safety endpoint was 30% (major vascular sequelae, 23%; life-threatening bleeding, 12%; myocardial infarction, 4%; major stroke, 4%; and acute kidney injury [stage 3], 2%). Eight patients (15%) required post-implantation balloon dilation and 2 (4%) required valve-in-valve implantation, for a technical device success rate of 77%. Mean peak transvalvular gradient decreased from 74 ± 29 to 17 ± 8 mmHg and mean transvalvular gradient from 40 ± 17 to 8 ± 4 mmHg (both P=0.001). Moderate or severe aortic regurgitation decreased from 32% to 18% (P=0.12) and mitral regurgitation from 32% to 13% (P=0.002). The 1-year survival rate was 81%.We found that TAVI with the CoreValve prosthesis was safe and feasible, with sustained long-term results, for treating aortic stenosis in patients at excessive surgical risk; nonetheless, serious adverse events occurred in 30% of the patients.

Clinical outcome following Transcatheter Aortic Valve Implantation in patients with impaired left ventricular systolic function.

OBJECTIVES: To determine the prevalence of impaired left ventricular (LV) systolic function and its impact on the in-hospital and long-term outcome in patients who underwent Transcatheter Aortic Valve Implantation (TAVI). BACKGROUND: Although impaired LV function may be considered a contra-indication for aortic valve replacement, the hemodynamic characteristics of transcatheter valves may offer procedural and long-term clinical benefit in such patients. METHODS: 230 consecutive patients underwent TAVI with the Medtronic-CoreValve System. Impaired LV function was defined by a Left Ventricular Ejection Fraction (LVEF) ≤ 35% (European Multicenter Study on Operative Risk Stratification and Long-term Outcome in patients with Low-Flow/Low-Gradient Aortic Stenosis). Study endpoints were selected and defined according to the Valve Academic Research Consortium recommendations. RESULTS: Compared with patients with a LVEF > 35% (n = 197), those with LVEF ≤ 35% (n = 33) were more often male (78.8 % vs. 46.7%, P < 0.001), more symptomatic (NYHA class III or IV, 97.0% vs. 77.2%, P = 0.008) and had a higher prevalence of prior coronary artery disease (63.6% vs. 43.1%, P = 0.029). The Logistic EuroSCORE was 14.8% and 22.8, respectively (P = 0.012). No difference was observed between the two groups in in-hospital or 30-day mortality (3.0% vs. 9.6%, P = 0.21), the Combined Safety Endpoint at 30 days (24.2% and 24.4%, P = 0.99) and survival free from readmission at one year (69.2% and 69.7%, P = 0.85). After adjustment, LVEF ≤ 35% was not associated with an increased risk of 30-day mortality, in-hospital complications and survival free from readmission at follow-up. CONCLUSION: The immediate and long-term outcome after TAVI did not differ between patients with an impaired and preserved LVEF. LVEF ≤ 35% did not predict adverse immediate and long-term outcome. These findings suggest that TAVI should not be withheld in selected patients with impaired LV function.

Left ventricular mass regression one year after transcatheter aortic valve implantation.

BACKGROUND: Left ventricular (LV) hypertrophy is associated with LV diastolic dysfunction and constitutes a risk factor for cardiac morbidity and mortality. The objective of this study was to investigate the degree of LV mass regression and the changes of LV diastolic function one year after transcatheter aortic valve implantation (TAVI). METHODS: Echocardiography was performed at baseline, before discharge, and at one-year follow-up in 63 consecutive patients with severe aortic stenosis who underwent TAVI with the Medtronic CoreValve System (Medtronic Inc, Minneapolis, MN). The LV mass was calculated using the Devereux formula and indexed to body surface area. RESULTS: One-year all-cause mortality was 29%. The LV mass index decreased from 126 ± 42 g/m(2) at baseline to 110 ± 30 g/m(2) at one-year follow-up (p < 0.001). Left ventricular ejection fraction and LV diastolic function did not change significantly. Mean transaortic gradient decreased from 47 ± 19 mm Hg at baseline to 9 ± 5 mm Hg at discharge and 9 ± 4 mm Hg at one year (p < 0.001), and was accompanied by significant clinical improvement. More than mild paravalvular aortic regurgitation was found in 24% and 15% of patients at discharge and one-year follow-up, respectively. CONCLUSIONS: A significant regression in LV mass was found one year after TAVI. However, regression was incomplete and was not accompanied by an improvement in LV diastolic function.

How should I treat a staggering TAVI procedure?

BACKGROUND: A 79-year-old female patient with past medical history of chronic myeloid leukaemia, presented to the outpatient cardiology clinic with shortness of breath (NYHA class 3) and fatigue. INVESTIGATION: Echocardiography (ECG) and multislice computed tomography (MSCT). DIAGNOSIS: Severe calcified aortic valve stenosis by echocardiography. Logistic EuroSCORE 10.3. Porcelain aorta by multislice computed tomography (MSCT). TREATMENT: Transcatheter aortic valve implantation (TAVI) with an 18 Fr Medtronic-CoreValve system (Medtronic Inc., Minneapolis, MN, USA) using a right transfemoral arterial approach.