Outcomes among patients with coronary bifurcation lesions undergoing Impella-supported high-risk percutaneous coronary intervention.

Coronary bifurcation lesions are frequent challenging findings during percutaneous coronary intervention (PCI). Contemporary evidence has explored the potential sex-specific differences in patients undergoing PCI. In the present meta-analysis, we compared clinical outcomes of patients undergoing bifurcation PCI between women and men. Using the random-effects method, we compared the clinical outcomes of patients with a coronary bifurcation lesion following PCI between women and men. The results were reported using relative risk (RR) and 95% confidence interval (CI). Baseline comorbidities and mean age were compared between the 2 studied groups. Four observational studies comprising 30,684 patients (8898 women and 21,786 men) were included in the meta-analysis. Women were significantly older than men with a relatively higher prevalence of baseline comorbidities. After using adjusted data from 2 out of 4 available studies, performing PCI for bifurcation lesions in women was not associated with an increased risk of mortality (RR 1.33, 95% CI, 0.78-2.29), myocardial infarction (RR 1.22, 95% CI, 0.41-3.61), target lesion revascularization (RR 1.06, 95% CI, 0.40-2.81), stent thrombosis (RR 0.99, 95% CI, 0.09-10.52), and stroke (RR 1.19, 95% CI, 0.64-2.22). Women were at higher risk of major bleeding compared to male counterparts (RR 2.23, 95% CI, 1.73-2.89). The present study showed no difference in the risk of adverse clinical outcomes except the risk of bleeding between genders with coronary bifurcation lesions. Future studies with adjustment of age and baseline comorbidities are needed to confirm these findings.

Background: Coronary bifurcation lesions (CBLs) encompass stenotic segments of the coronary artery that are situated near or encroach upon the origin of a major side branch. These lesions are implicated in nearly 20% of all percutaneous coronary intervention. The Objective of this Study: The objective of this study was to evaluate the clinical and interventional methodologies applied to patients with CBL in the context of AMI. Furthermore, it sought to compare the immediate outcomes and six-month follow-up results between the single-stent and dual-stent approaches for managing CBL in AMI patient. Methods: This prospective study included 100 patients with a true CBL in the setting of AMI, at the Cardiology Department, Benha University Hospitals and International Medical Center Hospital. Patients were divided into 2 equal groups: Group I included patients planned one‐stent (provisional one‐stenting) and Group II included patients with planned two‐stents. All studied cases underwent complete clinical examination, laboratory investigations, complete 12-leads electrocardiography and echocardiography. Results: Type of drug eluting stent was significantly different between both groups (P=0.001). Group 2 had significantly longer procedural and fluoroscopy time than group 1 (P<0.001). Follow up in hospital (MACCE, cardiac death, target lesion revascularization, MI, and ejection fraction) and follow up at 6 months (MACCE, cardiac death, target lesion revascularization, MI, ejection fraction, stent technique, and degree of mitral regurgitation) were insignificantly different between both groups. Conclusion: Despite the greater complexity, extended fluoroscopy duration, and increased contrast volume associated with the two-stent strategy in STEMI cases, the procedural success rate and the incidence of MACE were found to be similar to those observed with the single-stent approach during medium-term follow-up.

Background: Impella is a mechanical circulatory support device indicated in severe cardiogenic shock and high-risk percutaneous coronary intervention. ECMO is also used during the percutaneous coronary intervention (PCI) in an acute coronary syndrome that is complicated by refractory cardiogenic shock. There have been few studies examining short-term mechanical circulatory support devices for patients that undergo PCI, so the choice between Impella and ECMO is still a matter of debate. We investigated the in-hospital outcomes of Impella and ECMO in patients who underwent multi-vessel PCI (MVPCI). Methods: In a retrospective cohort study of National Inpatient Sample 2017 data, we used ICD-10 codes to identify patients who underwent MVPCI and received Impella or ECMO support. Multivariate logistic regression was used to adjust for patient demographics, hospital demographics, and relevant comorbidities. Primary outcomes (inpatient mortality, length of stay (LOS), and total hospital charges. Secondary outcomes, such as respiratory failure (RF), gastrointestinal hemorrhage, cerebrovascular accident (CVA)/transient ischemic attack (TIA), intracerebral hemorrhage (ICH), acute kidney injury (AKI), ventricular tachycardia (VT), and atrial fibrillation, were also analyzed. Results: Among 64,489 patients who had MVPCI, 102 (%) received ECMO support, and 927 (%) received Impella support. Both Impella and ECMO use was associated with high in-hospital mortality (Impella 21.8% vs ECMO (49.5%), high hospital LOS (ECMO 19.9 days vs Impella 9.28 days), and total hospital charges (Impella $3,200,000 vs ECMO $7,500,00). Mortality (OR 4.27, p<0.0001), hospital LOS (OR 5.9, p<0.0001), and total hospital charges (OR 7.52, p<0.0001) for patients undergoing MVPCI. There was no statistically significant difference in complications such as RF, gastrointestinal hemorrhage, CVA/TIA, ICH, AKI, VT, and atrial fibrillation. Hispanic patients had higher mortality with ECMO (OR 2.28, p <0.024) than all other ethnicities and races. Conclusions: Both patients with Impella support and ECMO support had significant inpatient mortality. Our analysis suggests that Impella patients had better outcomes than patients on ECMO for MVPCI.

The impact of final kissing balloon inflation (FKB) in patients treated with an upfront provisional strategy for coronary bifurcation lesions is controversial. We aimed to assess the impact of FKB on patient- and lesion-oriented outcomes in a large real-world cohort. The ULTRA-BIFURCAT registry was obtained by patient-level merging the BIFURCAT and ULTRA registries. Pairs of patients were generated with propensity score matching (PSM). The primary outcome of interest was major adverse cardiac events (MACE) - a composite of all-cause death, myocardial infarction (MI), target lesion revascularisation (TLR) or stent thrombosis. A lesion-oriented composite outcome (LOCO) - a composite of target vessel MI (TVMI) or TLR - along with each single component of MACE represented the secondary outcomes. Subgroup analyses included the site of bifurcation (unprotected left main [ULM] vs non-ULM), side branch involvement (true bifurcation vs non-true bifurcation), side branch diameter and lesion length. Follow-up was censored at 800 days. A total of 5,607 patients undergoing a provisional stenting technique were selected for the present analysis. PSM generated 1,784 pairs. Between the matched patients with FKB versus no FKB, no significant difference in MACE was observed (9.0% vs 8.6%; p=0.68). FKB was associated with a lower rate of the LOCO (1.9% vs 2.9%; p=0.04) compared to the no FKB group, driven by lower rates of TVMI (0.2% vs 0.5%; p=0.03) and TLR (1.8% vs 2.6%; p=0.14). These results were confirmed in the subgroups of patients treated for bifurcations with side branches with a diameter >2.5 mm and for true coronary bifurcation lesions. Among patients treated for coronary bifurcation lesions with provisional stenting, FKB had no significant impact on MACE but was associated with a mild reduction in the incidence of the LOCO.

BACKGROUND: Atrioventricular nodal reentrant tachycardia (AVNRT) is considered a sporadic disease occurring in ≈22.5 cases per 10 000 in the general population.We define the prevalence and characteristics of familial AVNRT among patients who underwent radiofrequency ablation. METHODS AND RESULTS:Ablation reports of all patients with familial AVNRT (at least 2 first-degree family members) who underwent radiofrequency ablation in our institution and in another hospital were reviewed.There were 1587 patients from our institution, of whom 20 had ≥1 first-degree relatives with AVNRT.This indicates a familial AVNRT prevalence of 127 cases per 10 000 (95% confidence interval, 82-196/10 000).First-degree relatives of patients with AVNRT presented a hazard ratio of at least 3.6 for exhibiting AVNRT compared with the general population.After inclusion of 4 families with familial AVNRT who underwent ablation at another hospital our population study comprised a total of 24 families (50 patients) with AVNRT.Patients at ablation were younger in the familial AVNRT group when compared with the sporadic AVNRT group (44.2±19 versus 54.8±18 years old, P=0.0001).The male/female ratio was similar, with female predominance.The supraventricular tachycardia mechanism was typical slow/fast reentry in most cases in both groups.The most common familial relationship in our 24 families included a parent and a child in 67% of cases and less often 2 siblings (29%).CONCLUSIONS: Familial AVNRT prevalence is higher than previously believed suggesting that this arrhythmia may have a genetic component.Autosomal dominance with incomplete penetrance is the most likely mode of inheritance.

Mortality After Repeat Revascularization Following PCI or CABG for Left Main Disease: The EXCEL Trial

Background Patients with coronary bifurcation lesions represent a group with a greater risk of mortality when referred for e percutaneous coronary intervention (PCI). Aim We aimed to compare the clinical outcomes in patients with or without present atrial fibrillation (AF) undergoing bifurcation PCI. Methods Investigator-initiated prospective study of patients with stable coronary artery disease, with a significant angiographic bifurcation lesion defined as diameter stenosis ≥50% who were referred for a PCI. All patients were followed up by telephone contact and/or clinical visit at 30 days and then monthly for vital status. Cardiovascular (CV) death was defined as death with clearly determined cardiac origin or death from an unknown reason. Log-rank test was used to assess the difference in mortality between the two groups. Propensity-matching was performed to account for differences in age, sex, hypertension, dyslipidemia, diabetes, smoking, cancer, renal failure, LV ejection fraction, and SYNTAX score between the two groups. The primary endpoint was the incidence of all-cause and cardiovascular death. Results A total of 358 patients were included – 179 in each group. The mean age was 71.1 ± 9.6, 31% (112) were females, 32% (119) were smokers, 98% (353) -hypertensive, 92% (329) with dyslipidemia, 44% (156) -diabetics, 28% (99) had previous MI, mean EF was 51.9 ±10.8 %. After 1:1 propensity-score matching, baseline characteristics between the two groups were similar. Intervention vessel was LAD in 69% (n=247), LCx – 17% (62), RCA – 10% (37) of the patients. For a median follow-up time of 56.5 [39-110] months, total mortality was 40%, whereas CV death occurred in 30.5% (n=109) of the patients. Both all-cause and CV death were significantly higher in patients with AF - 64 (35.8%) versus 79 (44.1%); p=0.040, and - 47 (26.3%) versus 62 (34.6%); p=0.031, respectively. Furthermore, atrial fibrillation was revealed as an independent predictor of cardiovascular death in Cox-regression analysis, together with the following factors: AF – HR 1.704, 95%CI [1.156-2.510], p=0.007, age – HR 1.057, 95%CI [1.032-1.082], p<0.01; diabetes HR 1.556, 95%CI [1.059-2.2287], p=0.024; COPD HR 2.037 95%CI [1.328-3.123], p=0.001; EF –HR 0.968, 95% CI [0.950-0.987], p=0.001. Conclusion The presence of atrial fibrillation in patients with coronary bifurcation lesions referred for PCI is associated with higher all-cause and cardiovascular mortality.

Percutaneous Coronary Intervention Guided by Optical Coherence Tomography or Intravascular Ultrasound for True Bifurcation Lesions.

Objective: To investigate the prognostic value of SYNTAX score on 1 year outcome in coronary heart disease patients underwent percutaneous coronary intervention(PCI). Methods: The present study (PANDA Ⅲ trial) was a perspective, multi-center, randomized controlled trial. Between December 2013 and August 2014, 2 348 patients who underwent PCI from 46 centers were enrolled. SYNTAX score was calculated from all patients. Patients were divided into 3 groups based on SYNTAX score: lower risk group (SYNTAX score≤22, 1 777 patients), intermediate risk group (SYNTAX score 23-32, 412 patients), and higher risk group (SYNTAX score≥33, 159 patients). The patients were followed up after the procedure for one year.Primary endpoint was target lesion failure (TLF), including cardiac death, target vessel myocardial infarction,and ischemia driven target lesion revascularization. Secondary endpoints included stent thrombosis and major adverse cardiac events were defined as a composite of all-cause death, myocardial infarction and any revascularization. Results: (1) A total of 1 766 (99.2%), 411 (99.8%),and 159 (100%) patients in the lower risk group, intermediate risk and higher risk group completed the 1 year follow up. (2) Incidence of TLF were 5.6%(99/1 763) in lower risk group, 8.8%(36/411) in intermediate risk group,and 8.8%(14/159) in higher risk group(P=0.03). The incidence of target vessel myocardial infarction in lower risk group was 3.9%(68/1 763), 6.6%(27/411) in intermediate risk group,and 7.5% (12/159) in higher risk group(P=0.01).Prevalence of cardiac death and ischemia driven target lesion revascularization was similar among the 3 groups(P>0.05).(3) The probable stent thrombosis events rate was 0.1% (1/1 763), 0.7% (3/411), and 0.6% (1/159) in the lower, intermediate,and higher risk groups respectively (P=0.02). The incidence of major adverse cardiac events was 8.1% (142/1 763) in lower-risk group, 11.7% (48/411) in intermediate risk group, and 14.5% (23/159) in higher risk group (P<0.01). The incidence of all-cause death was 1.7%(30/1 763) in lower-risk group, 1.7%(7/411) in intermediate risk group, and 6.3%(10/159)in higher risk group (P<0.01). The incidence of myocardial infarction was 4.2% (74/1 763) in lower-risk group, 6.6% (27/411) in intermediate risk group, and 8.2% (13/159) in higher risk group(P=0.02).Incidence of any revascularization was similar among groups(P=0.59). (4) The multivariable Cox analysis showed that age (HR=1.04, 95%CI 1.02-1.06, P<0.01), total implanted stent length (HR=1.01, 95%CI 1.00-1.02, P=0.03), and baseline SYNTAX score (HR=1.02, 95%CI 1.02-1.04, P=0.02) were independent risk factors of TLF after PCI in this patient cohort. Conclusion: The SYNTAX score is a valuable tool for predicting prognosis on 1 year in coronary heart disease patients underwent PCI. Trial Registration www.clinicaltrials.gov, NCT02017275.

Impella was approved by the Food and Drug Administration in 2015 for use during high-risk percutaneous coronary interventions (PCIs); however, its safety and efficacy compared with intra-aortic balloon pump (IABP) has not been evaluated in contemporary practice and remains debated. We aimed to compare postapproval outcomes and costs of Impella versus IABP support for high-risk PCI in real-world practice across hospitals in the United States. We identified patients from the Premier Healthcare Database undergoing nonemergent Impella- or IABP-supported high-risk PCI. We used propensity adjustment to control baseline, procedure, and post-PCI medical treatment differences between treatment groups. We included patients undergoing nonemergent single-PCI procedures with either Impella or IABP support and excluded patients presenting with acute ST-elevation myocardial infarction or cardiogenic shock or requiring >1 mechanical support devices during index hospitalization. Outcomes included in-hospital survival, myocardial infarction (MI), cardiogenic shock, stroke, bleeding requiring transfusion, acute kidney injury, index hospitalization length of stay, and costs. From April 2016 to June 2019, a total of 48,179 patients were treated with Impella or IABP mechanical circulatory support at 304 hospitals in the United States. Among these, we identified 2,156 patients undergoing nonemergent high-risk PCI treated with Impella (n=1,447) or IABP (n=709). After propensity adjustment, Impella use was associated with improved survival (odds ratio [OR] 1.55, 95% confidence interval [CI] 1.02 to 2.36) and less MI (OR 0.29, 95% CI 0.18 to 0.46) and cardiogenic shock (OR 0.54, 95% CI 0.39 to 0.74). Stroke, bleeding requiring transfusion, and acute kidney injury were similar between groups. In conclusion, this Premier Healthcare Database propensity-adjusted analysis, Impella use during nonemergent high-risk PCI was associated with improved survival and reduced in-hospital MI and cardiogenic shock compared with IABP.

Choosing the method of revascularization - coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) - remains debatable. We selected 406 patients with multivessel disease who underwent PCI with a drug-eluting stent (DES) (n = 200, 100 with a SYNTAX score (SS) ≤ 22 and 100 with a SS 23-32); and CABG (n = 206, 100 with a SS ≤ 22 and 106 with a SS 23-32). The mean follow-up period was 9±1.9 years. The endpoints of the study were as follows: major adverse cardiac and cerebrovascular events (МАССЕ), a repeat revascularization (RR), diminished left ventricular ejection fraction (LVEF), and high SS in dynamics. Patients with an intermediate SS needed RR more often with PCI than after CABG (64 % vs 22.6 %; HR: 3.52; CI: 2.19-5.66; р < 0.001). We found no significant differences for other MACCE between the groups. The decrease in LVEF was greater in the low SS subgroup in operated patients than after PCI (39.5 % vs 27.7 %; HR: 0.57; CI: 0.34-0.98; p = 0.04). The difference between the initial and final SS, was greater after the CABG than after PCI (43.5 % vs 10.9 %; HR: 0.26; CI: 0.14-0.47; р < 0.001). After 9 ± 1.9 years in intermediate SS group CABG exhibited an advantage over PCI with DES in terms of the MACCE indicators due to a smaller number of RR in the CABG group. The CABG group showed a more significant progression of atherosclerosis, and more heart failure cases (Tab. 2, Fig. 4, Ref. 29). Text in PDF www.elis.sk Keywords: coronary artery disease, coronary artery bypass grafting, percutaneous coronary intervention, SYNTAX score.

Background Intravascular ultrasound (IVUS) guided percutaneous coronary intervention (PCI) has potential benefits. This meta-analysis aimed to explore whether IVUS-guided PCI had better short- and long-term prognoses than angiography-guided PCI. Methods We retrieved studies from PubMed, Embase, and Cochrane Library. Clinical trials including retrospective and randomized controlled trials (RCTs) that compared IVUS-guided PCI with angiography-guided PCI were included. The patients were followed up after operation at 30 days, 1 year, 2 years, and 3 years. The clinical outcomes were target lesion revascularization (TLR), target vessel revascularization (TVR), and MACEs, including stent thrombosis (ST), myocardial infarction (MI), cardiac death, and all-cause death. The study population included patients with MI, coronary bifurcation lesions, short or long lesions, and unprotected left main coronary artery stenosis (ULMCA). The quality of retrospective trials was evaluated using the Newcastle–Ottawa Scale, and the quality of randomized controlled trials was evaluated using the Jadad score. A total of 20 clinical trials met the criteria. Three trials were randomized controlled trials, while 17 were retrospective trials. Results A total of 24,783 patients were included. In observational trials, the OR of MACEs was 0.49 (95% CI: 0.38–0.62) in 30 days, 0.65 (95% CI: 0.58–0.73) in one year, 0.51 (95% CI: 0.36–0.71) in two years, and 0.45 (95% CI: 0.31–0.65) in three years. In patients with long coronary lesions, the OR of MACEs in 1 year was 0.64 (95% CI: 0.28–1.50). In patients with left main artery disease, the OR of MACEs in 3 years was 0.42 (95% CI: 0.26–0.67). Compared with angiography-guided PCI, IVUS-guided PCI was associated with a lower incidence of MACEs during the same following period. Conclusion Compared with angiography-guided PCI, IVUS-guided PCI has better performance in reducing the occurrence of MACEs.

Alice K. Jacobs, MD, FACC, FAHA, Chair Jeffrey L. Anderson, MD, FACC, FAHA, Chair-Elect Nancy Albert, PhD, CCNS, CCRN, FAHA Mark A. Creager, MD, FACC, FAHA Steven M. Ettinger, MD, FACC Robert A. Guyton, MD, FACC Jonathan L. Halperin, MD, FACC, FAHA Judith S. Hochman, MD, FACC, FAHA

Background: Rates of major adverse cardiac events (MACE) after functionally guided percutaneous coronary intervention (PCI) of coronary bifurcation lesions have not been specifically analysed. Methods: Patients from FIESTA registry (ClinicalTrials.govNCT01724957) with stable angina, bifurcation lesions in a coronary artery with diameter ≥ 2.5 mm and ≤ 4.5 mm and SB diameter≥2.0 mm were included in the analysis. Subjects with ST-segment elevation myocardial infarction, left main disease, hemodynamic instability were excluded. Provisional stenting was the default strategy in all patients. Fractional flow reserve (FFR) was performed using the PrimeWire or PrimeWire Prestige (Volcano Corp., USA). Bifurcation lesion with FFR above 0.80 were deferred from PCI. Follow-up for vital status at every 3-month period was performed and rates of MACE, including cardio-vascular death, nonfatal myocardial infarction and stroke, were analyzed. Results: Overall 165 patients were included, mean age was 67±10 years, 66% males, 72 (44%) had functionally significant bifurcation lesions (FSL) and 93 (56%) were with non-significant lesions (nFSL). There were no differences (FSL vs. nFSL) regarding: dyslipidemia (88% vs 96%), diabetes (44% vs. 32%), smoking (52% vs 40%), previous MI (24% vs 15%), previous PCI (54% vs 49%), atrial fibrillation (17% vs 29%), PAD (10% vs. 9%), renal failure (29% vs 31%) – all p&gt;0.05. On a median follow-up of 34±14 months there were no differences between FSL and nFSL regarding rates of cardio-vascular death -12.5% (n=9/72) vs. 7.5% (n=7/93), p=0.4, MACEs - 13.9% (n=10/72)vs 8.6 (8/93), p=0.512. On multivariate Cox-regression analysis factors associated with occurrence of MACE were: presence of cancer OR 3.692, (CI 0.955-14.269); renal failure OR 2.550, (CI 0.961-6.767) SYNTAX ≥9 OR 1.836, (CI 0.490-6.874); SB RVD ≥ 2.4mm OR 2.546, (CI 0.708-9.160); SB BARI 13.5% OR 2.013, (CI 0.652-6.211); WBC≥7OR 3.647, (CI 0.824-16.134); Platelet count ≥ 256.106/ml OR 3.814, (CI 1.220-11.925). Conclusion: Less than a half of angiographically significant coronary bifurcation lesions were functionally significant requiring stent implantation. The rates of MACE were not-significantly different in deferred and treated stenoses up to 3 years follow-up.

BackgroundThere is uncertainty regarding the best revascularization approach—whether coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI)—for obese patients suffering from multi-vessel coronary artery disease.Results406 patients with low and intermediate SYNTAX scores (SS) underwent PCI with drug-eluting stents (n = 200, 100 with SS ≤ 22, and 100 with SS 23–32) and CABG (n = 206, 100 with SS ≤ 22, and 106 with SS 23–32). Patients were also categorized by body mass index (BMI): normal weight (12%, 48 patients), overweight (41.6%, 169 patients), and obese (46.6%, 189 patients). The follow-up period averaged 9 ± 1.9 years. The endpoints of the study were as follows: major adverse cardiac and cerebrovascular events, a repeat revascularization, diminished left ventricular ejection fraction (LVEF), and high SS (≥ 33) observed over time. When comparing PCI and CABG in overweight individuals, the risk of myocardial infarction (MI) following PCI was greater than after CABG (Hazard Ratio [HR] 2.7, 95% Confidence Interval [CI] 1.1–6.7, p = 0.03). In patients with overweight and Class I obesity, CABG was associated with the risk of coronary atherosclerosis progression (SS ≥ 33) (HR 4.4, 95% CI 1.5–13, p = 0.009 and HR 4.9, 95% CI 1.9–12, p = 0.001, respectively); whereas PCI was connected with the likelihood of repeat revascularization (HR 2.7, 95% CI 1.6–4.55, p < 0.0001 and HR 2, 95% CI 1.3–3.1, p = 0.002, respectively). At the same time, for stented patients, Class III obesity was associated with the risk of repeat revascularization (HR 2.5, 95% CI 1.02–6, p = 0.044).ConclusionThere were no significant weight-related impacts on long-term outcomes among patients who underwent surgery. Whereas in stented patients, Class III obesity was associated with the risk of repeat revascularization. When comparing PCI and CABG, for overweight and Class I obesity patients, CABG was associated with a likelihood of coronary atherosclerosis progression (SS ≥ 33), while PCI was linked to the risk of repeat revascularization. For overweight patients, CABG outperformed PCI in terms of the risk of MI. For other adverse events in patients of different weight categories, PCI and CABG did not reveal any significant benefits.