The effect of standardization of insertion and removal of percutaneous left ventricular assist device.

BACKGROUND: The effect of standardizing an insertion and removal protocol for pVAD devices has not been previously described. OBJECTIVES: We sought to evaluate clinical outcomes in patients who underwent pVAD insertion pre- and post-protocol standardization. METHODS: All patients who underwent pVAD insertion that remained in place at index procedure completion between January 2017 and September 2023 at a single academic center for both high-risk PCI and cardiogenic shock indications were included in the study. The primary outcome was the incidence of limb ischemia and major bleeding before and after the protocol initiation. Secondary outcomes included in-hospital and 30-day MACCE rate (death, myocardial infarction, stroke, emergent CABG), and how often the operators followed the protocol. RESULTS: A total of 89 patients had pVAD left in place (29 pre-protocol initiation and 60 post-protocol initiation). There was a significant decrease in incidence of limb ischemia post-protocol initiation compared to pre (17.2 % vs 1.7 %, p = 0.01) but no difference in bleeding incidence (13.8 % vs 20.0 %, p = 0.47). Adherence increased in all components of the protocol except for right heart catheterization. CONCLUSION: Standardization of an insertion and removal protocol for pVAD devices led to a statistically significant decrease in limb ischemia in a high-risk patient population.

In adults with stable angina, PCI vs. a placebo procedure reduced angina symptoms at 12 wk.

SOURCE CITATION: Rajkumar CA, Foley MJ, Ahmed-Jushuf F, et al; ORBITA-2 Investigators. A placebo-controlled trial of percutaneous coronary intervention for stable angina. N Engl J Med. 2023;389:2319-2330. 38015442.

Practice differences and knowledge gaps in complex and high-risk interventions between Japan and the USA: A case-based discussion.

Advances in percutaneous coronary intervention (PCI) devices and techniques have expanded the pool of eligible patients for revascularization, including those with comorbidities, reduced left ventricular function, or anatomical complexity (defined as CHIP: complex and high-risk interventions in indicated patients). CHIP interventions are typically performed by selected operators who specialize in complex PCI. This review presents two cases performed in the USA, to discuss the similarities and differences in practice patterns between CHIP operators in Japan and the USA. The first case involves a 58-year-old male presenting with myocardial infarction and cardiogenic shock, and the second case involves a 51-year-old female with a history of coronary artery bypass grafting presenting with a chronic total occlusion and PCI complicated by vessel perforation. The discussion focuses on appropriate patient selection, the role of the heart team approach for decision-making, the use of hemodynamic support devices, and other relevant factors. By comparing practices in Japan and the USA, this review highlights opportunities for knowledge exchange and potential areas for improving patient outcomes.

Meta-Analysis Assessing Efficacy and Safety of Vitamin K Antagonists Versus Direct Oral Anticoagulants for Atrial Fibrillation After Transcatheter Aortic Valve Implantation.

Patients who underwent transcatheter aortic valve implantation (TAVI) with concomitant atrial fibrillation (AF) are at a higher risk for thromboembolic and bleeding events. The optimal antithrombotic strategy for patients with AF after TAVI remains unclear. We sought to determine the comparative efficacy and safety of direct oral anticoagulants (DOAC) versus oral vitamin K antagonists (VKAs) in these patients. Electronic databases such as PubMed, Cochrane, and Embase databases were searched till January 31, 2023, for relevant studies evaluating clinical outcomes of VKA versus DOAC in patients with AF after TAVI. Outcomes assessed were (1) all-cause mortality, (2) stroke, (3) major/life-threatening bleeding, and (4) any bleeding. Hazard ratios (HRs) were pooled in meta-analysis using random effect model. Nine studies (2 randomized and 7 observational) were included in systematic review, and 8 studies with 25,769 patients were eligible to be included in the meta-analysis. The mean age of the patients was 82.1 years, and 48.3% were male. Pooled analysis using random-effects model showed no statistically significant difference in all-cause mortality (HR 0.91, 95% confidence interval [CI] 0.76 to 1.10, p = 0.33), stroke (HR 0.96, 95% CI 0.80 to 1.16, p = 0.70), and major/life-threatening bleeding (HR 1.05, 95% CI 0.82 to 1.35, p = 0.70) in patients that received DOAC compared with oral VKA. Risk of any bleeding was lower in the DOAC group compared with oral VKA (HR 0.83, 95% CI 0.76 to 0.91, p = 0.0001). In patients with AF, DOACs appear to be a safe alternative oral anticoagulation strategy to oral VKA after TAVI. Further randomized studies are required to confirm the role of DOACs in those patients.

In HF with secondary mitral regurgitation, transcatheter mitral valve repair reduced HF hospitalizations at 5 y.

SOURCE CITATION: Stone GW, Abraham WT, Lindenfeld J, et al; COAPT Investigators. Five-year follow-up after transcatheter repair of secondary mitral regurgitation. N Engl J Med. 2023;388:2037-2048. 36876756.

In older adults with hypertension, chlorthalidone vs. hydrochlorothiazide did not reduce major CV events or deaths at 2.4 y.

SOURCE CITATION: Diuretic Comparison Project Writing Group; Ishani A, Cushman WC, Leatherman SM, et al. Chlorthalidone vs. hydrochlorothiazide for hypertension-cardiovascular events. N Engl J Med. 2022;387:2401-10. 36516076.

Antihypertensive therapy reduced incident dementia vs. placebo at a median 4.3 y.

SOURCE CITATION: Peters R, Xu Y, Fitzgerald O, et al. Blood pressure lowering and prevention of dementia: an individual patient data meta-analysis. Eur Heart J. 2022;43:4980-90. 36282295.

Statins increase muscle pain or weakness at 1 y, with an absolute excess of 11 events/1000 person-y.

SOURCE CITATION: Cholesterol Treatment Trialists' Collaboration. Effect of statin therapy on muscle symptoms: an individual participant data meta-analysis of large-scale, randomised, double-blind trials. Lancet. 2022;400:832-45. 36049498.

In acute decompensated HF, adding acetazolamide to IV loop diuretics reduced congestion at 3 d.

SOURCE CITATION: Mullens W, Dauw J, Martens P, et al. Acetazolamide in acute decompensated heart failure with volume overload. N Engl J Med. 2022;387:1185-95. 36027559.

Three versus 12-month dual antiplatelet therapy duration in patients with acute coronary syndrome undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials.

INTRODUCTION: The American Heart Association/American College of Cardiology guidelines on dual antiplatelet therapy (DAPT) recommend at least 12 months of a P2Y12 inhibitor and low dose aspirin in patients with an acute coronary syndrome (ACS) treated with a stent. Since that recommendation, several randomized controlled trials (RCTs) have studied an abbreviated duration of DAPT in ACS. Therefore, we sought to perform a meta-analysis of RCTs comparing 3- versus 12-month DAPT in patients presenting with ACS undergoing percutaneous coronary intervention (PCI). METHODS: PubMed, Embase, and Cochrane Central databases were searched until July 31, 2022, for RCTs comparing 3- versus 12-month DAPT in patients with ACS undergoing PCI. Outcomes assessed were major adverse cardiovascular events (MACE), cardiovascular mortality, all-cause mortality, myocardial infarction (MI), stent thrombosis (ST) and bleeding. A random-effects model was used to calculate pooled relative risk (RR) and 95% confidence intervals (CI). RESULTS: We included 5 trials comprising 16,781 patients with an ACS that underwent PCI. There was no significant difference in MACE (RR: 0.92; 95% CI: 0.76-1.11), cardiovascular mortality (RR: 1.26; 95% CI: 0.38-4.17), or all-cause mortality (RR: 0.92; 95% CI: 0.48-1.77) between the 2 groups. In addition, there was no difference in rates of MI (RR: 0.98; 95% CI: 0.74-1.30), or ST (RR: 1.30; 95% CI: 0.55-3.05) between 3- and 12-month DAPT. However, compared with 12-month DAPT, 3-month DAPT significantly reduced risk of major bleeding (RR: 0.53; 95% CI: 0.43-0.64). CONCLUSIONS: In patients with ACS undergoing PCI, 3-month DAPT reduced risk of bleeding without evidence of harm.

Renal denervation in the antihypertensive arsenal - knowns and known unknowns.

Even though it has been more than a decade since renal denervation (RDN) was first used to treat hypertension and an intense effort on researching this therapy has been made, it is still not clear how RDN fits into the antihypertensive arsenal. There is no question that RDN lowers blood pressure (BP), it does so to an extent at best corresponding to one antihypertensive drug. The procedure has an excellent safety record. However, it remains clinically impossible to predict whose BP responds to RDN and whose does not. Long-term efficacy data on BP reduction are still unconvincing despite the recent results in the SPYRAL HTN-ON MED trial; experimental studies indicate that reinnervation is occurring after RDN. Although BP is an acceptable surrogate endpoint, there is complete lack of outcome data with RDN. Clear indications for RDN are lacking although patients with resistant hypertension, those with documented increase in activity of the sympathetic system and perhaps those who desire to take fewest medication may be considered.

Implementation of Robotic-Assisted Percutaneous Coronary Intervention Into a High-Risk PCI Program.

BACKGROUND: How to implement robotic-assisted PCI safely and when to escalate to more complex cases has not been previously described. We sought to evaluate clinical outcomes in patients undergoing robotic-assisted PCI in the first year of a newly established robotic-assisted PCI program. METHODS: All patients who underwent robotic-assisted PCI in the first 12 months at a single academic center were included in the study. Lesion complexity was characterized as "PRECISE-like", "CORA-PCI-like", or "CORA-PCI excluded" based on established criteria. The primary outcome was clinical success, defined as <30% residual stenosis after stenting with a final TIMI flow grade 2-3 and no procedural complications. Secondary outcomes included robotic success, defined as clinical success with robotic completion, unintentional manual conversion rate, procedure time, and procedural complications. RESULTS: Of the 57 consecutive lesions treated, 12 (22.6%) had a PRECISE-like lesion complexity while 32 (56.1%) had a CORA- PCI-like, and 13 (22.8%) a CORA-PCI excluded lesion complexity. There was no significant difference in clinical success (100.0% vs. 96.7% vs. 100.0%, p = 1.00) among the groups but robotic success was numerically lower as complexity increased (100.0% vs. 80.0% vs. 72.7%, p = 0.15), with an increased frequency of manual conversion. There was no significant difference in procedural complication rates among the groups. The robotic completion rate improved during the study period. CONCLUSION: Robotic-assisted PCI, can be safely implemented in a moderate-sized academic center, with a rapid escalation in patient and lesion complexity.

Does the ISCHEMIA Trial Apply to My Patients?

PURPOSE OF REVIEW: The ISCHEMIA trial demonstrated no difference in myocardial infarction or death in patients with stable coronary disease and moderate or large ischemia territory treated either with invasive revascularization or optimal medical therapy. Whether the findings of the randomized control trial relates to real-world outcomes is uncertain. RECENT FINDINGS: Contemporary guideline-directed medical therapy has had a significant impact on the prognosis of coronary artery disease. Various observational data appear to indicate limited generalizability of the ISCHEMIA trial in different populations. Further studies are warranted to evaluate the optimal modality of therapy in patients with stable coronary disease and moderate or severe ischemia. The applicability of ISCHEMIA and ISCHEMIA-CKD trials still requires further validation.

Predictors of In-Hospital De-Escalation of P2Y12 Inhibitors to Clopidogrel in Patients With Acute Myocardial Infarction Treated With Percutaneous Coronary Intervention.

BACKGROUND: Ticagrelor or prasugrel are recommended to reduce ischemic events in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI). However, in clinical practice, patients are often switched from a potent P2Y12 inhibitor to clopidogrel prior to or at discharge ('de-escalation'). We sought to assess the incidence and predictors of de-escalation. METHODS: Consecutive patients who received either a ticagrelor or prasugrel loading dose for AMI PCI at two tertiary centers between Jan 2015-Mar 2019 who survived to discharge were included. Data were obtained from the electronic health record and institutional NCDR CathPCI data. Patients who were de-escalated to clopidogrel were compared with those who remained on potent P2Y12 inhibitors through the time of discharge. RESULTS: Of the1818 patients in the cohort, 1146 (63%) were de-escalated. Patients in the de-escalation group were older, more often Black, had lower prevalence of co-morbidities, less often had private insurance, and had less complex PCI. After adjustment, older age remained positively associated (OR 1.2, CI 1.08-1.34, p = .001) and Caucasian race (OR 0.5, CI 0.33-0.77, p = .002), prior MI (OR 0.7, CI 0.5-0.97, p = .032), bifurcation lesion (OR 0.71, CI 0.53-0.95, p = .019), and greater number of stents (OR 0.82, CI 0.75-0.91, p = .0001) were negatively associated with de-escalation. In de-escalated patients, the rationale was not documented in 75.9% of cases. CONCLUSIONS: De-escalation occurred frequently in patients with AMI and was associated with both non-clinical and clinical factors. Medical decision making was poorly documented and represent an area for improvement.

Delays to Hospital Presentation in Women and Men with ST-Segment Elevation Myocardial Infarction: A Multi-Center Analysis of Patients Hospitalized in New York City.

PURPOSE: Previous studies have shown longer delays from symptom onset to hospital presentation (S2P time) in women than men with acute myocardial infarction. The aim of this study is to understand the reasons for delays in seeking care among women and men presenting with an ST-Segment Elevation Myocardial Infarction (STEMI) through a detailed assessment of the thoughts, perceptions and patterns of behavior. PATIENTS/METHODS AND RESULTS: A total of 218 patients with STEMI treated with primary angioplasty at four New York City Hospitals were interviewed (24% female; Women: 68.7 ± 13.1 years and men: 60.7 ± 13.8 years) between January 2009 and August 2012. A significantly larger percentage of women than men had no chest pain (62% vs 36%, p<0.01). Compared to men, a smaller proportion of women thought they were having a myocardial infarction (15% vs 34%, p=0.01). A larger proportion of women than men had S2P time >90 minutes (72% of women vs 54% of men, p= 0.03). Women were more likely than men to hesitate before seeking help, and more women than men hesitated because they did not think they were having an AMI (91% vs 83%, p=0.04). Multivariate regression analysis showed that female sex (Odds Ratio: 2.46, 95% CI 1.10-5.60 P=0.03), subjective opinion it was not an AMI (Odds Ratio 2.44, 95% CI 1.20-5.0, P=0.01) and level of education less than high school (Odds ratio 7.21 95% CI 1.59-32.75 P=0.01) were independent predictors for S2P >90 minutes. CONCLUSION: Women with STEMI have longer pre-hospital delays than men, which are associated with a higher prevalence of atypical symptoms and a lack of belief in women that they are having an AMI. Greater focus should be made on educating women (and men) regarding the symptoms of STEMI, and the importance of a timely response to these symptoms.

Relation of abnormal cardiac stress testing with outcomes in patients undergoing renal transplantation.

Cardiovascular risk stratification is often performed in patients considered for renal transplantation. In a single center, we sought to examine the association between abnormal stress testing with imaging and post-renal transplant major adverse cardiovascular events (MACE) using multivariable logistic regression. From January 2006 to May 2016 232 patients underwent renal transplantation and 59 (25%) had an abnormal stress test result. Compared to patients with a normal stress test, patients with an abnormal stress test had a higher prevalence of dyslipidemia, diabetes mellitus, obesity, coronary artery disease (CAD), and heart failure. Among those with an abnormal result, 45 (76%) had mild, 10 (17%) moderate, and 4 (7%) severe ischemia. In our cohort, 9 patients (3.9%) had MACE at 30-days post-transplant, 5 of whom had an abnormal stress test. The long-term MACE rate, at a median of 5 years, was 32%. After adjustment, diabetes (OR 2.37, 95% CI 1.12-5.00, p = 0.02), CAD (OR: 3.05, 95% CI 1.30-7.14, p = 0.01) and atrial fibrillation (OR: 5.86, 95% CI 1.86-18.44, p = 0.002) were independently associated with long-term MACE, but an abnormal stress test was not (OR: 0.83, 95% CI 0.37-1.92, p = 0.68). In conclusion, cardiac stress testing was not an independent predictor of long-term MACE among patients undergoing renal transplant.