Safety and efficacy of aminophylline in the prevention of bradyarrhythmia during coronary atherectomy.

Coronary calcified lesions are commonly encountered and coronary atherectomy is commonly used for lesion modification during percutaneous coronary interventions (PCI). The release of adenosine during atherectomy can result in bradyarrhythmias and aminophylline is commonly used to prevent this reaction. We identified 138 patients to evaluate the safety and efficacy of intravenous (IV) aminophylline administration prior to coronary atherectomy. A total of 159 calcified lesions were treated, and the atherectomy device was orbital atherectomy, rotational atherectomy, and both in 52 %, 42 %, and 6 %; respectively. After administration of aminophylline, 4.3 % of patients required intraprocedural insertion of a transvenous pacer (TVP), and 18.1 % of patients required administration of IV atropine. Technical success was achieved in 98.6 % of patients, and no adverse reactions to aminophylline were reported. All patients survived to discharge. In conclusion, aminophylline administration prior to coronary atherectomy was safe and effective. No adverse effects of aminophylline were seen, and the rate of bailout TVP placement was low.

Feasibility and Outcomes of a Cardiovascular Medicine Inclusive Extracorporeal Membrane Oxygenation (ECMO) Service.

Background: There has been a significant increase in the utilization of venoarterial extracorporeal membrane oxygenation (VA-ECMO) in recent years. Cardiothoracic surgery teams have historically led VA-ECMO care teams, with little data available on alternative care models. Methods: We performed a retrospective review of a cardiovascular medicine inclusive VA-ECMO service, analyzing patients treated with peripheral VA-ECMO at a large quaternary care center from 2018 to 2022. The primary outcome was death while on VA-ECMO or within 24 hours of decannulation. Univariate and multivariate analyses were used to identify predictors of the primary outcome. Results: Two hundred forty-four patients were included in the analysis (median age 61 years; 28.7% female), of whom 91.8% were cannulated by interventional cardiologists, and 84.4% were managed by a cardiology service comprised of interventional cardiologists, cardiac intensivists or advanced heart failure cardiologists. Indications for VA-ECMO included acute myocardial infarction (34.8%), decompensated heart failure (30.3%), and refractory cardiac arrest (10.2%). VA-ECMO was utilized during cardiopulmonary resuscitation in 26.6% of cases, 48% of which were peri-procedural arrest. Of the patients, 46% survived to decannulation, the majority of whom were decannulated percutaneously in the cardiac catheterization laboratory. There was no difference in survival following cannulation by a cardiac surgeon vs interventional cardiologist (50% vs 45%; P = .90). Complications included arterial injury (3.7%), compartment syndrome (4.1%), cannulation site infection (1.2%), stroke (14.8%), acute kidney injury (52.5%), access site bleeding (16%) and need for blood transfusion (83.2%). Elevated baseline lactate (odds ratio [OR], 1.13 per unit increase) and sequential organ failure assessment score (OR, 1.27 per unit increase) were independently associated with the primary outcome. Conversely, an elevated baseline survival after VA ECMO score (OR, 0.92 per unit increase) and 8-hour serum lactate clearance (OR, 0.98 per % increase) were independently associated with survival. Conclusions: The use of a cardiovascular medicine inclusive ECMO service is feasible and may be practical in select centers as indications for VA-ECMO expand.

Implications of anemia in patients undergoing PCI with Impella-support: insights from the PROTECT III study.

Background: Anemia is prevalent among patients with cardiovascular disease and is associated with adverse outcomes. However, data regarding the impact of anemia in high-risk percutaneous coronary intervention (HRPCI) are limited. Objectives: This study aimed to evaluate the impact of anemia in patients undergoing Impella-supported HRPCI in the PROTECT III study. Methods: Patients undergoing Impella-supported HRPCI in the multicenter PROTECT III study were assessed for anemia based on baseline hemoglobin levels according to World Health Organization criteria. Patients were stratified into three groups, namely, no anemia, mild anemia, and moderate or severe anemia. Major adverse cardiovascular and cerebrovascular events (MACCE: all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 30 and 90 days, and major bleeding events were compared across groups. Results: Of 1,071 patients with baseline hemoglobin data, 37.9% had no anemia, 43.4% had mild anemia, and 18.7% had moderate or severe anemia. Anemic patients were older and more likely to have comorbidities. Anemia was associated with higher MACCE rates at 30 days (moderate to severe, 12.3%; mild, 9.8%; no anemia, 5.4%; p = 0.02) and at 90 days (moderate to severe, 18.7%; mild, 14.6%; none, 8.3%; p = 0.004). These differences persisted after adjustment for potential confounders at 30 and 90 days, and sensitivity analysis excluding dialysis showed similar results. Major bleeding at 30 days was also higher in anemic patients (5.5% vs. 1.2%, p = 0.002). Conclusion: Baseline anemia in Impella-supported HRPCI is common and independently associated with MACCE and major bleeding, emphasizing its significance as a prognostic factor. Specific management strategies to reduce anemia-associated MACCE risk after HRPCI should be examined. Clinical Trial Information Trial Name: The Global cVAD Study (cVAD)ClinicalTrial.gov Identifier: NCT04136392URL: https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.

Mechanical Circulatory Support Devices in Patients with High-Risk Pulmonary Embolism.

Pulmonary embolism (PE) is a common acute cardiovascular condition. Within this review, we discuss the incidence, pathophysiology, and treatment options for patients with high-risk and massive pulmonary embolisms. In particular, we focus on the role of mechanical circulatory support devices and their possible therapeutic benefits in patients who are unresponsive to standard therapeutic options. Moreover, attention is given to device selection criteria, weaning protocols, and complication mitigation strategies. Finally, we underscore the necessity for more comprehensive studies to corroborate the benefits and safety of MCS devices in PE management.

Geographic diversity in chronic total occlusion percutaneous coronary intervention: insights from the PROGRESS-CTO registry.

BACKGROUND: There is variability in clinical and lesion characteristics as well as techniques in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We analyzed patient and lesion characteristics, techniques, and outcomes in 11 503 CTO-PCI procedures performed in North America (NA) and in the combined regions of Europe, Asia, and Africa from 2017 to 2023 as documented in the PROGRESS-CTO registry. RESULTS: Eight thousand four hundred seventy-nine (74%) procedures were performed in NA. Compared with non-NA patients, NA patients were older, with higher body mass index and higher prevalence of diabetes, hypertension, dyslipidemia, family history of coronary artery disease, prior history of PCI, coronary artery bypass graft surgery and heart failure, cerebrovascular disease, and peripheral arterial disease. Their CTOs were more complex, with higher J-CTO (2.56 ± 1.22 vs 1.81 ± 1.24; P less than .001) and PROGRESS-CTO (1.29 ± 1.01 vs 1.07 ± 0.95; P less than .001) scores, longer length, and higher prevalence of proximal cap ambiguity, blunt/no stump, moderate to severe calcification, and proximal tortuosity. Retrograde (31.0% vs 22.1%; P less than .001) and antegrade dissection and re-entry (ADR) (21.2% vs 9.2%; P less than .001) were more commonly used in NA centers, along with intravascular ultrasound (69.0% vs 10.1%; P less than .001). Procedure and fluoroscopy times were longer in NA, while contrast volume and radiation dose were lower. Technical (86.7% vs 86.8%; P > .90) and procedural (85.4% vs 85.8%; P = .70) success and in-hospital major adverse cardiovascular events (MACE) (1.9% vs 1.7%; P = .40) were similar in NA and non-NA centers. CONCLUSIONS: Compared with non-NA patients, NA patients undergoing CTO PCI have more comorbidities, higher CTO lesion complexity, are more likely to undergo treatment with retrograde and ADR, and have similar technical success and MACE.

Ranolazine in chronic total occlusion percutaneous coronary intervention.

Ranolazine is an anti-anginal medication given to patients with chronic angina and persistent symptoms despite medical therapy. We examined 11 491 chronic total occlusion (CTO) percutaneous coronary interventions (PCI) that were performed at 41 US and non-US centers between 2012 and 2023 in the PROGRESS-CTO Registry. Patients on ranolazine at baseline had more comorbidities, more complex lesions, lower procedural and technical success (based on univariable but not multivariable analysis), and higher incidence of major adverse cardiac events (MACE) (on both univariable and multivariable analysis).

Equipment entrapment/loss during chronic total occlusion percutaneous coronary intervention.

BACKGROUND: There is limited data on equipment loss or entrapment during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We analyzed the baseline clinical and angiographic characteristics and outcomes of equipment loss/entrapment at 43 US and non-US centers between 2017 and 2023. RESULTS: Equipment loss/entrapment was reported in 40 (0.4%) of 10 719 cases during the study period. These included guidewire entrapment/fracture (n = 21), microcatheter entrapment/fracture (n = 11), stent loss (n = 8) and balloon entrapment/fracture/rupture (n = 5). The equipment loss/entrapment cases were more likely to have moderate to severe calcification, longer lesion length, higher J-CTO and PROGRESS-CTO complications scores, and use of the retrograde approach compared with the remaining cases. Retrieval was attempted in 71.4% of the guidewire, 90.9% of the microcatheter, 100% of the stent loss, and 100% of the balloon cases, and was successful in 26.7%, 30.0%, 50%, and 40% of the cases, respectively. Procedures complicated by equipment loss/entrapment had higher procedure and fluoroscopy time, contrast volume and patient air kerma radiation dose, lower procedural (60.0% vs 85.6%, P less than .001) and technical (75.0% vs 86.8%, P = .05) success, and higher incidence of major adverse cardiac events (MACE) (17.5% vs 1.8%, P less than .001), acute MI (7.5% vs 0.4%, P less than .001), emergency coronary artery bypass graft (CABG) (2.5% vs 0.1%, P = .03), perforation (20.0% vs 4.9%, P less than .001), and death (7.5% vs 0.4%, P less than .001). CONCLUSIONS: Equipment loss is a rare complication of CTO PCI; it is more common in complex CTOs and is associated with lower technical success and higher MACE.

Comparative Analysis of Polymer Versus Non-Polymer Jacketed Wires in Chronic Total Occlusion Percutaneous Coronary Intervention.

There is significant variation in wire utilization patterns for chronic total occlusion (CTO) percutaneous coronary intervention. This study aimed to compare the outcomes of polymer-jacketed wires (PJWs) versus non-PJWs in anterograde procedures. We analyzed clinical and angiographic characteristics, and procedural outcomes of 7,575 anterograde CTO percutaneous coronary interventions that were performed at 47 centers between 2012 and 2023. Cases in which PJWs were exclusively used were classified in the PJW group, whereas cases where at least one non-PJW was employed were classified in the non-PJW group. Study end points were as follows: technical success, coronary perforation, major adverse cardiac event. PJWs were exclusively used in 3,481 cases (46.0%). These cases had lower prevalence of proximal cap ambiguity, blunt stump, and moderate/severe calcification. They also had lower Japanese CTO (J-CTO), Prospective Global Registry for the Study of Chronic Total Occlusion (PROGRESS-CTO), and PROGRESS-CTO complications scores, higher technical success (94.3% vs 85.7%, p <0.001), and lower perforation rates (2.2% vs 3.2%, p = 0.013). Major adverse cardiac event rates did not differ between groups (1.3% vs 1.5%, p = 0.53). Exclusive use of PJWs was independently associated with higher technical success in both the multivariable (odds ratio [OR] 2.66, 95% confidence interval [CI] 2.13 to 3.36, p <0.001) and inverse probability of treatment weight analysis (OR 2.43, 95% CI 2.04 to 2.89, p <0.001). Exclusive use of PJWs was associated with lower risk of perforation in the multivariable analysis (OR 0.69, 95% CI 0.49 to 0.95, p = 0.02), and showed a similar trend in the inverse probability of treatment weight analysis (OR 0.77, 95% CI 0.57 to 1.04, p = 0.09). Exclusive use of PJWs is associated with higher technical success and lower perforation risk in this non-randomized series of patients.

Clinical characteristics and outcomes of patients requiring prolonged mechanical circulatory support after high-risk percutaneous coronary intervention.

BACKGROUND: There are limited data on the clinical characteristics and outcomes of patients who require prolonged mechanical circulatory support (MCS) after Impella-supported high-risk percutaneous coronary intervention (HR-PCI). AIMS: The aim of this study is to describe the contemporary clinical characteristics, outcomes, and predictors associated with prolonged MCS support after assisted HR-PCI. METHODS: Patients enrolled in the prospective, multicentre, clinical endpoint-adjudicated PROTECT III study who had undergone HR-PCI using Impella were evaluated. Patient and procedural characteristics and outcomes for those who received prolonged MCS beyond the duration of their index procedure were compared to those in whom MCS was successfully weaned and explanted at the conclusion of the index PCI. RESULTS: Among 1,155 patients who underwent HR-PCI with Impella between 2017 and 2020 and had sufficient data to confirm the duration of Impella support, 16.5% received prolonged MCS (mean duration 25.2±31.1 hours compared with 1.8±5.8 hours for those who only received intraprocedural MCS). Patients receiving prolonged support presented with more urgent indications (e.g., acute coronary syndromes [ACS], lower ejection fraction [EF], elevated baseline heart rate and lower systolic blood pressure). Use of the Impella CP, intraprocedural complications, periprocedural complications and in-hospital mortality were all more common amongst the prolonged MCS group. Prolonged MCS was associated with increased rates of major adverse cardiovascular and cerebrovascular events, cardiovascular death, and all-cause mortality at 90-day follow-up. CONCLUSIONS: Patients receiving prolonged MCS after Impella-supported HR-PCI presented with more ACS, reduced EF and less favourable haemodynamics. Additionally, they were more likely to experience intraprocedural and periprocedural complications as well as increased in-hospital and post-discharge mortality.

Impact of target vessel on the procedural techniques and outcomes of chronic total occlusion percutaneous coronary intervention.

BACKGROUND: There is limited information on the impact of the target vessel on the procedural techniques and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We analyzed the baseline clinical and angiographic characteristics and procedural outcomes of 11,580 CTO PCIs performed between 2012 and 2022 at 44 centers. RESULTS: The most common CTO target vessel was the right coronary artery (RCA) (53.1%) followed by the left anterior descending artery (LAD) (26.0%) and the left circumflex artery (LCX) (19.8%). RCA CTOs were longer and more complex, with a higher Japanese CTO score compared with LAD or LCX CTOs. Technical success was higher among LAD (88.8%) lesions when compared with RCA (85.7%) or LCX (85.8%) lesions (P less than .001). The incidence of major adverse cardiovascular events (MACE) was overall 1.9% (n = 220) and was similar among target vessels (P=.916). There was a tendency toward more frequent utilization of the retrograde approach for more proximal occlusions in all 3 target vessels. When compared with all other RCA lesions combined, distal RCA lesions had higher technical success (87.7% vs 85.3%; P=.048). Technical success was similar between various locations of LAD CTOs (P=.704). First/second/third obtuse marginal branch had lower technical success when compared with all other LCX lesion locations (82.7% vs 86.8%; P=.014). There was no association between MACE and CTO location in all 3 target vessels. CONCLUSIONS: LAD CTO PCIs had higher technical and procedural success rates among target vessels. The incidence of MACE was similar among target vessels and among various locations within the target vessel.

Impact of calcium on the procedural techniques and outcomes of chronic total occlusion percutaneous coronary intervention.

BACKGROUND: Coronary calcification is common and increases the difficulty of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined the impact of calcium on procedural outcomes of 13,079 CTO PCIs performed in 12,799 patients at 46 US and non-US centers between 2012 and 2023. RESULTS: Moderate or severe calcification was present in 46.6% of CTO lesions. Patients whose lesions were calcified were older and more likely to have had prior coronary artery bypass graft surgery. Calcified lesions were more complex with higher J-CTO score (3.0 ± 1.1 vs. 1.9 ± 1.2; p < 0.001) and lower technical (83.0% vs. 89.9%; p < 0.001) and procedural (81.0% vs. 89.1%; p < 0.001) success rates compared with mildly calcified or non-calcified CTO lesions. The retrograde approach was more commonly used among cases with moderate/severe calcification (40.3% vs. 23.5%; p < 0.001). Balloon angioplasty (76.6%) was the most common lesion preparation technique for calcified lesions, followed by rotational atherectomy (7.3%), laser atherectomy (3.4%) and, intravascular lithotripsy (3.4%). The incidence of major adverse cardiovascular events (MACE) was higher in cases with moderate or severe calcification (3.0% vs. 1.2%; p < 0.001), as was the incidence of perforation (6.5% vs. 3.4%; p < 0.001). On multivariable analysis, the presence of moderate/severe calcification was independently associated with lower technical success (odds ratio, OR = 0.73, 95% CI: 0.63-0.84) and higher MACE (OR = 2.33, 95% CI: 1.66-3.27). CONCLUSIONS: Moderate/severe calcification was present in nearly half of CTO lesions, and was associated with higher utilization of the retrograde approach, lower technical and procedural success rates, and higher incidence of in-hospital MACE.

Aortocoronary dissection during percutaneous coronary interventions for chronic total occlusion: Insights from the PROGRESS-CTO registry.

BACKGROUND: Aortocoronary dissection is a potentially serious complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined the incidence, mechanisms, treatment, and outcomes of aortocoronary dissection among 12,117 CTO PCIs performed between 2012 and 2022 in a large multicenter CTO PCI registry. RESULTS: The incidence of aortocoronary dissection was 0.2% (n = 27). Most aortocoronary dissections occurred in the right coronary artery (96.3%, n = 26). The baseline clinical characteristics of patients with and without aortocoronary dissection were similar, except for dyslipidemia, which was less common in patients with aortocoronary dissection (70.4% vs. 86.0%; p = 0.019). The retrograde approach was used more commonly among cases complicated by aortocoronary dissection (59.3% vs. 31.0%; p = 0.002). Technical (74.1% vs. 86.6%; p = 0.049) and procedural (70.4% vs. 85.2%; p = 0.031) success rates were lower among aortocoronary dissection cases, with a similar incidence of in-hospital major adverse cardiovascular events (3.7% vs. 2.0%; p = 0.541). Of the 27 patients with aortocoronary dissection, 19 (70.4%) were treated with ostial stenting and 8 (29.6%) were treated conservatively without subsequent adverse clinical outcomes. No patients required emergency surgery. Follow-up was available for 22 patients (81.5%): during a mean follow up of 767 (±562) days, the incidence of in-stent restenosis was 11.1% (n = 3). CONCLUSIONS: Aortocoronary dissection occurred in 0.2% of CTO PCIs performed by experienced operators, was associated with lower technical and procedural success, and was treated most commonly with ostial stenting. None of the patients required emergency cardiac surgery.

National Trends for Temporary Mechanical Circulatory Support Utilization in Patients With Cardiogenic Shock From Decompensated Chronic Heart Failure: Incidence, Predictors, Outcomes, and Cost.

Background: Trends in temporary mechanical circulatory support (tMCS) use with associated outcomes and cost in cardiogenic shock secondary to decompensated chronic heart failure (HF-CS) remains poorly understood. We describe trends in tMCS use, associated outcomes, and cost in HF-CS. Methods: We included adults enrolled in a national insurance claims dataset with HF-CS who received intra-aortic balloon pump (IABP), Impella, or extracorporeal membrane oxygenation (ECMO) without acute coronary syndrome, or postcardiotomy shock. We identified predictors of device use, associated outcomes, and inflation-adjusted costs. Results: We studied 2722 HF-CS patients receiving tMCS: 1799 (66%) male, 1771 (65%) White, and 1836 (67%) with ischemic cardiomyopathy. Rate of tMCS use increased from 2010-2019. Impella use showed the largest increase (Δ+344%), followed by ECMO (Δ+112%). Patients receiving ECMO had a higher comorbidity burden, and patients receiving IABP were more likely to have valvular heart disease. Compared with IABP, 30-day mortality rate was no different for Impella (adjusted odds ratio, 1.24; 95% CI, 0.93-1.66) but was higher with ECMO (adjusted odds ratio, 3.08; 95% CI, 2.22-4.27). Adjusted hospitalization cost was highest for ECMO (median, $191,079 [IQR, $165,760-$239,373]), followed by Impella (median, $142,518 [IQR, $126,845-$179,938]), and IABP (median, $132,060 [IQR, $113,794-$160,244]). We observed a linear association between price standardized cost-quartile and complications, but not for 30-day mortality. Conclusions: The use of Impella and ECMO is increasing with an associated cost increase. The use of ECMO coincided with higher 30-day mortality compared with IABP in HF-CS. These findings likely reflect increasing disease severity and evolving practice patterns rather than causation.

Design and Rationale of the Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System (SAFE-MCS) Study.

Background: High-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS) has been associated with varying rates of bleeding due to variable bleeding definitions, incomplete data relative to site-specific bleeding, and inclusion of variable patient populations. Study Design and Objectives: SAFE-MCS (NCT05077657) is a multicenter, single-arm, open-label study designed to evaluate the safety of complex high-risk PCI using Impella and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS). The study aims to enroll 184 evaluable subjects at up to 15 US centers. The primary clinical end point is the incidence of access-site related BARC type III or V bleeding. Secondary clinical end points include the incidence of each of the Saranas EBBMS level 1, 2, and 3 indicators and the incidence of all BARC type III or V bleeding. Enrollment is anticipated to complete in September 2023 with no longitudinal follow-up. Conclusions: SAFE-MCS is the first study to exclusively assess bleeding complications in patients undergoing PCI with Impella with independent adjudication via a clinical end point committee and will gather meaningful real-world data using contemporary practice.

A Visual Depiction of Left Ventricular Unloading in Veno-Arterial ExtraCorporeal Membrane Oxygenation With Impella.

Left ventricular (LV) unloading has been associated with improved survival in patients treated with venoarterial extracorporeal membrane oxygenation. This case describes a patient with a COVID-19 infection who subsequently developed non-ischemic cardiomyopathy with an LV ejection fraction of 10% to 15% (baseline echocardiography). He did poorly in the outpatient setting and was admitted to an outside hospital with heart failure symptoms and was subsequently transferred to our hospital for escalation of care and consideration of advanced heart failure therapies. This clinical image and related video series help to visually demonstrate the effect of LV unloading in a 30-year-old male with a history of COVID-19 myocarditis.