The "Lollipop" During Catheter-Directed Thrombectomy: 2 Case Examples.

Intraprocedural embolization has been described as a potential complication of catheter thrombectomy for acute pulmonary embolism and may be under-recognized. We describe 2 case examples of "Lollipopping" during thrombectomy, which may be a mechanism of intraprocedural embolization and describe our treatment approach. (Level of Difficulty: Advanced.).

Pulmonary Embolism Response Team utilization during the COVID-19 pandemic.

Coronavirus disease 2019 (COVID-19) may predispose patients to venous thromboembolism (VTE). Limited data are available on the utilization of the Pulmonary Embolism Response Team (PERT) in the setting of the COVID-19 global pandemic. We performed a single-center study to evaluate treatment, mortality, and bleeding outcomes in patients who received PERT consultations in March and April 2020, compared to historical controls from the same period in 2019. Clinical data were abstracted from the electronic medical record. The primary study endpoints were inpatient mortality and GUSTO moderate-to-severe bleeding. The frequency of PERT utilization was nearly threefold higher during March and April 2020 (n = 74) compared to the same period in 2019 (n = 26). During the COVID-19 pandemic, there was significantly less PERT-guided invasive treatment (5.5% vs 23.1%, p = 0.02) with a numerical but not statistically significant trend toward an increase in the use of systemic fibrinolytic therapy (13.5% vs 3.9%, p = 0.3). There were nonsignificant trends toward higher in-hospital mortality or moderate-to-severe bleeding in patients receiving PERT consultations during the COVID-19 period compared to historical controls (mortality 14.9% vs 3.9%, p = 0.18 and moderate-to-severe bleeding 35.1% vs 19.2%, p = 0.13). In conclusion, PERT utilization was nearly threefold higher during the COVID-19 pandemic than during the historical control period. Among patients evaluated by PERT, in-hospital mortality or moderate-to-severe bleeding were not significantly different, despite being numerically higher, while invasive therapy was utilized less frequently during the COVID-19 pandemic.

An Updated Healthcare System-Wide Clinical Pathway for Managing Patients With Chest Pain and Acute Coronary Syndromes.

Clinical pathways reinforce best practices and help healthcare institutions standardize care delivery. The NewYork-Presbyterian/Columbia University Irving Medical Center has used such a pathway for the management of patients with chest pain and acute coronary syndromes for almost 2 decades. A multidisciplinary panel of stakeholders serially updates the algorithm according to new data and recently published guidelines. Herein, we present the 2019 version of the clinical pathway. We explain the rationale for changes to the algorithm and describe our experience expanding the pathway to all the 8 affiliated institutions within the NewYork Presbyterian healthcare system.

WIRION Embolic Protection System in Lower Extremity Arterial Interventions: Results of the Pivotal WISE LE Trial.

OBJECTIVES: The WISE LE (WIRION™ EPS in Lower Extremities Arteries) study was designed to assess the clinical performance of the WIRION Embolic Protection System (EPS) in subjects undergoing lower extremity atherectomy for the treatment of peripheral artery disease. BACKGROUND: Embolization is ubiquitous during endovascular procedures for lower extremity peripheral artery disease. METHODS: The WISE LE was a multicenter study, performed in the United States and Germany. The primary endpoint was freedom from major adverse events (MAEs) occurring within 30 days post-procedure and was compared with an objective performance goal derived from historical atherectomy trials. MAE was defined as a serious adverse event that resulted in death, acute myocardial infarction, thrombosis, pseudoaneurysm, dissection (grade C or greater), or clinical perforation at the filter location, clinically relevant distal embolism, unplanned amputation, or clinically driven target vessel revascularization. The study also included a histopathological analysis of debris captured by the filter during the procedures. RESULTS: The study protocol specified enrollment of 153 patients with the primary endpoint successfully met if 18 (12.0%) or fewer MAEs occurred. A pre-specified interim analysis performed after 103 patients revealed only 2 MAEs, and the study was stopped because it had met its pre-determined metric for success. Lesion deemed not accessible by the WIRION EPS occurred in 7 patients. Debris of <1-mm, 1- to 2-mm, and >2-mm diameter were found in 98%, 22%, and 9% of patients, respectively. CONCLUSIONS: The WIRION EPS is safe and noninferior to the pre-specified performance goal in capturing debris in the vast majority of patients and with the use of a broad range of atherectomy systems.

Neurologic and cardiac benefits of therapeutic hypothermia.

Numerous studies have shown the favorable effects of lowering the core temperature of the body in various conditions such as acute myocardial infarction, acute cerebrovascular disease, acute lung injury, and acute spinal cord injury. Therapeutic hypothermia (TH) works at different molecular and cellular levels. TH improves oxygen supply to ischemic areas and increases blood flow by decreasing vasoconstriction, as well as oxygen consumption, glucose utilization, lactate concentration, intracranial pressure, heart rate, cardiac output, and plasma insulin levels. TH has been shown to improve neurologic outcome in acute cerebrovascular accidents. Furthermore, recent studies revealed that TH is a useful method of neuroprotection against ischemic neuronal injury after cardiac arrest. TH in out-of-hospital cardiac arrest is becoming a standard practice nationwide. Further studies need to be performed to develop a better understanding of the benefits and detrimental effects of TH, to identify the most efficacious TH strategy, and the candidates most likely to derive benefit from the procedure. Although many animal studies have demonstrated benefit, larger human clinical trials are recommended to investigate the beneficial effect of TH on reducing myocardial infarction size and coronary reperfusion injuries.

Major adverse cardiac events in patients with hepatitis C infection treated with bare-metal versus drug-eluting stents.

BACKGROUND: There are no data comparing the long-term outcome of bare-metal stents (BMS) vs drug-eluting stents (DES) in patients with hepatitis C virus (HCV) infection. HYPOTHESIS: In patients with HCV infection, the rate of major adverse cardiac events (MACE) would be less, and the mortality rates similar, in patients treated with DES than in patients treated with BMS. METHODS: The incidence of major adverse cardiac events (MACE) during long-term follow-up, including death, myocardial infarction, and target-vessel revascularization, was investigated in HCV-infected patients who also underwent percutaneous coronary intervention with bare-metal or drug-eluting stents. RESULTS: Of 78 patients studied, BMS were placed in 41 patients and DES stents in 37 patients. Stepwise Cox regression analyses were performed to identify significant independent risk factors for MACE. At 42 +/- 11-month follow-up, MACE occurred in 9 of 41 patients (22%) in the BMS group (mean age 63 +/- 11 years, 66% men) vs in 7 of 37 patients (19%) in the DES group (mean age 61 +/- 9 years, 65% men). There was no significant difference in MACE in the BMS group vs the DES group. This persisted even after controlling for length of the stent, complexity of lesion, and other comorbidities. All-cause mortality was not significantly different in the BMS group vs the DES group (7% vs 5%). CONCLUSIONS: At long-term follow-up of HCV-infected patients with stable liver function, the rates of MACE and of all-cause mortality were similar in the BMS and DES groups.

Mortality at long-term follow-up of patients with no, nonobstructive, and revascularized 1-, 2-, and 3-vessel obstructive coronary artery disease.

BACKGROUND: To investigate the 5-year survival of patients with coronary angiographic evidence of no coronary artery disease (CAD), nonobstructive CAD, and revascularized 1-vessel, 2-vessel, and 3-vessel obstructive CAD. MATERIAL/METHODS: Coronary angiography was performed in 2,057 unselected patients, mean age 69 years (57% men and 43% women), with an acute coronary syndrome (50%) or anginal chest pain.(50%). RESULTS: Of 2,057 patients, 760 (37%) had obstructive CAD with >50% obstruction of at least 1 major coronary artery (left anterior descending, left circumflex, and right coronary) and were revascularized, 695 (34%) had nonobstructive CAD (<50% obstruction), and 602 (29%) had normal coronary arteries. At 60+/-16-month follow-up, all-cause mortality occurred in 41 of 602 patients (7%) with no CAD (group 1), in 80 of 695 patients (12%) with nonobstructive CAD (group 2), in 50 of 302 patients (17%) with revascularized 1-vessel obstructive CAD (group 3), in 47 of 201 patients (23%) with 2-vessel revascularized obstructive CAD (group 4), and in 72 of 257 patients (28%) with 3-vessel revascularized obstructive CAD (group 4). Log-rank tests to compare survival curves among the 5 groups showed p=0.004 for groups 1 versus 2; p<0.0001 for groups 1 versus 3, 1 versus 4, 1 versus 5, 2 versus 4, and 2 versus 5; and p=0.007 for groups 3 versus 5. CONCLUSIONS: Patients with nonobstructive CAD had a worse survival than those with no CAD, a nonsignificant difference in survival than those with revascularized 1-vessel obstructive CAD, and a better survival than those with revascularized 2-vessel or 3-vessel obstructive CAD.

Vascular complications after percutaneous coronary intervention following hemostasis with the Mynx vascular closure device versus the AngioSeal vascular closure device.

UNLABELLED: We investigated the prevalence of vascular complications after PCI following hemostasis in 190 patients (67% men and 33% women, mean age 64 years) treated with the AngioSeal vascular closure device (St. Jude Medical, Austin, Texas) versus 238 patients (67% men and 33% women, mean age 64 years) treated with the Mynx vascular closure device (AccessClosure, Mountain View, California). RESULTS: Death, myocardial infarction or stroke occurred in none of the 190 patients (0%) treated with the AngioSeal versus none of 238 patients (0%) treated with the Mynx. Major vascular complications occurred in 4 of 190 patients (2.1%) treated with the AngioSeal versus 5 of 238 patients (2.1%) treated with the Mynx (p not significant). Major vascular complications in patients treated with the AngioSeal included removal of a malfunctioning device (1.1%), hemorrhage requiring intervention (0.5%) and hemorrhage with a loss of > 3g Hgb (0.5%). The major vascular complications in patients treated with the Mynx included retroperitoneal bleeding requiring surgical intervention (0.8%), pseudoaneurysm with surgical repair (0.8%) and hemorrhage with a loss of > 3g Hgb (0.4%). These complications were not significantly different between the two vascular closure devices (p = 0.77). Minor complications included hematoma > 5 cm (0.5%, n = 1) within the AngioSeal group, as well as procedure failure requiring > 30 minutes of manual compression after device deployment, which occurred in 7 out of 190 patients (3.7%) treated with the AngioSeal versus 22 of 238 patients with the Mynx (9.2%) (p = 0.033). CONCLUSIONS: Major vascular complications after PCI following hemostasis with vascular closure devices occurred in 2.1% of 190 patients treated with the AngioSeal vascular closure device versus 2.1% of 238 patients treated with the Mynx vascular closure device (p not significant). The Mynx vascular closure device appears to have a higher rate of device failure.

Major adverse cardiac events in patients with moderate to severe renal insufficiency treated with first-generation drug-eluting stents.

No data are available comparing the long-term outcome of sirolimus-eluting stents (SESs) versus paclitaxel-eluting stents (PESs) in patients with moderate to severe renal insufficiency. The incidence of major adverse cardiac events (MACE), including death, myocardial infarction, and target vessel revascularization, during long-term follow-up were studied in patients with a glomerular filtration rate of <60 ml/min/1.73 m(2), as measured by the Modification of Diet in Renal Disease (MDRD) study equation, who also underwent percutaneous coronary intervention with drug-eluting stents. Of 428 patients studied, PESs were placed in 287 patients and SESs in 141 patients. Stepwise Cox regression analyses were performed to identify significant independent risk factors for MACE. At 47 + or - 19 months of follow-up, MACE had occurred in 49 (17%) of 287 patients in the PES group (mean age 71 + or - 11 years, 55% men) and in 31 (22%) of 141 patients in the SES group (mean age 71 + or - 12 years, 53% men). No significant difference was found in the MACE rate between the PES and SES groups. This persisted even after controlling for stent length, lesion complexity, and other co-morbidities. Also, all-cause mortality was not significantly different between the PES and SES groups (7.1% vs 8.5%, respectively). In conclusion, during long-term follow-up of patients with moderate to severe renal insufficiency, the rates of MACE and all-cause mortality were similar in the PES and SES groups.

Incidence of myocardial infarction or stroke or death at 47-month follow-up in patients with diabetes and a predicted exercise capacity 85% during an exercise treadmill sestamibi stress test.

A treadmill exercise sestamibi stress test (TESST) was performed in 609 consecutive diabetic persons with a mean age of 70 years and no history of coronary artery disease (CAD) who were referred for a TESST because of chest pain or dyspnea. Of 609 patients, 301 (49%) had a predicted exercise capacity 85% (group B). Group A patients had a higher prevalence of myocardial ischemia (43% vs 30%, P=.0005), 2- or 3-vessel obstructive CAD (38% vs 18%, P=.001), myocardial infarction (17% vs 9%, P=.004), death (10% vs 4%, P=.008), and myocardial infarction or stroke or death at 47-month follow-up (21% vs 12%, P=.001). Stepwise Cox regression analysis showed that the only significant independent predictor for the time to development of myocardial infarction or stroke or death was a predicted exercise capacity >85% (hazard ratio, 0.52; 95% confidence interval, 0.34-0.78; P=.002). Diabetic persons with a predicted exercise capacity >85% had a 48% lower chance of myocardial infarction, stroke, or death than those with a predicted exercise capacity

Interhospital transfer of patients with ST-segment elevation myocardial infarction for percutaneous coronary intervention.

We investigated in 277 consecutive patients, mean age 63 years, with ST-segment elevation acute myocardial infarction transferred from 25 community hospitals to a tertiary percutaneous coronary intervention (PCI) center from a median distance of 21 miles the incidences of in-hospital mortality, stroke, and recurrent myocardial infarction associated with transfer times. Of the 277 patients, 158 (57%) had thrombolytic therapy at the referring hospital. Of the 277 patients, 63 (23%) had adjunctive PCI, 119 (43%) had primary PCI, and 95 (34%) had rescue PCI. Of the 277 patients, 42 (15%) were hemodynamically unstable. Median transfer times were 102 minutes with primary PCI, 119 minutes with rescue PCI, and 144 minutes for adjunctive PCI (P < 0.0001 for adjunctive PCI versus primary PCI; P = 0.011 for adjunctive PCI versus rescue PCI). Median transfer time was 98 minutes for hemodynamically unstable patients and 121 minutes for hemodynamically stable patients (P = 0.005). In-hospital death occurred in eight of 277 patients (3%). In-hospital stroke occurred in three of 277 patients (1%). In-hospital recurrent myocardial infarction occurred in none of 277 patients (0%). There was no association of transfer times with in-hospital mortality or stroke. In-hospital mortality occurred in three of 112 patients (3%) who had bare metal stents and in five of 165 patients (3%) who had drug-eluting stents.

Risk factors for major bleeding and for minor bleeding after percutaneous coronary intervention in 634 consecutive patients with acute coronary syndromes.

Of 634 consecutive patients who had percutaneous coronary intervention (PCI) for acute coronary syndromes, 34 (5%) had major bleeding after PCI, 253 (40%) had minor bleeding after PCI, and 347 (55%) had no bleeding after PCI. Significant independent risk factors for major bleeding after PCI were increased troponin I level (P = 0.004; odds ratio [OR] = 4.7), prior coronary artery disease (P = 0.029; OR = 3.7), platelet glycoprotein IIb/IIIa inhibitors (P = 0.002; OR = 9.8), glomerular filtration rate (GFR) <30 versus >or=60 mL/min/1.73 m(2) (P < 0.0001; OR = 39.7), GFR 30-59 versus >or=60 mL/min/1.73 m(2) (P = 0.0001; OR = 9.4), and clopidogrel loading dose >300 mg (P = 0.0001; OR = 8.9). Significant independent risk factors for minor bleeding after PCI were increased troponin I level (P = 0.0004; OR = 2.1), platelet glycoprotein IIb/IIIa inhibitors (P = 0.039; OR = 2.4), GFR 30-59 versus >or=60 mL/min/1.73 m(2) (P < 0.0001; OR = 2.5), thrombolytics (P = 0.01; OR = 2.7), clopidogrel loading dose >300 mg (P < 0.0001; OR = 4.2), and systolic blood pressure during PCI (P < 0.0001; OR = 1.03 per mm Hg). In-hospital deaths included 5 of 34 patients (15%) with major bleeding, none of 253 patients (0%) with minor bleeding, and none of 347 patients (0%) with no bleeding (P < 0.0001). Hospital duration was 11.0 days in patients with major bleeding, 3.4 days in patients with minor bleeding, and 1.8 days in patients with no bleeding (P < 0.0001).

Prevalence of in-hospital complications in 500 patients undergoing percutaneous coronary intervention treated with heparin 5000 IU administered systemically versus 500 age-matched and sex-matched patients treated with heparin 70 IU/kg administered systemically.

We investigated the prevalence of in-hospital complications in 500 patients undergoing percutaneous coronary intervention (PCI) treated with heparin 5000 IU administered systemically (group 1) at the time of PCI versus in 500 age-matched and sex-matched patients undergoing PCI treated with heparin 70 IU/kg administered systemically (group 2) at the time of PCI. There was no significant difference in baseline characteristics, indications for PCI, cardiovascular drug therapy at the time of PCI, prevalence of 1-vessel, 2-vessel, and 3-vessel obstructive coronary artery disease, and in-hospital complications between the 2 groups. In-hospital death occurred in 0.2% of group 1 patients versus 0.8% of group 2 patients. Non-ST-segment elevation myocardial infarction occurred in 0.2% of group 1 patients versus 0.4% of group 2 patients. Stroke occurred in 0.2% of group 1 patients versus 0.2% of group 2 patients. Stent thrombosis occurred in 0.2% of group 1 patients versus 0.8% of group 2 patients. Occlusion of a side branch occurred in 0.2% of group 1 patients versus 0.4% of group 2 patients. A hematoma needing intervention occurred in 0.2% of group 1 patients versus 0.2% of group 2 patients. Regression analysis showed that none of the differences between the 2 groups were significant. The sample size was adequate to conclude that a fixed low dose of heparin 5000 IU administered systemically at the time of PCI is noninferior to standard therapy with heparin.

A planar QRS-T angle >90 degrees is associated with multivessel coronary artery disease in patients undergoing coronary angiography.

BACKGROUND: The aim of the study was to investigate the severity of coronary artery disease (CAD) in patients who had a planar QRS-T angle >90 degrees versus 50% obstruction of >or=1 major coronary artery. All QRS-T angle measurements were made from a 12-lead electrocardiogram by 2 authors who agreed on the measurement and who were blinded to the coronary angiographic findings. A QRS-T angle >90 degrees was considered abnormal. RESULTS: Obstructive CAD of 2 or 3 vessels was present in 309 of 495 patients (62%) with a planar QRS-T angle >90 degrees and in 250 of 734 patients (34%) with a planar QRS-T angle or=30 kg/m2 (odds ratio =1.5). CONCLUSIONS: The prevalence of 2- or 3-vessel obstructive CAD was significantly higher in patients with a planar QRS-T angle >90 degrees than in patients with a planar QRS-T angle

Major adverse cardiac events at long-term follow-up in patients treated with single versus multiple stents during single-vessel percutaneous coronary intervention.

BACKGROUND: Although insertion of multiple stents into a single coronary vessel during single-vessel percutaneous coronary intervention (PCI) is common, there are no data on long-term occurrence of major adverse cardiac events (MACE) in patients treated with multiple stents versus a single stent. METHODS: The incidence of MACE (death, myocardial infarction, or target vessel revascularization) during long-term follow-up was investigated in 634 patients who underwent single-vessel PCI. Of the 634 patients, 319 (50%) had a single stent, and 315 (50%) had multiple stents inserted. Stepwise Cox regression analyses were performed to identify significant independent prognostic factors for MACE. RESULTS: At 47-month follow-up, MACE occurred in 61 of 319 patients (19%) who had a single stent versus in 57 of 315 patients (18%) who had multiple stents (P not significant). Significant independent predictors of MACE were use of vein grafts (hazard ratio = 1.94; 95% CI, 1.24-3.03; P = 0.0038) and use of drug-eluting stents (hazard ratio = 0.49; 95% CI, 0.34-0.72; P = 0.0002). CONCLUSIONS: At long-term follow-up of single-vessel PCI, the incidence of MACE was similar in patients with multiple or single stents inserted even after controlling for the length of stents.

Major adverse cardiac events at follow-up after bare-metal stenting versus drug-eluting stenting in ST-elevated myocardial infarction.

After thrombolytic therapy with tenecteplase for ST-segment elevation acute myocardial infarction, 376 patients were transferred from their hospital to Westchester Medical Center for percutaneous coronary intervention with stenting. Of 376 patients, 102 (27%) received bare-metal stents and 274 (73%) received drug-eluting stents with sirolimus-eluting or paclitaxel-eluting stents. At 43 months of follow-up, major adverse cardiac events occurred in 25 (25%) of 102 patients treated with bare-metal stents versus 40 (15%) of 274 patients treated with drug-eluting stents (p = 0.024). Cox regression analysis showed that significant independent prognostic factors for major adverse cardiac events were previous coronary artery bypass surgery (hazard ratio 2.2, p = 0.019), width of stent (hazard ratio 0.44, p = 0.006), and bare-metal stent (hazard ratio 1.8, p = 0.019). In conclusion, patients with bare-metal stents had a 1.8 times greater risk of developing major adverse cardiac events than did those using drug-eluting stents after controlling the confounding effects of previous coronary artery bypass surgery and stent width.

Obstructive coronary artery disease in high-risk diabetic patients with and without atrial fibrillation.

OBJECTIVE: To investigate the severity of coronary artery disease by coronary angiography in age-matched and sex-matched patients with diabetes mellitus with atrial fibrillation versus sinus rhythm. METHODS: The patients included 245 men and women, mean age of 70 years, with diabetes and atrial fibrillation and 245 age-matched and sex-matched patients with diabetes and sinus rhythm who underwent coronary angiography. Baseline characteristics and indications for coronary angiography were similar in both groups. RESULTS: Greater than 50% narrowing of one, two, or three major coronary arteries were present in 229 of 245 patients (94%) with diabetes and atrial fibrillation and in 211 of 245 patients (86%) with diabetes and with sinus rhythm (P<0.01). Greater than 50% narrowing of three major coronary arteries were present in 150 of 245 patients (61%) with diabetes and atrial fibrillation and in 75 of 245 patients (31%) with diabetes and sinus rhythm (P<0.001). CONCLUSION: Patients with diabetes and atrial fibrillation have a significantly higher prevalence of greater than 50% narrowing of one or more major coronary arteries and of three major coronary arteries than patients with diabetes and sinus rhythm.

Relation of bone mineral density to frequency of coronary heart disease.

Coronary angiography was performed because of chest pain in 198 patients (146 women, 52 men; mean age 66 years) who had dual-energy x-ray absorptiometry scans of the spine and left hip because of suspected osteoporosis or osteopenia. Of the 198 patients, 53 (27%) had osteoporosis, 79 (40%) had osteopenia, and 66 (33%) had normal bone mineral density (BMD). Obstructive coronary artery disease with >50% narrowing of > or =1 major coronary artery was present in 40 of 53 patients (76%) with osteoporosis, in 54 of 79 patients (68%) with osteopenia, and in 31 of 66 patients (47%) with normal BMD (p <0.005 comparing osteoporosis with normal BMD, p <0.01 comparing osteopenia with normal BMD). In conclusion, in patients who undergo coronary angiography because of chest pain, patients with osteoporosis or osteopenia have a higher prevalence of obstructive coronary artery disease than those with normal BMD.