Effectiveness, safety, and patient reported outcomes of a planned investment procedure in higher-risk chronic total occlusion percutaneous coronary intervention: Rationale and design of the invest-CTO study.

BACKGROUND: The anatomical complexity of a chronic total occlusion (CTO) correlates with procedural failure and complication rates. CTO modification after unsuccessful crossing has been associated with subsequent higher technical success rates, but complication rates remain high with this approach. While successful CTO percutaneous coronary intervention (PCI) has been associated with improved angina and quality of life (QOL) this has not been demonstrated in anatomically high-risk CTOs. Whether a planned CTO modification procedure, hereafter named Investment procedure, could improve patient outcomes has never been investigated. STUDY DESIGN: Invest-CTO is a prospective, single-arm, international, multicenter study, evaluating the effectiveness and safety of a planned investment procedure, with a subsequent completion CTO PCI (at 8-12 weeks), in anatomically high-risk CTOs. We will enroll 200 patients with CTOs defined as high-risk according to our Invest CTO criteria at centers in Norway and United Kingdom. Patients with aorto-ostial lesions, occlusion within a previous stent, or a prior attempt at target vessel CTO PCI within 6 months will be excluded. The co-primary endpoints are cumulative procedural success (%) after both procedures, and a composite safety endpoint at 30 days after completion CTO PCI. Patient reported outcomes (PROs), treatment satisfaction, and clinical endpoints will be reported. CONCLUSION: This study will prospectively evaluate the effectiveness and safety of a planned two staged PCI procedure in the treatment of high-risk CTOs and may have the potential to change current clinical practice.

Right ventricular postsystolic shortening: Resolution after opening a totally occluded right coronary artery.

Acute myocardial ischemia induces reduced systolic shortening and causes postsystolic shortening (PSS). Right ventricular (RV) PSS in coronary artery disease has been less studied. We present here the case of a 51-year-old woman admitted with a non-ST segment elevation myocardial infarction and significant PSS in the RV free-wall segments on two-dimensional speckle tracking echocardiography, suggesting ongoing ischemia. A cardiac CT demonstrated occluded proximal right coronary artery with a low-attenuated/soft plaque, confirmed by coronary angiography which was treated by percutaneous coronary intervention. At 3-week follow-up, there was complete resolution of the RV-PSS, with a more synchronized pattern of maximum myocardial shortening at systole.

Intravascular Lithotripsy for Calcium Modification in Chronic Total Occlusion Percutaneous Coronary Intervention.

Intravascular lithotripsy (IVL) has been shown to be safe and effective for calcium modification in nonocclusive coronary artery disease (CAD), but there are only case reports of its use in calcified chronic total occlusions (CTO). We report data from an international multicenter registry of IVL use during CTO percutaneous coronary intervention (PCI) and provide provisional data regarding its efficacy and safety. During the study period, IVL was used in 55 of 1053 (5.2%) CTO PCI procedures. IVL was used within the occluded segment after successful CTO crossing in 53 procedures and during incomplete CTO crossing in 2 cases. The mean J-CTO score was 3.1. CTO PCI technical and procedural success was achieved in 53 (96%) and 51 (93%) cases. Six patients had a procedural complication, with 3 main vessel perforations (5%). Two had covered stent implantation, one required pericardiocentesis, and one was managed conservatively. All had combination therapy with another calcium modification device. Two patients had a procedural myocardial infarction (PMI) (4%), and two others had a major adverse cardiovascular event (MACE) (4%) at a median follow-up of 13 (4-21) months. IVL can effectively facilitate calcium modification during CTO PCI. More data are required to establish the efficacy and safety of IVL and other calcium modification devices when used extraplaque or in combination during CTO PCI.

Intravascular lithotripsy in saphenous vein grafts and graft stent failure: A case series.

The long-term patency of saphenous vein grafts (SVGs) is poor compared to arterial bypass grafts. Re-do coronary artery bypass graft surgery (CABG) is high risk, thus graft failure often requires revascularization with percutaneous coronary intervention (PCI). While PCI to the native vessels is preferable, PCI to SVGs is sometimes necessary despite being associated with a high incidence of stent failure. While early SVG degeneration is associated with friable disease, calcification becomes an increasing problem in older grafts. Intravascular Lithotripsy (IVL) has been demonstrated to be safe and effective in the treatment of calcified native coronary artery disease (CAD). We present the first case series of five patients undergoing PCI to de novo SVG disease or SVG stent failure utilizing IVL for calcium modification.

Baseline frailty status and outcomes important for shared decision-making in older adults receiving transcatheter aortic valve implantation, a prospective observational study.

AIMS: The objective of this study was to examine baseline frailty status (including cognitive deficits) and important clinical outcomes, to inform shared decision-making in older adults receiving transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We conducted a prospective, observational study of 82 TAVI patients, recruited 2013 to 2015, with 2-year follow-up. Mean age was 83 years (standard deviation (SD) 4.7). Eighteen percent of the patients were frail, as assessed with an 8-item frailty scale. Fifteen patients (18%) had a Mini-Mental Status Examination (MMSE) score below 24 points at baseline, indicating cognitive impairment or dementia and five patients had an MMSE below 20 points. Mean New York Heart Association (NYHA) class at baseline and 6 months was 2.5 (SD 0.6) and 1.4 (SD 0.6), (p < 0.001). There was no change in mean Nottingham Extended Activities of Daily Living (NEADL) scale between baseline and 6 months, 54.2 (SD 11.5) and 54.5 (SD 10.3) points, respectively, mean difference 0.3 (p = 0.7). At 2 years, six patients (7%) had died, four (5%, n = 79) lived in a nursing home, four (5%) suffered from disabling stroke, and six (7%) contracted infective endocarditis. CONCLUSIONS: TAVI patients had improvement in symptoms and maintenance of activity of daily living at 6 months. They had low mortality and most patients lived in their own home 2 years after TAVI. Complications like death, stroke, and endocarditis occurred. Some patients had cognitive impairment before the procedure which might influence decision-making. Our findings may be used to develop pre-TAVI decision aids.

Retrograde Dissection and Reentry: Strategies: Common Pitfalls and Troubleshooting.

The retrograde dissection reentry (RDR) technique is often required to treat the most complex chronic total occlusions (CTOs). This involves a sequence of procedural steps with many potential pitfalls. Procedural planning, knowledge of the equipment, including task-specific wires and microcatheters, and the ability to systematically trouble shoot is necessary to achieve consistent success. With the combination of more complex anatomy and collateral crossing, RDR is associated with higher rates of procedural complications, which the CTO operator must be specifically trained to avoid and to manage.

Impella use in acute myocardial infarction complicated by cardiogenic shock and cardiac arrest: Analysis of 10 years registry data.

AIMS: To assess characteristics and outcome of patients treated with Impella for acute myocardial infarction (AMI) complicated by severe cardiogenic shock (CS) or cardiac arrest (CA). METHODS AND RESULTS: From 2008 through 2017, 92 patients with AMI complicated by CS were treated with Impella. Survival varied according to clinical presentation. Patients in cardiogenic shock without CA had a 75% 30-day survival. Patients with CA and return of spontaneous circulation (ROSC) had a 43% survival and those with CA and ongoing cardio-pulmonary resuscitation (CPR) had a 6% 30-day survival. Age, pre-existing hypertension, coronary disease, ventilatory support and use of adrenergic agents were associated with worse prognosis. Complications were predominantly access site related. CONCLUSIONS: In this registry of patients with AMICS treated with Impella, hypertension and older age were found to be negatively predictive for survival. Patients without CA had the highest 30-day survival. In patients with ROSC, survival was strongly related to age and comorbidity. Patients with ongoing CPR had very high mortality.