Impact of Left Ventricular Outflow Tract Calcification on Outcomes Following Transcatheter Aortic Valve Replacement.

BACKGROUND: We aimed to determine left ventricular outflow tract (LVOT) calcification impact following transcatheter aortic valve replacement (TAVR) with contemporary transcatheter heart valves. Recent studies reported a higher rate of 2-year mortality with greater than moderate LVOT calcium, but they have not established a reliable and validated method to assess the degree of valve calcification and utilized first-generation valves for their analyses. MATERIALS/METHODS: We conducted a retrospective analysis of patients who underwent TAVR at our institution from 2013 through 2017 with available valves. LVOT calcification quantification was assessed as a continuous variable. RESULTS: We included 273 patients: 179 had a non-calcified LVOT (NOLVOTCA) and 96 had a calcified LVOT (LVOTCA). Balloon post-dilatation (BPD) was utilized in 31.3% of LVOTCA vs. 19% of NOLVOTCA (p = 0.029). The Evolut R valve was used in 40.6% vs. 23.4% (p = 0.002), while the Sapien 3 was used in 59.4% vs. 76.6% (p = 0.004), for the LVOTCA and NOLVOTCA, respectively. Paravalvular leak (PVL) at hospital discharge was higher in LVOTCA (47.5%) versus NOLVOTCA (29.1%; p = 0.004). All-cause mortality (11.5% vs. 10.1%; p = 0.5) and need for permanent pacemaker implantation were similar between the groups. There was a positive trend between LVOT calcification volume and the probability of any PVL (OR 1.012; 95% CI, 0.99-1.02). CONCLUSIONS: TAVR performed in patients with calcified LVOT is safe, but LVOT calcification adversely impacts TAVR outcomes, with a higher PVL rate despite greater usage of BPD. Calcium quantification did not predict any PVL degree post-TAVR.

Impact of intravascular ultrasound on Outcomes following PErcutaneous coronary interventioN for In-stent Restenosis (iOPEN-ISR study).

BACKGROUND: Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) remains common. Intravascular imaging allows for the determination of the mechanism of ISR, potentially guiding appropriate therapy. Intravascular ultrasound (IVUS)-guided stent implantation is associated with a reduction in adverse events after PCI, but its impact on treatment of ISR is not clear. METHODS: All patients with 1-year follow-up after ISR treatment from 2003 through 2016 were included and stratified by IVUS use. The primary endpoint was the rate of major adverse cardiac events (MACE) at 1 year, defined as the composite of all-cause mortality, Q-wave myocardial infarction, and target vessel revascularization (TVR). RESULTS: The final analysis included 1522 ISR patients, 65.9% of whom were treated with IVUS guidance. The primary endpoint occurred in 18.0% of patients treated with IVUS guidance vs. 24.5% of patients treated with angiography guidance (p = 0.0014). Post-dilatation was used more often with IVUS (18.6% vs. 14.1%, p < 0.001), with a larger diameter of new stents (3.04 ± 0.35 mm vs. 2.94 ± 0.47 mm, p = 0.001). At 1 year, TVR occurred in 14.5% with IVUS guidance and 19.2% with angiography guidance (p = 0.021). CONCLUSIONS: The use of IVUS is associated with decreased MACE at 1 year following PCI for ISR. These results support routine IVUS for the treatment of ISR lesions.

Adverse Events and Modes of Failure Related to Rotational Atherectomy System: The Utility of the MAUDE Database.

BACKGROUND/PURPOSE: Coronary artery calcification is a marker of advanced atherosclerosis and a predictor of adverse clinical outcomes. Rotational atherectomy (RA) can effectively modify calcified lesions, optimizing procedural outcomes. We interrogated the most commonly reported adverse events involving rotational atherectomy systems (Rotablator and Rotapro) by analyzing post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. METHODS/MATERIALS: We queried MAUDE from September 1, 2016, through December 31, 2019. After excluding duplicate reports, we included 363 reports for Rotablator and 63 reports for Rotapro in the final analysis. RESULTS: Percentages represent the proportion of total submitted MAUDE reports. The most commonly reported complications for Rotablator and Rotapro included dissection (2.7% and 6.3%, respectively) and perforation (4.1% and 19%, respectively). The most commonly reported device-related issues included detachment or structural damage, or both, for Rotablator (39.1%) and entrapment of the device component for Rotapro (47.6%). The most commonly damaged device component was the Rotawire, whereas the most commonly entrapped device component was the Rotaburr for both device configurations. Rotablator and Rotapro device-related complications were most commonly reported for the left anterior descending artery. CONCLUSION: An analysis of the MAUDE database demonstrates that in real-world practice, RA devices are associated with important complications. Ongoing surveillance of safety profiles, patient outcomes, and failure modes of RA devices is warranted. Our analysis provides important insights into the mechanisms of failure of RA devices and associated complications but cannot verify causality.

Return of the Left Internal Mammary Artery.

Competitive flow from a non-critical native vessel leading to longitudinal narrowing/atresia of the left internal mammary artery (LIMA) is described as "the string phenomenon." We describe spontaneous recanalization of an atretic LIMA following coronary artery bypass grafting for multivessel coronary artery disease.

Effects of Cangrelor as Adjunct Therapy to Percutaneous Coronary Intervention.

Percutaneous coronary intervention (PCI) in patients with angiographic evidence of intracoronary thrombus is associated with in-hospital and 30-day adverse clinical outcomes. Cangrelor, a direct, rapid-onset acting intravenous P2Y12 receptor inhibitor, has been proved to be effective by reducing peri-PCI ischemic complications in subjects who underwent PCI. This study aimed to assess the angiographic and in-hospital clinical outcomes in all-comer patients receiving cangrelor immediately before PCI at a tertiary care center. The study analyzed consecutive unselected subjects treated with cangrelor at the time the decision was made to proceed with PCI. At the end of the procedure, all patients were transitioned to oral antiplatelet therapy. The target lesion angiographic assessment of Thrombolysis in myocardial infarction flow grade (TIMI-Flow), TIMI-thrombus grade (TIMI-Thrombus), myocardial blush grade, and TIMI-myocardial perfusion grade (TMPG) was performed before and post-PCI. Clinical events were recorded during the procedure and at discharge. In total, 223 patients (244 lesions) were included in the analysis (106, 97, and 20 patientswith TIMI-Flow 0/1, TIMI-Flow 2/3, and cardiogenic shock, respectively). The overall mean age was 63 ± 12 years, 70% men and 38% with diabetes mellitus. Acute myocardial infarction was the main presentation (72%). The use of cangrelor improved TIMI-Flow, MGB, TMPG, and TIMI-Thrombus in patients with initial TIMI-Flow 0 to 2. Major bleeding rate was 2.0%. In conclusion, cangrelor was effective and safe in restoring TIMI-Flow 3, reducing thrombus burden and improving myocardial blush grade and TMPG when administered to unselected subjects who underwent PCI. Therefore, cangrelor should be considered in patients presenting with intracoronary thrombus before intervention.

Clinical outcomes of complete revascularization using either angiography-guided or fractional flow reserve-guided drug-eluting stent implantation in non-culprit vessels in ST elevation myocardial infarction patients: insights from a study based on a systematic review and meta-analysis.

Current guidelines recommend that percutaneous coronary intervention (PCI) should be restricted to the culprit vessel in ST elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD) and without cardiogenic shock. However, newer data suggests that performing complete revascularization (CR) in MVD patients may lead to better outcomes compared to intervention in the culprit vessel only. The aim of this meta-analysis is to examine the available data to determine if CR (using either angio- or fractional flow reserve guidance-FFR) following primary PCI in STEMI patients without cardiogenic shock impacts clinical outcomes. Meta-analysis was performed by conducting a literature search of PubMed from January 2004 to July 2017. Pooled estimates of outcomes, presented as odds ratios (OR) [95% confidence intervals], were generated using random-effect models. A total of 9 studies (3317 patients) were included. CR showed a significant MACE reduction (OR 0.49, 95% CI 0.36-0.66, p < 0.001); All-cause mortality (OR 0.69, 95% CI 0.48-0.98, p = 0.04) and repeat revascularization (OR 0.38, 95% CI 0.28-0.51, p < 0.001) at ≥ 12 months follow-up. The FFR-guiding CR group presented a MACE reduction (odds ratio 0.52, 95% CI 0.30-0.90, p = 0.02) due to a decrease of repeat revascularization (OR 0.41, 95% CI 0.21-0.80, p = 0.009). Overall, performing complete revascularization in STEMI patients showed a MACE reduction, all-cause death and repeat revascularization. Compared to culprit-only revascularization, treating multi-vessel disease in STEMI patients using FFR guidance is associated with decreased incidence of MACE, due to a decreased rate of revascularization.

Optical coherence tomography-guided percutaneous coronary intervention compared with other imaging guidance: a meta-analysis.

The use of optical coherence tomography (OCT) in PCI guidance is limited perhaps by the lack of adequately powered studies which compare its efficacy and outcomes to the other more popular imaging modalities. We therefore performed a meta-analysis to compare clinical outcomes following OCT-guided PCI with the other imaging modalities in two separate comparisons. We abstracted data from randomized control trials and observational comparative studies focusing on OCT versus either angiography- or IVUS-guided PCI outcomes identified following a systematic search (April 2006 and May 2017). This meta-analysis included a total of 2781 patients; OCT-guidance versus Angiography guidance (n = 1753) and OCT-guidance versus IVUS-guidance (n = 1028). Pooled estimates of outcomes, presented as odds ratios (OR) [95% confidence intervals], were generated with random-effect models. OCT guidance showed lower rates of MACE (OR 0.70 [0.49, 1.00] p = 0.05) and cardiac deaths (OR 0.40 [0.18, 0.90] p = 0.03) compared to Angiography-guidance alone but no statistical significant results for myocardial infarction (OR 0.70 [0.42, 1.16] p = 0.17), stent thrombosis (OR 1.17 [0.40, 3.43] p = 0.77) and target lesion revascularizations (OR 1.07 [0.48, 2.38] p = 0.86).No statistical significance was observed in the OCT versus IVUS comparison; MACE (OR 0.89 [0.46, 1.73] p = 0.73), cardiac deaths (OR 0.56 [0.12, 2.70] p = 0.47), MI (OR 0.56 [0.12, 2.70] p = 0.47), ST (OR 0.43 [0.06, 2.95] p = 0.39), and TLR(OR 0.99 [0.45, 2.18] p = 0.99). OCT-guided PCI in comparison with angiography-guided was associated with reduction in adverse events for the composite of cardiac deaths, myocardial infarction and repeat revascularizations. There was no statistically significant difference in clinical outcomes observed in the comparison between OCT- and IVUS-guidance.

Intravascular ultrasound assessment of the effect of laser energy on the arterial wall during the treatment of femoro-popliteal lesions: a CliRpath excimer laser system to enlarge lumen openings (CELLO) registry study.

The CliRpath Excimer Laser System to Enlarge Lumen Openings (CELLO) registry included patients treated with modified excimer laser catheters for the endovascular treatment of peripheral artery disease affecting the superficial femoral artery (SFA) and proximal popliteal artery. The aim of this study was to assess, via intravascular ultrasound (IVUS) the dissections in the vessel wall following treatment with the laser catheters. IVUS grayscale images from the CELLO registry were systematically reviewed for dissections in the treated vessel segments by two investigators. Images from 33 patients; 66 pullbacks (1867 IVUS frames in 2 phases), were successfully matched frame-to-frame to evaluate identical segments of the treated vessels in the two phases; post-2 mm Turbo-Elite laser pilot channel creation and post Turbo-Booster laser atherectomy. Dissections were categorized as; (1) intimal, (2) medial, (3) intramural hematoma, and (4) adventitial according to the ACC Clinical Expert Consensus Document classification of dissections. An average of 57 frames was evaluated per pullback, giving a total of 3734 frames (1867 matched for pre-ablation (post channel creation) and post-ablation phases). Treatments with the modified Excimer laser catheters resulted in a significant increase in lumen area of 5.5 ± 3.2-mm2 (95% CI 4.3-6.8, p < 0.0001) and reduction in plaque plus media volume of -10.6 ± 36.0 mm3 (95% CI -25.8 to 4.6, p = 0.1619) whilst giving rise to mainly intramural hematoma formations post Turbo-Booster laser treatment in 55% of frames assessed and 24% medial dissections with less than 1% adventitial disruption. The Excimer laser based Turbo-Booster treatment of peripheral artery lesions resulted in significant plaque debulking and increased lumen diameter with negligible degree of adventitial layer injury.