Safety, Efficacy and Long-Term Outcomes of Patients Treated with the Occlutech Paravalvular Leak Device for Significant Paravalvular Regurgitation.

Between December 2014 and March 2021, 144 patients with aortic (Ao) or mitral (Mi) paravalvular leaks (PVLs) were enrolled at 21 sites in 10 countries. Safety data were available for 137 patients, who were included in the safety analysis fraction (SAF), 93 patients with Mi PVLs and 44 patients with Ao PVLs. The full analysis set (FAS) comprised 112 patients with available stratum (aortic/mitral leak) as well as baseline (BL), 180-day or later assessments (2 years). Procedural success (implantation of the device with a proper closure of the PVL, defined as reduction in paravalvular regurgitation of ≥one grade as assessed by echocardiography post implantation) was achieved in 91.3% of FAS patients with Mi PVLs and in 90.0% of those with Ao PVLs. The proportion of patients suffering from significant or severe heart failure (HF), classified as New York Heart Association (NYHA) class III/IV, decreased from 80% at baseline to 14.1% at 2-year follow-up (FAS). The proportion of FAS patients needing hemolysis-related blood transfusion decreased from 35.5% to 3.8% and from 8.1% to 0% in Mi patients and Ao patients, respectively. In total, 35 serious adverse events (SAEs) were reported in 27 patients (19.7%) of the SAF population. The SAEs considered possibly or probably related to the device included device embolization (three patients), residual leak (two patients) and vascular complication (one patient). During follow-up, 12/137 (8.8%) patients died, but none of the deaths was considered to be device-related. Patients implanted with the Occlutech Paravalvular Leak Device (PLD) showed long-lasting improvements in clinical parameters, including NYHA class and a reduced dependency on hemolysis-related blood transfusions.

IntravaScular Lithotripsy for the Management of UndILatable Coronary StEnt: The SMILE Registry.

BACKGROUND: Intravascular lithotripsy (IVL) showed to be effective in dilating heavily calcified de novo coronary lesions but little is known about its performance in under-expanded stents management. Aim of this study was to assess the feasibility, effectiveness and safety of IVL for the treatment of stent underexpansion refractory to balloon dilatation. METHODS: A multicentre, retrospective cohort analysis was performed in patients undergoing IVL to treat under-expanded stents following non-compliant balloon expansion failure. Primary endpoint was successful IVL dilatation defined as IVL balloon delivery and application at the target site followed by an increase of at least 1 mm2 in minimal stent cross-sectional area (MSA) on intracoronary imaging or an increase of at least 20% in minimal stent diameter (MSD) by quantitative coronary analysis (QCA). RESULTS: Thirty-nine under-expanded stents (34 patients) were included. Two cases (5.1%) of multiple stent layers and one (2.5%) acutely under-expanded stent were treated. The median IVL balloon diameter was 3.1 mm (IQR: 2.5-3.5 mm) while the number of pulses emitted was 56.7 (IQR: 30-80). IVL was successful in 34 cases (87.1%), with significant improvement in MSD (post: 3.23 mm [IQR: 3-3.5 mm] vs. pre: 0.81 mm [IQR: 0.35-1.2], p < 0.00001) and MSA (post: 7.61mm2 [IQR: 6.43-7.79mm2] vs. pre: 3.35 [IQR: 2.8-4 mm2], p < 0.00001). Non-fatal peri-procedural ST-elevation myocardial infarction occurred in one case (2.5%) due to IVL balloon rupture. No cardiac death, target lesion revascularization and stent thrombosis occurred in-hospital and at 30-day follow-up. CONCLUSIONS: Bailout IVL was feasible, efficacious and safe to improve refractory stent under-expansion.

ST-elevation Myocardial Infarction Due to Stent Underexpansion Managed with Coronary Lithoplasty.

BACKGROUND: Coronary calcified lesions may limit optimal stent deployment resulting in stent underexpansion, increasing the risk of thrombosis. The Shockwave Lithoplasty System, a new technology combining a balloon angioplasty catheter with the use of sound waves, it is able to break calcium deposits without affecting vascular soft tissue. CASE PRESENTATION: An 80-year-old Caucasian man with ST elevation myocardial infarction underwent emergent coronary angiography showing complete intrastent thrombosis at the proximal trait of LAD. After thrombus removal, it was evident that stent under-expansion at its proximal edge was caused by vascular calcification. Coronary shockwave lithoplasty was chosen to treat this lesion. After calcium deposits disruption we were able to obtain complete stent expansion. CONCLUSION: Our case demonstrates the usefulness and safety of the lithoplasty system in the context of ST elevation myocardial infarction.

Ectopic Origin of the Left Anterior Descending Artery from the Proximal Right Coronary Artery: An Imaging Report.

Anomalies of the coronary arteries represent rare congenital disorders, which are characterized by a wide spectrum of clinical manifestations. Usually, they are asymptomatic, but sometimes they cause myocardial ischemia or sudden cardiac death. Here, we describe the case of a patient who suffered from angina. Coronary angiography revealed an ectopic origin of the left anterior descending coronary artery from the proximal trait of the right coronary artery and the left circumflex artery, originating from the left sinus; the whole coronary tree was free of atherosclerosis. To better define the coronary anatomy, we performed computed tomography angiography with a three-dimensional reconstruction. The patient was discharged from the clinic after 48 h under optimal medical treatment.

A Case of Critical Calcified Innominate Artery Stenosis Successfully Treated With the Shockwave Lithoplasty.

PURPOSE: The Shockwave Lithoplasty System represents a novel technology combining a balloon angioplasty catheter with the use of sound waves. Evidences suggest that it is a reliable tool to overcome calcified stenosis in both peripheral and coronary arteries. Here, we describe the case of a patient with calcified innominate artery stenosis successfully treated with the Shockwave Lithoplasty System. CASE REPORT: A 78-year-old woman with hypertension, and dyslipidemia, came to our observation for dizziness. Instrumental examinations showed critical calcified stenosis of the innominate artery. The lesion was successfully treated with the Shockwave Lithoplasty System and subsequent stent apposition. Final angiography demonstrated excellent position of the stent, good wall apposition, and confirmed patency of the right common and right vertebral artery origins. CONCLUSION: Our clinical experience demonstrates that Lithoplasty is safe and effective also for the treatment of supra-aortic vessels.

Acute coronary stent thrombosis: A case of type 3 Kounis syndrome.

Kounis syndrome refers to an acute coronary syndrome, consequent to an allergic reaction. It results from mast cell degranulation with subsequent release of numerous inflammatory mediators, leading to coronary vasospasm, atheromatous plaque rupture, or stent thrombosis. Here, we describe the case of a 47-year-old Caucasian man with acute stent thrombosis, as a consequence of allergic reaction to contrast media. .

Intravascular ultrasound-guided shockwave treatment of stents overlapping underexpansion of calcified left anterior descending artery.

Heavily calcified lesions may limit optimal stent deployment resulting in stent underexpansion, thus increasing the risk of restenosis and thrombosis. We describe the case of overlapping stents underexpansion treated with a shockwave intravasuclar lithoplasty system (Shockwave Medical Inc., Santa Clara, CA, USA). A 65-year-old man with angina, underwent coronary angiography and intravascular ultrasound showing restenosis, in a site of overlapping stents, due to calcified tissue. Shockwave lithoplasty balloon was able to break calcified tissue in a site of overlapping stents, allowing subsequent vessel dilation and repeat stent implantation with optimal final stent expansion. Heavily calcified lesions may limit optimal stent deployment resulting in stent underexpansion. Treating stent underexpansion or restenosis due to calcified tissue is a great challenge. Shockwave lithoplasty is effective in breaking calcified tissue also in a site of overlapping stents. The improved plaque compliance allows to repeat stent implantation with optimal final stent expansion.

A Case of Stent Under-Expansion due to Calcified Plaque Treated with Shockwave Lithoplasty.

We report the case of a stent under-expansion due to heavily calcified plaque treated with the shockwave lithoplasty system. A 77-year-old woman underwent coronary angiography, and intravascular ultrasound revealed stent under-expansion due to calcified plaque. Shockwave lithoplasty balloon was used to disrupt calcium deposits around the stent, thereby allowing a correct stent expansion with an excellent angiographic and intravascular ultrasound result.

When Calcium Gets Tough, the Tough Cardiologist Starts to Play .

Coronary calcification is a hard challenge for the interventional cardiologist, as it is associated with incomplete stent expansion and frequently stent failure. In recent years, innovative techniques, such as rotational atherectomy, have been developed to treat coronary calcification. However, these are burdened with an increased procedural risk. We report the case of a 60-year-old Caucasian man treated 1 month before at another center with primary coronary angioplasty and stenting of the ramus intermedius for coronary syndrome. Coronary angiography showed a critical stenosis of the left main coronary artery as well as critical calcified stenosis of the left anterior descending artery and the diagonal branch. Coronary calcification was treated with rotational atherectomy that preceded the angioplasty and stenting. Because of persistence of the symptomatology, coronary angiography was repeated 1 month later and showed a critical calcified restenosis of the ramus intermedius at the site of the previous stenting. Considering the high risk of traditional atherectomy, we performed lithotripsy-enhanced disruption of calcium beyond the stents with the Shockwave Coronary Lithoplasty System. The Shockwave Coronary Lithoplasty System has been introduced recently in order to treat calcified coronary lesions with greater safety. The procedure allows most calcified coronary lesions to be treated with simplicity and safety. This system employs sound waves, similar to those used for treating kidney stones, to crush the calcified lesions. We present the first case described to date in whom this technique was successfully used to treat calcified restenosis in a previous stent.

Pathophysiology and ECG patterns of isolated right ventricular infarction with nondominant right coronary artery.

The prevalence of isolated right ventricular infarction is 0.4-2.4% in autopsy series and may occur by at least three different mechanisms, of which occlusion of a nondominant right coronary artery is reviewed here. Although rare, as oxygen demand/supply of the right is lower than that of the left ventricle, due to the smaller muscular mass, and it has a good prognosis, sudden death and cardiac rupture have been reported. Differential diagnosis with anterior infarction is needed. ECG may help but specific criteria should be adopted: dome-like and decreasing ST segment elevation from V1 to V3 leads; rapid ST segment normalization and no Q wave evolution from V1 to V3 leads, either accompanied or not by modest ST segment elevation in DIII (but not aVF) evolving in no Q wave; ST segment elevation in right-sided leads which should be explored; absence of ST segment depression in aVL; absent concomitant ST segment elevation in all inferior leads (DII, DIII, aVF). Applying these criteria may prevent erroneous management of right ventricular infarction if it is confused with left ventricular infarction. Right ventricular function evaluation should always be performed by echocardiography. Magnetic resonance imaging should be useful. An illustrative case and an ECG flow-chart are presented.

Long-term efficacy of high-dose tirofiban versus double-bolus eptifibatide in patients undergoing percutaneous coronary intervention.

BACKGROUND: There is no head-to-head comparison between tirofiban versus eptifibatide in patients undergoing percutaneous coronary intervention (PCI) when added to standard antiaggregating drugs (AAD) to prevent ischemic events within 1 year. METHODS: We compared real-world patients undergoing PCI who were on oral single AAD and were block randomized to receive, immediately preintervention, high-dose tirofiban (n = 519) or double-bolus eptifibatide (n = 147) and a second oral antiplatelet agent. The incidence of composite ischemic events within 1 year, including death, acute myocardial infarction, angina, stent thrombosis or repeat PCI or coronary bypass surgery (primary end-point) was modelled by forced Cox's regression. RESULTS: There were overall 65 composite ischemic events: 47 (9.1%) in the tirofiban group and 18 (12.2%) in the eptifibatide group (univariate log-rank test: P = 0.22). On the basis of 21 potential covariates fitted simultaneously, multivariable adjusted hazard ratios showed that age [hazard ratio 1.03, 95% confidence interval (CI) 1.01-1.07, P = 0.01], chronic renal failure (hazard ratio 3.21, 95% CI 1.02-10.10, P = 0.05), pre-PCI values of creatine kinase-myocardial band (CK-MB) (hazard ratio 1.002, 95% CI 1.0002-1.0054, P = 0.04), intra-aortic balloon pump (hazard ratio 5.88, 95% CI 12.33-14.85, P = 0.0002) and the presence of eptifibatide (hazard ratio 1.85, 95% CI 1.04-3.29, P = 0.04) were significant risk factors whereas thrombolysis by tenecteplase (hazard ratio 0.19, 95% CI 0.05-0.69, P = 0.01) was a significant protector. Interestingly, eptifibatide versus tirofiban efficacy was explained based on pre-PCI values of CK-MB. CONCLUSION: Head-to-head comparison between eptifibatide and tirofiban in patients undergoing PCI while on double AAD showed that eptifibatide had a lower efficacy on the incidence of composite ischemic events within 1 year, which might be explained by a reduced action on CK-MB pre-PCI.

GPIIb/IIIa Receptor Antagonism Using Small Molecules Provides no Additive Long-Term Protection after Percutaneous Coronary Intervention as Compared to Clopidogrel Plus Aspirin.

BACKGROUND: There is some controversy as to whether tirofiban or eptifibatide, two small anti-aggregating drugs (AAD), may reduce the incidence of composite ischemic events within one year in patients undergoing percutaneous coronary intervention (PCI) in the real clinical world. METHODS: We compared consecutive patients on oral double AAD (with clopidogrel and aspirin) who underwent PCI (n=207) and patients who were on single AAD and received a second AAD, just prior to PCI, and either high-dose tirofiban or double-bolus eptifibatide (double AAD plus small molecules group, n=666). The primary end point (incidence of composite ischemic events within one year) included death, acute myocardial infarction, unstable angina, stent thrombosis or repeat PCI or coronary bypass surgery (related to the target vessel PCI failure) and was modelled by Cox's regression. RESULTS: There were 89 composite ischemic events: 24 (11.6%) in double AAD alone and 65 (9.8%) in double AAD plus small molecules groups (log-rank test: p=0.36). Incidences by type of ischemic events were similar between the 2 groups. Based on 21 potential covariates fitted simultaneously, adjusted hazard ratios (HR and 95% confidence intervals) showed that age (HR 1.03, 1.01-1.06, p=0.01), diabetes (HR 1.68, 1.01-2.79, p=0.05) and intra aortic balloon pump (HR 5.12, 2.36-11.10, p=0.0001) were significant risk factors whereas thrombolysis by tenecteplase (HR 0.35, 0.13-0.98, p=0.05) and having had hypertension or anti-hypertensive treatment (HR 0.58, 0.36-0.93, p=0.03) were significant protectors for events. Whether small molecules were present provided a non significant additional benefit as compared to double AAD alone (HR 0.83, 0.51-1.36, p=0.46). Pre-PCI CK-MB were not useful to predict events (HR 1.01, 0.99-1.01, p=0.17). CONCLUSIONS: In clinical world patients undergoing PCI (rescue plus primary <13%) while on double AAD, based on clopidogrel plus aspirin, small molecules (tirofiban or eptifibatide) provided no additive long-term protection against the occurrence of composite ischemic events whereas thrombolysis by tenecteplase did.

Safety of downstream high-dose tirofiban bolus among 1578 patients undergoing percutaneous coronary intervention: the Sant'ANna TIrofiban Safety study.

BACKGROUND: The Sant'ANna TIrofiban Safety study (SANTISS) is an open-label investigator-initiated single-centre registry launched to assess the combination of bleeding and access site in-hospital complications (primary end-point) in patients undergoing percutaneous coronary intervention (PCI) by femoral approach only. METHODS: We compared patients who were on oral single antiaggregating drug (AAD) and received, just prior to PCI, high-dose tirofiban and a second oral antiplatelet agent (triple AAD: group 1, n = 970) with those who were already on an oral double AAD regimen and did not receive tirofiban (double AAD: group 2, n = 608). RESULTS: Group 2 patients were slightly older, presented less frequently with unstable angina and had chronic renal failure more frequently. They were more than twice as frequently on rescue PCI, being more than three-fold less frequently on primary PCI (all: 0.01>P < 0.001). Overall, there were 87 in-hospital (average 4.7 days of stay) complications: 51 (5.3%) in group 1 and 36 (5.9%) in group 2 (not significant). Haemotransfusions were needed in 34 patients: 21 (2.2%) in group 1 and 13 (2.1%) in group 2 (not significant). Of the 16 hospital deaths, eight (0.8%) were seen in group 1 and eight (1.3%) in group 2 (not significant). Multivariate prediction showed a high predictive accuracy (areas under the curve >0.700) of female sex, rescue PCI and chronic renal failure to index complications, with highly significant odds ratios. The presence of high-dose tirofiban did not increase complication risk. CONCLUSION: In the real world, high-dose tirofiban is well tolerated by patients on elective, primary or rescue PCI, and the in-hospital complication rate, including major bleeding, is low. This may have pharmacoeconomic consequences.

Prophylactic intra-aortic balloon pump is useful to facilitate percutaneous coronary interventions: images from rescue cases.

Images are presented of coronary reperfusion that occurred shortly after insertion of an intra-aortic balloon pump for counter-pulsation in 3 patients with acute myocardial infarction refractory to thrombolytic therapy and hemodynamic derangement. It is shown that prophylactic intra-aortic balloon pump use may facilitate percutaneous coronary intervention during acute myocardial infarction and it is useful to provide a visual assessment of myocardial flow restoring.

Comparative application of multivariate models developed in Italy and Europe to predict early (28 days) and late (1 year) postoperative death after on- or off-pump coronary artery bypass grafting.

OBJECTIVES: The aim of this study was to compare the risk of death predictive performances of the OP-RISK, EuroSCORE, and Italian coronary artery bypass grafting (CABG) Outcome studies' functions when applied to a southern Italian cardiac surgery center (Sant'Anna hospital in Catanzaro [SAHCZ]), which contributed data to the Italian CABG Outcome study, and to see if this predictive index may be applied to on- and off-pump interventions. METHODS: The OP-RISK study data set was used to derive Weibull and logistic functions to predict early (28 days) and late (1 year) death rates following CABG based on ejection fraction, heart rate, age, and aortic cross-clamping time. Then the data of 385 CABG patients who underwent operations in 2003 in SAHCZ were collected with 1-year follow-up data, which also included data used to obtain EuroSCORE and Italian CABG Outcome study risk indices. RESULTS: Short- and long-term observed mortality rates after CABG were 2.59% and 5.88% in the SAHCZ series, largely dependent on whether CABG was alone (1.26% and 3.55%) or associated with ventriculoplasty (4.87% and 10.81%) or valve surgery (15.38% and 28.57%). There was a significant increasing trend (P = .002) of observed death rates in equinumeric tertiles of either OP-RISK (both Weibull and logistic) or EuroSCORE in the short term, whereas the trend was not significant for the Italian CABG Outcome study index. OP-RISK functions were significantly predictive for the long term (P < .005), as well as when only ejection fraction, heart rate, and age were considered (P < .011). CONCLUSIONS: It is essential to use clinical data following CABG when outcome prediction is concerned. OP-RISK and EuroSCORE indices are equally predictive in our experience, and a statistically significant (P = 0.02) difference was observed with the Italian CABG Outcome study index, whose trend in tertiles of calculated risk was not apparent, which is unexpected and unexplained. OP-RISK functions were adequate for long-term prediction. Since aortic cross-clamping time may be absent from tested predictive functions (for both short and long term), off-pump CABG mortality may also be predicted as similar to on-pump intervention mortality.

Coronary rotational atherectomy in current practice: acute and mid-term results in high- and low-volume centers.

We conducted a prospective observational study to evaluate the indications, technique, in-hospital and 9-month results of consecutive patients treated with rotational atherectomy (RA) in 12 centers during 1 year, as well as their relationship with volume of RA activity. The study included 345 lesions in 289 patients treated (4.4% +/- 2.6% of procedures at the participating centers). The lesions were mostly calcified (63%) and type B2 or C (74%). Procedural success was obtained in 94% of patients, with a major adverse cardiac event (MACE) rate of 4.5%. At 9 months, MACE occurred in 17.3%. Multivariate analysis identified multivessel disease and slow flow as negative predictors of procedural success, whereas balloon pressure