Giuseppe Calligaris

Rationale and design of the PERFECTION (comparison between stress cardiac computed tomography PERfusion versus Fractional flow rEserve measured by Computed Tomography angiography In the evaluation of suspected cOroNary artery disease) prospective study

BACKGROUND Non-invasive stress tests are commonly used as gatekeepers to invasive coronary angiography (ICA) in patients with suspected coronary artery disease (CAD). New computed tomography angiography (CTA) techniques such as fractional flow reserve calculated by CTA (FFRCT) and stress myocardial computed tomography perfusion (CTP) have emerged as potential strategies to combine anatomical and functional evaluation of CAD in one technique. The aim of this study is to compare per-vessel diagnostic accuracy of FFRCT versus stress myocardial CTP for the detection of functionally significant coronary artery disease (CAD), using invasive FFR as the reference standard. METHODS Subjects with suspected CAD due to chest pain who have no contra-indications to FFRCT or stress myocardial CTP and who are referred for non-emergent, clinically indicated invasive coronary angiography (ICA), will be enrolled. A total of 300 subjects will be enrolled within 24 months. RESULTS The primary study endpoint will be the comparison of per-vessel diagnostic accuracy of CTA versus FFRCT versus stress myocardial CTP for the diagnosis of hemodynamically significant stenosis as defined by invasive FFR ≤0.80. CONCLUSIONS In the PERFECTION study, the comparison between FFRCT and stress myocardial CTP will provide understanding about which technology is more accurate for the diagnosis of functionally significant CAD.

Carotid Artery Stenting With Proximal Embolic Protection via a Transradial or Transbrachial Approach: Pushing the Boundaries of the Technique While Maintaining Safety and Efficacy

Purpose: To compare the feasibility and safety of proximal cerebral protection to a distal filter during carotid artery stenting (CAS) via a transbrachial (TB) or transradial (TR) approach. Methods: Among 856 patients who underwent CAS between January 2007 and July 2015, 214 (25%) patients (mean age 72±8 years; 154 men) had the procedure via a TR (n=154) or TB (n=60) approach with either Mo.MA proximal protection (n=61) or distal filter protection (n=153). The Mo.MA group (mean age 73±7 years; 54 men) had significantly more men and more severe stenosis than the filter group (mean age 71±8 years; 100 men). Stent type and CAS technique were left to operator discretion. Heparin and a dedicated closure device or bivalirudin and manual compression were used in TR and TB accesses, respectively. Technical and procedure success, crossover to femoral artery, 30-day major adverse cardiovascular/cerebrovascular events (MACCE; death, all strokes, and myocardial infarction), vascular complications, and radiation exposure were compared between groups. Results: Crossover to a femoral approach was required in 1/61 (1.6%) Mo.MA patient vs 11/153 (7.1%) filter patients mainly due to technical difficulty in engaging the target vessel. Five Mo.MA patients developed acute intolerance to proximal occlusion; 4 were successfully shifted to filter protection. A TR patient was shifted to filter because the Mo.MA system was too short. CAS was technically successful in the remaining 55 (90%) Mo.MA patients and 142 (93%) filter patients. The MACCE rate was 0% in the Mo.MA patients and 2.8% in the filter group (p=0.18). Radiation exposure was similar between groups. Major vascular complications occurred in 1/61 (1.6%) and in 3/153 (1.96%) patients in the Mo.MA and filter groups (p=0.18), respectively, and were confined to the TB approach in the early part of the learning curve. Chronic radial artery occlusion was detected by Doppler ultrasound in 2/30 (6.6%) Mo.MA patients and in 4/124 (3.2%) filter patients by clinical assessment (p=0.25) at 8.1±7.5-month follow-up. Conclusion: CAS with proximal protection via a TR or TB approach is a feasible, safe, and effective technique with a low rate of vascular complications.

Noninvasive Cardiac Output Measurement by Inert Gas Rebreathing in Suspected Pulmonary Hypertension

The objective of this study was to evaluate inert gas rebreathing (IGR) reliability in cardiac output (CO) measurement compared with Fick method and thermodilution. IGR is a noninvasive method for CO measurement; CO by IGR is calculated as pulmonary blood flow plus intrapulmonary shunt. IGR may be ideal for follow-up of patients with pulmonary hypertension (PH), sparing the need of repeated invasive right-sided cardiac catheterization. Right-sided cardiac catheterization with CO measurement by thermodilution, Fick method, and IGR was performed in 125 patients with possible PH by echocardiography. Patients were grouped according to right-sided cardiac catheterization-measured mean pulmonary and wedge pressures: normal pulmonary arterial pressure (n = 20, mean pulmonary arterial pressure = 18 ± 3 mm Hg, pulmonary capillary wedge pressure = 11 ± 5 mm Hg), PH and normal pulmonary capillary wedge pressure (PH-NW, n = 37 mean pulmonary arterial pressure = 42 ± 13 mm Hg, pulmonary capillary wedge pressure = 11 ± 6 mm Hg), and PH and high pulmonary capillary wedge pressure (PH-HW, n = 68, mean pulmonary arterial pressure = 37 ± 9 mm Hg, pulmonary capillary wedge pressure = 24 ± 6 mm Hg). Thermodilution and Fick measurements were comparable. Fick and IGR agreement was observed in normal pulmonary arterial pressure (CO = 4.10 ± 1.14 and 4.08 ± 0.97 L/min, respectively), whereas IGR overestimated Fick in patients with PH-NW and those with PH-HW because of intrapulmonary shunting overestimation in hypoxemic patients. When patients with arterial oxygen saturation (SO2) ≤90% were excluded, IGR and Fick agreement improved in PH-NW (CO = 4.90 ± 1.70 and 4.76 ± 1.35 L/min, respectively) and PH-HW (CO = 4.05 ± 1.04 and 4.10 ± 1.17 L/min, respectively). In hypoxemic patients, we estimated pulmonary shunt as Fick - pulmonary blood flow and calculated shunt as: -0.2423 × arterial SO2 + 21.373 L/min. In conclusion, IGR is reliable for CO measurement in patients with PH with arterial SO2 >90%. For patients with arterial SO2 ≤90%, a new formula for shunt calculation is proposed.

Use of multiple overlapping sirolimus-eluting stents for treatment of long coronary artery lesions: Results from a single-center registry in 318 consecutive patients

UNLABELLED Drug-eluting stents (DES) are superior to bare metal stents in the prevention of restenosis and target lesion revascularization (TLR). This has led to a more aggressive use of DES in everyday interventional cardiology practice. METHODS All consecutive patients who underwent coronary artery stenting with greater than 34 mm of overlapping, sirolimus-eluting stent (SES) were reviewed from a prospectively created database. A prespecified group of patients with greater than 60 mm of SES was also followed. RESULTS 318 patients were followed up at a minimum of 6 months and a mean of 9 months. The mean target lesion stented length was over 55 mm. Use of IVUS was 19.8%. Forty patients (12.6%) suffered a peri-procedural CK-MB rise. The MACE rate at 9 months was 17% with 12.6% being periprocedural myocardial infarction (MI). Clinically driven TLR was 4.4% and cardiac death was 1.3%. There were 4 cases defined as late stent thrombosis. The independent predictors of periprocedural MI were the presence of a major side branch and longer target lesion stented length, with stable angina being a negative predictor. The independent predictors of in-stent restenosis were unstable angina and target lesion number per patient. There was a trend to increased MACE in the subgroup with longer than 60 mm of SES length. CONCLUSION The use of multiple, overlapping SES is safe and effective with an acceptably low follow up MACE rate. A significant peri-procedural CK-MB rise appears to be a risk of long segment stenting. Whether this translates to long-term sequelae needs further investigation.

Stent thrombosis after sirolimus- and paclitaxel-eluting stent implantation in daily clinical practice: Analysis of a single center registry

Objectives: To evaluate stent thrombosis (ST) rate after sirolimus‐eluting stent (SES) and paclitaxel‐eluting stent (PES) implantation in daily clinical practice. Background: The safety profile of drug‐eluting stents (DES) was predominantly determined in randomized clinical trials with narrow inclusion criteria. Concerns about ST have been raised in unselected patients treated with DES. Methods: We prospectively evaluated 867 patients undergoing DES implantation, 618 patients with SES, and 249 with PES, in a single academic center. Results: Multivessel disease was present in 72% of patients, multivessel stenting was performed in 17%, long (>18 mm) lesions were treated in 30%, and multiple stents per lesion were needed in 31%. On average, 1.7 ± 0.8 stents per patient were implanted (stented segment length: 32 ± 25 mm/vessel). IIb/IIIa inhibitors were used in 7.5%. Intravascular ultrasound (IVUS) guidance was employed in 65% of SES and 50% of PES implantations, and the procedural success rate was 100% in SES and 99% in PES cases. Six‐month follow‐up was performed in all patients, whereas one‐year follow‐up was completed in 87% patients of the SES group and in 95% of the PES group. We considered that ST occurred when angiographic evidence of thrombus was available, or when patients experienced sudden cardiac death or either ST‐elevation or non‐ST‐elevation myocardial infarction (MI) through the 12‐month follow‐up period. The overall incidence of ST was 0.9% (0.4% in SES and 2% in PES, P = 0.03). Of the eight ST, two (25%) were acute, four (50%) subacute, one (12.5%) was a late event, and one (12.5%) a very late event. Seven ST were confirmed by angiography. No IVUS guidance was used in 4/8 (50%) ST patients, while antiplatelet therapy was prematurely discontinued in 3/8 (37.5%). Among ST patients, mortality and nonfatal MI rates were 25% and 37.5%, respectively. No ST was diagnosed between 6 and 12 months, while one very late thrombosis occurred at 15 months. Conclusions: The incidence of ST after DES use in daily clinical practice is low and similar to that observed in randomized clinical trials.

Elective coronary stent implantation in cardiogenic shock complicating acute myocardial infarction: in-hospital and six-month clinical and angiographic results.

Effective treatment of patients with acute myocardial infarction and cardiogenic shock depends on restoring persistent patency of the infarct‐related artery. Coronary stenting, reducing abrupt or delayed closure related to dissection and suboptimal result, may improve PTCA results in cardiogenic shock. Eighteen patients (14 males and 4 females, mean age 59 ± 7 years), referred to catheterization laboratory for acute myocardial infarction and shock, had elective stent implantation during 14 primary and 4 rescue PTCA. Time delay between shock onset and PTCA was 4.1 ± 3 hr (range, 30 min to 12 hr). The IRA was LAD in seven patients (38%), LCx in two (11%), and RCA in eight (45%). One patient (5.%) had distal LMCA occlusion. Stent deployment was successful in 100% of patients and resulted in TIMI 3 flow in 13 (72%) patients. In 13 (72%) cases, cardiogenic shock gradually resolved and the patients were discharged alive. Five patients (28%) died because of irreversible hemodynamic deterioration without evidence of reinfarction. At 6‐month follow‐up, all the discharged patients were alive and no patient had reinfarction or recurrent angina. Heart transplant was required in one patient 5 months after stenting because of refractory congestive heart failure. Angiography demonstrated patency of all the coronary arteries treated, with TIMI 3 flow in all patients. Stent restenosis rate was 30%, and target lesion revascularization with CABG or re‐PTCA was not required in any case. LV function improved from 39% ± 15% to 51% ± 15% (P < 0.01). Elective coronary stenting is an effective treatment for acute myocardial infarction complicated by cardiogenic shock and may improve acute and long‐term survival. Cathet. Cardiovasc. Intervent. 50:384–389, 2000.

AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure

AIMS The aim of this observational study was to compare acute and 12-month results of percutaneous closure of patent foramen ovale (PFO) with two occluder devices. METHODS AND RESULTS Between June 2007 and October 2014, 406 consecutive patients (48.1±13.3 years, 243 women) underwent percutaneous PFO closure with either the AMPLATZER (n=179) or the Figulla (n=227) device after a stroke or a transient ischaemic attack ascribed to the PFO. A right-to-left shunt grade >1 was previously detected in all patients and atrial septal aneurysm was present in 111 (27.5%) patients. Patients were followed up with a contrast transthoracic echocardiogram and clinically at 24 hours, six months, and 12 months after the procedure. A high procedural success was observed in both groups. Despite a trend towards a higher incidence of acute residual shunt immediately after device deployment among Figulla occluder patients, a residual grade ≥2 right-to-left shunt was observed in 4.5% of patients, independently of the device used for PFO closure. The only difference reported after Figulla device implantation was a lower rate of supraventricular arrhythmias (9% vs. 17%, p=0.02). CONCLUSIONS According to this two-centre study, PFO closure appears safe and effective with the Figulla occluder as well as with the AMPLATZER device.

Diagnostic accuracy of simultaneous evaluation of coronary arteries and myocardial perfusion with single stress cardiac computed tomography acquisition compared to invasive coronary angiography plus invasive fractional flow reserve

BACKGROUND Coronary computed tomography angiography (cCTA) has limited diagnostic accuracy in patients with intermediate to high pre-test likelihood of coronary artery disease (CAD) that may have large amounts of coronary calcium. Stress computed tomography myocardial perfusion (CTP) has emerged as a valuable strategy, combining anatomical and functional assessment of CAD. Purpose of the study is to evaluate the diagnostic accuracy of combining coronary artery imaging and myocardial perfusion in a single stress dataset versus invasive coronary angiography (ICA) and invasive fractional flow reserve (FFR) as reference standard. METHODS One-hundred-thirty consecutive symptomatic patients (age: 65 ± 9 years; men: 70%) scheduled for clinically indicated ICA plus invasive FFR were prospectively enrolled. cCTA + CTP were simultaneously evaluated in a single stress-dataset by blinded readers and compared to ICA and invasive FFR findings. RESULTS CTP was successfully performed in all patients. The most common artifacts observed in the stress dataset for coronary artery imaging were blooming effect and motion effect related. Overall evaluability of coronary arteries by using cCTA stress dataset was 93%. In a vessel and patient-based model, stress cCTA + stress CTP showed sensitivity, specificity, negative predictive value, positive predictive value and diagnostic accuracy of 93%, 94%, 97%, 85%, 94%, and 98%, 86%, 98%, 85%, 92%, respectively. The overall effective dose (ED) of stress protocol acquisition alone was 2.5 ± 1.1 mSv. CONCLUSIONS Simultaneous evaluation of coronary arteries and myocardial perfusion with single stress acquisition is feasible and it has diagnostic accuracy and low ED to identify functionally significant stenosis in patients with intermediate to high risk for CAD.

Quantitative vs. qualitative evaluation of static stress computed tomography perfusion to detect haemodynamically significant coronary artery disease

Aims To compare the diagnostic accuracy of stress computed tomography myocardial perfusion (CTP) for the detection of significant coronary artery disease with visual approach vs. quantitative analysis with transmural perfusion ratio (TPR) in consecutive symptomatic patients scheduled for invasive coronary angiography (ICA) plus invasive fractional flow reserve (FFR). Methods and results Eighty-eight consecutive symptomatic patients underwent rest coronary computed tomography angiography (cCTA) followed by static stress-CTP. Diagnostic accuracy of cCTA + stress-CTP with visual evaluation and with TPR measurement was calculated and compared with ICA and invasive FFR. Addition of stress-CTP with qualitative evaluation to rest-cCTA showed sensitivity, specificity, negative and positive predictive values, and accuracy at a vessel and patient level of 92%, 92%, 97%, 82%, 92% and 98%, 80%, 97%, 82%, 89%, respectively indicating a significant improvement of specificity, positive predictive value, and accuracy values vs. rest-cCTA in both models. Similarly, addition of stress-CTP with TPR evaluation to rest-cCTA showed sensitivity, specificity, negative and positive predictive values, and accuracy at a vessel and patient level of 84%, 90%, 93%, 76%, 88% and 91%, 71%, 89%, 75%, 81%, respectively indicating a significant improvement of specificity, positive predictive value values vs. rest-cCTA only in a vessel-based model and of positive predictive value in a patient-based model. When cCTA + stress-CTP with qualitative evaluation was compared with cCTA + stress-CTP with TPR estimation, no differences were found in terms of diagnostic performance. Conclusion The addition of stress-CTP with visual evaluation to cCTA imaging has similar diagnostic performance when compared with the quantitative analysis of myocardial perfusion based on TPR measurement.

TCT-474 Ten-year follow-up of the Xience stent in 7655 consecutive patients: single center registry results.

Safety and effectiveness of the XIENCE stent in the real world have been previously demonstrated with low rates of target lesion revascularization (TLR), cardiac death, myocardial infarction (MI) and stent thrombosis (ST) up to 2 years. Whether these results are sustained over long-term FU has not