Giovanni Teruzzi

Prevention of contrast nephropathy by furosemide with matched hydration: The MYTHOS (induced diuresis with matched hydration compared to standard hydration for contrast induced nephropathy prevention) trial

OBJECTIVES This study investigated the effect of furosemide-forced diuresis and intravenous saline infusion matched with urine output, using a novel dedicated device designed for contrast-induced nephropathy (CIN) prevention. BACKGROUND CIN is a frequent cause of acute kidney injury associated with increased morbidity and mortality. METHODS A total of 170 consecutive patients with chronic kidney disease (CKD) undergoing coronary procedures were randomized to either furosemide with matched hydration (FMH group, n = 87) or to standard intravenous isotonic saline hydration (control group; n = 83). The FMH group received an initial 250-ml intravenous bolus of normal saline over 30 min followed by an intravenous bolus (0.5 mg/kg) of furosemide. Hydration infusion rate was automatically adjusted to precisely replace the patients urine output. When a urine output rate >300 ml/h was obtained, patients underwent the coronary procedure. Matched fluid replacement was maintained during the procedure and for 4 h post-treatment. The definition of CIN was a ≥25% or ≥0.5 mg/dl rise in serum creatinine over baseline. RESULTS In the FMH group, no device- or therapy-related complications were observed. Four (4.6%) patients in the FMH group developed CIN versus 15 (18%) controls (p = 0.005). A lower incidence of cumulative in-hospital clinical complications was also observed in FMH-treated patients than in controls (8% vs. 18%; p = 0.052). CONCLUSIONS In patients with CKD undergoing coronary procedures, furosemide-induced high urine output with matched hydration significantly reduces the risk of CIN and may be associated with improved in-hospital outcome. (Induced Diuresis With Matched Hydration Compared to Standard Hydration for Contrast Induced Nephropathy Prevention [MYTHOS]; NCT00702728).

Drug-eluting balloon for treatment of in-stent restenosis after carotid artery stenting: Preliminary report

Purpose To evaluate the safety and efficacy of drug-eluting balloons (DEB) for the treatment of in-stent restenosis (ISR) after carotid artery stenting (CAS). Methods Among 830 consecutive patients undergoing CAS between November 2001 and June 2012, significant ISR (>80% stenosis) occurred in 10 (1.2%) asymptomatic patients. Angioplasty with DEB treatment was performed in 7 patients (6 internal and 1 common carotid arteries) at a mean of 20.9 ± 19.4 months (median 12.1) after CAS. Intravascular ultrasound (IVUS)–guided predilation with distal cerebral protection was carried out with a cutting balloon followed by inflation of a DEB with a 1:1 stent-to-balloon size ratio. Results Technical/procedural success was achieved in all cases. Angiographic stenosis decreased from 83% ± 5% to 18% ± 6%. At IVUS evaluation, minimal lumen area increased from 3.19 ± 1.73 to 12.78 ± 1.97 mm2 (p=0.0001), stent area was unchanged (from 17.36 ± 4.36 to 17.52 ± 4.34 mm2, p=0.70), and the restenosis area decreased from 13.58 ± 5.27 to 4.71 ± 3.06 mm2 (p=0.0005). At a mean follow-up of 13.7 ± 1.5 months (median 13.7), 1 patient had a minor stroke ipsilateral to the ISR vessel 2 months after DEB treatment; the stent was widely patent on duplex ultrasound and angiographic images. Overall, the average PSV decreased from 4.0 ± 1.0 to 0.9 ± 0.1 m/s (p=0.0001). At 6 and 12 months, PSVs after DEB treatment were significantly lower compared to those assessed at comparable intervals after CAS. Conclusion The use of DEBs to treat ISR after CAS shows promising acute and midterm results.

Sustained long-term benefit of patent foramen ovale closure on migraine†

Objectives: This single‐center, observational, prospective study evaluated the impact of patent foramen ovale (PFO) closure on migraine attacks over time. Background: PFO closure may reduce the frequency and severity of migraine headaches in patients with significant right‐to‐left shunts. Methods: Between May 2000 and September 2009, 305 consecutive patients (mean age, 43 ± 12 years; 54.5% women) with a prior embolic cerebrovascular event underwent PFO closure with the Amplatzer PFO occluder for recurrence prevention. All patients had right‐to‐left shunts; the shunts were associated with migraine symptoms in 77 (25%), either alone (n = 64, 83%) or with aura (n = 13, 17%). Septal aneurysm was present in 15 (19.5%) migraine patients, and 43 (56%) had a previous transient brain ischemic attack. All migraine patients had a computed tomography scan or magnetic resonance imaging, indicating a previous brain ischemic lesion. All 305 patients underwent transthoracic echocardiography with clinical follow‐up at 24 hr, at 3, 6, and 12 months, and then yearly. Results: An acute migraine attack occurred 24–48 hr after PFO closure in 28 (36.4%) of 77 patients. There was a significant reduction (>50%) in the number and intensity of attacks in 46 (60.5%) of 77 patients at the 3‐month follow‐up. At the 12‐month follow‐up, migraine had ceased in 23 (46%) patients, and 20 (40%) had a reduction in the migraine recurrence rate and disabling symptoms. These results were maintained at follow‐up (mean, 28 ± 27 months). There was overall improvement in migraine in 89% of the treated patients. Conclusions: Percutaneous PFO closure in migraineurs may provide beneficial mid‐term and long‐term results, with significant reduction in the intensity and frequency of headache symptoms.

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.

Dysfunction of bileaflet aortic prosthesis: Accuracy of echocardiography versus fluoroscopy

OBJECTIVES The authors sought to investigate the accuracy of transthoracic echocardiography (TTE)-derived parameters in the identification of bileaflet aortic prosthesis dysfunction, compared with fluoroscopy (FL). BACKGROUND Identification of bileaflet aortic prosthesis dysfunction is challenging, because high mean pressure gradient (MPG >20 mm Hg) is not proof of prosthetic obstruction (AVPO), and may be due to prosthesis-patient mismatch (PPM). Conversely, high gradients may not be manifest in AVPO and low cardiac output. METHODS TTE and FL were prospectively performed in 100 nonconsecutive patients with bileaflet aortic prosthesis. TTE included the estimation of MPG, indexed effective orifice area (EOAi), Doppler velocity index (DVI), intraprosthetic regurgitation, acceleration time (AT), ejection time (ET), AT/ET, and the difference (dA) between the expected prosthetic orifice area and EOA. FL allowed the calculation of opening and closing angles, and the discrimination of AVPO from normal (NL) and PPM. RESULTS On the basis of FL examination and MPG and EOAi at TTE, patients were classified as NL (42%), PPM (32%), and AVPO (26%). High MPG (>20 mm Hg) was present in 65% of the patients, with higher values in PPM (36 ± 8 mm Hg) and AVPO (43 ± 16 mm Hg) than in NL (16 ± 6 mm Hg). DVI was reduced in PPM (0.30 ± 0.05) and AVPO (0.25 ± 0.04) compared with NL (0.42 ± 0.09). In AVPO, dA (0.59 ± 0.32 cm(2)), AT (108 ± 20 ms), and AT/ET (0.35 ± 0.05) significantly differed from NL (dA = -0.12 ± 0.43 cm(2), AT = 74 ± 15 ms, AT/ET = 0.25 ± 0.05) and PPM (dA = 0.15 ± 0.24 cm(2), AT = 78 ± 13 ms, AT/ET = 0.26 ± 0.04). Moderate or severe intraprosthetic regurgitation was observed only in AVPO. All considered TTE-derived parameters were found related to obstruction, and dA (accuracy = 87%), AT (94%), and AT/ET (89%) showed the highest accuracy in discriminating normofunctioning prostheses from AVPO. CONCLUSIONS In the presence of high MPG, TTE parameters play a key role in aortic prosthesis examination. Especially time indices and dA add to the functional assessment of prosthetic aortic valves. However, the TTE discrimination between AVPO and PPM may be suboptimal, and fluoroscopy is a complementary and essential diagnostic step.

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.

Use of a new diagnostic catheter for transradial internal mammary artery angiography early after minimally invasive coronary bypass

We describe a new diagnostic catheter specifically designed for selective catheterization of the left internal mammary artery via the ipsilateral radial approach. We used this catheter to assess the patency of the distal mammary‐left anterior descending coronary artery anastomosis in 30 consecutive patients early after minimally invasive direct coronary artery bypass grafting. The new catheter design allowed easy and fast engagement of the left internal mammary artery leading to optimal vessel opacification in all cases. Angiography revealed graft problems in seven (23.3%) patients, two of whom required anastomosis revision, surgical in one case and with PTCA in the other. No LIMA injury occurred as a result of selective catheterization. Patients with functionally normal anastomosis were discharged on the same day of the diagnostic procedure. Cathet. Cardiovasc. Intervent. 50:371–374, 2000.