Transradial versus tibiopedal access approach for endovascular intervention of superficial femoral artery chronic total occlusion.

BACKGROUND: Improved equipment and techniques have resulted in transition from surgical bypass to endovascular intervention to treat superficial femoral artery (SFA) chronic total occlusions (CTO). A change in access site to radial (TRA) or tibiopedal (TPA) artery for the treatment of these SFA CTO has been reported. The feasibility, efficacy and safety of these two access sites for treatment of SFA CTO have not been reported. METHODS: We performed an as treated analysis of 184 SFA CTO interventions in 161 patients from 01/2014 to 09/2016 using either primary TRA or TPA (operator discretion) at two institutions. Primary end point was 30 day major adverse event (MAE) - death, amputation or target vessel revascularization, secondary endpoint was success of procedure. RESULTS: Primary TRA was used in 46 patients with 47 CTO lesions .Primary TPA was used in 115 patients with 137 CTO lesions. Primary crossing success rate was higher with TRA compared to TPA (74% vs 54%, P = 0.01). Dual TRA-TPA was required in 72 prior uncrossed lesions resulting in a crossing and procedural success of 99% and 96% respectively. The overall crossing and procedural success rate using either of these approaches was 99% and 98% respectively. The 30 day MAE was 5% in TRA arm, 0% in TPA arm and 2% in dual TRA-TPA arm, P = 0.08. All access sites were patent, confirmed by ultrasound. CONCLUSION: The treatment of SFA CTO is feasible and safe using both TRA or TPA approach providing high success rates and no access site complications.

Comparison of TR Band™ and VasoStat™ Hemostasis Devices following Transpedal Catheterization for Lower Extremity Revascularization for Peripheral Arterial Disease.

BACKGROUND: Transpedal access is increasingly utilized for peripheral vascular catheterization. There is a paucity of data on the use of radial hemostasis devices as an alternative to manual compression for achievement of hemostasis after this approach. OBJECTIVE: To compare safety and efficacy of two hemostasis devices following transpedal catheterization for lower extremity revascularization for peripheral arterial disease. METHODS: A consecutive cohort of patients with bilateral Rutherford 2-5 disease who underwent transpedal catheterization for peripheral vascular interventions were retrospectively analyzed. In each patient, retrograde tibial artery access was obtained, a 4 French sheath was placed, and all revascularization was performed via tibial access. In all patients, a TR Band™ (Terumo Medical, n = 215) and/or VasoStat™ (Forge Medical, n = 99) were used to apply puncture site compression, following removal of the tibial sheath until hemostasis was achieved. Safety and efficacy of each device was compared. RESULTS: Puncture site hemostasis was achieved in all patients within 2 hours of sheath removal facilitating early discharge. Two access site pseudoaneurysms occurred within 30 days of revascularization, one of which followed TR Band™ placement and the other following VasoStat™ placement (P = 0.53). Each patient was successfully treated with ultrasound-guided thrombin injection. Loss of access site patency by duplex ultrasound occurred in 2 patients following the TR Band™ and a single patient following the VasoStat™ (P = 1.0). CONCLUSION: Both the TR Band™ and the VasoStat™ were effective in achieving hemostasis following transpedal catheterization with low rates of complications.

Comparative Assessment of Guidewire and Microcatheter vs a Crossing Device-Based Strategy to Traverse Infrainguinal Peripheral Artery Chronic Total Occlusions.

PURPOSE: To compare success rates of a guidewire and microcatheter strategy vs the use of specialized crossing devices to traverse infrainguinal peripheral artery chronic total occlusions (CTOs). METHODS: For this analysis, data on 438 consecutive infrainguinal CTO interventions in 438 patients (mean age 63.2 years; 402 men) performed between August 2006 and May 2014 were extracted from the multicenter Excellence in Peripheral Artery Disease (XLPAD) database (ClinicalTrials.gov; identifier NCT01904851). Primary technical success constituted placement of a guidewire in the true lumen, past the distal CTO cap, with the initial crossing strategy. RESULTS: A wire-catheter strategy was used in 295 (67.4%) and a specialized CTO crossing device in 143 (32.6%) patients (p<0.001). Primary crossing technical success was higher with CTO devices (72.1% vs 51.9%, p<0.001). The primary wire-catheter arm used significantly more secondary CTO devices (28.1% vs 17.5%) and/or provisional re-entry devices (26.7% vs 4.9%) compared with the primary CTO device arm (both p<0.001). Secondary crossing technical success (defined as crossing with an alternate strategy: 67.5% vs 71.4%, p=1.000), provisional crossing technical success (defined as use of a re-entry device: 84.2% vs 87.5%, p=0.768), and procedure success (93.6% vs 90.9%, p=0.332) were similar between the wire-catheter and CTO device strategies, respectively. No differences were observed in periprocedural complications or 30-day adverse events; however, at 12 months, there was a significantly higher surgical revascularization rate in the primary wire-catheter arm (8.8% vs 2.8%, p=0.025). CONCLUSION: Infrainguinal peripheral artery CTO crossing is frequently attempted with a wire-catheter technique; however, an initial CTO crossing device approach is associated with higher primary technical success. Overall procedure success is similar with both strategies.

Unique Aspects of Coronary Artery Disease in Indian Women.

PURPOSE: Epidemiologic and clinical research suggests important gender-related differences in the prevalence, presentation, associated conventional and non-conventional risk factors, management and outcomes of coronary heart disease (CHD) patients. Adequate data is not available for Indian population where prevalence of CHD and depression is high. METHOD: We conducted an observational, single-center, study from January 2010 to December 2011 on 10450 consecutive patients visiting a tertiary care center, Ahmedabad, Gujarat, India who presented with complaints related to CHD. RESULTS: Of these, 6867 patients had coronary artery disease (CAD) as confirmed by angiographic investigation; 5678 were males, and 1189 were females with similar mean age. As compared to males, females had higher prevalence of hypertension, diabetes and obesity while males had higher prevalence of smoking. Invasive treatment options like Coronary Artery Bypass Grafting (p < 0.001) and Percutaneous Coronary Intervention (p = 0.001) were used less often to treat females, and medical therapy (p < 0.001) was the preferred treatment option irrespective of the contributing risk factors/extent of CAD. Depression was observed in 39.8% of acute coronary syndrome patients (n = 1648) as assessed by MARDS scale. It was higher in female patients and in low socioeconomic strata (p < 0.001).At 12 and 36 months, rates of revascularization (p < 0.001) and mortality (p < 0.005) were higher with poor quality of life (QoL) (P < 0.001) in depressed CAD patients. CONCLUSION: In India, women appear to have a higher prevalence of hypertension, diabetes, obesity, and family history of CHD. Yet women get invasive treatments less often than men. Depression is also more common in women and is associated with poor QoL and early mortality than men.

Diagnostic Performance and Clinical Impact of Photon-Counting Detector Computed Tomography in Coronary Artery Disease.

BACKGROUND: Photon-counting detector-computed tomography (PCD-CT) has emerged as a promising technology, offering improved spatial resolution. OBJECTIVES: This study aimed to evaluate the clinical impact and diagnostic performance of PCD-CT vs conventional energy-integrating detector computed tomography (EID-CT) for obstructive coronary artery disease (CAD). METHODS: From 2022 to 2023, we retrospectively identified 7,833 consecutive patients who underwent clinically indicated coronary computed tomography angiography (CCTA) at a single center, with either PCD-CT (n = 3,876; NAEOTOM Alpha [Siemens Healthineers]) or EID-CT (n = 3,957; Revolution Apex 256 [GE HealthCare] or Aquilion ONE ViSION 320 [Canon Medical Systems]) scanners. Subsequent invasive coronary angiography (ICA) and percutaneous or surgical revascularization were performed as part of routine clinical care. Among those referred for ICA after coronary CTA, the presence of obstructive CAD in each vessel was determined by coronary CTA (severe stenosis on visual assessment per the Coronary Artery Disease Reporting and Data System) and ICA (≥50% diameter stenosis on quantitative coronary angiography) in a blinded fashion. The diagnostic performance of EID-CT and PCD-CT was compared by using quantitative coronary angiography as the reference standard. RESULTS: Patients who underwent PCD-CT were less frequently referred to subsequent ICA than those undergoing EID-CT (9.9% vs 13.1%; P < 0.001). Among those who underwent ICA, revascularization was more frequently performed in the PCD-CT group than in the EID-CT group (43.4% vs 35.5%; P = 0.02). In the vessel-level analysis (n = 1,686), specificity (98.0% vs 93.0%; P < 0.001), positive predictive value (83.3% vs 63.0%; P = 0.002), and diagnostic accuracy (97.2% vs 92.8%; P < 0.001) were improved by PCD-CT. Sensitivity (90.9% vs 90.7%; P = 0.95) and negative predictive value (98.9% vs 98.7%; P = 0.83) for obstructive CAD were similar between the PCD-CT and EID-CT groups, respectively. CONCLUSIONS: PCD-CT exhibited excellent diagnostic performance for detecting obstructive CAD. Compared with patients undergoing conventional EID-CT, fewer patients were referred to ICA after PCD-CT, but those referred were more likely to undergo revascularization.

Inversion recovery and saturation recovery pulmonary vein MR angiography using an image based navigator fluoro trigger and variable-density 3D cartesian sampling with spiral-like order.

Contrast enhanced pulmonary vein magnetic resonance angiography (PV CE-MRA) has value in atrial ablation pre-procedural planning. We aimed to provide high fidelity, ECG gated PV CE-MRA accelerated by variable density Cartesian sampling (VD-CASPR) with image navigator (iNAV) respiratory motion correction acquired in under 4 min. We describe its use in part during the global iodinated contrast shortage. VD-CASPR/iNAV framework was applied to ECG-gated inversion and saturation recovery gradient recalled echo PV CE-MRA in 65 patients (66 exams) using .15 mmol/kg Gadobutrol. Image quality was assessed by three physicians, and anatomical segmentation quality by two technologists. Left atrial SNR and left atrial/myocardial CNR were measured. 12 patients had CTA within 6 months of MRA. Two readers assessed PV ostial measurements versus CTA for intermodality/interobserver agreement. Inter-rater/intermodality reliability, reproducibility of ostial measurements, SNR/CNR, image, and anatomical segmentation quality was compared. The mean acquisition time was 3.58 ± 0.60 min. Of 35 PV pre-ablation datasets (34 patients), mean anatomical segmentation quality score was 3.66 ± 0.54 and 3.63 ± 0.55 as rated by technologists 1 and 2, respectively (p = 0.7113). Good/excellent anatomical segmentation quality (grade 3/4) was seen in 97% of exams. Each rated one exam as moderate quality (grade 2). 95% received a majority image quality score of good/excellent by three physicians. Ostial PV measurements correlated moderate to excellently with CTA (ICCs range 0.52-0.86). No difference in SNR was observed between IR and SR. High quality PV CE-MRA is possible in under 4 min using iNAV bolus timing/motion correction and VD-CASPR.

The Prognostic Value of CAC Zero Among Individuals Presenting With Chest Pain: A Meta-Analysis.

BACKGROUND: There is little consensus on whether absence of coronary artery calcium (CAC) can identify patients with chest pain (CP) who can safely avoid additional downstream testing. OBJECTIVES: The purpose of this study was to conduct a systematic review and meta-analysis investigating the utility of CAC assessment for ruling out obstructive coronary artery disease (CAD) among patients with stable and acute CP, at low-to-intermediate risk of obstructive CAD undergoing coronary computed tomography angiography (CTA). METHODS: The authors searched online databases for studies published between 2005 and 2021 examining the relationship between CAC and obstructive CAD (≥50% coronary luminal narrowing) on coronary CTA among patients with stable and acute CP. RESULTS: In this review, the authors included 19 papers comprising 79,903 patients with stable CP and 13 papers including 12,376 patients with acute CP undergoing simultaneous CAC and coronary CTA assessment. Overall, 45% (95% CI: 40%-50%) of patients with stable CP and 58% (95% CI: 50%-66%) of patients with acute CP had CAC = 0. The negative predictive values for CAC = 0 ruling out obstructive CAD were 97% (95% CI: 96%-98%) and 98% (95% CI: 96%-99%) among patients with stable and acute CP, respectively. Additionally, the prevalence of nonobstructive CAD among those with CAC = 0 was 13% (95% CI: 10%-16%) among those with stable CP and 9% (95% CI: 5%-13%) among those with acute CP. A CAC score of zero predicted a low incidence of major adverse cardiac events among patients with stable CP (0.5% annual event rate) and acute CP (0.8% overall event rate). CONCLUSIONS: Among over 92,000 patients with stable or acute CP, the absence of CAC was associated with a very low prevalence of obstructive CAD, a low prevalence of nonobstructive CAD, and a low annualized risk of major adverse cardiac events. These findings support the role of CAC = 0 in a value-based health care delivery model as a "gatekeeper" for more advanced imaging among patients presenting with CP.

Cardiac Computed Tomography for Comprehensive Coronary Assessment: Beyond Diagnosis of Anatomic Stenosis.

Cardiac computed tomography angiography (CCTA) has evolved into a versatile imaging modality that can depict atherosclerosis burden, determine functional significance of a stenotic lesion, and guide the management and treatment of stable coronary artery disease.1 With newer-generation scanners, diagnostic CCTA can be obtained in the majority of patients with a very acceptable radiation dose. We discuss the ability of CCTA to provide comprehensive assessment of a patient with suspected CAD, including functional techniques of stress-rest myocardial perfusion assessment using a vasodilator and a purely post-processing approach that assesses fractional flow reserve derived by CCTA. In addition, recent data validated the role of CCTA in managing stable patients with chest pain and suspected CAD, serving as a gatekeeper for invasive coronary angiogram as well as optimizing the preprocedural planning of percutaneous coronary revascularization and coronary artery bypass surgery.

Role of Teleproctoring in Challenging and Innovative Structural Interventions Amid the COVID-19 Pandemic and Beyond.

Teleproctoring can be used successfully in performing challenging and innovative structural heart interventions using sophisticated technology that allows real-time bidirectional audiovisual communication with digital transmission of live videos and direct observation of the operative field by a remote proctor. The authors share an illustrative case that was performed amid the coronavirus disease-2019 global pandemic that led to travel restrictions to limit spread of the virus. Teleproctoring has future implications beyond the current global health crisis to facilitate rapid dissemination and exchange of knowledge for ultimately helping patients around the globe.

A Novel Patent Hemostasis Protocol - Prevention of Pseudoaneurysm after Tibiopedal Arterial Access for Evaluation and Treatment of Peripheral Arterial Disease.

BACKGROUND: Pseudoaneurysm (PSA) is a rare complication (0.2%) after transpedal arterial access (TPA) for endovascular treatment of peripheral arterial disease, occurring only in the posterior tibial artery (PTA) likely related to the anatomy of the vessel leading to unfavorable circumstances for adequate hemostasis. We describe a novel patent hemostasis protocol for TPA access to avoid PSA. METHODS: We prospectively studied 586 patients with symptomatic PAD who underwent 1038 peripheral procedures between 02/2016 and 02/2017 via TPA (dorsalis pedis artery (DP)/anterior tibial artery (ATA), PTA or peroneal artery (PA)). Hemostasis for the DP/ATA was achieved with the Vasostat™ device, while TR Band™ was used for PTA/PA, as per our new protocol (figure). Patent hemostasis technique was confirmed using Doppler. RESULTS: Of the 1038 procedures, 733 (88% interventional) were done via the DP/ATA, 176 (92% interventional) were done via the PTA and 129 (64% interventional) were via the PA. The incidence of PSA related to any access site was 0.0%. All access sites were patent on Doppler ultrasound at 30 day follow up. CONCLUSION: PSA associated with TPA is very rare, it can be easily prevented with the above described patent hemostasis protocol while preserving the patency of the access site. CONDENSED ABSTRACT: Pseudoaneurysm (PSA) is a rare complication (0.2%) after transpedal arterial access (TPA). We describe a novel patent hemostasis protocol for TPA access to avoid PSA. We prospectively studied 586 patients with symptomatic PAD who underwent 1038 endovascular procedures via TPA (dorsalis pedis artery (DP)/anterior tibial artery (ATA), PTA or peroneal artery (PA)). Hemostasis for the DP/ATA was achieved with the Vasostat™ device, while TR Band™ was used for PTA/PA, as per our new protocol (figure). Patent hemostasis technique was confirmed using Doppler. The incidence of PSA related to any access site was 0.0%. All access sites were patent on Doppler ultrasound at 30 day follow up. PSA associated with TPA is very rare, it can be easily prevented with the above described patent hemostasis protocol while preserving the patency of the access site.

Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease.

BACKGROUND: There has been an increasing use of transpedal arterial access (TPA) for evaluation and treatment of peripheral arterial disease (PAD) over a transfemoral approach (TFA). TPA, it is expected to be associated with better patient comfort, less recovery time and possibly less access site complications compared to standard TFA. Access site complications and pseudoaneurysm (PSA) associated with the TPA have not been previously reported. OBJECTIVE: Here we report a series of pedal artery PSA related to access site complicating TPA catheterization. METHODS: We studied 1460 patients with symptomatic PAD who underwent 2236 peripheral diagnostic and/or interventional procedures between 06/2014 and 01/2016 via TPA. Hemostasis was achieved using patent hemostasis technique by a radial artery compression device for 2h. PSA related to the access site were suspected clinically and confirmed with arterial duplex ultrasound. RESULTS: The incidence of PSA related to any access site was 0.002%. In this series all PSA occurred only in the posterior tibial artery, after an interventional procedure. All patients were treated successfully with thrombin injection with no residual complications. CONCLUSIONS: PSA associated with TPA is extremely rare and seems to occur exclusively after posterior tibial artery access. It is easily treatable by thrombin injection.

Frequency and factors associated with inappropriate for intervention cardiac catheterization laboratory activation.

BACKGROUND: Current guidelines emphasize timely coronary intervention with a door to balloon time of ≤90min for favorable survival impact after STEMI. Efforts to achieve these targets may result in unnecessary emergent angiography for inappropriate activations. OBJECTIVE: Evaluate the frequency, trend and factors which are significantly associated with inappropriate for intervention cardiac catheterization laboratory (CCL) activation. METHODS: We analyzed 1764 consecutive emergent CCL activation for possible ST segment elevation myocardial infarction (STEMI) between 7/2005 and 8/2013. Inappropriate for intervention activation was defined as negative STEMI (incorrect diagnosis: insignificant coronary lesion, not requiring any intervention) and inappropriate patients (true STEMI but poor CCL candidacy). RESULTS: Inappropriate for intervention CCL activation occurred in 317 patients (17.9%): 292 incorrect diagnosis (negative STEMI diagnosis), 25 inappropriate patients, with no difference in the frequency based on time of the day (18.6% regular hours vs. 17.6% off-hours, p=0.6). On multivariable analysis, female gender (OR 1.9 [1.2-3.0]), African American race (OR 1.9[1.3-2.7]), and prior coronary artery bypass graft surgery (OR 3.6 [2.3-5.5]) were significantly associated with incorrect diagnosis (negative STEMI diagnosis) (all p<0.005) and hyperlipidemia (OR 0.2 [0.1-0.3]), tobacco use (OR 0.2 [0.1-0.3]), and stroke/TIA (OR 0.2 [0.1-0.4]) had a significant inverse association (all p<0.001). ST Elevation with no reciprocal depression and pericarditis/myocarditis were the most common ECG finding and etiology respectively. CONCLUSION: Inappropriate for intervention CCL activation is not uncommon and should be closely monitored to maximize resource utilization. Females, African American patients with few or no risk factors and patients presenting ST elevation but no reciprocal depression constitute a population that may require attention.

Synergistic Utility of Brain Natriuretic Peptide and Left Ventricular Strain in Patients With Significant Aortic Stenosis.

BACKGROUND: In aortic stenosis (AS), symptoms and left ventricular (LV) dysfunction represent a later disease state, and objective parameters that identify incipient LV dysfunction are needed. We sought to determine prognostic utility of brain natriuretic peptide (BNP) and left ventricular global longitudinal strain (LV-GLS) in patients with aortic valve area <1.3 cm(2). METHODS AND RESULTS: Five-hundred and thirty-one patients between January 2007 and December 2008 with aortic valve area <1.3 cm(2) (86% with aortic valve area ≤1.1 cm(2)) and left ventricular ejection fraction ≥50% who had BNP drawn ≤90 days from initial echo were included. Society of Thoracic Surgeons (STS) score and mortality were recorded. Mean STS score, glomerular filtration rate, and median BNP were 11±5, 73±35 mL/min per 1.73 m , and 141 (60-313) pg/mL, respectively; 78% were in New York Heart Association class ≥II. Mean LV-stroke volume index (LV-SVI) and LV-GLS were 39±10 mL/m(2) and -13.9±3%. At 4.7±2 years, 405 patients (76%) underwent aortic valve replacement; 161 died (30%). On multivariable survival analysis, age (hazard ratio [HR] 1.46), New York Heart Association class (HR 1.27), coronary artery disease (HR 1.72), decreasing glomerular filtration rate (HR 1.15), increasing BNP (HR 1.16), worsening LV-GLS (HR 1.13) and aortic valve replacement (time dependent) (HR 0.34) predicted survival (all P<0.01). For mortality, the c-statistic incrementally increased as follows (all P<0.01): STS score (0.60 [0.58-0.64]), STS score+BNP (0.67 [0.62-0.70]), and STS score+BNP+LV-GLS (0.74 [0.68-0.78]). CONCLUSIONS: In normal LVEF patients with significant aortic stenosis, BNP and LV-GLS provide incremental (additive not duplicative) prognostic information over established predictors, suggesting that both play a synergistic role in defining outcomes.

Mini-cog performance: novel marker of post discharge risk among patients hospitalized for heart failure.

BACKGROUND: Heart failure (HF) guidelines recommend screening for cognitive impairment (CI) but do not identify how. The Mini-Cog is an ultrashort cognitive "vital signs" measure that has not been studied in patients hospitalized for HF. The purpose of this study was to evaluate whether CI as assessed by the Mini-Cog is associated with increased readmission or mortality risk after hospitalization for HF. METHODS AND RESULTS: We analyzed 720 consecutive patients who completed the Mini-Cog as a part of routine clinical care during hospitalization for HF. Our primary outcome was time between hospital discharge and first occurrence of readmission or mortality. There was a high prevalence of CI as quantified by Mini-Cog performance (23% of cohort). During a mean follow-up time of 6 months, 342 (48%) patients were readmitted, and 24 (3%) died. Poor Mini-Cog performance was an independent predictor of composite outcome (adjusted hazard ratio, 1.90; 95% confidence interval, 1.47-2.44; P<0.0001) and was identified as the most important predictor among 55 variables by random survival forest analysis. Inclusion of Mini-Cog performance in risk models improved accuracy (bootstrapped c-index, 0.602 versus 0.624) and risk reclassification (category-free net reclassification improvement, 27%; 95% confidence interval, 14%-40%; P<0.001). Secondary analysis of initial 30 days post discharge showed effect modification by venue of discharge, whereby patients with CI discharged to a facility had longer time to outcome as compared with those discharged home. CONCLUSIONS: Mini-Cog performance is a novel marker of posthospitalization risk. Discharge to facility rather than home may be protective for those patients with HF and CI. It is unknown whether structured in-home support would yield similar outcomes.

Long-term safety and performance of the orbital atherectomy system for treating calcified coronary artery lesions: 5-Year follow-up in the ORBIT I trial.

BACKGROUND/PURPOSE: The ORBIT I trial, a first-in-man study, was conducted to evaluate the safety and performance of the orbital atherectomy system (OAS) in treating de novo calcified coronary lesions. METHODS/MATERIALS: Fifty patients were enrolled between May and July 2008 based on several criteria, and were treated with the OAS followed by stent placement. The safety and performance of the OAS were evaluated by procedural success, device success, and overall major adverse cardiovascular event (MACE) rates, including cardiac death, myocardial infarction (MI) and need for target lesion revascularization (TLR). Our institution enrolled and treated 33 of the 50 patients and continued follow-up for 5 years. RESULTS: Average age was 54 years and 91% were males. Mean lesion length was 15.9 mm. Device success was 100%, and average number of orbital atherectomy devices (OAD) used per patient was 1.3. Stents were placed directly after OAS in 31/32 patients (96.9%). All stents (average stent per lesion 1.1) were successfully deployed with 0.3% residual stenosis. The overall cumulative MACE rate was 6.1% in-hospital, 9.1% at 30 days, 12.1% at 6 months, 15.2% at 2 years, 18.2% at 3 years and 21.2% at 5 years (4 total cardiac deaths). None of the patients had Q-wave MIs. Angiographic complications were observed in 5 patients. No flow/slow flow due to distal embolization was observed. CONCLUSIONS: The ORBIT I trial suggests that OAS treatment continues to offer a safe and effective method to change compliance of calcified coronary lesions to facilitate optimal stent placement in these difficult-to-treat patients.

Outcomes of surgical aortic valve replacement for severe aortic stenosis: Incorporation of left ventricular systolic function and stroke volume index.

OBJECTIVES: We sought to assess predictors of mortality in consecutive patients with severe aortic stenosis undergoing aortic valve replacement and to determine whether there are differences in mortality, separated on the basis of different aortic stenosis subtypes and left ventricular stroke volume index. METHODS: We studied 875 patients (aged 69 ± 12 years, 67% were men) with severe aortic stenosis (aortic valve area ≤ 1 cm(2)) who underwent aortic valve replacement between January 2007 and December 2008 (excluding other severe valve disease, balloon aortic valvuloplasty, and transcatheter aortic valve replacement). Clinical and echocardiographic data were recorded. Left ventricular stroke volume index was measured as left ventricular outflow tract velocity time integral × left ventricular outflow tract area/body surface area. Patients were classified into the following subtypes: (1) standard severe (n = 536, left ventricular ejection fraction ≥ 50% and mean gradient ≥ 40 mm Hg); (2) paradoxic severe (n = 152, left ventricular ejection fraction ≥ 50%, mean gradient <40 mm Hg and left ventricular stroke volume index <35 mL/m(2)); and (3) low left ventricular ejection fraction severe (n = 187, ejection fraction <50%). Society of Thoracic Surgeons score and all-cause mortality were recorded. RESULTS: At 4.8 ± 2 years, 153 patients (18%) died (30-day mortality 1.8%). On multivariable Cox analysis, age (hazard ratio [HR], 1.49), New York Heart Association class (HR, 1.52), prior cardiac surgery (HR, 1.41), aortic stenosis subtypes (standard severe reference HR, 1; paradoxic severe HR, 1.48; and low left ventricular ejection fraction severe HR, 2.03), and reduced glomerular filtration rate (HR, 1.17) were associated with higher long-term mortality (P < .05). CONCLUSIONS: In patients with severe aortic stenosis undergoing aortic valve replacement, patients with standard severe aortic stenosis had better long-term survival than those with paradoxic severe or low left ventricular ejection fraction severe aortic stenosis.

Orbital atherectomy system in treating calcified coronary lesions: 3-Year follow-up in first human use study (ORBIT I trial).

BACKGROUND/PURPOSE: The ORBIT I trial evaluated the safety and performance of an orbital atherectomy system (OAS) in treating de novo calcified coronary lesions. Severely calcified coronary arteries pose ongoing treatment challenges. Stent placement in calcified lesions can result in stent under expansion, malapposition and procedural complications. OAS treatment may be recommended to facilitate coronary stent implantation in these difficult lesions. MATERIALS/METHODS: Fifty patients with de novo calcified coronary lesions were enrolled in the ORBIT I trial. Patients were treated with the OAS followed by stent placement. Our institution treated 33/50 patients and continued follow-up for 3 years. RESULTS: Average age was 54.4 years and 90.9% were males. Mean lesion length was 15.9mm. The average number of OAS devices used per patient was 1.3. Procedural success was achieved in 97% of patients. Angiographic complications were observed in five patients (two minor dissections, one major dissection and two perforations). The cumulative major adverse cardiac event (MACE) rate was 6.1% in-hospital, 9.1% at 30 days, 12.1% at 6 months, 15.2% at 2 years, and 18.2% at 3years. The MACE rate included two in-hospital non Q-wave myocardial infarctions (MI), one additional non Q-wave MI at 30 days leading to target lesion revascularization (TLR), and three cardiac deaths. CONCLUSIONS: The ORBIT I trial suggests that OAS treatment may offer an effective method to modify calcified coronary lesion compliance to facilitate optimal stent placement in these difficult-to-treat patients with acceptable levels of safety up to 3 years post-index procedure.