Comparison of Frequency of Vascular Complications With Ultrasound-Guided Versus Fluroscopic Roadmap-Guided Femoral Arterial Access in Patients Who Underwent Transcatheter Aortic Valve Implantation.

To compare outcomes of ultrasound guidance (USG) versus fluoroscopy roadmap guidance (FG) angiography for femoral artery access in patients who underwent transfemoral (TF) transcatheter aortic valve implantation (TAVI) to determine whether routine USG use was associated with fewer vascular complications. Vascular complications are the most frequent procedural adverse events associated with TAVI. USG may provide a decreased rate of access site complications during vascular access compared with FG. Patients who underwent TF TAVI between July 2012 and July 2017 were reviewed and outcomes were compared. Vascular complications were categorized by Valve Academic Research Consortium-2 criteria and analyzed by a multivariable logistic regression adjusting for potential confounding risk factors including age, gender, body mass index, peripheral vascular disease, Society of Thoracic Surgeons score and sheath to femoral artery ratio. Of the 612 TAVI patients treated, 380 (63.1%) were performed using USG for access. Routine use of USG began in March 2015 and increased over time. Vascular complications occurred in 63 (10.3%) patients and decreased from 20% to 3.9% during the study period. There were fewer vascular complications with USG versus FG (7.9% vs 14.2%, p = 0.014). After adjusting for potential confounding risk factors that included newer valve systems, smaller sheath sizes and lower risk patients, there was still a 49% reduction in vascular complications with USG (odds ratio 0.51, 95% confidence interval 0.29 to 0.88, p = 0.02). In conclusion, USG for TF TAVI was associated with reduced vascular access site complications compared with FG access even after accounting for potential confounding risk factors and should be considered for routine use for TF TAVI.

Impact of concomitant treatment of non-chronic total occlusion lesions at the time of chronic total occlusion intervention.

BACKGROUND: During chronic total occlusion (CTO) percutaneous coronary intervention (PCI), sometimes non-CTO lesions are also treated. METHODS: We compared the clinical and procedural characteristics and outcomes of CTO PCIs with and without concomitant treatment of a non-CTO lesion in a contemporary multicenter CTO registry. RESULTS: Of the 3598 CTO PCIs performed at 21 centers between 2012 and 2018, 814 (23%) also included PCI of at least one non-CTO lesion. Patients in whom non-CTO lesions were treated were older (65 ±â€¯10 vs. 64 ±â€¯10 years, p = 0.03), more likely to present with an acute coronary syndrome (32% vs. 23%, p < 0.01), and less likely to undergo PCI of a right coronary artery (RCA) CTO (46% vs. 58%, p < 0.01). The most common non-CTO lesion location was the left anterior descending artery (31%), followed by the circumflex (29%) and the RCA (25%).Combined non-CTO and CTO-PCI procedures had similar technical (88% vs. 87%, p = 0.33) and procedural (85% vs. 85%, p = 0.74) success and major in-hospital complication rates (3.4% vs. 2.7%, p = 0.23), but had longer procedure duration (131 [88, 201] vs. 117 [75, 179] minutes, p < 0.01), higher patient air kerma radiation dose (3.0 [1.9, 4.8] vs. 2.8 [1.5, 4.6] Gray, p < 0.01) and larger contrast volume (300 [220, 380] vs. 250 [180, 350] ml, p < 0.01). CONCLUSIONS: Combined CTO PCI with PCI of non-CTO lesions is associated with similar success and major in-hospital complication rates compared with cases in which only CTOs were treated, but requires longer procedure duration and higher radiation dose and contrast volume.

The Impact of Peripheral Artery Disease in Chronic Total Occlusion Percutaneous Coronary Intervention (Insights From PROGRESS-CTO Registry).

The impact of peripheral artery disease (PAD) in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We reviewed 3999 CTO PCIs performed in 3914 patients between 2012 and 2018 at 25 centers, 14% of whom had a history of PAD. We compared the clinical and angiographic characteristics and procedural outcomes of patients with versus without history of PAD. Patients with PAD were older (67 ± 9 vs 64 ± 10 years, P < .001) and had a higher prevalence of cardiovascular risk factors. They also had more complex lesions as illustrated by higher Japanese CTO score (2.7 ± 1.2 vs 2.4 ± 1.3, P < .001). In patients with PAD, the final crossing technique was less often antegrade wire escalation (40% vs 51%, P < .001) and more often the retrograde approach (23 vs 20%, P < .001) and antegrade dissection/reentry (20% vs 16%, P < .001). Technical success was similar between the 2 study groups (84% vs 87%, P = .127), but procedural success was lower for patients with PAD (81% vs 85%, P = .015). The incidence of in-hospital major adverse cardiac events was higher among patients with PAD (3% vs 2%, P = .046). In conclusion, patients with PAD undergoing CTO PCI have more comorbidities, more complex lesions, and lower procedural success.

Transcatheter Aortic Valve Replacement After Prior Mitral Valve Surgery: Results From the Transcatheter Valve Therapy Registry.

BACKGROUND: Due to perceived technical challenges, patients with previous surgical mitral valve repair or replacement (SMVR) have been excluded from most transcatheter aortic valve replacement (TAVR) trials. Our objective was to compare the 30-day and 1-year outcomes of TAVR for patients with and without prior SMVR. METHODS: In a retrospective review of The Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry, we compared 1097 patients with prior SMVR to 46,327 patients without prior SMVR who underwent TAVR between November 2011 and September 2015 at 394 US centers. Preoperative characteristics, procedural details, and clinical outcomes were analyzed. RESULTS: Patients with previous SMVR were younger, more often female, and had higher STS predicted risk of mortality (8.6% vs 6.8%, P < .001). However, there was no difference in 30-day mortality (4.6% vs 5.5%, P = .293), myocardial infarction, stroke, reintervention, new dialysis, or readmission. Moderate/severe paravalvular leak at discharge was also similar (5.8% vs 4.9%, P = .343). At 1 year, morbidity was similar with slightly higher mortality among patients with prior SMVR (20% vs 17.5%, P = .087) that was significant after adjustment (hazard ratio 1.18, P = .043). The type of prior SMVR (repair, bioprosthetic replacement, or mechanical replacement) had no impact on 30-day or 1-year survival. CONCLUSIONS: Patients with prior SMVR undergoing TAVR had similar 30-day outcomes, slightly higher 1-year mortality, and no increase in early paravalvular leak compared with patients who did not have previous SMVR. Prior SMVR should not preclude TAVR for appropriately selected patients.

In-Hospital Outcomes of Chronic Total Occlusion Percutaneous Coronary Interventions in Patients With Prior Coronary Artery Bypass Graft Surgery.

BACKGROUND: We examined the procedural outcomes of chronic total occlusions (CTO) percutaneous coronary interventions in patients with prior coronary artery bypass graft surgery (CABG). METHODS AND RESULTS: We compared the clinical, angiographic characteristics and outcomes of 3486 CTO interventions performed in patients with (n=1101) and without (n=2317) prior CABG at 21 centers. Prior CABG patients (32% of total cohort) were older (67±9 versus 63±10 years; P<0.001) and had more comorbidities and lower left ventricular ejection fraction (50% [40-58] versus 55% [45-60]; P<0.001). The CTO target vessel in prior CABG patients was the right coronary artery (56%), circumflex (26%), and left anterior descending artery (17%). The mean J-CTO (2.9±1.2 versus 2.2±1.3; P<0.001) and PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention; 1.5±1.1 versus 1.2±1.0; P<0.001) score was higher in prior CABG patients. Retrograde (53% versus 30%, P<0.001) and antegrade dissection reentry (35% versus 28%; P<0.001) techniques were used more frequently in prior CABG patients. Prior CABG patients had lower technical (84% versus 89%; P<0.001) and procedural (82% versus 87%, P<0.001) success, but similar incidence of in-hospital major complications (3.1% versus 2.5%; P=0.287). In-hospital mortality (1% versus 0.4%; P=0.016) and coronary perforation (7.1% versus 3.1%; P<0.001) occurred more frequently in prior CABG patients, however, CABG patients had a lower incidence of pericardial tamponade (0.1% versus 1.0%; P=0.002) and pericardiocentesis (0% versus 1.3%; P<0.001). CONCLUSIONS: In a large multicenter CTO percutaneous coronary interventions registry, prior CABG patients had lower success rate but similar overall risk for complications, although mortality was higher and the incidence of tamponade was lower. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02061436.

Procedural Outcomes of Percutaneous Coronary Interventions for Chronic Total Occlusions Via the Radial Approach: Insights From an International Chronic Total Occlusion Registry.

OBJECTIVES: This study examined the frequency and outcomes of radial access for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: Radial access improves the safety of PCI, but its role in CTO PCI remains controversial. METHODS: We compared the clinical, angiographic, and procedural characteristics of 3,790 CTO interventions performed between 2012 and 2018 via radial-only access (RA) (n = 747) radial-femoral access (RFA) (n = 844) and femoral-only access (n = 2,199) access at 23 centers in the United States, Europe, and Russia. RESULTS: Patients' mean age was 65 ± 10 years, and 85% were men. Transradial access (RA and RFA) was used in 42% of CTO interventions and significantly increased over time from 11% in 2012 to 67% in 2018 (p < 0.001). RA patients were younger (age 62 ± 10 years vs. 64 ± 10 years and 65 ± 10 years; p < 0.001), less likely to have undergone prior coronary artery bypass graft surgery (18% vs. 39% and 35%; p < 0.001), and less likely to have undergone prior PCI (60% vs. 63% and 66%; p = 0.005) compared with those who underwent RFA and femoral-only access PCI. RA CTO PCI lesions had lower J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 1.4 vs. 2.6 ± 1.3 and 2.5 ± 1.3; p < 0.001) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) complication (2.3 ± 1.9 vs. 3.2 ± 2.0 and 3.2 ± 1.9; p < 0.001) scores. The mean sheath size was significantly smaller in the RA group (6.6 ± 0.7 vs. 7.0 ± 0.6 and 7.3 ± 0.8; p < 0.0001), although it increased with lesion complexity. Antegrade dissection re-entry (20% vs. 33% and 32%; p < 0.001) was less commonly used with RA, whereas use of retrograde techniques was highest with RFA (47%). The overall rates of technical success (89% vs. 88% vs. 86%; p = 0.061), procedural success (86% vs. 85% vs. 85%; p = 0.528), and in-hospital major complication (2.47% vs. 3.40% vs. 2.18%; p = 0.830) were similar in all 3 groups, whereas major bleeding was lower in the RA group (0.55% vs. 1.94% and 0.88%; p = 0.013). CONCLUSIONS: Transradial access is increasingly being used for CTO PCI and is associated with similar technical and procedural success and lower major bleeding rates compared with femoral-only access interventions. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436).

Usefulness of Atherectomy in Chronic Total Occlusion Interventions (from the PROGRESS-CTO Registry).

There is limited data on the use of atherectomy during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We compared the clinical and procedural characteristics and outcomes of CTO PCIs performed with or without atherectomy in a contemporary multicenter CTO PCI registry. Between 2012 and 2018, 3,607 CTO PCIs were performed at 21 participating centers. Atherectomy was used in 117 (3.2%) cases: rotational atherectomy in 105 cases, orbital atherectomy in 8, and both in 4 cases. Patients in whom atherectomy was used, were older (68 ± 8 vs 64 ± 10 years, p <0.0001) and had higher Japan-chronic total occlusion score (3.0 ± 1.2 vs 2.4 ± 1.3, p <0.0001). CTO PCI cases in which atherectomy was used had similar technical (91% vs 87%, p = 0.240) and procedural (90% vs 85%, p = 0.159) success and in-hospital major adverse cardiac event (4% vs 3%, p = 0.382) rates. However, atherectomy cases were associated with higher rates of donor vessel injury (4% vs 1%, p = 0.031), tamponade requiring pericardiocentesis (2.6% vs 0.4%, p = 0.012) and more often required use of a left ventricular assist device (9% vs 5%, p = 0.031). Atherectomy cases were associated with longer procedural duration (196 [141, 247] vs 119 [76, 180] minutes, p <0.0001), and higher patient air kerma radiation dose (3.6 [2.5, 5.6] vs 2.8 [1.6, 4.7] Gray, p = 0.001). In conclusion, atherectomy is currently performed in approximately 3% of CTO PCI cases and is associated with similar technical and procedural success and overall major adverse cardiac event rates, but higher risk for donor vessel injury and tamponade.

Frequency and Outcomes of Ad Hoc Versus Planned Chronic Total Occlusion Percutaneous Coronary Intervention: Multicenter Experience.

BACKGROUND: For patients needing coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI), a planned, staged intervention has been recommended by experts. Ad hoc CTO-PCI, however, occurs in practice. METHODS: Observational, contemporary, multicenter, international registry. Our goals were to determine the frequency, characteristics, procedural techniques, and outcomes of patients who underwent ad hoc vs planned CTO-PCI. RESULTS: Among 2282 patients who underwent CTO-PCI between 2012 and 2017, 318 (14%) were ad hoc. Patients undergoing ad hoc CTO-PCI had lower J-CTO, PROGRESS CTO, and PROGRESS Complications scores. Antegrade-wire escalation was used more often in ad hoc PCI (96% vs 81%; P<.001), whereas antegrade-dissection re-entry (22% vs 32%) and retrograde approaches (14% vs 38%) were more common in planned PCI (P<.001). There was no difference in ad hoc vs planned PCI in technical (85% vs 86%) and procedural success (84% vs 84%). In-hospital major adverse cardiac events (MACE) were more common in patients who underwent planned procedures (0.6% vs 2.9%; P=.02). Multivariable analyses showed that ad hoc CTO-PCI was not associated with technical success or MACE. CONCLUSIONS: Ad hoc CTO-PCI occurs more commonly in less complex lesions and is associated with similarly high success rates as planned CTO-PCI in lower J-CTO score lesions, suggesting that ad hoc CTO-PCI may be an acceptable option for experienced hybrid operators in carefully selected cases. Complex cases, as quantified by the J-CTO score, have a higher in-hospital MACE rate and should preferably be performed following proper planning and preparation.

Comparison Between Traditional and Guide-Catheter Extension Reverse Controlled Antegrade Dissection and Retrograde Tracking: Insights From the PROGRESS-CTO Registry.

OBJECTIVES: The most common re-entry technique during retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is reverse controlled antegrade and retrograde tracking (rCART). The use of guide-catheter extensions can facilitate rCART, but has received limited study. METHODS: We compared the clinical and procedural characteristics and outcomes of traditional rCART vs guide-catheter extension rCART vs cases in which both techniques were used (combined rCART) in patients with successful retrograde CTO crossing in a contemporary multicenter CTO-PCI registry. RESULTS: Between 2012 and 2018, rCART was used in 467 of 1336 retrograde CTO-PCI cases. Guide-catheter extension rCART was used in 60/467 cases (13%; use increased from 0% in 2012 to 26% in 2017). The traditional rCART group, guide-catheter extension rCART group, and combined rCART group had similar target lesion J-CTO scores (3.3 ± 1.1 vs 3.2 ± 1.2 vs 3.6 ± 0.8, respectively; P=.28), technical success rates (99% vs 100% vs 96.4%, respectively; P=.36), procedural success rates (93.2% vs 93.8% vs 96.3%, respectively; P=.82), and major in-hospital adverse cardiac event (MACE) rates (6.4% vs 9.4% vs 3.6%, respectively; P=.66). Total procedural time was longer in the combined rCART group (196 min [IQR, 146-256 min] vs 200 min [IQR, 164-293 min] vs 255 min [IQR, 195-280 min], respectively; P<.01), with a trend for lower patient air kerma radiation dose in the guide-catheter extension groups (4.11 Gray [IQR, 2.49-5.77 Gray] vs 3.19 Gray [IQR, 1.29-4.74 Gray] vs 3.47 Gray [IQR, 2.89-5.56 Gray]; P=.07). CONCLUSIONS: Guide-catheter extension rCART is increasingly being used for retrograde CTO crossing and is associated with similar success and MACE rates as traditional rCART.

Prevalence and Outcomes of Percutaneous Coronary Interventions for Ostial Chronic Total Occlusions: Insights From a Multicenter Chronic Total Occlusion Registry.

BACKGROUND: Ostial chronic total occlusions (CTOs) can be challenging to recanalize. METHODS: We sought to examine the prevalence, angiographic presentation, and procedural outcomes of ostial (side-branch ostial and aorto-ostial) CTOs among 1000 CTO percutaneous coronary interventions (PCIs) performed in 971 patients between 2015 and 2017 at 14 centres in the US, Europe, and Russia. RESULTS: Ostial CTOs represented 16.9% of all CTO PCIs: 9.6% were aorto-ostial, and 7.3% were side-branch ostial occlusions. Compared with nonostial CTOs, ostial CTOs were longer (44 ± 33 vs 29 ± 19 mm, P < 0.001) and more likely to have proximal-cap ambiguity (55% vs 33%, P < 0.001), moderate/severe calcification (67% vs 45%, P < 0.001), a diffusely diseased distal vessel (41% vs 26%, P < 0.001), interventional collaterals (64% vs 53%, P = 0.012), and previous coronary artery bypass graft surgery (CABG) (51% vs 27%, P < 0.001). The retrograde approach was used more often in ostial CTOs (54% vs 29%, P < 0.001) and was more often the final successful crossing strategy (30% vs 18%, P = 0.003). Technical (81% vs 84%, P = 0.280), and procedural (77% vs 83%, P = 0.112) success rates and the incidence of in-hospital major complication were similar (4.8% vs 2.2%, P = 0.108), yet in-hospital mortality (3.0% vs 0.5%, P = 0.010) and stroke (1.2% vs 0.0%, P = 0.030) were higher in the ostial CTO PCI group. In multivariable analysis, ostial CTO location was not independently associated with higher risk for in-hospital major complications (adjusted odds ratio 1.27, 95% confidence intervals 0.37 to 4.51, P = 0.694). CONCLUSIONS: Ostial CTOs can be recanalized with similar rates of success as nonostial CTOs but are more complex, more likely to require retrograde crossing and may be associated with numerically higher risk for major in-hospital complications.

In-Hospital Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease.

OBJECTIVES: The effect of chronic kidney disease (CKD) on in-hospital outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We evaluated the prevalence of CKD and its impact on CTO-PCI outcomes in 1979 patients who underwent 2040 procedures between 2012 and 2017 at 18 centers. CKD was defined as preprocedural estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m². RESULTS: Compared with patients without CKD (n = 1444; 73%), patients with CKD (n = 535; 27%) had more comorbidities (hypertension, diabetes mellitus, heart failure, peripheral arterial disease, prior myocardial infarction, PCI, coronary artery bypass graft surgery, and stroke), and more severe calcification and proximal vessel tortuosity. Patients with and without CKD had similar technical success rates (84% vs 86%; P=.49) and procedural success rates (83% vs 84%; P=.44). Patients with CKD had higher in-hospital mortality rate (1.9% vs 0.3%; P<.001) and in-hospital major adverse cardiovascular event (MACE) rate (4.3% vs 2.2%; P<.01). In-hospital mortality and MACE rates increased with decreasing eGFR levels (P=.03). In multivariate analysis, an independent association was observed between CKD and in-hospital mortality (adjusted odd ratio, 4.4; 95% confidence interval, 1.2-16.0; P=.02), but not overall MACE (adjusted odds ratio, 1.4; 95% confidence interval, 0.8-2.7; P=.28). CONCLUSIONS: CKD is common among patients undergoing CTO-PCI. High success rates can be achieved in patients with decreased glomerular filtration rate, but CKD may be associated with higher in-hospital mortality.

In-hospital Outcomes of Attempting More Than One Chronic Total Coronary Occlusion Through Percutaneous Intervention During the Same Procedure.

The frequency and outcomes of patients who underwent chronic total occlusion (CTO) percutaneous coronary intervention (PCI) of more than one CTO during the same procedure have received limited study. We compared the clinical and angiographic characteristics and procedural outcomes of patients who underwent treatment of single versus >1 CTOs during the same procedure in 20 centers from the United States, Europe, and Russia. A total of 2,955 patients were included: mean age was 65 ± 10 years and 85% were men with high prevalence of previous myocardial infarction (46%), and previous coronary artery bypass graft surgery (33%). More than one CTO lesions were attempted during the same procedure in 58 patients (2.0%) and 70% of them were located in different major epicardial arteries. Compared with patients who underwent PCI of a single CTO, those who underwent PCI of >1 CTOs during the same procedure had similar J-CTO (2.4 ± 1.3 vs 2.5 ± 1.3, p = 0.579) and Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (1.5 ± 1.2 vs 1.3 ± 1.0 p = 0.147) scores. The multi-CTO PCI group had similar technical success (86% vs 87%, p = 0.633), but higher risk of in-hospital major complications (10.3% vs 2.7%, p = 0.005), and consequently numerically lower procedural success (79% vs 85%, p = 0.197). The multi-CTO PCI group had higher in-hospital mortality (5.2% vs 0.5%, p = 0.005) and stroke (5.2%vs 0.2%, p <0.001), longer procedure duration (162 [117 to 242] vs 122 [80 to 186] minutes, p <0.001) and higher radiation dose (3.6 [2.1 to 6.4] vs 2.9 [1.7 to 4.7] Gray, p = 0.033). In conclusion, staged revascularization may be the preferred approach in patients with >1 CTO lesions requiring revascularization, as treatment during a single procedure was associated with higher risk for periprocedural complications.

Clinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Aortic Valves by Four-Dimensional Computed Tomography.

BACKGROUND: The incidence of leaflet thrombosis after transcatheter aortic valve replacement (TAVR) with active surveillance by four-dimensional computed tomography (4DCT) ranges from 7% to 14%. The incidence of leaflet thrombosis when 4DCT is performed for clinical and echocardiographic indications is unknown. METHODS: All patients with prior TAVR or surgical aortic valve replacement (SAVR) who underwent evaluation between October 2015 and January 2017 at our institution and had clinical or echocardiographic indications of leaflet thrombosis were evaluated by 4DCT. Indications for 4DCT by echocardiography included (1) interval increase in mean gradient of 10 mm Hg or more, (2) interval decrease in ejection fraction of 10% or more, (3) thrombus seen on transthoracic echocardiography, (4) persistent or increasing paravalvular leak, or (5) valve dehiscence or thickened leaflets seen on transthoracic echocardiography. Clinical indicators were (1) stroke, (2) transient ischemic attack, or (3) new or worsening heart failure. RESULTS: During the study period, 612 patients underwent TAVR, and 101 patients (55 TAVR; 46 SAVR) met the criteria for 4DCT imaging. Leaflet thrombosis was seen in 17 of 55 TAVR patients (30.9%) and 15 of 46 SAVR patients (32.6%). Follow-up imaging with 4DCT after treatment with anticoagulation showed improvement or resolution in thrombus burden and leaflet excursion in all TAVR patients and in two-thirds of SAVR patients. CONCLUSIONS: One-third of patients with clinical or echocardiographic indications suggestive of leaflet thrombosis were found to have evidence of leaflet thrombosis using 4DCT. This allowed tailored anticoagulation therapy with resolution of the thrombus in most patients and avoiding unnecessary anticoagulation in the remaining two-thirds of patients.

The Hybrid Approach to Chronic Total Occlusion Percutaneous Coronary Intervention: Update From the PROGRESS CTO Registry.

OBJECTIVES: The aim of this study was to determine the techniques and outcomes of hybrid chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a diverse group of patients and operators on 2 continents. BACKGROUND: CTO PCI has been evolving with constant improvement of equipment and techniques. METHODS: Contemporary outcomes of CTO PCI were examined by analyzing the clinical, angiographic, and procedural characteristics of 3,122 CTO interventions performed in 3,055 patients at 20 centers in the United States, Europe, and Russia. RESULTS: The mean age was 65 ± 10 years, and 85% of the patients were men, with high prevalence of diabetes (43%), prior myocardial infarction (46%), prior coronary artery bypass graft surgery (33%), and prior PCI (65%). The CTO target vessels were the right coronary artery (55%), left anterior descending coronary artery (24%), and left circumflex coronary artery (20%). The mean J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores were 2.4 ± 1.3 and 1.3 ± 1.0, respectively. The overall technical and procedural success rate was 87% and 85%, respectively, and the rate of in-hospital major complications was 3.0%. The final successful crossing strategy was antegrade wire escalation in 52.0%, retrograde in 27.1%, and antegrade dissection re-entry in 20.9%; >1 crossing strategy was required in 40.9%. Median contrast volume, air kerma radiation dose, and procedure and fluoroscopy time were 270 ml (interquartile range: 200 to 360 ml), 2.9 Gy (interquartile range: 1.7 to 4.7 Gy), 123 min (interquartile range: 81 to 188 min) and 47 min (interquartile range: 29 to 77 min), respectively. CONCLUSIONS: CTO PCI is currently being performed with high success and acceptable complication rates among various experienced centers in the United States, Europe, and Russia. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436).

Novel renal biomarker evaluation for early detection of acute kidney injury after transcatheter aortic valve implantation.

Acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The biomarkers neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), and interleukin-18 (IL-18) are predictive of AKI after cardiac surgery, but there is little data regarding these biomarkers after TAVI. We evaluated the associations between NGAL, KIM-1, and IL-18 levels and the incidence and severity of AKI and changes in serum creatinine after TAVI. This was a prospective pilot study of 66 TAVI cases. Urinary biomarkers were measured at baseline and at 2, 4, and 12 hours after TAVI. Demographics, procedural features, and renal function until discharge were compared between patients with and without subsequent AKI. Seventeen patients (25.8%) developed AKI postoperatively (stage 1, n = 14; stage 2, n = 1; stage 3, n = 2). There were no significant differences in unadjusted mean NGAL, KIM-1, and IL-18 levels between patients with and without AKI at 2, 4, and 12 hours following surgery. After adjusting for the Society of Thoracic Surgeons risk of mortality, this study of three urinary biomarkers showed no association with AKI or creatinine after TAVI. Ongoing efforts to predict and modify the risk of AKI after TAVI remain challenging.

Description of a Method to Obtain Complete One-Year Follow-Up in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

The Centers for Medicare and Medicaid Services National Coverage Determination requires centers performing transcatheter aortic valve implantation (TAVI) to report clinical outcomes up to 1 year. Many sites encounter challenges in obtaining complete 1-year follow-up. We report our process to address this challenge. A multidisciplinary process involving clinical personnel, data and quality managers, and research coordinators was initiated to collect TAVI data at baseline, 30 days, and 1 year. This process included (1) planned clinical follow-up of all patients at 30 days and 1 year; (2) query of health-care system-wide integrated data warehouse (IDW) to ascertain last date of clinical contact within the system for all patients; (3) online obituary search, cross-referencing for unique patient identifiers to determine if mortality occurred in remaining unknown patients; and (4) phone calls to remaining unknown patients or patients' families. Between January 2012 and December 2016, 744 patients underwent TAVI. All 744 patients were eligible for 30-day follow-up and 546 were eligible for 1-year follow-up. At routine clinical follow-up of 22 of 744 (3%) patients at 30 days and 180 of 546 (33%) patients at 1 year had unknown survival status. The integrated data warehouse query confirmed status-alive for an additional 1 of 22 patients at 30 days (55%) and 91 of 180 patients at 1 year (51%). Obituaries were identified for 23 of 180 additional patients at 1 year (13%). Phone contact identified the remaining unknown patients at 30 days and 1 year, resulting in 100% known survival status for patients at 30 days (744 of 744) and at 1 year (546 of 546). In conclusion, using a comprehensive approach, we were able to determine survival status in 100% of patients who underwent TAVI.

Sex-Specific Outcomes of Transcatheter Aortic Valve Replacement With the SAPIEN 3 Valve: Insights From the PARTNER II S3 High-Risk and Intermediate-Risk Cohorts.

OBJECTIVES: The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve. BACKGROUND: A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown. METHODS: The PARTNER (Placement of Aortic Transcatheter Valves) II S3 trial included high-risk (HR) (Society of Thoracic Surgeons risk score >8% or heart team determination) and intermediate-risk (IR) (Society of Thoracic Surgeons risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the SAPIEN 3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex. RESULTS: Between October 2013 and December 2014, 1,661 patients were enrolled: 583 were HR (338 men, 245 women) and 1,078 were IR (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs. 13%; p < 0.001), but less likely to have comorbid conditions of renal insufficiency, coronary artery disease, atrial fibrillation, or chronic obstructive pulmonary disease. Women were more likely to receive ≤23-mm valves (74.1% vs. 11.1%; p < 0.001) and were less likely to receive 29-mm valves (1.4% vs. 35.1%; p < 0.001). In the combined cohorts, there was no difference in mortality for women compared with men at 30 days (2.0% vs. 1.2%; p = 0.20) or 1 year (9.3% vs. 10.2%; p = 0.59). There were no differences in disabling stroke or any stroke at 30 days or 1 year; however, women had an increased rate of minor stroke at 30 days (2.1% vs. 0.7%; p = 0.01). Female sex was associated with increased major vascular complications (7.9% vs. 4.4%; p = 0.003), but not with moderate or severe paravalvular regurgitation. Notably, similar outcomes regarding sex-specific outcomes were obtained within stratified analyses of the HR and IR cohorts. CONCLUSIONS: The study found no apparent sex-specific differences in survival or stroke in this trial of TAVR. This may reflect the changing demographic of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques.

Validation of a low-dose contrast 64-slice cardiac computed tomography angiography protocol for aortic valve annulus sizing.

Cardiac computed tomography angiography (CCTA) is the gold standard for accurately sizing the aortic valve annulus prior to aortic valve replacement. A reduction of contrast volume administered for CCTA, without sacrificing image quality, is desirable. Signal-to-noise ratio represents final CCTA image quality. Consecutive patients referred to CCTA for aortic valve annulus sizing were retrospectively analyzed. Patients were grouped into a low-dose contrast (LDCT) group and traditional dose contrast (TDCT) group. In the LDCT group, contrast dose was <50% of the maximal allowable dose (3.7 × estimated glomerular filtration rate). Guided by a time-density curve, the contrast was administered in a two-stage infusion, and retrospectively gated images were acquired with a 64-multidetector computed tomography scanner. Out of 123 patients (age 80 ± 9 years; 46% female), 65 (52.9%) underwent LDCT and 58 (47.2%) underwent TDCT. Contrast volume was significantly lower in the LDCT group (LDCT 41.2 ± 9.8 vs TDCT 76.2 ± 14.2 mL; P < 0.001). The signal-to-noise ratio of the aortic root was 10.4 ± 4.1 for the LDCT group and 8.4 ± 3.3 for the TDCT group (P = 0.004). Aortic root dimensions could be measured in both LDCT and TDCT groups. In conclusion, LDCT with 64-slice CCTA can effectively size the aortic valve annulus to direct aortic valve replacement while offering reduced contrast exposure.

Balloon aortic valvuloplasty to improve candidacy of patients evaluated for transcatheter aortic valve replacement.

OBJECTIVES: Evaluate the role of balloon aortic valvuloplasty (BAV) in improving candidacy of patients for transcatheter aortic valve replacement (TAVR). BACKGROUND: Patients who are not candidates for TAVR may undergo BAV to improve functional and clinical status. METHODS: 117 inoperable or high-risk patients with critical aortic stenosis underwent BAV as a bridge-to-decision for TAVR. Frailty measures including gait speed, serum albumin, hand grip, activities of daily living (ADL); and NYHA functional class before and after BAV were compared. RESULTS: Mean age was 81.6 ± 8.5 years and the mean Society of Thoracic Surgeons predicted risk of mortality was 9.57 ± 5.51, with 19/117 (16.2%) patients non-ambulatory. There was no significant change in mean GS post-BAV, but all non-ambulatory patients completed GS testing at follow-up. Albumin and hand grip did not change after BAV, but there was a significant improvement in mean ADL score (4.85 ± 1.41 baseline to 5.20 ± 1.17, P = 0.021). The number of patients with Class IV congestive heart failure (CHF) was significantly lower post BAV (71/117 [60.7%] baseline versus 18/117 [15.4%], P = 0.008). 78/117 (66.7%) of patients were referred to definitive valve therapy after BAV. CONCLUSIONS: When evaluating frailty measures post BAV, we saw no significant improvement in mean GS, however, we observed a significant improvement in non-ambulatory patients and ADL scores. We also describe improved Class IV CHF symptoms. With this improved health status, the majority of patients underwent subsequent valve therapy, demonstrating that BAV may improve candidacy of patients for TAVR.

Usefulness of Balloon Aortic Valvuloplasty in the Management of Patients With Aortic Stenosis.

We aim to evaluate the contemporary role and outcomes of balloon aortic valvuloplasty (BAV), based on physician intent, for the management of severe aortic stenosis. This is a prospective, 2-center study of 100 consecutive high-risk patients with severe aortic stenosis who underwent BAV. Before BAV, physicians assigned intent as (1) bridge to decision (BTD); (2) therapeutic bridge to planned therapy; or (3) palliation. Patients in the BTD arm underwent clinical assessment at 30 days to determine eligibility for definitive valve therapy. All patients were followed up to 1 year, with outcomes measured including procedural complications, Kansas City Cardiomyopathy Questionnaires scores, 30-day and 1-year mortality, and definitive valve therapy. Enrolled patients had a mean age of 80.6 (±9.6) years, Society of Thoracic Surgeons predicted risk of mortality of 11.4% (±7.1%), and 91 (91.0%) patients had class III or IV New York Heart Association congestive heart failure. Intent in the 100 study patients was 76 BTD; 20 therapeutic bridge to planned therapy; and 4 palliation. Thirty-day mortality for all patients was 6 of 100 (6.0%), and 1-year mortality for all patients who received definitive valve therapy was 6 of 54 (11.1%). For patients surviving to 30 days, adjusted (by Society of Thoracic Surgeons predicted risk of mortality) Kansas City Cardiomyopathy Questionnaires scores were significantly improved from baseline for all patients and BTD patients. In conclusion, as a bridge to decision and treatment tool, BAV appears to have a valuable role in properly selecting and improving patients to undergo definitive valve replacement.