Outcomes of Percutaneous Revascularization in Severe Ischemic Left Ventricular Dysfunction.

PURPOSE OF REVIEW: This article presents a comprehensive review of coronary revascularization versus optimal medical therapy (OMT) in patients with severe ischemic left ventricular dysfunction. RECENT FINDINGS: The REVIVED-BCIS2 trial randomized 700 patients with extensive coronary artery disease and left ventricular (LV) ejection fraction (LVEF) ≤ 35% and viability in more than four dysfunctional myocardial segments to percutaneous coronary intervention (PCI) plus OMT versus OMT alone. Over a median duration of 41 months, there was no difference in the composite of all-cause mortality, heart failure hospitalization, or improvement in LVEF with PCI plus OMT versus OMT alone at 6 and 12 months, quality of life scores at 24 months, or fatal ventricular arrhythmia. The STICH randomized trial was conducted between 2002 and 2007, involving patients with LV dysfunction and coronary artery disease. The patients were assigned to either CABG plus medical therapy or medical therapy alone. At the 5-year follow-up, the trial showed that CABG plus medical therapy reduced cardiovascular disease-related deaths and hospitalizations but no reduction in all-cause mortality. However, a 10-year follow-up showed a significant decrease in all-cause mortality with CABG. The currently available evidence showed no apparent benefit of PCI in severe ischemic cardiomyopathy as compared to OMT, but that CABG improves outcomes in this patient population. The paucity of data on the advantages of PCI in this patient population underscores the critical need for optimization of medical therapy for better survival and quality of life until further evidence from RCTs is available.

Activated clotting time and outcomes of chronic total occlusion percutaneous coronary intervention: insights from the PROGRESS-CTO Registry.

BACKGROUND: The optimal range of activated clotting time (ACT) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We examined the association between ACT and in-hospital ischemic and bleeding outcomes in patients who underwent CTO PCI in the Prospective Global Registry for the Study of CTO Intervention. RESULTS: ACT values were available for 4377 patients who underwent CTO PCI between 2012 and 2023 at 29 centers. The mean ACT distribution was less than 250 seconds (19%), 250 to 349 seconds (50%), and greater than or equal to 350 seconds (31%). The incidence of ischemic events, bleeding events, and net adverse cardiovascular events (NACE) was 0.8%, 3.0%, and 3.8%, respectively. In multiple logistic regression analysis, increasing nadir ACT was associated with decreasing ischemic events (adjusted odds ratio [aOR] per 50-second increments: 0.69 [95% confidence interval (CI), 0.50-0.94; P=.017]; and increasing peak ACT was associated with increasing bleeding events (aOR per 50-second increments: 1.17 [95% CI ,1.01-1.36; P=.032]). A U-shaped association was seen between mean ACT and NACE, where restricted cubic spline analysis demonstrated that patients with a low ( less than 200 seconds) or high ( greater than 400 seconds) ACT had increasing NACE risk compared with an ACT of 200 to 400 seconds (aOR 2.06, 95% CI 1.18-3.62; P=.012). CONCLUSIONS: Among patients who underwent CTO PCI, mean ACT had a U-shaped relationship with NACE, where patients with a low ( less than 200 seconds) ACT (driven by ischemic events) or high ( greater than 400 seconds) ACT (driven by bleeding) had higher NACE compared with an ACT of 200 to 400 seconds.

Trends and Outcomes of Antegrade Dissection and Re-Entry in Chronic Total Occlusion Percutaneous Coronary Intervention.

BACKGROUND: The contemporary frequency and outcomes of antegrade dissection and re-entry (ADR) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) have received limited study. OBJECTIVES: The aim of this study was to determine the frequency and outcomes of ADR use in a large multicenter CTO PCI registry. METHODS: The characteristics and outcomes of ADR were examined among 12,568 patients who underwent 12,841 CTO PCIs at 46 U.S. and non-U.S. centers between 2012 and 2023. RESULTS: ADR was used in 2,385 of the procedures (18.6%). ADR use declined from 37.9% in 2012 to 14.5% in 2022 (P < 0.001). Patients in whom ADR was used had a high prevalence of comorbidities. Compared with cases that did not use ADR, ADR cases had more complex angiographic characteristics, higher mean J-CTO (Multicenter CTO Registry in Japan) score (2.94 ± 1.11 vs 2.23 ± 1.26; P < 0.001), lower technical success (77.0% vs 89.3%; P < 0.001), and higher in-hospital major adverse cardiac events (3.7% vs 1.6%; P < 0.001). The use of the CrossBoss declined from 71% in 2012 to 1.4% in 2022 and was associated with higher technical success (87%) compared with wire-based techniques (73%). The Stingray device displayed higher technical success (86%) compared with subintimal tracking and re-entry (STAR) (74%) and limited antegrade subintimal tracking (78%); however, its use has been decreasing, with STAR becoming the most used re-entry technique in 2022 (44% STAR vs 38% Stingray). CONCLUSIONS: The use of ADR has been decreasing. ADR was used in more complex lesions and was associated with lower technical success and higher major adverse cardiac events compared with non-ADR cases. There has been a decrease in Stingray use and an increase in the use of STAR for re-entry.

Impact of calcium on the procedural techniques and outcomes of chronic total occlusion percutaneous coronary intervention.

BACKGROUND: Coronary calcification is common and increases the difficulty of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined the impact of calcium on procedural outcomes of 13,079 CTO PCIs performed in 12,799 patients at 46 US and non-US centers between 2012 and 2023. RESULTS: Moderate or severe calcification was present in 46.6% of CTO lesions. Patients whose lesions were calcified were older and more likely to have had prior coronary artery bypass graft surgery. Calcified lesions were more complex with higher J-CTO score (3.0 ± 1.1 vs. 1.9 ± 1.2; p < 0.001) and lower technical (83.0% vs. 89.9%; p < 0.001) and procedural (81.0% vs. 89.1%; p < 0.001) success rates compared with mildly calcified or non-calcified CTO lesions. The retrograde approach was more commonly used among cases with moderate/severe calcification (40.3% vs. 23.5%; p < 0.001). Balloon angioplasty (76.6%) was the most common lesion preparation technique for calcified lesions, followed by rotational atherectomy (7.3%), laser atherectomy (3.4%) and, intravascular lithotripsy (3.4%). The incidence of major adverse cardiovascular events (MACE) was higher in cases with moderate or severe calcification (3.0% vs. 1.2%; p < 0.001), as was the incidence of perforation (6.5% vs. 3.4%; p < 0.001). On multivariable analysis, the presence of moderate/severe calcification was independently associated with lower technical success (odds ratio, OR = 0.73, 95% CI: 0.63-0.84) and higher MACE (OR = 2.33, 95% CI: 1.66-3.27). CONCLUSIONS: Moderate/severe calcification was present in nearly half of CTO lesions, and was associated with higher utilization of the retrograde approach, lower technical and procedural success rates, and higher incidence of in-hospital MACE.

Same day discharge versus overnight observation following chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO registry.

BACKGROUND: Same day discharge (SDD) following chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We evaluated the clinical, angiographic, and procedural characteristics of patients discharged the same day versus those kept for overnight observation in the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO, NCT02061436). RESULTS: Of the 7181 patients who underwent CTO PCI, 943 (13%) had SDD. The SDD rate increased from 3% in 2015 to 21% in 2022. Patients with SDD were less likely to have a history of heart failure (21% vs. 26%, p = 0.005), chronic lung disease (10% vs. 15%, p = 0.001), or anemia (12% vs. 19%, p < 0.001). Technical success (87% vs. 88%, p = 0.289) was similar, but in-hospital major adverse cardiovascular events (0.0% vs. 0.4%, p = 0.041) were lower in SDD. In multivariable logistic regression analysis, prior myocardial infarction odds ratio (OR): 0.71 (95% confidence interval [CI]: 0.59-0.87, p = 0.001), chronic lung disease OR: 0.64 (95% CI: 0.47-0.88, p = 0.006), and increasing procedure time OR: 0.93 (95% CI: 0.91-0.95, p < 0.001, per 10-min increase) were associated with overnight observation, while radial-only access OR: 2.45 (95% CI: 2.03-2.96, p < 0.001) had the strongest association with SDD. In the SDD, 2 (0.4%) of 514 patients were readmitted, due to retroperitoneal bleeding (n = 1) and ischemic stroke (n = 1). CONCLUSION: The overall frequency of SDD after CTO PCI was 13% and has been increasing over time. SDD is feasible in select patients following CTO PCI, and radial-only access had the strongest association with SDD.

Equipment Utilization in Chronic Total Occlusion Percutaneous Coronary Interventions: Update From the PROGRESS-CTO Registry.

BACKGROUND: Guidewires and microcatheters are critical to the success of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined equipment utilization in 11,202 CTO-PCIs performed in 10,952 patients at 42 United States (US) and non-US centers between 2012 and 2022. RESULTS: Antegrade-only crossing was attempted in 7628 CTO-PCIs (68%) and the retrograde approach was used in 3574 CTO-PCIs (32%). The median number of guidewires used during antegrade wiring increased with lesion complexity from 3 (interquartile range [IQR], 2-4) for J-CTO score of 0 to 5 (IQR, 4-7) for J-CTO score of 5 (P<.001). Antegrade-only procedures had higher technical (90% vs 79%; P<.001) and procedural success (89% vs 77%; P<.001) compared with retrograde procedures. In antegrade-only cases, Pilot 200 (28%; Abbott Vascular) and Fielder XT (24%; Asahi Intecc) were the most frequently used guidewires, while Corsair (21%; Asahi Intecc) and Turnpike Spiral (20%; Vascular Solutions) were the most commonly used microcatheters. In retrograde cases, Sion (32%; Asahi Intecc) was the most common guidewire used, followed by Sion Black (22%; Asahi Intecc), Pilot 200 (22%), and Suoh 03 (19%; Asahi Intecc), while Corsair (16%) and Turnpike LP (11%) were the most commonly used microcatheters. The most successful guidewire for collateral crossing was the Sion (32%), followed by Sion Black (15%) and Suoh 03 (11%). CONCLUSION: Polymer-jacketed guidewires are the most commonly used guidewires for antegrade wiring, while non-polymer-jacketed, torquable guidewires are the most frequently used guidewires for retrograde techniques. Turnpike and Corsair are the most commonly used microcatheters in CTO-PCI.

Development and validation of a scoring system for predicting clinical coronary artery perforation during percutaneous coronary intervention of chronic total occlusions: the PROGRESS-CTO perforation score.

BACKGROUND: Coronary artery perforation is a feared complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and often leads to serious adverse clinical events. AIMS: We sought to develop a risk score to predict clinical coronary artery perforation in patients undergoing CTO PCI. METHODS: We analysed clinical and angiographic parameters from 9,618 CTO PCIs in the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO). Logistic regression prediction modelling was used to identify variables independently associated with clinical perforation, and the model was internally validated with bootstrapping. Clinical coronary artery perforation was defined as any perforation requiring treatment. RESULTS: The incidence of clinical coronary perforation was 3.8% (n=367). Five factors were independently associated with perforation and were included in the score: patient age ≥65 years +1 point (odds ratio [OR] 1.79, 95% confidence interval [CI]: 1.37-2.33), moderate/severe calcification +1 point (OR 1.85, 95% CI: 1.41-2.42), blunt/no stump +1 point (OR 1.45, 95% CI: 1.10-1.92), use of antegrade dissection and re-entry +1 point (OR 2.43, 95% CI: 1.61-3.69), and use of the retrograde approach +2 points (OR 4.02, 95% CI: 2.95-5.46). The resulting score showed acceptable performance on receiver operating characteristic (ROC) curve (area under the curve [AUC]: 0.741, 95% CI: 0.712-0.773). The Hosmer-Lemeshow test indicated a good fit (p=0.991), and internal validation with bootstrapping demonstrated good agreement with the model with observed AUC: 0.736 (95% bias-corrected CI: 0.706-0.767). CONCLUSIONS: The PROGRESS-CTO perforation score may be a useful tool for predicting clinical coronary perforation during CTO PCI.

Advances in Percutaneous Management of Pulmonary Embolism.

Acute pulmonary embolism (PE) is a leading cause of morbidity and mortality worldwide. Systemic anticoagulation remains the recommended treatment for low-risk PE. Systemic thrombolysis is the recommended treatment for PE with hemodynamic compromise (massive/high-risk PE). A significant number of patients are not candidates for systemic thrombolysis due to the bleeding risk associated with thrombolytics. Historically, surgical pulmonary embolectomy (SPE) was recommended for massive PE with hemodynamic compromise for these patients. In the last decade, catheter-directed thrombolysis (CDT) has largely replaced SPE in the patient population with intermediate risk PE (submassive), defined as right heart strain (as evidenced by right ventricle enlargement on echocardiogram and/or computed tomography, usually along with elevation of troponin or B-type natriuretic peptide). Use of CDT increased in the last few years due to high incidence of PE in hospitalized patients with coronavirus disease 2019 pneumonia, and the use of mechanical thrombectomy (initially reserved for those with contraindications to thrombolysis) has also grown. In this article, we discuss the value of the PE response team, our approach to management of submassive (intermediate risk) and massive (high risk) PE with systemic thrombolytics, CDT, mechanical thrombectomy, and surgical embolectomy.

Incidence, Mechanisms, Treatment, and Outcomes of Coronary Artery Perforation During Chronic Total Occlusion Percutaneous Coronary Intervention.

Coronary artery perforation is a feared complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Our objective was to describe the incidence, mechanisms, treatment, and outcomes of coronary artery perforation during CTO PCI. We analyzed the baseline clinical and angiographic characteristics and procedural outcomes of 10,454 CTO PCIs performed in 10,219 patients between 2012 and 2022. The incidence of coronary perforation was 4.9% (n = 503). Patients who experienced coronary perforation were older and were more likely to have had previous coronary artery bypass graft surgery. Procedures that resulted in perforation were more complex, with higher Japanese CTO and Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO) scores. Technical (66% vs 87%, p <0.001) and procedural (55% vs 87%, p <0.001) success rates were lower in perforation cases. The CTO target vessel was the most common perforation site (66%). The retrograde approach was responsible for the perforation in 47% of cases, and guidewire exit was the most common perforation mechanism. The proportion of Ellis class 1, 2, 3, and 3 -"cavity spilling" coronary perforations was 20%, 41%, 28%, and 11%, respectively. In 52% of perforations, 1 or more interventions were required: prolonged balloon inflation (23%), covered stent deployment (21%), coil embolization (6%), and/or autologous fat embolization (4%). Tamponade requiring pericardiocentesis occurred in 69 patients (14%). The incidence of major adverse cardiovascular events was higher in perforation cases (18% vs 1.3%, p <0.001). In conclusion, coronary artery perforation occurred in 4.9% of CTO PCIs performed by experienced operators and was associated with lower technical success and higher in-hospital major adverse cardiovascular events.

Intravascular lithotripsy in chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO registry.

BACKGROUND: The use of intravascular lithotripsy (IVL) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We analyzed the baseline clinical and angiographic characteristics and procedural outcomes of 82 CTO PCIs that required IVL at 14 centers between 2020 and 2022. RESULTS: During the study period, IVL was used in 82 of 3301 (2.5%) CTO PCI procedures (0.4% in 2020 and 7% in 2022; p for trend < 0.001). Mean patient age was 69 ± 11 years and 79% were men. The prevalence of hypertension (95%), diabetes mellitus (62%), and prior PCI (61%) was high. The most common target vessel was the right coronary artery (54%), followed by the left circumflex (23%). The mean J-CTO and PROGRESS-CTO scores were 2.8 ± 1.1 and 1.3 ± 1.0, respectively. Antegrade wiring was the final successful crossing strategy in 65% and the retrograde approach was used in 22%. IVL was used in 10% of all heavily calcified lesions and 11% of all balloon undilatable lesions. The 3.5 mm lithotripsy balloon was the most commonly used balloon (28%). The mean number of pulses per lithotripsy run was 33 ± 32 and the median duration of lithotripsy was 80  (interquartile range: 40-103) seconds. Technical and procedural success was achieved in 77 (94%) and 74 (90%) cases, respectively. Two (2.4%) Ellis Class 2 perforations occurred after IVL use and were managed conservatively. CONCLUSION: IVL is increasingly being used in CTO PCI with encouraging outcomes.

Radial access for chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO registry.

Use of radial access for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has been increasing. We examined the clinical characteristics and procedural outcomes of patients who underwent CTO PCI with radial versus femoral access in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO, NCT02061436). Of 10,954 patients who underwent CTO PCI at 55 centers in 7 countries between 2012 and 2022, 2578 (24%) had a radial only approach. Patients who underwent radial only access were younger (63 ± 10 vs. 65 ± 10, years, p &lt; 0.001), more likely to be men (84% vs. 81%, p = 0.001), and had significantly lower prevalence of comorbidities compared with the femoral access group including diabetes mellitus (39% vs. 45%, p &lt; 0.001) and coronary artery bypass graft surgery (57% vs. 64%, p &lt; 0.001). In addition, radial only cases had lower angiographic complexity with lower J-CTO and PROGRESS-CTO scores. After adjusting for potential confounders, radial only access was associated with lower risk of access site complications (odds ratio [OR]: 0.45, 95% confidence interval [CI]: 0.22-0.91), similar technical success (OR: 0.87, 95% CI: 0.74-1.04) and major adverse cardiovascular events (MACE) (OR: 0.65, 95% CI: 0.40-1.07), compared with the femoral access group. Radial only access was used in 24% of CTO PCIs and was associated with lower access site complications, and similar technical success and MACE as compared with the femoral access group.

Antegrade dissection and re-entry versus parallel wiring in chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO registry.

BACKGROUND: The comparative efficacy and safety of parallel wiring versus antegrade dissection and re-entry (ADR) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is controversial. METHODS: We compared the clinical and angiographic characteristics and outcomes of parallel wiring versus ADR after failed antegrade wiring in a large, multicenter CTO PCI registry. RESULTS: A total of 1725 CTO PCI procedures with failed antegrade wiring with a single wire were approached with parallel wiring (692) or ADR (1033) at the discretion of the operator. ADR patients were older (65 ± 10 vs. 62 ± 10, years, p < 0.001) and had higher prevalence of comorbidities, such as diabetes mellitus (43% vs. 32%, p < 0.001), prior coronary artery bypass graft surgery (31% vs. 19%, p < 0.001), and lower left ventricular ejection fraction (50 ± 14 vs. 53 ± 11%, p < 0.001). The ADR group had higher J-CTO (2.8 ± 1.1 vs. 2.1 ± 1.3, p < 0.001) and PROGRESS-CTO (1.6 ± 1.1 vs. 1.2 ± 1.0, p < 0.001) scores. Equipment use including guidewires, balloons, and microcatheters was higher, and the procedures lasted longer in the ADR group. Technical success (78% vs. 75%, p = 0.046) and major adverse cardiovascular events (composite of all-cause mortality, stroke, acute myocardial infarction, emergency surgery or re-PCI, and pericardiocentesis) (3.7% vs. 1.9%, p = 0.029) were higher in the ADR group, with similar procedural success (75% vs. 73%, p = 0.166). CONCLUSION: In lesions that could not be crossed with antegrade wiring, ADR was associated with higher technical but not procedural success, and also higher MACE compared with parallel wiring.

Predictors of success in primary retrograde strategy in chronic total occlusion percutaneous coronary intervention: insights from the PROGRESS-chronic total occlusion registry.

BACKGROUND: An upfront (primary) retrograde strategy is often used in complex chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined the clinical, angiographic characteristics, and procedural outcomes of CTO PCIs that were approached with a primary retrograde strategy in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO, NCT02061436). RESULTS: Of 10,286 CTO PCIs performed between 2012 and 2022, a primary retrograde strategy was used in 1329 (13%) with an initial technical success of 66%, and a final success of 83%. Patients who underwent successful versus unsuccessful primary retrograde cases had similar characteristics: age (65 ± 10 vs. 65 ± 9, years, p = 0.203), men (83% vs. 87%, p = 0.066), prior PCI (71% vs. 71%, p = 0.809), and prior coronary artery bypass graft surgery (52% vs. 53%, p = 0.682). The PROGRESS-CTO score (1.3 ± 0.9 vs. 1.6 ± 0.9, p < 0.001), air kerma radiation (3.9 ± 2.8 vs. 3.4 ± 2.6, gray, p = 0.013), and contrast use (294 ± 148 ml vs. 248 ± 128, ml, p < 0.001) were higher in the unsuccessful group, whereas the presence of interventional collaterals (95% vs. 72%, p < 0.001) and Werner collateral connection grade 2 (43% vs. 31%, p < 0.001) were higher in the successful group. On multivariable logistic regression analysis, the only variable associated with a successful primary retrograde strategy was the presence of interventional collaterals: odds ratio: 6.52 (95% confidence intervals; 3.5-12.1, p < 0.001). CONCLUSION: Presence of interventional collaterals is independently associated with higher success rates with a primary retrograde strategy in CTO PCI.

Timing of Coronary Angiography in Patients Following Out-of-Hospital Cardiac Arrest Without ST-Segment Elevation: A Systematic Review and Meta-Analysis of Randomized Trials.

INTRODUCTION: Out-of-hospital cardiac arrest (OHCA) has a poor prognosis. The timing and role of early coronary angiography (CAG) in OHCA patients without ST elevation remains unclear. OBJECTIVE: We performed a meta-analysis of randomized controlled trials (RCTs) that compared early CAG to delayed CAG in OHCA patients without ST elevation. METHODS: We searched PubMed, Cochrane, and ClinicalTrials.gov databases (from inception to September 2021) for studies comparing early CAG to delayed CAG in OHCA patients without ST elevation. We used a random-effect model to calculate relative ratio (RR) with 95% confidence interval (CI). The primary outcome was all-cause mortality at 30 days. Secondary outcomes included neurological status with cerebral performance category ≤2 (CPC) and the rate of percutaneous coronary intervention (PCI) following CAG. RESULTS: A total of 6 RCTs including 1822 patients, of whom 895 underwent early CAG, and 927 underwent delayed CAG, were included in this meta-analysis. There was no statistically significant difference between the 2 groups in terms of 30-day all-cause mortality (Relative risk [RR] 1.06; 95%CI 0.94-1.20; P = 0.32; I2 = 13%), neurological status (CPC ≤2) (RR 1.01; 95%CI 0.90-1.13; P = 0.85, I2 = 37%), and rates of PCI following CAG (RR 1.08; 95%CI 0.84-1.39; P = 0.56; I2 = 49%). CONCLUSION: In patients suffering OHCA without ST-elevation, early CAG is not associated with reduced 30-day mortality when compared to patients who underwent delayed CAG. Given our meta-analysis results including multiple trials that have not shown a benefit, it is likely that updated guidelines will not support early angiography in patients suffering OHCA without ST-elevation.

Comparing outcomes of general anesthesia and monitored anesthesia care during transcatheter aortic valve replacement: The Cleveland Clinic Foundation experience.

BACKGROUND: Monitored anesthesia care (MAC) has become more widely used during transcatheter aortic valve replacement (TAVR) to avoid the complications of general anesthesia (GA). METHODS: We included consecutive patients who underwent transfemoral-TAVR at our institution between January 2012 and April 2017. We compared outcomes with GA versus MAC. RESULTS: Of 998 patients, MAC was used in 43.9%. MAC was associated with shorter procedural time (96.9 ± 30.9 vs. 135 ± 64.6 mins; p < .001), fluoroscopy time (20.4 ± 8.9 vs. 29 ± 18.7 mins; p < .001), lower contrast volume (45.5 ± 27 vs. 60.4 ± 43 cc; p < .001), and decreased radiation exposure (12,869 ± 8,099 vs. 20,630 ± 16,276 cGy-cm2 ; p < .001). Patients who underwent MAC had a briefer median (IQR) intensive care unit stay [23.3 (21-24) vs. 23.4 (20.8-26) hrs; p < .001], and hospital stay [2 (2, 3) vs. 3 (2-6) days; p < .001], and were more frequently discharged to home (93.4% vs. 82.9%; p < .001). MAC was associated with lower mortality at 30 days (0.5% vs. 2.9%; log-rank p = .012; adjHR 0.22, 95% CI 0.06-0.82; p = .024), but not at 1 year (11.7% vs. 14.6%; log-rank p = .157) or 3 years (36.8% vs. 38.4%; log-rank p = 0.433). There were no differences in major adverse cardiac and cerebrovascular events (MACCE) at either 30 days (4.6% vs. 9.3%; log-rank p = .14) or 1 year (21.1% vs. 21.5%; log-rank p = .653). Similar findings were seen among patients who received newer-generation SAPIEN-3 valves. CONCLUSION: Utilizing MAC and omitting intraprocedural transesophageal echocardiography during TAVR seems to be more efficient without compromising safety. Better TAVR outcomes can be achieved with newer generation valves without needing GA.

Meta-analysis of the Impact of Avoiding Balloon Predilation in Transcatheter Aortic Valve Implantation.

Balloon predilation (BPD) has been an integral part of transcatheter aortic valve implantation (TAVI) since inception. We sought to investigate the effect of avoiding BPD on outcomes of TAVI across different valve types. Articles were included if outcomes of TAVI without BPD were reported. Pooled meta-analysis used a random effects model and reported odds ratios (ORs). Twenty-one studies with 10,752 patients were pooled for analysis. Age and gender were well matched between NoBPD and BPD groups. There was no difference in mortality, stroke, bleeding, and acute kidney injury. NoBPD showed lower pacemaker rates (OR 0.84, 95% confidence interval [CI] 0.72 to 0.97), vascular complications (OR 0.77, 95% CI 0.62 to 0.95), and early safety at 30 days (OR 0.81, 95% CI 0.66 to 0.99). For balloon-expandable valves, lower rates of aortic regurgitation (OR 0.73, 95% CI 0.53 to 0.99) and early safety (OR 0.68, 95% CI 0.55 to 0.85) were seen. Self-expanding valves showed lower pacemaker (OR 0.80, 95% CI 0.66 to 0.97) and vascular complications (OR 0.70, 95% CI 0.50 to 0.99), with a trend toward higher postdilation (OR 1.51, 95% CI 0.85 to 2.67). TAVI without BPD is safe and effective. NoBPD is associated with fewer vascular complications, less aortic regurgitation, and fewer pacemaker requirements and composite early safety end points.