Coronary and Structural Heart Disease Interventions During COVID-19 Pandemic: A Road Map for Clinicians and Health Care Delivery Systems.

BACKGROUND: Because of the COVID-19 pandemic, cath labs have had to modify their workflow for elective and urgent patients. METHODS: We surveyed 16 physicians across 3 hospitals in our healthcare system to address COVID-19 related concerns in the management of interventional and structural heart disease patients, and to formulate system wide criteria for deferring cases till after the pandemic. RESULTS: Our survey yielded common concerns centered on the need to protect patients, cath lab staff and physicians from unnecessary exposure to COVID-19; for COVID-19 testing prior to arrival to the cath lab; for clear communication between the referring physician and the interventionalist; but there was initial uncertainty among physicians regarding the optimal management of ST elevation myocardial infarction (STEMI; percutaneous coronary intervention versus thrombolytics). Patients with stable angina and hemodynamically stable acute coronary syndromes were deemed suitable for initial medical management, except when they had large ischemic burden. Most transcatheter aortic valve implantations (TAVI) were felt appropriate for postponement except in symptomatic patients with aortic valve area <0.5 cm2 or recent hospitalization for heart failure (HF). Most percutaneous mitral valve repair (pMVR) procedures were felt appropriate for postponement except in patients with HF. All left atrial appendage closure (LAAC) and patent foramen ovale (PFO)/atrial septal defect (ASD) closure procedures were felt appropriate for postponement. CONCLUSION: Our survey of an experienced team of clinicians yielded concise guidelines to direct the management of CAD and structural heart disease patients during the initial phases of the COVID-19 pandemic.

Efficiency, Safety, and Quality of Life After Transcatheter Aortic Valve Implantation Performed With Moderate Sedation Versus General Anesthesia.

There is growing interest in "minimalist" transcatheter aortic valve implantation (M-TAVI), performed with conscious sedation instead of general anesthesia (GA-TAVI). We assessed the impact of M-TAVI on procedural efficiency, long-term safety, and quality of life (QoL) in 477 patients with severe aortic stenosis (82 years, women 50%, STS 5.0), who underwent M-TAVI (n = 278) or GA-TAVI (n = 199). M-TAVI patients were less likely to have NYHA Class ≥3, valve-in-valve TAVI, and receive self-expanding valves. M-TAVI was completed without conversion to GA in 269 (97%) patients. M-TAVI was more efficient that GA-TAVI including shorter lengths of stay (2 vs 3 days, p <0.0001), higher likelihood of being discharged home (87% vs 72%, p <0.0001), less use of blood transfusions (10% vs 22%, p = 0.0008), inotropes (13% vs 32%, p <0.0001), contrast volume (50 vs 90 ml, p <0.0001), fluoroscopy time (20 vs 24 minute, p <0.0001), and need for >1 valves (0.4 vs 5.5%, p = 0.0004). At 1-month, death/stroke (M-TAVI vs GA-TAVI 4.0 vs 6.5%) and a "safety composite" end point (death, stroke, transient ischemic attack, myocardial infarction, new dialysis, major vascular complication, major or life-threatening bleeding, and new pacemaker: 17.6% vs 21.1%) were similar (p = NS for both). At a median follow-up of 365 days, survival curves showed similar incidence of death/stroke as well as the safety composite end point between the groups. QoL scores were similar at baseline and 1-month after TAVI. In multivariable analyses, M-TAVI showed significant improvements in all parameters of procedural efficiency. In conclusion, M-TAVI is more efficient than GA-TAVI, with similar safety at 1-month and long-term, and similar QoL scores at 1 month.

Aorto-Right Ventricular Fistula and Paravalvular Leak After Transcatheter Aortic Valve Implantation.

Aorto-right ventricular fistula is a potentially fatal complication following transcatheter aortic valve implantation (TAVI). This paper presents a case of successful percutaneous repair of aorto-right ventricular fistula and paravalvular leak after TAVI by using 3D-printed models for pre-procedural planning, and a review of published aorto-right ventricular fistula cases to date. (Level of Difficulty: Advanced.).

Transcatheter aortic valve replacement: The year in review 2017.

This article is a continuation of our previously published annual reviews of transcatheter aortic valve replacement (TAVR). In 2017, TAVR further established a foothold in the management of intermediate risk patients with the publication of SURTAVI trial. Randomized trials also addressed the use of cerebral protection during TAVR and single versus dual antiplatelet therapy after TAVR. Newer generation valve systems continued to be studied for their efficacy and safety. This paper summarizes the major studies published in 2017.

Transcatheter aortic valve replacement: The year in review 2016.

Transcatheter aortic valve replacement (TAVR) continued to make major strides in 2016, simultaneously expanding its application to lower risk patients as well as more technically challenging subsets of patients with aortic stenosis (AS). The two major accomplishments this year were the establishment of TAVR as the preferred treatment strategy over surgical aortic valve replacement (SAVR) in intermediate risk patients, and initial signals that TAVR and SAVR may be clinically equivalent in low-risk populations. Meanwhile, there is continued expansion of TAVR to challenging clinical subsets (bicuspid aortic valve [BAV], patients with concomitant advanced coronary artery disease [CAD], and failed surgical bioprostheses), and encouraging initial experiences with newer transcatheter heart valve systems. This paper summarizes the major research studies published on TAVR in 2016.

Percutaneous Coronary Intervention: 2015 in Review.

In order to keep the interventional community up-to-date with the overwhelming amount of new data, we have selected where we believe to be the most important publications in percutaneous coronary intervention from January 1, 2015 to mid-November 2015. We hope that this will serve as an important overview of 2015, and ongoing reference for future years.

Transcatheter Aortic Valve Replacement: 2015 in Review.

Transcatheter aortic valve replacement (TAVR) has emerged as an attractive option for patients with severe symptomatic aortic stenosis (AS) who are either at high risk or extreme risk for surgical aortic valve replacement (SAVR). This article summarizes the major advances in TAVR that were published or reported in 2015.

Longitudinal necrotic shafts near TCFAs--a potential novel mechanism for plaque rupture to trigger ACS?

It has been questioned for over 15 years why only less than 20% of TCFAs trigger ACS. We illustrate TCFA rupture into adjacent longitudinal necrotic shafts of massive amounts of thrombogenic material into the blood, leading to catastrophic clot formation. This is the potential mechanism for TCFAs triggering ACS. One case presented also illustrates the dangers of stent edges rupturing TCFAs.

Utilization patterns of single-photon emission cardiac tomography myocardial perfusion imaging studies in a rural tertiary care setting.

BACKGROUND: Appropriate use criteria (AUC) for single-photon emission computed tomographic myocardial perfusion imaging (SPECT MPI) were revised in 2009 to include 15 new clinical scenarios. We assessed multivariable predictors and overall appropriateness of MPI studies performed in a rural tertiary care setting. HYPOTHESIS: We hypothesized that appropriate utilization rates of SPECT MPI imaging in a rural tertiary care center are similar for cardiology and non cardiology providers. METHODS: We reviewed all SPECT MPI studies performed for over a 6-month period at our center. Using 67 scenarios in AUC, we categorized these studies as appropriate, inappropriate, uncertain, or unclassifiable. RESULTS: Of 328 MPI studies, 287 (88%) studies were classified as appropriate, 18 (5.5%) as inappropriate, 23 (7%) as uncertain, and none as unclassifiable. Preoperative testing accounted for 44% of the inappropriate studies; 61% of uncertain tests were ordered for cardiovascular risk assessment in patients with prior normal coronary angiography or normal stress tests. The ordering provider specialty did not show any relation with appropriateness of the test (P = 0.46). Patients with inappropriate and uncertain studies were younger than patients with appropriate studies (P = 0.007). CONCLUSIONS: We found that a majority of MPI studies are performed for appropriate indications regardless of ordering provider specialty. Few common scenarios accounted for the majority of the inappropriate or uncertain studies.

Transcatheter aortic valve replacement: game-changing innovation for patients with aortic stenosis.

Transcatheter aortic valve replacement (TAVR) is an emerging technology for the management of patients with severe aortic stenosis (AS). First reported in 2002, TAVR has made remarkable progress in the past decade with completion of major randomized clinical trials, multiple observational registries, and evolution of several new devices. This article is a brief introductory overview of the TAVR procedure, devices, trials and registries, and newer developments in the field.

Current OCT Approaches Do Not Reliably Identify TCFAs.

It is now clearly established that Thin-Capped Fibroatheromas (TCFAs) lead to most Acute Coronary Syndromes (ACSs). The ability to selectively intervene on TCFAs predisposed to rupture and ACSs would dramatically alter the practice of cardiology. While the ability of OCT to identify thin walled plaques at micron scale resolutions has represented a major advance, it is a misconception that it can reliably identify TCFAs. One major reason is that the 'diffuse border' criteria currently used to determine 'lipid plaque' is almost undoubtedly from high scattering in the intima and not because of core composition (necrotic core). A second reason is that, rather than looking at lipid collections, studies need to be focused on identifying necrotic cores with OCT. Necrotic cores are characteristic of TCFAs and not lipid collections. Numerous other OCT approaches are available which can potentially accurately assess TCFAs, but these have not been aggressively pursed which we believe likely stems in part from the misconceptions over the efficacy of 'diffuse borders'.

Variability in maximal suggested door-in-door-out time for hospitals transferring patients for primary angioplasty in STEMI.

OBJECTIVES: We derived a formula for maximal suggested door-in-door-out time (DIDO) for hospitals that do not perform primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). BACKGROUND: Efforts to minimize DIDO at non-PCI hospitals can improve door-to-balloon time (D2B). Targeting a maximal suggested DIDO for a transferring hospital can influence reperfusion strategy. METHODS: We examined time to treatment intervals for 193 STEMI patients who underwent primary PCI at our hospital. D2B in transferred patients (D2BT ) was divided into 3 intervals: transferring hospital DIDO, inter-hospital transport time, and interventional time. We defined maximal suggested DIDO as the maximum DIDO that would allow PCI with D2BT ≤ 120 minutes. RESULTS: D2B was higher in transfer compared to on-site patients (147 ± 52 vs. 75 ± 44 minutes, P < 0.0001). In transfer patients, treatment time intervals were: DIDO 80 ± 42 minutes, transport time 37 ± 18 minutes, interventional time 35 ± 16 minutes. The greatest variability in D2BT was related to DIDO. We estimated that maximal suggested DIDO = [120 - (transport time plus interventional time)]. Using a fixed interventional time of 40 minutes, we simplified this as: maximal DIDO = 80 - transport time. Maximal suggested DIDO for 4 transferring hospitals in our network ranged from 1 to 65 minutes. DIDO under the hospital-specific threshold was the strongest predictor of achieving D2BT <120 minutes. CONCLUSIONS: Transferring hospitals' maximal suggested DIDO is variable, and can be calculated from inter-hospital transport time. Instead of a universal target DIDO (e.g., <30 minutes), maximal suggested DIDO can be calculated individually for each non-PCI hospital within a STEMI network.

Drug-eluting stents versus bare-metal stents in patients with decreased GFR: a meta-analysis.

BACKGROUND: Decreased estimated glomerular filtration rate (eGFR) is a strong predictor of both mortality and subsequent cardiac events after percutaneous coronary intervention. The safety and efficacy of drug-eluting (DESs) versus bare-metal stents (BMSs) in this population have not been evaluated adequately. STUDY DESIGN: A systematic review and meta-analysis. SETTING & POPULATION: Studies involving the comparison of clinical outcomes between DESs and BMSs in patients with eGFR <60 mL/min/1.73 m(2). Studies exclusively involving patients with ST-segment elevation myocardial infarction were excluded. SELECTION CRITERIA FOR STUDIES: MEDLINE (on Ovid), EMBASE, and the Cochrane Library databases from 2002-2013 were searched for studies comparing DESs with BMSs in patients with eGFR <60 mL/min/1.73 m(2). INTERVENTION: DES versus BMS implantation. OUTCOMES: Mortality, repeat revascularization, myocardial infarction, and stent thrombosis. RESULTS: Data from 26 comparative studies with 66,840 patients were included. Compared with BMSs, DESs were associated with significant reductions in repeat revascularization (OR, 0.61; 95% CI, 0.50-0.74; P < 0.001) and myocardial infarction (OR, 0.85; 95% CI, 0.79-0.92; P < 0.001), with no detectable difference in stent thrombosis (OR, 0.72; 95% CI, 0.46-1.12; P = 0.1). The superiority of DESs over BMSs in decreasing mortality also was documented (OR, 0.77; 95% CI, 0.65-0.90; P = 0.01). This survival benefit of DESs over BMSs was attenuated in randomized controlled trials or adjusted observational studies versus unadjusted observational studies. LIMITATIONS: Most studies were observational studies. Meta-analysis was not performed on individual patient data. CONCLUSIONS: DES use in patients with eGFR <60 mL/min/1.73 m(2) is associated with a reduced rate of repeat revascularization and myocardial infarction without increased risk of stent thrombosis. The true effect of DESs versus BMSs on mortality needs to be confirmed by randomized controlled trials.

Short-term outcomes of balloon angioplasty versus stent placement for patients undergoing primary percutaneous coronary intervention: Implications for patients requiring early coronary artery bypass surgery.

BACKGROUND: In patients with acute ST-elevation myocardial infarction (STEMI) needing early coronary artery bypass graft (CABG) surgery, it is unknown whether primary percutaneous balloon angioplasty (PTCA)-without stent implantation-allows safe transition to subsequent CABG. METHODS: We examined acute STEMI patients enrolled in the Stent-PAMI and CADILLAC trials to study the differences in the early clinical events between those treated with primary PTCA (n = 1494) or primary stenting (n = 1488). RESULTS: Baseline clinical and pre- and post-procedural angiographic features including post-intervention TIMI 3 flow rates were similar in the 2 groups with the exception of higher median infarct-artery residual stenosis in the PTCA group (26% [IQR 19%-34%] vs. 18% [IQR 11-25%], P < .001]. Provisional stenting was required in 16% of patients in PTCA group, while stents could not be implanted in 2% of the stent group. Sixty-percent of PTCA patients had stent-like balloon result. The rate of 30-day ischemia-driven target vessel revascularization was higher in the PTCA group (4.3% vs. 2.0%, P < .001 [4.6% vs 2.3%, P < .001 among patients with multivessel disease and 3.4% vs. 2.0%, P = .044 in patients with stent-like balloon results]) while 30-day major adverse cardiac events (6.2% vs 4.9%), death (1.8% versus 2.8%), and reinfarction (0.9% vs. 0.7%) were similar in the 2 groups. CONCLUSIONS: Compared with primary stenting, primary PTCA of infarct artery in STEMI patients was associated with significant increase in ischemia-driven target vessel revascularization (ITVR) rate, yet with no increased risk of major adverse cardiac events, reinfarction or death. Thus, provided close surveillance is maintained and prompt treatment initiated for early ischemic events, PTCA (particularly in those with stent-like balloon result) may be a reasonable and safe option in STEMI patients needing early CABG.

Everolimus-eluting stents versus sirolimus- or paclitaxel-eluting stents: two-year results from the Guthrie Health Off-Label Stent (GHOST) registry.

OBJECTIVES: We sought to compare the safety and effectiveness of everolimus-eluting stents (EES) versus first generation drug-eluting stents (FG-DES; sirolimus-eluting stent [SES] or paclitaxel-eluting stent [PES]). METHODS: In 2,126 patients undergoing percutaneous coronary intervention (PCI), we compared the 2-year incidence of stent thrombosis (ST) and target vessel revascularization (TVR) between the EES versus FG-DES groups. Secondary end-points included all-cause death, myocardial infarction (MI), death or MI, and major adverse cardiovascular events (MACE, including death, MI, ST, or TVR). Further, we evaluated these end-points in 2 propensity-matched subgroups: EES versus SES; EES versus PES. RESULTS: Complete 2-year follow-up was available in 1,911 (90%) patients. Compared to FG-DES, implantation of EES was associated with trends towards lower ST (0.9% vs. 2.8%, P = 0.068) and TVR (3.8% vs. 7.2%, P = 0.052), which persisted after adjustment for baseline differences (for ST, adjusted hazard ratio, HR 0.32; 95% confidence interval, 95% CI 0.10-1.02, P = 0.053; for TVR, HR 0.40; 95% CI 0.22-0.75, P = 0.004). Compared to SES, EES implantation was associated with lower TVR and a trend towards lower ST. Compared to PES, EES implantation was associated with less ST and TVR and trends towards lower death/MI and MACE. In the EES group, no ST was seen after the first 3 months. CONCLUSIONS: The use of EES compared to FG-DES appears to be associated with reductions in ST and TVR at 2-year follow-up. Improved outcomes with EES are observed in comparison with SES as well as PES.

Developing a new hybrid revascularization program: a road map for hospital managers and physician leaders.

Hybrid coronary revascularization, which involves minimally invasive direct coronary artery bypass surgery using the left internal mammary artery to left anterior descending and percutaneous coronary intervention using drug-eluting stents for the remaining diseased coronary vessels, is an innovative approach to decrease the morbidity of conventional surgery. Little information is available to guide hospital managers and physician leaders in implementing a hybrid revascularization program. In this article, we describe the people-process-technology issues that managers and leaders are likely to encounter as they develop a hybrid revascularization program in their practice.

Early readmissions after percutaneous coronary intervention in a rural tertiary care center (from the Guthrie Health Off-label Stent [GHOST] Registry).

Early readmissions (ERs) impose a huge cost to the health care system, lower patients' quality of life, and may be an indicator of quality of initial care. We performed this single-center study to assess the incidence, predictors, and implications of 30-day readmission after percutaneous coronary intervention (PCI) in a tertiary care rural setting. In 4,262 consecutive patients who underwent PCI, we evaluated 30-day readmission rates and assessed demographic, clinical, and angiographic correlates of ER. Using Cox regression analyses, we estimated the multivariable impact of an ER on 1-year all-cause mortality and major adverse events (MACEs; death, myocardial infarction, target vessel revascularization, stent thrombosis). ER occurred in 486 patients (11.4%) including 366 (8.6%) for cardiac reasons and 120 (2.8%) for noncardiac reasons. Multivariable models predicting any readmission, cardiac readmission, and noncardiac readmission had c-statistic values of 0.63, 0.63, and 0.68, respectively. One-year mortality and MACEs were higher in the readmitted versus not readmitted patients (7.9% vs 3.2%, 18 vs 9.7%, p <0.0001 for the 2 comparisons). ER had a significant and independent impact on 1-year mortality (adjusted hazards ratio 2.2, 95% confidence interval 1.4 to 3.4) and MACEs (hazards ratio 2.2, 95% confidence interval 1.8 to 2.8). In conclusion, readmission within 30 days after PCI is common and frequently related to cardiac causes. Patients who require an ER after PCI have higher 1-year mortality and MACEs.