BACKGROUND:Significant tricuspid regurgitation (TR) is common in patients after left ventricular assist device (LVAD) implantation and is associated with an increased risk of mortality. Studies evaluating concomitant surgical tricuspid valve intervention have not consistently demonstrated benefit. FIRST-IN-HUMAN SUMMARY:We describe a first-in-human transcatheter tricuspid valve replacement (TTVR) using the Evoque system in a 46-year-old man with medically refractory, severe TR and right ventricular failure after LVAD implantation. DISCUSSION:Our case demonstrates that TTVR is a technically feasible treatment option for LVAD patients with refractory TR, in this case improving symptoms and reducing the need for chronic inotropic support. NOVELTY:To our knowledge, this is the first report of TTVR using the Evoque valve system in a patient with an LVAD. TAKE-HOME MESSAGES:Patients with severe TR after LVAD implantation have worse outcomes, but surgical tricuspid valve intervention at the time of LVAD implantation has not consistently shown benefit. TTVR platforms may represent a therapeutic alternative for patients with persistent symptomatic TR.
Background There is currently no standard clinical approach to patients in need of left atrial appendage (LAA) occlusion device with persistent LAA thrombus. The steerable, balloon-tipped SafeCross transseptal introducer system provides the opportunity for a novel approach to LAA thrombectomy by blockading the LAA os with its balloon tip, creating a closed system for embolic protection during aspiration. Case Summary Consecutive patients from the Medical University of South Carolina were included who underwent balloon-occlusive aspiration thrombectomy (BOAT) of the LAA with the SafeCross system followed by LAA occlusion device implantation. Discussion Four patients, with a mean age of 79.5 ± 4.04 years and 75% male, were included. Balloon occlusion was achieved in 75% of cases during BOAT of the LAA. All cases resulted in successful aspiration of the LAA thrombus and subsequent successful placement of Watchman FLX Pro without periprocedural complications or adverse events at 45-day follow-up. Take-Home Message Our small case series demonstrates the feasibility of performing a transseptal LAA BOAT thrombectomy with the SafeCross transseptal system to facilitate LAA occluder implant.
Background: This study aimed to determine whether artificial intelligence (AI)-based automated assessment of left atrioventricular coupling index (LACI) can provide incremental value above other traditional risk factors for predicting mortality among patients with severe aortic stenosis (AS) undergoing coronary CT angiography (CCTA) before transcatheter aortic valve replacement (TAVR). Methods: This retrospective study evaluated patients with severe AS who underwent CCTA examination before TAVR between September 2014 and December 2020. An AI-prototype software fully automatically calculated left atrial and left ventricular end-diastolic volumes and LACI was defined by the ratio between them. Uni- and multivariate Cox proportional hazard methods were used to identify the predictors of mortality in models adjusting for relevant significant parameters and Society of Thoracic Surgeons Predicted Risk of Mortality (STSPROM) score. Results: A total of 656 patients (77 years [IQR, 71-84 years]; 387 [59.0 %] male) were included in the final cohort. The all-cause mortality rate was 21.6 % over a median follow-up time of 24 (10-40) months. When adjusting for clinical confounders, LACI >43.7% independently predicted mortality (adjusted HR, 1.52, [95 % CI: 1.03, 2.22]; p = 0.032). After adjusting for the STS-PROM score in a separate model, LACI >43.7% remained an independent prognostic parameter (adjusted HR, 1.47, [95 % CI: 1.03-2.08]; p = 0.031). In a sub-analysis of patients with preserved left ventricular ejection fraction, LACI remained a significant predictor (adjusted HR, 1.72 [95 % CI: 1.02, 2.89]; p = 0.042). Conclusions: AI-based fully automated assessment of LACI can be used independently to predict mortality in patients undergoing TAVR, including those with preserved LVEF.
BACKGROUND:The PASCAL Precision transcatheter valve repair system provides a new option for treating prohibitive surgical risk patients with significant, symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES:The authors report early U.S. commercial experience with the PASCAL Precision system. METHODS:Patients with DMR treated with the PASCAL Precision system in the United States were analyzed from the STS/ACC TVT Registry. Procedural, clinical, echocardiographic, functional, and quality-of-life outcomes to 30 days were assessed. All outcomes, including echocardiographic assessments, were site-assessed. RESULTS:In 1,995 DMR patients, the median age was 81.6 years, and 57.0% were male. Median STS-PROM for mitral valve repair was 3.6%, and 69.4% were in NYHA functional class III/IV. Mixed etiology (DMR + other etiology) was present in 11.4%, and 66.9% had complex anatomy (annular/leaflet calcification, mitral valve area <4 cm2, bileaflet flail/prolapse/tethering, or mitral stenosis). The device was successfully implanted in 97.7%. MR reduction was significant at 30 days with 94.2% achieving ≤moderate MR and 72.6% ≤mild MR (P < 0.001 vs baseline). Patients experienced significant functional and quality-of-life improvements with a mean 21.0-point increase in Kansas City Cardiomyopathy Questionnaire score and 84.6% in NYHA functional class I/II (all P < 0.001). Mitral valve reintervention and single-leaflet device attachment rates were 0.4% and 0.5%, respectively, and all-cause mortality, cardiovascular mortality, and heart failure readmission rates were 2.2%, 1.2%, and 2.6%, respectively, at 30 days. CONCLUSIONS:Early U.S. STS/ACC TVT Registry commercial experience confirms the safety and effectiveness of the novel PASCAL Precision system in the treatment of a broad population of real-world DMR patients.
RATIONALE AND OBJECTIVES:Coronary CT angiography (CCTA) is mandatory before transcatheter aortic valve replacement (TAVR). Our objective was to evaluate the efficacy of artificial intelligence (AI)-powered software in automatically analyzing cardiac parameters from pre-procedural CCTA to predict major adverse cardiovascular events (MACE) in TAVR patients. MATERIALS AND METHODS:Patients undergoing pre-TAVR CCTA were retrospectively included. AI software automatically extracted 34 morphologic and volumetric cardiac parameters characterizing the ventricles, atria, myocardium, and epicardial adipose tissue. Clinical information and outcomes were recorded from institutional database. Cox regression analysis identified predictors of MACE, including non-fatal myocardial infarction, heart failure hospitalization, unstable angina, and cardiac death. Model performance was evaluated with Harrell's C-index, and nested models were compared using the likelihood ratio test. Manual analysis of 170 patients assessed agreement with automated measurements. RESULTS:Among the 648 enrolled patients (77 ± 9.3 years, 58.9% men), 116 (17.9%) experienced MACE within a median follow-up of 24 months (interquartile range 10-40). After adjusting for clinical parameters, only left ventricle long axis shortening (LV-LAS) was an independent predictor of MACE (hazard ratio [HR], 1.05 [95% confidence interval, 1.05-1.11]; p = 0.04), with significantly improved C-index (0.620 vs. 0.633; p < 0.001). When adjusted for the Society of Thoracic Surgeons Predicted Risk of Mortality score, LV-LAS was also predictive of MACE (HR, 1.08 [95%CI, 1.03-1.13]; p = 0.002), while improving model performance (C-index: 0.557 vs. 0.598; p < 0.001). All parameters showed good or excellent agreement with manual measurements. CONCLUSION:Automated AI-based comprehensive cardiac assessment enables pre-TAVR MACE prediction, with LV-LAS outperforming all other parameters.
The Systolic Blood Pressure Intervention Trial (SPRINT) trial demonstrated the efficacy and safety of targeting a systolic blood pressure of <120 mmHg compared to <140 mmHg in selected hypertensive patients. Some evidence, however, suggests a J-curve for; diastolic blood pressure (DBP) particularly in subjects with cardiovascular (CV) and chronic kidney disease. We evaluated the risk of events in SPRINT with focus on these subgroups according to DBP.Mean DBP (±standard deviation) throughout follow-up time was calculated for each patient. Patients were then categorized into five groups according to mean DBP (<60 mmHg, 60–69 mmHg, 70–79 mmHg [reference], 80–89 mmHg, ≥90 mmHg); hazard ratio for outcomes was assessed overall and in the predefined subgroups.A higher risk for CV events was observed in the lower DBP range overall (hazard ratio 1.46, confidential interval 95% 1.1–1.95, P < .001), but not in the absence of pre-existing CV or renal disease. Indeed, such risk significantly increased above 80 mmHg in patients with CV disease and below 70 mmHg in those with chronic kidney disease for selected outcomes. DBP<70 mmHg particularly affected renal outcomes irrespective of renal status.Different risk profiles according to DBP appear to be related to specific clinical characteristics in SPRINT. These findings require further testing in dedicated trials with appropriate follow-up.
Background The role of CT angiography-derived fractional flow reserve (CT-FFR) in pre-transcatheter aortic valve replacement (TAVR) assessment is uncertain. Purpose To evaluate the predictive value of on-site machine learning-based CT-FFR for adverse clinical outcomes in candidates for TAVR. Materials and Methods This observational retrospective study included patients with severe aortic stenosis referred to TAVR after coronary CT angiography (CCTA) between September 2014 and December 2019. Clinical end points comprised major adverse cardiac events (MACE) (nonfatal myocardial infarction, unstable angina, cardiac death, or heart failure admission) and all-cause mortality. CT-FFR was obtained semiautomatically using an on-site machine learning algorithm. The ability of CT-FFR (abnormal if ≤0.75) to predict outcomes and improve the predictive value of the current noninvasive work-up was assessed. Survival analysis was performed, and the C-index was used to assess the performance of each predictive model. To compare nested models, the likelihood ratio χ2 test was performed. Results A total of 196 patients (mean age ± standard deviation, 75 years ± 11; 110 women [56%]) were included; the median time of follow-up was 18 months. MACE occurred in 16% (31 of 196 patients) and all-cause mortality in 19% (38 of 196 patients). Univariable analysis revealed CT-FFR was predictive of MACE (hazard ratio [HR], 4.1; 95% CI: 1.6, 10.8; P = .01) but not all-cause mortality (HR, 1.2; 95% CI: 0.6, 2.2; P = .63). CT-FFR was independently associated with MACE (HR, 4.0; 95% CI: 1.5, 10.5; P = .01) when adjusting for potential confounders. Adding CT-FFR as a predictor to models that include CCTA and clinical data improved their predictive value for MACE (P = .002) but not all-cause mortality (P = .67), and it showed good discriminative ability for MACE (C-index, 0.71). Conclusion CT angiography-derived fractional flow reserve was associated with major adverse cardiac events in candidates for transcatheter aortic valve replacement and improved the predictive value of coronary CT angiography assessment. © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Choe in this issue.
Coronary artery pseudoaneurysms are extremely rare and most often occur after trauma or endovascular procedures [Aoki 2008; Kar 2017]. Delay in diagnosis or treatment may lead to coronary thrombosis with resultant ischemia or hemorrhage subsequent tamponade. Here, we present the case of a 66-year-old female who developed a coronary artery pseudoaneurysm of a non-grafted vessel three weeks after coronary artery bypass grafting. To avoid re-sternotomy, the pseudoaneurysm was successfully managed with a covered coronary stent and mini-left anterior thoracotomy to evacuate the hemopericardium and relieve tamponade.
Minimally invasive strategies to treat valvular heart disease have emerged over the past 2 decades. The use of transcatheter aortic valve replacement in the treatment of severe aortic stenosis, for example, has recently expanded from high- to low-risk patients and became an alternative treatment for those with prohibitive surgical risk. With the increase in transcatheter strategies, multimodality imaging, including echocardiography, CT, fluoroscopy, and cardiac MRI, are used. Strategies for preprocedural imaging strategies vary depending on the targeted valve. Herein, an overview of preprocedural imaging strategies and their postprocessing approaches is provided, with a focus on CT. Transcatheter aortic valve replacement is reviewed, as well as less established minimally invasive treatments of the mitral and tricuspid valves. In addition, device-specific details and the goals of CT imaging are discussed. Future imaging developments, such as peri-procedural fusion imaging, machine learning for image processing, and mixed reality applications, are presented.
Background: Reducing congestion remains a primary target of therapy for acutely decompensated heart failure. The VENUS-HF EFS (VENUS-Heart Failure Early Feasibility Study) is the first clinical trial testing intermittent occlusion of the superior vena cava with the preCARDIA system, a catheter mounted balloon and pump console, to improve decongestion in acutely decompensated heart failure. Methods: In a multicenter, prospective, single-arm exploratory safety and feasibility trial, 30 patients with acutely decompensated heart failure were assigned to preCARDIA therapy for 12 or 24 hours. The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events through 30 days. Secondary end points included technical success defined as successful preCARDIA placement, treatment, and removal and reduction in right atrial and pulmonary capillary wedge pressure. Other efficacy measures included urine output and patient-reported symptoms. Results: Thirty patients were enrolled and assigned to receive the preCARDIA system. Freedom from device- or procedure-related major adverse events was observed in 100% (n=30/30) of patients. The system was successfully placed, activated and removed after 12 (n=6) or 24 hours (n=23) in 97% (n=29/30) of patients. Compared with baseline values, right atrial pressure decreased by 34% (17±4 versus 11±5 mm Hg, P <0.001) and pulmonary capillary wedge pressure decreased by 27% (31±8 versus 22±9 mm Hg, P <0.001). Compared with pretreatment values, urine output and net fluid balance increased by 130% and 156%, respectively, with up to 24 hours of treatment ( P <0.01). Conclusions: We report the first-in-human experience of intermittent superior vena cava occlusion using the preCARDIA system to reduce congestion in acutely decompensated heart failure. PreCARDIA treatment for up to 24 hours was well tolerated without device- or procedure-related serious or major adverse events and associated with reduced filling pressures and increased urine output. These results support future studies characterizing the clinical utility of the preCARDIA system. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03836079.
Abstract Background Post-myocardial infarction ventricular septal defects (VSDs) have become rare in the reperfusion era but remain associated with very high morbidity and mortality. As patients defer prompt evaluation and management of acute coronary syndromes during the COVID-19 global pandemic, the incidence of these and other post-infarction mechanical complications is expected to increase. Case summary A 37-year-old gentleman with multiple coronary artery disease risk factors presented with intermittent chest discomfort and 1 week of heart failure symptoms. An echocardiogram demonstrated a large muscular VSD and coronary angiography confirmed the presence of an anterior wall infarction. He was subsequently referred for transcatheter VSD repair and showed rapid clinical improvement in his symptoms. Discussion Post-infarction VSDs remain associated with a high degree of morbidity and mortality. Surgical repair of acutely ruptured myocardium can be technically challenging, and transcatheter repair has emerged as a safe and effective alternative.
Patients with congenitally-corrected transposition of the great arteries (ccTGA) commonly develop significant systemic tricuspid valve regurgitation and systemic right ventricular dysfunction in adulthood, both of which presenting a therapeutic dilemma for the care team. Here we describe the case of a 35-year-old male with congenitally-corrected transposition of the great arteries who presented with severe systemic tricuspid valve regurgitation, biventricular systolic failure, and pulmonary hypertension. Due to prohibitive surgical risk, he underwent percutaneous tricuspid valve repair via MitraClip placement. Post-procedure, he demonstrated rapidly improved symptoms and sustained echocardiographic and hemodynamic evaluations. Few reports exist describing the safety and feasibility of the MitraClip procedure on a systemic tricuspid valve, but to our knowledge, this is the first to describe invasive hemodynamic improvements in patients with this degree of cardiopulmonary sequelae from the congenital lesion. There may be optimism for the MitraClip procedure as "bridge to list" in patients with ccTGA otherwise initially ineligible for surgical valve intervention or transplant.
HomeCirculation: Heart FailureVol. 13, No. 11Role of Pulmonary Artery Wedge Pressure Saturation During Right Heart Catheterization Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessLetterPDF/EPUBRole of Pulmonary Artery Wedge Pressure Saturation During Right Heart CatheterizationA Prospective Study Michael C. Viray, MD Eric L. Bonno, MD Nicholas D. Gabrielle, BS Bradley A. Maron, MD Jessica Atkins, MD Nicholas S. Amoroso, MD Valerian L.C. Fernandes, MD Anbukarasi Maran, MD Christopher D. Nielsen, MD Eric R. Powers, MD Daniel H. Steinberg, MD Thomas M. Todoran, MD Thomas G. Di Salvo, MD Gregory R. Jackson, MD Brian A. Houston, MD Ryan J. TedfordMD Michael C. VirayMichael C. Viray Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Eric L. BonnoEric L. Bonno Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Nicholas D. GabrielleNicholas D. Gabrielle Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Bradley A. MaronBradley A. Maron https://orcid.org/0000-0002-6784-764X Division of Cardiovascular Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA (B.A.M.). Search for more papers by this author , Jessica AtkinsJessica Atkins Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Nicholas S. AmorosoNicholas S. Amoroso https://orcid.org/0000-0001-6785-6899 Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Valerian L.C. FernandesValerian L.C. Fernandes Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Anbukarasi MaranAnbukarasi Maran https://orcid.org/0000-0002-2829-5555 Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Christopher D. NielsenChristopher D. Nielsen Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Eric R. PowersEric R. Powers Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Daniel H. SteinbergDaniel H. Steinberg Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Thomas M. TodoranThomas M. Todoran Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Thomas G. Di SalvoThomas G. Di Salvo Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Gregory R. JacksonGregory R. Jackson Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Brian A. HoustonBrian A. Houston https://orcid.org/0000-0001-6188-8072 Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author , Ryan J. TedfordRyan J. Tedford Correspondence to: Ryan J. Tedford, MD, Division of Cardiology, Department of Medicine, Medical University of South Carolina, Gazes Bldg, Room 215, 30 Courtenay Dr, Charleston, SC 29464. Email E-mail Address: [email protected] https://orcid.org/0000-0001-9045-7722 Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston (M.C.V., E.L.B., N.D.G., J.A., N.S.A., V.L.C.F., A.M., C.D.N., E.R.P., D.H.S., T.M.T., T.G.D.S., G.R.J., B.A.H., R.J.T.). Search for more papers by this author Originally published3 Oct 2020https://doi.org/10.1161/CIRCHEARTFAILURE.120.007981Circulation: Heart Failure. 2020;13:e007981Diagnosis and proper classification of pulmonary hypertension (PH) is challenging. Even when gold-standard right heart catheterizations (RHCs) are performed, PH is often misdiagnosed, resulting in inappropriate and potentially harmful treatment approaches.1 Additionally, the definition of PH has expanded recently, putting even more emphasis on accurate hemodynamic assessment during RHC.2–4 A critical component of the hemodynamic evaluation is measurement of pulmonary artery wedge pressure (PAWP) since this is the sole parameter that delineates precapillary PH (PCPH) from PH due to left heart disease, conditions with disparate therapeutic strategies. The PAWP is also a key determinant of pulmonary vascular resistance that is used to delineate the two PH due to left heart disease subgroups: isolated postcapillary PH and combined pre- and postcapillary PH.2 Importantly, PAWP only reflects left atrial pressure if a complete occlusion of the PA occurs. If the occlusion is incomplete, the measured pressure will include contributions from the PA, falsely elevating the recorded PAWP and possibly leading to misdiagnosis.5 To address this point, recently published consensus statements recommend confirming an elevated PAWP and complete occlusion by measuring the oxyhemoglobin saturation (SaO2) of blood from the distal tip of the PA catheter when in the wedge position.2 With complete occlusion, SaO2 will approximate that of the left atrium whereas lower SaO2 values may indicate incomplete occlusion and should prompt additional PAWP measurement attempts.Accordingly, we instituted a standard of care clinical protocol at our institution as follows: SaO2 level is measured from a wedge blood sample for all RHC where PAWP is >15 mm Hg. If the initial PAWP is confirmed to be occlusive (SaO2 >90% or within 5% of systemic arterial saturation), it is the final reported value. However, if PAWP saturation suggests an incomplete occlusion, up to 2 additional attempts are made to obtain PAWP with an occlusive SaO2. The final reported PAWP is the value associated with an occlusive SaO2.Because data regarding the feasibility and clinical impact of this method are lacking, we sought to prospectively study the overall success rate of obtaining an occlusive PAWP SaO2, the differences between the initial and final reported hemodynamics, and any clinically relevant PH reclassification. After Institutional Review Board approval, and several months after instituting the standard of care protocol, investigators not performing the RHC enrolled and observed subjects undergoing clinically indicated RHC from September 2019 to June 2020. Demographic, clinical, echocardiographic, procedural, and hemodynamic data were collected. Subjects undergoing routine post-transplant RHC and those with PAWP ≤15 mm Hg were excluded. All hemodynamics were measured in a standardized fashion and were reported by the proceduralists (not investigational observers). Initial and final hemodynamics were compared using the Signed-Rank Test.A total of N=111 consecutive subjects were enrolled. One subject was excluded due to incomplete data. The cohort was 58±14 years old, 60% male, 60% White/35% Black race, and had body mass index of 31±7 kg/m2. The average left ventricular ejection fraction was 41±23%, with 47/110 (43%) having left ventricular ejection fraction ≥50%. Clinical indications for RHC included assessment of advanced heart failure therapy candidacy (38%), uncertain volume/perfusion status (26%), preoperative optimization/risk stratification (24%), and evaluation of known/suspected PCPH (12%). RHC were performed by interventional cardiologists (52/110; 47%) and heart failure cardiologists (58/110; 53%).Despite apparent confirmation of PAWP occlusion by fluoroscopy and typical hemodynamic waveform appearance, an occlusive PAWP SaO2 was obtained on the first attempt only 50% of the time (55/110; Figure). There was no difference in initial success rate between interventional and heart failure cardiologists or based on left ventricular ejection fraction. With up to 2 additional attempts, an occlusive PAWP SaO2 was obtained in 91% of subjects. In subjects in whom additional attempts were successful in obtaining occlusive PAWP SaO2 (n=45; initial SaO2 68.8±14.3% versus 94.5±2.7%; P<0.001), 29 had a lower final PAWP compared with the initial PAWP (20±6 versus 25±7 mm Hg; P<0.001), and 14 of the 45 subjects (31%) had ≥4 mm Hg difference between final and initial PAWP values. This also led to significant differences in final versus initial pulmonary vascular resistance (3.8±3.5 versus 2.4±1.8 WU; P<0.001). Reclassification from PH due to left heart disease to PCPH was made in 6 subjects and from isolated postcapillary PH to combined pre- and postcapillary PH in 4 subjects. Additionally, of the 10 subjects without an occlusive PAWP SaO2 after 3 attempts, 5 (50%) were noted to have a lower final reported PAWP compared with the initial PAWP, which resulted in reclassification of 3 additional subjects. This suggests that even the attempt to obtain a PAWP saturation, with deflation and reinflation of the balloon, may lead to lower and likely more accurate PAWP values. In total, 13 subjects (12%) were ultimately reclassified. There were no observed complications.Download figureDownload PowerPointFigure. Study flow chart. CpcPH indicates combined pre- and postcapillary pulmonary hypertension; IpcPH, isolated postcapillary pulmonary hypertension; PAWP, pulmonary artery wedge pressure; PCPH, precapillary pulmonary hypertension; PH-LHD, pulmonary hypertension due to left heart disease; and PVR, pulmonary vascular resistance. *P<0.001 and #P>0.05.In this prospective, single-center study, half of initial PAWP measurements were not occlusive when the initial measured PAWP was >15 mm Hg. The practice of obtaining a PAWP saturation resulted in significantly lower PAWP, higher pulmonary vascular resistance, and clinically relevant disease reclassification. A PAWP saturation is a simple, safe, and effective technique to verify complete PAWP occlusion during RHC and should be considered in clinical practice.Nonstandard Abbreviation and AcronymsPAWPpulmonary artery wedge pressurePCPHprecapillary pulmonary hypertensionPHpulmonary hypertensionRHCright heart catheterizationSaO2oxyhemoglobin saturationSources of FundingNoneDisclosuresDr Todoran receives consulting fees from Medtronic and GE Healthcare. Dr Maron receives research funding from the National Institutes of Health (NIH U01HL125215-01; 1R01HL139613-01; R01HL153502; R21HL134320; U54HL119145), Cardiovascular Medical Research Education Foundation, and Boston Biomedical Innovation Center; is a co-inventor on US patent 9 605 047, US pending patent PCT/US2019/059890, and provisional patent applications 62475955 and 029672 and is a member of the steering committee for a research grant supported by Actelion Pharmaceuticals. Dr Maran serves a consultant and speaker for Boston Scientific, Medtronic and Phillips. Dr Houston receives grant funding from Medtronic. Dr Tedford reports general conflicts include consulting relationships with Medtronic, Aria CV Inc, Acceleron, Arena Pharmaceuticals and United Therapeutics. Dr Tedford is on a steering committee for Medtronic and Abbott, and a research advisory board for Abiomed. He also does hemodynamic core lab work for Actelion and Merck. The other authors report no conflicts.FootnotesPresented in part at the Heart Failure Society of America Annual Meeting, September 30, 2020–October 6, 2020.For Sources of Funding and Disclosures, see page 661.Correspondence to: Ryan J. Tedford, MD, Division of Cardiology, Department of Medicine, Medical University of South Carolina, Gazes Bldg, Room 215, 30 Courtenay Dr, Charleston, SC 29464. Email [email protected]eduReferences1. Deaño RC, Glassner-Kolmin C, Rubenfire M, Frost A, Visovatti S, McLaughlin VV, Gomberg-Maitland M. Referral of patients with pulmonary hypertension diagnoses to tertiary pulmonary hypertension centers: the multicenter RePHerral study.JAMA Intern Med. 2013; 173:887–893. doi: 10.1001/jamainternmed.2013.319CrossrefMedlineGoogle Scholar2. Vachiery JL, Tedford RJ, Rosenkranz S, Palazzini M, Lang I, Guazzi M, Coghlan G, Chazova IDe Marco T. Pulmonary hypertension due to left heart disease.Eur Respir Journal. 2019; 53:1801897. doi: 10.1183/13993003.01897-2018CrossrefMedlineGoogle Scholar3. Maron BA, Brittan EL, Hess E, Waldo SW, Barón AE, Huang S, Goldstein RH, Assad T, Wertheim BM, Alba GA, et al.. Pulmonary vascular resistance and clinical outcomes in patients with pulmonary hypertension: a retrospective cohort study.Lancet Respir Med. 2020; 8:873–884. doi: 10.1016/S2213-2600(20)30317-9CrossrefMedlineGoogle Scholar4. Maron BA, Hess E, Maddox TM, Opotowsky AR, Tedford RJ, Lahm T, Joynt KE, Kass DJ, Stephens T, Stanislawski MA, et al.. Association of borderline pulmonary hypertension with mortality and hospitalization in a large patient cohort: insights from the veterans affairs clinical assessment, reporting, and tracking program.Circulation. 2016; 133:1240–1248. doi: 10.1161/CIRCULATIONAHA.115.020207LinkGoogle Scholar5. Johnson S, Witkin A, Rodriguez-Lopez JChannick R. Room for improvement in pulmonary capillary wedge pressure reporting: a review of hemodynamic tracings at a large academic medical center.Pulm Circ. 2020. doi: 10.1177/2045894020929157CrossrefGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited ByViray M, Bonno E, Houston B and Tedford R (2021) Response by Viray et al to Letter Regarding Article, “Role of Pulmonary Artery Wedge Pressure Saturation During Right Heart Catheterization: A Prospective Study”, Circulation: Heart Failure, 14:3, Online publication date: 1-Mar-2021.Hardin E and Araj F (2021) Letter by Hardin and Araj Regarding Article, “Role of Pulmonary Artery Wedge Pressure Saturation During Right Heart Catheterization: A Prospective Study”, Circulation: Heart Failure, 14:3, Online publication date: 1-Mar-2021. November 2020Vol 13, Issue 11Article InformationMetrics Download: 274 © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCHEARTFAILURE.120.007981PMID: 33016102 Originally publishedOctober 3, 2020 Keywordspulmonary hypertensionpulmonary artery wedge pressureheart failurehemodynamicsright heart catheterizationoxyhemoglobinPDF download SubjectsPulmonary HypertensionHemodynamicsHeart FailureQuality and Outcomes
Data regarding the optimal dual antiplatelet therapy (DAPT) duration in patients treated with a 1- versus a 2-stent strategy in LM bifurcation PCI are scant. A literature search based on Cochrane Library, Embase, PubMed and Google Scholar was performed to locate articles published between January 2015 and January 2020. The following MeSH terms were used for the search: “Left Main” AND “DAPT Duration” AND “stent” OR “stenting”. The analysis was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Occurrence of major adverse cardiovascular events (MACEs) according to length of DAPT and stenting strategy was analysed. A total of 256 articles were retrieved and after evaluation, 3 articles evaluating the results of 8 large registries were included into the analysis including a final population of 4117 patients [mean age 65.7 years, 3133 (76.0%) males]. A short-term DAPT resulted in a lower risk of MACEs in patients treated with a single stent strategy (OR: 0.49, 95% CI [0.33–0.67], p < 0.001, I2 = 0%), whereas a DAPT >12 months resulted in a significant higher risk of MACEs in the same group (OR: 7.39, 95% CI [5.09–10.7], p < 0.001, I2 = 61%) compared to double stent strategy. The available data support the use of short DAPT in single cross-over LM stenting whereas a long DAPT seems to be more appropriate after a double stenting strategy in LM bifurcation PCI.
Introduction Inadequate balloon occlusion while measuring pulmonary artery wedge pressure (PAWP) during right heart catheterization (RHC) may lead to inaccurate measures and clinically relevant misdiagnosis of disease. Following the 6th World Symposium on Pulmonary Hypertension (PH) recommendations, we instituted a standard of care clinical protocol at the Medical University of South Carolina that required obtaining a PAWP saturation (sat) to confirm complete occlusion whenever initially measured PAWP is >15 mmHg. We sought to determine: 1) The difference between initial and lowest reported PAWP 2) The frequency in which this practice leads to a change in PH classification 3) The overall success rate in obtaining a PAWP sat. Methods After IRB approval, investigators not performing the RHC procedure prospectively collected demographic, echocardiographic and hemodynamic data. Subjects undergoing routine post-transplant RHC were excluded. After the initial PAWP measurement (as determined by the RHC operator), a PAWP sat was drawn to confirm occlusion (defined as >90% or within 5% of the systemic arterial oxygen saturation). If the PAWP sat did not confirm occlusion, the balloon was deflated and up to two additional attempts were made to re-measure the PAWP and confirm with a PAWP sat. PAWP were recorded at the same point in the respiratory cycle with each attempt. Repeated measures were compared using Signed Rank Test. Results We enrolled 75 subjects (age 58.3 +/- 13.3 years, 60% men, 59% with LVEF 15 mmHg. Despite apparent confirmation of PAWP position by fluoroscopy and/or typical hemodynamic waveforms, an occlusive PAWP sat was unable to be confirmed in 39 (52%) of subjects during the first attempt. In these subjects, the mean difference between initial and lowest PAWP was -4.1 +/- 7.7 mmHg (p 5 mmHg. Three of the 4 subjects referred for PH with preserved EF were ultimately reclassified as having pre-capillary PH. Eight of the 16 referred for advanced heart failure evaluation were re-classified as combined post- and pre-capillary PH with PVR > 3 WU, which then required vasodilator testing. With additional attempts, a PAWP sat was confirmed in 83% of subjects. There were no observed complications during additional PAWP attempts. Conclusion The practice of requiring a PAWP sat resulted in significantly lower PAWP, higher PVR and clinically relevant disease reclassification. A PAWP sat is a simple and safe technique to verify an elevated PAWP during RHC.
Central MessageSurgical placement of a transcatheter valve in mitral annular calcification avoids pitfalls of open and transcatheter approaches.See Commentaries on pages 38, 39, and 41. Surgical placement of a transcatheter valve in mitral annular calcification avoids pitfalls of open and transcatheter approaches. See Commentaries on pages 38, 39, and 41. The presence of mitral annular calcification (MAC) has been reported to increase risk of perioperative morbidity and mortality in mitral valve replacement (MVR).1Cammack P.L. Edie R.N. Edmunds Jr., L.H. Bar calcification of the mitral anulus. A risk factor in mitral valve operations.J Thorac Cardiovasc Surg. 1987; 94: 399-404Abstract Full Text PDF PubMed Google Scholar With the advent of transcatheter MVR, many patients with MAC have been treated successfully with transcatheter valve deployment.2Guerrero M. Urena M. Himbert D. Wang D.D. Eleid M. Kodali S. et al.1-year outcomes of transcatheter mitral valve replacement in patients with severe mitral annular calcification.J Am Coll Cardiol. 2018; 71: 1841-1853Crossref PubMed Scopus (158) Google Scholar Access options include trans-septal, transapical, and transatrial. The "Achilles heel" of trans-septal and transapical access is left ventricular outflow tract obstruction (LVOTO), as valve deployment may displace the anterior mitral leaflet into the ventricular outflow tract, causing hemodynamic compromise. Interventional techniques such as the intentional laceration of the anterior mitral leaflet procedure have been devised to address this complication in patients at high or extreme risk for surgery.3Khan J.M. Babaliaros V.C. Greenbaum A.B. Foerst J.R. Yazdani S. McCabe J.M. et al.Anterior leaflet laceration to prevent ventricular outflow tract obstruction during transcatheter mitral valve replacement.J Am Coll Cardiol. 2019; 73: 2521-2534Crossref PubMed Scopus (66) Google Scholar For patients who are able to tolerate surgery, transatrial implantation of a transcatheter prosthetic allows for partial resection of the anterior leaflet to obviate the risk of LVOTO and valve implantation without debridement of calcium and subsequent risk of atrioventricular groove disruption. We herein report a surgical technique for minimally invasive, robot-assisted, transatrial mitral valve implantation using a balloon-expandable prosthetic. An 84-year-old female patient with a history of hypertension, hyperlipidemia, rheumatic fever, aortic stenosis, and mitral stenosis and regurgitation presented with progressive fatigue and dyspnea. Transthoracic echocardiography revealed an ejection fraction of 71%, mean aortic valve gradient of 27 mm Hg with aortic valve area of 0.90 cm2, and mean mitral valve gradient of 23 mm Hg. Computed tomography revealed severe, circumferential MAC (Figure 1). Society of Thoracic Surgeons Predicted Risk of Mortality was 5.49% for aortic valve replacement (AVR) and 8.66% for MVR. To minimize debridement of the mitral annulus and the risk of open surgery, the patient was offered minimally invasive, robotic-assisted deployment of a balloon-expandable valve in the mitral position, combined with transcatheter AVR. Preoperatively, her mitral valve was sized using measurements from her computed tomography scan (Figure 1). The procedure was undertaken in a hybrid operating suite. The left femoral vessels were cannulated for cardiopulmonary bypass. An Intraclude intra-aortic occlusion device (Edwards Lifesciences, Irvine, Calif) was used for clamping and cardioplegia (now recalled and suspended from use). The DaVinci SI system (Intuitive Surgical, Sunnyvale, Calif) was docked and used to access the left atrium. Robotic ports were 12 and 8 mm, for the camera and arm ports, respectively, and a 2-cm incision was made for delivery of the valve. As shown in Video 1, the A2 scallop of the mitral valve anterior leaflet was resected. Two felt strips were parachuted onto the mitral annulus over Gore-Tex sutures (W. L. Gore & Associates, Newark, Del) to augment the landing zone and minimize perivalvular leak. These sutures were taken through the annulus where possible, and if prohibited by calcium, through the periannular atrial tissue. A 26-mm SAPIEN S3 valve (Edwards Lifesciences) was deployed, and the Gore-Tex sutures were secured to the struts of the valve stent. While on bypass, with the heart beating, right femoral access was obtained to deploy a 26-mm CoreValve Evolut R valve (Medtronic, Minneapolis, Minn) in the aortic position. Recovery was uneventful, and the patient was discharged home postoperative day 6. Transthoracic echocardiography revealed an aortic valve gradient of 9 mm Hg with trivial paravalvular regurgitation and a mitral valve gradient of 8 mm Hg with no regurgitation. There was no LVOTO. The patient provided informed consent for the publication of the study data. This surgical technique using a balloon-expandable prosthesis allows for mitral valve implantation in the setting of severe MAC with no debridement of the annulus, essentially obviating the risk of atrioventricular groove disruption. In fact, the heavy, concentric calcification is advantageous to this technique, as it provides a suitable landing zone for a transcatheter valve. It has become clear that transcatheter mitral valve strategies must account for the risk of LVOTO induced by displacement of the anterior mitral leaflet. In results from the transcatheter MVR in MAC Global Registry, 6 patients (9.3%) suffered from postdeployment LVOTO, and subsequently 5 of those patients (83.3%) died.4Guerrero M. Dvir D. Himbert D. Urena M. Eleid M. Wang D.D. et al.Transcatheter mitral valve replacement in native mitral valve disease with severe mitral annular calcification: results from the first multicenter global registry.JACC Cardiovasc Interv. 2016; 9: 1361-1371Crossref PubMed Scopus (188) Google Scholar The reported robot-assisted transatrial technique allows for partial resection of the anterior mitral valve leaflet to reduce the risk of LVOTO. In addition, it can be combined with other procedures without undue difficulty, as demonstrated in our concurrent replacement of the aortic valve via a transfemoral transcatheter AVR. In patients with severe MAC who can tolerate surgery, we believe this procedure offers the best option to replace the mitral valve successfully. Overall, this technique offers the opportunity to treat a severe disease with a reduced risk of complications, and it can be completed in a minimally invasive fashion, helping to reduce patient discomfort, length of stay, and recovery. eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiI3OTkzMTg5YzcwZDBkMzQ1MmY3NTU2YjRjOWY0OWI3ZiIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjM1MDUxMzczfQ.Tf5iHAToRjQWLUGLQspCzU9EDTHgbeQW6FL6aVGW6nmnWZXgWEQr13t3uNZdbYT8OGfkLmYt7Hy8lHMKpzMtrsCPmwKBL7RseqUdWruvudHpfeK9gPErgP0jRix89wpAxsoBFfpx0DyqcxND6ivQgyXtusdVFh5cuXOay_Q-3z71a6t7iLyxuG3S6wJ0ndL3P-IpZb5DVfX2riaFauAJAr5myE4p456OKFBcM6LzAgN0K02h0efUmoj8lmYR_I76ZMnpwJ10lRAN_2vA9vX9EO2Ks_sB9VTQaqXw1jHnoce4o-PX53v5do06gx3OAD5QHz4L8k4QFXgXrMmv2hfgQA Download .mp4 (142.05 MB) Help with .mp4 files Video 1The video illustrates robot-assisted placement of a SAPIEN S3 valve (Edwards Lifesciences) within mitral annular calcium. Concomitant resection of the A2 scallop of the anterior mitral leaflet helps to prevent left ventricular outflow tract obstruction. Video available at: https://www.jtcvs.org/article/S2666-2507(20)30104-8/fulltext.