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Coronary microvascular dysfunction assessment: A comparative analysis of procedural aspects

Merdler, Ilan; Wallace, Ryan; Banerjee, Avantika; Medranda, Giorgio A; Reddy, Pavan; Cellamare, Matteo; Zhang, Cheng; Ozturk, Sevket Tolga; Sawant, Vaishnavi; Lopez, Kassandra; Ben-Dor, Itsik; Waksman, Ron; Case, Brian C; Hashim, Hayder D
BACKGROUND:Full adoption of coronary microvascular dysfunction (CMD) assessment faces challenges due to its invasive nature and concerns about prolonged procedure time and increased contrast and/or radiation exposure. We compared procedural aspects of CMD invasive assessment to diagnostic left heart catheterization (DLHC) in patients with chest pain who were not found to have obstructive coronary artery disease. METHODS:A total of 227 patients in the Coronary Microvascular Disease Registry were compared to 1592 patients who underwent DLHC from August 2021 to November 2023. The two cohorts were compared using propensity-score matching; primary outcomes were fluoroscopy time and total contrast use. RESULTS:The participants' mean age was 64.1 ± 12.6 years. CMD-assessed patients were more likely to be female (66.5% vs. 45.2%, p < 0.001) and have hypertension (80.2% vs. 44.5%, p < 0.001), history of stroke (11.9% vs. 6.3%, p = 0.002), and history of myocardial infarction (20.3% vs. 7.7%, p < 0.001). CMD assessment was safe, without any reported adverse outcomes. A propensity-matched analysis showed that patients who underwent CMD assessment had slightly higher median contrast exposure (50 vs. 40 mL, p < 0.001), and slightly longer fluoroscopy time (6.9 vs. 4.7 min, p < 0.001). However, there was no difference in radiation dose (209.3 vs. 219 mGy, p = 0.58) and overall procedure time (31 vs. 29 min, p = 0.37). CONCLUSION/CONCLUSIONS:Compared to DLHC, CMD assessment is safe and requires only slightly additional contrast use (10 mL) and slightly longer fluoroscopy time (2 min) without clinical implications. These findings emphasize the favorable safety and feasibility of invasive CMD assessment.
PMID: 38520176
ISSN: 1522-726x
CID: 5641052

Editorial: Screen failure in transcatheter mitral valve replacement: Knowledge is power [Editorial]

Medranda, Giorgio A
PMID: 38553276
ISSN: 1878-0938
CID: 5645342

Editorial: Less is more: Striving to abolish acute kidney injury in TAVI [Editorial]

Medranda, Giorgio A
PMID: 37690932
ISSN: 1878-0938
CID: 5594362

Cardiac arrest in infective endocarditis: An ounce of prevention is worth a pound of cure [Editorial]

Medranda, Giorgio A
PMID: 36740552
ISSN: 1878-0938
CID: 5420692

Lifetime management of patients with symptomatic severe aortic stenosis: a computed tomography simulation study

Medranda, Giorgio A; Soria Jimenez, Cesar E; Torguson, Rebecca; Case, Brian C; Forrestal, Brian J; Ali, Syed W; Shea, Corey; Zhang, Cheng; Wang, John C; Gordon, Paul; Ehsan, Afshin; Wilson, Sean R; Levitt, Robert; Parikh, Puja; Bilfinger, Thomas; Hanna, Nicholas; Buchbinder, Maurice; Asch, Federico M; Weissman, Gaby; Shults, Christian C; Garcia-Garcia, Hector M; Ben-Dor, Itsik; Satler, Lowell F; Waksman, Ron; Rogers, Toby
BACKGROUND:Given enough time, transcatheter heart valves (THVs) will degenerate and may require reintervention. Redo transcatheter aortic valve implantation (TAVI) is an attractive strategy but carries a risk of coronary obstruction. AIMS/OBJECTIVE:We sought to predict how many TAVIs patients could undergo in their lifetime using computed tomography (CT) simulation. METHODS:We analysed paired CT scans (baseline and 30 days post-TAVI) from patients in the LRT trial and EPROMPT registry. We implanted virtual THVs on baseline CTs, comparing predicted valve-to-coronary (VTC) distances to 30-day CT VTC distances to evaluate the accuracy of CT simulation. We then simulated implantation of a second virtual THV within the first to estimate the risk of coronary obstruction due to sinus sequestration and the need for leaflet modification. RESULTS:We included 213 patients with evaluable paired CTs. There was good agreement between virtual (baseline) and actual (30 days) CT measurements. CT simulation of TAVI followed by redo TAVI predicted low coronary obstruction risk in 25.4% of patients and high risk, likely necessitating leaflet modification, in 27.7%, regardless of THV type. The remaining 46.9% could undergo redo TAVI so long as the first THV was balloon-expandable but would likely require leaflet modification if the first THV was self-expanding. CONCLUSIONS:Using cardiac CT simulation, it is possible to predict whether a patient can undergo multiple TAVI procedures in their lifetime. Those who cannot may prefer to undergo surgery first. CT simulation could provide a personalised lifetime management strategy for younger patients with symptomatic severe aortic stenosis and inform decision-making. CLINICALTRIALS/RESULTS:gov: NCT02628899; NCT03557242; NCT03423459.
PMID: 35321859
ISSN: 1969-6213
CID: 5321172

Impact of baseline imaging of non-culprit coronary lesions and adverse events: Insight from LRP study

Case, Brian C; Shea, Corey; Torguson, Rebecca; Zhang, Cheng; Yerasi, Charan; Medranda, Giorgio A; Kuku, Kayode O; Garcia-Garcia, Hector M; Mintz, Gary S; Waksman, Ron
BACKGROUND/PURPOSE/OBJECTIVE:Intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) can identify vulnerable coronary atherosclerotic plaques. We aimed to compare the presence or absence of baseline intravascular imaging of non-culprit lesions and their subsequent adverse events. METHODS/MATERIALS/METHODS:We identified patients from the Lipid Rich Plaque (LRP) study who had a non-culprit-lesion adverse event and divided them into 2 cohorts: those with lesions detected with NIRS-IVUS imaging at baseline and those with lesions not imaged at baseline. RESULTS:Overall, 73 patients had an adverse event (99 coronary segments) during the 24-month follow-up period. Among them, 41 patients (56.2%) had a non-culprit-lesion adverse event related to a coronary segment imaged at baseline, and 32 patients (43.8%) had a non-culprit-lesion adverse event adjudicated to a segment that was not scanned at baseline. Angiographic core laboratory analysis suggested that unscanned lesions were more often in the right coronary artery (~50%); branches of the left coronary artery, i.e., diagonal or left obtuse marginal arteries (~20%); smaller vessels; or more tortuous vessels; and less often in the left anterior descending or distal locations. There was a weak trend for acute severe events (adjudicated myocardial infarction and acute coronary syndrome) in patients with lesions not scanned at baseline (50.0% versus 36.6%, p = 0.250). CONCLUSIONS:In patients with follow-up non-culprit-lesion adverse events, nearly half were not imaged with NIRS-IVUS at baseline. Because events related to non-imaged lesions were at least as severe as events related to imaged lesions, future clinical trials and clinical protocols should be designed to minimize this issue. CLINICAL TRIAL REGISTRATION/BACKGROUND:The Lipid-Rich Plaque Study (LRP),, NCT02033694.
PMID: 34972665
ISSN: 1878-0938
CID: 5155542

Impact of Left Ventricular Outflow Tract Calcium on Hemodynamics and Outcomes in Patients After Transcatheter Aortic Valve Implantation With a Contemporary Self-Expanding Valve

Medranda, Giorgio A; Rogers, Toby; Case, Brian C; Ali, Syed W; Zhang, Cheng; Wang, John C; Weissman, Gaby; Satler, Lowell F; Ben-Dor, Itsik; Waksman, Ron
Left ventricular outflow tract (LVOT) calcium remains a challenge for transcatheter aortic valve implantation (TAVI) and is associated with an increased risk of debris embolization, permanent pacemaker requirement, and annular rupture. We report the results of the (EPROMPT) CoreValve Evolut PRO Prospective Registry, which sought to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter heart valve (THV) according to computed tomography-defined extent of LVOT calcium. The prospective, investigator-initiated, multicenter registry includes patients who underwent TAVI using the CoreValve Evolut PRO/PRO+ THV system. Analyzed patients were dichotomized on the basis of the severity of their LVOT calcium at baseline (none/mild vs moderate/severe). Patients were followed with 30-day clinical assessment and echocardiography. Of the 277 patients included, 177 had computed tomography-defined none/mild LVOT calcium (63.9%), and 100 had moderate/severe LVOT calcium (36.1%). Device success was similar in both cohorts (97.7% vs 95.0%; p = 0.217). Stroke rates were numerically higher in the moderate/severe LVOT calcium cohort (in-hospital and 30 day: 1.7% vs 4.0%; p = 0.240). Patients with none/mild LVOT calcium had higher rates of permanent pacemaker implantation (in-hospital: 21.5% vs 9.0%; p = 0.008 and 30-day: 22.0% vs 12.0%; p = 0.027). At 30 days, there were numerically higher rates of >mild paravalvular leak in patients with moderate/severe LVOT calcium (1.7% vs 4.0%; p = 0.240). Thirty-day mean gradients were similar (7.5 vs 7.6 mm Hg; p = 0.782). In conclusion, patients in the EPROMPT registry receiving the contemporary self-expanding CoreValve Evolut PRO/PRO+ THV demonstrated similar short-term outcomes and hemodynamics across the entire spectrum of LVOT calcium.
PMID: 35067347
ISSN: 1879-1913
CID: 5155562

Prosthetic valve endocarditis after transcatheter aortic valve replacement in low-risk patients

Medranda, Giorgio A; Rogers, Toby; Ali, Syed W; Zhang, Cheng; Shea, Corey; Sciandra, Kathryn A; Case, Brian C; Forrestal, Brian J; Sutton, Joseph A; McFadden, Eugene P; Malla, Prerna; Gordon, Paul; Ehsan, Afshin; Wilson, Sean R; Levitt, Robert; Parikh, Puja; Bilfinger, Thomas; Torguson, Rebecca; Asch, Federico M; Weissman, Gaby; Ben-Dor, Itsik; Shults, Christian C; Garcia-Garcia, Hector M; Satler, Lowell F; Waksman, Ron
OBJECTIVES/OBJECTIVE:We sought to report details of the incidence, organisms, clinical course, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter aortic valve replacement (TAVR) in low-risk patients. BACKGROUND:PVE remains a rare but devastating complication of aortic valve replacement. Data regarding PVE after TAVR in low-risk patients are lacking. METHODS:We performed a detailed review of all patients in the low-risk TAVR trials who underwent TAVR from 2016 to 2020 and were adjudicated to have definitive PVE by the independent Clinical Events Committee. RESULTS:We analyzed 396 low-risk patients who underwent TAVR (including 72 with bicuspid valves). PVE occurred in 11 patients at a median 379 days (210, 528) from TAVR. The incidence within the first 30 days was 0%; days 31-365, 1.5%; and after day 365, 2.8%. The most common organism identified was Streptococcus (n = 4/11). Early PVE (≤ 365 days) occurred in five patients, of whom three demonstrated evidence of embolic stroke and two underwent surgical aortic valve re-intervention. Late PVE (> 365 days) occurred in six patients, of whom thee demonstrated evidence of embolic stroke and only one underwent surgical aortic valve re-intervention. Of the six patients with evidence of embolic stroke, two died, two were discharged to rehabilitation, and two were discharged home with home care. CONCLUSIONS:PVE was infrequent following TAVR in low-risk patients but was associated with substantial morbidity and mortality. Embolic stroke complicated the majority of PVE cases, contributing to worse outcomes in these patients. Efforts must be undertaken to minimize PVE in TAVR.
PMID: 34505737
ISSN: 1522-726x
CID: 5155502

Contemporary post-marketing adverse events and modes of failure related to VASCADE Vascular Closure System: The utility of the MAUDE database

Case, Brian C; Kumar, Sant; Medranda, Giorgio A; Yerasi, Charan; Forrestal, Brian J; Satler, Lowell F; Ben-Dor, Itsik; Hashim, Hayder; Bernardo, Nelson L; Rogers, Toby; Waksman, Ron
OBJECTIVES/OBJECTIVE:To analyze post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for the VASCADE Vascular Closure System (Cardiva Medical Inc., Santa Clara, CA). BACKGROUND:The VASCADE Vascular Closure System is a closure device for femoral arterial and venous access-site closure that was approved by the FDA in 2013. However, post-marketing data and experience on the most commonly reported complications and modes of failure associated with the VASCADE Vascular Closure System are limited. METHODS:Post-marketing surveillance data from the FDA MAUDE database from October 2013 through March 2020 were analyzed, yielding 201 reports. RESULTS:Of the 201 reports of major complications involving VASCADE devices, 156 reports involved either injury (145) or death (11) related to the device. Of the 145 injury reports, bleeding was the most common adverse outcome described (85), followed by pseudoaneurysm (29) and pulselessness of an extremity (21). The device malfunction incidents (41 reports) were reported in three main categories, with deployment failure being the most commonly reported complication. CONCLUSIONS:Our analysis of the MAUDE database demonstrates that in contemporary post-marketing practice, physicians should be well-trained and educated to use the VASCADE closure device because improper utilization is a common cause of device failure, and complications with the VASCADE device can have profound clinical implications.
PMID: 34480524
ISSN: 1522-726x
CID: 5155492

Exploiting the Transformation Temperature to Reform an Infolded Nitinol Self-Expanding Peripheral Stent

Medranda, Giorgio A; Forrestal, Brian J; Case, Brian C; Waksman, Ron; Bernardo, Nelson L
PURPOSE/UNASSIGNED:Nickel-titanium (nitinol) alloys possess a special set of properties that allow for a wide range of applications. Specifically, the transformation temperature for self-expanding nitinol peripheral stents allows for easy crimping at or below room temperature and reformation at body temperature becoming superelastic. CASE REPORT/UNASSIGNED:We report the case of an elderly man with iliac stenting 1 month prior, who presented several weeks after recovering from coronavirus disease 2019 with recurrent anterior-wall ST-elevation myocardial infarction. This was complicated by deformation and infolding of the previously implanted nitinol self-expanding stent in his right common iliac artery (CIA). Understanding nitinol's specific properties, we proceeded with rapid injections of iced saline to cool the nitinol stent to its transformation temperature while nudging the distal end of the stent with a partially inflated balloon. This maneuver softened the nitinol stent, allowing us to "unfold" and reappose it against the wall of the right CIA, resulting in successful restoration of the original shape of the nitinol self-expanding stent. CONCLUSION/UNASSIGNED:This represents the first reported case describing treatment of an infolded nitinol self-expanding peripheral stent by exploiting the transformation temperature of nitinol using iced cold saline to successfully restore the stent's original shape and structure.
PMID: 35018852
ISSN: 1545-1550
CID: 5155552