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Robotic Primary and Revisional Hiatal Hernia Repair is Safe and Associated with Favorable Perioperative Outcomes: A Single Institution Experience

Rodier, Simon; Henning, Justin; Kukreja, Janvi; Mohammedi, Taher; Shah, Paresh; Damani, Tanuja
PMID: 37417969
ISSN: 1557-9034
CID: 5539432

Best practice considerations on the assessment of robotic assisted surgical systems: results from an international consensus expert panel

Erskine, Jamie; Abrishami, Payam; Charter, Richard; Cicchetti, Americo; Culbertson, Richard; Faria, Eliney; Hiatt, Jo Carol; Khan, Jim; Maddern, Guy; Patel, Anita; Rha, Koon Ho; Shah, Paresh; Sooriakumaran, Prasanna; Tackett, Scott; Turchetti, Giuseppe; Chalkidou, Anastasia
BACKGROUND:Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS. METHODS:A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements. RESULTS:A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits. CONCLUSIONS:Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.
PMID: 37272397
ISSN: 1471-6348
CID: 5539852

Publisher Correction: Impact of type of minimally invasive approach on open conversions across ten common procedures in different specialties

Shah, Paresh C; de Groot, Alexander; Cerfolio, Robert; Huang, William C; Huang, Kathy; Song, Chao; Li, Yanli; Kreaden, Usha; Oh, Daniel S
PMID: 35212823
ISSN: 1432-2218
CID: 5175202

Impact of type of minimally invasive approach on open conversions across ten common procedures in different specialties

Shah, Paresh C; de Groot, Alexander; Cerfolio, Robert; Huang, William C; Huang, Kathy; Song, Chao; Li, Yanli; Kreaden, Usha; Oh, Daniel S
BACKGROUND:Conversion rates during minimally invasive surgery are generally examined in the limited scope of a particular procedure. However, for a hospital or payor, the cumulative impact of conversions during commonly performed procedures could have a much larger negative effect than what is appreciated by individual surgeons. The aim of this study is to assess open conversion rates during minimally invasive surgery (MIS) across common procedures using laparoscopic/thoracoscopic (LAP/VATS) and robotic-assisted (RAS) approaches. STUDY DESIGN/METHODS:Retrospective cohort study using the Premier Database on patients who underwent common operations (hysterectomy, lobectomy, right colectomy, benign sigmoidectomy, low anterior resection, inguinal and ventral hernia repair, and partial nephrectomy) between January 2013 and September 2015. ICD-9 and CPT codes were used to define procedures, modality, and conversion. Propensity scores were calculated using patient, hospital, and surgeon characteristics. Propensity-score matched analysis was used to compare conversions between LAP/VATS and RAS for each procedure. RESULTS:A total of 278,520 patients had MIS approaches of the ten operations. Conversion occurred in 5% of patients and was associated with a 1.77 day incremental increase in length of stay and $3441 incremental increase in cost. RAS was associated with a 58.5% lower rate of conversion to open surgery compared to LAP/VATS. CONCLUSION/CONCLUSIONS:At a health system or payer level, conversion to open is detrimental not just for the patient and surgeon but also puts a significant strain on hospital resources. Use of RAS was associated with less than half of the conversion rate observed for LAP/VATS.
PMID: 35141775
ISSN: 1432-2218
CID: 5167232

Acute Appendicitis During The COVID-19 Pandemic: A Multicenter, Retrospective Analysis From The US Epicenter

Tamirian, Richard; Klein, Michael; Chui, Patricia; Park, Julia; Frangos, Spiros; Shah, Paresh; Malino, Cris M K
BACKGROUND:Acute appendicitis (AA) is the most common surgical emergency, with a relatively stable yearly incidence. During the first wave of the COVID-19 pandemic, as New York City (NYC) emerged as the US epicenter, hospitals saw a marked reduction in patients presenting with non-COVID-related diseases. The objective of this study was to characterize the effects of the pandemic on the incidence, presentation, and management of AA. METHODS:A retrospective analysis of patients with AA who presented to two academic medical centers during the NYC COVID peak (March 22nd-May 31st, 2020) was performed. This group was compared to a control cohort presenting during the same period in 2019. Primary outcomes included the incidence of AA, complicated disease, and management. Secondary outcomes included duration of symptoms, hospital length of stay, and complication rates. Statistical analyses were performed using Mann-Whitney U, Chi-square, and Fisher's exact tests. RESULTS:< .02). Hospital length of stay and complication rates were similar between years. DISCUSSION/CONCLUSIONS:Significantly fewer AA patients presented during the initial phase of the pandemic. Patients presented later, which may have contributed to a higher proportion of complicated disease. Surgeons were also more likely to treat uncomplicated AA nonoperatively than they were prior. Further research is needed to understand the long-term consequences of these changes.
PMID: 35599614
ISSN: 1555-9823
CID: 5236402

Elective paraesophageal hernia repair in elderly patients: an analysis of ACS-NSQIP database for contemporary morbidity and mortality

Damani, Tanuja; Ray, Juliet J; Farag, Mahmoud; Shah, Paresh C
BACKGROUND:Elective paraesophageal hernia (PEH) repair in asymptomatic or minimally symptomatic patients ≥ 65 years of age remains controversial. The widely cited Markov Monte Carlo decision analytic model recommends watchful waiting in this group, unless the mortality rate for elective repair was to reach ≤ 0.5%; at which point, surgery would become the optimal treatment. We hypothesized that with advances in minimally invasive surgery, perioperative care, and practice specialization, that mortality threshold has been reached in the contemporary era. However, the safety net would decrease as age increases, particularly in octogenarians. METHODS:We identified 12,422 patients from the 2015-2017 ACS-NSQIP database, who underwent elective minimally invasive PEH repair, of whom 5476 (44.1%) were with age ≥ 65. Primary outcome was 30-day mortality. Secondary outcomes were length of stay (LOS), operative time, pneumonia, pulmonary embolism, unplanned intubation, sepsis, bleeding requiring transfusion, readmission, and return to OR. RESULTS:Patients age ≥ 65 had a higher 30-day mortality (0.5% vs 0.2%; p < 0.001). Subset analysis of patients age 65-80 and > 80 showed a 30-day mortality of 0.4% vs. 1.8%, respectively (p < 0.001). Independent predictors of mortality in patients ≥ 65 years were age > 80 (OR 5.23, p < 0.001) and COPD (OR 2.59, p = 0.04). Patients ≥ 65 had a slightly higher incidence of pneumonia (2% vs 1.2%; p < 0.001), unplanned intubation (0.8% vs 0.5%; p < 0.05), pulmonary embolism (0.7% vs 0.3%; p = 0.001), bleeding requiring transfusion (1% vs 0.5%; p < 0.05), and LOS (2.38 vs 1.86 days, p < 0.001) with no difference in sepsis, return to OR or readmission. CONCLUSION/CONCLUSIONS:This is the largest series evaluating elective PEH repair in the recent era. While morbidity and mortality do increase with age, the mortality remains below 0.5% until age 80. Our results support consideration for a paradigm shift in the management of patients < 80 years toward elective repair of PEH.
PMID: 33712938
ISSN: 1432-2218
CID: 4817222

International Delphi Expert Consensus on Safe Return to Surgical and Endoscopic Practice: From the Coronavirus Global Surgical Collaborative

Asbun, Horacio J; Abu Hilal, Mohammad; Kunzler, Filipe; Asbun, Domenech; Bonjer, Jaap; Conlon, Kevin; Demartines, Nicolas; Feldman, Liane S; Morales-Conde, Salvador; Pietrabissa, Andrea; Pryor, Aurora D; Schlachta, Christopher M; Sylla, Patricia; Targarona, Eduardo M; Agra, Yolanda; Besselink, Marc G; Callery, Mark; Cleary, Sean P; De La Cruz, Luis; Eckert, Philippe; Evans, Chad; Han, Ho-Seong; Jones, Daniel B; Gan, Tong Joo; Koch, Daniel; Lillemoe, Keith D; Lomanto, Davide; Marks, Jeffrey; Matthews, Brent; Mellinger, John; Melvin, William Scott; Moreno-Paquentin, Eduardo; Navarrete, Claudio; Pawlik, Timothy M; Pessaux, Patrick; Ricciardi, Walter; Schwaitzberg, Steven; Shah, Paresh; Szokol, Joseph; Talamini, Mark; Torres, Ricardo; Triboldi, Alessandro; Udomsawaengsup, Suthep; Valsecchi, Federica; Vauthey, Jean-Nicolas; Wallace, Michael; Wexner, Steven D; Zinner, Michael; Francis, Nader
OBJECTIVE:The aim of this work is to formulate recommendations based on global expert consensus to guide the surgical community on the safe resumption of surgical and endoscopic activities. BACKGROUND:The COVID-19 pandemic has caused marked disruptions in the delivery of surgical care worldwide. A thoughtful, structured approach to resuming surgical services is necessary as the impact of COVID-19 becomes better controlled. The Coronavirus Global Surgical Collaborative sought to formulate, through rigorous scientific methodology, consensus-based recommendations in collaboration with a multidisciplinary group of international experts and policymakers. METHODS:Recommendations were developed following a Delphi process. Domain topics were formulated and subsequently subdivided into questions pertinent to different aspects of surgical care in the COVID-19 crisis. Forty-four experts from 15 countries across 4 continents drafted statements based on the specific questions. Anonymous Delphi voting on the statements was performed in 2 rounds, as well as in a telepresence meeting. RESULTS:One hundred statements were formulated across 10 domains. The statements addressed terminology, impact on procedural services, patient/staff safety, managing a backlog of surgeries, methods to restart and sustain surgical services, education, and research. Eighty-three of the statements were approved during the first round of Delphi voting, and 11 during the second round. A final telepresence meeting and discussion yielded acceptance of 5 other statements. CONCLUSIONS:The Delphi process resulted in 99 recommendations. These consensus statements provide expert guidance, based on scientific methodology, for the safe resumption of surgical activities during the COVID-19 pandemic.
PMCID:8189258
PMID: 33630471
ISSN: 1528-1140
CID: 4923932

Incidence of acute postoperative robotic port-site hernias: results from a high-volume multispecialty center

Damani, Tanuja; James, Les; Fisher, Jason C; Shah, Paresh C
Fascial closure at 8-mm robotic port sites continues to be controversial. As the use of the robotic platform increases across multiple abdominal specialties, there are more case reports describing reoperation and small bowel resection for acute port-site hernias. A retrospective review of all robotic abdominal surgeries performed from 2012 to 2019 at NYU Langone Medical Center was conducted. Patients who had a reoperation in our facility within 30 days were identified, and medical records reviewed for indications for reoperation and findings. The study included 11,566 patients, of which 82 patients (0.71%) underwent a reoperation related to the index robotic surgery within 30 days. Fifteen of 11,566 patients (0.13%) had acute port-site hernias, and 3 of these 15 patients required small bowel resection. Eleven of 15 acute port-site hernias (73%) were at 8-mm robotic port site, 2 of which required a small bowel resection. More than a third of the patients had a hernia at an 8-mm port site where a surgical drain had been placed. Considering that each robotic case, regardless of specialty, has three ports at a minimum, the true incidence of acute postoperative robotic port-site hernia is 0.032% (11/34,698), with the incidence of concomitant small bowel resection being 0.006% (2/34,698). The incidence of acute port-site hernias from 8-mm robotic ports is exceedingly low across specialties. Our results do not support routine fascial closure at 8-mm robotic port sites due to an extremely low incidence. However, drain sites require special consideration.
PMID: 32710254
ISSN: 1863-2491
CID: 4539892

Hyperlipasemia in absence of acute pancreatitis is associated with elevated D-dimer and adverse outcomes in COVID 19 disease

Ahmed, Awais; Fisher, Jason C; Pochapin, Mark B; Freedman, Steven D; Kothari, Darshan J; Shah, Paresh C; Sheth, Sunil G
BACKGROUND:Coronavirus SARS-CoV-2 affects multiple organs. Studies have reported mild elevations of lipase levels of unclear significance. Our study aims to determine the outcomes in patients with COVID-19 and hyperlipasemia, and whether correlation with D-dimer levels explains the effect on outcomes. METHODS:Case-control study from two large tertiary care health systems, of patients with COVID-19 disease admitted between March 1 and May 1, 2020 who had lipase levels recorded. Data analyzed to study primary outcomes of mortality, length of stay (LOS) and intensive care utilization in hyperlipasemia patients, and correlation with D-dimer and outcomes. RESULTS:992 out of 5597 COVID-19 patients had lipase levels, of which 429 (43%) had hyperlipasemia. 152 (15%) patients had a lipase > 3x ULN, with clinical pancreatitis in 2 patients. Hyperlipasemia had a higher mortality than normal lipase patients (32% vs. 23%, OR = 1.6,95%CI = 1.2-2.1, P = 0.002). In subgroup analysis, hyperlipasemia patients had significantly worse LOS (11vs.15 days, P = 0.01), ICU admission rates (44% vs. 66%,OR = 2.5,95%CI = 1.3-5.0,P = 0.008), ICU LOS (12vs.19 days,P = 0.01), mechanical ventilation rates (34% vs. 55%,OR = 2.4,95%CI = 1.3-4.8,P = 0.01), and durations of mechanical ventilation (14 vs. 21 days, P = 0.008). Hyperlipasemia patients were more likely to have a D-dimer value in the highest two quartiles, and had increased mortality (59% vs. 15%,OR = 7.2,95%CI = 4.5-11,P < 0.001) and LOS (10vs.7 days,P < 0.001) compared to those with normal lipase and lower D-dimer levels. CONCLUSION/CONCLUSIONS:There is high prevalence of hyperlipasemia without clinical pancreatitis in COVID-19 disease. Hyperlipasemia was associated with higher mortality and ICU utilization, possibly explained by elevated D-dimer.
PMCID:7929790
PMID: 33741267
ISSN: 1424-3911
CID: 4836642

Narrative review of laparoscopic management of hepatic cysts

Shah, Paresh C.
Hepatic cysts are a common and often asymptomatic finding. In this review we will discuss the diagnosis and treatment of hepatic cysts with a specific focus on minimally invasive surgical approaches. Most simple cysts are asymptomatic and do not require intervention. As cysts increase in size they may cause a range of symptoms including satiety, fullness, a palpable mass, and rarely bleeding or secondary infection. Surgical approaches are reserved for symptomatic lesions, and hydatid disease. It is important to rule out bacterial infection (abscess) and neoplasm in the work up of hepatic cysts. While cysts are often detected by ultrasound, Computed tomography and Magnetic Resonance Imaging are the primary modes of assessment for these lesions. Most cysts can be managed by unroofing or marsupialization alone, with formal liver resection rarely required. Minimally invasive surgery (MIS) techniques have been described for many years including laparoscopic and recently, robotic approaches. Hydatid cysts require special attention to control of contents to avoid anaphylaxis but can also be managed laparoscopically. Laparoscopic and/or robotic surgery can be performed safely and is effective in the treatment of cystic disease of the liver. Mortality should be below 1%, and overall morbidity less than 10%. Recurrence rates for simple cysts are generally below 10%, however polycystic liver disease (PLD) does have a higher recurrence rate after marsupialization than simple cysts.
SCOPUS:85110242345
ISSN: 2616-4221
CID: 4964032